This Week in Washington: Congress passes continuing resolution; CMS releases final rule concerning prior authorization.

Congress

House

The House is in district work week.

Congress Passes Continuing Resolution

On Jan. 18, the House and Senate passed a continuing resolution (CR) and averted a partial government shutdown. The CR will maintain staggered funding deadlines and will extend funding to March 1 and 8. Funding had originally been scheduled to expire on Jan. 19 and Feb. 2.

Funding for the departments of Agriculture, Energy, Veterans Affairs, Transportation and Housing and Urban Development has been extended to March 1 and funding for the departments of Commerce, Justice, Defense, Homeland Security, Interior, Labor, Education and Health and Human Services has been extended to March 8. The CR notably extends healthcare extenders such as funding for community health centers, teaching hospitals and diabetes programs and a delay of Medicaid disproportionate hospital share cuts.

House Budget Committee Favorably Reports Fiscal Commission Act of 2024

On Jan. 18, the House Budget Committee marked up and reported out of committee H.R. 5779, the Fiscal Commission Act of 2024. The legislation would create a bipartisan debt commission, which would be tasked with addressing the national debt and making spending and revenue reform recommendations. Some Democrats and Medicare advocates argue that the bill will fast-track cuts to Social Security, Medicare and Medicaid.

In addition to H.R. 5779, the committee also reported H.R. 6952, the Fiscal State of the Nation Act and H.R. 6957, the Debt to GDP Transparency and Stabilization Act out of committee.

For more information, click here.

Senate

Senate HELP Committee to Vote on Issuing Subpoenas to Pharmaceutical Company CEOs

On Jan. 18, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) announced that the committee will vote on Jan. 31 on whether to issue subpoenas for Johnson and Johnson chief executive officer (CEO) Joaquin Duato and Merck CEO Robert Davis to testify before the committee concerning the higher prices they charge for medicine in the U.S. compared to other countries.

For more information, click here.

Senate HELP Committee Ranking Member Seeks Information on Pharmacy 340B Revenue

On Jan. 17, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) sent letters to president and chief executive officer (CEO) of CVS Health Karen Lynch and Walgreens CEO Tim Wentworth, requesting they submit information on CVS Health’s and Walgreens’ participation in the 340B Drug Discount Program.

The ranking member has been investigating how healthcare providers use revenue generated from the 340B program and is interested in understanding how major contract pharmacies generate revenue and whether that revenue is directly benefiting patients.

For more information, click here.

Senate HELP Committee Holds Hearing on Long COVID

On Jan. 18, the Senate Health, Education, Labor and Pensions Committee held a hearing on Long COVID and discussed how Long COVID research and patient care could be improved. Witnesses included:

  • Angela Meriquez Vázquez, M.S.W., Long COVID Patient
  • Rachel Beale, M.B.A., Long COVID Patient
  • Nicole Heim, Parent of Long COVID Patient
  • Michelle Harkins, M.D., University of New Mexico Professor of Medicine
  • Ziyad Al-Aly, M.D., Clinical Epidemiologist at Washington University in St. Louis
  • Charisse Madlock-Brown, Ph.D., University of Iowa Associate Professor of Health Informatics
  • Tiffany Walker, M.D., Emory University School of Medicine Assistant Professor

For more information, click here.

Health Care PRICE Transparency Act 2.0 Introduced

On Jan. 10, Sens. Braun (R-IN), Grassley (R-IA), Smith (D-MN) and Hickenlooper (D-CO) and Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) introduced the Health Care PRICE Transparency Act 2.0.

The legislation seeks to strengthen the transparency of healthcare pricing by:

  • Requiring machine-readable files of all negotiated rates and cash prices between plans and providers;
  • Requiring actual prices for 300 shoppable services to be published, with all services by 2025;
  • Increasing maximum annual penalties to $10,000,000;
  • Codifying the Transparency in Coverage rule; and
  • Providing group health plans the right to access, audit and review claims encounter data.

For more information, click here.

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

This Week in Washington: House Speaker and Senate Majority Leader reach topline appropriations deal; OCR releases final rule on conscience rights; Senate HELP Committee Democrats launch investigation into cost of asthma inhalers; State of the Union scheduled for March 7.

Congress

House

House Speaker and Senate Majority Leader Reach Topline Appropriations Deal

On Jan. 7, House of Representatives Speaker Mike Johnson (R-LA) and Senate Majority Leader Chuck Schumer (D-NY) reached an agreement on topline appropriations levels for fiscal year 2024. The Speaker and Senate Majority Leader agreed to a topline amount of $1.59 trillion, of which $886 billion would go to defense and $704 billion would go to non-defense discretionary spending.

Due to the tight turnaround before the approaching Jan. 19 funding deadline, the Senate Majority Leader has already taken the first procedural step on creating a short-term continuing resolution (CR) to allow for more time to work on the specifics of the agreement and avoid a partial government shutdown. However, it remains unclear whether the House would pass a CR.

Senate

Senate HELP Committee Democrats Launch Investigation into Cost of Asthma Inhalers

On Jan. 8, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) and Sens. Baldwin (D-WI), Luján (D-NM) and Markey (D-MA) sent letters to the chief executive officers of AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva, concerning the prices they charge for asthma inhalers.

The chairman and senators are concerned over the tactics used on inhaler product patents and are seeking information on the costs involved in inhaler manufacturing and asthma and chronic obstructive pulmonary disease research and development. This investigation piggybacks on the Federal Trade Commission’s work on improperly listed patents in the Food and Drug Administration’s Orange Book.

For more information, click here.

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

This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final rule concerning clinical use of AI.

Congress

House

House Passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization

Last week, the House passed the Lower Costs, More Transparency Act, a legislative package that includes provisions seeking to increase hospital and other provider price transparency, implement site-neutral payments for off-campus hospital outpatient departments, ban pharmacy benefit manager spread pricing and extend funding for health programs.

The House also passed the Support for Patients and Communities Reauthorization Act. The legislation reauthorizes opioid-use disorder prevention, treatment and recovery programs; permanently extends Medicaid coverage for medication-assisted treatments; improves overdose response training programs; and places xylazine in Schedule III of the Controlled Substances Act.

In addition, the House passed the Dr. Emmanuel Bilirakis and Honorable Jennifer Wexton National Plan to End Parkinson’s Act. The legislation would require the Department of Health and Human Services to develop a national plan to prevent and cure Parkinson’s disease.

Forty-Eight Members Send Letter Concerning Manufacturer Copay Accumulators

On Dec. 12, Rep. Carter (R-GA) led 48 members in sending a letter to the Secretaries of HHS, Labor and Treasury—Xavier Becerra, Julie Su and Janet Yellen—concerning copay accumulators and the recent decision by the U.S. District Court for the District of Columbia that vacated the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule that permitted the use of copay accumulator adjustment programs.

The members believe HHS should notify beneficiaries and reaffirm the 2020 NBPP Final Rule that states group health plans and health insurers must count copay assistance toward a patient’s maximum annual limitation on cost-sharing (MOOP) for drugs that do not have a medically appropriate generic equivalent available.

For more information, click here.

House Energy and Commerce Committee Chairmen Threaten to Subpoena FDA Over Foreign Drug Inspection Program

On Dec. 14, 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 follow-up letter to Food and Drug Administration (FDA) Commissioner Robert Califf, warning that the committee could subpoena the FDA if it does not submit documents and information concerning the FDA foreign drug inspection program.

The chairmen are concerned about the effectiveness of the program after reports indicated a reduction in the total number of FDA foreign inspections and an increase in drug manufacturing facility citations in 2022.

For more information, click here.

Senate

Senate HELP Committee Marks Up SUPPORT Act Reauthorization and Three Other Bills

On Dec. 12, the Senate Health, Education, Labor and Pensions Committee marked up and reported out of committee four bills. Among them was the SUPPORT for Patients and Communities Reauthorization Act, which would reauthorize programs that provide substance use disorder prevention, treatment and recovery services, and increase funding for mental and behavioral health training and the National Child Traumatic Stress Initiative.

In addition, the committee reported out of committee the Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023, which would reauthorize the National Breast and Cervical Cancer Early Detection Program, the Advancing Research in Education Act, which would reauthorize the Education Science Reform Act and the Modernizing Opioid Treatment Access Act, which would allow certain providers to prescribe methadone for opioid use disorder.

For more information, click here.

Senate Finance Committee Chairman Sends Letter Concerning Pharmacy Prescription Record Sharing Practices

On Dec. 12, Senate Finance Committee Chairman Ron Wyden (D-OR) and Reps. Jayapal (D-WA) and Jacobs (D-CA) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, expressing their concern over the practice by some pharmacies to provide patient prescription records to law enforcement agencies without requesting a warrant.

The chairman and members have been investigating pharmacy prescription record-sharing practices and discovered through inquiries with pharmacy companies that several do not require a warrant prior to sharing records with law enforcement agencies. The chairman and members are urging HHS to address pharmacy privacy practices and revise Health Insurance Portability and Accountability Act regulations to require a warrant for law enforcement to access prescription records.

For more information, click here.

MACPAC Releases 2023 Medicaid and CHIP Data Book

On Dec. 15, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) released the 2023 MACStats: Medicaid and CHIP Data Book. The data book contains the latest data and information on the Medicaid and CHIP programs and is divided into the following six sections:

  • Key statistics on Medicaid and CHIP;
  • Trends in Medicaid spending, enrollment and share of state budgets;
  • Medicaid and CHIP enrollment and spending;
  • Medicaid and CHIP eligibility;
  • Measures of beneficiary health, use of services and access to care; and
  • A technical guide regarding data sources and methods.

 For more information, click here.

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

This Week in Washington: House Energy and Commerce Committee markup includes 19 healthcare bills; Senate HELP Committee to mark up SUPPORT Act Reauthorization and three other bills; House to vote on Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Comments sought on march-in rights.

Congress

House

House Energy and Commerce Committee Marks Up 19 Healthcare Bills

On Dec. 5 and 6, the House Energy and Commerce Committee marked up and reported out of committee 44 bills, including 19 healthcare bills. The bills were:

H.R. 2365, National Plan to End Parkinson’s Act
This legislation would direct the Department of Health and Human Services Secretary (HHS Secretary) to coordinate and improve federal prevention, treatment and cure strategies for Parkinson’s disease. It would also require HHS to form an advisory council to assess current national Parkinson’s disease recommendations and strategies.

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. 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 network pharmacies 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 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 information on drug costs and pricing, generic and biosimilar formulary placement, PBM affiliates, conflicts of interest, drug dispensing and Part D drugs to the HHS Secretary.

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 Centers for Medicare and Medicaid Services (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 deductible requirements for Medicare Part B diabetes outpatient self-management training services.

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

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. 6545, Physician Fee Schedule Update and Improvements Act
This legislation would increase the Medicare payment add-on adjustment made in the 2024 Physician Fee Schedule from 1.25 percent to 2.5 percent and extend incentive payments for participation in alternative payment models. It would also extend the floor for the work geographic index.

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.

In addition, the committee marked up bills related to energy and manufacturing infrastructure, consumer protections, internet broadband and technology innovation and safety. 

For more information, click here.

House to Vote on Lower Costs, More Transparency Act and Support for Patients and Communities Reauthorization Act

This week, the House plans to vote on the Lower Costs, More Transparency Act and the Support for Patients and Communities Reauthorization Act. The vote will be held under suspension of the rules. This prohibits amendments from being offered.

The Lower Costs, More Transparency Act is a legislative package that includes provisions seeking to increase healthcare pricing transparency by implementing site-neutral payments for off-campus hospital outpatient departments, extending funding for health programs, banning pharmacy benefit manager spread pricing and requiring hospitals and other providers to publish the prices they charge for services.

The Support for Patients and Communities Reauthorization Act will reauthorize community-based opioid use disorder prevention, treatment and recovery programs. The legislation was not considered earlier because Republicans sought to include a provision that would reclassify xylazine as a Schedule III drug under the Controlled Substances Act.

House Energy and Commerce Committee Chairman Announces Hearing on AI

On Dec. 6, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) announced that the committee will hold a hearing to discuss the projected impacts of artificial intelligence on supply chains, energy, healthcare and emerging technologies. The hearing will be held on Dec. 13. Announced witnesses are:

  • Director Helena Fu, Director of Critical and Emerging Technology of the Department of Energy Office of the Undersecretary for Science
  • Micky Tripathi, National Coordinator for Health Information Tech at the U.S. Department of Health and Human Services
  • Saif Khan, Senior Advisor to the Department of Commerce Secretary for Critical and Emerging Technologies

For more information, click here.

House Energy and Commerce Committee Chairmen Threaten to Subpoena CDC Over Lab Safety Practices

On Dec. 7, 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 Centers for Disease Control and Prevention (CDC) Director Mandy Cohen, warning that the committee could subpoena the CDC if it does not provide documents regarding laboratory safety practices at CDC facilities.

For more information, click here.

Innovation in Pediatric Drugs Act of 2023 Introduced

On Dec. 7, Reps. Eshoo (D-CA) and McCaul (R-TX) introduced the Innovation in Pediatric Drugs Act of 2023. The legislation would require rare disease drugs to be studied in children, grant the Food and Drug Administration additional authority to penalize companies that fail to complete required pediatric studies and increase funding for the National Institutes of Health Best Pharmaceuticals for Children Act Program.

For more information, click here.

Senate

Senate HELP Committee to Mark Up SUPPORT Act Reauthorization and Three Other Bills

On Dec. 12, the Senate Health, Education, Labor and Pensions Committee will mark up the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Reauthorization Act. The bipartisan legislation would reauthorize programs that provide community-based prevention, treatment and recovery services for individuals with substance use and behavioral health disorders.

The markup is also scheduled to include the Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023, which would reauthorize the National Breast and Cervical Cancer Early Detection Program, the Advancing Research in Education Act, which would reauthorize the Education Science Reform Act and the Modernizing Opioid Treatment Access Act, which would allow certain providers to prescribe methadone for opioid use disorder.

For more information, click here.

Senate HELP Committee Ranking Member Sends Letter Concerning Patient Access to Gene Therapies

On Dec. 5, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) sent a letter to gene therapy stakeholders, requesting feedback on how access to gene therapies for patients with ultra-rare diseases could be improved.

The ranking member is seeking responses to questions concerning gene therapy insurance coverage, pricing strategies, supply chain contract designs and physician prescribing methods. The ranking member is also seeking input on how the federal government could play a role in overseeing access to gene therapies in the commercial market. Responses are due by Jan. 22.

For more information, click here.

Senate Finance Committee Reports Final Legislative Text of Better Mental Health Care, Lower-Cost Drugs and Extenders Act

On Dec. 7, the Senate Finance Committee reported the final legislative text of the Better Mental Health Care, Lower-Cost Drugs and Extenders Act, which was marked up and reported out of committee on Nov. 8. 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 that are set to expire.

For more information, click here.

Senate Finance Committee Holds Hearing on Prescription Drug Shortages

On Dec. 5, the Senate Finance Committee held a hearing to examine the causes of prescription drug shortages and supply chain challenges. The committee also discussed the impacts of shortages on patients and providers and potential policy solutions. Announced witnesses were:

  • Inmaculada Hernandez, PharmD., Ph.D., Professor at the University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences Division of Clinical Pharmacy
  • Marta E. Wosińska, Ph.D., Senior Fellow at the Brookings Institution Schaeffer Initiative on Health Policy
  • Allan Coukell, Senior Vice President of Public Policy at Civica Rx
  • Jason Westin, M.D., M.S., FACP, Director of the Clinical Research Program and Section Chief of Aggressive Lymphoma at the M.D. Anderson Cancer Center Department of Lymphoma and Myeloma

For more information, click here.

Senators Send Letters Concerning Private Equity Ownership of Hospitals

On Dec. 6, Sens. Whitehouse (D-RI) and Grassley (R-IA) sent letters to four private equity firm chief executive officers, requesting that they provide information concerning their ownership of hospitals. The senators are concerned that private equity ownership in healthcare is negatively impacting quality of care and resources among hospitals and resulting in facility staffing shortages, closures and debt.

In addition, the senators sent a letter to the chief executive officer of the Ottumwa Regional Health Center, seeking information on whether the health center experienced operational and financial hardships after it was acquired by a private equity firm in 2010.

For more information, click here.

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

This Week in Washington: House Energy and Commerce subcommittees look at role of AI and CDC respiratory disease preparedness; FDA releases final rule on prescription drug advertisements.

Congress

House

House Energy and Commerce Committee Oversight and Investigations Subcommittee Holds Hearing on CDC Respiratory Disease Preparedness

On Nov. 30, the House Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing to discuss Centers for Disease Control and Prevention (CDC) readiness and preparedness plans for future public health crises and the spread of influenza, COVID-19 and respiratory syncytial virus.

The subcommittee also evaluated efforts the CDC has taken to resolve decision-making, health department coordination and data collection and analysis challenges it experienced during the COVID-19 pandemic. Witnesses included:

  • The Honorable Mandy Cohen, M.D., Director of the Centers for Disease Control and Prevention

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Role of AI in Healthcare

On Nov. 29, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss how artificial intelligence (AI) is being implemented in medical devices, and how it could reduce administrative burden for physicians. The subcommittee also discussed the risks and benefits of using AI technology and the implications it could have on patient and consumer data privacy, cybersecurity and drug development. Witnesses included:

  • Michael Schlosser, M.D., MBA, Senior Vice President of Care Transformation and Innovation at HCA Healthcare
  • Benjamin Nguyen, Senior Product Manager at Transcarent
  • Peter Shen, Head of Digital Health in North America for Siemens Healthineers
  • Christopher Longhurst, M.D., Chief Medical Officer, Chief Digital Officer and Association Dean at UC San Diego Health
  • David Newman-Toker, M.D., Ph.D., Professor of Neurology and Director of the Johns Hopkins University School of Medicine Department of Neurology Division of Neuro-Visual and Vestibular Disorders

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter Regarding Rise of Respiratory and Pneumonia Cases in China

On Nov. 29, 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 Centers for Disease Control and Prevention (CDC) Director Mandy Cohen in response to the rise of respiratory disease and pneumonia cases in China. The chairmen are requesting that the CDC provide information on any communications it has had with Chinese health officials and federal agencies concerning the recent virus outbreak.

For more information, click here.

Senate

Senators Send Letter Concerning Attempts by Insurers to Evade Medical Loss Ratio Requirement

On Nov. 22, Sens. Warren (D-MA) and Braun (R-IN) sent a letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm, requesting that the HHS Office of Inspector General investigate whether health insurance companies, including Cigna, CVS, Aetna and United Health Group, are attempting to evade the Medical Loss Ratio (MLR) statutory requirement by increasing the cost of generic drug prices at specialty pharmacies that they own. The MLR requires insurance companies to spend a minimum of 80 or 85 percent of consumers’ premium dollars on medical claims and quality improvements.

The senators are concerned over the findings of a report that revealed that insurers are charging significantly more for generic drugs dispensed by specialty pharmacies they own compared to generic drugs dispensed by independent pharmacies.

For more information on the letter, click here.

Senate Majority Whip Sends Letter Regarding New Medicare Coverage for Dental Care Services

On Nov. 28, Senate Majority Whip Dick Durbin (D-IL) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, urging CMS to notify states about changes made to Medicare coverage and billing practices for oral healthcare services in the 2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System final rule.

In addition, the majority whip is requesting that the CMS Medicaid Director send a letter to states to encourage them to expand coverage and billing practices for dental care services for Medicaid enrollees.

For more information, click here.

Senate HELP Committee Chairman Announces Hearing on Prescription Drug Costs

On Nov. 21, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) announced that the HELP committee will hold a hearing on Jan. 25 to discuss the cost of prescription drugs. The hearing will focus on the impacts high prescription drug prices are having on public health.

For more information, click here.

Senate Finance Committee Chairman Announces Hearing on Prescription Drug Shortages

On Nov. 21, Senate Finance Committee Chairman Ron Wyden (D-OR) announced that the Finance committee will hold a hearing on prescription drug shortages on Dec. 5. The committee will examine supply chain challenges and impacts and will discuss potential policy solutions. Announced witnesses are:

  • Inmaculada Hernandez, PharmD., Ph.D., Professor at the University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences Division of Clinical Pharmacy
  • Marta E. Wosińska, Ph.D., Senior Fellow at the Brookings Institution Schaeffer Initiative on Health Policy
  • Allan Coukell, Senior Vice President of Public Policy at Civica Rx
  • Jason Westin, M.D. M.S., FACP, Director of the Clinical Research Program and Section Chief of Aggressive Lymphoma at the M.D. Anderson Cancer Center Department of Lymphoma and Myeloma

For more information, click here.

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

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.