Health Care Watch: April 1, 2024
he following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 25– March 31. 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 March 27, Rep. Annie Kuster (D-NH) announced that she will retire from the House at the end of the 118th Congress. Rep. Kuster chairs the moderate New Democrat Coalition, serves on the Energy & Commerce Health Subcommittee and founded the Bipartisan Addiction and Mental Health Task Force.
On March 27, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairman Brett Guthrie (R-KY), and Oversight & Investigations Subcommittee Chairman Morgan Griffith (R-VA) sent a letter to National Institutes of Health (NIH) Director Monica Bertagnolli requesting that NIH provide the files of all SARS-CoV-2 submissions to GenBank prior to January 10, 2020. The letter states that any such data would better inform the Committee’s ongoing investigation into the origins of COVID-19.
Senate
On March 25, Heath, Education, Labor & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent a letter to Department of Health & Human Services (HHS) Secretary Xavier Becerra regarding HHS’ failure to notify Congress of a cyberattack against the Department, resulting in the theft of $7.5 million. Ranking Member Cassidy has asked for a response to his questions by April 5, 2024.
REGULATORY UPDATE
On March 22, the Food & Drug Administration (FDA) issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents.
On March 25, FDA proposed banning electrical stimulation medical devices used for the treatment of aggressive or self-harming behaviors. FDA determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This is the agency’s second attempt to prohibit the practice after Congress gave the agency the authority to ban specific uses of approved medical devices.
On March 25, FDA announced the Center for Drug Evaluation and Research’s (CDER) new Quantitative Medicine (QM) Center of Excellence (CoE). The goal of this CoE is to facilitate and coordinate the continuous evolution and consistent application of QM across CDER. CDER will host a public workshop on April 25, and QM and will share more about the new CoE. Registration can be found here.
On March 25, FDA approved an updated label for the emergency contraception pill Plan B. The change removes language suggesting that the drug may also prevent fertilization of a released egg and implantation in the uterus.
On March 26, the Centers for Medicare & Medicaid Services (CMS) announced that 41 drugs available through Medicare Part B will have a lowered Part B coinsurance rate from April 1 through June 30, 2024, as a result of an Inflation Reduction Act (IRA) policy that requires drug manufacturers to pay back Medicare when they raise drug prices faster than the rate of inflation. An estimated 763,700 people with Medicare use one or more of these drugs annually. More information on inflation rebate program can be found here. A fact sheet detailing the 41 Part B drugs with a coinsurance reduction can be found here.
On March 26, FDA issued warning letters to six companies for marketing unapproved, misbranded products. FDA is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. FDA stated that high concentrations of lidocaine in the misbranded products could lead to increased absorption of the drug product through the skin that in turn may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties.
On March 26, FDA approved Merck’s drug, WINREVAIR, for injection, for the treatment of adults with pulmonary arterial hypertension to increase exercise capacity, improve functional class, and reduce the risk of clinical worsening events.
On March 27, CMS released the Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year (FY) 2025 and Updates to the IRF Quality Reporting Program proposed rule. The proposed rule provides for an increase to IRF payment rates by 2.8% for FY 2025. The proposed rule also includes an update to the geographic wage index values under the IRF PPS for FY 2025, consistent with its routine annual process, and also revises geographic delineations as a result of updates OMB. Additionally, the proposed rule does not include a proposed home health transfer policy, which was the subject of a request for information (RFI) in the FY23 IRF PPS final rule. CMS is also proposing to modify, remove, and adopt a number of measures for the IRF quality data reporting (QRP). Beginning with the FY 2028 IRF QRP, CMS is proposing the adoption of four new items in the IRF-PAI as standardized patient assessment data elements under the following Social Determinants of Health (SDOH) categories: 1) Living Situation; 2) Food; and 3) Utilities. Comments on the proposed rule are due May 28, 2024.
On March 27, CMS released the Streamlining Medicaid, Children’s Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes final rule. The final rule simplifies the process for eligible individuals to enroll in Medicaid coverage and keep their coverage, with the goal of preventing eligible people from experiencing gaps in Medicaid’s complex administrative processes. The final rule also aims to reduce the number of eligible individuals who lose coverage and must enroll again by establishing specific guidelines for states to check available data prior to terminating eligibility, requiring states to use certain types of available information to update addresses, and implementing a minimum timeframe (at least 15 days) for individuals to return information requested in connection with an initial application. A fact sheet detailing the final rule can be found here. The rule will take effect on May 26, 2024.
On March 27, CMS announced that it will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) on May 21, 2024. The panel will discuss devices for self-management of Type 1 and insulin-dependent Type 2 diabetes on May 21, 2024. Meeting details can be found here.
On March 27, the Cybersecurity and Infrastructure Security Agency (CISA) released a proposed rule outlining its plan for carrying out the Cyber Incident Reporting for Critical Infrastructure Act. The proposed rule would require that private firms, including large hospitals and certain medical manufacturers, report hacks to the government within 72 hours and ransom payments within 24 hours. Comments are due on May 3, 2024.
On March 27, FDA approved Akebia Therapeutics’ Vafseo (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia.
On March 28, the Office of the National Coordinator for Health Information Technology (ONC), released the draft 2024–2030 Federal Health IT Strategic Plan for public comment. The draft plan outlines federal health IT goals and objectives that are focused on improving access to health data, delivering a better, more equitable health care experience, and modernizing our nation’s public health data infrastructure, and places an emphasis on the policy and technology components necessary to support the diverse data needs of all health IT users. Additionally, the draft plan aligns with the HHS Health Care Sector Cybersecurity concept paper and voluntary health care specific Cybersecurity Performance Goals (CPGs) to help health care organizations prioritize implementation of high-impact cybersecurity practices. Comments are due on May 28, 2024.
On March 28, HHS and the Departments of Labor and the Treasury released final rules regarding short-term, limited-duration insurance (STLDI) and independent, noncoordinated excepted benefits coverage. The rule aim to improve access to affordable and comprehensive coverage, strengthen health insurance markets, and promote consumer understanding of their coverage options. Highlights include:
The Short-Term, Limited-Duration Insurance Final Rule amends the federal definition of STLDI to limit the length of the initial contract term to no more than three months and the maximum coverage period to no more than four months, taking into account any renewals or extensions.
The Fixed Indemnity Excepted Benefits Coverage Final Rule revises the consumer notice that is currently required for fixed indemnity excepted benefits coverage in the individual market and establishes a new requirement to provide a consumer notice in the group market. The rule also requires that plans and issuers prominently display the notice in marketing, application, and enrollment (and reenrollment) materials in the individual and group markets.
On March 28, CMS announced additional actions to help people maintain coverage as states continue Medicaid and CHIP eligibility renewals. CMS is extending a temporary special enrollment period (SEP) to help people who are no longer eligible for Medicaid or CHIP transition to Marketplace coverage in states using HealthCare.gov. The end date of the SEP unwinding will be extended from July 31, 2024, to November 30, 2024. CMS also released new guidance and other resources to help protect coverage. New guidance includes: Guidance on unwinding processes and tools for states reinforcing important federal renewal requirements that states must follow; Guidance to Medicaid managed care plans on completing signatures for enrollees so plans can help more people renew coverage; and new resources for partners to help families navigate their state Medicaid fair-hearing process.
On March 28, CMS released the Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF); Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal FY 2025 proposed rule. The rule proposes that SNFs receive a 4.1% increase in annual payment update for FY 2025. CMS also includes an RFI on the PPS payment component for non-therapy ancillary services (NTAs) in the proposed rule. Additionally, the rule proposes to require SNFs to report four new social determinants of health (SDOH) measures: one item for Living Situation; two items for Food; and one item for Utilities. A fact sheet detailing the proposed rule can be found here. Comments on the proposed rule are due May 28, 2024.
On March 28, CMS released the FY 2025 Hospice Wage Index and Payment Rate, Hospice Conditions of Participation, and Hospice Quality Reporting Program Requirements proposed rule. The proposed rule updates payments by 2.6%. The rule also proposes to adopt the most recent OMB statistical area delineations, which would change the hospice wage index, and proposes to clarify current policy related to the hospice “election statement” and the “notice of election” (NOE), as well as adding clarifying language regarding hospice certification. Additionally, the rule contains an RFI to solicit comments regarding implementing a separate payment mechanism to account for high-intensity palliative care services. A fact sheet detailing the proposed rule can be found here. Comments on the proposed rule are due May 28, 2024.
On March 28, CMS released the FY 2025 Inpatient Psychiatric Facilities (IPF) Prospective Payment System - Rate Update Proposed Rule. CMS is proposing to update the IPF PPS payment rates by 2.7%. The rule proposes annual updates to the prospective payment rates, the outlier threshold, the wage index, and associated impact analysis, as well as including a proposal to revise patient-level adjustment factors, and a proposal to increase the per-treatment amount for Electroconvulsive Therapy (ECT). Additionally, the rule proposes to update the wage index using the Core‑Based Statistical Area (CBSA) Labor Market Areas defined in the OMB Bulletin 23-01. A fact sheet detailing the proposed rule can be found here. Comments on the proposed rule are due on May 28, 2024.
On March 29, CMS announced that it will hold a webinar entitled, Meet MADiE: The Electronic Clinical Quality Measure (eCQM) Development and Testing Tool. The webinar will take place on April 24 and registration can be found here.
On March 29, HHS’ Office for Civil Rights (OCR) announced a settlement with Phoenix Healthcare, an Oklahoma multi-facility organization in nursing care. The settlement resolves a potential violation under the Health Insurance Portability and Accountability Act (HIPAA) Right of Access provision, which requires that individuals or their personal representatives have timely access to their health information. A copy of the Settlement Agreement can be found here.
White House
On March 26, President Biden released a fact sheet detailing actions that his Administration is taking to lower health care costs and protect and strengthen the Affordable Care Act (ACA), Medicaid, and Medicare. Actions include permanently lowering health insurance premiums, closing the coverage gap, increasing the availability of at home care, and increasing access to mental health care.
On March 27, as part of the Biden Cancer Moonshot initiative, First Lady Jill Biden convened executives from leading health insurance companies, community health plans, and health plan professional associations to highlight recent commitments to expanding access to navigation services to help patients and their families navigate health care treatments for cancer and other serious illnesses.
On March 28, Vice President Kamala Harris announced that the White House Office of Management and Budget (OMB) is issuing OMB’s first government-wide policy to mitigate risks of artificial intelligence (AI) and harness its benefits. The policy requires Federal agencies to improve public transparency in their use of AI by requiring agencies to publicly: release expanded annual inventories of their AI use cases, report metrics about the agency’s AI use cases that are withheld from the public inventory because of their sensitivity, notify the public of any AI exempted by a waiver from complying with any element of the OMB policy, and release government-owned AI code, models, and data, where such releases do not pose a risk to the public or government operations. The policy also requires that agencies complete and document risk mitigation policies for “rights impacting” AI and “safety-impacting” AI. OMB is also releasing detailed draft instructions to agencies detailing the contents of this public reporting. OMB’s policy will also remove unnecessary barriers to Federal agencies’ responsible AI innovation such as allowing the Centers for Disease Control and Prevention (CDC) to continue using AI to predict the spread of disease and detect the illicit use of opioids and allowing CMS to continue using AI to reduce waste and identify anomalies in drug costs.
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
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (CMS-2439); Final Rule; 12/20/23
Ensuring Access to Medicaid Services (CMS-2442); Final Rule; 1/26/24
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS-1808); Proposed Rule; 1/31/24
HHS Notice of Benefit and Payment Parameters for 2025 (CMS-9895); Final Rule; 2/15/24
Contract Year 2025 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4205); Final Rule; 2/22/24
Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (CMS-3442); Final Rule; 3/1/24
Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434); Final Rule; 3/22/24
FDA
Medical Devices; Laboratory Developed Tests; Final Rule; 3/1/24
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564.; Notice; 3/5/24
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 3/7/24
OCR
Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities; Final Rule; 3/4/24
Health and Human Services Grants Regulation; Final Rule; 3/6/24
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
REPORTS
Government Accountability Office (GA0)
On March 25, GAO released a report detailing FDA’s efforts to recruit and retain its inspection workforce. GAO found that FDA's clinical research inspections peaked in fiscal year 2017 but have since declined. FDA officials attributed this decrease to the COVID-19 pandemic and not having enough investigators. GAO recommends that FDA evaluate its recruitment and retention efforts to determine their effectiveness and incorporate results, as appropriate, to help ensure the agency is using the most appropriate tools to maintain its investigator workforce.
On March 26, GAO released a report detailing information on agencies’ FY 2023 estimates and improper payments. GAO found that HHS programs accounted for more than $100 billion of an estimated $236 billion in inappropriate payments across the federal government in FY 2023. HHS improper payments include $51 billion in improper payments in Medicare and $50 billion in Medicaid.
On March 27, GAO released a report examining maternal and infant health and ways HHS can strengthen processes for measuring program performance. OIG found that HHS' updates to the measures during the 2019-2024 grant period made it challenging for grantees to collect consistent and therefore reliable data. GAO stated that this occurred because HHS lacks a documented process to review its performance measures before implementation. GAO stated that HHS officials said that they try to align performance measures across Healthy Start and two related programs; however, HHS lacks a documented process to coordinate the selection of measures used across the programs, and officials could not provide examples of coordination. GAO recommends that HHS should implement documented processes to: 1) review Healthy Start performance measures to ensure they are clear and allow for the collection of reliable data; and 2) coordinate the selection of performance measures across Healthy Start and related programs.
Office of Inspector General (OIG)
On March 25, OIG released a report detailing Delaware's capitation payments to Medicaid Managed Care Organizations (MCOs) after enrollees’ deaths. OIG found that for 53 of the 100 capitation payments in OIG’s sample, the State agency made unallowable capitation payments totaling $102,867 ($71,751 Federal share). Based on sample results, OIG estimates that Delaware made unallowable capitation payments totaling at least $4.2 million (over $3.4 million Federal share) to MCOs on behalf of the 409 deceased enrollees during the audit period. OIG recommends that Delaware: 1) refund the Federal share to the Federal Government; 2) identify and recover unallowable capitation payments made to MCOs during the audit period on behalf of deceased enrollees; and 3) identify and recover unallowable capitation payments made on behalf of deceased enrollees in 2022 and 2023.
On March 26, OIG released its cybersecurity toolkit regarding cybersecurity considerations for HHS’ rapid rollout of information systems. The toolkit aims to help HHS leaders improve or maintain effective cybersecurity posture of systems or applications that are being rolled out. As a resource, the toolkit identifies key questions and considerations that HHS leaders should think about and are based on cybersecurity standards that HHS-OIG has used in its work assessing HHS information systems. The full toolkit can be found here.
On March 28, OIG released a report examining CMS oversight of selected states compliance with Medicaid MCOs mental health and substance use disorder (MH/SUD) parity requirements. OIG found that CMS did not ensure that selected States complied with Medicaid managed care MH/SUD parity requirements. For all eight States reviewed, State contracts with Medicaid MCOs did not contain required parity provisions by the compliance date. Further, OIG found that five States and their MCOs did not conduct required parity analyses, and eight States did not make documentation of compliance available to the public by the compliance date. OIG recommended that CMS improve its oversight of States’ compliance with MH/SUD parity requirements and require States to improve their monitoring of MCOs’ ongoing compliance with MH/SUD parity requirements.
UPCOMING HEARINGS
Senate
HELP Committee
Subcommittee Field Hearing
April 3; 10:00 AM; Boston, MA
Witnesses: Ellana Stinson, MD, Emergency Medicine Physician, President, New England Medical Association; Eileen O'Grady, Research & Campaign Director, Healthcare, Private Equity Stakeholder Project; Hannah Drummond, RN, Emergency Department, Mission Hospital, National Nurses Organizing Committee (NNOC) / National Nurses United (NNU); Donald Berwick, MD, President Emeritus and Senior Fellow, Institute for Healthcare Improvement; Ralph de la Torre (Invited), Chairman and CEO, Steward Health Care Systems LLC
Finance Committee
Hearing on UnitedHealth Group
April TBD
Potential Witnesses: United Health Group CEO Andrew Witty
OTHER POLICY NEWS
On March 22, Amgen filed a lawsuit in a Colorado federal district court against Colorado’s prescription drug affordability board (PDAB), arguing that the board’s actions are unconstitutional. The board is currently considering whether to set an upper payment limit on Enbrel, used to treat various forms of arthritis and psoriasis, after the board declared the drug “unaffordable” in February.
On March 25, the Supreme Court heard oral arguments in a case that could curtail access to abortion pills nationwide. This is the first major reproductive-rights-related case before the high court since the Dobbs.
On March 26, AstraZeneca filed a lawsuit to block an Arkansas law that expands the federal 340B drug discount program to include for-profit pharmacy chains like CVS and Walgreens. AstraZeneca argues that the state law imposes price caps on patented goods that are prohibited under federal law and that the mandated discounts violate the constitutional prohibition against government takings of private property. Arkansas said it will challenge the lawsuit. Note that PhRMA earlier filed a lawsuit to block the Arkansas; however, the U.S. Court of Appeals for the Eighth Circuit upheld the law in that case.