May 15, 2023
This Week in Health Policy for May 15
This Week (May 15 - 19)
House Ways and Means Committee Health Subcommittee will hold a hearing on "Health Care Price Transparency: A Patient's Right to Know."
Senate Health, Education Labor & Pensions Subcommittee on Primary Health and Retirement Security will hold a hearing on "A Crisis in Mental Health and Substance Use Disorder Care: Closing Gaps in Access by Bringing Care and Prevention to Communities."
House Ways and Means Committee Health Subcommittee will hold a hearing on "Why Health Care is Unaffordable: Anticompetitive and Consolidated Markets."
Senate Finance Committee Subcommittee on Health Care will hold a hearing on "Improving Health Care Access in Rural Communities: Obstacles and Opportunities."
Last Week (May 8 - 12)
Health Care Highlights
FDA finalizes blood donor eligibility assessment guidelines. On Thursday (May 11), the Food and Drug Administration (FDA) issued revised recommendations for assessing blood donor eligibility, which now rely upon individual risk-based questions to reduce the risk of human immunodeficiency virus transmission by blood and blood products.
HHS extends PREP Act liability protections. On Thursday (May 11), the Department of Health and Human Services (HHS) officially extended its Public Readiness and Emergency Preparedness (PREP) Act declaration for COVID-19 beyond the end of the public health emergency (PHE). The declaration extends liability immunity to pharmacists, pharmacy interns and pharmacy technicians who administer COVID-19 and seasonal flu vaccines and COVID-19 tests, as well as for all COVID-19 medical countermeasure activities provided through a federal agreement through 2024.
COVID-19 PHE is over. On Thursday (May 11), the COVID-19 public health emergency in the United States expired, bringing to an end hundreds of waivers that health care providers and workers, states, agencies, payers, manufacturers and others across the supply chain have been operating under since 2020. In the runup to the PHE's end date, CMS updated its frequently asked questions, HHS published a new fact sheet on the expiration, as well as a specific factsheet on telehealth flexibilities, and CMS issued a new informational bulletin.
FDA seeks feedback on AI drug development oversight. On Wednesday (May 10), the FDA published a discussion paper and asked for feedback on ways to regulate artificial intelligence and machine learning that is used in drug development. FDA in the paper wrote, "FDA is soliciting feedback on the opportunities and challenges with utilizing AI/ML in the development of drugs, as well as in the development of medical devices intended to be used with drugs. This feedback will provide an additional resource to help inform the regulatory landscape in this area." FDA is accepting comments for 90 days.
DEA extends telehealth prescribing flexibilities. On Tuesday (May 9), the Drug Enforcement Agency (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule to extend the COVID-19 pandemic telemedicine prescribing flexibilities for controlled substances. The rule extends current flexibilities for six months, from May 12, 2023, through November 11, 2023. The rule also provides for a one-year grace period for patients who have an established telemedicine relationship with the prescribing practitioner on or before November 11, 2023. DEA and SAMHSA said the temporary rule will provide more time to go through the more than 38,000 comments received on the proposal and develop final regulations "consistent with public health, safety, and effective controls against diversion."
USPSTF lowers age for breast cancer screening. On Tuesday (May 9), the US. Preventive Services Task Force (USPSTF) published draft guidance recommending women get screened for breast cancer annually at age 40, down from the previous recommendation that screening begin at age 50. USPSTF will accept comments on the proposal through June 5.
CDC updates masking recommendations. On Monday (May 8), the Centers for Disease Control and Prevention (CDC) recommended that health care facilities adopt a risk-based assessment based on stakeholder input and local respiratory virus metrics to determine when and how to require universal masking to prevent COVID-19 transmission. The updated guidelines replace CDC's community transmission metric, which the CDC will no longer be able to update after the PHE ends.
Hearings, Markups, and Other Committee Action
Senate Health, Education, Labor & Pensions (HELP) Committee hearing on "The Need to Make Insulin Affordable for All Americans." On Wednesday (May 10), the Committee heard testimony from a panel of executives from the three major insulin makers and the three major pharmacy benefit managers (PBMs) in the US. During the hearing, there was bipartisan frustration with the high cost of prescription drugs in the US compared with other developed nations, as well as bipartisan frustration about the role PBMs play in lowering drug costs. However, several Republican committee members, including Sen. Rand Paul (R-KY), raised concerns about the unintended consequences of legislation before the committee. In their testimony, the drugmaker executives defended their approach to pricing and asked Congress to address misaligned financial incentives elsewhere in the health care industry that can prevent patients from accessing the lowest cost product. Meanwhile, PBM executives criticized drugmakers for setting high prices and urged Congress to pass bills to increase competition in the drug market.
House Ways & Means Health Subcommittee will hold a hearing on "Examining Policies that Inhibit Innovation and Patient Access." On Wednesday (May 10), the Subcommittee held a hearing on policies that inhibit innovation and patient access. Throughout the hearing, Republicans spoke critically of a range of policies from the Biden administration and Congressional Democrats, including a recently announced proposal from the CMS Innovation Center to reduce reimbursement for accelerated approval pathways drugs, negotiate drug prices through the Inflation Reduction Act (IRA), and CMS' decision not to broadly cover anti-amyloid Alzheimer's Disease drugs approved by the FDA. The subcommittee's ranking member, Rep. Lloyd Doggett (D-TX) said Congress should be able to encourage innovation without requiring patients to pay "monopoly prices" for drugs, also noting that innovative research is often funded in part by the government.
Senate Health, Education, Labor & Pensions Committee executive session on "CONTINUATION: S. 1067, S. 1114, S. 1214, and S. 1339." On Thursday (May 11), the Senate HELP Committee resumed advanced a package of four bills aimed at increasing access to generic drugs and prohibiting certain PBM practices, such as spread pricing and pharmacy clawbacks, as well as enhancing transparency. Most of the debate and amendments focused on the Pharmacy Benefit Manager Reform Act, with members offering more than a dozen amendments to the bill, of which eight were adopted. Much of the markup's debate centered on the bill's provision to ban spread pricing in PBM-insurer contracts, with several Republicans instead favoring guardrails on spread pricing, raising concerns that a complete ban limits plans' contracting options.
Senate Finance Committee hearing on "Cross-border Rx: Pharmaceutical Manufacturers and US International Tax Policy." On Thursday (May 11), the Committee held a hearing featuring a panel of expert witnesses. During the hearing, Democratic members and some witnesses criticized perceived profit shifting by the pharmaceutical industry even after enactment of the 2017 TCJA's guardrails, while Republican members expressed concern about the effect of the OECD-led Pillar Two global minimum tax on US multinational companies, particularly the undertaxed profits rule (UTPR) and treatment of US tax credits including the R&D tax credit.
House Oversight and Accountability's Health Care and Financial Services Subcommittee hearing: "FDA Oversight Part II: Responsibility for the Infant Formula Shortage." On Thursday (May 11), the subcommittee held a hearing during which they heard testimony from Susan T. Mayne, director of the FDA's Center for Food Safety and Applied Nutrition. During the hearing lawmakers, raised concerns that the US could experience another shortage similar to last summer's infant formula crisis and asked Ms. Mayne how the FDA is evolving.
House Energy & Commerce Health Subcommittee will hold a hearing on "Preparing for and Responding to Future Public Health Security Threats." On Thursday (May 11), the Subcommittee heard from a panel of two witnesses made up of government health care leaders and experts and academics. During the hearing, all lawmakers voiced their support for reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), with much of the discussion focused on ways to bolster the health care workforce and whether to give FDA and CDC new authorities around data collection to better monitor and respond to drug shortages and future pandemics.
House Energy & Commerce Oversight and Investigations Subcommittee will hold a hearing on "Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains." On Thursday (May 11), the Subcommittee held a hearing on prescription drug shortages impacting the US. The Subcommittee heard from a panel of expert witnesses who all spoke in favor of modernizing supply chains to better understand where pharmaceutical ingredients originate, reducing the US' reliance on foreign manufacturers, and improving the US' ability to create a stopgap for shortages of lifesaving drugs.
Senate Health, Education, Labor & Pensions Committee held a roundtable field hearing on "How Can We Improve Health Workforce Diversity and Address Shortages? A Conversation with Historically Black College and University Leaders and Students." On Friday (May 12), the Committee held its first field hearing of the 118th Congress to discuss workforce and diversity issues at Morehouse School of Medicine in Atlanta, Georgia. The hearing featured a panel of leaders and students of several of the nation's Historically Black Colleges and Universities, who spoke about the barriers people of color face entering the medical field and the importance of not only shoring up the health care workforce but ensuring it reflects the diverse populations served.
Reports, Studies, and Journals
Health Affairs: Advancing Health Equity Through The CMS Innovation Center: First Year Progress And What's To Come. In the article, CMMI Chief Medical Officer Dora Lynn Hughes shares four actions the center has taken to advance health equity and plans for the remainder of 2023.
Government Accountability Office: 340B Drug Discount Program: Information about Hospitals That Received an Eligibility Exception as a Result of COVID-19. The report, which was requested by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), provides an overview of hospitals that received an exception to the 340B Drug Discount Program's eligibility requirements as a result of the COVID-19 PHE.
HHS Office of Inspector General: Medicare Improperly Paid Providers for Some Psychotherapy Services, Including Those Provided via Telehealth, During the First Year of the COVID-19 Public Health Emergency. The report found over $348 million in improper Medicare payments for telemental health services during the COVID-19 pandemic. OIG said in many cases the payments were made to providers who did not meet Medicare requirements, such as documenting psychotherapy time or including the providers' signature.