Final Summ_2009_Part D Application_Revisions

12/03/2007

High-Level Summary of All Part D Application Revisions from 2008 Version of Part D Application to 2009 Final Version

Clarification	Purpose of the Clarification			Application
				PDP		MA-PD		Cost
GENERAL INFORMATION and INSTRUCTIONS
1. Added regulatory and Prescription Drug Benefit Manual references for each attestation section; Changed instructions to provide attachments as uploads in HPMS; and amended the instructions related to not accepting any hard copy and CD submissions.		Included references to Part D guidance. The application will be completed entirely in HPMS, so prior instructions about how to submit attachments have been changed to how to upload documents into HPMS.	Throughout document		Throughout document				Throughout document
2. Technical change to the instructions to related to automation of the applications.		All uploads will be required to be in either excel, a CMS provided template or pdf format to be properly uploaded in HPMS.	Throughout document		Throughout document				Throughout document
3. Changed the time the applications are due to CMS.		To coordinate with HPMS and be consistent with the Medicare Advantage Group, we changed the time the Part D application is due to CMS from 5:00PM EST to 11:59PM EST.	Instructions		Instructions				Instructions
4. Added language to make the Part D applications consistent with the newly-final Compliance Regulation (CMS-4124-P)		Attestations and contractual provision requirements were amended to address the new definition of subcontractor. Other changes were made to ensure compliance plan requirements are consistent with provisions in the new regulation.	Throughout document		Throughout document				Throughout document
APPLICANT EXPERIENCE, CONTRACTS, LICENSURE AND FINANCIAL STABILITY
5. Deleted attestation asking type of product.	This attestation is no longer necessary due to automation. Applicants will only be given those questions appropriate to the type of product line already identified in HPMS.			N/A		3.1.1A1		3.1.1A1
6. Deleted “some type” wording in attestation.	Received a comment stating that the wording made the attestation too broad.			3.1.3A5		N/A		N/A
7. Amend attestations related to licensure waivers.	MMA changes the licensure waiver authority for year three of the program and the attestations were amended to reflect statutory authority. Language was modified from referencing licensure in any state to licensure in each state.			3.1.3B		N/A		N/A
8. Amended a statutory reference.	The statutory reference related to staff being excluded by the Department of Health and Human Services Office of the Inspector General or by the General Services Administration has changed.			3.1.4		3.1.4		3.1.4
BENEFIT DESIGN
9. Added new attestation related to formulary that was in 2008 application.	The other Part D applications contain this attestation and it was included in the 2008 application. It appears to have been accidentally dropped from the MA-PD and is being reinserted.			N/A		3.2.1A1		N/A
10. Added new attestations related to formulary.	Added attestations to highlight several aspects of previously existing formulary guidance related to six classes of drugs that CMS wanted to highlight to initial applicants.			3.2.1A		3.2.1A		3.2.1A
11. Added new attestations related to bundling home infusion drugs as part of a supplemental benefit.	Based on the 2008 Call Letter, existing policy clarified how certain Part D sponsors may bundle Part D home infusion drugs as part of the supplemental benefit and how this should be reported on a formulary and the information relayed to beneficiaries.			N/A		3.2.1D		3.2.1D
12. Added an attestation related to guidance on vaccine administration.	Legislation passed in 2007 requires the shift of vaccine administration from Part B to Part D. This guidance implements this legislative change.			3.2.1B		3.2.1B		3.2.1B
13. Deleted a new attestation related to the CAHPS survey.	Based on comments received during the 60-day posting of the Draft 2009 application, this attestation has been deleted since guidance has not been issued related to any follow-up requirements for Part D sponsors in relation to the CAHPS survey thus the attestation has been removed.			3.2.3A5		3.2.3A5		3.2.3A5
14. Added in clarifying instruction related to how applicants will submit MTM plans to set fees for pharmacists.	This instructions was inadvertently dropped from the 2009 drafts of the application but was in the 2008 final version.			3.2.4A10		3.2.4A10		3.2.4A10
15. Adds a new attestation, which limits the number of bids up to the parent organization.	Based on the 2008 Call Letter, CMS is implementing a policy that provides parent organizations of multiple Part D sponsors to limit the number of benefit offerings to no more than 2 basic benefit plans throughout all subsidiaries.			3.2.6A3		N/A		N/A
PHARMACY ACCESS
16. Added new attestations related to Private Fee For Service Part D sponsors.	Based on the 2008 Call Letter, these new attestations address on line billing and paper claims.			N/A		3.4A		N/A
17. Added clarifying language to a mail order attestation related to a level-playing field with retail and providing of extended day supply.	Added clarifying language that is part of Chapter 5 of the Prescription Drug Benefit Manual to ensure applicants understand the policy with providing extended day supply of medications via mail order or at retail New language ensures that the availability of an extended day supply at retail does not increase the costs to the government and that cost-sharing for an extended day supply never exceeds what the enrollee would have paid had he/she filled the prescription in multiple 30-day supply increments at retail pharmacy rates.			3.4.3A3		3.5.3A3		3.3.3A3
18. Clarified language in long-term care attestations.	Clarified existing language references to long term care pharmacies throughout this table and where appropriate included specific references to Chapter 5 of the Prescription Drug Benefit Manual, which incorporated previously separate guidance. This allowed CMS to delete references to any of the separate guidance.			3.4.5		3.5.5		3.3.5
19. Added instructions to provide applicants the choice of software vendors to complete the pharmacy access network reports.	Based on comments received during the 60-day posting of the Draft 2009 Part D application, added detailed instructions to use either Quest Analytics or GeoNetworks software to produce the required pharmacy network access reports.			3.4.1B		3.5.1B		3.3.1B
ENROLLMENT AND ELIGIBILITY
20. Added 2 attestations related to involuntary disenrollments.		Based on the 2008 Call Letter and HPMS guidance, attestations were added to address involuntary disenrollments when beneficiaries fail to pay premiums.	3.5A19 3.5A20		3.6A9 3.6A10				3.4A9 3.4A10
21. Changed language in attestation related to 4Rx data.		Based on a comment received from the 30-day comment period, CMS recognized the attestation did not mesh with current operation guidance. The revised attestation incorporates the process for plan-generated and CMS-generated enrollments.	3.5A18		3.6A8				3.4A8
COMPLAINTS TRACKING
22. Added clarifying language related to applicants’ requirement to monitor and document complaints in CTM.		Added language that applicants must monitor and document complaints in CTM in accordance with CMS standard operating procedures for sponsors. Previous language required applicants to monitor and document resolutions for complaints associated with their contracts in HPMS. Language was added so that the monitoring and documenting of resolutions are in accordance with CMS standard operating procedures.	3.6A2		3.7A2				3.5A2
COVERAGE DETERMINATIONS (INCLUDING EXCEPTIONS) AND APPEALS
23. Reorganized and clarified language of existing attestations. Added new attestations to further highlight key aspects of coverage determination and appeals policy.	Attestation language was clarified and the order was redone for a better flow of understanding for the applicants.			3.9		3.10		3.8
COORDINATION OF BENEFITS
24. Added new attestations related to plan-to-plan reconciliation and reconciliation when another payer paid as primary instead of the Part D sponsor.		Addresses applicant’s responsibility to reconcile payments with other Part D sponsors (where appropriate) and other payers that should not pay for Part D drugs as primary.	3.10A13 3.10A14		3.11A11 3.11A12				3.9A11 3.9A12
TRUE OUT-OF-POCKET COSTS (TrOOP)
25. Added two attestations related to processing of TrOOP-related data.		Attestations highlight applicant’s system requirements necessary to appropriately process TrOOP-related data in a timely fashion.	3.11A14 3.11A15		3.12A15 3.12A16				3.10A15 3.10A16
MARKETING/BENEFICIARY COMMUNICATION
26. Added a new bullet within an existing attestation related to beneficiary call centers.		Highlights the guideline for returning a beneficiary call when the call goes appropriately to a voice mailbox. Also changed the 80% of calls answered within 30 seconds to average wait time being two minutes or less.	3.13A5		3.14A5				3.12A5
27. Added new attestation specific to marketing of formularies.		Based on current practices, this attestation highlights to applicants that they may only market a CMS-approved formulary.	3.13A7		3.14A7				3.12A7
28. Added a new attestation addressing the release of prescription drug event data for research and other purposes.		Based on the forthcoming data regulation, this attestation highlights that Applicants must notify enrollees that prescription drug event data may be released by CMS for research and other purposes. CMS will delete this attestation if the proposed rule does not receive OMB approval.	3.13A11		3.14A11				3.12A11
PROVIDER COMMUNICATIONS
29. Clarified attestation related to pharmacist and provider call centers.		Clarified that if a network pharmacy is open 24 hours then the call center must be available 24 hours. Also clarified that the average wait time must be two minutes or less.	3.14A1		3.15A1				3.13A1
REPORTING REQUIREMENTS
30. Added new attestation related to reporting direct and indirect remuneration dollars for payment reconciliation.		Based on CMS guidance, this reporting requirement was highlighted to address payment reconciliation with DIR data.	3.16A17		3.17A17		3.15A17
DATA EXCHANGE BETWEEN PART D SPONSOR AND CMS
31. Deleted an attestation related to enrollment transactions and replaced it with new attestations that more specifically highlight system requirements.		The new attestations focus more appropriately on testing, lifecycle memos and disaster and recovery plans for systems.	3.17		3.18				3.16
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 AND RELATED CMS REQUIREMENTS
32. Reordered and added new attestations related to data security, off shore contracting, and the National Provider Identifier.	Added new attestations based on the 2008 Call Letter and implementation of the National Provider Identifier.			3.18		3.19		3.17
33. Amended and deleted attestations related to offshore subcontracting.	Consolidated and revised attestations related to offshore subcontracts to be less burdensome for Applicants so that they will submit attestations at an appropriately designated time instead of receiving CMS prior approval under specified conditions.			3.18		3.19		3.17
34. Added new section to have Applicants complete an appendix for data use agreements.	The Data Use Agreement will require initial applicants to agree to only use the data received through the Part D program for Part D purposes. Existing sponsors have completed the data use agreement through the contracting process. Deleted the Appendix from the MA-PD and Cost applications as the information will be collected through the Part C applications.			Appendix XI		N/A		N/A
CLAIMS PROCESSING
35. Clarified attestation related to paper claims processing.	Based on comments received, clarified an attestation related to paper claims processing timelines for non-network pharmacies compared to claims submitted by beneficiaries.			3.21A2		3.22A2		3.20A2
PREMIUM BILLING
36. Added a new section to highlight requirements of Applicants related to premium withhold and billing issues.	Based on existing CMS guidance, these attestations were added to the application to highlight premium billing and withholding concerns and when beneficiaries need to be reimbursed.			3.22		3.24		3.21
APPENDICES
37. Deleted Banking Information Form appendix.	Appendix is not part of the application review and is not completed in HPMS so it has been removed from the application.		Appendix I			Appendix I		Appendix I
38. Updated language throughout Application to Request Federal Waiver of State Licensure Requirement for Prescription Drug Plan.	Updated language to address automation of the Part D application. Clarified language related to the dates of submission for the waiver application in conjunction with the Part D application.		Appendix II			N/A		N/A
39. Deleted Certification of Monthly Enrollment and Payment Data Relating to CMS Payment to a Part D Sponsor.	Appendix is not part of the application review and is not completed in HPMS so it has been removed from the application.		Appendix III			Appendix III		Appendix III
40. Deleted Certification by Prescription Drug Plan Organization that Subcontracts Meet the Requirements of Section 3.1.2D.	Deleted certification because it is duplicative of statements addressed in the 4.0 Certification.		Appendix V			Appendix IV		Appendix IV
41. Clarified language for the Retail Network Pharmacy Access appendix.	Clarified the instructions for developing the retail network pharmacy access reports. Added in language specific to using the Quest Analytics software to produce the network pharmacy access reports.		Appendix XIII			Appendix XII		Appendix XII

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Rows in black denote a change from the Final 2008 Part D application.

Rows in red denote a change from the 30-day posted version of the 2009 Draft Part D application to current version.