Washington Healthcare Update

February 7, 2022

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This Week in Washington: House Passes America COMPETES Act

Congress

Upcoming Hearings/Markups

House

Senate

Administration

Other Activity

Proposed Rules

Final Rules

Courts

Reports

Upcoming Hearings/Markups

February 8

Senate Health, Education, Labor and Pensions Committee Hearing: “Lessons Learned from COVID-19: Highlighting Innovations, Maximizing Inclusive Practices and Overcoming Barriers to Employment for People with Disabilities”
10:00 a.m.
The hearing page can be found here.

Senate Finance Committee Hearing: “Protecting Youth Mental Health: Part I – An Advisory and Call to Action”
10:00 a.m.
The hearing page can be found here.

House Committee on Energy and Commerce Subcommittee on Health Hearing: “ARPA-H: The Next Frontier of Biomedical Research”
10:30 a.m.
The hearing page can be found here.

House Committee on Veterans’ Affairs Subcommittee on Disability Assistance and Memorial Affairs Hearing: “Honoring Our Promise: Reviewing the Effectiveness of Services for Survivors and Dependents”
2:00 p.m.
The hearing page can be found here.

February 9

House Committee on Veterans’ Affairs Subcommittee on Technology Modernization Hearing: “IT Infrastructure Modernization: Addressing the Ongoing Challenges and the Path Forward”
10:00 a.m.
The hearing page can be found here.

February 10

Senate Special Committee on Aging Hearing: “Improving Care Experiences for People with both Medicare and Medicaid”
9:30 a.m.
The hearing page can be found here.

Senate Committee on Health, Education, Labor and Pensions Subcommittee on Employment and Workforce Safety Hearing: “Recruiting, Revitalizing & Diversifying: Examining the Health Care Workforce Shortage”
10:00 a.m.
The hearing page can be found here.

Congress

House

House Passes COMPETES Act

On Feb. 4, the House voted 220-210 to pass the America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022. The bill aims to increase investment in U.S.-made products and strengthen domestic supply chains. Specifically, the bill would increase the number of critical products at the Strategic National Stockpile, increase monitoring of foreign manufacturing sites and grant the Food and Drug Administration the authority to mandate drug recalls.

The bill text can be found here.

Senate

Sens. Thune and Casey Introduce Bill to Extend Liability Coverage to Volunteer Health Practitioners at Community Health Centers

On Feb. 3, Sens. John Thune (R-SD) and Bob Casey (D-PA) introduced the Help Expand Liability Protections (HELP) for Volunteers Act. The bill would permanently extend the Public Health Service Act’s healthcare professional liability coverage for healthcare professionals volunteering at Community Health Centers (CHCs).

The bill text can be found here.

Sens. Baldwin and Cassidy Introduce Bill to Improve Pathogen Tracking

On Jan. 31, Sens. Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduced the Tracking Pathogens Act, which aims to improve efforts to track and identify pathogens. The bill would support existing genomic sequencing efforts, establish centers of excellence and provide sustained funding.

The bill text can be found here.

Administration

President Biden Relaunches Cancer Moonshot Initiative

On Feb. 2, President Biden announced that the White House would be relaunching the “Cancer Moonshot” initiative, which was first launched five years ago when President Biden was vice president. The initiative’s objective is to reduce the U.S. cancer death rate by 50 percent over the next 25 years. In the announcement, President Biden stated that Dr. Danielle Carnival of the White House Office of Science and Technology Policy would be the White House Cancer Moonshot coordinator, with other members across the executive branch forming a “Cancer Cabinet.”

A fact sheet on the initiative can be found here.

HHS Announces New Guidance for Providing Healthcare to People with Disabilities

On Feb. 4, the Department of Health and Human Services’ (HHS) Office of Civil Rights issued a guidance to healthcare providers clarifying civil right protections for people with disabilities. The guidance stressed that even in times when resources are scare, such as a public health emergency, it is illegal to prevent someone with disabilities from receiving necessary healthcare benefits and services.

A FAQ document on the guidance can be found here.

HHS Announces Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

On Feb. 3, the Department of Health and Human Services (HHS) announced that the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) will be holding a public meeting on March 2 from 10 a.m. to 4 p.m.

Registration information can be found here.

HRSA Announces $19.2 Million in Funding for the Teaching Health Center Graduate Medical Education Program

On Feb. 3, the Health Resources and Services Administration (HRSA) announced that $19.2 million in American Rescue Plan funds would be made available to support community-based primary care residency programs through the Teaching Health Center Graduate Medical Education (THCGME) program. The funding opportunity will support 120 resident positions.

Additional information on the funding opportunity can be found here.

SAMHSA Announces $10 Million in Funding to Meet the Needs of Pregnant Women and Children Impacted by Substance Use Disorder

On Feb. 3, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced it would begin accepting applications for the Services Grant Program for Residential Treatment for Pregnant and Postpartum Women. The grant program will provide substance use treatment and recovery support services to pregnant and postpartum women and their children.

Additional information on the funding opportunity can be found here.

CMS Announces That Medicare Will Cover Over-the-Counter COVID-19 Tests

On Feb. 3, the Centers for Medicare and Medicaid Services (CMS) announced that it has identified a pathway for Medicare beneficiaries to access over-the-counter COVID-19 tests for free. Under the new pathway, Medicare beneficiaries will be able to pick up free tests at participating pharmacies, and the pharmacies will be reimbursed by Medicare. Medicare beneficiaries can access up to eight tests per month. CMS says that additional information on participating pharmacies will be available later this spring.

A CMS Frequently Asked Question document regarding this policy can be found here.

CMS to Hold Public Listening Session on Transitional Coverage for Emerging Technologies

On Feb. 3, the Centers for Medicare and Medicaid Services (CMS) announced it would be holding two public sessions titled “CMS Listening Sessions on Transitional Coverage for Emerging Technologies.” In November, CMS rescinded a Trump-era rule that would have provided Medicare coverage to breakthrough devices approved by the Food and Drug Administration (FDA). CMS is now seeking feedback to inform the development of an alternative coverage pathway to provide transitional coverage for emerging technologies.

The listening sessions will be held on Feb. 17 from 3 to 4 p.m. ET and March 31 from 3 to 4 p.m. ET. The March meeting will build off of feedback gathered in the February meeting.

Registration information for the event can be found here.

CMS Releases Advance Notice with Payment Policy Changes for MA and Part D Plans

On Feb. 2, the Centers for Medicare and Medicaid Services (CMS) released an Advance Notice titled “Calendar Year (CY) 2023 Advance Notice for Medicare Advantage (MA) and Part D Plans.” The Advance Notice includes proposed payment policy changes for MA and Part D drug programs for 2023 with the goal of providing more affordable choices for consumers. Specifically, the notice details a proposed 7.98 percent increase to MA payment, which is nearly double the pay increase from the previous year. In addition, CMS stated that MA groups could potentially be judged on value-based care arrangements with providers in the future. The comment period lasts 30 days, and CMS has specifically requested feedback focused on health equity.

The 2023 Advance Notice can be found here.

A CMS fact sheet on the Advance Notice can be found here.

FDA Advisory Committee to Meet Feb. 15 to Discuss COVID-19 Vaccine for Children

On Feb. 1, the Food and Drug Administration (FDA) announced that its vaccine advisory committee will meet on Feb. 15 to discuss Pfizer and BioNTech’s COVID-19 vaccine for children aged 6 months to 4 years. The vaccine is currently authorized for children aged 5 to 15 and is fully approved for all patients 16 and above. The meeting announcement follows Pfizer’s announcement that it was seeking FDA authorization for the first two doses of a three-dose COVID-19 vaccine regime for children under the age of 5.

FDA Grants Moderna COVID-19 Vaccine Full Authorization

On Jan. 31, the Food and Drug Administration (FDA) approved Moderna’s COVID-19 vaccine Spikevax but retained the vaccine’s emergency use authorization (EUA). The vaccine is now fully approved for individuals aged 18 and older. The vaccine had already been available under the EUA since December 2020.

CDC Releases New Webpage to Help Healthcare Professionals Support Pregnant and Postpartum Individuals

On Feb. 1, the Centers for Disease Control and Prevention (CDC) released a new webpage with materials and resources for healthcare professionals that aims to reduce pregnancy-related deaths. The new webpage is part of the Hear Her campaign and includes campaign materials intended to be distributed to pregnant and postpartum individuals.

The new webpage can be found here.

Other Activity

Virginia and West Virginia Governors Request Limited Waiver From CMS Vaccination Rule

On Jan. 31, Virginia Governor Glenn Youngkin and West Virginia Governor Jim Justice wrote to the Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure requesting a limited waiver from the CMS interim rule on COVID-19 vaccinations for healthcare staff. In the letter, the governors state that they believe the vaccine requirement will contribute to greater staffing issues in healthcare facilities. The governors are seeking a limited waiver that would increase hospitals’ flexibility in interpreting the CMS rule, and could include measures such as broader conscience exemptions and delay of enforcement.

Proposed Rules

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 Issues Notice Announcing the Final Industry Guidance Regarding the Uniform National Policy on Drug Product Tracing

On Feb. 4, the Food and Drug Administration (FDA) issued a notice to announce the availability of final guidance for industry titled “Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act—Questions and Answers; Guidance for Industry; Availability.” The notice explains that the guidance will help industry, state and local governments better understand the effects of the uniform national policy set forth in the Federal Food, Drug, and Cosmetic Act that was added by the Drug Supply Chain Security Act.

The notice 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.

Courts

Federal Appeals Court Dismisses Cancer Patients’ Right-to-Try Case

On Jan. 31, the 9th U.S. Circuit Court of Appeals dismissed a lawsuit brought by a hospice doctor and two cancer patients against the Drug Enforcement Agency (DEA), citing a lack of jurisdiction. In the case, the plaintiffs sought permission to use psilocybin to treat anxiety and depression in termin