The following is the latest health policy news from the federal government for November 22 – December 5.  Some of the language used below is taken directly from government documents.

Congress
  • The House has posted its session calendar for 2025.  Find that calendar here.
  • Yesterday, House Republicans made an offer to House Democrats regarding health care provisions to be included in the continuing resolution (CR) that must pass before December 20.  The offer is a conversation-opener and very few details are available.  Although most of the proposed policies have bipartisan support, there are some tangible policy differences, including House Democrats’ disagreement with using repeal of the Biden administration’s nursing home staffing regulation as a pay-for.   Some Ways and Means committee staff say they expect the continuing resolution to pass with few extra measures.  Below you will find an outline of House Republicans’ first offer.

Proposed:

  • a three-year extension of Medicare telehealth and hospital at home
  • one year of traditional Medicare/Medicaid provisions (including Medicaid DSH)
  • a one-year doc fix for 2.5 percent (it is unclear if this means physicians will have no cut or if they will see an increase)
  • a Medicare cancer screening bill
  • flat funding for FQHCs
  • full reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) and the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT)

Potential offsets:

  • repeal of the nursing home staffing rule
  • Part D delinking/PBM transparency
  • National Provider Identifier (NPI) policy from Lower Cost More Transparency legislation (requires a unique NPI for hospital-owned outpatient departments.  Though not site-neutral, an NPI could facilitate future site-neutral reforms)
Proposed Medicare Regulation Governing Medicare Advantage, Medicare Part D, the Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)

CMS has issued a proposed rule that would revise the Medicare Advantage Program, Medicare Part D, the Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE).  The proposed rule includes:

  • Policies that seek to remove barriers to care stemming from the use of inappropriate prior authorization practices by clarifying requirements for plan use of internal coverage criteria; making prior authorization requirements and criteria more transparent; ensuring that patients are advised of their appeal rights; and proposing guardrails for the use of artificial intelligence.
  • Expanding access to anti-obesity medications under the Medicare Part D and Medicaid programs.
  • Promoting access to behavioral health care providers.
  • Improving the administration of Medicare Advantage supplemental benefits.
  • Addressing misleading marketing practices.
  • Four modifications to strengthen existing regulations regarding Medicare Advantage organizations’ coverage of and responsibility to provide all reasonable and necessary Medicare Part A and B benefits.
  • A requirement that Medicare Advantage organizations provide very current provider directory information to CMS, for inclusion by CMS in its Medicare Plan Finder, so individuals can more effectively search those directories through the Medicare Plan Finder.  Another provision codifies definitions of community-based organizations and in-home or at-home supplemental benefit providers and direct furnishing entities and requires their inclusion in provider directories.  The plans would be required to report changes in their current provider directories within 30 days of any changes.
  • Modification and expansion of an Inflation Reduction Act of 2022 requirement that Part D plans offer their enrollees the option of paying out-of-pocket prescription drug costs in the form of monthly payments instead of all at once at the pharmacy through a new Medicare Prescription Payment Plan.
  • Cost-sharing in Medicare Advantage and Section 1876 Cost Plans so that their in-network cost-sharing may be no greater than cost-sharing in traditional Medicare for a variety of mental health specialties.
  • New federal requirements for certain dual eligible special needs plans (D-SNPs), including integrated member identification cards that serve as ID cards and a mandatory integrated health risk assessment for Medicare and Medicaid rather than separate assessments for each program.
  • A requirement that Part D plans have a medication therapy management program that ensures that targeted beneficiaries appropriately use covered Part D drugs to optimize therapeutic outcomes and reduce the risk of adverse events and that Part D sponsors target enrollees who have multiple chronic diseases, are taking multiple Part D drugs, and are likely to meet an annual cost threshold for covered Part D drugs.

Learn more about the proposed rule from this CMS news release; this CMS fact sheet; and this preview version of the proposed regulation, which is scheduled for official publication on December 10.  The deadline for submitting comments is January 27.

Centers for Medicare & Medicaid Services
  • CMS has sent a memo to state survey agencies updating its guidance on what constitutes “immediate jeopardy” in health care settings.  A designation of immediate jeopardy places an organization at risk of losing federal funding.  The memo is a revision of Appendix Q, CMS’s guidance on immediate jeopardy.  Find the memo here.
  • CMS has posted a bulletin on Medicare change-of-status notice instructions addressing expedited determinations when a patient is reclassified from an inpatient to an outpatient receiving observation services.  Find that bulletin here.
  • CMS has posted a bulletin summarizing Medicare deductible, coinsurance, and premium rates for CY 2025.  Find that bulletin here.
  • CMS has posted a bulletin summarizing the Medicare physician fee schedule for CY 2025.  The bulletin highlights payment changes for telehealth, caregiver training, therapy, cardiovascular risk assessment and management, evaluation and management (E/M) services, behavioral health, advanced primary care management, global surgery payments, and dental and oral health.  Find the bulletin here.
  • CMS has posted updated information about 2025 changes in the physician fee schedule for the provision of opioid treatment; for payment rates for opioid treatment programs; and for locality rates.
  • CMS has updated its booklet describing its policies for Medicare’s global surgery package.  The booklet covers surgery, endoscopy, and split global surgical packages’ billing and payment rules between two or more providers.  Find the updated booklet here.
  • CMS has posted a bulletin summarizing changes in the end-stage renal disease (ESRD) prospective payment system and payments for renal dialysis service that will take effect in CY 2025.  Find that bulletin here.
  • CMS has updated its fact sheet on payments to rural emergency hospitals.  Find the updated fact sheet here.
  • CMS has posted the January 25 update of the home health prospective payment system grouper.  Go here and scroll down for a direct download of the zip file.
  • CMS has sent a memo with an FAQ to all Medicare Part D sponsors and other interested parties to help them prepare for the implementation of the Medicare Prescription Payment Plan on January 1; the FAQ is an updated version of CMS’s October 1 FAQ.  On January 1, Part D sponsors are required to provide all Part D enrollees with the option to pay their out-of-pocket prescription drug costs in monthly amounts over the course of the plan year instead of paying those costs at the point of sale.  These FAQs were updated to reflected interactions with patient assistance programs.  Find that memo and FAQ here.
  • CMS has sent an informational bulletin to state Medicaid and CHIP officials as part of a series of guidance documents supporting states’ efforts to verify eligibility and conduct renewals in compliance with federal requirements.  The purpose of this bulletin is to remind states about current requirements and expectations for renewing eligibility for Medicaid and CHIP beneficiaries based on reliable information available to the state without contacting the beneficiary, also referred to as ex parte renewals.  Learn more from this CMS informational bulletin.
  • CMS has written to state Medicaid directors to provide guidance about protecting Medicaid beneficiaries from impermissible sanctions and penalties related to Medicaid beneficiary eligibility-related fraud and abuse.  With narrow exceptions, federal law does not permit state Medicaid agencies to recoup funds from, or lock-out from Medicaid coverage, a beneficiary who the state determined abused or defrauded the Medicaid program.  Find the CMS letter here.
  • CMS has finalized a rule establishing a new, six-year mandatory model that seeks to increase access to kidney transplants while improving quality of care for people seeking kidney transplants and reducing disparities among individuals undergoing the process to receive a kidney transplant.  The Increasing Organ Transplant Access Model’s mandatory participation of 103 transplant hospitals – one-half of all hospitals that perform kidney transplants – seeks to spur innovation nationwide by evenly distributing the model’s effects across the nation while engaging more specialists in value-based care.  Participating hospitals will have financial incentives to perform more transplants and will receive performance-based payments.  Learn more about the model from this CMS news release; the final regulation; and a more detailed description of the program on the Organ Transplant Access Model’s web page.
  • CMS announced that two drug manufacturers with FDA-approved gene therapies for sickle cell disease have entered into agreements to participate in the Cell and Gene Therapy Access Model.  This voluntary model will test outcomes-based agreements for cell and gene therapies with the goals of improving health outcomes, increasing access to cell and gene therapies, and lowering health care costs.  These outcomes-based agreements will tie payments to whether the therapy improves health outcomes for people with Medicaid who receive these drugs.  Learn more about the program and these new agreements from this CMS news release.
  • CMS has published a data a brief documenting prematurity and severe maternal morbidity among Medicaid- and CHIP-covered live births in 2021.  Find that data brief here.
  • A new CMS analysis examines the impact of Medicaid and CHIP eligibility unwinding on different Medicaid/CHIP eligibility categories by evaluating individuals who left full benefit Medicaid/CHIP coverage in a given state for at least one day between March 31, 2023 and December 31, 2023.  Find the CMS report here.
  • CMS has published an FAQ addressing special enrollment periods for Medicare plans when significant changes in provider networks trigger special enrollment periods.  Find that FAQ here.
Department of Health and Human Services
  • With CMS’s recent proposal to ease current restrictions limiting Medicare coverage for weight-loss drugs to treat obesity, HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) has published an issue brief that presents an overview of those drugs and their use and the potential financial implications of extending such coverage to Medicare and possibly Medicare beneficiaries.  Learn more from the ASPE issue brief “Medicare Coverage of Anti-Obesity Medications.”
  • With prescription drug prices a major concern for policymakers and the public, the Consolidated Appropriations Act of 2021 directed group health plans and health insurance issuers offering group or individual (non-group) health insurance coverage to submit annually certain data on premiums, enrollment, non-drug medical spending, spending on prescription drugs, and prescription drug rebates to HHS, the Department of Labor, and the Department of the Treasury and for those departments to report their findings biannually to Congress.  HHS’s ASPE has just submitted that report to Congress.  Read about what the agencies learned from their report “Prescription Drug Spending, Pricing Trends, and Premiums in Private Health Insurance Plans Report Required by the Consolidated Appropriations Act, 2021.”
  • With state Medicaid programs having the option to cover supported employment services, ASPE has published a study quantifying state use of this Medicaid benefit option.  Learn more from the ASPE issue brief “Use of Supported Employment in the Medicaid and CHIP Working-Age Population (2019).”
  • HHS’s Health Resources and Services Administration (HRSA) has awarded nearly $52 million in grants to 54 HRSA-funded health centers to increase access to primary care for people soon to be released from incarceration.  Learn more about the grants and their purpose and find a link to a list of the grant recipients in this HRSA news release.
  • HHS’s Office for Civil Rights has issued a letter to the health care community reminding HHS-funded health and human service providers of their obligation under federal civil rights laws to prevent and address discrimination based on antisemitism, Islamophobia, and other forms of discrimination based on religion, shared ancestry, or ethnicity.  The letter points to previously issued guidance and provides examples of prohibited actions.  Learn more about the letter from this HHS news release, which includes a link to the letter itself.
  • HHS has published a final rule that seeks to expand access to kidney and liver transplants for people with HIV by removing clinical research requirements for these transplants.  The final rule, which further implements the HIV Organ Policy Equity (HOPE) Act, removes the need to seek and obtain clinical research and institutional review board approval requirements for kidney and liver transplants between donors with HIV and recipients with HIV.  This change is based on research demonstrating the safety and effectiveness of kidney and liver transplants between donors and recipients with HIV.  Learn more about this change in policy from this HHS news release and the final rule itself.
  • Simultaneous with publication of this final rule, the NIH published a notice seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung, and pancreas.  This effort aims to streamline HOPE Act research requirements and continue to build a base of outcomes data on HOPE Act transplants of organs other than livers and kidneys.  Learn more from this NIH announcement.  The deadline for submitting comments is December 12.
  • HHS’s Office of the Assistant Secretary for Technology Policy’s (ASTP) (formerly ONC, the Office of the National Coordinator for Health IT) has posted a blog entry on its various efforts to foster the collection, use, and exchange of data to advance health and health equity.  Find that entry here.
  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) has published resources to help communities address trauma and the mental health effects of gun violence.  The resources are “Tips for Survivors:  Coping With Grief After Community Violence;” “Behavioral Health Best Practice Resources for Addressing Trauma and Violence;” and “Strengthening Mental Health and Resilience After Community Violence:  A Summary of Lessons Learned From ReCAST.”  Learn more from this HHS news release, which includes links to the three resources.
Department of Health and Human Services/Office of the Inspector General
  • HHS’s Office of the Inspector General (OIG) is soliciting proposals and recommendations for developing new or modifying existing safe-harbor provisions under section 1128B(b) of the Social Security Act, the federal anti-kickback statute, and the development of new OIG special fraud alerts.  Learn more from this HHS/OIG notice.  The deadline for submissions is January 27.
  • An OIG audit has concluded that HHS’s Office for Civil Rights should enhance its HIPAA audit program to enforce HIPAA requirements and improve the protection of electronic protected health information.  Go here to see the OIG report presenting its findings and offering its recommendations.
  • An OIG audit has concluded that the organ procurement and transplantation network’s IT system’s cybersecurity controls were partially effective but that improvements are needed.  Learn more about what the audit found and the recommendations the OIG offered from this report.
  • An OIG audit has found that non-profit and government-owned nursing homes generally comply with federal requirements regarding the infection preventionist position.  Learn more from this OIG report.
  • HHS’s OIG has submitted its semi-annual report to Congress.  Find a summary of the report in this HHS news release and find the full report here.
HHS Newsletters and Reports
HHS Videos
  • CMS has posted the video of a webinar that provides an overview of the quality improvement program updates in the CY 2025 Medicare physician fee schedule rule.  Find that video here.
  • HHS has posted a video presenting its new toolkit for providers caring for and supporting individuals with sickle cell disease.  Find that video here.
  • HHS’s Health Resources and Services Administration (HRSA) has posted a series of 10 short videos on kidney transplants as a treatment option for kidney disease.  Find those videos here.
Centers for Disease Control and Prevention

The CDC has confirmed a human infection with avian influenza (bird flu) in a child in California, the first such infection in the U.S.  Learn more from this CDC news release.

Medicaid and CHIP Payment and Access Commission

MACPAC has published an issue brief summarizing CMS’s Medicaid unwinding reporting metrics from April 2023 through June 2024.  These reporting metrics include state-reported monthly data on renewals, disenrollment, call center operations, and transitions to the federally facilitated and state-based marketplaces.  Learn more from the MACPAC issue brief “State Reported Medicaid Unwinding Data.”

Stakeholder Events

CMS – ESRD Open Door Forum – December 10

CMS will hold an open-door forum for ESRD providers on Tuesday, December 10 at 2:00 (eastern).  Go here to register to participate.

CMS – 2024 CMS Optimizing Health Care Delivery to Improve Patient Lives Conference – December 12

CMS will hold a virtual conference that will convene change-makers from the health care community and federal government to share innovative ideas, lessons learned, and best practices that strengthen patient health care delivery and access to high-quality care by reducing the administrative burdens that affect patients and the health care workforce.  The conference will be held on Thursday, December 12 at 11:00 (eastern).  Go here for further information and to register to participate.

MedPAC – Commissioners Meeting – December 12-13

MedPAC’s commissioners will hold their next public meeting on Thursday, December 12 and Friday, December 13.  Information about participating in the meeting and the meeting’s agenda is not yet available but when it is it will be posted here.

MACPAC – Commissioners Meeting – December 12-13

MACPAC’s commissioners will hold their next public meeting on Thursday, December 12 and Friday, December 13.  Information about participating in the meeting and the meeting’s agenda is not yet available but when it is it will be posted here.