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Objectives

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

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Objectives

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

  2. 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

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

  4. 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

  5. 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

  6. 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

  7. 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

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

  9. 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

  10. 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

  11. 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

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

  13. 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

  14. 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

  15. 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

  16. 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

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

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