Federal Health Policy Update for December 14

The following is the latest health policy news from the federal government for December 8-14. Some of the language used below is taken directly from government documents.

MedPAC Rate Recommendations

At their latest public meeting, members of the Medicare Payment Advisory Commission voted preliminary approval of the following rate updates for 2025 Medicare payments:

Inpatient and outpatient services –update provided for in current law plus 1.5% and adoption of a safety-net index policy to pay safety-net hospitals another $4 billion.
Physicians and other health professionals –update of 50% of the Medicare economic index and a new add-on payment for services provided to low-income Medicare patients.
Inpatient rehabilitation hospital services – minus 5%.
Skilled nursing facilities – minus 3%.
Home health services – minus 7%.

MedPAC will vote on its final, official recommendations next month.

For a summary of the issues and links to the presentations delivered during the meeting go here and go here for a transcript of the entire meeting.

HHS/HTI-1 Rule (Artificial Intelligence in Health Care, Transparency, Interoperability)

HHS and its Office of the National Coordinator for Health Information Technology (ONC) have finalized their Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule, which they proposed in April. The final rule seeks to advance patient access, interoperability, and standards through:
- Algorithm Transparency – establishing transparency requirements for artificial intelligence (AI) and other predictive algorithms that are part of certified health IT.
- Standardization – the rule adopts the United States Core Data for Interoperability Version 3 as the new baseline standard within the ONC Health IT Certification Program as of January 1, 2026.
- Enhanced Information-Blocking Requirements – 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.
- New Interoperability-Focused Reporting Metrics for Certified Health IT – implementation of the 21^st Century Cures Act’s requirement to adopt a Condition of Certification for developers of certified health IT to report certain metrics as part of their participation in the certification program.

The rule, which will take effect at the end of 2024, requires greater transparency about AI when it is used in clinical settings. It also establishes new standards for interoperability, modifies exceptions to current HHS rules that prevent providers from refusing to share their patients’ data, and establishes interoperability reporting requirements. Learn more from this HHS news release and this pre-publication version of the final rule. In addition, CMS has published a series of more technical resources:

Fact Sheets on the Final Rule

Measurement Spec Sheets on the Final Rule

The White House

The White House has announced new actions to promote competition in health care and support lowering prescription drug costs, including the release of a proposed framework for agencies on the exercise of march-in rights on taxpayer-funded drugs and other inventions that specifies that price can be a factor in considering whether a drug is accessible to the public. Among these new actions are promoting equitable access to lower-priced taxpayer-funded drugs, scrutinizing anti-competitive acquisitions and anti- competitive practices, increasing transparency in the ownership of health care organizations, and more. Learn more about the framework the administration envisions for addressing anti-competitive actions in the health care industry from this White House fact sheet.

Department of Health and Human Services

HHS and ONC have announced that nationwide health data exchange governed by the Trusted Exchange Framework and Common Agreement (TEFCA) is now operational. As a result, patients should have increased access to their records and health care providers and plans can improve their secure exchange of electronic health information. The five organizations officially designated Qualified Health Information Networks (QHINs) are eHealth Exchange, Epic Nexus, Health Gorilla, KONZA, and MedAllies. These designated QHINs can immediately begin supporting the exchange of data under TEFCA policies and technical requirements. QHINs are the pillars of TEFCA network-to-network exchange, providing shared services and governance to securely route queries, responses, and messages across networks for eligible participants, including patients, providers, hospitals, health systems, payers, and public health agencies. Learn more about the TEFCA launch from this HHS news release and about TEFCA from the TEFCA website.
HHS has announced a series of actions to reduce prescription drug prices for Medicare participants. These actions include:
- Release of a report on the ten drugs the agency has chosen for price negotiations with their manufacturers as enabled by the Inflation Reduction Act.
- Release of a list of 48 prescription drugs for which price increases have exceeded the rate of inflation, thereby meeting the criteria for the Inflation Reduction Act’s Medicare Part B inflation rebate provisions for calendar year 2023. As a result, some Medicare beneficiaries will pay lower copays for these drugs – often referred to as prescription drug rebates – beginning on January 1. CMS also has posted a fact sheet on how this process works.
- Publication of a CMS memo detailing revised Medicare Part B Drug Inflation Rebate Program guidance; a fact sheet about this guidance; and another CMS memo detailing the same for the Part D program.
- CMS has sent a letter to pharmacy benefit managers (PBMs), Medicare Part D plans, Medicaid managed care plans, and private insurers expressing its concern about certain practices by some plans and PBMs that threaten the sustainability of many pharmacies, impede access to care, and increase the burden on health care providers. The letter expresses specific concerns and warns that CMS will be closely monitoring the organizations’ practices in these areas.
- HHS’s Administration for Strategic Preparedness and Response (ASPR) is making fair pricing a standard part of contract negotiations for medical products developed with its financial support or assistance.

These and other developments are presented in context in this HHS news release.

More than 25 years ago, HHS’s Health Resources and Services Administration (HRSA) published “Patient Definition Guidelines,” which presented HRSA’s interpretation of several statutory requirements that guide HRSA’s audit activities. To help covered entities with 340B program compliance activities, HRSA has compiled existing resources on how it conducts 340B audits and determines non-compliance to ensure compliance with the 340B statutory prohibition against diversion. Find that updated collection of resources here.
An audit performed by HHS’s Office of the Inspector General (OIG) has found that Medicare enrollees continue to face challenges gaining access to medication, including opioid overdose-reversal drugs, to treat their opioid use disorders. The OIG also found that certain groups of enrollees face even greater challenges than others, including those without the low-income subsidy, and that there are notable disparities by race and ethnicity in those receiving medication. Learn more from this summary of the report’s findings, which includes a link to the complete report.
The HHS OIG has published a toolkit that offers Medicare Advantage organizations information that will enable them to replicate its own techniques for identifying and evaluating high-risk diagnosis codes to ensure proper payments and provide better care for enrollees. This toolkit is intended to help Medicare Advantage organizations improve the accuracy of their submitted diagnoses that are at high risk of being miscoded. Go here to learn more about the toolkit and its intended use and to find a link to the toolkit itself.
HHS has published its data strategy, which seeks to advance its management and use of data to improve health outcomes. It envisions data that is available, accessible, timely, equitable, meaningfully usable, and protected and available for use by HHS, its partners, and the public. Learn more about the data strategy and its intended uses from this HHS news release and from the data strategy itself.
HHS has released its released “National Plan to Address Alzheimer’s Disease: 2023 Update,” a road map 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. The document also highlights progress made in 2023. Learn more from this HHS news release and the document itself.
Reporting Period 6 for HHS’s Provider Relief Fund opens on January 1, 2024. Go here to learn more about Provider Relief Fund reporting.
HHS’s Health Sector Cybersecurity Coordination Center and its Office of Information Security have published “Open-Source Software (OSS): Risks in the Health Sector.” The document, organized as a presentation and written for a non-technical audience, offers background information on open-source software, the pros and cons of open-source software, case studies in health care, threats leveraging open-source software, and open-source software security. Find it here.

Centers for Medicare & Medicaid Services

CMS has issued an informational bulletin to state Medicaid and CHIP programs to remind those programs and stakeholders that the use of worker management platforms, often called registries, is an important strategy for ensuring that individuals receiving Medicaid-covered home- and community-based services are aware of and have access to qualified workers who deliver services and that the use of such registries does not require CMS approval. Learn more about this CMS action, including how registries work and why CMS believes they are beneficial, from the CMS bulletin and this CMS news release.
The American Rescue Plan provided qualifying states with a temporary 10 percentage point increase of their federal medical assistance percentage (FMAP) for certain Medicaid expenditures for home and community-based services beginning April 1, 2021 and ending March 31, 2022. States were required to use those funds to supplement but not to supplant existing state funds spent for Medicaid home- and community-based services in effect as of April 1, 2021. Now, CMS has published a report on how states have been using this money. Learn more from the CMS report “Overview of State Spending Under American Rescue Plan Act of 2021 (ARP) Section 9817, as of the Quarter Ending December 31, 2022.”
CMS has posted Medicare Part B inflation rebate guidance providing information on the modifiers that different categories of 340B-covered entities should use in calendar year 2024 and starting January 1, 2025. Learn more from this CMS fact sheet.
CMS has sent an informational bulletin to state Medicaid programs advising them that starting on January 1, 2024, Medicare will begin paying for the services of marriage and family therapists, mental health counselors, and intensive outpatient program services for dually eligible beneficiaries who receive these services from hospital outpatient departments, community mental health centers, rural health clinics, federally qualified health centers (FQHC), or opioid treatment programs. Learn more from the memo “Guidance to State Medicaid Agencies on Dually Eligible Beneficiaries Receiving Medicare Part B Marriage and Family Therapist Services, Mental Health Counselor Services, and Intensive Outpatient Services Effective January 1, 2024.”
CMS has posted a notice about the Medicare Part B clinical laboratory fee schedule with revised information for laboratories on collecting and reporting for the private payer rate-based payment system. Find notice here.
CMS has published notices advising providers about quality measures that will be removed from the skilled nursing facility, long-term-care hospital, and inpatient rehabilitation facility quality reporting programs beginning on January 1, 2024. Find those notices here.
In a new entry on the CMS blog, the agency describes how one of its care delivery models, the Medicare Advantage Value-Based Insurance Design Model, is testing innovations that have the potential to reduce Medicare spending while improving the quality of care for Medicare beneficiaries. CMS notes that Medicare Advantage organizations may target supplemental benefits and reduce cost-sharing to certain enrollees, based on their members’ socioeconomic status and/or chronic health condition(s), to address their members’ unique medical and health-related social needs. Go here to see CMS’s summary of the model’s efforts to date.
CMS’s Center for Medicare and Medicaid Innovation has announced that it will extend that same Medicare Advantage Value-Based Insurance Design Model for calendar years 2025 through 2030 and will introduce changes intended to address more fully the health-related social needs of patients, advance health equity, and improve care coordination for patients with serious illnesses. Learn more about the model’s extension from this fact sheet and about the program from its web page, which includes a link to a formal request for applications to participate in the program that describes the program and its expected changes in greater detail, outlines the criteria for participation, and notes the application deadline of April 12.
CMS reports that U.S. health care spending grew 4.1 percent, to $4.5 trillion, in 2022 and that this increase was greater than the increase of 3.2 percent in 2021 but much slower than the rate of 10.6 percent in 2020. Learn more about the growth, and spending in individual sectors within the health care field, from this CMS news release.
CMS has posted instructions on how to submit feedback during the 45-day comment period, from December 15, 2023 until January 29, 2024, for Merit-Based Incentive Payment System (MIPS) value pathway (MVP) candidates for ocular care, dermatological care, gastroenterology, urologic care, pulmonary care, and surgical care. These resources also detail the measures and activities included in the draft MVP for each of these types of care. To find them go here, scroll down to “Full Resource Library,” and click on the individual link or links for downloadable files.
CMS has posted comprehensive descriptions of its 2024 web interface measures for ACOs reporting the CMS web interface measures via the APM Performance Pathway (APP) for the 2024 performance year. This CMS web interface is an available collection type only for Medicare Shared Savings Program ACOs reporting via the APP and is not an available collection type for any other Quality Payment Program participants. To find the descriptions go here, scroll down to “Full Resource Library,” and click the link for “Performance Year 2024 APM Performance Pathway: CMS Web Interface Measure Specifications and Supporting Documents for ACOs” for the downloadable zip files.
CMS has posted a template for Qualified Clinical Data Registries and Qualified Registries to use as guidance when submitting their Data Validation Execution Report. To find the template go here, scroll down to “Full Resource Library,” and click the link for “2023 MIPS Data Validation Execution Report (DVER) Template” for the downloadable template.
CMS has posted documents that provide instructions on how to submit a MIPS (MVP) candidate to CMS for consideration. To find the documents go here, scroll down to “Full Resource Library,” and click the link for “MIPS Value Pathways (MVPs) Development Resources” for the downloadable zip file.
CMS has posted a performance pear 2023 APP toolkit zip file that includes 2023 APM Performance Pathway Toolkit Table of Contents, 2023 APM Performance Pathway for MIPS APM Participants Fact Sheet, 2023 APM Performance Pathway Quick Start Guide, 2023 APM Performance Pathway Infographic, and 2023 APM Performance Pathway Scoring Guide. To find the toolkit go here, scroll down to “Full Resource Library,” and click “PY 2023 APM Performance Pathway (APP) Toolkit” for the downloadable zip file.

HHS Newsletters

CMS – MLN Connects – December 14
AHRQ News Now – December 12
HRSA eNews – December 7

National Institutes of Health

The NIH has announced the expansion of the Home Test to Treat program, an entirely virtual community health program that offers free COVID-19 health services – at-home rapid tests, telehealth sessions, and at-home treatments – to eligible participants nationwide. The program, a collaboration of the NIH, HHS’s Administration for Strategic Preparedness and Response, and the CDC, launched as a pilot in selected locations earlier this year. With its expansion, the Home Test to Treat program will now offer free testing, telehealth and treatment for both COVID-19 and the flu. Learn more about Home Test to Treat and its expansion from this NIH news release.

Centers for Disease Control and Prevention

The CDC has issued a health alert about an outbreak of Rocky Mountain spotted fever among people in the U.S. who have recently traveled to or resided in the city of Tecate, state of Baja California, Mexico. RMSF is a severe, rapidly progressive, and often deadly disease transmitted by the bite of infected ticks. Learn more about the alert, the disease’s symptoms, and how to treat it from this CDC notice.

Government Accountability Office

The No Surprises Act of 2020 has faced many obstacles in its early period of implementation. Aside from the legal challenges that have slowed that implementation, the work involved in operationalizing the law’s independent dispute resolution process has proven challenging. The Consolidated Appropriations Act of 2021 called on the GAO to review that process, and in the new GAO report “Roll Out of Independent Dispute Resolution Process for Out-of-Network Claims Has Been Challenging,” the agency shares what it has found, including data on the number and types of disputes submitted between April 2022 and June 2023 and the status of their resolution; selected stakeholders’ experiences with the process and agency actions to address challenges; and how federal agencies oversee the process.
The GAO has reviewed states’ use of state-directed payments in their Medicaid programs in light of the increasing use of this financing mechanism and concluded that the practice suffers from weak fiscal guardrails, lack of CMS consideration of payment outcomes when renewing, lack of transparency, and other problems. Learn more about what the GAO found and what it recommends in response from the GAO report “Medicaid Managed Care: Rapid Spending Growth in State Directed Payments Needs Enhanced Oversight and Transparency.”
Amid growing recognition that the number of Medicare beneficiaries living with cognitive impairments such as Alzheimer’s disease was increasing, Medicare began covering cognitive assessment and care plan services visits in 2017. To ensure that access to cognitive care services in Medicare actually increased, the Consolidated Appropriations Act of 2021 directed the GAO to review use of this service in the Medicare program. In a new analysis, the GAO reports that utilization of cognitive assessments tripled between 2018 and 2022 but remains below expectations and obstacles appear to be limiting greater use of the assessment. Learn more about what the GAO found in its report “Medicare Cognitive Assessments: Utilization Tripled between 2018 and 2022, but Challenges Remain.”

Stakeholder Events

MedPAC – January 11-12

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on Thursday, January 11 and Friday, January 12. The meeting’s agenda and information about how to participate virtually have not yet been released but when they are they will be posted here.

CMS – Hospital Price Transparency Webinar – January 17

To help hospitals prepare for meeting new requirements for price transparency, CMS will hold a webinar on Wednesday, January 17 at 2:00 (eastern) to review the new requirements; to present examples of how to encode machine-readable file standard charge information in the template layout CMS will require hospitals to use; and to demonstrate its “GitHub” repository. Go here to register to participate.

CMS – Health Equity Conference – May 29-30

CMS will hold its second annual CMS Health Equity Conference on Wednesday, May 29 and Thursday, May 30. The free, hybrid conference will be held in person in Bethesda, Maryland and available online for virtual participation and involve health equity leaders from federal and local agencies, health provider organizations, academia, community-based organizations, and others. Conference participants will hear from CMS leadership on recent developments and updates to CMS programs; explore the latest health equity research; discuss promising practices and creative solutions; and collaborate on community engagement strategies. Learn more from the conference web page.

Stakeholder Events: Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule

HHS’s Office of the National Coordinator for Health Information Technology (ONC) will host the following information sessions to explain the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HT1-1) final rule.

Federal Health Policy Update for December 14