CMS-10221.Supporting Statement

Supporting Statement for Paperwork Reduction Act Submissions

Worksheet for Recording Results of Medicare Site Visits of Independent

Diagnostic Testing Facilities (IDTFs)

1. BACKGROUND

Consistent with the policies described in CMS-1321-FC, “Revisions to Payment Policies and Five-Year Review of Relative Value Units Under the Physician Fee Schedule for CY 2007 and Other Changes to Payment Under Part B; Revisions to Ambulance Fee Schedule; Ambulatory Inflation Factor Update for CY 2007,” CMS is proposing to collect and verify information regarding the compliance of independent diagnostic testing facilities (IDTFs) with the performance standards found in 42 CFR § 410.33(g).

The Worksheet will be used to collect and record information obtained on IDTF site visits; the data collected during site visits will also help verify the accuracy and completeness of the information the IDTF furnished on its CMS-855B enrollment application.

This PRA submission is necessary because, although the Worksheet itself will be completed by CMS or its contractor, some of the answers to the questions/data elements on the Worksheet will have to be furnished by the IDTF.

JUSTIFICATION

1. Need and Legal Basis

Various sections of the Act and the Code of Federal Regulations require providers and suppliers to furnish information concerning the amounts due and the identification of individuals or entities that furnish medical services to beneficiaries before payment can be made.

• Sections 1814(a), 1815(a), and 1833(e) of the Act require the submission of information necessary to determine the amounts due to a provider or other person.

• Section 1842(r) of the Act requires us to establish a system for furnishing a unique identifier for each physician who furnishes services for which payment may be made. In order to do so, we need to collect information unique to that provider or supplier.

• Section 1842(u) of the Act requires us to deny billing privileges under Medicare to physicians and certain other health care professionals certified by a State Child Support Enforcement Agency as owing past-due child support.

• Section 1834(j) of the Act states that no payment may be made for items furnished by a supplier of durable medical equipment, prosthetics, and supplies (DMEPOS) unless that supplier obtains, and renews at such intervals as we may require, a billing number. In order to issue a billing number, we need to collect information unique to that supplier.

• Section 1866(j)(1)(C) of the Act requires us to consult with providers and suppliers of services before making changes in provider enrollment forms.

• The Balanced Budget Act of 1997 (BBA) (Public Law 105-33) section 4313, amended sections 1124(a)(1) and 1124A of the Act to require disclosure of both the Employer Identification Number (EIN) and Social Security Number (SSN) of each provider or supplier, each person with ownership or control interest in the provider or supplier, as well as any managing employees. The Secretary of Health and Human Services (the Secretary) signed and sent to the Congress a “Report to Congress on Steps Taken to Assure Confidentiality of Social Security Account Numbers as Required by the Balanced Budget Act” on January 26, 1999, with mandatory collection of SSNs and EINs effective on or about April 26, 1999.

• Section 31001(I) of the Debt Collection Improvement Act of 1996 (DCIA) (Public Law 104-134) amended 31 U.S.C. 7701 by adding paragraph (c) to require that any person or entity doing business with the Federal Government must provide their Tax Identification Number (TIN).

• We are authorized to collect information on the CMS-855 (Office of Management and Budget (OMB) approval number 0938-0685) to ensure that correct payments are made to providers and suppliers under the Medicare program as established by Title XVIII of the Act.

2. Purpose and users of the information

Per 42 CFR § 410.33, any IDTF that wishes to enroll in the Medicare program must undergo a site visit. The purpose of the site visit is to ensure that the IDTF is in compliance with the provisions of 42 CFR § 410.33, as well as all other applicable Federal, State and local laws and regulations. It is also used to verify the information the IDTF furnished on its CMS-855B enrollment application.

3. Improved Information Techniques

This collection does not lend itself to electronic collection methods.

4. Duplication and Similar Information

There is no duplicative information collection instrument or process.

5. Small Business

This Worksheet will affect small businesses. However, these businesses have always been required to provide CMS with substantially the same information during IDTF site visits.

6. Less Frequent Collections

This information is collected on an as needed basis.

7. Special Circumstances

There are no special circumstances associated with this collection.

8. Federal Register Notice/Outside Consultation

The 60-day Federal Register notice for this collection published on April 13, 2007.

9. Payment/Gift to Respondents

N/A.

10. Confidentiality

CMS will comply with all Privacy Act, Freedom of Information laws and regulations that apply to this collection. Privileged or confidential commercial or financial information is protected from public disclosure by Federal law 5 U.S.C. 522(b)(4) and Executive Order 12600.

11. Sensitive Questions

There are no sensitive questions associated with this collection.

12. Burden Estimate (hours)

The total annual hour burden for respondents is 4,000 hours and $200,000. This is based on the following estimates.

2,000 respondents per year @ 2 hours each = 4,000 hours

Although the Worksheet itself will be completed by CMS or its contractor, some of the answers to the questions/data elements on the Worksheet will have to be furnished by the IDTF.

Cost to the respondents is calculated as follows based on the following assumptions:

Worksheet = $200,000 (4,000 hours* $50 per hour)

The cost per respondent per form has been determined using the follow wages: $50.00 per hour (administrator wage)

13. Cost to Respondents (Capital)

There are no capital costs associated with this collection.

14. Cost to Federal Government

There is no additional cost to the Federal government.

15. Changes in Burden/Program Changes

There are no changes in burden previous reported.

16. Publication/Tabulation

N/A.

17. Expiration Date

We are planning on displaying the expiration date.

18. Certification Statement

There are no exceptions to item 19 of OMB Form 83-I.

2. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

N/A.

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