Health Care Watch: May 28, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 19 – May 25. 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 May 20, Ways and Means Committee Chairman Jason Smith (R-MO) and Budget Committee Chairman Jodey Arrington (R-TX) sent a letter to Congressional Budget Office (CBO) Director Phillip Swagel and Joint Committee on Taxation (JCT) Chief of Staff Thomas Barthold requesting a comprehensive analysis of the budgetary effects of making permanent the enhanced Affordable Care Act subsidies. In the letter, the Chairmen express concerns about the growing cost of taxpayer-funded premium tax credits, including the impact they have on increasing the cost of insurance.
On May 23, Reps. Vern Buchanan (R-FL) and Gwen Moore (D-WI) announced the launch of the bipartisan Congressional Preventive Health and Wellness Caucus. The caucus will work to bring awareness to the obesity epidemic and help promote and advance policy-centric solutions. Specifically, the bipartisan group will focus on prevention, medical research and innovation, food as medicine, exercise, health disparities, coverage, stigma, obesity’s effect on military readiness, and physical fitness.
On May 23, the Budget Committee held a hearing entitled Breaking Up Health Care Monopolies: Examining the Budgetary Effects of Health Care Consolidation. The hearing examined consolidation in the health care market and the effects it has on federal spending and access to and cost of health care.
Senate
On May 21, Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urging the Agency to enforce civil monetary penalties established by Congress on brokers who submit fraudulent enrollments for a health plan. The letter also urged CMS to take additional steps, such as providing clear rules and guidelines on what marketing practices are acceptable.
On May 22, Sen. Rick Scott (R-FL) launched a bid to succeed Sen. Mitch McConnell (R-KY) as the next Republican leader.
On May 23, the Finance Committee held a hearing entitled Front Lines of the Fentanyl Crisis: Supporting Communities and Combating Addiction through Prevention and Treatment. The hearing examined ways to combat the fentanyl crisis through policies such as expanding access to opioid use disorder (OUD) education in schools and extending telehealth flexibilities.
REGULATORY UPDATE
On May 20, the Advanced Research Projects Agency for Health (ARPA-H) announced the launch of the Universal Patching and Remediation for Autonomous Defense (UPGRADE) program, a cybersecurity effort that will invest more than $50 million to create tools for information technology (IT) teams to better defend the hospital environments they are tasked with securing. UPGRADE seeks performer teams to submit proposals on four technical areas: creating a vulnerability mitigation software platform, developing high-fidelity digital twins of hospital equipment, auto-detecting vulnerabilities, and auto-developing custom defenses.
On May 20, CMS appointed Dr. Martin Mendoza as the new Director of the Office of Minority Health. Dr. Mendoza previously served as Director of health equity for the “All of Us” research program at the National Institutes of Health.
On May 20, the Food & Drug Administration (FDA) approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) as interchangeable biosimilars to Eylea (aflibercept) for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
On May 20, FDA announced a public workshop, Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. The workshop will take place on July 11 and 12 on-site at FDA’s White Oak campus and virtually and will discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on the developing fetus and newborn infant. Registration can be found here.
On May 20, FDA’s Oncology Center of Excellence (OCE) announced the formation of the OCE Equity Program. The new program expands Project Equity, continuing the OCE’s work to improve access to clinical trials of oncology medical products for populations that have been historically underrepresented in clinical research. The OCE Equity Program will continue the OCE’s efforts to improve trial access for individuals who live in rural areas, sexual and gender minorities, and individuals with economic, linguistic, or cultural barriers to healthcare services.
On May 20, FDA announced the launch of the Center for Devices and Radiological Health and Office of Digital Transformation’s precision FDA Phase 1 of the Digitally-Derived Endpoints for Freezing-of-Gait Detection Challenge. The Challenge seeks artificial intelligence (AI) models to identify and predict digitally-derived endpoints for freezing of gait events related to Parkinson’s disease. Medical device developers, tech innovators, software developers, and academic researchers are invited to participate. Registration can be found here and submissions are due before August 2, 2024.
On May 21, CMS launched a new option on CMS.gov to allow individuals to more easily file an Emergency Medical Treatment and Labor Act (EMTALA) complaint. CMS stated that it continues to work to enforce federal law, to ensure access to quality health care services protected by EMTALA.
On May 21, the National Institutes of Health (NIH) issued a draft policy proposal to promote equitable access to products stemming from NIH-owned inventions. The draft policy would require organizations partnering with NIH through patent license agreements to outline detailed plans for patient access to drugs, biologics, vaccines, or devices developed from NIH-owned inventions. NIH aims to accelerate how breakthroughs in medical research originating from the NIH’s Intramural Research Program can translate into affordable and sustainable solutions for patients across the country. Additionally, NIH released a request for information and is looking for public input to help inform the new policy.
On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a decision affirming the U.S. District Court for the District of Columbia and rejecting the government’s position that the 340B statute categorically prohibits manufacturers from imposing contractual conditions on how their products may be distributed via contract pharmacy restrictions. The decision holds that the conditions imposed by the manufacturers on contract pharmacies in the case “do not violate section 340B on their face.”
On May 23, FDA announced a campaign aimed at promoting resources to help primary care providers identify and treat opioid use disorder (OUD). The campaign focuses on medications that help treat OUD and provides resources – including videos, free trainings, and informational documents – to primary care providers.
On May 23, the Federal Trade Commission (FTC) and the Justice Department’s (DOJ) Antitrust Division jointly launched a public inquiry to identify serial acquisitions and roll-up strategies throughout the economy that have led to consolidation that has harmed competition. In a joint Request for Information, the agencies are seeking information from the public on serial acquisitions and roll-up strategies that drive consolidation.
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
Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434); Final Rule; 3/22/24
CY 2025 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1805); Proposed Rule; 4/18/24
CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1807); Proposed Rule; 4/18/24
CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1809); Proposed Rule; 4/24/24
CY 2025 Home Health Prospective Payment System Rate Update and Home Infusion Therapy and Home IVIG Services Payment Update (CMS-1803); Proposed Rule; 4/26/24
FDA
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry; Notice; 4/10/24
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Notice; 5/21/24
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
REPORTS
Office of Inspector General (OIG)
On May 20, OIG released a report examining the Department of Health & Human Services (HHS) compliance with the Payment Integrity Information Act of 2019 (PIIA) and applicable improper payment guidance for FY 2023. OIG found that HHS did not comply with several PIIA requirements. Specifically, OIG found that HHS: 1) did not report an improper and unknown payment estimate for Temporary Assistance for Needy Families, and Foster Care; 2) reported a partial improper payment error rate for Advance Premium Tax Credit; 3) reported improper and unknown payment rates in excess of 10 percent for the Children’s Health Insurance Program; 4) did not effectively demonstrate improvements to payment integrity for the Medicare Part C program; 5) HHS’s Sampling and Estimation Methodology Plan (S&EMP) did not completely measure all key characteristics of the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program; and 6) had recovery audit activities for the identified improper payments for the Medicare Advantage program which were delayed or missing cost-effectiveness documentation.
On May 21, OIG released a report examining California’s federal Medicaid reimbursement for capitation payments on behalf of noncitizens with unsatisfactory immigration status (UIS). OIG found that of the $372.9 million in total Federal Medicaid reimbursement for capitation payments made on behalf of noncitizens with UIS, California did not claim $52.7 million in accordance with Federal requirements. Specifically, the proxy percentage, 39.87%, that California applied to capitation payments did not correctly account for the costs of providing nonemergency services to noncitizens with UIS. OIG recommends that California: 1) refund to the Federal Government the improperly claimed Federal reimbursement of $52.7 million for capitation payments made on behalf of noncitizens with UIS; and 2) work with CMS to determine the amount of any improperly claimed Federal reimbursement for capitation payments made on behalf of noncitizens with UIS for an agreed-upon period not covered by OIG’s audit.
On May 22, OIG released a report examining selected Centers for Disease Control and Prevention (CDC) Racial and Ethnic Approaches to Community Health (REACH) program recipients. OIG found that selected recipients generally used their REACH program funding in accordance with Federal requirements and award terms. In addition, the selected recipients complied with requirements for working with the priority populations and in the required strategy areas. However, the recipients did not meet all targeted performance measures, and some charged or may have charged unallowable costs. Specifically, all 10 selected recipients did not meet all targeted performance measures, five charged unallowable costs totaling $236,587, and six may have charged unallowable costs totaling $1,377,025 because staff salaries and fringe benefit expenditures were not properly allocated to their REACH award. OIG made several recommendations to CDC, including that it provide additional technical assistance to recipients to ensure that only allowable, allocable, and documented costs are charged to their REACH program awards.
On May 23, the HHS OIG released a report examining Medicaid managed care data for drug claims. OIG found that state requirements varied for how plans should report the paid amount for drug claims. OIG also found that for 37 of 252 managed care drug claims in the review, the Transformed Medicaid Statistical Information System (T-MSIS) paid amount did not equal pharmacy‑reported reimbursement, raising concerns about the accuracy or consistency of the paid amounts on these claims. Finally, OIG found that although all States relied on drug claim paid amounts to safeguard and administer the Medicaid program, many States did not conduct certain activities to validate these data. OIG recommends that CMS: 1) revise the T‑MSIS Data Dictionary to instruct States to report the paid amount as the amount paid to the pharmacy for all Medicaid managed care drug claims; 2) provide additional technical assistance to States to clarify what to include or exclude from the reported paid amounts to providers for Medicaid managed care drug claims; and 3) follow up with States that did not verify that paid amounts for managed care drug claims were complete.
UPCOMING HEARINGS
House
Oversight and Accountability Committee
Early June; TBD
Hearing on Pharmacy Benefit Manager (PBM) Practices
OTHER POLICY NEWS
On May 20, digital pharmacy startup Hims & Hers Health announced that it is launching compounded GLP-1 injections with the same active ingredient in weight-loss drugs Ozempic and Wegovy. Hims & Hers is partnering with an unidentified 503B compounder to produce the injectable medicines.
On May 20, Public Citizen, a consumer advocacy nonprofit, filed a lawsuit against the FDA citing inaction on a petition requesting that FDA require the revision of product labels for selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). The requested revision seeks to warn of the drugs’ risk of serious sexual side effects, which may persist after stopping SSRI or SNRI treatment, and may even be permanent.
On May 24, new results published in the New England Journal of Medicine revealed that Ozempic cut the risk of death in a trial of patients with type 2 diabetes and chronic kidney disease, suggesting it may offer some added benefits over other classes of drugs approved to treat this population. Specifically, the drug cut the risk of cardiovascular-related deaths by 29% and all-cause deaths by 20%.