Applications for Medicare Part D Plans; PDP Plans, MA-PD Plans, Cost Plans, PACE Organizations, SAE and EGWP

10/27/2008

High-Level Summary of All Part D Application Revisions from 2009 Version of Part D Application to 2010 Version

Clarification	Purpose of the Clarification	Application
		PDP		MA-PD		Cost	800 series (PDP and Cost)	Directs (PDP and MA-PD)	PACE
GENERAL INFORMATION and INSTRUCTIONS
1. Updated dates (language where appropriate) and regulatory and Prescription Drug Benefit Manual references for each attestation section.	Updated dates (language where appropriate) and references to statutes, regulations and Part D guidance.	Through-out document	Through-out document		Through-out document		Through-out document	Through-out document	Through-out document
2. Clarified instructions related to the application submission and correction process.	Clarified instructions related to the courtesy opportunity to cure deficiencies, the Notice of Intent to Deny process to cure deficiencies, and the retail pharmacy access review process.	Instructions	Instructions		Instructions		Instructions	Instructions	Instructions
3. Clarify dates on the calendar for courtesy cure period and Notices of Intent to Deny.	In response to comments received, CMS will include the dates of the cure periods.	Instructions	Instructions		Instructions		Instructions	Instructions	Instructions
APPLICANT EXPERIENCE, CONTRACTS, LICENSURE AND FINANCIAL STABILITY
4. Clarified contractual requirements related to the MMA and Compliance regulations.	Deleted the reference to abiding by all applicable State laws and regulations as the MMA regulations only refer to Federal laws and regulations. Two of the contractual provisions were clarified to properly reflect CMS authority under the compliance regulation related to CMS or its designee’s access to books and records related to the Part D program.	3.1.1D8 3.1.1D11 3.1.1D13	3.1.1D8 3.1.1D11 3.1.1D13		3.1.1D8 3.1.1D11 3.1.1D13		N/A	N/A	Mgmt & Operations
5. Added contractual requirements to reflect the enactment of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)	Based on sections 171 and 173 of MIPPA all Part D sponsors are required to include contractual provisions that relate to prompt payment and notice of reimbursement standard updates.	3.1.1D17 3.1.1D18	3.1.1D17 3.1.1D18		3.1.1D17 3.1.1D18		N/A	N/A	Mgmt & Ops
Formulary/Pharmacy and Therapeutics (P&T) Committee
6. Amend attestation to reflect submission of transition policies directly to HPMS instead of through CMS-formulary website.	Existing attestation required initial applicants to provide the transition policy to CMS through a website on the formulary due date. Automation will now require the transition policy be submitted directly to new HPMS module.	3.2.1A6	3.2.1A6		3.2.1A6		N/A	N/A	Formulary/P&T Committee
BIDS
7. Deleted attestation related to submitting meaningful and distinct bids.	The attestation is only applicable to stand-alone PDPs and should not be applied to other types of Part D sponsors.	N/A	3.2.6		3.2.6		N/A	N/A	N/A
APPENDICES
8. Updated language throughout Application to Request Federal Waiver of State Licensure Requirement for Prescription Drug Plan.	Clarified language related to the dates of submission for the waiver application in conjunction with the Part D application.	Appendix I	N/A		N/A		N/A	N/A	N/A
9. Clarified language in contract templates to properly address the MMA and compliance regulations.	Deleted the reference to abiding by all applicable State laws and regulations as the MMA regulations only refer to Federal laws and regulations. Language was clarified to properly reflect CMS authority under the compliance regulation related to CMS or its designee’s access to books and records related to the Part D program.	Appendices III-VIII	Appendices II-VII		Appendices II-VII		N/A	N/A	Mgmt & Operations
10. Added language to address the enactment of MIPPA.	Based on section 171 of MIPPA all Part D sponsors are required to include contractual provisions that relate to prompt payment with its PBM, retail, home infusion, and ITU pharmacies.	Appendices III, IV, VI, VIII	Appendices II, III, V, VII		Appendices II, III, V, VII		N/A	N/A	Mgmt & Ops
11. Added language to address the enactment of MIPPA.	Based on section 173 of MIPPA all Part D sponsors are required to include contractual provisions that relate to notice of reimbursement standard updates.	Appendices III-VIII	Appendices II-VII		Appendices II-VII		N/A	N/A	Mgmt & Ops
12. Added language to address the finalization of a home infusion contractual requirement based on the Policy and Technical Regulation.	Based on the final approval in April 2008 of the Policy and Technical correction regulation, all Part D sponsors are required to include a contractual provision related to the delivery of home infusion drugs within 24 hours of discharge.	Appendix VI	Appendix V		Appendix V		N/A	N/A	N/A
13. Added language to address the enactment of MIPPA.	Based on section 172 of MIPPA all Part D sponsors are required to include contractual provisions with long-term care pharmacies that related to timeframes for claims submission.	Appendix VII	Appendix VI		Appendix VI		N/A	N/A	Mgmt & Ops

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Red signifies changes since the Emergency PRA package.