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This Week (Sept. 19-23)

The House will next meet on Monday, September 19 and the Senate will convene at 3:00 p.m. on Monday.

Last Week (Sept. 12-16)

Health Care Highlights

Congress is back in session. This week, lawmakers in the House and Senate returned from their August recess, facing a looming Sept. 31 deadline to pass either a continuing resolution (CR) or fiscal year 2023 spending bill, as well as advance User Fee Agreements for the Food and Drug Administration (FDA) that also expire at the end of the month. Expectations are that an upcoming CR would fund the government until mid-December. Congress is working out which, if any, policy riders would accompany the CR, and some advocates are wary that a push to attach FDA user fee legislation to the bill would exclude long-sought policy changes included in the House-passed legislation. The FDA, however, could lay off thousands of employees if an agreement is not reached by the expiration of FDA funding. In addition to funding the government, lawmakers on both sides of the aisle have said they plan to focus on mental health and telehealth in the coming weeks, however these discussions could roll over into 2023 and a new legislative session, especially in light of the upcoming midterm elections.

• For additional detail on Congressional priorities through the end of the year, see WCEY Alert: "Congress returns to pre-election session"

House passes MA prior authorization bill. On Wednesday (Sept. 14), the House unanimously passed legislation (H.R. 3173) that would require Medicare Advantage (MA) insurers to use an electronic prior authorization process, create a real-time approval process for certain products and services, and increase transparency around the MA prior authorization process. The Congressional Budget Office (CBO) on Wednesday (Sept. 14) estimated the bill would cost more than $16 billion over 10 years and increase payments to plans to cover the cost of additional services. The bill now heads to the Senate. Companion legislation in the Senate (S. 3018), has been introduced by Sen. Roger Marshall (R-KS), and has 40 cosponsors. The legislation has overwhelming bipartisan support and is supported by more than 400 medical groups along with the Better Medicare Alliance, an advocacy group that supports MA.

Earlier in the week, the House Energy and Commerce Health Subcommittee approved four other health bills along with H.R. 3173. These include: the "Vaccine Injury Compensation Modernization Act of 2021" (H.R. 3655); the "Maximizing Outcomes through Better Investments in Lifesaving Equipment for Health Care Act" (H.R. 5141); the "Improving Trauma Systems and Emergency Care Act" (H.R. 8163); and the "Flint Registry Reauthorization Act" (H.R. 6737).

Biden signs EO to spur biotech innovation. On Monday (Sept. 12), President Joe Biden signed an executive order (EO) to create a National Biotechnology and Biomanufacturing Initiative to reduce the United States' reliance on China for medicines and other products. The EO calls on the Department of Health and Human Services (HHS), the FDA and other federal agencies to create a plan to bolster domestic biomanufacturing capacity and accelerate the United States' ability to detect diseases and manufacture vaccines. In addition, the initiative aims to lower prices of active pharmaceutical ingredients and other products.

Biden names inaugural ARPA-H director. On Monday (Sept. 12), President Biden announced he plans to appoint Dr. Renee Wegrzyn to lead the Advanced Research Projects Agency for Health (ARPA-H). Wegrzyn is currently a vice president of business development at Ginkgo Bioworks and Head of Innovation at Concentric by Ginkgo. Prior to her role at Ginkgo she worked at the Defense Advanced Research Projects Agency (DARPA) — which ARPA-H is modeled after — and the Intelligence Advanced Research Projects Activity (IARPA). Wegrzyn is expected to assume her new role by Oct. 1, the start of fiscal 2023. President Biden said this week during a speech on his Cancer Moonshot initiative that ARPA-H will prove "critical" in the fight against cancer.

Lawmakers introduce bill to stave off 2023 Medicare physician fee cuts. On Tuesday (Sept. 13), Reps. Ami Bera (D-CA) and Larry Bucshon (R-IN) introduced legislation to increase the Medicare physician fee schedule conversion factor by 4.42%. The bill would effectively eliminate the proposed 4.4% decrease if the decrease is included in the Medicare Physician Fee Schedule final rule expected this fall.

Biden admin issues RFI on surprise billing provisions. On Friday (Sept. 16), the Biden administration published a request for information asking for stakeholders' input on future rulemaking for advanced explanation of benefits (AEOB) and good faith estimate (GFE) requirements of the No Surprises Act. The RFI seeks information and recommendations on transferring data from providers and facilities to plans, issuers, and carriers; other policy approaches; and the economic impacts of implementing these requirements.

FDA finalizes annual "Right to Try" reporting requirements for manufacturers. On Tuesday (Sept. 13), the FDA finalized a rule that details annual reporting requirements for drug manufacturers of investigational drugs that are available through the so-called "Right to Try" pathway. The final rule sets a March 31, 2023 deadline for the first annual summary reports.

HHS' Office of Civil Rights gets new leadership. On Wednesday (Sept. 14), Melanie Fontes Rainer was named director of HHS' Office for Civil Rights. Fontes Rainer had been serving as acting director of the office since the previous director, Lisa Pino, departed this summer.

ICYMI: Health Care Highlights From the August Recess

Judge strikes down parts of ACA's preventive coverage requirements. On Wednesday (Sept. 7), a federal judge ruled that provisions in the Affordable Care Act (ACA) requiring health insurers and self-insured employers to cover preventive services that receive an "A" or "B" rating from the U.S. Preventive Services Task Force (USPSTF) must be covered at no cost to the member are unconstitutional because members of USPSTF are not appointed by the president and confirmed by the Senate. The judge also ruled that requiring insurers to cover HIV pre-exposure prophylaxis, or PrEP, at no cost violates the Religious Freedom Restoration Act of 1993. The Biden administration is expected to appeal the ruling.

CMS rescinds health care language in public charge rule. On Thursday (Sept. 8), CMS issued a that reverses the 2019 public charge rule's language allowing the Department of Homeland Security to consider a person's likelihood of receiving Medicaid/CHIP and other health benefits as part of their green card application to remain or enter into the United States.

CMS rule to streamline Medicaid/CHIP enrollment. On Wednesday (Aug. 31), CMS issued a proposed rule that would streamline the application and renewal process for Medicaid and CHIP enrollees. For example, the rule would limit renewals to once a year, establish standardized renewal processes, and grant applications 30 days to respond to information requests. The rule comes as state Medicaid programs prepare for redeterminations when the COVID-19 public health emergency (PHE) ends. The Biden administration has vowed to give states at least 60 days' notice before the PHE ends.

Reports, Studies, and Journals

House Ways and Means Committee: Health Care and Climate Crisis: Preparing America's Health Care Infrastructure. A five part survey provides an overview of the role the U.S. health system plays in the climate crisis including an overview of the RFI responses received by the committee. Part One provides an overview and RFI feedback. Part Two examines effect of climate crisis on health care organizations. Part Three describes how health care organizations are responding to the crisis. Part Four summarizes findings and implications. Part Five is an appendix with survey methodology, limitations, and supplemental tables.

U.S. Census Bureau: Income, Poverty and Health Insurance Coverage in the United States: 2021. The report found 8.3%, or 27.2 million Americans lacked health insurance in 2021, down slightly from 2020. According to the report, about 1.1 million additional Americans reported having health insurance in 2021 compared with 2020, with. Most of the coverage gains occurred among families above 400% of the federal poverty level who enrolled in Medicaid and CHIP. The most common form of coverage was employer-sponsored insurance (53.4%).

Centers for Disease Control and Prevention: Two Cases of Monkeypox-Associated Encephalomelitis — Colorado and the District of Columbus, July-August 2022. In the latest Morbidity and Mortality Weekly Report, the CDC shared two cases in which previously healthy young gay men developed brain and spinal cord inflammation after becoming infected with monkeypox.

HHS' Office of Inspector General: Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Than Others To Use Telehealth During the First Year of the COVID-19 Pandemic. The report found Medicare beneficiaries in urban areas were more likely to use telehealth than those in rural areas. In addition, beneficiaries who were younger, dually eligible, Hispanic, or female were more likely to use telehealth than other beneficiaries. Older beneficiaries were more likely to use audio only visits.

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