This Week in Washington: Supreme Court Rules in Favor of 340B Hospitals, FDA Approves COVID-19 Vaccines for Children Under Five

Congress

House

House Veterans Affairs Committee to Hold Legislative Hearing on Healthcare Bills

On June 22, the House Committee on Veterans Affairs Subcommittee on Health will hold a legislative hearing on the following bills related to healthcare:

  • H.R. 291, the VA COST SAVINGS Enhancements Act,
  • H.R. 345, the Reproductive Health Information for Veterans Act,
  • H.R. 1216, the Modernizing Veterans’ Health Care Eligibility Act,
  • H.R. 1957, the Veterans Infertility Treatment Act of 2021,
  • H.R. 6273, the VA Zero Suicide Demonstration Project Act of 2021, and
  • H.R. 7589, the REMOVE Copays Act.

House Rules Committee to Consider Four Healthcare Bills

On June 21, the House Rules Committee will meet to discuss the following four healthcare bills. Bills typically go to the House Rules Committee before they go to the House floor, as the Rules Committee sets rules that govern how the bills will be considered.

Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies Votes to Approve FY 2023 Funding Bill

On June 15, the House Appropriations Committee Subcommittee on Agriculture, Rural Development, Food and Drug Administration (FDA) and Related Agencies approved the fiscal year 2023 funding draft bill. The bill provides $27.2 billion in funding, an increase of $2.075 billion from 2022, and includes measures to strengthen the safety of the baby formula market, add more fruits and vegetables to government nutrition assistance programs, invest in rural broadband and fund grants to promote equitable participation in USDA programs. The full Appropriations Committee will mark up the bill on June 23.

Reps. Pallone and Scott Call on FTC to Protect Consumers Buying Infant Formula Online

On June 13, Reps. Frank Pallone (D-NJ) and Bobby Scott (D-VA) wrote to the Federal Trade Commission (FTC) calling on the agency to address the failure of online marketplaces to protect consumers from fraudulent and deceptive practices in the sales of infant formula.

Senate

Senate Commerce Committee to Consider Healthcare Bills

On June 22, the Senate Commerce Committee will hold an executive session on a number of bills. The bills to be considered that are related to healthcare can be found below.

  • S. 2510, Preventing HEAT Illness and Deaths Act of 2021, and
  • S. 4293, Pharmacy Benefit Manager Transparency Act of 2022.

Senate Passes Bill to Expand Veterans’ Access to Healthcare Related to Burn Pit Exposure

On June 16, the Senate voted 84-14 to pass the Honoring our Promise to Address Comprehensive Toxics (PACT) Act, which would require the Department of Veterans Affairs to cover veterans’ healthcare services related to toxic exposure due to burn pits. The bill now goes to President Biden’s desk to be signed.

Sens. Wyden, Crapo, Carper and Cassidy Release Discussion Draft on Youth Mental Health

On June 15, Sens. Ron Wyden (R-OR), Mike Crapo (R-ID), Tom Carper (D-DE) and Bill Cassidy (R-LA) released a discussion draft on youth mental health policies. The discussion draft includes policies that would allow all providers to receive Medicaid reimbursement for behavioral and physical health services on the same day, update Medicaid guidance on mental health care in schools and improve oversight of Medicaid’s Early and Periodic Screening, Diagnostic and Treatment benefit.

Sens. Murray, Cantwell and Casey Call on FTC to Investigate Retail Chains’ Infant Formula Pricing Practices

On June 14, Sens. Patty Murray (D-WA), Maria Cantwell (D-WA) and Bob Casey (D-PA) wrote to the Federal Trade Commission (FTC), directing the agency to investigate whether national retail chains have engaged in unfair practices by raising specialized infant formula prices during the shortage.

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

This Week in Washington: House Passes FDA User Fee Reauthorization Package

 

Congress

House

House to Consider the ARPA-H Act

On June 20, the House will consider H.R. 5585, the Advanced Research Projects Agency-Health (ARPA-H) Act. The bill would establish ARPA-H, a new biomedical research agency, within the Department of Health and Human Services (HHS). The bill would also require ARPA-H to coordinate with the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on product and coverage decisions, and would allocate $5 million to fund the agency. The ARPA-H Act would override HHS’s recent decision to place ARPA-H in the National Institutes of Health (NIH).

House Passes FDA User Fee Reauthorization Package

On June 8, the House voted 392-28 to pass the Food and Drug Amendments of 2022, which would reauthorize the Food and Drug Administration (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs. The legislation would require sponsors to begin post-approval studies before drugs go on the market and for manufacturers to develop a clinical trial diversity action plan. In addition, the legislation would extend additional hiring flexibility to the FDA.

Reps. Hoyer and Clyburn Call in Op-Ed for Preserving American Rescue Plan Premium Tax Credits

On June 7, House Majority Leader Steny Hoyer (D-MD-05) and Majority Whip James Clyburn (D-SC-06) wrote an op-ed in The Hill titled “Congress must not forget about protecting access to affordable health coverage.” In the article, Reps. Hoyer and Clyburn stressed the importance of preserving the American Rescue Plan premium tax credits.

Rep. Jacobs Introduces Bill to Protect Reproductive Health Data

On June 2, Rep. Sara Jacobs (D-CA-35) introduced the My Body, My Data Act. The bill would create a national standard to protect personal reproductive health data, enforced by the Federal Trade Commission. The bill would prevent reproductive health data that is collected from being disclosed or misused. This bill is introduced amid concerns that reproductive health data could be used to target people if the Supreme Court overturns Roe v. Wade.

Senate

Senate HELP Committee to Discuss Four Bills

On June 14, the Senate Health, Education, Labor and Pensions (HELP) Committee will hold an executive session to discuss four bills. The bills can be found below.

  • 4353, Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg (RISE and SHINE) Act
  • R. 1193, Cardiovascular Advances in Research and Opportunities Legacy Act
  • 4052, Early Hearing Detection and Intervention Act of 2022
  • 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act
  • 958, Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act

Sen. Barrasso Leads 25 Senators in a Letter to HHS Calling for Clarification on PHE Unwinding

On June 10, Sen. John Barrasso (R-WY) and 24 other senators sent a letter to Secretary of Health and Human Services (HHS) Xavier Becerra calling for HHS to clarify its plans for transitioning out of the COVID-19 public health emergency (PHE).

Sen. Wyden and Rep. Pallone Call on CMS To Ensure Provider Choice for Medicaid Beneficiaries

On June 8, Sen. Ron Wyden (D-OR) and Rep. Frank Pallone (D-NJ) wrote to the Administrator of the Centers for Medicare and Medicaid Services (CMS) Chiquita Brooks-LaSure expressing their concern about state efforts to exclude Planned Parenthood and other family planning providers from Medicaid. Sen. Wyden and Rep. Pallone note that this violates federal law, and called on CMS to take measures to ensure that Medicaid beneficiaries can access services from the providers they choose.

Sens. Leahy and Cornyn Call on Patent and Trade Office to Address Patent Thickets

On June 8, Sens. Patrick Leahy (D-VT) and John Cornyn (R-TX) led six senators in a letter to the U.S. Patent and Trademark Office (USPTO). In the letter, the senators call for the USPTO to address patent thickets, which is defined as a large number of patents that cover a single product, extending patent protections for longer. The senators raised concerns that patent thickets were negatively impacting competition in the pharmaceutical sector.

18 Members of Congress Write to FDA Expressing Concern with Method of Authorizing COVID-19 Vaccines for Children

On June 7, Sens. Ron Johnson (R-WI) and Ted Cruz (R-TX), along with Rep. Bill Posey (R-FL) and Rep. Louie Gohmert (R-TX), led a group of 18 members of Congress in a letter to the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). In the letter, the members raise concerns about the Centers for Disease Control and Prevention (CDC) and the FDA’s approach to emergency use authorizations of COVID-19 vaccines for children under five.

Sens. Rosen and Young Introduce Bill to Improve Medical Device Cybersecurity

On June 3, Sens. Jacky Rosen (D-NV) and Todd Young (R-IN) introduced the Strengthening Cybersecurity for Medical Devices Act. The bill would require the Food and Drug Administration (FDA) to update medical device cybersecurity guidelines to better protect devices from possible cyberattacks.

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

This Week in Washington: HHS Withdraws SUNSET Final Rule

 

Congress

The House and Senate are in recess for Memorial Day.

House

Rep. Underwood Leads 26 Democratic House Members in Letter Calling for Measures to Lower Healthcare Costs to be Included in Reconciliation Package

On May 23, Rep. Lauren Underwood (D-IL) led a group of 26 Democratic House members in a letter to Speaker Nancy Pelosi (D-CA) and Chuck Schumer (D-NY). In the letter, Rep. Underwood called on House leadership to include measures to lower healthcare costs and expand Medicaid coverage in the upcoming reconciliation legislation. The letter also expressed support for a permanent expansion of the enhanced advance premium tax credits.

Senate

Senate Finance Committee Releases Tele-Mental Health Discussion Draft

On May 26, Senators Ron Wyden (D-OR), Mike Crapo (R-ID), Ben Cardin (D-MD) and John Thune (R-SD) released a discussion draft for one of the committee’s mental health initiatives, tele-mental health. This is the first portion of the committee’s work on mental health to be released since the committee began working on mental health policies in February.

The discussion draft includes policies that would:

  • Remove Medicare’s in-person visit requirement for tele-mental health services.
  • Establish benefit transparency for mental health care services delivered via telehealth to inform Americans with Medicare how and when they can access telehealth.
  • Preserve access to audio-only mental health coverage in Medicare when necessary and appropriate.
  • Direct Medicare and Medicaid to promote and support provider use of telehealth.
  • Incentivize states to use their CHIP programs to establish local solutions to serve behavioral health needs in schools, including through telehealth.

Sens. Kaine, Collins, Hassan and Portman Introduce Bill to Increase Interchangeable Biosimilar Competition

On May 25, Sens. Tim Kaine (D-VT), Susan Collins (R-ME), Maggie Hassan (D-NH) and Rob Portman (R-OH) introduced the Interchangeable Biologics Clarity Act. The bill would allow multiple interchangeable biosimilars to share exclusivity if they are approved on the same day. In addition, the bill clarifies that the Food and Drug Administration (FDA) can tentatively approve interchangeable biosimilars while an earlier interchangeable products exclusivity is still pending. The goal of these changes is to speed the rate that interchangeable biosimilars are brought to market.

Sens. Cantwell and Grassley Introduce Bill to Increase Drug Pricing Transparency and Increase Scrutiny of PBMs

On May 24, Sens. Maria Cantwell (D-WA) and Chuck Grassley (R-IA) introduced the Pharmacy Benefit Manager Transparency Act of 2022. The bill would ban pharmacy benefit managers (PBMs) from receiving money back that they have paid to pharmacies for dispensing drugs, unless the concessions are disclosed to health plans and payers and the PBMs share relevant price, reimbursement and rebate information. In addition, the bill would provide the Federal Trade Commission (FTC) with increased authority to improve drug pricing transparency.

FDA User Fee Bill Introduced in the Senate

The Senate Health, Education, Labor and Pensions (HELP) Committee Chair Senator Patty Murray (D-WA) and Ranking Member Senator Richard Burr (R-NC) introduced the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act which would reauthorize the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee agreements. The legislation also includes provisions to strengthen oversight of cosmetics and dietary supplements, modernize the regulation of diagnostic tests, bring more competition to the market, and prepare the FDA for the next generation of medical products.

The Senate FDA user fee bill includes accelerated approval reforms that mirror the House user fee bill with the addition of a new measure to create an “intra-agency coordinating council” to ensure uniform usage of accelerated approvals. This council would periodically review accelerated approvals and issue guidance to ensure that they are applied in a consistent manner.

Legislation Introduced to Study Impact of Non-Profit Drug Manufacturers

On May 27, Sens. Jacky Rosen (D-NV) and Mitt Romney (R-UT) introduced The Advancing Affordable Medicines for Families Act, which would direct the Government Accountability Office (GAO) to study the impact of nonprofit generic drug makers on the drug industry and the barriers to their prominence. The bill would require the GAO to report to Congress on the impact of nonprofit drug makers on drug affordability, drug shortages and patient and federal drug spending. The GAO also would investigate ways nonprofit drug makers could speed development of generics, biosimilars and new biologic drugs and to identify barriers to capital.

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

This Week in Washington: President Biden Invokes Defense Production Act to Increase Supply of Infant Formula

Congress

House

House Passes Bill to Help the FDA Address the Infant Formula Shortage

On May 18, the House passed a supplemental appropriations bill that would provide $28 million in emergency funding to help the Food and Drug Administration (FDA) address the current infant formula shortage. The funding would help the FDA increase the number of inspection staff and provide additional resources to personnel working on formula issues.

The Congressional Budget Office (CBO) published a cost estimate of the bill the same day.

House Energy and Commerce Committee Advances User Fee Legislation

On May 18, the House Energy and Commerce Committee voted unanimously to pass the comprehensive user fee legislation. The bill, the Food and Drug Amendments of 2022, now goes to the House floor. If approved, the bill would allow the Food and Drug Administration (FDA) to collect funds from industry, which could be used to hire new reviewers.

On May 17, the Senate Health, Education, Labor and Pensions Committee released a bipartisan draft bill to reauthorize the FDA’s user fee programs. The Senate discussion draft has a further reach than the House legislation.

Rep. Robin Kelly Introduces Bill to Increase Diversity of NIH-Funded Clinical Trials

On May 19, Rep. Robin Kelly (D-IL) introduced the NIH Clinical Trial Diversity Act, which would increase the diversity of National Institutes of Health (NIH)-funded trial participants. The bill is cosponsored by Reps. Brian Fitzpatrick (R-PA), Yvette Clarke (D-NY), Tony Cárdenas (D-CA) and G.K. Butterfield (D-NC).

Rep. Schakowsky Introduces Bill to Reduce Exclusivity Period for Brand-Name Biologics to 5 Years

On May 18, Rep. Jan Schakowsky (D-IL) introduced a bill that would amend the Public Health Service Act to shorten the exclusivity period for brand-name biological products from 12 years to 5 years. The bill has seven Democratic cosponsors.

Senate

Sens. Baldwin and Capito Introduce Bill to Improve the Palliative and Hospice Care Workforce

On May 19, Sens. Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV) reintroduced the Palliative Care and Hospice Education and Training Act. The bill aims to improve the palliative and hospice care workforce.

Sen. Bennet Introduces Bill to Reduce Healthcare Costs for Retired Public Safety Officers

On May 19, Sen. Michael Bennet introduced the Public Safety Officer Health Improvement Act. The bill would reduce the healthcare costs for retired public safety officers who are not yet eligible for Medicare by creating a tax credit of up to $4,800.

30 Democratic Senators Call on President Biden to Assign a White House Infant Formula Coordinator

On May 18, Sens. Patty Murray (D-WA) and Bob Casey (D-PA) led 30 Democratic senators in a letter calling on President Biden to assign a White House coordinator on infant formula to address the current shortage. In addition, the senators call for a national strategy to increase the infant formula supply chain resiliency.

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

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.