June 13, 2022 This Week in Health Policy for June 13 This Week (June 13-17) The Senate Committee on Health, Education, Labor and Pensions will hold a hearing to markup several health care bills, including the FDA User Fee Agreement.
The House Energy & Commerce Committee will hold a hearing on "Protecting America's Consumers: Bipartisan Legislation To Strengthen Data Privacy and Security."
The Senate Health, Education, Labor and Pensions Committee will hold a hearing on "the Ongoing Federal Response to COVID-19: Current Status and Future Planning."
Last Week (June 6-10) Health Care Highlights CMS issues first hospital price transparency penalties. On Wednesday (June 8), the Centers for Medicare and Medicaid Services (CMS) fined two Georgia-based hospitals for disobeying price transparency rules — marking the first financial penalties levied since the rule took affect nearly a year and a half ago. CMS said the action followed warning notices and requested corrective action plans, which were deemed not adequately addressed. This could be the first of many. CMS has sent 352 warning notices to hospitals and requests for corrective action plans to 157 hospitals that didn't make adequate changes. The penalties come just weeks before the Transparency in Coverage rule targeting insurers is set to begin rolling out. Beginning July 1, insurers must disclose pricing information by positing machine-readable files containing costs for in-network items and services along with allowed amounts and billed charges from out-of-network providers. House passes FDA User Fee Package. On Wednesday (June 8), the House in a 392-28 suspension vote passed legislation (H.R. 7667) to reauthorize the Food and Drug Administration's (FDA) user fee agreements for another five years. The Food and Drug Amendments of 2022 includes several policy riders, including those to increase generic drug competition, bolster the FDA's authority under the accelerated approval program, improve diversity in clinical trials, increase access to therapies and treatments for rare diseases, and improve the FDA's use of real-world evidence and patient feedback in its decision making. The Senate Committee on Health, Education, Labor and Pensions is scheduled to markup its version of the bill next Tuesday (June 14). Both chambers will need to pass a final bill before the current user fee agreements expire on Sept. 30. FTC greenlights PBM probe. On Monday (June 6), the Federal Trade Commission (FTC) unanimously voted to examine pharmacy benefit managers' (PBM) business practices. The inquiry will include data from six PBMs on their pharmacy contracts, formulary development processes, administrative procedure practices, such as patient steering, use of prior authorizations, and more. FDA advisors recommend Novavax COVID-19 vaccine. On Tuesday (June 7), an FDA advisory panel unanimously voted to recommend Novavax's COVID-19 vaccine. The vaccine differs from Pfizer-BioNTech's and Moderna's mRNA vaccines by taking a protein-based approach that is more commonly used in vaccine development. FDA now must determine whether to issue an emergency use authorization (EUA) for the vaccine. FDA advisory panels next week are scheduled to discuss Moderna's EUA request for children ages 6 to 17, Moderna's EUA request for children 6 months to 5 years old, and Pfizer-BioNTech's EUA request for children 6 months to 4 years old. Supreme Court ruling in Medicaid case. TheSupreme Court in a 7-2 opinion ruled that Medicaid can seize a patient's personal injury settlement to reimburse for past care related to the accident, even if the settlement is earmarked for "future care." "The heavy financial burden that states bear under Medicaid means that every option the States have for recouping costs is important," the justices wrote. ICYMI: Health Care Highlights While Congress Was on Recess (May 30-June 3) Hospital groups push for gun safety measures. In the wake of recent mass shooting, including one at a Tulsa, OK, medical center, the American Medical Association (AMA), the American Hospital Association, and the Federation of American Hospitals issued statements calling on Congress to pass bipartisan legislation to reduce gun violence. The AMA, specifically, has come out in support of the Protecting Our Kids Act (H.R. 7910), which the House passed this week among other gun safety measures. The Senate is working on its own bipartisan package to improve gun safety. HHS establishes Office of Environmental Justice. On Wednesday (June 1), HHS published a notice establishing a new office under the Office of the Assistant Secretary for Health's Office of Climate Change and Health Equity that will focus on environmental inequities in health, such as lead exposure or waste water treatment. The office will be led by interim director Sharunda Buchanan, a former official at the Centers for Disease Control. Congressional Republicans reveal health care "modernization" agenda. On Wednesday (June 1), the Healthy Futures Task Force, a group of Republican leaders tasked with setting the party's health care agenda for the next Congress, released solutions to improve health care from its Modernization Subcommittee. The solutions include expanding access to telehealth after the public health emergency expires, using new technology to address fraud, waste, and abuse, and increasing access to "patient-centered technologies to improve patients' well-being." Biden admin unveils Medicare Trustees report. On Thursday (June 2), the Biden administration released the 2022 annual Social Security and Medicare Trustees report. The latest report projects the Medicare Hospital Insurance (HI) Trust Fund, which funds Medicare Part A benefits, will be unable to pay full benefits in 2028, two years later than the last year's projection that insolvency would occur in 2026. HHS gives states an additional year to use ARP Medicaid funding. On Friday (June 3), HHS informed states that it will grant them an additional year to use enhanced funds for Medicaid home and community-based services authorized by the American Rescue Plan (ARP). States will now have until March 31, 2025 to use their funding. Reports, Studies, and Journals CMS. 2022 Strategic Framework White Paper. The report provides an overview of CMS initiatives over the past year, as well as ways the agency is advancing its six strategic pillars: Advance Equity, Expand Access, Engage Partners, Drive Innovation, Protect Programs, and Foster Excellence. Kaiser Family Foundation: 2022 Medical Loss Ratio Rebates. The analysis estimated private insurance companies will pay out $1 billion in rebates to consumers this fall under the Affordable Care Act's medical loss ratio provision. According to the analysis, the rebate totals continue to show how the COVID-19 pandemic restrained patient volumes and expected health care claims. RAND Corp.: Preparedness for 988 Throughout the United States: The New Mental Health Emergency Hotline. A survey of state and local public health officials responsible for deploying the new 988 national suicide prevention hotline suggest fewer than half are confident their areas have the appropriate resources to meet the July launch date. Health Affairs: Strengthening Behavioral Healthcare To Meet The Needs Of Our Nation. CMS officials in the article detail the agency's plans to address the nation's mental health and substance use disorder crisis. ———————————————
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