b. Medically Frail Definition

As noted in section II.E.5.a. of this IFC, consistent with our statutory authority at section 1902(xx)(9)(A)(ii)(V) of the Act, we are defining a medically frail individual at § 435.554(c)(5) as an individual whose physical, mental, or other behavioral health condition significantly impairs the individual's ability to comply with the community engagement requirement in this subpart and who is blind or disabled (as defined at section 1614 of the Act); with an SUD; with a disabling mental disorder; with a physical, intellectual, or developmental disability that significantly impairs their ability to perform one or more ADLs; or with a serious or complex medical condition. Individuals only need to fit within one of these categories to qualify for the medically frail exclusion to the community engagement requirement.

The best reading of the statutory phrase “medically frail or otherwise has special medical needs” is one that considers not only the presence of a particular diagnosis or condition, but also the extent to which the condition impairs an individual's ability to engage in community engagement activities (including but not limited to work) or otherwise comply with the statutory requirements in section 1902(xx) of the Act. Reading the statute to require automatic classification as medically frail or otherwise having special medical needs based solely on diagnosis or condition would risk sweeping in individuals whose conditions do not significantly impair their functional capacity, meaning that they are able to perform 80 hours per month of qualifying activities, and thus would fail to give full meaning to the term “medically frail or who otherwise has special medical needs.” The phrase “medically frail or who otherwise has special medical needs” connotes diminished functional capacity that significantly impairs an individual's ability to meet ordinary demands. In this context, the relevant demand is meeting the community engagement requirement. Accordingly, we interpret the statute to require consideration of the severity of an individual's condition as relevant to whether that individual is capable of meeting the community engagement requirement. An individual who lacks the capacity to meet the community engagement requirement may properly be determined to be medically frail or otherwise to have special medical needs. But, if a person is able to demonstrate community engagement by performing 80 hours per month of qualifying community engagement activities, notwithstanding their physical, mental, or other behavioral health condition, they would not qualify as medically frail and would not be a specified excluded individual.

The statute also expressly delegates definitional authority to the Secretary by providing that individuals who are “medically frail” or “otherwise ha[ve] special medical needs” are those “as defined by the Secretary.” This language demonstrates Congress's intent to afford the Secretary discretion to establish standards governing the scope and application of this term in the context of administering the statute. Of note, section 1902(xx)(9)(A)(ii)(V), setting forth the exclusion for individuals who are medically frail or otherwise have special medical needs, is the only item in the statutory list of specified excluded individual categories that includes this express grant of definitional authority, which indicates that Congress specifically intended to authorize the Secretary to place parameters around which individuals will qualify for this exclusion.

Additionally, we are not aligning the definition of the medically frail categories for an individual who is disabled; with a disabling mental disorder; or with a physical, intellectual, or developmental disability that significantly impairs their ability to perform one or more ADL, with our definition of a disabled individual at § 435.554(a) or the veteran disability standard we describe in section II.E.4. of this IFC. We do not believe it would be appropriate to apply these definitions to these medically frail exclusion categories as the exclusion at section 1902(xx)(9)(A)(ii)(V)(aa) of the Act is expressly tied to the definition of a disabled individual at section 1614 of the Act, and it would be difficult to set one standard that appropriately defines individuals with disabling mental disorders or with a physical, intellectual, or developmental disability that significantly impairs their ability to perform one or more ADLs.

For the first medically frail exclusion, we are specifying at § 435.554(c)(5)(i)(A) that an individual who is blind or disabled (as defined in section 1614 of the Act) and who otherwise meets the ( printed page 33374) criteria at § 435.554(c)(5)(i) is medically frail, consistent with section 1902(xx)(9)(A)(ii)(V)(aa) of the Act. Under section 1614 of the Act, a person is blind if they have central visual acuity of 20/200 or less in the better eye with use of a correcting lens. Under section 1614 of the Act, a person is disabled if they are unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than twelve months.

For the second medically frail exclusion, we are specifying at § 435.554(c)(5)(i)(B) that an individual with an SUD and who otherwise meets the criteria at § 435.554(c)(5)(i) is medically frail, consistent with section 1902(xx)(9)(A)(ii)(V)(bb) of the Act, excluding individuals who are in stable recovery (which means, in recovery for 5 or more years). As we describe in more detail in the paragraph after next, we are excluding individuals in stable recovery from this definition since their SUDs are unlikely to significantly impair their ability to comply with the community engagement requirement. We decline to further define the term SUD in regulation, with the exception of excluding individuals who are in stable recovery, as there are numerous definitions of an SUD. While we are not further defining the term SUD, except for excluding individuals who are in stable recovery, it is our understanding that the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) [ 61 ] and International Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) [ 62 ] are most commonly used to define and classify SUDs, and States may find the DSM-5 and ICD-10 to be useful resources for setting criteria to identify individuals with SUDs. We also believe it would be reasonable for States to consider certain conditions as SUDs, including alcohol use disorder, opioid use disorder, and stimulant use disorder provided an individual's SUD significantly impairs their ability to comply with the community engagement requirement. We note that this is a list of examples, and not an exhaustive list.

SUDs are characterized by cognitive, behavioral, and physiological symptoms indicating that an individual continues using a substance (for example, alcohol, opioids, hallucinogens, etc.) despite significant substance-related problems that impact the individual's life. [ 63 ] In addition, SUDs have different clinical levels: mild, moderate, and severe. It is our understanding that under current clinical standards SUDs are chronic diseases and that individuals in recovery are considered to have an SUD. [ 64 ] However, there are stages of recovery that are generally based on the length of recovery: early recovery, sustained recovery, and stable recovery. Generally, individuals in early recovery have been in recovery for less than 12 months, individuals in sustained recovery have been in recovery for 1 to less than 5 years, and individuals in stable recovery have been in recovery for 5 years or longer. [ 65 ]

We interpret the statutory reference to this medically frail category to apply to individuals with an SUD regardless of whether they are in an active treatment program. We believe our interpretation is supported by the statute, which does not include language limiting this exclusion only to individuals in an active treatment program. We also interpret the statutory reference to individuals with an SUD to include individuals who are in recovery from an SUD, including individuals who are in early or sustained recovery. However, we believe that it is inappropriate to include individuals with an SUD who are in stable recovery (which means individuals who are in recovery for 5 or more years) in the medically frail exclusion. The risk of SUD recurrence for an individual in stable recovery is approximately the same as the general population. [ 66 ] Therefore, we believe that such individuals are better able to participate in community engagement activities than an individual who is in active treatment or early or sustained recovery. In addition, we believe that participating in community engagement activities, such as employment, has the potential to help these individuals maintain their recovery by helping them escape isolation and dependency, build confidence, achieve self-sufficiency and prosperity, and improve health. As noted in section II.E.5.a. and preceding paragraphs in this section of this IFC, section 1902(xx)(9)(A)(ii)(V) of the Act provides the Secretary with the authority to define an individual who is medically frail, so we believe it is consistent with our statutory authority to exclude individuals who are in stable recovery from the definition of an individual with an SUD as we are defining the term. States must ensure that they have reasonable processes and criteria in place for individuals to identify themselves as meeting the SUD medically frail exclusion, including for individuals who have a relapse.

We note that for community engagement purposes the medically frail exclusion for individuals with an SUD is a distinct exclusion from the exclusion at section 1902(xx)(9)(A)(ii)(VII) of the Act for individuals participating in a drug addiction or alcoholic treatment and rehabilitation program (as defined in section 3(h) of the Food and Nutrition Act of 2008), described further in section II.E.7. of this IFC. While we acknowledge that individuals participating in a drug addiction or alcoholic treatment and rehabilitation program generally have SUDs, as we stated in the previous paragraph, we interpret the medically frail exclusion for individuals with SUDs at section 1902(xx)(9)(A)(ii)(V)(bb) of the Act as not limited to individuals in an active treatment program.

For the third medically frail exclusion, we are specifying in our regulation at § 435.554(c)(5)(i)(C) that an individual with a disabling mental disorder and who otherwise meets the criteria at § 435.554(c)(5)(i) is medically frail, consistent with section 1902(xx)(9)(A)(ii)(V)(cc) of the Act. There are numerous definitions of disabling mental disorders. The American Psychiatric Association defines mental disorders as conditions that impact an individual's thinking, emotion, or behavior and may impact an individual's functioning. [ 67 ] Further, a disabling mental disorder may significantly impair an individual's ability to complete major life activities, such as their ability to work or ( printed page 33375) volunteer [ 68 ] and can be either permanent or temporary. [ 69 ]

The statute specifically requires the mental disorder to be disabling, so an individual with a non-disabling mental disorder would not qualify for this exclusion. We decline to further define disabling mental disorder in our regulation, as it would be incredibly difficult to set one standard that appropriately defines individuals with disabling mental disorders, and we instead direct States to consider whether the disabling mental disorder significantly impairs an individual's ability to comply with the community engagement requirement. However, it is our understanding that the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC), DSM-5, and ICD-10 criteria for serious mental illness (SMIs) are commonly used to define and classify disabling mental disorders, and States may find the ISMICC, DSM-5, and ICD-10 to be useful resources for setting criteria to identify individuals with disabling mental disorders. We also believe it would be reasonable for States to consider certain conditions, when such conditions are disabling and significantly impair an individual's ability to comply with the community engagement requirement, as disabling mental disorders, including schizophrenia, schizotypal disorder, delusional disorder, other non-mood psychotic disorders, moderate or severe bipolar disorder, major depressive disorder, and panic disorder. We note that this is a list of examples, not an exhaustive list.

For the fourth medically frail exclusion, we are specifying in our regulation at § 435.554(c)(5)(i)(D) that an individual with a physical, intellectual, or developmental disability that significantly impairs their ability to perform one or more ADLs and who otherwise meets the criteria at § 435.554(c)(5)(i) is medically frail, consistent with section 1902(xx)(9)(A)(ii)(V)(dd) of the Act. There are numerous definitions of a physical, intellectual, or developmental disability. Processes used to determine that an individual has a physical, intellectual, or developmental disability are also generally dependent on an individual's functional status and the severity of their condition, which is consistent with our criteria at § 435.554(c)(5)(i) that an individual's physical, mental, or behavioral health condition must significantly impair their ability to comply with the community engagement requirement. The Eunice Kennedy Shriver National Institute for Child Health and Human Development has indicated that physical disabilities either temporarily or permanently impact an individual's physical function, intellectual disabilities generally permanent and impact an individual's intellectual functioning and adaptive behavior, and developmental disabilities are generally permanent and can impair physical or intellectual functioning, or both. [ 70 ] ADLs are activities related to personal care including bathing or showering, dressing, getting in and out of bed or a chair, walking, using the toilet, and eating. Instrumental activities of daily living (IADLs) are activities that allow an individual to live independently in the community (for example, shopping, meal preparation, etc.). [ 71 ]

The statute specifically requires that the individual's physical, intellectual, or developmental disability significantly impair their ability to perform one or more ADLs. An individual with such a disability that does not significantly impair their ability to perform one or more ADLs would not qualify for this exclusion. We interpret the statute as requiring an individual's physical, intellectual, or developmental disability to significantly impair their ability to perform one or more ADLs, but not IADLs, as IADLs are different from ADLs and the statute makes no reference to IADLs. We decline to further define a physical, intellectual, or developmental disability that significantly impairs an individual's ability to perform one or more ADLs in our regulation, as it would be incredibly difficult to set one standard that appropriately defines individuals who would qualify for such an exclusion, and instead direct States to consider the effect of the physical, intellectual, or developmental disability on an individual's ability to comply with the community engagement requirement. We believe it would be reasonable for States to consider certain conditions as physical, intellectual, or developmental disabilities for purposes of this exclusion, when such disabilities significantly impair an individual's ability to perform one or more ADLs and comply with the community engagement requirement, including muscular dystrophy, cerebral palsy, cystic fibrosis, spina bifida, impairments resulting from injuries (for example, spinal cord injury, brain injury, and amputation), Down syndrome, Fragile X syndrome, and Prader-Willi syndrome. We note that this is a list of examples, not an exhaustive list.

For the final medically frail exclusion, we are specifying at § 435.554(c)(5)(i)(E) that an individual with a serious or complex medical condition who otherwise meets the criteria in § 435.554(c)(5)(i) is medically frail, consistent with section 1902(xx)(9)(A)(ii)(V)(ee) of the Act. Since the statute uses the term “or,” we interpret this exclusion as applying to individuals with a serious medical condition, a complex medical condition, or a medical condition that is both serious and complex. We considered including specific conditions within our definition of a serious or complex medical condition, including human immunodeficiency virus and acquired immunodeficiency syndrome (HIV/AIDS), end stage renal disease (ESRD), cancer, and sickle cell disease (SCD) but, for reasons stated in a later paragraph, we do not believe it is reasonable to categorically consider conditions as serious or complex without factoring in criteria such as the severity of the condition.

In 1999, the Institute of Medicine, [ 72 ] in response to a request from the Health Care Financing Administration (now CMS), authored the report “Definition of Serious and Complex Medical Conditions.” [ 73 ] The report detailed difficulties with defining patient populations with “serious and complex” medical conditions but included the following criteria that could be used to describe medical conditions as serious and complex”: conditions that are life threatening, conditions that cause serious disability without necessarily being life threatening, conditions that cause significant pain or discomfort that can cause serious interruptions to life activities, conditions that require major commitments of time and effort from caregivers for a substantial period of time, conditions that may require frequent monitoring, conditions that predict or are associated with severe ( printed page 33376) consequences, conditions associated with negative consequences for someone else, conditions that affect multiple organ systems, conditions that require management to tight physiological parameters, conditions whose management requires coordination of multiple specialties, conditions whose treatment carries a risk of serious complications, and conditions requiring adjustment in a nonmedical environment. [ 74 ]

As the Institute of Medicine's report states: “It is important to recognize that these conditions may be serious and complex for some patients at some points during the course of their disease or disability. The conditions will not necessarily be serious and complex for all patients at all times.” This approach is relevant to our criteria at § 435.554(c)(5)(i), as an individual with a serious or complex condition must have their ability to comply with the community engagement requirement significantly impaired by their condition to be determined medically frail. We understand that, as discussed in the Institute of Medicine's report, the acuity of patients with serious or complex medical conditions can, and does, improve. An individual with a well-managed serious or complex medical condition that does not significantly impair their ability to meet the community engagement requirement should not be determined medically frail. We therefore expect States to evaluate an individual's serious or complex medical condition according to the serious or complex medical condition's impact on the individual's ability to comply with the community engagement requirement.

Based on the Institute of Medicine's list of possible criteria that could be used to identify a “serious and complex medical condition,” we are specifying at § 435.554(c)(5)(i)(E) that a serious or complex medical condition is a medical condition that is life threatening, seriously disabling without necessarily being life threatening, causing significant pain or discomfort that can cause serious interruptions to life activities, requiring a major time or effort commitment from caregivers for a substantial period of time, requiring frequent monitoring, associated with severe consequences or negative consequences for someone else, affecting multiple organ systems, requiring management to tight physiological parameters, requiring coordination of multiple specialties, requiring treatment that carries a risk of serious complications, or requiring adjustment in non-medical environments. States will need to ensure fidelity to the definition at § 435.554(c)(5)(i)(E) and our criteria at § 435.554(c)(5)(i) that an individual's physical, mental, or other behavioral health condition significantly impair their ability to comply with the community engagement requirement, when determining if an individual has a serious or complex medical condition for purposes of the community engagement exclusion.

We do not believe it would be appropriate to include an exhaustive list of conditions in regulation. However, we believe it would be reasonable for States to consider certain conditions as serious or complex, when such conditions significantly impair an individual's ability to comply with the community engagement requirement, including cancer, ESRD, viral hepatitis, SCD, chronic obstructive pulmonary disease, HIV/AIDS, sarcoidosis, cognitive impairment, heart disease, amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, cystic fibrosis, multiple sclerosis, spinocerebellar ataxias, muscular dystrophy, hemophilia, trauma disorders, and Thalassemia major. Examples of conditions that we would not typically expect to significantly impair an individual's ability to meet the community engagement requirement include asthma, hypertension, anemia, generalized pain, pre-diabetes, Type I or II diabetes, obesity, psoriasis, headaches, and Attention-Deficit/Hyperactivity Disorder.

We note that these are not exhaustive lists. As previously stated, according to the Institute of Medicine's report, “It is important to recognize that these conditions may be serious and complex for some patients at some points during their disease or disability. The conditions will not necessarily be serious and complex for all patients at all times.” [ 75 ] We further note that, in line with our approach to defining an individual who is medically frail at § 435.554(c)(5)(i), as discussed in a preceding paragraph, we do not believe that it is reasonable for States to categorically exclude individuals with certain serious or complex medical conditions from the community engagement requirement without considering whether their condition significantly impairs their ability to comply with the community engagement requirement. Whether a person with a serious or complex medical condition qualifies as a specified excluded individual on the basis of medical frailty will depend on the condition significantly impairing their ability to comply with the community engagement requirement. For example, individuals with HIV/AIDS are medically frail if they are determined to have a serious or complex medical condition that significantly impairs the individual's ability to comply with the community engagement requirement, which is less likely to be the case if the acuity of their condition is not severe. We recognize that the acuity may change over time. For example, individuals with pressure ulcers, pneumonia, or fractures that heal would likely be able to comply with the community engagement requirement in relatively short order as their condition would likely no longer be determined as a serious or complex medical condition that significantly impairs their ability to do so. In addition, we believe that if individuals with a serious or complex medical condition do not have significantly impaired ability to comply with the community engagement requirement participating in community engagement activities, such as employment, could potentially help them escape isolation and dependency, build confidence, achieve self-sufficiency and prosperity, and improve health.

Except as discussed in the preceding paragraphs, we decline to further define in regulation an individual with an SUD; with a disabling mental disorder; with a physical, intellectual or developmental disability that significantly impairs their ability to perform one or more ADLs; or with a serious or complex medical condition. As we specify at § 435.554(c)(5)(ii), States must use lists of diseases, diagnoses, disorders, or other health conditions to help define these categories and identify individuals who might potentially qualify as medically frail if they also meet the standard in § 435.554(c)(5)(i). The lists must be auditable, justifiable, and consistent with the definitions established at § 435.554(c)(5)(i)(A) through (E). We anticipate these lists will generally take the form of health care code sets (for example, ICD-10 codes, etc.). Further, such lists must be revised on a regular basis to add or remove diseases, diagnoses, disorders, or health conditions (as applicable) based on States' implementation experiences. For ( printed page 33377) example, States may determine that health conditions no longer need to be included on their lists because of advancements in treatment or that health conditions need to be added that are rare and were missed during their initial implementation of the community engagement requirement. In addition, if an individual does not have a disease, diagnosis, disorder, or health condition on the State's list, the State must have reasonable processes and criteria in place for such individuals to request consideration for the medically frail exclusion. We expect that individuals will request consideration on an infrequent basis as we believe such lists are likely to capture the breadth of diseases, diagnoses, disorders, or other health conditions that could be reasonably considered to meet the definitions at § 435.554(c)(5)(i)(A) through (E).

We note that any lists of diseases, diagnoses, disorders, or health conditions or other processes that States use to identify medically frail individuals must be shared with us upon request as part of our oversight and data monitoring activities. If through Payment Error Rate Measurement Program (PERM) audits and reporting, or any other CMS audits, we determine that States determined that an individual is medically frail in a manner inconsistent with § 435.554(c)(5)(i) (meaning there is frequent approval of individuals as medically frail with little to no support for the conclusion that their physical, mental, or other behavioral health condition significantly impairs their ability to comply with the community engagement requirement), States would not be in compliance with the regulation. Over time and with advances in treatment, we expect that the number of individuals who are determined to be medically frail by States will decline and then stabilize.

As States develop their lists and implement the medically frail exclusion, they must ensure that they are conducting outreach consistent with the Medicaid outreach requirements at § 435.561. We also encourage States to consider general public outreach efforts to complement the outreach required at § 435.561, so the public can clearly understand in which circumstances individuals might qualify as medically frail. In particular, individuals who are medically frail might not realize that they qualify for an exclusion from the community engagement requirement and will need clear, consumer-friendly information to help them understand if they are excluded. Additional information on Medicaid outreach requirements is found in section II.L. of this IFC.