Medicare Advantage Quality Measurement & Performance Assessment Conference

April 8, 2008

Medicare Part D Reporting Requirements

Alice Lee-Martin, PharmDDivision 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 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, terminologyData 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 submissionsStatistical tests for outliersData entry errors

Frequent resubmissions, failure to resubmit data flagged Sponsors contacted if identified as outliers

Review and resubmit data if necessaryAdditional data may be requested to support

Data “locked” after 4-6 weeks for analysis and reportingSubmissions 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

For More Part D Information

CY2008 Reporting Requirements and related guidance:

www.cms.hhs.gov/PrescriptionDrugCovContra/01_Overview.asp

Questions Partd-planreporting@cms.hhs.gov

Alice Lee-Martin

410-786-1103

Alice.Leemartin@cms.hhs.gov

Contact Information