2024-06359. Proposed of Information Collection; Authorization Request Form and Certification/Letter of Medical Necessity for Compounded Drugs (OWCP-26)

AGENCY:

Office of Workers' Compensation (OWCP), Labor.

ACTION:

Request for public comments.

SUMMARY:

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance request for comment to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This request helps to ensure that: requested data can be provided in the desired format; reporting burden (time and financial resources) is minimized; collection instruments are clearly understood; and the impact of collection requirements on respondents can be properly assessed. Currently, OWCP is soliciting comments on the information collection for Authorization Request Form and Certification/Letter of Medical Necessity for Compounded Drugs (OWCP–26).

DATES:

All comments must be received on or before May 28, 2024.

ADDRESSES:

You may submit comment as follows. Please note that late, untimely filed comments will not be considered.

Written/Paper Submissions: Submit written/paper submissions in the following way:

• Mail/Hand Delivery: Mail or visit DOL–OWCP/, Office of Workers' Compensation Programs, U.S. Department of Labor, 200 Constitution Ave. NW, Room S–3524, Washington, DC 20210.

• OWCP will post your comment as well as any attachments, except for information submitted and marked as confidential, in the docket at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Anjanette Suggs, Office of Workers' Compensation Programs, OWCP, at [e-mail] (email); (202) 354–9660 (phone).

SUPPLEMENTARY INFORMATION:

I. Background

In 2013, the President of the United States, Barack Obama, signed a law, which provides greater federal oversight over compounding pharmacies that custom mix medication in bulk for patients who may benefit from prescriptions that are specific to their individual medical needs. See Compounding Quality Act,Public Law 113–54, 127 Stat. 587 (2013).

Compounded drugs have two or more ingredients and are offered as an alternative to Food and Drug Administration (FDA)-approved medications that do not meet an individual patient's health needs, such as when a patient has an allergy that requires a medication to be made without a certain dye. See Compounding and the FDA: Questions and Answers, http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​PharmacyCompounding/​ucm339764.htm.

Compounded drugs are not FDA-approved. This means that the FDA does not verify the safety or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective, and made in accordance with Federal quality standards. Compounded drugs also lack an FDA finding of manufacturing quality before they are marketed.

Health risks associated with compounded drugs include the use of ingredients that may be sub- or super-potent, contaminated, or otherwise adulterated. Additionally, patients may use ineffective compounded drugs instead of FDA-approved drugs, which have been shown to be safe and effective.

Impacts on the Office of Workers' Compensation Programs (OWCP)

Due to the safety concerns surrounding compounded drugs, the Department of Labor has deemed it necessary to scrutinize the medical necessity of these medications in OWCP claims more closely by instituting a pre-authorization process. The OWCP believes that using a form to monitor compounded medications will improve the quality of medical management, increase patient safety, assist our stakeholders in controlling costs due to medically unnecessary treatments, and lessen the potential for fraud, waste, and abuse in the compensation programs administered by the OWCP. Requiring justification before payment will assist the OWCP in determining whether the prescribed medication will assist in curing, giving relief, and lessening the degree of disability.

OWCP's authority to require use of the OWCP–26 is derived from the following sources:

• FECA:5 U.S.C. 8103; 20 CFR 10.310, 10.800 and 10.809.

• EEOICPA:42 U.S.C. 7384t; 20 CFR 30.700(b).

• BLBA:33 U.S.C. 907, as incorporate by 30 U.S.C. 932(a); 20 CFR part 725, subpart J.

• LHWCA:33 U.S.C. 907, 939; 20 CFR part 702, subpart D.

II. Desired Focus of Comments

OWCP is soliciting comments concerning the proposed information collection (ICR) titled, “Authorization Request Form and Certification/Letter of Medical Necessity for Compounded Drugs”, OWCP–26.

OWCP is particularly interested in comments that:

• Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information has practical utility;
• Evaluate the accuracy of OWCP's estimate of the burden related to the information collection, including the validity of the methodology and assumptions used in the estimate;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the information collection on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Background documents related to this information collection request are available at https://regulations.gov and at DOL–OWCP located at 200 Constitution Avenue NW, Room S–3524, Washington, DC 20210. Questions about the information collection requirements may be directed to the person listed in the FOR FURTHER INFORMATION section of this notice.

III. Current Actions

This information collection request concerns the Authorization Request Form and Certification/Letter of Medical Necessity for Compounded Drugs (OWCP–26).

OWCP has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request from the previous information collection request.

Type of Review: Extension, without change, of a currently approved collection.

Agency: Office of Workers' Compensation Programs OWCP.

OMB Number: 1240–0NEW.

Affected Public: Individuals or Households; Business or other for-profit.

Number of Respondents: 78.

Frequency: On occasion.

Number of Responses: 490.

Annual Burden Hours: 245 hours.

Annual Respondent or Recordkeeper Cost: $28,116.20.

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

Comments submitted in response to this notice will be summarized in the request for Office of Management and Budget approval of the proposed information collection request; they will become a matter of public record and will be available at https://www.reginfo.gov.

Anjanette Suggs,

Certifying Officer.