The White House and the U.S. Department of Health and Human Services (HHS) announced major public health initiatives. The White House unveiled a new national COVID-19 Action Plan to combat the Delta variant, while HHS released its long-awaited plan for lowering prescription drug prices (the “Drug Pricing Plan”).
1. COVID-19 Action Plan
The White House’s COVID-19 Action Plan to combat COVID-19 focuses on six key areas: vaccinating the unvaccinated, further protecting the vaccinated, keeping schools safely open, increasing testing and requiring masking, protecting our economic recovery, and improving care for those with COVID-19. Below, we detail some of the provisions that are likely to be of most interest to ASHP members:
- New Hospital/Health-System Vaccine Mandates: The Action Plan is heavily focused on increasing the vaccination rate by imposing new vaccination mandates and increasing penalties for those who remain unvaccinated. In particular, the Action Plan requires that all hospitals and health systems that participate in Medicare impose a vaccination mandate for staff. This is an expansion of the previously imposed vaccine mandate for staff at federal healthcare facilities.
- Preparing for Vaccine Booster Delivery: The Action Plan directs federal agencies, states, health officials, and others to begin preparing for the rollout of vaccine booster shots as soon as they are approved by the Food & Drug Administration and recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The Action Plan notes that the boosters will be free and “widely available” from pharmacies and other providers across the country.
- Increasing Testing and Requiring Masking: The Action Plan invokes the Defense Production Act (a law that allows the government to step in during emergencies to speed up certain manufacturing functions) for rapid COVID-19 tests, including those for at-home use. To increase test accessibility, Amazon, Walmart, and Kroger have agreed to provide the at-home tests at cost for the next three months, and the administration will also provide free rapid tests to community health centers. The Action Plan also includes an expansion of the free HHS COVID-19 testing program to additional retail pharmacy locations.
- Improving Care for Those with COVID-19: The Action Plan includes new support for hospitals struggling with the Delta surge. For hard-hit states, the Department of Defense (DOD) is doubling the number of COVID-19 clinician strike teams it is deploying and opening up beds in Veterans Affairs’ facilities in an effort to reduce the burden on hospitals. To improve access to monoclonal antibody treatments, the Action Plan includes the new Public Readiness and Emergency Response (PREP) Act declaration amendment allowing qualified pharmacists to order and administer COVID-19 prophylaxis and treatment, including subcutaneous or intramuscular monoclonal antibody treatment. The amendment, which ASHP advocated for, broadly addresses COVID-19 therapeutics given orally, subcutaneously, or intramuscularly, including current and future medications that are approved, authorized, cleared, or licensed to treat or prevent COVID-19. Licensed pharmacists, licensed or registered pharmacy interns, and qualified pharmacy technicians who meet the criteria in the amendment are also authorized to administer certain COVID-19 therapeutics. The Action Plan also calls for sending COVID-19 surge teams of HHS, DOD, and FEMA clinicians to help stand up or expand monoclonal antibody treatment facilities at hospitals and health systems and doubling the number of weekly monoclonal antibody shipments across the country.
Federal agencies can begin implementing some of these steps immediately, including preparing for COVID-19 booster shots, increasing the number of tests available, and sending out clinician support teams. However, the vaccine mandate for Medicare-participating hospitals and health systems will require a rulemaking (i.e., a formal change to the Medicare Conditions of Participation) and will almost certainly be the subject of legal challenges. Thus, it may be some time before that mandate takes effect. ASHP has joined other provider organizations in supporting vaccine mandates for healthcare professionals.
2. HHS’ Drug Pricing Plan
According to HHS, the new Drug Pricing Plan is “part of a broader initiative stemming from President Biden’s Executive Order on Promoting Competition in the American Economy” with an “overall goal…to foster innovation, increase competition, and improve the market environment, all in pursuit of reduced drug spending for consumers and throughout the healthcare system.”
Unlike previous drug pricing proposals, the Drug Pricing Plan centers on allowing the Centers for Medicare & Medicaid Services (CMS) to directly negotiate the prices of both Medicare Parts B and D drugs, and to then make those prices available to commercial manufacturers and employers. This proposal, which will certainly face opposition from pharmaceutical manufacturers, cannot be required without new legislation passed by Congress. The plan also calls for legislative action to slow drug price increases on existing drugs, to prohibit “pay-for-delay” and other tactics that unfairly extend patent protection for drugs, and to cap Medicare Part D catastrophic spending to reduce beneficiary out-of-pocket costs. Implementation of these provisions will be entirely dependent on Congress’ willingness to pass the necessary legislation to authorize these policy changes.
Other elements of the Drug Pricing Plan can be accomplished by regulatory agencies without new legislation. These include proposals to test new payment models, including tying drug reimbursement to the clinical value of drugs, reviewing total cost of care, and incentivizing the use of generics and biosimilars. The Drug Pricing Plan also includes agency collaboration with “states and Indian Tribes to develop drug importation programs that reduce costs to consumers without increasing risks to safety.” Agencies can begin implementing these policy changes immediately, but given the need for rulemaking and/or subregulatory guidance, there may be significant delays in implementation.
ASHP is broadly supportive of efforts to reduce prescription drug prices by targeting drug list prices rather than cutting provider reimbursement. At present, the broad outlines of the Drug Pricing Plan do not include sufficient detail for ASHP to specifically support or oppose certain provisions. However, regarding importation, we remain highly skeptical that wholesale importation programs can be structured to meaningfully reduce drug prices without sacrificing patient safety. As the administration implements the Drug Pricing Plan, ASHP will carefully evaluate all regulatory and legislative actions taken to reduce drug prices to determine their impact on our members and their patients.
ASHP will continue to monitor and update members about policy changes stemming from both the COVID-19 Action Plan and the HHS Drug Pricing Plan..