[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40721-40722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14818]
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DEPARTMENT OF LABOR
Office of Workers' Compensation Programs
Proposed Collection of Information; Comment Request
AGENCY: Division of Federal Employees' Compensation, Office of Workers'
Compensation Programs, Department of Labor.
ACTION: Notice.
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SUMMARY: The Department of Labor, as part of its continuing effort to
reduce paperwork and respondent burden, conducts a preclearance
consultation program to provide the general public and Federal agencies
with an opportunity to comment on proposed and/or continuing
collections of information in accordance with the paperwork Reduction
Act of 1995 (PRA95) [44 U.S.C. 3506 (c)(2)(A)] This program 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.
[[Page 40722]]
Currently, the Office of Workers' Compensation Programs is
soliciting comments concerning the proposed collection: Authorization
Request form and Certification/Letter of Medical Necessity for
Compounded Drugs (CA-26) and Authorization Request form and
Certification/Letter of Medical Necessity for Opioid Medications (CA-
27). A copy of the proposed information collection request can be
obtained by contacting the office listed below in the addresses section
of this Notice.
DATES: Written comments must be submitted to the office listed in the
addresses section below on or before August 22, 2016.
ADDRESSES: Ms. Yoon Ferguson, U.S. Department of Labor, 200
Constitution Ave. NW., Room S-3323, Washington, DC 20210, telephone/fax
(202) 354-9647, Email [email protected]. Please use only one method
of transmission for comments (mail or Email).
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Labor (DOL) is requesting an approval of a new
information collection. This information collection is essential to the
mission of DOL and the Office of Workers' Compensation Programs (OWCP),
to monitor and assure the appropriate use of opioids and compounded
drugs in treating employment-related injuries under the Federal
Employees Compensation Act (FECA), 5 U.S.C. 8101 et seq.
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. 20 CFR 10.310. 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. The FECA program does not currently have any
limitations on payment for opioids generally or for compounded drugs.
The FECA program is establishing a prior authorization policy for
opioid and compounded drugs (at this time after first fill) utilizing
the pre-authorization authority already contained in its regulations at
20 CFR 10.310(a) and Sec. 10.800(b). In requiring the use of these
forms for opioid and compounded drugs, OWCP is implementing a prior-
authorization process based on medical necessity.
The forms, Authorization Request Form and Certification/Letter of
Medical Necessity for Compounded Drugs (CA-26) and Authorization
Request Form and Certification/Letter of Medical Necessity
Certification/Letter of Medical Necessity for Opioid Medications (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 will also permit
OWCP to more easily track the volume, type, and characteristics of
opioids and compounded drugs authorized by the FECA program. The forms
will 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.
II. Review Focus
The Department of Labor is particularly interested in comments
which:
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 submissions of responses.
III. Current Actions
The Department of Labor seeks the approval of this new information
collection in order to carry out its responsibility to meet the
statutory requirements of the Federal Employees' Compensation Act.
Agency: Office of Workers' Compensation Programs.
Type of Review: New Collection (Request for New OMB control
Number).
Title: Authorization and Certification/Letter of Medical Necessity.
OMB Number: 1240-0NEW.
Agency Number: CA-26 and CA-27.
Affected Public: Individuals or households; Businesses or other
for-profit.
Total Respondents: 80,000.
Total Annual Responses: 65,600.
Estimated Total Burden Hours: 40,000.
Estimated Time per Response: 30 minutes.
Frequency: On occasion.
Total Burden Cost (capital/startup): $0.
Total Burden Cost (operating/maintenance): $0.
Comments submitted in response to this notice will be summarized
and/or included in the request for Office of Management and Budget
approval of the information collection request; they will also become a
matter of public record.
Dated: June 16, 2016.
Yoon Ferguson,
Agency Clearance Officer, Office of Workers' Compensation Programs,
U.S. Department of Labor.
[FR Doc. 2016-14818 Filed 6-21-16; 8:45 am]
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