McGuireWoods Consulting - Washington Healthcare Update

Senate Health, Education, Labor and Pensions Committee Hearing: “FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients”
10:00 a.m.

House Committee on Natural Resources Subcommittee on Oversight and Investigations Hearing: “The Opioid Crisis in Tribal Communities”
10:00 a.m.

Senate Finance Committee Hearing: “The President’s Fiscal Year 2023 Health and Human Services Budget”
10:00 a.m.

House Committee on Energy and Commerce Subcommittee on Health Hearing: “Communities in Need: Legislation to Support Mental Health and Well-Being”
10:15 a.m.

House Committee on Ways and Means Hearing: Proposed Fiscal Year 2023 Budget with Health and Human Services Secretary Becerra”
2:00 p.m.

April 6

House Education and Labor Committee Hearing: “Examining the Policies and Priorities of the U.S. Department of Health and Human Services”
9:00 a.m.

Senate Committee on Armed Services Subcommittee on Personnel Hearing to receive testimony on suicide prevention and related behavioral health interventions in the Department of Defense
10:00 a.m.

House Committee on Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related Agencies Hearing: “FY 2023 Department of Veterans Affairs Budget Hearing”
10:30 a.m.

Congress

House

House Passes the Affordable Insulin Now Act

On March 31, the House passed the Affordable Insulin Now Act with a vote of 232-193. The bill, introduced by Reps. Angie Craig (D-MN), Dan Kildee (D-MI) and Lucy McBath (D-GA), would cap insulin costs at $35 a month. The bill would also limit cost sharing in private plans to either $35 or 25 percent of the health plan’s negotiated price, whichever is lower.

The Congressional Budget Office published a cost estimate of the bill on March 30.

House Energy and Commerce Committee to Discuss 19 Mental Health Bills

On April 5, the House Energy and Commerce Subcommittee on Health will hold a hearing titled “Communities in Need: Legislation to Support Mental Health and Well-Being.” The hearing will discuss the following bills:

R. 2376, the “Excellence in Recovery Housing Act”
R. 2929, the “Virtual Peer Support Act”
R. 4251, “Native Behavioral Health Access Improvement Act of 2021”
R. 4944, “Helping Kids Cope Act of 2021”
R. 5218, the “Collaborate in an Orderly and Cohesive Manner”
R. 7073, the “Into the Light for Maternal Mental Health Act”
R. 7076, the “Supporting Children’s Mental Health Care Access Act of 2022”
R. 7232, the“9–8–8 and Parity Assistance Act of 2022”
R. 7233, the “Keeping Incarceration Discharges Streamlined for Children and Accommodating Resources in Education (KIDS CARES) Act”
R. 7234, the “Summer Barrow Prevention, Treatment, and Recovery Act”
R. 7235, the “Substance Use Prevention, Treatment, and Recovery Services Block Grant Act of 2022”
R. 7236, the “Strengthen Kids’ Mental Health Now Act of 2022”
R. 7237, the “Reauthorizing Evidence-based and Crisis Help Initiatives Needed to Generate (REACHING) Improved Mental Health Outcomes for Patients Act of 2022”
R. 7238, the “Timely Treatment for Opioid Use Disorder Act of 2022”
R. 7241, the “Community Mental Health Services Block Grant Reauthorization Act”
R. 7248, the “Continuing Systems of Care for Children Act”
R. 7249, the “Anna Westin Legacy Act of 2022”
R. 7254, the “Mental Health Justice and Parity Act of 2022”
R. 7255, the “Garrett Lee Smith Memorial Reauthorization Act”

Senate

Sens. Baldwin and Cassidy Introduce Bill to Address Healthcare Cyber Infrastructure

On April 1, Sens. Tammy Baldwin and Bill Cassidy (R-LA) introduced the Protecting and Transforming Cyber Health Care (PATCH) Act. The bill would require manufacturers seeking premarket approval from the Food and Drug Administration (FDA) to meet cybersecurity requirements. The bill would also require that a plan be developed to monitor and address threats to postmarket cybersecurity.

Senate Advances Alvaro Bedoya’s Nomination to the Federal Trade Commission

On March 30, the Senate voted 50-50 to advance the nomination of Alvaro Bedoya as Federal Trade Commissioner. Vice President Kamala Harris cast the tiebreaking vote, and Bedoya’s nomination will face a final confirmation vote this week. If Bedoya is confirmed, he would break the current 2-2 partisan split of Federal Trade Commissioners and give the Commission a Democratic majority.

Members of the New Jersey Delegation Express Concern with the Pharmaceutical Supply Chain Stability

On March 29, Sen. Cory Booker (D-NJ) and Reps. Bill Pascrell (D-NJ), Donald Payne (D-NJ), Albio Sires (D-NJ), Bob Menendez (D-NJ), Mikie Sherrill (D-NJ) and Josh Gottheimer (D-NJ) wrote a letter to President Biden expressing their concern about the U.S. pharmaceutical supply chain stability. Specifically, the letter raises concern with the exclusion of critical packaging components from the recent report on the supply chain prepared by the Office of the Assistant Secretary for Preparedness and Response.

Administration

President Biden Releases Budget Request

On March 28, President Biden released his budget request for Fiscal Year 2023. The request includes $127 billion for the Department of Health and Human Services (HHS), a 15 percent increase from the previous year. In addition, President Biden is requesting $81.7 billion over five years to improve pandemic preparedness and biodefense, which includes $28 billion for the Centers for Disease Control and Prevention (CDC) and $12.1 billion for the National Institutes of Health (NIH). The request would also allocate $5 million to establish the Advanced Research Projects Agency for Health (ARPA-H). White House fact sheets on the budget request can be found here.

CMS Announces Funding Opportunity Through Money Follows the Person Program

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a Notice of Funding Opportunity (NOFO) announcing that it would allocate $110 million to Medicaid’s Money Follows the Person (MFP) program to increase access to home and community-based services. Individual grants of up to $5 million will be available in states that are not participating in MFP.

CMS Announces Expanded Medicaid and CHIP Postpartum Coverage

On April 1, the Centers for Medicare and Medicaid Services (CMS) announced that due to the American Rescue Plan, pregnant and postpartum individuals are now guaranteed coverage under the Medicaid and Children’s Health Insurance Program (CHIP) for 12 months after pregnancy. This change will expand coverage to an estimated 720,000 people.

FDA Advisory Committee Votes Against Approval of ALS Drug

On March 30, the Food and Drug Administration’s (FDA) neurological drug advisory committee voted against approving a drug known as AMX0035 to treat amyotrophic lateral sclerosis (ALS). The committee stated that more compelling data was needed.

FDA Revokes Sotrovimab’s EUA in 20 More States and Territories

On March 30, the Food and Drug Administration (FDA) revoked its emergency use authorization (EUA) for GlaxoSmithKline’s COVID-19 monoclonal antibody sotrovimab in 20 states and territories. This brings the total list of states and territories where sotrovimab cannot be used to treat COVID-19 to 30. Sotrovimab is likely ineffective against the COVID-19 BA.2 subvariant, which accounts for a majority of cases in the states where the EUA was revoked.

FDA Vaccine Advisory Committee Will Meet to Discuss COVID-19 Booster and Strain Selection

The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee will meet on April 6 from 8:30 a.m. to 5:00 p.m. to consider COVID-19 vaccine booster doses and vaccine strain selection to address variants. The meeting will be public and information on the meeting and how to submit comments can be found here.

CDC Recommends Additional COVID-19 Booster Shot for All Adults Over 50 and Immunocompromised Children 12 and Older

On March 29, the Centers for Disease Control and Prevention (CDC) recommended that all adults over 50 years of age and immunocompromised children 12 and older receive an additional COVID-19 booster shot.

HRSA Announces $4.5 Million to Support Community-Based Doulas

On April 1, the Health Resources and Services Administration (HRSA) announced that $4.5 million in funding would be available for hiring and training community-based doulas. The grant opportunity can be found here.

Proposed Rules

CMS Releases Proposed Rule with Updates for the Inpatient Psychiatric Facilities Prospective Payment System

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Fiscal Year 2023 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update and Quality Reporting.” The proposed rule would make updates to prospective payment rates, the outlier threshold and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF). The proposed rule would also establish a mitigation policy to facilitate the yearly changes in IPF payments. The changes are summarized in this CMS fact sheet. The proposed changes would be in effect from Oct. 1, 2022, to Sept. 30, 2023.

Public comments will be accepted until May 31, 2022.

CMS Releases Proposed Rule to Update the Hospice Wage Index, Payment Rate and Hospice Quality Reporting Requirements

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” The proposed rule would establish a mitigation policy to facilitate the yearly changes to the hospice wage index. The proposed rule would also update the hospice wage index, payment rates and aggregate cap amount for Fiscal Year 2023, and make changes to the Hospice Quality Reporting Program (HQRP). The changes are summarized in this CMS fact sheet.

Public comments will be accepted until May 31, 2022.

CMS Releases Proposed Rule to Update Medicare

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the Inpatient Rehabilitation Facility Quality Reporting Program.” The proposed rule would update Medicare payment policies and rates under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program for Fiscal Year 2023. The changes are summarized in this CMS fact sheet.

Public comments will be accepted until May 31, 2022.

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.

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 Telehealth and Quality of Care for Medicaid Beneficiaries

On March 31, the Government Accountability Office (GAO) published a report titled “CMS Should Assess Effect of Increased Telehealth Use on Beneficiaries’ Quality of Care.” The report found that Medicare beneficiaries increased their use of telehealth services during the COVID-19 pandemic. The report noted that the Centers for Medicare and Medicaid Services (CMS) does not collect information about the quality of care beneficiaries receive from telehealth services, and recommended that CMS do so.

GAO Report on the IHS Use of COVID-19 Relief Funds

On March 31, the Government Accountability Office (GAO) published a report titled “Indian Health Service: Relief Funding and Agency Response to COVID-19 Pandemic.” The report notes that the Indian Health Service (IHS) received $9 billion in COVID-19 relief funding, which was used to mitigate workforce and supply challenges.

GAO Report on Challenges to Accessing Mental Health Care

On March 29, the Government Accountability Office (GAO) published a report titled “Mental Health Care: Access Challenges for Covered Consumers and Relevant Federal Efforts.” The report found that many people face difficulties seeking in-network mental health providers that accept new patients. The report details federal efforts to address these challenges.

CMS Releases National Health Expenditure Report

On March 28, the Centers for Medicare and Medicaid Services (CMS) released the National Health Expenditure (NHE) report for the years 2021-2030. The report, which is published annually, is prepared by the CMS Office of the Actuary and shows health spending and predicts enrollment for the coming decade. The report found that national health spending in 2021 was less than in 2020. The predictions and findings in the report can be found summarized in this CMS fact sheet.

CONSISTENTLY DELIVERS