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

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ACTION:

Notice of availability; request for comments.

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 DOL_PRA_PUBLIC@dol.gov.

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: OIRA_submission@omb.eop.gov. 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: DOL_PRA_PUBLIC@dol.gov.

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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 DOL_PRA_PUBLIC@dol.gov.

End Further Info End Preamble Start Supplemental Information

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 Start Printed Page 8030contained in its regulations at 20 CFR 10.310(a) and § 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.

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

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Dated: February 4, 2020.

Frederick Licari,

Departmental Clearance Officer.

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[FR Doc. 2020-02730 Filed 2-11-20; 8:45 am]

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