Washington Healthcare Update – March 2022 #4 | McGuireWoods Consulting

This Week in Washington: Senate Questions Supreme Court Justice Nominee Ketanji Brown Jackson

Upcoming Hearings

Congress

House

  • Reps. Kind, McKinley, Barragán and Carter Introduce Bill to Expand Medicare Coverage of Pharmacy Services
  • Rep. Krishnamoorthi Requests Information from the FDA on HVAD System Device

Senate

  • Senate Passes the Cannabidiol and Marihuana Research Expansion Act
  • Sen. Schumer Says Senate Will Vote on Bipartisan Insulin Bill After Easter Break
  • Sens. Rosen and Cassidy Introduce Bill to Strengthen Healthcare Cybersecurity
  • Sens. Sanders and Smith Introduce Bill to Address EMS Staffing

Administration

  • CMS Releases Medicaid Drug Rebate Program Notice for Participating Manufacturers and States
  • CMS Releases Templates to Help States Meet PHE Unwinding Requirements
  • FDA Announces Agreement on Medical Device User Fee Agreement
  • FDA Vaccine Advisory Committee Will Meet to Discuss Future Plan for COVID-19 Boosters
  • HRSA to Distribute Phase 4 Provider Relief Fund Payments
  • SAMHSA Announces Funding to Expand Certified Community Behavioral Health Clinics
  • OSHA Seeks Public Comment on New COVID-19 Standard

Proposed Rules

  • FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database
  • FDA Releases Draft Guidance on Verification System Requirements for Certain Prescription Drugs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  • FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives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  • FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs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

Reports

  • GAO Report on Opioid Misuse on Older Workers
  • CMS Releases State of the ACA Report

Upcoming Hearings

March 29

House Committee on Oversight and Reform Hearing: “Examining Pathways to Universal Health Coverage”
9:00 a.m.

Senate Committee on Appropriations Subcommittee on Defense Hearing: “Hearings to Examine the Defense Health Program”
10:00 a.m.

Senate Committee on Banking, Housing, and Urban Affairs Hearing: “Economic Impact of the Growing Burden of Medical Debt”
10:00 a.m.

House Committee on Veterans’ Affairs Subcommittee on Disability Assistance and Memorial Affairs Legislative Hearing
2:00 p.m.

Senate Committee on Veterans’ Affairs Hearing: “Honoring Our Promise to Address Comprehensive Toxics Act of 2021”
3:30 p.m.

March 30

House Committee on Energy and Commerce Subcommittee on Health Hearing: “FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices”
10:00 a.m.

House Committee on Agriculture Subcommittee on Nutrition, Oversight, and Department Operations Hearing: “A 2022 Review of the Farm Bill: Stakeholder Perspectives on SNAP”
10:00 a.m.

Senate Finance Committee Hearing: “Behavioral Health Care When Americans Need It: Ensuring Parity and Care Integration”
10:00 a.m.

March 31

House Committee on Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education and Related Agencies Hearing: “FY 2023 Budget Request for the Department of Health and Human Services”
10:00 a.m.

House Committee on Science Subcommittee on Investigations and Oversight Committee Hearing: “The New Normal: Preparing for and Adapting to the Next Phase of COVID-19”
10:00 a.m.

Senate Committee on Foreign Affairs Subcommittee on Africa, Global Health, and Global Human Rights Hearing: Present Challenges and Progress on COVID-19 in Africa”
2:00 p.m.


Congress

House

Reps. Kind, McKinley, Barragán and Carter Introduce Bill to Expand Medicare Coverage of Pharmacy Services

On March 24, Reps. Ron Kind (D-WI), David McKinley (R-WV), Nanette Diaz Barragán (D-CA) and Buddy” Carter (R-GA) introduced the Equitable Community Access to Pharmacist Services Act. The bill would make it so pharmacy services are covered under Medicare Part B. Services covered would include vaccinations, testing and treatment for COVID-19 and influenza.

Rep. Krishnamoorthi Requests Information from the FDA on HVAD System Device

On March 23, Rep. Raja Krishnamoorthi (D-IL) wrote to Food and Drug Administration (FDA) Commissioner Robert Califf requesting information on the FDA’s regulation of the heart pump device HeartWare Ventricular Assist Device (HVAD) System. The HVAD System was recalled in June 2021 after being associated with 20,000 patient injuries and 3,000 deaths. In the letter, Rep. Krishnamoorthi, who chairs the House Committee on Oversight’s Subcommittee on Economic and Consumer Policy, stated that the FDA failed to protect consumers and did not share knowledge of the device’s defects with other agencies. He called on the FDA to take a more proactive approach to regulating devices.

Senate

Senate Passes the Cannabidiol and Marihuana Research Expansion Act

On March 24, the Senate voted unanimously to advance the Cannabidiol and Marihuana Research Expansion Act. The bill, which was introduced by Sens. Chuck Grassley (R-IA) and Dianne Feinstein (D-CA) would expand research opportunities for institutions and manufacturers with the objective of streamlining development of cannabidiol and marijuana drugs.

Sen. Schumer Says Senate Will Vote on Bipartisan Insulin Bill After Easter Break

On March 23, Senate Majority Leader Chuck Schumer (D-NY) stated that the Senate would vote after the Easter break on a bipartisan bill to cap insulin costs. Legislative negotiations are currently ongoing, with efforts led by Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME). Sens. Shaheen and Collins introduced the Insulin Price Reduction Act in 2019, which would restrict rebates for insulins whose manufacturers reduce list prices. Sen. Raphael Warnock (D-GA) also introduced a bill to cap consumers’ insulin costs at $35 a month.

Sens. Rosen and Cassidy Introduce Bill to Strengthen Healthcare Cybersecurity

On March 24, Sens. Jacky Rosen (D-NV) and Bill Cassidy (R-LA) introduced the Healthcare Cybersecurity Act. The bill would direct the Cybersecurity and Infrastructure Security Agency (CISA) to work with the Department of Health and Human Services (HHS) to improve healthcare and public health cybersecurity.

Sens. Sanders and Smith Introduce Bill to Address EMS Staffing

On March 23, Sens. Bernie Sanders (I-VT) and Tina Smith (D-MN) introduced the Emergency Medical Services (EMS) Staffing and Support Act. The bill would allocate $500 million to establish a grant program within the Health Resources and Services Administration (HRSA) to fund EMS needs. The grant funding would be used to strengthen EMS departments’ capacity to hire and retain personnel and purchase equipment.

Administration

CMS Releases Medicaid Drug Rebate Program Notice for Participating Manufacturers and States

On March 23, the Centers for Medicare and Medicaid Services (CMS) released a notice for drug manufacturers and a notice for states that participate in the Medicaid Drug Rebate Program (MDRP) program. The notices provide technical guidance for Value Based Purchasing (VBP) Arrangements for drug therapies. Starting on July 1, 2022, states can use certain VBP arrangements for drugs that will be reported to CMS by manufacturers, following CMS’s newly expanded authority. The arrangements will include additional rebates or price concessions based on the drug’s clinical outcome for Medicaid beneficiaries.

CMS Releases Templates to Help States Meet PHE Unwinding Requirements

On March 21, the Centers for Medicare and Medicaid Services (CMS) released templates and information to help states meet the reporting requirements that will take effect once the COVID-19 public health emergency (PHE) ends and routine Medicaid, Children’s Health Insurance Program (CHIP) and Basic Health Programs resume. States will be required to submit a form titled “State Report on Plans for Prioritizing and Distributing Renewals Following the End of the Medicaid Continuous Enrollment Provisions,” which will summarize state plans to mitigate coverage loss during the 12-month unwinding period. The form must be submitted 45 days before the end of the month that the PHE designation ends.

FDA Announces Agreement on Medical Device User Fee Agreement

On March 22, the Food and Drug Administration (FDA) announced proposed recommendations for the fifth reauthorization of the medical device user fee agreement (MDUFA). The proposed recommendations were agreed to by the FDA and industry representatives, and would authorize the FDA to collect $1.78 in user fees from 2023 through 2027. The FDA is seeking public comment on the proposed recommendations, and will hold a public meeting on April 19. In addition, the proposed recommendations will be published in the Federal Register for public comment. The final recommendations will be made to Congress in April 2022.

FDA Vaccine Advisory Committee Will Meet to Discuss Future Plan for COVID-19 Boosters

On March 21, the Food and Drug Administration (FDA) issued a press release to announce that its Vaccines and Related Biological Products Advisory Committee will meet on April 6 to discuss the plan for future COVID-19 booster doses. The meeting will include a discussion of how to best select strains of COVID-19 for vaccines that are effective against current and future variants.

HRSA to Distribute Phase 4 Provider Relief Fund Payments

On March 22, the Health Resources and Services Administration (HRSA) announced that $413 million in provider relief funds (PRF) would be paid to 3,600 providers impacted by the COVID-19 pandemic as part of the PRF Phase 4 payments.

SAMHSA Announces Funding to Expand Certified Community Behavioral Health Clinics

On March 24, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it would be distributing $300 million in grant funding through two Certified Community Behavioral Health Clinic (CCBHC) programs. The funding aims to increase access to mental health services in vulnerable communities.

OSHA Seeks Public Comment on New COVID-19 Standard

On March 23, the U.S. Occupational Safety and Health Administration (OSHA) published a rule in the Federal Register titled “Occupational Exposure to COVID-19 in Healthcare Settings.” The rule signals a limited reopening rulemaking with the objective of creating a new permanent OSHA COVID-19 safety standard for the healthcare sector. The regulation will be open for public comment until April 22, 2022, and a public hearing will be held virtually on April 27, 2022.

OSHA previously published an emergency temporary standard (ETS) on June 21, 2021, that would have required large employers to ensure that their employees were either vaccinated against COVID-19 or received regular tests. OSHA withdrew the ETS in January 2022 following a Supreme Court ruling.

Proposed Rules

FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database

On March 22, the Food and Drug Administration (FDA) issued a notice titled “Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database” to establish a public docket and request public comment. The public comments will help the FDA determine how to best prioritize maximum daily exposure (MDE) information for inactive ingredients that are not currently included in the Centers for Drug Evaluation and Research’s Inactive Ingredient Database, as well as if the database should be restructured by removing dosage form information.

Public comments will be accepted until June 21, 2022.

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.

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.

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.

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.

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.

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 Providers.” 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.

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.

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.

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.

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 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.

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.

Reports

GAO Report on Opioid Misuse on Older Workers

On March 25, the Government Accountability Office (GAO) released a report titled “Older Workers: Opioid Misuse and Employment Outcomes.” The report stated that older adults who misused opioids were 22 percent less likely to be employed or seeking work. In addition, the report found that virtual delivery of workforce programs had a mixed impact on the participation of older adults who misused opioids.

CMS Releases State of the ACA Report

On March 23, the Centers for Medicare and Medicaid Services (CMS) released a report titled “The State of the Affordable Care Act (ACA)” to mark 12 years of the program. The report found that 2.8 million more Americans are receiving ACA tax credits in 2022 than in 2021.

Source: https://www.jdsupra.com/legalnews/washington-healthcare-update-march-2022-2286471/