Policy Round Up: DIAL, input needed, COVID test, CMS resources, and more

September 30, 2023

Vicki Gottlich, Deputy Administrator for Policy and Evaluation

In this policy round up:

ICYMI: ACL Expands DIAL to include self-service features
Input needed
- Department of Justice proposed rule to strengthen web and mobile app access for people with disabilities (due Oct. 3)
- Proposed rules to strengthen Mental Health Parity and Addiction Equity Act (due Oct. 2)
- CMS selects the first drugs for Medicare drug price negotiations (due Oct. 2)
COVID-19 and the end of the Public Health Emergency
- Additional free COVID-19 rapid tests available for every U.S. household; more accessible tests available for people who are blind or have low vision
- New CMS materials on Medicaid renewals
- New CMS materials on Medicare no cost vaccine coverage
- CMS releases new guidance to ensure continuity of key flexibilities implemented during the COVID-19 Public Health Emergency
New CDC disability inclusion toolkit for healthcare professionals
CMS resources on supporting adults with intellectual and developmental disabilities and their aging caregivers
CMS extends spousal impoverishment rules for married applicants and recipients of home and community-based services
Department of Transportation finalizes rule on accessible airline lavatories for wheelchair users
Report on HHS efforts to increase language access for people with limited English proficiency
New data briefs detail Medicaid/CHIP enrollee demographics
CMS launches new School-Based Services Technical Assistance Center
Broader Medicare coverage of Leqembi available following FDA traditional approval

ACL Expands DIAL to include self-service features

ACL’s Disability Information and Access Line has launched a new tool to help people with disabilities to find local services and resources to support community living. Through DIAL’s new website and its searchable database, users can now find the information they need, at any time of day, every day of the year.

Input needed: Department of Justice proposed rule to strengthen web and mobile app access for people with disabilities

The Department of Justice (DOJ) is seeking input on a proposed rule that aims to improve access to web and mobile applications for people with disabilities. The proposed rule would establish accessibility standards for state and local governments’ web and mobile app-based services. This proposed rule will better enable state and local governments to meet their ADA obligation to provide equal access to their services, programs, and activities for people with disabilities. It suggests clear technical standards, such as including text descriptions of images so people using screen readers can understand the content, providing captions on videos, and enabling navigation through use of a keyboard instead of a mouse for those with limited use of their hands.

State and local governments use websites and mobile apps for many of their services, programs, and activities. When these websites and mobile apps are not accessible, they can create barriers for people with disabilities trying to, for example, request an absentee ballot, learn about public meetings, and access information from their child’s school. Clearer standards will both ensure that people with disabilities can access vital services and make it easier for states and localities to understand their ADA obligations.

Comments can be submitted online or by mail until October 3.

Input needed: Proposed rules to strengthen Mental Health Parity and Addiction Equity Act

The Departments of Labor, Health and Human Services (HHS), and Treasury are seeking input on proposed rules to better ensure that coverage for mental health and substance use disorder treatment is as accessible as coverage for other medical treatment.. The proposed rules establish criteria to fully protect the rights of people seeking treatment for mental health and substance use disorders and provide clear guidance to health plans and issuers on how to comply with the requirements of the Mental Health Parity and Addiction Equity Act.

Comments on the proposed rules can be submitted online or by mail until October 2.

In addition to the proposed rules, the Department of Labor, in consultation with HHS and Treasury, is also seeking input on a technical release that proposes new data requirements for limitations related to the composition of a health plan’s or issuer’s network.

Please send comments via email to mhpaea.rfc.ebsa@dol.gov by October 2.

Input needed: CMS selects the first drugs for Medicare drug price negotiations

As we’ve discussed before, the Inflation Reduction Act gives the Centers for Medicare & Medicaid Services (CMS) the authority to negotiate prescription drug prices for some drugs covered by Medicare. CMS has published a list of the first 10 drug selected for the initial round of negotiations. The negotiated prices will be in effective beginning in 2026.

The drugs selected are:

Eliquis
Jardiance
Xarelto
Januvia
Farxiga
Entresto
Enbrel
Imbruvica
Stelara
Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill

As we noted in August, CMS will host a series of patient-focused listening sessions on the drugs selected. More information on those listening sessions and how to register to speak is available here. You do not need to register to attend the listening sessions, but if you wish to speak, you will need to register by October 2.

You can also submit a written comment by October 2. Written comments can include data on the selected drugs, therapeutic alternatives to the selected drugs, data related to unmet medical need, and impacts on specific populations as well as the patient or caregiver experience.

For more information on the drugs selected for the initial round of negotiation, see this CMS fact sheet and this fact sheet from the Assistant Secretary for Planning and Evaluation. You can also find more information on the Medicare Drug Price Negotiation Program on CMS’ website.

Additional free COVID-19 rapid tests available for every U.S. household; more accessible tests available for people who are blind or have low vision

Beginning this week, every U.S. household can again place an order to receive four more free COVID-19 rapid tests delivered directly to their home. The tests are being provided through a partnership between the HHS Administration for Strategic Preparedness and Response and the United States Postal Service. 

People who are blind or who have low vision can order Ellume COVID Home Tests, which are more accessible than other options. Supplies of the more accessible tests are limited, so people are asked to order them only if they do not have a way to use the other types of tests, such as assistive technology or a trusted family member or friend who can assist (in person or via video call).  

New CMS materials on Medicaid renewals

As we’ve discussed before, now that the COVID-19 public health emergency declaration is over, all states are beginning to resume their regular processes for renewing individuals’ Medicaid coverage. CMS has released new materials that identify strategies states are using to ensure compliance with requirements for Medicaid renewals and discuss how CMS is working with states to ensure compliance.

Those include:

New CMS materials on Medicare no cost vaccine coverage

As we’ve discussed before, the Inflation Reduction Act provides vaccination coverage at no cost ($0 copay) through the Medicare Part D program for immunizations recommended by the Advisory Committee on Immunization Practices. 

CMS has released materials to make people aware of this new benefit:

People with Medicare (both Medicare B and Medicare Advantage) also can get vaccines for free with Medicare B and Medicare Advantage, such as seasonal flu, COVID-19, and respiratory syncytial virus, otherwise known as RSV.

You can also call 1-800-MEDICARE for more information. If you need additional assistance, the State Health Insurance Assistance Program (SHIP) is available to anyone with Medicare, their families, or caregivers, to provide help with understanding and accessing Medicare benefits, or enrolling in the program. SHIPs provide local, free, and unbiased assistance. Learn more information about the SHIPs and find your local SHIP at SHIPhelp.org.

CMS releases new guidance to ensure continuity of key flexibilities implemented during the COVID-19 Public Health Emergency

The Centers for Medicare & Medicaid Services (CMS) released guidance giving states the option to continue using home and community-based services (HCBS) waiver flexibilities they put in place during the COVID-19 public health emergency (PHE), which ended on May 11, 2023.

These flexibilities were set to expire on November 11, 2023. However, the guidance allows these flexibilities to remain in effect for a longer period of time if the state submits a 1915(c) waiver amendment by November 11 incorporating the flexibilities into its waiver programs. This will help limit disruption to the HCBS delivery system resulting from the end of the PHE.

New CDC disability inclusion toolkit for healthcare professionals

The CDC has launched a new digital toolkit with shareable graphics and sample social media posts to help healthcare providers advocate for inclusion and accessibility in healthcare settings.

This is important because people with disabilities often face barriers to accessing care, including physical barriers such inaccessible building entrances or medical equipment, communication barriers such as not being able to get materials in braille or large print; attitudinal barriers such as the assumption people with disabilities can’t understand information about their health, and more.

The toolkit describes ways providers can improve accessibility and inclusion for people with disabilities and their families. It also includes videos featuring healthcare providers and people with disabilities describing the importance of inclusion.

Supporting adults with intellectual and developmental disabilities and their aging caregivers

CMS released a set of resources addressing the needs of adults with intellectual and developmental disabilities (I/DD) living with, and receiving care from, aging parents or guardians. The set includes resources for state Medicaid and partner agencies to provide new or additional support to adults with I/DD and their caregivers as they age and experience life transitions. They include:

CMS releases new guidance to ensure continuity of key flexibilities implemented during the COVID-19 Public Health Emergency

These flexibilities were set to expire on November 11, 2023. However, the guidance allows these flexibilities to remain in effect for a longer period of time if the state submits a 1915(c) waiver amendment by November 11 incorporating the flexibilities into its waiver programs. This will help limit disruption to the HCBS delivery system resulting from the end of the PHE.

CMS extends spousal impoverishment rules for married applicants and recipients of home and community-based services

CMS released an informational bulletin informing states that their Medicaid agencies are required under the Consolidated Appropriations Act of 2023 (CAA) to apply the spousal impoverishment rules to married applicants and beneficiaries eligible for home and community-based services (HCBS) through September 30, 2027.

As we’ve discussed before, under “spousal impoverishment rules” states can disregard, or not include in their eligibility calculations, some income and assets of married individuals when one of the spouses needs long-term services and supports in a nursing home. This means the person going into the nursing home does not have to use all of the couple’s resources for their nursing home care, a situation which often leaves their spouse with very little.

The Affordable Care Act authorized the same spousal impoverishment rules to apply to people seeking HCBS. This promotes community living by removing a financial incentive for a Medicaid beneficiary to receive services in a nursing home rather than in their own home.

That authorization was set to expire in 2018 but has been extended several times, most recently in the CAA until September 30, 2027.

U.S. Access Board issues final rule on public right-of-way accessibility guidelines

The U.S. Access Board published new guidelines for federal, state, and local government agencies on how to make sidewalks, crosswalks, shared use paths, on-street parking, and other pedestrian spaces more accessible to people with disabilities.

These minimum guidelines are not yet enforceable. They will become enforceable once they are adopted as mandatory standards under the Americans with Disabilities Act by the Departments of Justice and Transportation, or the four Federal agencies that set standards for the federal government under the Architectural Barriers Act. Those agencies are the US Postal Service, the General Services Administration, the Department of Defense, and the Department of Housing and Urban Development. The agencies can choose to adopt the guidelines with or without modifications.

Learn more about the guidelines on the Access Board’s website.

Department of Transportation finalizes rule on accessible airline lavatories for wheelchair users

The Department of Transportation issued a new rule that requires airline lavatories to be more accessible. The rule requires airlines to make lavatories on new single-aisle aircraft large enough to permit a passenger with a disability and an attendant to approach, enter, and maneuver within using an on-board wheelchair. It also requires improvements to on-board wheelchairs to make them easier and safer to use. These changes are intended to make travel easier and less stressful for people who use wheelchairs.

The rule also requires lavatories in new single aisle aircraft to have important accessibility features, including:

Grab bars
Accessible faucets and controls
Accessible call buttons and door locks
Minimum obstruction to the passage of an on-board wheelchair
Toe clearance
An available visual barrier for privacy

The rule takes effect on October 2, 2023, with changes phased in over the next twelve years.

Report on HHS efforts to increase language access for people with limited English proficiency

The Department of Health and Human Services (HHS) Office for Civil Rights published its first annual report on the progress HHS has made in providing meaningful access to language assistance services to individuals with limited English proficiency, as required by the 2022 HHS Equity Action Plan. The report also discusses ways that HHS can build on this work. Increasing language access is important because miscommunication may lead to misdiagnosis, improper or delayed medical treatment, and inequitable access to necessary services and programs.

The report discusses the need to reduce barriers and increasing language access in internet and public information access; telephonic access; access to programs and activities; and ensuring adequate federal funds to provide needed language services. It then maps out specific benchmarks and describes the progress that has been made to date, as well as ongoing efforts.

The report also is available in Spanish, traditional Chinese, and simplified Chinese.

New data briefs detail Medicaid/CHIP enrollee demographics

As part of its commitment to measuring disparities in access to care, CMS has, for the first time, released data briefs detailing various demographic characteristics of Medicaid and Children’s Health Insurance Program (CHIP) enrollees. Together, the Medicaid and CHIP programs provide essential coverage to one in five Americans, including many low-income and older adults, children, and people with disabilities. These data briefs can help us better understand where gaps might exist in access to care through these programs.

The data briefs include:

CMS launches new School-Based Services Technical Assistance Center

CMS recently launched the School Based Services (SBS) Technical Assistance (TA) Center, developed in conjunction with the Department of Education. The TA Center was launched following the release of the School-Based Services (SBS) Comprehensive Guide to Medicaid Services and Administrative Claiming, which we’ve discussed in a previous blog.

CMS encourages stakeholders to use the TA Center’s resources to assist in implementing the flexibilities and requirements discussed in the SBS Guide and in further enhancing or expanding their current SBS programs. Future resources will include more in-depth guidance on various aspects of billing for school-based Medicaid for state Medicaid agencies, state education agencies, local education agencies, and schools.

Broader Medicare coverage of Leqembi available following FDA traditional approval

The Food and Drug Administration (FDA) has approved Leqembi for use by individuals with Alzheimer’s disease and the Centers for Medicare & Medicaid Services (CMS) has announced that it will be broadly covered by Medicare.

To be eligible for coverage, people will need to:

Be enrolled in Medicare,
Be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with documented evidence of beta-amyloid plaque on the brain, and
Have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care.

CMS has opened a registry for clinicians to collect evidence on how the drug works in the real world. Registries are common tools in clinical settings that have successfully gathered information on patient outcomes for decades. Other registries may become available in the coming months and will be posted on CMS’ website.

Individuals with original Medicare will pay the standard coinsurance (20% of the Medicare-approved amount for Leqembi) once they meet their Part B deductible. Costs may be different for people with Medicare supplemental coverage (such as a Medigap plan), other secondary insurance, or a Medicare Advantage plan. Medicare beneficiaries should contact their plan for more specific cost information.

CMS has published additional background information for providers and for patients. CMS also published a fact sheet last month with details about how people can get drugs that may slow the progression of Alzheimer’s disease covered by Medicare. If the FDA grants traditional approval to other drugs in this class in the future, Medicare will cover them using this same coverage framework.