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McDermottPlus Check-Up: January 22, 2021

Joe Biden was inaugurated as the 46th President of the United States and issued a series of executive orders (EOs) in his first days in office. The new Administration also released a national coronavirus (COVID-19) response plan along with a series of staff appointments within the Department of Health and Human Services (HHS). In this document, we review the likely healthcare policy reforms and actions expected from the Biden Administration in its first 100 days.

Administration

Biden Issued a Series of Executive Orders on His First Days as President. 

As anticipated, President Joe Biden began his term by quickly issuing EOs, including a few relevant to healthcare stakeholders, which reverse certain Trump Administration policies and begin implementing a plan to address the COVID-19 pandemic. The EOs include policies to create a 100-day nation-wide mask mandate on federal property and inter-state travel (including on airplanes and in airports); reengage with the World Health Organization; restore the National Security Council’s Directorate for Global Health Security and Biodefense; and formally create the position of COVID-19 Response Coordinator responsible for coordinating the nation’s COVID-19 response efforts across all levels of government (Biden previously appointed Jeff Zients, former Director of the National Economic Council, to this role). On day two, President Biden also issued orders to expand testing capacity, increase vaccine roll-out and ensure adequate pandemic response supplies and personal protective equipment for frontline workers, as well as for schools (the text of the EOs can be found here). The President has said he plans to issue new EOs every weekday in January, focusing each day on different policy areas with healthcare as the focus on January 28 (though there could be additional policy announcements before then). In addition, the White House issued a regulatory freeze memo that directs the withdrawal of certain Trump Administration regulations that were not yet published. For rules that have been published but have not taken effect, the Biden Administration can consider postponing the rules’ effective dates for 60 days to allow agency heads and the Office of Management and Budget to review and determine appropriate actions for the rules. The Biden Administration already paused a final rule that would require health centers funded under section 330(e) of the Public Health Service Act to provide access to insulin and injectable epinephrine to low-income patients at the price the health center purchased these two drugs through the 340B Drug Pricing Program. This rule’s effective date has been delayed until March 22, 2021. We expect to see more of these announcements in the coming weeks.

Biden Announced National COVID-19 Response Plan. 

The National Strategy for the COVID-19 Response and Pandemic Preparedness will be the blueprint for the federal government to address the COVID-19 pandemic. The proposal highlights President Biden’s EOs creating a COVID-19 Response Office, requiring mask wearing in federal buildings and on public transportation, filling supply shortfalls by invoking the Defense Production Act, increasing emergency funding to states and bolstering the Federal Emergency Management Agency (FEMA) response. Additionally, the strategy seeks to address COVID-19 disparities by creating a COVID-19 Health Equity Task Force, focusing on vaccine distribution for high-risk groups, and ensuring equitable access to personal protective equipment, tests, therapies and vaccines. The plan also includes a national vaccination campaign (more on that below), and notes that the Administration will hold regular public briefings and release reports on the status of the pandemic and lead public health campaigns.

Biden Vaccine Plan Calls for Increased Eligibility and Supply. 

As part of the Administration's COVID-19 response plan, Biden outlined a national vaccination program, which encourages states to expand eligibility for vaccination to essential workers and those over 65 (who is eligible for vaccination is left up to the states, though previous federal guidance recommended prioritizing healthcare workers and residents of long-term care facilities). The plan also ends the policy of holding significant levels of doses in reserve, and calls for targeted strategies to help vaccines reach high-risk populations (as determined by the Centers for Disease Control and Prevention) and hard-hit communities in consultation with local public health officials. The vaccination strategy also calls on Congress to expand the Federal Medical Assistance Percentage to 100% for vaccinations of Medicaid beneficiaries, directs HHS to consider whether current payment rates for vaccine administration are appropriate, and allows state and local governments to reimburse vaccination administration expenses through the FEMA Disaster Relief Fund. To accelerate the administration of COVID-19 vaccines, the plan also calls for the creation of federally funded community vaccination sites, mobile vaccination clinics and allowing pharmacies, and federally-supported facilities like community health centers, rural health clinics, and critical access hospitals to administer vaccines. Finally, the plan includes proposals to boost vaccine production, improve data sharing between federal and local governments, and mobilize the public health workforce. Strengthening the vaccination effort is one of President Biden’s top priorities as he begins his term. The vaccine-focused proposals that need legislative support may be part of the broader $1.9 trillion COVID-19 relief package that President Biden has outlined.

Congress

Congressional Democrats Prepare to Work on Biden’s Agenda and Impeachment. 

In one of her first acts as Vice President, Kamala Harris swore in Senators Raphael Warnock (D-GA), Jon Ossoff (D-GA) and Alex Padilla (D-CA), who was appointed to fill her vacated seat, bringing the Senate to a 50/50 split with Democrats taking functional control (more on that below). With the Democratic majority in place, Congress will take up confirmation of President Biden’s nominees, and is expected to begin work on another COVID-19 relief package among other healthcare priorities. The timing and impact of a possible Senate impeachment trial of former President Trump remains an open question. The House is expected to submit the article of impeachment to the Senate on Monday, and Senate Majority Leader Chuck Schumer (D-NY) has suggested that the chamber could begin impeachment proceedings at that time, holding the trial in the afternoons while conducting confirmations and other legislative business in the mornings. Other Democrats, however, have called for acting on President Biden’s agenda first and delaying, or abandoning, impeachment efforts. Biden has proposed a $1.9 trillion COVID-19 relief package that will require bipartisan support to pass, something that could be made significantly more difficult amid contentious impeachment proceedings. Our consultants discuss these dynamics on this week’s episode of the Health Policy Breakroom.

Parties Continue Negotiations on Senate Power Sharing Agreement. 

In addition to impeachment, the procedural factors of the 50/50 divide in the Senate are complicating legislative action. Typically, committee seats are allocated based on the margin of party control, and the majority party directs the floor schedule. Though Democrats are technically the majority party given Vice President Harris’ ability to break potential ties, the 50/50 split requires Majority Leader Schumer and Minority Leader Mitch McConnell (R-KY) to negotiate a power sharing agreement to determine the operating procedures of the chamber. Democrats and Republicans are expected to have equal numbers of seats on committees and shared ability to send tied committee votes to the floor, though Leader McConnell has asked Democrats for a commitment not the abolish the filibuster as part of the agreement, a provision many in the party oppose and that Schumer has rejected. Until a power sharing agreement is reached, Republicans will continue to chair committees and new members cannot be added, meaning several committees have not moved forward with confirmations or legislation.

Quick Hits

Representative Brett Guthrie (R-KY) will replace Representative Michael Burgess (R-TX) as Ranking Member of the House Energy and Commerce Health Subcommittee for the 117th Congress.

  • House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) and incoming Senate Finance Committee Chairman Ron Wyden (D-OR) sent a letter urging outgoing Administrator of the Centers for Medicare and Medicaid Services Seema Verma to rescind her recent letters to states asking them to sign on to a policy that would make it more difficult for the agency to repeal state Medicaid waivers, though Verma did not do so before leaving office. So far, Tennessee, Georgia and South Carolina have signed the agreement, and Ohio and Nebraska are considering it. These and other Republican-led states have sought waivers in the last few years to implement controversial changes to their Medicaid programs, such as establishing work requirements, which the Biden Administration opposes and is expected to reverse.

  • Senator Patty Murray (D-WA), incoming Chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, sent a letter to HHS urging the Department to rescind a series of policies that the Trump Administration imposed on the Food and Drug Administration in recent months.

  • The Biden Administration announced a slate of HHS appointments, many of whom served in the Obama Administration, and acting leadership of the Department who will serve until Biden’s nominees are confirmed. More announcements are expected in the coming days as Biden continues to staff his Administration and the Senate works to confirm his nominees.

  • The Government Accountability Office published a report on rural hospital closures. 

© 2021 McDermott Will & EmeryNational Law Review, Volume XI, Number 25
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About this Author

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...

202-204-1462
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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Government Relations Professional and Registered Lobbyist

Emma is a government relations professional and registered lobbyist who supports clients on a range of health policy issues.

As a policy consultant, Emma lobbies and consults with legislators and congressional staff on issues relating to Medicare, Medicaid payment and regulation, and the 340B Drug Pricing Program. She provides analysis of the federal political and regulatory environment, and routinely monitors pertinent Hill activities including congressional hearings, bill markups and think tank events.

Emma graduated...

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