December 6, 2021

Volume XI, Number 340

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December 03, 2021

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McDermottPlus Check-Up: October 15, 2021

THIS WEEK’S DOSE

Congress raises debt limit with intent of extending to early December. Vaccine mandate rules await final review. Robert Califf is expected to be nominated to lead the U.S. Food and Drug Administration (FDA).

CONGRESS

Debt Limit Raised as Pelosi Hints at Possible Reconciliation Approach. On Tuesday, the House passed the $480 billion debt limit increase passed by the Senate last week. This increase is expected to defer the debt limit crisis until early December, though some estimates indicate it may allow the federal government to continue borrowing through the end of 2021. In either case, government funding is still set to run out again on December 3, so Congressional action will be required by that date. Stakeholders believe that some key policy priorities, including looming Medicare cuts, could be addressed along with an appropriations measure towards the end of the year.

With regard to ongoing negotiations among Democrats on reconciliation, Congress faces another deadline with the expiration of federal highway spending authority, which runs out on October 31, 2021. However, unlike the highly partisan issues of government funding or the debt limit, this deadline is likely less contentious can be more easily avoided by Congress passing another extension of federal highway spending authority. While no new details have surfaced regarding Democrats’ reconciliation package, Speaker Nancy Pelosi’s most recent remarks on Tuesday indicate that lead negotiators may be looking at a combination approaches to reduce the overall cost of the package. This could include shortening the duration of certain policies funded by the package as well as scaling back the number of policies ultimately included. Democrats in the House would be able to achieve a wider breadth of the education, climate, family and healthcare policies in the Build Back Better Agenda while lowering the $3.5 trillion price tag to a level that will win the support of Senators Kyrsten Sinema (D-AZ) and Joe Manchin (D-WV). The House and Senate are both in session next week, so more details are likely to emerge then.

ADMINISTRATION

Vaccine Mandate Rules Arrived at the Office of Management and Budget. Twin regulations from the Centers for Medicare and Medicaid Services (CMS) and the Occupational Health and Safety Administration (OSHA) implementing the Administration’s workplace vaccine mandates announced in early September are expected to be publicly released soon. The CMS interim final rule is expected to apply to all healthcare providers that participate in Medicare and/or Medicaid, accounting for the vast majority of healthcare providers nationwide and cover more than 17 million healthcare workers. According to the White House, this rule is intended to “create a consistent standard across the country” and prevent vaccination from being a competitive element for staffing. Additionally, the OSHA Emergency Temporary Standard will apply to public and private companies that employ more than 100 individuals or more, accounting for more than 80 million workers. The White House indicated that the OSHA rule would be slightly more flexible, requiring proof of vaccination or committing to weekly testing. To facilitate vaccination, the OSHA rule also includes a requirement for paid time off so that workers can get the vaccine and recover from any side effects. Pending clearance from OMB, these rules will be issued imminently. Stakeholders are looking for details on how the requirements will be enforced and if this will impact staffing shortages that are growing across the country

Biden Expected to Tap Former Commissioner Robert Califf to Lead FDA Again. The nation’s federal drug and medical device regulator has been without an official head since President Biden took office in January. Califf, currently a professor and clinical researcher at Duke University, would be returning to the agency after serving as a deputy commissioner from 2015-2016 and as commissioner from 2016-2017. The expected nomination comes with just a month left in Janet Woodcock’s legal term as acting commissioner. The Biden administration has been committed to a noncontroversial nominee, given the role the next commissioner will play in overseeing a number of politicized policies, including the approval of therapies and vaccines for COVID-19, potential changes to market exclusivities and other policies that effect drug pricing, cannabis and e-cigarettes.

PODCASTS

  • Listen Here: Rodney Whitlock sits down with Brian Stimson for a conversation on the value of listening; how it is still relevant during health policymaking in Congress today during an episode of “In the Trenches,” a McDermott Will & Emery Health Law Podcast.

QUICK HITS

  • This week, McDermottPlus was proud to announce the launch of the Advanced Care at Home Coalition. This group includes premiere healthcare leaders committed to advocating for the continuation of current hospital-level care-at-home flexibilities during and beyond the COVID-19 public health emergency, as well as for the creation of an advanced-care-at-home delivery model at the Center for Medicare & Medicaid Innovation.

  • The FDA’s Vaccine and Related Biological Products Advisory Committee unanimously voted to recommend authorizing a booster dose of Moderna’s COVID-19 vaccine for emergency use for high-risk individuals and those 65 and older.

  • Melanie Anne Egorin was sworn in as Assistant Secretary of Legislation for HHS.

  • Colorado earns approval from CMS for coverage of gender-affirming care as an essential health benefit in individual and small group state markets.

  • Three grantees received a total of $753,000 from CMS for minority health research.

  • Health Resources and Services Administration announced $100 million for its State Loan Repayment Program to help grow primary care workforce in underserved areas.

  • letter from 247 Members of Congress to Speaker Pelosi and Minority Leader Kevin McCarthy urged action to address impending Medicare payment cuts totaling at least 9 percent before the end of the year.

NEXT WEEK’S DIAGNOSIS

The House Energy and Commerce Health Subcommittee will hold a legislative hearing on several preventive and research-focused healthcare proposals. The Senate Finance Committee will look at federal health insurance programs. House Appropriations will get an update on electronic health records implementation the Department of Veterans Affairs.

© 2021 McDermott Will & EmeryNational Law Review, Volume XI, Number 288
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About this Author

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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Debra Curtis Health Policy Attorney Congress McDermott Will Emery

Debbie is a highly respected health policy authority who helps clients advance their missions in Congress and beyond. With more than three decades of experience working both on the Hill and with the health insurance exchange marketplace, she helps clients execute payment strategy, see around the corner on policy and regulatory changes, and pursue effective advocacy. In addition, Debbie has deep experience working closely with payers, industry stakeholders and government officials at the federal, state and local levels.

During her 24 years as a...

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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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