Improving Drug Utilization Review
Controls in Part D
Brian Martin, Pharm.D.
Deputy Director,
Division of Formulary and Benefit Operations
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Improving Drug Utilization Review Controls in Part D
• Part D sponsors are, and have been, responsible for
establishing reasonable and appropriate drug utilization
management programs that assist in preventing
overutilization of prescribed medications
• 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, and to reduce fraud,
waste and abuse in the Part D program
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2013 Requirements (Call Letter)
• Level One: Improved Use of Concurrent Claim Edits (Safety
Controls at POS)
• Level Two: Improved Use of Formulary Utilization
Management Designs (QLs at POS)
• Level Three: Improved Retrospective DUR Programming
and Case Management
• Data Sharing Between Sponsors
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Level One: Improved Use of Concurrent Claim Edits (Safety Controls
at POS)
• As long as they are consistent with FDA labeling, the safety
edits at this level can be implemented without submission to
or approval by CMS
• Applies to all drugs (including the six protected classes and
controlled substances)
• Edits include: early refill edits, therapeutic duplication edits
and dose limitations at or above the maximum dose
• Level One controls should be applied to all medications
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Level Two: Improved Use of Formulary Utilization Management Designs
(QLs at POS)
• QLs/At or Above FDA Maximum Dose (No HPMS Submission)
• Part D sponsors are permitted to apply QLs at or above the FDA maximum
approved dosing to covered Part D drugs, including drugs within a protected
class, in order to promote safe use (by not allowing dosages beyond
maximum dose or unsafe dosages) and to decrease fraud, waste and abuse
• QLs/No FDA Maximum Dose (HPMS Submission)
• Part D sponsors may also apply QLs to drugs, as appropriate, for which
there is no clearly defined maximum dose in the approved labeling, such as
most opioid analgesics, to ensure safety, promote cost-effectiveness through
dose optimization, and to decrease fraud, waste and abuse
• QLs/Below FDA Maximum Dose (HPMS Submission)
• Part D sponsors may submit QLs, as appropriate, below the FDA maximum
approved dosing to promote cost-effectiveness through dose optimization,
and to decrease fraud, waste and abuse, if the approved maximum dose is
accessible on the plan formulary
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Level Two Cont’d.
• HPMS Formulary Submission Requirements:
• QLs for drugs that have no FDA-labeled maximum dose
• QLs for drugs below the FDA-labeled maximum dose
• Dose-optimization edits
• QLs/edits that prevent the dispensing of drugs above the
FDA-labeled maximum dose are not required to be
submitted on the HPMS formulary
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Level Three: Improved Retrospective DUR Programming and Case
Management
• For 2013, Level Three controls apply to opioids
• Sponsors should have DUR programming (that is,
retrospective report-generation criteria) that identifies
patterns which suggest that the identified patients may be at
risk of overutilization, so that these cases may be further
analyzed clinically for possible overutilization
• Part D sponsors should create and monitor Part D utilization
reports to identify patterns of apparent duplicative drug use
over sustained periods of time and/or across multiple drug
products
• We expect sponsors to implement programs in a manner
that eliminates the need to review borderline cases
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Level Three Cont’d.
• When warranted by review of the retrospective DUR
programmed reports and the beneficiaries’ medication
histories, clinical staff should communicate with prescribers
and beneficiaries to ascertain medical necessity
• This clinician-to-clinician communication should include
information about the existence of multiple prescribers and
the beneficiary’s total opioid utilization, as well as elicit any
complicating factors
• Results of case management may confirm that the current
level of opioids is medically necessary, or in some cases,
that a lower level or no opioids, are warranted
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Level Three Cont’d.
• To the extent that a Part D sponsor has identified a bona
fide safety concern, the sponsor may move forward with an
overutilization protocol; provided, the sponsor has made
reasonable efforts to contact the prescriber and beneficiary
• If medical necessity cannot be established, sponsors may
implement beneficiary-level edits at POS at all network
pharmacies that will result in the rejection of claims, or
rejection of quantities in excess of plan established limits for
the beneficiary
• While the end result of a case management approach may
be that prescriptions from certain prescribers who do not
communicate with the sponsor may be denied, this is not
the same thing as the sponsor restricting (or “locking-in”) the
beneficiary to certain providers in advance
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Data Sharing Between Sponsors
• HIPAA permits such data sharing between sponsors
• Sponsors can share the record and actions generated by
overutilization review, e.g., the record from the retrospective
DUR review/case management, as well as beneficiaryspecific POS edits, with the successor sponsor
• CMS will develop a process for sponsors to share data
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Reporting Suspected Fraudulent Activity
• Sponsors are reminded that if a sponsor believes a
beneficiary, prescriber, and/or pharmacy is involved in
fraudulent activity, they should make referrals to the
appropriate agencies in accordance with the policy set forth
in Chapter 9 of the Medicare Prescription Drug Benefit
Manual
• The MEDIC may be reached at the following number 1-8777SAFERX (1-877-772-3379)
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CMS Overutilization Analysis
• Conducted an analysis of methods utilized by a sample of
Part D sponsors to detect and manage overutilization of
opioid analgesics
• Identified 20 high-utilizing outlier beneficiaries of opioids per
plan based on:
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Total claims
Total days supply
Average daily dose
Number of prescribers
Number of pharmacies
• Cancer patients were excluded based on specific RxHCC
categories
• Requested responses from each plan about their utilization
management process for each of the outlier beneficiaries
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CMS Overutilization Analysis
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•
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Did you previously identify this beneficiary as having a potential pain medication
overutilization problem?
Had you reviewed this beneficiary’s pain prescription records prior to receiving
this inquiry from CMS?
Based on your review (now or previously) of the claims information:
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Do you have concurrent drug utilization review edits (e.g. maximum dose, early
refill, therapeutic duplication) in place to control overutilization of the identified
drugs?
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Did you find at least one medically acceptable indication for the beneficiary’s high
utilization of pain medication(s)?
What was the diagnosis (ICD-9 or condition)?
If an acceptable diagnosis was not identified, what was the justification for the high
utilization of pain medication(s)?
Was a concurrent drug utilization review edit to control overutilization of pain
medications exceeded for any of the beneficiary’s pain medications?
Did you contact anyone or utilize any type of intervention in relation to this
beneficiary’s utilization of pain medications?
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CMS Overutilization Analysis
• 24% of beneficiaries were not previously identified by the
sponsor as potentially over utilizing opioid analgesics
• Of the beneficiaries identified, 45% would not have
experienced a POS edit as a result of their utilization
• A medically accepted indication for the identified utilization
of the opioid analgesic was not identified for 34% of
beneficiaries
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Case Studies from Overutilization
Analysis
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Case 1. Medications.
• Oxycodone/APAP 10/325 mg #180 per 30 days filled once
monthly
• Hydrocodone/APAP 10/325 mg #360 per 30 days filled once
monthly
• Hydrocodone/APAP 7.5/750 mg #60 per 10 days filled once
monthly
• Several chronic meds filled regularly
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Case 1. Prescribers.
• Oxycodone/APAP 10/325 mg – Routinely prescribed by
psychiatrist who also prescribes beneficiary’s chronic mental
health drugs
• Hydrocodone/APAP 10/325 mg – Routinely prescribed by
same psychiatrist
• Hydrocodone/APAP 7.5/750 mg – Routinely prescribed by
internist who prescribes beneficiary’s chronic meds
• Occasional prescriptions for opioid analgesics from other
providers
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Case 1. Pharmacies and Fill Dates.
• Oxycodone/APAP 10/325 mg – Only fills this drug at
independent pharmacy A
• Hydrocodone/APAP 10/325 mg – Fills on the same day as
Oxy/APAP each month, along with chronic meds, at
independent pharmacy B
• Hydrocodone/APAP 7.5/750 mg – Fills between chain A and
chain B, along with rare fills for chronic meds
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Case 1. Discussion
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Case 2. Medications.
• Multiple fills for various strengths of Oxycodone/APAP,
Hydrocodone/APAP, Codeine/APAP
• October 2010:
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Codeine/APAP 60/300 mg #100 per 8 days
Oxycodone 10/325 mg #180 per 30 days
Hydrocodone/APAP 7.5/750 mg #100 per 20 days
Hydrocodone/APAP 10/650 mg #120 per 20 days
Hydrocodone/APAP 5/500 mg # 60 per 30 days
Hydrocodone/APAP 10/500 mg #120 per 30 days
Codeine/APAP 30/300 mg #100 per 8 days
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Case 2. Prescribers.
• A surgeon prescribed:
• Codeine/APAP 300/60 mg #100 per 8 days
• Hydrocodone/APAP 7.5/750 mg #100 per 20 days
• Codeine/APAP 300/30 mg #100 per 8 days
• Remainder prescribed by three different internists and an
ER physician
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Case 2. Pharmacies.
• The following were filled at the same chain pharmacy:
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•
•
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Codeine/APAP 300/60 mg #100 per 8 days
Oxycodone 10/325 mg #180 per 30 days
Hydrocodone/APAP 7.5/750 mg #100 per 20 days
Codeine/APAP 300/30 mg #100 per 8 days
• The following were each filled at different chain pharmacies:
• Hydrocodone/APAP 10/650 mg #120 per 20 days
• Hydrocodone/APAP 5/500 mg # 60 per 30 days
• Hydrocodone/APAP 10/500 mg #120 per 30 days
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Case 2. Discussion
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Next Steps for CMS
• Collect implementation comments:
• Submit comments to PartDformularies@cms.hhs.gov by April
30, 2012
• “Improving DUR Controls” in subject line
• Continue to monitor outlier sponsors:
• Excessive acetaminophen doses;
• Continued, high utilization of opioid analgesics
• Develop model notices for prescribers and beneficiaries
• Initiate educational campaigns for prescribers, pharmacies,
and beneficiaries with respect to overutilization control
efforts
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CMS Oversight
• Oversight of Level Three Controls
• CMS will be reviewing case files for any complaints relating
to the implementation of controls:
• Evidence of overly restrictive controls
• Outreach methods and attempts
• Provider communication
• Analyses to look behind Part D sponsors to ensure effective
identification of potential overutilizers
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Summary
• Part D sponsors should optimize their use of Level One and
Level Two drug utilization review controls
• The implementation of beneficiary-level edits at POS, when
warranted, is not the same as pharmacy/prescriber lock-in
as it currently exists outside of Part D
• Part D sponsors are responsible for identifying beneficiaries
for Level Three controls, but CMS will monitor the
effectiveness of sponsors’ efforts
• Improving drug utilization review controls is not a substitute
for referrals to MEDIC, local law enforcement, etc
• CMS will provide additional guidance, model documents,
and educational materials
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