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September 18, 2023

This Week in Health Policy for September 18

This Week (Sept. 18 - 22)

On Monday (September 18), the House is expected to take up a tri-committee health care package, the Lower Costs, More Transparency Act, along with Veterans' Affairs bills. The Lower Costs, More Transparency Act contains provisions to reauthorize expiring health care programs, ban certain PBM practices and add new PBM transparency requirements, add new Medicare billing requirements for off-campus hospital outpatient departments, extend site-neutral payments to Medicare drug administration services, and more. In addition, there are several committee hearings scheduled on health care topics:

Senate Health, Education, Labor & Pensions Committee will hold a mark on "S. 1573, S. 2415, S. 1624, S._, Bipartisan Primary Care and Health Workforce Act."

  • Date: Thursday, September 21 at 10:00am ET
  • More information available here.

House Energy and Commerce Subcommittee on Health will hold a hearing on "Examining Policies To Improve Seniors' Access To Innovative Drugs, Medical Devices, And Technology."

  • Date: Tuesday, September 19 at 10:00am ET
  • More information available here.

House Energy and Commerce Committee will hold a member day hearing.

  • Date: Tuesday, September 19 at 2:00pm ET
  • More information available here.

Senate Finance Subcommittee on Health Care will hold a hearing on "Aging in Place: The Vital Role of Home Health in Access to Care."

  • Date: Tuesday, September 19 at 10:00am ET
  • Witnesses: Carrie Edwards, Director, Home Care Services, Mary Lanning Healthcare; Judith Stein, Executive Director/Attorney, Center for Medicare Advocacy; Tracy Mroz, Associate Professor, University of Washington; William Dombi, President, National Association of Home Care & Hospice; David C. Grabowski, Professor, Harvard Medical School
  • More information available here.

House Energy and Commerce Oversight and Investigations Subcommittee will hold a hearing on "At What Cost: Oversight of How the IRA's Price Setting Scheme Means Fewer Cures for Patients."

  • Date: Wednesday, September 20 at 2:00pm ET
  • More information available here.

House Committee on Oversight and Accountability will hold a hearing on "The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What the Doctor Ordered."

  • Date: Tuesday, September 19 at 10:00am ET
  • More information available here.

House Ways & Means Committee will hold a hearing on "Hearing on Reduced Care for Patients: Fallout From Flawed Implementation of Surprise Medical Billing Protections."

  • Date: Tuesday, September 19 at 10:00am ET
  • More information available here.

Senate Veterans Affairs Committee will hold a hearing on "Invisible Wounds of War: Improving Mental Health and Suicide Prevention Measures for our Nation's Veterans."

  • Date: Wednesday, September 20 at 3:30pm ET
  • More information available here.

House Ways & Means Committee will hold a hearing on "Trade Subcommittee Hearing on Reforming the Generalized System of Preferences to Safeguard U.S. Supply Chains and Combat China."

  • Date: Wednesday, September 20 at 2:00pm ET
  • More information available here.

Last Week (Sept. 11-15)

Health Care Highlights

Congress activity on fiscal cliff. The House and Senate last week continue to face the challenge of addressing the expiration of government funding on September 30. The Senate took another procedural vote (91-7) in relation to the minibus appropriations package on Military Construction/VA, Agriculture, and Transportation-HUD. Leaders of both chambers have cited a desire to pass their versions of each of the dozen annual appropriations bills in an attempt to gain the upper hand in negotiations. In contrast to the bipartisan support for how the appropriations process is unfolding in the Senate, the House this week was unable to secure sufficient votes to consider the Department of Defense appropriations bill. The Washington Post reported that conservative Freedom Caucus members are withholding their support for the DoD bill because of a long-running demand to see all appropriations bills first, in addition to other assurances.

Senate HELP Workforce bill. On September 14, Senate Health Committee Chair Bernie Sanders (I-VT) and Sen. Roger Marshall (R-KS) announced a bipartisan bill to reauthorize several health care programs and expand primary care health services in the US, paid for in part by site-neutral payment policy and a ban on anticompetitive contracts. The bill, which will be marked up in committee next Thursday (September 21), sets funding levels above the House Lower Costs, More Transparency Act's community health center (CHC) reauthorization provisions. Click here for the summary and click here for the bill text. Bill highlights include:

  • $5.8 billion annually to CHCs through FY 2026 plus a one-time $3 billion investment for construction, renovation, and other CHC capital improvement projects.
  • Reauthorizes the National Health Service Corps at nearly $1 billion annually.
  • Reauthorizes Teaching Health Center Graduate Medical Education and establishes more than 700 new primary care residency slots.
  • Reauthorizes rural residency planning and development program at $12.5 million in fiscal 2023, with funding rising by $500,000 annually through fiscal 2026.
  • Allocates $1.2 billion for two-year nursing education programs to train 60,000 additional nurses.
  • Allocates $300 million for primary care doctor education.

The bill includes some funding offsets but is facing opposition from Ranking Member Bill Cassidy (R-LA) for failing to cover all costs and include the Hyde amendment. Funding offsets include:

  • Banning anticompetitive terms in hospital and insurance contracts that limit access to higher quality, lower cost care.
  • Requiring a separate National Provider Identifier number and an attestation for each off-campus hospital outpatient department.
  • Banning hospitals from charging facility fees for telehealth services and for evaluation and management health care services.

DEA holds public listening session on telemedicine. Last week, the Drug Enforcement Agency (DEA) held a two-day listening session to collect additional feedback as the agency considers next steps on rulemaking to allow prescribing for certain controlled substances via telemedicine. During the sessions, DEA Administrator Anne Milgram suggested the agency could issue a supplemental proposed rule this fall given the feedback received. The temporary rule extending COVID-era telemedicine flexibilities remains in place through November 11, 2023, and providers who have an established relationship up to November 11, 2023, can continue to use telemedicine flexibilities through November 11, 2024.

FTC warns drugmakers on improper patent listings. On September 14, the Federal Trade Commission (FTC) voted 3-0 to issue a statement warning pharmaceutical companies against improper Orange Book patent listing. The statement says FTC will investigate potential improper listings and those deemed invalid could face criminal action and the FTC may refer such cases to the Department of Justice. The warning comes as members of Congress — including Senator Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) — have urged the FDA to help the US Patent Trademark Office address the issue.

IRS halts new claims processing for ERC. On September 14, Internal Revenue Service (IRS) Commissioner Danny Werfel said the IRS has halted processing new claims of the COVID-19 employee retention tax credit (ERC) due to concerns about fraud. Commissioner Werfel said the agency received 600,000 claims in just the past 90 days. As a result, applications for the credit are expected to be delayed until at least the end of this year. To date, the IRS has paid out more than $150 billion in claims.

CMS unveils new inflation rebate data. On September 13, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare Part B beneficiaries could save between $1 and $618 per average dose between October and December on the 34 prescription drugs subject to the Medicare Prescription Drug Inflation Rebate Program.

CDC panel OKs updated COVID booster shot. On September 12, the Centers for Disease Control and Prevention (CDC) formally recommended an updated COVID-19 booster for everyone age 6 months and older ahead of the Fall/Winter virus season. CDC said updated COVID-19 vaccines will be available from Pfizer-BioNTech and Moderna.

Another drugmaker restricts 340B contract pharmacies. On September 11, Jazz Pharmaceuticals announced it will restrict the eligibility of certain contract pharmacies to receive prescription drugs at 340B discounted prices, bringing the number of pharmaceutical companies with restrictions on the 340B Drug Pricing Program to 25.

Hearings, Markups, and Other Committee Action

House Energy and Commerce Subcommittee on Health held a hearing on "Legislative Proposals to Prevent and Respond to Generic Drug Shortages." On September 14, the Health Subcommittee held a hearing to discuss five legislative proposals to address generic drug shortages:

  • H.R. ___, Stop Drug Shortages Act, a discussion draft by Committee Chair Cathy McMorris Rodgers (R-WA) that would exempt certain generic and injectable drugs from 340B rebates and inflation penalties and add new reporting requirements to increase transparency into contracting practices.
  • H.R. 3008, Drug Shortage Prevention Act of 2023, a bipartisan bill introduced by Rep. Sara Jacobs (D-CA) that would require manufacturers of critical essential medicines to notify the Food and Drug Administration (FDA) of increased demand.
  • H.R. 3810, Drug Origin Transparency Act of 2023, a bill sponsored by Subcommittee Ranking Member Anna Eshoo (D-CA) that would add new reporting requirements related to active pharmaceutical ingredients (APIs).
  • H.R. 3793, Ensuring Access to Lifesaving Drugs Act of 2023, a bill sponsored by Rep. Elissa Slotkin (D-MI) that would require manufacturers to report to the FDA on the longest possible shelf life of their drugs.
  • H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act of 2023, a bipartisan bill by Rep. Morgan Griffith (R-VA) that would relax certain requirements for compounding drugs that are facing shortages.

During the hearing, the subcommittee heard from witnesses representing health system pharmacists, group purchasing organizations (GPOs), distributors, generic drug manufacturers, nonprofit generic drug company Civica Rx, and academics on the potential impact of the five bills discussed at the hearing.

  • More information available here.

House Committee on Oversight and Accountability Subcommittee on Health Care and Financial Services held a hearing on "The Inflation Reduction Act: A Year in Review." On September 14, the Subcommittee on Health Care and Financial Services held a hearing on the one-year anniversary of the Inflation Reduction Act with Republicans criticizing the law for failing to address inflation and Democrats celebrating the law's provisions to lower costs for Americans. Subcommittee members heard from a panel of three witnesses representing conservative and liberal think tanks and an advocacy group.

  • More information available here.

House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing on "Oh Doctor, Where Art Thou? Pandemic Erosion of the Doctor-Patient Relationship." On September 14, the Subcommittee held a hearing on current state of the doctor-patient relationship and the impact of the COVID-19 pandemic. During the hearing, many Republican members raised concerns about the impact government guidance and rules had on the medical community, while many Democrats criticized Republicans for holding the hearing instead of making progress on averting a federal shutdown and conservative proposals to restrict reproductive and gender-confirming care.

  • More information available here.

House Ways & Means Committee held a member day. On September 14, the Committee held a member day during which several members raised health care topics they would like the committee to take up:

  • Rep. Glenn Thompson (R-PA) spoke about HR 4315, the Medicare Orthotics and Prosthetics Patient-Centered Care Act;
  • Rep. Earl Carter (R-GA) spoke about HR 2880, Protecting Patients Against PBM Abuses Act;
  • Rep. Victoria Spartz (R-IN) spoke about:
    • HR 2862, Empowering Patient Choice of Medical Care Act
    • HR 2863, Preventing Hospital Overbilling of Medicare Act
    • HR 2859, Holding Nonprofit Hospitals Accountable Act
  • Rep. Marilyn Strickland (D-WA) spoke about HR 3481, FAMILY Act and the Improving Access to Home Dialysis Act; and
  • Rep. Mark Green (R-TN) spoke about:
    • HR 1128, Rural Health Care Access Act of 2023
    • HR1129, to remove the requirement under the Medicare program that an off-campus facility or organization shall be located within a 35-mile radius of a hospital or critical access hospital
    • HR 5213, Reducing Medically Unnecessary Delays in Care Act of 2023.
  • More information available here.

Reports, Studies, and Journals

Government Accountability Office: CARES Act: Experts Identified Safeguards to Help Selected HHS Agencies Protect Against Potential Political Interference. The report highlights HHS' plans to finalize a new scientific integrity policy, which will include procedures for reporting and handling allegations of political interference, and other initiatives aimed at preventing political interference in health decisions early next year.

Congressional Budget Office: Estimated Direct Spending and Revenue Effects of H.R. 5378, the Lower Costs, More Transparency Act. The Congressional Budget Office score of a tri-House committee package (HR 5378) found that the total package would have no effect on direct spending or revenues.

Health Affairs: Medicare Switching: Patterns Of Enrollment Growth In Medicare Advantage, 2006-22. The study, which is based on data from CMS' enrollment database, show Medicare Advantage enrollment has grown steadily since 2006, increasing from 6.3 million in December 2005 to 30.3 million in December 2022, with increases largely driven by beneficiaries who switched from traditional fee-for-service Medicare.


Contact Information
For additional information concerning this Alert, please contact:
Washington Council Ernst & Young
   •  Heather Bell (