Wheelchair users who are Medicare beneficiaries are subject to a twenty-year-old policy that requires wheelchairs to be necessary for a beneficiary’s “mobility-related activities of daily living” (MRADLs) such as grooming or toileting in the home before Medicare will cover their cost. For people with mobility disabilities who might be able to use crutches or a walker in their home, but who cannot travel far or at all outside of their home, the policy means that they will have to endure virtual house arrest.
On Monday, August 26, 2024, DREDF filed a complaint (.doc) with the U.S. Department of Health and Human Services’ Office for Civil Rights. DREDF’s complainant was denied a medically needed power wheelchair and forced to wait months to get a chair that would allow her to navigate through her community, attend school, and visit her friends. The In-Home Use policy has even influenced the wheelchair manufacturing industry since Medicare makes up close to 20% of the health insurance market, leading to chairs that are commonly lightweight and less sturdy since they are only assessed for their suitability for use within a home.
If you have similarly experienced a denial of an appropriate medically needed wheelchair by Medicare because it is not needed for MRADLs in the home or you are expected to get by with a wheelchair that does not do much except help you with MRADLs in the home, please send DREDF your story at info@dredf.org.
Complaint of Discrimination
U.S. Department of Health and Human Services, Office of Civil Rights
Date: Monday, August 26, 2024
Complainant:
Saleema Render Hornsby
c/o Silvia Yee
Disability Rights Education and Defense Fund
Ed Roberts Campus
3075 Adeline Street, Suite 210
Berkeley, CA 94703
Complainant’s Representatives:
Silvia Yee
Policy Director and Senior Attorney
Disability Rights Education and Defense Fund
Ed Roberts Campus
3075 Adeline Street, Suite 210
Berkeley, CA 94703
syee@dredf.org
Jillian MacLeod
Legal Fellow
Disability Rights Education and Defense Fund
Ed Roberts Campus
3075 Adeline Street, Suite 210
Berkeley, CA 94703
jmacleod@dredf.org
Respondents:
Centers for Medicare and Medicaid Services
Office of External Affairs
7500 Security Blvd.
Baltimore, MD 21244
877-267-2323
Attention:
Janice L. Hoffman
Associate General Counsel
U.S. Department of Health and Human Services Medicare and Medicaid Services Division
330 Independence Ave., SW, Room 5309
Washington, DC 20201
202-619-0300
Discrimination Alleged
Disability-based discrimination in violation of Section 504 of the Rehabilitation Act.
I. Introduction
Power wheelchairs and wheelchairs with custom features regularly cost thousands of dollars, and many wheelchair users struggle to pay for them without insurance coverage. According to a recent survey, wheelchair users who are Medicare beneficiaries experience severe barriers to obtaining the wheelchairs they need:
- 63% reported that it was difficult or very difficult for them to get their wheelchair
- 49% reported that their insurance (Medicare, Medicare Advantage, Medicare/Medicaid, or Medicare plus other insurance) did not fully cover the cost of their wheelchair or scooter
- 41% reported that their insurance had denied coverage for a type of chair or chair components in the last five years
- 32% reported that they were dissatisfied or very dissatisfied with the ability of the device they eventually acquired to meet their home and community-based activity needs.[1]
One survey respondent, explaining their experience of not being able to acquire the type of wheelchair they need to comfortably leave their home: “I just wish I didn’t have to depend on people in order to get around my own home and outside. Since acquiring this new type of wheelchair, I no longer go outside…and could almost be considered a shut in because I never want to leave my home…if I was able to get something better, I could better myself and my life.”[2]
One reason for these barriers is the Medicare “in-home use” policy. The Center for Medicare and Medicaid Services (CMS) improperly interprets the Medicare Act and its implementing regulations as limiting required coverage for durable medical equipment (including wheelchairs) to only those devices that a recipient needs for performing a limited list of mobility-related activities of daily living (MRADLs) in their home.[3] Based on this policy, Medicare insurers deny recipients coverage for wheelchairs that they need to be integrated into their communities. This policy prevents people with a wide range of mobility disabilities from obtaining coverage for wheelchairs that enable them to venture out into their communities if they do not need that type of wheelchair for toileting, feeding, dressing, grooming, and bathing at home. The result is de facto isolation for a problem that will recur and worsen as wheelchairs must be periodically replaced/repaired and the long-term operation of the in-home use policy erodes the sturdiness of wheelchair design over time.
Under Section 504 of the Rehabilitation Act, federally conducted programs like Medicare and agencies of the federal government like CMS may not discriminate in their programs and services on the basis of a person’s disability.[4] Prohibited discrimination includes failing to provide services in the most integrated setting appropriate.[5] CMS’s in-home use policy violates Section 504 of the Rehabilitation Act because it leaves many people with disabilities unnecessarily segregated from their communities and confined within their homes. Further, it discriminates against people who need sturdy and reliable mobility aids to function outside their homes by denying coverage of devices needed for community-based activities.
Moreover, the policy was arbitrarily adopted by CMS and is not required by the language of the Medicare Act. As such, CMS should modify its durable medical equipment coverage policy and evaluate a recipient’s need for durable medical equipment in all facets of their daily lives when determining Medicare coverage.
II. Facts
Ms. Saleema Render Hornsby is a young, active woman with Spina Bifida who lives in New York City with her mother. Ms. Render Hornsby uses durable medical equipment to navigate her daily life independently. She regularly uses a walker in her home to travel short distances of no more than 10 feet at a time. To travel distances longer than 10 feet, including travel outside of her home, she uses a wheelchair. Although Ms. Render Hornsby is able to self-propel a properly configured manual wheelchair for very short distances in her home, she is unable to self-propel over longer distances (especially over uneven terrain or inclines). When she has access to an appropriate wheelchair that can propel itself, she regularly goes to the gym, attends cosmetology school classes, shops for groceries, picks up prescriptions from the pharmacy, and attends doctor’s appointments. She values spending time with her friends and family, and enjoys activities like going to museums, amusement parks, the beach, and painting classes. When she does not have access to an appropriate wheelchair, her ability to live independently and do the things she loves is extremely limited.
In February 2022 Ms. Render Hornsby was referred to On a Roll Mobility Clinic for an assessment of her seating and mobility needs. She needed a new wheelchair for community mobility. Her old power wheelchair was unreliable and Ms. Render Hornsby could no longer use it. Between 2019 and 2022, the chair broke down at least five different times while she was out in the community. Once, her chair stopped moving in the middle of a busy intersection and she was dangerously stranded in the middle of the street. Another time, her chair broke down on a wheelchair ramp at the beach and she had to rely on help from strangers to fix her chair. Yet another time, part of the chair’s motor fell off. As a result of these malfunctions, she experienced extreme anxiety when using her power chair in public. She sent her chair to the manufacturing company to be fixed several times, but the process took weeks; as a result, Ms. Render Hornsby was left without a wheelchair and confined to her home for weeks at a time.
Further, her old power wheelchair was bulky and heavy and could not be easily lifted or transported. For example, the power chair could not be lifted up a single step or easily lifted into a car for transport. This limited Ms. Render Hornsby’s community engagement with friends and family. Ms. Render Hornsby needed the flexibility of a manual chair and the independence associated with a power chair that enables travel over longer distances.
During her assessment by On a Roll in March 2022, the provider determined that a customized K005 manual wheelchair (an ultralight chair with adjustable axel placement) with a power assist feature was the best fit for Ms. Render Hornsby because it fulfilled her mobility needs at home and allowed her to navigate her community without fatigue and with much improved efficiency. Ms. Render Hornsby then attended an appointment with her primary care physician who submitted a statement of medical necessity and other necessary documentation to a Medicare Part B carrier to request prior authorization for the ultralight manual chair with the power assist component.
In June 2022, Medicare denied the request. Medicare stated that they denied the request because “the documentation does not demonstrate [that] . . . use of the manual wheelchair will significantly improve the beneficiary’s ability to participate in mobility related activities of daily living (MRADLs) and the beneficiary will use it on a regular basis in the home.” This denial affected Ms. Render Hornsby deeply; she felt both confused and saddened that Medicare had denied her request for a mobility aid that she needed to live an independent life.
The same request was submitted to and denied by her New York State Medicaid Managed Care plan in July 2022. Ms. Render Hornsby appealed the denial which was upheld by the plan. She then submitted the denial for a New York State Fair Hearing. While waiting for a Fair Hearing date, the Managed Care Dual-Eligible Special Needs Plan (D-SNP)[6] in which she was enrolled agreed to review the request again. Ms. Render Hornsby was required to repeat the whole process for the new request, including an updated assessment and letter of medical necessity, which were completed and submitted over a year later in June 2023. In August 2023, her D-SNP plan finally approved the request, and she received the chair on October 27, 2023 – more than a year and a half after it was recommended.
During the many months between when her old chair broke down and when she finally received her new chair through Medicaid, Ms. Render Hornsby endured extensive hardships. After her power chair permanently broke down, her mother paid out of pocket for a temporary “off the shelf” power chair for her to use. This chair was not customized to fit Ms. Render Hornsby’s body, and using it was very difficult and uncomfortable. Because of the pain and discomfort the non-customized chair caused, she could not use it for long periods of time or for traveling long distances. For example, Ms. Render Hornsby could not travel across the large campus of her cosmetology school which had not been a problem when she had a working, customized power chair. She could no longer do many of the things she enjoyed. Ultimately, she only used this chair for a couple of months.
For more than a year, without an appropriate wheelchair and often without any wheelchair at all, Ms. Render Hornsby was trapped at home. She missed doctor and dentist appointments and was unable to pick up prescriptions from the pharmacy. She could no longer go to the gym, go grocery shopping, or see friends and family. She was forced to start taking her cosmetology classes online and fell behind without in-person instruction and help. She missed multiple graduation celebrations for friends and family. The extreme isolation caused her to become depressed to the point where she began seeing a therapist to treat her depression.
The new chair finally arrived October 27, 2023, greatly improving Ms. Render Hornsby’s mobility and spirits. This relief was short lived. After two weeks of use, the power assist feature broke. She reached out to the manufacturer to get the power assist feature fixed. This feature was eventually fixed and the chair was working as of the end of March, but Ms. Render Hornsby continues to be at risk for isolation in her home and decreased community mobility should she need wheelchair repairs, maintenance, or chair replacement in future as long as the in-home use policy continues to apply to her ongoing wheelchair needs because Medicare provides her primary coverage and Medicaid is the payer of last resort.[7]
Ms. Render Hornsby’s medical condition is such that she will continue to need a wheelchair throughout her lifetime. She obtained her current wheelchair over 180 days ago but as a Medicare beneficiary, the discriminatory in-home use policy will be a recurring barrier every time she seeks coverage for a replacement wheelchair, approximately every five to seven years, even in the improbable event that her wheelchair will never need repair or maintenance. It is unacceptable for Ms. Render Hornsby and all other Medicare beneficiaries who use wheelchairs to be forced to endure isolation and segregation every time they need a new chair or chair component. If Ms. Render Hornsby were to lose eligibility for Medicaid, she would lose her current secondary wheelchair coverage and be forced to “choose” between trying to pay out-of-pocket for a wheelchair that meets her civil right to community integration or forgoing such a wheelchair.
III. Background
A. Durable Medical Equipment Coverage Under Medicare
1. The Medicare Act
Part B of the Medicare Act covers durable medical equipment.[8] Durable medical equipment includes, inter alia, “wheelchairs (which may include a power-operated vehicle that may be appropriately used as a wheelchair, but only where the use of such a vehicle is determined to be necessary on the basis of the individual’s medical and physical condition and the vehicle meets such safety requirements as the Secretary may prescribe) used in the patient’s home (including an institution used as his home …).”[9]
2. Medicare Regulations
The federal regulations that enforce the Medicare Act state that “Medicare Part B pays for the rental or purchase of durable medical equipment” which includes “wheelchairs, if the equipment is used in the patient’s home or in an institution that is used as a home.”[10] Under the Medicare regulations, durable medical equipment must meet the following five criteria to be covered by Medicare “(1) Can withstand repeated use; (2) … has an expected life of at least 3 years; (3) Is primarily and customarily used to serve a medical purpose; (4) Generally is not useful to an individual in the absence of an illness or injury; and (5) Is appropriate for use in the home.”[11]
B. CMS’s In-Home Use Policy for Wheelchair Coverage Under Medicare
In May 2005, in response to “[r]ecent allegations of wheelchair fraud and abuse,” CMS published a Decision Memo that modified the Medicare National Coverage Determination Manual (Coverage Determination Manual) and replaced the clinical coverage indications for mobility assistive equipment, including wheelchairs.[12] Before May 2005, wheelchairs were covered under Medicare if “[the] patient’s condition is such that without the use of a wheelchair he would otherwise be bed or chair confined.”[13] Power wheelchairs and wheelchairs with other “special features” were covered if “[the] patient’s condition is such that a wheelchair is medically necessary and the patient is unable to operate the wheelchair manually.”[14]
Under the updated coverage indications, CMS determined that “[mobility assistive equipment] is reasonable and necessary for beneficiaries who have a personal mobility deficit sufficient to impair their participation in mobility-related activities of daily living (MRADLs) such as toileting, feeding, dressing, grooming, and bathing in customary locations within the home.”[15] CMS adopted the consideration of a recipient’s ability to perform MRADLs as an arbitrary proxy for whether the mobility assistive equipment is medically necessary for the recipient (since the Medicare regulations state that DME must be “primarily and customarily used to serve a medical purpose”[16]).
CMS decided to require consideration of MRADLs in its clinical criteria over consideration of instrumental activities of daily living (IADLs). IADLs refer to activities that allow an individual to live independently like working, cooking, traveling, shopping for groceries, managing finances, and attending doctors’ appointments in the community. CMS reasoned that MRADLs were “activities necessary to serve a medical purpose in the home,” whereas IADLs “are not limited to describing mobility functions in the home for a medical purpose.”[17] Notably, 52% of respondents in a recent survey of wheelchair users who are Medicare recipients reported that their most recent experience obtaining a wheelchair was harder or much harder than their pre-2005 experience.[18] This difference is likely attributable to the adoption of the in-home use policy.
CMS determines what equipment is covered by Medicare based exclusively on a recipient’s need for the device for activities inside their home. CMS does not consider recipients’ need for the device outside of their home, no matter how medically necessary or essential the activities they must perform outside their home are. Failing to account even for MRADLs such as toileting, eating, and grooming outside of one’s home necessarily assumes that a beneficiary will never leave the vicinity of one’s home for any significant period of time. But simply taking a paratransit ride to attend a medically necessary doctor’s appointment can take several hours in itself; it is nonsensical to assume that a recipient with a disability would not need to eat or find and go to the bathroom while outside their home. To acquire a power wheelchair under the CMS in-home use policy, a Medicare recipient must require the power wheelchair for performing MRADLs within the home and must be unable to use a cane, walker, or a manual wheelchair to complete these activities while at home.[19] Accordingly, a power wheelchair will not be provided where it will be used often or exclusively outside the home, even if it will be used for a medically necessary purpose or for performing MRADLs outside of the home. Further, the policy fails to consider the needs of individuals who have conditions that vary in severity episodically or over time so that mobility devices such as walkers or manual wheelchairs can be used sometimes, but not always.
In practice, this in-home use policy means that recipients who can use other mobility assistive equipment like crutches, a walker, or a manual wheelchair for performing MRADLs in the limited context of their living space or on days when their medical symptoms are less severe, but need a motorized wheelchair to consistently travel longer distances and travel beyond the confines of their homes, will be denied coverage for a motorized wheelchair.
IV. Analysis
A. The In-Home Use Policy Violates Section 504 of the Rehabilitation Act.
CMS’s in-home use policy is a violation of Section 504 of the Rehabilitation Act because it unnecessarily segregates people with disabilities from their communities by denying coverage for wheelchairs necessary for mobility and community integration, thereby confining them to their home or its close vicinity. The policy arbitrarily ties wheelchair coverage to two concurrent conditions: the need for a wheelchair to perform activities of daily living (ADLs) such as toileting, feeding, dressing, grooming, and bathing, in the home. A disabled person who might be able to crawl or use a walker or crutches in the home to perform some ADLs but cannot ambulate beyond a few feet without an appropriate wheelchair, and even someone with significant mobility disabilities such that a power wheelchair in itself does not necessarily enhance their capacity to perform ADLs, are equally subject to a denial of mobility assistive equipment that would allow them to participate in their communities.[20] When the in-home use policy was proposed, many healthcare professionals and rehabilitation experts specifically pointed out how the policy failed to meet the medical needs of people with mobility disabilities and disregarded their right to community integration. These are the very health professionals who should have been closely consulted about an appropriate clinical standard of care for CMS’s coverage of mobility devices. The resulting finalization of the in-home use policy discriminates against people with disabilities by denying coverage of wheelchairs needed to perform any activity outside of the home and beyond the most basic functions of life within that home. Section 504 is applicable to the administration of this policy because CMS falls under the direct purview of the Department of Health and Human Services (HHS) and administers Medicare, a program conducted by HHS.
1. The In-Home Use Policy Unnecessarily Confines Wheelchair Users to Their Homes and Segregates Them From Their Communities.
The in-home use policy’s limitation of coverage for wheelchairs to only those that allow disabled recipients to survive in the limited context of their homes violates Section 504 of the Rehabilitation Act because it unnecessarily segregates disabled people from their communities. The ultimate goal of disability rights laws and policies in the United States is to support people with disabilities seeking integration into their communities and to ensure that they are not unnecessarily segregated or institutionalized because of their disabilities. The CMS in-home use policy flies in the face of these goals.
For example, Congress stated in the Americans with Disabilities Act of 1990 (ADA), that the isolation, segregation, and exclusion of people with disabilities is a form of discrimination that is a serious and pervasive problem.[21] To address this issue, ADA Title II regulations provide that “a public entity shall administer services, programs, and activities in the most integrated setting appropriate to the needs of qualified individuals with disabilities.”[22] The preamble to the Title II regulations further states that integration is “a setting that enables individuals with disabilities to interact with non-disabled persons to the fullest extent possible” because “provision of segregated accommodations and services relegates persons with disabilities to second-class status.”[23] This requirement is called the “integration mandate.” HHS reiterated its commitment to the integration mandate in its final updated regulations to Section 504 of the Rehabilitation Act by detailing that segregated settings can be exemplified by “policies or practices limiting visitors or limiting individuals’ ability to engage freely in community activities and to manage their own activities of daily living.“[24]
Further, the Supreme Court has held that Americans with disabilities may not be needlessly isolated from independent living and mainstream community activities. See Olmstead v. L.C. by Zimring, 527 U.S. 581 (1999); see also Townsend v. Quasim, 328 F.3d 511, 517 (9th Cir. 2003). In Olmstead, the Court based its decision, in part, on the understanding that “institutional placement of persons who can handle and benefit from community settings perpetuates unwarranted assumptions that persons so isolated are incapable or unworthy of participating in community life.” Olmstead, 527 U.S. 581 at 600. Congress has made clear that the principles underlying the ADA also apply to Section 504 of the Rehabilitation Act, and the Department of Justice has clarified that the Assistant Attorney General for Civil Rights must ensure consistent interpretations of Section 504 and Title II.[25], [26] HHS’s federally conducted regulations under Section 504 commits the agency to administer its programs and activities “in the most integrated setting appropriate to the needs” of qualified individuals with disabilities. It would be hypocritical for HHS, CMS, and the HHS Office for Civil Rights to require states, state entities, and federally-funded recipients to adhere to the integration mandate while excusing itself from doing so when administering Medicare.
CMS’ in-home use policy relegates people with disabilities to isolation in their homes and prevents them from interacting with non-disabled people to the fullest extent possible. In Ms. Render Hornsby’s case, Medicare’s denial of coverage for a customized wheelchair with a power assist component resulted in significant trouble traveling longer distances outside of her home. It prevented her from being able to independently perform medically necessary activities like picking up medications at the pharmacy and attending doctor and dentist appointments. Further, it prevented her from being able to independently grocery shop, travel to work outside of her home, socialize with friends, and participate in the activities she enjoys doing out in her community. The policy and resulting denial forced her to stop attending cosmetology school in-person and ultimately caused her to fall behind in her program while she was working towards starting a career in cosmetology. The CMS policy made Ms. Render Hornsby’s life very small by segregating her from her community and limiting her life to a short list of functional activities such as toileting, bathing and feeding herself in her home.
2. The In-Home Use Policy Discriminates Against People with Disabilities Who Use Wheelchairs for Mobility Outside of Their Homes.
The in-home use policy also violates Section 504 because it discriminates against people with disabilities who need different types of mobility aids to perform MRADLs versus any other activity that is part of their daily life by denying them the benefits of full Medicare coverage for mobility aids needed outside of the home irrespective of the documented medical need for such an aid. The policy may also exclude from coverage people whose mobility needs change based on the severity of their condition, like someone with multiple sclerosis or Huntington’s Disease.
As an illustrative example, under CMS’s in-home use policy, a person who can use a walker to perform all their daily activities will receive full coverage for their mobility aid. Comparatively, a person who can use a walker for MRADLs but needs a power wheelchair for community-based activities will be denied coverage of their wheelchair. This is true even if the recipient needs the wheelchair to perform necessary activities of a medical nature like picking up medications at the pharmacy, or attending doctor, dentist, or therapist appointments.
Because of the high cost of power wheelchairs, Medicare’s exclusion of wheelchairs from coverage can prevent a person with disabilities from independently traveling beyond the four walls of their home for a very long period of time. In some instances, recipients can pay out of pocket or get secondary coverage under Medicaid for their necessary wheelchairs, but this process can take months or years.
Ms. Render Hornsby’s story is illustrative. She can use crutches in her home to travel distances of less than 10 feet. For this reason, CMS denied her coverage for a manual wheelchair with a power assist feature under Medicare because she could use another mobility aid for the limited activities of toileting, feeding, dressing, grooming, and bathing in her home. The fact that Ms. Render Hornsby’s healthcare provider indicated her medical need for the wheelchair with the power assist feature did not matter under the CMS in-home use policy. Practically, the coverage denial meant that she was unable to independently navigate in her community and was confined to her home. This denial also made independently participating in other health related activities outside of the home (like going to the pharmacy or attending doctor’s appointments) very difficult. Further, it denied her the opportunity to fully participate in her community through working, socializing, and traveling outside of her home. This is discrimination that violates Section 504 of the Rehabilitation Act because it denies coverage to people with disabilities, like Ms. Render Hornsby, who can use mobility aids other than a wheelchair to perform MRADLs in their home but need a wheelchair to travel beyond the walls of their home.
B. CMS has Mis-Interpreted the Medicare Act and Its Implementing Regulations and Has Adopted a Discriminatory In-Home Use Policy.
1. The In-Home Use Policy is Not Required by the Language of the Medicare Act or Its Implementing Regulations.
Medicare Part B covers durable medical equipment, including wheelchairs, that are “necessary on the basis of the individual’s medical and physical condition” and that are “used in the patient’s home.”[27] The regulations that implement the Medicare Act elaborate by stating that Medicare Part B covers durable medical equipment, including wheelchairs, “if the equipment is used in the patient’s home or in an institution that is used as a home”[28] as long as it meets five criteria: “(1) Can withstand repeated use; (2) … has an expected life of at least 3 years; (3) Is primarily and customarily used to serve a medical purpose; (4) Generally is not useful to an individual in the absence of an illness or injury; and (5) Is appropriate for use in the home.”[29]
The preeminent characteristic of durable medical equipment is a recipient’s need for the equipment based on their medical and physical condition, not the equipment’s use in the home. The Medicare Act’s reference to durable medical equipment’s use in the home is meant to distinguish Part B coverage from Medicare Part A coverage; Part A covers equipment used in an in-patient or hospital setting, whereas Part B covers equipment used in an outpatient setting or at home. The language of the Medicare Act and its implementing regulations does not specify that covered wheelchairs must exclusively be necessary for use in the home and there is no evidence that such a policy was the intent of Congress.[30]
Therefore, CMS’s policy limiting coverage for wheelchairs to those that are needed to perform a limited list of activities within the home without accounting for the right to community integration and performance of those same activities outside of the home is unnecessary under the language of the Medicare Act and illegal under Section 504 of the Rehabilitation Act. The policy results in the segregation of people with disabilities from their communities by substituting the confines of a private apartment or room for the confines of an institution, but both settings similarly impose confinement and isolation on recipients with disabilities who either need different mobility aids inside versus outside of their homes, or who need wheelchairs that can functionally handle vigorous engagement with the outside world.
2. Coverage of Durable Medical Equipment Under Medicare Should Not be Limited to the Performance of Mobility Related Activities of Daily Living as a Proxy for Medical Necessity.
As with the in-home use policy as a whole, CMS’s adoption of MRADL performance as the clinical criterion for durable medical equipment coverage rather than activities of daily living more broadly is not necessary under the Medicare Act. The Medicare Act states that a wheelchair may be covered under Medicare if it is “necessary on the basis of the individuals medical and physical condition” and is “used in the patient’s home.”[31] The regulations implementing the Medicare Act require durable medical equipment to be, inter alia, “primarily and customarily used to serve a medical purpose, … [g]enerally not useful to an individual in the absence of an illness or injury” and “appropriate for use in the home.”[32]
First, MRADLs are not an adequate measurement of medical necessity—CMS created the category and handpicked which activities would count as necessary to serve a medical purpose in the home.[33] While toileting, feeding, dressing, grooming, and bathing are necessary for functional survival, they are not the only medically necessary activities of daily living. Other daily activities that are necessary and medical in nature include managing medications, attending doctor’s appointments, attending dentist appointments, attending therapy appointments, getting diagnostic scans, being fitted for glasses, dentures, and hearing aids, and picking up medications from the pharmacy. By limiting Medicare coverage to those wheelchairs that are necessary for performance of MRADLs, people with disabilities are potentially deterred from performing other medically necessary activities.
Second, the meaning of medical necessity in the context of wheelchair use should not be limited to activities of a strictly medical nature such as changing the bandages on a wound. The Medicare Act specifically states that a wheelchair may be covered under Medicare if it is “necessary on the basis of the individuals medical and physical condition.”[34] As such, a person’s physical need for a wheelchair to aid them in typical activities of daily living due to a physical/medical condition is enough for them to receive coverage under the language of the Medicare Act, regardless of whether that activity is deemed to be “mobility-related” and irrespective of where the activity takes place. A medical condition that requires use of a wheelchair is enough to make use of that wheelchair for any activity used for a “primarily medical purpose” as required by Medicare’s implementing regulations.[35] CMS’s elevation of MRADLs to a clinical criterion lacks even internal consistency. If MRADLs have a primarily medical purpose when performed inside one’s home, they do not change character simply because they occur in a public restroom in the community or while the wheelchair user is on vacation. At a time in history when the great majority of bathrooms in both public buildings and business establishments are required to be accessible, it would be senseless if wheelchair users with Medicare coverage were required to use wheelchairs that are often incapable of reaching those buildings and establishments.
Third, nearly two decades of CMS’s misguided application of the in-home use policy has inevitably led to an overall wheelchair market that favors motors, parts, and designs that are tailored to operation in a home. Medicare covered 18.7% of the health insurance market in 2022[36] and its coverage policies can exert an outsize influence over the private insurance market because insurers that offer both private and Medicare Advantage plans will prefer to administer a single coverage policy. The in-home use policy has led manufacturers to sell wheelchairs that are cheaper to make and potentially lighter, but that are also less capable of going longer distances and holding up to more rugged terrain and travel. Furthermore, the policy disincentivizes technological innovation and the honest professional needs assessments of rehabilitation and occupational therapists because CMS will not cover “anything that improves lives outside of a user’s home.”[37]
C. CMS is Not Entitled Now or in the Past to Auer Deference for Its Interpretation of the Medicare Act’s Implementing Regulations.
Courts usually give deference to federal agencies’ reasonable readings of genuinely ambiguous regulations. See generally Auer v. Robbins, 519 U.S. 452 (1997). But in order to receive this deference, the regulation in question must be genuinely ambiguous, and the reviewing court must have exhausted all “‘traditional tools’ of construction” such as considering the “text, structure, history and purpose” of the regulation.” Kisor v. Wilkie, 588 U.S. 558, 559 (2019) (quoting Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 843, n. 9 (1984)). The agency’s interpretation must also be reasonable, meaning that it “come[s] within the zone of ambiguity the court has identified after employing all its interpretive tools to receive deference.” Id. Even if the regulation is genuinely ambiguous and the agency’s interpretation is reasonable, it must reflect “fair and considered judgment.” Id. at 17 (quoting Christopher v. SmithKline Beecham Corp., 567 U.S. 142, 155 (2012)). For reasons discussed below, CMS is not entitled now or in the past to Auer deference for its in-home use policy.
1. The Text of the Medicare Regulations is Not Ambiguous.
The Medicare regulation defining durable medical equipment, the category of coverage which includes wheelchairs, is not ambiguous. The definition of DME in the Medicare Act describes equipment that “is primarily and customarily used to serve a medical purpose,” “is not useful to an individual in the absence of an illness or injury,” and “is appropriate for use in the home.”[38] Despite this clarity, CMS conflates two of these factors in its 2005 Decision Memo to require mobility assistance equipment that is used to improve “mobility functions in the home for a medical purpose.” CMS then takes a further step away from the clear definition of DME in the Medicare regulations by flipping “in the home” and “medical purpose,” confining the universe of possible medical purposes that a mobility device can serve to activities that exclusively take place in the home, even though the two factors of medical purpose and in the home are distinct in the regulatory definition of DME:
Consistent with IWWG [Interagency Wheelchair Work Group] recommendations and our internal review, CMS chose to use activities of daily living such as toileting, feeding, dressing, grooming, and bathing as these are activities necessary to serve a medical purpose in the home. We collectively named these mobility related activities of daily living (MRADLs). Medicare is a defined benefit program. MAE is covered under the benefit category of DME. DME is defined as equipment that 1) can withstand repeated use, 2) is primarily and customarily used to serve a medical purpose, 3) generally is not useful to an individual in the absence of an illness or injury, and 4) is appropriate for use in the home (42 C.F.R. § 414.202). Instrumental activities of daily living (IADLs) were not used in determining coverage since they are not limited to describing mobility functions in the home for a medical purpose, as defined by 42 C.F.R. § 414.[39]
We have already discussed, in Section B. 2 above, how a mobility assistance device that primarily and customarily serves a medical purpose when used for activities of daily living in the home continues to fill that primary and customary medical purpose when used outside of a home for the same activities. Even if one accepts CMS’s narrow reasoning that the factor of medical purpose is met when a mobility device helps a person perform mobility-related activities of daily living (MRADLs), that medical purpose would be filled wherever the MRADL takes place—not just in the context of the home. Similarly, a mobility device can be used appropriately inside a home without being a device that is used exclusively inside a home. The third factor, that the mobility device is useful to an individual because of the presence of an illness or injury, is also clearly satisfied when a person has a functional mobility limitation traceable to an injury or illness.
Moreover, even if ambiguity exists within the regulations defining covered DME, that ambiguity should first be resolved by considering the “text, structure, history and purpose” of the regulation. The history and purpose of Medicare Part B provisions is to provide for insurance coverage of outpatient services, in contrast with Medicare Part A’s coverage of inpatient and institutional care. The requirement in the DME definition that covered mobility devices be appropriate for use in the home is meant to differentiate Medicare Part B coverage from Medicare Part A coverage, which can also include wheelchairs and other mobility assistance devices that are typically found in hospitals. The provision was intended to ensure that Medicare beneficiaries could gain access to needed mobility devices when they are outside of institutional settings. It was not intended to prevent coverage of appropriate mobility devices that Medicare beneficiaries can use outside their homes—and such a reading would frustrate the purpose of Medicare Part B coverage.
2. CMS’s Interpretation of the Medicare Regulations is not Reasonable.
Even if the regulation was ambiguous about the factors necessary for wheelchair coverage, CMS’s interpretation of those factors must still come within the “zone of ambiguity the court has identified after employing all its interpretive tools” before it would receive deference as reasonable. Kisor, 588 U.S. at 559. The question, then, is whether it is reasonable of CMS to decide that the medical purpose of a wheelchair must necessarily relate to a small set of activities undertaken exclusively in the home, instead of the multiple medical purposes achieved through providing mobility to someone who has a functional mobility disability. CMS noted in the Decision Memo that impaired mobility combined with difficulty in performing MRADLs can negatively affect health and wellbeing. But impaired mobility, which can range from a complete lack of ambulation to ambulation with significant pain and/or slowness, negatively affects health and wellbeing in and of itself. Further, impaired mobility, in combination with commonly inaccessible environments, is the root cause of difficulty performing many activities that human beings consider vital to their health and wellbeing.
On paper and in practice, CMS’s development and application of MRADL criterion to evaluate whether a beneficiary needs a mobility assistance device is unreasonable. It arbitrarily equates the measure of a wheelchair’s appropriateness with meeting the lowest common denominator of human needs such as eating and toileting within one’s home. In doing so, CMS ignores the actual prescription practices of relevant healthcare providers. Health professionals such as rehabilitation therapists who work with people with mobility disabilities recognize that mobility equipment can and should meet a patient’s multiple and interlocking needs. As stated in a 2011 guide, “[w]heelchair prescription is complex and involves the intersection of three variables: the wheelchair user, the wheelchair technology, and the environment or context of the user. . . . AT [assistive technology] devices facilitate quality of life and psychosocial and functional health. Given the known benefits and associated costs of wheeled mobility and seating, it is critical that people with mobility impairments be provided with the most appropriate equipment to meet their specific needs.”[40]
The language used in the 2005 Decision Memo reveals that CMS’s attention seemed to be on fraud rather than the individualized needs of patients with mobility disabilities.
Recent allegations of wheelchair fraud and abuse have focused considerable public interest on the provision of wheelchairs under the Medicare benefit. The agency has responded with a multifaceted plan to ensure the appropriate prescription of wheelchairs to beneficiaries who need them. One facet of this plan is the delineation of suggested clinical conditions of wheelchair coverage. CMS solicited public comment through a number of open door forums and other methods. Many advocacy groups have suggested that the agency adopt a function-based interpretation of its historical “bed or chair confined” criterion for wheelchair coverage.[41]
The MRADL criteria is a slight improvement over criteria that calls for a Medicare beneficiary be otherwise “bed or chair confined” without a mobility device. The earlier criteria required a level of disability severity that is altogether absent from the regulatory factors required for DME coverage. The MRADL criterion at least purports to be related to a Medicare beneficiary’s functional mobility capacity rather than a stereotyped phrase, but MRADLs are only a narrow subset of the kinds of assessments that healthcare professionals undertake before prescribing a wheelchair. The MRADL criterion places an exacting bar on wheelchair coverage akin to giving patients with debilitating migraines pain medication limited to in-home use and only after they reach a point of being unable to perform an activity of daily living. The unreasonableness of the MRADL criteria was highlighted at the time by the professional comments of relevant healthcare professionals such as rehabilitation and occupational therapists who submitted comments to the draft of the CMS Decision Memo before it was finalized,[42] explaining why the new criterion would harm real Medicare patients on the ground.
Ms. Render Hornsby and those similarly situated have diagnosed conditions or injuries that lead to limited or no mobility and therefore require mobility devices. The other four factors relating to DME provide additional criteria that still must be met before a wheelchair will be covered. CMS’s adherence to the MRADL criterion as determinative of wheelchair coverage fails to meet health-related needs of Medicare beneficiaries with mobility disabilities, and fails even to act as an effective check on DME fraud. Investigations by CMS, other federal agencies such as the Department of Justice, and news media point to provider bad faith as the primary element in power wheelchair fraud.[43] Wheelchair fraud more commonly occurs when medical and equipment providers collude to pocket lucrative Medicare payments by targeting multiple older Medicare beneficiaries who are “given” unnecessary equipment on the basis of fictional functional needs.[44] Wheelchair users are rarely perpetrators of wheelchair fraud. Arbitrarily tightening Medicare’s mobility assistive equipment criteria by adding an in-home MRADL requirement only forces innocent Medicare beneficiaries to forego needed wheelchairs. It does not deter fraudulent providers who are clearly willing to lie about the functional needs of their patients/customers. CMS has not revisited its “MRADL in the home” criterion despite seemingly lacking any data that establishes the effectives of the criterion as either a fraud deterrence measure or as a way to “ensure the appropriate prescription of wheelchairs to beneficiaries who need them.”[45]
3. Even If a Court Were to Find That CMS Reasonably Interpreted a Genuinely Ambiguous Regulation, The Interpretation Is Discriminatory and Cannot Constitute “Fair and Considered Judgment.”
If a regulation’s language at the time of its passage is genuinely ambiguous, and CMS’s MRADL in the home criterion is found to be a reasonable addition, the decision still must reflect “fair and considered judgment.” Kisor, 588 U.S. at 17 (quoting Christopher v. SmithKline Beecham Corp., 567 U.S. 142, 155 (2012)). It is not “fair and considered” for a federal agency to issue nondiscrimination guidance to entities that receive state funding and simultaneously disregard that guidance in its own Medicare coverage policies.
At the time the Decision Memo was finalized, the Supreme Court’s seminal 1999 decision in Olmstead v. L.C. by Zimring was already several years old. 527 U.S. 581 (1999). Shortly after Olmstead was decided, CMS issued a policy directive to all state Medicaid Directors highlighting the importance of the Olmstead decision and the need to prevent unjustified segregation of disabled people: “This decision confirms what this Administration already believes: that no one should have to live in an institution or a nursing home if they can live in the community with the right support. Our goal is to integrate people with disabilities into the social mainstream, promote equality of opportunity and maximize individual choice.”[46] A person with a mobility disability using a wheelchair tailored to provide only assistance with MRADLs in the home does not have a mobility aid that allows them to integrate into the social mainstream and maximize individual choice.
The fundamental emphasis on community integration was detailed in further updated Olmstead guidance to states. A July 2000 directive reviewed federal Medicaid policies to facilitate state compliance with the Americans with Disabilities Act of 1990 (ADA),[47] and prohibited homebound requirements in Medicaid home health services, including “part-time or intermittent nursing services, home health aide services, and medical supplies, equipment, and appliances suitable for use in the home.”[48] The directive further clarified that:
The restriction of home health services to persons who are homebound to the exclusion of other persons in need of these services ignores the consensus among health care professionals that community access is not only possible but desirable for individuals with disabilities. New developments in technology and service delivery have now made it possible for individuals with even the most severe disabilities to participate in a wide variety of activities in the community with appropriate supports.[49]
The Supreme Court in Olmstead interpreted a regulation enacted under Title II of the ADA that require public entities such as states to “administer services, programs, and activities in the most integrated setting appropriate to the needs of qualified individuals with disabilities.”[50] Regulations enacted under Section 504 that apply to recipients of federal financial assistance and to federally conducted agencies mirror the ADA language with a requirement to “administer programs and activities in the most integrated setting appropriate to the needs of qualified individuals.”[51] The federal financial assistance regulations have recently been updated through a final rule issued by HHS OCR that includes a new section highlighting the requirements of integration[52] and defines most integrated setting to mean a setting that:
[P]rovides individuals with disabilities the opportunity to interact with nondisabled persons to the fullest extent possible . . .[and] opportunities to live, work, and receive services in the greater community, like individuals without disabilities; are located in mainstream society; offer access to community activities and opportunities at times, frequencies and with persons of an individual’s choosing; and afford individuals choice in their daily life activities.[53]
While the “federally conducted” regulation has not yet been updated, HHS OCR has explicitly noted its intention to issue an updated rule soon and noted that the existing regulation remains in effect.[54] This includes the integration provision of Section 504, Part 85, noted immediately above.
The Medicare in-home use policy cannot be a fair and justified interpretation of Medicare’s coverage of wheelchairs and other mobility assistance equipment because it directly contradicts CMS’s own long-held interpretation of the integration mandate since 2000, predating the 2005 development of the in-home use policy. Since then, CMS has consistently issued Medicaid directives that endorse the right to community integration. HHS OCR’s 2023 commemoration of the Olmstead decision proclaimed that “people with disabilities have a right to receive services in the most integrated setting appropriate to their needs.”[55] A 2024 press release from HHS OCR raises how federal disability rights law, without mention of specific Medicaid provision, “requires that services are provided in the most integrated setting appropriate to the needs of a person with a disability—including within their own home and community.”[56]
CMS is not entitled to Auer deference in its interpretation of the Medicare Act and its implementing regulations because the regulations are not genuinely ambiguous, CMS’s interpretation of the regulations is not reasonable, and the interpretation cannot constitute fair and considered judgment because it is discriminatory.
V. Conclusion and Requested Relief
As Ms. Render Hornsby’s case illustrates, the in-home use policy inserts arbitrary additional MRADL criterion within the home as clinical criterion for Medicare coverage that discriminates against recipients with disabilities who need mobility assistance equipment for activities of daily living outside of their home. This has the practical effect of segregating them from their communities. Further, CMS’s development and implementation of the in-home use policy and consideration of MRADLs are not grounded in the clear language of the Medicare Act and accompanying regulations. The ongoing application of the in-home use policy has only become increasingly unreasonable in the years since it was first applied as HHS expanded upon its recognition of the Olmstead decision’s integration mandate .
We ask the Office for Civil Rights (OCR) to investigate CMS’s application of its in-home use policy to Medicare beneficiaries who are wheelchair users, like Ms. Render Hornsby, and all those similarly situated to determine the extent to which the policy violates Section 504 of the Rehabilitation Act and the Olmstead integration requirement. First, OCR should evaluate the way in which CMS denies coverage of medically necessary wheelchairs that Medicare beneficiaries need to meet their functional needs in their homes and the community. Second, OCR should evaluate how CMS fails to timely address the maintenance and repair needs of mobility device users to ensure that Medicare beneficiaries can fully access their homes and communities. Third, OCR should evaluate how CMS’s development and application of the unnecessary in-home use policy has undermined the durability and reliability of approved wheelchairs and other mobility devices, thereby leaving Medicare beneficiaries with mobility impairments unnecessarily isolated and segregated within their homes. Finally, in the event the in-home use policy is found to violate Section 504, we ask OCR to provide technical assistance to CMS to ensure that Medicare’s wheelchair coverage policies facilitate community access in accordance with the Olmstead integration requirement.
Signatures
I declare under penalty of perjury that the foregoing is true and correct to the best of my knowledge
/Saleema Render Hornsby/
DISABILITY RIGHTS EDUCATION AND DEFENSE FUND
/Silvia Yee/
Policy Director and Senior Attorney
/Jillian MacLeod/
Legal Fellow
Footnotes
[1] Nancy R. Mudrick, et al., Mobility Device User Survey: A Brief Summary Report, Disability Rights Education and Defense Fund (2024), https://dredf.org/wp-content/uploads/2024/03/DREDF_Summary-of-Mobility-Device-User-Survey_March-2024.pdf.
[2] Id. at 3 – 4.
[3] Ctrs for Medicare and Medicaid Servs., Medicare National Coverage Determination Manual, Chapter 1, Part 4 (Sections 200-310.1), Coverage Determinations at Section 280.3. (June 29, 2023) (hereinafter “Medicare NCD Manual”) https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part4.pdf.
[4] 29 U.S.C. § 794(a).
[5] 45 C.F.R. § 85.21(d).
[6] A D-SNP plan is a Medicare Advantage Plan that serves individuals who are eligible for both Medicare and Medicaid in their state. See Medicare.gov, “Special Needs Plans,” https://www.medicare.gov/health-drug-plans/health-plans/your-coverage-options/SNP (last visited Aug. 23, 2024).
[7] Centers for Medicare & Medicaid Services, “Medicaid: People Who Have Both Medicare and Medicaid,” https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaId=143&fromTracking=Y& (last visited Aug. 23, 2024).
[8] 42 U.S.C. § 1395m(a).
[9] 42 U.S.C. § 1395x(n) (emphasis added).
[10] 42 C.F.R. § 410.38(a).
[11] 42 C.F.R. § 414.202.
[12] Ctrs for Medicare and Medicaid Servs., Decision Memo for Mobility Assistive Equipment (CAG-00274N) (May 5, 2005) (hereinafter “CMS Decision Memo”).
[13] Id.
[14] Id.
[15] Medicare NCD Manual, supra n. 3 (emphasis added).
[16] 42 C.F.R. § 414.202.
[17] Medicare NCD Manual, supra n. 3.
[18] Nancy R. Mudrick et al., supra n. 1 at 3.
[19] Medicare NCD Manual, supra n. 3.
[20] See, for example, the March 7, 2005 comments submitted by Elizabeth Cole and by the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) among others, in response to CMS’s request for public comment on its proposed Draft Decision Memo for Mobility Assistance Equipment (CAG-00274N) and revised National Coverage Determination for Mobility Assistance Equipment (MAE), Centers for Medicare & Medicaid Services, https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaId=143&fromTracking=Y&. (last visited Aug. 22, 2024).
[21] See 42 U.S.C. §§ 12101(a)(2), (5).
[22] 28 CFR § 35.130(d).
[23] 28 C.F.R. Part 35, App. B (1991) (emphasis added).
[24] 45 C.F.R. Part 84, § 84.76(c). Part 84 applies to recipients of federal financial assistance, but HHS is also expected to issue an updated rule applying to programs and activities conducted by federal entities that will mirror the provisions contained in Part 84.
[25] U.S. Dep’t of Justice, Memorandum on Coordination of Federal Agencies’ Implementation of Title II of the Americans with Disabilities Act and Section 504 of the Rehabilitation Act (Apr. 24, 2018), https://www.justice.gov/crt/page/file/1060321/download.
[26] See Public Law 102-569 (1992).
[27] 42 U.S.C. § 1395x(n).
[28] 42 C.F.R. § 410.38(a).
[29] 42 C.F.R. § 414.202.
[30] Medicare Rights Center, Forcing Isolation: Medicare’s “In the Home” Coverage Standard for Wheelchairs, 6 Care Management J. 9 (2005).
[31] 42 U.S.C. § 1395x(n) (emphasis added).
[32] 42 C.F.R. § 414.202(3-5).
[33] CMS Decision Memo, supra n.10 (“CMS chose to use activities of daily living such as toileting, feeding, dressing, grooming, and bathing as these are activities necessary to serve a medical purpose in the home. We collectively named these mobility related activities of daily living (MRADLs).”).
[34] 42 U.S.C. § 1395x(n) (emphasis added).
[35] 42 C.F.R. § 414.202.
[36] Katherine Keisler-Starkey, et al., Health Insurance Coverage in the United States: 2022, Current Population Reports, U.S. Census Bureau (September 2023) https://www.census.gov/library/publications/2023/demo/p60-281.html.
[37] Barry Dean, Wheelchair Users Live outside the home, not just inside. Medicare policies need to acknowledge that, STAT News (June 29, 2022) https://www.statnews.com/2022/06/29/medicare-policies-cover-wheelchair-riders-safety-outside-home/.
[38] 42 C.F.R. § 414.202. There are two other required factors in the definition of DME, (1) Can withstand repeated use and (2) … has an expected life of at least 3 years. CMS did not discuss these factors in the CMS Decision Memo, and they were not at issue in any denial of Ms. Render Hornsby’s needed wheelchair.
[39] CMS Decision Memo, supra n. 10 (emphasis added).
[40] Rehabilitation Engineering & Assistive Technology Society of North America (RESNA), RESNA Wheelchair Service Provision Guide (January 26, 2011), https://www.resna.org/Portals/0/Documents/Position%20Papers/RESNAWheelchairServiceProvisionGuide.pdf. (Internal citations omitted). The RESNA Guide had not yet been published in 2004 when the CMS Decision Memo was developed, but it was based on the existing practice of rehabilitation and habilitation professions and cites several studies that predate 2004. The Guide essentially formalized pre-existing clinical and professional practice. RESNA was founded in 1979.
[41] CMS Decision Memo, supra n. 10.
[42] See generally public comments on proposed Draft Decision Memo for Mobility Assistance Equipment (CAG-00274N) and revised National Coverage Determination for Mobility Assistance Equipment (MAE), Centers for Medicare & Medicaid Services, https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaId=143&fromTracking=Y& (last visited Aug. 22, 2024).
[43] HHS Office of Inspector General, New Efforts Aimed at Stopping Abuse of the Power Wheelchair Benefit in the Medicare Program (Sept. 9, 2003), https://oig.hhs.gov/newsroom/news-releases-articles/new-efforts-aimed-stopping-abuse-power-wheelchair-benefit-medicare-program/; David Fahrenthold, A Medicare Scam that Just Kept Rolling, The WA Post (Aug. 16, 2014), https://www.washingtonpost.com/sf/national/2014/08/16/a-medicare-scam-that-just-kept-rolling/; U.S. Attorney’s Office, Southern District of Texas, Harlingen Business Operators Charged in Multi-Million Dollar Power Wheelchair Fraud Scheme (Aug. 30, 2023), https://www.justice.gov/usao-sdtx/pr/harlingen-business-operators-charged-multi-million-dollar-power-wheelchair-fraud.
[44] Id.
[45] U.S. Gov’t Accountability Office, Medicare: Actions Needed to Better Manage Fraud Risks, (GAO-18-660T), (July 17, 2018), https://www.gao.gov/products/gao-18-660t (“CMS took some steps to identify fraud risks in Medicare but had not conducted a fraud risk assessment or designed and implemented a risk-based antifraud strategy for Medicare.”)
[46] Letter from Dep’t of Health and Human Services (January 14, 2000), https://www.medicaid.gov/federal-policy-guidance/downloads/SMD011400C.pdf.
[47] 42 U.S.C. §12101 et seq.
[48] Letter from Dep’t of Health and Human Services – Olmstead Update No. 3, Attachment 3-G (July 25, 2000), , https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://downloads.cms.gov/cmsgov/archived-downloads/SMDL/downloads/smd072500b.pdf&ved=2ahUKEwiP45mX3YSIAxU4HzQIHTxhHLwQFnoECB0QAQ&usg=AOvVaw39i30SEFZ1c8dAyRz06xH7.
[49] Id.
[50] 28 C.F.R. § 35.130(d).
[51] See 45 C.F.R. § 84.68(d) (recipients of federal financial assistance); see also 45 C.F.R. § 85.21(d) (federal agencies and the U.S. Post Office).
[52] 45 C.F.R. § 84.76.
[53] 45 C.F.R. § 84.10.
[54] See the preamble to 45 C.F.R. Part 84, https://www.federalregister.gov/d/2024-09237/p-1514.
[55] Dep’t of Health and Human Services, Commemorating the Olmstead Anniversary with Revitalized Enforcement Initiative (Jun. 22, 2023), https://www.hhs.gov/blog/2023/06/22/commemorating-olmstead-anniversary-revitalized-enforcement-initiative.html.
[56] Dep’t of Health and Human Services, HHS Office for Civil Rights Ensures Individuals with Disabilities Are Able to Live in Their Homes and Communities (June 18, 2024), https://www.hhs.gov/about/news/2024/06/18/hhs-office-civil-rights-ensures-individuals-disabilities-live-homes-communities.html.