Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, the Biden Administration announced increased COVID-19 vaccine supplies and launched a federal retail pharmacy vaccination program. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
There were no relevant regulations published in the Federal Register this week.
- February 10-11, 2021: The Department of Health and Human Services (HHS) announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria (PACCARB). The February 10-11 public meeting will be dedicated to presentations from two new working groups of the PACCARB, one on Inter-Professional Education and another on Antibiotics Access and Use, which were formed in response to a task letter from the Assistant Secretary for Health. The two-day virtual public meeting will also include an update on the impact of COVID-19 on antimicrobial resistance.
- February 11, 2021: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the National Cancer Institute President’s Cancer Panel. The purpose of the meeting is to discuss innovation to increase cancer screening.
- February 11-12, 2021: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. During the meeting, the Advisory Committee will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include a presentation on potential processes for reviewing conditions on the RUSP; potential revisions to the condition nomination form; continuity of operations planning; innovations in long-term follow-up for conditions identified through newborn screening; and workgroup dates.
- February 17, 2021: HHS announced a public meeting entitled, Tenth Meeting of the National Clinical Care Commission. The tenth meeting will consist of updates from the Commission’s three subcommittees, and include another round of potential “action plans,” or recommendations, from each subcommittee.
- February 24-25, 2021: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on cholera vaccine, hepatitis B vaccine, influenza vaccines, zoster vaccine, orthopoxvirus vaccine, pneumococcal vaccine, rabies vaccine, and tickborne encephalitis vaccine. A recommendation vote on the rabies vaccine is scheduled.
II. Congressional Hearings
U.S. House of Representatives
- On February 2, 2021, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, No Time to Lose: Solutions to Increase COVID-19 Vaccinations in the States. Witnesses present included: Dr. Ngozi Ezike, Director, Illinois Department of Public Health; Dr. Joneigh Khaldun, Chief Medical Executive and Chief Deputy Director, Michigan Department of Health and Human Services; Dr. Clay Marsh, COVID-19/Coronavirus Czar, West Virginia; Dr. Courtney Phillips, Secretary, Louisiana Department of Health; and Jill Hunsaker Ryan, Executive Director, Colorado Department of Public Health and Environment.
- On February 3, 2021, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Road to Recovery: Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain. Witnesses present included: Dr. Luciana Borio, Vice President, In-Q-Tel, Former Acting Chief Scientist, FDA, Former Director for Medical and Biodefense Preparedness, National Security Council; Greg Burel, President and Principal Consultant, Hamilton Grace, Former Director, U.S. Strategic National Stockpile; The Honorable Michael Leavitt, Founder and Chair, Leavitt Partners, Former Secretary of Health and Human Services, Former Governor of Utah; and Dr. Julie Morita, Executive Vice President, Robert Wood Johnson Foundation.
III. Reports, Studies & Analyses
- On February 4, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Price Increases Continue to Outpace Inflation for Many Medicare Part D Drugs. As context for understanding the rationale for efforts to limit drug price increases, this analysis compares changes in list prices for drugs covered by Medicare Part D in 2019 to the inflation rate, based on data from the most recent Medicare Part D drug spending dashboard from the Centers for Medicare & Medicaid Services (CMS). This analysis is based on changes in unit prices reported in the Part D dashboard, which do not reflect manufacturer rebates and discounts to plans because they are considered proprietary and therefore not publicly available. The authors believe this analytic approach is reasonable because both of the previous legislative proposals to require inflation rebates were based on changes in list prices, as measured by the Wholesale Acquisition Cost, which is equivalent to a list price, or the Average Manufacturer Price, which is a measure of price that may include some discounts to wholesalers but not rebates paid to plan sponsors or pharmacy benefit managers.
- On February 5, 2021, RAND Corporation published a report entitled, Using Claims-Based Estimates of Post-Operative Visits to Revalue Procedures with 10- and 90-Day Global Periods. Medicare payment for many health care procedures covers not just the procedure itself but also most post-operative care over a fixed period of time (the "global period"). CMS sets payment rates assuming that a certain number and type of post-operative visits specific to each procedure typically occur. This report describes how CMS might use new claims-based data on the number of post-operative visits to adjust valuation for procedures with 10- and 90-day global periods. There are links between the number of bundled post-operative visits and the components of valuation addressed in this report: work, practice expense (PE), and malpractice relative value units (RVUs). There is some ambiguity regarding how a reduction in post-operative visits translates into changes in work RVUs. In contrast, a reduction in post-operative visits has clear implications on physician time and direct PE. Changes in physician work, physician time, and direct PE will in turn affect the allocation of pools of PE and malpractice RVUs to individual services. The idiosyncrasies of the resource-based relative value scale system used to determine payment for Medicare services result in some ambiguity about how procedures should be revalued to reflect reductions in post-operative visits. These results may inform further policy development around revaluation for global procedures.
IV. Other Health Policy News
- On February 2, 2021, President Joe Biden announced increased vaccine supply and launched a Federal Retail Pharmacy Program as part of the federal government’s efforts to boost COVID-19 vaccination in the U.S. The Federal Retail Pharmacy Program is a public-private partnership with 21 national pharmacy partners and networks of independent pharmacies representing over 40,000 pharmacy locations nationwide. It is a key component of the Administration’s National Strategy to expand equitable access to vaccines for the American public. As the first phase of this program launches, select retail pharmacies nationwide will receive limited vaccine supply to vaccinate priority groups at no cost. The CDC worked with states to select initial pharmacy partners based on a number of factors, including their ability to reach some of the populations most at risk for severe illness from COVID-19. More information about this program can be found here.
- This week, Democrats in the Senate and House voted to adopt a budget blueprint for President Biden’s $1.9 trillion virus relief package, signaling that Democrats are ready to move forward on the legislation without Republican support if an agreement cannot be reached. More information about the vote can be found here.
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