Weekly Roundup: December 9, 2022

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Independent Review Recommends Sweeping Changes to FDA Human Foods Program
Earlier this week, the Reagan-Udall Foundation published a report with recommendations from an independent expert panel evaluation of the U.S. Food and Drug Administration’s (FDA) Human Foods Program. The panel recommends several options for how the program could be strengthened and restructured, including the creation of a separate food agency, led by its own commissioner, which would focus on nutrition and food safety. FDA Commissioner Califf commissioned the report after facing widespread criticism about the agency’s slow response to the infant formula shortage earlier this year. The report notes that chronic diseases have been associated with food consumption and more than a million Americans die from diet-related diseases, underscoring the need for more effective nutrition initiatives as part of the FDA’s work. It also describes how the agency’s current governance structure, workforce, and authorities hamper its ability to provide effective oversight of food safety and public health. Ultimately the report emphasizes the need for the Human Foods program to have clear leadership to make critical decisions to prevent and respond to future emergencies.
Diagnostic Reform Bill “VALID” Revisions Might Include Exemptions for Academic Medical Centers
The diagnostics reform bill—Verifying Accurate Leading-Edge IVCT Development (VALID) Act— which seeks to create a risk-based regulatory framework for laboratory-developed tests (LDTs) and create a user fee program for in-vitro clinical tests— is being revised (subscription required) to potentially exempt some academic medical centers (AMCs) as part of a year-end legislative package. In June, the Senate health committee included VALID in their user fee package that cleared the committee, but the measures were left out of the user fee bill that Congress passed at the end of September. VALID is being revised to include language exempting some AMCs from the proposed device pathway requirements to win the support of the AMC community.
Administration Action
  • CMS released a proposed rule (fact sheet) on new requirements related to interoperability and prior authorization (PA) processes for the following payers: Medicare Advantage (MA) plans, state Medicaid and CHIP FFS, Medicaid managed care plans, and Qualified Health Plan (QHP) issuers on the Federally Facilitated Exchange (FFE). The rule withdraws and replaces a previous proposed rule published in December 2020, and addresses comments received on that rule. Comments on the rule are due March 13, 2023. CMS also proposed a number of policies to streamline and increase transparency of the PA process. CMS included 5 Requests for Information in the proposed rule.
  • Last week, the Centers for Disease Control and Prevention (CDC) finalized the procurement of $3.2 billion in funding from the American Rescue Plan to help strengthen the workforce and infrastructure of state, local, and territorial jurisdiction health departments. CDC Director, Rochelle Walensky, M.D., M.P.H. released a statement emphasizing the importance of this first-of-its-kind funding to provide public health agencies the means to rebuild and reinforce the nation’s public health departments to better protect communities locally and nationally. A portion of the funds—$140 million—is reserved for targeted improvements to infrastructure—including food and water safety, child and maternal health care provision, and data monitoring.
  • HHS issued a FAQ last Friday announcing that it will extend its enforcement discretion of the No Surprises Act requirement for providers to get cost estimates from any providers or facilities involved to develop a good faith estimate (GFE) for patients paying their own bills. This extension comes to providers’ and hospitals’ relief, as they argue that data-sharing standards around cost of medical services still need further development.
  • To support consumer and patient safety, the Department of Health and Human Services, the Federal Trade Commission, and the Food and Drug Administration released an updated Mobile Health App Interactive Tool to help health app developers identify which federal rules apply to their technologies. This tool ensures that health tool developers better comply with privacy, cybersecurity, data sharing, and other regulatory requirements given the sensitive nature of personal health data and healthcare’s growing digital presence. The tool is provided for informational purposes only and is not intended to give legal advice. Rather, it describes potential compliance obligations and directs health app developers to educational materials and best practices.
  • On Thursday, the National EMS Information System (NEMSIS) launched a national Opioid Overdose Tracker dashboard to track nonfatal opioid overdoses – strong predictors of fatal overdose – in near real-time to monitor the state of the opioid crisis. The dashboard draws from the National EMS Information System with only a two-week lag. With the implementation of this new dashboard, first responders and policymakers have more accurate data to better target naloxone distribution (which can reverse overdoses), improve response times, and improve addiction and substance use disorder support. However, the dashboard still lacks valuable demographic and geographic information that will ideally be incorporated in the next year.
Congressional Action
  • The Select Committee on Economic Disparity and Fairness in Growth released its final report, Bridging the Divide: Building an Economy that Works for All, which outlines an array of bipartisan policy recommendations to provide economic support and address drastic divides between high- and low-income groups. In the US, families with low incomes are more likely to be uninsured or have less comprehensive insurance coverage and research suggests that the connection between low household income and lack of insurance means that these individuals are also less likely to receive preventive care, provider-recommended healthcare treatment, and are more heavily impacted by medical bills and out-of-pocket costs.
  • Late last week, the Texas Medical Association (TMA) filed its third lawsuit against the implementation of the No Surprises Act, which bars providers from balance billing patients who seek emergency care out-of-network or who receive care from an out-of-network provider working at an in-network facility and establishes an independent resolution process to resolve payment disputes between providers and payers. The TMA’s most recent challenge argues that the Biden administration’s methodology for calculating the qualifying payment amount (QPA) conflicts with statute and enables insurers to artificially decrease the QPA, harming provider reimbursement.
  • Over a hundred health care groups, including the American Medical Association, the Surgical Care Coalition, and the American College of Physicians, rallied against the 4.5 percent reduction in the Medicare physician fee schedule (MPFS) and another 4 percent pay-as-you-go (PAYGO) cut in a letter to Congressional leadership. Physicians and provider groups argue that these compensation cuts damage physician groups’ financial viability and patient care access, and they request that these cuts be postponed or removed from Congress’ year-end spending deal.
  • Few firms offer retiree health benefits, but half of those that do provide them through Medicare Advantage (MA) plans, according to 2022 Kaiser Family Foundation Employer Health Benefits Survey data, up 26% from 2017. The 24th annual survey of employers provided a detailed look at trends in employer-sponsored health coverage and included 2,188 interviews with non-federal public and private firms. The analysis further found that among larger employers with 1,000 or more workers that offer retiree health benefits through a Medicare Advantage plan, the most common reason the employer elected this option was lower cost.
    • This week, the Urban Institute released a research report on what may happen to health coverage after the public health emergency (PHE) expires and states resume normal Medicaid eligibility determinations. Using administrative data on Medicaid enrollment, recent household survey data on health coverage, and the Urban Institute’s Health Insurance Policy Simulation Model, the report estimates that if the PHE expires in April 2023, 18.0 million people will lose Medicaid coverage in the following 14 months.
    • The 340B program, which permits safety-net hospitals, health centers, and clinics to purchase prescription drugs at heavily discounted prices from drug manufacturers, has ensuring that low-income, underserved, and rural patients can receive care. Former Representative Henry A. Waxman explains (subscription required) in Health Affairs that 340B hospitals continue to provide valuable care to those with Medicaid, communities of color, and people with disabilities who tend to have higher healthcare costs than other groups. Looking back at the past thirty years of the 340B program’s existence, he discusses how the different policy levers that make 340B possible preserve the nation’s safety-net and shares insights regarding 340B’s successes.
    • At least 19 states are actively implementing strategies to address direct care worker wages through reporting and/or enforcement mechanisms, according to a recent National Governors Association (NGA) publication. Direct care workers – home health aides, nursing assistants, and other non-licensed health workers – have long experienced low wages despite their work intensity and recent COVID-19 risks. The report examines state approaches to increase direct care worker wages, with a focus on those that have reporting requirements, enforcement vehicles or other mechanisms to help ensure funds go to intended recipients working in facility and HCBS settings.
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