This Week in Washington: President Biden Reiterates Healthcare Priorities and Announces Initiatives in his State of the Union Address

Congress

Upcoming Hearings

House

• Appropriations Update
• Rep. DeLauro Calls for Investigation of FDA’s Handling of Infant Formula Recall
• House Passes the Methamphetamine Response Act
• House Passes the STANDUP Act of 2021
• House Passes the “Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act”

Senate

• Senate Passes Bill to End the National Emergency Declaration for COVID-19
• Senate Passes Joint Resolution to Repeal CMS Vaccine Mandate for Healthcare Workers
• Bill to Increase Abortion Protections Fails
• Sens. Luján and Murphy Introduce Bill to Address Health Misinformation
• Sens. Collins and Capito Call for Stakeholder Input on CMS Alzheimer’s Disease Treatment National Coverage Determination
• Sens. Tillis and Blackburn Oppose Use of March-In Rights to Lower Drug Costs

Administration

• White House Releases National COVID-19 Preparedness Plan
• President Biden’s State of the Union Includes Commitments on Healthcare Policies
• CMS Guidance Gives State Medicaid Programs 14 Months to Process Renewals Upon the End of the PHE and Waives Some MCO Restrictions
• CMS Innovation Center Accepting Applications for the 2023 Kidney Care Choices Model
• CMS Releases Updated Enrollment Figures for Medicare, Medicaid and CHIP
• FDA Releases Guidance for Voluntary Recalls
• FDA Announces Final Guidance on Including Older Adults in Cancer Clinical Trials
• CDC No Longer Recommends Universal Contact Tracing
• Dr. Emeka Egwim to Lead the Office of Pharmacy Affairs in the Health Resources and Services Administration (HRSA)

Proposed Rules

• 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• FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives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• FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs
• FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages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

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

Courts

• U.S. Supreme Court Rules that Kentucky Attorney General Can Defend Abortion Law

Reports

• GAO Report on Tribal Epidemiology Centers’ Access to HHS Data
• GAO Report on VA Market Assessments
• NAS Recommends Increasing Medical Stockpiles Instead of Onshoring Medical Supply Chains
• GAO Report on Long COVID

Upcoming Hearings

March 15

Senate Health, Education, Labor and Pensions Committee Executive Session: “S.___, PREVENT Pandemics Act”
10:00 a.m.
The executive session page can be found here.

Congress

House

Appropriations Update

The current continuing resolution (CR) funding the government expires on March 11. House Majority Leader Steny Hoyer (D-MD) announced that the House expects to consider an omnibus appropriations bill by March 8. Members were still discussing programmatic funding levels, having already agreed on “top-line” numbers for the different functions of the government. In addition, there are discussions about how to move funding to assist Ukraine. Republicans want to move the assistance as a separate measure.

The president’s request for fiscal year (FY) 2022 supplemental funding for assistance to Ukraine and short-term COVID-19 prevention methods can be found here.

Rep. DeLauro Calls for Investigation of FDA’s Handling of Infant Formula Recall

On March 3, Rep. Rosa DeLauro (D-CT) wrote to the Inspector General of the Department of Health and Human Services (HHS) requesting an investigation into whether the Food and Drug Administration (FDA) took appropriate and timely action in the leadup to the recall of powdered infant formula produced by Abbott Nutrition’s plant in Sturgis, Michigan. Abbott Nutrition announced a recall of several infant formulas on Feb. 17 after consumer complaints of illness brought about by pathogens. However, the FDA was first aware of a case of pathogen contamination related to Abbott formula in September 2021. Rep. DeLauro expressed concern that the FDA acted too slowly in pulling potentially dangerous formula off shelves, potentially leading to additional illness and death.

The letter can be found here.

House Passes the Methamphetamine Response Act

On Feb. 28, the House passed the Methamphetamine Response Act of 2021 which would direct the Office of National Drug Control Policy (ONDCP) to implement a strategy to address the rising use of methamphetamine and would designate methamphetamine as an emerging drug threat. The bill was original introduced by Sens. Chuck Grassley (R-IA) and Dianne Feinstein (D-CA). The bill passed the Senate in December and now goes to President Biden’s desk.

The bill text can be found here.

House Passes the STANDUP Act of 2021

On Feb. 28, the House passed the “Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act of 2021,” which would require state, local and tribal governments that receive funding for mental health to establish and implement suicide awareness and prevention training efforts. The bill has already passed the Senate and now goes to President Biden’s desk.

The bill text can be found here.

House Passes the “Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act”

On Feb. 28, the House passed the “Supporting the Foundation for the National Institutes of Health (NIH) and the Reagan-Udall Foundation for the Food and Drug Administration (FDA) Act,” which would authorize the NIH and FDA to increase transfer authority to help fund their respective supporting foundations, the Foundation for the National Institutes of Health (FNIH) and the Reagan-Udall Foundation. The bill previously passed the Senate, and will now go to President Biden’s desk.

The bill text can be found here.

Senate

Senate Passes Bill to End the National Emergency Declaration for COVID-19

On March 3, a measure that would terminate the national emergency declaration for the COVID-19 pandemic passed the Senate with a vote of 48-47. The bill is not likely to pass the House and President Biden has said he would veto the bill.

Senate Passes Joint Resolution to Repeal CMS Vaccine Mandate for Healthcare Workers

On March 2, the Senate voted 49-44 on a joint resolution that would repeal the Centers for Medicare and Medicaid Services (CMS) rule requiring that healthcare staff be vaccinated against COVID-19. The joint resolution was introduced by Sen. Roger Marshall (R-KS), who argued that the rule would exacerbate staffing shortages. The resolution is not likely to pass the House. The Supreme Court upheld the CMS vaccine rule last month.

Bill to Increase Abortion Protections Fails

On Feb. 28, the “Women’s Health Protection Act” was defeated with a vote of 46-48. The bill, which was passed earlier in the House, would have barred states from restricting abortion both later and earlier in pregnancy, going further than the current Roe v. Wade standard to protect the right to abortion.

The Supreme Court will rule on abortion in the coming months and is expected to limit access.

Sens. Luján and Murphy Introduce Bill to Address Health Misinformation

On March 2, Sens. Ben Ray Luján (D-NM) and Chris Murphy (D-CT) introduced the “Promoting Public Health Information Act,” which would support efforts within the Department of Health and Human Services (HHS) to address misinformation. The bill would establish a Public Health Information and Communications Advisory Committee within HHS and fund awards for initiatives that educate the public and promote fact-based public health.

A press release on the bill can be found here.

Sens. Collins and Capito Call for Stakeholder Input on CMS Alzheimer’s Disease Treatment National Coverage Determination

On March 1, Sens. Susan Collins (R-ME) and Shelley Moore Capito (R-WV) wrote to the Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure calling for stakeholder feedback to be included in CMS’s National Coverage Determination (NCD) for monoclonal antibodies that target amyloid plaque for the treatment of Alzheimer’s disease. CMS released a draft NCD in January that detailed plans to restrict coverage of monoclonal antibodies targeting amyloid plaque to Alzheimer’s patients who are enrolled in qualified clinical trials. Sens. Collins and Capito called on Administrator Brooks-LaSure to incorporate stakeholder feedback into the final NCD to ensure that it does not result in decreased access to treatment or stifle developments to treat Alzheimer’s disease.

The full letter can be found here.

Sens. Tillis and Blackburn Oppose Use of March-In Rights to Lower Drug Costs

On Feb. 24, Sens. Thom Tillis (R-NC) and Marsha Blackburn (R-TN) wrote to Health and Human Services (HHS) Secretary Xavier Becerra urging him to reject the use of the march-in provision of the Bayh-Dole Act to lower the cost of Astellas Pharma’s prostate cancer drug Xtandi. The march-in provision of the Bayh-Dole Act enables small businesses and universities to receive patents and license technology for inventions developed with federal funding, and was only intended to be used when small businesses and universities fail to commercialize these inventions. Sens. Tillis and Blackburn state that using the march-in provisions to lower drug prices would deter investments in drug development and hinder innovation.

Administration

White House Releases National COVID-19 Preparedness Plan

On March 2, the White House released a National COVID-19 Preparedness Plan which details the administration’s plans to fight COVID-19 going forward. The plan stresses the need to be prepared for new COVID-19 variants. In addition, the plan calls on Congress to provide funding to streamline the Food and Drug Administration’s (FDA) development and review of future COVID-19 vaccines and therapies.

The National COVID-19 Preparedness Plan can be found here.

A summary of the plan can be found here.

President Biden’s State of the Union Includes Commitments on Healthcare Policies

On March 1, President Biden used his State of the Union address to explain how his administration will address nursing home oversight, mental health, substance use disorder and the opioid crisis, and will also prepare for a potential next wave of COVID-19. In the speech, he called on Democrats to revisit parts of the stalled Build Back Better Act, expressing support for moving forward measures to extend the temporarily enhanced Affordable Care Act premium tax credits, close the Medicaid coverage gap, improve home and long-term care and allow for drug price negotiations. In addition, President Biden called on Congress to fund ARPA-H which would consolidate efforts to foster innovation in health research. In his speech, President Biden also announced that his administration would be launching a “Test to Treat” program in March that would allow people to get tested for COVID-19 at a pharmacy and receive antiviral pills to treat COVID-19 immediately from the same pharmacy, at no cost.

The White House Fact Sheet on its plans to address addiction and the overdose epidemic can be found here.

The White House Fact Sheet concerning the administration’s nursing home initiative can be found here.

CMS Guidance Gives State Medicaid Programs 14 Months to Process Renewals Upon the End of the PHE and Waives Some MCO Restrictions

On March 3, the Centers for Medicare and Medicaid Services (CMS) released guidance on how state Medicaid programs should restart eligibility reviews upon the end of the public health emergency (PHE). The guidance provides states with 14 months to finish processing renewals after the PHE ends. This is two months longer than the previous timeline that provided state Medicaid programs with 12 months. The guidance also allows states to start the redetermination process up to two months before the end of the PHE.

The guidance does not estimate when the PHE will end, but the Department of Health and Human Services (HHS) has committed to providing a 60-day notice. The guidance can be found here.

CMS also announced that it would waive certain restrictions on Medicaid managed care organizations (MCOs) so plans can engage with states and consumers when the PHE ends and Medicaid determination begins. The guidance can be found here.

CMS Innovation Center Accepting Applications for the 2023 Kidney Care Choices Model

On March 1, the Centers for Medicare and Medicaid Services’ Innovation Center published a Request for Applications for the second cohort of the Kidney Care Choices (KCC) Model. The KCC Model will begin on Jan. 1, 2023. Applications are due by March 25, 2022, and the CMS Innovation Center is not planning to solicit further participants for Performance Year 2023 of the KCC model after that.

Additional information on the model and the application can be found here.

CMS Releases Updated Enrollment Figures for Medicare, Medicaid and CHIP

On Feb. 28, the Centers for Medicare and Medicaid Services (CMS) released the most recent enrollment figures for Medicare, Medicaid and the Children’s Health Insurance Program (CHIP).

The enrollment numbers can be found here.

FDA Releases Guidance for Voluntary Recalls

On March 3, the Food and Drug Administration (FDA) finalized guidance intended to help companies prepare to quickly remove violative products from the market in the case of a voluntary recall. The guidance details how companies can develop policies and procedures

to reduce the time a recalled product is on the market.

The guidance can be found here.

FDA Announces Final Guidance on Including Older Adults in Cancer Clinical Trials

On March 2, the Food and Drug Administration (FDA) released a notice of availability announcing the final guidance for industry titled “Inclusion of Older Adults in Cancer Clinical Trials.” The guidance includes recommendations on including patient above age 65 in clinical trials to treat cancer, and emphasizes the importance of including adults over age 75.

The notice can be found here.

CDC No Longer Recommends Universal Contact Tracing

On Feb. 28, the Centers for Disease Control and Prevention (CDC) updated their COVID-19 tracing guidelines. The CDC no longer recommends universal case investigation and contact tracing, and instead recommends that health departments prioritize contact tracing in high-risk settings or groups.

The CDC recommendations can be found here.

Dr. Emeka Egwim to Lead the Office of Pharmacy Affairs in the Health Resources and Services Administration (HRSA)

On Feb. 28, the Department of Health and Human Services (HHS) announced that Dr. Emeka Egwim would be the new Director of the Office of Pharmacy Affairs (OPA) in HRSA’s Office of Special Health Initiatives (OSHI). Dr. Egwim previously served in the Centers for Medicare and Medicaid Services’ (CMS) Division of Pharmacy and was Senior Policy Analyst in HRSA’s HIV/AIDS Bureau.

Proposed Rules

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 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 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

President Biden Announces Final Rule to Change Qualifications for Products to be Considered “Made in America”

On March 4, President Biden announced a final rule as part of his wider “Made in America” policy that aims to increase manufacturing of critical supplies in the U.S. 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 October 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

U.S. Supreme Court Rules that Kentucky Attorney General Can Defend Abortion Law

On March 3, the U.S. Supreme Court ruled 8-1 that the Sixth Circuit Court was wrong to deny Kentucky Attorney General Daniel Cameron’s request to further defend a state abortion law after other state officials declined to pursue further appeals. This decision appealed an earlier appeals court decision that prevented Attorney General Cameron from defending Kentucky law HB 454 which restricts second trimester abortions.

Reports

GAO Report on Tribal Epidemiology Centers’ Access to HHS Data

On March 4, the Government Accountability Office (GAO) published a report titled “Tribal Epidemiology Centers: HHS Actions Needed to Enhance Data Access.” The report notes that tribal epidemiology centers were created to improve public health outcomes for American Indians and Alaskan Natives. The GAO notes that 12 tribal epidemiology centers had varying access to the Health and Human Services’ (HHS) data, and recommended that HHS improve the centers’ access to data.

The full report can be found here.

GAO Report on VA Market Assessments

On March 4, the Government Accountability Office (GAO) published a report titled “VA Health Care: Incomplete Information Hinders Usefulness of Market Assessments for VA Facility Realignment.” The report notes that the Department of Veterans Affairs (VA) is carrying out an assessment of 96 healthcare markets to identify potential ways to realign its medical facilities. The GAO stated that more information was needed to assess the non-VA provider care that occurs when care cannot be delivered at a VA facility.

The full report can be found here.

NAS Recommends Increasing Medical Stockpiles Instead of Onshoring Medical Supply Chains

On March 3, the National Academies of Sciences, Engineering, and Medicine (NAS) released a Congressionally mandated study titled “Building Resilience into the Nation’s Medical Product Supply Chains.” Congress called on NAS to study potential improvements to improve the resiliency of the U.S. medical supply chains. The NAS report states that onshoring of entire medical product supply chains is costly and is not often feasible, and instead recommends improving the U.S. stockpile of emergency healthcare products to prepare for the next pandemic. The report also recommends negotiating a new international trade agreement to ban export restrictions on essential medical products and components.

The report can be found here.

GAO Report on Long COVID

On March 2, the Government Accountability Office (GAO) published a report titled “Science and Tech Spotlight: Long COVID.” The report explains the science behind long COVID and explains what actions the federal government has taken to address it. The report also details challenges that exist for research and policymaking.

The full report can be found here.