81 FR 40721 - Proposed Collection of Information; Comment Request

DEPARTMENT OF LABOR
Office of Workers' Compensation Programs

Federal Register Volume 81, Issue 120 (June 22, 2016)

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. 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.

[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40721-40722]
From the Federal Register Online  [www.thefederalregister.org]
[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]
 BILLING CODE 4510-CH-P