Washington Watch for August 2021

Carter L. Alleman, J.D.

Breakthrough COVID-19 Cases Amongst Fully-Vaccinated in White House, Congress
Amidst the nationwide surge in the Delta variant, several fully-vaccinated White House and congressional lawmakers and staff have tested positive for COVID-19. Reports have indicated that the individuals are asymptomatic or experiencing mild, flu-like symptoms. Two positive cases have been reported on the House side, and one Senate staffer has tested positive for COVID-19.

HHS Extends COVID-19 Emergency Declaration
The U.S. Department of Health and Human Services (HHS) extended its declaration of the COVID-19 pandemic as a public health emergency (PHE) on July 19. The emergency declaration has been in place since January 27, 2020. This latest renewal is effective for an additional 90 days.

Support for Health Worker Vaccine Requirements
The American Hospital Association (AHA) has joined dozens of provider and other health associations in support of vaccine mandates for health care workers. America’s Essential Hospitals, the Association of American Medical Colleges, and the Association for Professionals in Infection Control and Epidemiology also support such requirements.

The American College of Surgeons along with over 50 organizations released a joint statement in support of COVID-19 vaccine mandates for all workers in health and long-term care framing the move as a moral imperative as new infections mount sharply. 

Oversight Committee Advances PPE Supply Chain Bill
The House Committee on Oversight and Reform advanced the Made in America Pandemic Preparedness Act (H.R. 4470) in a unanimous vote. The bill aims to increase preparedness for future pandemics by addressing shortages in the domestic personal protective equipment (PPE) supply chain.

CMS Releases CY 2022 MPFS Proposed Rule
The Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2022 Medicare Physician Fee Schedule (MPFS) proposed rule on July 13. CMS proposes a CY 2022 conversion factor of $33.58, a decrease of $1.31 from last year's conversion factor. The cut to general surgery under the proposed rule will be -3.75 percent, but other Congressionally mandated cuts may affect the final general surgery payment change for 2022. 

The rule outlines proposed changes to the two quality reporting pathways under the QPP—Merit-based Incentive Payment System (MIPS) and Alternative Payment Models. These updates include an increase of the overall MIPS threshold, adjustments to the Cost and Quality performance category weights, and the implementation of seven introductory MIPS Value Pathways (MVPs) beginning with the CY 2023 performance period.

The proposed rule is available for public review, along with a fact sheet on its payment provisions and with a fact sheet on its QPP provisions.

Biden Signs EO on Competition in U.S. Economy and Pharmaceutical Market
President Joe Biden signed an executive order (EO) to encourage competition across the U.S. economy, with a specific focus on the agriculture, technology, and pharmaceutical markets. According to the White House, the President aims to break up concentrated markets and reverse the trends of consolidation that the White House believes has weakened markets and widened racial, income, and wealth inequality. The EO includes 72 initiatives to be implemented by more than a dozen federal agencies.

The U.S. Department of Health and Human Services (HHS) is directed to develop a plan to counter high drug prices and to increase support for generic and biosimilar drugs. The Food and Drug Administration (FDA) is directed to work with states to import prescription drugs from Canada. The EO also directs the Federal Trade Commission (FTC) to ban pay-for-delay agreements and other similar agreements that can impact competition for low-cost treatment options for patients.

CBO Update to the Budget and Economic Outlook: 2021 to 2031
The Congressional Budget Office (CBO) has released its latest publication presenting projections of federal budget deficits, debt, revenues, and spending for the current year and for the following 10 years if current tax and spending laws remain unchanged. The agency finds that the federal budget deficit will total $3.0 trillion, federal debt will reach 103% of gross domestic product (GDP) in fiscal year (FY) 2021, and real GDP will grow by 7.4% in calendar year 2021. CBO is expected to release more detailed information about its projections later this month.