Medicare Part D Overutilization Monitoring System

Lisa Thorpe, Division of Part D Policy

Gary Wirth, Division of Clinical and Operational Performance

Medicare Drug Benefit and C&D Data Group

July 17, 2013

• Summary• Background• Overutilization Monitoring System• Overutilization Issue Types• Review Process • Website• Reports• Response Form• Future Development• Additional Information• Questions

Presentation Overview

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• The Overutilization Monitoring System (OMS) will help CMS to ensure that sponsors have established reasonable and appropriate drug utilization management programs to assist in preventing overutilization of prescribed medications as required by 42 C.F.R §423.153 et seq.

• Beneficiaries with potential opioid or acetaminophen (APAP) overutilization issues or referred by the CMS Center for Program Integrity (CPI) due to possible utilization issues will be reported to sponsors on a quarterly basis.

• Sponsors will be required to respond to CMS within 30 days on the status of their review of each beneficiary case.

• The first reports will be available on July 31, 2013.

Summary

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• GAO Report, Sept. 6, 2011,“Medicare Part D, Instances of Questionable Access to Prescription Drugs”1

• In September 2011, CMS began working on an approach to help sponsors identify and manage the most egregious cases of opioid overutilization.

• Comprehensive policy was set forth in the final Call Letter (April 2, 2012) for CY 2013 and in more detail in final supplemental guidance (September 6, 2012), effective January 1, 2013.

BackgroundPolicy Development

1GAO-11-699. (Washington, D.C.: Sept. 6, 2011).4

• Level One: Improved Use of Concurrent Claim Edits (Safety Controls at POS)– Part D sponsors expected to prevent coverage of unsafe

daily doses of acetaminophen (APAP). – Maximum dose is 4 grams/day as recommended by FDA.

• Level Two: Improved Use of Formulary Management Designs (Quantity Limits at POS)– Part D sponsors may also submit QLs to CMS for approval

when no FDA maximum dose (e.g., most opioid analgesics) or below FDA maximum dose.

– Sponsors may submit plan-level POS edits based upon cumulative MED across the opioid class (Final CY 2014 Call letter – April 1, 2013)

BackgroundThree “Levels” for Improving Drug Utilization

Review Controls in Part D

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• Part D sponsors should look for apparent duplicative opioid drug use over sustained periods of time and/or across multiple opioid drug products in high doses.

• CMS’ methodology identified a narrow target population of non-borderline cases of opioid overutilization.– Use of more than 120 mg MED for at least 90 consecutive days from

more than 3 prescribers and more than 3 pharmacies

• Clinical staff to communicate with prescribers to ascertain medical necessity, and include information about the existence of multiple prescribers and the beneficiary’s total opioid utilization.

• Results of case management to confirm: 1) current level of opioids; 2) lower level of opioids; or 3) no opioids.

Background “Level Three”: Improved Retrospective DUR

Programming & Case Management

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• Part D sponsors must determine appropriate claim edit for beneficiary when current level is not confirmed to be medically necessary.

• Part D sponsors must provide 30-day advance written notice to beneficiary and opioid prescriber(s) of pending POS edit with the right to contest, and send copy of notice to CMS.

• CMS expected to see implementation of claim edits by Q2 2013.

• CMS will be monitoring Part D sponsors’ implementation through the new Overutilization Monitoring System (OMS).

Background “Level Three”: Improved Retrospective DURProgramming & Case Management (cont.)

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Where: The OMS module adds new functionality to the Patient Safety Analysis Website.

Who is included: Each beneficiary with a potential overutilization issue (i.e., APAP, Opioid, or CPI Referral) will be assigned a ticket number, which may include multiple overutilization issues.

– Beneficiaries for whom CMS has been notified that a POS edit is in place will be suppressed from the overutilization reports for a given contract ID and issue type.

Overutilization Monitoring System (OMS)Overview

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What is included: Contract-level reports of beneficiaries with potential overutilization issues will be available to Part D sponsors. Sponsors will be required to send responses to CMS describing the status of the review of each beneficiary’s case.

– The OMS reports are not a substitute for sponsors’ own internal processes to identify which beneficiaries should be targeted for case management.

When: The first reports will be available through the Patient Safety Analysis Website at the end of July 2013, with sponsors’ responses due within 30 days. Sponsors will be notified by email when their reports and the response form are available for download.

Overutilization Monitoring System (OMS)Overview (continued)

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Overutilization Issue TypesMethodology Overview

• Potential overutilization is identified through analysis of PDE data with dates of service within the prior two calendar quarters.– May encompass multiple contract IDs

– Beneficiaries’ current enrollment determined through the Common Medicare Environment (CME) file

• The medication lists for each drug class were created using data from Medi-Span and First Databank.

• NDCs with obsolete dates more than one year before the start of the analysis period are excluded.

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Overutilization Issue TypesAcetaminophen (APAP)

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• Overutilization of APAP: Use of APAP with daily dose exceeding 4 grams for a total of 30 days or more during the measurement period.

Overutilization Issue TypesOpioids

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• Overutilization of Opioid Drugs: Use of opioids with cumulative daily morphine equivalent dose (MED) exceeding 120mg for at least 90 consecutive days, and opioid medications received from more than 3 prescribers and more than 3 pharmacies. – Excludes patients with cancer diagnoses, as listed in the

2011 Risk Adjustment Processing System (RAPS) dataset.

– Excludes patients receiving hospice care determined by the 2013 Enrollment Database (EDB).

– Updated opioid product list and conversion factors from the Centers for Disease Control and Prevention (CDC).

Overutilization Issue TypesCenter for Program Integrity (CPI) Referrals

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• Potential utilization issues referred by the Medicare Center for Program Integrity (CPI) for review.– Cases were originally referred to the MEDIC, and

subsequently referred to local law enforcement.

– Involve potential fraud or abuse of prescriptions in the Part D program.

– May include non-opioid cases.

– Analysis may use more than the previous six months of PDE data.

Review Process

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• Authorized users of the Patient Safety Analysis Website will receive email notification that their OMS package is ready for download.

• Sponsors will then:

– Download the OMS package from the Patient Safety Analysis Website.

– Compare the overutilization data for each beneficiary on the OMS Reports with their Part D plan’s DUR and case management records.

– Complete the Response Form within 30 days by entering the responder’s contact information and selecting the appropriate response codes for each beneficiary’s potential overutilization issues.

– Upload the completed response form to the Patient Safety Analysis Website through the secure Upload Files feature.

• Sponsors can view the number and types of overutilization issues at the contract level, and monitor the submission status of their quarterly overutilization responses through the Patient Safety Analysis Website.

• Currently authorized users of the Patient Safety Analysis Website will be automatically granted comparable access to OMS functionality.

• The Medicare Compliance Officer selects up to five users and their access levels.

• At least one user from each contract must have access to Summary and Confidential Beneficiary Reports to view and respond to beneficiary-level overutilization issues.

• Add new users or modify users’ access for the OMS by July 16, 2013.

• PACE plans must assign authorized users of the Patient Safety Analysis Website if they have not already done so.

WebsiteAccess

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WebsiteSummary Tracking

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Website Ticket Tracking

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Website Download Files

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Website Upload Files

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Website Upload File History

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Reports

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• OMS Reports will be available at the contract and beneficiary levels.1. Contract Summary – current and historical contract-level information about

beneficiaries in this contract that were identified as having potential overutilization issues.

2. Beneficiary Summary – beneficiary-level history of overutilization issues for all beneficiaries ever reported in the overutilization monitoring reports.

3. Current APAP Issues – detailed information about each beneficiary requiring review for a potential APAP overutilization issue identified during the period measured.

4. Current Opioid Issues – detailed information about each beneficiary requiring review for a potential opioid overutilization issue identified during the period measured.

5. Current CPI Referrals – detailed information about each beneficiary referred by the Medicare Center for Program Integrity for review of a potential overutilization issue.

6. Closed Issues – detailed information about all potential overutilization issues that have been closed by the sponsor in previous reporting periods and currently do not require a response.

Reports Contract Summary

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ReportsBeneficiary Summary

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ReportsCurrent APAP Issues

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ReportsCurrent Opioid Issues

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ReportsCurrent CPI Referrals

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ReportsClosed Issues

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Response FormRequirements

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• Part D sponsors must provide a response on the status of their reviews and assessments of all beneficiaries identified on the OMS Reports.

• Completed Response Forms are due within 30 days of the Report Date.– Upload one Response Form for all open tickets for a

Contract or multiple Response Forms for subsets of tickets for a Contract.

• Also use the Response Form to update responses for open tickets. – The most recent response received for a given ticket

number and issue at the close of the submission period will be analyzed.

Response FormRequirements (continued)

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• Response Forms must be uploaded via the secure Upload Files feature of the Patient Safety Analysis Website in order to be considered for review. Forms will not be accepted via any other means.

• Response Forms submitted after the submission deadline for a ticket will not be reviewed.

Response FormExample

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Response FormResponse Codes

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Code Response Known Exception

BDC No further review planned: Beneficiary is deceased. Yes.

BIINo further review planned: Beneficiary is

incarcerated/institutionalized.

BDSNo further review planned: Beneficiary dis-enrolled

from contract.

BXDNo further review planned: Beneficiary has exempt

diagnosis.

Yes, for measure of same

drug class.

BSCNo further review planned: Beneficiary did not meet

the sponsor's internal criteria.

INC Review in progress.

PS1 POS edit determined necessary: No drugs in the

class allowed.

Yes, for measure of same

drug class and contract ID.

PS2 POS edit determined necessary: One or more drugs

in the class allowed.

Yes, for measure of same

drug class and contract ID.

BORPOS edit not determined necessary: Beneficiary’s

overutilization resolved.

DMNPOS edit not determined necessary: Drug(s) and

dose(s) are deemed medically necessary.

Yes, for measure of same

drug class and contract ID.

Future Development

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• Collect POS edit information from sponsors, including notification, implementation and discontinuation dates, which is partially provided to CMS by email to the Part D Policy mailbox (PartDPolicy@cms.hhs.gov).

• Collect information from sponsors on beneficiaries they identified with potential APAP or opioid overutilization issues that are not included in the OMS reports.

Additional Information

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• Additional information will be available on the Patient Safety Analysis Website under Help Documents, including the OMS User Guide and National Drug Code (NDC) medication lists used to identify the opioid and APAP overutilization issues.

• If you need help accessing the Overutilization Monitoring Package or have questions about its content, contact the Acumen, LLC help desk:

Email: PatientSafety@AcumenLLC.com Phone: (650) 558-8006

• For questions related to the Overutilization Monitoring System, send an email with “OMS” in the subject line to PartDPolicy@cms.hhs.gov.

• For questions related to CMS overutilization management policy, send an email with “Overutilization Policy” in the subject line to PartDPolicy@cms.hhs.gov.

Questions?

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