Health Care Watch: December 10, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from December 10 – December 17. 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 December 11, the House passed H.R. 5378, the Lower Costs, More Transparency Act, in a 320-71 vote. The legislation would increase reporting requirements for insurers, hospitals and pharmacy benefit managers (PBMs). The legislation also renews a number of federal health programs and introduces Medicare site-neutral payment policies for physician administered drugs. Senate HELP Committee Chairman Bernie Sanders (I-VT) are drafting similar transparency legislation called the Health Care PRICE Transparency Act 2.0.
On December 12, the House passed H.R.4531, the Support for Patients and Communities Reauthorization Act, in a 386-37 vote. The legislation reauthorizes an array of addiction treatment and recovery programs. The Senate Health, Education, Labor & Pensions (HELP) committee advanced its own version of the legislation the same day in a 19-1 vote.
On December 14, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chair Brett Guthrie (R-KY), and Oversight & Investigations Subcommittee Chair Morgan Griffith (R-VA) sent a letter to Food & Drug Administration (FDA) Commissioner Dr. Robert Califf following up on a previous request for information related to the agency’s foreign drug inspection program.
On December 14, Ways & Means Committee member Rep. Drew Ferguson (R-GA) announced that he will not seek re-election. In total, 40 members have announced they are retiring or running for a higher office and seven Senators have announced their retirement. More announcements are expected after the holidays.
Senate
On December 12, the HELP Committee held a markup of S. 3393, the SUPPORT for Patients and Communities Reauthorization Act, which provides grants for states to pay for prevention, treatment and recovery services for people with opioid use disorders. The committee advanced the legislation in a 19-1 vote.
On December 12, Finance Committee Chairman Ron Wyden (D-OR) and Reps. Pramila Jayapal (D-WA) and Sara Jacobs (D-CA) released new findings from an inquiry into health data privacy which revealed that major pharmacy chains failed to protect the privacy of their customers. The members called on the Department of Health & Human Services (HHS) to improve federal health privacy regulations to better protect Americans’ prescriptions and other health records held by pharmacies, conduct follow-up pharmacy privacy policy surveys, and publish any findings.
On December 14, the HELP Committee held a hearing entitled “What is fueling the diabetes epidemic?” The Committee heard expert testimony and discussed actions Congress and the administration can take to combat the growing epidemic and lower the cost of diabetes management medications.
REGULATORY UPDATE
Drug Pricing Updates
On December 14, CMS released revised guidance detailing key requirements and procedures for calculating rebates and invoicing manufacturers that owe rebates to Medicare under the Inflation Reduction Act’s (IRA) Medicare Prescription Drug Inflation Rebate Program for certain drugs covered under Part B and Part D. The revised guidance includes additions to describe how CMS will reduce the inflation rebate amount for a Part B or Part D rebatable drug on an FDA drug shortage list, reflect that CMS will apply a time-limited standard reduction in the rebate amount when there is a severe supply chain disruption, and clarify the methods CMS will use to calculate inflation rebate amounts in cases where certain data are not reported. A CMS press release can be found here. A fact sheet on the Medicare Prescription Drug Inflation Rebate Program revised guidance can be found here. The Part B revised guidance can be found here and the Part D revised guidance can be found here.
On December 14, CMS released the list of 48 prescription drugs that may be subject to the Part B inflation rebate under the IRA’s Medicare Prescription Drug Inflation Rebate Program. between January 1, 2024 – March 31, 2024. As a result of being subject to the rebates, Part B beneficiary coinsurances for these drugs may be lower, starting January 1, 2024. CMS estimates that some beneficiaries who take these drugs may save between $1 and $2,786 per average dose depending on their individual coverage. A fact sheet detailing which Part B drugs met the criteria to trigger a coinsurance adjustment can be found here. President Biden’s statement on the revised guidance can be found here.
On December 14, HHS issued a report that provides an in-depth review of the 10 drugs selected for the first cycle of the IRA’s Medicare drug price negotiation program. The report, from the Office of the Assistant Secretary for Planning and Evaluation (ASPE), reviews the common conditions treated by the selected drugs, including key health disparities associated with these conditions. The report explores current utilization and spending trends for each of the 10 drugs over a 5-year period.
On December 14, HHS announced that the Administration for Strategic Preparedness and Response (ASPR) is making “fair pricing” a standard part of contract negotiations for medical products developed or purchased as part of its commitment to obtain best value for the US taxpayer. These clauses will be in effect if and when a company’s candidate vaccine is selected to move into ASPR-supported Phase 2b trials to evaluate clinical safety and efficacy.
Other Updates
On December 12, the Centers for Medicare & Medicaid Services (CMS) released new guidance aimed at improving access to home- and community-based services (HCBS) by reminding states of tools to better connect direct support workers to individuals receiving Medicaid-covered HCBS. The guidance focuses on building and maintaining worker registries so more individuals receiving Medicaid-covered services can receive care in a setting of their choice. Additionally, CMS’ guidance reiterates that states can access enhanced federal funding, including through the American Rescue Plan (ARP). CMS also released data on how enhanced funding for HCBS provided through the ARP has been invested to strengthen access to HCBS across the country.
On December 12, HHS, through the Office of the National Coordinator for Health Information Technology (ONC), announced that the nationwide health data exchange governed by the Trusted Exchange Framework and Common Agreement (TEFCA) is now operational. As a result of the program, patients will have increased access to their records, and health care providers and plans can improve their secure exchange of electronic health information. HHS also announced five designated Qualified Health Information Networks. The chosen networks include, eHealth Exchange, Epic Nexus, Health Gorilla, KONZA, and MedAllies.
On December 12, FDA announced the creation of a new advisory committee related to potential treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee will provide FDA independent knowledgeable advice and recommendations on technical, scientific and policy issues around medical products for genetic metabolic diseases. FDA is encouraging qualified individuals interested in serving or nominating a representative to serve on the committee to submit nominations. Nominations can either be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal or by mail.
On December 12, HHS released its National Plan to Address Alzheimer's Disease: 2023 Update. The National Plan is a roadmap of strategies and actions of how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors. It highlights the progress made in 2023, and provides six goals for future action including to: 1) prevent and effectively treat Alzheimer's disease and related dementias by 2025; 2) enhance care quality and efficiency; 3) expand supports for people with Alzheimer's disease and related dementias and their families; 4) enhance public awareness and engagement; 5) improve data to track progress; and 6) accelerate action to promote healthy aging and reduce risk factors.
On December 13, CMS released the national health expenditure highlights from 2022. CMS stated that health care spending grew 4.1% to reach $4.5 trillion in 2022. Additionally, CMS noted that in 2022, the insured share of the population reached 92%, private health insurance enrollment increased by 2.9 million individuals and Medicaid enrollment increased by 6.1 million individuals. CMS also noted that in 2022, private health insurance spending increased by 5.9% to $1.3 trillion (29% of total spending), Medicare spending increased 5.9% to $944.3 billion (21% of total spending), and Medicaid spending increased 9.6% to $805.7 billion (18% of total spending). Additional information on 2022 healthcare spending can be found here.
On December 13, HHS through ONC finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule. The final rule advances patient access, interoperability, and standards, including:
Establishing transparency requirements for artificial intelligence (AI) and other predictive algorithms that are part of certified health IT;
Adopting the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health;
Revising certain information blocking definitions and exceptions to support information sharing, and adding a new exception to encourage secure, efficient, standards-based exchange of electronic health information; and
Implementing the 21st Century Cures Act’s requirement to adopt a Condition of Certification for developers of certified health IT to report certain metrics.
Additional information is included in the fact sheet.
On December 14, HHS released a new data strategy to enhance data capabilities and accelerate progress on Cancer Moonshot goals. The strategy contains 5 priorities for improving data infrastructure and capabilities department-wide, and a series of near-term initiatives for each including: 1) cultivating data talent; 2) fostering data sharing; 3) integrating administrative data into program operations; 4) enabling whole-person care delivery by connecting human services data; and 5) leveraging AI. Additionally, the strategy includes an expansion of the role of ONC to include the coordination of human services interoperability in addition to its current role in enabling interoperability in the U.S. healthcare system.
On December 14, CMS sent a letter to PBMs, Medicare Part D plans, Medicaid managed care plans, and private insurance plans regarding concerns about certain practices by some plans and PBMs that “threaten the sustainability of many pharmacies, impede access to care, and put increased burden on health care providers.” CMS encourages the plans to work with providers and pharmacies to alleviate these issues and safeguard access to care. The Agency notes this is especially important for vaccines and treatments that can prevent and treat influenza, COVID-19, and RSV during the winter months.
On December 14, HHS announced voluntary commitments from leading healthcare companies to harness the potential and manage the risks posed by AI. The 28 companies announced, are committing to: 1) vigorously developing AI solutions to optimize healthcare delivery and payment by advancing health equity and expanding access; 2) working with their peers and partners to ensure outcomes are aligned with AI principle; 3) deploying trust mechanisms that inform users if content is largely AI-generated and not reviewed or edited by a human; 4) adhering to a risk management framework; and 5) researching, investigating, and developing AI swiftly but responsibly.
On November 15, CMS announced that it was reopening the No Surprises Act Independent Dispute Resolution (IDR) portal to process all dispute types.
On December 15, CMS announced actions to improve maternal health and birth outcomes for pregnant and postpartum women and their infants through the new Transforming Maternal Health (TMaH) Model. This 10-year payment and care-delivery model will support participating state Medicaid agencies (SMAs) in developing and implementing a whole-person approach to pregnancy, childbirth, and postpartum care for women with Medicaid and Children's Health Insurance Program (CHIP) coverage.
On December 15, CMS announced that the Long-Term Care Hospital (LTCH) and Inpatient Rehabilitation Facility (IRF) Provider Preview Reports have been updated and are now available. Providers have until January 16, 2024 to review their performance data.
WHITE HOUSE
On December 14, senior Biden-Harris Administration officials met with manufacturers of respiratory syncytial virus (RSV) immunizations including Sanofi and AstraZeneca and their partners. They discussed the need for manufacturers to work quickly to meet demand for dose availability through the commercial market this viral season. Manufacturers confirmed that they will make available 230,000 additional doses of RSV immunizations for infants in January.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
ASPR
Health Resources Priority and Allocations System (HRPAS); Final Rule; 11/17/23
CMS
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Proposed Rule; 9/18/23
Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057); Final Rule; 10/25/23
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
Advance Notice of Methodological Changes for Calendar Year 2025 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies & Draft CY 2025 Part D Redesign Program Instructions; Proposed Rule; 12/1/23
Disproportionate Share Hospital (DSH) Third Party Payer (CMS-2445); Final Rule; 12/8/23
FDA
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Revised Draft Guidance for Industry (CDER, 2023-36); Notice; 12/1/23
Medical Devices; Quality System Regulation Amendments; Final Rule; 12/6/23
Conducting Remote Regulatory Assessments--Questions and Answers; Revised Draft Guidance for Industry; Notice; 12/7/23
OCR
Safeguarding the Rights of Conscience as Protected by Federal Statutes; Final Rule; 9/15/23
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing; Final Rule; 10/19/23
Confidentiality of Substance Use Disorder Patient Records; Final Rule; 12/4/23
SAMHSA
Medications for the Treatment of Opioid Use Disorder; Final Rule; 10/24/23
REPORTS
Office of Inspector General (OIG)
On December 11, OIG released a report examining Washington State nursing homes’ compliance with federal safety requirements for life safety, emergency preparedness, and infection control. OIG found that Washington State did not ensure that selected nursing homes in Washington that participated in the Medicare or Medicaid programs complied with Federal requirements for life safety, emergency preparedness, and infection control. OIG found 91 deficiencies related to life safety, 155 deficiencies related to emergency preparedness, and 279 deficiencies related to infection control. As a result, residents, staff, and visitors at the 20 nursing homes are at an increased risk of injury, significant illness, or death during a fire or other emergency, or in the event of an infectious disease outbreak. OIG recommends that Washington State follow up with the 20 nursing homes reviewed in the audit to ensure that these nursing homes have taken corrective actions to address the deficiencies identified.
On December 11, OIG released a report examining the consistently low percentage of Medicare enrollees receiving medication to treat their opioid use disorder. OIG found that about 52,000 people enrolled in Medicare experienced an opioid overdose during 2022, and of the about 1.1 million enrollees who have opioid use disorder, only 18% received medication to treat their disorder. Additionally, OIG found that the number of Part D enrollees receiving the opioid overdose-reversal drug naloxone grew to more than 600,000 – an all-time high. OIG recommends that CMS continue to work to ensure access to medication to treat opioid use disorder and opioid overdose-reversal drugs. Additionally, OIG recommends that CMS educate enrollees and providers about options for access to overdose-reversal medications, as Narcan and its generic equivalents will no longer be covered by Part D (given their change from prescription to over-the-counter status).
Government Accountability Office (GAO)
On December 11, GAO released a report detailing Medicare’s cognitive assessments. GAO stated that cognitive assessment and care plan services is a service available to Medicare beneficiaries in which providers diagnose and develop a plan to manage cognitive impairments, such as Alzheimer's disease. GAO found that use of the service in traditional fee-for-service Medicare tripled from 2018 through 2022. From 2018 through 2022, certain types of providers—neurologists, nurse practitioners, internists, family physicians, and geriatricians—delivered more than 80% of services, mostly in urban locations.
On December 12, GAO released a report examining federal funding for certain organizations providing health-related services from 2019 through 2022. GAO examined federal funding for various organizations, including certain health centers, Planned Parenthood Federation of America, and International Planned Parenthood Federation. GAO found that these organizations received federal funds through several sources from 2019 through 2021. These sources included grants and cooperative agreements, public health coverage programs, and Paycheck Protection Program loans. A list of all funding sources can be found here.
On December 12, GAO released a report examining the roll out of independent dispute resolution processes for out-of-network claims. GAO found that HHS and the departments of Labor and Treasury reported that parties submitted nearly 490,000 disputes from April 2022 through June 2023. About 61% of these disputes remained unresolved as of June 2023. According to officials from the departments, a primary cause of the large number of unresolved disputes is the complexity of determining whether disputes are eligible for the process. GAO made no recommendations.
UPCOMING HEARINGS
Senate
HELP Committee
January 25; 10:00 AM
Why Does the United States Pay, By Far, The Highest Prices in the World for Prescription Drugs?
OTHER POLICY NEWS
On December 13, the Supreme Court announced that it will hear a case seeking to revoke the FDA's two-decades-old approval of a widely used abortion pill called mifepristone. The justices are likely to hear arguments on the case in the spring and to issue a decision by the end of June