1. Medicare Advantage Quality Measurement & Performance Assessment Conference April 8, 2008 Medicare Part D Reporting Requirements Alice Lee-Martin, PharmD Division of Clinical and Economic Performance Medicare Drug Benefit Group

2. Objectives  Discuss purpose of Part D Reporting Requirements, and CY2008 changes  Outline CMS’ compliance actions related to reporting  Discuss CY2009 reporting requirements

3. Purpose of Reporting Requirements  Plan reported data –provides more timely information than other sources –updates Plan information –provides long-term monitoring and oversight of the Medicare Drug Benefit  New areas added to reflect policy changes

4. Changes to CY2007 Reporting Sections  Transition  Medication Therapy Management (MTM) Programs  Long-term Care (LTC) Rebates  Drug Benefit Analysis

5. Transition  Revised from CY2007 to collect more specific information about Plans’ safeguards in both retail and LTC settings  Reporting frequency changed to annual submission of 1 st quarter data

6. MTM Programs  Evaluation of MTMP outcomes requires non- aggregate MTM data  Information about MTM-eligible beneficiaries, including LTC enrollment  Period of MTMP participation  If applicable, reason for MTMP discontinuation  Elements also added for comprehensive reporting of MTM participants  # of beneficiaries discontinuing for other reason  For Period 1, # of beneficiaries pending

7. Long-term Care (LTC) Rebates  Potential UM conflicts may be specific to drug formulation –Report NDC and drug name  Special reporting cases:  Exemption for LTC pharmacies that serve less than 5% of LTC beds in an area  Non-compliant LTC pharmacy

8. Drug Benefit Analyses  Comprehensive representation of Plan’s enrollment –Include LIS and non-LIS members –Enrollees in all benefit phases, including the deductible phase  More timely submission of reports to CMS –Monthly instead of quarterly

9. New Reporting Sections for CY2008  Retail, Home Infusion, and Long-Term Care Pharmacy Access  Access to Extended Day Supplies at Retail Pharmacies  Vaccines

10. Retail, HI and LTC Pharmacy Access  Updates information from Plans’ initial Part D applications  Confirms pharmacy access standards continue to be met  Retail access figures  Contracted HI and LTC network pharmacies  Additional data from plans receiving waivers –any willing pharmacy requirement –retail pharmacy convenient access standards

11. Access to Extended Day Supplies at Retail Pharmacies  Reported only by Part D Plans with mail-order pharmacies offering extended day supplies of covered Part D drugs  Verifies reasonable access to the same extended day supply benefits at retail  Reported annually

12. Vaccines  Statutory shift of Part D vaccine administration from Part B to Part D in 2008  Monitors methods to facilitate vaccine administration  Data reported quarterly by Contact:  Total # of Part D vaccines processed  # of vaccines  administered in a clinic setting  adjudicated through network pharmacies  processed through a paper enhanced process  processed through an internet based web tool  via other processing method

13. Other Changes  Call Center and Reversal reporting sections removed  Generic Drug Utilization (Generic Drug Rate)  Other clarifications  Language, terminology  Data elements  Field formats

14. Beyond CY2008  CY2008 Reporting requirements will remain in effect for CY2009  Additional areas and changes for future contract year requirements  Technical specifications – Spring 2008 –Data element definitions –Validation and QA thresholds –Analyses –Other clarifications, e.g. FAQ

15. Analysis and Reporting  Initial QA by CMS:  Missing data submissions  Statistical tests for outliers  Data entry errors  Frequent resubmissions, failure to resubmit data flagged  Sponsors contacted if identified as outliers  Review and resubmit data if necessary  Additional data may be requested to support  Data “locked” after 4-6 weeks for analysis and reporting  Submissions after this point may be excluded

16. Potential Compliance Actions  Compliance considered timely submission of accurate data  Warning notices, and/or request corrective action plans –Based on significance and/or persistence of non- compliance  Intermediate sanctions (suspending marketing/enrollment activities), civil monetary penalties (CMPs), or contract termination if persistent non-compliance

17. For More Part D Information  CY2008 Reporting Requirements and related guidance:  www.cms.hhs.gov/PrescriptionDrugCovContra/01_Overvie w.asp www.cms.hhs.gov/PrescriptionDrugCovContra/01_Overvie w.asp  Questions  Partd-planreporting@cms.hhs.gov Partd-planreporting@cms.hhs.gov

18. Alice Lee-Martin 410-786-1103 Alice.Leemartin@cms.hhs.gov Contact Information