Supporting Statement Form CMS-381 (OMB 0938-0273)

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    A. Background

This is a request for revision of Form CMS-381, which is approved for collection under OMB Control Number (0938-0273). CMS has provided greater clarity in the “Instructions for Completing Form CMS-381” and updated CMS website information. The changes included submitting the form during recertification through an attestation process in lieu of an on-site survey by state survey agencies. After the 60-day Federal Register notice, which was published May 18, 2026 (91 FR 28596), CMS determined that we would not pursue attestation through recertification. Instead, we will continue recertification through an onsite survey, and CMS removed the attestation instructions.  Additionally, a small change in burden resulted from an omission in the calculation. 

Form CMS-381 was developed to ensure that each OPT/OSP extension location at which OPT/OSP providers furnish services must be reported by the providers to the State Survey Agencies (SAs). 
CMS currently requires the CMS-381 form for initial certification, during recertification surveys, and when the OPT/OSP requests changes to its locations. CMS issued guidance consistent with this change via policy memorandum QSO-24-18-OPT.

The OPT/OSP providers may render services on their already approved premises and the premises of other institutions (e.g., skilled nursing facilities) or on a premise owned/leased/rented by the OPT/OSP.   If the OPT/OSP bills the Medicare program for these services and renders these services in an area within the institution set aside for rehabilitation care, these premises are considered extension locations of the OPT/OSP.  However, a patient’s home is not considered an extension location.

Extension locations are considered part of the OPT/OSP provider’s primary location and are subject to the same approval policy as is applicable to the OPT/OSP primary site.  In addition to meeting applicable sections of the conditions of participation for all outpatient physical therapy/speech pathology providers, these extension locations fall under the OPT/OSP provider agreement and are identified under the OPT/OSP provider number.

Form CMS-381 is completed when: (1) new OPT/OSP providers enter the Medicare program (initial certification); (2) when existing OPT/OSP providers delete or add a service, or close or add an extension location; or, (3) when existing OPT/OSP providers are recertified by the State Survey Agency (SA) through survey. Note, for deemed OPT/OSP providers under a CMS-approved Accrediting Organization (AO), the CMS-381 will continue to voluntarily be part of the reaccreditation surveys at least every 36 months.

Form CMS-381 is used by the SA, AO, and by the CMS Survey Operations Group to identify extension locations where services are furnished by providers of outpatient physical therapy and speech-language pathology services.  These locations must be known to surveyors to ensure the appropriate monitoring of providers’ compliance with the Federal requirements.

    B. Justification

        1. Need and Legal Basis

In accordance with Title XVIII of the Social Security Act, Section 1861(p), the collection of this information is authorized by 42 CFR Part 485.701-485.729 pursuant to Sections 1864 and 1875 of the Social Security Act, requiring that providers and suppliers of services to Medicare beneficiaries meet such requirements as the Secretary finds necessary to ensure the health and safety of individuals who are furnished such services.  For Medicare purposes, certification is based on the State survey agency’s reporting of a provider’s or supplier’s compliance or noncompliance with the health and safety requirements published in federal regulations.  To determine compliance with these requirements, the Secretary has authorized CMS to contract with State Survey Agencies to conduct surveys of providers and suppliers.

Form CMS-381 supports the initial certification process for a prospective OPT/OSP and aligns with the process for obtaining a decision on whether the conditions of participation are met.  The form is used by the State Agencies (SAs) to enter the new provider into the national surveyor database. The form is also used for recertification of the provider as well as when the provider makes any changes to its primary or extension locations. As defined in 42 CFR 485.703, an extension location is “a location or site from which a rehabilitation agency provides services within a portion of the total geographic area served by the primary site. The extension location is part of the rehabilitation agency. The extension location should be located sufficiently close to share administration, supervision, and services in a manner that renders it unnecessary for the extension location to independently meet the conditions of participation as a rehabilitation agency.” The regulations at 42 CFR 485.703 have no restrictions that require an organization wishing to participate in the Medicare program to have a CMS-approved primary site prior to a request for an extension location.

Collection of this information is used in conjunction with Conditions of Participation at 42 CFR §485.701 through §485.729 governing the operation of providers of outpatient physical therapy and speech-language pathology services. 

In short, the provider will use the CMS-381 upon 1) initial certification; 2) reporting any changes to operations (as needed); and 3) when existing OPT/OSP providers are recertified by the SA through survey every 6 years. Deemed OPT/OSPs will continue to report at least every 36 months upon survey from a CMS-approved AO. 


        2. Information Users

Form CMS-381 is used by the SAs, AOs, and the CMS Survey Operations Group to identify information about the OPT/OSP’s operation, including its extension locations where services are furnished by providers of outpatient physical therapy and speech-language pathology services.  The Form ensures appropriate monitoring of providers’ compliance with the Federal requirements.



        3. Improved Information Technology

This form does not request anything other than identifying data for the OPT/OSP providers, including primary and extension sites and the types of services provided at these sites. OPT/OSP providers can complete Form CMS-381 using PDF form-filler software such as Adobe Acrobat Pro or by handwriting their responses on the form.  

OPT/OSP providers will send the revised Form CMS-381 to the MAC with the initial request for participation (e.g., CMS-855 application) and when the OPT is requesting a new extension location or closing an extension location. The OPT/OSP will also complete the form upon a recertification survey at least every six years for SAs and at least every 36 months if deemed under a CMS AO.


        4. Duplication

Form CMS-381 does not duplicate existing data collection.  No forms exist that are similar or collect this data.


        5. Small Business

Form CMS-381 will affect large and small business OPT/OSP providers alike.  However, the burden of completing Form CMS-381 is minimal and would not place undue stress on small business OPT/OSP providers.  This data is also not available from any other source.


        6. Less Frequent Collection

Collection of this information coincides with the certification survey. If the information were collected less frequently than annually, it would result in surveys not being completed in projected timeframes and inefficient use of survey personnel.


        7. Special Circumstances

No special circumstances exist for this information collection. 


        8. Federal Register and Outside Consultation

The 60-day Federal Register notice published on May 18, 2026 (91 FR 28596). There were no public comments received.

The 30-day Federal Register notice published on October 29, 2026 (91 FR 68150).

        9. Payments or Gifts

There are no payments/gifts to respondents.

        10. Confidentiality

CMS does not assure confidentiality.


        11. Sensitive Questions

There are no sensitive questions on this form.


        12. Estimate of Burden (Hours and Wages)


    a. Time and Cost Burdens Related to the Completion of the CMS-381 Forms By OPT/OSP Providers for All Purposes.  

The Form CMS-381 is completed when the following circumstances occur:
    (1) When new OPT/OSP providers enter the Medicare program; 
    (2) When existing OPT/OSP providers: 
    a. delete a service, 
    b. add a service, or 
    c. close an extension location; or 
    d. add an extension location; or 
(3) When existing OPT/OSP providers are recertified by the State Survey Agency through survey every 6 years or for deemed OPT/OSPs at least every 36 months. 

There are approximately 44 new OPT/OSP providers each year. The average was calculated based on the last three years of data (62 new in FY 2023; 41 new in FY 2024; 28 new in FY 2025).  There are currently 1,923 active OPT/OSP providers as of November 2025.

We estimate that approximately 5% of our 1,923 existing OPT/OSP providers would delete or add a service, or close or add an extension location each year.  This means 96 OPT/OSP providers would need to complete Form CMS-381 due to programmatic changes.

        ◦ 1,923 OPT/OSP providers X .05 = 96


OPT/OSP providers are recertified by the State Survey Agency every 6 years via survey.  There are currently 1,923 existing OPT/OSP providers.  Of the total active OPTs/OSPs, 247 are deemed through a CMS approved AO.

This means that the State Survey Agency would recertify approximately 279 non-deemed OPT/OSP providers each year, and the OPT/OSP would complete Form CMS-381.

        ◦ 1,676 non-deemed OPT/OSP providers divided by 6 years = 279 

For deemed OPTs/OSPs, this means that the AO would recertify approximately 82 deemed OPT/OSP providers each year. This means the OPT/OSP would complete Form CMS-381 at least every 36 months upon reaccreditation survey (optional).

        ◦ 247 deemed OPT/OSP providers divided by 3 years = 82

Based on the information above, we estimate that a total of 501 OPT/OSP providers would complete Form CMS-381 each year.

    • 44 new OPT/OSP providers each year + 96 (5% updates) + 279 (non-deemed) + 82 (deemed)= 501 

We estimate that it would take the OPT/OSP providers approximately 30 minutes to complete Form CMS-381. The form changes do not increase the time required from the previous iteration. We believe that the information required to respond to each question would be easily accessible in the OPT/OSP facility.

We estimate that the total annual time burden for the completion of all 501 Form CMS-381 forms annually would be 251 hours.

    • 501 Form CMS-381 annually x 30 minutes per each form = 15,030 minutes
    • 15,030 minutes divided by 60 minutes per hour = 251 hours

We believe that the person at the OPT/OSP facility that would complete the CMS-381 would be a Healthcare Support Staff.  According to the U.S. Bureau of Labor Statistics, the mean average hourly wage for Healthcare Support positions is $32.04 (https://www.bls.gov/oes/current/oes310000.htm )  

We estimate that the total cost burden associated with the completion of each form CMS-381 would be $16.02.

    • $ 32.04 per hour x 0.5 hour = $16.02

We further estimate the total annual cost burden across all CMS-381 forms at $8,026.

    • ($16.02 x 44) + ($16.02 x 96) + ($16.02 x 279) + ($16.02 x 82) = $8,026 


    b. Summary of Time and Cost Burdens Associated With The CMS-381 Form.

Task
Number of Annual Responses
Time Per Response
Annual Hour Burden
Across All Providers
Cost Per Response
Annual Cost Burden Across All Providers
Number of new OPT/OSP providers that complete the CMS-381 form when submitting their initial application for participation in the Medicare program
44 

0.5 
hours 
22 hours
$16.02
$704.88
Completion of the CMS-381 form for addition or deletion of a service; or add or close an extension
96
0.5 
hours
48 
hours
$16.02
$1,537.92
Completion of CMS-381 forms for recertification of non-deemed OPT/OSP providers
279
0.5 
hours
140 
hours
$16.02
$4,469.58
Completion of CMS-381 forms for deemed OPT/OSP providers
82
0.5 
hours
41 hours
$16.02
$1,313.64
TOTAL TIME & COST BURDENS RELATED TO THE CMS-381 FORM
501 responses
0.5 
hours
251 hours
$16.02
$8,026


        13. Capital Costs

There are no capital costs.


        14. Federal Cost Estimates

CMS pays all states $397 million per year to conduct surveys of all providers. This amount is appropriated by Congress each year and is intended to cover the costs associated with surveying providers, including completing/reviewing the CMS 381 form.


        15. Burden Changes/Program Changes

The table below compares the time and cost burden in the current PRA package to that which was approved in the previous PRA package, and shows what, if any, change in burden has occurred.

Description
Amount Requested In Current PRA Package
Amount Approved in Previous PRA Package
Change in Burden
Number of new OPT/OSP providers that complete the CMS-381 form when submitting their initial application for participation in the Medicare program
44 
respondents
78 
respondents
-34 
respondents
Number of annual respondents who use the CMS-381 form to delete or add a service, or close or add an extension location 
96 
respondents
99 
respondents
-3 
respondents
Number of annual deemed respondents (accredited by an AO) who would submit the CMS-381 form at the time of  recertification
82 
respondents
0 
respondents
+82 
respondents
Number of non-deemed annual respondents who submit the CMS-381 form at the time of recertification
279 
respondents
329 respondents
-50 
respondents
Annual time burden related to the CMS-381 form across all OPT/OSP providers
251 
hours
253 
hours
-2 
hours
Annual cost burden related to the CMS-381 form across all OPT/OSP providers
$8,026
$8,106
-$80
Total Annual Number of Respondents
501 
respondents
506 
respondents
-5 
respondents
Annual Time Burden Across All OPT/OSPs
251 
hours
253 
hours
-2
hours
Annual Total Cost Across OPT/OSPs
$8,026
$ 8,106
-$80

Between the 60-day and 30-day notices, CMS corrected an omission in the burden calculations section.  We added approximately 44 new OPT/OSP providers per year who complete the CMS-381 form. Overall, between the last PRA submission and the current one, the number of respondents decreased by 5, the total annual time burden decreased by 2 hours, and the total annual cost burden decreased by $80. These changes are minimal and can be attributed to the decrease in the number of respondents.

        16. Publication and Tabulation Dates

There are no publication or tabulation dates.

        17. Expiration Date

CMS will display the expiration date on the collection instrument.

        18. Certification Statement

There are no exceptions to the certification statement.

    C. Collections Of Information Employing Statistical Methods

There are no statistical methods employed in this information collection.