This Week in Washington: President Biden Signs Omnibus Appropriations Package into Law to Fund the Federal Government Through FY 2022

Upcoming Hearings

Congress

House

• Reps. Maloney, Pressley and Bush Call for Expansion of Medication Abortion Care
• Rep. Burgess Introduces Bill to Address High Insulin Cost

Senate

• STANDUP Act Signed into Law
• Legislation to Support the Foundation for the NIH and the Reagan-Udall Foundation Signed into Law
• Methamphetamine Response Act Signed into Law
• Senate HELP Committee Votes to Advance the PREVENT Pandemics Act
• Sens. Markey, Kaine and Duckworth Call for Improved Guidance to Help Individuals with Long COVID Access Disability Benefits
• Senate Approves Measure to End Mask Mandate on Public Transportation

Administration

• Ashish Jha to Take White House COVID-19 Response Coordinator Role
• HHS Secretary Becerra Says CMS to Decide on Medicare Part B Premiums After Finalizing Aduhelm National Coverage Policy
• DOJ and FTC Extend Deadline for Public Comment on Options to Strengthen Enforcement of Illegal Mergers
• OMB Reviewing Proposed Rule to Fix “Family Glitch”
• SAMHSA Announces $44 Million in Grants for Mental Health and Substance Abuse Services for People at Risk for or Living with HIV/AIDS
• SAMHSA Announces $25 Million in Grants for Substance Use Disorder Treatment and Prevention
• NIH Announces Clinical Trial Launch for Three mRNA HIV Vaccines

Proposed Rules

• FDA Releases Draft Guidance on Verification System Requirements for Certain Prescription Drugs
• HHS Issues RFI on the Impact of COVID-19 Misinformation
• DHS Issues Notice of Proposed Rulemaking to Edit Public Charge Definition
• FDA Issues Proposed Rule to Amend Medical Device Manufacturing Practice Requirements
• FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives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• FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs
• FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic

Final Rules

• Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
• HHS Delays SUNSET Final Rule Implementation

Courts

• District Court to Hear DOJ’s Challenge to UnitedHealth and Change Healthcare Merger

Reports

• GAO Report on Emergency Relief Funds
• MACPAC March Report to Congress
• MedPAC March Report to Congress
• HRSA Study on Mental Health Conditions in Children

Upcoming Hearings

March 23

Senate Health, Education, Labor and Pensions Committee Hearing: “Strengthening Federal Mental Health and Substance Use Disorder Programs: Opportunities, Challenges, and Emerging Issues”
10:00 a.m.
Hearing page can be found here.

Senate Special Committee on Aging Hearing: “An Economy That Cares: The Importance of Home-Based Services”
10:00 a.m.
Hearing page can be found here.

Senate Veterans’ Affairs Committee Hearing: “Honoring Our Commitment: Improving VA’s Program of Comprehensive Assistance for Family Caregivers”
3:00 p.m.
Hearing page can be found here.

Congress

House

Reps. Maloney, Pressley and Bush Call for Expansion of Medication Abortion Care

On March 15, Reps. Carolyn Maloney (D-NY), Ayanna Pressley (D-MA) and Cori Bush (D-MO) led a group of 12 Democratic congresswomen in a letter to Health and Human Services (HHS) Department Secretary Xavier Becerra. In the letter, the members call on Secretary Becerra to use the newly established Reproductive Health Care Access Task Force to expand access to medication abortion care following the elimination of the in-person dispensing requirement for mifepristone in December.

The letter can be found here.

Rep. Burgess Introduces Bill to Address High Insulin Cost

On March 14, Rep. Michael Burgess (R-TX) introduced the Insulin Savings for Patients Act. The bill would pass all rebate dollars for insulin to Medicare Part D beneficiaries at the pharmacy counter, with the objective of reducing out-of-pocket costs for insulin. In addition, the bill would require the Comptroller General to report to Congress on the insulin rebate and cost trends.

The bill text can be found here.

Senate

STANDUP Act Signed into Law

On March 15, President Biden signed the Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act of 2021 into law. The law was introduced by Sens. Maggie Hassan (D-NH) and Joni Ernst (R-IA) and Reps. Scott Peters (D-CA) and Gus Bilirakis (R-FL) and prioritizes grant programs and educational agencies that implement suicide awareness and prevention training policies.

The legislative text can be found here.

Legislation to Support the Foundation for the NIH and the Reagan-Udall Foundation Signed into Law

On March 15, President Biden signed the “Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act” into law. The law was introduced by Sens. Ben Ray Luján (D-NM), Mitt Romney (R-UT) and Susan Collins (R-ME), as well as Reps. Richard Hudson (R-NC) and Anna Eshoo (D-CA). The law increases the set-aside for the Foundation for the National Institutes of Health (NIH) and the Food and Drug Administration’s (FDA) Reagan-Udall Foundation.

The legislative text can be found here.

Methamphetamine Response Act Signed into Law

On March 14, President Biden signed the Methamphetamine Response Act into law. The law was introduced by Sens. Chuck Grassley (R-IA) and Dianne Feinstein (D-CA) and directs the Office of National Drug Control Policy (ONDCP) to create a plan to address rising methamphetamine use.

The legislative text can be found here.

Senate HELP Committee Votes to Advance the PREVENT Pandemics Act

On March 15, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20-2 to advance the Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT), and Pandemics Act. The legislation was drafted by HELP Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) and aims to improve public health and response capability. The PREVENT Pandemics Act incorporates ideas from 35 different bills related to public health and response capability, and eight amendments were approved by the committee during the executive session. The bill now goes to the Senate floor for consideration.

Sens. Markey, Kaine and Duckworth Call for Improved Guidance to Help Individuals with Long COVID Access Disability Benefits

On March 17, Sens. Ed Markey (D-MA), Tim Kaine (D-VA) and Tammy Duckworth (D-IL) wrote to the Acting Commissioner of the Social Security Administration (SSA) Kilolo Kijakazi to call for improved guidance for people living with long COVID who apply for disability benefits. The letter notes that current SSA guidance requires applicants to provide a positive COVID-19 test or diagnosis with limited exceptions, which is a barrier for many Americans who could not access COVID-19 testing.

The letter can be found here.

Senate Approves Measure to End Mask Mandate on Public Transportation

On March 15, the Senate voted 57-40 to approve a resolution that would nullify the Centers for Disease Control and Prevention’s (CDC) mask mandates on public transportation. Eight Democrats voted in favor of the resolution, which is unlikely to pass the House.

Administration

Ashish Jha to Take White House COVID-19 Response Coordinator Role

On March 17, President Biden announced that Ashish Jha would be the next White House COVID-19 response coordinator. Current COVID-19 response coordinator Jeff Zients will be returning to private life in April. Jha is the dean of Brown University’s School of Public Health.

HHS Secretary Becerra Says CMS to Decide on Medicare Part B Premiums After Finalizing Aduhelm National Coverage Policy

On March 17, Health and Human Services (HHS) Secretary Xavier Becerra stated that the Centers for Medicare and Medicaid Services (CMS) will announce whether or not it will adjust Medicare Part B premiums once it finishes the national coverage policy for the Alzheimer’s drug Aduhelm. The national coverage policy for Aduhelm is due by April 11. In November, CMS announced a $21.60 premium increase for Medicare Part B, an increase partly driven by the cost of Aduhelm.

DOJ and FTC Extend Deadline for Public Comment on Options to Strengthen Enforcement of Illegal Mergers

On March 15, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) announced that the deadline to submit public comments regarding the agencies’ plan to modernize merger guidelines to better detect and prevent anticompetitive conduct would be extended to April 21. The DOJ and FTC launched a public inquiry in January to solicit input on how to strengthen enforcement against illegal mergers and anticompetitive deals.

Public comments can be submitted here.

OMB Reviewing Proposed Rule to Fix “Family Glitch”

The Office of Management and Budget (OMB) is reviewing a Treasury Department proposed rule to fix the “family glitch.” The Affordable Care Act (ACA) includes a provision that determines a family’s eligibility for premium subsidies based on whether an employer-sponsored insurance plan is affordable for the employee. This provision only considers whether the employer-sponsored plan is affordable for the employee and does not consider if it is affordable for the employee’s whole family. This so-called “family glitch” is currently blocking millions of Americans from being able to access ACA tax credits.

SAMHSA Announces $44 Million in Grants for Mental Health and Substance Abuse Services for People at Risk for or Living with HIV/AIDS

On March 15, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced three funding opportunities for services to support mental health and substance services for people at risk for or living with HIV/AIDS.

Information on the grant opportunities can be found here.

SAMHSA Announces $25 Million in Grants for Substance Use Disorder Treatment and Prevention

On March 15, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that $25 million in funding would be allocated through two grant programs to increase access to opioid use disorder treatment and prevention. The funding is part of the Department of Health and Human Services’ (HHS) Overdose Prevention Strategy.

Information on the grant opportunities can be found here.

NIH Announces Clinical Trial Launch for Three mRNA HIV Vaccines

On March 14, the National Institutes of Health (NIH) announced that the National Institute of Allergy and Infectious Diseases (NIAID) launched a Phase 1 clinical trial to evaluate three experimental HIV vaccines based on an mRNA platform.

The NIH press release with additional information can be found here.

Proposed Rules

FDA Releases Draft Guidance on Verification System Requirements for Certain Prescription Drugs

On March 9, the Food and Drug Administration released draft guidance titled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The draft guidance details the statutory verification system requirements that products need to comply with under the Federal Food, Drug, and Cosmetic Act as amended by the Drug Supply Chain Security Act. Specifically, the draft guidance provides information on verification system requirements to quarantine and investigate products determined to be illegitimate. The guidance document includes non-binding recommendations.

Comments will be accepted until May 9, 2022.

The draft guidance can be found here.

HHS Issues RFI on the Impact of COVID-19 Misinformation

On March 7, the Department of Health and Human Services’ (HHS) Office of the Surgeon General published a notice titled “Request for Information: Impact of Health Misinformation in the Digital Information Environment in the United States Throughout the COVID-19 Pandemic.” The Office of the Surgeon General is seeking input on COVID-19 misinformation online to better understand the impact of misinformation on healthcare infrastructure and public health.

Public comments will be accepted until May 2, 2022.

The notice can be found here.

DHS Issues Notice of Proposed Rulemaking to Edit Public Charge Definition

On Feb. 24, the Department of Homeland Security (DHS) issued a notice of proposed rulemaking titled “Public Charge Ground of Inadmissibility,” which would make the public charge standard less restrictive, as it would no longer include people receiving Medicaid and Supplemental Nutrition Assistance Program (SNAP) benefits.

Under the current law, a noncitizen seeking admission to the U.S. or seeking a visa or status must prove that they are not “likely to become a public charge” in order to be admitted to the U.S. The new proposed rule states that someone is likely to become a public charge if they are “likely to become primarily dependent on the government for subsistence,” which includes the receipt of public cash assistance for income maintenance or long-term institutionalization at government expense. This represents a change from the 2019 Public Charge Final Rule definition of public charge, which also considered receipt of Medicaid, public housing or SNAP benefits as making someone a “public charge.” The 2019 final rule has not been in effect since 2021.

Public comments will be accepted until April 25, 2022.

The notice of proposed rulemaking can be found here.

FDA Issues Proposed Rule to Amend Medical Device Manufacturing Practice Requirements

On Feb. 23, the Food and Drug Administration (FDA) published a proposed rule titled “Medical Devices; Quality System Regulation Amendments.” The proposed rule would amend the Quality System Regulation’s device current good manufacturing practice (CGMP) requirements to align more closely with international device standards.

Public comments are accepted until May 24, 2022.

The proposed rule can be found here.

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.

Public comments are accepted 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.

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

Final Rule to Change Qualifications for Products to be Considered “Made in America” Released

On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule policy that aims to increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.

The White House Fact Sheet on the final rule can be found here.

The final rule can be found here.

HHS Delays SUNSET Final Rule Implementation

On March 4, the Department of Health and Human Services (HHS) released a final rule to postpone the final rule titled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET Final Rule). The SUNSET final rule was first published on Jan. 19, 2021, and was set to go into effect on March 22, 2022. The final rule would establish a new process to review HHS regulations, with automatic expiration of regulations that meet certain circumstances. The final rule will now be delayed further and will go into effect on Sept. 22, 2022.

The final rule can be found here.

Courts

District Court to Hear DOJ’s Challenge to UnitedHealth and Change Healthcare Merger

On March 17, U.S. District Judge Carl Nichols stated he would hear the Department of Justice’s (DOJ) lawsuit to block UnitedHealth Group from acquiring health IT company Change Healthcare on Aug. 1. In the suit, the DOJ alleges that the proposed merger would give UnitedHealth, the largest U.S. health insurer, access to sensitive information about its rivals and should be blocked.

Reports

GAO Report on Emergency Relief Funds

On March 17, the Government Accountability Office (GAO) published a report titled “Emergency Relief Funds: Significant Improvement Are Needed to Ensure Transparency and Accountability for COVID-19 and Beyond.” The report states that a review of the federal government’s COVID-19 response found that agencies had shortcomings in applying internal controls and financial and fraud risk practices. The report notes that existing financial management weaknesses were also an issue, contributing to billions of dollars’ being at risk for improper payments. The GAO recommended legislative action to address this issue.

The full report can be found here.

MACPAC March Report to Congress

On March 15, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its March 2022 Report to Congress. The report studies transitioning Medicaid beneficiaries from institutions to the community under the Money Follows the Person program, vaccination rates for Medicaid enrollees and hospital payment policy for safety net hospitals.

The report can be found here.

MedPAC March Report to Congress

On March 15, the Medicare Payment Advisory Commission (MedPaC) released its March report to Congress. The report considers the impact of COVID-19 on Medicare program spending, reviews payment adequacy for Medicare fee-for-service (FFS) payment policy and evaluates the status of the Medicare Advantage program, among other things.

The full report can be found here.

HRSA Study on Mental Health Conditions in Children

On March 14, a study carried out by the Health Resources and Services Administration (HRSA) was published as a report in JAMA Pediatrics. The report, titled “Five-Year Trends in US Children’s Health and Well-being, 2016-2020,” states that the number of children diagnosed with mental health conditions has increased significantly from 2016 to 2020. Between 2016 and 2020, the number of children aged 3-17 diagnosed with anxiety grew by 29 percent. Children aged 3-17 diagnosed with depression grew 27 percent in the same time frame.

The full report can be found here.