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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop S2-26-12 Baltimore, MD 21244-1850
July 31, 2026
Steve Ford Medicaid Director Virginia Department of Medical Assistance Services 600 E Broad St Richmond, VA 23219
Dear Director Ford,
The Centers for Medicare & Medicaid Services (CMS) is approving the Commonwealth of Virginia’s request to renew its Medicaid section 1115(a) demonstration entitled, “Building and Transforming Coverage, Services, and Supports for a Healthier Virginia” (BTCSSHV) (Project Number 11-W-00297/3), in accordance with section 1115(a) of the Social Security Act (the Act). This approval is effective August 1, 2026 through December 31, 2031 upon which date, unless renewed or otherwise amended, all authorities granted to operate this demonstration will expire.
CMS has determined that the Building and Transforming Coverage, Services, and Supports for a Healthier Virginia (BTCSSHV) section 1115(a) demonstration is likely to assist in promoting the objectives of the Medicaid statute by increasing access to high-quality, clinically appropriate treatment to beneficiaries with a substance use disorder (SUD) and/or serious mental illness (SMI) while they are short-term residents in residential and inpatient treatment settings that qualify as an Institution for Mental Diseases (IMD). This approval is in alignment with both State Medicaid Director Letter #17-003 RE: Strategies to Address the Opioid Epidemic1 and SMDL #18-011: Opportunities to Design Innovative Service Delivery Systems for Adults with a Serious Mental Illness or Children with a Serious Emotional Disturbance2 and will continue the SUD authority from the 2019 demonstration approval.
CMS’s approval of this section 1115(a) demonstration is subject to the limitations specified in the attached expenditure authorities, special terms and conditions (STCs), and any supplemental attachments defining the nature, character, and extent of federal involvement in this project. The state may deviate from the Medicaid state plan requirements only to the extent those requirements have been specifically listed as waived or not applicable to expenditures under the demonstration.
Program Integrity
1 SMDL #17-003: https://www.medicaid.gov/federal-policy-guidance/downloads/smd17003.pdf 2SMDL #18-011: https://www.medicaid.gov/sites/default/files/federal-policy-guidance/downloads/smd18011.pdf
Page 2 – Steve Ford States are responsible for following all applicable federal law and regulations when they claim and use federal Medicaid funds and must fully comply with all applicable Medicaid statutes and regulations under a section 1115 demonstration, except where specific provisions have been expressly waived or identified as not applicable for that demonstration. This obligation includes all requirements in Title XIX of the Social Security Act and implementing regulations governing provider screening and enrollment activities, pre- and post-payment review claiming, payment methodologies and rate-setting, utilization controls, and program integrity including processes to identify, investigate, and refer suspected fraud, and methods to receive complaints and identify questionable practices. States must maintain effective systems and safeguards to prevent, detect, and address any fraud, waste, or abuse (FWA) in the delivery of and payment for Medicaid services, including referrals to law enforcement when appropriate. States should have heightened monitoring and oversight mechanisms in place featuring robust internal controls to identify and remediate all vulnerabilities (including, but not limited to, FWA and beneficiary access issues) inherent in service areas approved as part of a demonstration. At any time, CMS may request that the state provide a plan detailing the state’s systems and safeguards to prevent, detect, and address any FWA relative to this demonstration. Failure to meet program integrity obligations under federal statutes and regulations or under the terms and conditions of this demonstration approval may result in compliance actions or other enforcement measures that could include requirements to develop and implement corrective action plans, withholdings, deferrals, disallowances, and termination of demonstration authority. Extent and Scope of Demonstration Renewal and Amendment With this renewal approval, under the demonstration, Virginia will continue to provide authority for SUD treatment services to individuals who are short-term residents in residential treatment facilities that meet the definition of an IMD and extend eligibility for Medicaid benefits for out of state former foster care youth (FFCY) who are under age 26, who turned age 18 on or before December 31, 2022, who aged out of foster care under the responsibility of another state or tribe and were enrolled in Medicaid while in foster care, currently reside in Virginia, and are not otherwise eligible for Medicaid. Section 1002(a) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act, Pub L. No. 115-271), created a new Former Foster Care Children (FFCC) Medicaid state plan eligibility group, providing coverage for individuals who were receiving Medicaid while in foster care under the responsibility of any state; however, the new requirements apply exclusively to those who turn 18 on or after January 1, 2023. As a result, Virginia will still need section 1115 demonstration authority to continue coverage for individuals who turned 18 years old before January 1, 2023. Additionally, this approval will sunset the expenditure authority for the High Needs Supports component of the demonstration that was not implemented. This approval will amend the demonstration to add the SMI demonstration initiative, to allow Virginia to receive federal financial participation (FFP) for services furnished to Medicaid beneficiaries during short term stays for acute care in psychiatric hospitals or residential treatment facilities that qualify as IMDs. The SMI component of the amendment will expand the settings which are eligible for reimbursement for clinically appropriate short term stays for acute
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psychiatric care via psychiatric inpatient treatment and residential crisis stabilization, to include IMDs. Beneficiaries served in IMDs will have access to a full set of Medicaid benefits and will be subject to the same medical necessity requirements. Virginia would not reimburse for stays of more than 60 consecutive days and will maintain an average length of stay of 30 days or less across all applicable settings for eligible members. All Virginia Medicaid beneficiaries eligible for a mandatory or optional eligibility group receiving full Medicaid coverage, and between the ages of 21-64, will be eligible for acute inpatient stays in an IMD. Budget Neutrality
This demonstration project is being renewed and amended using CMS’s current approach to determining budget neutrality as described in CMS SMDL #24-003.3 However, CMS acknowledges that section 71118 of subchapter C of chapter 1 of subtitle B of title VII of Public Law 119-21, which CMS refers to as the Working Families Tax Cuts legislation, adds a new subsection (g) to section 1115 of the Act with budget neutrality requirements that will apply beginning January 1, 2027 to CMS approvals of section 1115 Medicaid demonstration project applications, renewals, or amendments.4 CMS issued state Medicaid Director Letter #26-0035 on June 11, 2026 to provide states with early notice regarding the changes to budget neutrality that CMS intends to propose to implement section 1115(g) of the Act, and expects to provide additional guidance to states on implementation of this provision.
Under SMDL #24-003, as a condition of demonstration approval, demonstrations must be “budget neutral,” meaning the federal costs of the state’s Medicaid program with the demonstration cannot exceed what the federal government’s Medicaid costs likely would have been in that state absent the demonstration.6 The demonstration renewal is projected to be budget neutral to the federal government. In practice, budget neutrality generally means that the total computable (i.e., both state and federal) costs for approved demonstration expenditures are limited to a certain amount for the demonstration approval period. This limit is called the budget neutrality expenditure limit and is based on a projection of the Medicaid expenditures that could have occurred absent the demonstration (the “without waiver” [WOW] costs). The state will be held to the budget neutrality monitoring and general financial requirements as outlined in the STCs.
Rebasing Without Waiver Baselines Under this demonstration, for existing Medicaid Expenditure Groups (MEGs) that were implemented, CMS calculated the WOW baseline by using a weighted average of the state’s historical WOW per-member-per-month (PMPM) baseline and its recent actual PMPM costs. The projected demonstration expenditures associated with each MEG in the WOW baseline (except MEGs with aggregate cost limits) have been trended forward using the President’s Budget trend rate to determine the maximum expenditure authority for the new approval period.
3 https://www.medicaid.gov/federal-policy-guidance/downloads/smd24003.pdf 4 https://www.congress.gov/bill/119th-congress/house-bill/1/text 5 https://www.medicaid.gov/federal-policy-guidance/downloads/smd26003.pdf 6 https://www.medicaid.gov/medicaid/section-1115-demonstrations/budget-neutrality/index.html
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Using the President’s Budget trend rate aligns the demonstration trend rate with federal budgeting principles and assumptions.
Hypothetical Budget Neutrality Treatment Under its current approach to budget neutrality, CMS generally treats expenditures for populations or services which could have otherwise been covered via the Medicaid state plan, or other title XIX authority, such as a section 1915 waiver, as “hypothetical” for the purposes of budget neutrality. In these cases, CMS adjusts budget neutrality to account for the spending which the state could have hypothetically provided through the Medicaid state plan or other title XIX authority. CMS does not, however, currently allow for budget neutrality savings accrual as a result of including hypothetical populations or services in section 1115 demonstration projects. To allow for hypothetical expenditures, while preventing them from resulting in savings, CMS currently applies a separate, independent budget neutrality “supplemental test” for hypothetical expenditures. These supplemental budget neutrality tests subject the hypothetical expenditures to pre-determined limits to which the state and CMS agree, and that CMS approves, during negotiations. If the state’s “with waiver” (WW) hypothetical spending exceeds the supplemental test’s expenditure limit, the state agrees (as a condition of CMS approval) to offset that excess spending with savings elsewhere in the demonstration or to refund the FFP to CMS.
The SMI MEG will be treated as hypothetical for budget neutrality purposes. For each of these MEGs, CMS calculated the WOW baseline (which refers to the projected expenditures that could have occurred absent the demonstration and which is the basis for the budget neutrality expenditure limit for each approval period). The projected demonstration expenditures associated with each of these MEGs in the WOW baseline have been trended forward using the President’s Budget trend rate to determine the maximum expenditure authority for the new approval period. Using the President’s Budget trend rate aligns the demonstration trend rate with federal budgeting principles and assumptions.
CMS has deemed this renewal of the FFCY demonstration to be budget neutral because the demonstration authority to cover the FFCY population is needed for only a temporary period, through 2030, when all FFCY will be covered via the Medicaid state plan FFCC population. Further, through monitoring budget neutrality, CMS determined that the actual experience of states’ covering out-of-state FFCY resulted in limited total expenditures and low enrollment within the demonstrations. CMS generally believes that this FFCY demonstration coverage poses minimal financial risk to the federal government since FFCY demonstration spending is miniscule across states. This decision will increase the administrative ease of maintaining FFCY demonstration coverage in Virginia.
The state will be required to report total expenditures and member months in its demonstration monitoring reports. The state must still report quarterly claims and report expenditures on the CMS 64.9 WAIVER form. Failure to report FFCY expenditures and member months will result in reinstatement of the budget neutrality requirement.
Mid-Course Correction CMS has included a mid-course correction STC in this demonstration approval to provide flexibility and stability for the state over the life of a demonstration. This update identifies a list
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of circumstances under which a state’s baseline may be adjusted based on actual expenditure data to accommodate circumstances that are either out of the state’s control (for example, if expensive new drugs that the state is required to cover enter the market); and/or the effect is not a condition or consequence of the demonstration (for example, unexpected costs due to a public health emergency); and/or the new expenditure (while not a new demonstration-covered service or population that would require the state to propose an amendment to the demonstration) is likely to further strengthen access to care (for example, a legislated increase in provider rates). CMS also explains in the STCs what data and other information the state should submit to support a potentially approvable request for an adjustment.
Monitoring and Evaluation
Consistent with the demonstration STCs, the state submitted the Interim Evaluation Report for the prior demonstration approval period with the renewal application.7 The report evaluated demonstration performance from January 2020 through December 20228 but also included data from the initial demonstration approval period (January 2015 through December 2019) to provide context for demonstration performance in the subsequent approval period against the backdrop of events like the COVID-19 Public Health Emergency and Medicaid expansion. Findings in this report are in support of several demonstration goals and corresponding hypotheses, particularly those associated with increases in access to and utilization of SUD services. For example, the percentage of members with opioid use disorders who received medication for opioid use disorder treatment increased from 43 percent in 2016 to 78 percent in 2022. Additionally, the number of Medicaid members using any addiction and recovery treatment service (ARTS) per 100,000 members increased from 864 in 2017 to 2,911 in 2022. The Interim Evaluation Report also identified opportunities for improvement, for example, in SUD related emergency department visits and inpatient admissions. However, monitoring data through the end of 2024 showed steady decreases in SUD related emergency department visits relative to 2022. Monitoring data from 2023 and 2024 also suggests continued trends of increased access to and utilization of SUD services. For the FFCY policy in the demonstration, the demonstration findings suggest progress toward the demonstration goal that beneficiaries are able to maintain Medicaid coverage and utilize services.
With this renewal of the demonstration, which newly authorizes the SMI program as well, the state is required to continue conducting systematic monitoring and evaluation of the demonstration, consistent with the requirements in the STCs and applicable CMS guidance. In collaboration with CMS, the state must undertake demonstration monitoring, including reporting of relevant metrics data and narrative details describing progress with implementation of all components of the demonstration. The state must conduct an independent mid-point assessment of the SUD and SMI programs, which will help identify any necessary mitigation strategies to ensure ongoing progress toward the SUD and SMI program milestones and goals. Additionally, the state is required to conduct an evaluation of the demonstration to support a comprehensive assessment of whether the demonstration components are effective in producing the desired
7 The Interim Evaluation Report is available on Medicaid.gov: https://www.medicaid.gov/medicaid/section-1115- demonstrations/downloads/va-gov-access-plan-gap-sud-interim-evltn-rpt-06122025.pdf. 8 The draft Interim Evaluation Report was first submitted to CMS on January 23, 2024, and due to the state’s claims lag and the necessary time to conduct the evaluation, included data through the end of 2022.
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outcomes for its beneficiaries. To support the evaluation, the state is required to develop a robust Evaluation Design, including reframing and refocusing as needed the evaluation hypotheses and research questions for policies being extended to account for areas it can reasonably expect continued improvements.
Consideration of Public Comments
The federal comment period for the BTCSSHV demonstration renewal application was open from August 5, 2024, through September 4, 2024, and CMS received two comments that were applicable to the demonstration. Both comments were supportive of Virginia’s demonstration renewal, focusing on the state’s request to maintain coverage for SUD services at facilities classified as an IMD.
The federal comment period for the SMI amendment application was open from January 16, 2025, through February 15, 2025, and CMS received four comments. All four comments were supportive of the state’s request to add the SMI opportunity to the demonstration. One commentor urged the state to incorporate Medicaid coverage of inpatient psychiatric services for individuals under the age of 21 into its SMI program.
CMS has concluded that renewing the BTCSSHV Section 1115(a) demonstration is likely to promote the objectives of Medicaid.
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Other Information
CMS’s approval of this renewal and amendment is conditioned upon compliance with the enclosed set of expenditure authorities and the STCs defining the nature, character, and extent of anticipated federal involvement in the demonstration. The award is subject to CMS receiving written acceptance of this award within 30 days of the date of this approval letter. Your project officer for this demonstration is Anisha Truitt-Joyner, who is available to answer any questions concerning your section 1115 demonstration and her contact information is as follows:
Centers for Medicare & Medicaid Services Center for Medicaid and CHIP Services Mail Stop: S2-25-26
7500 Security Boulevard
Baltimore, MD 21244-1850
Email: anisha.truittjoyner@cms.hhs.gov
If you have any questions regarding this approval, please contact Sarah Aker, Acting Director, State Demonstrations Group, Center for Medicaid and CHIP Services, at Sarah. Aker@cms.hhs. gov.
Sincerely,
Dan Brillman Deputy Administrator, CMS Director, Center for Medicaid and CHIP Services
Enclosures
cc: Margaret Kosherzenko, State Lead, Medicaid and CHIP Operations Group
Building and Transforming Coverage, Services and Supports for a Healthier Virginia Approval Period: August 1, 2026 through December 31, 2031 Page 1 of 51
CENTERS FOR MEDICARE & MEDICAID SERVICES EXPENDITURE AUTHORITY
NUMBER: 11-W-00297/3
TITLE: Building and Transforming Coverage, Services, and Supports for a Healthier Virginia Section 1115(a) Demonstration
AWARDEE: Virginia Department of Medical Assistance Services (DMAS)
Under the authority of section 1115(a)(2) of the Social Security Act (“the Act”), expenditures made by Virginia for the items identified below, which are not otherwise included as expenditures under section 1903 of the Act shall, for the period from August 1, 2026 through December 31, 2031, unless otherwise specified, be regarded as expenditures under the state’s title XIX plan. All requirements of the Medicaid statute will be applicable to such expenditure authorities.
The following expenditures authorities may only be implemented consistent with the approved Special Terms and Conditions (STC) and shall enable Virginia to operate the above-identified section 1115(a) demonstration.
Title XIX Expenditure Authority
1. Residential and Inpatient Treatment for Individuals with Substance Use Disorder (SUD). Expenditures for Medicaid state plan services furnished to otherwise eligible individuals who are primarily receiving treatment and/or withdrawal management services for substance use disorder (SUD) who are short-term residents in facilities that meet the definition of an institution of mental diseases (IMD).
2. Residential and Inpatient Treatment for Individuals with Serious Mental Illness (SMI) or Serious Emotional Disturbance (SED). Expenditures for Medicaid state plan services furnished to otherwise eligible individuals who are primarily receiving treatment for a serious mental illness (SMI) or serious emotional disturbance (SED) who are short- term residents in facilities that meet the definition of an institution for mental diseases (IMD).
3. Expenditures related to Former Foster Care Youth. Expenditures to extend eligibility for full Medicaid state plan benefits to former foster care youth (FFCY) who are under age 26, who turned 18 on or before December 31, 2022, who were in foster care under the responsibility of another state or tribe in such other state on the date of attaining 18 years of age (or such higher age as the state has elected for termination of Federal foster care assistance under title IV-E of the Act), were enrolled in Medicaid at any time during the foster care period in which they aged out of foster care, and are now applying for Medicaid in Virginia.
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CENTERS FOR MEDICARE & MEDICAID SERVICES SPECIAL TERMS AND CONDITIONS
NUMBER: 11-W-00297/3
TITLE: Building and Transforming Coverage, Services, and Supports for a Healthier Virginia Section 1115(a) Demonstration
AWARDEE: Virginia DMAS
I. PREFACE The following are the Special Terms and Conditions (STC) for the “Building and Transforming Coverage, Services, and Supports for a Healthier Virginia” (BTCSSHV) section 1115(a) Medicaid demonstration (hereinafter “demonstration”), to enable the Commonwealth of Virginia DMAS (referred to herein as the “state”) to operate this demonstration. The Centers for Medicare & Medicaid Services (CMS) has granted expenditure authorities authorizing federal matching of demonstration costs not otherwise matchable, which are separately enumerated. These STCs set forth conditions and limitations on those expenditure authorities, and describe in detail the nature, character, and extent of federal involvement in the demonstration and the state’s obligations to CMS related to the demonstration. These STCs neither grant additional expenditure authorities, nor expand upon those separately granted. The STCs related to the programs for those populations affected by the demonstration are effective from August 1, 2026, through December 31, 2031, unless otherwise specified.
The STCs have been arranged into the following subject areas:
I. Preface II. Program Description and Objectives III. General Program Requirements IV. Eligibility and Enrollment V. Substance Use Disorder (SUD) Program and Benefits VI. Serious Mental Illness (SMI)/Serious Emotional Disturbance (SED) Program and Benefits VII. Cost Sharing VIII. Delivery System IX. Monitoring and Reporting Requirement X. General Financial Requirements XI. Monitoring Budget Neutrality for the Demonstration XII. Evaluation of the Demonstration XIII. Schedule of Deliverables for the Demonstration Period
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Additional attachments have been included to provide supplementary information and guidance for specific STCs.
Attachment A: Evaluation Design (Reserved) Attachment B: SUD Implementation Plan (Reserved) Attachment C: SMI/SED Implementation Plan (Reserved)
II. PROGRAM DESCRIPTION AND OBJECTIVES
Virginia’s BTCSSHV section 1115 demonstration provides authority for substance use disorder (SUD) treatment services to individuals who are short term residents in residential treatment facilities that meet the definition of an Institution for Mental Diseases (IMD); and extend Medicaid eligibility for former foster care youth (FFCY) under age 26 who aged out of foster care in another state or tribe and currently reside in Virginia.
In July 2020, CMS approved an amendment to the demonstration for the High Needs Support component to provide certain otherwise allowable 1915(i) state plan amendment (SPA) services, including: housing and employment supports Home and Community Based Services (HCBS) for Medicaid beneficiaries age 18 or older who were eligible under the Medicaid state plan and enrolled in the managed care delivery system and for those who were eligible under the out-of- state FFCY component of the demonstration age 18 up to 26 and enrolled in the managed care delivery system, and who met specific needs based criteria and risk factors.
On July 31, 2026, CMS approved a five-year renewal of the demonstration to allow Virginia to continue the existing demonstration authorities, which provide authority for SUD treatment services to individuals who are short-term residents in residential treatment facilities that meet the definition of an institution for mental diseases in an IMD and extend eligibility for full Medicaid state plan benefits to individuals who qualify as “out-of-state FFCY”, meaning individuals who are under age 26 and who turned age 18 on or before December 31, 2022, who aged out of foster care under the responsibility of another state or tribe, were enrolled in Medicaid while in foster care, currently reside in Virginia. The renewal will also remove the High Needs Support component of the demonstration because the state did not implement these services.
Lastly, CMS approved an amendment to add the SMI/SED demonstration opportunity to allow the state to receive federal financial participation (FFP) for services furnished to Medicaid beneficiaries during short term stays for acute care in psychiatric hospitals or residential treatment facilities that qualify as IMDs. The state will maintain and enhance access to mental health services, opioid use disorder (OUD) and other substance use disorder (SUD) services and continue delivery system improvements for these services to provide more coordinated and comprehensive treatment of Medicaid beneficiaries with SUD, serious mental illness (SMI), or serious emotional disturbance (SED). This demonstration will provide the state with authority to provide high-quality, clinically appropriate treatment to beneficiaries with SUD, SMI, or SED while they are short-term residents in residential and inpatient treatment settings that qualify as
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an IMD. It will also support state efforts to enhance provider capacity, improve the availability of Medication Assisted Treatment (MAT), and improve access to a continuum of SUD, SMI, or SED evidence-based services at varied levels of intensity, including withdrawal management services.
During the demonstration period, the state seeks to achieve the following goals:
FFCY Goals: The objectives of the FFCY demonstration component are to increase and strengthen overall coverage of former foster care youth and improve health outcomes for this population.
SUD Goals:
SMI/SED Goals:
1 Reduce utilization and lengths of stay in EDs among beneficiaries with SMI or SED while awaiting mental health treatment in specialized settings 2 Reduce preventable readmissions to acute care hospitals and residential settings 3 Improve availability of crisis stabilization services including services made available through call centers and mobile crisis units, intensive outpatient services, as well as services provided during acute short-term stays in residential crisis stabilization programs, psychiatric hospitals, and residential treatment settings throughout the state 4 Improve access to community-based services to address the chronic mental health care needs of beneficiaries with SMI or SED including through increased integration of primary and behavioral health care 5 Improve care coordination, especially continuity of care in the community following episodes of acute care in hospitals and residential treatment facilities
III. GENERAL PROGRAM REQUIREMENTS
1. Compliance with Federal Non-Discrimination Statutes. The state must comply with all applicable federal statutes relating to non-discrimination. These include, but are not limited to, the Americans with Disabilities Act of 1990 (ADA), Title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act of 1973 (Section 504), the Age 1 Increase rates of identification, initiation, and engagement in treatment for SUD 2 Increase adherence to and retention in treatment 3 Reduce overdose deaths, particularly those due to opioids 4 Reduce utilization of emergency departments and inpatient hospital settings for treatment where the utilization is preventable or medically inappropriate through improved access to other continuum of care services 5 Fewer readmissions to the same or higher level of care where the readmission is preventable or medically inappropriate 6 Improve access to care for physical health conditions among beneficiaries with SUD
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Discrimination Act of 1975, and section 1557 of the Patient Protection and Affordable 0Care Act (Section 1557). 2. Compliance with Medicaid and Children’s Health Insurance Program (CHIP) Law, Regulation, and Policy. All requirements of the Medicaid and CHIP programs expressed in federal law, regulation, and policy statement, not expressly waived or identified as not applicable in the expenditure authority document (of which these terms and conditions are part), apply to the demonstration. 3. Changes in Medicaid and CHIP Law, Regulation, and Policy. The state must, within the timeframes specified in federal law, regulation, or written policy, come into compliance with changes in law, regulation, or policy affecting the Medicaid or CHIP programs that occur during this demonstration approval period, unless the provision being changed is expressly waived or identified as not applicable. In addition, CMS reserves the right to amend the STCs to reflect such changes and/or changes as needed without requiring the state to submit an amendment to the demonstration under STC 7. CMS will notify the state 30 business days in advance of the expected approval date of the amended STCs to allow the state to provide comment. Changes will be considered in force upon issuance of the approval letter by CMS. The state must accept the changes in writing. 4. Impact on Demonstration of Changes in Federal Law, Regulation, and Policy. a. To the extent that a change in federal law, regulation, or policy requires either a reduction or an increase in federal financial participation (FFP) for expenditures made under this demonstration, the state must adopt, subject to CMS approval, a modified budget neutrality agreement for the demonstration as necessary to comply with such change, as well as a modified allotment neutrality worksheet as necessary to comply with such change. The trend rates for the budget neutrality agreement are not subject to change under this subparagraph. Further, the state may seek an amendment to the demonstration (as per STC 7 of this section) as a result of the change in FFP. b. If mandated changes in the federal law require state legislation, unless otherwise prescribed by the terms of the federal law, the changes must take effect on the earlier of the day such state legislation becomes effective, or on the last day such legislation was required to be in effect under the law, whichever is sooner.
5. State Plan Amendments. The state will not be required to submit title XIX or XXI state plan amendments (SPA) for changes affecting any populations made eligible solely through the demonstration. If a population eligible through the Medicaid or CHIP state plan is affected by a change to the demonstration, a conforming amendment to the appropriate state plan is required, except as otherwise noted in these STCs. In all such cases, the Medicaid and CHIP state plans govern.
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6. Changes Subject to the Amendment Process. Changes related to eligibility, enrollment, benefits, beneficiary rights, delivery systems, cost sharing, sources of non- federal share of funding, budget neutrality, and other comparable program elements must be submitted to CMS as amendments to the demonstration. All amendment requests are subject to approval at the discretion of the Secretary in accordance with section 1115 of the Act. The state must not implement changes to these elements without prior approval by CMS either through an approved amendment to the Medicaid or CHIP state plan or amendment to the demonstration. Amendments to the demonstration are not retroactive and no FFP of any kind, including for administrative or medical assistance expenditures, will be available under changes to the demonstration that have not been approved through the amendment process set forth in STC 7, except as provided in STC 3. 7. Amendment Process. Requests to amend the demonstration must be submitted to CMS for approval no later than 120 calendar days prior to the planned date of implementation of the change and may not be implemented until approved. CMS reserves the right to deny or delay approval of a demonstration amendment based on non-compliance with these STCs, including but not limited to the failure by the state to submit required elements of a complete amendment request as described in this STC, and failure by the state to submit required reports and other deliverables according to the deadlines specified therein. Amendment requests must include, but are not limited to, the following: a. An explanation of the public process used by the state, consistent with the requirements of STC 12. Such explanation must include a summary of any public feedback received and identification of how this feedback was addressed by the state in the final amendment request submitted to CMS; b. A detailed description of the amendment, including impact on beneficiaries, with sufficient supporting documentation; c. A data analysis which identifies the specific “with waiver” impact of the proposed amendment on the current budget neutrality agreement. Such analysis shall include current total computable “with waiver” and “without waiver” status on both a summary and detailed level through the current approval period using the most recent actual expenditures, as well as summary and detailed projections of the change in the “with waiver” expenditure total as a result of the proposed amendment, which isolates (by Eligibility Group) the impact of the amendment; d. An up-to-date CHIP allotment worksheet, if necessary;
e. The state must provide updates to existing demonstration reporting and quality and evaluation plans. This includes a description of how the evaluation design and monitoring reports will be modified to incorporate the amendment provisions, as well as the oversight, monitoring and measurement of the provisions.
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8. Extension of the Demonstration. States that intend to request an extension of the demonstration must submit an application to CMS from the Governor of the state in accordance with the requirements of 42 CFR 431.412(c). States that do not intend to request an extension of the demonstration beyond the period authorized in these STCs must submit a phase-out plan consistent with the requirements STC 9. 9. Demonstration Phase- Out. The state may only suspend or terminate this demonstration in whole, or in part, consistent with the following requirements. a. Notification of Suspension or Termination. The state must promptly notify CMS in writing of the reason(s) for the suspension or termination, together with the effective date and a transition and phase-out plan. The state must submit a notification letter and a draft transition and phase-out plan to CMS no less than six months before the effective date of the demonstration’s suspension or termination. Prior to submitting the draft transition and phase-out plan to CMS, the state must publish on its website the draft transition and phase-out plan for a 30-day public comment period. In addition, the state must conduct tribal consultation in accordance with STC 12, if applicable. Once the 30-day public comment period has ended, the state must provide a summary of the issues raised by the public during the comment period and how the state considered the comments received when developing the revised transition and phase-out plan. b. Transition and Phase-out Plan Requirements. The state must include, at a minimum, in its phase-out plan the process by which it will notify affected beneficiaries, the content of said notices (including information on the beneficiary’s appeal rights), the process by which the state will conduct redeterminations of Medicaid or CHIP eligibility prior to the termination of the demonstration for the affected beneficiaries, and ensure ongoing coverage for eligible beneficiaries, as well as any community outreach activities the state will undertake to notify affected beneficiaries, including community resources that are available. c. Transition and Phase-out Plan Approval. The state must obtain CMS approval of the transition and phase-out plan prior to the implementation of transition and phase-out activities. Implementation of transition and phase-out activities must be no sooner than 14 calendar days after CMS approval of the transition and phase-out plan. d. Transition and Phase-out Procedures. The state must redetermine eligibility for all affected beneficiaries in order to determine if they qualify for Medicaid eligibility under a different eligibility category prior to making a determination of ineligibility as required under 42 CFR 435.916(d)(1). For individuals determined ineligible for Medicaid and CHIP, the state must determine potential eligibility for other insurance affordability programs and comply with the procedures set forth in 42 CFR 435.1200(e). The state must comply with all applicable advance notice requirements and fair hearing rights described at 42 CFR, 431, Subpart E. If a beneficiary in the demonstration requests a hearing before the date of action, the state must maintain benefits as required in 42 CFR 431.230.
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e. Exemption from Public Notice Procedures, 42 CFR Section 431.416(g). CMS may expedite the federal and state public notice requirements under circumstances described in 42 CFR Section 431.416(g). f. Enrollment Limitation during Demonstration Phase-Out. If the state elects to suspend, terminate, or not extend this demonstration, during the last six months of the demonstration, enrollment of new individuals into the demonstration must be suspended. The limitation of enrollment into the demonstration does not impact the state’s obligation to determine Medicaid eligibility in accordance with the approved Medicaid state plan. g. Federal Financial Participation (FFP). If the project is terminated or any relevant waivers are suspended by the state, FFP must be limited to normal closeout costs associated with the termination or expiration of the demonstration including services, continued benefits as a result of beneficiaries’ appeals, and administrative costs of disenrolling beneficiaries. 10. Withdrawal of Waiver or Expenditure Authority. CMS reserves the right to withdraw waivers and/or expenditure authorities at any time it determines that continuing the waiver or expenditure authorities would no longer be in the public interest or promote the objectives of title XIX and title XXI. CMS will promptly notify the state in writing of the determination and the reasons for the withdrawal, together with the effective date, and afford the state an opportunity to request a hearing to challenge CMS’s determination prior to the effective date. If a waiver or expenditure authority is withdrawn, FFP is limited to normal closeout costs associated with terminating the waiver or expenditure authority, including services, continued benefits as a result of beneficiary appeals, and administrative costs of disenrolling beneficiaries. 11. Adequacy of Infrastructure. The state must ensure the availability of adequate resources for implementation and monitoring of the demonstration, including education, outreach, and enrollment; maintaining eligibility systems; compliance with cost sharing requirements; and reporting on financial and other demonstration components. 12. Public Notice, Tribal Consultation, and Consultation with Interested Parties. The state must comply with the state notice procedures as required in 42 CFR section 431.408 prior to submitting an application to extend the demonstration. For applications to amend the demonstration, the state must comply with the state notice procedures set forth in 59 Fed. Reg. 49249 (September 27, 1994) prior to submitting such request. The state must also comply with the Public Notice Procedures set forth in 42 CFR 447.205 for changes in statewide methods and standards for setting payment rates. The state must also comply with tribal and Indian Health Program/Urban Indian Health Organization consultation requirements at section 1902(a)(73) of the Act, 42 CFR 431.408(b), State Medicaid Director Letter #01-024, or as contained in the state’s approved Medicaid State Plan, when any program changes to the demonstration, either through amendment as set out in STC 7 or extension, are proposed by the state.
13. Federal Financial Participation (FFP). No federal matching funds for expenditures for this demonstration, including for administrative and medical assistance expenditures, will be available until the effective date identified in the demonstration approval letter, or if later, as expressly stated within these STCs.
14. Administrative Authority. When there are multiple entities involved in the administration of the demonstration, the Single State Medicaid Agency must maintain authority, accountability, and oversight of the program. The State Medicaid Agency must exercise oversight of all delegated functions to operating agencies, managed care organizations (MCOs), and any other contracted entities. The Single State Medicaid Agency is responsible for the content and oversight of the quality strategies for the demonstration.
15. Common Rule Exemption. The state must ensure that the only involvement of human subjects in research activities that may be authorized and/or required by this demonstration is for projects which are conducted by or subject to the approval of CMS, and that are designed to study, evaluate, or otherwise examine the Medicaid or CHIP program — including public benefit or services programs, procedures for obtaining Medicaid or CHIP benefits or services, possible changes in or alternatives to Medicaid or CHIP programs and procedures, or possible changes in methods or levels of payment for Medicaid benefits or services. CMS has determined that this demonstration as represented in these approved STCs meets the requirements for exemption from the human subject research provisions of the Common Rule set forth in 45 CFR 46.104(d)(5).
IV. ELIGIBILITY AND ENROLLMENT
16. Eligibility Groups Affected by the Demonstration. Only beneficiaries eligible for Medicaid under an eligibility group listed in Table 1 are subject to the provisions within this demonstration. State plan groups derive their eligibility through the Medicaid state plan, and coverage for these groups is subject to all applicable Medicaid laws and regulations in accordance with the Medicaid state plan, except as expressly waived in this demonstration and as described in these STCs.
Table 1 Medicaid Eligibility Groups Affected by the Demonstration
Demonstration Eligibility Group Citations Income Level Feature Former Foster Care | Former foster care youth up to age | e Expenditure Authority N/A Youth (FFCY) 26 who aged out of foster care in another state and now reside in Virginia Substance Use Adult group © 1902(a)(10)(A)()(VIIT) | 133% FPL Disorder (SUD) © 42 CFR 435.119
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Aged, blind, and disabled
• 42 CFR 435.121
80% FPL Parents and other caretaker relatives
• 1902(a)(10)(A)(i)(I) • 1931 (b) and (d) • 42 CFR 435.110 Dollar amounts by household size • Group 1: ~24% FPL • Group 2: ~32% FPL • Group 3: ~48% FPL Pregnant women • 1902(a)(10)(A)(i)(III) and (IV) • 1931(b) and (d); • 42 CFR 435.116 143% FPL Out of state FFCY (no income limit) • Expenditure Authority
N/A, no income limit Children with Title IV-E adoption assistance, foster care, or guardianship care • 473(b)(1) • 1902(a)(10)(A)(i)(I) • 42 CFR 435.145 N/A, no income limit
Children under age 19 • 1902(a)(10)(A)(i)(III) and (IV) • 1931(b) and (d); • 42 CFR 435.118 143% FPL Transitional medical assistance • 1902(a)(52) • 1902(e)(l) • 1925 • 1931(c)(2) N/A in first six-month extension; 185% FPL average monthly earnings in second six-month extension Extended Medicaid due to spousal support collections • 408(a)(11)(B) • 1902(a)(10)(A)(i)(I) • 1921(c) • 42 CFR 435.115 No limit so long as the reason the family no longer meets the income limit is due to increased spousal support. Former foster care youth up to age 26 who aged out of foster care in Virginia • 42 CFR 435.150 • 1902(a)(10)(A)(i)(IX) N/A, no income limit
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Serious Mental Illness (SMI)/Serious Emotional Disturbance (SED) Low-income Adults and Children
Adult group • 1902(a)(10)(A)(i)(VIII) • 42 CFR 435.119 133% FPL Aged, Blind, and Disabled • 42 CFR 435.121
80% FPL Pregnant Women • 42 CFR 435.116 143% FPL Former Foster Care Youth (FFCY) • Expenditure authority No income limit Former Foster Care Youth up to age 26 who aged out of foster care in Virginia • 42 CFR 435.150 • 1902(a)(10)(A)(i)(IX) N/A, no income limit 17. Former Foster Care Youth. a. Individuals eligible for this demonstration are limited to “out-of-state former foster care youth” who are defined as individuals under age 26 who meet the following criteria: i. were in foster care under the responsibility of a state other than Virginia or an out of state tribe in such other state when they turned age 18 (or such higher age at which the other state’s foster care assistance ends under title IV-E of the Act); ii. were enrolled in Medicaid at any time during the foster care period in which they aged out of foster care; iii. turned 18 on or before December 31, 2022; iv. are now applying for Medicaid in Virginia; and, v. are not otherwise eligible for Medicaid. b. The benefit for out-of-state former foster care youth will be the same Medicaid benefit set provided to the state plan eligibility group serving former foster care children, under section 1902(a)(10)(A)(i)(IX) of the Act. c. The cost sharing requirements for out-of-state former foster care youth conform to the requirements implemented for the state plan eligibility group serving former foster care children, under section 1902(a)(10)(A)(i)(IX) of the Act.
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V. SUBSTANCE USE DISORDER (SUD) PROGRAM AND BENEFITS 18. SUD Program Benefits. Effective upon CMS’s approval of the SUD Implementation Plan, the demonstration benefit package for Medicaid beneficiaries will include SUD treatment services, including services provided in residential and inpatient treatment settings that qualify as an IMD, which are not otherwise matchable expenditures under section 1903 of the Act. The state will be eligible to receive FFP for Medicaid beneficiaries who are short-term residents in IMDs under the terms of this demonstration for coverage of medical assistance, including OUD/SUD services, that would otherwise be matchable if the beneficiary were not residing in an IMD once CMS approves the state’s Implementation Plan. The state will aim for a statewide average length of stay of 30 days or less in residential treatment settings to be monitored pursuant to STC 35, to ensure short-term residential stays. Under this demonstration beneficiaries will have access to high quality, evidence-based SUD treatment services across a comprehensive continuum of care, ranging from residential and inpatient treatment to ongoing care for these conditions in cost-effective community-based settings.
19. SUD Implementation Plan. Given that CMS’s requirements for the SUD Implementation Plan have changed since the state’s original submission, the state must submit a revised implementation plan to CMS no later than 90 days post approval of this demonstration extension. The revised implementation plan will be affixed to the STCs as Attachment B. Any future modifications to the approved Implementation Plan will require CMS approval. Failure to progress in meeting the milestone goals agreed upon by the state and CMS will result in a funding deferral as described in STC 32. The SUD Implementation Plan describes the strategic approach and a detailed project implementation plan, including timetables and programmatic content where applicable, for meeting the following milestones which reflect the key goals and objectives of this SUD project: a. Access to Critical Levels of Care for OUD and other SUDs. Coverage of SUD treatment services across a comprehensive continuum of care including: outpatient; intensive outpatient; medication assisted treatment (medication as well as counseling and other services with sufficient provider capacity to meet needs of Medicaid beneficiaries in the state); intensive levels of care in residential and inpatient settings; and medically supervised withdrawal management, within 12-24 months of demonstration approval; b. Use of Evidence-based SUD-specific Patient Placement Criteria. i. Establishment of a requirement that providers assess treatment needs based on SUD-specific, multidimensional assessment tools, such as the American Society of Addiction Medicine (ASAM) Criteria or other assessment and
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placement tools that reflect evidence-based clinical treatment guidelines within 12-24 months of demonstration approval; ii. Utilization Management. Establishment of a utilization management approach such that beneficiaries have access to SUD services at the appropriate level of care and that the interventions are appropriate for the diagnosis and level of care, including an independent process for reviewing placement in residential treatment settings within 12-24 months of demonstration approval; c. Use of Nationally Recognized SUD-specific Program Standards to set Provider Qualifications for Residential Treatment Facilities. i. Implementation of residential treatment provider qualifications. Currently, residential treatment service providers must be licensed by the Virginia Department of Behavioral Health and Developmental Services (DBHDS) Substance Abuse Residential Treatment Services (RTS). The state must establish residential treatment provider qualifications in licensure, policy or provider manuals, managed care contracts or credentialing, or other requirements or guidance that meet program standards in the ASAM Criteria or other nationally recognized, SUD-specific program standards regarding in particular the types of services, hours of clinical care, and credentials of staff for residential treatment settings within 12-24 months of demonstration approval; ii. Standards of Care. Establishment of a provider review process to ensure that residential treatment providers deliver care consistent with the specifications in the ASAM Criteria or other comparable, nationally recognized SUD program standards based on evidence-based clinical treatment guidelines for types of services, hours of clinical care, and credentials of staff for residential treatment settings within 12-24 months of demonstration approval; iii. Availability of MAT. Establishment of a requirement that residential treatment providers offer MAT on-site or facilitate access to MAT off-site within 12-24 months of demonstration approval; d. Sufficient Provider Capacity at each Level of Care including Medication Assisted Treatment for SUD/OUD. An assessment of the availability of providers in the critical levels of care throughout the state, or in the regions of the state participating under this demonstration, including those that offer MAT within 12 months of demonstration approval; e. Implementation of Comprehensive Treatment and Prevention Strategies to Address Opioid Abuse and SUD/OUD. i. Implementation of opioid prescribing guidelines along with other interventions to prevent prescription drug abuse;
ii. Expand coverage of and access to naloxone for overdose reversal.
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iii. Implementation of strategies to increase utilization and improve functionality of prescription drug monitoring programs; f. Improved Care Coordination and Transitions between Levels of Care. Establishment and implementation of policies to ensure residential and inpatient facilities link beneficiaries with community-based services and supports following stays in these facilities within 24 months of demonstration approval; g. SUD Health IT Plan. Implementation of a Substance Use Disorder Health Information Technology Plan which describes technology that will support the aims of the demonstration. Further information which describes milestones and metrics are detailed in STC 20 and Attachment B. 20. SUD Health Information Technology Plan (“Health IT Plan”). The SUD Health IT plan applies to all states where the health IT functionalities are expected to impact beneficiaries within the demonstration. As outlined in SMDL #17-003, states must submit to CMS the applicable Health IT Plan(s), to be included as a section(s) of the associated Implementation Plan(s) (see STC 19[g]), to develop infrastructure and capabilities consistent with the requirements outlined in each demonstration-type. The Health IT Plan should describe how technology can support outcomes through care coordination; linkages to public health and prescription drug monitoring programs; establish data and reporting structure to monitor outcomes and support data driven interventions. Such technology should, per 42 CFR 433.112(b), use open interfaces and exposed application programming interfaces and ensure alignment with, and incorporation of, standards adopted by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) in accordance with 45 CFR part 170, subpart B. a. The state must monitor progress, each DY, on the implementation of its SUD Health IT Plan in relationship to its milestones and timelines—and report on its progress to CMS within its Annual Report (see STC 35). b. As applicable, the state should advance HHS-adopted standards in 45 CFR 170 Subpart B in developing and implementing the state’s SUD Health IT policies and in all related applicable State procurements (e.g., including managed care contracts) that are associated with this demonstration.0F1 c. Where there are opportunities at the state- and provider-level (up to and including usage in MCO or ACO participation agreements) to leverage federal funds to acquire, upgrade, or implement health IT that can be supported by standards
1 Where the plan involves health IT that is acquired, upgraded, or implemented by health care providers that have been eligible for CMS incentives to adopt health IT certified under the ONC Health IT Certification Program, states should advance the use of certified health IT, as applicable. Certified health IT incorporates the standards in 45 CFR 170 Subpart B.
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referenced in 45 CFR 170, Subpart B, the state should use the federally recognized standards. d. Where there are opportunities at the state- and provider-level to leverage federal funds to acquire, upgrade, or implement health IT that cannot be supported using a standard in 45 CFR 170, Subpart B the state should seek to use other non- proprietary standards and implementation specifications developed by consensus- based standards development organizations. This may include standards identified in the ASTP/ONC Interoperability Standards Advisory (ISA).1F2 e. Specific components of the Health IT Plan are listed below: i. The Health IT Plan must describe the state’s alignment with Section 5042 of the SUPPORT Act requiring Medicaid providers to query a Qualified Prescription Drug Monitoring Program (PDMP)2F3. ii. The Health IT Plan must address how the state’s Qualified PDMP will enhance ease of use for prescribers and other state and federal stakeholders3F4. States should favor procurement strategies that incorporate Qualified PDMP data into electronic health records as discrete data without added interface costs to Medicaid providers, leveraging existing federal investments in open interfaces and exposed application program interfaces. iii. The Health IT Plan will describe how technology will support substance use disorder prevention and treatment outcomes described by the demonstration. iv. In developing the Health IT Plan, states should use the following resources: 1. States may use federal resources available on Health IT.Gov including Behavioral Health IT resources (https://www.healthit.gov/topic/behavioral-health), Opioid Epidemic and Health IT (https://www.healthit.gov/playbook/opioid-epidemic-and-health- it/), and the HHS Health IT Alignment Program (https://www.healthit.gov/topic/hhs-health-it-alignment-program). 2. States may request from CMS technical assistance to conduct an assessment and develop plans to ensure they have the specific health IT infrastructure with regards to PDMP interoperability, electronic care plan sharing, care coordination, and behavioral health-physical health integration, to meet the goals of the demonstration.
2 https://www.healthit.gov/isp/
3 Prescription drug monitoring programs (PDMP) are electronic databases that track controlled substance prescriptions in states. PDMPs can provide health authorities timely information about prescribing and patient behaviors that contribute to the “opioid” epidemic and facilitate a nimble and targeted response. 4 Ibid.
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3. States should review the ASTP/ONC’s Interoperability Standards Advisory (https://www.healthit.gov/isa/) for information on additional non-proprietary standards and implementation specifications developed by consensus-based standards development organizations not included in 45 CFR part 170, Subpart B that can support health IT investments. 21. Unallowable Expenditures Under the SUD Expenditure Authority. The state may not receive FFP for room and board costs for residential treatment service providers unless they qualify as inpatient facilities under section 1905(a) of the Act.
VI. SERIOUS MENTAL ILLNESS (SMI)/SERIOUS EMOTIONAL DISTURBANCE (SED) PROGRAM AND BENEFITS 22. SMI/SED Program Benefits. Under this demonstration, beneficiaries will have access to the full range of otherwise covered Medicaid services, including SMI/SED treatment services provided in residential and inpatient treatment settings that qualify as an IMD, which are not otherwise matchable expenditures under section 1903 of the Act. These SMI/SED services will range in intensity from short-term acute care in inpatient settings for SMI/SED, to ongoing chronic care for such conditions in cost-effective community- based settings. The state will work to improve care coordination and care for co-occurring physical and behavioral health conditions. The state must achieve a statewide average length of stay of no more than 30 days for beneficiaries receiving treatment in an IMD treatment setting through this demonstration’s SMI/SED Program, to be monitored pursuant to STC 35. 23. SMI/SED Implementation Plan. a. The state must submit the SMI/SED Implementation Plan within 90 calendar days after approval of the demonstration for CMS review and comment. If applicable, the state must submit a revised SMI/SED Implementation Plan within 60 calendar days after receipt of CMS’s comments. The state may not claim FFP for services provided to beneficiaries residing in IMDs primarily to receive treatment for SMI/SED under expenditure authority until CMS has approved the SMI/SED Implementation Plan and the SMI/SED financing plan described in STCs 23(d). After approval of the required Implementation Plan and Financing Plan, FFP will be available prospectively, but not retrospectively. b. Once approved, the SMI/SED Implementation Plan will be incorporated into the STCs as Attachment C, and once incorporated, may be altered only with CMS approval. Failure to submit an SMI Implementation Plan, within 90 calendar days after approval of the demonstration, will be considered a material failure to comply with the terms of the demonstration project as described in 42 CFR 431.420(d) and, as such, would be grounds for termination or suspension of the SMI program under this demonstration. Failure to progress in meeting the milestone goals agreed upon by the state and CMS will result in a funding deferral as described in STC 32.
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c. At a minimum, the SMI Implementation Plan must describe the strategic approach, including timetables and programmatic content where applicable, for meeting the following milestones which reflect the key goals and objectives for the program: i. Ensuring Quality of Care in Psychiatric Hospitals and Residential Settings. 1. Hospitals that meet the definition of an IMD in which beneficiaries receiving demonstration services under the SMI program are residing must be licensed or approved as meeting standards for licensing established by the agency of the state or locality responsible for licensing hospitals prior to the state claiming FFP for services provided to beneficiaries residing in a hospital that meets the definition of an IMD. In addition, hospitals must be in compliance with the conditions of participation set forth in 42 CFR Part 482 and either: a) be certified by the state agency as being in compliance with those conditions through a state agency survey, or b) have deemed status to participate in Medicare as a hospital through accreditation by a national accrediting organization whose psychiatric hospital accreditation program or acute hospital accreditation program has been approved by CMS 2. Residential treatment providers that meet the definition of an IMD in which beneficiaries receiving demonstration services under the SMI program are residing must be licensed, or otherwise authorized, by the state to primarily provide treatment for mental illnesses. They must also be accredited by a nationally recognized accreditation entity prior to the state claiming FFP for services provided to beneficiaries residing in a residential facility that meets the definition of an IMD. 3. Establishment of an oversight and auditing process that includes unannounced visits for ensuring participating hospitals and residential treatment settings in which beneficiaries receiving coverage pursuant to the demonstration are residing meet applicable state licensure or certification requirements as well as a national accrediting entity’s accreditation requirements; 4. Use of a utilization review entity (for example, a managed care organization or administrative service organization) to ensure beneficiaries have access to the appropriate levels and types of care and to provide oversight to ensure lengths of stay are limited to what is medically necessary and only those who have a clinical need to receive treatment in psychiatric hospitals and residential treatment settings are receiving treatment in those facilities; 5. Establishment of a process for ensuring that participating psychiatric hospitals and residential treatment settings meet applicable federal program integrity requirements, and establishment of a state process to conduct risk-based screening of all newly enrolling providers, as well as revalidation of existing providers (specifically, under existing
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regulations, the state must screen all newly enrolling providers and reevaluate existing providers pursuant to the rules in 42 CFR Part 455 Subparts B and E, ensure providers have entered into Medicaid provider agreements pursuant to 42 CFR 431.107, and establish rigorous program integrity protocols to safeguard against fraudulent billing and other compliance issues) 6. Implementation of a state requirement that participating psychiatric hospitals and residential treatment settings screen beneficiaries for co-morbid physical health conditions and SUDs and demonstrate the capacity to address co-morbid physical health conditions during short-term stays in residential or inpatient treatment settings (e.g., with on-site staff, telemedicine, and/or partnerships with local physical health providers). ii. Improving Care Coordination and Transitions to Community-Based Care. 1. Implementation of a process to ensure that psychiatric hospitals and residential treatment facilities provide intensive pre-discharge, care coordination services to help beneficiaries transition out of these settings into appropriate community-based outpatient services, including requirements that facilitate participation of community- based providers in transition efforts (e.g., by allowing beneficiaries to receive initial services from a community-based provider while the beneficiary is still residing in these settings and/or by engaging peer support specialists to help beneficiaries make connections with available community-based providers and, where applicable, make plans for employment); 2. Implementation of a process to assess the housing situation of a beneficiary transitioning to the community from psychiatric hospitals and residential treatment settings and to connect beneficiaries who have been experiencing or are likely to experience homelessness or who would be returning to unsuitable or unstable housing with community providers that coordinate housing services, where available; 3. Implementation of a requirement that psychiatric hospitals and residential treatment settings that are discharging beneficiaries who have received coverage pursuant to this demonstration have protocols in place to ensure contact is made by the treatment setting with each discharged beneficiary and the community-based provider to which the beneficiary was referred within 72 hours of discharge to help ensure follow-up care is accessed by individuals after leaving those facilities by contacting the individuals directly and, as appropriate, by contacting the community-based provider the person was referred to; 4. Implementation of strategies to prevent or decrease the length of stay in emergency departments (ED) among beneficiaries with SMI or SED (e.g., through the use of peer support specialists and psychiatric
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consultants in EDs to help with discharge and referral to treatment providers); 5. Implementation of strategies to develop and enhance interoperability and data sharing between physical, SUD, and mental health providers, with the goal of enhancing care coordination so that disparate providers may better share clinical information to improve health outcomes for beneficiaries with SMI or SED. iii. Increasing Access to Continuum of Care Including Crisis Stabilization Services. 1. Establishment of a process to annually assess the availability of mental health services throughout the state, particularly crisis stabilization services, and updates on steps taken to increase availability (the state must provide a yearly update on the availability of mental health services via the Annual Monitoring Report); 2. Commitment to implementation of the SMI financing plan described in STC 25. The state must maintain a level of state and local funding for outpatient community-based mental health services for Medicaid beneficiaries for the duration of the SMI program under the demonstration that is no less than the amount of funding provided at the beginning of the SMI program under the demonstration. The annual MOE will be reported and monitored as part of the Annual Monitoring Report described in STC 35; 3. Implementation of strategies to improve the state’s capacity to track the availability of inpatient and crisis stabilization beds to help connect individuals in need with that level of care as soon as possible; 4. Implementation of a requirement that providers, plans, and utilization review entities use an evidence-based, publicly available patient assessment tool, preferably endorsed by a mental health provider association [e.g., Level of Care Utilization System (LOCUS) or the Child and Adolescent Service Intensity Instrument (CASII)] to determine appropriate level of care and length of stay. vi. Earlier Identification and Engagement in Treatment and Increased Integration. 1. Implementation of strategies for identifying and engaging individuals, particularly adolescents and young adults, with SMI in treatment sooner, including through supported employment and supported education programs; 2. Increasing integration of behavioral health care in non-specialty care settings, including schools and primary care practices, to improve identification of SMI/SED conditions sooner and improve awareness of and linkages to specialty treatment providers;
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3. Establishment of specialized settings and services, including crisis stabilization services, focused on the needs of young people experiencing SMI or SED. d. The Implementation Plan must also include sections containing the SMI Health IT Plan and the SMI Financing Plan. Further information which describes the requirements are detailed in STC 24, STC 25 and Attachment C. 24. SMI/SED Health Information Technology (Health IT) Plan. The state will provide CMS with an assurance that it has a sufficient health IT infrastructure “ecosystem” at every appropriate level (i.e., state, delivery system, health plan/MCO and individual provider) to achieve the goals of the demonstration. The Health IT Plan will detail the necessary health IT capabilities in place to support beneficiary health outcomes to address the SMI/SED goals of the demonstration. The plan(s) will also be used to identify areas of health IT ecosystem improvement. The Plan must include implementation milestones and projected dates for achieving them (see Attachment C) and must be aligned with the state’s broader State Medicaid Health IT Plan (SMHP) and, if applicable, the state’s Behavioral Health (BH) IT Health Plan. a. The state will monitor progress, each DY, on the implementation of its SMI/SED Health IT Plan in relationship to its milestones and timelines—and report on its progress to CMS within its Annual Monitoring Report (see STC 35). b. As applicable, the state should advance the HHS-adopted standards in 42 CFR 170 Subpart B in developing and implementing the state’s SMI/SED Health IT policies and in all related applicable State procurements (e.g., including managed care contracts) that are associated with this demonstration. c. Where there are opportunities at the state- and provider-level (up to and including usage in managed care organization (MCO) or Accountable Care Organization (ACO) participation agreements) to leverage federal funds to acquire, upgrade, or implement health IT that can be supported by standards referenced in 45 CFR 170 Subpart B the state should use the federally recognized standards. d. Where there are opportunities at the state- and provider-level to leverage federal funds to acquire, upgrade, or implement health IT that cannot be supported using a standard in 45 CFR 170, Subpart B the state should seek to use other non- proprietary standards and implementation specifications developed by consensus- based standards development organizations. This may include standards identified in the ASTP/ONC Interoperability Standards Advisory (ISA). e. Specific components of the Health IT Plan are listed below i. The Health IT Plan will, as applicable, describe the state’s capabilities to leverage a master patient index (or master data management service, etc.) in support of SMI/SED care delivery. The state will also indicate current efforts or plans to
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develop and/or utilize current patient index capability that supports the programmatic objectives of the demonstration. ii. The Health IT Plan will describe the state’s current and future capabilities to support providers implementing or expanding Health IT functionality in the following areas: (1) Referrals, (2) Electronic care plans and medical records, (3) Consent, (4) Interoperability, (5) Telehealth, (6) Alerting/analytics, and (7) Identity management. iii. In developing the Health IT Plan, states should use the following resources: 1. States may use federal resources available on Health IT.gov including behavioral health IT (https://www.healthit.gov/topic/behavioral-health), “Section 34: Opioid Epidemic and Health IT” (https://www.healthit.gov/playbook/opioid-epidemic-and-health-it), and the HHS Health IT Alignment Program (https://www.healthit.gov/topic/hhs-health-it-alignment-program). 2. States may request from CMS technical assistance to conduct an assessment and develop plans to ensure they have the specific health IT infrastructure with regards to electronic care plan sharing, care coordination, and behavioral health-physical health integration, to meet the goals of the demonstration. 3. States should review the ASTP/ONC’s Interoperability Standards Advisory (https://www.healthit.gov/isa/) for information on additional non-proprietary standards and implementation specifications developed by consensus-based standards development organizations not included in 45 CFR part 170, Subpart B that can support health IT investments. 25. SMI/SED Financing Plan. As part of the SMI/SED implementation plan referred to in STC 23(d), the state must submit, within 90 calendar days after approval of the demonstration, a financing plan for approval by CMS. Once approved, the Financing Plan will be incorporated into the STCs as part of the implementation plan in Attachment C and, once incorporated, may only be altered with CMS approval. Failure to submit an SMI/SED Financing Plan within 90 days of approval of the demonstration will be considered a material failure to comply with the terms of the demonstration project as described in 42 CFR 431.420(d) and, as such, would be grounds for termination or suspension of the SMI/SED program under this demonstration. Components of the financing plan must include: a. A plan to increase the availability of non-hospital, non-residential crisis stabilization services, including but not limited to the following: services made available through crisis call centers, mobile crisis units, coordinated community response services that includes law enforcement and other first responders, and observation/assessment centers; and
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b. A plan to increase availability of ongoing community-based services such as intensive outpatient services, assertive community treatment, and services delivered in integrated care settings; 26. Maintenance of Effort (MOE). The state must maintain a level of state and local funding for outpatient community-based mental health services for Medicaid beneficiaries for the duration of the SMI/SED program under the demonstration that is no less than the amount of funding provided at the beginning of the SMI/SED program under the demonstration. The annual MOE will be reported and monitored as part of the Annual Monitoring Report described in STC 35. 27. Average Length of Stay Requirements and FFP. Federal Financial Participation is only available for services provided to beneficiaries who are residing in an IMD when the beneficiary is a short-term resident in the IMD primarily to receive treatment for mental illness. The state may claim FFP for services furnished to beneficiaries during IMD stays of up to 60 days, as long as the state shows at its Mid-Point Assessment that it is meeting the requirement of a 30-day average length of stay (ALOS) for beneficiaries residing in an IMD who are receiving covered services under the demonstration. Demonstration services furnished to beneficiaries whose stays in IMDs exceed 60 days are not eligible for FFP under this demonstration. If the state cannot show that it is meeting the 30 day or less ALOS requirement within one standard deviation at the Mid-Point Assessment, the state may only claim FFP for services furnished to beneficiaries during IMD stays of up to 45 days until such time that the state can demonstrate that it is meeting the 30 day or less ALOS requirement. The state will ensure that medically necessary services are provided to beneficiaries that have stays in excess of 60 days or 45 days, as relevant. 28. Unallowable Expenditures Under the SMI/SED Expenditure Authority. In addition to the other unallowable costs and caveats already outlined in these STCs, the state may not receive FFP under any expenditure authority approved under this demonstration for any of the following: a. Room and board costs for residential treatment service providers unless they qualify as inpatient facilities under section 1905(a) of the Act. b. Costs for services furnished to beneficiaries who are residents in a nursing facility as defined in section 1919 of the Act that qualifies as an IMD. c. Costs for services furnished to beneficiaries who are involuntarily residing in a psychiatric hospital or residential treatment facility by operation of criminal law. d. Costs for services provided to beneficiaries under age 21 residing in an IMD unless the IMD meets the requirements for the “inpatient psychiatric services for individuals under age 21” benefit under 42 CFR 440.160, 441 Subpart D, and 483 Subpart G. VII. COST SHARING
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29. Cost Sharing. Cost sharing imposed upon individuals enrolled in the demonstration is consistent with the provisions of the approved state plan. VIII. DELIVERY SYSTEM 30. Delivery System. The demonstration will utilize the current statewide managed care delivery system and fee for service (FFS) delivery system. Beneficiaries may be enrolled in FFS prior to being enrolled into managed care. IX. MONITORING AND REPORTING REQUIREMENTS 31. Deferral for Failure to Submit Timely Demonstration Deliverables. CMS may issue deferrals in accordance with 42 CFR part 430 subpart C, in the amount of $5,000,000 per deliverable (federal share) when items required by these STCs (e.g., required data elements, analyses, reports, design documents, presentations, and other items specified in these STCs (hereafter singularly or collectively referred to as “deliverable(s)”) are not submitted timely to CMS or are found to not be consistent with the requirements approved by CMS. A deferral shall not exceed the value of the federal amount for the demonstration. The state does not relinquish its rights provided under 42 CFR part 430 subpart C to challenge any CMS finding that the state materially failed to comply with the terms of this agreement.
The following process will be used: 1) Thirty (30) days after the deliverable was due if the state has not submitted a written request to CMS for approval of an extension as described in subsection (b) below; or 2) Thirty days after CMS has notified the state in writing that the deliverable was not accepted for being inconsistent with the requirements of this agreement and the information needed to bring the deliverable into alignment with CMS requirements:
a. CMS will issue a written notification to the state providing advance notification of a pending deferral for late or non-compliant submission of required deliverable(s).
b. For each deliverable, the state may submit to CMS a written request for an extension to submit the required deliverable that includes a supporting rationale for the cause(s) of the delay and the state’s anticipated date of submission. Should CMS agree to the state’s request, a corresponding extension of the deferral process can be provided. CMS may agree to a corrective action as an interim step before applying the deferral, if corrective action is proposed in the state’s written extension request.
c. If CMS agrees to an interim corrective process in accordance with subsection (b), and the state fails to comply with the corrective action steps or still fails to submit the overdue deliverable(s) that meets the terms of this agreement, CMS may proceed with the issuance of a deferral against the next Quarterly Statement of Expenditures reported in Medicaid Budget and Expenditure System/State Children's Health
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Insurance Program Budget and Expenditure System (MBES/CBES) following a written deferral notification to the state.
d. If the CMS deferral process has been initiated for state non-compliance with the terms of this agreement for submitting deliverable(s), and the state submits the overdue deliverable(s), and such deliverable(s) are accepted by CMS as meeting the standards outlined in these STCs, the deferral(s) will be released.
As the purpose of a section 1115 demonstration is to test new methods of operation or service delivery, a state’s failure to submit all required reports, evaluations, and other deliverables will be considered by CMS in reviewing any application for an extension, amendment, or for a new demonstration. 32. Deferral of Federal Financial Participation from IMD Claiming for Insufficient Progress Toward Milestones. Up to $5,000,000 in FFP for services in IMDs may be deferred if the state is not making adequate progress on meeting the milestones as evidenced by reporting on the milestones in the Annual Monitoring Report. Once CMS determines the state has not made adequate progress, up to $5,000,000 will be deferred in the next calendar year and each calendar year thereafter until CMS has determined sufficient progress has been made.
33. Submission of Post-Approval Deliverables. The state must submit all deliverables as stipulated by CMS and within the timeframes outlined within these STCs, unless CMS and the state mutually agree to another timeline.
34. Compliance with Federal Systems Updates. As federal systems continue to evolve and incorporate additional 1115 demonstration reporting and analytics functions, the state will work with CMS to:
a. Revise the reporting templates and submission processes to accommodate timely compliance with the requirements of the new systems; b. Ensure all 1115, T-MSIS, and other data elements that have been agreed to for reporting and analytics are provided by the state; and c. Submit deliverables to the appropriate system as directed by CMS.
35. Monitoring Reports. The state must submit one Annual Monitoring Report each demonstration year (DY) that is due no later than the first business day following 180 calendar days after the end of the DY. The state must submit a revised Annual Monitoring Report no later than the first business day following 60 calendar days after receipt of CMS’s comments, if any. CMS might increase the frequency of monitoring reporting if CMS determines that doing so would be appropriate. CMS will make on-going determinations about reporting frequency under the demonstration by assessing the risk
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that the state might materially fail to comply with the terms of the approved demonstration during its implementation and/or the risk that the state might implement the demonstration in a manner unlikely to achieve the statutory purposes of Medicaid. See 42 CFR 431.420(d)(1)-(2).
The Annual Monitoring Report will include all required elements as per 42 CFR 431.428, and should not direct readers to links outside the report. Additional links not referenced in the document may be listed in a Reference/Bibliography section. The Annual Monitoring Report must follow the framework provided by CMS, which is subject to change as monitoring systems are developed/evolve and must be provided in a structured manner that supports federal tracking and analysis.
a. Operational Updates. The operational updates will focus on progress towards meeting the milestones identified in CMS’ framework. Additionally, per 42 CFR 431.428, the Monitoring Reports must document any policy or administrative difficulties in operating the demonstration. The reports shall provide sufficient information to document key challenges, underlying causes of challenges, how challenges are being addressed, as well as key achievements and to what conditions and efforts successes can be attributed. The discussion should also include any issues or complaints identified by beneficiaries; lawsuits or legal actions; unusual or unanticipated trends; legislative updates; and descriptions of any public forums held. The Monitoring Report should also include a summary of all public comments received through post-award public forums regarding the progress of the demonstration.
b. Performance Metrics. The performance metrics will provide data to demonstrate the state’s progress towards meeting the demonstration’s goals and any applicable milestones. Per 42 CFR 431.428, the Annual Monitoring Report must document the impact of the demonstration on beneficiaries’ outcomes of care, quality and overall cost of care, and access to care, as applicable. This should also include the results of beneficiary satisfaction or experience of care surveys, if conducted, as well as grievances and appeals. The Annual Monitoring Report must provide detailed information about deviations from CMS’s applicable metrics technical specifications, relevant methodology, plans for phasing in metrics, and data or reporting issues for applicable metrics, in alignment with CMS guidance and technical assistance.
The state and CMS will work collaboratively to finalize the list of metrics to be reported on in the Annual Monitoring Report. The demonstration’s monitoring metrics must cover categories to include, but not be limited to, eligibility, utilization of services, quality of care and health outcomes, and grievances and appeals. The state must report these metrics for all demonstration populations. Demonstration monitoring reporting does not duplicate or replace reporting requirements for other authorities, such as Home and Community Based Services and Managed Care authorities.
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In addition, the state is expected to report monitoring metrics per applicable CMS guidance, and including but not limited to as described below:
i. For the SUD and/or SMI/SED component(s), the state’s monitoring must cover metrics in alignment with CMS guidance and the demonstration’s milestones as outlined in the SUD State Medicaid Director Letter (SMDL) dated November 1, 2017 (SMD #17–003) and/or the SMI/SED SMDL dated November 13, 2018 (SMDL #18-011).
The reporting of these monitoring metrics may also be stratified by key demographic subpopulations of interest (e.g., by sex, age, race/ethnicity, or geography) and by demonstration component, as appropriate. Subpopulation reporting can support identifying any gaps in quality of care and health outcomes, and help track whether the demonstration’s initiatives help improve outcomes for the state’s Medicaid population. c. Evaluation Activities and Interim Findings. Per 42 CFR 431.428, the Annual Monitoring Report must document any results of the demonstration to date per the evaluation hypotheses. Additionally, the state shall include a summary of the progress of evaluation activities, including key milestones accomplished, as well as challenges encountered and how they were addressed. 36. Mid-Point Assessment. The state must contract with an independent entity (herein referred to as the Independent Assessor) to conduct an independent Mid-Point Assessment and submit to CMS by December 31, 2029. This timeline will allow for the Mid-Point Assessment to capture approximately the first two and a half years of program data, accounting for data run-out and data completeness. In addition, if applicable, the state should use the prior approval period experiences as context, and conduct the Mid- Point Assessment in light of the data from any such prior approval period(s). In the design, planning and execution of the Mid-Point Assessment, the state must require that the Independent Assessor consult with key stakeholders such as, representatives of MCOs, health care providers, beneficiaries, community groups, and other key partners. a. The state must require that the assessor provide a Mid-Point Assessment to the state that includes the methodologies used for examining progress and assessing risk, the limitations of the methodologies, its determinations, and any recommendations. If requested, the state must brief CMS on the Mid-Point Assessment. The state must submit a revised Mid-Point Assessment no later than the first business day following 60 calendar days after receipt of CMS’s comments, if any. b. Elements of the Mid-Point Assessment must include: 1. An examination of progress toward meeting each milestone and timeframe approved in the Implementation Plan; 2. A determination of factors that affected achievement on the milestones and performance metric gap closures to date;
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3. A determination of selected factors likely to affect future performance in meeting milestones and targets not yet met and information about the risk of possibly missing those milestones and performance targets; 4. For milestones or targets identified by the Independent Assessor as at medium to high risk of not being met, recommendations for adjustments in the state’s Implementation Plan, or to pertinent factors that the state can influence that will support improvement. 37. Corrective Action. If monitoring indicates that demonstration features are not likely to assist in promoting the objectives of Medicaid, CMS might require the state to submit a corrective action plan to CMS for approval. A state corrective action plan could include a temporary suspension of implementation of demonstration programs in circumstances where monitoring data indicate substantial and sustained directional change inconsistent with demonstration goals, such as substantial and sustained trends indicating increased difficulty accessing services. A corrective action plan may be an interim step to withdrawing waivers or expenditure authorities, as outlined in STC 10. CMS might withdraw an authority, as described in STC 10, if metrics indicate substantial and sustained directional change inconsistent with the state’s demonstration goals, the state has not implemented corrective action, and the circumstances described in STC 10, are met. CMS further has the ability to suspend implementation of the demonstration should corrective actions not effectively resolve these concerns in a timely manner.
38. Close Out Report. No later than the first business day following 120 calendar days after the expiration of the demonstration, the state must submit a draft Close-Out Report to CMS for comments. a. The Close-Out Report must comply with the most current guidance from CMS. b. In consultation with CMS, and per guidance from CMS, the state will include an evaluation of the demonstration (or demonstration components) that are to phase out or expire without extension along with the Close-Out Report. Depending on the timeline of the phase-out during the demonstration approval period, in agreement with CMS, the evaluation requirement may be satisfied through the Interim or Summative Evaluation Reports stipulated in STCs 73 and 74, respectively. c. The state will present to and participate in a discussion with CMS on the Close–Out Report. d. The state must take into consideration CMS’s comments for incorporation into the final Close-Out Report. e. A revised Close-Out Report is due to CMS no later than the first business day following 30 calendar days after receipt of CMS’s comments. f. A delay in submitting the draft or final version of the Close-Out Report may subject the state to penalties described in STC 31.
39. Monitoring Calls. CMS will convene, no less frequently than quarterly, monitoring calls
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with the state. a. The purpose of these calls is to discuss ongoing demonstration operations and implementation which align with the state’s demonstration monitoring reports, including (but not limited to) any significant actual or anticipated developments affecting the demonstration. Examples include implementation activities, trends in reported data on metrics and associated mid-course adjustments, eligibility and access, and progress on evaluation activities. b. These calls will follow the structure of and focus on the topics in the Annual Monitoring Report. c. CMS will provide updates on any pending actions, as well as federal policies and issues that may affect any aspect of the demonstration. d. The state and CMS will jointly develop the agenda for the calls.
40. Post Award Forum. Pursuant to 42 CFR 431.420(c), within six months of the demonstration’s implementation and annually thereafter, the state must afford the public with an opportunity to provide meaningful comment on the progress of the demonstration. At least 30 calendar days prior to the date of the planned public forum, the state must publish the date, time and location of the forum in a prominent location on its website. The state must also post the most recent Annual Monitoring Report on its website with the public forum announcement. Pursuant to 42 CFR 431.420(c), the state must include a summary of the public comments in the Annual Monitoring Report associated with the year in which the forum was held.
X. GENERAL FINANCIAL REQUIREMENTS 41. Allowable Expenditures. This demonstration project is approved for authorized demonstration expenditures applicable to services rendered and for costs incurred during the demonstration approval period designated by CMS. CMS will provide FFP for allowable demonstration expenditures only so long as they do not exceed the pre-defined limits as specified in these STCs.
42. Standard Medicaid Funding Process. The standard Medicaid funding process will be used for this demonstration. The state will provide quarterly expenditure reports through the Medicaid and CHIP Budget and Expenditure System (MBES/CBES) to report total expenditures under this Medicaid section 1115 demonstration following routine CMS-37 and CMS-64 reporting instructions as outlined in section 2500 of the State Medicaid Manual. The state will estimate matchable demonstration expenditures (total computable and federal share) subject to the budget neutrality expenditure limit and separately report these expenditures by quarter for each federal fiscal year on the form CMS-37 for both the medical assistance payments (MAP) and state and local administration costs (ADM).
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CMS shall make federal funds available based upon the state’s estimate, as approved by CMS. Within 30 days after the end of each quarter, the state shall submit form CMS-64 Quarterly Medicaid Expenditure Report, showing Medicaid expenditures made in the quarter just ended. If applicable, subject to the payment deferral process, CMS shall reconcile expenditures reported on form CMS-64 with federal funding previously made available to the state and include the reconciling adjustment in the finalization of the grant award to the state.
43. Sources of Non-Federal Share. As a condition of demonstration approval, the state certifies that its funds that make up the non-federal share are obtained from permissible state and/or local funds that, unless permitted by law, are not other federal funds. The state further certifies that federal funds provided under this section 1115 demonstration must not be used as the non-federal share required under any other federal grant or contract, except as permitted by law. CMS approval of this demonstration does not constitute direct or indirect approval of any underlying source of non-federal share or associated funding mechanisms, and all sources of non-federal funding must be compliant with section 1903(w) of the Act and applicable implementing regulations. CMS reserves the right to deny FFP in expenditures for which it determines that the sources of non- federal share are impermissible.
a. If requested, the state must submit for CMS review and approval documentation of any sources of non-federal share that would be used to support payments under the demonstration.
b. If CMS determines that any funding sources are not consistent with applicable federal statutes or regulations, the state must address CMS’s concerns within the time frames allotted by CMS.
c. Without limitation, CMS may request information about the non-federal share sources for any amendments that CMS determines may financially impact the demonstration. 44. State Certification of Funding Conditions. As a condition of demonstration approval, the state certifies that the following conditions for non-federal share financing of demonstration expenditures have been met:
a. If units of state or local government, including health care providers that are units of state or local government, supply any funds used as non-federal share for expenditures under the demonstration, the state must certify that state or local monies have been expended as the non-federal share of funds under the demonstration in accordance with section 1903(w) of the Act and applicable implementing regulations.
b. To the extent the state utilizes certified public expenditures (CPE) as the funding mechanism for the non-federal share of expenditures under the demonstration, the state must obtain CMS approval for a cost reimbursement methodology. This
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methodology must include a detailed explanation of the process, including any necessary cost reporting protocols, by which the state identifies those costs eligible for purposes of certifying public expenditures. The certifying unit of government that incurs costs authorized under the demonstration must certify to the state the amount of public funds allowable under 42 CFR 433.51 it has expended. The federal financial participation paid to match CPEs may not be used as the non-federal share to obtain additional federal funds, except as authorized by federal law, consistent with 42 CFR 433.51(c).
c. The state may use intergovernmental transfers (IGT) to the extent that the transferred funds are public funds within the meaning of 42 CFR 433.51 and are transferred by units of government within the state. Any transfers from units of government to support the non-federal share of expenditures under the demonstration must be made in an amount not to exceed the non-federal share of the expenditures under the demonstration. d. Under all circumstances, health care providers must retain 100 percent of their payments for or in connection with furnishing covered services to beneficiaries. Moreover, no pre-arranged agreements (contractual, voluntary, or otherwise) may exist between health care providers and state and/or local governments, or third parties to return and/or redirect to the state any portion of the Medicaid payments in a manner inconsistent with the requirements in section 1903(w) of the Act and its implementing regulations. This confirmation of Medicaid payment retention is made with the understanding that payments that are the normal operating expenses of conducting business, such as payments related to taxes, including health care provider-related taxes, fees, business relationships with governments that are unrelated to Medicaid and in which there is no connection to Medicaid payments, are not considered returning and/or redirecting a Medicaid payment.
e. The State Medicaid Director or his/her designee certifies that all state and/or local funds used as the state’s share of the allowable expenditures reported on the CMS- 64 for this demonstration were in accordance with all applicable federal requirements and did not lead to the duplication of any other federal funds.
45. Financial Integrity for Managed Care Delivery Systems. As a condition of demonstration approval, the state attests to the following, as applicable:
a. All risk-based managed care organization, prepaid inpatient health plan (PIHP), and prepaid ambulatory health plan (PAHP) payments, comply with the requirements on payments in 42 CFR 438.6(b)(2), 438.6(c), 438.6(d), 438.60, and 438.74.
b. For non-risk-based PIHP and PAHPs, arrangements comply with the upper payment limits specified in 42 CFR 447.362, and if payments exceed the cost of services, the state will recoup the excess and return the federal share of the excess to CMS.
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46. Requirements for Health Care-Related Taxes and Provider Donations. As a condition of demonstration approval, the state attests to the following, as applicable:
a. Except as provided in paragraph (c) of this STC, all health care-related taxes as defined by Section 1903(w)(3)(A) of the Act and 42 CFR 433.55 are broad-based as defined by Section 1903(w)(3)(B) of the Act and 42 CFR 433.68(c).
b. Except as provided in paragraph (c) of this STC, all health care-related taxes are uniform as defined by Section 1903(w)(3)(C) of the Act and 42 CFR 433.68(d).
c. If the health care-related tax is either not broad-based or not uniform, the state has applied for and received a waiver of the broad-based and/or uniformity requirements as specified by 1903(w)(3)(E)(i) of the Act and 42 CFR 433.72.
d. The tax does not contain a hold harmless arrangement as described by Section 1903(w)(4) of the Act and 42 CFR 433.68(f).
e. All provider-related donations as defined by 42 CFR 433.52 are bona fide as defined by Section 1903(w)(2)(B) of the Social Security Act, 42 CFR 433.66, and 42 CFR 433.54.
47. State Monitoring of Non-federal Share. If any payments under the demonstration are funded in whole or in part by a locality tax, then the state must provide a report to CMS regarding payments under the demonstration no later than 60 days after demonstration approval. This deliverable is subject to the deferral as described in STC 31. This report must include:
a. A detailed description of and a copy of (as applicable) any agreement, written or otherwise agreed upon, regarding any arrangement among the providers including those with counties, the state, or other entities relating to each locality tax or payments received that are funded by the locality tax;
b. Number of providers in each locality of the taxing entities for each locality tax;
c. Whether or not all providers in the locality will be paying the assessment for each locality tax;
d. The assessment rate that the providers will be paying for each locality tax;
e. Whether any providers that pay the assessment will not be receiving payments funded by the assessment;
f. Number of providers that receive at least the total assessment back in the form of Medicaid payments for each locality tax;
g. The monitoring plan for the taxing arrangement to ensure that the tax complies with section 1903(w)(4) of the Act and 42 CFR 433.68(f); and
h. Information on whether the state will be reporting the assessment on the CMS form
64.11A as required under section 1903(w) of the Act.
48. Extent of Federal Financial Participation for the Demonstration. Subject to CMS approval of the source(s) of the non-federal share of funding, CMS will provide FFP at the applicable federal matching rate for the following demonstration expenditures, subject to the budget neutrality expenditure limits described in the STCs in section XI
a. Administrative costs, including those associated with the administration of the demonstration;
Net expenditures and prior period adjustments of the Medicaid program that are paid in accordance with the approved Medicaid state plan; and
Medical assistance expenditures and prior period adjustments made under section 1115 demonstration authority with dates of service during the demonstration extension period; including those made in conjunction with the demonstration, net of enrollment fees, cost sharing, pharmacy rebates, and all other types of third-party
liability.
49. Program Integrity. The state must have processes in place to ensure there is no duplication of federal funding for any aspect of the demonstration. The state must also ensure that the state and any of its contractors follow standard program integrity principles and practices including retention of data. All data, financial reporting, and sources of non-federal share are subject to audit.
50. Medicaid Expenditure Groups (MEG). Medicaid Expenditure Groups (MEG) are defined for the purpose of identifying categories of Medicaid or demonstration expenditures subject to budget neutrality, components of budget neutrality expenditure limit calculations, and other purposes related to monitoring and tracking expenditures under the demonstration. The Master MEG Chart table provides a master list of MEGs
defined for this demonstration.
Table 2. Master MEG Chart To Which wow MEG BN Test Per sah to! ww Brief Description
Does This Capita Aggregate
Apply? P All expenditures for services provided to an individual while they are a
SUD Hypo 1 x = patient in an IMD for SUD
treatment, described in Section V.
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All expenditures for services provided to an individual while they are a SMUSED (i 2S * patient in an IMD for SMI/SED treatment described in Section VI. All additional administrative costs that are directly attributable to the ADM N/A demonstration and not described elsewhere and are not subject to budget neutrality
BN — budget neutrality: MEG — Medicaid expenditure group: WOW - without waiver; WW — with waiver
51. Reporting Expenditures and Member Months. The state must report all demonstration expenditures claimed under the authority of title XIX of the Act and subject to budget neutrality each quarter on separate forms CMS-64.9 WAIVER and/or 64.9P WAIVER, identified by the demonstration project number assigned by CMS (11-W-00297/3). Separate reports must be submitted by MEG (identified by Waiver Name) and Demonstration Year (identified by the two-digit project number extension). Unless specified otherwise, expenditures must be reported by DY according to the dates of service associated with the expenditure. All MEGs identified in the Master MEG Chart as WW must be reported for expenditures, as further detailed in the MEG Detail for Expenditure and Member Month Reporting table below. To enable calculation of the budget neutrality expenditure limits, the state also must report member months of eligibility for specified MEGs.
a. Cost Settlements. The state will report any cost settlements attributable to the demonstration on the appropriate prior period adjustment schedules (form CMS- 64.9P WAIVER) for the summary sheet line 10b (in lieu of lines 9 or 10c), or line 7. For any cost settlement not attributable to this demonstration, the adjustments should be reported as otherwise instructed in the State Medicaid Manual. Cost settlements must be reported by DY consistent with how the original expenditures were reported.
b. Premiums and Cost Sharing Collected by the State. The state will report any premium contributions collected by the state from demonstration enrollees quarterly on the form CMS-64 Summary Sheet line 9D, columns A and B. To assure that these collections are properly credited to the demonstration, quarterly premium collections (both total computable and federal share) should also be reported separately by demonstration year on form CMS-64 Narrative, and on the Total Adjustments tab in the Budget Neutrality Monitoring Tool. In the annual calculation of expenditures subject to the budget neutrality expenditure limit, premiums collected in the demonstration year will be offset against expenditures
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incurred in the demonstration year for determination of the state's compliance with the budget neutrality limits.
Pharmacy Rebates. Because pharmacy rebates are not included in the base
expenditures used to determine the budget neutrality expenditure limit, pharmacy
rebates are not included for calculating net expenditures subject to budget neutrality.
The state will report pharmacy rebates on form CMS-64.9 BASE, and not allocate
them to any form 64.9 or 64.9P WAIVER.
. Administrative Costs. The state will separately track and report additional
administrative costs that are directly attributable to the demonstration. All
administrative costs must be identified on the forms CMS-64.10 WAIVER and/or
64.10P WAIVER. Unless indicated otherwise on the MEG Charts and in the STCS in section XI, administrative costs are not counted in the budget neutrality tests; however, these costs are subject to monitoring by CMS.
Member Months. Using the Budget Neutrality Monitoring Tool, the state must
report the actual number of “eligible member months” for all demonstration enrollees for all MEGs identified as WOW Per Capita in the Master MEG Chart
table above, and as also indicated in the MEG Detail for Expenditure and Member
Month Reporting table below. The term “eligible member months” refers to the number of months in which persons enrolled in the demonstration are eligible to receive services. For example, a person who is eligible for three months contributes three eligible member months to the total. Two individuals who are eligible for two months, each contribute two eligible member months, for a total of four eligible member months. The state must submit a statement accompanying the annual report certifying the accuracy of this information.
Budget Neutrality Specifications Manual. The state will create and maintain a Budget Neutrality Specifications Manual that describes in detail how the state will
compile data on actual expenditures related to budget neutrality, including methods used to extract and compile data from the state’s Medicaid Management Information
System, eligibility system, and accounting systems for reporting on the CMS-64, consistent with the terms of the demonstration. The Budget Neutrality
Specifications Manual will also describe how the state compiles counts of Medicaid member months. The Budget Neutrality Specifications Manual must be made available to CMS on request.
Table 3. MEG Detail for Expenditure and Member Month Reporting
How MEG ; CMS- | Expena. | Map | RePort | ec | MEG . Detailed : 64.9 Member (Waiver eae Exclusions : Are or Start End Description Line(s) : Months Name) To Use Assigned | ADM (v/N) Date Date to DY Report all Follow SUD medical standard MAP Y 12/15/16 | 12/31/31 assistance CMS Building and Transforming Coverage, Services and Supports for a Healthier Virginia Approval Period: August 1, 2026 through December 31, 2031 Page 34 of 51
expenditure Refer to 64.9 s for STC 21 for | Category services unallowabl of provided to e Service Date of an expenditure | Definitio | Service individual s ms while they are a patient in an IMD for SUD treatment. Report all medical assistance expenditure Follow s for Refer to ees . CMS services STC 28 for rovided to | unallowabl ed SMI/SED La Category | Dateof | MAP Y 08/01/26 | 12/31/31 _ an c of Service individual | expenditure | oi, while they s Deine are a patient ns in an IMD for SMI/SED. Report all Follow additional standard administrativ CMS e costs that 64.10 are directly Category attributable of to the Service Date of ADM demonstratio Definitio ADM N 12/15/16 | 12/31/31 n and are not ns payee described elsewhere and are not subject to budget neutrality
ADM - administration: DY — demonstration year; MAP — medical assistance payments; MEG — Medicaid expenditure group;
52. Demonstration Years. Demonstration Years (DY) for this demonstration are defined in the Demonstration Years table below.
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| __ Year 13 {August 1, 2026, to December 31, 2026 5 months
|Demonstration Year 14 January 1, 2027, to December 31,2027 [12 months
|Demonstration Year 15 January 1, 2028, to December 31, 2028 [12 months
|Demonstration Year 16 January 1, 2029, to December 31,2029 [12 months
[Demonstration Year 17 January 1, 2030, to December 31, 2030 [12 months
[ smonstration Year 18 January 1, 2031 to December 31, 2031 {12 months
53. Claiming Period. The state will report all claims for expenditures subject to the budget neutrality agreement (including any cost settlements) within two years after the calendar quarter in which the state made the expenditures. All claims for services during the demonstration period (including any cost settlements) must be made within two years after the conclusion or termination of the demonstration. During the latter two-year period, the state will continue to identify separately net expenditures related to dates of service during the operation of the demonstration on the CMS-64 waiver forms in order to properly account for these expenditures in determining budget neutrality.
54. Future Adjustments to Budget Neutrality. CMS reserves the right to adjust the budget neutrality expenditure limit:
a. To be consistent with enforcement of laws and policy statements, including regulations and guidance, regarding impermissible provider payments, health care related taxes, or other payments. CMS reserves the right to make adjustments to the budget neutrality limit if any health care related tax that was in effect during the base year, or provider-related donation that occurred during the base year, is determined by CMS to be in violation of the provider donation and health care related tax provisions of section 1903(w) of the Act. Adjustments to annual budget targets will reflect the phase out of impermissible provider payments by law or regulation, where applicable.
b. To the extent that a change in federal law, regulation, or policy requires either a reduction or an increase in FFP for expenditures made under this demonstration. In this circumstance, the state must adopt, subject to CMS approval, a modified budget neutrality agreement as necessary to comply with such change. The modified agreement will be effective upon the implementation of the change. The trend rates for the budget neutrality agreement are not subject to change under this STC. The state agrees that if mandated changes in the federal law require state legislation, the
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changes shall take effect on the day such state legislation becomes effective, or on the last day such legislation was required to be in effect under the federal law. c. The state certifies that the data it provided to establish the budget neutrality expenditure limit are accurate based on the state's accounting of recorded historical expenditures or the next best available data, that the data are allowable in accordance with applicable federal, state, and local statutes, regulations, and policies, and that the data are correct to the best of the state's knowledge and belief. The data supplied by the state to set the budget neutrality expenditure limit are subject to review and audit, and if found to be inaccurate, will result in a modified budget neutrality expenditure limit. 55. Budget Neutrality Mid-Course Correction Adjustment Request. No more than once per demonstration year, the state may request that CMS make an adjustment to its budget neutrality agreement based on changes to the state’s Medicaid expenditures that are unrelated to the demonstration and/or outside the state’s control, and/or that result from a new expenditure that is not a new demonstration-covered service or population and that is likely to further strengthen access to care.
a. Contents of Request and Process. In its request, the state must provide a description of the expenditure changes that led to the request, together with applicable expenditure data demonstrating that due to these expenditures, the state’s actual costs have exceeded the budget neutrality cost limits established at demonstration approval. The state must also submit the budget neutrality update described in STC 55(c). If approved, an adjustment could be applied retrospectively to when the state began incurring the relevant expenditures, if appropriate. After acknowledging receipt of the request, CMS will determine whether the state needs to submit an amendment pursuant to STC 7. CMS will evaluate each request based on its merit and will approve requests when the state establishes that an adjustment to its budget neutrality agreement is necessary due to changes to the state’s Medicaid expenditures that are unrelated to the demonstration and/or outside of the state’s control, and/or that result from a new expenditure that is not a new demonstration-covered service or population and that is likely to further strengthen access to care. b. Types of Allowable Changes. Adjustments will be made only for actual costs as reported in expenditure data. CMS will not approve mid-demonstration adjustments for anticipated factors not yet reflected in such expenditure data. Examples of the types of mid-course adjustments that CMS might approve include the following: i. Provider rate increases that are anticipated to further strengthen access to care; ii. CMS or state technical errors in the original budget neutrality formulation applied retrospectively, including, but not limited to the following: mathematical errors, such as not aging data correctly; or unintended omission of certain applicable costs of services for individual MEGs;
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iii. Changes in federal statute or regulations, not directly associated with Medicaid, which impact expenditures; iv. State legislated or regulatory change to Medicaid that significantly affects the costs of medical assistance; v. When not already accounted for under Emergency Medicaid 1115 demonstrations, cost impacts from public health emergencies; vi. High-cost innovative medical treatments that states are required to cover; or, vii. Corrections to coverage/service estimates where there is no prior state experience (e.g., SUD) or small populations where expenditures may vary widely. c. Budget Neutrality Update. The state must submit an updated budget neutrality analysis with its adjustment request, which includes the following elements: i. Projected without waiver and with waiver expenditures, estimated member months, and annual limits for each DY through the end of the approval period; and, ii. Description of the rationale for the mid-course correction, including an explanation of why the request is based on changes to the state’s Medicaid expenditures that are unrelated to the demonstration and/or outside the state’s control, and/or is due to a new expenditure that is not a new demonstration-covered service or population and that is likely to further strengthen access to care.
XI. MONITORING BUDGET NEUTRALITY FOR THE DEMONSTRATION
56. Monitoring Budget Neutrality for FFCY. CMS has determined that FFCY demonstration coverage is budget neutral based on CMS’s assessment that the expenditure authority granted for the demonstration has minimal federal Medicaid expenditures and these populations could have been covered through waiver only authority. The state will not be allowed to obtain budget neutrality “savings” from FFCY demonstration coverage. The demonstration will not include a budget neutrality expenditure limit for FFCY; however, the state is required to report total expenditures and member months in their demonstration monitoring reports, per STC 35. The state must still report quarterly claims and report expenditures on the CMS 64.9 WAIVER form. Failure to report FFCY expenditures and member months will result in reinstatement of the budget neutrality requirement. CMS reserves the right to request budget neutrality worksheets, requirements, limits, and analyses from the state at any time, or whenever the state seeks a change to the demonstration, per STC 7.
57. Limit on Title XIX Funding. The state will be subject to limits on the amount of federal Medicaid funding the state may receive over the course of the demonstration approval. The budget neutrality expenditure limits are based on projections of the amount of FFP that the state would likely have received in the absence of the demonstration. The limit consists of one or more Hypothetical Budget Neutrality Tests, as described below. CMS’s
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assessment of the state’s compliance with these tests will be based on the Schedule C CMS-64 Waiver Expenditure Report, which summarizes the expenditures reported by the state on the CMS-64 that pertain to the demonstration.
58. Risk. The budget neutrality expenditure limits are determined on either a per capita or aggregate basis as described in Table 2, Master MEG Chart and Table 3, MEG Detail for Expenditure and Member Month Reporting. If a per capita method is used, the state is at risk for the per capita cost of state plan and hypothetical populations, but not for the number of participants in the demonstration population. By providing FFP without regard to enrollment in the demonstration for all demonstration populations, CMS will not place the state at risk for changing economic conditions; however, by placing the state at risk for the per capita costs of the demonstration populations, CMS assures that the demonstration expenditures do not exceed the levels that would have been realized had there been no demonstration. If an aggregate method is used, the state accepts risk for both enrollment and per capita costs.
59. Calculation of the Budget Neutrality Limits and How They Are Applied. To calculate the budget neutrality limits for the demonstration, separate annual budget limits are determined for each DY on a total computable basis. Each annual budget limit is the sum of one or more components: per capita components, which are calculated as a projected without-waiver PMPM cost times the corresponding actual number of member months, and aggregate components, which project fixed total computable dollar expenditure amounts. The annual limits for all DYs are then added together to obtain a budget neutrality limit for the entire demonstration period. The federal share of this limit will represent the maximum amount of FFP that the state may receive during the demonstration period for the types of demonstration expenditures described below. The federal share will be calculated by multiplying the total computable budget neutrality expenditure limit by the appropriate Composite Federal Share.
60. Main Budget Neutrality Test. This demonstration does not include a Main Budget Neutrality Test. Budget neutrality will consist entirely of Hypothetical Budget Neutrality Tests. Any excess spending under the Hypothetical Budget Neutrality Tests must be returned to CMS.
61. Hypothetical Budget Neutrality. When expenditure authority is provided for coverage of populations or services that the state could have otherwise provided through its Medicaid state plan or other title XIX authority (such as a waiver under section 1915 of the Act), or when a WOW spending baseline for certain WW expenditures is difficult to estimate due to variable and volatile cost data resulting in anomalous trend rates, CMS considers these expenditures to be “hypothetical,” such that the expenditures are treated as if the state could have received FFP for them absent the demonstration. For these hypothetical expenditures, CMS makes adjustments to the budget neutrality test which effectively treats these expenditures as if they were for approved Medicaid state plan services. Hypothetical expenditures, therefore, do not necessitate savings to offset the
expenditures on those services. When evaluating budget neutrality, however, CMS does not offset non-hypothetical expenditures with projected or accrued savings from hypothetical expenditures; that is, savings are not generated from a hypothetical
population or service. To allow for hypothetical expenditures, while preventing them
from resulting in savings, CMS currently applies separate, independent Hypothetical Budget Neutrality Tests, which subject hypothetical expenditures to pre-determined limits to which the state and CMS agree, and that CMS approves, as a part of this demonstration approval. If the state’s WW hypothetical spending exceeds the Hypothetical Budget
Neutrality Test’s expenditure limit, the state agrees (as a condition of CMS approval) to offset that excess spending through savings elsewhere in the demonstration or to refund
the FFP to CMS. 62. Hypothetical Budget Neutrality Test: SUD #1 and SMI/SED #2. The table below identifies the MEGs that are used for Hypothetical Budget Neutrality Test. MEGs that are designated “WOW Only” or “Both” are the components used to calculate the budget neutrality expenditure limit. The Composite Federal Share for the Hypothetical Budget Neutrality Test is calculated based on all MEGs indicated as “WW Only” or “Both.” MEGs that are indicated as “WW Only” or “Both” are counted as expenditures against this budget neutrality expenditure limit. Any expenditures in excess of the limit from Hypothetical Budget Neutrality Test are counted as WW expenditures under the Main Budget Neutrality Test. Table 5. Hypothetical Budget Neutrality Test WOW PC |} Only, or | WW | Trend MEG Ag | Only, | Rate DY 13 DY 14 DY 15 DY 16 DY 17 DY 18 g* or Both SsuD PC | Both | 6.0% | $4,507.63 | $4,697.57 | $4,979.42 | $5,278.19 | $5,594.88 | $5,930.57 SMI/SED | PC | Both 5.0% | $6,755.97 | $6,993.96 | $7,344.15 | $7,711.87 | $8,097.46 | $8,502.33 63. Composite Federal Share. The Composite Federal Share is the ratio that will be used to
convert the total computable budget neutrality limit to federal share. The Composite Federal Share is the ratio calculated by dividing the sum total of FFP received by the state
on actual demonstration expenditures during the approval period by total computable
demonstration expenditures for the same period, as reported through MBES/CBES and summarized on Schedule C. Since the actual final Composite Federal Share will not be known until the end of the demonstration’s approval period, for the purpose of interim
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monitoring of budget neutrality, a reasonable estimate of Composite Federal Share may be developed and used through the same process or through an alternative mutually agreed to method. Each Budget Neutrality Test has its own Composite Federal Share, as defined in the paragraph pertaining to each particular test.
64. Budget Neutrality Monitoring Tool and Reporting Requirement. Per 4 CFR 431.428, the state must document the financial performance of the demonstration. The state must provide quarterly budget neutrality status updates that meet all reporting requirements for monitoring budget neutrality set forth in the General Financial Requirements section of these STCs (including submission of corrected budget neutrality data upon request), using the Budget Neutrality Monitoring Tool provided through the performance metrics database and analytics (PMDA) system. The tool incorporates the “Schedule C Report” for comparing the demonstration’s actual expenditures to the budget neutrality expenditure limits describe in the Monitoring Budget Neutrality for the Demonstration section. The quarterly budget neutrality status updates are due no later than 60 calendar days following the end of each demonstration quarter, while the fourth-quarter information is due no later than 90 calendar days following the end of the DY. These monitoring reports are subject to the deferral as described in STC 31. CMS will provide technical assistance upon request.4F5
65. Exceeding Budget Neutrality. CMS will enforce the budget neutrality agreement over the demonstration period, which extends from August 1, 2026 to December 31, 2031. If at the end of the demonstration approval period the Hypothetical Budget Neutrality Test(s) has been exceeded, the excess federal funds will be returned to CMS. If the demonstration is terminated prior to the end of the budget neutrality agreement, the budget neutrality test shall be based on the time elapsed through the termination date.
66. Corrective Action Plan. If at any time during the demonstration approval period CMS determines that the demonstration is on course to exceed its budget neutrality expenditure limit, CMS will require the state to submit a corrective action plan for CMS review and approval. CMS will use the threshold levels in the tables below as a guide for determining when corrective action is required.
5 Per 42 CFR 431.420(a)(2), states must comply with the terms and conditions of the agreement between the Secretary (or designee) and the state to implement a demonstration project, and 431.420(b)(1) states that the terms and conditions will provide that the state will perform periodic reviews of the implementation of the demonstration. CMS’s current approach is to include language in STCs requiring, as a condition of demonstration approval, that states provide, as part of their periodic reviews, regular reports of the actual costs which are subject to the budget neutrality limit. CMS has obtained Office of Management and Budget (OMB) approval of the monitoring tool under the Paperwork Reduction Act (OMB Control No. 0938 – 1148) and states agree to use the tool as a condition of demonstration approval.
Table 6. Budget Neutrality Test Corrective Action Plan Calculation
Demonstration Year Cumulative Target Definition Percentage
DY 13 Cumulative budget neutrality limit 2.0 percent plus:
DY 13 through DY 14 Cumulative aa ene limit 2.0 percent
DY 13 through DY 15 Cumulative aan neutrality limit 5 percent
DY 13 through DY 16 Cumulative anes hii 1.0 percent
DY 13 through DY 17 Cumulative oe neutrality limit 0.5 percent
DY 13 through DY 18 Cumulative budget neutrality limit 0.0 percent
XII. EVALUATION OF THE DEMONSTRATION
67. Cooperation with Federal Evaluators. As required under 42 CFR 431.420(f), the state shall cooperate fully and timely with CMS and its contractors in any federal evaluation of the demonstration or any component of the demonstration. This includes, but is not limited to, commenting on design and other federal evaluation documents and providing data and analytic files to CMS, including entering into a data use agreement that explains how the data and data files will be exchanged, and providing a technical point of contact to support specification of the data and files to be disclosed, as well as relevant data dictionaries and record layouts. The state shall include in its contracts with entities who collect, produce or maintain data and files for the demonstration, that they shall make such data available for the federal evaluation as is required under 42 CFR 431.420(f). This may also include the state’s participation — including representation from the state’s contractors, independent evaluators, and organizations associated with the demonstration operations, as applicable — in a federal learning collaborative aimed at cross-state technical assistance, and identification of lessons learned and best practices for demonstration measurement, data development, implementation, monitoring and evaluation. The state may claim administrative match for these activities. Failure to comply with this STC may result in a deferral being issued as outlined in STC 31.
68. Independent Evaluator. The state must use an independent entity (herein referred to as the Independent Evaluator) to conduct an evaluation of the demonstration to ensure that the necessary data is collected at the level of detail needed to research the approved hypotheses. The Independent Evaluator must sign an agreement to conduct the demonstration evaluation in an independent manner in accordance with the CMS- approved Evaluation Design. When conducting analyses and developing the evaluation reports, every effort should be made to follow the approved methodology. However, the state may request, and CMS may agree to, changes in the methodology in appropriate
circumstances.
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69. Evaluation Design. The state must submit, for CMS comment and approval, an Evaluation Design with implementation timeline no later than the first business day following 180 calendar days after the approval of the demonstration. The Evaluation Design must be developed in accordance with the STCs and any applicable CMS evaluation guidance and technical assistance for the demonstration’s policy components. The Evaluation Design must also be developed in alignment with CMS guidance on applying robust evaluation approaches, such as quasi- experimental methods like difference-in-differences and interrupted time series, as well as establishing valid comparison groups and assuring causal inferences in demonstration evaluations.
The state is strongly encouraged to use the expertise of the Independent Evaluator in the development of the Evaluation Design. The Evaluation Design also must include a timeline for key evaluation activities, including the deliverables outlined in STCs 73 and 74.
For any amendment to the demonstration, the state will be required to update the approved Evaluation Design to accommodate the amendment component, unless otherwise agreed upon by the state and CMS. The amended Evaluation Design must be submitted to CMS for review no later than the first business day following 180 calendar days after CMS’s approval of the demonstration amendment. The amendment components of the Evaluation Design must also be reflected in the state’s Interim and Summative Evaluation Reports, described below.
70. Evaluation Design Approval and Updates. The state must submit a revised Evaluation Design no later than the first business day following 60 calendar days after receipt of CMS’s comments, if any. Upon CMS approval of the Evaluation Design, the document will be posted to Medicaid.gov. Per 42 CFR 431.424(c), the state will publish the approved Evaluation Design no later than the first business day following 30 calendar days of CMS approval. The state must implement the Evaluation Design and submit a description of its evaluation progress in each Annual Monitoring Report. Once CMS approves the Evaluation Design, if the state wishes to make changes and the changes are substantial in scope, the state must submit a revised Evaluation Design to CMS for approval; otherwise, in consultation with CMS, the state may include updates to the Evaluation Design in an Annual Monitoring Report.
71. Evaluation Questions and Hypotheses. Consistent with the STCs and applicable CMS guidance, the evaluation deliverables must include a discussion of the evaluation questions and hypotheses that the state intends to test. In alignment with applicable CMS evaluation guidance and technical assistance, the evaluation must outline and address well-crafted hypotheses and research questions for all key demonstration policy components that support understanding of the demonstration’s impact and its effectiveness in achieving the demonstration’s goals.
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The hypothesis testing should include, where possible, assessment of both process and outcome measures. The evaluation must study outcomes, such as eligibility and various measures of access, utilization, costs, and health outcomes, as appropriate and in alignment with applicable CMS evaluation guidance and technical assistance for the demonstration policy components. The evaluation is expected to use applicable demonstration monitoring and other data on the provision of and beneficiary utilization of demonstration and other applicable services. Proposed measures should be selected from nationally recognized sources and national measures sets, where possible. Measures sets could include the Consumer Assessment of Health Care Providers and Systems (CAHPS), the Medicaid and CHIP Core Sets of Health Care Quality measures, commonly referred to as the Child and Adult Core Sets, the Behavioral Risk Factor Surveillance System (BRFSS) survey, or measures endorsed by National Quality Forum (NQF).
The state must develop robust evaluation questions and hypotheses related to each demonstration initiative, and per applicable CMS guidance. Specifically:
a. Hypotheses for the SUD component of the demonstration must align with the goals of the program, including increasing rates of identification and initiation of and engagement in treatment as well as adherence to and retention in treatment, reducing overdose deaths, reducing utilization of emergency departments and inpatient hospitalizations as well as readmissions to the same or higher levels of care, and improving access to care for physical health conditions. b. Hypotheses for the SMI/SED component must map to the goals of the program, including reducing utilization and lengths of stay in emergency departments, reducing preventable readmissions to acute care hospitals and residential settings, improving the availability of crisis stabilization services, improving access to community-based services, and improving care coordination.
As part of its evaluation efforts, the state must also conduct an overall demonstration cost assessment to include, but not be limited to, administrative costs of demonstration implementation and operation and Medicaid health services expenditures. In addition, the state must use findings from hypothesis tests aligned with other demonstration goals and cost analyses to assess the demonstration’s effects on the fiscal sustainability of the state’s Medicaid program.
CMS underscores the importance of the state undertaking a well-designed beneficiary survey or interviews to assess, for instance, beneficiary understanding of the demonstration policy components and beneficiary experiences with access to and quality of care. To better understand whether implementation of certain key demonstration policies happened as envisioned during the demonstration design process and whether specific factors acted as facilitators of—and barriers to—implementation, the state is strongly encouraged to undertake a robust process/implementation evaluation. The implementation evaluation can inform the state’s crafting and selection of testable hypotheses and research questions for the demonstration’s outcome and impact evaluations and provide context for interpreting the findings.
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Finally, the state may collect data to support analyses stratified by key subpopulations of interest (e.g., by sex, age, race/ethnicity, or geography). Such stratified data analyses can provide a fuller understanding of gaps in access to and quality of care and health outcomes, as well as help inform how the demonstration’s various policies support improving outcomes.
72. Evaluation Budget. A budget for the evaluations must be provided with the Evaluation Design. It will include the total estimated cost, as well as a breakdown of estimated staff, administrative and other costs for all aspects of the evaluations such as any survey and measurement development, quantitative and qualitative data collection and cleaning, analyses and report generation. A justification of the costs may be required by CMS if the estimates provided do not appear to sufficiently cover the costs of the design or if CMS finds that the designs are not sufficiently developed, or if the estimates appear to be excessive.
73. Interim Evaluation Report. The state must submit an Interim Evaluation Report for the completed years of the demonstration, and for each subsequent extension of the demonstration, as outlined in 42 CFR 431.412(c)(2)(vi). The draft Interim Evaluation Report must be developed in alignment with the approved Evaluation Design, and in accordance with the requirements outlined in these STCs and applicable CMS guidance.
a. The Interim Evaluation Report will discuss evaluation progress and present findings to date as per the approved Evaluation Design.
b. For demonstration authority or any component within the demonstration that expires prior to the overall demonstration’s expiration date, and depending on the timeline of the expiration/phase-out, the Interim Evaluation Report must include an evaluation of the authority, to be collaboratively determined by CMS and the state.
c. If the state is seeking to extend the demonstration, the draft Interim Evaluation Report is due when the application for extension is submitted, or one year prior to the end of the demonstration, whichever is sooner. When applying for an extension of the demonstration, the Interim Evaluation Report should be posted to the state’s website with the application for public comment. If the state does not request an extension for the demonstration, the Interim Evaluation Report is due one year prior to the end of the demonstration. For demonstration phase-outs prior to the expiration of the approval period, the draft Interim Evaluation Report is due to CMS on the date that will be specified in the notice of termination or suspension.
d. The state must submit a revised Interim Evaluation Report no later than the first business day following 60 calendar days after receiving CMS comments on the draft Interim Evaluation Report, if any.
e. Once approved by CMS, the state must post the final Interim Evaluation Report to
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the state’s Medicaid website no later than the first business day following 30 calendar days after CMS approval.
74. Summative Evaluation Report. The state must submit the draft Summative Evaluation Report for the demonstration’s current approval period no later than the first business day following 18 months after the end of the approval period represented by these STCs. The draft Summative Evaluation Report must be developed in alignment with the approved Evaluation Design, and in accordance with the requirements outlined in these STCs and applicable CMS guidance.
a. The state must submit a revised Summative Evaluation Report no later than the first business day following 60 calendar days after receiving comments from CMS on the draft Summative Evaluation Report, if any.
b. Once approved by CMS, the state must post the final Summative Evaluation Report to the state’s Medicaid website no later than the first business day following 30 calendar days after CMS approval.
75. Corrective Action Plan Related to Evaluation. If evaluation findings indicate that demonstration features are not likely to assist in promoting the objectives of Medicaid, CMS reserves the right to require the state to submit a corrective action plan to CMS for approval. These discussions may also occur as part of an extension process when associated with the state’s Interim Evaluation Report, or as part of the review of the Summative Evaluation Report. A corrective action plan could include a temporary suspension of implementation of demonstration programs, in circumstances where evaluation findings indicate substantial and sustained directional change inconsistent with demonstration goals, such as substantial and sustained trends indicating increased difficulty accessing services. A corrective action plan may be an interim step to withdrawing waivers or expenditure authorities, as outlined in STC 10. CMS further has the ability to suspend implementation of the demonstration should corrective actions not effectively resolve these concerns in a timely manner.
76. State Presentations for CMS. CMS reserves the right to request that the state present and participate in a discussion with CMS on the Evaluation Design, the Interim Evaluation Report, and/or the Summative Evaluation Report.
77. Public Access. The state shall post the final documents (e.g., Annual Monitoring Report, Close-Out Report, Evaluation Design, Interim Evaluation Report, and Summative Evaluation Report) on the state’s Medicaid website no later than the first business day following 30 calendar days of approval by CMS.
78. Additional Publications and Presentations. For a period of 12 months following CMS approval of the final reports, CMS will be notified prior to presentation of these reports or their findings, including in related publications (including, for example, journal articles),
by the state, contractor, or any other third party directly connected to the demonstration. Prior to release of these reports, articles or other publications, CMS will be provided a copy including any associated press materials. CMS will be given 30 calendar days to review and comment on publications before they are released. CMS may choose to decline to comment or review some or all of these notifications and reviews.
XII. SCHEDULE OF DELIVERABLES FOR THE DEMONSTRATION PERIOD
Annual Monitoring Report
No later than the first business day following 180 calendar days after the end of each demonstration year.
STC 35
Mid-Point Assessment
No later than December 31, 2029
Revised no later than the first business day following 60 days after receipt of CMS comments.
STC 36
Evaluation Design
No later than the first business day following 180 calendar days after approval of the demonstration.
Revised no later than the first business day following 60 days after receipt of CMS comments.
STCs 69, 70, 71
Interim Evaluation Report
One year prior to the end of the demonstration period, or when the extension application is submitted, whichever is sooner.
Revised no later than the first business day following 60 calendar days after receipt of CMS comments.
STC 73
Summative Evaluation Report
No later than the first business day following 18 months after the end of the demonstration
period.
Revised no later than the first business day following 60 calendar days after receipt of CMS comments.
STC 74
SUD Implementation Plan (including Health IT Plan)
90 calendar days after demonstration approval
Revised no later than the first business day following 60 calendar days after receipt of CMS comments.
STC 19 and 20
Building and Transforming Coverage, Services and Supports for a Healthier Virginia Approval Period: August 1, 2026 through December 31, 2031
Page 47 of 51
Building and Transforming Coverage, Services and Supports for a Healthier Virginia Approval Period: August 1, 2026 through December 31, 2031 Page 48 of 51
SMI/SED Implementation Plan (including Health IT Plan and Financing Plan)
90 calendar days after demonstration approval
Revised no later than the first business day following 60 calendar days after receipt of CMS comments. STC 23, 24, and 25 CMS-64 Quarterly Medicaid Expenditure Report
30 calendar days after the end of each quarter STC 42 Quarterly Budget Neutrality Monitoring Report
60 calendar days after the end of each demonstration quarter except the 4th quarter which is due 90 days after the end of each DY STC 64
Building and Transforming Coverage, Services and Supports for a Healthier Virginia Approval Period: August 1, 2026 through December 31, 2031 Page 49 of 51
Attachment A: Evaluation Design (RESERVED)
Building and Transforming Coverage, Services and Supports for a Healthier Virginia Approval Period: August 1, 2026 through December 31, 2031 Page 50 of 51
ATTACHMENT B: SUD Implementation Plan (RESERVED)
Building and Transforming Coverage, Services and Supports for a Healthier Virginia Approval Period: August 1, 2026 through December 31, 2031 Page 51 of 51
ATTACHMENT C: SMI/SED Implementation Plan (RESERVED)
DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop S2-26-12 Baltimore, Maryland 21244-1850
November 18, 2021
Karen Kimsey Director Virginia Department of Medical Assistance Services 600 East Broad Street Richmond, VA 23219
Dear Ms. Kimsey:
The Centers for Medicare & Medicaid Services (CMS) is approving Virginia’s request to amend its section 1115 demonstration project entitled, “Virginia Family Access to Medical Insurance Security (FAMIS) MOMS and FAMIS Select” (Project Nos. 21-W-00058/3 and 11-W-00381/3), in accordance with section 1115(a) of the Social Security Act. Approval of this demonstration amendment will enable the Commonwealth to test the effects of providing state plan benefits to postpartum individuals in Medicaid and the Children’s Health Insurance Program (CHIP), with income up to and including 200 percent of the federal poverty level (FPL), for a total of 12 months. The Commonwealth will also provide continuous eligibility for these individuals during the entire postpartum period, ensuring continuity of coverage.
We have determined that this amendment will promote the objectives of Medicaid and CHIP by increasing and strengthening overall coverage and improving the health of mothers in Virginia, as well as reducing the rate of maternal mortality in the Commonwealth by addressing continuity of care for individuals postpartum. This approval is effective November 18, 2021 through June 30, 2029, except where otherwise noted in the expenditure authorities; and upon such date, unless extended or otherwise amended, all authorities granted to operate this demonstration will expire.
Consistent with CMS’s requirements for all section 1115 demonstrations, and as outlined in the Special Terms and Conditions (STCs), Virginia will be required to undertake systematic monitoring and a thorough evaluation of the demonstration. Throughout the life-cycle of the demonstration approval period, monitoring will support tracking the Commonwealth’s progress towards its demonstration goals, and we expect that such monitoring will accommodate new policy areas such as those approved with this amendment. Similarly, the Commonwealth will update the evaluation design to address this amendment component, to ensure a careful assessment of whether the demonstration initiatives, including those in the amendment, are effective in producing the desired outcomes for enrollees as well as for the CHIP and Medicaid programs overall.
Page 2 – Ms. Karen Kimsey
CMS’s approval of this section 1115(a) demonstration amendment is subject to the limitations specified in the attached expenditure authorities, STCs, and any supplemental attachments defining the nature, character, and extent of federal involvement in this project. The Commonwealth may deviate from Medicaid and CHIP state plan requirements only to the extent those requirements have been specifically listed as waived or not applicable under the demonstration.
Consideration of Public Comments
The Commonwealth provided public notice for this amendment in accordance with the processes described in the September 27, 1994 Federal Register notice (59 FR 49249) as generally acceptable methods of state public notice for demonstration amendments. CMS generally considers a state to have provided acceptable public notice if the state provides for a formal notice and comment process on the section 1115 proposal in accordance with the state’s administrative procedure act; provided that such notice is given at least 30 days prior to submission to CMS. Accordingly, Virginia conducted a 31-day public comment period and held one virtual meeting for the public to provide input. The Commonwealth received 24 comments from individual members of the public as well as representatives of 20 organizations and all were in support of the amendment.
Virginia also conducted tribal consultation with its seven federally recognized tribes by providing written notice on January 29, 2021 and a 60-day tribal comment period on the proposed amendment. The Commonwealth did not receive any comments from the tribes.
Consistent with the CMS April 27, 2012 State Medicaid Director/State Health Official Letter on the “Revised Review and Approval Process for Section 1115 Demonstrations” (SHO# 12- 001), a federal public comment period was opened from April 7, 2021 to May 7, 2021. CMS received 14 comments that represented 50 enrollee and provider advocacy organizations. All commenters strongly advocated support of the state’s proposal to extend the postpartum eligibility period; providing national and Virginia specific maternal health statistics to promote this amendment as a critical step to reducing maternal mortality and morbidity for lower income individuals as well as racial disparities in maternal and infant health outcomes.
The award is subject to CMS receiving written acceptance of this award within 30 days of the date of this approval letter. Your project officer is Ms. Ticia Jones. Ms. Jones is available to answer any questions concerning implementation of the Commonwealth’s section 1115(a) demonstration and her contact information is as follows:
Centers for Medicare & Medicaid Services Center for Medicaid and CHIP Services Mail Stop: S2-01-16 7500 Security Boulevard Baltimore, Maryland 21244-1850 Email: Ticia.Jones@cms.hhs.gov
Page 3 – Ms. Karen Kimsey
We appreciate your commitment to improving the health of people in Virginia, and we look forward to our continued partnership on the Virginia FAMIS MOMS and FAMIS Select section 1115(a) demonstration. If you have any questions regarding this approval, please contact Ms. Judith Cash, Director, State Demonstrations Group, Center for Medicaid and CHIP Services, at (410) 786-9686.
Sincerely,
Daniel Tsai
Deputy Administrator and Director
Enclosures
cc: Margaret Kosherzenko, State Monitoring Lead, Medicaid and CHIP Operations Group
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Page 1 of 3 CMS Approved October 25, 2019 – June 30, 2029; amended November 18, 2021
CENTERS FOR MEDICARE & MEDICAID SERVICES EXPENDITURE AUTHORITY
NUMBER: 21-W-00058/3 and 11-W-00381/3
TITLE:
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration
AWARDEE: Virginia Department of Medical Assistance Services Expenditure Authority
All requirements of Medicaid and the Children’s Health Insurance Program (CHIP) shall apply to the demonstration populations and expenditures listed below, except those identified below as “not applicable.” All Medicaid and CHIP rules not expressly waived or identified as not applicable in this document shall apply to the demonstration. These expenditure and “non- applicable” authorities, as well as the associated Special Terms and Conditions (STCs), are in effect as of November 18, 2021, the date on the accompanying CMS approval letter, through June 30, 2029, except where otherwise noted in these expenditure authorities.
Under the authority of section 1115(a)(2) of the Social Security Act (the Act), expenditures made by the Commonwealth of Virginia for the items identified below (which are not otherwise included as expenditures under section 1903 or section 2107(e)(2)(A)) shall, for the period of this demonstration in accordance with the STCs, be regarded as matchable expenditures under Virginia’s title XXI and title XIX state plan:
Title XXI Expenditure Authority:
1. Expenditures for extending health insurance coverage through CHIP to uninsured pregnant individuals with income up to and including 200 percent of the federal poverty level (FPL), who are not otherwise Medicaid eligible. This includes those pregnant individuals who are lawfully residing in the United States and those with access to state employees’ health benefit coverage. These expenditures are authorized for the “FAMIS MOMS” component of the demonstration.
Should the Commonwealth freeze enrollment or otherwise discontinue coverage of the CHIP pregnant woman population, the title XXI expenditure authority will terminate and will not be subject to extension.
2. Expenditures for extending health insurance coverage to children in families with income up to and including 200 percent of the FPL, who are eligible for Virginia’s separate title XXI CHIP coverage but choose to elect a monthly premium assistance subsidy for private or employer-sponsored insurance coverage. These expenditures are authorized for the “FAMIS Select” component of the demonstration.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Page 2 of 3 CMS Approved October 25, 2019 – June 30, 2029; amended November 18, 2021
3. Expenditures for extending the postpartum eligibility period for FAMIS MOMS from the end of the month in which the 60th postpartum day occurs to the end of the 12th month following the end of the pregnancy. These expenditures are authorized for the “postpartum extension” component of the demonstration.
This expenditure authority is limited to a five-year period starting on April 1, 2022 through March 31, 2027 for CHIP “lawfully residing” pregnant individuals as described in STC 17.
4. Expenditures for pregnant and postpartum individuals to be continuously eligible without regard to changes in circumstances through the end of the 12-month extended postpartum eligibility period as set forth in STC 17.
This expenditure authority is limited to a five-year period starting on April 1, 2022 through March 31, 2027 for CHIP “lawfully residing” pregnant individuals as described in STC 17.
The following title XXI requirements are not applicable to the populations served under the Virginia FAMIS MOMS and FAMIS Select section 1115 demonstration.
Title XXI Requirements Not Applicable to the Expenditure Authorities:
1. General Requirements, Eligibility and Outreach
Section 2102
The Commonwealth’s CHIP does not have to reflect the demonstration populations, and eligibility standards do not have to be limited by the general principles in section 2102(b) of the Act. To the extent other requirements in section 2102 of the Act duplicate Medicaid or other CHIP requirements for these or other populations, they do not apply, except that the Commonwealth must perform eligibility screening to ensure that the demonstration populations do not include individuals otherwise eligible for Medicaid.
2. Cost Sharing
Section 2103(e)
Rules governing cost sharing under section 2103(e) of the Act shall not apply to the “FAMIS Select” component of the demonstration to the extent necessary to enable the Commonwealth to impose cost sharing in private or employer-sponsored insurance plans.
3. Cost-Sharing Exemption for American Indian/
Section 2102(b)(3)(D) Alaskan Native (Al/AN) Children
42 CFR Section 457.535
To the extent necessary to permit the Commonwealth to impose cost sharing on AI/AN children who elect to enroll in the premium assistance program.
4. Benefit Package Requirements
Section 2103
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Page 3 of 3 CMS Approved October 25, 2019 – June 30, 2029; amended November 18, 2021
To permit the Commonwealth to offer a benefit package that does not meet the requirements of section 2103 at 42 CFR section 457.4 10(b)(1) for the demonstration populations.
5. Federal Matching Payment and Family Coverage Limits Section 2105
Federal matching payment in excess of the 10-percent cap for expenditures related to the demonstration population and limits on family coverage are not applicable to the demonstration population.
Title XIX Expenditure Authority:
1. Expenditures for extending the postpartum eligibility period for pregnant and postpartum individuals enrolled in any Medicaid state plan eligibility group from the end of the month in which the 60th postpartum day occurs to the end of the 12th month following the end of the pregnancy. These expenditures are authorized for the “postpartum extension” component of the demonstration.
This expenditure authority is limited to a five-year period starting on April 1, 2022 through March 31, 2027 for Medicaid “lawfully residing” pregnant individuals as described in STC 17.
2. Expenditures for pregnant and postpartum individuals to be continuously eligible without regard to changes in circumstances through the end of the 12-month extended postpartum eligibility period as set forth in STC 17.
This expenditure authority is limited to a five-year period starting on April 1, 2022 through March 31, 2027 for Medicaid “lawfully residing” pregnant individuals as described in STC 17.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 1 of 61 CENTERS FOR MEDICARE & MEDICAID SERVICES SPECIAL TERMS AND CONDITIONS (STCs)
DEMONSTRATION NUMBERS: 21-W-00058/3 and 11-W-00381/3
TITLE: FAMIS MOMS and FAMIS Select
AWARDEE: Virginia Department of Medical Assistance Services
I. PREFACE
The following are Special Terms and Conditions (STCs) for the Virginia FAMIS MOMS and FAMIS Select section 1115 demonstration program. The parties to this agreement are the Virginia Department of Medical Services (Commonwealth) and the Centers for Medicare & Medicaid Services (CMS). These STCs set forth in detail the nature, character, and extent of federal involvement in the demonstration and the Commonwealth’s obligations to CMS during the approved demonstration period specified in these STCs. All previously approved STCs, waivers, and expenditure authorities are superseded by the STCs set forth below. These STCs are effective November 18, 2021, the date of the CMS approval letter that accompanied these STCs, through June 30, 2029.
The STCs have been arranged into the following subject areas:
II. Program Description and Historical Context III. General Program Requirements IV. Eligibility and Enrollment V. Benefits VI. Cost Sharing VII. Delivery System VIII. General Reporting Requirements IX. Monitoring X. Evaluation of the Demonstration XI. General Financial Requirements XII. Monitoring Allotment Neutrality XIII. Monitoring Budget Neutrality
Attachment A: Developing the Evaluation Design Attachment B: Preparing the Interim and Summative Evaluation Reports Attachment C: CMS Approved Demonstration Evaluation Plan Attachment D: Proxy Methodology for the Title XIX New Adult Group (reserved for CMS approval)
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 2 of 61
II. PROGRAM DESCRIPTION AND HISTORICAL CONTEXT
Demonstration Description
Virginia's FAMIS MOMS and FAMIS Select demonstration has three components.
The first component of the demonstration entitled, “FAMIS MOMS” provides coverage to uninsured pregnant individuals, including lawfully residing pregnant individuals, in families with income up to and including 200 percent of the federal poverty level (FPL) who are not otherwise eligible for Medicaid. “FAMIS MOMS” also provides coverage to pregnant individuals with access to state employees’ health benefit coverage (in accordance with the hardship exception as provided in section 2110(b)(6)(C) of the Social Security Act (the Act)); thereby aligning the Commonwealth’s coverage of pregnant individuals with the expansion of CHIP coverage to children of state employees. FAMIS MOMS coverage is the same as that provided to pregnant individuals under the Medicaid state plan. Under the demonstration, Virginia is also authorized to deem infants born to FAMIS MOMS to be eligible for Medicaid or CHIP coverage, as appropriate, consistent with 42 CFR 435.117 and 457.360. These infants are deemed eligible on the date of birth and remain eligible until attaining the age of 1.
The second component of the demonstration entitled, the “FAMIS Select” program, provides premium assistance for private or employer-sponsored insurance to uninsured children, ages 0 through 18, in families with income up to and including 200 percent of the FPL, who are eligible for direct CHIP state plan coverage. These individuals are provided the option to receive premium assistance for private employer-sponsored insurance and supplemental immunization benefits in lieu of receiving coverage under the CHIP state plan. However, these individuals still retain the right to elect to receive direct CHIP coverage at any time.
The third component of the demonstration, effective as of the date of these amended STCs, extends the postpartum eligibility period from the end of the month in which the 60th postpartum day occurs to the end of the 12th month following the end of the pregnancy, for the “FAMIS MOMS” population and pregnant individuals in any Medicaid state plan eligibility group. As described in STC 17, individuals who are within 12 months postpartum but whom are outside of the state plan 60-day postpartum coverage period (including those who were not enrolled in Virginia Medicaid or CHIP while pregnant), have household income up to and including 200 percent of the FPL, and meet all other Medicaid or CHIP eligibility criteria may receive extended postpartum coverage.
Demonstration History
The Virginia FAMIS MOMS and FAMIS Select demonstration was initially approved on June 30, 2005 and implemented August 1, 2005.
FAMIS MOMS Virginia implemented the FAMIS MOMS program incrementally beginning August 1, 2005. The intent of this demonstration program component is to provide prenatal care to uninsured
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 3 of 61 individuals within the title XXI income range and likely to give birth to FAMIS-eligible (i.e., CHIP state plan) children. The first stage expanded eligibility to pregnant individuals with family income above the Medicaid limit of 133 percent of the FPL but less than or equal to 150 percent of the FPL. The second stage, implemented September 1, 2006, covered pregnant individuals with incomes through 166 percent of the FPL. Subsequent stages covered pregnant individuals through 185 percent of the FPL (July 1, 2007) and through 200 percent of the FPL (July 1, 2009). Effective July 1, 2010, CMS approved an amendment to eligibility requirements to allow enrollment of pregnant individuals with income below 133 percent of the FPL who do not meet eligibility requirements for full Medicaid coverage but do meet the FAMIS MOMS requirements.
During the period January 1, 2014 through November 30, 2014, this demonstration component was phased-out because the Virginia General Assembly adopted an amendment to the Commonwealth’s biennial budget directing the Commonwealth to phase-out and eliminate the FAMIS MOMS program when health insurance coverage under the Federally Facilitated Marketplace (FFM) became available on January 1, 2014. New applications for FAMIS MOMS coverage were not accepted after December 31, 2013. However, individuals enrolled in FAMIS MOMS on or prior to December 31, 2013 retained eligibility for the duration of their coverage period. Any application received for pregnancy coverage beginning January 1, 2014 through November 30, 2014, was screened for Medicaid under pregnant individuals eligibility and for CHIP. If the applicant was ineligible for Medicaid or CHIP, the application was transferred to the FFM. Beginning on December 1, 2014, enrollment was reopened and new applications accepted for uninsured pregnant individuals with income up to and including 200 percent of the FPL. This income eligibility threshold aligns with children’s coverage levels under the CHIP state plan.
On April 3, 2015, CMS approved a demonstration amendment to add coverage for dental services to the FAMIS MOMS program component, consistent with the addition of these benefits for pregnant individuals under Medicaid. This demonstration amendment also allowed eligibility to be expanded to include pregnant individuals with access to subsidized health insurance through state employee benefits.
The title XXI goals and objectives of the FAMIS MOMS program are as follows:
• Facilitate access to prenatal care for FAMIS MOMS participants; and, • Improve selected birth outcomes of FAMIS MOMS participants and their newborns.
FAMIS Select Virginia implemented the FAMIS Select program beginning August 1, 2005. FAMIS Select replaced Virginia's former employer-sponsored health insurance program and provides an alternative for families with children enrolled in FAMIS (i.e., the CHIP state plan) and who have access to private or employer-sponsored coverage. The Commonwealth provides a set monthly premium assistance subsidy for health insurance coverage for children with family income up to 200 percent of the FPL who are eligible for direct coverage in FAMIS. All children are first enrolled in FAMIS. Parents may then choose the premium assistance subsidy in lieu of direct FAMIS coverage for their child(ren). Premium assistance payments are paid directly to the
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 4 of 61 family based on verified payroll withholding amounts; with the maximum subsidy not to exceed a family’s total share of the total monthly premium.
Parents that choose FAMIS Select are responsible for all cost-sharing associated with the private or employer-sponsored plan. Virginia does not wrap benefits with the exception of immunizations if the family’s chosen plan does not provide such coverage.
The title XXI goals and objectives of the FAMIS Select program is as follows:
• Facilitate access to affordable private and employer-sponsored health insurance for low- income families through premium assistance; • Monitor and ensure member satisfaction with the FAMIS Select program; and, • Assure the aggregate cost-effectiveness of the FAMIS Select program.
Postpartum Extension for FAMIS MOMS and Medicaid State Plan Pregnant Individuals On November 18, 2020, Virginia Governor Ralph Northam signed into law the 2020 Special Session I Virginia Acts of Assembly, Chapter 56, directing the Department of Medical Assistance Services (DMAS) to seek federal approval to cover pregnant individuals for up to 12‐ months postpartum. Accordingly, Virginia submitted this section 1115 amendment request on March 31, 2021, and following the effective date of these STCs and an operational ramp-up period, will begin to implement the extension of postpartum coverage to provide a full 12-month period following the end of pregnancy. The 12-month postpartum period will be implemented statewide and made available to pregnant and postpartum individuals as detailed in STC 17.
This program component will support the demonstration’s goal of facilitating access to prenatal, obstetric, and postpartum care, particularly for those in the Commonwealth facing the highest rates of maternal and infant mortality and morbidity. This amendment is expected to improve continuity of coverage and access to care for Medicaid and CHIP enrolled individuals during the postpartum period and will be evaluated on whether 12‐months postpartum coverage reduces maternal and infant mortality and morbidity, improves health outcomes for both the mother and the infant, and advances health equity.
III. GENERAL PROGRAM REQUIREMENTS
1. Compliance with Federal Non-Discrimination Statutes. The Commonwealth must comply with applicable federal statutes relating to non-discrimination. These include, but are not limited to, the Americans with Disabilities Act of 1990 (ADA), Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973 (Section 504), the Age Discrimination Act of 1975, and Section 1557 of the Affordable Care Act (Section 1557).
2. Compliance with Medicaid and CHIP Law, Regulation, and Policy. All requirements of Medicaid and CHIP expressed in law, regulation, and policy statement, not expressly waived or identified as not applicable in the waiver and expenditure authority documents (of which these terms and conditions are part), must apply to the demonstration.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 5 of 61 3. Changes in Medicaid and CHIP Law, Regulation, and Policy. The Commonwealth must, within the timeframes specified in law, regulation, or policy statement, come into compliance with any changes in federal law, regulation, or policy affecting the Medicaid or CHIP programs that occur during this demonstration approval period, unless the provision being changed is expressly waived or identified as not applicable. In addition, CMS reserves the right to amend the STCs to reflect such changes and/or changes as needed without requiring the state to submit an amendment to the demonstration under STC 7. CMS will notify the state 30 days in advance of the expected approval date of the amended STCs to allow the state to provide comment. Changes will be considered in force upon issuance of the approval letter by CMS. The state must accept the changes in writing.
4. Impact of Changes in Federal Law, Regulation, and Policy on the Demonstration.
a. To the extent that a change in federal law, regulation, or policy requires either a reduction or an increase in federal financial participation (FFP) for expenditures made under this demonstration, the Commonwealth must adopt, subject to CMS approval, a modified budget and/or allotment neutrality agreement for the demonstration as necessary to comply with such change. The modified budget and/or allotment neutrality agreement will be effective upon the implementation of the change. Further, the Commonwealth reserves the right to seek an amendment to the demonstration (as per STC 7) as a result of the change in FFP.
b. If mandated changes in the federal law requires legislation by the Commonwealth, unless otherwise prescribed by the terms of the federal law, the changes must take effect on the day such legislation enacted by the Commonwealth becomes effective, or on the last day such legislation was required to be in effect under federal law, whichever is sooner.
5. State Plan Amendments. The Commonwealth will not be required to submit title XIX or title XXI state plan amendments for changes affecting any populations made eligible solely through the demonstration. If a population eligible through the Medicaid or CHIP state plan is affected by a change to the demonstration, a conforming amendment to the appropriate state plan may be required, except as otherwise noted in these STCs. In all such instances, the Medicaid and CHIP state plans governs.
6. Changes Subject to the Amendment Process. Changes related to demonstration features, such as eligibility, enrollment, enrollee rights, benefits, beneficiary rights, delivery systems, cost-sharing, sources of non-federal share of funding, allotment neutrality, and other comparable program elements must be submitted to CMS as amendments to the demonstration. All amendment requests are subject to approval at the discretion of the Secretary in accordance with section 1115 of the Act. The Commonwealth must not implement or begin operational changes to these elements without prior approval by CMS of the amendment to the demonstration. In certain instances, companion amendments to the Medicaid or CHIP state plan may be required as well. Amendments to the demonstration are not retroactive and no FFP of any kind, including for administrative or service-based
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 6 of 61 expenditures, will be available for changes to the demonstration that have not been approved through the amendment process set forth in STC 7, except as provided in STC 3.
7. Amendment Process. Requests to amend the demonstration must be submitted to CMS for approval no later than 120 days prior to the planned date of implementation of the change and may not be implemented until approved. CMS reserves the right to deny or delay approval of a demonstration amendment based on non-compliance with these STCs, including but not limited to failure by the Commonwealth to submit required elements of a viable amendment request as specified in this STC and submission of required deliverables specified in these STCs in accordance with the deadlines specified herein. Amendment requests must include, but are not limited to, the following:
a. Demonstration Amendment Summary and Objectives. The Commonwealth must provide a detailed description of the amendment, including what Virginia intends to demonstrate via this amendment as well as the impact on beneficiaries, with sufficient supporting documentation, the objective of the change and desired outcomes including a conforming title XIX and/or title XXI state plan amendment, if necessary;
b. Allotment Neutrality Worksheet (for changes impacting title XXI funding). The Commonwealth must provide an up-to-date CHIP allotment neutrality worksheet that identifies the impact of the proposed amendment on the Commonwealth’s available title XXI allotment;
c. Budget Neutrality Worksheet (for changes impacting title XIX funding). The Commonwealth must provide an up-to-date data analysis which identifies the specific “with waiver” impact of the proposed amendment on the current budget neutrality agreement. Such analysis must include current total computable “with waiver” and “without waiver” status on both a summary and detailed level through the current approval period using the most recent actual expenditures, as well as summary and detailed projections of the change in the “with waiver” expenditure total as a result of the proposed amendment, which isolates (by Eligibility Group) the impact of the amendment.
d. Waiver and Expenditure Authorities. The Commonwealth must provide a list of waivers and expenditure authorities that are being requested or terminated, along with the programmatic description of why these waivers and expenditure authorities are being requested for the amendment;
e. Evaluation. The Commonwealth must provide updates to existing demonstration reporting and quality and evaluation plans. This includes a description of how the evaluation design and annual progress reports will be modified to incorporate the amendment provisions, as well as the oversight, monitoring, and measurement of the provisions; and,
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 7 of 61 f. Public Notice. An explanation of the public process used by Virginia, consistent with the requirements of STC 13. Such explanation must include a summary of any public feedback received and identification of how this feedback was addressed by the Commonwealth in the final amendment request submitted to CMS.
8. Extension of the Demonstration. States that intend to request an extension of the demonstration must submit an application to CMS from the Governor of the state in accordance with the requirements of 42 CFR 431.412(c). States that do not intend to request an extension of the demonstration beyond the period authorized in these STCs, must submit a phase-out plan consistent with the requirements of STC 9.
9. Demonstration Phase-Out. The Commonwealth may only suspend or terminate this demonstration in whole, or in part, consistent with the following requirements.
a. Notification of Suspension or Termination. The Commonwealth must promptly notify CMS in writing of the reason(s) for the suspension or termination, together with the effective date and a transition and phase-out plan. The Commonwealth must submit its notification letter and a draft transition and phase-out plan to CMS no less than six months before the effective date of the demonstration’s suspension or termination. Prior to submitting the draft transition and phase-out plan to CMS, the Commonwealth must publish on its website the draft transition and phase-out plan for a 30-day public comment period. In addition, the Commonwealth must conduct tribal consultation in accordance with STC 13. Once the 30-day public comment period has ended, the Commonwealth must provide a summary of each public comment received, the Commonwealth’s response to the comment, and how the Commonwealth considered the comments received when developing the revised transition and phase-out plan.
b. Transition and Phase-out Plan Requirements. The Commonwealth must minimally include in its phase-out plan the process by which it will notify affected beneficiaries; the content of said beneficiary notices (including information on the beneficiary’s appeal rights); the process by which the Commonwealth will conduct administrative reviews of Medicaid or CHIP eligibility prior to the termination of the demonstration for the affected beneficiaries; the process by which the Commonwealth will ensure ongoing coverage for eligible beneficiaries; and undertake any community outreach activities to notify affected beneficiaries (including any community resources that are available).
c. Transition and Phase-out Plan Approval: The Commonwealth must obtain CMS approval of the transition and phase-out plan prior to the implementation of transition and phase-out activities. Implementation of transition and phase-out activities must be no sooner than 14 calendar days after CMS approval of the transition and phase-out plan.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 8 of 61 d. Transition and Phase-out Procedures. The Commonwealth must comply with applicable notice requirements found in 42 CFR, part 431 subpart E, including sections 431.206, 431.210, and 431.213. In addition, the state must assure all applicable and hearing rights are afforded to beneficiaries in the demonstration as outlined in 42 CFR, part 431 subpart E, including 431.220 and 431.221. If a beneficiary in the demonstration requests a hearing before the date of action, the Commonwealth must maintain benefits as required in 431.230. In addition, the Commonwealth must conduct administrative renewals for all affected beneficiaries in order to determine if they qualify for Medicaid or CHIP eligibility under a different eligibility category prior to termination, as discussed in the October 1, 2010 State Health Official letter #10-008 and as required under 42 CFR 435.916(f)(1). For individuals determined ineligible for Medicaid, the Commonwealth must determine potential eligibility for other insurance affordability programs and comply with the procedures set forth in 42 CFR 435.1200(e).
e. Exemption from Public Notice Procedures per 42 CFR Section 431.416(g). CMS may expedite the federal and state public notice requirements under circumstances described in 42 CFR 431.416(g).
f. Enrollment Limitation during Demonstration Phase-Out. If the Commonwealth elects to suspend, terminate, or not extend this demonstration, during the last six months of the demonstration, enrollment of new individuals into the demonstration must be suspended. The limitation of enrollment into the demonstration does not impact the Commonwealth’s obligation to determine Medicaid or CHIP eligibility in accordance with the approved Medicaid or CHIP state plans.
g. Federal financial participation (FFP). If the demonstration project is terminated or any relevant waivers suspended by the state, FFP shall be limited to normal closeout costs associated with the termination or expiration of the demonstration, including services, continued benefits as a result of beneficiaries’ appeals, and administrative costs of disenrolling beneficiaries.
10. Close-out Report. Within 120 calendar days after the end of the demonstration (i.e., upon expiration or early termination), the Commonwealth must submit a draft Close-out Report to CMS for comments.
a. The draft report must comply with the most current guidance from CMS.
b. The state will present to and participate in a discussion with CMS on the Close- out report.
c. The state must take into consideration CMS’ comments for incorporation into the final Close-out Report.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 9 of 61 d. The final Close-out Report is due to CMS no later than 30 calendar days after receipt of CMS’ comments.
e. A delay in submitting the draft or final version of the Close-out Report may subject the state to penalties described in STC 26.
11. Withdrawal of Waiver or Expenditure Authority. CMS reserves the right to withdraw waivers and/or expenditure authorities at any time it determines that continuing the waivers or expenditure authorities would no longer be in the public interest or promote the objectives of titles XIX and/or XXI. CMS will promptly notify the Commonwealth in writing of the determination and the reasons for the withdrawal, together with the effective date, and must afford the Commonwealth an opportunity to request a hearing to challenge CMS’ determination prior to the effective date. If a waiver or expenditure authority is withdrawn, FFP is limited to normal closeout costs associated with terminating the waiver or expenditure authorities, including services, continued benefits as a result of beneficiary appeals, and administrative costs of disenrolling participants.
12. Adequacy of Infrastructure. The Commonwealth must ensure the availability of adequate resources for implementation and monitoring of the demonstration, including education, outreach and enrollment; maintaining eligibility systems; compliance with cost-sharing requirements; and reporting on financial and other demonstration components.
13. Public Notice, Tribal Consultation, and Consultation with Interested Parties. The Commonwealth must comply with the state notice procedures as required in 42 CFR 431.408 prior to submitting an application to extend the demonstration. For applications to amend the demonstration, the Commonwealth must comply with the state notice procedures set forth in 59 Fed. Reg. 49249 (September 27, 1994) prior to submitting such request. The Commonwealth must also comply with the public notice procedures set forth in 42 CFR 447.205 for changes in statewide methods and standards for setting payment rates.
The Commonwealth must also comply with tribal and Indian Health Program/Urban Indian Organization consultation requirements at section 1902(a)(73) of the Act, 42 CFR 431.408(b), State Medicaid Director Letter #01-024, or as contained in the state’s approved Medicaid or CHIP state plan, when any program changes to the demonstration, either through amendment as set out in STC 7 or extension, are proposed by the state
14. Federal financial participation (FFP). No federal matching for expenditures for this demonstration, including administrative and medical assistance expenditures, will be available until the effective date identified in the CMS demonstration approval letter that accompanied these STCs.
15. Administrative Authority. When there are multiple entities involved in the administration of the demonstration, the Single State Medicaid Agency must maintain authority, accountability, and oversight of the program. The State Medicaid Agency must exercise oversight of all delegated functions to operating agencies, managed care organizations
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 10 of 61 (MCOs), and any other contracted entities. The Single State Medicaid Agency is responsible for the content and oversight of the quality strategies for the demonstration.
16. Common Rule Exemption. The Commonwealth must ensure that the only involvement of human subjects in research activities that may be authorized and/or required by this demonstration is for projects which are conducted by or subject to the approval of CMS, and that are designed to study, evaluate, or otherwise examine the Medicaid or CHIP program – including public benefit or service programs, procedures for obtaining Medicaid or CHIP benefits or services, possible changes in or alternatives to Medicaid or CHIP programs or procedures, or possible changes in methods or levels of payment for Medicaid benefits or services. CMS has determined that this demonstration as represented in these approved STCs meets the requirements for exemption from the human subject research provisions of the Common Rule set forth in 45 CFR 46.104(b)(5).
IV. ELIGIBILITY AND ENROLLMENT
17. Eligibility Groups Affected by the Demonstration. The following populations are eligible under this demonstration as described therein:
a. FAMIS MOMS. Coverage is provided to uninsured pregnant individuals in families with income up to and including 200 percent of the FPL who are not eligible for Medicaid, including lawfully present (CHIPRA 214) individuals. FAMIS MOMS coverage is also provided to pregnant individuals with access to state employee’s health benefit coverage (in accordance with the hardship exception as provided in section 2110(b)(6)(C) of the Act), thereby aligning the Commonwealth’s coverage of pregnant individuals with the expansion of CHIP coverage to children of state employees. FAMIS MOMS coverage is the same as that provided to pregnant individuals under the Medicaid state plan.
Under the demonstration, Virginia is also authorized to deem infants born to FAMIS MOMS to be eligible for Medicaid or CHIP coverage, as appropriate, consistent with 42 CFR 435.117 and 457.360. These infants are deemed eligible on the date of birth and remain eligible until attaining the age of 1.
b. FAMIS Select Premium Assistance. Children eligible for and enrolled in Virginia’s separate CHIP program, may elect to enroll in FAMIS Select and receive CHIP premium assistance payments to purchase private or employer sponsored health insurance coverage. Such enrollment is voluntary and based on informed choice regarding all implications of choosing premium assistance in lieu of direct CHIP state plan coverage, including the possibility of reduced benefits and increased cost-sharing, and that the CHIP cost-sharing limit of five percent on annual, aggregate cost sharing will not apply.
The Commonwealth will ensure that enrollees are annually notified that they may choose direct CHIP state plan coverage at any time. The Commonwealth will inform families that all age-appropriate immunizations in accordance with the
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 11 of 61 recommendations of the Advisory Committee on Immunization Practices (ACIP) are covered by CHIP if their private or employer sponsored health insurance coverage does not provide for such immunizations. Families will continue to be told that this coverage is a factor to consider in choosing premium assistance in lieu of direct CHIP state plan coverage. The Commonwealth shall provide information as to where children may receive immunizations, well-baby, and well-child services in the event these services are not covered in the private or employer-sponsored health plan in which they are enrolled. In the case where title XXI eligibles are enrolled in private or employer-sponsored health insurance that does not include immunizations, the Commonwealth has an established mechanism in effect to reimburse providers for the cost of immunizations.
c. Postpartum Extension. The Commonwealth will extend continuous postpartum coverage for Medicaid and CHIP pregnant individuals from the end of the state plan 60-day postpartum benefit period to the end of the 12th month following the end of the pregnancy (including individuals enrolled while pregnant during a period of retroactive eligibility and/or for individuals who did not have enrollment in Medicaid or CHIP while pregnant). Eligible populations will be provided 12- month continuous extended postpartum coverage as follows:
i. Individuals enrolled in the “FAMIS MOMS” population as described in subparagraph a, with exception for individuals whose program eligibility is derived by section 1903(v)(4) or 2107(e)(l)(O) of the Act as described in subpart c.iv below.
ii. Pregnant and postpartum individuals in any Medicaid state plan eligibility group, with exception for individuals whose program eligibility is derived by section 1903(v)(4) or 2107(e)(l)(O) of the Act as described in subpart c.iv below.
iii. Individuals who are within 12 months postpartum but beyond the state plan 60-day postpartum coverage period (including those who were not enrolled in Medicaid or CHIP while pregnant), have household income up to and including 200 percent of the FPL, and meet all other Medicaid or CHIP eligibility criteria, with exception for individuals whose program eligibility is derived by section 1903(v)(4) or 2107(e)(l)(O) of the Act as described in subpart c.iv below.
iv. Lawfully present (CHIPRA 214) Individuals – Individuals determined to be “lawfully residing” in the United States for the purpose of establishing Medicaid or CHIP eligibility in accordance with section 1903(v)(4) or 2107(e)(l)(O) of the Act are only eligible for continuous 12-month postpartum coverage in accordance with sections 9812 and 9822 of the American Rescue Plan Act of 2021 (ARP) (Pub. L. 117-2), for a five-year period starting April 1, 2022 through March 31, 2027. During this time- limited 5-year coverage period, lawfully present pregnant individuals are
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 12 of 61 eligible to receive full Medicaid or CHIP state plan benefits for the duration of the pregnancy and the 12-month continuous postpartum period.
d. Enrollment upon the Effective Date of the Postpartum Extension Period: Upon the effective date of this approval, individuals who are within 12 months postpartum, but whom are outside of the state plan 60-day postpartum coverage period, may be enrolled or reenrolled in Medicaid or CHIP for the purpose of receiving extended postpartum coverage for the period of time that equates to the end of the 12th month following the end of the pregnancy. These individuals enrolled in the extended postpartum coverage period, not immediately following pregnancy but at a later point in time within the 12-month coverage period, are only eligible for the period of time that remains prior to the end of the 12th month following the end of the pregnancy. For example, an eligible individual who is enrolled in the fourth month following pregnancy, will only be eligible to receive eight additional months of continuous postpartum coverage.
e. Redetermination of Eligibility after the Postpartum Extension Period: The Commonwealth will conduct any required redetermination or renewal of eligibility at the end of the extended postpartum period consistent with 42 CFR 435.916 and 42 CFR 457.343. This includes determining Medicaid eligibility on all bases consistent with 42 CFR 435.916(f)(1) prior to determining an individual ineligible. Individuals determined eligible on another basis at the end of the postpartum period will be moved to the appropriate group at that time. Individuals determined ineligible for Medicaid on all bases will be provided advance notice of termination in accordance with 42 CFR 435.917 and 42 CFR Part 431, Subpart E and assessed for potential eligibility for other insurance affordability programs in accordance with 42 CFR 435.916(f)(2). Separate CHIP enrollees no longer eligible for CHIP must be screened for eligibility in other insurance affordability programs in accordance with 42 CFR 457.350(b), and receive timely written notice of termination in accordance with 42 CFR 457.340(e).
18. Screening for Medicaid. Applicants for the demonstration will continue to be screened for Medicaid eligibility. Demonstration applicants eligible for Medicaid will be enrolled in Medicaid and receive the full Medicaid benefit package.
19. Enrollment Limits. There is no enrollment cap for any component of this demonstration. Enrollment in an individual or employer-sponsored plan under FAMIS Select is voluntary and the child may continue to elect to switch to direct CHIP state plan coverage at any time.
20. Applicability of title XXI Maintenance of Effort to Demonstration Populations. The maintenance of effort provision at section 2105(d)(3)(A) of the Act applies to title XXI eligible children enrolled in FAMIS Select. This provision requires that, with certain exceptions, as a condition of receiving federal financial participation for Medicaid, states must maintain CHIP “eligibility standards, methodologies, and procedures” for children that are no more restrictive than those in effect on March 23, 2010. See STCs 49 and 50 related
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 13 of 61 to title XXI funding limits and shortfalls.
Section 2105(d)(3) of the Act is not applicable to pregnant individuals enrolled under the FAMIS MOMS component of the demonstration.
V. BENEFITS
21. Demonstration Benefits. There are three distinct benefit packages offered under this demonstration:
a. FAMIS MOMS – Individuals enrolled in FAMIS MOMS as described in STC 17.a receive the same package of benefits as provided to pregnant individuals covered by Virginia’s Medicaid program. The benefit package includes comprehensive health and dental benefits, including orthodontics (orthodontics benefit is limited to individuals under the age of 21). All dental services must be received through the Commonwealth's contracted Smiles for Children service provider.
If changes are made in the benefit package that would cause FAMIS MOMS to no longer receive the same benefits provided to pregnant individuals under the Medicaid state plan, the Commonwealth must submit the proposed change to CMS for review and approval, as outlined in STC 7, before modifications can be implemented by the Commonwealth.
b. FAMIS Select Premium Assistance. For families with CHIP eligible children who choose to receive premium assistance for private or employer-sponsored health insurance coverage, benefits are limited to premium assistance subsidies and immunizations as described in STC 17.b.
Consistent with 2105(c)(3) of the Social Security Act, cost-effectiveness for the purchase of employer-sponsored insurance shall be determined relative to the amount of expenditures (determined on an individual or aggregate basis) under the state child health plan, including administrative expenditures, that the state would have made to provide comparable coverage to the targeted low-income child or family involved (as applicable).
c. Postpartum Extension – Individuals who are eligible for the 12-month extended postpartum coverage period as described in STC 17.c will receive full state plan benefits during the pregnancy and postpartum period.
22. Minimum Essential Coverage (MEC). In accordance with CMS’ February 12, 2016 correspondence to the Virginia Department of Medicaid Assistance Services' Director, Cynthia Jones, the Commonwealth's benefit package provided to uninsured pregnant individuals and newborn children under the FAMIS MOMS component of the demonstration is equivalent to CHIP state plan coverage. Accordingly, CMS has determined coverage provided to these individuals and children under this demonstration is recognized as MEC.
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CMS also concluded that the Commonwealth’s coverage provided under the FAMIS Select component of the demonstration does not meet the comprehensive criteria for MEC. The FAMIS Select program does not provide premium assistance enrollees with wrap-around services or cost-sharing assistance that is comparable to CHIP state plan out-of-pocket limits, thus, this is a lesser benefit than coverage afforded to children who are eligible for CHIP state plan coverage. Accordingly, CMS has determined that the coverage provided to these children under the FAMIS Select demonstration component is not recognized as MEC.
For the 12-month postpartum extension, effective as of the date of these amended STCs, CMS also concluded that the Commonwealth’s benefit package provided to postpartum individuals is equivalent to Medicaid and CHIP state plan coverage. Accordingly, CMS has determined the postpartum coverage provided to these individuals under this demonstration is recognized as MEC.
VI. COST SHARING
23. Cost Sharing. The cost-sharing requirements for this demonstration are outlined below:
a. FAMIS MOMS - The cost-sharing requirements for the FAMIS MOMS component of the demonstration are consistent with those described in the Medicaid state plan. There are no monthly premiums or enrollment fees associated with participation in the demonstration.
Co-payments for services received by FAMIS MOMS are identical to co- payments required of pregnant individuals covered by Medicaid. By policy, there are no co-payments required for pregnancy related services or for medical conditions that may complicate the pregnancy, including dental services. Also, it is a contractual requirement that Managed Care Organization (MCO) not charge pregnant individuals co-payments for any services. Therefore, the only co- payments that may be charged to a pregnant individual receiving services through Medicaid or FAMIS MOMS would be for non-pregnancy related services delivered through fee-for-service.
b. Postpartum Extension – There is no cost-sharing requirement associated with services received during the 12-month extended postpartum coverage period.
c. FAMIS Select Premium Assistance. For families with CHIP eligible children who choose to receive premium assistance for private or employer-sponsored insurance and supplemental immunization benefits in lieu of receiving coverage under the CHIP state plan, cost-sharing requirements will continue to be set by their private or employer-sponsored insurance plan.
VII. DELIVERY SYSTEM
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 15 of 61 24. Demonstration Delivery System. The demonstration delivery system varies by population as described below:
a. FAMIS MOMS and Postpartum Extension - Health care services are delivered primarily through one of the Managed Care Organizations (MCOs) contracted by DMAS to provide Medicaid and FAMIS (CHIP) benefits. Initially, benefits are provided on a fee-for-service basis until the pregnant individual is enrolled in an MCO. Dental services are provided by the contracted Smiles for Children service provider.
b. FAMIS Select Premium Assistance. For families who select premium assistance, health care services are delivered through the private or employer- sponsored plan of choice.
VIII. GENERAL REPORTING REQUIREMENTS
25. Deferral for Failure to Submit Timely Demonstration Deliverables. CMS may issue deferrals in accordance with 42 CFR part 430 subpart C, in an amount up to $1,000,000 per deliverable (federal share) when items required by these STCs (e.g., required data elements, analyses, reports, design documents, presentations, and other items specified in these STCs) (hereafter singly or collectively referred to as “deliverable(s)”) are not submitted timely to CMS or are found to not be consistent with the requirements approved by CMS. A deferral shall not exceed the value of the federal amount for the current demonstration period. The Commonwealth does not relinquish its rights provided under 42 CFR part 430 subpart C to challenge any CMS finding that the state materially failed to comply with the terms of this agreement.
The following process will be used: 1) Thirty days after the deliverable was due if the state has not submitted a written request to CMS for approval of an extension as described in subsection (b) below; or 2) Thirty days after CMS has notified the Commonwealth in writing that the deliverable was not accepted for being insufficient, or inconsistent with the requirements of this agreement and the information needed to bring the deliverable into alignment with CMS requirements:
a. CMS will issue a written notification to the state providing advance notification of a pending deferral for late or non-compliant submissions of required deliverable(s).
b. For each deliverable, the Commonwealth may submit to CMS a written request for an extension to submit the required deliverable that includes a supporting rationale for the cause(s) of the delay and the Commonwealth’s anticipated date of submission. Should CMS agree to the Commonwealth’s request, a corresponding extension of the deferral process can be provided. CMS may agree to a corrective action plan submitted by the Commonwealth as an interim step before applying the deferral, if the Commonwealth proposes a corrective action plan in the state’s written extension request.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 16 of 61 c. If CMS agrees to an interim corrective plan in accordance with subsection (b), and the Commonwealth fails to comply with the corrective action plan or, despite the corrective action plan, still fails to submit the overdue deliverable(s) with all required contents in satisfaction of the terms of this agreement, CMS may proceed with the issuance of a deferral against the next Quarterly Statement of Expenditures reported in Medicaid Budget and Expenditure System/State Children's Health Insurance Program Budget and Expenditure System (MBES/CBES) following a written deferral notification to the Commonwealth.
d. If the CMS deferral process has been initiated for the Commonwealth's non-compliance with the terms of this agreement with respect to required deliverable(s), and the state submits the overdue deliverable(s), and such deliverable(s) are accepted by CMS as meeting the requirements specified in these STCs, the deferral(s) will be released.
As the purpose of a section 1115 demonstration is to test new methods of operation or service delivery, the Commonwealth’s failure to submit all required reports, evaluations and other deliverables will be considered by CMS in reviewing any application for an extension, amendment, or for a new demonstration.
26. Submission of Post-Approval Deliverables. The Commonwealth must submit all deliverables as stipulated by CMS and within the timeframes outlined within these STCs.
27. Compliance with Federal Systems Updates. As federal systems continue to evolve and incorporate additional section 1115 demonstration reporting and analytics functions, the state will work with CMS to:
a. Revise the reporting templates and submission processes to accommodate timely compliance with the requirements of the new systems;
b. Ensure all section 1115, Transformed Medicaid Statistical Information System (T-MSIS), and other data elements that have been agreed to for reporting and analytics are provided by the Commonwealth; and,
c. Submit deliverables to the appropriate system as directed by CMS.
IX. MONITORING
28. Monitoring Reports. The Commonwealth must submit one Semi-Annual Monitoring Report and one Annual Monitoring Report each demonstration year. The Semi-Annual Reports are due no later than 90 calendar days following the end of the six-month period from July through December (semi-annual report will be due by March 31 each year). The compiled Annual Report is due no later than 90 calendar days following the end of the demonstration year (i.e., the July–June compiled annual report will be due by September 28 each year). The reports will include all required elements as per 42 CFR 431.428 and should not direct readers to links outside the report. Additional links not referenced in the document may be listed in a reference/bibliography section. The Monitoring Reports must follow the
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 17 of 61 framework provided by CMS, which is subject to change as monitoring systems are developed/evolve, and must be provided in a structured manner that supports federal tracking and analysis.
a. Operational Updates. The operational updates will focus on progress toward meeting the demonstration’s milestones. Additionally, per 42 CFR 431.428, the Monitoring Reports must document any policy or administrative difficulties in operating the demonstration. The reports shall provide sufficient information to document key challenges, underlying causes of challenges, how challenges are being addressed, as well as key achievements and to what conditions and efforts successes can be attributed. The discussion should also include any issues or complaints identified by beneficiaries; lawsuits or legal actions; unusual or unanticipated trends; legislative updates; and descriptions of any public forums held. The Monitoring Report should also include a summary of all public comments received through post-award public forums conducted in accordance with required by 42 CFR 431.420(c) regarding the progress of the demonstration.
b. Performance Metrics. The performance metrics will provide data to demonstrate how the Commonwealth is progressing towards meeting the demonstration’s goals, and must cover all key policies under this demonstration. Additionally, per 42 CFR 431.428, the Monitoring Reports must document the impact of the demonstration in providing insurance coverage to beneficiaries and the uninsured population, as well as outcomes of care, quality and cost of care, and access to care. This may also include the results of beneficiary satisfaction surveys, if conducted, and any grievances and appeals. The requiring monitoring and performance metrics must be included in writing in the Monitoring Reports, and will follow the framework provided by CMS to support federal tracking and analysis.
c. Budget and Allotment Neutrality and Financial Reporting Requirements. Per 42 CFR 431.428, the Monitoring Reports must document the financial performance of the demonstration. The Commonwealth must provide an updated budget and allotment neutrality workbook with every Monitoring Report that meets all the reporting requirements for monitoring allotment neutrality set forth in the General Financial Requirements section of these STCs, including the submission of corrected budget and allotment neutrality data upon request. In addition, the Commonwealth must report quarterly expenditures associated with the populations affected by this demonstration on the appropriate Form CMS 64.9 or CMS-21. No later than six months after the end of each demonstration year, or as soon thereafter as data are available, the Commonwealth will calculate and report to CMS annual demonstration expenditures for the completed year. Administrative costs should be reported separately.
d. Evaluation Activities and Interim Findings. Per 42 CFR 431.428, the Monitoring Reports must document any results of the demonstration to date per the evaluation hypotheses. Additionally, the Commonwealth shall include a summary of the progress of evaluation activities, including rapid cycle evaluation assessments, key milestones accomplished, and any challenges encountered and how they were addressed.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 18 of 61 29. Corrective Action Plan Related to Monitoring. If monitoring indicates that demonstration features are not likely to assist in promoting the objectives of Medicaid or CHIP, CMS reserves the right to require the Commonwealth to submit a corrective action plan to CMS for approval. A corrective action plan could include a temporary suspension of implementation of demonstration programs, in circumstances where monitoring data indicate substantial and sustained directional change inconsistent with demonstration goals, such as substantial and sustained trends indicating increased difficulty accessing services. This may be an interim step to withdrawing waiver or expenditure authorities as outlined in STC 11. CMS will withdraw an authority, as described in STC 11, when metrics indicate substantial and sustained directional change inconsistent with the Commonwealth’s demonstration goals, and the Commonwealth has not implemented corrective action. CMS further has the ability to suspend implementation of the demonstration should corrective actions not effectively resolve these concerns in a timely manner.
30. Monitoring Calls. CMS and the Commonwealth will hold monitoring calls no later than 60 calendar days after submission of the Monitoring Reports described in STC 28 to discuss the program update provided in the reports and any issues associated with the continued operation of the demonstration. The purpose of these calls is to discuss any significant actual or anticipated developments affecting the demonstration. Examples include implementation activities, trends in reported data on metrics and associated mid-course adjustments, enrollment and access, allotment neutrality, and progress on evaluation activities. CMS will provide updates on any pending actions, as well as federal policies and issues that may affect any aspect of the demonstration. The Commonwealth and CMS will jointly develop the agenda for the calls.
31. Post Award Forum. As required by 42 CFR 431.420(c), within six months of the demonstration’s implementation, and annually thereafter, the Commonwealth must afford the public with an opportunity to provide meaningful comment on the progress of the demonstration. At least 30 days prior to the date of the planned public forum, the state must publish the date, time, and location of the forum in a prominent location on its website. The Commonwealth must also post the most recent annual report on its website with the public forum announcement. Pursuant to 42 CFR 431.420(c), the Commonwealth must include a summary of the comments in the Monitoring Report associated with the demonstration period in which the forum was held, as well as in its compiled Annual Report.
X. EVALUATION OF THE DEMONSTRATION
32. Evaluation Design Approval and Subsequent Updates. The Commonwealth’s CMS- approved evaluation design is incorporated into these STCs as Attachment C. A revised draft evaluation design addressing the postpartum extension component of the demonstration shall be submitted for CMS approval by no later than 180 calendar days after the approval of the demonstration. The revised draft Evaluation Design must be developed in accordance with Attachment A (Developing the Evaluation Design) of these STCs as well as any additional evaluation guidance provided by CMS specific to any program component being tested under this demonstration. Any CMS feedback on modifications needed to the revised draft Evaluation Design must be addressed within 60 calendar days after receipt of CMS’
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 19 of 61 comments. Upon CMS approval of the revised Evaluation Design, the document will be included as an updated Attachment C to these STCs.
Per 42 CFR 431.424(c), the Commonwealth will publish the approved revised Evaluation Design on the Commonwealth’s website within 30 calendar days of CMS approval. The Commonwealth must implement the Evaluation Design and submit a description of its evaluation implementation process in each of the Monitoring Reports, including any required rapid cycle assessments specified in these STCs. If the Commonwealth wishes to make additional changes to the CMS-approved evaluation design, it must submit a revised evaluation design with the proposed changes to CMS for approval.
Failure to comply with this STC may result in a deferral being issued as outlined in STC 25.
33. Cooperation with Federal Evaluators. As required under 42 CFR 431.420(f), the Commonwealth must cooperate fully and timely with CMS and its contractors in any federal evaluation of the demonstration or any component of the demonstration. This includes, but is not limited to, commenting on design and other federal evaluation documents and providing data and analytic files to CMS, including entering into a data use agreement that explains how the data and data files will be exchanged, and providing a technical point of contact to support specification of the data and files to be disclosed, as well as relevant data dictionaries and record layouts. The Commonwealth must include in its contracts with entities who collect, produce, or maintain data and files for the demonstration, that they must make such data available for the federal evaluation as is required under 42 CFR 431.420(f) to support federal evaluation. The Commonwealth may claim administrative match for these activities. Failure to comply with this STC may result in a deferral being issued as outlined in STC 25.
34. Evaluation Budget. A budget for the evaluation must be provided with the draft Evaluation Design. It will include the total estimated cost, as well as a breakdown of estimated staff, administrative and other costs for all aspects of the evaluations, such as any survey and measurement development, quantitative and qualitative data collection and cleaning, analyses and report generation. A justification of the costs may be required by CMS if the estimates provided do not appear to sufficiently cover the costs of the design or if CMS finds that the designs are not sufficiently developed, or if the estimates appear to be excessive.
35. Evaluation Questions and Hypotheses. Consistent with Attachments A and B (Developing the Evaluation Design and Preparing the Interim and Summative Evaluation Reports) of these STCs, the evaluation documents must include a discussion of the evaluation questions and hypotheses that the Commonwealth intends to test. Each demonstration component should have at least one evaluation question and hypotheses. The evaluation must outline and address well-crafted hypotheses and research questions for all key demonstration policy components that support understanding the demonstration’s impact and also its effectiveness in achieving the goals. The Commonwealth must also investigate cost outcomes for the demonstration as a whole, including but not limited to: administrative costs of demonstration implementation and operation and Medicaid/CHIP health service expenditures.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 20 of 61 The hypothesis testing should include, where possible, assessment of both process and outcome measures. Proposed measures should be selected from nationally-recognized sources and national measures sets, where possible. Measures sets could include CMS’ Core Set of Health Quality Measures for Children in Medicaid and CHIP, Consumer Assessment of Health Care Providers and Systems (CAHPS), the Initial Core Set of Health Quality Measures for Medicaid-Eligible Adults and/or measures endorsed by the National Quality Forum (NQF). The findings from each evaluation component must be integrated to help inform whether the Commonwealth met the overall demonstration goals, with recommendations for future efforts regarding all components.
36. Interim Evaluation Report. The Commonwealth must submit an Interim Evaluation Report for the completed years of the demonstration, and for each subsequent extension of the demonstration, as outlined in 42 CFR 431.412(c)(2)(vi). When submitting an application for extension, the Evaluation Report should be posted to the Commonwealth’s website with the application for public comment.
a. The Interim Evaluation Report will discuss evaluation progress and present findings to date as per the approved evaluation design.
b. For any demonstration authority that expires prior to the overall demonstration’s expiration date, the Interim Evaluation Report must include an evaluation of the authority as approved by CMS.
c. The Commonwealth must provide a draft Interim Evaluation Report for the corresponding years, no longer than one year after completion of the measurement period, as follows. The Commonwealth must submit a final Interim Evaluation Report for each measurement period 60 calendar days after receiving CMS comments on the draft Interim Evaluation Report and post the documents to the Commonwealth's website. i. An Interim Evaluation Report for the period of July 2019 through June 2022 will be due by no later than June 30, 2023. ii. An Interim Evaluation Report for the period of July 2019 – June 2024 will be due by no later than June 30, 2025. iii. An Interim Evaluation Report for the period of July 2019 – June 2027 will be due by no later than June 30, 2028.
d. If the Commonwealth is seeking to extend the demonstration, the draft Interim Evaluation Report is due when the application for extension is submitted. If the Commonwealth made changes to the demonstration in its application for extension, the research questions and hypotheses, and how the design was adapted should be included. If the Commonwealth is not requesting a demonstration extension, an Interim Evaluation report is due one year prior to the end of the demonstration. For demonstration phase-out prior to the expiration of this demonstration approval period, the draft Interim Evaluation Report is due to CMS on the date that will be specified in the notice of termination or suspension.
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e. The Commonwealth must submit a revised Interim Evaluation Report 60 calendar days after receiving CMS comments on the draft Interim Evaluation Report. The Commonwealth must post the final Interim Evaluation Report to the Commonwealth’s website within 30 calendar days of approval by CMS.
f. The Interim Evaluation Report must comply with attachment B (Preparing the Interim and Summative Evaluation Reports) of these STCs.
37. Corrective Action Plan Related to Evaluation. If evaluation findings indicate that demonstration features are not likely to assist in promoting the objectives of Medicaid, CMS reserves the right to require the Commonwealth to submit a corrective action plan to CMS for approval. These discussions may also occur as part of an extension process when associated with the Commonwealth’s Interim Evaluation Report, or as part of the review of the Summative Evaluation Report. A corrective action plan could include a temporary suspension of implementation of demonstration programs, in circumstances where evaluation findings indicate substantial and sustained directional change inconsistent with demonstration goals, such as substantial and sustained trends indicating increased difficulty accessing services. A corrective action plan may be an interim step to withdrawing waivers or expenditure authorities, as outlined in STC 11. CMS further has the ability to suspend implementation of the demonstration should corrective actions not effectively resolve these concerns in a timely manner.
38. Evaluation Outcomes. CMS may exercise its rights as described in STC 11 to not reauthorize any demonstration program authority for which there are no evaluation findings to support the conclusion that the state is making progress in achieving the goals of the demonstration program component in accordance with the CMS approved evaluation design for the demonstration. If CMS makes such determination, the Commonwealth must submit a phase-out plan for that demonstration component in accordance with STC 9.
39. Summative Evaluation Report. The draft Summative Evaluation Report must be developed in accordance with attachment B (Preparing the Interim and Summative Evaluation Reports) of these STCs. The Commonwealth must submit a draft Summative Evaluation Report for the demonstration approval period specified in these STCs within 18 months of the end of the approval period represented by these STCs. The Summative Evaluation Report must include the information in the approved Evaluation Design.
a. Unless otherwise agreed upon in writing by CMS, the Commonwealth shall submit the final Summative Evaluation Report within 60 calendar days of receiving comments from CMS on the draft.
b. The final Summative Evaluation Report must be posted to the Commonwealth’s website within 30 calendar days of approval by CMS.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 22 of 61 40. State Presentations for CMS. CMS reserves the right to request that the Commonwealth present and participate in a discussion with CMS on the Evaluation Design, the interim evaluation, and/or the summative evaluation.
41. Public Access. The Commonwealth shall post the final documents (e.g., Monitoring Reports, Close-out Report, approved Evaluation Design, Interim Evaluation Report, and Summative Evaluation Report) on its website within 30 calendar days of approval by CMS.
42. Additional Publications and Presentations. For a period of 12 months following CMS approval of the final reports, CMS will be notified prior to presentation of these reports or their findings, including in related publications (including, for example, journal articles), by the Commonwealth, contractor, or any other third party directly connected to the demonstration over which the Commonwealth has control. Prior to release of these reports, articles or other publications, CMS will be provided a copy including any associated press materials. CMS will be given ten business days to review and comment on publications before they are released. CMS may choose to decline to comment or review some or all of these notifications and reviews. This requirement does not apply to the release or presentation of these materials to state or local government officials.
XI. GENERAL FINANCIAL REQUIREMENTS
This project is approved for title XXI and title XIX expenditures applicable to services rendered during the demonstration period. This section describes the general financial requirements for these expenditures.
43. Extent of Federal Financial Participation (FFP) for the Demonstration. Subject to CMS approval of the source(s) of the non-federal share of funding, CMS will provide FFP only for the medical assistance services and premium assistance payments as described in STC 21 and associated administrative expenditures. CMS will provide FFP at the applicable federal matching rate for the demonstration as outlined below, subject to the Commonwealth’s title XXI allotment limit and the title XIX total computable expenditure limit set forth in STC 55:
a. Medicaid or CHIP program administrative costs, including those associated with the administration of the demonstration.
b. Net expenditures and prior period adjustments of the Medicaid or CHIP program that are paid in accordance with the approved state plans.
c. Medical assistance expenditures made under section 1115 demonstration authority, including those made in conjunction with the demonstration, net of enrollment fees, cost sharing, pharmacy rebates, and all other types of third party liability or CMS payment adjustments.
44. Sources of Non-Federal Share. The Commonwealth must certify that the matching non- federal share of funds for the demonstration are state/local monies. The Commonwealth further certifies that such funds shall not be used as the match for any other federal grant or
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 23 of 61 contract, except as permitted by law. All sources of non-federal funding must be compliant with section 1903(w) of the Act and applicable regulations. In addition, all sources of the non-federal share of funding are subject to CMS approval.
a. CMS may review the sources of the non-federal share of funding for the demonstration at any time. The state agrees that all funding sources deemed unacceptable by CMS shall be addressed within the time frames set by CMS.
b. Any amendments that impact the financial status of the program shall require the state to provide information to CMS regarding all sources of the non-federal share of funding.
c. The Commonwealth assures that all health care-related taxes comport with section 1903(w) of the Act and all other applicable federal statutory and regulatory provisions, as well as the approved Medicaid or CHIP state plan.
d. Certification of Funding Conditions. The Commonwealth must certify that the following conditions for non-federal share of demonstration expenditures are met:
i. Units of government, including governmentally operated health care providers, may certify that state or local tax dollars have been expended as the non-federal share of funds under the demonstration.
ii. To the extent the Commonwealth utilizes certified public expenditures (CPEs) as the funding mechanism for title XXI or title XIX (or under section 1115 authority) payments, CMS must approve a cost reimbursement methodology. This methodology must include a detailed explanation of the process by which the Commonwealth would identify those costs eligible under title XXI or title XIX (or under section 1115 authority) for purposes of certifying public expenditures.
iii. To the extent the Commonwealth utilizes CPEs as the funding mechanism to claim federal match for payments under the demonstration, governmental entities to which general revenue funds are appropriated must certify to the Commonwealth the amount of such tax revenue (state or local) used to satisfy demonstration expenditures. The entities that incurred the cost must also provide cost documentation to support the Commonwealth’s claim for federal match.
e. The Commonwealth may use intergovernmental transfers to the extent that such funds are derived from state or local tax revenues and are transferred by units of government within the Commonwealth. Any transfers from governmentally operated health care providers must be made in an amount not to exceed the non- federal share of title XXI or title XIX payments.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 24 of 61 f. Under all circumstances, health care providers must retain 100 percent of the reimbursement amounts claimed by the Commonwealth as demonstration expenditures. Moreover, no pre-arranged agreements (contractual or otherwise) may exist between the health care providers and the state and/or local government to return and/or redirect any portion of Medicaid or CHIP payments. This confirmation of Medicaid/CHIP payment retention is made with the understanding that payments that are the normal operating expenses of conducting business (such as payments related to taxes - including health care provider-related taxes - fees, and business relationships with governments that are unrelated to Medicaid or CHIP, and in which there is no connection to Medicaid or CHIP payments) are not considered returning and/or redirecting a Medicaid or CHIP payment.
45. Program Integrity. The state must have a process in place to ensure that there is no duplication of federal funding for any aspect of the demonstration.
XII. MONITORING ALLOTMENT NEUTRALITY
46. Reporting Expenditures Subject to the Title XXI Allotment Neutrality Agreement. The following describes the reporting of expenditures subject to the allotment neutrality agreement for this demonstration:
a. Tracking Expenditures: In order to track expenditures under this demonstration, the Commonwealth must report demonstration expenditures through the Medicaid and State Children’s Health Insurance Program Budget and Expenditure System (MBES/CBES), following routine CMS-21 reporting instructions as outlined in section 2115 of the State Medicaid Manual.
b. Use of Waiver Forms: Title XXI demonstration expenditures will continue to be reported on separate Forms CMS-21 Waiver and/or CMS-21P Waiver, identified by the demonstration project number assigned by CMS (including project number extension, which indicates the demonstration year in which services were rendered or for which capitation payments were made). The Commonwealth must submit separate forms CMS- 21 Waiver and/or CMS-21P Waiver for each demonstration population (i.e., FAMIS MOMS, FAMIS Select, and Postpartum Extension).
c. Premiums: Premium contributions under the demonstration shall be reported to CMS on Form CMS-21 Waiver, line 29, in order to assure that the demonstration is properly credited with premium collections.
d. Claiming Period: All claims for expenditures related to the demonstration (including any cost settlements) must be made within two years after the calendar quarter in which the Commonwealth made the expenditures. Furthermore, all claims for services during the demonstration period (including cost settlements) must be made within two years after the conclusion or termination of the demonstration. During the latter two-year period, the Commonwealth must continue to identify separately, on the Form CMS-21 Waiver, net
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47. Standard CHIP Funding Process. The standard CHIP funding process will continue to be used during the demonstration. Virginia will continue to estimate matchable CHIP expenditures on the quarterly Form CMS-21B. On a separate CMS-21B, the Commonwealth shall provide updated estimates of expenditures for the demonstration populations. CMS will make federal funds available based upon the Commonwealth’s estimate, as approved by CMS. Within 30 days after the end of each quarter, the Commonwealth must submit the Form CMS-21 quarterly CHIP expenditure report. CMS will reconcile expenditures reported on the Form CMS-21 with federal funding previously made available to the Commonwealth, and include the reconciling adjustment in the finalization of the grant award to the Commonwealth.
48. Title XXI Administrative Costs. Administrative costs will not be included in the allotment neutrality limit, but the Commonwealth must separately track and report additional administrative costs that are directly attributable to the demonstration, using Forms CMS- 64.10 Waiver and/or 64.10P Waiver, with waiver name “ADM”.
49. Limit on Title XXI Funding. Virginia will be subject to a limit on the amount of federal title XXI funding that the Commonwealth may receive on current eligible CHIP state plan populations and the demonstration populations described in STC 17 during the demonstration period. Federal title XXI funds for the Commonwealth's CHIP program (i.e., the approved title XXI state plan and this demonstration) are restricted to the Commonwealth's available allotment and reallocated funds. Title XXI funds (i.e., the allotment or reallocated funds) must first be used to fully fund costs associated with CHIP state plan populations. Demonstration expenditures are limited to remaining funds.
50. Exhaustion of Title XXI Funds. If the Commonwealth exhausts the available title XXI federal funds in a federal fiscal year during the period of the demonstration, the Commonwealth must continue to provide coverage to the approved title XXI state plan separate child health program population and the demonstration populations described in STC 17 with Commonwealth funds.
XIII. MONITORING BUDGET NEUTRALITY
51. Expenditures Subject to the Budget Neutrality Agreement. For the purpose of this section, the term “expenditures subject to the budget neutrality limit” will include all medical assistance expenditures made on behalf of Medicaid pregnant and postpartum individuals enrolled in the 12-month postpartum extension component of the demonstration.
52. Title XIX Administrative Costs. Administrative costs will not be included in the budget neutrality limit, but the Commonwealth must separately track and report additional administrative costs that are directly attributable to the demonstration, using separate CMS- 64.10 waiver and 64.10 waiver forms, with waiver name “ADM”.
53. Calculation of the Budget Neutrality Limit and How It Is Applied. For the purpose of
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 26 of 61 calculating the overall budget neutrality limit for the demonstration, a separate annual budget limit will be calculated for each demonstration year on a total computable basis, by multiplying the predetermined “per member, per month” (PMPM) cost for the (title XIX) “Postpartum Extension” eligibility group by the corresponding actual member months total, and summing the results of that calculation. The federal share of this limit will represent the maximum amount of FFP that the Commonwealth may receive during the demonstration period for the types of demonstration expenditures described below. The federal share will be calculated by multiplying the total computable budget neutrality limit by the Composite Federal Share, which is defined in STC 57 below. The demonstration expenditures subject to the budget neutrality limit are those reported using the assigned waiver name - “Postpartum Extension.”
54. Reporting Member Months. The following describes the reporting of member months for the demonstration:
a. For the purpose of calculating the budget neutrality expenditure limit, the state must provide to CMS, as part of the Annual Monitoring Report required per STC 28, the actual number of eligible member months for all demonstration enrollees. The state must submit a statement accompanying the Annual Monitoring Report certifying the accuracy of this information.
b. The term “eligible member months” refers to the number of months in which persons enrolled in the demonstration are eligible to receive services. For example, a person who is eligible for three month contributes three eligible member months to the total. Two individuals who are each eligible for two months, each contribute two eligible member months, for a total of four eligible member months.
55. Budget Neutrality Annual Expenditure Limits. For each demonstration year (reflected as “DY” in the below table), an annual budget limit will be calculated for the demonstration. For the purposes of this demonstration, the state’s demonstration cycle is based on the state fiscal year which starts July 1 through June 30 of each year. Virginia will report expenditures in accordance with the annual demonstration cycles outlined as follows:
Demonstration Year 17 – July 1, 2021 – June 30, 2022
Demonstration Year 18 – July 1, 2022 – June 30, 2023
Demonstration Year 19 – July 1, 2023 – June 30, 2024
Demonstration Year 20 – July 1, 2024 – June 30, 2025
Demonstration Year 21 – July 1, 2025 – June 30, 2026 Demonstration Year 22 – July 1, 2026 – June 30, 2027 Demonstration Year 23 – July 1, 2027 – June 30, 2028 Demonstration Year 24 – July 1, 2028 – June 30, 2029
PMPM Cost. The following table provides the PMPM (total computable) cost ceiling for each demonstration year represented in this demonstration approval period. The PMPM cost ceilings were constructed based on the state’s historical expenditures from July 1, 2015 through June 30, 2020 and increased by a 5.2 percent rate of
growth; which is the trend rate included in the President’s Medicaid Budget for
federal fiscal year 2022 for the same period of time that represents demonstration year 17 through demonstration year 24. The PMPM cost ceiling for each demonstration year represents the medical assistance payments for up to 12 months of continuous postpartum coverage for eligible individuals.
The budget limit for each demonstration year will be calculated using the below PMPM cost multiplied by the actual number of member months (as calculated in accordance with STC 54) and the Composite Federal Share.
Demonstration | Per Member Per | Demonstration Per Member Per Year (DY) Month (PMPM) Year (DY) Month (PMPM) Limit Limit DY17 $648.88 DY21 $794.50 DY18 $682.41 DY22 $835.81 DY19 $717.90 DY23 $879.27 DY20 $755.23 DY24 $924.99
56. Hypothetical Budget Neutrality Test. The title XIX (postpartum extension) component of the demonstration is structured as a “pass-through” or “hypothetical” expenditure test. Therefore, the Commonwealth may not accumulate or access budget neutrality “savings.” A prospective per capita cap on federal financial risk is established based on the costs that eligible individuals are expected to incur under the demonstration.
If total FFP for hypothetical expenditures should exceed the federal share of the Hypothetical Cap, the difference must be reported as a cost against the budget neutrality limit described in
STC 55.
57. Composite Federal Share Ratio. The Composite Federal Share is the ratio calculated by dividing the sum total of FFP received by the Commonwealth on actual demonstration expenditures during the approval period, as reported through the MBES/CBES and summarized on the Schedule C report, with consideration of additional allowable demonstration offsets such as, but not limited to, premium collections and pharmacy rebates, by total computable demonstration expenditures for the same period as reported on the same
forms.
58. Reporting Expenditures Subject to the Title XIX Budget Neutrality Agreement.
a. Tracking Expenditures. In order to track expenditures under this
demonstration, the Commonwealth must report demonstration expenditures through the Medicaid and Children’s Health Insurance Program Budget and Expenditure System (MBES/CBES), following routine CMS-64 reporting instructions outlined in section 2500 of the State Medicaid Manual. All demonstration expenditures claimed under the authority of title XIX of the Act and subject to the budget neutrality expenditure limit must be reported
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Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 28 of 61 each quarter on separate Forms CMS-64.9 Waiver and/or 64.9P Waiver, identified by the demonstration project number (11-W-00381/3) assigned by CMS, including the project number extension (i.e., 17, 18, 19, etc.) which indicates the demonstration year in which services were rendered.
b. Use of Waiver Forms. For each demonstration year, separate Forms CMS- 64.9 Waiver and/or 64.9P Waiver must be completed, using the waiver name “Postpartum Extension.”
c. Cost Settlements. For monitoring purposes, cost settlements attributable to the demonstration must be recorded on the appropriate prior period adjustment schedules (Form CMS-64.9P Waiver) for the Summary Sheet Line 10B, in lieu of Lines 9 or 10C. For any cost settlement not attributable to this demonstration, the adjustments should be reported as otherwise instructed in the State Medicaid Manual.
d. Pharmacy Rebates. When claiming these expenditures the Commonwealth may refer to the July 24, 2014 CMCS Informational Bulletin which contains clarifying information for quarterly reporting of Medicaid Drug Rebates in the Medicaid Budget and Expenditures (MBES) (http://www.medicaid.gov/Federal-Policy-Guidance/downloads/CIB-07-24- 2014.pdf). The Commonwealth must adhere to the requirement at section 2500.1 of the State Medicaid Manual that all state collections, including drug rebates, must be reported on the CMS-64 at the applicable Federal Medical Assistance Percentage (FMAP) or other matching rate at which related expenditures were originally claimed. Additionally, we are specifying that states unable to tie drug rebate amounts directly to individual drug expenditures may utilize an allocation methodology for determining the appropriate federal share of drug rebate amounts reported quarterly. This information identifies the parameters that states are required to adhere to when making such determinations.
59. Postpartum Coverage for the New Adult Group. The Commonwealth must submit to CMS a proxy methodology for state expenditures to qualify for the newly eligible FMAP under section 1905(y) of the Act, consistent with requirements provided in 42 CFR 433.206(d). This methodology must be approved by CMS and incorporated as Attachment D to these STCs, prior to the Commonwealth claiming enhanced newly eligible FMAP. The proxy methodology must identify the proportion of claimed expenditures for beneficiaries receiving post-partum benefits who are reasonably estimated to meet the definition of newly eligible under section 1905(y)(2)(A) of the Act for whom enhanced newly eligible FMAP may be claimed, and the proportion claimed for beneficiaries who do not meet this definition for whom the regular FMAP must be claimed.
60. Budget Neutrality Monitoring Tool. The Commonwealth and CMS will jointly develop a budget neutrality monitoring tool (using a mutually agreeable spreadsheet program) for the Commonwealth to use for quarterly budget neutrality status updates. The tool will
incorporate the “Schedule C Report” for monitoring actual expenditures subject to budget neutrality.
61. Risk. The Commonwealth will be at risk for the per capita cost (as determined by the method described below) for state plan and demonstration populations enrolled in the demonstration for the 12-month postpartum extension, but not at risk for the number of participants enrolled in the demonstration. By providing FFP without regard to enrollment for all demonstration populations, CMS will not place the Commonwealth at risk for changing economic conditions. However, by placing the Commonwealth at risk for the per capita costs of the demonstration populations, CMS assures that the demonstration expenditures do not exceed the levels that would have been realized had there been no demonstration.
62. Impermissible DSH, Taxes, or Donations. CMS reserves the right to adjust the budget neutrality ceiling to be consistent with enforcement of laws and policy statements, including regulations and letters regarding impermissible provider payments, health care related taxes, or other payments (if necessary adjustments must be made). CMS reserves the right to make adjustments to the budget neutrality limit if any health care related tax that was in effect during the base year, or provider-related donation that occurred during the base year, is determined by CMS to be in violation of the provider donation and health care related tax provisions of section 1903(w) of the Social Security Act. Adjustments to annual budget targets will reflect the phase out of impermissible provider payments by law or regulation, where applicable.
63. Enforcement of Budget Neutrality. If the Commonwealth exceeds the calculated cumulative target limit by the percentage identified below for any of the demonstration years (DYs), the Commonwealth must submit a corrective action plan to CMS for approval.
Year Cumulative target definition Percentage
DY17 DY 17 budget limit amount +1.75 percent
DY18 DY 17 through DY 18 combined +1.50 percent budget limit amount
DY19 DY 17 through DY 19 combined +1.25 percent budget limit amount
DY20 DY 17 through DY 20 combined +1.00 percent budget limit amount
DY21 DY 17 through DY 21 combined +.75 percent budget limit amount
DY22 DY 17 through DY 22 combined +.50 percent budget limit amount
DY23 DY 17 through DY 23 combined +0.25 percent budget limit amount
DY24 DY 17 through DY 24 combined +0.00 percent budget limit amount
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Attachment A Developing the Evaluation Design
Introduction
Both state and federal governments need rigorous quantitative and qualitative evidence to inform policy decisions. To that end, for states that are testing new approaches and flexibilities in their Medicaid programs through section 1115 demonstrations, evaluations are crucial to understand and disseminate information about these policies. The evaluations of new initiatives seek to produce new knowledge and direction for programs and inform Medicaid policy for the future. While a narrative about what happened during a demonstration provides important information, the principal focus of the evaluation of a section 1115 demonstration should be obtaining and analyzing data. Evaluations should include findings about the process (e.g., whether the demonstration is being implemented as intended), outcomes (e.g., whether the demonstration is having the intended effects on the target population), and impacts of the demonstration (e.g., whether the outcomes observed in the targeted population differ from outcomes in similar populations not affected by the demonstration).
Submission Timelines
There is a specified timeline for the state’s submission of its draft Evaluation Design and subsequent evaluation reports. The graphic below depicts an example of this timeline for a 5- year demonstration. In addition, the state should be aware that section 1115 evaluation documents are public records. The state is required to publish the Evaluation Design to the state’s website within thirty (30) calendar days of CMS approval, as per 42 CFR 431.424(e). CMS will also publish a copy to the Medicaid.gov website.
Interim Evaluation Summative Report (data from Evaluation Report Demo approved DY1-2.5) (data from DY1-5) Jan 1, 2017 Dec 31, 2020 June 30, 2023 @ @ @ @ @ Draft Evaluation Demo renewal Design Jan 1, 2022
April 30, 2017
Expectations for Evaluation Designs
CMS expects Evaluation Designs to be rigorous, incorporate baseline and comparison group assessments, as well as statistical significance testing. Technical assistance resources for constructing comparison groups and identifying causal inferences are available on Medicaid.gov: https://www.medicaid.gov/medicaid/section-1 1 15-demonstrations/1115-demonstration- monitoring-evaluation/1 1 15-demonstration-state-monitoring-evaluation-resources/index.html. If the state needs technical assistance using this outline or developing the Evaluation Design, the state should contact its demonstration team.
All states with section 1115 demonstrations are required to conduct Interim and Summative Evaluation Reports, and the Evaluation Design is the roadmap for conducting these evaluations.
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Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 31 of 61 The roadmap begins with the stated goals for the demonstration, followed by the measurable evaluation questions and quantifiable hypotheses, all to support a determination of the extent to which the demonstration has achieved its goals. When conducting analyses and developing the evaluation reports, every effort should be made to follow the approved methodology. However, the state may request, and CMS may agree to, changes in the methodology in appropriate circumstances.
The format for the Evaluation Design is as follows: A. General Background Information; B. Evaluation Questions and Hypotheses; C. Methodology; D. Methodological Limitations; E. Attachments.
A. General Background Information – In this section, the state should include basic information about the demonstration, such as:
1. The issue/s that the state is trying to address with its section 1115 demonstration and/or expenditure authorities, the potential magnitude of the issue/s, and why the state selected this course of action to address the issue/s (e.g., a narrative on why the state submitted an 1115 demonstration proposal). 2. The name of the demonstration, approval date of the demonstration, and period of time covered by the evaluation. 3. A description of the population groups impacted by the demonstration. 4. A brief description of the demonstration and history of its implementation, and whether the draft Evaluation Design applies to an amendment, extension, renewal, or expansion of, the demonstration. 5. For renewals, amendments, and major operational changes: a description of any changes to the demonstration during the approval period; the primary reason or reasons for the change; and how the Evaluation Design was altered or augmented to address these changes.
B. Evaluation Questions and Hypotheses – In this section, the state should:
1. Identify the state’s hypotheses about the outcomes of the demonstration, and discuss how the evaluation questions align with the hypotheses and the goals of the demonstration. 2. Address how the hypotheses and research questions promote the objectives of Titles XIX and/or XXI. 3. Describe how the state’s demonstration goals are translated into quantifiable targets for improvement, so that the performance of the demonstration in achieving these targets can be measured. 4. Include a Driver Diagram to visually aid readers in understanding the rationale behind the cause and effect of the variants behind the demonstration features and intended outcomes. A driver diagram, which includes information about the goals and features of the demonstration, is a particularly effective modeling tool when working to improve
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 32 of 61 health and health care through specific interventions. A driver diagram depicts the relationship between the aim, the primary drivers that contribute directly to achieving the aim, and the secondary drivers that are necessary to achieve the primary drivers for the demonstration. For an example and more information on driver diagrams: https://innovation.cms.gov/files/x/hciatwoaimsdrvrs.pdf.
C. Methodology – In this section, the state is to describe in detail the proposed research methodology. The focus is on showing that the evaluation meets the prevailing standards of scientific and academic rigor, that the results are statistically valid and reliable, and that it builds upon other published research, using references where appropriate.
This section also provides evidence that the demonstration evaluation will use the best available data. The state should report on, control for, and make appropriate adjustments for the limitations of the data and their effects on results, and discuss the generalizability of results. This section should provide enough transparency to explain what will be measured and how, in sufficient detail so that another party could replicate the results. Table A below is an example of how the state might want to articulate the analytic methods for each research question and measure. Specifically, this section establishes:
1. Methodological Design – Provide information on how the evaluation will be designed. For example, whether the evaluation will utilize pre/post data comparisons, pre-test or post-test only assessments. If qualitative analysis methods will be used, they must be described in detail.
2. Target and Comparison Populations – Describe the characteristics of the target and comparison populations, incorporating the inclusion and exclusion criteria. Include information about the level of analysis (beneficiary, provider, or program level), and if populations will be stratified into subgroups. Additionally, discuss the sampling methodology for the populations, as well as support that a statistically reliable sample size is available.
3. Evaluation Period – Describe the time periods for which data will be included.
4. Evaluation Measures – List all measures that will be calculated to evaluate the demonstration. The state also should include information about how it will define the numerators and denominators. Furthermore, the state should ensure the measures contain assessments of both process and outcomes to evaluate the effects of the demonstration during the period of approval. When selecting metrics, the state shall identify opportunities for improving quality of care and health outcomes, and controlling cost of care. The state also should incorporate benchmarking and comparisons to national and state standards, where appropriate. The state also should include the measure stewards (i.e., the organization(s) responsible for the evaluation data elements/sets by “owning”, defining, validating, securing, and submitting for endorsement, etc.) Proposed health measures could include CMS’s Core Set of Health Care Quality Measures for Children in Medicaid and CHIP, Consumer Assessment of Health Care Providers and Systems (CAHPS), the Initial Core Set of Health Care Quality Measures for Medicaid-Eligible
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 33 of 61 Adults and/or measures endorsed by National Quality Forum. Proposed performance metrics can be selected from nationally recognized metrics, for example from sets developed by the Center for Medicare and Medicaid Innovation or for meaningful use under Health Information Technology.
5. Data Sources – Explain from where the data will be obtained, describe any efforts to validate and clean the data, and discuss the quality and limitations of the data sources. If the state plans to collect primary data (i.e., data collected specifically for the evaluation), include the methods by which the data will be collected, the source of the proposed questions and responses, and the frequency and timing of data collection. Additionally, copies of any proposed surveys must be provided to CMS for approval before implementation.
6. Analytic Methods – This section includes the details of the selected quantitative and/or qualitative analysis measures that will adequately assess the effectiveness of the demonstration. This section should: a. Identify the specific statistical testing which will be undertaken for each measure (e.g., t-tests, chi-square, odds ratio, ANOVA, regression). b. Explain how the state will isolate the effects of the demonstration from other initiatives occurring in the state at the same time (e.g., through the use of comparison groups). c. Include a discussion of how propensity score matching and difference-in- differences designs may be used to adjust for differences in comparison populations over time, if applicable. d. Consider the application of sensitivity analyses, as appropriate.
7. Other Additions – The state may provide any other information pertinent to the Evaluation Design for the demonstration.
Table A. Example Design Table for the Evaluation of the Demonstration
Outcome measures Sample or population Research used to address the subgroups to be Analytic Question research question compared Data Sources Methods Hypothesis 1 Research -Measure 1 -Sample e.g. All -Medicaid fee-for- | -Interrupted question la -Measure 2 attributed Medicaid service and time series -Measure 3 beneficiaries encounter claims -Beneficiaries with records diabetes diagnosis Research -Measure 1 -Sample, e.g., PPS -Patient survey Descriptive question 1b -Measure 2 patients who meet statistics -Measure 3 survey selection -Measure 4 requirements (used services within the last 6 months) Hypothesis 2 Research -Measure 1 -Sample, e.g., PPS -Key informants Qualitative question 2a -Measure 2 administrators analysis of interview material
D. Methodological Limitations — This section provides more detailed information about the limitations of the evaluation. This could include limitations about the design, the data sources or collection process, or analytic methods. The state should also identify any efforts to minimize these limitations. Additionally, this section should include any information about features of the demonstration that effectively present methodological constraints that the state would like CMS to take into consideration in its review.
CMS also recognizes that there may be certain instances where a state cannot meet the rigor of an evaluation as expected by CMS. In these instances, the state should document for CMS why it is not able to incorporate key components of a rigorous evaluation, including comparison groups and baseline data analyses. For example, if a demonstration is long-standing, it may be difficult for the state to include baseline data because any pre-test data points may not be relevant or comparable. Other examples of considerations include:
1. When the demonstration is: a. Non-complex, unchanged, or has previously been rigorously evaluated and found
to be successful; or
b. Could now be considered standard Medicaid policy (CMS published regulations or
guidance).
2. When the demonstration is also considered successful without issues or concerns that
would require more regular reporting, such as: a. Operating smoothly without administrative changes; b. No or minimal appeals and grievances;
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Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 35 of 61 c. No state issues with CMS-64 reporting or budget neutrality; and d. No Corrective Action Plans for the demonstration.
E. Attachments
1. Independent Evaluator. This includes a discussion of the state’s process for obtaining an independent entity to conduct the evaluation, including a description of the qualifications that the selected entity must possess, and how the state will assure no conflict of interest. Explain how the state will assure that the Independent Evaluator will conduct a fair and impartial evaluation and prepare objective Evaluation Reports. The Evaluation Design should include a “No Conflict of Interest” statement signed by the independent evaluator.
2. Evaluation Budget. A budget for implementing the evaluation shall be provided with the draft Evaluation Design. It will include the total estimated costs, as well as a breakdown of estimated staff, administrative, and other costs for all aspects of the evaluation. Examples include, but are not limited to: the development of all survey and measurement instruments; quantitative and qualitative data collection; data cleaning and analyses; and reports generation. A justification of the costs may be required by CMS if the estimates provided do not appear to sufficiently cover the costs of the draft Evaluation Design, if CMS finds that the draft Evaluation Design is not sufficiently developed, or if the estimates appear to be excessive.
3. Timeline and Major Milestones. Describe the timeline for conducting the various evaluation activities, including dates for evaluation-related milestones, including those related to procurement of an outside contractor, if applicable, and deliverables. The final Evaluation Design shall incorporate milestones for the development and submission of the Interim and Summative Evaluation Reports. Pursuant to 42 CFR 431.424(c)(v), this timeline should also include the date by which the Final Summative Evaluation Report is due.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 36 of 61 Attachment B: Preparing the Interim and Summative Evaluation Reports
Introduction Both state and federal governments need rigorous quantitative and qualitative evidence to inform policy decisions. To that end, for states that are testing new approaches and flexibilities in their Medicaid programs through section 1115 demonstrations, evaluations are crucial to understand and disseminate information about these policies. The evaluations of new initiatives seek to produce new knowledge and direction for programs and inform Medicaid policy for the future. While a narrative about what happened during a demonstration provides important information, the principal focus of the evaluation of a section 1115 demonstration should be obtaining and analyzing data. Evaluations should including findings about the process (e.g., whether the demonstration is being implemented as intended), outcomes (e.g., whether the demonstration is having the intended effects on the target population), and impacts of the demonstration (e.g., whether the outcomes observed in the targeted population differ from outcomes in similar populations not affected by the demonstration).
Submission Timelines There is a specified timeline for the state’s submission of Evaluation Designs and Evaluation Reports. These dates are specified in the demonstration Special Terms and Conditions (STCs). The graphic below depicts an example of a deliverables timeline for a 5-year demonstration. In addition, the state should be aware that section 1115 evaluation documents are public records. In order to assure the dissemination of the evaluation findings, lessons learned, and recommendations, the state is required to publish the Interim and Summative Evaluation Reports to the state’s website within thirty (30) calendar days of CMS approval, as per 42 CFR 431.424(d). CMS will also publish a copy to the Medicaid.gov website.
Expectations for Evaluation Reports All states with Medicaid section 1115 demonstrations are required to conduct evaluations that are valid (the extent to which the evaluation measures what it is intended to measure), and reliable (the extent to which the evaluation could produce the same results when used repeatedly). The already-approved Evaluation Design is a map that begins with the demonstration goals, then transitions to the evaluation questions, and to the specific hypotheses, which will be used to investigate whether the demonstration has achieved its goals. When conducting analyses and developing the evaluation reports, every effort should be made to follow
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 37 of 61 the methodology outlined in the approved Evaluation Design. However, the state may request, and CMS may agree to, changes in the methodology in appropriate circumstances.
When submitting an application for renewal, the Interim Evaluation Report should be posted on the state’s website with the application for public comment. Additionally, the Interim Evaluation Report must be included in its entirety with the application submitted to CMS.
CMS expects Interim and Summative Evaluation Reports to be rigorous, incorporate baseline and comparison group assessments, as well as statistical significance testing. Technical assistance resources for constructing comparison groups and identifying causal inferences are available on Medicaid.gov: https://www.medicaid.gov/medicaid/section-1115- demonstrations/1115-demonstration-monitoring-evaluation/1115-demonstration-state- monitoring-evaluation-resources/index.html. If the state needs technical assistance using this outline or developing the evaluation reports, the state should contact its demonstration team.
Intent of this Attachment Title XIX of the Social Security Act (the Act) requires an evaluation of every section 1115 demonstration. In order to fulfill this requirement, the state’s evaluation report submissions must provide comprehensive written presentations of all key components of the demonstration, and include all required elements specified in the approved Evaluation Design. This Attachment is intended to assist states with organizing the required information in a standardized format and understanding the criteria that CMS will use in reviewing the submitted Interim and Summative Evaluation Reports.
Required Core Components of Interim and Summative Evaluation Reports The Interim and Summative Evaluation Reports present research and findings about the section 1115 demonstration. It is important that the reports incorporate a discussion about the structure of the Evaluation Design to explain the goals and objectives of the demonstration, the hypotheses related to the demonstration, and the methodology for the evaluation. The evaluation reports should present the relevant data and an interpretation of the findings; assess the outcomes (what worked and what did not work); explain the limitations of the design, data, and analyses; offer recommendations regarding what (in hindsight) the state would further advance, or do differently, and why; and discuss the implications on future Medicaid policy.
The format for the Interim and Summative Evaluation reports is as follows:
A. Executive Summary; B. General Background Information; C. Evaluation Questions and Hypotheses; D. Methodology; E. Methodological Limitations; F. Results; G. Conclusions; H. Interpretations, and Policy Implications and Interactions with Other State Initiatives; I. Lessons Learned and Recommendations; and, J. Attachment(s).
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A. Executive Summary – A summary of the demonstration, the principal results, interpretations, and recommendations of the evaluation.
B. General Background Information about the Demonstration – In this section, the state should include basic information about the demonstration, such as:
1. The issue/s that the state is trying to address with its section 1115 demonstration and/or expenditure authorities, how the state became aware of the issue, the potential magnitude of the issue, and why the state selected this course of action to address the issues. 2. The name of the demonstration, approval date of the demonstration, and period of time covered by the evaluation. 3. A description of the population groups impacted by the demonstration. 4. A brief description of the demonstration and history of the implementation, and if the evaluation is for an amendment, extension, renewal, or expansion of, the demonstration. 5. For renewals, amendments, and major operational changes: A description of any changes to the demonstration during the approval period; whether the motivation for change was due to political, economic, and fiscal factors at the state and/or federal level; whether the programmatic changes were implemented to improve beneficiary health, provider/health plan performance, or administrative efficiency; and how the Evaluation Design was altered or augmented to address these changes. Additionally, the state should explain how this Evaluation Report builds upon and expands earlier demonstration evaluation findings (if applicable).
C. Evaluation Questions and Hypotheses – In this section, the state should:
1. Identify the state’s hypotheses about the outcomes of the demonstration, and discuss how the goals of the demonstration align with the evaluation questions and hypotheses. 2. Address how the research questions / hypotheses of this demonstration promote the objectives of titles XIX and XXI. 3. Describe how the state’s demonstration goals were translated into quantifiable targets for improvement, so that the performance of the demonstration in achieving these targets could be measured. 4. The inclusion of a Driver Diagram in the Evaluation Report is highly encouraged, as the visual can aid readers in understanding the rationale behind the demonstration features and intended outcomes.
D. Methodology – In this section, the state is to provide an overview of the research that was conducted to evaluate the section 1115 demonstration, consistent with the approved Evaluation Design. The Evaluation Design should also be included as an attachment to the report. The focus is on showing that the evaluation builds upon other published research, (using references), meets the prevailing standards of scientific and academic rigor, and the results are statistically valid and reliable.
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An Interim Evaluation Report should provide any available data to date, including both quantitative and qualitative assessments. The Evaluation Design should assure there is appropriate data development and collection in a timely manner to support developing an Interim Evaluation Report.
This section provides the evidence that the demonstration evaluation used the best available data and describes why potential alternative data sources were not used. The state also should report on, control for, and make appropriate adjustments for the limitations of the data and their effects on results, and discusses the generalizability of results. This section should provide enough transparency to explain what was measured and how, in sufficient detail so that another party could replicate the results. Specifically, this section establishes that the approved Evaluation Design was followed by describing:
1. Methodological Design – Whether the evaluation included an assessment of pre/post or post-only data, with or without comparison groups, etc. 2. Target and Comparison Populations – Describe the target and comparison populations, describing inclusion and exclusion criteria. 3. Evaluation Period – Describe the time periods for which data will be collected. 4. Evaluation Measures – List the measures used to evaluate the demonstration and their respective measure stewards. 5. Data Sources – Explain from where the data were obtained, and efforts to validate and clean the data. 6. Analytic Methods – Identify specific statistical testing which was undertaken for each measure (t-tests, chi-square, odds ratio, ANOVA, regression, etc.). 7. Other Additions – The state may provide any other information pertinent to the evaluation of the demonstration.
E. Methodological Limitations – This section provides sufficient information for discerning the strengths and weaknesses of the study design, data sources/collection, and analyses.
F. Results – In this section, the state presents and uses the quantitative and qualitative data to demonstrate whether and to what degree the evaluation questions and hypotheses of the demonstration were addressed. The findings should visually depict the demonstration results, using tables, charts, and graphs, where appropriate. This section should include findings from the statistical tests conducted.
G. Conclusions – In this section, the state will present the conclusions about the evaluation results. Based on the findings, discuss the outcomes and impacts of the demonstration and identify the opportunities for improvements. Specifically, the state should answer the following questions:
1. In general, did the results show that the demonstration was/was not effective in achieving the goals and objectives established at the beginning of the demonstration?
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 40 of 61 2. If the state did not fully achieve its intended goals, why not? 3. What could be done in the future that would better enable such an effort to more fully achieve those purposes, aims, objectives, and goals?
H. Interpretations, Policy Implications and Interactions with Other State Initiatives – In this section, the state will discuss the section 1115 demonstration within an overall Medicaid context and long-range planning. This should include interrelations of the demonstration with other aspects of the state’s Medicaid program, interactions with other Medicaid demonstrations, and other federal awards affecting service delivery, health outcomes and the cost of care under Medicaid. This section provides the state with an opportunity to provide interpretations of the data using evaluative reasoning to make judgments about the demonstration. This section should also include a discussion of the implications of the findings at both the state and national levels.
I. Lessons Learned and Recommendations – This section of the evaluation report involves the transfer of knowledge. Specifically, it should include potential “opportunities” for future or revised demonstrations to inform Medicaid policymakers, advocates, and stakeholders. Recommendations for improvement can be just as significant as identifying current successful strategies. Based on the evaluation results, the state should address the following questions:
1. What lessons were learned as a result of the demonstration? 2. What would you recommend to other states which may be interested in implementing a similar approach?
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 41 of 61 ATTACHMENT C CMS APPROVED DEMONSTRATION EVALUATION PLAN
Demonstration Period: July 1, 2019 - June 30, 2029
General Background
Consisting of two components, Virginia’s Title XXI Section 1115 Demonstration expands Title XXI coverage to uninsured pregnant women with family income up to 200% FPL who are not eligible for Medicaid, through a program known as FAMIS MOMS, and uses Title XXI funds to support a health insurance premium assistance program known as FAMIS Select. Children must first be found eligible and enroll in FAMIS before electing to receive coverage through FAMIS Select.
FAMIS MOMS Background
The intent of the FAMIS MOMS program expansion is to provide prenatal care to uninsured women living within the Title XXI income range and likely to give birth to FAMIS-eligible children. Virginia implemented the FAMIS MOMS program incrementally beginning August 1, 2005; stage one expanded eligibility to pregnant women with family income above the Medicaid limit of 133% FPL but less than or equal to 150% FPL, while the second stage, implemented September 1, 2006, covered pregnant women with incomes through 166% FPL. Subsequent stages covered pregnant women at 185% FPL (July 1, 2007) and currently 200% FPL (July 1, 2009).
Effective July 1, 2010, eligibility requirements were amended to allow enrollment of pregnant women with income below 133% FPL who do not meet eligibility requirements for full Medicaid coverage but do meet the FAMIS MOMS requirements. In addition, infants born to FAMIS children and FAMIS MOMS are deemed eligible for Medicaid or CHIP coverage, as appropriate, on the date of birth and remain eligible until attaining the age of one, unless, after a reasonable opportunity period, the state fails to obtain satisfactory documentation of citizenship and identity.
In 2013, the Virginia General Assembly adopted an amendment to the biennial budget that directed DMAS to phase out and eliminate the FAMIS MOMS program. Following approval by the Centers for Medicare and Medicaid Services (CMS) of an amendment to the Demonstration, administrative efforts were taken to implement this phase-out by ceasing new enrollment (effective January 1, 2014), while maintaining current cases throughout their benefit period (two months postpartum). The 2014 General Assembly restored funding to support enrollment in FAMIS MOMS. The amended state budget for state fiscal year 2015 was passed and signed in late June 2014. An amendment to the demonstration, reinstating enrollment at an upper income level of 200% FPL (plus a 5% income disregard), was subsequently submitted to CMS and approved effective November 1, 2014. The Department began enrolling women in FAMIS MOMS again starting December 1, 2014.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 42 of 61 DMAS did not accept new applications for FAMIS MOMS between December 31, 2013 and November 30, 2014; for women already enrolled, FAMIS MOMS coverage continued throughout their pregnancy and postpartum periods. FAMIS MOMS enrollment dropped from close to 1,600 on July 1, 2013, to 1,363 on January 1, 2014, and to single digits at its lowest point in late 2014. After the December 1, 2014 reinstatement of FAMIS MOMS, enrollment began to climb again, reached 1,156 by August 2015, and currently remains stable. Monthly enrollment as of April 2020 was 1,642.
In April 2015, CMS approved an amendment to the demonstration adding coverage for dental services to the FAMIS MOMS program, consistent with the addition of these benefits for pregnant women under Medicaid. This amendment also allowed eligibility to be expanded to include pregnant women with access to subsidized health insurance through state employee benefits.
FAMIS Select Background
The FAMIS Select program was implemented in Virginia on August 1, 2005, replacing the former employer-sponsored health insurance (ESHI) program. FAMIS Select provides an alternative for families with children enrolled in FAMIS who have access to private or employer- sponsored coverage. All children are first enrolled in FAMIS. In some cases, the FAMIS Select payment may make health coverage affordable for the entire family; in other cases, it may allow a child to continue to see a doctor or dentist that may not accept FAMIS.
FAMIS Select has enrolled more families and proven to be easier to administer than the former ESHI program. In August 2005, 66 children transferred from the ESHI to FAMIS Select. Enrollment in FAMIS Select has been marked by periods of growth and decline. At the end of the first year of operation, there were 266 children enrolled, more than double the highest ever enrollment in ESHI; enrollment peaked in year four at 480 children. Average monthly enrollment for SFY2018 was 102. (Enrollment reflects the number of FAMIS-eligible children directly enrolled in FAMIS Select. Totals do not include incidentally enrolled family members such as adults and non-FAMIS-eligible children in the family.) The decline in participation is likely attributable to changes in employer-sponsored health insurance offerings; in Virginia and nationwide, employer-sponsored health insurance is becoming less widely available and more expensive, with higher employee cost-sharing, making family coverage a less affordable option for lower-income workers.
Driver Diagrams
FAMIS MOMS: The demonstration will maintain or improve healthcare access and health outcomes for women enrolled in FAMIS MOMS over the course of the 10-year demonstration renewal period by:
• Facilitating access to prenatal care for FAMIS MOMS participants • Improving selected birth outcomes of FAMIS MOMS participants and their newborns
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FAMIS Select: The demonstration will operate a cost-effective health insurance subsidy program that offers a consistently high-quality experience for FAMIS Select members over the course of the 10-year demonstration renewal period by:
• Assuring that consumer experience of FAMIS Select participants, with respect to customer service and health care access, is satisfactory or better • Ensuring the FAMIS Select program is cost-effective for DMAS
Maintain or improve healthcare access and health outcomes for women enrolled in FAMIS MOMS over the course of the 10-year demonstration renewal period Facilitate access to prenatal care for FAMIS MOMS participants Maintain or increase rates of FAMIS MOMS receiving adequate prenatal care (at least 80% of prenatal visits) Improve birth outcomes for babies born to FAMIS MOMS participants Maintain or decrease the proportion of births to FAMIS MOMS participants that are preterm (less than 37 weeks gestation) Maintain or decrease the incidence of low birth weights (birth weight less than 5 pounds, 8 ounces or 2500 grams) for babies born to FAMIS MOMS Operate cost-effective health insurance subsidy program that offers a consistently high quality experience for FAMIS Select members over the course of the 10-year demonstration renewal period Assure that consumer experience of FAMIS Select participants, with respect to customer service and health care access, is satisfactory or better FAMIS Select members’ families will report that they are satisfied with the service offered by the Select program, a subsidy for private or employer- sponsored insurance Families will report that children in FAMIS Select have a satisfactory level of access to health care services through their private or employer- sponsored insurance subsidized by FAMIS Select Ensure the FAMIS Select program is cost-effective for DMAS Average per-enrollee, per- month cost associated with FAMIS Select program will not exceed per-enrollee, per-month cost of providing the FAMIS benefit plan Aim Primary Drivers Secondary Drivers Aim Primary Drivers Secondary Drivers
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 44 of 61 Demonstration Populations
The FAMIS MOMS and FAMIS Select demonstration populations include:
A. Demonstration Population I – FAMIS MOMS FAMIS MOMS provides coverage to uninsured pregnant women in families with income up to and including 200 percent (plus a five percent income disregard) of the federal poverty level (FPL) who are not otherwise eligible for Medicaid. FAMIS MOMS also provides coverage to lawfully residing pregnant women and pregnant women with access to state employee health benefit coverage (in accordance with the hardship exception as provided in section 2110(bX6XC) of the Social Security Act (the Act)), thereby aligning the Commonwealth’s coverage of pregnant women with the expansion of CHIP coverage to children of state employees. FAMIS MOMS coverage is the same as that provided to pregnant women under the Medicaid state plan. Under the demonstration, Virginia is also authorized to deem infants born to FAMIS MOMS to be eligible for Medicaid or CHIP coverage, as appropriate. FAMIS MOMS beneficiaries receive health care services primarily through one of the managed care organizations (MCOs) contracted by the Commonwealth to provide Medicaid and FAMIS (CHIP state plan) benefits.
B. Demonstration Population II – FAMIS Select FAMIS Select provides premium assistance for private or employer-sponsored insurance to uninsured children, from birth through age 18, in families with income up to and including 200 percent (plus a five percent income disregard) of the FPL, who are eligible for direct CHIP coverage. These individuals are provided the option to receive premium assistance for private or employer-sponsored insurance and supplemental immunization benefits in lieu of receiving coverage under the CHIP state plan. However, these individuals still retain the right to elect to receive direct CHIP coverage instead at any time. FAMIS Select beneficiaries receive health care services through the private or employer-sponsored plan of choice.
Demonstration Objectives to be Evaluated
During the renewal period, the objectives of the demonstration to be evaluated are as follows:
FAMIS MOMS (Demonstration Population I):
• Facilitate access to prenatal care for FAMIS MOMS participants. • Improve selected birth outcomes of FAMIS MOMS participants and their newborns.
FAMIS Select (Demonstration Population II):
• Facilitate access to affordable private and employer-sponsored health insurance for low- income families through premium assistance. • Monitor and ensure member satisfaction with FAMIS Select program. • Assure the aggregate cost-effectiveness of the FAMIS Select program.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 45 of 61 Table 1. FAMIS MOMS and FAMIS Select Demonstration Evaluation Design FAMIS MOMS Hypothesis I: The proportion of pregnant women enrolled in FAMIS MOMS who are receiving adequate or better prenatal care will be maintained or will increase from SFY 2019 to SFY 2029. Research Question: Outcome Measures: Population: Data Sources and Analytic Methods: Benchmarks: Subgroups: Is enrollment in FAMIS MOMS enabling pregnant women to obtain better access to adequate prenatal care? Births with Early and Adequate Prenatal Care— Percentage of births with an Adequacy of Prenatal Care Utilization (APNCU) Index score greater than or equal to 80 percent
Live, singleton births to FAMIS MOMS during a given calendar year Deterministic and probabilistic data matching are used to create dataset of linked fee-for- service claims, managed care encounters, enrollment records, and birth registry records. Chi-square tests used to assess statistical significance of year-over-year changes. Healthy People 2030 goal Increase the proportion of pregnant women who receive early and adequate prenatal care – MICH-08 -Age -Race/ Ethnicity -Region
Hypothesis II: The proportion of FAMIS MOMS enrolled in the FAMIS MOMS program with preterm births (less than 37 weeks gestation) will remain the same or will decrease from SFY 2019 to SFY 2029. Research Question: Outcome Measures: Population: Data Sources and Analytic Methods: Benchmarks: Subgroups: Is enrollment in FAMIS MOMS improving birth outcomes of FAMIS MOMS participants? Preterm Births (< 37 Weeks Gestation)— Percentage of births that occurred before 37 completed weeks of gestation Live, singleton births to FAMIS MOMS during a given calendar year Deterministic and probabilistic data matching are used to create dataset of linked fee-for- service claims, managed care encounters, enrollment records, and birth registry records. Chi-square tests used to assess statistical significance of year-over-year changes. Healthy People 2030 goal Reduce preterm births – MICH‑07 -Age -Race/ Ethnicity -Region
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 46 of 61 Hypothesis III: The rate of low birth weight births (birth weight less than 5 pounds, 8 ounces [2,500 grams]) among FAMIS MOMS will decline or remain the same over the demonstration period. Research Question: Outcome Measures: Population: Data Sources and Analytic Methods: Benchmarks: Subgroups: Is enrollment in FAMIS MOMS improving birth outcomes of FAMIS MOMS participants? Newborns with Low Birth Weight (<2,500 grams)—The percentage of newborns weighing less than 2,500 grams at birth. This includes birth weights in the very low birth weight category (birth weights less than 1,500 grams) and the low birth weight category (birth weights between 1,500 and 2,499 grams).
Live, singleton births to FAMIS MOMS during a given calendar year
Deterministic and probabilistic data matching are used to create dataset of linked fee-for- service claims, managed care encounters, enrollment records, and birth registry records. Chi-square tests used to assess statistical significance of year-over-year changes. CMS Child Core Set measure Newborns with Low Birth Weight (<2,500 grams). Median and mean for state Medicaid programs in the most recent federal fiscal year -Age -Race/ Ethnicity -Region
FAMIS Select Hypothesis IV: FAMIS Select members’ families will report that they are satisfied with the service offered by the FAMIS Select program, a subsidy for private/employer-sponsored insurance. Research Question: Outcome Measures: Population: Data Sources: Analytic Methods: Is the self- reported consumer experience of participants in FAMIS Select satisfactory? What do participants report can be improved? Analysis of responses to focus group questions used to assess level of overall satisfaction Parents/guardians of current FAMIS Select enrollees
Responses to focus group questions about consumers’ experiences with DMAS-operated components of the program, such as customer service, responsiveness to customer inquiries, and timely processing of subsidy payments. Qualitative analysis of focus group material
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 47 of 61 Hypothesis V: FAMIS Select families will report that they are able to access preventive services, use specialty healthcare services, and schedule timely appointments with preferred providers. Research Question: Outcome Measures: Population: Data Sources: Analytic Methods: Do families report that children in FAMIS Select have a satisfactory level of access to health care services through their private or employer- sponsored insurance subsidized by FAMIS Select? Analysis of responses to focus group questions used to assess level of access to health care services Parents/guardians of current FAMIS Select enrollees
Responses to focus group questions about consumers’ perception of their child’s level of access to health care services and providers under their private or employer-sponsored health insurance plan, including access to preventive services and specialty healthcare services, and ability to schedule timely appointments with preferred providers.
Qualitative analysis of focus group material Hypothesis VI: The FAMIS Select program will be cost-effective as compared to the FAMIS program over the course of the demonstration year (state fiscal year) Research Question: Outcome Measures: Population: Data Sources: Analytic Methods: Is the FAMIS Select program cost-effective? Cost- effectiveness analysis (FAMIS Select- FAMIS comparison)
FAMIS Select enrollees during state fiscal year Fee-for-service claims, managed care encounters and capitation payments, and enrollment records Average per- enrollee, per- month cost and administrative expense associated with the FAMIS Select population, compared to the per-enrollee, per-month cost of providing the FAMIS benefit plan
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 48 of 61 DEMONSTRATION EVALUATION DESIGN
FAMIS MOMS (Demonstration Population I)
Methodology
For the FAMIS MOMS demonstration evaluation, Virginia will employ the dataset from the annual Birth Outcomes Study conducted by DMAS’ contractor.1 The dataset is created by the contractor and DMAS subject matter experts using deterministic and probabilistic data linking to match FAMIS MOMS members with birth registry records, thereby identifying births paid by Virginia Medicaid/CHIP during a given calendar year. Member claims and encounter data files are matched with birth registry data fields for members from each of the data linkage processes. All probabilistically or deterministically linked birth registry records are included in the eligible study population. The eligible population included in the demonstration evaluation dataset will consist of FAMIS MOMS who gave birth during a given calendar year. A birth will be included if the member was enrolled in FAMIS MOMS on the date of delivery, regardless of whether the birth occurred in Virginia. The birth registry contains records of live births; other pregnancy outcomes will be excluded from the dataset used to calculate the evaluation measures. Since multiple gestation births are subject to different clinical guidelines, results will be limited to singleton births, defined using the Plurality field in the birth registry data.
For each of the three FAMIS MOMS evaluation measures, DMAS will report year over year comparisons. Chi-square tests will be used to determine whether statistically significant differences are observed between the prior year and current year’s measures. For national benchmark comparisons of measures I and II (Births with Early and Adequate Prenatal Care and Preterm Births), DMAS proposes to use baseline and target data from the Healthy People 2030 goals. (Baselines are drawn from nationwide vital statistics from the Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS) National Vital Statistics System (NVSS)).2 For the Newborns with Low Birth Weight measure, DMAS proposes to use the CMS Core Set benchmark for the federal fiscal year that corresponds to the calendar year of the Birth Outcomes Study (e.g., FFY2019 Child Core Set benchmark for CY2019 Birth Outcomes Study measure).3 In annual and semiannual monitoring reports, DMAS will present additional supplemental analysis as appropriate to provide context for the reported outcomes, such as data on key maternal demographic characteristics (race/ethnicity, geographic region) and other relevant information (managed care vs. fee-for-service enrollment, timing and duration of enrollment).
1 Currently the Birth Outcomes Study is conducted by DMAS’ External Quality Review Organization (EQRO). 2 Healthy People 2030, “Pregnancy and Childbirth.” U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. Available at https://health.gov/healthypeople/objectives-and- data/browse-objectives/pregnancy-and-childbirth. Accessed January 4, 2021. 3 See, for example, “Performance on the Child Core Set Measures, FFY 2019.” Child Health Care Quality Measures, Centers of Medicare & Medicaid Services, Oct. 2020. Available at https://www medicaid.gov/medicaid/quality-of- care/performance-measurement/adult-and-child-health-care-quality-measures/childrens-health-care-quality- measures/index.html.
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Limitations
Analysis requires matching two data sources without a common unique identifier: 1) Medicaid enrollment data, and 2) birth records. Using this methodology enables DMAS to monitor outcomes not present in claims data such as gestational age, more comprehensive prenatal records, and birth weight. However, we may be underestimating the impact from mothers without Social Security numbers, the most common unique identifier in a deterministic match. DMAS has conducted analysis to determine likelihood of capturing a delivery through birth records and has confirmed that the match is sufficient for generalization.
Another limitation of our data is the limited sample size of the FAMIS MOMS population, which is typically no more than 1,650 members. Small sample sizes create challenges when conducting more complex models, or conducting analyses on subgroups, such as comparing women across race/ethnicities. Therefore, DMAS has concluded that all subpopulations should be grouped into the largest meaningful category and statistical tests limited to chi-squares.
Measure specifications and benchmarks for each measure are described in detail below.
Hypothesis I: The proportion of pregnant women enrolled in FAMIS MOMS who are receiving adequate or better prenatal care will be maintained or will increase from SFY 2019 to SFY 2029.
Measure I: Births with Early and Adequate Prenatal Care—The percentage of births with an Adequacy of Prenatal Care Utilization (APNCU) Index score greater than or equal to 80 percent (i.e., births scoring in the “Adequate” or “Adequate Plus” categories)
Measure 1 Percentage of FAMIS MOMS Participants Receiving Adequate or Adequate Plus Prenatal Care as Defined by APNCU Index Numerator Number of Births to FAMIS MOMS Participants Who Received Adequate or Adequate Plus Prenatal Care Denominator Number of FAMIS MOMS Participants with Births During the Calendar Year* * Numerator and denominator are limited to live, singleton births during the calendar year.
Demonstration Goal: Facilitate access to prenatal care for FAMIS MOMS participants.
Research Question: Is enrollment in FAMIS MOMS enabling pregnant women to obtain better access to adequate prenatal care?
Measure I Description, Specifications and Benchmarks: Data for Measure I will come from fee-for-service claims, managed care encounters, enrollment records, and birth registry data to determine eligibility group and prenatal visit utilization. As described above, the dataset will include live, singleton births to FAMIS MOMS during a given calendar year.
Adequate prenatal care will be defined using the Adequacy of Prenatal Care Utilization (APNCU) Index, also known as the Kotelchuck Index. The adequacy of prenatal care received during pregnancy has been associated with lower incidence of poor birth outcomes, such as preterm delivery and low-birth-weight births.* The APNCU Index uses birth certificate information to assess prenatal care in relation to two separate and distinct components. First, it measures at what point in the pregnancy a mother initiated prenatal care. Second, the index considers the number of prenatal visits throughout the pregnancy. The two components are combined into a single prenatal care utilization composite score. Higher composite scores on the APNCU Index are assigned to women who initiate prenatal care early in pregnancy and complete at least 80 percent of the visits expected based on the time frame, adjusted for gestational age at prenatal care initiation and the infant’s gestational age at delivery.°
The table below shows the composite score categories and criteria defining each category.
APNCU Index Criteria for Adequacy of Prenatal Care
Prenatal care initiated by the fourth month of pregnancy and 110% or more of expected visits received
Prenatal care initiated by the fourth month of pregnancy
Adequate Plus
Adequate and 80% to 109% of expected visits received - Prenatal care initiated by the fourth month of pregnancy Intermediate and 50 to 79% of expected visits received Prenatal care initiated after the fourth month of pregnancy Inadequate
or less than 50% of expected visits received
DMAS will use the annual baseline identified in the Healthy People 2030 goal “Increase the proportion of pregnant women who receive early and adequate prenatal care —- MICH-08” — which uses data derived from the CCDC, NCHS, NVSS, for the Births with Early and Adequate Prenatal Care measure — for each year corresponding to the calendar year of the Buth Outcomes Study. Healthy People 2030 published a national baseline in which 76.4 percent of women received early and adequate prenatal care during 2018, with an initial goal of 80.5 percent and a 1 percentage point improvement for each year.© DMAS will compare study indicator findings
4 Kreger PM, Scholl TO. Adequacy of prenatal care and pregnancy outcome. The Journal of the American Osteopathic Association. 2000; 100(8):485—492.
> Kotelchuck M. An evaluation of the Kessner Adequacy of Prenatal Care Index and a proposed Adequacy of Prenatal Care Utilization Index. American Journal of Public Health. 1994; 84(9):1414—-1420.
6 Healthy People 2030. “Increase the proportion of pregnant women who receive early and adequate prenatal care — MICH-08.” U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion.
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Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 51 of 61 for 2018 to the Healthy People 2030 baseline goal of 76.4 percent and will adjust the target goal on an annual basis.
Virginia has been using the APNCU to measure adequacy of prenatal care for pregnant women across the Medicaid programs. Using this index as one of the measures for the FAMIS MOMS evaluation will enable DMAS to compare adequacy of prenatal care rates to other pregnant women’s aid categories and identify disparities that may exist across programs, or findings from the strengths of one program that can be implemented in other programs.
DMAS will conduct additional analysis as appropriate, such as stratification of outcomes by geography, race and ethnicity, managed care enrollment, etc., to better understand and address trends that may disproportionately affect subgroups, and/or collection of additional input from current enrollees, case managers, providers, and managed care organization staff and to identify opportunities for improvement.
Hypothesis II: The proportion of individuals enrolled in the FAMIS MOMS program with preterm births (less than 37 weeks gestation) will remain the same or will decrease from SFY 2019 to SFY 2029.
Measure II: Preterm Births (< 37 Weeks Gestation)—The percentage of births that occurred before 37 completed weeks of gestation
Measure 2 Rate of preterm birth for FAMIS MOMS Numerator Number of live, singleton births to FAMIS MOMS born prior to 37 completed weeks gestation Denominator Total number of live, singleton births to FAMIS MOMS
Measure II Description, Specifications and Benchmarks: Data for Measure II will come from eligibility and enrollment records along with birth registry records for live births.
Available at https://health.gov/healthypeople/objectives-and-data/browse-objectives/pregnancy-and- childbirth/increase-proportion-pregnant-women-who-receive-early-and-adequate-prenatal-care-mich-08. Accessed on January 5, 2021. Demonstration Goal: Improve selected birth outcomes of FAMIS MOMS participants and their newborns.
Research Question: Is enrollment in FAMIS MOMS improving birth outcomes of participants?
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 52 of 61 Eligibility and enrollment records of FAMIS MOMS will be linked with birth registry records through probabilistic and deterministic matching in order to identify births to FAMIS MOMS members during the relevant evaluation year. Preterm births will be defined as any live birth occurring before 37 weeks gestation.
In order to evaluate incidence of preterm births among the FAMIS MOMS population over time, DMAS will monitor year-over-year percentage changes. DMAS will conduct further investigation as appropriate, such as geographic, provider, and co-morbidity analyses. Preterm birth (defined as birth prior to 37 weeks) is a common measure reported not only for other Virginia Medicaid populations, but also by other states’ Medicaid programs and for other comparable populations. This commonality enables Virginia to compare rates seen among the FAMIS MOMS population to other internal and national benchmarks.
DMAS will use the Healthy People 2030 goal “Reduce preterm births – MICH‑07” as a national benchmark for the preterm births measure. Healthy People 2030 published a national baseline in which 10.0 percent of live births were preterm in 2018, with an initial goal of no more than 9.4 percent of live births being preterm.7 DMAS will compare FAMIS MOMS performance on this measure to the Healthy People 2030 goal of 9.4 percent and will reassess the benchmark value on an annual basis.
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Hypothesis III: The rate of low birth weight births (birth weight less than 5 pounds, 8 ounces (2,500 grams)) among FAMIS MOMS will decline or remain the same over the demonstration period.
Measure III: Newborns with Low Birth Weight (<2,500 grams) – The percentage of newborns weighing less than 2,500 grams at birth. This includes birth weights in the very low birth weight category (birth weights less than 1,500 grams) and the low birth weight category (birth weights between 1,500 and 2,499 grams).
Measure 3 Infants born with low birth weight (weight < 2,500 grams) Numerator Number of infants born to FAMIS MOMS with a birth weight less than 5 pounds, 8 ounces (2,500 grams)
7 Healthy People 2030. “Reduce preterm births— MICH‑07.” U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. Available at https://health.gov/healthypeople/objectives-and- data/browse-objectives/pregnancy-and-childbirth/reduce-preterm-births-mich-07. Healthy People 2030 baseline is derived from NVSS reports. Martin JA, Hamilton BE, Osterman MJK, et al. Births: Final Data for 2018. National Vital Statistics Reports. 2019; 68(13). Hyattsville, MD: National Center for Health Statistics. 2019. Available at https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_13-508.pdf.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 53 of 61 Denominator Total number of live, singleton births to FAMIS MOMS
Measure III Description, Specifications and Benchmarks: Data for Measure III will come from enrollment records along with birth registry records for live births. Eligibility and enrollment records of FAMIS MOMS will be linked with birth registry records through probabilistic and deterministic matching in order to identify births to FAMIS MOMS members during the relevant evaluation year. Low birth weight will be defined as birth weight less than 2,500 grams.
In order to evaluate incidence of low birth weight infants born to FAMIS MOMS over time, DMAS will monitor year-over-year percentage changes. The number of live births to FAMIS MOMS with a gestational weight less than 2,500g will be compared to the total number of live births to FAMIS MOMS in a given year. Low birth weight is a common measure reported not only for other Virginia Medicaid populations, but also by other state Medicaid programs and for other comparable populations. This commonality enables Virginia to compare rates seen among the FAMIS MOMS population to other internal and national benchmarks. Virginia will analyze the change in rates of low birth weight births and will conduct further investigation, such as geographic, provider, and co- morbidity analyses as appropriate. As a benchmark for the FAMIS MOMS evaluation’s newborns with low birth weight measure, DMAS will use the CMS Child Core Set measure Newborns with Low Birth Weight (<2,500 grams). An update is released annually and includes data for all states and Washington, D.C., for Medicaid/CHIP populations.8 DMAS will compare evaluation data with the reported median and mean for state Medicaid programs in the most recent federal fiscal year for which data are available at the time of reporting.
FAMIS Select (Demonstration Population II)
Methodology
For the FAMIS Select evaluation, DMAS will conduct focus groups with FAMIS Select participants’ adult family members to gain an understanding of how the members’ families believe the program is working for their child. Due to concerns regarding the current public health emergency and social distancing requirements, DMAS believes virtual focus groups will be the most effective and efficient method of gathering input from FAMIS Select members’ family members. Additionally, resources are significantly limited at this time.
Questions will be grouped into two categories. One category of questions will aim to understand consumers’ experiences with DMAS-operated components of the program, such as customer
8 “Performance on the Child Core Set Measures, FFY 2019.” Child Health are Quality Measures, Centers of Medicare & Medicaid Services, Oct. 2020. Available at https://www medicaid.gov/medicaid/quality-of- care/performance-measurement/adult-and-child-health-care-quality-measures/childrens-health-care-quality- measures/index.html.
Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 54 of 61 service, responsiveness to customer inquiries, and timely processing of subsidy payments. Questions will aim to identify customer service issues or other shortcomings or strengths of the DMAS-operated aspects of the FAMIS Select program. The second category of questions will aim to understand consumers’ perception of their level of access to health care services and providers under their private or employer-sponsored health insurance plan. For both categories, focus groups will gauge consumer satisfaction and identify challenges encountered by FAMIS Select participants and ways the program could be improved. Focus group structure will also allow members to discuss additional items as introduced by other group members from discussion.
The FAMIS Select evaluation is qualitative in nature due to the limited size of the program. In future years, should the FAMIS Select population grow in size, more complex sampling strategies may be explored. The study population will consist of children enrolled in FAMIS Select for one or more months. DMAS will contact parents/guardians of FAMIS Select participants as part of this evaluation (current enrollment is approximately 50 children) and seek to include the family members in focus groups. Based on past experience with outreach to participants in this program, DMAS anticipates that we will be able to complete two focus groups, representing approximately 20 percent of participating families.
The focus group prompts will be refined in consultation with DMAS subject matter experts. The focus groups will be administered and data compiled and analyzed by DMAS staff following the proposed timeline attached. DMAS staff with training and background in focus group design, evaluation, and analysis will be consulted regarding content and analysis of responses.
Limitations In SFY2018, there were an estimated 102 enrollees covered under the FAMIS Select demonstration. This falls well short of the criteria for having at least 500 potential enrollees needed to include a comparison group in the evaluation, based on CMS’ Modified Evaluation Design for the Section 1115 Demonstration expanding Title XXI coverage. Most recently, the program included 50 children, with enrollment often dipping below even the 30 necessary to draw minimal statistical inferences. Therefore, DMAS will focus our efforts on gathering high quality qualitative data to determine our members’ satisfaction with the program and identify potential barriers or areas of improvement.
Descriptions of each measure are provided in detail below.
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Hypothesis IV: FAMIS Select members’ families will report that they are satisfied with the service offered by the FAMIS Select program, a subsidy for private/employer-sponsored insurance.
Measure IV: Analysis of responses gathered in focus groups with families of current FAMIS Select enrollees
Measure IV Description: Data for Measure IV will come from focus groups with FAMIS Select participants conducted by Virginia DMAS staff. Group questions will aim to understand consumers’ experiences with DMAS-operated components of the program, such as customer service, responsiveness to customer inquiries, and timely processing of subsidy payments. Questions will aim to identify customer service issues or other shortcomings or strengths of the DMAS-operated aspects of FAMIS Select.
Focus group responses will be systematically categorized into themes using dynamic methods to determine general satisfaction or dissatisfaction with the FAMIS Select program. Independent coders will determine relevant attributes and synthesize data to assign satisfaction levels as “not satisfied,” “somewhat satisfied,” “satisfied,” and “very satisfied.”
Hypothesis V: FAMIS Select families will report that they are able to access preventive services, use specialty healthcare services, and schedule timely appointments with preferred providers under their private or employer-sponsored insurance that is subsidized by FAMIS Select. Demonstration Goal: Monitor and ensure member satisfaction with the FAMIS Select program.
Research Questions: Is the self-reported consumer experience of participants in FAMIS Select satisfactory? What do participants report can be improved? Demonstration Goal: Monitor and ensure member satisfaction with the FAMIS Select program.
Research Question: Do families report that children in FAMIS Select have a satisfactory level of access to health care services through their private or employer- sponsored insurance subsidized by FAMIS Select?
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Measure V: Analysis of responses gathered in focus groups with families of current FAMIS Select enrollees
Measure V Description: Data for Measure V will come from focus groups with FAMIS Select participants conducted by Virginia DMAS staff. Focus group questions will aim to understand consumers’ perception of their child’s level of access to health care services and providers under their private or employer-sponsored health insurance plan, including access to preventive services and specialty healthcare services, and ability to schedule timely appointments with preferred providers.
Group responses will be systematically categorized into themes using dynamic methods to determine accessibility of healthcare services for members participating in the FAMIS Select program. Independent coders will determine relevant attributes and synthesize data to assign healthcare service accessibility levels as “not accessible,” “somewhat accessible,” “accessible,” and “very accessible.”
Hypothesis VI: The FAMIS Select program will be cost-effective as compared to the FAMIS program over the course of the demonstration year (state fiscal year)
Measure VI: Cost-effectiveness analysis (FAMIS Select-FAMIS comparison)
Measure VI Description: Data for Measure VI will come from fee-for-service claims, managed care encounters and capitation payments, and enrollment records.
Consistent with these STCs and 2105(c)(3) of the Social Security Act, DMAS monitors FAMIS Select program expenditures to ensure cost effectiveness. Specifically, DMAS compares the agency’s cost to subsidize the purchase of employer-sponsored insurance to the amount of expenditures, including administrative expenditures, that the state would have made to provide comparable coverage to the targeted low-income child or family involved under the state child health plan, FAMIS.
Cost-effectiveness will be assessed by calculating the average per-enrollee, per-month cost and administrative expense associated with the FAMIS Select enrolled population, compared to the per-enrollee, per-month cost of providing the FAMIS benefit plan.
Demonstration Goal: Assure the aggregate cost-effectiveness of the FAMIS Select program
Research Question: Is the FAMIS Select program cost-effective?
EVALUATION TIMELINE
FAMIS MOMS Annual Evaluation Timeline for the Demonstration Year
(Example: Semiannual report for April 29, 2021 will incorporate FAMIS MOMS bith outcomes data from Calendar Year 2019)
Task Date DMAS and subject matter experts, including EQRO, develop requirements April-Jul for quantitative analyses of prior calendar year data P y DMAS submits member, eligibility, enrollment, and claims/encounter data Tul through June vendor files to EQRO y EQRO processes, loads, and validates data through June vendor files Tul received from DMAS y DMAS obtains linked Birth Registry data from prior calendar year and submits files to EQRO June-August EQRO and DMAS SMEs conduct file review and resolve any questions or Auoust concerns gus EQRO calculates and validates Birth Outcomes Study indicators and August- stratification categories September EQRO generates and validates Birth Outcomes Study analytic tables and October figures EQRO generates and validates analytic dataset and corresponding data October- dictionary December EQRO submits draft report to DMAS October- November : . : November- DMAS provides feedback and EQRO incorporates into report December EQRO submits final Birth Outcomes Study report and analytic dataset to December- DMAS January DMAS conducts supplemental analysis of the FAMIS MOMS data, such . ; January-April as subgroup analyses, as appropriate DMAS delivers semi-annual report to CMS, to include reporting of the FAMIS MOMS evaluation metrics described in this document (drawn from Birth Outcomes Study analysis) No later than . April 29 of each year
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FAMIS Select Annual Evaluation Timeline for the Demonstration Year
DMAS proposes that this focus groups be conducted annually with FAMIS Select participating
families.
Task Date Finalize focus group questions in consultation with CMS and DMAS Fel subject matter experts January-Fe DMAS staff contact parent/caretaker of each child member to request and conduct focus groups (based on member experience over the past | February-March year of enrollment) Second round of calls to parents/caretakers for second focus group March-May DMAS compiles and analyzes results June-July DMAS composes update on FAMIS Select Evaluation incorporating July-September results DMAS delivers annual report to CMS, to include reporting of the No later than FAMIS Select evaluation metrics described in this document for the o fater
: September 28 prior calendar year
* As of end of April 2021, DMAS did not have an approved evaluation design. Therefore, focus group data may not be included and analyzed for September 2021 report due to time constraints.
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FAMIS MOMS and FAMIS Select Demonstration Milestones
Task
Date
DMAS delivers Draft Interim Evaluation Report for the period July 2019-June 2022.
No later than June 30, 2023
DMAS delivers Final Interim Evaluation Report for the No later than 60 days after period July 2019-June 2022; DMAS posts final document | receiving CMS comments on the and any supporting documents on DMAS website. Draft Interim Evaluation Report
DMAS delivers Draft Interim Evaluation Report for the period July 2019-June 2024.
No later than June 30, 2025
DMAS delivers Final Interim Evaluation Report for the No later than 60 days after period July 2019-June 2024; DMAS posts final document | receiving CMS comments on the and any supporting documents on DMAS website. Draft Interim Evaluation Report
DMAS delivers Draft Interim Evaluation Report for the period July 2019-June 2027.
(Draft Interim Evaluation Report will accompany application for demonstration extension, if applicable, and will be posted to the Commonwealth’s public website, along with the application, for public comment.)
No later than June 30, 2028
DMAS delivers Final Interim Evaluation Report for the period July 2019-June 2027; DMAS posts final document and any supporting documents on DMAS website.
No later than 60 days after receiving CMS comments on the Draft Interim Evaluation Report
DMAS delivers Draft Summative Evaluation Report for the demonstration period (July 2019-June 2029)
No later than December 30, 2030
DMAS delivers Final Summative Evaluation Report for the demonstration period (July 2019-June 2029)
No later than 60 days after receiving CMS comments on the Draft Summative Evaluation
Report DMAS posts Final Summative Evaluation Report to the Within 30 calendar days of Commonwealth’s website approval by CMS.
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Virginia FAMIS MOMS and FAMIS Select Section 1115 Demonstration Demonstration Period: October 25, 2019 through June 30, 2029; Amended November 18, 2021 Page 60 of 61 EVALUATION BUDGET
The data for Measures I through III are collected as part of the process for the annual Birth Outcomes Study conducted by DMAS’ External Quality Review Organization (EQRO). Additional analysis as well as monitoring and reporting tasks will be conducted in-house by DMAS staff and are not expected to incur additional costs.
Given the uncertainty posed by the COVID-19 public health emergency, for Measures IV and V DMAS has intentionally limited data collection methods in the draft evaluation plan to virtual focus groups conducted by DMAS staff. In the future, DMAS could potentially revisit this decision and consider hosting in-person interviews and/or focus groups onsite at the DMAS offices, conducted by DMAS staff. We do not expect any additional staffing or contract costs attributable to the evaluation. DMAS will continue to provide updated information regarding program enrollment and will work with CMS to revise the evaluation plan and budget for FAMIS Select if necessary.
Data for Measure VI are gathered and analyzed internally by DMAS Budget and Data Analytics staff.
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