This week in Medicare—4/10/2024

Guiding an Improved Dementia Experience (GUIDE) Model Implementation

On April 1, CMS published Demonstrations Transmittal 12563, which rescinds and replaces Transmittal 12536, dated March 7, to upload the ICD for the file layout into ECHIMP and update BR 13412.6.1.

The original transmittal was issued to implement the GUIDE Model, which is a demonstration that will test payment and service delivery models for people with dementia and their caregivers.

Effective date: April 1, 2024 - Analysis, Design and Coding; July 1, 2024 - Testing and Implementation

Implementation date: April 1, 2024 - Analysis, Design and Coding; July 1, 2024 - Completion of Coding, Testing and Implementation

 

Medical Record Maintenance & Access Requirements

On April 1, CMS updated an MLN Fact Sheet regarding medical record maintenance and access requirements. CMS added information on medical record and access guidelines applicable to teaching physicians and residents. The agency also added a reminder for Medicare’s signature requirements.

Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington

On April 1, CMS published a Notice in the Federal Register to announce that laboratories located in and licensed by the state of Washington that possess a valid license under the Medical Test Site law, chapter 70.42 of the Revised Code of Washington, are exempt from CLIA requirements for a period of four years.

Dates: The exemption granted by this notice is effective from April 1, 2024, to April 1, 2028.

 

2025 Medicare Advantage and Part D Rate Announcement

On April 1, CMS published the 2025 Medicare Advantage (MA) and Part D Rate Announcement regarding MA capitation rates and Parts C and D payment policies for CY 2025. Government payments to MA plans are expected to increase by an average of 3.7%, or over $16 billion, from 2024 to 2025. CMS is continuing the phase-in of the updated Part C Risk Adjustment model by blending 67% of the risk score calculated using the updated 2024 MA risk adjustment model with 33% of the risk score calculated using the 2020 MA risk adjustment model. CMS started the three-year phase-in during 2024.

CMS also published the CY 2025 Part D Redesign Program Instructions concurrently with the MA Rate Announcement. These instructions describe how CMS will implement changes to the structure of the Part D benefit as mandated by the Inflation Reduction Act of 2022. Changes to the Part D benefit include the following:

• A newly defined standard Part D benefit design consisting of three phases: annual deductible, initial coverage, and catastrophic coverage
• A lower annual out-of-pocket threshold of $2,000
• The sunset of the Coverage Gap Discount Program (CGDP) and establishment of the Manufacturer Discount Program
• Changes to the liability of enrollees, Part D sponsors, manufacturers, and CMS in the newly defined standard Part D benefit design

CMS published a Fact Sheet on the Rate Announcement on the same date, as well as a separate Fact Sheet on the Part D redesign instructions.

 

CMS Announces Minority Research Grant Program Notice of Funding Opportunity

On April 1, CMS published a Notice of Funding Opportunity for the 2024 Minority Research Grant Program (MRGP). The MRGP supports researchers at minority-serving institutions who are investigating or addressing healthcare disparities affecting all minority populations.

CMS will award up to five grants totaling up to $1,275,000, and the application deadline is June 3, 2024.

 

Revisions and Clarifications to Hospital Interpretive Guidelines for Informed Consent

On April 1, CMS published a Memorandum to state survey agency directors regarding informed consent guidelines. After increasing concerns about the absence of informed patient consent prior to allowing practitioners or supervised medical, advanced practice provider, or other applicable students to perform training- and education-related examinations outside the medically necessary procedure, CMS is revising guidance in Appendix A of the State Operations Manual to reinforce informed consent requirements in the Hospital Conditions of Participation.

Surveyors must ensure that a hospital’s patient informed consent policy, process, and forms contain elements and information that allow for a patient, or their representative, to make fully informed decisions about their care.

Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the State/CMS Location training coordinators within 30 days of this memorandum.

 

Concerns Remain About Safeguards To Protect Residents During Facility-Initiated Discharges From Nursing Homes

On April 3, the OIG published a Report regarding safeguards to protect residents during facility-initiated discharges from nursing homes. The OIG conducted this audit to assess the extent to which nursing homes comply with federal requirements for facility-initiated discharges.

In 107 of the 126 reviewed cases, the facility-initiated discharges were for allowable reasons. However, the findings raised the following concerns for the OIG about nursing homes’ understanding of and compliance with notice and documentation requirements for these discharges:

• Nursing homes sometimes fell short in providing required documentation
• Nursing homes often failed to notify residents of their discharges and frequently omitted required information in notices
• Even when nursing homes provided the resident with a facility-initiated discharge notice, only about half sent a copy of the notice to the ombudsman, as required

The OIG recommends for CMS to provide a standard notice template to help nursing homes provide complete and accurate information to residents facing discharge and ombudsmen, as well as require nursing homes to systematically document facility-initiated discharges in information available to CMS and states to enhance oversight.

On April 3, the OIG published another Report on nursing home facility-initiated discharges using the data collected in the aforementioned report. The secondary report revealed that nursing home residents with endangering behaviors and mental health disorders may be vulnerable to facility-initiated discharges.

In 72 out of the 126 cases, nursing homes initiated a discharge because the resident’s behavior endangered themselves or others in the facility. Of those 72 residents, 67 were diagnosed with a mental disorder. Most of the residents who were discharged by nursing homes due to endangering behaviors and with a mental health disorder had been admitted for long-term care.

 

A Lack of Behavioral Health Providers in Medicare and Medicaid Impedes Enrollees’ Access to Care

On April 3, the OIG published a Report on how low behavioral health provider participation in Medicare and Medicaid impacts enrollees’ access to care.

The OIG conducted this review due to Congressional interest in ensuring Medicare and Medicaid enrollees have access to behavioral health services. The report is focused on outpatient behavioral health service claims in 2021 by providers in 20 counties across 10 states.

The OIG determined that few behavioral health providers in the selected counties actively served Medicare and Medicaid enrollees. On average, there were fewer than five active behavioral health providers per 1,000 enrollees in each program. Compared to urban counties, rural counties had fewer than half the number of active providers per 1,000 enrollees.

Despite the unprecedented demand for behavioral health services after the COVID-19 pandemic, the OIG determined that less than 5% of Medicare and Medicare Advantage enrollees received services from a behavioral health provider in 2021.

The OIG had the following recommendations for CMS:

• Take steps to encourage more behavioral health providers to serve enrollees
• Explore options to expand coverage to additional behavioral health providers
• Use network adequacy standards to drive an increase in behavioral health providers
• Increase monitoring of enrollees’ use of behavioral health services and identify vulnerabilities

CMS concurred with (or concurred with the intent of) all four recommendations.

 

Final Rule: Contract Year (CY) 2025 Medicare Advantage and Part D Final Rule

On April 4, CMS published a draft copy of a Final Rule regarding policy and technical changes for CY 2025 Medicare Advantage (MA) plans, Part D plans, and Programs of All-Inclusive Care for the Elderly (PACE). Finalized changes include the following:

• Requiring brokers to be paid a fixed amount, regardless of the selected plan, starting the next annual enrollment period. Although CMS initially proposed a $31 increase to this fixed broker fee, it finalized a $100 increase.
• Establishing network adequacy evaluation standards for a new facility-specialty provider category, “Outpatient Behavioral Health.” This new category includes a range of behavioral health providers, including marriage and family therapists, mental health counselors, community mental health centers, and more.
• Requiring MA plans to issue a personalized notification of unused supplemental benefits to enrollees between June 30 and July 31 of the plan year.

The rule also includes provisions on the MA appeals process, biosimilar substitutions, contract terms for third-party marketing organizations, and more.

CMS published a Press Release and Fact Sheet on the rule on the same date. The rule is expected to be published in the Federal Register on April 23.

The regulations are effective June 3, 2024. Provisions in the rule are applicable to coverage beginning January 1, 2025, except as otherwise noted.

 

CMS Could Improve Its Procedures for Setting Medicare Clinical Diagnostic Laboratory Test Rates Under the Clinical Laboratory Fee Schedule for Future Public Health Emergencies

On April 5, the OIG published a Report on CMS’ procedures for clinical diagnostic laboratory test (CLDT) rate-setting. The purpose of this audit was to determine if these procedures could be improved for future public health emergencies (PHE). To make this determination, the OIG reviewed applicable laws and conducted interviews with CMS, MAC pricing coordinators, and officials from two laboratory associations.

The pricing coordinators and laboratory association officials stated that they did not have adequate communication with CMS during the MAC interim rate-setting process and when CMS issued rulings to adjust the rates for COVID-19 viral tests. The OIG recommends improving communication between all stakeholders in order to give CMS better access to quality information during future PHEs.

The pricing coordinators also revealed that MACs do not have the authority to adjust payment rates to encourage laboratories to provide a particular service, such as a new CDLT during a PHE, if needed. The OIG recommends for CMS to improve its procedures to provide MACs with additional flexibility when they set interim payment rates to respond to future PHEs.

 

Making Care Primary (MCP) Model Implementation

On April 5, CMS published Demonstrations Transmittal 12567, which rescinds and replaces Transmittal 12538, dated March 8, to revise the Interface Control Document and update BRs 13392.50 and 13392.78.

The original transmittal was issued to implement the MCP model, which is a demonstration testing alternative payment models and support to primary care participants.

Effective date: July 1, 2024

Implementation date: April 1, 2024 - Analysis, Design and Coding; July 1, 2024 – Complete Coding, Testing, and Implementation; October 7, 2024 - Implementation of BR 13392.12.4 for CWF only.

 

April 2024 Update to HCPCS Files

On April 5, CMS updated the Download Link for the April 2024 update to the HCPCS files.