Medicare Regulatory Compliance Updates

There are several upcoming changes to the Medicare regulatory landscape, and to help keep you informed, we’ve summarized a few of the more significant ones here:


CMS’ Part Two Final Guidance on the Medicare Prescription Drug Plan

CMS issued Final Part Two Guidance on the Medicare Prescription Drug Plan. 

Changes and clarifications from the Draft Part Two Guidance include:

  • Part D plans that exclusively charge $0 cost sharing for covered Part D drugs to all plan enrollees are not required to offer enrollees the option to pay their OOP costs through monthly payments or otherwise comply with the final part one or two guidance;

  • Part D sponsors may choose to either send a program election request form with the membership ID card mailing or separately in a different mailing sent out within the same timeframe

  • Part D sponsors must develop their own strategies for ongoing outreach during the plan year to enrollees who are likely to benefit from the program;

  • Provides CMS-developed model communication materials that Part D sponsors must send to enrollees regarding election into, participation in, and termination from the program;

  • Part D sponsors may only include the participant’s original Part D cost sharing in the Medicare Prescription Payment Plan, as determined by their plan-specific benefit structure, in situations where a supplemental payer to Part D returns a higher final patient pay amount to the pharmacy, and

  • Part D plan sponsors should require long-term care pharmacies to provide notice to the enrollee at the time of its typical enrollee cost-sharing billing process.

CMS and HHS’s proposed rule revises the Medicare Physician Fee Schedule for CY 2025

CMS and HHS published a proposed rule that revises the Medicare Physician Fee Schedule (PFS) for CY 2025. 

CMS-1807-P proposes CY 2025 average base payment rates under the PFS be reduced by 2.93% from CY 2024. 

The proposed rule also includes provisions that:

  • establish an advanced primary care payment “bundle” under the PFS;

  • implement new payment and coding for cardiovascular risk assessment and care management;

  • update Merit-based Incentive Payment System (MIPS) scoring methodologies and measure inventories;

  • introduce six new MIPS Value Pathways; 

  • allow eligible ACOs with a history of success in the program access to an advance on their prepaid shared savings;

  • adopt a health equity benchmark to incentivize participation in the Shared Savings Program;

  • introduce new coding and payments for behavioral health, oral health, and caregiver training;

  • expand access to Hepatitis B vaccinations and colorectal cancer screenings;

  • add payment for certain drugs and biological products under Medicare Part B; and

  • maintain telehealth services set to expire at the end of 2024.

There is a 60-day comment period for this CY 2025 proposed rule that ends September 9, 2024.

How the courts could affect Medicare

Here are some links to current movements in the courts that could have an impact on Medicare products:

Challenge to CMS's agent/broker compensation and administrative payment regulatory changes 

 Challenge to federal agencies power to interpret and enforce regulations

 Challenge to nondiscrimination in health programs and activities rule (Section 1557 of the Affordable Care Act) 


Exciting News!

You can now receive weekly regulatory updates by subscribing to our Insurance Regulatory Insights newsletter.

Telos Actuarial’s team of experienced regulatory compliance professionals can help you navigate and submit these reports, keeping you in compliance.

Reach out to compliance@telosactuarial.com to learn more about the Compliance services we provide!


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