October 25, 2021

Volume XI, Number 298

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October 22, 2021

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McDermottPlus Check-Up: August 27, 2021

This Week’s Dose

House passes rule for budget resolution and infrastructure. U.S. Food and Drug Administration (FDA) grants first COVID-19 vaccine approval to Pfizer-BioNTech

Congress

House Rule Advanced Senate Budget Agenda and Set Date for Bipartisan Infrastructure Vote. The rule, which passed Tuesday on a party-line vote of 220-212, deemed the Senate’s Democratic budget passed by the House and set September 27, 2021 as the anticipated date for a full House vote on the Senate’s bipartisan infrastructure package. Passage of the Democratic budget resolution by both the House and the Senate allows work to proceed on the up to $3.5T partisan reconciliation bill. The action starts in the House where Democrats will now begin to translate President Biden’s “Build Back Better” plan into actual legislation making significant investments in childcare, healthcare, and education.  Anticipated healthcare policies include the addition of dental, hearing and vision benefits to Medicare; permanent extension of Affordable Care Act subsidies enacted under the American Rescue Plan; closing the Medicaid coverage gap for states that have yet to expand their Medicaid programs; and new investments in home and community-based services. Democrats have not yet spelled out how they will pay for these policies, though drug pricing reform, tax policy changes, and other health policy changes are all expected to be major sources for offsets. House committees intend to start working on their sections of the reconciliation bill as soon as September 2 with a goal of wrapping up by September 15. This timetable would allow the House to bring the reconciliation bill to the House floor for a full vote by September 27. Adhering to this timetable will be important for the Speaker because House Progressives remain insistent that Congress pass the reconciliation bill before passing the bipartisan infrastructure package. That means September 27 is the effective deadline for getting reconciliation onto the House floor so the two bills (i.e., the $3.5T soft infrastructure bill and the Bipartisan Infrastructure Bill) can be considered at the same time. While House committees work to draft the legislation, there are also ongoing discussions with Senate Democrats in an effort to align policy as much as possible before House members vote on the reconciliation bill at the end of next month. 

Administration

FDA Approved Pfizer-BioNTech COVID-19 Vaccine. The agency’s full marketing approval of Comirnaty (the vaccine’s brand name) on Monday was the first granted to a COVID-19 vaccine. The FDA has authorized Pfizer’s vaccine for emergency use since December 2020.  The announcement comes less than a week after the White House issued a vaccine mandate for nursing home employees and announced that booster shots would be available starting September 20, 2021. Public health officials and policymakers are hopeful that full FDA approval will spur a new wave of vaccinations among hesitant individuals as the Delta variant surges. This announcement comes alongside the Centers for Medicare and Medicaid Services’ announcement that it will increase reimbursement for COVID-19 shots administered in the home (including assisted living facilities) by $35 per dose. On Wednesday, Moderna filed for full approval of its COVID-19 vaccine under the brand name Spikevax, while Pfizer filed for full approval of its vaccine for booster shots amid mounting evidence that they may be needed as early as six months after completing the initial doses.

States and Courts

Supreme Court Stops Biden Administration Eviction Moratorium Extension. The decision came Thursday night mere weeks after the Centers for Disease Control and Prevention issued a new halt on evictions set to end on October 3. The CDC’s order extending moratorium came amid significant pressure from Progressive Democrats in the House following the expiration of the previous moratorium on July 31. The CDC stated the ban on evictions was part of a public health effort to stop rising community transmission of the COVID-19 Delta variant in areas of high spread. Upon review, the Supreme Court stated that while this a desirable end, it could not permit a government agency to do so through unlawful means. The opinion stated that the moratorium was an extreme overreach of authority into private agreements between landlords and tenants and allowed an interpretation to the CDC’s authority that was virtually limitless. Justices Breyer, Kagan and Sotomayor dissented, arguing that the extraordinary circumstances created by the pandemic called for an expansive interpretation of the authority the law gives to the CDC. This ruling comes just days after the Biden Administration announced additional efforts to assist with eviction protection and rent relief through Departments and agencies outside the CDC. Nonetheless, this decision significantly limits further executive action and opens the door for mass evictions nationwide, unless Congress intervenes. 

Quick Hits

  • This week, the White House held a Virtual Conversation on Health Systems, Providers, and the COVID-19 Vaccination Effort.

  • The Departments of Labor, Treasury and Health and Human Services released updated FAQs on implementation of price transparency regulations and the No Surprises Act. The updates included a six-month delay of the Transparency in Coverage Final Rule until July 1, 2022.

  • The Centers for Medicare and Medicaid Services reported that Accountable Care Organizations in the Medicare Shared Savings Program saved Medicare $1.9 billion for 2020. 

© 2021 McDermott Will & EmeryNational Law Review, Volume XI, Number 239
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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
Execusitve

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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