Lawmakers Urge CMS to Address Physician Fee Cuts

A group of more than 70 bipartisan members of the House of Representatives have sent a letter to the administration urging Director of the Center for Medicare Meena Seshamani to not finalize the clinical labor policy in the 2022 physician fee schedule (PFS) final rule. The letter, led by Reps. Bobby Rush (D-Ill.) and Gus Bilirakis (R-Fla.), warns that the cuts in the proposed rule disproportionately impact certain providers and may lead to practices closing down or consolidating with larger health systems. “Year-over-year ‘budget-neutral’ cuts, being implemented during a pandemic, are causing significant disruption to the health care system and are being implemented without regard to patient outcomes, actual PFS provider resource needs, or any other rationale policy,” the lawmakers argue. They urge Seshamani to work with Congress on fundamental reform to the PFS this year to better address the scheduled cut to the conversion factor resulting from budget neutrality requirements.

Lawmakers Push for PCHETA Inclusion in Reconciliation Bill

Sen. Tammy Baldwin (D-Wis.) and Rep. Yvette Clarke (D-N.Y.) are urging congressional leadership to include investments in the hospice and palliative care workforce in the reconciliation package currently under consideration. The lawmakers argue this funding is necessary “to keep pace with patient need and to help improve the well-being of Americans with serious illnesses.” They suggest that the bipartisan Palliative Care and Hospice Education and Training Act (PCHETA) be used as a model for these efforts. The request was echoed by more than 40 patient, health professional, and health system organizations including the American Academy of Hospice and Palliative Medicine, Oncology Nursing Society, Alzheimer’s Association, American Cancer Society Cancer Action Network, and Catholic Health Association of the United States.

DeGette, Upton Prepare Cures 2.0 for Introduction This Month

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) expect to introduce their Cures 2.0 legislation later this month, with the goal to pass the bill before the end of the year. The bill will include provisions to increase telehealth flexibility, speed the development of cutting-edge treatments, improve clinical trial diversity, increase pandemic preparedness, and authorize the Advanced Research Projects Agency for Health (ARPA-H). The Build Back Better reconciliation package currently under negotiation includes $3 billion to start the President’s proposed biomedical research agency

FDA Opens New Office of Digital Transformation

The Food and Drug Administration (FDA) has announced the creation of a new Office of Digital Transformation (ODT). The agency will be reorganizing its information technology (IT), data management, and cybersecurity functions under the new office, which will report directly to the FDA commissioner. The change is intended to aid in the reduction of duplicative processes, implementation of technological efficiencies, and promotion of shared services within agency offices and centers. It stems from the FDA’s Technology Modernization Plan first launched in September 2019 and the Data Modernization Action Plan released earlier this year. Vid Desai, who has worked as the FDA’s Chief Technology Officer since August 2019, will serve as ODT’s Chief Information Officer.

FDA Panel Recommends Boosters for At-Risk, 65+

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted in favor of recommending the Pfizer COVID-19 vaccine booster shot for individuals aged 65 or older and those who are at high risk of severe COVID. The panel voted against providing the booster to the population at-large by a vote of 16-2. Advisory committee members argued that Pfizer had not provided adequate data on the safety of an extra dose and questioned the potential efficacy of a mass-booster shot campaign. While the FDA is not obligated to follow the recommendations of the panel, it typically does so. A final decision from the agency is expected this week. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will hold a two-day meeting this week to discuss COVID-19 booster shots for older Americans, nursing home residents, and front-line health care workers. Separate decisions from both the FDA and CDC will be required to move forward with providing booster shots for the three available COVID-19 vaccines. The U.S. has already approved an extra dose of the Pfizer and Moderna vaccines for populations with weakened immune systems. The White House had previously targeted September 20 to begin rolling out additional boosters.

New York Congressman Tests Positive for COVID-19

Rep. Joseph Morelle (D-N.Y.) announced that he has tested positive for COVID-19. He is the latest fully-vaccinated lawmaker to experience a breakthrough coronavirus case. Morelle stated that his vaccination against the virus has prevented him from experiencing a severe infection and urged others to get the COVID-19 vaccine to protect both themselves and their communities from the impacts of the disease.

Upcoming Congressional Hearings and Markups

House Rules Committee meeting on H.R. 3755, Women’s Health Protection Act; H.R. _____— An act making continuing appropriations for the fiscal year ending September 30, 2022, and for providing emergency assistance; H.R. 4350, National Defense Authorization Act for Fiscal Year 2022; 12:00 p.m., September 20

House Committee on Veterans’ Affairs hearing “Veteran Suicide Prevention: Innovative Research and Expanded Public Health Efforts;” 10:00 a.m., September 22

Senate Finance Committee hearing on the nomination of Christi A. Grimm, of Colorado, to be Inspector General, Department of Health and Human Services, and Neil Harvey MacBride, of Virginia, to be General Counsel for the Department of the Treasury; 10:00 a.m., September 22

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Putting Kids First: Addressing COVID-19’s Impacts on Children;” 10:30 a.m., September 22

House Oversight and Reform Select Subcommittee on the Coronavirus Crisis hearing “Recognizing and Building on the Success of Pandemic Relief Programs;” 2:00 p.m., September 22

Senate Special Committee on Aging hearing to examine fraud, scams, and COVID-19, focusing on how older Americans have been targeted during the pandemic; 9:30 a.m., September 23

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