This Week in Washington: Senate Fails to Advance Bill Protecting Abortion Rights After Supreme Court Draft Opinion Leak

Congress

House

House Committee on Energy and Commerce Health Subcommittee Advances ARPA-H Bill

On May 11, the House Committee on Energy and Commerce Subcommittee on Health voted to advance the Advanced Research Projects Agency-Health (ARPA-H) Act. The bill would house the new ARPA-H agency within the Department of Health and Human Services (HHS). This differs from HHS’s earlier decision to place ARPA-H in the National Institutes of Health (NIH).

106 House Republicans Call on FDA and President Biden to Act on Baby Formula Shortage

On May 11, Rep. Cathy McMorris Rodgers (R-WA) led a group of 106 House Republicans in a letter to President Biden and Food and Drug Administration Commissioner Califf calling for information on the current baby formula shortage and how the administration plans to address it.

100 House Democrats Call on CMS to Ensure Medicaid Provider Choice for Abortion Providers

On May 10, Reps. Lizzie Fletcher (D-TX) and Cori Bush (D-MO) led a group of 100 House Democrats in a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure calling for CMS to enforce Medicaid’s free choice of provider requirement. The letter claims that a number of states have cut abortion providers out of state Medicaid programs, which violates federal law.

Committees Release Staff Report Detailing Emergent’s Failure to Meet Quality Standards for COVID-19 Vaccines

On May 10, the House Committee on Oversight Reform and the Select Subcommittee on the Coronavirus Crisis released a staff report on their joint investigation of Emergent BioSolutions, Inc.’s COVID-19 vaccine manufacturing failures. The report states that 400 million doses of COVID-19 vaccines were destroyed as a result of Emergent’s failure to meet quality standards at its Bayview facility. In addition, the report states that Emergent executives attempted to hide evidence of contamination to evade government oversight efforts.

Reps. McMorris Rodgers and Pallone Introduce Bill to Reauthorize Mental Health and Substance Abuse Programs

On May 6, Reps. Cathy McMorris Rodgers (R-WA) and Frank Pallone (D-NJ) introduced the Restoring Hope for Mental Health and Well-Being Act of 2022. The bill would reauthorize mental health and substance use disorder programs at the Health Resources and Services Administration (HRSA) and the Substance Abuse and Mental Health Services Administration (SAMHSA).

House Committee on Energy and Commerce Health Subcommittee Advances the Medical User Fee Reauthorization Legislative Package

On May 4, the House Energy and Commerce Committee published the legislative package that would reauthorize the Food and Drug Administration’s (FDA) medical product user fee programs. The legislative package reauthorizes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA) and the Medical Device User Fee Act (MDUFA), and will allow the FDA to continue collecting fees from drug and medical device manufacturers. Reauthorization of the user fee programs happens every five years.

On May 11, the House Committee on Energy and Commerce Subcommittee on Health voted unanimously to advance the user fee legislation to the full committee.

Reps. Rodgers, Brady, Crapo and Sen. Burr Write to CMS Expressing Concern with Coverage of Drugs to Treat Alzheimer’s Disease

On May 2, Reps. Cathy McMorris Rodgers (R-WA), Kevin Brady (R-TX) and Mike Crapo (R-ID) and Sen. Richard Burr (R-NC) wrote to the Centers for Medicare and Medicaid Services (CMS) expressing their concern with the agency’s decision to restrict coverage of current and future Alzheimer’s treatments. In the letter, the members express concern that this decision could reduce access to drugs to treat Alzheimer’s and could reduce the investment in research and development.

Senate

Sen. Sanders Introduces the Medicare for All Act of 2022

On May 12, Sen. Bernie Sanders (I-VT) introduced the Medicare for All Act of 2022. The bill would guarantee healthcare as a fundamental right to all Americans. The bill was cosponsored by Sens. Tammy Baldwin (D-WI), Richard Blumenthal (D-CT), Cory Booker (D-NJ), Kirsten Gillibrand (D-NY), Martin Heinrich (D-NM), Mazie Hirono (D-HI), Patrick Leahy (D-VT), Ben Ray Luján (D-NM), Ed Markey (D-MA), Jeff Merkley (D-OR), Alex Padilla (D-CA), Brian Schatz (D-HI), Elizabeth Warren (D-MA) and Sheldon Whitehouse (D-RI).

Senate Fails to Pass Bill That Would Codify Abortion Protections

On May 11, the Senate failed to pass a bill that would ensure abortion rights with a vote of 49-51. Sen. Joe Manchin (D-WV) and all Senate Republicans opposed the bill.

Sens. Cassidy and Murphy Introduce Bill to Reauthorize Mental Health and Substance Use Disorder Programs

On May 10, Sens. Bill Cassidy (R-LA) and Chris Murphy (D-CT) introduced the Mental Health Reform Reauthorization Act of 2022. The bill would reauthorize mental health and substance use disorder programs that were created under the Mental Health Reform Act. The programs are currently set to expire in September.

Sens. Schatz and Booker Call on FDA and NIH to Carry Out More Research on the Therapeutic Potential of Psychedelics

On May 10, Sens. Brian Schatz (D-HI) and Cory Booker (D-NJ) wrote to the Food and Drug Administration (FDA) Commissioner Robert Califf and National Institutes of Health (NIH) Acting Director Lawrence Tabak calling for more research into the potential therapeutic uses of psychedelics.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: CMS announces the 2023 Notice of Benefit and Payment Parameters Final Rule

Congress

House

Republican Healthy Future Task Force Announces Solutions to Drug Costs and Increasing Access to Cures

On April 29, the Healthy Future Task Force announced its solutions for lowering drug costs and increasing the availability of cures and therapies. The Healthy Future Task Force is a 17-member task force that is working to develop healthcare policy solutions that align with the Republican party’s healthcare agenda. The recently announced solutions focus on promoting medicines produced in the U.S., lowering out-of-pocket costs and reducing bureaucracy in healthcare.

A one-pager on the Healthy Future Task Force solutions can be found here.

Reps. Rodgers, Banks and Wenstrup Introduce Bill to Prohibit QALYs in Federal Programs

On April 28, Reps. Cathy McMorris Rodgers (R-WA), Jim Banks (R-IN) and Brad Wenstrup (R-OH) introduced the Protecting Health Care for All Patients Act. The bill would prohibit the use of quality-adjusted life years (QALYs) in all federal programs. QALYs are currently used in federal programs, except for Medicare, to determine if a treatment is cost-effective and should be covered. The representatives argue that the metric devalues treatments for disabled individuals and people with chronic illness.

Senate

Sen. Crapo and Rep. Brady Express Concern with Proposed “Family Glitch” Fix

On April 28, Sen. Mike Crapo (R-ID) and Rep. Kevin Brady (R-TX) wrote to the Secretary of the Treasury Department Janet Yellen expressing their concern with a recent proposed rule by the Internal Revenue Service (IRS) that presents a solution to the “family glitch” in the Affordable Care Act (ACA). In the letter, Sen. Crapo and Rep. Brady argue that the statutory language of the ACA cannot be changed in this manner, and the proposed rule does not consider the potential economic effect on employees and employers.

Sens. Hassan and Braun Call on FDA to Update Opioid Prescription Labels

On April 28, Sens. Maggie Hassan (D-NH) and Mike Braun (R-IN) wrote to the Food and Drug Administration (FDA) Commissioner Robert Califf calling for the FDA to update its policies for labeling opioid prescriptions. The senators recommended that the FDA update opioid labels by removing unsupported claims of long-term efficacy and taking off the term “abuse deterrent,” which can be misleading to consumers.

Sens. Durbin and Braun Introduce the Dietary Supplement Listing Act of 2022

On April 26, Sens. Dick Durbin and Mike Braun introduced the Dietary Supplement Listing Act of 2022. The bill would require dietary supplement manufacturers to list their products with the Food and Drug Administration (FDA) and provide basic information about ingredients and labels that would be made available to the public.

Sens. Rubio, Blackburn and Others Introduce Bill to Prohibit the President from Issuing a TRIPS Waiver Without Congressional Authorization

On April 26, Sens. Marco Rubio (R-FL), Marsha Blackburn (R-TN), Thom Tillis (R-NC), Tommy Tuberville (R-AL), Kevin Cramer (R-ND), Bill Hagerty (R-TN), Cynthia Lummis and Mike Lee (R-UT) introduced the No Free TRIPS Act. The bill would prohibit the president from engaging in negotiations or making any changes to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) without congressional authorization. The Biden administration has announced it would seek TRIPS waivers to increase global access to COVID-19 vaccines.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: White House Releases National Drug Control Strategy

 

Congress

House

Reps. Rodgers, Guthrie and Griffith Call on Secretary Becerra to Investigate Cause of Overdose Deaths

On April 20, Reps. Cathy McMorris Rodgers (R-WA), Brett Guthrie (R-KY) and Morgan Griffith (R-VA) wrote to Health and Human Services Department (HHS) Secretary Xavier Becerra calling for the Department to investigate the cause of overdose deaths in the U.S.

Reps. Porter, DeLauro and Schakowsky and Sen. Warren Call on CMS to Address Medicare Advantage Program Overpayments

On April 20, Reps. Katie Porter (D-CA), Rosa DeLauro (D-CT) and Jan Schakowsky (D-IL) along with Sen. Elizabeth Warren (D-MA) wrote to the Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure expressing their concern about overpayments to Medicare Advantage plans. The letter calls on CMS to mitigate payment increases to keep them in line with Medicare and increase transparency within Medicare Advantage.

Rep. Kelly Calls for Action on Medicaid Priorities

On April 18, Rep. Robin Kelly (D-IL), on behalf of the Congressional Tri-Caucus, wrote to President Biden and congressional leadership calling for the inclusion of four Medicaid provisions in the next economic reconciliation agreement. The four policies Rep. Kelly is pursuing include: 12 months of continuous Medicaid and Children’s Health Insurance Program (CHIP) eligibility, 12 months of Medicaid and CHIP postpartum coverage and a solution to close the Medicaid coverage gap in states that have not expanded coverage.

Reps. Buchanan, Kelly and Wenstrup Reintroduce the American Innovation Act

On April 18, Reps. Vern Buchanan (R-FL), Mike Kelly (R-PA) and Brad Wenstrup (R-OH) reintroduced the American Innovation Act. The bill, which passed the House in 2018 with bipartisan support, aims to facilitate the creation of American drug companies by providing special tax treatment.

Senate

Sens. Whitehouse and Markey Ask NIH About Slow Pace of Long COVID Research

On April 20, Sens. Sheldon Whitehouse (D-RI) and Edward Markey (D-MA) wrote to the Acting Director of the National Institutes of Health (NIH) Lawrence Tabak requesting information on why research into post-acute sequelae of SARS-CoV-2 infection, or “long COVID,” is taking such a slow pace. In the letter, the senators note that Congress requested that the NIH study the long-term effects of COVID-19 over two years ago.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: COVID-19 Public Health Emergency Extended for 90 More Days

Congress

The House and Senate are in a district work period this week.

Senate

Bipartisan Group Calls on Naloxone Manufacturers to Apply for Over-the-Counter Status

On April 12, Sens. Tammy Baldwin (D-WI), Maggie Hassan (D-NH) and Angus King (I-ME) along with Reps. Carolyn Maloney (D-NY) and Brian Fitzpatrick wrote to seven manufacturers of naloxone, encouraging them to apply for over-the-counter status. Naloxone is an opioid reversal medication that is currently unavailable over the counter. The members stressed that making naloxone more easily accessible would save lives.

Sen. Murray Writes to FDA Calling for Action on Food Safety

On April 11, Sen. Patty Murray (D-WA) wrote to Food and Drug Administration (FDA) Commissioner Robert Califf asking for additional information regarding delays at the FDA’s food safety and nutrition center. Sen. Murray cited her concern regarding FDA’s delayed action on contaminated infant formula, as well as delayed inspections and recalls.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: President Biden Releases Budget Request

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.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

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


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.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

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

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.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Congress Passes Appropriations to Fund Government Through Fiscal Year 2023


Congress

House and Senate Pass FY 2022 Omnibus Appropriations Package

On March 9, the House of Representatives passed the Fiscal Year (FY) 2022 omnibus appropriations package. That vote was followed by Senate passage the next day. The appropriations package totals $1.5 trillion in funding, which includes approximately $14 billion for assistance to Ukraine. Notably, a measure that would have allocated $15 billion for COVID-19 relief was cut from the package after members opposed the way in which it was funded.

President Biden is likely to sign the appropriations package into law this week.

The appropriations package allocates $108.3 billion to the Department of Health and Human Services (HHS), an increase of $11.3 billion from the year prior. This total includes:

  • $1 billion to establish Advanced Research Projects Agency for Health (ARPA-H) within the HHS Office of the Secretary to accelerate scientific breakthroughs for ALS, Alzheimer’s disease, diabetes and cancer, among other diseases.
  • $45 billion for the National Institutes of Health (NIH), an increase of $2.25 billion from FY 2021.
  • $8.5 billion for the Centers for Disease Control and Prevention (CDC), an increase of $582 million from FY 2021.
  • $6.5 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA), an increase of $530 million from FY 2021.
  • $4 billion for the Centers for Medicare and Medicaid Services’ (CMS) administrative expenses, an increase of $50 million from FY 2021

In addition, the appropriations package extends pandemic health emergency (PHE) telehealth waivers to 151 days past the end of the PHE, continuing the Medicare originating site flexibility. The package also requires HHS, CMS and the Office of the Inspector General (OIG) to study telehealth utilization and develop recommendations and reforms to prevent fraud by June 15, 2023. The package also includes a provision to allow hospitals to file attestations to maintain their 340B eligibility even if their payer mixes would typically disqualify them from the 340B program. In addition, the appropriations package allocates $30 million to improve maternal health and would extend higher Medicaid funding for U.S. territories until Dec. 13. The package would also give the FDA the authority to regulate synthetic nicotine.

The 2022 Appropriations bill can be found here.

The report language on the Departments of Labor, Health and Human Services, Education and Related Agencies can be found here.

The House Appropriations Committee’s summary of the Appropriations language related to Labor, Health and Human Services, Education and related agencies can be found here.

House

Rep. DeLauro Introduces Standalone COVID-19 Relief Bill

On March 9, House Appropriations Committee Chair Rosa DeLauro (D-CT) introduced the Coronavirus Supplemental Appropriations Act, a standalone bill that would provide $15.6 billion to continue managing the COVID-19 pandemic. The bill does not include any offsets from state and local fiscal relief funds. This bill was introduced after a measure that would have allocated $15 billion for COVID-19 relief efforts was cut from the Appropriations package that passed the House of March 9.

The bill text can be found here.

Rep. Moulton Introduces Bill to Facilitate Veterans’ Use of Medical Marijuana

On March 8, Rep. Seth Moulton (D-CT) introduced a bill that aims to increase veterans’ use of medical marijuana to treat post-traumatic stress disorder, anxiety and chronic pain. The bill would require the Veterans’ Affairs (VA) medical providers to acknowledge medical cannabis as a legitimate alternative treatment and establish legal protections so veterans who use cannabis do not lose their benefits. The bill would also establish partnerships and programs to train VA providers on medical marijuana and medical cannabis.

The bill text can be found here.

Rep. Pallone Introduces Bill to Strengthen Requirements for the FDA’s Accelerated Approval Program

On March 7, Rep. Frank Pallone (D-NJ), chair of the House Energy and Commerce Committee, introduced the Accelerated Approval Integrity Act, which would provide the Food and Drug Administration (FDA) with additional authority to ensure that drugs that receive accelerated approval provide a clinical benefit to patients. The bill would require manufacturers to carry out post-approval studies on drugs that receive accelerated approval, and also require manufacturers and the FDA to agree on the parameters of these studies prior to the FDA’s granting accelerated approval. In addition, the bill outlines procedures for withdrawing accelerated approval, and when this would occur.

The bill text can be found here.

House Energy and Commerce to Discuss Health Legislation

The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight” on March 17 at 10:30 a.m. The hearing will include a discussion of a number of healthcare bills, which can be found below.

  • R. 1730, the Speeding Therapy Access Today Act of 2021
  • R. 2565, the FDA Modernization Act of 2021
  • R. 3085, the Equity in Neuroscience and Alzheimer’s Clinical Trials (ENACT) Act of 2021
  • R. 3927, the Manufacturing API, Drugs, and Excipients (MADE) in America Act 
  • R. 4472, the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act of 2021 
  • R. 4511, the FDA Advancing Collection of Transformative Science (FACTS) Act
  • R. 5030, the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act
  • R. 5566, the Finding Orphan-disease Remedies With Antifungal Research and Development (FORWARD) Act of 2021
  • R. 5585, the Advanced Research Project Agency–Health (ARPA-H) Act
  • R. 6000, the Cures 2.0 Act
  • R. 6584, the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act
  • R. 6888, the Helping Experts Accelerate Rare Treatments Act of 2022
  • R. 6963, the Accelerated Approval Integrity Act of 2022
  • R. 6972, the Give Kids a Chance Act
  • R. 6973, the Enhanced Access to Affordable Medicines Act
  • R. 6988, the Drug Manufacturing Innovation Act
  • R. 6996, the Accelerating Access for Patients Act
  • R. 7006, the Improving the Nation’s Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies (INSPECTIONS) Act 
  • R. 7008, the Pre-Approval Information Exchange Act
  • R. 7032, the Increasing Transparency in Generic Drug Applications Act
  • R. 7035, the Biologics Market Transparency Act
  • R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes

Senate

Sens. Murphy and Stabenow and Reps. Porter and Dingell Introduce Bill to Close Health Coverage Gaps for Public Servants

On March 11, Sens. Chris Murphy (D-CT) and Debbie Stabenow (D-MI) along with Reps. Katie Porter (D-CA) and Debbie Dingell (D-MI) introduced the Closing Health Coverage Gaps for Public Servants Act. The bill would sunset self-funded nonfederal governmental health plans from opting out of federal parity requirements for behavioral healthcare. This would apply to health plans for firefighters, police, public school teachers and state and city workers. In addition, the bill would expand coverage for postmastectomy reconstructive surgery and mother and newborn standards.

The bill text can be found here.

Sens. Capito and Shaheen and Reps. McKinley and Thompson Introduce Bill to Increase Access to Prescription Digital Therapeutics

On March 10, Sens. Shelley Moore Capito (R-WV) and Jeanne Shaheen (D-NH) along with Reps. David McKinley (R-WV) and Mike Thompson (D-CA) introduced the Access to Prescription Digital Therapeutics Act of 2022. The bill aims to extend Medicare coverage to prescription digital therapeutics (PDTs), which are software-based disease treatments that provide cognitive therapy and are prescribed by providers. PDTs can be used to treat a number of diseases and conditions, including substance use disorders, behavioral health issues, diabetes and Parkinson’s disease.

The bill text can be found here.

Sen. Grassley Calls on FTC Commissioner to Study PBM Practices

On March 9, Sen. Chuck Grassley (R-IA), Ranking Member of the Senate Judiciary Committee, wrote to Federal Trade Commission (FTC) Chair Lina Khan regarding the FTC’s Feb. 17 deadlocked vote on whether to initiative a study into pharmacy benefit managers’ (PBMs) business practices. In the letter, Sen. Grassley called on Chair Khan to move forward with a study to investigate PBM practices. He said that this study would determine how PBMs determine prescription drug prices and lead to a better understanding of how money flows in the prescription drug marketplace.

The letter can be found here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

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

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.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: President Biden Selects Judge Ketanji Brown Jackson to Nominate to the Supreme Court

Congress

House

Rep. McMorris Rodgers and Sen. Burr Oppose Additional $3 Billion for HRSA’s Uninsured Program

On Feb. 22, Rep. Cathy McMorris Rodgers (R-WA) and Sen. Richard Burr (R-NC) wrote to the Department of Health and Human Services (HHS) Secretary Xavier Becerra regarding the Health Resources and Services Administration’s (HRSA) uninsured program, which is used to reimburse providers for COVID-19 testing, treatments and vaccines to individuals without health insurance. Rep. McMorris Rodgers and Sen. Burr noted that Congress has already allocated $18.3 billion for this program through the provider relief fund, and stated that they oppose the Biden administration’s request for an additional $3 billion.

The full letter can be found here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.