Supporting Statement Part A
ASC Forms for Medicare Program Certification.
(CMS-370 & CMS-377)
I. Background
In order to receive Medicare payment, Ambulatory Surgical Centers (ASCs) are required to be in compliance with the Federal requirements set forth in the Medicare Conditions for Coverage (CfCs) found at 42 CFR Part 416, Subparts A through C (§416.1 to §416.54). Certification of 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 or an accrediting organization.
The form CMS-370 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”). This agreement, upon acceptance by the Secretary 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 available for the ASC’s services furnished to Medicare beneficiaries on or after the effective date of termination.
The CMS-377 form is used by ASCs to initiate both the initial and renewal survey by the State Survey Agency, which provides the certification required for an ASC to participate in the Medicare program. An ASC must complete the CMS-377 form and send it to the appropriate State Survey Agency prior to their scheduled accreditation renewal date. The CMS-377 form provides the State Survey Agency with information about the ASC facility’s characteristics, such as, determining the size and the composition of the survey team on the basis of the number of ORs/procedure rooms and the types of surgical procedures performed in the ASC. Knowing this information prior to the survey would help the SA determine what resources are required for the survey.
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 State Agencies 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 form CMS-370, which is titled “The Health Insurance Benefits Agreement” is used for the purpose of establishing eligibility of ASCs for payment under Title XVIII of the Social Security Act (the “Act”). This agreement, shall be binding on the ASC and the Secretary. The agreement may be terminated by either party in accordance with regulations.
The form CMS-377, which is titled “The Request for Certification or Update of Certification Information in the Medicare Program Form” is used by State agencies who conduct certification surveys on CMS’ behalf to maintain information on the facility’s characteristics that facilitate conducting surveys, e.g., determining the size and the composition of the survey team on the basis of the number of ORs/procedure rooms and the types of surgical procedures performed in the ASC. In addition, CMS receives inquiries periodically from members of Congress, the Government Accountability Office (GAO), or Office of Insepctor General (OIG) concerning the characteristics of participating providers and suppliers, in order to facilitate policy review and development. Collection of this data will allow CMS to be responsive to such inquiries.
3. Improved Information Technology
The CMS-370 and CMS-377 must be completed and signed by ASC staff. The forms are submitted via mail, fax, or email. There is not a process for electronic collection at this time.
4. Duplication of Similar Information
Neither form CMS-370 or form CMS-377 duplicates any information collection. Each form addresses specific requirements for either eligibility for payment or certification or update of certification in the Medicare program.
5. Small Businesses
Many ASCs affected by this requirement are small businesses; however, the information collection is necessary for the business to participate in the Medicare program. These paperwork requirements are minimal and are necessary to meet the participation requirements of the law.
6. Less Frequent Collection
The Form CMS-370 is collected one time only over the course of the duration of the agreement between CMS and the ASC applicant. It is necessary to prevent fraud and abuse in the Medicare program and to assure that ASCs understand they must comply with all applicable Federal requirements and make a binding commitment to compliance throughout their participation in theMedicare program. If the information were collected less frequently, CMS would not have a binding commitment on the part of ASCs to comply with all applicable Medicare requirements. 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 Form CMS-377 is collected upon entry of an ASC into the Medicare program and once every three years thereafter. Less frequent collection would not be possible because this form initiates the reaccreditation survey for ASC suppliers, which is generallyperformed every 3 years. Less frequest collection could result in reaccreditation surveys not being performed in a timely manner and also CMS potentially having significantly outdated information on 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 November 19, 2020 (85 FR 73720). There were no public comments received.
The 30-day Federal Register notice published on February 4, 2021 (86 FR 8200).
9. Payment/Gift 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)
There are currently 5,856 ASCs in the U.S. The State Survey Agencies (SAs) certify 4,016 out of these 5,856 ASCs. Accrediting organizations accredit 1,840 out of these 5,856 ASCs. There are an average of 228 new ASC suppliers each year.
The SAs survey the ASCs they certify every 3 years. This would equate to an average of 1,339 existing ASCs being re-surveyed per year by the SAs.
4,016 existing ASC suppliers divided by 3 years = 1,338.66
The CMS-370 form must be completed by all new ASCs, regardless of whether they are certified by the SA or an accreditng organization. Therefore, the burden calculations for the CMS-370 form will be based on the number of new ASCs that are established each year. Based on the CMS statistics, there are an average of 228 ASCs per year.
The CMS-377 form applies only to those ASCs that are certified by the SAs, because this form is required to initiate the certification and recertification surveys by the SA. Therefore, the burden calculations below will be based on the number of new ASCs established per year plus the number of existing ASCs that receive a re-accrediation survey each year, which equates to 1,567 ASCs per year. (228 new ASCs + 1,339 = 1,567).
Burden Associated with Form CMS-370 - Health Insurance Benefits Agreement
The CMS-370 form is only completed by new ASC suppliers when they enter the Medicare program. As stated sbove, there are an average of 228 new ASC suppliers established per year.
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
We believe that the person that would sign the CMS-370 form would be the ASC director. We estimate that it would take a person, who is unfamiliar or minimally familiar with this statutory and regulatory language, approximately 40 minutes to review the applicable law.
As stated above, the CMS-370 form is completed by new ASCs that are seeking participation in the Medicare program. There are an average of 228 new ASCs per year.
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 152 hours.
40 minutes x 228 new ASCs per year = 9,120 minutes
9,120 minutes divided by 60 minutes per hour = 152 hours
As also stated above, we believe that the person that would sign the CMS-370 form and review the statutory and regu;atory 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 $55.37 (See: https://www.bls.gov/oes/current/oes119111.htm This wage adjusted for the employer’s overhead and fringe benefits would be $110.74 per hour,
We estimate that the total annual cost burden to each ASC facility for the completion of each CMS-370 form would be $73.80.
$110.74 per hour divided by 60 min. per hr. = $1.845 per minute
$1.845 per minute x 40 minutes = $73.80
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 $16,832.48.
152 hours x $110.74 per hour = $16,832.48
Burden Associated with the Completion of the CMS-370 form
We estimate that it will take approximately 5 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 19 hours.
228 ASCs x 0.083 hour = 19 hours
We believe that the person at the ASC 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 $55.37 (See: https://www.bls.gov/oes/current/oes119111.htm ). This wage adjusted for the employer’s overhead and fringe benefits would be $110.74 per hour.
We estimate that the annual cost burden to each ASC facility for the completion of each CMS-370 form would be $9.23.
$110.74 per hour divided by 60 minutes = $1.845 per minute
$1.845 per minute x 5 minutes = $9.225
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 $2,104.06.
19 hours x $110.74 x annually = $2,104.06
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 mail the original copy of the completed form to the applicable State Survey Agency. Therefore, we believe that the director
would give the original completed CMS-370 form to a administrative assistant for processing. We believe that this person’s jobv duties would fall under the U.S. Bureau of Labor Statistic’s job category of “Medical Secretary.”
We further believe that the medical secretary would photpcopy the completed CMS-370 form so that the ASC would have this copy for their records and file this photocopy in the ASCs records. We also believe that the medical secretary would prepare a cover letter and envelope in which to mail the completed original CMS-370 forms to the SA. The medical secretary woulsd also have to affix the proper postage to the envelope and place it in the outgoing mail bin or a mailbox.
We believe that this task would take approximately 15 minutes per each CMS-370 form to complete. We further estimate that the time burden for this task across all ASCs that are required to complete the CMS-370 form annually would be 57 hours
0.25 hour x 228 CMS-370 forms completed annually = 57 hours
As stated above, we believe that the person that would perform this task would be a Medical Secretary. According to the U.S. Bureau of Labor, the mean hourly wage for a Medical Secretary is $18.31. (See: https://www.bls.gov/oes/current/oes436013.htm ). This wage adjusted for the employer’s overhead and fringe benefits would be $36.62.
We estimate that the cost burden for this task per each CMS-370 form would be $9.16.
$36.62 per hour x 0.25 hour = $9.155
We further estimate that the total cost for this task across all ASCs that are required to submit CMS-370 forms annually would be $2,087.34.
57 hours x $36.62 per hour = $2,087.34
Burden Associated with form CMS-377 - Request for Certification or Update of Certification Information
Burden Associated with the completion of the CMS-377 form.
The CMS-377 form must be completed by ASCs that are surveyed by the State Survey Agencies (SAs) but not those ASCs that are surveyed by the accrediting organizations. Submission of the CMS-377 form to the SA will initiate the s initial and recertification survey process for the purpose of obtaining a decision as to whether the Conditions for Coverage are met.
We estimate that there will be approximately 228 new ASCs per year seeking initial certifications which would require a survey. We further estimate that an additional 1,339 ASCs per year would be scheduled for a renewal survey by the SA each year and would required to complete and file the CMS-377 with the applicable SA to initiate the survey process. This would equate to a total of 1,567 form CMS-377s being completed annually.
228 new ASCs per year + 1,339 ASCs resurveyed per year = 1,567 total CMS-377 forms annually
Based on past usage of this form and the general nature of the questions, we estimate that it would take each ASC facility appropriately 15 minutes (0.25 hour) to complete and sign the CMS-377 form. We further estimate that the annual burden across all new ASCs associated with completion of the CMS-377 form by all new ASCs would be 57 hours.
228 new ASCs per year x 0.25 hour = 57 hours per all new ASC’s
We further estimate that the annual time burden assocuated with the completion of the CMS-377 form by all existing ASCs that are to be re-surveyed by the SAs would be 335 hours
1,339 existing ASCs resurveyed per year x 0.25 hour = 334.75 hours
The total annual time burden across all new ASCs and all existing deemed ASCs to be re-surveyed by the ASCs would be 392 hours
57 hours + 335 hours = 392 hours
We believe that the person at the ASC that would review, complete and sign the CMS-377 form would be the ASC director, whose job 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 $55.37 (See: https://www.bls.gov/oes/current/oes119111.htm. This wage adjusted for the employer’s overhead and fringe benefits would be $110.74 per hour,
We estimate that the annual cost burden to each ASC facility for the completion of each CMS-377 form would be $27.68.
$110.74/ hour divided by 60 minutes per hour = $1.845 per min.
$1.845 / min x 15 minutes = $27.68
We further estimate that the total annual cost for all of the CMS-377 forms completed across all new and all existing ASC facilities (certified by the SAs) would be $43,410.08.
392 hours x $110.74 per hour x = $43,410,08
Burden associated with sending the completed CMS-377 form to the State Survey Agency
After the director of the ASC has completed the CMS-377 form, the ASC is required to mail two (2) original copies to the applicable State Survey Agency. Therefore, we believe that the director would give the original completed copies of the CMS-377 form to a administrative assistant for processing. We believe that this person’s job duties would fall under the U.S. Bureau of Labor Statistic’s job category of “Medical Secretary.”
We further believe that the medical secretary would photocopy the completed CMS-377 form so that the ASC would have this copy for their records and file this photocopy in the ASCs records. We also believe that the medical secretary would prepare a cover letter and envelope in which to mail the completed original CMS-377 forms to the SA. The medical secretary woulsd also have to affix the proper postage to the envelope and place it in the outgoing mail bin or a mailbox.
We believe that this task would take approximately 15 minutes per each CMS-377 form to complete. We further estimate that the total time burden for this task across all ASCs that are required to complete the CMS-377 form annually would be 392 hours
0.25 hour x 1,567 CMS-377 forms completed annually = 391.75 hours
As stated above, we believe that the person that would perform this task would be a Medical Secretary. According to the U.S. Bureau of Labor, the mean hourly wage for a Medical Secretary is $18.31 (See:
https://www.bls.gov/oes/current/oes436013.htm ). This wage adjusted for the employer’s overhead and fringe benefits would be $36.62.
We estimate that the cost burden for this task per each CMS-377 form would be $9.16.
$36.62 per hour x 0.25 hour = $9.155 per hour
We further estimate that the total cost for this task across all ASCs that are required to submit CMS-377 forms annually would be $14,355.04.
392 hours x $36.62 per hour = $14,355.04
c. Total Burden Related to the Completion of the CMS-370 & CMS-377 forms.
Time Burden For Completion of EACH CMS-370 Form
Research of Statutes & Regulations 0.67 hour
Completion of CMS-370 form 0.083 hour
Processing of CMS-370 form 0.25 hour
TOTAL 1.00 hour
Time Burden For Completion of CMS-370 Forms Across All New & Existing ASC Facilities to Be Resurveyed
Research of Statutes & Regulations 152 hours
Completion of CMS-370 form 19 hours
Processing of CMS-370 form 57 hours
TOTAL 228 hours
Cost Burden For Completion of EACH CMS-370 Form
Research of Statutes & Regulations $73.80
Completion of CMS-370 form $ 9.23
Processing of CMS-370 form $ 9.16
TOTAL $92.19
Cost Burden For Completion of CMS-370 Forms Across ALL New & Existing ASC Facilities to Be Resurveyed
Research of Statutes & Regulations $16,832.48
Completion of CMS-370 form $ 2,104.06
Processing of CMS-370 form $ 2,087.34
TOTAL $21,023.88
Time Burden For Completion of EACH CMS-377 Form
Completion of CMS-377 form 0.25 hours
Processing of CMS-377 form 0.25 hours
TOTAL 0.50 hours
Time Burden For Completion of CMS-377 Forms Across ALL New & Existing ASC Facilities to Be Resurveyed
Completion of CMS-377 form 392 hours
Processing of CMS-377 form 392 hours
TOTAL 784 hours
Cost Burden For Completion of EACH CMS-377 Form
Completion of CMS-377 form $27.68
Processing of CMS-377 form $ 9.15
TOTAL $36.83
Cost Burden For Completion of CMS-377 Forms Across ALL New & Existing ASC Facilities to Be Resurveyed
Completion of CMS-377 form $43,410,08
Processing of CMS-377 form $14,355.04
TOTAL $57,765.12
xi. Total Annual Time Burden Associated with Both the CMS-370 & CMS-377 Forms
Total time burden for CMS-370 form 228 hours
Total time burden for CMS-377 form 784 hours
Total Time Burden For This Pra Pkg. 1,012 hours
Total Annual Cost Burden Associated with Both the CMS-370 & CMS-377 Forms
Total cost burden for CMS-370 form $21,023.88
Total cost burden for CMS-377 form $57,710.08
Total Cost Burden For This PRA Pkg. $78,733.96
13. Capital Costs
There are no capital costs associated with this collection.
14. Cost to Federal Government
Cost to Federal Government Associated with the CMS-370 form
The CMS Regional Offices (ROs) are responsible for approving the CMS Form 370. This approval would include having the CMS-370 form reviewed and signed by a RO supervisor.
We estimate that the review and approval signature by the RO supervisor would take approximately 30 minutes (0.5 hour). We estimate that there are 228 new ASCs established per year that would be required to submit the CMS-370 form. Therefore, we estimate that the total time annual burden across all new ASCs establsied per year would be 114 hours.
0.5 hour per each CMS-370 form x 228 new ASCs per year = 114 hours
We estimate that the staff person at the CMS RO who would review the CMS-370 form would be a government employee at a GS 11, step 6 level, with a gross yearly salary of $84,034. (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 $40.40.
$84,034 per year divided by 2,080 hours per year = $40.40/hour
This wage adjusted for the governments overhead, fringe benefits and locality pay would be $80.80.
We estimate that the cost to the Federal government per each CMS-370 form reviewed and signed by a RO supervisor would be $20.20.
0.5 hour x $80.80 = $40.40
We further estimate that the total annual cost to the Federal government across all CMS-370 forms submitted per year would be $9,211.20.
114 hours x $80.80 = $9,211.20
Cost to Federal Government Associated with the CMS-377 form
The State Survey Agencies are responsible for reviewing the completed Form 377, entering data from it into the survey and certification data base, and filing the hard copy.
We estimate that it would take 30 minutes (0.5 hour) to perform the required tasks. There are 1,567 CMS-377 forms submitted per year. Therefore, the total annual time burden for the processing of the CMS-377 form by the SA employees would be 784 hours.
1,567 CMS-377 forms x 0.5 hour per form = 783.5 hours
We estimate that the mean hourly wages for a State Survey Agency employee would be $38.00. This wage adjusted for the employer’s overhead and fringe benefits would be $76.00.
We estimate that the cost to the Federal government per each CMS-377 form submitted would be $38.00.
0.5 hour x $76.00 per hour = $38.00
We further estimate that the total annual cost to the Federal government for the processing of all CMS-377 forms by the SA employees would be $59,584.
784 hours x $76.00 per hours = $59,584
Cost for Printing the CMS-370 & CMS-377 Forms
We further estimate that the Federal government would incur costs for printing the CMS-370 and CMS-377 forms. We estimat that each copy would cost $0.25. We further estimate that the Government Printing Office would print approximately 2,000 CMS-370 and CMS-377 forms per year. We estimate that the government would incur the following printing costs:
CMS-370 form 2,000 copies x $0.25 per copy = $ 500
CMS-377 form 2,000 copies x $0.25 per copy = $ 500
TOTAL $1,000
Summary of the Total Cost to the Federal Government
Based on the information stated above, we estimate the following total annual costs to the Federal government for the CMS-370 and CMS-377 forms would be $65,151.60.
Processing of the CMS-370 form by the ROs $ 9,211.20
Processing of the CMS-377 form by the SAs $59,584.00
Priniting of the CMS-370 form $ 500.00
Printing of the CMS-377 form $ 500.00
TOTAL $69,795.20
15. Program/Burden Changes
See the table below for a detailed accounting of the burden changes in this PRA package. This table shows that while there has been a decrease in the total number of responses, and total burden hours, there has been an increase in the total burden cost in the amount of $37,010.80.
Table 1: Change in Burden Between Current and Previous PRA Package
Tasks |
Total Requested In This PRA Package |
Approved In Previous PRA Package |
Changes in Burden |
|
0.66 hour |
0.66 hour |
0 |
|
152 hours |
113 hours |
+39 hours |
|
$73.80 |
$62.40 |
+$11.40 |
|
$16,832.48 |
$10,608.00 |
+6,224.48 |
|
0.083 hour |
0.083 hour |
0 |
|
19 hours |
15 hours |
+ 4 hours |
|
$9.23 |
$7.80 |
+1.43 |
|
$2,104.06
|
$1,326.00 |
+$778.06 |
|
0.25 hour |
0.25 hour |
0 |
|
57 hours |
43 hours |
+14 hours |
|
$9.16 |
$2.70 |
+$6.46 |
|
$2,087.34 |
$688.50 |
+$1,398.84 |
|
0.25 hour |
0.33 hour |
-5 min (0.083 hour) |
|
392 hours |
686 hours |
-294.25 hours |
|
$27.68 |
$7.80 |
+$19.88 |
|
$43,410.08 |
$16,053.40 |
+$27,356.68 |
|
0.25 hour |
0.25 hour |
0 |
|
392 hours |
515 hours |
-123 |
|
$9.16 |
$4.05 |
+$5.11 |
|
$14,355.04 |
$8,334.90 |
+$6,020.14 |
Total Responses |
1,567 |
1,888 |
- 321 |
Total Annual Time Burden |
1,012 hours |
1,371 hours |
-359 hours |
Total Annual Cost Burden
|
$78,731.93 |
$37,010.80 |
+$41,721.13 |
We believe that the increase in total burden cost is due to several factors. First, for the CMS-370 form, the number of new ASC respondents increased from 170 to 228 based on the current statistics about the average number of new ASCs are established per year.
Also, in the current PRA package we have updated the job classification for the person that would complete the CMS-370 and CMS-377 forms from the facility CEO at a mean hourly wage of $93.44 to the ASC director, under the U.S. Bureau of Labor Statistics job category of Medical and Health Services Manager, at an mean hourly rate of $55.37. We have doubled this hourly wage rate to account for the employer’s overhead and fringer benefits. So, while we used the same time burden estimates as in the previous PRA package for these tasks, we used a mean average hourly wage of $110.74 for the work performed by the facility director. In the previous PRA package submission, these tasks were calculated using an hourly wage rate of only $93.44. This is an increase in $17.30 per hour.
Also, we updated the wage rate for a Medical Secretary, who would process the completed CMS-370 and CMS-377 forms (i.e. – photpcopy the completed form, file the photpcopy of the form, prepare a cover letter and envelope for mailing the form to the SA, putting the documents into the envelope, affixing the postage and putting the envelope into the outgoing mail) from a wage rate of $16.22 per hour to the current rate of $18.31. We have also doubles this wage rate to $36.63 to account for the employer’s overhead and fringe benefits. This was not done in the previous PRA package burden calculations.
16. Publication and Tabulation Dates
There are no publication and tabulation dates associated with collection.
17. Expiration Date
CMS will display the expiration date on the CMS-370 and CMS-377 forms.
pg.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Supporting Statement for Ambulatory Surgical Center |
| Subject | ASC Forms for Medicare Program Certification |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2021-02-06 |