This Week in Washington: President and Speaker McCarthy to meet on debt limit with 10 days to go, House Energy and Commerce Subcommittee on Health marks up 17 bills, House Appropriations Committee begins moving appropriation bills



House Energy and Commerce Health Subcommittee Holds Markup on 17 Bills

On May 17, the House Energy and Commerce Committee Subcommittee on Health marked up 17 healthcare-related bills and voted to move seven bills forward. They include:

  • H.R. 1418, the Animal Drug User Fee Amendments of 2023

This legislation would reauthorize ADUFA and AGDUFA for fiscal years 2024 to 2028. Reauthorization of these programs would include the negotiated agreement on performance goals and procedures between the FDA and industry for the upcoming five-year period. This would be the fifth iteration of ADUFA and the fourth iteration of AGDUFA.

  • H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act

This legislation would amend Section 372 of the Public Health Service Act to allow for additional flexibilities within the Organ Procurement and Transplantation Network (OPTN).

Note: A companion bill was introduced in the Senate on May 17 by Senate Finance Committee Chairman Ron Wyden (D-OR) and Sens. Grassley (R-IA), Cardin (D-MD), Young (R-IN) and Cassidy (R-LA) and referred to the Senate Health, Education, Labor and Pensions Committee.

  • H.R. 3281, the Transparent PRICE Act

This legislation would require hospitals to make their standard charges public through machine-readable files as well as payer specific negotiated charges, including for cash-paying patients, for 300 shoppable services. Additionally, the legislation would require health insurance companies to make personalized pricing information available to enrollees and post machine-readable files containing in-network negotiated rates, historical prescription drug prices and out-of-network allowed amounts. Finally, the bill would increase penalties for noncompliance with existing rules and implement policies to improve the quality of data reported by hospitals and insurers to provide actionable information for patients and employers.

  • H.R. 2666, the Medicaid VBPs for Patients (MVP) Act

This legislation would codify Medicaid rules that permit the use of varying best price points under value-based purchasing arrangements such as gene therapies.

  • H.R. 3285, the Fairness for Patient Medications Act

This legislation would establish deductible and cost-sharing limitations on highly rebated drugs. Specifically, cost-sharing would be capped at the price paid by the insurer for the drug in the previous year to ensure patients are never paying more than the cost of the drug.

  • H.R. 3284, Providers and Payers COMPETE Act

This legislation would require the U.S. Department of Health and Human Services (HHS), during each of its annual hospital and other provider payment rules like those for inpatient and outpatient care, to consider the implications that its proposals may have on further consolidating the healthcare system by studying both horizontal and vertical consolidation among both providers and payers.

  • H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program

This legislation would establish reporting requirements for hospitals participating in the 340B program. Specifically, participating hospitals would be required to report total 340B savings and other key metrics to the Health Resources and Services Administration on an annual basis.

  • H.R. 2559, the Strengthening Community Care Act of 2023

This legislation would extend funding for the Community Health Center Fund and National Health Service Corps.

  • H.R. 2547, the Special Diabetes Program for Indians Reauthorization Act of 2023

This legislation would extend funding for the Special Diabetes for Indians program.

  • H.R. 2550, the Special Diabetes Program Reauthorization Act of 2023

This legislation would extend funding for the Special Diabetes Program.

  • H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023

This legislation would require pass-through pricing and prohibit spread-pricing for payment arrangements with pharmacy benefit managers under Medicaid.

  • H.R. 2665, the Supporting Safety Net Hospitals Act

This legislation would eliminate the disproportionate share hospital payment reductions under the Medicaid program for fiscal years 2024 and 2025.

  • H.R. 2679, the PBM Accountability Act

This legislation would require pharmacy benefit managers (PBMs) regularly to furnish employers with detailed data on prescription drug spending, including the cost of drugs, total out-of-pocket spending, formulary placement rationale and aggregate rebate information. Additionally, the Comptroller General of the United States would be required to submit a report to Congress on pharmacy networks of group health plans, health insurance issuers and entities providing pharmacy management services under such group health plans or group or individual health insurance coverage.

  • H.R. 3248, Diagnostic Lab Testing Transparency Act

This legislation would require diagnostic laboratories to disclose three data points for clinical diagnostic laboratory tests included on the list of shoppable services specified by the Centers for Medicare and Medicaid Services: the discounted cash price of each test, the de-identified minimum rate for each test and the de-identified maximum rate for each test.

  • H.R. 3262, Ownership Transparency

This legislation would require hospitals, freestanding emergency centers, ambulatory surgical centers, physician practices with more than 25 physicians, physician practices owned by hospitals, insurance companies and other entities to report to the Department of Health and Human Services (HHS) upon changes in ownership. HHS would be required to use this data to submit annual reports on trends in healthcare consolidation.

  • H.R. 3282, The Promoting Transparency and Healthy Competition in Medicare Act

This legislation would increase transparency into the effects of vertical integration in healthcare by requiring Medicare Advantage Organizations and Part D plan sponsors to report data with respect to how these companies interact with healthcare providers that they share common ownership with—like physician groups, pharmacy benefit managers (PBMs) and pharmacies—compared to those that they do not.

  • 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 of a provider to submit to the Centers for Medicare & Medicaid Services an attestation with respect to each such department

This legislation would require that each department of a provider include a unique identification number on claims for services, and require hospitals with an outpatient department of a provider to submit to the Centers for Medicare and Medicaid Services an attestation with respect to each outpatient department.

For more information, click here.

House Appropriations Subcommittee Advances FDA Funding Bill

On May 18, the House Appropriations Committee’s Agriculture, Rural Development, and Food and Drug Administration (FDA) Subcommittee convened to mark up the fiscal year (FY) 2024 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Bill. The bill, also referred to as the FDA Funding Bill, was forwarded by the subcommittee with no amendment. House Democrats strongly oppose the bill, stating that it would override important FDA decisions and negatively impact public health. In addition, House Republicans omitted from the bill a longstanding policy rider that for years has blocked FDA from using appropriations funding to finalize a rule that would require pharmaceutical prescribing information to be shared electronically, rather than in paper format. The bill would:

  • Provide the FDA with $6.6 billion in funding in FY 2024;
  • Reverse the FDA decision to allow mifepristone to be dispensed by certified pharmacies;
  • Prevent the FDA from banning flavored cigars and menthol cigarettes;
  • Prevent the FDA from imposing nicotine limits on cigarettes; and
  • Delay any plans to impose population-wide sodium reduction targets;

For more information, click here.

Congressional Rare Disease Caucus Urges FDA to Create Rare Disease Task Force

On May 12, the Congressional Rare Disease Caucus urged the Food and Drug Administration (FDA) to improve reliability and consistency of the agency’s rare disease therapy review process. Caucus cochairs Klobuchar (D-MN), Wicker (R-MS), Bilirakis (R-FL) and Matsui (D-CA) led a group of 25 senators and representatives in sending a letter to FDA Commissioner Robert Califf, in which they asked the commissioner to establish a task force to review and address shortcomings in FDA rare disease policies and guidance. The members are requesting that the task force release a public report by December 2024 that would:

  • Explain how FDA advisory committees have addressed rare disease applications;
  • Identify inconsistent processes and policies;
  • Review how the accelerated approval pathway is used for rare disease therapies;
  • Clarify how real-world evidence can be used in regulatory approvals;
  • Include tracking metrics on rare disease policy implementation issues; and
  • Highlight FDA statutory changes and new authority.

For more information, click here.

Telemental Health Services Act Reintroduced

On May 16, Reps. Matsui (D-CA) and Johnson (R-OH) reintroduced the Telemental Health Services Act. The bill would remove a Medicare provision that requires beneficiaries who receive treatment for mental or behavioral health concerns via telehealth to see a doctor in-person within six months of receiving their virtual treatment.

For more information, click here.

Black Maternal Health Momnibus Act of 2023 Reintroduced

On May 15, Reps. Underwood (D-IL) and Adams (D-NC) reintroduced the Black Maternal Health Momnibus Act of 2023. The bill would increase investments to address social determinants of health and provide funding for community-based organizations. It would also diversify and expand the perinatal health workforce, broaden access to maternal mental health care, increase funding for veteran maternal healthcare services, improve maternal health crisis data collection processes and more.

For more information, click here.


Debt-Ceiling Talks Hit a Pause

On May 16, President Biden met with House Speaker Kevin McCarthy (R-CA), Senate Majority Leader Chuck Schumer (D-NY) and House Minority Leader Hakeem Jeffries (D-NY) to discuss the debt-ceiling.

Despite the ongoing gridlock, Tuesday’s meeting signaled a shift from Democratic leaders, as they acknowledged that the only way forward is through negotiations. However, negotiations while the President has been out of the country hit a snag with each side saying the other wanted a package that was unrealistic. The President and Speaker McCarthy will meet today with ten days to go until the debt limit and Treasury’s exhaustive measures will run out. Democrats are urging the President to use an untried measure involving the Fourteenth Amendment. In the House, democrats are also seeking the use of a discharge petition, but that would require some republicans also signing on.

Senate HELP Ranking Member Seeks Feedback on Dually-Eligible Beneficiary Draft Legislation

On May 18, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) announced that he is seeking feedback on draft legislation that would impact dually-eligible Medicare and Medicaid beneficiaries. The draft legislation would, among other things:

  • Direct states to choose an integrated care model to provide comprehensive care for full-benefit dual beneficiaries;
  • Require integrated plans that enroll dually-eligible beneficiaries to regularly update provider directories and collect quality measures data;
  • Require the Department of Health and Human Services (HHS) to review the processes states use to determine whether someone is a full-benefit or partial-benefit dual beneficiary;
  • Require HHS to identify legislative changes needed to align billing codes for Medicare, Medicaid and state integrated-dual beneficiary programs;
  • Direct the Centers for Medicare and Medicaid Services (CMS) to issue guidance for brokers on how to enroll dual beneficiaries;
  • Require states to make the Program of All-Inclusive Care for the Elderly (PACE) available to all Medicare beneficiaries under the age of 55; and
  • Direct CMS to review the hospital star rating program.

NIH Clinical Trial Diversity Act Introduced

On May 18, Sens. Menendez (D-NJ) and Collins (R-ME) introduced the NIH Clinical Trial Diversity Act. The bill would require the National Institutes of Health (NIH) to ensure the availability of less burdensome clinical trial follow-ups, to increase participation of underrepresented populations and to develop clear recruitment and retention objectives with clinical trial sponsors. The bill would also require the NIH to launch a public awareness campaign to highlight research opportunities across federal agencies.

A companion bill was introduced in the House by Reps. Kelly (D-IL) and Fitzpatrick (R-PA).

For more information, click here.

Sen. Sanders Develops Package on Healthcare Workforce

Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced a new package that would over five years provide $130 billion for community health centers and $60 billion in funding to grow the healthcare workforce. Within that $60 billion, the package would set aside $15 billion for graduate medical education programs with an emphasis on primary care. Overall the $200 billion package is the chairman’s response to the months-long discussion the committee members have had about how to address healthcare workforce shortages and concerns about community health centers in the wake of the pandemic. 

Medicare for All Act Reintroduced

On May 17, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) led 14 senators in introducing the Medicare for All Act. The bill would establish a Medicare-for-all health insurance program that would be implemented over a four-year period. The Medicare eligibility age would be reduced to 55 in the first year, and Medicare Part A, B and D deductibles would be eliminated. By the fourth year, all Americans, including children, would be entitled to Medicare benefits and comprehensive healthcare services.

A companion bill cosponsored by more than 110 members was introduced in the House by Reps. Jayapal (D-WA) and Dingell (D-MI).

For more information, click here.

Facilitating Access to Innovative Diagnostics Act Reintroduced

On May 16, Sens. Blackburn (R-TN) and Baldwin (D-WI) reintroduced the Facilitating Access to Innovative Diagnostics Act. The bill would improve patient access to diagnostic radiopharmaceuticals and technologies used to detect diseases such as cancer and Alzheimer’s. It would also revise payment policies for imaging diagnostics that use innovative technologies and promote further research and development opportunities. The bill is supported by a large number of prostate cancer, Alzheimer’s and Parkinson’s stakeholder groups.

For more information, click here.

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