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February 7, 2022

This Week in Health Policy for February 7

This Week (February 7-11)

The Senate Finance Committee holds a hearing on "Protecting Youth Mental Health: Part I - An Advisory and Call to Action."

  • Details: 10:00 AM EST on 02/08/2022
  • Witnesses: U.S. Surgeon General Vivek H. Murthy
  • More information available here.

The House Energy and Commerce Health Subcommittee holds a hearing on "ARPA-H (Advanced Research Project Agency for Health): The Next Frontier of Biomedical Research."

  • Details: 10:30 AM EST on 02/08/2022
  • Witnesses: Eric S. Lander, Ph.D., Director, White House Office of Science and Technology Policy; Keith R. Yamamoto, Ph.D., Vice Chancellor for Science Policy and Strategy, University of California San Francisco; Esther Krofah, Executive Director, FasterCures and Center for Public Health at the Milken Institute; Geoffrey Shiu Fei Ling, M.D., Ph.D., CEO, On Demand Pharmaceuticals, Professor of Neurology, Johns Hopkins Medicine; Admiral Brett P. Giroir, Former Assistant Secretary for Health, U.S. Department of Health and Human Services; Brian James Miller, M.D., M.B.A., M.P.H., Professor of Medicine, John Hopkins Medicine.
  • More information available here.

Senate (Special Committee on) Aging holds a hearing on “Improving Care Experiences for People with both Medicare and Medicaid."

  • Details: 9:30 AM EST on 02/10/2022
  • More information available here.

The Senate Health, Education, Labor and Pensions Employment and Workplace Safety Subcommittee holds a hearing on "Recruiting, Revitalizing & Diversifying: Examining the Health Care Workforce Shortage."

  • Details; 10:00 AM EST on 02/10/2022
  • Witnesses: Margaret Flinter, Senior vice president and clinical director of Community Health Center, Inc., and chair of the National Nurse Practitioner Residency and Fellowship Training Consortium's Board of Directors; Rachel Greszler, Research fellow in economics, budget and entitlements in the Heritage Foundation's Institute for Economic Freedom and Opportunity; Reynold Verret, President of Xavier University of Louisiana; Norma Quinones, Nursing services manager and National Institute for Medical Assistant Advancement site coordinator for Clinica Family Health.
  • More information available here.

Last Week (January 31-February 4)

Health Care Highlights

House passes America COMPETES Act. By a largely party-line vote of 222-210, the House Friday (Feb. 4) passed the $350 billion America Creating Opportunities for Manufacturing Preeminence in Technology and Economic Stability Act (the COMPETES Act, HR 4521), which is intended to strengthen domestic supply chains and boost scientific research in a bid to make the U.S. more competitive with China and other countries. The Senate passed its version of the sweeping bill, the U.S. Innovation and Competitiveness Act, (or USICA, S. 1260) in June 2021 with support from 18 Republican senators. The House and Senate will now move to a bicameral conference process to negotiate a version of the legislation that could pass both chambers. The White House is a strong supporter of the effort, with Commerce Secretary Gina Raimondo and other officials lobbying urgently for supply chain legislation for months. Health care provisions of the bill include:

  • Strategic Stockpiles. HR 4521 would provide, through fiscal 2024, $3.5 billion for a pilot grant program for states to expand or maintain strategic stockpiles of certain drugs, medical devices, and personal protective equipment necessary for public health emergencies. The bill would spend $500 million to increase the Strategic National Stockpile’s stock of medical supplies, diversify domestic production, enter into cooperative agreements for domestic manufacturing, and manage domestic reserves. HR 4521 would also allow HHS to transfer drugs, vaccines, and other medical products from the Strategic National Stockpile to other federal agencies for reimbursement until Sept. 30, 2024.
  • Drug Safety. HR 4521 would authorize the Food and Drug Administration (FDA) to order drug manufacturers to stop distribution and recall any products that could cause serious harm. Manufacturers would also have to report on their foreign drug manufacturing sites and report quarterly on the number of drugs they make. The bill imposes large civil monetary penalties for destroying or providing false information required for FDA drug approval applications.
  • Defense Production Act. HR 4521 would permit COVID-19 tests, PPE, drugs, and other medical supplies to be designated as scarce and critical materials under the Defense Production Act (DPA), allowing the president to compel companies to prioritize federal contracts to procure them. The president could prioritize materials ordered by state and local governments if they’re scheduled to be delivered to those governments within 15 days of a federal order or allocation. HR 4521 also would clarify the president’s authority to use the DPA to bolster the supply chain for critical medical supplies, including through payments to domestic companies that produce critical components or raw materials, and clarifies that the president may invoke the DPA to secure the domestic supply chain of vaccines.

Pandemic bill released by HELP leaders. Last week, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC), released a discussion draft of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act), bipartisan legislation focused on strengthening the nation’s public health and medical preparedness and response systems in the wake of the COVID-19 pandemic. The bill’s timeline remains unclear, however the bill or its components could be attached to legislation reauthorizing the FDA user fees. Chair Murray said in a statement “The pain of this pandemic is unforgettable, and we have a responsibility to make sure its lessons are unforgettable, too.” This includes establishment of an independent COVID-19 task force to “allow us to fully account for consequential gaps and breakdowns in our response efforts.” It also “takes action to address several of the longstanding challenges that have undermined our pandemic response from the start—like strengthening our medical supply chains, improving our public health data systems and workforce, updating the development process for tests, treatments and vaccines, combatting misinformation, and more.” See section-by-section summary here and full legislative text here.

CMS releases 2023 MA and Part D advanced notice. On Wednesday (Feb. 2), CMS proposed a 7.98 percent increase to Medicare Advantage (MA) payment next year, nearly double the pay increase that plans saw in 2022. CMS projects that a 3.5% revenue increase tied to the MA risk score trend is one factor leading to the almost 8% pay bump. CMS asks for feedback in a number of areas through its advanced notice, including “updates to risk adjustment models to continue to pay appropriately for the people enrolled in MA and Part D plans.” CMS also proposes a revised risk adjustment model for beneficiaries with end-stage renal disease, calibrated on more recent data and using CMS’ current approach to identify risk adjustment eligible diagnoses from encounter data. The agency also asks for stakeholders’ thoughts on the development of a Health Equity Index to summarize measure-level performance by social risk factors into a single score; a new star ratings measure that looks at whether and how MA plans are working on value-based care models with providers; the development of a measure that will screen beneficiaries for health-related social needs such as food, housing, and transportation; and more. Comments on the advanced notice are due March 4, and CMS says the final rate notice will be published no later than April 4.

Medicare to cover at-home COVID-19 tests. The Biden Administration announced this week Medicare will begin covering at-home COVID-19 tests in early spring, following backlash for leaving Medicare out of their plan to require private insurers to pay for at-home tests. CMS said people on Medicare will be able to get up to eight FDA-approved or authorized tests per month at select pharmacies and other participating entities. The statement says that “This new initiative will enable payment from Medicare directly to participating pharmacies and other participating entities to allow Medicare beneficiaries to pick up tests at no cost. CMS anticipates that this option will be available to people with Medicare in the early spring.” It notes that until that time, Medicare beneficiaries can request tests from, access tests free through various testing sites, and access no-cost lab tests when ordered by a health care professional.

Biden set to relaunch cancer “moonshot.” On Wednesday (Feb. 2), President Biden announced his administration will relaunch the “cancer moonshot” he led in the final year of the Obama administration, which focused on ending cancer through investments in research and treatment. The new moonshot will focus on reducing the disease’s death rate by at least 50% in the next 25 years and includes creation of a White House "Cancer Cabinet" with the goal of shoring up cancer screening and prevention, narrowing racial disparities in cancer outcomes and improving the experiences of patients, survivors and caregivers. The announcement comes as money to fund the moonshot effort will hit a funding cliff in the next year and a half, leaving more than 240 research projects without money to continue that work. The 21st Century Cures Act, passed in 2016, made $1.8 billion available over seven years through a special innovation fund, but that money runs out at the end of September 2023.

FDA vaccine news. This week, the FDA granted full approval to Moderna Inc.'s COVID-19 vaccine for adults, making it the country's second fully approved shot. Novavax Inc. also asked the agency to authorize its protein-based COVID-19 vaccine for adults, after production delays set back its timeline by months. Pfizer and BioNTech also said they’ve begun submitting data for authorization of their COVID-19 vaccine in younger children, saying in a statement that they have started a so-called “rolling submission” with the FDA seeking an emergency use authorization for the vaccine in children 6 months to four years of age. The application is for authorization of the first two doses of a planned three-dose primary series in this age group, with data on a third dose given at least 8 weeks after completion of the second dose expected in the coming months. A panel of outside advisers is set to meet Feb. 15 to weigh that request.


Senate Finance Committee Hearing on the Hospital Insurance Trust Fund and the Future of Medicare Financing. On Wednesday (Feb. 2), the Senate Finance Subcommittee on Fiscal Responsibility and Economic Growth held a hearing entitled, “The Hospital Insurance Trust Fund and the Future of Medicare Financing.” Witnesses representing the Medicare Payment Advisory Commission (MedPAC), physicians’ groups, academia and think tanks testified on their proposals to address the sustainability of the Medicare program. The witnesses varied in their suggestions for how to address the looming insolvency of the program and reduce the rate of spending over time, offering solutions that included adjusting payments for certain providers and Medicare Advantage (MA), enhancing competition and transparency across the health care ecosystem, redesigning and/or combining the various parts of Medicare, and aligning incentives across payers, providers, and patients. The lion’s share of the questioning came from Subcommittee Chair Elizabeth Warren (D-MA), who expressed her concern over the perceived privatization of Medicare and need for additional anti-trust enforcement across the industry. Ranking Member Bill Cassidy (R-LA) expressed support for modernizing care delivery and speculated about ways to leverage financial incentives such as cost-sharing and gain-sharing to drive investment, better outcomes, and lower costs for patients and the system. Other members asked the witnesses about how to design better value-based care models, such as Accountable Care Organizations (ACOs), along with other suggestions. Dr. Michael Chernew, Chair of MedPAC, said their June report will have suggestions outlining recommendations for improvements to these models.

  • More information available here.

House Energy and Commerce Health Subcommittee hearing on reauthorization of the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), and the Biosimilar User Fee Act (BsUFA). On Thursday (Feb. 3), the House Energy and Commerce Committee held a hearing entitled, "FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics." The hearing kicked off the congressional review process for the next round of user fee agreements between the FDA and the prescription drug, generic drug, and biosimilar industries. Congress must pass laws adopting the new deals for fiscal years 2023 through 2027, before the current agreements expire on September 30. FDA officials testified regarding the highlights of the user fee agreement, including a goal to increase the number of staff members at the Center for Biologics Evaluation and Research to review more applications for cell and gene therapies. Several House members also called on the FDA to make additional commitments in the user fee agreements to bring more rare disease treatments to market. The latest user fee agreement proposals include plans for a pilot program for the agency to provide more support to rare disease drug sponsors throughout the trial process. Lawmakers also pressed on FDA officials about the coordination between FDA and CMS, questioning why Medicare would propose to limit Aduhelm coverage to those enrolled in a clinical trial after FDA had already required a clinical trial as part of the drug’s approval, and also questioned the agency’s relationship with Biogen, citing news reports that the two parties had several off-book meetings while the drug was under review.

House Ways and Means and Senate HELP Committee hold mental health hearings. This week, two mental health hearings in the House Ways and Means and Senate HELP Committees ramped up the Congressional focus on how the pandemic has impacted the country’s mental health and substance abuse crisis. Lawmakers will continue their focus next week with a hearing on youth mental health next week, featuring Surgeon General Vivek Murthy. Throughout the hearings, mental health advocates urged Congress to invest in recruitment incentives that draw people into the behavioral health field, such as loan repayment or better ways, and others stressed the importance of engaging primary care providers on how to best integrate behavioral health providers into their offices, among other proposals. Legislators also seemed to support giving federal departments more power to force health insurers to comply with parity laws, following a report in late January finding widespread inequities between mental and medical benefits in the U.S. that resulted in outrage from provider groups.

  • More information available here.

House Ways and Means Committee hearing on bridging health equity gaps for people with disabilities and chronic conditions. On Thursday (Feb. 3), The House Ways and Means Committee held a hearing entitled, “Bridging Health Equity Gaps for People with Disabilities and Chronic Conditions.” During the hearing, witnesses stressed the need for more resources to support patients who develop long COVID-19, citing legislation known as the “Stop the Wait Act,” which seeks to help disabled people, including those with long COVID-19, receive medical coverage for disabilities more quickly. Rep. Vern Buchanan (R-FL) also emphasized that telehealth can be a powerful tool to increase access for patients with disabilities and chronic conditions and said essential pandemic-era telehealth flexibilities should be made permanent. Chairman Lloyd Doggett (D-TX) added that he wants to soon mark up the Telehealth Extension Act, which he sponsors with Rep. Buchanan and others, to permanently remove site-based and geographic restrictions that have a disproportionate impact on patients with disabilities and to extend a broad range of services permitted via telehealth under emergency waivers.

  • More information available here.
  • More information available here.

Reports, Studies, and Journals

Centers for Disease Control and Prevention: Self-Rated Physical Health Among Working-Aged Adults Along the Rural-Urban Continuum — United States, 2021. During 2021, working-aged adults in small/medium urban counties and rural counties reported worse physical health compared with residents of large urban counties. These differences are largely explained by differences in socioeconomic status (including lower educational attainment, household income, and probability of employment).

Kaiser Family Foundation: KFF COVID-19 Vaccine Monitor: January 2022 Parents and Kids Update. Growing shares of parents say that their eligible children have gotten at least one dose of a COVID-19 vaccine, and three in ten parents with children under age 5 say they want to get their child vaccinated immediately once they become eligible.

The Medicare Payment Advisory Commission (MedPAC) and Medicaid and CHIP Payment and Access Commission (MACPAC): Beneficiaries Dually Eligible for Medicare and Medicaid. This sixth edition of this book describes the dually eligible population’s composition, service use, and spending in 2019.

National Institutes of Health:Suicides by drug overdose increased among young people, elderly people, and Black women, despite overall downward trend. Nearly 92,000 people died from drug overdoses overall in the U.S. in 2020, but because it can be difficult to determine whether overdose deaths are intentional, the actual numbers are likely even higher.

JAMA Health Forum: Physician Compensation Arrangements and Financial Performance Incentives in US Health Systems. The study results suggest that despite growth in value-based payment arrangements from payers, health systems currently incentivize physicians to maximize volume, thereby maximizing health system revenues.


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