1. Medicare Part D Overutilization
Monitoring System
Kimberly M. Treier
PharmD candidate 2016
February 10, 2016
2. Overview
Background
CY 2013 Final Call Letter
Overutilization Monitoring System
CY 2015 Final Call Letter
Key Changes in CY 2016
CY 2016 Final Call Letter
Importance
Sponsor Resources
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3. Background
September 2011 Government Accountability Office report
identified substantial medication overutilization by Part D
beneficiaries:
Multiple prescribers
Opioids most often overprescribed
Need for more effective DUR efforts
3
4. CY 2013 Call Letter
“CMS has determined that sponsors need to employ more
effective concurrent and retrospective drug utilization review
(DUR) programs to address overutilization of medications in order
to protect beneficiaries, to comply with drug utilization
management (DUM) requirements at 42 CFR §423.153 et seq.
and to reduce fraud, waste and abuse in the Part D program.”
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5. Importance
Vary dangerous opioid epidemic
OMS is a way CMS and Part D sponsors can reduce adverse
consequences
Take action against fraud, waste and abuse AND preventable
deaths
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6. CY 2013 Call Letter
Guidance for more effective drug utilization monitoring:
Point-of-sale (POS) interventions
E.g. safety edits and quantity limits
Retrospective drug utilization review (DUR)
Specific instances of egregious overutilization
Case management
Prescriber and beneficiary involvement
Translation of necessary information between Part D plans
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7. CY 2013 Call Letter
“[CMS] would consider implementation of these levels by a
sponsor to be a minimum standard for compliance with 42 CFR
§423.153 with respect to overutilization of opioids beginning CY
2013.”
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8. Overutilization Monitoring System
“OMS”
Developed by CMS
Monitor effectiveness of Part D sponsors’ opioid and
acetaminophen overutilization interventions
Review potential overutilization issues identified by sponsors
and CMS
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9. Overutilization Monitoring System
Outliers identified based on Prescription Drug Event (PDE)
data
Date of service within previous 12 months
Reports released quarterly to plans for review
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10. Overutilization Monitoring System
Overutilization Issue Types
1. Opioid outliers: Daily morphine equivalent dose (MED) >
120 mg for ≥ 90 consecutive days, used > 3 prescribers and
> 3 pharmacies
2. Acetaminophen outliers: Taking > 4 grams per day for ≥ 30
days within any 6 month period during measurement cycle, and
≥ 1 day of overutilization occurs in the most recent calendar
quarter
3. CPI referral outliers: Referred by the Medicare Center for
Program Integrity (CPI) for review of possible utilization issues
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11. Overutilization Monitoring System
Ticket number generated for each beneficiary
Upon receipt of quarterly report:
Download Overutilization Issue Response Form (pre-populated
by CMS) and compare data with Part D plan records
Reviews issues and document on each form
Securely upload completed file to Patient Safety Analysis
Website within 30 days
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12. Overutilization Monitoring System
Sponsor-Identified Potential Overutilization Issues (SPIs)
January 2014 – sponsors to develop own criteria to identify
potential opioid overutilization issues not identified by CPI
Sponsor-Identified Potential Overutilization Issue Reporting
Form
Submit 30 days after release of Overutilization Monitoring
Packages
Sponsors alerted with PDE data from a new beneficiary’s prior
contracts of enrollment if contributory to current overutilization
issue
Implemented January 2014
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13. CY 2015 Call Letter
Modest reduction in APAP overutilization
January – December 2013: 54,569 unique beneficiaries possibly
receiving > 4 grams APAP per day for ≥ 30 days within a six-month
period
CMS encourages sponsors to implement soft edits at a minimum
and consider hard edits to further reduce APAP overutilization
Reminder: may implement safety edits based on FDA dosage
limits without advanced notice to the beneficiary or submission to
CMS
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14. CY 2015 Call Letter
Slight reduction in opioid overutilization
January – December 2013: 27,275 potential opioid overutilization
tickets
67% of reported issues did not meet sponsor’s internal criteria -
possible insufficiencies
Sponsors to lower internal opioid criteria to no less
restrictive than 120 mg MED daily dose over ≥ 90 consecutive
days as used by CMS
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16. CY 2016 Call Letter
APAP
Significant reduction in overutilization = sponsors not expected to
implement hard APAP formulary edits in CY 2016
CMS encourages hard edits with egregious use
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18. CY 2016 Call Letter
Opioids
CMS recommends soft formulary-level edits at POS
CMS to delay parameter specifications of POS edits until further
testing
Sponsors encouraged to develop more sophisticated POS edits in
preparation for CY 2017
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19. CY 2016 Call Letter
CMS adding new opioid and APAP daily rates to OMS for CY
2016 as information only:
Opioid Daily Dose rate:
# opioid days > 120 mg MED/1000 opioid utilization days
APAP Daily Dose Rate:
# APAP days > 4 g/1000 APAP utilization days
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20. CY 2016 Call Letter
CMS added 4 new measures:
High-dose opioids in opioid naïve patients
> 90 mg cumulative MED daily of short-acting opioids for > 90
consecutive days
Concurrent buprenorphine and opioid use for > 90
consecutive days
Concurrent opioid and other CNS depressant use from
multiple prescribers
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21. CY 2016 Call Letter
CMS may adopt 3 opioid overutilization measures currently under
development by Pharmacy Quality Alliance (PQA):
Measure 1 (Opioid High Dosage): The proportion of individuals*
receiving a daily dosage of opioids > 120 mg morphine
equivalent dose (MED) for ≥ 90 consecutive days
Measure 2 (Multiple Prescribers and Multiple Pharmacies): The
proportion of individuals* receiving prescriptions for opioids from ≥
4 prescriber AND ≥ 4 pharmacies
Measure 3 (Multi-Provider, High Dose): The proportion of
individuals* meeting Measures 1 & 2
*Age ≥ 18 years without cancer or enrolled in hospice
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22. CY 2016 Call Letter
CMS may utilize these measures if endorsed by PQA prior to
the 2017 bid deadline in June 2016
If adopted, CMS will not use these measures for Star Ratings
“Due to concerns about the lack of consensus clinical guidelines for
the use of opioids to treat chronic, non-cancer pain and potential
exceptions due to medical necessity”
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23. CY 2016 Call Letter
Utilization monitoring for other drugs
CMS currently not expanding the OMS beyond opioids
CMS to test monitoring concurrent use of opioids, benzodiazepines
and muscle relaxants (PQA “Triple Threat” measure under
development)
Sponsors encouraged to use same diligence and documentation
when monitoring overutilization of other drugs
Written notice to beneficiary if implementing POS edits
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24. Importance
Sponsors have an influential role in modern health care
Unique position to monitor an individual’s comprehensive
medication therapy
Opportunity (and ability) to identify and intervene in unsafe
medication practices
Current data validates effectiveness
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25. Sponsor Resources - Clinical
Common Elements in Guidelines for Prescribing Opioids for Chronic Pain,
published by the Centers for Disease Control and Prevention (CDC) at CDC.gov
(http://www.cdc.gov/HomeandRecreationalSafety/overdose/guidelines.html)
The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain,
Publication No. 14-E005-EF, September 2014, published by the Agency for Healthcare
Research and Quality (AHRQ) at AHRQ.gov
(http://www.ahrq.gov/research/findings/evidence-based-reports/opoidstp.html)
Opioids for chronic noncancer pain, A position paper of the American Academy of
Neurology, published in the September 30, 2014 issue of the journal Neurology, and
available at AAN.com (https://www.aan.com/uploadedFiles/Website_Library_Assets/
Documents/6.Public_Policy/1.Stay_Informed/2.Position_Statements/3.PDFs_of_all_
Position_Statements/Position%20and%20Policy%20Documents.pdf)
NIDAMED: Medical & Health Professionals provides tools, resources, continuing
education and training for medical and health professions through the website of the
National Institute on Drug Abuse (http://www.drugabuse.gov/nidamed-medical-
health-professionals)
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26. Sponsor Resources - Operational
OMS, POS edit information submission or overutilization management in
Part D questions:
PartD_OM@cms.hhs.gov
(Include “OMS” as subject line if related to OMS)
Technical questions:
PatientSafety@AcumenLLC.com or (650) 558-8006
Accessing OMS:
https://www.cms.gov/Medicare/Prescription-Drug-
coverage/PrescriptionDrugCovContra/RxUtilization.html
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27. References
Centers for Medicare and Medicaid Services. (2012). Announcement of Calendar Year (CY) 2013 Medicare Advantage
Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. Baltimore, MD.
Centers for Medicare and Medicaid Services. (2014). Announcement of Calendar Year (CY) 2015 Medicare Advantage
Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. Baltimore, MD.
Centers for Medicare and Medicaid Services. (2015). Announcement of Calendar Year (CY) 2016 Medicare Advantage
Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. Baltimore, MD.
Centers for Medicare and Medicaid Services. (25 Oct 2013). Medicare Part D Overutilization Monitoring System –
Updates. Baltimore, MD.
Centers for Medicare and Medicaid Services. (17 Jan 2014). Medicare Part D Overutilization Monitoring System.
Baltimore, MD.
Centers for Medicare and Medicaid Services. (25 Aug 2014). Beneficiary-Level Point-of-Sale Claim Edits and Other
Overutilization Issues. Baltimore, MD.
Centers for Medicare and Medicaid Services. (8 Apr 2014). UPDATES – 2015 Medicare Part D Patient Safety,
Overutilization Monitoring System Reports and MARx POS Edit User Interface. Baltimore, MD.
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Final CY 2013 Call Letter, section “Improving Drug Utilization Review Controls in Part D” (published April 2, 2012)
Final CY 2013 Call Letter, section “Improving Drug Utilization Review Controls in Part D” (published April 2, 2012)
July 5, 2013 memo “Medicare Part D Overutilization Monitoring System”
July 5, 2013 memo “Medicare Part D Overutilization Monitoring System”
July 5, 2013 memo “Medicare Part D Overutilization Monitoring System”
“Excluding patients with cancer or receiving hospice care…” updated in October 25, 2013 memo
3. “…These referrals involve potential fraud or abuse of prescriptions in the Part D program and may include non-opioid cases”
July 5, 2013 memo “Medicare Part D Overutilization Monitoring System”
Sponsors notified via email when report is ready
January 17, 2014 memo
*2011 PDE TAP Data (PDEs processed through 7JAN2012). For this comparison, CMS applied the revised 2013 opioid methodology, including the expanded drug list from CDC, and comparable PDE cut-off dates to 2011 data.
†2013 PDE TAP Data (PDEs processed through 4JAN2014) ‡2014 PDE TAP Data (PDEs processed through 3JAN2015)
*2011 PDE TAP Data (PDEs processed through 13AUG2012). For this comparison, CMS applied the 2014 OMS APAP methodology, including the 6-month measurement period, which reduced the potential APAP overutilization counts as compared to the prior 2011 analysis
†2013 PDE TAP Data (PDEs processed through 04JAN2014) ‡2014 PDE TAP Data (PDEs processed through 03JAN2015)
“A few commenters offered suggestions regarding other drugs and classes, such as the concomitant use of opioids, benzodiazepines, and muscle relaxants, which we will investigate or pilot test for future expansion of the policy. For CY 2016, we will not expand our overutilization policy beyond the opioid class.” CY 2016 Call Letter
“A few commenters offered suggestions regarding other drugs and classes, such as the concomitant use of opioids, benzodiazepines, and muscle relaxants, which we will investigate or pilot test for future expansion of the policy. For CY 2016, we will not expand our overutilization policy beyond the opioid class.” CY 2016 Call Letter
Proportion defined as (XX out of 1,000)
PQA = measurement development entity CMS collaborates with for Star Ratings criteria
SLIGHTLY DIFFERENT THAN CURRENT OPIOID MEASURE – THESE ARE SPLIT INTO 3 SEPARATE MEASURES
“If these measures are endorsed by the PQA prior to the 2017 bid deadline in June 2016, CMS may adopt them as future display measures or alternatively use in the Overutilization Monitoring System (OMS).”
“Due to concerns about the lack of consensus clinical guidelines for the use of opioids to teat chronic, non-cancer pain and potential exceptions due to medical necessity, CMS is not considering these measures for Star Ratings at this time.” CY 2016 Final Call Letter
“A few commenters offered suggestions regarding other drugs and classes, such as the concomitant use of opioids, benzodiazepines, and muscle relaxants, which we will investigate or pilot test for future expansion of the policy. For CY 2016, we will not expand our overutilization policy beyond the opioid class.” CY 2016 Call Letter
