[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Notices]
[Pages 8029-8030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02730]


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DEPARTMENT OF LABOR

Office of the Secretary


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Authorization Request Forms/Certification/
Letter of Medical Necessity

ACTION: Notice of availability; request for comments.

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SUMMARY: The Department of Labor (DOL) is submitting the Office of 
Worker's Compensation Programs (OWCP) sponsored information collection 
request (ICR) titled, ``Authorization Request Forms/Certification/
Letter of Medical Necessity'' to the Office of Management and Budget 
(OMB) for review and reinstatement, without change, in accordance with 
the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR 
are invited.

DATES: The OMB will consider all written comments that agency receives 
on or before March 13, 2020.

ADDRESSES: A copy of this ICR with applicable supporting documentation; 
including a description of the likely respondents, proposed frequency 
of response, and estimated total burden may be obtained free of charge 
from the RegInfo.gov website at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201906-1240-001 (this link will only become active 
on the day following publication of this notice) or by contacting 
Frederick Licari by telephone at 202-693-8073, TTY 202-693-8064, (these 
are not toll-free numbers) or by email at [email protected].
    Submit comments about this request by mail to the Office of 
Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-
OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW, 
Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free 
number); or by email: [email protected]. Commenters are 
encouraged, but not required, to send a courtesy copy of any comments 
by mail or courier to the U.S. Department of Labor--OASAM, Office of 
the Chief Information Officer, Attn: Departmental Information 
Compliance Management Program, Room N1301, 200 Constitution Avenue NW, 
Washington, DC 20210; or by email: [email protected].

FOR FURTHER INFORMATION CONTACT: Frederick Licari by telephone at 202-
693-8073, TTY 202-693-8064, (these are not toll-free numbers) or by 
email at [email protected].

SUPPLEMENTARY INFORMATION: This ICR seeks to reinstate PRA authority 
for the Authorization Request Forms/Certification/Letter of Medical 
Necessity information collection. The FECA statute grants OWCP 
discretion to provide an injured employee the ``services, appliances, 
and supplies prescribed or recommended by a qualified physician'' which 
OWCP 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. In other words, OWCP is mandated to 
provide medical supplies and services--including prescription drugs 
such as opioids and compounded drugs--that it considers medically 
necessary. The FECA statute and implementing regulations are not 
primarily focused on managing doctor/patient decisions relating to 
medication therapy and, with the exception of few limitations on 
fentanyl (an opioid) and other controlled substances, the FECA program 
policy on pharmacy benefits has generally been a policy of payment for 
prescribed medications in accordance with a fee schedule based on a 
percentage of the average wholesale price (AWP) for drugs identified by 
a National Drug Code (NDC). See 20 CFR 10.809. To this end, the FECA 
program has a prior authorization policy (based on medical necessity) 
for opioid and compounded drugs utilizing the pre-authorization 
authority already

[[Page 8030]]

contained in its regulations at 20 CFR 10.310(a) and Sec.  10.800(b). 
Information collected on the CA-26 and the CA-27, require an injured 
worker's treating physician to answer a number of questions about the 
prescribed opioids and/or compounded drugs and certify that they are 
medically necessary to treat the work-related injury. The responses to 
the questions on the forms are intended to ensure that treating 
physicians have considered non-opioid and non-compounded drug 
alternatives, and are only prescribing the most cost effective and 
medically necessary drugs. The forms also permit OWCP to more easily 
track the volume, type, and characteristics of opioids and compounded 
drugs authorized by the FECA program. The forms 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 appropriate use and gather additional 
data about their use.
    This information collection is subject to the PRA. A Federal agency 
generally cannot conduct or sponsor a collection of information, and 
the public is generally not required to respond to an information 
collection, unless the OMB under the PRA approves it and displays a 
currently valid OMB Control Number. In addition, notwithstanding any 
other provisions of law, no person shall generally be subject to 
penalty for failing to comply with a collection of information that 
does not display a valid Control Number. See 5 CFR 1320.5(a) and 
1320.6. The DOL obtains OMB approval for this information collection 
under Control Number 1240-0055.
    OMB authorization for an ICR cannot be for more than three (3) 
years without renewal. The DOL seeks to reinstate PRA authorization for 
this information collection for three (3) more years, without any 
change to existing requirements. For additional substantive information 
about this ICR, see the related notice published in the Federal 
Register on November 6, 2019 (84 FR 59842).
    Interested parties are encouraged to send comments to the OMB, 
Office of Information and Regulatory Affairs at the address shown in 
the ADDRESSES section within thirty-(30) days of publication of this 
notice in the Federal Register. In order to help ensure appropriate 
consideration, comments should mention OMB Control Number 1240-0055. 
The OMB is particularly interested in comments that:
     Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility:
     Evaluate the accuracy of the agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used.
     Enhance the quality, utility, and clarity of the 
information to be collected; and
     Minimize the burden of the collection of information 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.
    Agency: DOL-OWCP.
    Title of Collection: Authorization Request Forms/Certification/
Letter of Medical Necessity.
    OMB Control Number: 1240-0055.
    Affected Public: Individuals or households.
    Total Estimated Number of Respondents: 45,600.
    Total Estimated Number of Responses: 45,600.
    Total Estimated Annual Time Burden: 22,800 hours.
    Total Estimated Annual Other Costs Burden: $0.

    Authority:  44 U.S.C. 3507(a)(1)(D).

    Dated: February 4, 2020.
Frederick Licari,
Departmental Clearance Officer.
[FR Doc. 2020-02730 Filed 2-11-20; 8:45 am]
 BILLING CODE 4510-CH-P