In this policy round up:
- Input needed: Initial Guidance and Information Collection Request for Medicare Drug Price Negotiation Program
- New Unwinding Resources: Timelines, Civil Rights Protections, HCBS Waivers
- Autism Spectrum Disorder Prevalence Among Children – Updated Findings from CDC’s ADDM Network
- NTG Issues Advisory on Over-Medication of Older Adults with Intellectual Disabilities
Input needed: Initial Guidance and Information Collection Request for Medicare Drug Price Negotiation Program
The Inflation Reduction Act gives the Centers for Medicare & Medicaid Services (CMS) authority to negotiate prescription drug prices for some drugs covered by Medicare. CMS is seeking comments on its implementation of the provision, which could reduce drug costs for some older people and people with disabilities who have Medicare coverage.
On March 15, CMS released initial guidance on the Medicare Drug Price Negotiation Program and a fact sheet outlining key points from the initial guidance. CMS is soliciting comments on topics including:
- Metrics that CMS should exclude from consideration when developing offers and reviewing counteroffers.
- Specifically, the Act requires CMS to not use evidence that relies on metrics that may treat extending the life of an older adult, person with a disability, or person who is terminally ill as of lower value than extending the life of an individual who is not. CMS is therefore not relying on certain uses of quality-adjusted life years (QALYs) in the negotiation process and is seeking comment on other metrics it should similarly exclude.
- CMS’ proposed drug price negotiation process.
- Whether guidance would be appropriate or necessary with respect to the interaction between the Negotiation Program and the Part B inflation rebate program, which we discussed in a previous blog.
Comments on the initial guidance can be submitted until April 14, 2023. Comments should be submitted by email to IRARebateandNegotiation@cms.hhs.gov with the following subject line “Medicare Drug Price Negotiation Program Guidance.”
On March 21, CMS published an information collection request regarding the program’s negotiation data elements. The Inflation Reduction Act lists factors CMS must consider when negotiating the maximum fair price of a selected drug. The new request seeks public input on the data it should include in these factors.
Those factors include manufacturer-specific data as well as evidence about alternative treatments, including:
- The extent to which a drug represents a therapeutic advance as compared to existing therapeutic alternatives and the costs of such existing therapeutic alternatives.
- Prescribing information approved by the Food and Drug Administration for a drug and therapeutic alternatives to it.
- Comparative effectiveness of a drug and therapeutic alternatives to it as well as the effects of that drug and therapeutic alternatives to it on specific populations, including individuals with disabilities and older adults.
- The extent to which a drug and therapeutic alternatives to it address unmet medical needs for a condition.
Comments on the information collection request can be submitted online or by mail until May 22, 2023.
New Unwinding Resources: Timelines, Civil Rights Protections, HCBS Waivers
Public Health Emergency Ends May 11
President Biden signed legislation on April 10 immediately ending the national emergency related to COVID-19. It is important to note that this is not the same as the COVID-19 public health emergency (PHE), which is set to expire on May 11. The end of the national emergency does not change the expiration date of the PHE and does not affect any unwinding plans related to the PHE. Existing pandemic-related Medicare and Medicaid waivers currently in effect remain in place until the end of the PHE.
Medicaid Eligibility Timeline in Your State
CMS released a chart of anticipated state timelines for initiating unwinding-related renewals. As we explained in a recent blog post, during the pandemic, significant changes were made to Medicaid enrollment and eligibility rules to promote continuous health insurance coverage. The end of those pandemic-specific changes is known as “unwinding.”
If a state determines someone is ineligible for Medicaid and CHIP, states can terminate their coverage starting on April 1, 2023. However, state-by-state timelines will determine when someone can lose their coverage for procedural reasons, such as not responding to a renewal form. Those anticipated timelines are laid out in the new CMS chart. Organizations that assist people with disabilities and older adults who may need to renew their Medicaid applications should check the chart for the timeframes in their state.
OCR Letter on Civil Rights Protections and Language Access
On April 4, the Department of Health and Human Services Office for Civil Rights (OCR) released a letter reminding states of their obligations under federal civil rights laws as they start unwinding-related renewals. The letter also provides best practices states can use as they begin the unwinding process.
Under federal civil rights laws, states are required to take reasonable steps in communications with Medicaid and CHIP enrollees and applicants to provide meaningful language access for individuals with limited English proficiency (LEP) and ensure effective communication with individuals with disabilities. These services must be provided free of charge and in a timely manner.
Reasonable steps to provide meaningful language access may include:
- Translating documents written in English, such as notices pertaining to renewals and other eligibility actions during the unwinding period, by a qualified translator.
- Provision of oral language assistance from a qualified interpreter, either in-person or using remote communication technology (e.g., telephone, internet, or video).
Effective communication might require providing appropriate auxiliary aids and services, such as:
- Braille
- Large print
- Captioning
- Plain language explanations
- Qualified sign language interpreters
- Qualified readers
- Qualified speech-to-speech transliterators
- Accessible websites
Medicaid HCBS Flexibilities
States were permitted to request flexibilities in their Home and Community-Based Services (HCBS) programs to support older adults and people with disabilities during the pandemic, including coverage of home-delivered meals or paying family caregivers. ADvancing States, the National Association of Medicaid Directors (NAMD), and the National Association of State Directors of Developmental Disabilities Services (NASDDDS) released a new guide to help to state Medicaid and aging and disability agencies prepare for the end of those flexibilities.
The guide outlines how states used these emergency flexibilities (most often through the 1915(c) Appendix K authority) and which of those changes can be added to states’ 1915(c) waivers, should states choose to do so. Many of those flexibilities provided benefits that can improve HCBS for people with disabilities and older adults even beyond the pandemic, making this is a key resource for the aging and disability networks as they work with their states, and advocate for flexibilities they believe will benefit the communities they serve.
For the latest information and tools, visit ACL’s new unwinding resources page.
Autism Spectrum Disorder Prevalence Among Children – Updated Findings from CDC’s ADDM Network
The Centers for Disease Control and Prevention (CDC) released two new reports from the Autism and Developmental Disabilities Monitoring (ADDM) Network on March 24. The reports, Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years and Early Identification of Autism Spectrum Disorder Among Children Aged 4 Years, focus on identifying trends in the demographic makeup of children with autism and how many children with autism are being identified early. Early identification is one of the most important tools to make a difference in the lives of autistic children, leading to better outcomes, and empowering autistic children to access the services and supports that can help them thrive in the community.
Key findings from the reports include:
- The prevalence estimate of autism spectrum disorder has increased since the last report, published in December of 2021. It has increased from 1 in 44 8-year-old children to 1 in 36.
- For the first time, the percentage of 8-year-old Black (2.9%), Hispanic (3.2%) and Asian or Pacific Islander (3.3%) children identified with autism was higher than the percentage of 8-year-old white children identified with autism (2.4%). The report speculates that these shifts may reflect improved screening, awareness, and access to services among historically underserved groups.
- While there have been improvements in early autism identification over time, the COVID-19 pandemic has disrupted progress. These disruptions in the timely evaluation of children and delays in connecting children to the services and support they need could have long-lasting effects.
Follow ACL on Facebook and Twitter this month for additional autism resources as we celebrate Autism Acceptance Month.
Comment Period Extended for HUD’s Affirmatively Furthering Fair Housing Proposed Rule
The U.S. Department of Housing and Urban Development (HUD) has extended the deadline for comments on its Affirmatively Furthering Fair Housing proposed rule by two weeks. Comments are now due by April 24.
The proposed rule outlines the process through which HUD-funded housing programs — including localities, states, and Public Housing Authorities (PHAs) — should assess barriers to fair and equitable housing in their communities and commit to actions to address these barriers. The proposed rule includes several changes of relevance to the disability and aging communities.
This February announcement from ACL includes many more details on the rule, notable provisions, and how to comment.
In addition, Justice in Aging recently released a fact sheet, Highlights of HUD’s Proposed Affirmatively Furthering Fair Housing (AFFH) Rule for Aging and Disability Advocates, which provides a summary of the proposed AFFH rule and an overview of some of its key features.
NTG Issues Advisory on Over-Medication of Older Adults with Intellectual Disabilities
Earlier this month, the National Task Group on Intellectual Disabilities and Dementia Practices (NTG) and the Health Matters Program at the University of Illinois Chicago issued a new brief, Over Medication of Older Adults with Intellectual Disabilities: Risks for Brain Health, that examines the health risks of over-medication for older adults with intellectual disabilities, including a higher risk of dementia and cognitive impairment. This comes on the heels of concerns raised by CMS, which we discussed in a previous Policy Round-Up, about inappropriate schizophrenia diagnoses in some nursing homes masking the facilities’ true rate of antipsychotic medication use.
The brief discusses how common it is for older adults to take multiple medications — about 67% of older adults take five or more medications or supplements — which greatly increases the risk of adverse events. The brief recommends that family members and caregivers undertake regular reviews with clinical professionals to ensure they understand any potential adverse effects of the medications their loved one is taking and that providers and agencies educate their clients on the risks associated with over-medication.