May 22, 2022

Volume XII, Number 142

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May 20, 2022

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McDermottPlus Check-Up: May 13, 2022 and [PODCAST]

This Week’s Dose

It was a busy week in Congress, with House approval of $40 billion in funding for Ukraine after agreeing to detach it from COVID relief. In response to the leaked Supreme Court decision, the Senate debated and failed to move forward the Women’s Health Protection Act and continued nomination votes with Vice President Harris breaking ties on key appointments to the Federal Trade Commission and Federal Reserve as well as a bipartisan vote of 80-19 to confirm Jay Powell as Chair of the Federal Reserve. The House also voted to permit employees of Members of Congress to unionize. 

Congress

Senate Fails on Attempt to Codify Roe v. Wade. On May 11, the Senate, for a second time, failed to advance the “Women’s Health Protection Act,” a bill that would codify a national right to an abortion. The bill previously passed the House in September 2021. As anticipated, the vote failed 49-51, with Senator Manchin (D-WV) opposing the bill alongside all Senate Republicans. Democrats will now have to consider potential next steps, which could include consideration of a narrower bill being developed by Senators Susan Collins (R-ME) and Lisa Murkowski (R-AK). Any potential legislative solution, however, likely does not have the votes to survive a filibuster.

Energy & Commerce Health Subcommittee Advances FDA User Fee Agreements, Mental Health Reform, ARPA-H and More. The House Energy & Commerce Subcommittee on Health approved six bills on May 11, the most notable of which was the “Food and Drug Amendments of 2022” (H.R. 7667), legislation to reauthorize the Food and Drug Administration’s (FDA) user fee programs, which also incorporates various programmatic improvements across the whole of FDA.

The subcommittee also approved the “Advanced Research Project Agency-Health Act” or the “ARPA-H Act” (H.R. 5585), legislation that would accelerate innovation in health and medicine by investing in high-risk, high-reward research projects. ARPA-H is a signature priority for President Biden and is modeled on the similar DARPA program within the Defense Department.  This bill is notable as it authorizes ARPA-H within HHS, conflicting with the Administration’s efforts already underway to establish ARPA-H within the National Institutes of Health.

Lastly, amid the Centers for Disease Control announcing an all-time high of drug overdose deaths, the Committee also approved the “Restoring Hope for Mental Health and Well-Being Act” (H.R. 7666), a bill to reauthorize key programs within the Substance Abuse and Mental Health Services Administration and Health Resources and Services Administration that address national mental health and substance use disorders.

Other bills approved by the subcommittee include the following: “Keeping Incarceration Discharges Streamlined for Children and Accommodating Resources in Education Act” (H.R. 7233), “Gabriella Miller Kids First Research Act 2.0” (H.R. 623), and the “South Asian Heart Health Awareness Act of 2021” (H.R. 3771).

All six bills advanced out of the subcommittee, and onto the Full Committee, which is expected to hold its own markup next week. Links to the bills and amendments can be found here. The Senate HELP Committee is expected to release its draft user fee legislation soon. In order to avoid FDA furloughs, user fee legislation needs to be enacted by August 1. 

Administration

CMS Finalizes Home-Care Rule. On May 12, 2022, CMS finalized the Reassignment of Medicaid Provider Claims final rule that overturns a 2019 policy from the previous Administration. The rule allows state Medicaid agencies to make payments to third parties on behalf an individual Medicaid practitioner for benefits or union dues. The rule applies to home-care workers and personal attendants who are primarily home and community-based services providers.

International COVID-19 Summit Spurs More than $3 Billion in Investments. The White House on May 12 convened virtually the second Global COVID-19 Summit focused on accelerating international vaccination efforts, enhancing testing and treatment, protecting health workforce, and building health security for future pandemics. The Summit garnered financial commitments totaling more than $3 billion in new funding that will include $2 billion for COVID-19 response and $962 million towards preparedness and global health security. The event was co-hosted by the United States, Belize, Germany, Indonesia, and Senegal. The list of financial commitments can be viewed here.

U.S. Reports 1 Million COVID Deaths. The U.S. reached a grim milestone this week by surpassing more than 1 million deaths from COVID-19. President Biden addressed the moment during the virtual Global COVID-19 Summit on May 12 and announced flags will be flown at half-staff to mourn those lost. The news comes as the United States is experiencing an increase in infections in some regions due to a new Omicron subvariant, with positive cases up more than 20% over the last two weeks. Hospitalizations and death rates remain relatively low.

Hearings

  • House Energy & Commerce Oversight and Investigations Subcommittee announced that it will hold a hearing on May 25 to better understand the infant formula shortage, increase production, and ensure formula safety.

  • Senate Committee on Budget held a full Committee hearing on May 12 on “Medicare for All: Protecting Health, Saving Lives, Saving Money,” where the Committee heard from a number of experts in academia and think-tanks, as well as the Congressional Budget Office director Phillip Swage.

  • House Appropriations Committee held a hearing on May 12, entitled “Healthy Aging: Maximizing the Independence, Well-being, and Health of Older Adults,” where the Committee heard from mental health and aging experts.

  • House Appropriations Committee held a hearing on May 11 on the “FY2023 Budget Request for the National Institutes of Health,” where the Committee heard from directors of the different institutes and centers housed under the National Institutes of Health.

Quick Hits

  • The Government Accountability Office released a report on May 12 evaluating the FDA’s actions to make COVID-19 tests available, the number of tests authorized and enforcement discretion.

  • Senate Democrats on May 12 announced the reintroduction of the “Medicare for All Act,” to extend Medicare coverage to all over the course of a four-year transition period.

  • The American Journal of Managed Care released a new study on May 12, “Characteristics of Home-Based Care Provided by Accountable Care Organizations (ACO),” that analyzes ACO characteristics, governance, and risk model participation.

 

Health Policy Breakroom Podcast

Sheila Madhani discusses the recent CMS, HHS and Biden Administration initiatives that impact Medicare quality, PHE flexibilities, health equity and upcoming regulatory updates.

 

 

© 2022 McDermott Will & EmeryNational Law Review, Volume XII, Number 133
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