Supporting Statement Part A
Medicaid Drug Use Review (DUR) Program
CMS-R-153, OMB 0938-0659
Section 4401 of the Omnibus Budget Reconciliation Act of 1990 and section 1927(g) of the Social Security Act requires States to provide for a Medicaid Drug Use Review (DUR) program for covered outpatient drugs under fee-for-service (FFS) and managed care organizations (MCOs). The DUR program is required to assure that prescriptions are appropriate, medically necessary, and are not likely to result in adverse medical events. Each State DUR program must consist of prospective drug use review (ProDUR), retrospective drug use review (RetroDUR), data assessment of drug use against predetermined standards, and ongoing educational outreach activities. In addition, States are required to submit an annual DUR program survey that includes a description of the nature and scope of State DUR activities as outlined in the statute and regulations.
In this 2024 information collection, we added, revised and/or deleted certain FFS, MCO, and Abbreviated MCO survey questions. Additionally, aspects of the survey were simplified with grammar updates and formatting edits, resulting in a net burden increase of 1 hour per response. This iteration also adds Puerto Rice for a total of 52 respondents.
Overall, this iteration increases our time estimate by 856 hours and our cost estimate by $350,146. See section 15 of this Supporting Statement for details.
The authority for requiring States and MCOs to collect data for the DUR program is section 1927(g) of the Social Security Act (the Act) and implementing regulations at 42 CFR 456.700 and 438.3(s).
The information collection requirement is necessary to establish patient profiles in pharmacies, identify problems in prescribing and/or dispensing, determine each program’s ability to meet minimum standards required for Federal financial participation, and ensure quality pharmaceutical care for Medicaid patients.
State Medicaid agencies that have prescription drug programs are required to perform prospective and retrospective DUR in order to identify aberrations in prescribing, dispensing and/or patient behavior.
States must provide for a review of drug therapy before each prescription is filled or delivered to a Medicaid patient. This review includes screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Pharmacists must make a reasonable effort to obtain, record, and maintain Medicaid patient profiles. These profiles must reflect at least the patient’s name, address, telephone number, date of birth/age, gender, history, e.g., allergies, drug reactions, list of medications, and pharmacist’s comments relevant to the individual’s drug therapy.
The State must conduct RetroDUR which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact.
The states and MCOs are provided the reporting instrument (a survey) by CMS for the purposes of monitoring compliance and evaluating the progress of states’ DUR programs. The survey and the annual recordkeeping and reporting requirements under the pertinent regulations, are completed by pharmacists employed by, or contracted with the various state Medicaid programs and their MCOs. The annual surveys submitted by states are reviewed and results are compiled by CMS in a format intended to provide information, comparisons and trends related to states’ experiences with DUR. The states benefit from the information and may enhance their programs each year based on state reported innovative practices that are compiled by CMS from the annual surveys. A comparison/summary of the data from the annual surveys is published on Medicaid.gov annually, and serves as a resource for stakeholders, including but not limited to states, manufacturers, researchers, congress, CMS, the Office of Inspector General (OIG), non-governmental payers and clinicians on the topic of DUR in state Medicaid programs.
Use of Information Technology
States are required to submit their annual FFS, MCO, and Abbreviated MCO responses via the CMR-R-153 reporting instrument (a survey) using a CMS-hosted online information technology system called Medicaid Drug Program (MDP).
Duplication/Similar Information
CMS is the only Department of Health and Human Services (HHS) component collecting Medicaid DUR data. Therefore, there is no existing initiative which duplicates this data collection that could yield findings in place of DUR data.
Small Business
These information collection requirements do not affect small businesses. When processing prescriptions, pharmacies have an automated system that utilizes the prospective data edits to complete the proper filling of the prescription. The pharmacy itself does not collect the data. The data is submitted to the state as the claim is being processed electronically.
RetroDUR activity is required by regulation at least quarterly according to § 456.709(a) and State and MCO surveys are required to be submitted annually according to §§ 456.712(b) and 438.3(s)(5) by June 30th of each calendar year for the previous Federal Fiscal Year, as determined by the Secretary. Less frequent data collection is not applicable.
There are no special circumstances that would require an information collection to be conducted in a manner that requires respondents to:
Report information to the agency more often than quarterly;
Prepare a written response to a collection of information in fewer than 30 days after receipt of it;
Submit more than an original and two copies of any document;
Retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;
Collect data in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study,
Use a statistical data classification that has not been reviewed and approved by OMB;
Include a pledge of confidentiality that is not supported by authority established in statute or regulation that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
Submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
Federal Register Notice/Outside Consultation
The 60-day notice published in the Federal Register on June 28, 2024 (89 FR 54002). While comments were due August 27, 2024, none were received.
The 30-day notice published on September 3, 2024 (89 FR 71283). Comments must be received by October 3, 2024.
There are no payments/gifts to respondents.
States are required under § 431.300(a) to safeguard recipient protected information. Accordingly, each State maintains a State Plan providing safeguards that restrict the use or disclosure of information concerning applicants and recipients to purposes directly connected with the administration of the plan per Section 1902(a)(7) of the Social Security Act.
Sensitive Questions
There are no sensitive questions associated with this collection. Specifically, the collection does not solicit questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
In accordance with section 1927(g) of the Social Security Act (the Act), and regulations at §§ 456.700, 456.709, 456.711, 456.712, and 438.3(s), states and MCOs are required to collect data for their DUR programs. State Medicaid agencies that have prescription drug programs are required to perform prospective and retrospective DUR in order to identify aberrations in prescribing, dispensing and/or patient behavior. We expect pharmacists employed by or contracted with the individual states to facilitate the states’ responses. The sub-sections below estimate the associated burden of complying with the statutes and regulations for both FFS programs and MCOs. While the content of the FFS survey differs marginally from that of the MCO survey, we estimate that the burden for individual states combined FFS and MCO will increase by 1 hour.
To derive average costs, we used data from the U.S. Bureau of Labor Statistics’ May 2023 National Occupational Employment and Wage Estimates for all salary estimates (http://www.bls.gov/oes/2023/may/oes_nat.htm). In this regard, the following table presents BLS’ mean hourly wage, our estimated cost of fringe benefits and other indirect costs (calculated at 100 percent of salary), and our adjusted hourly wage.
Occupation Title |
Occupation Code |
Mean Hourly Wage ($/hr) |
Fringe Benefits and Other Indirect Costs ($/hr) |
Adjusted Hourly Wage ($/hr) |
Pharmacist |
29-1051 |
64.81 |
64.81 |
129.62 |
As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and other indirect costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
Requirements and Burden Estimates
Claims Data and Other Record Reports Preparation (§ 456.709)
As previously stated above, the pharmacist’s profiling and documentation is primarily an automated function due to the implementation of electronic processing systems. The pharmacist does not produce exception reports. The details of the prescriptions presented to be filled are what create the data that the State gathers and the State or its vendor produces exception reports and drug claims expenditures reporting from this data.
States are required to collect prescription drug utilization data from claims and assess the data against predetermined standards in order to identify potential problems in prescribing and/or dispensing. Data collection involves sorting prescription drug claims data through the use of exception reports. These reports generate specific information on claims using predetermined criteria for exceptions, such as prior authorization and types of drug therapy problems. States generally have their pharmacy point-of-sales vendor produce the exception reports.
The DUR Medicaid Contact form is included in this package to ensure eligible state Medicaid contacts have access to the annual Medicaid DUR survey to incorporate state collected data into the survey. Contacts include State Medicaid DUR Contacts, State Medicaid Pharmacy Directors, and State Medicaid Directors. Requested information includes work Email Address, Telephone Number, Fax Number (Area Code), Street Address, City, State and Zip Code.
Time: 1,040 hours annually
20 hours per year (or 5 quarterly hours) per State x 52 states
Cost: $134,805annually
1,040 hours x $129.62/hr (point of service vendor pharmacist wage).
Review Claims Data and Other Record Reports & Interventions (§ 456.711)
The DUR Board conducts reviews of the exception reports at their quarterly meetings. As part of the review process, the DUR Board or a specially selected committee determines if intervention is warranted. If intervention is necessary, a pharmacist contractor executes the interventions by form of telephone contact, correspondence, or face-to- face interviews. Interventions are conducted to educate the physician or pharmacist on appropriate prescribing or dispensing practices.
Time: 12,480 hours annually
240 hours (10 members at 24 hours per member) per year per State (or 60 quarterly hours) x 52 Medicaid programs
Cost: $648,960 annually
12,480 hours x $50/hr (DUR Board members wage).
DUR board members typically receive a nominal honorarium as represented above. Being a member of the DUR board is looked favorably upon by their employers and the medical community, as they provide their medical expertise for public service.
Time: 24,960 hours annually
480 hours per year (or 120 quarterly hours) x 52 states
Cost: $3,235,315 annually
24,960 hours x $129.62/hr (pharmacist contractor wage)
Annual Report (§§ 456.712 and 438.3)
These sections of the regulation state that the DUR Board and the Medicaid agency are required to report annually to the Medicaid agency and the Secretary, respectively. While the content of the FFS survey differs marginally from that of the MCO survey, we estimate that the burden for individual states combined FFS and MCO will increase by 1 hour.
Time: 3,380 hours
It is estimated that the yearly reporting burden for the surveys is 65 hours per State, making the total burden for 52 Medicaid programs.
Cost: $438,116
3,380 hours x $129.62/hr (pharmacist contractor wage)
Burden Summary
Annual Recordkeeping and Reporting Requirements
Regulation |
|
Responses |
|
|
|
Labor |
Total |
|
Under Title 42 of the |
Respondents |
(per respondent) |
Total Responses |
Time per Response |
Total Annual Time (hr) |
Rate ($/hr) |
Capital/ Maintenance |
Total Annual Cost ($) |
CFR |
|
|
|
|
|
|
Costs ($) |
|
456.709 |
52 |
4 |
208 |
5 hr |
1,040 |
129.62 |
0 |
134,804 |
456.711 |
52 |
4 |
208 |
60 hr (review) |
12,480 |
50.00 |
0 |
624,000 |
4 |
208 |
120 hr (intervention) |
24,960 |
129.62 |
0 |
3,235,315 |
||
456.712 & 438.3 |
52 |
1 |
52 |
65 hr |
3,380 |
129.62 |
0 |
438,116 |
TOTAL |
52 |
13 |
676 |
250 hr |
41,860 |
Varies |
0 |
4,432,235 |
When processing prescriptions, pharmacies have an automated system that utilizes the prospective data edits to complete the proper filling of the prescription. The pharmacy itself does not collect the data. The data is submitted to the state as the claim is being processed electronically.
Information Collection Instruments and Instruction/Guidance Documents
States are required to submit their annual survey responses via the CMS-R-153 reporting instrument using a CMS-hosted online information technology system called Medicaid Drug Program (MDP). The DUR State Agency Contact form ensures system access to eligible state representatives. To generate their annual reports, states submit their responses to the FFS, MCO (or MCO Abbreviated) Surveys to the CMS hosted online MDP system.
FFS Annual Surveys (Revised)
MCO Annual Surveys (Revised)
Abbreviated MCO Surveys (Revised)
State DUR Agency Contact Form (Nonsubstantive change)
Capital Costs
There are no capital costs.
Cost to Federal Government
The federal government pays 50% of the states’ costs, which is $2,216,118 ($4,432,235 x 0.5).
In this 2024 information collection, we added, revised and/or deleted certain FFS, MCO, and Abbreviated MCO survey questions. Additionally, aspects of the survey were simplified with grammar updates and formatting edits, resulting in a net burden increase of 1 hour per response (from 64 to 65 hr/response) for the FFS and MCO annual surveys.
As of January 1, 2023, the territory of Puerto Rico now participates in the CMS Medicaid Drug Rebate Program (MDRP) and therefore is required to provide for a DUR program for covered outpatient drugs under fee-for-service (FFS) and managed care organizations (MCOs) as provided for under CMS-2345-IFC3. Consequently, this collection of information request includes 50 states, the District of Columbia and Puerto Rice for a total of 52 respondents (an increase of one respondent).
We have also adjusted our cost estimates by using more recent BLS wage data (2020 vs 2023).
Overall, this iteration increases our time estimate by 856 hours (from 41,004 hr to 41,860 hr) and our cost estimate by $350,146 (from $4,082,089 to $4,432,235).
See the attached Redlines and Crosswalks for changes to the FFS Annual Surveys, MCO Annual Surveys, and Abbreviated MCO Surveys.
While the use of statistical methods do not apply to this collection of information, we have also included Supporting Statement B as we reconsidered our use of the terms “reports” and “surveys.”
The Agency Contact Form is now fillable.
CMS plans to post the comparison/summary on Medicaid.gov within six months from the submission due date.
Expiration Date:
The revised expiration date will be displayed.
Certification Statement:
This submission does not contain exceptions to the certification statement.
The use of statistical methods does not apply to this collection of information.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | DUR_PRA_CMS_R_153 |
| Author | cms |
| File Modified | 0000-00-00 |
| File Created | 2024-09-06 |