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Medicare Part D Reporting Requirements Medicare Advantage Quality Measurement & Performance Assessment Conference April 8, 2008 Alice Lee-Martin, PharmD Division of Clinical and Economic Performance Medicare Drug Benefit Group Objectives Discuss purpose of Part D Reporting Requirements, and CY2008 changes Outline CMS’ compliance actions related to reporting Discuss CY2009 reporting requirements 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 Changes to CY2007 Reporting Sections Transition Medication Therapy Management (MTM) Programs Long-term Care (LTC) Rebates Drug Benefit Analysis 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 1st quarter data MTM Programs Evaluation of MTMP outcomes requires nonaggregate 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 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 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 New Reporting Sections for CY2008 Retail, Home Infusion, and Long-Term Care Pharmacy Access Access to Extended Day Supplies at Retail Pharmacies Vaccines 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 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 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 Other Changes Call Center and Reversal reporting sections removed Generic Drug Utilization (Generic Drug Rate) Other clarifications Language, terminology Data elements Field formats 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 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 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 noncompliance Intermediate sanctions (suspending marketing/enrollment activities), civil monetary penalties (CMPs), or contract termination if persistent non-compliance For More Part D Information CY2008 Reporting Requirements and related guidance: www.cms.hhs.gov/PrescriptionDrugCovContra/01_Overvie w.asp Questions [email protected] Contact Information Alice Lee-Martin 410-786-1103 [email protected]