Form CMS-R-153, CMS-R-1 CMS-R-153, CMS-R-1 Medicaid Drug Utilization Review Annual Report

OMB approved #: 0938-0659

MEDICAID DRUG UTILIZATION REVIEW
ANNUAL REPORT
FEDERAL FISCAL YEAR ________
Section 1927 (g) (3) (D) of the Social Security Act requires each State to submit an annual report on
the operation of its Medicaid Drug Utilization Review (DUR) program. Such reports are to include:
descriptions of the nature and scope of the prospective and retrospective DUR programs; a summary
of the interventions used in retrospective DUR and an assessment of the education program; a
description of DUR Board activities; and an assessment of the DUR program’s impact on quality of
care as well as any cost savings generated by the program.
This report covers the period October 1, _____to September 30, _____and is due for submission to
your CMS Regional Office by no later than June 30, _____. Answering the attached questions
and returning the requested materials as attachments to the report will constitute compliance
with the above-mentioned statutory requirement.
To locate your Regional Office, go to the
Centers for Medicare and Medicaid Services (CMS) website at
http://www.cms.hhs.gov/RegionalOffices/
If you have any questions regarding this survey instrument or the DUR Annual Report please contact
CMS: DURPolicy@cms.hhs.gov.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information
unless it displays a valid O.M.B. control number. The valid O.M.B. control number for this information collection is
0938-0659. The time required to complete this information collection is estimated to average 30 hours per response,
including the time to review instructions, search existing data resources, gather the data needed, and complete and review
the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for
improving this form, please write to: CMS, 7500 Security Boulevard, Attn: Paperwork Reduction Act Reports Clearance
Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

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MEDICAID DRUG UTILIZATION REVIEW
ANNUAL REPORT
FEDERAL FISCAL YEAR ________

I.

STATE NAME ABBREVIATION
______________________________

II.

MEDICAID AGENCY INFORMATION
1. Identify State person responsible for DUR Annual Report Preparation.
Name:

_________________________________

Street Address:

_________________________________

City/State/Zip Code:

_________________________________

Area Code/Phone Number: _________________________________
2. Identify pharmacy POS vendor - (contractor, state-operated, other).
____________________________________________________
3. If not state-operated, is the POS vendor also the MMIS fiscal agent?
____ Yes

III.

____ No

PROSPECTIVE DUR
1. Identify prospective DUR criteria source.
____ First Data Bank ____ Other (specify): __________________________
2. Are new prospective DUR criteria approved by the DUR Board?
____ Yes

____ No

If answer above is “No,” please explain:

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3. When the pharmacist receives prospective DUR messages that deny the claim, does your
system:
a) ____ Require preauthorization
b) ____ Allow the pharmacist to override with the correct “conflict,” “intervention,”
and “outcome” codes?
c) ____ a) and/or b) above - depending on the situation. Please explain:

4. Early Refill:
a) At what percent threshold do you set your system to edit?
i) Non-controlled drugs:

_____%

ii) Controlled drugs:

_____%

b) When an early refill message occurs, does the state require prior authorization?
i) Non-controlled drugs:

____ Yes

____ No

ii) Controlled drugs:

____ Yes

____ No

c) For non-controlled drugs, if the answer to 4 (b) above is “Yes,” who obtains
authorization?
____ Pharmacist

____ Prescriber

____ Either

d) For controlled drugs, if the answer to 4 (b) above is “Yes,” who obtains
authorization?
____ Pharmacist

____ Prescriber

____ Either

e) For non-controlled drugs, if the answer to 4 (b) above is “No,” can the pharmacist
override at the point of service?
____ Yes

____ No

f) For controlled drugs, if the answer to 4 (b) above is “No,” can the pharmacist
override at the point of service?
____ Yes

____ No

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5. Therapeutic Duplication:
a) When there is therapeutic duplication, does the State require prior authorization
for:
i) Non-controlled drugs:

____ Yes

____ No

____ Sometimes

If answer above is “Sometimes,” please explain:

ii) Controlled drugs:

____ Yes

____ No

____ Sometimes

If answer above is “Sometimes,” please explain:
b) If the answer to 5 (a) above is “Yes,” who obtains authorization?
i) Non-controlled drugs:
____ Pharmacist

____ Prescriber

____ Either

____ Prescriber

____ Either

ii) Controlled drugs:
____ Pharmacist

c) If the answer to 5 (a) above is “No,” can the pharmacist override at the point of
service?
i) Non-controlled drugs:

____ Yes

____ No

ii) Controlled drugs:

____ Yes

____ No

Additional Comment:

6. State has provided DUR criteria data requested on Table 1 - Pro DUR Criteria Reviewed
by DUR Board 1, indicating by problem type those criteria with the most significant
severity level reviewed in-depth by the DUR Board in this reporting period.
____ Yes

____ No

7. State has included Attachment 1 – Prospective DUR Review Summary 2.
____ Yes

1
2

____ No

Please see Instruction for Table 1 on page 13
Please see Explanation for Attachment 1 on page 10

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8. State has included Attachment 2 – Prospective DUR Pharmacy Compliance Report 3, a
report on State efforts to monitor pharmacy compliance with the oral counseling
requirement.
____ Yes

IV.

____ No

RETROSPECTIVE DUR
1. Identify the vendor that performed your retrospective DUR activities during the time
period covered by this report (company, academic institution, or other organization).
___________________________________________________________________
a) Is the retrospective DUR vendor also the Medicaid fiscal agent?
____ Yes

____ No

b) Is the retrospective DUR vendor also the developer/supplier of your retrospective
DUR criteria?
____ Yes

____ No

If “No,” please explain:

2. Does the DUR Board approve the retrospective DUR criteria supplied by the criteria
source?
____ Yes

____ No

3. State has provided the DUR Board approved criteria requested on Table 2 - Retrospective
DUR Approved Criteria 4 .
____ Yes

____ No

4. State has included Attachment 3 - Retrospective DUR Screening and Intervention
Summary Report 5.
____ Yes

____ No

3

Please see Explanation for Attachment 2 on page 10
Please see Instruction for Table 2 on page 13
5
Please see Explanation for Attachment 3 on page 11
4

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V.

PHYSICIAN ADMINISTERED DRUGS
The Deficit Reduction Act required collection of NDC numbers for covered outpatient
physician administered drugs. These drugs are paid through the physician and hospital
programs. Has your MMIS been designed to incorporate this data into your DUR criteria for
both prospective DUR and retrospective DUR?
____ Yes

____ No

If “No,” when do you plan to include this information in your DUR criteria? mm/dd/yyyy

VI.

DUR BOARD ACTIVITY
1. State has included a summary report of DUR Board activities and meeting minutes
during the time period covered by this report as Attachment 4 - Summary of DUR Board
Activities 6.
____ Yes

____ No

2. Does your state have a Disease Management Program?
____ Yes

____ No

If “Yes,” is your DUR Board involved with this program?
____ Yes

____ No

3. Does your state have a Medication Therapy Management Program?
____ Yes

____ No

If “Yes,” is your DUR Board involved with this program?
____ Yes

VII.

____ No

GENERIC POLICY AND UTILIZATION DATA
1. State has included a description of new policies used to encourage the use of
therapeutically equivalent generic drugs as Attachment 5 - Generic Drug Substitution
Policies 7.
____ Yes

6
7

____ No

Please see Explanation for Attachment 4 on page 11
Please see Explanation for Attachment 5 on page 12

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2. Indicate the generic utilization percentage for all covered outpatient drugs paid during
this reporting period, using the computation instructions in Table 3 - Generic Utilization
Data 8.
Number of Generic Claims:

_______________

Total Number of Claims:

_______________

Generic Utilization Percentage: _______________
3. Indicate the percentage dollars paid for generic covered outpatient drugs in relation to all
covered outpatient drug claims paid during this reporting period using the computation
instructions in Table 3 - Generic Utilization Data 9.
Generic Dollars:

_______________

Total Dollars:

_______________

Generic Expenditure Percentage: _______________

VIII. PROGRAM EVALUATION / COST SAVINGS
1. Did your state conduct a DUR program evaluation/cost savings estimate?
____ Yes

____ No

2. Who conducted your program evaluation/cost savings estimate (company, academic
institution, other institution)?
____________________________________________________________________
3. State has provided the Medicaid program evaluation/cost savings estimate as Attachment
6 - Cost Savings Estimate 10.
____ Yes

____ No

4. Please provide the total net cost savings estimate.

$______________

5. Please provide the estimated percent impact of your state’s cost savings program
compared to total drug expenditures for covered outpatient drugs. Divide the estimated
net savings amount provided in Section VIII, Question 4 above by the total dollar amount
provided in Section VII, Question 3. Then multiply this number by 100.
Estimated Net Savings Amount ÷ Total Dollar Amount × 100 =

__________%

8

Please see Instruction for Table 3 on page 13
Please see Instruction for Table 3 on page 13
10
Please see Explanation for Attachment 6 on page 12
9

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IX.

FRAUD, WASTE, AND ABUSE DETECTION
1. Do you have a process in place that identifies potential fraud or abuse of controlled drugs
by recipients?
____ Yes

____ No

If “Yes,” what action(s) does this process initiate? Check all that apply.
a. ____ Deny claim and require pre-authorization
b. ____ Refer recipient to lock-in program
c. ____ Refer to Medicaid Fraud Control Unit (MFCU) or Program Integrity
d. ____ Other - please explain:
2. Do you have a process in place that identifies possible fraud or abuse of controlled drugs
by prescribers?
____ Yes

____ No

If “Yes,” what actions does this process initiate? Check all that apply.
a. ____ Deny claims written by this prescriber
b. ____ Refer to MFCU or Program Integrity
c. ____ Refer to the appropriate Medical Board
d. ____ Other - please explain
3. Do you have a process in place that identifies potential fraud or abuse of controlled drugs
by pharmacy providers?
____ Yes

____ No

If “Yes,” what actions does this process initiate? Check all that apply.
a. ____ Deny claim
b. ____ Refer to MFCU or Program Integrity
c. ____ Refer to Board of Pharmacy
d. ____ Other - please explain:

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4. Does your state have a Prescription Drug Monitoring Program (PDMP)? See Attachment
7 - Prescription Drug Monitoring Program 11 for a description of this program.
____ Yes

____ No

If “Yes,” please explain how the State applies this information to control fraud and abuse.

If “No,” does your State plan to establish a PDMP?
____ Yes

X.

____ No

INNOVATIVE PRACTICES
Have you developed any innovative practices during the past year which you have included
in Attachment 8 - Innovative Practices 12?
____ Yes

XI.

____ No

E-PRESCRIBING
1. Has your state implemented e-prescribing?
____ Yes

____ No

If “Yes,” please respond to Questions 2 and 3 below. If “No,” are you planning to
develop this capability?
____ Yes

____ No

2. Does your system use the NCPDP Origin Code that indicates the prescription source?
____ Yes

____ No

3. Does your program system (MMIS or pharmacy vendor) have the capability to
electronically provide a prescriber, upon inquiry, patient drug history data and pharmacy
coverage limitations prior to prescribing?
____ Yes

____ No

a) If “Yes,” do you have a methodology to evaluate the effectiveness of providing
drug information and medication history prior to prescribing?
____ Yes
11
12

____ No

Please see Explanation for Attachment 7 on page 12
Please see Explanation for Attachment 8 on page 12

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b) If “Yes,” please explain the evaluation methodology in Attachment 9 - EPrescribing Activity Summary 13.
c) If “No,” are you planning to develop this capability?
____ Yes

13

____ No

Please see Explanation for Attachment 9 on page 12

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MEDICAID DRUG UTILIZATION REVIEW
ANNUAL REPORT
ATTACHMENT AND TABLE SUPPLEMENT
I.

EXPLANATION FOR ATTACHMENTS
ATTACHMENT 1 – PRODUR REVIEW SUMMARY
This attachment is a year-end summary report on prospective DUR screenings. It should be
limited to the Top 20 type/drug combinations which generate the largest number of
messages. For each problem type/drug combination included, a denominator must be
reported. The denominator is the total number of prescription claims adjudicated (during a
given time period) for the drug compared to the number of messages generated for the
problem type/drug (incorrect dosage/drug) during the same time period. Denominators
permit comparison in percentage terms of the relative frequency of different problem
type/drug combinations. For problem type/drug combinations involving more than one drug
(e.g., drug/drug interactions), the denominator is the number of prescription claims for the
drug submitted for adjudication.
Include for the Top 20 problem type/drug alerts with a severity of Level I:
•

The number of messages generated by the system and a denominator. The number of
messages must relate to problem type/drug combinations (incorrect dosage/drug).
Report levels of messages by problem type only, incorrect dosage or drug only are
not acceptable.

•

The number of messages overridden (i.e., adjudication process carried through to
completion even though a message was generated).

•

The number of reversals/cancellations/denials (i.e., adjudication not carried through
to completion) and data on types of interventions by pharmacists and the outcomes of
such interventions using applicable NCPDP standards (e.g., Standard Format Version
5.1)

•

The number of refill too soon messages, duplicate prescription messages transmitted,
and, where applicable, claims denials.

ATTACHMENT 2 – PROSPECTIVE DUR PHARMACY COMPLIANCE REPORT
This attachment reports the monitoring of pharmacy compliance with all prospective DUR
requirements performed by the State Medicaid Agency, the State Board of Pharmacy, or
other entity responsible for monitoring pharmacy activities. If the State Medicaid Agency
itself monitors compliance with these requirements, it may provide a survey of a random
sample of pharmacies with regard to compliance with the Omnibus Budget Reduction Act
(OBRA) of 1990 prospective DUR requirement. This report details state efforts to monitor
pharmacy compliance with the oral counseling requirement. This attachment should describe
in detail the monitoring efforts that were performed and how effective these efforts were in
the fiscal year reported.
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ATTACHMENT 3 – RETROSPECTIVE DUR SCREENING AND INTERVENTION
SUMMARY REPORT
This is a year-end summary report on retrospective DUR screening and interventions.
Separate reports on the results of retrospective DUR screening and interventions are
acceptable at the option of the State. The report(s) should:
•

Report the level of criteria exceptions by drug class (or drugs within the class) and
problem type. (An exception is an instance where a prescription submitted for
adjudication does not meet the DUR Board-approved criteria for one or more problem
types within a drug class.)
NOTE:

a) Reporting levels of criteria exceptions by only drug class (drug) or
problem type is not acceptable.
b) Year-end summary reports should be limited to the Top 20 problem
types with the largest number of exceptions.

•

Include a denominator for each drug class/problem type for which criteria exceptions
are reported. A denominator is the number of prescription claims adjudicated for a
drug class (or individual drugs in the class) during a given time period compared to
the number of criteria exceptions for the drug class (or individual drugs in the class)
during that time period.

•

Report, for each drug class (or drugs within the class) and problem type included in
this summary report, the number of interventions (letters, face-to-face visits, etc.)
undertaken during the reporting period.

•

For states which engage in physician or pharmacy profile analysis (i.e., review
prescribing or dispensing of multiple prescriptions for multiple patients involving a
particular problem type or diagnosis) or engage in patient profiling, include the
number of each type of profile (physician, pharmacy, patient) reviewed and identify
the subject(s) (diagnosis, problem type, etc.) involved.

ATTACHMENT 4 – SUMMARY OF DUR BOARD ACTIVITIES
This summary should be a brief descriptive report on DUR Board activities during the fiscal
year reported. This summary should:
•

Indicate the number of DUR Board meetings held.

•

List additions/deletions to DUR Board approved criteria.
a) For prospective DUR, list problem type/drug combinations added or deleted.
b) For retrospective DUR, list therapeutic categories added or deleted.

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•

Describe Board policies that establish whether and how results of prospective DUR
screening are used to adjust retrospective DUR screens. Also, describe policies that
establish whether and how results of retrospective DUR screening are used to adjust
prospective DUR screens.

•

Describe DUR Board involvement in the DUR education program (e.g., newsletters,
continuing education, etc.). Also, describe policies adopted to determine mix of
patient or provider specific intervention types (e.g., letters, face-to-face visits,
increased monitoring).

ATTACHMENT 5 – GENERIC DRUG SUBSTITUTION POLICIES
Describe any policies used to encourage the use of generic drugs such as State
maximum/minimum allowable cost (pricing, higher dispensing fee for generic and/or lower
co-pay for generics). Include relevant documentation.
ATTACHMENT 6 – COST SAVINGS ESTIMATES
Include copies of program evaluations/cost savings estimates prepared by state or contractor
noting methodology used.
ATTACHMENT 7 – PRESCRIPTION DRUG MONITORING PROGRAM
In FY 2002, Congress appropriated funding to the U.S. Department of Justice to support
Prescription Drug Monitoring Programs (PDMPs). These programs prevent and detect the
diversion and abuse of pharmaceutical controlled substances, particularly at the retail level
where no other automated information collections system exists. States that have
implemented PDMPs have the capability to collect and analyze data on filled and paid
prescriptions more efficiently than those without such programs, where the collection of
prescription information can require a time-consuming manual review of pharmacy files. If
used properly, PDMPs are an effective way to identify and prevent diversion of the drugs by
health care providers, pharmacies, and patients.
ATTACHMENT 8 – INNOVATIVE PRACTICES
Please describe in detailed narrative form any innovative practices that you believe have
improved the administration of your DUR program, the appropriateness of prescription drug
use and/or have helped to control costs (e.g., disease management, academic detailing,
automated pre-authorizations, continuing education programs).
ATTACHMENT 9 – E-PRESCRIBING ACTIVITY SUMMARY
Please describe all development and implementation plans/accomplishments in the area of eprescribing. Include any evaluation of the effectiveness of this technology (e.g., number of
prescribers e-prescribing, percent e-prescriptions to total prescriptions, relative cost savings).

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II.

INSTRUCTION FOR TABLES
TABLE 1 – PROSPECTIVE DUR CRITERIA REVIEWED BY DUR BOARD
Indicate by problem type those criteria with the most significant severity levels that were
reviewed in-depth by DUR Boards. (COMPLETE ATTACHED TABLE 1)
TABLE 2 – RETROSPECTIVE DUR BOARD APPROVED CRITERIA
On the vertical axis, list the therapeutic categories reviewed by the DUR Board and on the
horizontal axis list the problem types that may be associated with a therapeutic category. If
the retrospective DUR program has approved criteria for drugs in a given therapeutic
category, check boxes for the relevant problem types for which criteria have been
established. You may add additional problem types as appropriate. (COMPLETE
ATTACHED TABLE 2)
TABLE 3 – GENERIC UTILIZATION DATA
Please provide the following utilization data for this DUR reporting period for all covered
outpatient drugs paid. Exclude Third Party Liability. (COMPLETE ATTACHED TABLE 3)
Computation Instructions:
1. Generic Utilization Percentage: To determine the generic utilization percentage of all
covered outpatient drugs paid during this reporting period, use the following formula:
N ÷ (S + N + I) × 100 = Generic Utilization Percentage
2. Generic Expenditures Percentage of Total Drug Expenditures: To determine the generic
expenditure percentage (rounded to the nearest $1000) for all covered outpatient drugs
for this reporting period use the following formula:
$N ÷ ($S + $N + $I) × 100 = Generic Expenditure Percentage

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TABLE 1
PROSPECTIVE DUR CRITERIA
FOR EACH PROBLEM TYPE BELOW
LIST (DRUGS/ DRUG CATEGORY/ DISEASE COMBINATIONS) FOR WHICH DUR BOARD CONDUCTED IN-DEPTH REVIEWS.
PLEASE INDICATE WITH AN ASTERISK (*) THOSE FOR WHICH CRITERIA WERE IMPLEMENTED.

INAPPROPRIATE DOSE

THERAPEUTIC DUPLICATION

DRUG ALLERGY INTERACTION

1.

1.

1.

2.

2.

2.

3.

3.

3.

INAPPROPRIATE DURATION

DRUG/ DRUG INTERACTIONS

DRUG DISEASE CONTRAINDICATION

1.

1.

1.

2.

2.

2.

3.

3.

3.

OTHER (specify)

OTHER (specify)

OTHER (specify)

1.

1.

1.

2.

2.

2.

3.

3.

3.

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TABLE 2
RETROSPECTIVE DUR CRITERIA
(Check All Relevant Boxes)
DRUG PROBLEM TYPE
THERAPEUTIC CATEGORY

PROBLEM TYPE KEY
ID = Insufficient Dose
IDU = Incorrect Duration
OU = Over Utilization
UU = Under Utilization
O1, 2, 3 = Other Problem Type
Specify (1)

ID

IDU

OU

UU

DDI

DDC

TD

AG

O1

O2

O3

DDI = Drug/ Drug Interaction
DDC = Drug/ Disease Contradiction
TD = Therapeutic Duplication
AG = Appropriate Use of Generics
(2)

(3)

______________
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TABLE 3
GENERIC DRUG UTILIZATION

Single-Source (S) Drugs
Total
Number of Claims

Total
Reimbursement
Amount Less
Co-Pay

Non-Innovator (N) Drugs
Total
Number of Claims

Total
Reimbursement
Amount Less
Co-Pay

Innovator Multi-Source (I) Drugs
Total
Number of Claims

Total
Reimbursement
Amount Less
Co-Pay

CMS has developed an extract file from the Medicaid Drug Rebate Program Drug Product Data File identifying each NDC along with
sourcing status of each drug: S, N, or I (see Key below). This file will be made available from CMS to facilitate consistent reporting across
States with this data request.
KEY:
Single-Source (S) - Drugs that have an FDA New Drug Application (NDA) approval for which there are no generic alternatives available on
the market.
Non-Innovator Multiple-Source (N) - Drugs that have an FDA Abbreviated New Drug Application (ANDA) approval and for which there
exists generic alternatives on the market.
Innovator Multiple-Source (I) - Drugs which have an NDA and no longer have patent exclusivity.

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