Govind Persad, JD, PhD
A change in presidential administrations has implications across the health sector, including for oncology. In this column, we review some recent actions by Congress and the Biden administration and their implications for the oncology community. We focus on three areas: funding for patients and providers in the recent stimulus bill, pharmaceutical policy, and executive branch personnel.
Cancer and the Biden-Harris Administration
President Joe Biden has a long-standing interest in cancer policy. As Vice President in the Obama administration, he was involved in the launch, in 2016, of the National Cancer Moonshot Initiative, which promised to accelerate cancer discoveries. Both the President and Vice President Kamala Harris have lost close family members to cancer. Vice President Harris’ mother, Shyamala Gopalan, a breast cancer researcher, died of colorectal cancer in 2009, and Beau Biden, the President’s son, died of glioblastoma multiforme in 2015. Before their election, both President Biden and Vice President Harris stressed the importance of funding for cancer research and treatment, drawing on their personal experiences.
Not all appointees for important positions in the administration have been approved, or even selected, but many have done work related to oncology. Decorated geneticist Eric Lander, PhD, the nominee for Director of the Office of Science and Technology Policy, has been heavily involved in research on cancer genomics. U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra worked on standards for medical imaging during his time in Congress. The Director of the National Institutes of Health, Francis Collins, MD, PhD, and Director of the National Cancer Institute Norman E. Sharpless, MD, both continue in their positions from the prior administration. As of this writing, the selection of the U.S. Food and Drug Commissioner is unclear, but the choice of who will occupy that position will be important to oncology.
Implications of the American Rescue Plan Act
In March, Congress passed the American Rescue Plan Act.1 Although many aspects of the legislation’s health provisions focus specifically on the COVID-19 pandemic, some of those provisions also have important implications for patients with cancer and oncology providers.
In addition, several provisions concern health insurance. Subsidies to purchase individual marketplace plans, purchased through the Affordable Care Act’s (ACA’s) exchanges, are now available to people whose incomes exceed 400% of the federal poverty line. This subsidy may improve insurance access, including for patients with cancer and people at risk for the disease.
The legislation also increases funding for Medicaid and provides states with additional financial incentive to expand Medicaid. These two provisions may reduce the number of uninsured patients and decrease uncompensated care provided by oncologists and other health-care providers. They may also allow patients to access more screening services through Medicaid and the ACA health exchanges at zero cost to patients, leading to malignancies being caught at an earlier stage. The law also extends several types of family and sick leave, which are relevant to patients with cancer and their families, and it requires Medicare prescription drug plans to allow patients to obtain a 90-day refill for medications.
The American Rescue Plan also contains provisions for people who have lost their jobs during the pandemic, which may be particularly relevant to patients with cancer who had to leave their jobs because of fears about exposure to COVID-19. Those who left their jobs due to COVID-19 concerns or layoffs can receive subsidies for purchasing an ACA insurance plan and, in some cases, subsidies for premiums for a continuation of health coverage through COBRA (Consolidated Omnibus Budget Reconciliation Act) from their former employer.
On the medical provider side, the American Rescue Plan includes funding to address burnout among medical professionals, an issue that has been heightened during the pandemic. Funding priorities include the promotion of mental health among health-care professionals, an awareness campaign, and mental health and substance use disorder training for health-care providers. There are also funds for teaching centers that operate graduate medical residency programs to establish and expand new programs. Finally, there is direct funding to rural health-care providers to reimburse their expenses and lost revenues associated with the pandemic.
Pharmaceutical Policy
Pharmaceutical policy has been a major area of interest in the oncology community. Although major drug pricing legislation has not yet been pursued, HHS has already required Medicare plans to include all “protected class” anticancer drugs in their formularies, reversing the permission for formulary exclusions that had been previously proposed. Additionally, some drugs whose prices have risen faster than the rate of inflation may be required to provide Medicaid with larger rebates than they previously did, under modifications to Medicaid rules that were passed as part of the American Rescue Plan.2 Some of these drugs are cancer therapies, including therapies for lymphoma and other cancers.
The current administration has also shown some interest in pushing pharmaceutical firms to work together—as in the case of Merck’s partnership to produce the Johnson & Johnson COVID-19 vaccine—and is currently weighing whether to use various legal powers, such as leveraging currently held government patent rights, to attempt to increase global vaccine production. These steps could have implications for longer-term efforts to address pharmaceutical pricing and innovation.
Next Steps
Many more health-care issues are on the legislative agenda, including additional regulations on pharmaceutical pricing, potential expansions to the Medicare program, and additional funding for research and development activities (including clinical trials). These and other topics are likely to be debated in Congress over the coming year.
DISCLOSURE: Dr. Persad has received grant funding from the Greenwall Foundation and personal fees from the World Health Organization.
REFERENCES
1. Keith K: Final coverage provisions in the American Rescue Plan and what comes next. Health Affairs Blog, March 11, 2021. Available at https://www.healthaffairs.org/do/10.1377/hblog20210311.725837/full. Accessed April 19, 2021.
2. Gardner J: The top drugs that could be impacted by an obscure provision in the pandemic relief law. BioPharmaDive, March 12, 2021. Available at www.biopharmadive.com/news/medicaid-penny-rule-removal-impact-pharma/596554. Accessed April 19, 2021.
Dr. Persad is Assistant Professor at the University of Denver Sturm College of Law and Greenwall Foundation Faculty Scholar in Bioethics.
Editor’s Note: The Law and Ethics in Oncology column is meant to provide general information about legal topics, not legal advice. The law is complex, varying from state to state, and each factual situation is different. Readers are advised to seek advice from their own attorney.
Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO or The ASCO Post.
