Supporting Statement A: Attachment 1

Attachment 1

Summary of Medicare Part D Regulatory Requirements Waived for

Medicare Advantage Prescription Drug (MA-PD) Applicants

This table summarizes the Medicare Part D regulatory provisions that are waived for MA-PD applicants, primarily because they are duplicative of Medicare Part C regulatory requirements. This table demonstrates why the Part D application burden is reduced for MA-PD applicants compared to stand-alone PDP applicants.

Part D Regulation	Regulatory Requirement(s) Description	Basis for Waiver
42 CFR 423 Subpart I, excepting 42 CFR §423.440 (which concerns Federal preemption of State law and prohibition of State premium taxes)	Licensure and Solvency – Applicant must be licensed to bear risk in the State in which it intends to operate or apply for a licensure waiver and meet CMS solvency standards.	Duplicative of MA Organization requirements for licensure and solvency under 42 CFR §422.6 (i); 42 CFR §422.400; and 42 CFR §422.501).
42 CFR §423.153(b) &(d) Waiver applies to MA-PFFS only	Utilization Management – Applicant must have a cost effective utilization management system.	Waiver stated in regulations at 42 CFR §423.153 (e) excuses MA PFFS organizations from meeting the utilization management requirements specified in 42 CFR §423.153 (b).
42 CFR §423.153(b) &(d) Waiver applies to MA-PFFS only	Medication Therapy Management Program – Applicant must have a program to manage medication therapy to optimize outcomes, reduce adverse drug interactions.	Waiver stated in regulations at 42 CFR §423.153 (e) excuses MA PFFS organizations from meeting Medication Therapy Management Program requirements specified in 42 CFR §423.155.
42 CFR §423.112 (a)	Service Area – Applicant must offer a Part D plan that serves at least an entire PDP region.	Conflicts with MA regulations (42 CFR §422.2) that allow MA organizations to offer local MA plans (i.e., plans that serve less than an entire state).
42 CFR §423.120 (a)(7)(i) Waiver applies only to MA-PDs that operate their own pharmacies	Pharmacy Network – Applicant must offer its Part D plan benefit through a contracted retail pharmacy network that meets CMS convenient access standards.	Waiver stated in regulations at 42 CFR §423.120(a)(7) (i) excuses from the CMS convenient access standards those MA organizations that administer their Part D benefit through pharmacies owned by the MA organization if that organization’s pharmacy network access is comparable to the CMS convenient access standards .
42 CFR §423.120(a)(7)(ii) Waiver applies to MA-PFFS plan that provides access through all pharmacies.	Pharmacy Network – Applicant must offer its Part D plan benefit through a contracted retail pharmacy network that meets CMS convenient access standards	Waiver stated in regulations at 42 CFR §423.120 (a) (7) (ii) excuses from the CMS convenient access standards those MA-PFFS organizations that offer a qualified prescription drug coverage, and provide plan enrollees with access to covered Part D drugs dispensed at all pharmacies, without regard to whether they are contracted network pharmacies and without charging cost-sharing in excess of the requirements for qualified prescription drug coverage.
42 CFR §423.120(a)(8)(i) Waiver applies only to MA-PDs that operate their own pharmacies	Pharmacy Network – Applicant must offer its Part D benefit through any willing pharmacy that agrees to meet reasonable and relevant standard network terms and conditions.	Waiver promotes the coordination of Parts C and D benefits. Excuses from CMS any willing pharmacy requirement those MA organizations that administer their Part D benefit through pharmacies owned by the MA organization and dispense at least 98% of all prescriptions through pharmacies owned and operated by Applicant.
42CFR §423.34 42 CFR §423.36 42 CFR §423.38 42 CFR §423.42 42 CFR §423.44	Enrollment and Eligibility – Applicant agrees to accept Part D plan enrollments and determine Part D plan eligibility consistent with Part D program requirements.	Duplicative of MA requirements under 42 CFR 422 Subpart B - Eligibility, Election, and Enrollment. MA organizations will conduct enrollment and determine eligibility consistent with MA program requirements. These requirements mirror those stated in the Part D regulation.
42 CFR §423.514(b) and (c)	Reporting Requirements – Applicant must report information concerning significant business transactions.	Duplicative of MA requirements for reporting significant transactions under 42 CFR §422.500 and 42 CFR §422.516(b) and (c) and requirements for providing annual financial statements.
42 CFR §423.514(e)	Reporting Requirements – Applicant must notify CMS of any loans or any other special arrangements it makes with contractors, subcontractors, and related entities.	Duplicative of MA requirement for reporting loans or special arrangements under 42 CFR §422.516(e).
42 CFR §423.512	Experience and Capabilities – Applicant must reach the minimum enrollment standard within the first year it offers a Part D benefit.	Conflicts with MA regulation that permits three years to achieve the minimum enrollment level.

1