[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5263-5265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01535]


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DEPARTMENT OF LABOR

Office of the Worker's Compensation Programs

[OMB Control No. 1240-0055]


Proposed Extension of Information Collection; [Authorization and 
Certification/Letter of Medical Necessity (CA-26/CA-27)

AGENCY: Division of Federal Employees' Longshore and Harbor Workers' 
Compensation, Office of Workers' Compensation, (OWCP/DFELHWC), Labor.

ACTION: Request for public comments.

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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/DFELHWC is soliciting comments on the information 
collection for Authorization and Certification/Letter of Medical 
Necessity, CA-26/CA-27.

DATES: All comments must be received on or before March 26, 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/DFELHWC, 
Office of

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Workers' Compensation Programs, Division of Federal Employees' 
Longshore and Harbor Workers' Compensation, U.S. Department of Labor, 
200 Constitution Ave. NW, Room S-3323, Washington, DC 20210.
     OWCP/DFELHWC 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, Division of Federal Employees Longshore, and 
Harbor Workers' Compensation, OWCP/DFELHWC, at [email protected] 
(email); (202) 354-9660.

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 medications (which may contain opioids) 
have two or more ingredients and are offered as an alternative to 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, FDA, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm.
    The President had previously announced in October 2015 that several 
initiatives would be undertaken by the Federal Government as it related 
to opioid abuse and the heroin epidemic, noting that the Centers for 
Disease Control and Prevention (CDC) reported that overdose deaths 
involving prescription opioids quadrupled between 1999 and 2013, with 
more than 16,000 deaths in 2013. The CDC has identified addiction to 
prescription pain medication as the strongest risk factor for heroin 
addiction.
    On March 23, 2016, the President, responding to the escalation of 
prescription opioid abuse and the heroin epidemic, announced several 
actions taken by his Administration to address the epidemic, including 
steps to expand access for treatment, prevent overdose deaths and 
increase community prevention strategies.
    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 such drugs 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 that have been shown to 
be safe and effective.

Impacts on the FECA Program

    The Federal Employees' Compensation Act (FECA), 5 U.S.C. 8101 et 
seq., provides compensation benefits to Federal employees for work-
related injury/illness and to their surviving dependents if a work-
related injury/illness results in the employee's death. Section 8145 
provides the Secretary of Labor the authority to delegate the 
responsibility to administer the FECA program to OWCP; through this 
delegation OWCP has the authority and the responsibility to decide all 
questions arising under the FECA. 5 U.S.C. 8145.
    Section 8103 provides:
    The United States shall furnish to an employee who is injured while 
in the performance of duty, the services, appliances, and supplies 
prescribed or recommended by a qualified physician, which the Secretary 
of Labor considers likely to cure, give relief, reduce the degree or 
the period of disability, or aid in lessening the amount of the monthly 
compensation. 5 U.S.C. 8103.
    A number of injured workers receiving benefits under the FECA 
program are prescribed opioid medication. While most prescriptions are 
short term in nature, some patients remain on these habit-forming 
medications for a long period of time.
    Statutorily, FECA is mandated to provide medically necessary 
supplies and services to treat work related injuries. However, the FECA 
statute gives broad discretionary authority to determine the medical 
necessity of supplies and services used to treat work related injuries. 
Due to the safety concerns for both compounded drugs and opioids, the 
Department of Labor has deemed it necessary to more closely review the 
medical necessity of these medications in FECA claims by instituting a 
pre-authorization process.
    OWCP believes that the two forms used to monitor compound and 
opiate medication further strengthens medical management procedures for 
prescription drugs, assist our stakeholders in controlling costs from 
medically unnecessary treatments, and lessen the impact of potential 
drug addiction and medical fraud.
    A major goal of the FECA program is to return an injured employee 
back to employment as soon as medically feasible. The forms that are in 
use serve as a means for injured workers to continue receiving opioids 
and compounded drugs only where medically necessary and simultaneously 
give OWCP greater oversight in monitoring their use.
    OWCP has issued regulations relating to its authority to require 
prior authorization for medical treatment which will now be applied 
through these forms to compounded drugs and opioids. (20 CFR 10.310, 
10.800 & 10. 809). Requiring Prior Authorization will assist OWCP in 
determining whether the prescribed medication will assist in curing, 
giving relief, and lessening the degree of disability. FECA further 
provides OWCP the authority to conduct such investigation as necessary 
before making an award of compensation (including the need for medical 
treatment by certain prescription drugs). 5 U.S.C. 8124(a)(2). Finally, 
5 U.S.C. 8149 provides OWCP the authority to prescribe rules and 
regulations necessary for the administration of FECA.
    As such, the CA-26, Authorization Request form and Certification/
Letter of Medical Necessity for Compounded Drugs, and CA-27, 
Authorization Request form and Certification/Letter of Medical 
Necessity or Opioid Medications, fulfill these requirements and 
obligations under the FECA.

II. Desired Focus of Comments

    OWCP is soliciting comments concerning the proposed information 
collection (ICR) titled, ``Authorization and Certification/Letter of 
Medical Necessity'', CA-26/CA-27.
    OWCP/DFELHWC 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/DFELHWC's estimate of the 
burden related to the information collection, including the validity of 
the

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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/DFELHWC 
located at 200 Constitution Avenue NW, Room S-3323, Washington, DC 
20210. Questions about the information collection requirements may be 
directed to the person listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice.

III. Current Actions

    This information collection request concerns the Authorization and 
Certification/Letter of Medical Necessity, CA-26/CA-27.
    OWCP/DFELHWC 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, Division of 
Federal Employees' Longshore, and Harbor Workers' Compensation, OWCP/
DFELHWC.
    OMB Number: 1240-0055.
    Affected Public: Individuals or households; business or other for-
profit.
    Number of Respondents: 1,104.
    Frequency: On occasion.
    Number of Responses: 4,212.
    Annual Burden Hours: 2,106 hours.
    Annual Respondent or Recordkeeper Cost: $241,685.00.
    OWCP Form CA-26/CA-27, Authorization and Certification/Letter of 
Medical Necessity.
    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.
[FR Doc. 2024-01535 Filed 1-25-24; 8:45 am]
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