The following is the latest health policy news from the federal government for September 6-12.  Some of the language used below is taken directly from government documents.

ASH Advocacy

  • ASH has written to congressional leaders urging them to eliminate scheduled cuts in Medicaid disproportionate share hospital payments (Medicaid DSH) in the next continuing resolution to fund the federal government.  Earlier this year Congress delayed such cuts through the end of calendar year 2024 and now, ASH has asked Congress to eliminate the cuts that would take effect on January 1, 2025 without congressional intervention and to permanently eliminate the long-planned, always-delayed cuts in Medicaid DSH allotments to the states.  See ASH’s letter to congressional leaders for more details.
  • In response to CMS’s proposed outpatient prospective payment system rule for FY 2025, ASH submitted a formal comment letter to the agency in which it maintained that the proposed increase of 2.6 percent for outpatient services is inadequate; that CMS should withdraw its proposed changes and additions to Medicare’s Conditions of Participation that address obstetrical services; and that it supports CMS’s proposal to establish a regulatory requirement making Medicaid and CHIP coverage continuously available to children under the age of 19 regardless of changes in eligibility for reasons such as the failure to pay program premiums.  Learn more from ASH’s formal comment letter to CMS.
  • In July, CMS proposed a revised Medicare physician fee schedule for 2025.  In a letter in response to that proposal, ASH criticized the agency for proposing to slash physician payments even though the cost of caring for Medicare patients has risen; praised CMS for its continued focus on improving Medicare patients’ access to services that address their health-related social needs; and thanked CMS for preserving many of the flexibilities in the delivery of care via telehealth that proved so effective when introduced during the COVID-19 public health emergency, noting that those flexibilities are especially helpful for patients who live in geographically isolated areas with few physicians and those who live in urban areas and find it difficult to arrange and pay for transportation to doctors’ offices.  Learn more about ASH’s views on the proposed 2025 Medicare physician fee schedule from ASH’s letter to CMS.

340B

A federal court has declined to issue a preliminary order to block implementation of a Maryland law that requires pharmaceutical companies to provide discounts on drugs dispensed by eligible 340B providers by contract pharmacies.  The challenge to the Maryland law, filed by Pharmaceutical Research and Manufacturers of America (PhRMA) and several pharmaceutical companies, will be heard without a temporary order suspending the law’s implementation.  Learn more from the court order.

Centers for Medicare & Medicaid Services

  • CMS has published a list of 741 acute-care hospitals (an Excel download) located in the Core-Based Statistical Areas (CBSAs) selected for participation in its new “TEAM” model program.  The Transforming Episode Accountability Model (TEAM) is a mandatory, episode-based, alternative payment model in which selected acute-care hospitals will coordinate care for people with traditional Medicare undergoing one of several surgical procedures included in the model and assume responsibility for the cost and quality of care from surgery through the first 30 days after the Medicare beneficiary leaves the hospital.  Go here to learn more about TEAM and to find a downloadable file with the names of all the hospitals for which TEAM participation will be mandatory.  In addition, CMS requests that participating hospitals complete an online form on which they name their two primary points of contact for TEAM-related communications; find that form here.
  • This spring, CMS issued an informational bulletin to state Medicaid programs indicating that under the recently adopted Medicaid managed care rule it would begin enforcing a prohibition against health care tax programs, including but not limited to state-directed payments, that include impermissible hold-harmless arrangements but that it would exercise discretion over its enforcement of this prohibition for existing programs – that is, not directly enforce it – until 2028.  In the meantime, it will work with states to identify such impermissible arrangements and help them make suitable transitions to permissible payment programs with the understanding that health care-related taxes that do not meet federal requirements – and this applies to all arrangements, regardless of which Medicaid delivery system or type of payment the arrangements support – may result in CMS disapproval of state Medicaid payment proposals or disallowance of federal Medicaid matching funds after January 1, 2028.  To clarify its intentions and assist states and stakeholders with the necessary transitions, CMS has posted the presentation “Overview of CMS Enforcement Discretion Regarding Existing Health Care-Related Tax Programs with Impermissible Redistributions.”  Find that presentation here.
  • CMS has issued what it calls an “informal” request for comments, explaining that to improve implementation of parity in Medicaid and CHIP it has developed a new set of templates and instructional guides for state agencies to document how mental health and substance use disorder benefits provided through a state’s Medicaid managed care program, Medicaid alternative benefit plans, and/or CHIP comply with federal Medicaid and CHIP Mental Health Parity and Addiction Equity Act requirements. These new tools are intended to standardize, streamline, and strengthen the process for states to demonstrate, and for CMS to determine compliance with, mental health/substance use disorder parity requirements in coverage and delivery of state Medicaid and CHIP benefits.  CMS is seeking preliminary comments on these proposed new templates and instructional guides and writes that it intends to take these comments into account before finalizing these tools.  Learn more about this initiative, find links to the individual templates and instructional guides, read the specific questions about the documents for which CMS seeks input, and find directions for submitting comments in this CMS request for comments.  The deadline for submitting comments is October 29.
  • CMS has posted updated Version 42 Medicare Severity Diagnosis Related Group (MS-DRG) Grouper and Medicare Code Editor (MCE) software.   It also has posted updated Version 42 Java Source Code and Reference Implementation Binaries and updated Version 42 ICD-10 MS-DRG Definitions Manual Files (text version).  The HTML version is not yet available.  This update does not affect the Definitions of Medicare Code Edits V42 file.  Go here (and scroll halfway down) for the new downloads.
  • CMS has posted on Medicare.com new materials about the Medicare Prescription Payment Plan – what it is, how it works, and how Medicare beneficiaries can use it to spread out their prescription drug costs over the course of an entire year instead of needing to make large out-of-pocket payments at the beginning of the year as they spend up to the new $2000 annual limit on their prescription drug costs.  The materials include a video, links to two fact sheets, and a link to a decision tree that helps users determine “Will this payment option help me.”  Find them all here.
  • CMS and the Wisconsin Physicians Service Insurance Corporation (WPS) are notifying people whose protected health information or other personally identifiable information may have been compromised in connection with Medicare administrative services provided by WPS.  WPS is a CMS contractor – a Medicare Administrative Contractors (MAC) – that administers Medicare Part A and B claims and related services for CMS in Iowa, Kansas, Missouri, Nebraska, Indiana, Michigan.  The notification comes following the discovery of a security vulnerability in the MOVEit software, a third-party application WPS uses to transfer files.  CMS and WPS are mailing written notifications to nearly one million Medicare beneficiaries whose personal data may have been exposed, informing them of the breach and explaining actions being taken in response.  Learn more from this CMS news release.
  • CMS is forming a technical expert panel to advise a contractor the agency has hired to implement and refine its Quality Measure Index (QMI), which supports the assessment and selection of quality measures that provide meaningful performance information and align with national health care quality priorities.  Learn more about the panel, the qualifications the agency seeks among its members, the time commitment involved, and how to apply by going here, scrolling down to “Assessment of Quality Measures and Programs – Quality Measure Index (QMI),” and clicking the arrow.  The deadline for submitting applications to participate is September 25.
  • CMS has issued a request for information (RFI) to obtain feedback from industry and the public about the potential consolidation of four Medicare Administrative Contractor (MAC) jurisdictions into two jurisdictions; it also seeks views about extending MAC contracts to 10 years.  Find the RFI here.  The deadline for submitting comments is October 4.
  • CMS has posted a bulletin outlining changes in its Medicare outpatient prospective payment system that will take effect in October.  Among the subjects the bulletin addresses are proprietary laboratory analysis codes, device pass-throughs, drugs, biologicals, and radiopharmaceuticals, skin substitutes, blood products, and other coding changes.  Find the bulletin here.
  • CMS has updated its Medicare payment schedule for flu vaccines for the 2024-2025 flu season and for COVID-19 vaccines and monoclonal antibody treatments.  Find the updated fee schedule here.  It also has updated its COVID-19 vaccine toolkit.
  • CMS has posted a bulletin summarizing changes in the Medicare ambulatory surgical center payment system that will take effect in FY 2025, on October 1.  In particular, the bulletin highlights new CPT and HCPCS codes and changes in coding for drugs, biologicals, and skin substitutes.  Find the bulletin here.
  • CMS has updated its guidance on how eligible hospitals can convert to the new rural emergency hospital provider type.  Rural emergency hospitals are a new provider type established by the Consolidated Appropriations Act of 2021 to address concerns over rural hospital closures; they provide emergency and outpatient medical and health services to patients who generally stay less than 24 hours and receive payments over and above regular Medicare rates for these services.  Find the guidance here and learn more about rural emergency hospitals here.
  • CMS has posted a bulletin outlining changes in the Medicare laboratory national coverage determination (NCD) edit software that take effect next January.  The bulletin describes newly available codes, recent coding changes, and how to find NCD coding information.  Find that bulletin here.
  • CMS has posted an FAQ to address a supply issue disrupting the availability of some blood culture media bottles – specifically the BD BACTEC blood culture bottle shortage.  The FAQ addresses the three main stakeholder concerns regarding the blood culture shortage, including CMS awareness, the use of expired blood culture bottles, and the verification of glass blood culture bottles.  Find the FAQ here.

Department of Health and Human Services

  • Along with the departments of Labor and the Treasury, HHS will issue a final rule that seeks to clarify and strengthen protections to expand equitable access to mental health and substance use disorder care benefits and reduce barriers to obtaining these services.  The rule seeks to build on the Mental Health Parity and Addiction Equity Act of 2008, which requires group health plans and health insurance issuers offering group and individual health insurance coverage that offer mental health or substance use disorder benefits to cover those benefits in parity with medical and surgical benefits.  The new rules add protections against more restrictive, non-quantitative treatment limitations for mental health and substance use disorder benefits, such as prior authorization requirements, step therapy, and standards for provider admission to participate in a network.  The final rule also prohibits plans from using biased or non-objective information and sources that might hinder access to mental health and substance use disorder care when designing and applying a non-quantitative treatment limitation.  It makes clear that health plans and insurers must evaluate the impact of their non-quantitative treatment limitations on access to mental health and substance use disorder benefits, as compared to medical/surgical benefits, and provides additional clarity regarding documentation requirements added to the 2008 law by the Consolidated Appropriations Act of 2021.  The rule gives special emphasis to the design and management of provider networks to strengthen access to mental health and substance use disorder care.  Most provisions of the final rule apply generally to group health plans and health insurance issuers that offer group health insurance coverage starting on the first day of the first plan year beginning on or after January 1, 2025.  In some cases the rule will take effect on January 1, 2025 but in other instances it will take effect one year later.  Learn more from this HHS news release; a Labor Department fact sheet; and this pre-publication version of the final rule that has not yet been scheduled for official publication and may be subject to change.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) has announced a notice of funding opportunity through which it will fund as many as 15 state-based health care extension cooperatives for a period of five years.  These cooperatives will seek to engage key stakeholders such as Medicaid, Medicaid managed care organizations, clinicians and staff from safety-net health care delivery organizations, and patients, families, and caregivers who receive care from safety-net health care delivery organizations and are members of uninsured and/or medically underserved populations; work with health care policy, payment, community, care delivery, and research organizations to build their capacity to implement patient-centered, evidence-based health care delivery improvements and support ongoing learning through training and other tools; evaluate the cooperatives’ activities; and provide the support structure to ensure that these activities are integrated and aligned.  Learn more about this initiative, and additional notices of funding opportunities AHRQ intends to issue in the coming weeks, from this HHS news release and the notice of funding opportunity.  The deadline for submitting applications is December 12 and letters of intent are due 30 days before that.
  • HHS and its Substance Abuse and Mental Health Services Administration (SAMHSA) have awarded $68 million in grants for suicide prevention and mental health care programs.  Learn more about the specific purposes for which grant money will be used and find links to lists of the grant recipients from this HHS news release.
  • HHS’s Office of The Assistant Secretary for Planning and Evaluation (ASPE) has published a study that addresses the current state of metrics for public health and health care preparedness in the U.S., including gaps in existing metrics and the limitations of existing metrics identified during the COVID-19 pandemic and strategies for improving measurement of public health and health care preparedness.  Learn more from the ASPE report “Measuring Preparedness for Public Health and Health Care Emergencies:  The Current State of Preparedness Metrics in the United States and Considerations for the Future.”
  • In a report to Congress, ASPE describes cardiovascular disease and its adverse health outcomes, risk factors, and prevention and treatment options.  It also discusses disparities in disease burden and barriers patients may face in gaining optimal treatment and the economic costs of untreated or undertreated cardiovascular disease.  The report includes an analysis of the prevalence of cardiovascular disease among Medicare fee-for-service beneficiaries and related health care utilization and costs and concludes with a brief overview of HHS programs that specifically address cardiovascular disease.  Learn more from ASPE’s “Report to Congress – The Burden of Cardiovascular Disease in the United States:  Patterns and Barriers to Care.”
  • HHS’s Office of the Inspector General has updated its resources on how it enforces the Emergency Medical Treatment and Labor Act (EMTALA), the federal law that imposes specific obligations on Medicare-participating hospitals that offer emergency services.  Find the update here.
  • The Provider Relief Fund reporting portal is now open for reporting period 7.  Providers that received Provider Relief Fund (general or targeted) and/or American Rescue Plan Rural payments exceeding $10,000 in the aggregate between January 1 and June 30, 2023 are required to report on their use of those funds during reporting period 7.  The deadline to submit a report is September 30.  Learn more on the Provider Relief Fund’s reporting and auditing web page.

HHS Newsletters

HHS Videos

In cooperation with authorities from the United Kingdom, Canada, New Zealand, Japan, the Republic of Korea, Singapore, and The Netherlands, the U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency has issued a publication that defines a baseline for event-logging best practices to mitigate cyber threats.  Find the document here.

Food and Drug Administration

The FDA has issued draft guidance titled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.”  When finalized, this guidance will provide recommendations on how patient preference information might be collected and shared with the FDA and potentially be considered in FDA decision-making.  It also provides recommendations on designing patient preference studies that may provide reliable scientific evidence.   Learn more from the draft guidance document.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC’s commissioners met last Thursday, September 5.  The agenda items for the meeting were cost-sharing for outpatient services at critical access hospitals; Medicare’s measurement of rural provider quality; and the context for Medicare payment policy.  Go here to find a description of each of these issues, a the presentations offered by MedPAC staff, and a transcript of the sessions.
  • MedPAC has submitted formal comment letters to CMS in response to CMS’s proposed rule governing Medicare outpatient and ambulatory surgical center payments for 2025 and CMS’s proposed rule on 2025 revisions to payment policies under the Medicare physician fee schedule and other changes to Part B payment policies.  Find MedPAC’s outpatient/ambulatory surgical center letter here and the physician fee schedule/Part B letter here.

Government Accountability Office (GAO)

In a new report, the GAO describes the behavioral health benefits available under Medicare and Medicare Advantage programs, what beneficiaries pay out of pocket, and more.  Learn more from the GAO report “Behavioral Health:  Information on Cost-Sharing in Medicare and Medicare Advantage.”

American Medical Association (AMA)

The AMA has announced 420 changes in its CPT code set for 2025, among them 270 new codes, 38 revisions, and 112 deletions.  Learn more about the code changes for 2025 and their implications for billing from this AMA news release.

Stakeholder Events

CMS – Maternal Health Webinar – September 17

CMS will hold a maternal health informational webinar offering an overview of maternal health affinity groups and the expression-of-interest process on Tuesday, September 17 at 2:00 (eastern).  Go here to register to participate.

CMS – Home Health, Hospice, and DME Open Door Forum – September 17

CMS will hold an open-door forum for home health, hospice, and DME providers on Wednesday, September 17 at 2:00 (eastern).  Go here to register to participate.

CDC – Outreach Webinar on Lyme Disease – September 19

As part of its clinician outreach and communication efforts, the CDC will hold a webinar on new clinical tools and resources to support patients with prolonged symptoms and   concerns about Lyme disease.  Presenters will offer a brief overview of Lyme disease, provide a diagnostic and management framework for patients with prolonged symptoms and concerns about Lyme disease, and review new clinical tools and resources to help support these patients.  Continuing education credits are available.  Learn more about the webinar and how to participate from this CDC notice.

MACPAC – Commissioners Meeting – September 19-20

MACPAC commissioners will hold their next public meeting on Thursday, September 19 and Friday, September 20.  The meeting agenda has not been posted but interested parties can go here to register to participate remotely.

CMS – Medicare Open Enrollment Boot Camp – September 25 and 26

CMS will hold a two-day “boot camp” for those who help people with Medicare make informed decisions about their 2025 health and drug coverage.  The session on Wednesday, September 25 will address Medicare plan finder basics and user tips, 2024 plan finder updates, information about the Medicare Prescription Payment Plan, and a Q&A session while on Thursday, September 26 the focus will shift to an overview of the Medicare open enrollment period and general program updates, 1-800-MEDICARE overview and activities, open enrollment period media outreach campaigns, a State Health Insurance Assistance Program (SHIP) overview and virtual counseling toolkit, a Medicare account experience live demonstration, health and drug plan marketing updates, and more questions and answers.  Go here to register to participate; both will be held from 1:00 to 3:30 (eastern).

CMS – Hospital Price Transparency Webinar – October 21

CMS will hold a webinar on hospital price transparency during which it will address encoding new January 2025 price transparency requirements data in machine-readable files on Monday, October 21 at 1:00 (eastern).  Go here to register to participate.