In this Policy Round-Up:
- Input Needed
- Comments Due Today: Medicare Coverage for PrEP
- Child Care and Development Fund Proposed Rule
- CMS Seeking Comments on Accessing Home Health Aide Services
- HHS Proposed Rule to Advance LGBTQI+ Non-Discrimination in HHS Programs
- Updates on Inflation Reduction Act Drug Affordability Provisions
- CMS Releases Revised Guidance for Medicare Drug Price Negotiation Program; Seeks Additional Input
- Update on Provisions to Lower Out-of-Pocket Prescription Drug Costs for Drugs with Price Increases Above Inflation
- CMS Announces Guiding an Improved Dementia Experience (GUIDE) Model
- CMS Issues Guidance on Hospital Discharges to Post-Acute Care Providers
- Department of Education Strengthens Guidance to Improve Equal Educational Opportunity for Children with Disabilities
Input Needed by Friday: CMS Proposes Medicare Coverage for PrEP
The Centers for Medicare & Medicaid Services (CMS) is seeking input on a proposed National Coverage Determination to cover pre-exposure prophylaxis (PrEP) using FDA-approved antiretroviral drugs to prevent HIV infection in high-risk individuals. CMS is also proposing to cover additional HIV screenings up to seven times annually and a single screening for hepatitis B virus for people at high risk.
PrEP involves the use of antiretroviral drugs on an ongoing basis, or before and after HIV exposure. When taken as directed, it is highly effective at preventing HIV. PrEP medications are currently covered under Medicare Part D, but may have cost-sharing and deductibles. Under the proposal, both oral and injectable forms of the medication would be covered under Part B as an “additional preventive service” and without requiring payment of coinsurance or a deductible.
Comments can be submitted online until close of business today, August 11, 2023.
Input needed: New Rule Proposed to Improve Child Care Access, Affordability, and Stability
The U.S. Department of Health and Human Services (HHS) Administration for Children and Families (ACF) is seeking comment on a proposed rule that amends the Child Care and Development Fund (CCDF) regulations to help more families, including those with children with disabilities, access the child care they need.
The proposal would ensure that families receiving assistance under CCDF pay no more than 7% of their family income for child care. It would also encourage states to waive child care co-payments for eligible families with income up to 150% of the federal poverty level and eligible families with a child with a disability.
If states elect to waive co-payments for families with a child with a disability, the waiver would apply to the entire family, not only to the child with a disability. Available data suggests that CCDF is serving a low percentage of children with disabilities. Families with children with disabilities experience unique challenges to accessing appropriate child care options and these changes are aimed at reducing those barriers.
Comments can be submitted online until August 28, 2023.
Input needed: CMS Seeking Comments on Accessing Home Health Aide Services
CMS is now seeking public comments in an effort to better understand challenges facing Medicare beneficiaries in accessing home health aide services. The request for input is included as part of a proposed rule that sets forth routine updates to Medicare’s home health payment rates for 2024.
CMS is seeking this feedback to help ensure appropriate access to and provision of home health aide services for all beneficiaries receiving care under the home health benefit. Specifically, CMS seeks feedback on a number of questions, including:
- Why is the use of home health aides declining even though there’s still strong need for those services?
- To what extent are people eligible for Medicare who have multiple or more severe impairments having more difficulty accessing home health care services, specifically home health aide services?
- What are notable barriers or obstacles that home health agencies (HHAs) experience in recruiting and retaining home health aides? What steps could HHAs take to improve the recruitment and retention of home health aides?
- Are HHAs paying home health aides less than equivalent positions in other care settings and if so, why?
- How effective is the coordination between Medicare and Medicaid to ensure adequate access to home health aide services?
- What are the consequences of beneficiary difficulty in accessing home health aide services?
Comments can be submitted online or by mail until 5:00 PM ET on August 29, 2023.
Input needed: HHS Issues Proposed Rule to Advance Non-Discrimination in HHS Programs for LGBTQI+ Community
HHS is seeking input on a proposed rule that would protect LGBTQI+ people from discrimination in important health and human services programs by clarifying and reaffirming the prohibition on discrimination on the basis of sexual orientation and gender identity in certain federal laws.
The proposed rule would confirm non-discrimination protections in HHS programs, including Head Start, as well as services and grants that provide aid to refugees, assistance to people experiencing homelessness, substance abuse treatment and prevention, community mental health services, maternal and child health services, and community services.
Comments can be submitted online or by mail until September 11, 2023.
CMS Releases Revised Guidance for Medicare Drug Price Negotiation Program; Input Needed on Information Request
CMS released revised guidance detailing the requirements and parameters for the first round of negotiations of the new Medicare Drug Price Negotiation Program. This round of negotiations will occur in 2023 and 2024 and will result in prices that will be effective beginning in 2026. We discussed the initial guidance in a previous Policy Round-Up.
Changes from the initial guidance are aimed at improving transparency and fostering an effective negotiation process. CMS has published a fact sheet and additional resources on the guidance.
CMS is also now seeking information for the revised drug price negotiation process. CMS invites public comments on the data and information the federal government will collect for consideration if a primary manufacturer submits a counteroffer for a selected drug during the negotiation process.
Comments can be submitted online until August 24, 2023.
By September 1, 2023, CMS will publish a list of the first 10 drugs covered under Part D selected for the initial round of negotiations. CMS will then host a series of patient-focused listening sessions on the drugs selected, and the public will be invited to submit data on therapeutic alternatives to the selected drugs, data related to unmet medical need, and data on impacts on specific populations by October 2, 2023.
More information on the listening sessions and how to submit comments will be available later this summer.
Update on Inflation Reduction Act Provisions to Lower Out-of-Pocket Prescription Drug Costs for Drugs with Price Increases Above Inflation
The Inflation Reduction Act created a new prescription drug inflation rebate program that, for the first time, requires drug companies to pay rebates to Medicare when their prescription drug prices increase faster than the rate of inflation for certain drugs, as we've discussed in a previous Policy Round-Up. Under that program, CMS released a list of 43 prescription drugs for which Part B beneficiary coinsurances may be lower beginning between July 1-September 30, 2023.
Some people with Medicare who take these drugs may save between $1 and $449 per average dose starting July 1, depending on their individual coverage. A fact sheet about the coinsurance deduction is available on the CMS website.
CMS announces Guiding an Improved Dementia Experience (GUIDE) Model
CMS recently announced its Guiding an Improved Dementia Experience (GUIDE) Model, which aims to improve the quality of life for people living with dementia, reduce strain on unpaid caregivers, and help people remain in their homes and communities through a package of care coordination and management, caregiver education and support, and respite services.
Read CMS’ fact sheet and frequently asked questions to learn more about the GUIDE model.
CMS Issues Guidance on Hospital Discharges to Post-Acute Care Providers
CMS issued guidance reminding state agencies, accrediting organizations, and hospitals of the requirements for discharges and transfers to post-acute care, including the provision of appropriate patient information to the post-acute care provider and caregivers.
The guidance identifies areas of concern related to missing or inaccurate patient information, including information related to:
- Durable medical equipment;
- Patients' underlying diagnoses for patients with serious mental illness (SMI), complex behavioral needs, and/or substance use disorder (SUD) and specific treatments that were implemented to help manage these conditions while in the hospital for another acute condition;
- Skin tears, pressure ulcers, bruising, or lacerations, including orders or instructions for cultures, treatments, or dressings;
- Patient preferences and goals for care; and
- Communication about a patient’s needs at home, or how their home environment may impact their ability to maintain their health and safety.
It also offers recommendations hospitals can use to improve and protect patients’ health and safety during the discharge and transfer process, including information on:
- Using available resources to improve discharge policies and procedures;
- Collaborating with post-acute care (PAC) providers;
- Conducting case reviews of previous discharges to improve the outcomes of future discharges; and
- Enabling access to patient information in electronic health records (EHRs) across hospitals and PAC providers.
Department of Education Strengthens Guidance to Improve Equal Educational Opportunity for Children with Disabilities
On July 24, the Department of Education released an updated policy guidance, accompanied by a Dear Colleague Letter, to ensure and strengthen the rights and protections guaranteed to children with disabilities and their families under the Individuals with Disabilities Education Act (IDEA).
The guidance and letter address what states need to do to meet their responsibilities under the IDEA’s “general supervision” requirement, under which states are required to monitor the compliance of local educational agencies and early intervention service programs and providers with IDEA. The goal of this monitoring is to ensure all school-age children with disabilities can access a free and appropriate public education in the least restrictive environment and that infants and toddlers with disabilities and their families receive appropriate early intervention services to the maximum extent appropriate.