Form CMS-R-153 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
the
CMS Central 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.

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. DEMOGRAPHIC INFORMATION
State Name Abbreviation

Medicaid Agency Information
Identify State person responsible for DUR Annual Report Preparation.
Name:
Email Address:
Area Code/Phone Number:

II.

PROSPECTIVE DUR (ProDUR)
Identify by name and indicate the type of your pharmacy POS vender – (contractor, state-operated
other).

1. If not state-operated, is the POS vendor also the MMIS fiscal agent?
☐

Yes

☐

No

2. Identify prospective DUR criteria source.
☐

First Data Bank

☐

Other

3. Are new prospective DUR criteria approved by the DUR Board?
☐

Yes

☐

No
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If answer above is “No,” please explain:

4. When the pharmacist receives a ProDUR alert message that requires a pharmacist’s review, does
your system allow the pharmacist to override the alert using the “conflict, intervention and
outcome” codes?
☐

Yes

☐

No

5. Do you receive and review periodic reports from your ProDUR contractor providing individual
pharmacy provider activity in summary and in detail?
☐

Yes

☐

No

If answer above is “Yes”, how often is the report received by the agency:
☐

monthly

☐

quarterly

☐

annually

a) If you receive reports, do you follow-up with those providers who routinely override with
interventions?
☐

Yes

☐

No

b) If the answer to above is “Yes”, by what method do you follow-up?
☐ Contact pharmacy
☐ Refer to Program Integrity for Review
☐ Other (explain)

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

%

Controlled drugs:

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

☐

Yes

☐

No

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

7. When the pharmacist receives an early refill DUR alert message that requires the Pharmacist’s
review, does your system allow the pharmacist to override for situations such as:
a) Lost/stolen Rx
b) Vacation
c) Other: provide details

☐
☐

Yes
Yes

☐
☐

No
No

8. Does your system have an accumulation edit to prevent patients from obtaining additional
refills during the calendar year?
☐

Yes

☐

No

If “no” do you plan to implement this edit?
☐

Yes

☐

No

9. Has the state provided DUR criteria data requested on Table 1 – Top 10 Pro DUR Alerts by
Problem Type indicating by problem type those criteria with the most significant severity level
reviewed by the DUR Board?
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☐

Yes

☐

No

10. Section 1927(g)(A) of the Social security Act requires that the pharmacist offer patient
counseling at the time of dispensing. Who in your state has responsibility for monitoring
compliance with the oral counseling requirement? Check all that apply:
a) ☐
b) ☐
c) ☐

Medicaid agency
State Board of Pharmacy
Other – please explain

11. Has the state included Attachment 1 – Pharmacy Oral Counseling Compliance Report a
report on state efforts to monitor pharmacy compliance with the oral counseling requirement?
☐

Yes

☐

No

III. RETROSPECTIVE DUR (RetroDUR)
1. Identify, by name and type, the vendor that performed your Retro DUR activities during the
time period covered by this report (company, academic institution, or other organization).

a) Is the Retro DUR vendor also the Medicaid fiscal agent?
☐

Yes

☐

No

b) Is the Retro DUR vendor also the developer/supplier of your retrospective DUR criteria?
☐

Yes

☐

No

If “No”, please explain:
2. Does the DUR Board approve the Retro DUR criteria?
☐

Yes

☐

No

If “No”, please explain

3. Has the state included Attachment 2 – Retrospective DUR Educational Outreach
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Summary, a year end summary of the Top 10 problem types for which educational
interventions were taken?
☐

Yes

☐

No

IV. DUR BOARD ACTIVITY
1. State is including a brief summary of DUR Board activities and meeting minutes during the
time period covered by this report as Attachment 3 - Summary of DUR Board Activities.
☐

Yes

☐

No

2. Does your state have a Disease Management Program?
☐

Yes

☐

No

If “Yes”, have you performed an analysis of the program’s effectiveness?
☐

Yes

☐

No

If “Yes”, please provide a brief summary of your findings:

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

Yes

☐

No

3. Does your state have an approved CMS Medication Therapy Management Program?
☐

Yes

☐

No

If “Yes”, have you performed an analysis of the program’s effectiveness?
☐

Yes

☐

No

If “Yes”, please provide a brief summary of your findings.

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

Yes

☐

No
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If “No” are you planning to develop and implement a program?
☐

V.

Yes

☐

No

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 Pro DUR and Retro DUR?
☐

Yes

☐

No

If “No,” do you have a plan to include this information in your DUR criteria in the future?
☐

Yes

☐

No

VI. GENERIC POLICY AND UTILIZATION DATA
1. State is including a description of policies that may affect generic utilization percentage as
Attachment 4 - Generic Drug Substitution Policies.
☐

Yes

☐

No

2. In addition to the requirement that the prescriber write in his own handwriting “Brand
Medically Necessary” for a brand name drug to be dispensed in lieu of the generic
equivalent, does your state have a more restrictive requirement?
☐

Yes

☐

No

If “Yes”, check all that apply:
a)
b)
c)
d)

☐
☐
☐
☐

Require that a MedWatch Form be submitted
Require medical reason for override accompany prescriptions
Preauthorization is required
Other – please explain

3. Indicate the generic utilization percentage for all covered outpatient drugs paid during
this reporting period, using the computation instructions in Table 2 - Generic
Utilization Data
Number of Generic Claims
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Total Number of Claims
Generic Utilization Percentage
4. 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 2 - Generic Utilization Data
Generic Dollars:
Total Dollars:
Generic Expenditure Percentage:

VII. PROGRAM EVALUATION / COST SAVINGS/COST AVOIDANCE
1. Did your state conduct a DUR program evaluation of the estimated cost savings/cost avoidance?
☐

Yes

☐

No

2. Who conducted your program evaluation for the cost savings estimate/cost avoidance?
(company, academic institution, other institution) (name)

3. Please provide your ProDUR and RetroDUR program cost savings/cost avoidance in the chart
below.
ProDUR Total Estimated Avoided Costs
RetroDUR Total Estimated Avoided Costs
Other cost avoidance
Grand Total estimated Avoided Costs

4. Please provide the estimated percent impact of your state’s cost savings/cost avoidance
program compared to total drug expenditures for covered outpatient drugs.
Use the following formula:
Divide the estimated Grand Total Estimated Avoided Costs from Question 3 above
by the total dollar amount provided in Section VI, Question 4. Then multiply this
number by 100.
Grand Estimated Net Savings Amount ÷ Total Dollar Amount × 100 =

%
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5. State has provided the Medicaid Cost Savings/Cost Avoidance Evaluation as Attachment
5 – Cost Savings/Cost Avoidance Methodology.
☐

Yes

☐

No

VIII. FRAUD, WASTE, AND ABUSE DETECTION
A. LOCK-IN or PATIENT REVIEW AND RESTRICTIVE PROGRAMS
1. Do you have a documented process in place that identifies potential fraud or abuse of
controlled drugs by beneficiaries?
☐

Yes

☐

No

If “Yes,” what actions does this process initiate? Check all that apply.
a)
b)
c)
d)

☐
☐
☐
☐

Deny claims and require pre-authorization
Refer to Lock In Program
Refer to Program Integrity Unit
Other (e.g. SURS, Office of Inspector General), please explain:

2. Do you have a “lock-in” program?
☐

Yes

☐

No

If “Yes”, what criteria does your state use to identify candidates for lock-in? Check all that
apply.
☐
☐
☐
☐
☐
☐
☐

Number of controlled substances (CS)
Different prescribers of CS
Multiple pharmacies
Number days’ supply of CS
Exclusivity of short acting opioids
Multiple ER visits
Other

If “Yes” do you restrict the beneficiary to:
i.
a prescriber only
☐
Yes

☐

No
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ii.
iii.

a pharmacy only
a prescriber and pharmacy

☐
☐

Yes
Yes

☐
☐

No
No

What is the usual “lock-in” time period?
☐ 6 months
☐ 12 months
☐ Other, please explain:

3. On the average, what percentage of the FFS population is in lock-in status annually?
%
4. Please provide an estimate of the savings attributed to the lock-in program for the fiscal year
under review.
$
5. Do you have a documented 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.
b.
c.
d.

☐
☐
☐
☐

Deny claims written by this prescriber
Refer to Program Integrity Unit
Refer to the appropriate Medical Board
Other – please explain:

6. Do you have a documented 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
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a.
b.
c.
d.

☐
☐
☐
☐

Deny claim
Refer to Program Integrity Unit
Refer to Board of Pharmacy
Other – please explain:

B. PRESCRPTION DRUG MONITORING PROGRAM (PDMP)
1. Does your state have a Prescription Drug Monitoring Program (PDMP)?
☐

Yes

☐

No

If “Yes” does your agency have the ability to query the state’s PDMP database?
☐

Yes

☐

No

If “Yes”, do you require prescribers (in your provider agreement with the agency) to access the
PDMP patient history before prescribing restricted substances?
☐

Yes

☐

No

If “Yes,” please explain how the state applies this information to control fraud and abuse.
If “Yes”, do you also have access to border states’ PDMP information?
☐

Yes

☐

No

2. Are there barriers that hinder the agency from fully accessing the PDMP that prevent the
program from being utilized the way it was intended to be to curb abuse?
☐

Yes

☐

No

If “Yes” please explain the barriers (e.g. lag time in prescription data being submitted,
prescribers not accessing, pharmacists unable to view prescription history before filling script)

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C. PAIN MANAGEMENT CONTROLS
1. Does your state or your agency require that Pain Management providers be certified?
☐
2

Yes

☐

No

Does your program obtain the DEA Active Controlled Substance Registrant’s File in order to
identify prescribers not authorized to prescribe controlled drugs?
☐

Yes

☐

No

If “Yes” do you apply this DEA file to your ProDur POS edits to prevent unauthorized
prescribing?
☐

Yes

☐

No

If “Yes” please explain how the information is applied

If “No” do you plan to obtain the DEA Active Controlled Substance Registrant’s file and apply
it to your POS edits?
☐

Yes

☐

No

3. Do you apply this DEA file to your RetroDUR reviews?
☐

Yes

☐

No

If “Yes” please explain how it is applied.

4. Do you have measures in place to monitor/manage the prescribing of
methadone for pain management? If “yes” check all that apply:
☐
☐
☐
☐

pharmacist override
deny claim and require PA
quantity limits
intervention letters
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D. OPIOIDS
1. Do you currently have POS edits in place to limit the quantity of short-acting opioids?
☐

Yes

☐

No

If “Yes” what are your limitations?
☐ 30 day supply
☐ 90 day supply
☐ other, please explain

2. Do you currently have POS edits in place to limit the quantity of long-acting opioids?
☐

Yes

☐

No

If “Yes” what are your limitations?
☐ 30 day supply
☐ 90 day supply
☐ other, please explain

E.

MORPHINE EQUIVALENT DAILY DOSE (MEDD)
1. Have you set recommended maximum morphine equivalent daily dose measures?
☐

Yes

☐

No

If “Yes”, what is your maximum morphine equivalent daily dose limit in milligrams?
mg per day
2. Do you provide information to your prescribers on how to calculate the morphine
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equivalent daily dosage?
☐

Yes

☐

No

If “Yes” how is the information disseminated?
☐
☐
☐
☐

website
provider notice
educational seminar
other, explain

3. Do you have an algorithm in your POS system that alerts the pharmacy provider that the
morphine equivalent daily dose prescribed has been exceeded?
☐

F.

Yes

☐

No

BUPRENORPHINE
1. Does your agency set mg per day limits on the use of buprenorphine?
☐

Yes

☐

No

If “Yes”, please specify the total
mg/day?
☐
☐
☐
☐

8mg
12 mg
16 mg
other, please explain

2. What are your limitations on the allowable length of treatment?
☐ 6 months
☐ 12 months
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☐ no limit
☐ other, please explain

3. Do you require that the maximum mg per day allowable be reduced after a set period of time?
☐

Yes

☐

No

If “Yes”, what is your reduced (maintenance) dosage?
☐ 8mg
☐ 12mg
☐ other, please explain
4. What are your limitations on the allowable length of treatment?
☐
☐
☐
☐

6 months
12 months
no limit
other, please explain

5. Do you limit the type of dosage form that can be dispensed to only the sublingual film?
☐

F.

Yes

☐

No

PSYCHOTROPIC DRUGS/STIMULANTS
1. Do you have a documented program in place to manage/monitor the appropriate
use of psychotropic drugs in children?
☐

Yes

☐

No

If “Yes”, do you manage/monitor:
☐ only children in foster care
☐ all children
☐ other, please explain
Please briefly explain the specifics of your program(s).
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If “No” do you plan on implementing a program in the future?
☐

Yes

☐

No

2. Do you have any documented restrictions or special program in place to
monitor/manage or control the use of stimulants?
If “yes” is your program limited to:
☐ children
☐ adults
☐ both
Please briefly explain your program.

IX. INNOVATIVE PRACTICES
Have you developed any innovative practices during the past year which you have included in
Attachment 6 - Innovative Practices?
☐

Yes

☐

No

X. 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
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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

☐

No

b) If “Yes,” please explain the evaluation methodology in Attachment 7 – E-Prescribing
Activity Summary.
c) If “No,” are you planning to develop this capability?
☐

Yes

☐

No

XI. MANAGED CARE ORGANIZATIONS (MCOs)
1. Is your pharmacy program included in the capitation rate (carved-in)?
☐

Yes

☐

No

☐

Partial

If “partial” please specify the drug-categories that are carved out.

2. Does the state set requirements for the MCO’s pharmacy benefit?
☐

Yes

☐

No

If “Yes” please briefly explain your policy.

If “No” do you plan to set standard in the future?
☐

Yes

☐

No

3. Does the state require the MCOs to monitor or report their DUR activities?
☐

Yes

☐

No
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4. If “no” do you plan to develop a program to monitor or report MCO DUR activities in the
future?
☐

XII.

Yes

☐

No

EXECUTIVE SUMMARY - Attachment 8 – Executive Summary

MEDICAID DRUG UTILIZATION REVIEW ANNUAL REPORT
INSTRUCTIONS: Nomenclature Format for Attachments
States: Please use this standardized format for naming attachments.
ATT#-FFY- State Abbrev-Abbreviated Report name (NO
SPACES!) Example for Arizona: (each state should insert their 2
letter state code) Attachments:

ATT1-201_-AZ-POCCR

(Pharmacy Oral Counseling Compliance Report)

ATT2-201_-AZ-REOS

(RetroDUR Educational Outreach Summary)

ATT3-201_-AZ-SDBA

(Summary of DUR BD Activities)

ATT4-201_-AZ-GDSP

(Generic Drug Substitution Policies)

ATT5-201_-AZ-CSCAM

(Cost Savings/Cost Avoidance Methodology)

ATT6-201_-AZ-IPN

(Innovative Practices Narrative)

ATT7-201_-AZ-EAS

(E-Prescribing Activity Summary)

ATT8-201_-AZ-ES

(Executive Summary)

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I.

EXPLANATION FOR ATTACHMENTS AND TABLES
ATTACHMENT 1 – PHARMACY ORAL COUNSELING 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.

ATTACHMENT 2 – RETROSPECTIVE EDUCATIONAL OUTREACH
SUMMARY This is a year-end summary report on RetroDUR screening and
educational interventions.
The year-end summary reports should be limited to the TOP 10 problem with the largest
number of exceptions. The results of RetroDUR screening and interventions
should be included.
ATTACHMENT 3 – 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.
• Describe Board policies that establish whether and how results of prospective
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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 4 – GENERIC DRUG SUBSTITUTION POLICIES
Please report any factors that could affect your generic utilization percentage and
include any relevant documentation.

ATTACHMENT 5 – COST SAVINGS/COST AVOIDANCE METHODOLOGY
Include copy of program evaluations/cost savings estimates prepared by state or contractor
noting methodology used.

ATTACHMENT 6 – 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 7 – E-PRESCRIBING ACTIVITY SUMMARY
Please describe all development and implementation plans/accomplishments in the
area of e- prescribing. 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).
ATTACHMENT 8 – EXECUTIVE SUMMARY

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TABLE 1 – TOP 10 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 Board. For each problem type below in the first column list the drugs/ drug
category/ disease combinations for which DUR Board conducted in-depth reviews.
PROBLEM TYPE KEY: INAPPROPRIATE - IA; THERAPEUTIC - TC; DRUG DRUG - D/D;
DRUG ALLERGY - D/A; DRUG DISEASE – D/D;
Table1

AHFS TC
(Level 2)

AHFS TC
(Level 4)

AHFS TC
(Level 6)

AHFS TC
(Level 8)

Drug
Name

Disease

Criteria
Implemented

IA DOSE1
IA DOSE2
IA DOSE3
TC DUPLICATION1
TC DUPLICATION2
TC DUPLICATION3
D/A INTERACTION1
D/A INTERACTION2
D/A INTERACTION3
IA DURATION1
IA DURATION2
IA DURATION3
D/D INTERACTIONS1
D/D INTERACTIONS2
D/D INTERACTIONS3
D/Dis CONTRAINDICATION1
D/Dis CONTRAINDICATION2
D/Dis CONTRAINDICATION3
OTHER (specify)1
OTHER (specify)2
OTHER (specify)3
OTHER (specify)4
OTHER (specify)5
OTHER (specify)6
OTHER (specify)7
OTHER (specify)8
OTHER (specify)9

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TABLE 2 – 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 TABLE 2)
Computation Instructions:
KEY:
Single-Source (S) - Drugs having an FDA New Drug Application (NDA), and
there are no generic alternatives available on the market.
Non-Innovator Multiple-Source (N) - Drugs that have an FDA Abbreviated New Drug
Application (ANDA), and there exists generic alternatives on the market.
Innovator Multiple-Source (I) - Drugs which have an NDA and no longer have patent
exclusivity.

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
TABLE 2: 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.

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