This Week in Washington: The Senate waits to see if budget reconciliation agreement has enough votes to pass.

Congress

House

House Passes Three Healthcare Bills

On July 27, the House of Representatives voted to pass three healthcare bills. Information on the bills and their content can be found below.

More Than 100 Members Call for Additional Funding to Aid Health Clinics’ Monkeypox Response

On July 25, Reps. Jerrold Nadler (D-NY) and David Cicilline (D-RI) led a group of more than 100 members of Congress in a letter to President Biden, Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky. In the letter, the members commended recent actions to improve monkeypox vaccine distribution and expand testing capacity, and requested that additional funding be provided to support health clinics.

Senate

Sen. Leahy Releases Appropriations Package

On July 28, Sen. Pat Leahy (D-CT) released 12 appropriations bills. The legislation would provide $10.5 billion for the Centers for Disease Control and Prevention and $1.4 billion for the Mental Health Block Grant. Sens. Leahy, Patty Murray (D-WA) and Chris Coons (D-DE) also introduced a $21 billion emergency supplemental funding bill to address the ongoing COVID-19 pandemic. Additional information on the Labor, Health and Human Services, Education, and Related Agencies section of the Appropriations package can be found below.

Sens. Manchin and Schumer Reach Agreement on Budget Reconciliation

On July 27, Senate Majority Leader Chuck Schumer (D-NY) announced that he had reached an agreement with Sen. Joe Manchin (D-WV) on the Fiscal Year (FY) 2022 Budget Reconciliation Package. As part of the agreement, the Inflation Reduction Act of 2022 will be added to the FY 2022 Budget Reconciliation bill. The agreement revives the reconciliation package, which was previously thought to be dead as it did not have enough votes. Votes will be held on the new reconciliation package next week. Information on the Inflation Reduction Act of 2022 can be found below.

Five Senate Democrats Introduce Bill to Allow U.S. Foreign Assistance for Abortion Care Abroad

On July 27, Sens. Cory Booker (D-NJ), Tammy Duckworth (D-IL), Mazie Hirono (D-HI), Tina Smith (D-MN) and Richard Blumenthal (D-CT) introduced the Abortion is Health Care Everywhere Act. The bill would ensure that U.S. foreign assistance could be used to provide comprehensive healthcare, including abortion services, by repealing the 1973 Helms Amendment to Foreign Assistance Act.

Sen. Hassan Calls for No Surprises Act to be Extended to Additional Facilities

On July 25, Sen. Maggie Hassan (D-NH) wrote a letter to the Health and Human Services Secretary Xavier Becerra, Labor Secretary Marty Walsh and Treasury Secretary Janet Yellen calling for additional surprise medical billing protections. Sen. Hassan called for the protections in the No Surprises Act to be extended to all relevant facilities, including birthing centers, clinics, hospice facilities, nursing homes, urgent care centers and addiction treatment centers.

Sen. Peters Calls on HHS and DHS to Clarify Guidance on the Importation of and Travel with Abortion Medication

On July 21, Sen. Gary Peters (D-MI) wrote to the Secretary of Health and Human Services (HHS) Xavier Becerra and Secretary of Homeland Security (DHS) Alejandro Mayorkas, calling on them to more proactively protect reproductive healthcare. In his letter, Sen. Peters asked for HHS and DHS to clarify guidance on the importation of abortion medication and travel with abortion medication.

Sens. Schumer, Wyden and Booker Introduce Bill to Remove Cannabis from the Federal List of Controlled Substances

On July 21, Sens. Chuck Schumer (D-NY), Ron Wyden (D-OR) and Cory Booker (D-NJ) introduced the Cannabis Administration and Opportunity Act (CAOA), which would remove cannabis from the federal list of controlled substances. The bill would also establish a Center for Cannabis Products at the Food and Drug Administration (FDA) to regulate the cannabis industry. A summary of the bill can be found here.

Sen. Klobuchar Calls on FTC to Investigate Amazon’s Proposed Acquisition of One Medical

On July 21, Sen. Amy Klobuchar (D-MN) wrote to Federal Trade Commission (FTC) Chair Lina Khan calling for an investigation into Amazon’s proposed acquisition of One Medical. Sen. Klobuchar expressed concern that the acquisition would harm competition and could have negative implications for personal health data.

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

This Week in Washington: Sen. Manchin Expresses Support for a More Limited Budget Reconciliation Package That Includes Health Provisions

Congress

House

House Energy and Commerce Committee Passes the Lymphedema Treatment Act

On July 13, the House Energy and Commerce Committee passed the Lymphedema Treatment Act by a voice vote. The bill would extend Medicare coverage to lymphedema compression treatment items.

Rep. Rosa DeLauro and Sen. Dick Durbin Introduce Bill to Create a New Food Safety Administration

On July 13, Rep. Rosa DeLauro (D-CT-03) and Sen. Dick Durbin (D-IL) introduced the Food Safety Administration Act, which would transfer the Food and Drug Administration’s food authorities to a new agency within the Department of Health and Human Services (HHS) called the Food Safety Administration.

Reps. Eshoo and Pallone Call for USPSTF Process Reevaluation

On July 13, Reps. Anna Eshoo (D-CA) and Frank Pallone (D-NJ) wrote to Secretary of Health and Human Services (HHS) Xavier Becerra calling for a reevaluation of the United States Preventive Services Taskforce (USPSTF) process to improve patient access to preventative services. The USPSTF is a volunteer panel of disease prevention experts that makes recommendations related to clinical preventative services. Private insurers are required to cover preventative services that receive a grade A or B from the USPSTF with no cost-sharing. In the letter, Reps. Eshoo and Pallone argue that time lapses between USPSTF recommendations and decreased funding have resulted in a disconnect between best clinical practices and the most recent USPSTF recommendations.

Energy and Commerce Committee Leadership Request Update on FDA’s Efforts to Improve Food Safety

On July 12, Reps. Cathy McMorris Rodgers (R-WA), Frank Pallone (D-NJ), Brett Guthrie (R-KY), Anna Eshoo (D-CA), Morgan Griffith (R-VA) and Diana DeGette (D-CO) wrote to Food and Drug Administration (FDA) Commissioner Robert Califf requesting an update on the agency’s plans to improve food safety. The members cited concerns with the FDA’s recent handling of the infant formula shortage.

Rep. Huffman Introduces Bill to Increase HCSM Transparency

On July 11, Rep. Jared Huffman (D-CA) introduced the Health Share Transparency Act, which would provide consumers with information directly before they enroll in Health Care Sharing Ministry (HCSM) coverage, in an effort to prevent deceptive practices. Health Care Sharing Ministries are organizations in which healthcare costs are shared among members, who are typically of the same religious group. HCSM members generally contribute monthly payments to cover the expenses of other members. The bill also includes measures to hold accountable HCSMs that fail to make timely disclosures. In a press release, Rep. Huffman argued that HCSMs sometimes take advantage of citizens seeking care, and use their religious basis to avoid regulation.

Senate

Sen. Manchin Expresses Support for Limited Budget Reconciliation Package

On July 14, Sen. Joe Manchin (D-WV) said he would only support a budget reconciliation package with provisions that permit two years of Affordable Care Act (ACA) tax credits and Medicare drug price negotiations. Sen. Manchin’s position means that Democrats will have to decide whether to support a less ambitious reconciliation package that leaves out measures to address the Medicare trust fund tax loophole and the Medicaid gap. Manchin has said he will not support other provisions related to climate change and tax changes. The tight margins in the Senate mean that Sen. Manchin’s vote is needed to pass the reconciliation package.

Sens. Warren, Booker and Padilla Call for Declaration of National and Public Health Emergency Due to Restrictions to Reproductive Care

On July 14, Sens. Elizabeth Warren (D-MA), Cory Booker (D-NJ) and Alex Padilla (D-CA) led a group of 18 Senate Democrats in a letter to President Biden and Health and Human Services (HHS) Secretary Xavier Becerra calling for the declaration of a national and public health emergency due to Americans’ lack of access to reproductive care. In the letter, the senators state that declaring a national and public health emergency would ensure that abortion and reproductive care are available and affordable.

Sen. Burr Introduces New Bill to Reauthorize FDA User Fee Programs

On July 14, Sen. Richard Burr (R-NC) introduced the Food and Drug Administration Simple Reauthorization Act. The bill would reauthorize the Food and Drug Administration’s (FDA) prescription, generic, biosimilar and medical device user fee agreements. Sen. Burr’s bill is a narrower version of the Food and Drug Administration Safety and Landmark Advancements Act, which passed the Senate Health, Education, Labor and Pensions Committee in June. Sen. Burr’s version does not contain measures granting the FDA authority to regulate cosmetics, dietary supplements, laboratory-developed tests and other measures that he believes could stifle innovation. Sen. Patty Murray (D-WA), Chair of the Health, Education, Labor and Pensions Committee which has jurisdiction over the FDA stated she was still interested in the broader bill the committee produced. Reps. Frank Pallone (D-NJ) and Cathy McMorris Rodgers (R-WA) stated that Sen. Burr’s bill will only delay the user fee reauthorization process. If the user fee reauthorization is not passed by September, a number of FDA programs will be disrupted and staff will have to be let go.

Sens. Feinstein, Murray and Warren Ask for Robust Funding for the Title X Family Planning Program

On July 13, Sens. Dianne Feinstein (D-CA), Patty Murray (D-WA) and Elizabeth Warren (D-MA) led a group of 15 senators in a letter to congressional leadership calling for robust funding for the Title X Family Planning Program. The senators argued that the Title X Family Planning Program, which provides birth control and family planning services, needs more funding now that 19 states have moved to impose bans or severe restrictions on abortion. A companion letter in the House was led by Reps. Judy Chu, Dina Titus (D-NV), Chrissy Houlahan (D-PA), Diana DeGette (D-CO) and Barbara Lee (D-CA) and was signed by 128 members.

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

This Week in Washington: CMS Releases the Physician Fee Schedule Proposed Rule

 

Congress

House

House Rules Committee to Discuss Two Healthcare Bills

On June 12, the House Rules Committee will meet to discuss the Women’s Health Protection Act of 2022 and the Ensuring Access to Abortion Act of 2022. In the meeting, the Rules Committee will decide matters related to the bills’ House floor discussion, including the length of the discussion, any amendments, and other relevant measures.

Reps. Fletcher, Strickland and Raskin Introduce Bill to Protect Americans Traveling for Abortion Services

On July 7, Reps. Lizzie Fletcher (D-TX), Marilyn Strickland (D-WA) and Jamie Raskin (D-MD) introduced the Ensuring Access to Abortion Act of 2022. The bill would prohibit anyone operating under state law from punishing Americans who travel for reproductive healthcare.

House Appropriations Committee Advances the FY 2023 Labor, HHS, Education and Related Agencies Funding Bill

On June 30, the House Appropriations Committee voted to advance the Fiscal Year (FY) 2023 Labor, Health and Human Services (HHS), Education and Related Agencies funding bill. The bill provides $242.1 billion in funding, an increase of $28.5 billion over the 2022 amount. A bill summary can be found here.

Senate

Senate Democrats Release Text of Drug Pricing Deal

On July 6, Senate Democrats released the legislative text of a drug pricing deal. The legislation would allow Medicare to negotiate the prices of 10 drugs starting in 2026, with the number increasing to 15 in 2027 and increasing by an additional 20 in 2029 and every year after. The drugs subject to negotiation will be chosen by the Department of Health and Human Services (HHS) based on their total Medicare Parts B and D spending. In addition, the legislation would also repeal the Part D rebate rule sought to eliminate the safe harbor for Part D drug rebates. The bill would also cap Medicare Part B and D rebates for single-source drugs and biologics’ manufacturers whose prices are increasing above the rate of inflation. Lastly, the bill would cap prescription drug plans’ cost-sharing payments in Medicare Advantage and Part D plans.

Sen. Wyden Releases Finance Committee Report on Big Pharma Tax Practices

On July 7, Sen. Ron Wyden (D-OR) released an interim report titled “Big Pharma Tax Avoidance,” which is part of the Senate Finance Committee’s investigation into the pharmaceutical industry’s tax practices. The report states that pharmaceutical company AbbVie uses tax loopholes and tax havens to avoid paying U.S. taxes on prescription drug sales. In addition, the report states that the 2017 Tax Cuts and Jobs Act halved AbbVie’s effective tax rate. A press release on the report and its findings can be found here.

Sens. Toomey, Barrasso, Portman, Sasse and Daines Call for Insulin Proposal to Go to the Senate Finance Committee Prior to Floor Consideration

On July 6, Sens. Pat Toomey (R-PA), John Barrasso (R-WY), Rob Portman (R-OH), Ben Sasse (R-NE) and Steve Daines (R-MT) wrote to Senate Finance Committee Chair Ron Wyden (D-OR) and Sen. Mike Crapo, Ranking Member (R-ID), to stress the importance that the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act undergo proper committee procedure. The INSULIN Act was introduced by Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME). Specifically, the senators called for the bill to go to the Senate Finance Committee for a markup before being brought to the Senate floor.

Sens. Bennet and Cortez Masto Call on HHS to Update HIPAA to Protect the Privacy of Reproductive Health Services

On July 1, Sens. Michael Bennet (D-CO) and Catherine Cortez Masto (D-NV) wrote to the Secretary of the Health and Human Services Department (HHS), Xavier Becerra, calling on HHS to update the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to protect the privacy of reproductive healthcare services following the Supreme Court’s decision to overturn Roe v. Wade.

Sen. Shaheen Calls on Congressional Leadership to Make ACA’s Enhanced Premium Tax Credits Permanent

On June 30, Sen. Jeanne Shaheen (D-NH) led a group of 13 senators in a letter to Senate Majority Leader Chuck Schumer (D-NY) and House Speaker Nancy Pelosi (D-CA). In the letter, the senators requested that a measure making the Affordable Care Act’s (ACA) enhanced premium tax credit permanent be included in the upcoming reconciliation legislation. The tax credits are set to expire at the end of this year.

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

This Week in Washington: Supreme Court Overturns Roe v. Wade and Rules in Becerra v. Empire Health Foundation


Congress

House

House Committee on Energy and Commerce Subcommittee on Health to Consider 11 Healthcare Bills

On June 29, the House Committee on Energy and Commerce Health Subcommittee on Health will consider 11 healthcare bills. The bills can be found below.

  • H.R. 2007, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021
  • H.R. 3773, the Pediatricians Accelerate Childhood Therapies (PACT) Act of 2021
  • H.R. 5141, the Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act
  • H.R. 5442, the Fix Nondisclosure of Influence in Health Research Act
  • H.R. 5478, the Protecting the Integrity of our Biomedical Research Act of 2021
  • H.R. 6305, the Protect America’s Biomedical Research Enterprise Act of 2021
  • H.R. 7565, the NIH Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Act of 2022
  • H.R. 7845, the NIH Clinical Trial Diversity Act of 2022
  • H.R. 8151, the Building a Sustainable Workforce for Healthy Communities Act
  • H.R. 8163, the Improving Trauma Systems and Emergency Care Act
  • H.R. 8169, the Rural Telehealth Access Task Force Act

House Appropriations Committee Advances FY 2023 Spending Bill for Agriculture, Rural Development, FDA and Related Agencies

On June 23, the House Committee on Appropriations voted 31-26 to advance the Fiscal Year 2023 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies Appropriations bill. The bill provides $27.2 billion total, with $3.66 billion designated for the FDA. The bill’s report can be found here.

House Appropriations Committee Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Approves FY 2023 Spending Bill

On June 23, the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies approved its fiscal year (FY) 2023 funding bill by a voice vote. The bill allocates $242.1 billion to strengthen public health infrastructure, increase funding for the National Institutes of Health and fund the new Advanced Research Projects Agency for Health (ARPA-H) research agency. The bill now goes to the full Appropriations committee for a markup.

House Passes Legislative Package to Address Mental Health and Substance Abuse

On June 22, the House voted to pass the Restoring Hope for Mental Health and Well-Being Act with a vote of 402-20. The legislative package would reauthorize a number of federal health programs, direct the Centers for Medicare and Medicaid Services (CMS) to update its Medicaid in Schools program guidance and allow states to provide Medicaid or Children’s Health Insurance Program (CHIP) coverage to incarcerated youth. The bill would also create a Behavioral Health Crisis Coordinating Office within the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase access to crisis care.

House Passes the Amended ARPA-H Act

On June 22, the House voted 336-85 to pass the Advanced Research Projects Agency for Health (ARPA-H) Act. The bill authorizes the creation of ARPA-H, the new biomedical research agency, and allocates $500 million to fund it from 2023 to 2027. The bill was recently amended to remove a requirement that the ARPA-H director require Senate confirmation and to prohibit the director from awarding grants or contracts to foreign research entities.

Senate

Sens. Baldwin, Gillibrand and Warren Lead Letter Calling on FDA to Update Discriminatory Blood Donation Policies

On June 24, Sens. Tammy Baldwin (D-WI), Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA) led 23 members in a letter to Health and Human Services (HHS) Secretary Xavier Becerra and Food and Drug Administration (FDA) Commissioner Robert Califf requesting an update on the FDA’s efforts to change their discriminatory blood donor deferral policies. In the letter, the senators state that the current three-month donor deferral blood donation policy for men who have sex with men stigmatizes and harms the LGBTQ community and decreases the eligible donor base.

Senate Passes Gun Control Bill with Mental Health Provisions

On June 23, the Senate voted 65-33 to pass the Bipartisan Safer Communities Act, a bipartisan gun control bill. The bill, which provides new protections for victims of domestic violence, improves screenings for individuals under 21 buying a gun and incentivizes states to implement “red flag laws,” also includes resources to address mental health. The healthcare measures in the bill include additional funding for telehealth programs to expand mental health services and support for community-based mental health programs. The Congressional Budget Office (CBO) cost estimate of the bill can be found here.

Senate Commerce, Science, and Transportation Committee Advances the Pharmacy Benefit Manager Transparency Act

On June 22, the Senate Committee on Commerce, Science, and Transportation voted to advance the Pharmacy Benefit Manager (PBM) Transparency Act to the full Senate. The bill would ban unfair and deceptive pricing schemes and require PBMs to report to the Federal Trade Commission (FTC) money gained from spread pricing and pharmacy fees.

Sens. Shaheen and Collins Introduce Bill to Cap Insulin Costs

On June 22, Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME) introduced the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act. The bill would cap insulin costs at $35 a month.

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

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.