Medicare (Title XVIII of the Social Security Act)
Subpart 1 – Part D Eligible Individuals and Prescription Drug Benefits

Subpart 1 – Part D Eligible Individuals and Prescription Drug Benefits

Eligibility, Enrollment and Information423

The Secretary may provide to each Prescription Drug Plan sponsor and each Medicare Advantage organization such identifying information about Part D eligible individuals as the Secretary determines to be necessary to facilitate efficient marketing of and enrollment in prescription drug plans and Medicare Advantage-Part D plans.424

Beneficiary Protections for Qualified Prescription Drug Coverage425

The PDP sponsor will have in place, with respect to covered Part D drugs, a cost-effective drug utilization management program,426 quality assurance measures and systems to reduce medication errors and adverse drug interactions and improve medication use,427 a medication therapy management program428 and a program to control fraud, waste and abuse.429  A medication therapy management program is a program that may be furnished by a pharmacist that is designed to assure, with respect to targeted beneficiaries,430 that covered Part D drugs are appropriately used to optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse events, including adverse drug interactions.431  Such a program may include elements that promote detection of adverse drug events and patterns of overuse and underuse of prescription drugs.432  Beginning in 2012, PDP sponsors shall offer medication therapy management services to targeted beneficiaries that must include an annual comprehensive medication review furnished face-to-face or using telehealth technologies by a qualified provider,433 and follow-up interventions as warranted based on the findings of the annual review.434

The PDP sponsor shall have in place a process to assess, at least on a quarterly basis, the medication use of individuals who are at risk but not enrolled in the medication therapy management program.435

The Secretary will establish guidelines for the coordination of any medication therapy management program with respect to a targeted beneficiary with any care management plan established with respect to such beneficiary under a chronic care improvement program.436

Prescriptions and other information for covered Part D drugs prescribed for Part D eligible individuals that are transmitted electronically shall be transmitted in accordance with the electronic prescription program.437  The electronic prescription program will provide for the electronic transmittal of information that relates to the medical history concerning the individual and related to a covered Part D drug being prescribed or dispensed upon request of the professional or pharmacist involved.438  The Secretary will provide for the promulgation of uniform standards relating to the requirements for electronic prescription drug programs,439 consistent with the objectives of improving patient safety,440 the quality of care provided to patients441 and efficiencies in the delivery of care.442

Each PDP sponsor shall provide meaningful procedures for hearing and resolving grievances between the sponsor and enrollees with prescription drug plans.443

To the extent that a PDP Sponsor and prescription drug plan maintains medical records or other health information regarding enrollees, the organization will establish procedures to safeguard the privacy of any individually identifiable enrollee information444 and to assure timely access of enrollees to such records and information.445