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OMB Control No: 0938-1368	ICR Reference No: 202607-0938-012
Status: Received in OIRA	Previous ICR Reference No: 202405-0938-022
Agency/Subagency: HHS/CMS	Agency Tracking No: CPI
Title: Prior Authorization Process and Requirements for Certain Hospital Outpatient Department (OPD) Services (CMS-10711)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 07/14/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2027
Responses	847,339	564,010
Time Burden (Hours)	357,967	316,412
Cost Burden (Dollars)	14,529,836	846,013

Abstract: The Centers for Medicare & Medicaid Services (CMS) is requesting the Office of Management and Budget (OMB) approval for adding an additional service category to the established prior authorization process and requirements for certain outpatient department (OPD) services. This process is under the authority of §1833(t)(2)(F) which authorizes the Secretary to develop a method for controlling unnecessary increases in the volume of covered OPD services. In the CY 2020 OPPS/ASC final rule, CMS established criteria for identifying a list of outpatient department services requiring prior authorization and focused on five groups of OPD services – blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty, vein ablation, and their related services. As part of the CY 2021 OPPS/ASC Final Rule (CMS -1736-FC), we added two more service categories to the prior authorization process - cervical fusion with disc removal and implanted spinal neurostimulators. Through the CY 2023 OPPS/ASC Final Rule (CMS-1772-FC), CMS added eighth service category to the list of OPD services requiring prior authorization- facet joint interventions. As part of the CY 2027 OPPS/ASC rule, CMS is expanding prior authorization requirements to include additional Botulinum Toxin Injection services. This addition would be incorporated into the existing list of OPD services requiring prior authorization at § 419.83(a) for dates of service provided on or after July 1, 2027. CMS recently completed an analysis of the volume of covered OPD services furnished and recognized significant increases in the utilization volume of these additional services. CMS believes a prior authorization process for these additional services would ensure beneficiaries receive medically necessary care while protecting the Medicare Trust Funds from improper payments and unnecessary utilization.

Authorizing Statute(s): US Code: 42 USC 1895I Name of Law: Social Security Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV83	Proposed rulemaking	91 FR 41734	07/07/2026

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	847,339	564,010	283,329
Annual Time Burden (Hours)	357,967	316,412	41,555
Annual Cost Burden (Dollars)	14,529,836	846,013	13,683,823

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: As part of the CY 2027 OPPS/ASC rule, CMS is expanding prior authorization requirements to include additional Botulinum Toxin Injection services. This addition would be incorporated into the existing list of OPD services requiring prior authorization at § 419.83(a) for dates of service on or after July 1, 2027. Data analysis for this service showed a claim volume increase greater than expected based on the growth rate for OPD services overall. This increase has increased the collections burden.

Annual Cost to Federal Government: $57,800,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov

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