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 ( printed page 8030) contained 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. See5 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).

85 FR 8029