Every year, Medicare Advantage Organizations (MAO)¹ must update their member communication materials, such as the Annual Notice of Change (ANOC), Evidence of Coverage (EOC), Provider Directory, Excluded Provider Model, Formulary (Comprehensive and Abridged), Low-Income Subsidy (LIS) Rider, Notice of Formulary Changes, and Transition Letter, among others.  

The Centers for Medicare & Medicaid Services (CMS) provides standardized model materials to facilitate the process. When MAOs choose to use the standardized model materials, they submit them under the File and Use (F&U) protocol and can use them five (5) days after submission. However, MAOs must certify that the material complies with all applicable standards. The alternative is to request a review by CMS, which takes 45 days.  

Revised Regulations for MAOs Member Communication Materials CY 2025 

On June 12, 2024, CMS announced the issuance of the model materials for CY 2025² reflecting the considerable revisions to Part D and other changes under the Inflation Reduction Act of 2022 (IRA) and multiple final regulations that will take effect in CY 2025³. 

Notable changes related to Part D Re-design and regulations in the final rule are highlighted below: 

• Part D Coverage Gap is removed in CY 2025, as all references should be (e.g., Section 2.1 in Chapter 6 of the EOC) 
• Zero copayments in the Part D Catastrophic Stage (Section 6, Chapter 6, EOC) and definition of Catastrophic Coverage Stage (under Definitions, Chapter 12, EOC) 
• Medicare Prescription Payment Plan (Section 7, Chapter 2, EOC) 
• Enrollees have 65 calendar days from the date on the written notice of the coverage decision to file an appeal, not 60 calendar days (Section 6.5, Chapter 9, EOC) 
• MAOs should insert a list of situations when they will cover prescriptions out of the network and any limits on their out-of-network policies, including coverage for self-administered drugs provided in an outpatient setting (Section 2.5, Chapter 5, EOC) 
• Biosimilar products are explained in “The Drug List tells which Part D drugs are covered” (Section 3.1, Chapter 5 and under Definitions in Chapter 12, EOC) 
• Lengthy explanation for requesting exceptions to the formulary (Sections 6.2, 6.3, and 6.4, Chapter 5, EOC) 
   
• Fast track appeal to the Quality Improvement Organization (QIO) to extend coverage of care (Section 8.3, Chapter 9, EOC) 
• A monthly cap of $35.00 for applicable insulin products also applies to Part B benefit (Medicare Part B Prescription Drugs in the Medical Benefits Chart, Chapter 4, EOC) 
• Urgently needed services are explained in four different sections in the EOC, including primary care provider referrals are not required, and out-of-network providers are eligible for coverage (Section 2.2 and Section 3.2, Chapter 3, Section 2.1 Medical Benefits Chart, Chapter 4, and Definitions, Chapter 12) 
• Coverage for telehealth services provided by qualified occupational therapists (OTs), physical therapists (PTs), speech-language pathologists (SLPs), and audiologists (Section 2.1, Medical Benefits Chart, Chapter 4) 
• For new enrollees, MA coordinated care plan must provide a minimum 90-day transition period, during which time the new MA plan may not require prior authorization for any active course of treatment, even if the course of treatment was for a service that commenced with an out-of-network provider (Section 2.1 Medical Benefits Cart, Chapter 4, EOC) 

Last but not least, each year, CMS also provides MAOs training and testing guidelines for developing training and testing of their agents and brokers. MAOs and the third-party marketing organizations (TPMOs) that operate on their behalf must ensure that all the agents and brokers (including employed, subcontracted, downstream, and/or delegated entities) that sell Medicare products on their behalf are trained and tested annually on Medicare rules and regulations and on the specific benefits of the plan(s) the agents and brokers sell. It is advisable to consult the training and testing guidelines for agents and brokers before the Annual Election period for 2025. 

CY 2025 is a transformational year for Part D and some significant regulatory changes. Reviewing the Evidence of Coverage can refresh staff memories of the rule announcements during 2024 and prior years.  

The standardized ANOC must be sent to enrollees by September 30, 2024. Other model materials should also be ready before October 15, 2024. It is not too early to begin reviewing the model materials to ensure readiness and compliance for 2025.  

Inovaare offers professional staff with subject matter expertise and analytical tools to assist MAOs in staying compliant.  

We would be glad to discuss ways we can help. Call us at 1.408.850.2235 or email us at info@inovaare.com

References:
1. MAOs include Prescription Drug Plans and 1876 Cost Plans 
2. Issuance of Contract Year 2025 Standardized and Model Materials June 12, 2024 
3. CMS Final Rule 4205 F for CY 2025