Health Care Watch: July 15, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 10 – July 15. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On July 12, the Education & the Workforce Committee overwhelmingly passed the following health-related bills:
H.R. 4509, Transparency in Billing Act, which would require accurate billing practices by hospitals so that commercial health plans pay for appropriately billed services.
H.R. 4507, Transparency in Coverage Act, which would require increased transparency in commercial health plans and pharmacy benefit managers (PBMs);
H.R. 4527, Health DATA Act, which would allow health plan fiduciaries to access de-identified cost and quality of care information; and
H.R. 4508, Hidden Fee Disclosure Act; which would strengthen requirements that PBMs and third-party administrators disclose compensation information to plan fiduciaries.
On July 12, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) announced that the committee will release legislation to address drug shortages “in the coming weeks.” This legislation stems from a request for proposal from Senate Finance Committee Ranking Member Mike Crapo (R-ID) and Chair Rodgers. Committee Ranking Member Frank Pallone (D-NJ) and Health Subcommittee Ranking Member Anna Eshoo (D-CA) have been pushing for committee action in this area.
On July 13, the Energy and Commerce Health Subcommittee favorably reported 17 health care-related bills. Many of these policies need to be reauthorized before October 1. A summary of bills can be found here. The full committee is expected to take up this legislation as early as the week of July 17.
On July 13, the Education & the Workforce Committee passed H.R. 824, the Telehealth Benefit Expansion for Workers Act, by a vote of 21-14. This legislation would allow employers to offer standalone telehealth coverage. The Energy & Commerce Health Subcommittee passed this bill the same day and it is expected to see floor action in the coming weeks.
On July 14, Energy & Commerce Committee Chair McMorris Rodgers, Ways & Means Committee Chairman Jason Smith (R-MO), and GOP members of these committees sent a letter to Department of Health & Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure asking that CMS provides transparency when it makes National Coverage Determinations (NCDs) under the recently proposed Transitional Coverage of Emerging Technologies (TCET) pathway.
The Ways & Means Committee is expected to markup legislation dealing with PBMs and equalizing Medicare payments for physician-administered drugs in the hospital and physician office setting as early as next week. The Energy & Commerce Committee moved similar legislation on May 24. These policies are intended to help offset the costs of extending other health care priorities, including funding community health centers, that expire on October 1.
Senate
On July 10, Senate HELP Committee Chairman Bernie Sanders (I-VT) sent a new letter to HHS Secretary Becerra urging the Department to take actions to reduce the price of Alzheimer’s disease therapies and to develop a plan to lower the price for all new prescription drugs. Specifically, the Chairman Sanders asked the Secretary to describe how beneficiaries will be affected by the price of the recently FDA-approved Leqembi.
On July 12, Sens. Catherine Cortez Masto (D-NV) and Thom Tillis (R-NC), as well as Senate Finance Committee leaders Ron Wyden (D-OR) and Mike Crapo (R-ID) introduced the Medicare PBM Accountability Act, which would set new requirements on PBMs requiring disclosure of certain business practices that include annual reports to Medicare Prescription Drug Plans (PDPs) showing price negotiations and rebate information that impact beneficiary premiums and copayments.
On July 12, Finance Committee Chairman Wyden and Ranking Member Crapo announced that the Finance Committee would mark up PBM proposals on July 26. The legislative package will focus on addressing PBM practices that have grown “increasingly complex and opaque in recent years at the expense of patients and taxpayers.” A Chairman’s Mark of the legislation will be provided 48 hours before the markup. In April, the Senators released a legislative framework to address PBMs and the prescription drug supply chain.
On July 13, HELP Committee Ranking Member Bill Cassidy (R-LA) introduced the Community Health Care Reauthorization Act which would reauthorize and extend funding for the Community Health Center Fund, the National Health Service Corps and Teaching Health Center Graduate Medical Education programs, all of which expire on September 30, 2023. Ranking Member Cassidy’s legislation closely tracks with legislation that passed the House Energy and Commerce Committee in May. Like that bill, Ranking Member Cassidy’s legislation includes a 5% increase in funding for community health centers for the next two years.
Also this week, HELP Committee Chairman Sanders announced a full committee markup of the Pandemic and All-Hazards Preparedness and Response Act on July 20.
REGULATORY UPDATE
On July 11, CMS’ Center for Program Integrity announced implementation of a provisional period of enhanced oversight for newly enrolled hospice providers in Arizona, California, Nevada, and Texas. The oversight will focus on the medical review of claims of a sample of hospice beneficiaries in the four states. Hospices that will be subject to enhanced oversight include those who have enrolled in Medicare starting July 13, 2023, started the enrollment or certification process before July 13 but have not received a final approval letter, or received approval on a change of ownership request on or after July 13. Additional information regarding enhanced oversight can be found here.
On July 11, CMS posted a proposed NCD on Percutaneous Transluminal Angioplasty of the Carotid Artery Concurrent with Stenting. Comments are due by August 10.
On July 11, HHS’ Office for Civil Rights issued a proposed rule entitled Health and Human Services Grants Regulation (HHS Grants Rule). If finalized, the rule would protect LGBTQI+ people from discrimination in health and human services programs by clarifying and reaffirming the prohibition on discrimination based on sexual orientation and gender identity in certain statutes. The proposed rule also includes a provision that ensures that those with religious objections may seek an exemption from or modification of program requirements, as appropriate. A fact sheet on the rule can be found here. Comments are due by September 11.
On July 11, HHS issued a proposed rule entitled Improving Child Care Access, Affordability, and Stability in the Child Care and Development Fund (CCDF). The rule would cap co-payments for all families to no more than 7% of their income, increase parent child care options by stabilizing operations for participating providers, and reduce paperwork and bureaucratic tasks for parents. A fact sheet on the rule can be found here. Comments are due by August 28.
On July 12, CMS posted on a proposed NCD on Pre-exposure Prophylaxis (PrEP) Using Antiretroviral Drugs to Prevent HIV Infection. Comments on the NCD are due by August 28.
On July 13, CMS issued a proposed rule entitled CY 2024 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies. For CY 2024, the proposed physician conversion factor (CF) is $32.7476, that represents a decrease of 3.36% from the CY 2023 conversion factor. CMS also reaffirms that G2211, an add-on code for complexity, will go into effect on January 1, 2024 – after implementation of the code originally proposed for CY 2021 was delayed by Congress. CMS notes that implementation of the code would result in a significant payment reduction to the PFS overall for CY 2024 (i.e., approximately 90% of a negative 2.17% budget neutrality adjustment to the CF for CY 2024 is attributable to G2211). The rule also includes proposed updates to Medicare Shared Savings Program requirements; the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; among others. A fact sheet on the rule can be found here. Comments on the proposed rule are due by September 11.
On July 13, CMS issued a proposed rule entitled CY 2024 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System etc. For CY 2024, CMS proposes to increase payment rates under OPPS and the ASC payment system by a factor of 2.8%. The rule also includes proposed requirements for hospitals to make public their standard charge information and updates on enforcement of hospital price transparency; as well as updates to Community Mental Health Centers Conditions of Participation. The rule also seeks comment on separate payment under the Inpatient Prospective Payment System (IPPS) for establishing and maintaining access to a buffer stock of essential medicines to foster a more reliable supply of these medicines. A fact sheet on the rule can be found here. Comments on the proposed rule are due by September 11.
On July 13, CMS Administrator Chiquita Brooks-LaSure sent a letter to Medicare plans, private plans, and State Medicaid and CHIP programs regarding coverage of COVID-19 vaccines post commercialization. The letter details vaccine coverage requirements both pre- and post- commercialization and encourages providers to start planning for the fall vaccination campaign.
On July 13, the Centers for Disease Control and Prevention (CDC) announced that it will launch a “Bridge Access Program” in Fall 2023 to provide free COVID-19 vaccines and treatments to uninsured and underinsured adults. A team within CDC’s Immunization Services Division has been established to help launch the new program this fall. The program is temporary and is scheduled to end in December 2024.
On July 13, the Food and Drug Administration (FDA) approved the Opill (norgestrel) tablet for nonprescription use to prevent pregnancy. Opill is the first daily oral contraceptive approved in the for use without a prescription. HHS Secretary Xavier Becerra released a statement on the approval, stating that the drug will lower barriers and increase access to contraception nationwide.
On July 13, HHS Secretary Xavier Becerra sent a letter to COVID-19 vaccine manufacturers advising them that they should plan the updated COVID-19 vaccine supply and regulatory submissions so that FDA can take regulatory action and CDC can make recommendations on vaccination by the latter part of September. The letter asks that manufacturers continue to enable visibility of provider networks and availability of vaccines to both HHS and patients.
On July 14, CMS issued a request for information (RFI) seeking input on the design of a future episode-based payment model to be developed by the Center for Medicare and Medicaid Innovation. CMS notes that responses to the RFI may be used to inform potential future rulemaking or other policy development. Comments to the RFI are due by August 17.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061); Final Rule; 3/1/22
Minimum Staffing Standards for Long-Term Care Facilities (CMS-3442); Proposed Rule; 5/30/23
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule; 6/28/23
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2024 Rates (CMS-1785); Final Rule; 6/29/23
FY 2024 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1779); Final Rule; 7/3/23
FY 2024 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1781); Final Rule; 7/5/23
FY 2024 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1787); Final Rule; 7/5/23
FY 2024 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1783); Final Rule; 7/6/23
FDA
Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Notice; 5/19/23
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format; Final Rule; 5/19/23
Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President's Emergency Plan for Acquir; Notice; 6/12/23
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under the President's Emergency Plan; Notice; 6/12/23
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; 6/12/23
Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials (Draft Guidance); Notice; 6/29/23
Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Certain Legally Marketed Medical Products: Questions and Answers (CDER, 2023-155); Notice; 7/13/23
REPORTS
Government Accountability Office
On July 11, the GAO issued a report entitled COVID-19: GAO Recommendations Can Help Federal Agencies Better Prepare for Future Public Health Emergencies. The report includes a comprehensive list of recommendations, including several from previous reports, that the GAO believes could help better prepare federal agencies, including the Department of Health and Human Services (HHS), for future emergencies. These recommendations focus on the areas of public health preparedness, improper payments and fraud, vulnerable populations, distribution of federal COVID-19 funding, and COVID-19 and the economy. This report also includes several key data updates focused on the COVID-19 pandemic.
On July 13, the GAO issued a report entitled Regenerative Medicine: Therapeutic Applications, Challenges, and Policy Options. The report describes the GAO’s assessment of current and emerging regenerative medicine technologies and therapeutic applications. In particular, it examines (1) current and emerging regenerative medicine technologies and therapies and their potential benefits, (2) challenges that hinder their development and use, and (3) policy options that could help enhance benefits and mitigate challenges associated with these technologies and therapies. The report concludes that regenerative medicine offers the hope of being able to restore or replace cell, tissue, and organ functions affected by disease, injury, or aging that may eventually help manage or cure many conditions that are currently considered chronic, untreatable, or terminal.
UPCOMING CONGRESSIONAL HEARINGS
House
Oversight and Accountability Committee
Health Care and Financial Services Subcommittee
July 18; 2:00 PM; 2247 Rayburn
Why Expanding Medicaid to DACA Recipients Will Exacerbate the Border Crisis
Witness: Dr. Ellen Montz, Center for Consumer Information and Insurance Oversight; CMS
Energy & Commerce Committee
Health Subcommittee
July 18; 10:30 AM; 2322 Rayburn
Witnesses: TBD
Likely the week of July 17; TBD
Markup of the Pandemic and All-Hazards Preparedness Act and other health legislation
Ways & Means Committee
Weekly of July 17 (likely); TBD
Markup: PBM reform and hospital site neutral legislation
Small Business Committee
Oversight, Investigations, and Regulations Subcommittee
July 19; 10:00 AM; 2360 Rayburn
Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses
Witnesses: TBD
Senate
Special Committee on Aging
July 20, 2023; 9:30AM; 366 Dirksen
Witnesses: TBD
Finance Committee
Subcommittee on Health Care
July 20, 2023; 10:00 AM; 215 Dirksen
The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System
Witnesses: LaQuayia Goldring, patient; Molly McCarthy, Vice Chair & Region 6 Patient Affairs Committee Representative, Organ Procurement and Transplantation Network; Matthew Wadsworth, President and CEO, Life Connection of Ohio; Donna Cryer, Founder and CEO, Global Liver Institute.
HELP Committee
July 20, 2023; 10:30 AM; 430 Dirksen
Markup: Pandemic and All-Hazards Preparedness and Response Act
Finance Committee
July 26, 2023; 2:00PM; 215 Dirksen
Markup: Pharmacy Benefit Manager Proposals (TBD)
Joint Economic Committee
July 19, 2023; 2:00PM; 210 Cannon
The Economic Impact of Diabetes
Witnesses: Benedict Ippolito, Senior Fellow, American Enterprise Institute; Mark A, Herman, MD; E.L. Wagner, MD Chair of Internal Medicine II, Chief Section of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine.