CMS 370 and 377 Supporting Statement. 08.21.24

Supporting Statement Part A

ASC Forms for Medicare Program Certification 

(CMS-370 & CMS-377)

I. Background

This is a reinstatement with change package. This package includes an increase in the burden time for both CMS-370 and CMS-377. To receive Medicare payment, Ambulatory Surgical Centers (ASCs) are required to comply with the Federal requirements set forth in the Medicare Conditions for Coverage (CfCs) at 42 CFR Part 416, Subparts A through C (§416.1 to §416.54). An ASC’s compliance with the Centers for Medicare and Medicaid Services (CMS) requirements and CfCs is accomplished through survey and certification by the State Survey Agency (SA) or by an accrediting organization (AO).

The CMS-370 form, titled “Health Insurance Benefits Agreement”, is used for the purpose of establishing an ASC’s eligibility for payment under Title XVIII of the Social Security Act (the “Act”). An ASC must complete the CMS-370 form when requesting initial participation in the Medicare program.

The agreement set forth in the CMS-370 form, upon acceptance by the Secretary of The Department of Health & Human Services, shall be binding on the ASC and the Secretary. The agreement may be terminated by either party in accordance with regulations. In the event of termination of this agreement, payment will not be made for the services furnished by the ASC to Medicare beneficiaries on or after the effective date of termination.

The CMS-377 must be completed new ASCs at the time they request participation in the Medicare program. The submission of a completed CMS-377 form by a new ASC will trigger the SA to perform the initial certification survey.

The CMS-377 form is used by existing ASCs to initiate their renewal survey. ASCs must complete the CMS-377 form and send it to the applicable SA prior to their scheduled renewal date.

The CMS-377 form provides the SA with information about the ASC facility’s characteristics such as the number of operating rooms (ORs), procedure rooms and the types of surgical procedures performed in the ASC. Knowing this information prior to the survey helps the SA determine what resources are required for the survey.

The time

II. Justification

1. Need and Legal Basis

The survey and certification process for ASCs is authorized by Section 934 of the Omnibus Budget Reconciliation Act (OBRA) of 1980, which is implemented under 42 CFR Part 416. This regulation allows ASCs that meet health, safety, and other standards specified by the Secretary, to participate in Medicare. Section 934 of OBRA amended various sections of the Act, including sections 1832 and 1863 which instruct the Secretary to consult with appropriate SAs and recognized national accreditation bodies in developing the conditions for coverage (health and safety requirements).

Section 1864 of the Act authorized the Secretary to use the SAs in determining compliance with the ASC CfCs.

2. Information Users

The CMS-370 form is used to establish an ASC’s eligibility for payment under Title XVIII of the Social Security Act (the “Act”). The agreement set forth in the CMS-370 form is binding on the ASC and the Secretary. The agreement may be terminated by either party in accordance with regulations.

The SAs conduct certification surveys on several provider and supplier types, including

ASCs. The CMS-377 form is used to gather information on an ASC’s characteristics, such as number of operating and procedure rooms and the types of surgical procedures performed in the ASC. This information assists the SA in determining the size and the composition of the survey team.

In addition, CMS receives inquiries periodically from members of Congress, the Government Accountability Office (GAO), or Office of Inspector General (OIG) concerning the characteristics of participating providers and suppliers. Collection of this data allows CMS to be responsive to inquiries about ASCs.

3. Improved Information Technology

The CMS-370 and CMS-377 forms must be completed and signed by authorized ASC staff member. The CMS-370 form is submitted to the applicable CMS Location. The CMS-377 form is submitted to the SA for the area in which the ASC is located via mail or email.

At this time, there is no process for electronic collection of the CMS-370 and CMS-377 forms. However, CMS has converted the CMS-370 and CMS-377 forms to .pdf fillable versions so that the facilities can fill in their responses using a free pdf program, such as Adobe Acrobat. The facility can save the completed version of the forms and send them to the CMS Location and SA via email. The CMS Location and SA can import the responses from the .pdf fillable electronic versions of the CMS-370 and CMS-377 forms into Excel spreadsheets.

4. Duplication of Similar Information

The CMS-370 and CMS-377 forms address specific requirements for eligibility for participating in the Medicare program, and initial or renewal of certification for Medicare participation and payment purposes. The data collected by these forms is not duplicated by any other information collections.

5. Small Businesses

Many ASCs are small businesses. The time required to complete the CMS-370 and CMS-377 form is minimal. Completion of these forms is necessary to meet the Medicare participation requirements. For example, ASCs are required to submit a CMS-370 form to participate in the Medicare program. New and existing ASCs must submit a CMS-377 form to the applicable SA to initiate an initial or renewal survey.

The use of the .pdf fillable CMS-370 and CMS-377 forms, which are easier to complete and submit to the SAs, will further reduce the burden to small businesses.

6. Less Frequent Collection

ASCs are only required to submit the CMS-370 once when they first seek participation in the Medicare program. Requiring ASCs to enter into the agreement set forth in the CMS-370 form is necessary to assure that they understand all applicable Federal requirements with which they must comply and make a binding commitment for compliance throughout their participation in the Medicare program. Requiring ASCs to enter into this agreement helps to prevent fraud and abuse in the Medicare program and to

If CMS did not require ASCs to enter into the agreement set forth in the CMS-370 form, a binding commitment on the part of ASCs to comply with all applicable Medicare requirements would not exist. The presence of unsafe, fraudulent, or abusive entities in the Medicare program puts patients/residents at risk of harm and diverts resources from the Medicare Trust Funds that are needed to reimburse legitimate claims for medical care provided to Medicare beneficiaries.

The CMS-377 form is collected upon entry of an ASC supplier into the Medicare program and once every three years thereafter when the SA performs the renewal survey. Less frequent collection would not be possible because this form initiates the initial survey for new ASCs and renewal surveys for existing ASC suppliers, which are generally performed every 3 years.

Less frequent collection could result in renewal surveys not being performed in a timely manner. Not having surveys performed on time could result in deficiencies not being detected and corrected in a timely manner which could expose patients to potentially poor care and/or unsafe conditions for a longer period of time before being detected and corrected. Also, CMS would have outdated information about the ASC’s characteristics, which could adversely impact oversight activities.

7. Special Circumstances

There are no special circumstances associated with this collection. This information collection complies with the general guidelines in 5 CFR 1230.6.

8. Federal Register Notice/ Outside Consultation

The 60-day Federal Register notice published on June 14, 2024. (89 FR 50589).

No public comments were received.

The 30-day Federal Register notice published on August 28, 2024 (89 FR 68616).

9. Payment/Gifts to Respondent

There are no payments or gifts associated with this collection.

10. Confidentiality

We do not pledge confidentiality.

11. Sensitive Questions

There are no questions of a sensitive nature on these forms.

12. Burden Estimate (Total Hours & Wages)

As the below table shows. there is a 5-year average of 235 new ASCs established each year.¹

Year	Number of New ASCs
2019	241
2020	189
2021	252
2022	235
2023	256
Average = 235 (Total = 1,173) (1,173 ÷5 = 234.6 )

1. Burden Associated with CMS-370 Form.

The CMS-370 form is completed only by new ASC suppliers when they enter the Medicare program. As stated above, there are an average of 235 new ASCs established each year.

1. Burden Associated with Review of Applicable Statutory and Regulatory Authority by Facility.

Since the form CMS-370 is based on certain statutes and regulatory law, the signer of the form should take time to read the applicable statutory and regulatory language. This statutory and regulatory law includes:

• Section 1832(A)(2)(F) of the Social Security Act

• 42 CFR §416

• 42 CFR §416.120

• 42 CFR §416.130

As stated above, the CMS-370 form is completed by new ASCs that are seeking participation in the Medicare program. There is an average of 235 new ASCs established per year.

We estimate that it would take a someone, who is unfamiliar or minimally familiar with this statutory and regulatory language, approximately 40 minutes to review the applicable law.

We estimate that the annual time burden across all new ASCs for the review of the statutory and regulatory authority associated with the CMS-370 form would be 157 hours.

• 40 minutes x 235 new ASCs per year = 9,400 minutes

• 9,400 minutes divided by 60 minutes per hour = 156.66 hours

We believe that the ASC staff member that would sign the CMS-370 form and review the statutory and regulatory authority associated with this form would be the ASC director, whose job would fall under the U.S. Bureau of Labor’s job classification of Medical and Health Services Manager. According to the U.S. Bureau of Labor, the mean hourly wage for a Medical and Health Services Manager is $61.53 (See: https://www.bls.gov/oes/current/oes119111.htm This wage adjusted for the employer’s overhead and fringe benefits would be $123.06 per hour.

We estimate that the total annual cost burden to each ASC facility for the completion of each CMS-370 form would be $82.04.

• $123.06 per hour divided by 60 min. per hr. = $2.051 per minute

• $2.051 per minute x 40 minutes = $82.04

We further estimate that the total annual cost burden across all ASC deemed facilities, accredited by the SAs, for all of the CMS-370 forms completed would be $19,320.

• 157 hours x $123.06 per hour = $19,320.42

2. Burden Associated with the Completion of the CMS-370 form by New ASCs.

We estimate that it will take approximately 15 minutes for each new ASC supplier to complete the CMS-370 form.

We further estimate that the total annual time burden across all new ASCs (certified by the SAs) would be 59 hours.

• 235 new ASCs x 15 min. = 3,525 min.

• 3,525 min ÷ 60 min per hour = 58.75 hours

We believe that the ASC staff member that would review, complete, and sign the CMS-370 form would be the ASC director, whose job would fall under the U.S. Bureau of Labor Statistic’s job classification of Medical and Health Services Manager. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a Medical and Health Services Manager is $61.53 (See: https://www.bls.gov/oes/current/oes119111.htm ). This wage adjusted for the employer’s overhead and fringe benefits would be $123.06 per hour.

We estimate that the annual cost burden to each ASC facility for the completion of each CMS-370 form would be $30.76.

• $123.06 per hour divided by 60 minutes = $2.051 per minute

• $2.051 per minute x 15 minutes = $30.76

We further estimate that the total cost across all new ASC facilities per year for the completion of all the CMS-370 forms annually would be $7,261.

• 59 hours x $123.06 x annually = $7,260.54

3. Burden Associated with Processing the Completed CMS-370 form.

After the director of the ASC has completed the CMS-370 form, the ASC is required to send the original copy of the completed CMS-370 form to the applicable SA via U.S. mail or email.

We believe that the procedure for preparing the completed CMS-370 form for mailing to the SA would include the following steps:

• The ASC director would give the completed original CMS-370 form to a medical secretary for processing.

• If the CMS-370 form is being sent to the SA via U.S. mail, the medical secretary will do the following:

• Photocopy the completed CMS-370 form and file the photocopy in the ASCs records.

• Prepare a cover letter to and envelope addressed to the applicable SA in which to mail the completed original CMS-370 form and 2 copies to the SA.

• Put the cover letter, completed original CMS-370 form and 2 photocopies into the envelope, seal it, affix the proper amount of postage to the envelope and place the envelope into the outgoing mail bin or a mailbox.

• If the CMS-370 form is to be sent to the SA via email, the medical secretary would do the following:

• Scan the completed original CMS-370 form to convert it into an electronic format.

• Prepare a cover email.

• Attach the electronic version of the CMS-370 form to the cover email, as an attachment.

• Send the email with delivery and read notifications requested.

We believe that the above-stated tasks would take approximately 15 minutes per each new ASC that is required to complete a CMS-370 form.

We further estimate that the time burden for this task across all new ASCs per year would be 59 hours

• 235 new ASCs per year x 0.25 hour per each form = 58.75 hours

As noted above, we believe that the above tasks would be performed by a Medical Secretary. According to the U.S. Bureau of Labor, the mean hourly wage for a Medical Secretary is $19.84. (See: https://www.bls.gov/oes/current/oes436013.htm). This wage adjusted for the employer’s overhead and fringe benefits would be $39.68.

We estimate that the cost burden for this task per each new ASC would be $9.92.

• $39.68 ÷ 60 min. - $0.661 per min.

• $0.661 per min. x 15 min. = $9.92

OR

• $39.68 per hour x 0.25 hour = $9.92

We further estimate that the total cost burden for this task across all new ASCs annually would be $2,341.

• 59 hours x $39.68 per hour = $2,341.12

2. Burden Associated with the CMS-377 form.

The CMS-377 form must be completed by new ASCs that are seeking to participate in the Medicare Program and initial certification from the SA. As stated above, there is an average of 235 new ASCs established each year.

The CMS-377 form must also be completed by existing ASCs when it is time for the facility to undergo its renewal survey. There are currently 6,088 ASCs in the U.S.² The SAs certify 4,427 out of these 6,088 existing ASCs. The SAs survey the ASCs they certify every 3 years. This would equate to an average of 1,476 existing ASCs re-surveyed by the SAs each year.

• 4,427 existing ASC suppliers divided by 3 years = 1,476

We estimate that there would be a combined total of 1,711 CMS-377 forms completed per year by both new and existing ASCs.

• 235 new ASCs + 1,476 existing ASCs = 1,711

1. Burden associated with the completion of the CMS-377 form.

We estimate that it will take each ASC facility appropriately 30 minutes (0.5 hour) to complete and sign the CMS-377 form.

The total annual time burden across all new ASCs and all existing deemed ASCs to be re-surveyed by the ASCs would be 856 hours

• 235 new ASCs x 0.5 hour = 118 hours

• 1,476 existing ASCs x 0.5 hour = 738 hours

• 118 hours (new ASCs) + 738 hours (existing ASCs) = 856 hours

We believe the ASC director would be responsible for reviewing, completing, and signing the CMS-377 form. We further believe that the job of ASC Director would fall under the U.S. Bureau of Labor Statistics job classification of Medical and Health Services Manager. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a Medical and Health Services Manager is $61.53 (See:

https://www.bls.gov/oes/current/oes119111.htm. This wage adjusted for the employer’s overhead and fringe benefits would be $123.06 per hour,

We estimate that the annual cost burden to each ASC for the completion of each CMS-377 form would be $62.

• $123.06 per hour divided by 60 minutes per hour = $2.051 per min.

• $2.051 per min x 30 minutes = $61.53

We further estimate that the total annual cost across all new ASCs and existing ASCs being resurveyed each year would be $105,339.

• 856 hours x $123.06 per hour x = $105,339.36

2. Burden associated with processing of the completed CMS-377 form for sending to the SA

After the director of the ASC has completed the CMS-377 form, the ASC is required to send the original copy of the completed CMS-377 form to the applicable SA via U.S. mail or email.

We believe that the procedure for preparing the completed CMS-377 form for mailing to the SA would include the following steps:

• The ASC director would give the completed original CMS-377 form to a medical secretary for processing.

• If the CMS-377 form is being sent to the SA via U.S. mail, the medical secretary will do the following:

• Photocopy the completed CMS-377 form and file the photocopy in the ASCs records.

• Prepare a cover letter to and envelope addressed to the applicable SA in which to mail the completed original CMS-377 form and 2 copies to the SA.

• Put the cover letter, completed original CMS-377 form and 2 photocopies into the envelope, seal it, affix the proper amount of postage to the envelope and place the envelope into the outgoing mail bin or a mailbox.

• If the CMS-377 form is to be sent to the SA via email, the medical secretary would do the following:

• Scan the completed original CMS-377 form to convert it into an electronic format.

• Prepare a cover email.

• Attach the electronic version of the CMS-377 form to the cover email, as an attachment.

• Send the email with delivery and read notifications requested.

We believe that this task would take approximately 15 minutes per each ASC.

We further estimate that the time burden for this task across all ASCs required to submit a CMS-377 forms annually would be 428 hours.

• 1,711 CMS-377 forms completed annually x 0.25 hour = 428 hours

According to the U.S. Bureau of Labor, the mean hourly wage for a Medical Secretary is $19.84. (See: https://www.bls.gov/oes/current/oes436013.htm ). This wage adjusted for the employer’s overhead and fringe benefits would be $39.68.

We estimate that the cost burden for this task per each CMS-377 form would be $10.

• $39.68 ÷ 60 min. per hour = $0.661 per min.

• $0.661 per min x 15 min = $9.92

OR

• 0.25 hour x $39.68 per hour = $9.92

We further estimate that the total annual cost burden for this task across all ASCs that are required to submit CMS-370 forms would be $16,983.

• 428 hours x $39.68 per hour = $16,983.04

3. Total Burden Related to the Completion of the CMS-370 & CMS-377 forms.

The tables below show the estimated time and cost burdens associated with the CMS-370 and CMS-377 forms.

Time & Cost Burdens for the CMS-370 form
Task	Number of Respondents	Time Per Each Response	Annual Hour Burden Across All ASCs	Cost Per Response	Annual Cost Burden
Review of statutory & regulatory law associated with the CMS-370 form	235	0.67 hour (40 min.)	157 hours	$82.04	$19,320
Completion of all CMS-370 forms across all new ASCs.	235	0.25 hour (15 min.)	59 hours	$30.76	$7,261
Preparation of completed CMS-370 forms for mailing or emailing to the applicable SAs across all new ASCs	235	0.25 hour (15 min.)	59 hours	$9.92	$2,341
Total Burden for the CMS-370 form	235	1.17 hour	275 hours	$122.72	$28,922

Time & Cost Burdens for the CMS-377 form
Task	Number of Respondents	Time Per Each Response	Annual Hour Burden Across All ASCs	Cost Per Response	Annual Cost Burden
Completion of all CMS-377 forms across all new and existing ASCs	1,711	0.5 hour (30 min.)	856 hours	$61.53	$105,339
Preparation of completed CMS-377 forms for mailing or emailing to the applicable SAs by all new & existing ASCs	1,711	0.25 hour (15 min.)	428 hours	$9.92	$16,983
Total Burden for the CMS-377 form	1,711	0.75 hours	1,284 hours	$71.45	$122,322

Combined Time & Cost Burdens for Both the CMS-370 & CMS-377 Forms
Task	Number of Respondents	Time Per Each Response	Annual Hour Burden Across All ASCs	Cost Per Response	Annual Cost Burden
Total time & cost burdens for the CMS-370 form	235	1.17 hours	275 hours	$122.72	$28,922
Total time & cost burdens for the CMS-377 form	1,711	0.75 hours	1,284 hours	$71.45	$122,322
Total annual time & cost burdens for both the CMS-370 & CMS-377 forms	1,711 responses	1.92 hours	1,559 hours	$194.17	$151,244

13. Capital Costs

There are no capital costs associated with this collection.

14. Cost to Federal Government

1. Cost to Federal Government Associated with the CMS-370 form.

The CMS Locations (formerly known as CMS Regional Offices) are responsible for reviewing and approving the CMS 370 form. The approval process would include having the CMS-370 form reviewed and signed by a CMS Location supervisor.

We estimate that the review of the CMS-370 form would be performed by a CMS Location supervisor and that this task would take approximately 30 minutes (0.5 hour) per each CMS-370 form.

We estimate that there is an average of 154 new ASCs established each year that would be required to submit the CMS-370 form. Therefore, we estimate that the total time annual burden to the CMS Locations would be 118 hours.

• 0.5 hour per each CMS-370 x 235 new ASCs per year = 117.5 hours

We further estimate that the CMS Location supervisor who would review and sign the CMS-370 form would be a government employee, at a GS 11, step 6 level, with a gross yearly salary of $96,556³. (See https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2020/DCB.pdf ). This would equate to an average hourly wage of $46.42.

• $96,556 per year divided by 2,080 hours per year = $46.42/hour

We estimate that the cost to the Federal government per each CMS-370 form reviewed and signed by a RO supervisor would be $23.21.

• 0.5 hour x $46.42 = $23.21

We further estimate that the total annual cost to the Federal government across all CMS-370 forms submitted per year would be $.2,739

• 118 hours x $23.21 = $2,738.78

2. Cost to State Survey Agencies Associated with the CMS-377 form.

The SAs are responsible for reviewing the CMS-377 forms submitted by ASCs, entering data from the forms into the survey and certification data base, and filing the original hard copy of the form in the SA records. We estimate that it would take an SA staff member 30 minutes (0.5 hour) to perform these required tasks.

We estimate that approximately 1,711 CMS-377 forms will be submitted each year.

The estimated total annual time burden for review and approval of the CMS-377 form by an SA employees would be 856 hours.

• 1,711 CMS-377 forms x 0.5 hour per form = 855.5 hours

We estimate that the mean hourly wages for a SA employee would be $40.00. This wage adjusted for the employer’s overhead and fringe benefits would be $80.00.

We estimate that the cost to the Federal government per each CMS-377 form submitted would be $40.00.

• 0.5 hour x $80.00 per hour = $40.00

We further estimate that the total annual cost to the SAs for the processing of all CMS-377 forms received annually would be $68,480.

• 856 hours x $80.00 per hours = $68,480

The total annual estimated cost to the SAs for the review and approval of both the CMS-370 and CMS-377 forms is $71,219.

• $2,739 + $68,480 = $71,219

15. Program/Burden Changes

The tables below show that changes in time and cost burden from the previous PRA package.

Changes in Burden for the CMS-370 form
Tasks	Total Requested In This PRA Package	Approved In Previous PRA Package	Changes in Burden
Annual number of respondents for the CMS-370 form	235 responses	228 responses	+7 responses
Time burden for review of the statutory and regulatory law related to the CMS-370 form by each new ASC.	0.67 hour	0.66 hour	0 hours
Annual time burden for the review the statutory and regulatory law related to all CMS-370 forms across all new ASCs	157 hours	152 hours	+5 hours
Time burden to complete each CMS-370 form	0.25 hour	0.083 hour	+0.166 hour
Time burden across all new ASCs for completing the CMS-370 forms	59 hours	19 hours	+40 hours
Time burden to process each form CMS-370 form	0.5 hour	0.25 hour	+0.25 hour
Time burden across all new ASCs to process all CMS-370 forms	59 hours	57 hours	+2 hours
Cost burden for the review of the statutory & regulatory law per each new ASC and per each CMS-370 form	$82.04	$73.80	+$8.24
Cost burden for review of the statutory & regulatory law by all new ASCs for all CMS-370 forms.	$19,320	$16,832	+$2,488
Cost burden to complete per each CMS-370 form	$30.76	$9.23	+$21.53
Cost burden across all new ASCs for completion of all CMS-370 forms	$7,261	$2,104	+$5,157
Cost burden to process each CMS-370 form.	$9.92	$9.16	+$0.76
Cost burden across all new ASCs to process all CMS-370 forms	$2,341	$2,104	+$237
Total Number of Responses	235	228	+7
Total Annual Time Burden	275 hours	228 hours	+47 hours
Total Annual Cost Burden	$28,922	$21,040	+$7,882

Changes in Burden for the CMS-377 form
Tasks	Total Requested In This PRA Package	Approved In Previous PRA Package	Changes in Burden
Number of respondents for the CMS-377 form	1,711 responses	1,567 responses	+144 responses
Time burden to complete each form CMS-377 form	0.5 hour	0.25 hour	+0.25 hour
Annual time burden across all CMS-377 forms	856 hours	392 hours	+464 hours
Time burden to process each CMS-377 form	0.25 hours	0.25 hour	hours
Annual time burden to process all CMS-377 forms	428 hours	392 hours	+36 hours

Cost burden to complete each CMC-377 form	$61.53	$27.68	+$33.85
Annual cost burden across all CMS-377 forms	$105,339	$43,410	+$61,929
Cost burden to process each CMS-377 form	$9.92	$9.16	+$0.76
Annual cost burden to process all CMS-377 forms	$16,983	$14,355	+$2,628
Total Responses	1,711	1,567	+144
Total Annual Time Burden	1,284 hours	1,012 hours	+272 hours
Total Annual Cost Burden	$122,322	$78,732	+$43,590

Combined Change in Burden for Both the CMS-370 & CMS-377 Forms
Tasks	Total Requested In This PRA Package	Approved In Previous PRA Package	Changes in Burden
Total Number of Responses for the CMS-370 form	235 responses	228 responses	+7 responses
Total Annual Time Burden for the CMS-370 form	275 hours	228 hours	+47 hours
Total Annual Cost Burden for the CMS-370 form	$28,922	$21,040	+$7,882
Total Number of Responses for the CMS-377 form	1,711	1,567	+144
Total Annual Time Burden for the CMS-377 form	1,285 hours	1,012 hours	+547 hours
Total Annual Cost Burden for the CMS-377 form	$122,322	$78,732	+$43,590
TOTAL CHANGE IN NUMBER OF RESPONSES	1.946 responses	1,795 responses	+151 responses
TOTAL CHANGE IN TIME BURDEN	1,559 hours	1,240 hours	+319 hours
TOTAL CHANGE IN COST BURDEN	$151,244	$99,772	+$51,472

As the above tables show, there has been an increase in the time and cost burden since the last PRA package. For example:

• The total annual number of responses for both the CMS-370 & CMS-377 forms has been increased from 1,567 in the previous PRA package to 1,946 in the current PRA package. This is an increase of 151 responses.

• The total annual combined time burden for the CMS-370 & CMS-377 forms has increased from 1,240 hours in the previous PRA package to 1,559 hours in the current PRA package. This is an increase of 319 hours.

• The total annual combined cost burden for the CMS-370 & CMS-377 forms has increased from $99,772 in the previous PRA package to $151,244 in the current PRA package. This is an increase of $51,472.

These increases in time and cost burdens are directly attributable to several factors. First, the total number of respondents have increased from 1,567 in the previous PRA package to 1,711 respondents annually in the current PRA package. When the number of respondents increases, the time and cost burdens increase proportionally.

Second, we have increased the time burden estimate for completion of each CMS-370 form from five (5) minutes to 15 minutes. We made this change because the time estimate in the previous PRA package is too low. The CMS-370 form is a Health Insurance Benefits Agreement, in which the ASC facility agrees to comply with six (6) specifically enumerated requirements which are set forth on the form. The CMS-370 form also contains four (4) additional paragraphs regarding the terms for acceptance and effective date of the agreement. Also, there is a warning about proving false or misleading statements.

The ASC staff member completing the CMS-370 form should take time to read and understand each of the requirements, terms for acceptance and other information on the form before signing it. While it may only take only 5 minutes to fill in the required information and sign the form, the staff member completing the CMS-370 form would not have adequate time to thoroughly review and understand the terms of the agreement in the allotted 5 minute period. They would also not have time to consult other staff members or legal counsel if they had questions about the contents of the CMS-370 form in only 5 minutes. We believe that 15 minutes is a more accurate estimate of the time required to read and complete the CMS-370 form.

Third, we have increased the time burden for the CMS-377 form from 15 minutes to 30 minutes. We have made this change the CMS-377 form requires the ASC staff to provide information about the ASC and the type of services it provides. It may not be possible for the ASC staff member completing the form to obtain all necessary information required to complete the CMS-377 form in 15 minutes. For example, they may not know whether the facility has non-profit status or whether one or more ASC services are provided by the ASC, under arrangement or by an outside source or a combination of the ASC and an outside source. If so, the ASC staff member completing the CMS-377 form would have to consult others or perform research to obtain this information and may not be able to do this within the allotted 15 minutes. We believe that 30 minutes is a more accurate estimate of the time it takes to gather the required information and complete the CMS-377 form.

Finally, we adjusted the hourly wage rates to be consistent with the current U.S. Bureau of Labor Statistics rates. For example:

• The adjusted wage of a Medical and Health Services Manager was increased from $­­110.74 to $123.06. This is an increase of $12.32 per hour.

• The adjusted wage rate for a Medical Secretary was increased from $36.62 to $39.68. This is an increase of $3.06 per hour.

These increased wage rates, in conjunction with the increased time burdens for both the CMS-370 and CMS-377 forms and increased number of annual responses, have led to the increased annual time and cost burden for this PRA package.

16. Publication and Tabulation Dates

There are no publication and tabulation dates associated with collection.

17. Expiration Date

CMS will display the OMB approval expiration date on the CMS-370 and CMS-377 forms.

18. Certification Statement

There is no exception to this statement.

1 This information was obtained from the Survey & Certification Quality Certification and Oversight Reports (S&C QCOR Reports) at https://qcor.cms.gov/main.jsp and IQIES.

2 S&C QCOR Reports (https://qcor.cms.gov/main.jsp).

3 This is the OPM 2024 wage rate with locality pay for the Washington DC/Baltimore Metro area.

Page 21 of 21