Health Care Watch: September 23, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 15– September 21. 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 September 17, the House passed several health-care bills via voice vote. Legislation advanced includes H. R. 4758 the Accelerating Kids’ Access to Care Act, H. R. 8089 the Medicare and Medicaid Fraud Prevention Act of 2024, H.R. 8111 the Medicaid Program Improvement Act, and H.R. 7218, the BOLD Infrastructure for Alzheimer’s Reauthorization Act of 2024. The House also passed, by voice vote, a $3 billion supplemental spending package for the Department of Veterans Affairs (VA). A list of all health care related legislation passed can be found here.
On September 17, Rep. Andy Harris (R-MD) was elected as the next chair of the House Freedom Caucus after Rep. Andy Biggs (R-AZ) dropped out of the race.
On September 17, the Ways & Means Health Subcommittee held a hearing entitled Investing in a Healthier America: Chronic Disease Prevention and Treatment. The hearing detailed the increase in chronic disease diagnoses and obesity. The discussion focused on “food as medicine” as well Medicare Advantage (MA) supplemental benefits.
On September 18, Speaker Mike Johnson’s (R-LA) six-month stopgap funding bill was defeated on the House floor when 14 Republicans voted against the funding package. Government funding expires on October 1.
On September 18, the Energy & Commerce Committee held a markup of 16 bills including many pieces of health care related legislation. The Committee advanced, in a 21-0 vote, H.R. 7623, the Telehealth Modernization Act,which would extend pandemic-era Medicare telehealth flexibilities for two years. Under the legislation, the two-year extension would be paid for through pharmacy benefit manager (PBM) reform.
On September 23, the House will consider:
H.R. 6829, HEARTS Act of 2024;
H.R. 3884, Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023;
H.R. 2706, Charlotte Woodward Organ Transplant Discrimination Prevention Act;
H.R. 4527, HEALTH Data Act;
S. 134, Alzheimer’s Accountability and Investment Act;
H.R. 7189, Congenital Heart Futures Reauthorization Act of 2024;
H.R. 5526, Seniors’ Access to Critical Medications Act; and
S. 150, Affordable Prescriptions for Patients Act of 2023.
Senate
On September 16, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT)announced that more than 250 clinicians from across the country sent a letter to Congress urging it take action to reign in in the high prices for novel diabetes and obesity treatments.
On September 17, the Senate, in a 51-44 vote, blocked the passage of a bill that would federally protect access to in vitro fertilization (IVF) and require public and private insurance to cover IVF and other fertility treatments.
On September 18, a group of five Senate Democrats, led by Senate Majority Whip Dick Durbin (D-IL), sent a letter to the U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal regarding recent research that found pharmaceutical companies may be benefitting from errors in USPTO’s calculation of patent term adjustment (PTA). The letter states that the errors can extend the lives of drug patents held by the companies beyond the expiration dates dictated by statute and as a result, pharmaceutical companies are able to improperly delay generic competition. The letter urges USPTO to update its approach to calculating PTA and inquire about potential alternatives by October 11.
On September 19, the HELP Committee voted, 20-0, to hold Steward Health Care CEO Ralph de la Torre in contempt for defying a subpoena to testify before the committee last week. The vote marks the first time the committee has pursued a contempt charge in decades.
REGULATORY UPDATE
On September 16, the Food & Drug Administration (FDA) issued draft guidance for industry that provides sponsors with recommendations for conducting multiregional clinical trials (MRCT) in support of applications for drugs intended to treat cancer. The draft guidance expands on current principles for MRCTs and provides additional recommendations to improve the planning, design, conduct and analysis of future oncology MRCTs. It also aids sponsors in planning multiregional clinical development programs that consider the agency’s evaluation of trial results that can be applied to the intended use population in the U.S., and to U.S. standard oncological care.
On September 16, the Advanced Research Projects Agency for Health (ARPA-H) announced the ARPA-H Emerging Health Innovators (EHI) Initiative that aims to increase access to government research funding and address health care gaps in the U.S. The EHI Initiative will begin with a Network Survey, which will gather information and insights from early career investigators, community innovators, and administrators at academic institutions, including minority-serving institutions (MSIs) and community-based organizations (CBOs). Through the EHI Network Survey, ARPA-H seeks to learn from these emerging health innovators about their specific needs, challenges, and concerns. These responses will inform a forthcoming funding solicitation, anticipated to be available in late 2024. ARPA-H intends the solicitation to offer two tracks: 1) technology-driven innovation; and 2) community-center innovation.
On September 17, the Centers for Medicare & Medicaid Services (CMS) announced that the Inpatient Rehabilitation Facility (IRF) and Long-Term Care Hospital (LTCH) Provider Preview Reports have been updated and are now available. The reports contain provider performance scores for quality measures, which will be published on Care Compare and Provider Data Catalog (PDC) during the December 2024 refresh.
On September 17, the Oklahoma Insurance Department (OID) and CMS announced the launch of a first-of-its-kind provider directory pilot program for those participating in a Qualified Health Plan (QHP). The pilot will establish and implement an automated, one-stop shop, statewide centralized directory that allows QHPs and providers to submit and access pre-populated provider data to improve accuracy and reduce burden.
On September 17, CMS announced that it will hold an educational session on the Transitional Coverage for Emerging Technologies (TCET) pathway. The session will share additional information on TCET as well as answer public questions. CMS asks the public to submit questions on the TCET pathway in advance of the meeting toTCET@cms.hhs.gov. The meeting will take place on September 23, 2024, from 2:30 to 3:30 PM EDT. A registration link can be found here.
On September 17, FDA announced that it will hold a Digital Health Advisory Committee meeting on November 20 and 21 from 9:00 AM to 6:00 PM EDT to discuss total product life-cycle considerations for generative artificial intelligence-enabled devices.
On September 17, the Department of Health & Human Services (HHS), through the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP), announced two awards totaling $2 million under the Leading Edge Acceleration Projects in Health Information Technology (LEAP in Health IT) funding opportunity. The LEAP in Health IT awardees seek to create methods and tools to improve care delivery, advance research capabilities, and address emerging challenges related to interoperable health IT.
On September 17, the Health Resources and Services Administration (HRSA) announced nearly $100 million in awards to grow, support, and strengthen the health workforce and improve access to quality care in high-need areas across the country. The announcement was made in conjunction with an HHS Health Workforce Roundtable convened as part of HHS Secretary Xavier Becerra’s Health Workforce Initiative.
On September 17, HHS’ Administration for Community Living (ACL) delivered to Congress a progress report on federal implementation of the 2022 National Strategy to Support Family Caregivers. The strategy provided recommendations for ensuring that family caregivers have the support and resources they need. The strategy also includes commitments from 15 federal agencies to nearly 350 actions to implement these recommendations. The progress report states that nearly all actions have been completed or are in progress, and federal agencies have committed to almost 40 new actions since the strategy’s release.
On September 17, FDA issued draft guidance entitled Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice, which, when finalized, will support the conduct of randomized controlled trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.
On September 17, FDA issued final guidance entitled Conducting Clinical Trials with Decentralized Elements. The guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.
On September 19, HRSA announced $240 million in awards to launch and expand mental health and substance use disorder services in more than 400 community health centers across the country that care for more than 10 million people. A list of all awards can be found here.
On September 19, the Indian Health Service and HHS announced an award of $1.19 million through six cooperative agreements to enhance tribal and urban Indian health system local capacity to provide dementia care and services. The total commitment for the new three-year awards is nearly $3.6 million.
On September 19, HRSA announced the first ever multi-vendor contract awards to modernize the nation’s organ transplant system to improve transparency, performance, governance, and efficiency of the organ donation and transplantation system. HRSA also announced multiple Organ Procurement and Transplantation Network (OPTN) modernization awards to support critical actions, including: improving patient safety; supporting OPTN IT modernization; increasing transparency and public engagement in OPTN policy development; strengthening patient-centered communications; and improving OPTN financial management.
On September 20, the Federal Trade Commission (FTC) filed a lawsuit against the three largest prescription drug benefit managers (PBMs)—Caremark Rx, Express Scripts (ESI), and OptumRx—and their affiliated group purchasing organizations (GPOs) for engaging in anticompetitive and unfair rebating practices. FTC’s administrative complaint alleges that CVS Health’s Caremark, Cigna’s ESI, and United Health Group’s Optum, and their respective GPOs—Zinc Health Services, Ascent Health Services, and Emisar Pharma Services—have abused their economic power by rigging pharmaceutical supply chain competition in their favor, forcing patients to pay more for life-saving medication. According to the complaint, these PBMs together administer about 80% of all prescriptions in the United States. FTC alleges that the three PBMs created a perverse drug rebate system that prioritizes high rebates from drug manufacturers, leading to artificially inflated insulin list prices.
On September 20, HHS, through CMS, launched an innovative grant program to provide almost $9 million to improve women’s health coverage and access to critical health benefits. These funds may be used to develop activities and launch educational campaigns to address disparities in access to reproductive health care and maternal health outcomes. The Expanding Access to Women’s Health program grantees include the District of Columbia and the following 14 states: Arkansas, Colorado, Hawaii, Massachusetts, Maine, Mississippi, Nebraska, New Hampshire, New Jersey, New Mexico, Pennsylvania, Vermont, Washington, and Wisconsin.
On September 20, a Texas appeals court ruled in favor of the National Infusion Center Association (NICA) in a case regarding Medicare’s drug price negotiations. In February, a lower Texas federal district court threw out the case, saying NICA lacked standing and that the court was an improper venue. The Texas appeals court overruled the district court holding that NICA does have standing, and that the district court has the appropriate subject-matter jurisdiction over NICA’s claims.
WHITE HOUSE
On September 16, leaders from the National Security Council and the White House Office of Pandemic Preparedness and Response Policy convened a roundtable with Federal agencies, global and domestic public health partners, advocacy organizations, and community leaders to discuss the escalating mpox outbreak in the Democratic Republic of the Congo (DRC) and multiple other countries. The convening affirmed the United States leadership role in the global mpox response and identified efforts to bolster domestic preparedness and improve U.S. readiness for a clade I mpox case.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule; 6/27/24
HHS Notice of Benefit and Payment Parameters for 2026 (CMS-9888); Proposed Rule; 7/17/24
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Proposed Rule; 8/8/24
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Final Rule; 8/22/24
Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023 (CMS-1799); Final Rule; 8/23/24
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rate Changes (CMS-1808); Interim Final Rule; 9/13/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Notice; 8/26/24
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry; Availability (2024-94); Notice; 9/16/24
OASH
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act; 8/6/24; Proposed Rule
REPORTS
Agency for Healthcare Research and Quality (AHRQ)
On September 17, AHRQ released a report examining sepsis in the U.S. and its burden on hospital care. AHRQ found that inpatient stays related to sepsis at non-Federal acute-care hospitals increased from 1.8 million in 2016 to 2.5 million in 2021, an increase of nearly 40% over five years. Additionally, AHRQ found that the aggregate hospital cost for sepsis inpatient stays at non-Federal acute-care hospitals increased from $31.2 billion in 2016 to $52.1 billion in 2021. The report concluded by stating that to sustain and improve care and outcomes, international guidelines for sepsis recognition and management must be updated and refined on an ongoing basis.
Office of Inspector General (OIG)
On September 17, OIG released a report examining Medicare Part B drug payments and the impact of price substitutions. OIG shared three key findings: 1) CMS’ price-substitution policy has saved Medicare and its enrollees $74.3 million since 2013, including nearly a million dollars for 2022; 2) CMS could have achieved even greater savings by expanding its criteria for price substitutions; and 3) potential errors in the average manufacturer price data submitted to CMS prevented OIG from determining whether 30 drugs qualified for a price substitution. OIG recommends that CMS expand its price-substitution criteria to include additional drugs to more effectively limit excessive payment amounts and to generate greater savings for Medicare and its enrollees. OIG also encourages CMS to continue to work with manufacturers to review and respond to potential errors in the drug data identified by OIG each quarter to bolster the effectiveness of the price substitution policy.
On September 19, OIG released a report examining Medicare recovered payments from providers under the COVID-19 Accelerated and Advanced Payments (CAAP) Program. OIG found that of the 100 sampled providers totaling $4.4 billion in CAAP Program payments, the Medicare Administrative Contractors completed recovery from 97 sampled providers and continued the recovery from the remaining 3 providers. OIG made no recommendations.
HEARINGS
House
Oversight and Accountability
September 16; 2:00 PM; 2154 Rayburn
Meddling with Medicare: The Biden-Harris Cover-Up
Senate
HELP Committee
September 24; 10:00 AM; SD-562
Witness: Lars Fruergaard Jorgenson, CEO, Novo Nordisk
September 26; 10:00 AM; 562 Dirksen
Legislation to be considered: S. 2305, Biosimilar Red Tape Elimination Act; S. 2780, Medication Affordability and Patent Integrity Act; S. 4436, Protect Infant Formula from Contamination Act; S. 4583, Creating Hope Reauthorization Act of 2024; S._, Medical Graduate Investment Act; S. 5103, Food and Drug Administration Foods Accountability Act
Finance Committee
September 24; 10:00 AM; 215 Dirksen
Chaos and Control: How Trump Criminalized Women’s Health Care
Witnesses: Kaitlyn Joshua, Baton Rouge, LA; Michele Goodwin, Linda D. & Timothy J. O'Neill Professor Of Constitutional Law and Global Health Policy, Georgetown University School of Law; Amelia Huntsberger, MD, Obstetrician and Gynecologist; Christina Francis, MD, Obstetrician and Gynecologist Chief Executive Officer, American Association of Pro-Life Obstetricians and Gynecologists; Heather G. Hacker, Partner, Hacker Stephens LLP
ADDITIONAL POLICY NEWS
On September 17, Express Scripts filed a lawsuit against the FTC, demanding that the agency retract a report that suggests that PBMs, including Express Scripts, may be driving up drug prices. The lawsuit describes the report as “unsupported innuendo under a false and defamatory headline” and accuses FTC Chair Lina Khan of being biased against the PBM industry.