June 13, 2021

Volume XI, Number 164

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June 10, 2021

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McDermottPlus Check-Up: May 14, 2021

This Week’s Dose

The Administration endorsed waiving intellectual property protections for coronavirus (COVID-19) vaccines and announced a new program that will reimburse providers for vaccine administration fees.

Congress

Palm secures confirmation as Brooks-LaSure advances on slim margins. The Department of Health and Human Services (HHS) now has a second-in-command following a 61-37 Senate vote to confirm Andrea Palm as Deputy Secretary. Palm will step into a key operational role within the administration, helping execute the policy priorities laid out by President Biden and HHS Secretary Xavier Becerra. Just a day after the Senate confirmed Palm, Senate Majority Leader Chuck Schumer also advanced Chiquita Brooks-LaSure’s nomination to the post of Centers for Medicare and Medicaid Services (CMS) Administrator, but did so with the narrowest of margins on 51-48 procedural vote. While Brooks-LaSure is expected to be confirmed with a final vote prior to the Senate’s next recess on May 28, her confirmation has been a proxy battle over the Biden Administration’s revocation of Texas’ Section 1115 Medicaid Waiver. Another perceived slight could further undermine support and compromise her nomination.

Administration

Biden Administration directs HHS to begin enforcing LGBTQ discrimination claims. Returning to an Obama-era policy, the Biden Administration announced it would reinstate protections under Section 1557 of the Patient Protection and Affordable Care Act (ACA). That section and accompanying regulations outline that an individual “shall not be excluded from participation in, be denied the benefits of, or be subjected to discrimination on the grounds prohibited” on the basis of sex, race, color, national origin, age or disability. While widely expected after the President issued a day-one Executive Order on gender protections, it is unclear exactly how the Administration intends to effectuate this policy change, leaving the door open for litigation on issues of religious freedom and administrative procedure.

Quick Hits

  • Seventy-seven Members of Congress sent a letter to Secretary Becerra urging the distribution of remaining money in the Provider Relief Fund and requesting an extension beyond the June 30 deadline to spend the money.

  • The Senate Health, Education, Labor and Pensions Committee held a hearing on federal updates on COVID-19 vaccinations and public health guidance. The House Energy and Commerce Committee held a hearing with HHS Secretary Becerra on the President’s fiscal year (FY) 2022 budget for the department.

  • The FDA authorized Pfizer's mRNA COVID-19 vaccine for use in children ages 12 to 15, which was previously authorized only for individuals 16 and older.  The CDC also announced new guidance that permits fully vaccinated individuals to take off masks while outside or inside non-crowded areas.

  • A group of bipartisan House lawmakers introduced the Improving Seniors’ Timely Access to Care Act (H.R.3173), which would address prior authorization practices by health plans that result in delayed access to a care.

  • Facing an inspection backlog from COVID-19, the FDA estimates that it will only reach a 27% completion rate for domestic inspections of drug manufacturing facilities in 2021.

  • The ACA special enrollment period opened by President Biden in January and extended through August has garnered over 1 million new enrollees.

  • CMS released guidance in a letter to State Medicaid Directors to help them access additional Federal Medical Assistance Percentage funding to support home and community-based services under the American Rescue Plan.  

  • The White House announced a $7 billion investment in public health workforce development under the American Rescue Plan. 

M+ Resources

Next Week’s Diagnosis

The Senate Appropriations Committee will look at the CDC budget proposal for FY2022. The Senate Finance will examine lessons learned from COVID-19 healthcare flexibilities, while the Senate Judiciary Committee will hold a hearing on hospital consolidation concerns. Senate Homeland Security will hear testimony on securing the nation’s medical supply chain. The House Committee on Oversight and Reform will hold part three of a series on unsustainable drug pricing.

© 2021 McDermott Will & EmeryNational Law Review, Volume XI, Number 134
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Aaron Badida Healthcare Attorney McDermott

Aaron leverages a health-focused legal background with research and writing expertise to help clients analyze the impact of, and respond to, pending regulatory and legislative actions.

Aaron works with clients to provide data-driven insights to inform stakeholder comments on proposed regulations and tracks regulatory developments to ensure clients are engaged and informed on the policy matters that impact their businesses. He is also experienced in assessing Medicare payment regulations, as well as regulations from the Centers for Medicare & Medicaid Services, the Centers for...

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Mara McDermott, McDermott Law Firm, Washington DC, HealthCare Law Executive

Mara is an accomplished health care executive with a deep understanding of federal health care law and policy, including delivery system reform, physician payment and Medicare payment models.

Most recently Mara served as the senior vice president of federal affairs at America’s Physician Groups (formerly the California Association of Physician Groups, CAPG), a professional association representing medical groups and independent practice associations practicing in capitated, coordinated care models. As head of the Washington, DC, office, Mara...

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Kristen O’Brien Healthcare Executive McDermott Consulting
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Kristen O’Brien is an accomplished healthcare executive with a deep understanding of regulatory advocacy and healthcare policy efforts.

Kristen offers a strong background and a keen eye for solutions to barriers and challenges impacting healthcare clients. With more than 10 years of experience, her work focuses on implementing new laws through the rulemaking process, as well as working with relevant agency officials to develop and improve agency guidance.

Kristen recently served as Principal of the Health Industry Policy and Regulatory Practice Group at a law and lobbying...

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Katie Waldo Healthcare Attorney

Katie is an experienced government relations strategist who helps clients navigate the complex issues surrounding Medicare, Medicaid and the healthcare marketplace.

Katie works with clients to represent their needs before the US Congress and the US Department of Health and Human Services (HHS) and its agencies by relying on extensive experience as a policy advisor on the Medicaid and Medicare programs, as well as the 340B program and other aspects of the Public Health Service Act. She anticipates the effects of state and federal policymaking on issues impacting their businesses and...

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