On October 11, 2011, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would revise Medicare Advantage (MA) and Part D prescription drug benefit program (Part D) regulations. Among many other things, the proposed rule would:
- Implement new statutory requirements, including codifying Medicare Part D Coverage Gap Discount Program rules under the Affordable Care Act (ACA) and finalizing Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requirements related to coverage of benzodiazepines and barbiturates;
- Terminate the contract of MA and Part D plan sponsors that have failed to achieve at least a 3-star rating under CMS’s 5-star plan rating system for a period of three years;
- Modify rules for medication therapy management comprehensive medication reviews for beneficiaries in long term care (LTC) settings;
- Allow physicians to request Independent Review Entity reconsideration of a denied Part D prescription on their patient’s behalf without obtaining a signed authorized representative form;
- Require Part D sponsors to provide beneficiaries with the option of a daily prorated cost-sharing rate for prescriptions for fewer than 30 days in certain circumstances;
- Require Part D sponsors to include the prescriber’s National Provider Identifier on prescription drug event records to enhance CMS efforts to address fraud and abuse;
- Increase transparency by requiring Part D pharmacy benefit managers to report additional financial information; and
- Allow MA plans to limit coverage of durable medical equipment (DME) to specific manufacturers or brands if certain conditions are met (discussed in greater detail below).
CMS also requested comment (without proposing regulatory text) on a potential new requirement for LTC facility consultant pharmacists to be independent of the LTC facility pharmacy, pharmaceutical manufacturers or distributors, or any affiliate of these entities. Comments on the rule will be accepted until December 12, 2011.