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This document outlines the objectives of the CY2008 Medicare Part D reporting requirements, highlighting changes in compliance actions and the evaluation of Medication Therapy Management Programs (MTMP). It discusses the importance of timely data reporting for long-term monitoring of the Medicare Drug Benefit and details new reporting areas introduced in 2008, including vaccine administration and access provisions. The updated reporting standards ensure comprehensive data collection to facilitate oversight and compliance, with specific metrics for beneficiaries and pharmacy access.
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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 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
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 non-compliance • Intermediate sanctions (suspending marketing/enrollment activities), civil monetary penalties (CMPs), or contract termination if persistent non-compliance
CY2008 Reporting Requirements and related guidance: www.cms.hhs.gov/PrescriptionDrugCovContra/01_Overview.asp Questions Partd-planreporting@cms.hhs.gov For More Part D Information
Alice Lee-Martin 410-786-1103 Alice.Leemartin@cms.hhs.gov Contact Information