1240-0050 Pharmacy Billing Requirements 2025 7 28

Pharmacy Billing Requirements

OMB Control Number: 1240-0050

OMB Expiration Date: 9/30/2025

SUPPORTING STATEMENT FOR

PHARMACY BILLING REQUIREMENTS

OMB CONTROL NO. 1240-0050

This ICR seeks to extend this information collection.

1. JUSTIFICATION

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The Office of Workers’ Compensation Programs (OWCP) is the agency responsible for administering the Black Lung Benefits Act (BLBA), 30 U.S.C. 901 et seq.; Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384 et seq.; and Federal Employees Compensation Act (FECA), 5 U.S.C. 8101 et seq. All three statutes require the OWCP to pay for medical treatment provided to beneficiaries; this medical treatment may include drugs dispensed by pharmacies. The regulations implementing these statutes require the collection of information needed to determine if bills submitted by pharmacies or as reimbursement requests by claimants should be paid. (20 CFR 10.801, 30.701, 725.701 and 725.705).

There is no standardized paper form for submission of the billing information collected in this Information Collection Request (ICR). Pharmacy bills submitted to the OWCP are submitted electronically using one of the industry-standard formats for electronic transmission of billing data through nationwide data clearinghouses that have been developed by the National Council for Prescription Drug Programs (NCPDP). While the electronic billing formats were not developed by the OWCP, the three programs (BLBA, EEOICPA, and FECA) provide instructions for the submission of necessary pharmacy bill data elements through their contracted pharmacy bill processors.

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

The required data elements are used by the OWCP and contractor bill processing staff to promptly evaluate the appropriateness of bills submitted for payment. The required data elements are the same as those used by other federal agencies and private health insurance carriers to process bills for payment. If all the billing data elements required by the OWCP are not collected, bills cannot be processed for payment.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also, describe any consideration of using information technology to reduce burden.

Pharmacies submit their bills to the OWCP bill processing contractor electronically through one of several nationwide billing clearinghouses (e.g., National Data Corporation). The NCPDP has developed standard specifications for the electronic transmission of these billing data elements, which are used by pharmacies for billing government programs (e.g., Medicare) and private, third-party payers. The OWCP’s acceptance of these standard specifications minimizes the public’s burden because they are widely available in various automated billing software and provide all the information needed to process bills. Electronic submission reduces burden by eliminating the need for pharmacies to print hard copies of paper billing forms and eliminates keying time for bill processors.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item A.2 above.

The pharmacy billing requirements are used by the BLBA, EEOICPA, and FECA programs to obtain the information necessary to appropriately process pharmacy bills. Duplicate information is not obtained; each program serves a different population. Other federal entities (e.g., the Centers for Medicare and Medicaid Services and the Defense Health Agency) collect similar information, but their claimant populations differ from those of the OWCP; no duplication is expected in information collection.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

Efforts to minimize burden on providers include acceptance of the NCPDP standardized electronic billing data formats, which are in wide use by pharmacies and facilitate automated bill processing through standard coding language for the data elements provided. NCPDP data formats are reviewed and updated periodically by user work groups who are members of the NCPDP.

In addition, the BLBA, EEOICPA, and FECA programs have included instructions for the submission of the required billing data and the use of electronic transmission standards in program manuals, which are available online. The instructions are also covered during workshops conducted by the OWCP bill processing contractor.

6. Describe the consequences to federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing the burden.

All information collected is bill-specific and necessary to properly adjudicate and process each bill for payment. Billing data are compiled and submitted by the pharmacy after each prescription (or set of prescriptions) is filled, and decisions about which billing cycle to use are made by the pharmacy. The OWCP does not require pharmacies to submit their bills at set intervals. Requiring the submission of pharmacy bills less frequently would result in delayed payment; may not meet program accounting requirements; and might cause problems with prescription refill requests, which could adversely affect a claimant’s medical treatment.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:

• requiring respondents to report information to the agency more often than quarterly;

• requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• requiring respondents to submit more than an original and two copies of any document;

• requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;

• 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;

• requiring the use of statistical data classification that has not been reviewed and approved by OMB;

• that includes 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

• requiring respondents to submit proprietary trade secret, 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.

There are no special circumstances for the collection of this information

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years -- even if the collection-of-information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

Contact	Organization	Email	Phone
Christensen, PharmD, Kristen	Optum Workers’ Comp and Auto No-Fault	[email protected]	+614.212.8512
Dunwell, PharmD, Gwendolyn	Conduent	[email protected]	+770.744.5108
Krah, Peter	AQIWO (Midnight Sun Technologies)	[email protected]	+571.218.5488

A Federal Register Notice inviting public comment was published on 05/09/2025 (90 FR 19731). Comments were not received.

9. Explain any decision to provide any payments or gifts to respondents, other than remuneration of contractors or grantees.

The only payment made to respondents is for drugs and similar products provided under the three programs. No gifts or other forms of remuneration are made.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

All payment requests are fully protected by the Privacy Act in the following systems of records: DOL/GOVT-1 (FECA); DOL/OWCP-2 (BLBA); DOL/OWCP-11 (EEOICPA).

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

There are no questions of a sensitive nature in the pharmacy billing requirements.

12. Provide estimates of the hour burden of the collection of information. The statement should:

• Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

• If this request for approval covers more than one form, provide separate hour burden estimates for each form.

• Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included in Item 14.

Estimated Annualized Respondent Cost and Hour Burden

Form/Activity/Section	No. of Respondents	No. of Responses per Respondent	Total Responses	Average Burden per Response (in hours)	Total Annual Burden (in hours)	Avg. Hourly Wage Rate	Monetized Value of Time
BLBA	43,231	43,231	43,231	0.0167 (1 minute)	722.0	$66.10	$47,721.40
EEOICPA	276,187	276,187	276,187	0.0167 (1 minute)	4,621.3	$66.10	$304,874.54
FECA	458,110	458,110	458,110	0.0167 (1 minute)	7,650.4	$66.10	$505,693.89
TOTAL	777,528		777,528		12,994		$858,289.83

Approximately 777,528 pharmacy bills are processed for the OWCP annually. Each bill takes approximately one minute to prepare electronically.

13. Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden shown in Items 12 and 14).

• The cost estimate should be split into two components: (a) total capital

and start-up cost component (annualized over its expected useful life); and (b) a

total operation and maintenance and purchase of service component.

The estimates should consider costs associated with generating,

maintaining, and disclosing or providing the information. Include descriptions of

methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the period during which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

• If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collection services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.

• Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

The cost of submitting the pharmacy bill data is included in the amount billed by respondents for the prescriptions filled. Therefore, no operation or maintenance costs are experienced by respondents.

14. Provide estimates of the annualized cost to the Federal Government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), any other expense that would not have been incurred without this collection of information. Agencies also may aggregate cost estimates from Items 12, 13, and 14 into a single table.

There are no developmental, printing, or mailing costs associated with this collection of information. All bills are submitted electronically. The instructions for the required bill data elements are included in the provider manuals, which are available online. The cost to the pharmacy for the electronic submission of bills using the NCPDP standardized data formats is minimal and comparable to other payment request submission costs.

Processing/Reviewing Costs:

The cost to process 777,528 bills for the OWCP during Calendar Year 2024 was $8,301,483.75 or $8,301,484 rounded. This cost is derived from the cost to process one pharmacy bill 10.67 x 777,528 bills 8,301,483.75.

15. Explain the reasons for any program changes or adjustments.

OWCP no longer accepts paper bills. All bills are submitted electronically. This reduced response time from 5 minutes to 1 minute on bills that were previously approved as manual bill submissions therefore reduced burden hours. Responses decreased from 874,414 to 777,528 due to less respondents (874,414 to 777,528). The decreases in responses as well as shortening response time due to electronic submissions also led to the corresponding decrease in total burden hours from 14,481 to 12,994. The previously submitted cost to respondents were none but erroneously recorded with a value. It is now corrected as no cost to respondents which matched the previous supporting statement.

16. For collections of information whose results will be published, outline plans for tabulations, and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

There are no plans to publish the data collected.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

The OMB number and expiration date cannot be displayed because there is no paper form for this collection. The OWCP will publish a notice in the Federal Register containing the OMB number and expiration date for this collection.

18. Explain each exception to the certification statement.

There are no exceptions to the certification statement.

B. COLLECTIONS OF INFORMATON EMPLOYING STATISTICAL METHODS.

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