HHS Proposes Amendments to 340B Administrative Dispute Resolution Process
The Department of Health and Human Services (HHS) proposed a more informal administrative dispute resolution (ADR) process for diversions, duplicate discounts, and overcharges under the 340B program. This program allows hospitals and healthcare providers (covered entities) to purchase drugs at steep discounts to provide low-cost medications to vulnerable populations. HHS proposed the following amendments to the ADR process to help providers save time and legal resources:
- Make ADR more accessible and less of a “trial-like proceeding”
- Waive the $25,000 minimum dispute threshold for drug makers and 340B providers to use the ADR process
- Restructure the ADR panel to be experts from the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs
- Require that providers and drug makers first attempt to resolve disputes on their own before initiating ADR
- Allow for appeals process if providers or drug makers are dissatisfied with the ADR outcome
MA Coverage Increases for Small Share of Medicare Beneficiaries with Retiree Health Benefits
According to an analysis from the Kaiser Family Foundation (KFF), fewer employers are offering health benefits for retirees. In 2022, only 13% of large employers offer retiree health benefits to Medicare-age retirees. Employers and unions have implemented changes to limit their financial liability while continuing to offer retiree health benefits. These changes include establishing financial caps on their liability, shifting toward defined contribution approaches, increasing retirees’ premium contribution, and offering their Medicare-eligible retirees coverage through Medicare Advantage (MA) plans. Half of large employers offering retiree health benefits to Medicare-age retirees offer coverage through MA plans, nearly doubling the share in 2017 (26%). According to KFF, increased utilization of MA plans could affect beneficiary and federal spending.
- HHS announced a notice of proposed changes (fact sheet) to the Confidentiality of Substance Use Disorder (SUD) Patient Records under 42 CFR Part 2 to make it easier for providers to share patient’s substances use disorder treatment records. Current regulations are stricter than the health privacy law known as HIPPA, and proposed changes would allow providers to have the full scope of a patient’s medical information after a single consent from the patient and allow for better, more holistic treatment. Specifically, the proposed changes implement Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. HHS is seeking comments from stakeholders on the proposed language, which are due 60 days after the scheduled publication date on December 2nd.
- The Office of Disease Prevention and Health Promotion of the Department of Health and Human Services (HHS) recently announced the release of the Federal Plan for Equitable Long-Term Recovery and Resilience (Federal Plan for ELTRR) that lays out an approach for federal agencies to cooperatively strengthen the vital conditions needed for improving individual and community resilience and well-being nationwide. The Plan was developed to address disparities in health, well-being, and economic opportunity and leverages the Vital Conditions for Health and Well-Being Framework. At the center of the Framework is the vital condition of “Belonging and Civic Muscle,” and within that lies the critical importance of social connection.
- Last week, the Department of Health and Human Services (HHS) unveiled its new Long COVID Plan to manage the disease—and its 50 linked conditions—that impacts between 7.7 million and 23 million Americans. The report further details that between 5% and 30% of people who have had COVID-19 may have long COVID symptoms, with an estimated 1 million people out of the workforce at any given time due to long COVID, resulting in approximately $50 billion in lost salaries annually. Additionally, HHS sent a $750 million supplemental funding request to Congress to support 1) Long COVID research and treatment 2) the goals outlined in the Long COVID Plan, 3) providers who serve patients with Long COVID and its associated conditions, and 4) community-based organizations that assist with case management and provide other essential services and supports.
- The Senate Finance Committee released the fifth and final bipartisan mental health package discussion draft, addressing mental health parity. The draft would require Medicare Advantage, Medicaid Managed Care organizations, and Medicaid fee-for-service systems to maintain publicly available and regularly updated provider directories. It also directs CMS to provide guidance on how Medicare beneficiaries with SUD may receive partial hospitalization program services and for GAO to complete two reports on Medicare Advantage behavioral health cost sharing and a comparison of Medicaid payment rates for behavioral health and medical services. Additionally, the committee published a summary of the key provisions of all five discussion drafts.
- Last week, Senator Bill Cassidy (R-LA) and a bipartisan group of other Senators published a letter requesting information on how Congress can improve health care coverage and alignment for individuals dually eligible for Medicare and Medicaid. The questions seek additional data on dually eligible populations, feedback on current systems and existing dual eligible models, and recommendations for future improvements. The Senators note that the responses to the RFI will be used to inform new policies the Senators committed to developing. Responses to the RFI will be collected through January 13, 2023.
- Senator Bill Cassidy (R-LA) recently said (subscription required) that he is optimistic that bipartisan legislation designed to enhance cybersecurity coordination between the Departments of Health and Human Services (HHS) and Homeland Security (DHS)—The Healthcare Cybersecurity Act, (H.R.8806/S.3904) (117th Congress)—will pass as part of upcoming year-end spending legislation. The bill is co-sponsored by Senator Jacky Rosen (D-Nev) and was introduced in March in response to foreign and domestic hackers targeting health systems and critical healthcare infrastructure.
- Earlier this month, more than 75 physician organizations signed a letter in strong opposition to H.R. 8812, the “Improving Care and Access to Nurses Act,” or the “I CAN Act.” The legislation would broaden the authority of nurse practitioners, certified nurse midwives, certified registered nurse anesthetists, clinical nurse specialists and physician assistants while narrowing or removing supervisory requirements. The signatories state the bill would allow non-physician practitioners (NPPs) to perform tasks and services outside their education and training and could result in increased utilization of services, increased costs, and lower quality of care for patients. The letter was sent to ranking members of the U.S. House of Representatives’ Ways and Means and Energy and Commerce committees.
Georgia is on track to become the only state to have work requirements for Medicaid coverage. Following a nearly year-long battle with the Biden Administration, Georgia’s Medicaid expansion, which requires newly qualified beneficiaries to complete 80 hours of work or education a month, is set to go live on July 1, 2023. Although the U.S. Department of Health and Human Services decided against appealing a federal court’s ruling in the state’s favor, the Biden Administration maintains its opposition to work requirements in Medicaid because of the potential impact on beneficiaries’ access to coverage and care. In December 2021, the Biden Administration rescinded the requirement that Georgia’s expansion population complete a minimum of 80 hours of certain activities in the month prior to approval, citing the pandemic’s impact on unemployment.
Last week, MedStar Health, EPIC and Ascension Health released study results (IHP subscription needed), collected from Medicare, Medicaid, and private insurer data, that found that telehealth care is substitutive for in-person care in certain consultative specialties and for patients who see their primary care providers four or more times a year. All the groups found that billable evaluation and management visits across in-person and telehealth modalities were lower in 2021 than before the public health emergency — which they say means that adopting permanent telehealth policies would not increase costs for CMS. The studies by the groups found that telehealth was being used somewhat equally across racial and ethnic groups, though the modality differed by race.