Pre-Claim Review Demonstration For Home Health Services (CMS-10599)

Forms and Documents

Document Name	Status
Form CMS-10599 HH Demo Fax and Electronic Submissions and Resubmissions (16 States) Form	Modified
CMS-10599 Supporting Statement .docx Supporting Statement A	2025-09-22

IC Document Collections

IC ID	Document Title	Status
222826	HH Demo - Home Health Agency Education (16 States) Instruction	Modified
222825	HH Demo for Mailed Requests (16 States) Instruction	Modified
222824	HH Demo Fax and Electronic Submissions and Resubmissions (16 States) Form	Modified

ICR Details

OMB Control No: 0938-1311	ICR Reference No: 202509-0938-019
Status: Received in OIRA	Previous ICR Reference No: 202205-0938-011
Agency/Subagency: HHS/CMS	Agency Tracking No: CPI
Title: Pre-Claim Review Demonstration For Home Health Services (CMS-10599)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/22/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	3,177,716	2,688,139
Time Burden (Hours)	1,600,608	1,357,224
Cost Burden (Dollars)	74,047,943	2,675,200

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Abstract: The Centers for Medicare & Medicaid Services (CMS) is requesting the Office of Management and Budget (OMB) approval for the Pre-Claim Review Demonstration for Home Health Services. This demonstration would help assure that payments for home health services are appropriate before the claims are paid, thereby preventing fraud, waste, and abuse. CMS proposes performing prior authorization before processing claims for home health services in: Florida, Texas, Illinois, Michigan, and Massachusetts.

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Authorizing Statute(s): PL: Pub.L. 90 - 248 234 Name of Law: Social Security Act
  

Citations for New Statutory Requirements: PL: Pub.L. 90 - 248 234 Name of Law: Social Security Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 31207	07/14/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 45216	09/19/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
HH Demo - Home Health Agency Education (16 States)
HH Demo Fax and Electronic Submissions and Resubmissions (16 States)	CMS-10599	Home Health Instrument
HH Demo for Mailed Requests (16 States)

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	3,177,716	2,688,139	0	489,577	0	0
Annual Time Burden (Hours)	1,600,608	1,357,224	0	243,384	0	0
Annual Cost Burden (Dollars)	74,047,943	2,675,200	0	71,372,743	0	0

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: Due to the addition of a sixth state and an increase in the annual clerical hourly rate and loaded rate, the burden estimate has increased from $26.9 million to $33.8 million for the initial demonstration states and from $49.1 million to $74 million for all 16 states.

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Annual Cost to Federal Government: $88,700,000

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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/22/2025

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