Authorization Request Form and Certification /Letter of Medical Necessity for Compounded Drugs (OWCP-26)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form OWCP-26 Authorization Request form/Letter of Medical Necessity for Compounded Drugs	Form and Instruction	New	Available
Form OWCP-26 Authorization Form/Letter of Medical Necessity for Compounded Drugs	Form and Instruction	New	Repair queued
1240-0NEW OWCP Form Auth Req Form and Certi_Ltr of Medical Necessity for Compounded Drugs (OWCP-26)_Supporting Statement_20240529.docx	Supporting Statement A	Uploaded 2024-05-29	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
267907	Authorization Form/Letter of Medical Necessity for Compounded Drugs	Form and Instruction	New	Authorization Request form/Letter of Medical Necessity for Compounded Drugs
267907	Authorization Form/Letter of Medical Necessity for Compounded Drugs	Form and Instruction	New

ICR Details

OMB Control No: 1240-0062	ICR Reference No: 202405-1240-007
Status: Active	Previous ICR Reference No:
Agency/Subagency: DOL/OWCP	Agency Tracking No:
Title: Authorization Request Form and Certification /Letter of Medical Necessity for Compounded Drugs (OWCP-26)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/08/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/05/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved
Responses	490	0	0
Time Burden (Hours)	245	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: OWCP will require the claimant’s treating physician to complete a Form OWCP-26 online before payment will be made for a compounded drug. The physician will be required to specify the ingredients in the compounded drug, indicate whether the compounded drug and each of its ingredients are medically necessary, and explain why the claimant cannot use an FDA-approved drug instead of the compounded drug being prescribed. The form will permit the OWCP to more easily track the volume, type, and characteristics of compounded drugs prescribed for claimants. It will allow additional oversight of the pharmacy benefit—improving patient safety, decreasing cost for stakeholders, and decreasing the risk for fraud, waste, and abuse. Completed forms will be reviewed by a clinical pharmacist or physician before being reviewed for decision by the individual program staff.

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Authorizing Statute(s): US Code: 5 USC 8101 Name of Law: Federal Employees Compensation Act
   US Code: 41 USC 7384 Name of Law: Energy Employees Occupational Illness Compensation Act
   US Code: 30 USC 901-44 Name of Law: Black Lung Benefits Act
   US Code: 30 USC 901-950 Name of Law: Longshore and Harbor Workers' Compensation Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 21015	03/26/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 48193	06/05/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Authorization Form/Letter of Medical Necessity for Compounded Drugs	OWCP-26	Authorization Request form/Letter of Medical Necessity for Compounded Drugs

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	490	0	0	490	0	0
Annual Time Burden (Hours)	245	0	0	245	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: OWCP will require the claimant’s treating physician to complete a Form OWCP-26 online before payment will be made for a compounded drug. The physician will be required to specify the ingredients in the compounded drug, indicate whether the compounded drug and each of its ingredients are medically necessary, and explain why the claimant cannot use an FDA-approved drug instead of the compounded drug being prescribed. The form will permit the OWCP to more easily track the volume, type, and characteristics of compounded drugs prescribed for claimants. It will allow additional oversight of the pharmacy benefit—improving patient safety, decreasing cost for stakeholders, and decreasing the risk for fraud, waste, and abuse. Completed forms will be reviewed by a clinical pharmacist or physician before being reviewed for decision by the individual program staff.

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Annual Cost to Federal Government: $28,783

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/05/2024

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