Medicare Program - Medicare Prescription Drug Benefit Program

There are many changes that the Centers for Medicare & Medicaid Services (CMS) passed last year, and there are many changes that will be in effect from next year. One of the crucial changes added in the Part D Prescription Drug Benefit Manual (PDBM) was introduced in June 2024. CMS Medicare has revised the Medicare Prescription Drug Benefit (Part D) and has included the guidelines and regulations of ONC. This final rule focuses on implementing changes related to mandatory standards for electronic prescribing and the adoption of health information technology (IT) standards for use by the Department of Health and Human Services (HHS).

What's New in the CMS Medicare Prescription Drug Benefit Program

The new regulations came into effect on July 17, 2024. On this date, the Federal Register has approved the incorporation by reference of certain publications listed in the rule.

In this final rule, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) address the remaining proposals from the "Medicare Program; Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications" (88 FR 78476), which was published in the Federal Register on November 15, 2023, known as the "November 2023 proposed rule."

The finalized changes involve Part D requirements for electronic prescribing standards to ensure they meet the healthcare industry's needs. To enhance alignment across the Department of Health and Human Services (HHS), the final rule mandates that Part D sponsors, prescribers, and dispensers of Part D drugs comply with standards either directly adopted by CMS or referenced by ONC for the electronic transmission of prescriptions and related information.

Currently, Part D sponsors, prescribers, and dispensers are required to follow the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard version 2017071 for electronic transmission of prescriptions, medication history, and electronic prior authorization (ePA), as well as the NCPDP Formulary and Benefit (F&B) standard version 3.0 for formulary and benefit information. They must also implement electronic real-time benefit tools (RTBTs) capable of integrating with at least one prescriber's electronic prescribing system or electronic health record (EHR), although there is no specific standard for RTBTs.

ONC is Adopting New Standards

The final rule specifies that Part D electronic prescribing regulations will now require compliance with standards adopted by ONC. This includes both NCPDP SCRIPT standard version 2017071 and NCPDP SCRIPT standard version 2023011 until the former expires on January 1, 2028. After this date, entities must exclusively use NCPDP SCRIPT standard version 2023011.

Regarding electronic transmission of formulary and benefits information, Part D sponsors, prescribers, and dispensers can use either NCPDP F&B standard version 3.0 or a standard adopted by ONC. However, starting January 1, 2027, they must exclusively use NCPDP F&B standard version 60.

Additionally, by January 1, 2027, Part D sponsor RTBTs must comply with the NCPDP RTPB standard version 13 adopted by ONC.

The final rule also includes a provision aligning Part D requirements with future updates to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations in 45 CFR part 162 for eligibility transactions. It also reorganizes requirements and makes technical changes throughout § 423.160.

Benefits of the Medicare Prescription Drug Program

The CMS Medicare Prescription Drug Program, also known as Medicare Part D, offers numerous benefits to its enrollees, significantly improving access to necessary medications and reducing overall healthcare costs. This program has become a crucial component of Medicare, providing coverage for both brand-name and generic prescription drugs through private plans approved by Medicare.

One of the primary benefits of Medicare Part D is cost savings. Enrollees can choose from a range of plans with different premium and deductible levels, allowing them to select a plan that best fits their financial situation and medication needs. The program also includes a catastrophic coverage threshold, which caps out-of-pocket expenses once a beneficiary's spending reaches a certain limit. This provision is particularly beneficial for individuals with chronic conditions requiring expensive medications, as it ensures they are not financially overwhelmed by high drug costs.

Access to a wide variety of medications is another significant advantage. Part D plans are required to cover a broad range of prescription drugs, ensuring that beneficiaries have access to the medications they need. This includes drugs for chronic conditions like diabetes, heart disease, and mental health disorders. Additionally, the competitive nature of Part D plans often results in negotiated lower prices with pharmaceutical companies, further reducing costs for beneficiaries.

Medicare Part D also provides preventive benefits. By covering medications that manage chronic conditions, the program helps prevent complications and hospitalizations, ultimately leading to better health outcomes and reduced overall healthcare costs. This preventive aspect is vital for maintaining the health and well-being of older adults and individuals with disabilities.

Moreover, the program includes medication therapy management (MTM) services for eligible beneficiaries. These services involve comprehensive reviews of an individual's medications by healthcare professionals, which help optimize therapeutic outcomes, enhance medication adherence, and identify potential drug interactions or other medication-related issues.