June 12, 2023
This Week in Health Policy for June 12
This Week (June 12 - 16)
The House Energy and Commerce Health Subcommittee will hold a hearing on “Legislative Solutions to Bolster Preparedness and Response for All Hazards and Public Health Security Threats.”
The Committee on Education and the Workforce is expected to hold a hearing on “Examining the Policies and Priorities of the Department of Health and Human Services.”
The House Committee on Veterans’ Affairs Subcommittee on Health will hold a hearing on “Care Coordination: Assessing Veteran Needs and Improving Outcomes.”
The Senate Judiciary Subcommittee on Human Rights and the Law will hold a hearing on “Artificial Intelligence and Human Rights.”
The House Energy and Commerce Health Subcommittee will hold a hearing on “Examining Proposals That Provide Access To Care For Patients And Support Research For Rare Diseases.”
The Senate Veterans’ Affairs Committee will hold a hearing on “Connections to Care: Improving Substance Use Disorder Care for Veterans in Rural America and Beyond.”
The Senate Health, Education, Labor & Pensions Committee will hold a markup of legislation on health care program reauthorizations and NIH report requirements related to Alzheimer’s research.
Last Week (June 5 - 9)
Health Care Highlights
HHS publishes new data on Part B inflationary rebates. On Friday (June 9), the Centers for Medicare and Medicaid Services (CMS) published an updated list of 43 Medicare Part B drugs and biologics that will be subject to inflation rebates under the Inflation Reduction Act. CMS said Medicare beneficiaries could see savings up to $499 on average per dose between July 1 and September 30. Click here for a fact sheet. Click here for the drug pricing files.
CMMI unveils new primary care model. On Thursday (June 8), the Center for Medicare and Medicaid Innovation (CMMI) announced a three-tracked, multi-payer primary care model, the Making Care Primary Model, that it will test in eight states. Participants will receive enhanced payments to improve care coordination between primary care providers and specialists with those with the least experience with value-based care receiving additional funding to build the needed infrastructure. CMMI said the pilot will run for 10 years, from July 1, 2024, to Dec. 31, 2034. The agency will start take applications late this summer, however, CMS providers who are already in an accountable care organization will be unable to participate in both programs. Click here for the press release.
FTC proposes changes to breach notification requirements for non-HIPAA entities. On Thursday (June 8), the Federal Trade Commission issued (FTC) a notice of proposed rulemaking to update breach notification requirements for entities that collect health information but are not covered by HIPAA’s privacy and security requirements. The rule clarifies its application to health apps and other technologies not covered by HIPAA, the definition of a data security breach, and the requirements around consumer notification when a breach of unsecured personal health records has occurred. The FTC will collect comments for 60 days.
FTC expands inquiry into PBMs. On Thursday (June 8), the FTC ordered a third group purchasing organization (GPOs) that negotiates drug rebates on behalf of pharmacy benefit managers (PBMs) to provide information and records on their business practices. The order follows similar requests sent to two GPOs and the nation’s six largest PBMs.
HHS releases plan to combat STIs. On Thursday (June 8), the Department of Health and Human Services (HHS) unveiled a federal plan to reduce the burden of sexually transmitted infections in the US through 2025. The STI Federal Implementation Plan highlights more than 200 actions that federal stakeholders will take to better coordinate efforts to prevent new STIs, reducing adverse outcomes of STIs, accelerate research into STIs, and reduce STI-related health disparities and inequities.
Supreme Court preserves patients’ right to sue nursing homes. On Thursday (June 8), the Supreme Court ruled 7-2 that patients can file lawsuits against nursing homes in federal court for violations of their rights granted under Medicaid via the Federal Nursing Home Reform Act. The case, Health and Hospital Corp. of Marion County v. Talevski, had challenged a patient’s right to sue his nursing home facility for violating the FNHRA, which grants residents protection from being medicated for purposes of discipline or convenience and requires notice and consent before residents can be transferred or discharged.
CMS finalizes Medicare DSH policy. On Wednesday (June 7), CMS published a rule that finalizes its proposal for how to treat Medicare Part C days when calculating a hospital’s disproportionate patient percentage for discharges that occurred prior to Oct. 1, 2013. The policy change was made in response to the Supreme Court’s ruling in Azar v. Allina Health Services.
Merck takes CMS to court over drug price negotiation process. On Tuesday (June 6), Merck filed a lawsuit in the US District Court for the District of Columbia challenging CMS’ drug price negotiation process, arguing it is unconstitutional and aiming to prevent CMS from forcing the drugmaker to agree to negotiated prices.
Hearings, Markups, and Other Committee Action
The Committee on Education and the Workforce held a markup on telehealth and other health care legislation. On Tuesday (June 6), the House Committee on Education and the Workforce advanced four bills, including two bills related to health insurance coverage: H.R. 2813, Self-Insurance Protection Act and H.R. 2868, the Association Health Plans Act. Lawmakers voted along party lines to advance the two health care bills, with Republicans voting in favor and Democrats voting against. During the discussion, Republican committee members spoke favorably about the bills increasing coverage options for employers, while Democrats raised concerns about the type of coverage patients would have access to.
House Energy and Commerce Oversight and Investigations Subcommittee held a hearing on “Looking Back Before Moving Forward: Assessing CDC's Failures in Fulfilling its Mission.” On Wednesday (June 7), the Subcommittee held a hearing that examined the Centers for Disease Control (CDC). During the hearing, Republican members criticized the agency’s COVID-19 response and its response to GOP concerns with the CDC’s overhaul plans, while Democratic members defended the agency, pointed to Republicans as a reason the public has lost trust in the agency, and criticized the subcommittee’s decision to hold a hearing without a CDC representative.
Senate Judiciary Subcommittee on Intellectual Property held a hearing on “Artificial Intelligence and Intellectual Property – Part I: Patents, Innovation, and Competition.” On Wednesday (June 7), the Subcommittee held a hearing on artificial intelligence (AI) and intellectual property law. During the hearing, there was bipartisan support for AI and the potential for the technology to support US innovations, including drug research and development. Lawmakers focused their questions on whether or not the US needs to update existing patent laws to account for AI-developed inventions, which are currently ineligible for patent protection. The subcommittee heard from a panel of witnesses representing academics, the pharmaceutical industry, the technology industry, and non-profits focused on bolstering US competitiveness through AI. Each of the witnesses praised the potential for AI to accelerate research and innovation but noted human involvement is still integral to the invention process. Only one witness felt Congress should update patent law to better take AI involvement into account.
Senate Veterans’ Affairs Committee held a hearing on “An Abiding Commitment to Those Who Served: Examining Veterans’ Access to Long Term Care.” On Wednesday (June 7), the Committee held a hearing during which they discussed staffing challenges and access to care at the VA. The Committee heard testimony from representatives of HHS and the VA who spoke about efforts their staff are taking to address those challenges.
The House Ways and Means Committee held a markup of health care legislation. On Wednesday (June 7), the Committee sent to the full House nine bills, including six bills related to health insurance coverage and employer reporting. During the markup, several Democrats focused their comments on concerns with the equity implications of health savings accounts (HSAs), while Republicans said proposals to expand access to HSAs and other tax-advantaged accounts, such as those considered, increase flexibilities and choice for both employers and employees. There was some bipartisan support for making permanent a pandemic-era provision enabling employers to offer telehealth services below the deductible for employees with a HSA, as well as some employer reporting provisions, however other provisions including those aimed at expanding individual coverage Health Reimbursement Arrangements (HRAs) advanced on party lines.
The Senate Finance Committee held a hearing on “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs.” On Thursday (June 8), the Committee held a hearing, which was marked for the bipartisan nature of the conversation, with both Republicans and Democrats expressing concern about increased consolidation in the health care industry and the impact consolidated markets can have on patients’ health care costs. Committee members raised concerns about vertical and horizontal consolidation, PBMs, as well as the role of private equity in health care. Committee members heard testimony from a panel of witnesses including academics and providers, all of whom spoke about the need to better align economic incentives to promote quality and accessible health care for patients. Witnesses and lawmakers discussed ways to address policies that inadvertently drive consolidation, as well as the need for better data systems to measure ownership and costs, in addition to quality and access.
The Senate Health, Education, Labor & Pensions Committee held a hearing on “Why Are So Many American Youth in a Mental Health Crisis? Exploring Causes and Solutions.” On Thursday (June 8), the Committee held a hearing centered on the severe state of youth mental health and the specific impact of social media on this crisis. There was also a focus on not only implementing solutions but also on evaluating their effectiveness. During the hearing, lawmakers heard testimony from two witness panels who represented the perspectives of education administrators and health care specialists.
Reports, Studies, and Journals
Centers for Disease Control and Prevention: Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months–5 Years — United States, June 17, 2022–May 7, 2023. The data show a third mRNA COVID-19 vaccine dose is safe for children ages 6 months to 5 years old. The data show most adverse reactions were mild or transient and most reports of adverse events were attributed to vaccination errors.
HHS Office of Inspector General: Spring 2023 Semiannual Report to Congress. The report describes OIG's work from October 1, 2022, through March 31, 2023, identifying significant risks, problems, abuses, deficiencies, remedies, and investigative outcomes related to the administration of HHS programs and operations.
Congressional Budget Office: How the Fiscal Responsibility Act of 2023 Affects CBO’s Projections of Federal Debt. The report found the law would reduce projected federal debt in 2033 by about 3%, from $46.7 to $45.2 trillion.