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Medicare Part D Final Regulations

Medicare is a federal health insurance program administered by the Centers for Medicare & Medicaid Services (CMS). Part D is the prescription drug benefit available to Medicare beneficiaries. When Introduced in 2006, Part D was not without problems. Since then, new rules have been revised and finalized by CMS. These were released by CMS in 2009 and called the Part D Final Regulations.

  1. CMS-4068-F

    • The first rule establishes Part D as a program and outlines the purpose of Part D as a program. It left room for the exception of state laws when implementing Part D regulations.

    CMS-4124-FC

    • The next regulation finalizes all program changes to Part D. It finalizes the contract review processes and the intermediate sanction and civil money penalty provisions that Part D plan insurance companies must undergo. It also continues the self-reporting process for Part D plans and allows the Department of Health and Human Services access to books and records of the Part D plan.

    CMS-0016-F and CMS-0018-F

    • These rules finalize the e-prescribing regulations and standards under Part D.

    CMS-4133-F

    • This regulation gives a formula used to calculate the Part D low-income benchmark premium. Those who qualify for the federal program Extra Help qualify to have their Part D premium paid for by the program if it is under the "benchmark" amount. This formula calculates what that amount should be.

    CMS-4130-F

    • This rule clarifies CMS expectations of Part D plans in terms of access to pharmacies for the consumers, the administration of insulin and information about vaccines. This rule also finalizes some changes to the retiree drug subsidy, which allows the plan to choose on which year it bases actuarial equivalence, or how they set the premiums.

    CMS-4119-F

    • Before this rule was established, CMS could use only some data for payment purposes, and it could not be released to the public. This rule allows CMS more freedom to access Part D data in order to oversee and monitor for public health, disease management and more.

    CMS 4138--IFC

    • This regulation revises and finalizes governing regulations over the Part D program. This rule reflects changes from the Medicare Improvements for Patients and Providers Act (MIPPA), and includes regulations on marketing, payment time frames, pricing standards and claims submissions.

    CMS 4131--F

    • This rule finalizes all marketing provisions outlined by the Centers for Medicare & Medicaid Services. It outlines how they can contact beneficiaries and when and where they can sign new enrollees up.

    CMS 4138-IFC2

    • This rule clarifies how the agent and broker relationship works, including how each should be compensated and paid.

    CMS-4131-FC

    • This rule affects Part D in two ways. First, it finalizes regulations on the enrollment and appeals processes for Part D plans. Second, it deals with a negotiated price payment issue.

    CMS 4138-IFC4

    • The final rule implements MIPPA changes to Part D. It defines what a Part D covered drug is and sets a requirement for Part D formularies (or list of covered drugs).

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