This Week in Washington: Continuing Resolution Moves Forward and Senate Sets Up Vote on FDA Commissioner Nomination this Week

Congress

Upcoming Hearings/Markups

House

• 70 Republican House Members Call for Unwinding the Public Health Emergency Designation
• 74 House Members Express Concern with CMS National Coverage Determination of Alzheimer’s Treatments
• House Passes Continuous Resolution to Fund Government Until March 11
• 61 Members of Congress Write to Congressional Leadership Expressing Concern with the Physician Fee Schedule

Senate

• Majority Leader Schumer Files Cloture on Califf’s Nomination
• Sens. Shaheen and Collins Introduce Bill That Aims to Ease Provider Relief Fund Requirements
• Sens. Cassidy and Baldwin Introduce Bill That Would Update Health Privacy Laws
• Sens. Sanders and Klobuchar Introduce Bill to Cap Prescription Drug Costs for Medicare Parts B and D
• Sens. Thune and Menendez Introduce Bill That Aims to Incentivize Uptake of CHIP Health Services Initiatives

Administration

• HHS Announces Purchase of Monoclonal Antibody Effective Against Omicron
• CMS Announces National Coverage Determination for Lung Cancer Screening
• CMS Posts Data on Nursing Home COVID-19 Booster Vaccinations
• HRSA Allocated $66.5 Million to Increase COVID-19 Vaccination Efforts
• FTC to Consider a Study on Pharmacy Benefit Managers’ Practices Impact Drug Prices and Pharmacies
• Director of the Office of Science and Technology Policy Eric Lander Resigns

Proposed Rules

• FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives
• FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers
• FDA Issues Proposed Rule to Amend Certain Prescription Drug Marketing Regulations
• FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs
• CMS Issues CY 2023 Medicare Advantage and Part D Proposed Rule
• FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages
• FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic

Final Rules

• CMS Issues Final Rule to Revise Procedures for Announcing Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
• FDA Issues Final Rule to Revoke Regulations for Human Tissue Intended for Transplantation Recovered Prior to 2005
• CMS Issues Durable Medical Equipment Final Rule

Reports

• GAO Report on Federal Telework Data
• GAO Report on Federal Efforts to Provide COVID-19 Vaccines to Racial and Ethnic Groups
• GAO Report on the FDA’s Foreign Inspection Program

Upcoming Hearings/Markups

February 15

Senate Health, Education, Labor and Pensions Hearing: “Supporting Quality Workforce Development Opportunities and Innovation to Address Barriers to Employment”
10:00 a.m.
The hearing page can be found here.

Senate Finance Committee Hearing: “Protecting Youth Mental Health: Part II – Identifying and Addressing Barriers to Care”
10:00 a.m.
The hearing page can be found here.

House Committee on the Judiciary Subcommittee on Immigration and Citizenship Hearing: “Is There a Doctor in the House? The Role of Immigrant Physicians in the U.S. Healthcare System”
2:00 p.m.
The hearing page can be found here.

February 16

House Committee on Education and Labor Subcommittee on Early Childhood, Elementary, and Secondary Education Subcommittee Hearing: Serving All Students: Promoting a Healthier, More Supportive School Environment”
12:15 p.m.
Hearing page can be found here.

February 17

Senate Committee on Homeland Security and Governmental Affairs Hearing: “Addressing the Gaps in America’s Biosecurity Preparedness”
10:15 a.m.
The hearing page can be found here.

Congress

House

70 Republican House Members Call for Unwinding the Public Health Emergency Designation

On Feb. 11, House Energy and Commerce Committee Ranking Member Cathy McMorris Rodgers (R-WA), leading a group of 70 House Republicans, wrote to President Biden and Health and Human Services (HHS) Secretary Xavier Becerra, calling on them to accept the COVID-19 pandemic has become endemic, and requesting that the public health emergency designation be wound down.

The letter can be found here.

74 House Members Express Concern with CMS National Coverage Determination of Alzheimer’s Treatments

On Feb. 9, Sens. Cathy McMorris Rodgers (R-WA), Kevin Brady (R-TX), Brett Guthrie (R-WY) and Vern Buchanan (R-FL) led a group of 74 House Republican members in a letter to Health and Human Services (HHS) Secretary Xavier Becerra. In the letter, members requested Secretary Becerra abandon and repropose the national coverage determination (NCD) that limited Medicare coverage for a class of Alzheimer’s treatments. The NCD only allows for Medicare coverage of Alzheimer’s treatments for clinical trials approved by the Centers for Medicare and Medicaid Services (CMS). The letter notes that the NCD also excludes people with Down syndrome from participating in covered trials for Alzheimer’s treatments.

The letter can be found here.

House Passes Continuous Resolution to Fund Government Until March 11

On Feb. 8, the House voted 272-162 to pass a short-term government funding extension, also called a continuous resolution, that would push the funding deadline to March 11. The continuous resolution also includes an extension of Medicaid funding for territories and an extension of the Schedule 1 designation for fentanyl-related substances.

61 Members of Congress Write to Congressional Leadership Expressing Concern with the Physician Fee Schedule

On Feb. 8, Reps. Bobby Rush (D-IL) and Gus Bilirakis (R-FL) led 61 members of Congress in a letter to House and Senate leadership expressing their concerns regarding recent changes to the Physician Fee Schedule. In the letter, the members state that the 2022 Physician Fee Schedule cuts for office-based specialists will threaten the viability of these specialists, and request that relief be provided in upcoming omnibus appropriations legislation.

The letter can be found here.

Senate

Majority Leader Schumer Files Cloture on Califf’s Nomination

On Feb. 10, Senate Majority Leader Chuck Schumer (D-NY) filed cloture on Dr. Robert Califf’s nomination to be Food and Drug Administration (FDA) Commissioner. This decision will limit debate on Califf’s nomination and set the stage for a full Senate vote this week.

Sens. Shaheen and Collins Introduce Bill That Aims to Ease Provider Relief Fund Requirements

On Feb. 9, Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME) introduced the Provider Relief Fund (PRF) Improvement Act, which aims to delay PRF reporting requirements until the end of the public health emergency. In addition, the bill would extend the use of PRF funding to improve workplace safety.

The bill text can be found here.

Sens. Cassidy and Baldwin Introduce Bill That Would Update Health Privacy Laws

On Feb. 9, Sens. Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) introduced the Health Data Use and Privacy Commission Act, which aims to modernize health privacy laws and regulations by creating a health and privacy commission to research and make recommendations to Congress. In their press release, the senators state that healthcare technology companies have demonstrated the limits of the Health Insurance Portability and Accountability Act (HIPAA).

Sens. Sanders and Klobuchar Introduce Bill to Cap Prescription Drug Costs for Medicare Parts B and D

On Feb. 9, Sens. Bernie Sanders (I-VT) and Amy Klobuchar (D-MN) introduced a bill that would establish a cap for covered prescription drug costs under Medicare Parts B and D. The bill would tie the Medicare reimbursement rates for prescription drugs to the rate paid by the Veterans Administration. On Wednesday afternoon Sens. Sanders and Klobuchar attempted to use a procedure that requires unanimous consent to have their bill be debated on the Senate floor, but Sen. Mike Crapo (R-ID) blocked the motion.

The bill text can be found here.

Sens. Thune and Menendez Introduce Bill That Aims to Incentivize Uptake of CHIP Health Services Initiatives

On Feb. 8, Sens. John Thune (R-SD) and Bob Menendez (D-NJ) introduced the Children’s Health Insurance Program (CHIP) School Behavioral Health Incentive Act. The bill aims to provide funding opportunities for states to participate in CHIP health services initiatives, or allow for states to develop their own health service initiatives with funding support from CHIP.

The bill text can be found here.

Administration

HHS Announces Purchase of Monoclonal Antibody Effective Against Omicron

On Feb. 10, Health and Human Services (HHS) Secretary Xavier Becerra announced that the agency purchased 600,000 treatment courses of a new monoclonal antibody treatment that data shows is effective against the Omicron variant of COVID-19. Secretary Becerra stated that if the monoclonal antibody treatment, bebtelovimab, receives emergency use authorization (EUA) by the Food and Drug Administration, it will be made available free of charge.

CMS Announces National Coverage Determination for Lung Cancer Screening

On Feb. 10, the Centers for Medicare and Medicaid Services (CMS) announced a national coverage determination (NCD) to expand coverage for lung cancer screening with low dose computer tomography (LDCT). LDCT screening is used for early detection of non-small cell lung cancer. The NCD will expand eligibility for Medicare beneficiaries seeking LCDT by starting the screening at 50 years of age instead of 55, and lowering the tobacco smoking history from at least 30 packs per year to at least 20 packs per year.

Additional information on the NCD can be found here.

CMS Posts Data on Nursing Home COVID-19 Booster Vaccinations

On Feb. 9, the Centers for Medicare and Medicaid Services (CMS) started posting data on COVID-19 booster rates among nursing home facility staff and residents on its website. The information is aimed to help families and caregivers determine which nursing home would be best for their loved one.

The webpage can be found here.

HRSA Allocated $66.5 Million to Increase COVID-19 Vaccination Efforts

On Feb. 8, the Health Resources and Services Administration (HRSA) announced it would be providing $66.5 million in American Rescue Plan funding in efforts to increase COVID-19 vaccine confidence and vaccinations. The funding will be provided to eight grantees.

Additional information on the grant opportunity can be found here.

FTC to Consider a Study on Pharmacy Benefit Managers’ Practices Impact Drug Prices and Pharmacies

On Feb. 11, the Federal Trade Commission (FTC) announced that it would be holding a vote on Feb. 17 to determine whether or not it will study the impact of pharmacy benefit managers’ practices on drug prices and pharmacies. The potential study would consider the competitive impact of contractual provisions, reimbursement adjustments and other practices that may disadvantage independent or specialty pharmacies.

Director of the Office of Science and Technology Policy Eric Lander Resigns

On Feb. 7, Director of the Office of Science and Technology Policy Eric Lander announced his resignation. Dr. Lander, who served in President Biden’s cabinet as his top science advisor, admitted that he was disrespectful and demeaning to his colleagues after an internal investigation found he violated the administration’s policy for respectful workplace conduct.

Proposed Rules

FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives

On Feb. 9, the Food and Drug Administration (FDA) published a draft guidance titled “Development of Non-Opioid Analgesics for Acute Pain.” The guidance provides recommendations to companies for developing non-opioid analgesics for acute pain lasting up to 30 days. The guidance includes information about what type of data would be necessary to demonstrate acute pain management. The guidance stresses the FDA’s commitment to providing non-addictive alternatives to opioids and decreasing exposure to opioids.

The FDA will accept public comments on the draft guidance until April 11, 2022.

The draft guidance can be found here.

FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

On Feb. 4, the Food and Drug Administration (FDA) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics.” The proposed rule includes proposed national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers.

Public comments are accepted until June 6, 2022.

The proposed rule can be found here.

FDA Issues Proposed Rule to Amend Certain Prescription Drug Marketing Regulations

On Feb. 4, the Food and Drug Administration (FDA) issued a proposed rule titled “Certain Requirements Regarding Prescription Drug Marketing.” The proposed rule would amend certain drug marketing regulations of the Federal Food, Drug, and Cosmetic Act to reflect changes resulting from the Drug Supply Chain Security Act.

Public comments are accepted until April 5, 2022.

The proposed rule can be found here.

FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs

On Feb. 4, the Food and Drug Administration (FDA) released a notice to announce the availability of draft guidance for industry titled “Formal Meetings Between the FDA and Sponsors or Requestors of Over-the-Counter (OTC) Monograph Drugs.” The draft guidance makes non-binding recommendations to industry on the procedures and principles for formal meetings between the FDA and sponsors or requestors for OTC monograph drugs.

Comments will be accepted until April 8, 2022.

The draft guidance can be found here.

CMS Issues CY 2023 Medicare Advantage and Part D Proposed Rule

On Jan. 12, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare Program: Contract Year (CY) 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit Programs.” The proposed rule makes a number of revisions to the following topics: MA and Part D regulations on marketing and communications, new or expanded MA and Part D plan criteria, MA and Part D plan quality ratings, provider network adequacy requirements, disaster or public emergency special requirements, medical loss ratio reporting, D-SNPs regulations and pharmacy price concessions. The proposed rule aims to lower out-of-pocket Medicare Part D prescription drug costs and improve health equity in MA and Part D.

Public comments are accepted until March 7, 2022.

The proposed rule can be found here.

FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages

On Jan. 11, the Food and Drug Administration (FDA) issued a draft guidance to explain how device makers should notify the agency of potential shortages during or before public health emergencies. The guidance requests that manufacturers inform the FDA of meaningful supply disruptions at least six months in advance, and if this is not possible, to notify the FDA as soon as is “practicable,” and no later than seven days after a disruption happens. The guidance is almost identical to a May 2020 guidance, and its recommendations are nonbinding.

Public comments will be accepted until March 12, 2022.

The draft guidance can be found here.

FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic

On Dec. 23, the Food and Drug Administration (FDA) issued two draft guidance documents related to medical devices that received Emergency Use Authorization (EUA) during the COVID-19 pandemic. The guidance documents, titled “Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency (PHE)” and “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 PHE,” are intended to help manufacturers and stakeholders adapt to the eventual resumption of normal operations upon the end of the PHE.

Public comments will be accepted until March 23, 2022.

The guidance document titled “Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency” can be found here.

The guidance document titled “Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” can be found here.

Final Rules

CMS Issues Final Rule to Revise Procedures for Announcing Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications

On Jan. 13, the Food and Drug Administration (FDA) published a final rule titled “Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications.” The final rule amends medical device regulations regarding the procedures for announcing approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs).

The rule will be effective on Feb. 14, 2022.

The final rule can be found here.

FDA Issues Final Rule to Revoke Regulations for Human Tissue Intended for Transplantation Recovered Prior to 2005

On Jan. 13, the Food and Drug Administration (FDA) published a final rule titled “Revocation of the Regulations for Human Transplantation and Human Dura Mater.” The final rule revokes regulations for human tissue products intended for transplantation that were recovered before May 25, 2005, saying these regulations are outdated as no human tissue products remain in inventory from that time.

The final rule goes into effect on Feb. 14, 2022.

The rule can be found here.

CMS Issues Durable Medical Equipment Final Rule

On Dec. 28, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “Medicare Program; Durable Medical Equipment (DME), Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas.” The final rule aims to increase access to certain DME by establishing methodologies to adjust the Medicare DMEPOS fee schedule amounts. In addition, the final rule sets procedures for creating benefit categories and payment determinations for new DMEPOS.

The final rule will go into effect on Feb. 28, 2022.

The final rule can be found here.

Reports

GAO Report on Federal Telework Data

On Feb. 8, the Government Accountability Office (GAO) published a report titled “Federal Telework Increased during the Pandemic, but More Reliable Data Are Needed to Support Oversight.” The report notes that the Office of Personnel Management (OPM) collects data on federal telework, but has only made limited progress in addressing data issues. The GAO recommends that OPM develop a plan to address GAO recommendations on this topic.

The full report can be found here.

GAO Report on Federal Efforts to Provide COVID-19 Vaccines to Racial and Ethnic Groups

On Feb. 7, the Government Accountability Office (GAO) published a report titled “Federal Efforts to Provide Vaccines to Racial and Ethnic Groups.” The report notes that the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA) and the Federal Emergency Management Agency (FEMA) all launched programs dedicated to supplementing COVID-19 vaccination efforts, with a focus on providing vaccines to underserved and marginalized communities. The GAO report provides detailed information on the racial and ethnic demographics of the populations vaccinated by the CDC, HRSA and FEMA.

The full report can be found here.

GAO Report on the FDA’s Foreign Inspection Program

On Feb. 7, the Government Accountability Office (GAO) published a report titled “FDA Should Take Additional Steps to Improve Its Foreign Inspection Program.” The report states that the Food and Drug Administration (FDA) plans to create a pilot program to better understand the impact of unannounced inspections and using independent translation services, but these efforts have been delayed by the COVID-19 pandemic. The GAO recommends that the FDA develop a methodology for evaluating this pilot. In addition, the GAO notes that there are many vacancies in the FDA’s drug inspection workforce.

The report can be found here.