The 2020 Presidential campaign was conducted against the backdrop of the months-long COVID-19 pandemic, with the United States struggling to overcome the public health crisis amidst persistent outbreaks and lockdowns. Confronted with this reality, President Joe Biden focused his campaign almost entirely on the pandemic and proposed one of the most ambitious and detailed health care agendas in generations. Upon taking the oath of office on January 20, he wasted little time in pursuing those policies, issuing numerous executive orders and taking other actions to combat COVID-19, expand coverage options for Americans, address health care disparities, and advance his ideas for reducing drug prices. Many of these actions can be done unilaterally, but others will require legislative action and Congressional cooperation.
To address the ongoing COVID-19 pandemic, the Biden administration will focus on growing PPE supply, accelerating vaccine manufacturing and distribution, and requiring more strict social distancing protocols to attempt to better contain the virus. In his first week in office, President Biden signed no fewer than eight executive orders directly related to the COVID-19 public health response, including:
- The 100 Days Masking Challenge – Requiring masks and social distancing for all employees and contractors in all federal buildings and on all federal property
- Masking Requirement for All Public Transportation – Required masks on all public transportation, including mass transit, as well as commercial trains, planes, and buses; international travelers required to present a negative COVID-19 test before entering the U.S. and quarantine upon arrival
- Creating a Unified National Response – Coordination across all federal agencies and creating a “COVID-19 Response Coordinator”
- Ensuring a Data-Driven COVID-19 Response – Direct all federal agencies to facilitate gathering, sharing, and publication of COVID-19 data, in coordination with the COVID-19 Response Coordinator
- Sustainable Public Health Supply Chain – Authorizing federal agencies to utilize all legal authorities, including the Defense Production Act, to address shortfalls in PPE and other medical supplies
- Establishing the COVID-19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce – The Testing Board will oversee implementation of a clear, unified approach to testing, work to expand the supply of tests, bring test manufacturing to the United States, expand laboratory testing capacity, and work to expand the public health workforce.
- Ensuring Equitable Pandemic Response and Recovery – Establishing a task force to address health and social inequities to ensure an equitable federal response
- Improving and Expanding Access to COVID-19 Care and Treatments – Directs the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) to develop studies to identify optimal clinical strategies and support promising treatments; further directs the Department of Defense, HHS, and the Department of Veterans Affairs to provide targeted surge assistance to critical care and long-term care facilities
In addition to these executive orders, President Biden also committed to rejoining and being a full participant in the World Health Organization, encouraged greater use of the National Guard to assist state and local officials’ COVID-19 response, and announced the following steps to boost vaccine supply:
- Increased the weekly vaccine supply to states from 8.6 million does to a minimum of 10 million doses for at least three weeks
- Increased transparency to help state and local governments better manage their vaccination efforts by directing HHS to provide vaccine allocation estimates for the upcoming three weeks, instead of the current one-week forecast
- The purchase of an additional 200 million COVID-19 vaccine doses by the end of the summer. This increase will deliver a total 600 million doses in that time, up from the previously announced 400 million.
Access to healthcare coverage
In addition to his COVID-19 actions, President Biden has also announced plans to prioritize the expansion of healthcare coverage options for Americans and has already taken some action in that regard. Most notably, President Biden signed an executive order directing HHS through the Healthcare.gov site to establish and open a Special Enrollment Period from February 15, 2021 – May 15, 2021. Additionally, President Biden directed agency heads to examine actions taken by the Trump administration that they deem to have impeded access to healthcare or health insurance by reconsidering policies related to: preexisting conditions, Medicaid work requirements, health insurance marketplace marketing, health insurance marketplace and Medicaid open enrollment, and access to financial assistance for insurance coverage.
The swift action outlined above will surely be followed by broader efforts to shore up the Affordable Care Act health care exchanges, though the prospects for the President’s longer-term priorities are less clear given that some may require Congressional action and approval. Those priorities include: addressing the “family glitch” that has stopped family members of low-income workers from receiving marketplace subsidies, adopting new special enrollment periods as needed to respond to pandemic- and economically-driven hardship, providing temporary relief from premium tax credit requirements, and adopting standardized plan options for the health insurance exchange. In addition to these more technical policy priorities, the Biden administration has been clear that it will seek to bridge the gap in health disparities, particularly in communities of color that have been disproportionately affected by the pandemic.
Reducing prescription drug costs remains a high priority for voters and, as it was for the Trump administration, will be a priority for the Biden administration. However, with its primary focus on the COVID-19 pandemic and “building back better” infrastructure and economic recovery plan, the Biden administration may largely be left to decide whether to build on Trump administration drug pricing policies or to start over.
While the Biden administration has not yet taken explicit executive action on drug pricing, its January 20 “regulatory freeze” memorandum – which pauses recently implemented, new or pending rules issued by the Trump administration until the Biden administration has had a chance to review them -- will likely impact several drug pricing reform actions taken by HHS in the waning days of the Trump administration.
Indeed, the administration’s regulatory freeze has paused – if not permanently halted – the controversial “rebate rule,” which would remove the safe harbor for rebates negotiated between manufacturers and Part D plans and move to a point-of-sale discount model, as well as the requirement that Federally Qualified Health Centers pass along to patients the discounts they receive through the 340B program for insulin and epinephrine products.
Also in a holding pattern is the Most Favored Nation (MFN) Model – released as an interim final rule just weeks before the Biden administration was installed – to lower the prices of Medicare Part B drugs by pegging reimbursement to the lowest price drug manufacturers receive among a large group of Organization of Economic Cooperation and Development (OECD) nations. While the MFN regulation was scuttled by a temporary court injunction in the final days of the Trump administration due to violations of the Administrative Procedure Act, the Biden administration has not yet signaled whether it will revive the policy.
At this point it’s not yet clear through what means and in what timeframe drug pricing will move forward in the Biden administration. What is clear, however, is that even with a narrow majority in the Senate and a diminished number of seats in the House, a Democratic White House and control of both chambers may present the clearest path in several years to enacting some form of drug pricing legislation.
Authored by Crowell & Moring, health policy consultants for Cardinal Health