Notice2024-01535
Proposed Extension of Information Collection; [Authorization and Certification/Letter of Medical Necessity (CA-26/CA-27)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 26, 2024
Issuing agencies
Labor DepartmentWorkers' Compensation Programs Office
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 18 (Friday, January 26, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5263-5265]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-01535]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
<bullet> Mail/Hand Delivery: Mail or visit DOL- OWCP/DFELHWC,
Office of
[[Page 5264]]
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.
<bullet> OWCP/DFELHWC will post your comment as well as any
attachments, except for information submitted and marked as
confidential, in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Anjanette Suggs, Office of Workers'
Compensation Programs, Division of Federal Employees Longshore, and
Harbor Workers' Compensation, OWCP/DFELHWC, at <a href="/cdn-cgi/l/email-protection#e89b9d8f8f9bc689868289868d9c9c8da88c8784c68f879e"><span class="__cf_email__" data-cfemail="c4b7b1a3a3b7eaa5aaaea5aaa1b0b0a184a0aba8eaa3abb2">[email protected]</span></a>
(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, <a href="http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm">http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm</a>.
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:
<bullet> 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;
<bullet> Evaluate the accuracy of OWCP/DFELHWC's estimate of the
burden related to the information collection, including the validity of
the
[[Page 5265]]
methodology and assumptions used in the estimate;
<bullet> Suggest methods to enhance the quality, utility, and
clarity of the information to be collected; and
<bullet> 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 <a href="https://regulations.gov">https://regulations.gov</a> 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 <a href="https://www.reginfo.gov">https://www.reginfo.gov</a>.
Anjanette Suggs,
Certifying Officer.
[FR Doc. 2024-01535 Filed 1-25-24; 8:45 am]
BILLING CODE 4510-CH-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 26, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.