Regulatory roundup: CMS proposes 2025 payment system rules for home health, ESRD; Final rule sets disincentives for provides that commit information blocking; and more

CMS releases 2025 proposed payment system rule for home health

The Centers for Medicare & Medicaid Services (CMS) this week issued the Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) proposed rule, which provides planned updates to the Medicare payment policies and rates for Home Health Agencies (HHAs).

CMS proposes a permanent prospective adjustment to the CY 2025 home health payment rate of -4.067 percent, to account for the impact of implementing the Patient-Driven Groupings Model (PDGM). In a fact sheet, CMS estimates Medicare payments to HHAs in CY 2025 would decrease in the aggregate by 1.7 percent, or $280 million, compared to CY 2024, based on the proposed policies. The agency also proposes to:

  • Recalibrate the PDGM case-mix weights 
  • Update the fixed dollar loss (FDL) for outlier payments • Update the low utilization payment adjustment (LUPA) thresholds, functional impairment levels, and comorbidity adjustment subgroups for CY 2025
  • Establish a home health occupational therapy (OT) LUPA add-on factor and update other LUPA add-on factors • Adopt the core-based statistical area (CBSA) delineations for the home health wage index using the 2020 Decennial Census
  • Update the proposed rate for the CY 2025 intravenous immune globulin (IVIG) items and services’ payment under the IVIG benefit
  • Collect new four new items in the social determinants of health category in the HH Quality Reporting Program 
  • Release a request for information on future performance measure concepts for the expanded home health value-based purchasing model
  • Provide an update on the advancement of health equity into the expanded home health value-based purchasing model 
  • Add a new standard in the Home Health Condition of Payment to require HHAs to develop, implement, and maintain through an annual review, a patient acceptance to service policy that is applied consistently to each prospective patient referred for home health care
  • Add providers and suppliers that are reactivating their Medicare billing privileges to the categories of new providers and suppliers subject to additional oversight

CMS proposes 2025 ESRD Prospective Payment System rule

CMS on Thursday issued a proposed rule to update payment rates and policies and includes requests for information under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services provided to Medicare beneficiaries on or after January 1, 2025. The rule proposes to:

  • Increase the ESRD PPS base rate to $273.20 for all freestanding and hospital-based ESRD facilities, an increase of appropriately 2.2 percent.
  • Establish a new ESRD PPS-specific wage index to adjust ESRD PPS payment for geographic differences in area wages.
  • Expand the list of ESRD outlier services to include drugs and biological products that were or would have been included in the composite rate prior to establishment of the ESRD PPS. 
  • Modify the Low-Volume Payment Adjustment (LVPA) policy to create two-tiers, paying a 28.4 percent increase to the ESRD PPS base rate to facilities that provide fewer than 3,000 treatments per cost reporting year and an 18.1 percent adjustment to facilities that provide 3,000 to 3,999 treatments. CMS also proposes that tier determination for facilities that are eligible for LVPA will be based on median treatment count over the past three cost reporting years. • Include oral-only drugs in the ESRD PPS bundled payment.
  • Update the Acute Kidney Injury (AKI) dialysis payment rate for CY 2025 to be $273.20, which is equal to the CY 2025 ESRD PPS base rate and apply the CY 2025 ESRD PPS wage index to calculate AKI dialysis payments. 
  • Allow payment for AKI renal dialysis services provided to beneficiaries in their homes, allowing Medicare beneficiaries with AKI a wider range of choices about how and where they receive renal dialysis services. • Permit ESRD facilities to bill Medicare for the home and self-dialysis training add-on payment adjustment for beneficiaries with AKI.
  • Replace the single Kt/V Dialysis Adequacy Comprehensive clinical measure with a measure topic comprised of four individual measures beginning with payment year 2027. 
  • Remove the National Healthcare Safety Network (NHSN) Dialysis Event reporting measure from the ESRD QIP measure set beginning with payment year 2027.
  • Requests public comment on a potential future health equity payment adjustment and potential future updates to the data validation policy. 

For more information, see the CMS fact sheet.

HHS final rule sets disincentives for provides that commit information blocking

The U.S. Department of Health and Human Services (HHS) has released a final rule that establishes disincentives for health care providers that have committed information blocking. The rule follows the 21st Century Cures Act (Cures Act) provision for HHS to establish “disincentives” for health care providers who engage in practices that they knew were unreasonable and were likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information (EHI), except as required by law or covered by a regulatory exception.

“This final rule is designed to ensure we always have access to our own health information and that our care teams have the benefit of this information to guide their decisions. With this action, HHS is taking a critical step toward a health care system where people and their health providers have access to their electronic health information,” said HHS Secretary Xavier Becerra in the announcement. “When health information can be appropriately accessed and exchanged, care is more coordinated and efficient, allowing the health care system to better serve patients. But we must always take the necessary actions to ensure patient privacy and preferences are protected – and that’s exactly what this rule does.”

The final rule establishes the following disincentives:

  • Under the Medicare Promoting Interoperability Program, an eligible hospital or critical access hospital (CAH) that has committed information blocking and is referred to CMS by OIG will not be a meaningful electronic health record (EHR) user during the calendar year of the EHR reporting period in which OIG refers its determination to CMS. If the eligible hospital is not a meaningful EHR user, the eligible hospital will not be able to earn three quarters of the annual market basket increase they would have been able to earn for successful program participation; for CAHs, payment will be reduced to 100 percent of reasonable costs instead of 101 percent. This disincentive will be effective 30 days after publication of the final rule.
  • Under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS), a MIPS eligible clinician (including a group practice) who has committed information blocking will not be a meaningful EHR user during the calendar year of the performance period in which OIG refers its determination to CMS. If the MIPS eligible clinician is not a meaningful EHR user, then they will receive a zero score in the MIPS Promoting Interoperability performance category. If an individual eligible clinician is found to have committed information blocking and is referred to CMS, the disincentive under the MIPS Promoting Interoperability performance category will only apply to the individual, even if they report as part of a group. This disincentive will be effective 30 days after publication of the final rule.

  • Under the Medicare Shared Savings Program, a health care provider that is an Accountable Care Organization (ACO), ACO participant, or ACO provider or supplier who has committed information blocking may be ineligible to participate in the program for a period of at least one year. This disincentive will be effective 30 days after publication of the final rule; however, any disincentive under the Shared Savings Program would be imposed after January 1, 2025. Additional disincentives may be established through future rulemaking.

Blue Shield of California MA members gain app access to new member health record

Blue Shield of California announced plans to improve the way Medicare Advantage users access and interact with their health information all within the Blue Shield member app and website.

The new health record feature will combine all of a member’s health data from their medical history and allow them to view and use it electronically. “Simply put, this is health care the way it should be,” said Paul Markovich, president and chief executive officer at Blue Shield of California in the announcement. “Our new Member Health Record is a huge step in our journey to empower members to make informed decisions, more easily manage their health care and ultimately live healthier lives without having to ask permission, navigate multiple physician and hospital portals, or rely on antiquated technology like fax machines.”

 An initial version of the Member Health Record will be released to a select group of Blue Shield Medicare Advantage members. By the end of the year, all Blue Shield of California members will have access, which the insurer plans to enhance with additional features and data from more health care providers throughout 2025. Upon release to all Blue Shield members in 2024, the Member Health Record will include:

  • Access to health records available to Blue Shield, including lab results, immunizations, diagnoses, and conditions
  • Access to historical health data shared with Blue Shield, even prior to Blue Shield membership 
  • Connections between clinical data and resulting claims
  • Personalized health reminders for important tasks such as preventive care and well-being tips and the ability to seamlessly add to calendar
  • Downloadable health record that can be shared, printed, and emailed

Planned enhancements for 2025 include:

  • Dependent health record visibility to support children or elder care
  • Personalized benefit recommendations, such as a no-additional-cost diabetes treatment program 
  • Access to care management plans for members with acute or chronic health conditions

CHAI releases draft health AI framework for public comment

The Coalition for Health AI (CHAI), a nonprofit network of health systems, government agencies, and advocacy groups focused on developing a set of consensus-driven guidelines and best practices for responsible AI in health, has released a draft framework for public review and comment. The public review period is open for 60 days.

The framework, consisting of an Assurance Standards Guide, provides considerations to ensure standards are met in the deployment of AI in health care. The organization said the draft framework was created with a consensus-based approach, drawing upon the expertise and knowledge of multiple, diverse stakeholders from across the health care ecosystem.

A set of draft companion documents, called The Assurance Reporting Checklists, provides criteria to evaluate standards across the AI lifecycle; from identifying a use case and developing a product to deployment and monitoring.

The principles underlying the design of these documents align with the National Academy of Medicine’s AI Code of Conduct, the White House Blueprint for an AI Bill of Rights, several frameworks from the National Institute of Standards and Technology, as well as the Cybersecurity Framework from the Department of Health and Human Services Administration for Strategic Preparedness & Responses.

“We reached an important milestone today with the open and public release of our draft assurance standards guide and reporting tools,” said Dr. Brian Anderson, CHAI’s chief executive officer, in the announcement. “This step will demonstrate that a consensus-based approach across the health ecosystem can both support innovation in health care and build trust that AI can serve all of us.”

The Guide aims to help build consensus among stakeholders from diverse backgrounds, providing a common language and understanding of the life cycle of health AI solutions, and highlighting best practices when designing, developing, and deploying AI within health care workflows. This will help ensure effective, useful, safe, secure, fair, and equitable care. CHAI will use input from the public to finalize the Guide and update it as needed in the future.

The Checklists translate the consensus considerations into actionable evaluation criteria, to assist the independent review of health AI solutions throughout their lifecycle to ensure they are effective, valid, secure and minimize bias. The Checklists are to be used by independent reviewers and organizations evaluating AI solutions, as well as individuals involved in the AI lifecycle for reviewing their work. Public reporting of the results of applying the Checklists ensures transparency of the risks and benefits of an AI solution, which will help organizations and their leadership make decisions about the development and deployment of these technologies.

“Shared ways to quantify the usefulness of AI algorithms will help ensure we can realize the full potential of AI for patients and health systems,” said Dr. Nigam H. Shah, a CHAI co-founder and board member, and chief data scientist for Stanford Health Care. “The Guide represents the collective consensus of our 2,500 strong CHAI community including patient advocates, clinicians and technologists.”