This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth flexibilities; White House launches Women’s Health Research initiative.

Congress

House

House and Senate Pass Continuing Resolution

Last week, the House and Senate passed a “laddered” continuing resolution (CR) that will extend funding at current levels through early next year. The CR, which was proposed by the Speaker of the House, will extend funding for Agriculture, Military Construction-VA, Energy-Water and Transportation-HUD appropriations until Jan. 19.

In addition, it will extend funding for Commerce-Justice-Science, Defense, Financial Services, Homeland Security, Interior-Environment, Labor-HHS-Ed., Legislative Branch and State-Foreign Ops appropriations until Feb. 2. If no long-term funding is approved, a 1 percent across-the-board cut will occur. This was agreed to as part of the deal reached to avoid the government defaulting earlier in the year.

House Considers Labor-HHS Appropriations Bill But Postpones Vote on Final Passage

On Nov. 15, the House was scheduled to vote on the Labor-HHS appropriations bill after it considered several amendments to the bill. However, House Republican leadership determined they would not vote on final passage and decided to recess early for the Thanksgiving break because it was unclear whether the bill would pass.

The Labor-HHS bill would cut social spending programs by $60 billion by implementing reductions to 50 programs and eliminating 60.

House Energy and Commerce Committee Subcommittee on Health Reports Out 21 Healthcare Bills

On Nov. 15, the House Energy and Commerce Committee Subcommittee on Health marked up and reported out of committee 21 healthcare bills. Among them were three bills concerning pharmacy benefit managers (PBMs) and one bill regarding home infusion drugs. They are:

H.R. 2880, Protecting Patients Against PBM Abuses Act
This legislation would ban PBM spread pricing and would delink PBM compensation from the cost of medications. It would also prohibit PBMs from compensating a network pharmacy less than affiliated pharmacies and would increase data transparency of PBM rebates and administrative fees.

H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D, and for other purposes
This legislation would require prescription drug plans (PDPs) to only use pharmacy performance measures that are established by the Secretary of the Department of Health and Human Services (HHS Secretary). It would also establish a process to allow PDPs to submit information about pricing prescription drug claims to their network pharmacies. 

H.R. 5385, Medicare PBM Accountability Act
This legislation would strengthen reporting requirements for PBMs and would require them to submit to the HHS Secretary information on drug costs and pricing, generic and biosimilar formulary placement, PBM affiliates, conflicts of interest, drug dispensing and Part D drugs.

H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023
This legislation would codify a proposed Centers for Medicare and Medicaid Services (CMS) durable medical equipment (DME) policy that clarifies coverage of an external infusion pump under the Medicare DME benefit.

The other bills are:

H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023
This legislation would allow changes in insurance plan formularies for biosimilar products to be made mid-year beginning in 2025.

H.R. 5386, Cutting Copays Act
This legislation would set copays for generic drugs to $0 for low-income patients in the Medicare Low-Income Subsidy program. 

H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program
This legislation would limit patient cost-sharing for Medicare Part D drugs beginning in 2027 and would limit beneficiary out-of-pocket costs to no more than what an insurance company pays for highly rebated drugs once all discounts are accounted for.

H.R. 5389, National Coverage Determination Transparency Act
This legislation would require the HHS Secretary to determine whether a request for a National Coverage Determination (NCD) is complete within 30 days of receiving a request. It would also require the Secretary to make all NCD applications public on the CMS website and would allow the Secretary to work directly with entities that submit NCD applications.

H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act
This legislation would clarify that NCDs for Medicare-covered drugs and biologics must be made with respect to each drug or biologic and not the class of the drug or biologic.

H.R. 5396, Coverage Determination Clarity Act of 2023
This legislation would prohibit Local Coverage Determinations (LCDs) from being more restrictive than NCDs and would require the HHS Secretary to review LCDs annually to evaluate their consistency.

H.R. 5371, Choices for Increased Mobility Act of 2023
This legislation would clarify that expenses for titanium or carbon fiber materials used in the construction of wheelchair bases are not covered under Medicare Part B. It would also clarify that Medicare Part B beneficiaries may pay out-of-pocket for wheelchair upgrades if they wish.

H.R. 5388, Supporting Innovation for Seniors Act
This legislation would expand a flexibility under the Medicare Advantage (MA) Value-Based Insurance Design Model that allows MA plans to expand access to innovative medical devices and technologies using their existing supplemental benefit funds.

H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage
This legislation would require MA plans to report on the utilization of supplemental benefits by enrollees.

H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023
This legislation would require the Center for Medicare and Medicaid Innovation to test a model covering virtual diabetes outpatient self-management training services and would remove patient cost-sharing and deducible requirements for Medicare Part B diabetes outpatient self-management training services.

H.R. 6366, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program and to revise the phase-in of clinical laboratory test payment changes under such program
This legislation would delay cuts and reporting under the clinical lab fee schedule and would increase the work geographic index to 1.00 for any locality where the index would be less than 1.00, until Jan. 1, 2025.

H.R. 6369, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models
This legislation would extend incentive payments for participation in eligible alternative payment (APM) models for one year and would adjust the size of payment to the length that a provider has participated in an APM.

H.R. 5555, DMEPOS Relief Act of 2023
This legislation would require the HHS Secretary to make payment adjustments to certain Medicare items and durable medical equipment included in the 2021 Durable Medicare Equipment, Prosthetics/Orthotics and Supplies competitive bidding program.

H.R. 6371, Provider Reimbursement Stability Act of 2023
This legislation would increase the Physician Fee Schedule budget neutrality threshold and require the HHS Secretary to update prices and rates for direct cost inputs for practice expense relative value units no less than every five years. It would also limit year-to-year conversion factor variance.

H.R. 6364, Medicare Telehealth Privacy Act of 2023
This legislation would prohibit the HHS Secretary from publicly disclosing the addresses of physician and practitioner residences from which telehealth services are provided.

H.R. 1352, Increasing Access to Biosimilars Act of 2023
This legislation would create a pilot program to evaluate the benefits of providing additional shared savings payments to Medicare biosimilar providers.

H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act of 2023
This legislation would provide four years of temporary or transitional Medicare coverage to medical breakthrough devices and enable the HHS Secretary to assign coding for approved products.

For more information, click here.

Senate

Senate Finance Committee Subcommittee on Healthcare Holds Hearing on Telehealth Flexibilities

On Nov. 14, the Senate Finance Committee Subcommittee on Healthcare held a hearing to discuss telehealth flexibilities issued during the COVID-19 public health emergency and to evaluate whether flexibilities set to expire next year should be made permanent. Witnesses included:

  • Nicki Perisho, BSN, R.N., Principal Investigator and Program Director of the Northwest Regional Telehealth Resource Center
  • Eric Wallace, M.D., FASN, Professor of Medicine and Medical Director at UAB EMedicine, Co-Director of Home Dialysis and Director of the Division of Nephrology Rare Kidney Disease Clinic at the UAB Department of Medicine
  • Chad Ellimoottil, M.D., M.S., Associate Professor and Medical Director of Virtual Care at the University of Michigan
  • Ateev Mehrotra, M.D., MPH, Professor of Health Care Policy at the Harvard Medical School Department of Health Care Policy

For more information, click here.

Senate HELP Committee Ranking Member Requests Information on Use of 340B Program Revenue

On Nov. 16, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent letters to two federally qualified community health centers, requesting information on how they use the revenue they generate from the 340B Drug Pricing Program. The Ranking Member is concerned over reports that reveal some 340B entities are not passing on the revenue they generate from the 340B program to improve healthcare services for low-income patients.

For more information, click here.

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

This Week in Washington: Senate Finance Committee reports out Better Mental Health Care, Lower-Cost Drugs and Extenders Act; Senate confirms NIH Director; House Speaker Proposes Laddered Continuing Resolution.

Congress

House

House Speaker Proposes Laddered Continuing Resolution

With the expiration of the current continuing resolution (CR) set for Friday, Speaker Johnson has floated a “laddered” CR. The first part of the CR would extend at current levels funding for Agriculture, Military Construction-VA, Energy-Water and Transportation-HUD appropriations until Jan. 19. The second part of the CR would fund at current levels all other appropriations until Feb. 2. The proposal does not provide funding for Ukraine or Israel. 

The House Rules Committee is expected to consider the legislation this afternoon. If the proposal makes it through the Rules Committee, a floor vote is expected on Tuesday.

House Ways and Means Committee Chairman Sends Letter Regarding No Surprises Act Implementation

On Nov. 9, House Ways and Means Committee Chairman Jason Smith (R-MO) led Republican committee members in sending letters to Department of Health and Human Services Secretary Xavier Becerra, Department of Treasury Secretary Janet Yellen and Department of Labor Acting Secretary Julie Su concerning the implementation of the No Surprises Act.

The Chairman and members are concerned that the agencies have not initiated rulemaking related to Advanced Explanation of Benefits for health plans and have not yet enforced independent dispute resolution patient protections. On Sept. 19, the committee held a hearing to discuss challenges surrounding the bill’s implementation and on Oct. 18, the committee held a roundtable with federal officials to evaluate the status of the bill’s implementation among federal agencies.

For more information, click here.

House Energy and Commerce Committee Chairmen Threaten to Subpoena SAMHSA Over Use of COVID-19 Supplemental Funds

On Nov. 1, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Substance Abuse and Mental Health Services Administration (SAMHSA) Assistant Secretary and Administrator Miriam Delphin-Rittmon, warning that the committee could subpoena SAMHSA if it fails to provide information regarding the use of COVID-19 supplemental funds.

The chairmen are requesting that SAMHSA provide state payment management system and federal financial reports for programs that received supplemental funds including those related to certified community behavioral health clinics, suicide prevention programs, 9-8-8 crisis care services and the Substance Use Prevention, Treatment and Recovery Services Block Grant.

For more information, click here.

House Energy and Commerce Chairmen Threaten to Subpoena FDA Over Risky Virus and Biological Agent Research

On Nov. 9, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, warning that the committee could subpoena the FDA if it does not provide documents regarding research on risky viruses and biological agents conducted at FDA facilities.

The committee has been investigating the origins of the COVID-19 pandemic and federal laboratory biosafety protocols since earlier this year and sent letters to the FDA in March and June requesting information on gain-of-function studies.

For more information, click here.

House Members Send Letter Concerning Use of AI in Prior Authorization

On Nov. 3, Rep. Chu (D-CA) led 31 Democratic representatives in sending a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure regarding the use of artificial intelligence (AI) tools by Medicare Advantage (MA) plan issuers when making prior authorization coverage decisions.

The members are concerned that the use of AI tools during the prior authorization process is resulting in more frequent and repeated denials of care and they are calling on CMS to strengthen its oversight and monitoring of MA plans’ use of such tools. They are also urging CMS to implement stricter prior authorization reporting requirements.

For more information, click here.

Senate

Senate Finance Committee Reports Out Better Mental Health Care, Lower-Cost Drugs and Extenders Act

On Nov. 8, the Senate Finance Committee marked up and reported out of committee the Better Mental Health Care, Lower-Cost Drugs and Extenders Act. The legislation seeks to increase Medicare reimbursement rates for doctors and providers, expand mental health and substance use disorder services, lower prescription drug costs and extend Medicare and Medicaid programs set to expire.

The legislation would also implement new disclosure requirements for Medicare Advantage (MA) plans. MA plans would be required to publicly display provider directory information on a website starting in 2026, which would need to be updated every 90 days. They would also be required to submit annual reports of the accuracy of these directories to the Department of Health and Human Services.

To read the Chairman’s Mark of the bill, click here.

For more information, click here.

Senate Finance Committee Chairman and Ranking Member Send Letter Concerning Federal Agency Use of AI

On Nov. 8, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) sent a letter to Department of Homeland Security (DHS) Secretary Alejandro Mayorkas and Customs and Border Protection (CBP) Acting Commissioner Troy Miller regarding the agencies’ use of artificial intelligence (AI) technology.

The Chairman and Ranking Member are concerned that the use of AI is resulting in unsafe and biased outcomes and are requesting that the agencies provide information on whether any safety guardrails have been implemented. On Oct. 5, the Chairman and Ranking Member sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra requesting information on HHS’ implementation of AI tools.

To read the letter to DHS and CBP, click here.

To read the letter to HHS, click here.

Senate Confirms NIH Director

On Nov. 7, the Senate confirmed Dr. Monica Bertagnolli to be the next director of the National Institutes of Health on a 62-36 vote. Fourteen Republican senators joined Democrats in voting to confirm Dr. Bertagnolli. 

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

This Week in Washington: Senate Finance Committee releases discussion draft for Nov. 8 markup; White House issues executive order on AI; House passes two appropriations bills; Senate passes minibus.

Congress

House

House Passes Two Appropriations Bills and Continues to Discuss a Continuing Resolution

Last week, the House passed the Legislative Branch and Interior-Environment appropriations bills. It is unclear if the Senate will accept these bills and they will likely have to be conferenced. On Nov. 2, the House was scheduled to vote on the Transportation-HUD funding bill but the vote was postponed.

The Speaker of the House continues to discuss a continuing resolution (CR) with the Republican Caucus. On Nov. 2, Speaker Johnson proposed a “laddered CR,” which would set staggered funding deadlines for each appropriations bills. This would likely force Congress to pass appropriations bills on an individual basis instead of combining and passing them together in an omnibus package as has typically been done.

Please see Senate story on the minibus.

House Energy and Commerce Chairmen Send Letters Concerning Improper Medicaid Payments and Budget Neutrality Requirements

On Oct. 31, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure concerning the prevalence of improper payments within the Medicaid program. The chairmen are requesting information on the steps the agencies have taken to address them.

In addition, the chairmen sent letters to CMS Administrator Chiquita Brooks-LaSure and Government Accountability Office (GAO) Comptroller General Gene Dodaro regarding changes made to budget neutrality requirements for Medicaid demonstrations. The chairmen are concerned about the potential for fraud in the calculation of state budget neutrality limits under Section 1115 Medicaid waivers.

For more information on the letter to HHS, click here.
For more information on the letter to CMS on improper payments, click here.
For more information on the letter to CMS on budget neutrality, click here.
For more information on the letter to the GAO, click here.

House Energy and Commerce Chairmen Threaten to Subpoena FDA Over Laboratory Safety Rules Violations

On Nov. 1, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, warning that the committee could subpoena the FDA if it fails to provide information regarding federal laboratory safety rules violations. The chairmen are concerned about the FDA’s noncompliance with federal workplace safety regulations and its delays in addressing laboratory safety recommendations from the Government Accountability Office.

The committee began this Congress with an oversight hearing that investigated the origins of the COVID-19 pandemic and in April, it held a subcommittee hearing on biosafety and risky research practices.

For more information, click here.

Senate

Senate Passes Minibus

On Nov. 1, the Senate passed the mini-omnibus funding package by an 82-15 vote. The minibus contains the Agriculture-FDA, Military Construction-VA and Transportation-HUD appropriations bills.

Please see House story on appropriations.

Senate Finance Committee Chairman and Ranking Member Release Discussion Draft Containing PBM, MA and Mental Health Proposals

On Nov. 2, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a discussion draft that includes legislative proposals aimed at addressing Medicare and Medicaid mental health and substance use disorder providers, prescription drug costs, funding for primary care physicians and access to telehealth mental health services. It also includes extenders for Medicare and Medicaid provisions that are set to expire this year.

The committee will mark up the discussion draft on Nov. 8 alongside legislation concerning pharmacy benefit manager (PBM) reforms that was reported favorably by the committee in July. The Chairman and Ranking Member have been focused on reforming PBMs and lowering prescription drug costs since releasing a legislative framework in April.

For more information, click here.

Senate HELP Committee Ranking Member Launches Healthcare Cybersecurity Working Group

On Nov. 2, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA), Senate Intelligence Committee Chairman Mark Warner (D-VA) and Sens. Cornyn (R-TX) and Hassan (D-NH) established a bipartisan healthcare cybersecurity working group.

The working group will examine cybersecurity proposals under HELP committee jurisdiction and will work towards crafting legislation aimed at strengthening cybersecurity within the healthcare and public health sectors.

For more information, click here.

Senate HELP Committee Ranking Member Pushes for Oversight on School-Based Health Centers

On Oct. 17, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member and Senate Finance Committee member Bill Cassidy (R-LA) sent a letter to HELP Committee Chairman Bernie Sanders (I-VT) regarding school-based health centers (SBHCs).

The Ranking Member is requesting that the Chairman establish a process to review and evaluate SBHCs within the HELP Committee, and schedule a hearing on the SBHC Program and the Full-Service Community Schools Program.

For more information, click here.

Senate HELP Committee to Hold Subcommittee Hearing on Role of AI in Healthcare

On Nov. 8, the Senate Health, Education, Labor and Pensions (HELP) Committee Subcommittee on Primary Health and Retirement Security will hold a hearing on the role of artificial intelligence (AI) in healthcare.

The hearing comes after the White House issued an executive order on AI that directs federal agencies to develop AI standards and oversight strategies. On Oct. 31, the subcommittee held a hearing to examine the role of AI in the workforce.

For more information, click here.

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

This Week in Washington: House elects new Speaker; Senate HELP Committee advances nomination of NIH Director nominee; House and Senate resume appropriations work.

Congress

House

House Resumes Work on Appropriations Bills

The House is resuming work on appropriations bills following the election of a Speaker. Speaker Johnson has said that he wants to pass a continuing resolution through Jan. or April 15, because it will take time to conference the House and Senate differences on appropriations.

On Oct. 26, the House passed the Energy-Water Development funding bill. This week, the House is expected to consider the Legislative Branch, Interior-Environment and Transportation-HUD funding bills. 

House Budget Committee Healthcare Task Force Holds Roundtable to Discuss CBO New Drug Development Model

On Oct. 26, the House Budget Committee Health Care Task Force held a roundtable with Congressional Budget Office (CBO) Director Phillip Swagel and drug innovation experts to discuss improvements that could be made to the CBO New Drug Development model. The task force also discussed drug pricing provisions included in the Inflation Reduction Act (IRA).

Task Force Chairman Michael Burgess (R-TX) is concerned that the CBO is not adequately assessing the impacts that drug development and innovation legislation have on federal spending.

For more information, click here.

Ninety-One Representatives Send Letter Concerning Nursing Home Staffing Requirement Proposed Rule

On Oct. 20, Rep. Pence (R-IN) led a group of 90 representatives in sending a letter to Department of Health and Human Services Secretary Xavier Becerra concerning a Centers for Medicare and Medicaid Services proposed rule that would establish minimum staffing requirements and standards for nursing homes. The members are concerned that the rule may limit seniors’ access to care and lead to widespread nursing home closures. 

For more information, click here.

House Energy and Commerce Committee Chairmen Warn NIH Over Possible Subpoena

On Oct. 20, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chairman Brett Guthrie (R-KY) and Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) sent a letter to National Institutes of Health (NIH) Acting Director Lawrence Tabak.

The chairmen are warning that the committee will issue a subpoena against the agency if it fails to provide documents concerning NIH mpox gain-of-function research by Oct. 31.

For more information, click here.

Senate

Senate Moves Forward with Minibus

On Oct. 24, Senate Appropriations Committee Chairman Patty Murray (D-WA) announced that a bipartisan agreement had been reached to move forward with the mini-omnibus appropriations package, which contains the Agriculture-FDA, Military Construction-VA and Transportation-HUD funding bills. The Senate will consider 40 amendments before holding a final vote, which could occur this week.

Senate HELP Committee Favorably Reports Nomination of NIH Director Nominee

On Oct. 25, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 15-6 to favorably report the nomination of Dr. Monica Bertagnolli to become the next National Institutes of Health Director.

Republican and Democratic committee members worked together to pass her nomination out of committee, with Republican Sens. Collins (ME), Murkowski (AK), Romney (UT), Marshall (KS) and Ranking Member Bill Cassidy (LA) voting yes. Chairman Bernie Sanders (I-VT) voted against Dr. Bertagnolli, citing his concern over her decision to decline making commitments to lowering prescription drug prices.

Senate Finance Committee Chairman Sends Letter Concerning Deceptive MA Plan Marketing

On Oct. 25, Senate Finance Committee Chairman Ron Wyden (D-OR) led Democratic committee members in sending a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urging CMS to implement stronger Medicare Advantage (MA) plan marketing and transparency requirements.

On Oct. 18, the committee held a hearing to discuss ghost networks and deceptive marketing practices used to target MA beneficiaries during the Medicare Annual Enrollment Period.

For more information, click here.

Senate HELP Committee Chairman Sends Letter Concerning NIH Exclusive Patent License

On Oct. 23, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) sent a letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm concerning a National Institutes of Health (NIH) proposal that would grant an exclusive patent license for a cervical cancer therapy to Scarlet Therapeutics.

The Chairman is urging HHS to investigate the proposal and is calling on the NIH to offer a non-exclusive license to allow other manufacturers to produce the cervical cancer therapy.

For more information, click here.

Bipartisan Bill Introduced to Make Permanent Medicaid Option to Treat Adults with Substance Use Disorders in Large Facilities

On Oct. 19, Sens. Thune (R-SD), Hassan (D-NH) and Blackburn (R-TN) introduced the Securing Advances and a Variety of Evidence-Based (SAVE) Institutions for Mental Disease (IMD) Options Act, a bill to make permanent the Medicaid option for states to treat adults with substance use disorders in facilities larger than 16 beds. 

This legislation comes several weeks after Congress allowed the SUPPORT Act to expire. Without this state plan amendment pathway, states are bound to the so-called IMD exclusion where they cannot use federal funds to pay for a patient’s behavioral health treatment at a hospital, nursing home or other facility that is more than 16 beds.

The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, included a state plan option in Medicaid that allowed federal Medicaid funds to be used for patients in IMD with substance use disorders. 

For more information, click here.

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

This Week in Washington: Still No Speaker in the House; NIH Director Nominee has Hearing; FDA Seeking Feedback on Innovative Drug Clinical Trial Design.

Congress

House

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Medicare Payment Reform

On Oct. 19, the House Energy and Commerce Committee Subcommittee on Health held a legislative hearing and considered 23 bills concerning Medicare payment for providers. The witnesses were:

  • Meena Seshamani, M.D., Ph.D., Director of the Centers for Medicare and Medicaid Services Center for Medicare
  • Leslie Gordon, MPP, Director of Health Care at the Government Accountability Office
  • Paul Masi, MPP, Executive Director of the Medicare Payment Advisory Commission
  • Steven Furr, M.D., FAAFP, President-Elect of the American Academy of Family Physicians
  • Debra Patt, M.D., Ph.D., MBA, Executive Vice President of Texas Oncology
  • Joe Albanese, MPP, Senior Policy Analyst of Paragon Health Institute
  • Matthew Fiedler, Ph.D., Joseph A. Pechman Senior Fellow in Economic Studies at the Brookings Institution Brookings Schaeffer Initiative on Health Policy

The bills discussed in the hearing are:

H.R.__, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program
This legislation would extend a policy to increase the work geographic index for Medicare physician payments to 1.00 for any locality where the index would be less than 1.00.

H.R.__, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program and to improve the accuracy of geographic adjustment factors under such a program
This legislation would extend a policy to increase the work geographic index for Medicare physician payments to 1.00 for any locality where the index would be less than 1.00 and would include reforms to improve the accuracy of geographic data adjustment factors.

H.R. 2377, the Saving Access to Laboratory Services Act
This legislation would direct the Centers for Medicare and Medicaid Services (CMS) to use statistical sampling of private-payer rates when establishing Medicare reimbursement amounts for clinical diagnostic tests.

H.R.__, To amend title XVIII of the Social Security Act to revise the phase-in of clinical laboratory test payment changes under the Medicare program
This legislation would delay changes to how clinical laboratories are paid under the Medicare program until Jan. 1, 2025.

H.R.__, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models
This legislation would extend incentive payments for participation in eligible alternative payment models through 2026 and would establish a 5-year cap on payment incentives for qualifying participants.

H.R.__, the Improving Seniors Timely Access to Care Act of 2023
This legislation would require Medicare Advantage plans with prior authorization requirements to establish an electronic prior authorization program.

H.R. 1352, the Increasing Access to Biosimilars Act of 2023
This legislation would create a new pilot program to evaluate the benefits of providing more shared savings payments to biosimilar providers under Medicare.

H.R.__, the Provider Reimbursement Stability Act of 2023
This legislation would increase the Physician Fee Schedule (PFS) budget neutrality threshold, set a limitation on year-to-year conversion fact (CF) variance and require the Secretary of the Department of Health and Human Services (HHS) to update prices and rates for direct cost inputs for practice expense (PE) relative value units (RVUs).

H.R. 5526, the Seniors’ Access to Critical Medications Act of 2023
This legislation would make permanent a CMS waiver that allows Medicare patients to receive medications through the mail and allows family members and caregivers to obtain medications on the patient’s behalf.

H.R. 1406, the Sustainable Cardiopulmonary Rehabilitation Services in the Home Act
This legislation would allow cardiopulmonary rehabilitation services to be furnished via telehealth from a beneficiary’s home permanently.

H.R. 2583, the Increasing Access to Quality Cardiac Rehabilitation Care Act of 2023
This legislation would allow nurses and physician assistants to supervise and administer Medicare cardiac rehabilitation care programs.

H.R.__, To amend title XVIII of the Social Security Act to exempt certain practitioners from MIPS payment adjustments under the Medicare program based on participation in certain payment arrangements under Medicare Advantage
This legislation would allow practitioners who participate in certain Medicare Advantage payment arrangements to be exempted from MIPS reporting requirements and adjustments.

H.R. 4402, To amend title XI of the Social Security Act to clarify manufacturer transparency reporting requirements for certain transfers used for educational purposes
This legislation would clarify that manufacturers of a covered drug, device, biological or medical supply will not be required to submit information regarding educational materials that directly benefit patients.

H.R. 3674, the Providing Relief and Stability for Medicare Patients Act of 2023
This legislation would increase the non-facility practice expense relative value units for certain Medicare services.

H.R.__, To amend title XVIII of the Social Security Act to revise certain physician self-referral exemptions relating to physician-owned hospitals
This legislation would modify the physician self-referral exemptions related to Physician-Owned Hospitals (POHs) for certain rural hospitals.

H.R.__, the Fewer Burdens for Better Care Act of 2023
This legislation would require the HHS Secretary to provide a 30-day public comment period for stakeholders to provide feedback on quality and efficiency measures that should be considered for removal.

H.R. 5395, the SURS Extension Act
This legislation would extend the Quality Payment Program-Small Practice, Underserved, and Rural support program for fiscal years (FYs) 2024-2029.

H.R.__, To amend title XVIII of the Social Security Act to promote provider choice using real-time benefit information
This legislation would require prescription drug plan (PDP) sponsors to provide patients real-time information related to formularies and benefit information within one year of enactment.

H.R. 5555, the DMEPOS Relief Act of 2023
This legislation would require the HHS Secretary to provide certain adjustments to Medicare payment for items and medical equipment that were included in round 2021 of the Durable Medical Equipment, Prosthetics/Orthotics and Supplies (DMEPOS) competitive bidding program.

H.R. 4104, the Preserving Patient Access to Home Infusion Act
This legislation would allow nurse practitioners and physician assistants to establish and review home infusion plans of care and require CMS to pay home infusion providers for drugs administered to patients on a daily basis.

H.R. 4878, the EMPOWER Act
This legislation would remove direct supervision requirements for physical therapy assistants and occupational therapy assistants and would require the U.S. Government Accountability Office (GAO) to analyze how the Medicare Part B 15 percent payment differential for services provided by therapy assistants has affected access to therapy services.

H.R.__, the Telehealth Privacy Act of 2023
This legislation would prohibit the HHS Secretary from making a physician’s or practitioner’s address of residence publicly available if they choose to provide telehealth services from that address.

H.R.__, To amend title XVIII of the Social Security Act to allow for the use of alternative measures of performance under the Merit-based Incentive Payment System under the Medicare program
This legislation would grant MIPS reporting flexibility to physicians who perform the majority of their work in a facility-based setting.

For more information, click here.

House Ways and Means Committee Holds Roundtable Regarding Implementation of No Surprises Act

On Oct. 18, the House Ways and Means Committee held a roundtable with officials from the Departments of Health and Human Services, Labor and Treasury, regarding the implementation of the No Surprises Act.

On Sept. 19, the committee held a hearing to discuss the ability of small practices to access the system for arbitration, and other issues including network restrictions, payment reductions and dispute resolution process delays.

For more information, click here.

House Members Send Letter Concerning Home Dialysis for AKI Patients

On Oct. 18, Reps. DelBene (D-WA), Miller (R-WV), Cardenas (D-CA) and Bucshon (R-IN) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urging CMS to expand access and coverage of home dialysis for Medicare patients with acute kidney injury (AKI).

For more information, click here.

Senate

Senate Finance Committee Holds Hearing on Deceptive MA Marketing Tactics and “Ghost Networks”

On Oct. 18, the Senate Finance Committee held a hearing regarding “ghost networks” and common deceptive marketing practices that target Medicare Advantage (MA) beneficiaries during the Annual Open Enrollment period. The witnesses were:

  • Christina Reeg, Senior Health Insurance Information Program Director at the Ohio Department of Insurance
  • Cobi Blumenfeld-Gantz, Co-Founder and Chief Executive Officer of Chapter
  • Krista Hoglund, ASA, MAAA, Chief Executive Officer of Security Health Plan

During the hearing, committee Chairman Ron Wyden (D-OR) stressed the importance of eliminating MA “ghost networks.” 

In addition, the Chairman and Sens. Bennet (D-CO) and Tillis (R-NC) introduced the Requiring Enhanced and Accurate Lists (REAL) of Health Providers Act. The bill would require MA plans to maintain accurate and updated provider directories and would protect patients from paying for care obtained at providers that were incorrectly listed as being in-network.

For more information on the hearing, click here.

For more information on the bill, click here.

Senate HELP Committee Holds Hearing on Nomination of NIH Director

On Oct. 18, the Senate Health, Education, Labor and Pensions (HELP) committee held a hearing on the nomination of Monica Bertagnolli to be Director of the National Institutes of Health (NIH).

In his questioning of Dr. Bertagnolli, Chairman Bernie Sanders (I-VT) focused on reducing the cost of prescription drugs, which is not in the purview of the NIH. Ranking Member Bill Cassidy (R-LA) asked if Dr. Bertagnolli would apply Reasonable Pricing Clauses to NIH contracts.

The committee will vote on whether to send Dr. Bertagnolli’s nomination to the Senate floor on Oct. 25.

For more information, click here.

Bipartisan Bill Introduced to Make Permanent SUPPORT Act SPA Option

On Oct. 19, Sens. John Thune (R-SD), Maggie Hassan (D-NH) and Marsha Blackburn (R-TN) introduced the Securing Advances and a Variety of Evidence-Based (SAVE) Institutions for Mental Disease (IMD) Options Act, a bill to make permanent the Medicaid option for states to treat adults with substance use disorders in facilities larger than 16 beds. This legislation comes several weeks after Congress allowed the SUPPORT Act to expire. Without this state plan amendment pathway, states are bound to the so-called IMD exclusion where they cannot use federal funds to pay for a patient’s behavioral health treatment at a hospital, nursing home or other facility that has more than 16 beds.

The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, included a state plan option in Medicaid that allowed federal Medicaid funds to be used for patients in IMD with substance use disorder. 

For the text of the legislation, click here.

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

This Week in Washington: Still No Speaker in the House; 2024 Medicare Part B Premiums and Deductibles to Rise.

Congress

House

House returns from recess.

Senate

Senate HELP Committee Majority Staff Releases Report on Nonprofit Hospital Charity Care Spending

On Oct. 10, the Senate Health, Education, Labor and Pensions (HELP) Committee Majority Staff released a report on nonprofit hospitals and the amount of revenue they directed toward charity care programs. The report examined the revenue of major nonprofit hospitals for fiscal year (FY) 2021, the cost of their charity care and the percentage of revenue they spent on charity programs.

The report recommends Congress and the Internal Revenue Service (IRS) better monitor nonprofit hospitals’ use of funds and strengthen charity care requirements.

For more information, click here.

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

This Week in Washington: Congress passes Continuing Resolution to keep the government funded until Nov. 17; CMS announces premium increase for Medicare Advantage plans in FY 2024; HHS releases shutdown contingency plan

Congress

House

House Passes 45-Day Continuing Resolution

On Sept. 30, the House of Representatives passed a Continuing Resolution that keeps the government open until Nov. 17. It was passed with the support of Democratic members. The CR is a “clean” CR which contains no funding cuts, and includes funding for disaster relief. It also extended the FAA authority until Dec. 31. It is likely that Ukraine funding will be considered with border security issues in the coming days. The Senate also passed the CR in a vote of 88 to 9 with no debate. 

House Passes Three Appropriations Bills

On Sept. 28, House Republicans passed the Defense, State-Foreign Ops and Homeland Security appropriations bills.

Debate began on Sept. 26 and included the Agriculture-Food and Drug Administration (FDA) appropriations bill as well. However, the Agriculture-Food and Drug Administration (FDA) failed to pass because of issues related to the abortion pill and other funding matters.

House Republican leaders had hoped that by allowing debate and amendments on the appropriations bills, they would be able to convince holdouts among their conference to support a short-term continuing resolution that Speaker McCarthy brought to the floor on Friday in the hopes of averting a government shutdown. However, the House rejected the CR in a 198-232 vote.

House Energy and Commerce Committee Chairmen Warn NIH and HHS Over Possible Subpoenas

On Sept. 28, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chairman Brett Guthrie (R-KY) and Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) sent letters to National Institutes of Health (NIH) Acting Director Lawrence Tabak and Secretary of the Department of Health and Human Services (HHS) Xavier Becerra stating that the committee would be forced to issue subpoenas against the agencies if they fail to comply with previously issued requests for documents and information.

The chairmen are seeking information on the NIH’s involvement in virus mutation and manipulation research and the appointment and reappointment of NIH institute and center directors.

For more information, click here.

Senate

Senate Finance Committee Chairman to Investigate MCO-Prior Authorization Denials

On Sept. 28, Senate Finance Committee Chairman Ron Wyden (D-OR) and House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ) launched a bicameral investigation into Medicaid managed care organization (MCO) prior authorization practices and sent letters to large MCOs, requesting that they submit information on their rate of prior authorization approvals, partial denials and full denials. They are also requesting information on the rate of appeals and on the prior authorization algorithms used by insurers.

The Chairman and Ranking Member are concerned about findings of a recent Department of Health and Human Services (HHS) Office of Inspector General (OIG) report that revealed MCOs are denying Medicaid prior authorizations at nearly twice the rate of Medicare Advantage prior authorizations.

Senate HELP Committee Ranking Member Requests Information on CDC Reform and 340B Drug Program Revenue

On Sept. 26, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent a letter to stakeholders requesting information regarding how the Centers for Disease Control and Prevention (CDC) can be modernized. The Ranking Member is seeking input on how data-sharing and transparency partnerships between the CDC, federal agencies and the private sector can be broadened and how innovation and collaboration can be strengthened. Public comments will be accepted until Oct. 20.

In addition, the Ranking Member sent letters to two 340B-eligible hospitals on Sept. 28, requesting that they provide information on the revenue they generate from the 340B program. The Ranking Member is concerned over reports that entities are not passing on the revenue they generate from the 340B program to improve healthcare services for low-income patients.

For more information on the request for information on CDC reform, click here.

For more information on the request for information on 340B program revenue, click here.

Senators Oppose In-Person Visit Requirement in Expected DEA Telehealth Final Rule

On Sept. 12 and 13, Drug Enforcement Administration (DEA) leaders met with a number of stakeholder groups to discuss a DEA flexibility that allows providers to prescribe controlled substances via telehealth to patients who have not conducted a prior in-person visit. The flexibility, originally issued during the COVID-19 pandemic, is set to expire on Nov. 11. The DEA has announced that it will release a final rule addressing the flexibility this fall.

Following the listening sessions, a group of senators including Sens. Cassidy (R-LA), Thune (R-SD), Feinstein (D-CA), Markey (D-MA) and Warren (D-MA) met with telehealth stakeholders and announced that they will apply pressure and oversight on the DEA if the agency’s final rule requires providers to conduct an in-person visit with a patient before they are able to prescribe controlled substances via telehealth.

Sen. Markey Expresses Concern Over Prohibition of Facility Fees for Telehealth Providers

On Sept. 21, the Senate Health, Education, Labor and Pensions (HELP) Committee marked up the Primary Care and Health Workforce Act, which would reauthorize community health and medical education programs and address primary care and health workforce challenges. The legislation contains a provision that would prohibit hospitals from billing facility fees for telehealth and evaluation and management services.

During the markup, Sen. Markey (D-MA) expressed his concern over the provision, noting that it would create barriers for individuals who rely on telehealth services to receive care, particularly disabled, elderly and low-income patients. Many hospital stakeholders also expressed their concerns and noted that it would be detrimental to telehealth.

Modernizing and Ensuring PBM Accountability Act Introduced

On Sept. 28, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) introduced the Modernizing and Ensuring PBM Accountability Act. The legislation aims to increase the accountability and transparency of pharmacy benefit manager (PBM) practices. It would:

  • Prohibit PBM compensation in Medicare Part D from being tied to the price of a drug;
  • Allow Part D plan sponsors to audit their PBM for compliance with contract requirements;
  • Require the Secretary of the Department of Health and Human Services (HHS) to implement standard Part D measures to assess the performance of network pharmacies;
  • Ban PBM spread pricing in Medicaid;
  • Require retail community pharmacies to participate in the National Average Drug Acquisition Cost (NADAC) Survey; and
  • Implement stricter PBM reporting requirements.

For more information, click here.

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

This Week in Washington: House appropriations talks continue, Senate vote to advance mini omnibus fails; Lower Costs, More Transparency Act pulled from House consideration; House Budget Committee marks up budget resolution

Congress

House

Appropriations Talks Continue As Shutdown Nears

Both the House and Senate return Tuesday to consider appropriations. In the Senate, they are prepping a Continuing Resolution (CR) to go to sometime in December. Both Republicans and Democrats are involved in crafting it. However, because Sen. Rand Paul (R-KY) objects to the inclusion of funding for Ukraine, the Senate cannot speed up consideration of the legislation. Thus, the Senate legislation is unlikely to be sent to the House until the end of the week or Saturday at the earliest.

In the House, Speaker McCarthy has been discussing a CR only through early or mid-November. He has been told by several Republicans that if he gets a bill done with Democrats, they will trigger consideration of his removal.

The House leaders have lined up 4 appropriations bills to be considered this week – Defense, Ag, State-Foreign Ops and Homeland Security. However, there is a complicated rule to allow this to happen. Leadership is now trying to determine if they have enough votes for the rule. If the rule fails, they cannot move forward. On Saturday, McCarthy floated to his caucus a 30 day CR or a 45 day CR. He may try to attach a CR to the border security bill and possibly include a debt commission, after the four appropriations bills are considered. By then the Senate may be wrapping up their CR.

Lower Costs, More Transparency Act Pulled from House Consideration

On Sept. 18, the House was expected to hold a floor vote on the Lower Costs, More Transparency Act but the bill was unexpectedly pulled from consideration. The bill is a large healthcare package that includes provisions to increase hospital and other provider price transparency, implement site-neutral payments for off-campus hospital outpatient departments, ban pharmacy benefit manager (PBM) spread pricing and extend funding for health programs.

House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) has announced that she remains committed to getting the bill passed by year’s end.

House Budget Committee Marks Up Budget Resolution for FYs 2024-2033

On Sept. 20, the House Budget Committee reported out of committee the Concurrent Resolution on the Budget for fiscal years (FYs) 2024-2033. The budget resolution outlines House Republican spending priorities over the next 10 years. It seeks to balance the budget and reduce the deficit by a projected $16.3 trillion by 2033, resulting in an estimated $130 billion budget surplus in FY 2033. It would:

  • Cap FY 2024 discretionary spending at $1.47 trillion and limit spending growth at 1 percent per year;
  • Cut total discretionary spending by $4.6 trillion by FY 2033;
  • Cut mandatory spending by $8.7 by FY 2033;
  • Lower interest payments on the national debt by $3 trillion;
  • Repeal Inflation Reduction Act and Green New Deal provisions; and
  • Create a bipartisan commission to recommend changes and oversee the solvency of Social Security and Medicare.

In addition, the resolution contains several policy statements, including one that urges Congress to enact legislation implementing Medicaid work requirements and decreasing the share of federal funds supporting state healthcare services. It is doubtful that the budget resolution will be considered by the full House.

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter to CDC and USDA Regarding Federal Select Agent Program

On Sept. 15, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) and Subcommittee on Health Chairman Brett Guthrie (R-KY) sent a letter to Centers for Disease Control and Prevention Director Mandy Cohen and Department of Agriculture Secretary Tom Vilsack requesting information on the federal select agent program (FSAP).

The FSAP oversees the possession, use and transfer of potentially dangerous biological agents and toxins. The chairmen are interested in the program because the committee is investigating the safety and security of federal high-containment laboratories.

For more information, click here.

Vote Planned for SUPPORT Act Reauthorization and Maternal Health Legislation

The House plans to vote this week on legislation to reauthorize the SUPPORT Act, and vote on maternal health legislation that was reported out of the Senate Health Education Labor and Pensions (HELP) Committee on Sept. 21.

The Preventing Maternal Deaths Reauthorization Act of 2023 reauthorizes the Center for Disease Control and Prevention’s support for state-based mortality review committees through fiscal year 2028. The legislation also includes a new provision directing CDC, in consultation with the Health Resources and Services Administration, to disseminate best practices on maternal mortality prevention to hospitals, state-based professional societies and perinatal quality collaboratives. 

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act would advance the requirement that state Medicaid plans provide medication-assisted treatment and continued support for Naloxone for first responders. 

Senate

Senate Vote to Move Forward “Mini Omnibus” Fails

On Sept. 20, the Senate failed to move forward a package of three appropriations bills known as a “mini omnibus” that combines the Agriculture-FDA, Military Construction-VA and Transportation-HUD appropriations bills. Republican senators continue holding out on supporting the bill, notably Sen. Rand Paul (R-KY) who announced that he will not support any bill that includes military aid to Ukraine.

Senate HELP Committee Marks Up Bipartisan Primary Care and Health Workforce Act

On Sept. 21, the Senate Health, Education, Labor and Pensions (HELP) Committee marked up and moved out of committee the Bipartisan Primary Care and Health Workforce Act. The legislation, which was introduced by Chairman Bernie Sanders (I-VT) and Sen. Marshall (R-KS), aims to address primary care challenges and health workforce shortages and would reauthorize community health and medical education programs. It would:

  • Reauthorize $5.8 billion per year in funding for the Community Health Center Fund through fiscal year (FY) 2026;
  • Reauthorize $1.5 billion in funding for the Teaching Health Center Graduate Medical Education Program through FY 2028;
  • Reauthorize $950 million per year in funding for the National Health Service Corps through FY 2026;
  • Provide $1.2 billion in grants to community colleges and universities to increase nursing program enrollment;
  • Provide $300 million to primary care doctor residency programs and invest in dental training and workforce programs; and
  • Implement provisions aimed at prohibiting anticompetitive practices by hospitals and insurance companies, including banning certain facility fees.

Ranking Member Bill Cassidy (R-LA) opposed the legislation, announcing that it is rushed and fails to specify how funding increases will be paid for. During the mark up, he submitted 67 amendments but withdrew the majority of them, citing a lack of support.

The Ranking Member and a number of HELP committee senators are concerned about cost offsets included in the bill that would draw funds from the Prevention and Public Health Fund. The Chairman has announced that he was continuing to look for other funding sources, including drawing funds from bills related to pharmacy benefit managers (PBMs) and generic drug access. He is also in discussions with the Chair of the Senate Finance Committee, Sen. Ron Wyden (D-OR), concerning potential pay for mechanisms. 

In addition, the committee reported out of committee bills related to maternity and pediatric healthcare programs.

For more information, click here.

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

This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to vote on large healthcare package on transparency

Congress

House

House Delays Vote on Defense Spending Bill

On Sept. 13, House Republicans delayed a procedural vote on the defense appropriations bill after House Freedom Caucus members stated they would not vote for the bill due to a lack of spending cuts outlined in other appropriations bills. In the meantime, the Main Street Republican Caucus and the House Freedom Caucus negotiated to develop a plan to have a Continuing Resolution through Oct. 31, with an eight percent across-the-board reduction in spending except for the Department of Defense and the Department of Veterans Affairs. It is unclear that there are enough votes in the House to pass such a measure.

House to Vote on Lower Costs, More Transparency Act

The House is expected to vote on the Lower Costs, More Transparency Act, a large healthcare package seeking to increase healthcare pricing transparency. The legislation contains provisions that would implement site-neutral payments for off-campus hospital outpatient departments, ban pharmacy benefit manager (PBM) spread pricing, extend funding for health programs and require hospitals and other providers to publish the prices they charge for services.

The package includes:

H.R. 3561, PATIENT Act of 2023
This legislation would expand hospital price transparency requirements, extend funding for the Community Health Center Fund and other programs, and implement site-neutral payments for drugs administered by physicians in off-campus hospital outpatient departments.

H.R. 4839, Hospital and ASC Price Transparency Act of 2023
This legislation would require hospitals to publicly disclose the standard charges for all items and services for at least 300 shoppable services.

H.R. 3248, Diagnostic Lab Testing Transparency Act
This legislation would strengthen price transparency of clinical diagnostic laboratory tests under the Medicare program and require providers to disclose the discounted cash price and insurer- negotiated minimum and maximum rates of tests.

H.R. 4882, Clinical Laboratory Price Transparency Act of 2023
This legislation would require providers to publicly disclose the cash and insurer-negotiated rates for clinical diagnostic laboratory tests offered by a lab included on the list of shoppable services by the Centers for Medicare and Medicaid Services (CMS).

H.R. 4828, Imaging Services Price Transparency Act of 2023
This legislation would require providers to disclose the cash price and insurer-negotiated rates for certain imaging services.

H.R. 4905, Health Insurance Price Transparency Act of 2023
This legislation would require health insurers to share cost-sharing and pricing information with patients.

H.R. 4507, Transparency in Coverage Act of 2023
This legislation would require insurers to share pricing information for healthcare services and require PBMs to share cost information with plan sponsors.

H.R. 2697, Pharmacy Benefit Manager Accountability Act
This legislation would require PBMs to disclose information regarding the rebates, fees and alternative discounts they receive from prescription drugs. It would also require PBMs to disclose drug wholesale acquisition costs and enrollee total out-of-pocket spending.

H.R. 4822, Health Care Price Transparency Act
This legislation would require PBMs to share net price data, aggregate rebate information, out-of-pocket spending and acquisition costs for all drug classes upon request by an employer.

H.R. 3282, Promoting Transparency and Health Competition in Medicare Act
This legislation would require public reporting of data from healthcare entities who share common ownership interests within the Medicare program, specifically insurers who own pharmacies, PBMs and healthcare providers.

H.R. 4883, Medicare Common Ownership Transparency Act of 2023
This legislation would require Medicare Advantage (MA) organizations to disclose common ownership of pharmacies, PBMs and providers to the Department of Health and Human Services (HHS).

H.R. 3284, Providers and Payers COMPETE Act
This legislation would require the HHS Secretary to submit an annual report to Congress detailing the impact Medicare regulations have on healthcare payer and provider consolidation.

H.R. 3839, Increasing Transparency in Generic Drug Applications Act
This legislation would improve the Food and Drug Administration’s (FDA) review process of generic drugs and allow the FDA to inform drug sponsors about differences between their application and the reference product.

H.R. 1613, Drug Price Transparency in Medicaid Act
This legislation would prohibit PBMs from using spread pricing within the Medicaid program.

H.R. 3237, to amend title XVIII of the Social Security Act to require each off-campus outpatient department of a provider to include a unique identifier on claims for items and services, and to require providers with a department to submit to the Centers for Medicare and Medicaid services an attestation with respect to each such department.
This legislation would require off-campus outpatient departments to use a unique health identifier when billing for services.

H.R. 3417, FAIR Act
This legislation would require off-campus outpatient departments to bill for services provided using a unique health identifier.

H.R. 4509, Transparency in Billing Act
This legislation would require group health plans to only pay claims submitted by hospitals that have implemented accurate billing practices, policies and procedures.

H.R. 2559, Strengthening Community Care Act of 2023
This legislation would extend funding for the Community Health Center Fund, the National Health Service Corps and the Teaching Health Center Graduate Medical Education Program.

H.R. 2550, Special Diabetes Program Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program through calendar year (CY) 2025.

H.R. 2547, Special Diabetes Program for Indians Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program for Indians through CY2025.

H.R. 2665, Supporting Safety Net Hospitals Act
This legislation would delay cuts to the Medicaid Disproportionate Share Hospital (DSH) payment for fiscal years (FYs) 2024-2025.

H.R. 4527, Health Data Access, Transparency, and Affordability (DATA) Act
This legislation would improve transparency of the health insurance market and ensure that plan fiduciaries can access cost and quality of care information of their plan.

H.R. 4508, Hidden Fee Disclosure Act
This legislation would clarify and strengthen employer-sponsored health plan disclosure requirements.

For more information, click here.

House Committee Chairmen Send Letter to HHS Reiterating Request for COVID-19 Origin Information

On Sept. 14, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) and Subcommittee on Health Chairman Brett Guthrie (R-KY) sent a letter to the Secretary of the Department of Health and Human Services (HHS) Xavier Becerra, requesting that officials comply with the committee’s requests for COVID-19 origins information.

The chairmen are urging HHS to send requested COVID-19 origin documents and communications by Sept. 21 and stated that they will consider the use of subpoenas if they do not receive them in time. House Committee on Oversight and Accountability Chairman James Comer (R-KY) and Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-OH) also signed the letter.

For more information, click here.

Rep. Stewart Resigns from Congress

On Sept. 15, Rep. Stewart (R-UT) resigned from Congress. He represented Utah’s 2nd congressional district and was a member of the House Appropriations Committee and the House Permanent Select Committee on Intelligence. There will be a two-month gap before a special election is held to elect his successor on Nov. 21. His resignation comes at a critical time in Congress, with the GOP holding a slim nine vote majority in the House of Representatives.

Senate

Senate Vote on “Mini Omnibus” of Three Appropriations Bills May Be Delayed

On Sept. 12, the Senate voted 85-12 to begin debate on the Agriculture-FDA, Military Construction-VA, and Transportation-HUD appropriations bills. The Senate was expected to vote on the mini omnibus this week, however, one senator is objecting because he wants a freestanding Military Construction bill. This is providing time for the House Republicans to continue their negotiations.

Majority Leader Leads Senate Forum on AI

On Sept. 13, Senate Majority Leader Chuck Schumer (D-NY) led the Senate AI Insight Forum. The forum was attended by tech industry leaders and more than 60 senators and staff, and aimed to spur discussion on artificial intelligence (AI) and on the manner in which Congress should draft legislation to regulate the development and use of AI technologies. It was the first of a series of AI-focused forums that the Majority Leader had called for in his AI framework released in June.

For more information, click here.

Senate HELP Committee Chairman Unveils Bipartisan Primary Care and Health Workforce Act

On Sept. 14, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released a draft of the Bipartisan Primary Care and Health Workforce Act and announced that he and Sen. Marshall (R-KS) had reached an agreement on the bill. The legislation would address primary care challenges and health workforce shortages and would reauthorize community health and medical education programs. It would:

  • Reauthorize $5.8 billion per year in funding for the Community Health Center Fund through fiscal year (FY) 2026;
  • Reauthorize $1.5 billion in funding for the Teaching Health Center Graduate Medical Education Program through FY 2028;
  • Reauthorize $950 million per year in funding for the National Health Service Corps through FY 2026;
  • Provide $1.2 billion in grants to community colleges and universities to increase nursing program enrollment;
  • Provide $300 million to primary care doctor residency programs and invest in dental training and workforce programs; and
  • Implement provisions aimed at prohibiting anticompetitive practices by hospitals and insurance companies, including banning certain facility fees.

The Senate HELP Committee will mark up the legislation on Sept. 21. Ranking Member Bill Cassidy (R-LA) announced that he opposes the bill, arguing that it lacks full Hyde amendment protections related to abortion and fails to specify how funding increases will be paid.

For more information on the bill, click here.

Sen. Romney Announces Plan to Retire

On Sept. 13, Sen. Romney (R-UT) announced that he will not run for reelection and will retire after his current term ends on Jan. 3, 2025.

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

This Week in Washington: House to unveil sweeping health bill

Congress

House

Appropriations Process Remains Top Priority

With the fiscal year set to expire on Sept. 30, time is running out for Congress to pass appropriations bills to fund the government through the new fiscal year. The House is expected to move appropriations bills for the Department of Defense, Department of Homeland Security and Department of Agriculture-Food and Drug Administration. The Senate is expected to move appropriations bills for the Department of Agriculture, Military Construction, and Veterans’ Affairs, the Department of Transportation and the Department of Housing and Urban Development. It is not yet known whether a continuing resolution will be passed to avert a government shutdown.

House Republicans Release Healthcare Package Draft

On Sept. 6, Republicans on the House Energy and Commerce, Ways and Means, and Education and Workforce committees released a draft of the Lower Cost, More Transparency Act. The legislation is a major healthcare package composed of bills advanced by the committees relating to price transparency, pharmacy benefit managers (PBMs), Medicare site-neutral payments and healthcare program funding. The proposal could change after consideration by the full GOP caucus. The package includes:

H.R. 3561, PATIENT Act of 2023
This legislation would expand hospital price transparency requirements, extend funding for the Community Health Center Fund and other programs, and implement site-neutral payments for drugs administered by physicians in off-campus hospital outpatient departments.

H.R. 4839, Hospital and ASC Price Transparency Act of 2023
This legislation would require hospitals to publicly disclose the standard charges for all items and services for at least 300 shoppable services.

H.R. 3248, Diagnostic Lab Testing Transparency Act
This legislation would strengthen price transparency of clinical diagnostic laboratory tests under the Medicare program and require providers to disclose the discounted cash price and insurer- negotiated minimum and maximum rates of tests.

H.R. 4882, Clinical Laboratory Price Transparency Act of 2023
This legislation would require providers to publicly disclose the cash and insurer-negotiated rates for clinical diagnostic laboratory tests offered by a lab included on the list of shoppable services by the Centers for Medicare and Medicaid Services (CMS).

H.R. 4828, Imaging Services Price Transparency Act of 2023
This legislation would require providers to disclose the cash price and insurer-negotiated rates for certain imaging services.

H.R. 4905, Health Insurance Price Transparency Act of 2023
This legislation would require health insurers to share cost-sharing and pricing information with patients.

H.R. 4507, Transparency in Coverage Act of 2023
This legislation would require insurers to share pricing information for healthcare services and require PBMs to share cost information with plan sponsors.

H.R. 2697, Pharmacy Benefit Manager Accountability Act
This legislation would require PBMs to disclose information regarding the rebates, fees and alternative discounts they receive from prescription drugs. It would also require PBMs to disclose drug wholesale acquisition costs and enrollee total out-of-pocket spending.

H.R. 4822, Health Care Price Transparency Act
This legislation would require PBMs to share net price data, aggregate rebate information, out-of-pocket spending and acquisition costs for all drug classes upon request by an employer.

H.R. 3282, Promoting Transparency and Health Competition in Medicare Act
This legislation would require public reporting of data from healthcare entities who share common ownership interests within the Medicare program, specifically insurers who own pharmacies, PBMs and healthcare providers.

H.R. 4883, Medicare Common Ownership Transparency Act of 2023
This legislation would require Medicare Advantage (MA) organizations to disclose common ownership of pharmacies, PBMs and providers to the Department of Health and Human Services (HHS).

H.R. 3284, Providers and Payers COMPETE Act
This legislation would require the HHS Secretary to submit an annual report to Congress detailing the impact Medicare regulations have on healthcare payer and provider consolidation.

H.R. 3839, Increasing Transparency in Generic Drug Applications Act
This legislation would improve the Food and Drug Administration’s (FDA) review process of generic drugs and allow the FDA to inform drug sponsors about differences between their application and the reference product.

H.R. 1613, Drug Price Transparency in Medicaid Act
This legislation would prohibit PBMs from using spread pricing within the Medicaid program.

H.R. 3237, to amend title XVIII of the Social Security Act to require each off-campus outpatient department of a provider to include a unique identifier on claims for items and services, and to require providers with a department to submit to the Centers for Medicare and Medicaid services an attestation with respect to each such department.
This legislation would require off-campus outpatient departments to use a unique health identifier when billing for services.

H.R. 3417, FAIR Act
This legislation would require off-campus outpatient departments to bill for services provided using a unique health identifier.

H.R. 4509, Transparency in Billing Act
This legislation would require group health plans to only pay claims submitted by hospitals that have implemented accurate billing practices, policies and procedures.

H.R. 2559, Strengthening Community Care Act of 2023
This legislation would extend funding for the Community Health Center Fund, the National Health Service Corps and the Teaching Health Center Graduate Medical Education Program.

H.R. 2550, Special Diabetes Program Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program through calendar year (CY) 2025.

H.R. 2547, Special Diabetes Program for Indians Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program for Indians through CY2025.

H.R. 2665, Supporting Safety Net Hospitals Act
This legislation would delay cuts to the Medicaid Disproportionate Share Hospital (DSH) payment for fiscal years (FYs) 2024-2025.

H.R. 4527, Health Data Access, Transparency, and Affordability (DATA) Act
This legislation would improve transparency of the health insurance market and ensure that plan fiduciaries can access cost and quality of care information of their plan.

H.R. 4508, Hidden Fee Disclosure Act
This legislation would clarify and strengthen employer-sponsored health plan disclosure requirements.

For more information, click here.

House Ways and Means Committee Chair Requests Information on Rural Health Disparities

On Sept. 7, House Ways and Means Committee Chairman Jason Smith (R-MO) sent a letter to stakeholders requesting their input on how to address the challenges facing patients living in rural and underserved areas when accessing healthcare services.

The Chairman noted that the committee is particularly interested in payment disparities that exist between geographic areas, payments for identical care provided in different sites of service and the long-term financial health of healthcare providers and facilities. The committee is also interested in innovative care models that could improve patient outcomes and incentives aimed at revitalizing the healthcare workforce.

Public comments will be accepted until Oct. 5. For more information, click here.

Senate

Senate HELP Committee Ranking Member Releases White Paper on AI

On Sept. 6, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a white paper on artificial intelligence (AI) and its projected risks and benefits to society. The white paper focuses on AI’s potential role within the healthcare space and examines how AI could strengthen pharmaceutical research and development, disease detection and treatment, health data privacy and healthcare workload. The paper also examines AI’s potential impact on education and job security.

The Ranking Member is requesting that stakeholders submit feedback on the outlined topics by Sept. 22.

For more information, click here.

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