This Week in Washington: Congress Focuses on FDA User Fee Legislation, Telehealth and Continuing Resolution; Administration Issues Executive Order on Biomanufacturing

Congress

House

House Passes Legislation to Streamline Prior Authorization in Medicare Advantage

On Sept. 14, the House unanimously passed legislation by voice vote to streamline the Medicare Advantage prior authorization system. The vote came shortly after the Energy & Commerce health subcommittee unanimously passed a version of the Improving Seniors’ Timely Access to Care Act earlier in the day. A vast majority of the House cosponsored the bill, along with 40 senators in the upper chamber. It is expected that the legislation will be part of the year-end package in the Senate.

The bill establishes an electronic prior authorization process for Medicare Advantage, as well as a real-time approvals process for routinely approved products and services, and increased data transparency surrounding MA and the prior authorization process. Prior authorization in MA has come under fire after a controversial HHS Office of the Inspector General report found inappropriate denials.

The legislation was sponsored in the House by Reps. Suzan DelBene (D-WA), Mike Kelly (R-PA), Ami Bera (D-CA) and Larry Bucshon (R-IN). It had more than 320 cosponsors.

Bipartisan Legislation Introduced to Mitigate Physician Fee Schedule Cuts

On Sept. 13, Reps. Ami Bera (D-CA) and Larry Bucshon (R-IN) introduced legislation to mitigate CMS’s proposed physician fee schedule cuts slated for 2023. Physicians have been concerned about reductions in the fee schedule since the Centers for Medicare and Medicaid Services released the fee schedule for 2023. CMS proposed a 4.4 percent decrease in the conversion factor for 2023. While the rule is not yet final, there is concern CMS may not have the ability to make changes to increase reimbursement as it has with other pay rules in the past, because some of the fee reductions CMS proposed were tied to evaluation and management changes already in place, because of prior years’ cuts mitigated by Congress and because Medicare Access and CHIP Reauthorization Act (MACRA) set up pay updates of the fee schedule, which includes a 0 percent pay update for 2023.

Bera and Bucshon also recently asked stakeholders how to change MACRA. They also introduced a Sense of Congress that the Department of Health and Human Services and the House and Senate should work to ensure Medicare’s payment system is predictable and stable.

Senate

Senate Pushed to Pass Extension of Pandemic Telehealth Waivers

On Sept. 13, a group of 375 telehealth stakeholders sent a letter to the Senate urging it to pass a two-year extension of pandemic telehealth waivers that also includes access to clinically appropriate controlled substances without in-person prescribing requirements and pre-deductible coverage for telehealth services under high-deductible health plans. Senate movement on the House-passed telehealth extensions, coupled with the controlled substances and HDHP waivers, would give stakeholders an extra couple years to lobby for permanent reforms.

The Alliance for Connected Care, American Telemedicine Association (ATA), College of Healthcare Information Management Executives (CHIME), Connected Health Initiative, Consumer Technology Association, Executives for Health Innovation, Health Innovation Alliance, HIMSS and Partnership to Advance Virtual Care organized the coordinated effort among the nearly 400 telehealth stakeholders.

The groups are asking the Senate to pass a two-year extension of pandemic telehealth flexibilities, as the House recently did when it passed HR 4040. However, the groups also want to extend a provision that lets health plans offer coverage of telehealth services pre-deductible to people enrolled in high-deductible health plans linked to health savings accounts or remove in-person requirements for prescription of controlled substances via telehealth, which is not included in the House bill.

The Joint Committee on Taxation and Congressional Budget Office scored the temporary HDHP provision included in the CARES Act at $90 million a year. Ninety-six percent of employers adopted the pre-deductible coverage for telehealth services under the CARES Act and 76 percent would like to make the provision permanent, according to the Employee Benefit Research Institute issue brief on pre-deductible coverage in HSA-eligible health plans.

HELP Committee Members Write

This week, a group of 29 Democrats led by Senate HELP Committee chair Patty Murray (D-WA) wrote to Secretary of HHS Becerra urging the administration to strengthen federal privacy protections under the Health Information Portability and Accountability Act (HIPAA) to broadly restrict providers from sharing patients’ reproductive health information without their explicit consent—particularly with law enforcement or in legal proceedings over accessing abortion care. The senators specifically said HHS should update the HIPAA Privacy Rule to prevent covered entities from sharing reproductive health information, especially for purposes of potential criminal or civil proceedings. The senators also said HHS should increase education for patients about their rights under the HIPAA Privacy Rule and should ensure all cases involving reproductive health information receive timely compliance and enforcement response.

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

This Week in Washington: The House and Senate return to face funding the government and other issues; the administration reverses for good the Trump-era “public charge” rule.

Congress

House

Funding the Government

Current funding for the federal government runs out on Oct. 1; Congress will need to do a short-term Continuing Resolution (CR). Currently being discussed in the House is a CR to run through Dec. 16. What is unclear is whether the CR will have anything attached to it.

The White House has asked that COVID and monkeypox funding be attached. They have requested $22.4 billion in COVID money and $4.5 billion for monkeypox funding. Republican senators state that there is already unspent money that could be used for these purposes. The administration also released a list of programs that should be included or programs they would not object to being included on the CR.

Meanwhile, Senate Budget Committee Chairman Bernie Sanders (I-VT) announced that he will vote against the CR if it includes a package of energy provisions meant to satisfy Sen. Joe Manchin (D-WVA). Sanders says that “at least” 59 House Democrats will be releasing a letter opposing the energy provisions as well.

Bipartisan Group of Members Ask for Input on How to Revamp the Medicare Access and CHIP Reauthorization Act (MACRA)

Eight House members led by Reps. Ami Bera (D-CA) and Larry Bucshon (R-IN) are asking stakeholders for feedback concerning how to fix MACRA without dramatically increasing Medicare spending.

Members Push for Audio-Only Telehealth Coverage

Reps. Ann McLane Kuster (D-NH), Lori Trahan (D-MA) and Peter Welch (D-VT) wrote CMS Administrator Chiquita Brooks-LaSure to urge Medicare coverage of audio-only telehealth continue beyond the pandemic, raising concerns that ending reimbursement would add to health disparities. However, CMS has said it cannot do so without congressional action. CMS proposed to extend audio-only coverage for mental healthcare but said legislative restrictions prevent it from doing so for other telehealth services.

The letter asks CMS to answer several questions, including how the agency is measuring the effectiveness of audio-only telehealth and what data it has about the factors that impact audio-only usage as opposed to other kinds of telehealth. It also asks what CMS believes the impact of ending audio-only telehealth coverage would be on rural beneficiaries and on other groups that are more likely to use the modality, including Black patients.

Senate

FDA User Fee Bill Drama Continues

Congress has until Sept. 29 to reauthorize the FDA User Fee program. FDA Commissioner Robert Califf has said the agency could fund the programs into early November using carryover user fees. Some believe that reauthorization should be added to the short-term CR in order to give more time for members to negotiate an agreement.

Senators Ask AHIP about HIV Prevention Medication Coverage

On Sept. 8, a letter lead by Sens. Jeff Merkley (D-OR) and Tina Smith (D-MN) asked the America’s Health Insurance Plans (AHIP) about reports that some insurers are not providing cost-free coverage of HIV prevention medication and related services as required under the Affordable Care Act.

The letter comes after a federal district judge ruled that the pre-exposure prophylaxis (PrEP) mandate violates rights of a Texas employer under the Religious Freedom Restoration Act (RFRA) and that the ACA violates the appointments clause of the Constitution by deferring decisions on coverage requirements to the U.S. Preventive Services Task Force (USPSTF).

Under the ACA, insurers must cover all preventive services rated “A” or “B” by the USPSTF without cost-sharing. In June 2019, the task force gave PrEP an “A” rating, and plans were required to cover the drug as of Jan. 1, 2021. CMS issued additional guidance to clarify that ancillary services, like testing fees and adherence consultations, must also be covered without cost-sharing.

The judge has yet to issue any remedies related to the decision, so it’s unclear whether it will apply only to the plaintiffs, or nationwide.

In their letter, the senators stressed it is an insurer’s responsibility to ensure the cost-free coverage is provided.

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

This Week in Washington: Administration focuses on mental health and monkeypox issues

Congress

The House and Senate are in Recess

House

Restoring Hope for Mental Health and Well-being Act

The House recently passed the Restoring Hope for Mental Health and Well-being Act, which is designed to support mental health care, prevention, education and workforce training programs.

In addition to promoting compliance with mental health parity laws, the legislation would allocate $14 million each year through 2025 and $30 million each year for 2026 and 2027 for the Pediatric Mental Health Care Access grant program. That funding would permit every state to establish a program if they want to improve the integration of pediatric primary care providers with behavioral health providers by telehealth. A bipartisan group of House members is now holding discussions with key senators to create momentum for the Senate to pass the legislation when the Senate returns.

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

This Week in Washington:  House Passes Inflation Reduction Act by a vote of 220-207

Congress

The Senate is in its Recess

Senate

Members Push FDA to Finalize Risk-Mitigation Strategy for Mifepristonea

On Aug. 3, Sens. Warren (D-MA), Hirano (D-HI) and Baldwin (D-WI) wrote a letter asking the FDA to quickly finalize updates to the risk-mitigation strategy for mifepristone that would make the medication abortion drug more accessible in the wake of the Supreme Court’s reversal of Roe v. Wade, and to also approve the drug for miscarriage procedures.

The FDA announced in December 2021 a series of risk mitigation strategies but has yet to officially approve them. The letter requests the FDA to expedite its review of the manufacturers’ plans to certify pharmacies and to finalize the updated REMS well before the 180-day statutory deadline.

FDA has said it is starting a certification process for pharmacies, including mail order pharmacies, to dispense mifepristone but has not finalized it yet, according to a policy professional who is involved with the Protecting Access to Medication Abortion Act.

The senators also ask FDA to review the remaining pieces of the REMS to determine whether any restrictions placed on the prescription and distribution of mifepristone, including patient consent forms, are medically unnecessary.

In addition, the senators ask FDA to work toward adding a miscarriage indication to the mifepristone with misoprostol label.

House

House Passes Inflation Reduction Act

Following the Senate passage of the Inflation Reduction Act (budget reconciliation), the House returned from its recess to pass the legislation. The rule by which the House considered the legislation did not permit any amendments. In addition to including Medicare negotiation of drug prices, and an extension of the ACA credits, the legislation would require adults enrolled in Medicare, Medicaid or CHIP to receive all vaccines by the Advisory Committee on Immunization Practices without cost sharing. This means Medicare beneficiaries would not have cost sharing for adult vaccine administration covered under Medicare Part D beginning in 2023.

Text of the legislation can be found https://rules.house.gov/bill/117/hr-5376-sa

In addition, prior to Senate consideration the Congressional Budget Office (CBO) released an estimate of the bill and answered other questions in a report that can be found at https://www.cbo.gov/publication/58366

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

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.