CMS Pub. 100-08, ch. 10, § 10.2.2.4

IDTFs are a supplier type that enrolls via the Form CMS-855B.

A. Introduction

1. General Background

An IDTF is a facility that is independent both of an attending or consulting physician’s office

and of a hospital. However, IDTF general coverage and payment policy rules apply when an

IDTF furnishes diagnostic procedures in a physician’s office (see 42 CFR § 410.33(a)(1)).

Effective for diagnostic procedures performed on or after March 15, 1999, MACs pay for

diagnostic procedures under the physician fee schedule when performed by an IDTF. An IDTF

may be a fixed location or a mobile entity. It is independent of a physician’s office or hospital.

2. Place of IDTF Service

i. “Indirect IDTFs” – Background

IDTFs generally perform diagnostic tests on beneficiaries in, for instance, a health care facility,

physician’s office, or mobile setting. The IDTF standards at § 410.33(g) (as well as other

provisions in § 410.33) were, in fact, designed for traditional IDTF suppliers that engage in

direct or in-person beneficiary interaction, treatment, and/or testing. Yet some health care

entities have developed or utilize diagnostic tests that do not require such interaction (hereafter

occasionally referenced as “indirect IDTFs”). That is, certain IDTFs perform diagnostic services

via computer modeling and analytics, or other forms of testing not involving direct beneficiary

interaction. The service is often conducted by a technician who undertakes a computer analysis

offsite or at another location at which the patient is not present. The physician then reviews the

image to determine the appropriate course of action. In short, these entities generally, though not

exclusively, have two overriding characteristics. First, the tests they perform do not involve

direct patient interaction, meaning that the test is conducted away from the patient’s physical

presence and is non-invasive. Second, the test involves off-site computer modeling and

analytics.

Despite the comparatively new and innovative forms of testing these entities undertake, they can

still qualify as IDTFs (notwithstanding the offsite and indirect nature of the test) so long as they

meet the applicable requirements of § 410.33. In the past, however, these entities have often

been unable to meet certain IDTF requirements (and thus cannot enroll in Medicare) strictly

because of the test’s indirect nature. In other words, the types of tests at issue do not fall within

the category of those to which several of the standards in § 410.33 were intended to apply

(specifically, to in-person procedures).

ii. “Indirect IDTFs” – General Description, Exemptions, and Verification

To account for such technological advances in diagnostic testing, we revised § 410.33 in the CY

2022 Physician Fee Schedule final rule such that IDTFs that have no beneficiary interaction,

treatment, or testing whatsoever at their practice location are wholly exempt from the

following requirements in § 410.33(g).

• § 410.33(g)(6)) - The IDTF must have a comprehensive liability insurance policy of at least

$300,000 per location that covers both the place of business and all customers and employees

of the IDTF.

• § 410.33(g)(8)) - The IDTF must answer, document, and maintain documentation of a

beneficiary's written clinical complaint at the physical site of the IDTF.

• § 410.33(g)(9)) - The IDTF must openly post the standards outlined in § 410.33(g) for review

by patients and the public.

In addition. 42 CFR § 410.33(c) previously stated in full: “Any nonphysician personnel used by

the IDTF to perform tests must demonstrate the basic qualifications to perform the tests in

question and have training and proficiency as evidenced by licensure or certification by the

appropriate State health or education department. In the absence of a State licensing board, the

technician must be certified by an appropriate national credentialing body. The IDTF must

maintain documentation available for review that these requirements are met.” This requirement

(now codified in § 410.33(c)(1)) remains intact for IDTFs that perform direct, in-person testing.

For indirect IDTFs, however, new § 410.33(c)(2) states that---for services that do not require

direct or in-person beneficiary interaction, treatment, or testing---any nonphysician personnel

performing the test must meet all applicable state licensure requirements for doing so; if such

state licensure requirements exist, the IDTF must maintain documentation available for review

that these requirements have been met. If no state licensure requirements for such personnel

exist, the contractor need not undertake additional verification activities under § 410.33(c)(2)

concerning the technician in question; the contractor shall not establish its own additional

certification, credentialing, or similar technician requirements (e.g., federal accreditation) above

and beyond the requirements in § 410.33(c)(2).

The only complete or partial exemptions in § 410.33 that apply to indirect IDTFs are those

described in this subsection (A)(2) (i.e., § 410.33(c)(2), (g)(6), (g)(8), and (g)(9)).

iii. Synopsis

In sum:

(A) IDTFs that perform direct, in-person testing on beneficiaries must still meet all requirements

and standards in 42 CFR § 410.33. Also, the personnel performing these tests must comply with

the requirements in § 410.33(c)(1).

(B) Indirect IDTFs need not meet the standards in § 410.33(g)(6), (g)(8), and (g)(9). The

personnel performing these tests must comply with the requirements in § 410.33(c)(2) rather than

§ 410.33(c)(1).

(C) If an IDTF performs both direct and indirect tests:

• It must meet the standards in § 410.33(g)(6), (g)(8), and (g)(9). An IDTF must exclusively

and only perform tests involving no beneficiary interaction, treatment, or testing to be

exempt from § 410.33(g)(6), (g)(8), and (g)(9). Thus, even if the overwhelming majority

of the IDTF’s tests are those described in the previous sentence, the above-mentioned

exemptions are inapplicable if the IDTF conducts any tests requiring direct, in-person

patient interaction.

• Personnel performing direct patient interaction tests must meet the requirements of §

410.33(c)(1). Personnel conducting indirect, non-person tests must meet the requirements of

§ 410.33(c)(2). If a particular technician at an IDTF performs both categories of tests, the

technician must meet § 410.33(c)(1)’s requirements for the direct, in-person tests and §

410.33(c)(2)’s requirements for the indirect, non-in-person tests.

(D) The contractor will typically be able to determine during application processing whether the

IDTF is an “indirect IDTF.” This can be done via, for instance, reviewing: (1) the site visit

results; or (2) the tests reported in Attachment 2 of the Form CMS-855B. In this matter, the

contractor shall abide by the following:

• Unless there is evidence that the IDTF only performs indirect tests, the contractor may

assume that the supplier is not an “indirect IDTF.”

• If the contractor determines that the IDTF performs both indirect and direct tests, it shall

follow the instructions described in this subsection (A)(2).

Note that the contractor is not required to submit all potential indirect IDTF applications to

PEOG for review or prior approval. The contractor need only contact its PEOG BFL if it: (1) is

truly unsure if an indirect IDTF situation is involved; or (2) does not believe the supplier is an

indirect IDTF but the supplier states that it is.

B. IDTF Standards

Consistent with 42 CFR § 410.33(g)—and excluding § 410.33(g)(6), (g)(8), and (g)(9) for

indirect IDTFs---each IDTF must certify on its Form CMS-855B enrollment application that it

meets the following standards and all other requirements:

1. Operates its business in compliance with all applicable federal and state licensure and

regulatory requirements for the health and safety of patients (§ 410.33(g)(1)).

• The purpose of this standard is to ensure that suppliers are licensed in the business and

specialties being provided to Medicare beneficiaries. Licenses are required by state and/or

federal agencies to make certain that guidelines and regulations are being followed and to

ensure that businesses are furnishing quality services to Medicare beneficiaries.

• The responsibility for determining what licenses are required to operate a supplier’s business

is the sole responsibility of the supplier. The contractor is not responsible for notifying any

supplier of what licenses are required or that any changes have occurred in the licensure

requirements. No exemptions to applicable state licensing requirements are permitted,

except when granted by the state.

• The contractor shall not grant billing privileges to any business not appropriately licensed as

required by the appropriate state or federal agency. If a supplier is found providing services

for which it is not properly licensed, billing privileges may be revoked and appropriate

recoupment actions taken.

2. Provides complete and accurate information on its enrollment application. Changes in

ownership, changes of location, changes in general supervision, and final adverse actions must

be reported to the contractor within 30 calendar days of the change. All other changes to the

enrollment application must be reported within 90 days (§ 410.33(g)(2)).

(NOTE: This 30-day requirement takes precedence over the certification in Section 15 of

the Form CMS-855B whereby the supplier agrees to notify Medicare of any changes to its

enrollment data within 90 days of the effective date of the change. By signing the

certification statement, the IDTF agrees to abide by all Medicare rules for its supplier type,

including the 30-day rule in 42 CFR §410.33(g)(2)).

3. Maintain a physical facility on an appropriate site. (For purposes of this standard, a post

office box, commercial mailbox, hotel, or motel is not an appropriate site. The physical facility,

including mobile units, must contain space for equipment appropriate to the services designated

on the enrollment application, facilities for hand washing, adequate patient privacy

accommodations, and the storage of both business records and current medical records within the

office setting of the IDTF, or IDTF home office, not within the actual mobile unit.)

(§410.33(g)(3)).

• IDTF suppliers that provide services remotely and do not see beneficiaries at their practice

location are exempt from providing hand washing and adequate patient privacy

accommodations.

• The requirements in 42 CFR § 410.33(g)(3) take precedence over the guidelines in section

10.3.1(B)(1)(d) of this chapter pertaining to the supplier’s practice location requirements.

• The physical location must have an address, including the suite identifier, which is

recognized by the United States Postal Service (USPS).

4. Has all applicable diagnostic testing equipment available at the physical site excluding

portable diagnostic testing equipment. The IDTF must—

(i) Maintain a catalog of portable diagnostic equipment, including diagnostic testing equipment

serial numbers at the physical site;

(ii) Make portable diagnostic testing equipment available for inspection within 2 business days

of a CMS inspection request; and

(iii) Maintain a current inventory of the diagnostic testing equipment, including serial and

registration numbers, and provide this information to the designated fee-for-service contractor

upon request, and notify the contractor of any changes in equipment within 90 days. (§

410.33(g)(4)).

5. Maintain a primary business phone under the name of the designated business. The IDTF

must have its –

(i) Primary business phone located at the designated site of the business or within the home

office of the mobile IDTF units.

(ii) Telephone or toll free telephone numbers available in a local directory and through directory

assistance. (§ 410.33(g)(5)).

The requirements in 42 CFR § 410.33(g)(5) take precedence over the guidelines in section

10.3.1(B)(1)(d) of this chapter regarding the supplier’s telephone requirements.

IDTFs may not use “call forwarding” or an answering service as their primary method of

receiving calls from beneficiaries during posted operating hours.

6. Have a comprehensive liability insurance policy of at least $300,000 per location that covers

both the place of business and all customers and employees of the IDTF. The policy must be

carried by a non-relative-owned company. Failure to maintain required insurance at all times

will result in revocation of the IDTF’s billing privileges retroactive to the date the insurance

lapsed. IDTF suppliers are responsible for providing the contact information for the issuing

insurance agent and the underwriter. In addition, the IDTF must--

(i) Ensure that the insurance policy remains in force at all times and provide coverage of at least

$300,000 per incident; and

(ii) Notify the CMS designated contractor in writing of any policy changes or cancellations. (§

410.33(g)(6))

7. Agree not to directly solicit patients; this includes - but is not limited to - a prohibition on

telephone, computer, or in-person contacts. The IDTF must accept only those patients referred

for diagnostic testing by an attending physician who: (a) is furnishing a consultation or treating a

beneficiary for a specific medical problem; and (2) uses the results in the management of the

beneficiary’s specific medical problem. Non-physician practitioners may order tests as set forth

in § 410.32(a)(3). (§ 410.33(g)(7))

• By the signature of the authorized official in Section 15 of the Form CMS-855B, the IDTF

agrees to comply with 42 CFR § 410.33(g)(7).

• The supplier is prohibited from directly contacting any individual beneficiary for the purpose

of soliciting business for the IDTF. This includes contacting the individual beneficiary by

telephone or via door-to-door sales.

• There is no prohibition on television, radio, or Internet advertisements, mass mailings, or

similar efforts to attract potential clients to an IDTF.

8. Answer, document, and maintain documentation of a beneficiary’s written clinical complaint

at the physical site of the IDTF. (For mobile IDTFs, this documentation would be stored at their

home office.) This includes, but is not limited to, the following:

(i) The name, address, telephone number, and health insurance claim number of the beneficiary.

(ii) The date the complaint was received, the name of the person receiving the complaint, and a

summary of actions taken to resolve the complaint.

(iii) If an investigation was not conducted, the name of the person making the decision and the

reason for the decision. (§ 410.33(g)(8))

9. Openly post these standards for review by patients and the public. (§ 410.33(g)(9))

10. Disclose to the government any person having ownership, financial, or control interest or

any other legal interest in the supplier at the time of enrollment or within 30 days of a change. (§

410.33(g)(10))

11. Have its testing equipment calibrated and maintained per equipment instructions and in

compliance with applicable manufacturers’ suggested maintenance and calibration standards. (§

410.33(g)(11))

12. Have technical staff on duty with the appropriate credentials to perform tests. The IDTF

must be able to produce the applicable federal or state licenses or certifications of the individuals

performing these services. (§ 410.33(g)(12))

13. Have proper medical record storage and be able to retrieve medical records upon request

from CMS or its fee-for-service contractor within 2 business days. (§ 410.33(g)(13))

14. Permit CMS, including its agents, or its designated fee-for-service contractors, to conduct

unannounced, on-site inspections to confirm the IDTF’s compliance with these standards. The

IDTF must---

(i) Be accessible during regular business hours to CMS and beneficiaries; and

(ii) Maintain a visible sign posting its normal business hours. (§ 410.33(g)(14))

15. With the exception of hospital-based and mobile IDTFs, a fixed-base IDTF is prohibited

from the following:

(i) Sharing a practice location with another Medicare-enrolled individual or organization;

(ii) Leasing or subleasing its operations or its practice location to another Medicare-enrolled

individual or organization; or

(iii) Sharing diagnostic testing equipment used in the initial diagnostic test with another

Medicare-enrolled individual or organization. (§ 410.33(g)(15))

16. Enrolls in Medicare for any diagnostic testing services that it furnishes to a Medicare

beneficiary, regardless of whether the service is furnished in a mobile or fixed-base location. (§

410.33(g)(16))

17. Bills for all mobile diagnostic services that are furnished to a Medicare beneficiary, unless

the mobile diagnostic service is part of a service provided under arrangement as described in

section 1861(w)(1) of the Act (§ 410.33(g)(17)) (Section 1861(w)(1) states that the term

“arrangements” is limited to arrangements under which receipt of payments by the hospital,

critical access hospital, skilled nursing facility, home health agency or hospice program (whether

in its own right or as an agent), with respect to services for which an individual is entitled to have

payment made under this title, discharges the liability of such individual or any other person to

pay for the services.)

If the IDTF claims that it is furnishing services under arrangement as described in section

1861(w)(1), the IDTF must provide documentation of such with its initial or revalidation Form

CMS-855 application.

The IDTF must meet all of the standards in 42 CFR § 410.33 – as well as all other federal and

state statutory and regulatory requirements – in order to be enrolled in, and to maintain its

enrollment in, the Medicare program. Failure to meet any standard in 42 CFR § 410.33 or any

other applicable requirement will result in the denial of the supplier’s Form CMS-855

application or, if the supplier is already enrolled in Medicare, the revocation of its Medicare

billing privileges.

C. Leasing and Staffing

For purposes of the provisions in 42 CFR § 410.33, a "mobile IDTF" does not include entities

that lease or contract with a Medicare enrolled provider or supplier to provide: (1) diagnostic

testing equipment; (2) non-physician personnel described in 42 CFR § 410.33(c); or (3)

diagnostic testing equipment and non-physician personnel described in 42 CFR § 410.33(c).

This is because the provider/supplier is responsible for providing the appropriate level of

physician supervision for the diagnostic testing.

An IDTF is not required to report equipment that the IDTF is leasing for a period less than 90

days unless the IDTF is leasing equipment for services that they have not already reported on a

Form CMS-855B IDTF Attachment. For all new services being provided, IDTFs would need to

complete a change of information to include the equipment and CPT/HCPCS codes that will be

billed. Any accreditation for the services provided would need to be obtained by the IDTF.

D. Sharing of Space and Equipment

As previously noted, the standard in § 410.33(g)(15) states that, with the exception of hospital-based and mobile IDTFs, a fixed-base IDTF cannot: (i) share a practice location with another

Medicare-enrolled individual or organization; (ii) lease or sublease its operations or its practice

location to another Medicare-enrolled individual or organization; or (iii) share diagnostic testing

equipment used in the initial diagnostic test with another Medicare-enrolled individual or

organization.

If the contractor determines that an IDTF is violating at least one of the three prohibitions in §

410.33(g)(15), the contractor shall revoke the supplier’s Medicare billing privileges.

E. Multi-State IDTFs

As stated in 42 CFR § 410.33(e)(1), an IDTF that operates across state boundaries must:

a. Maintain documentation that its supervising physicians and technicians are licensed and

certified in each of the states in which it operates; and

b. Operate in compliance with all applicable federal, state, and local licensure and regulatory

requirements with regard to the health and safety of patients.

Under § 410.33(e)(2), the point of the actual delivery of service means the place of service on the

claim form. When the IDTF performs or administers an entire diagnostic test at the beneficiary's

location, the beneficiary’s location is the place of service. When one or more aspects of the

diagnostic testing are performed at the IDTF, the IDTF is the place of service.

F. One Enrollment per Practice Location

An IDTF must separately enroll each of its practice locations (with the exception of locations

that are used solely as warehouses or repair facilities). This means that an enrolling IDTF can

only have one practice location on its Form CMS-855B enrollment application; thus, if an IDTF

is adding a practice location to its existing enrollment, it must submit a new, complete Form

CMS-855B application for that location and have that location undergo a separate site visit.

Also, each of the IDTF’s mobile units must enroll separately; if a fixed IDTF site also contains a

mobile unit, the mobile unit must therefore enroll separately from the fixed location.

Each separately enrolled practice location of the IDTF must meet all applicable IDTF

requirements. The location’s failure to comply with any of these requirements will result in the

revocation of its Medicare billing privileges.

If an IDTF adds equipment for diagnostic testing that is mobile in nature but is fixed

permanently to the IDTF’s physical location (i.e., a CT scanner that is mounted in a bus or trailer

but is parked at the IDTF’s site for use by the IDTF), a second enrollment is not necessary. This

equipment can be listed in the Form CMS-855B along with the services performed on the

equipment. In these cases, the contractor shall indicate the use of a fixed mobile unit is in use at

the IDTF’s site in the site visit request so the site inspector will know to view the fixed mobile

equipment as part of the IDTF.

G. Interpreting Physicians

1. Reporting Interpreting Physicians on the Form CMS-855B

The applicant shall list all physicians for whose diagnostic test interpretations it will bill. This

includes physicians who will provide interpretations subject to the anti-markup payment

limitation as detailed in CMS Pub. 100-04, chapter 1, § 30.2.9 - whether the service is provided

to the IDTF on a contract basis or is reassigned.

The contractor shall ensure and document that:

• All listed physicians are enrolled in Medicare;

• All interpreting physicians who are reassigning their benefits to the IDTF have the right to do

so; and

• The interpreting physicians listed are qualified to interpret the types of tests (codes) listed.

(The contractor may need to contact another contractor to obtain this information.) If the

applicant does not list any interpreting physicians, the contractor need not request additional

information because the applicant may not be billing for the interpretations; that is, the

physicians may be billing for the interpretation themselves.

If an interpreting physician has been recently added or changed, the new interpreting physician

must have met all of the interpreting physician requirements at the time any tests were

performed.

A Form CMS-855R need not accompany a Form CMS-855B application submitted by an IDTF

that employs or contracts with an interpreting physician.

2. Changes of Interpreting Physicians

If an interpreting physician is being added or changed, the updated information must be reported

via a Form CMS-855B change request. To perform services as an interpreting physician, the new

interpreting physician must have met all requirements at the time any tests were performed.

If the contractor receives notification from an interpreting physician that the latter is no longer

interpreting tests at the IDTF, the contractor shall request from the supplier a Form CMS-855B

change of information to end date the interpreting physician from the enrollment.

H. Effective Date of IDTF Billing Privileges

As stated in 42 CFR § 410.33(i), the filing date of an IDTF Medicare enrollment application is

the date the contractor receives a signed application that it is able to process to approval. The

effective date of billing privileges for a newly enrolled IDTF is the later of the following:

(1) The filing date of the Medicare enrollment application that was subsequently approved by the

contractor; or

(2) The date the IDTF first started furnishing services at its new practice location.

A newly-enrolled IDTF, therefore, may not receive reimbursement for services furnished before

the effective date of billing privileges.

The contractor shall note that if it rejects an IDTF application under 42 CFR § 424.525 and a

new application is later submitted, the date of filing is the date the contractor receives the new

enrollment application.

If an IDTF undergoes an ownership change that results in a new enrollment (e.g., a new federal

tax information number (TIN) results from this change), the contractor should use the transfer of

ownership/business date as indicated by the IDTF, instead of establishing a new effective date.

I. IDTF Technicians Must Be Listed on the Form CMS-855B

Each non-physician who performs IDTF diagnostic tests must be listed. These persons are often

referred to as technicians.

J. IDTF Technician Licensure and Certification Requirements

All technicians must meet state licensure or state certification standards at the time of the IDTF’s

enrollment. The contractor may not grant temporary exemptions from such requirements.

In lieu of requiring a copy of the technician’s certification card, the contractor may validate a

technician’s credentials online via organizations such as the American Registry for Diagnostic

Medical Sonography (ARDMS), the American Registry of Radiology Technologists (ARRT),

and the Nuclear Medicine Technology Certification Board (NMTCB). If online verification is

not available or cannot be made, the contractor shall request a copy of the technician’s

certification card.

K. IDTF - Changes of Technicians

If a technician is being added or changed, the updated information must be reported via a Form

CMS-855B change request. The new technician must have met all of the necessary credentialing

requirements at the time any tests were performed.

If the contractor receives notification from a technician that the latter is no longer performing

tests at the IDTF, the contractor shall request from the supplier a Form CMS-855B change of

information. If the supplier did not have another technician qualified to perform the tests listed

on the current application, the supplier must submit significant documentation in the form of

payroll records, etc. to substantiate the performance of the test by a properly qualified technician

after the date the original technician was no longer performing procedures at the IDTF.

L. IDTF Supervising Physicians – General Principles

An IDTF must have one or more supervising physicians who are responsible for:

• The direct and ongoing oversight of the quality of the testing performed;

• The proper operation and calibration of equipment used to perform tests; and

• The qualifications of non-physician IDTF personnel who use the equipment.

Not every supervising physician has to be responsible for all of these functions. For instance,

one supervising physician can be responsible for the operation and calibration of equipment,

while another supervising physician can be responsible for test supervision and the qualifications

of non-physician personnel. The basic requirement, however, is that all supervising physician

functions must be properly met at each location, regardless of the number of physicians involved.

This is particularly applicable to mobile IDTF units that are allowed to use different supervising

physicians at different locations. They may have a different physician supervise the test at each

location. The physicians used need only meet the proficiency standards for the tests they are

supervising.

Under 42 CFR § 410.33(b)(1), each supervising physician must be limited to providing general

supervision at no more than three IDTF sites. This applies to both fixed sites and mobile units

where three concurrent operations are capable of performing tests.

M. IDTF - Information about Supervising Physicians

The contractor shall ensure and document in PECOS that each supervising physician is: (1)

licensed to practice in the state(s) where the diagnostic tests the physician supervises will be

performed; (2) Medicare-enrolled; and (3) not currently excluded or debarred. The physician(s)

need not necessarily be Medicare-enrolled in the state where the IDTF is enrolled; moreover, the

physician need not be furnishing medical services outside of the physician’s role as a supervising

physician (i.e., the physician need not have a medical practice separate from the IDTF). If the

physician is enrolled in another state or with another contractor, however, the contractor shall

ensure that the physician is appropriately licensed in that state.

In addition:

• Each physician of the group who actually performs an IDTF supervisory function must be

listed.

• If a supervising physician has been recently added or changed, the updated information must

be reported via a Form CMS-855B change request. The new physician must have met all of

the supervising physician requirements at the time any tests were performed.

• If the contractor knows that a reported supervising physician has been listed with several

other IDTFs, the contractor shall check with the physician to determine whether the latter is

still acting as supervising physician for these other IDTFs.

• If the supervising physician is enrolling in Medicare and does not intend to perform medical

services outside of the physician’s role as a supervising physician: (1) the contractor shall

still send the physician an approval letter (assuming successful enrollment) and issue a

PTAN; (2) the physician shall list the IDTF’s address as a practice location; and (3) the

space-sharing prohibition in 42 CFR § 410.33(g) does not apply in this particular scenario.

N. IDTF - General, Direct, and Personal Supervision

Section 410.33(b)(2) states that if a procedure requires the direct or personal supervision of a

physician as set forth in, respectively, 42 CFR § 410.32(b)(3)(ii) or (iii), the contractor shall

ensure that the IDTF’s supervising physician furnishes this level of supervision.

The contractor shall: (a) be familiar with the definitions of personal, direct and general

supervision set forth at 42 CFR § 410.32(b)(3); and (b) ensure that the applicant has checked the

highest required level of supervision for the tests being performed.

Each box that begins with “Assumes responsibility” must be checked. However, as indicated

previously, the boxes can be checked through the use of more than one physician.

O. IDTF - Attestation Statement for Supervising Physicians

A separate attestation statement must be completed and signed by each supervising physician

listed. If Question E2 is not completed, the contractor may assume – unless it has reason to

suspect otherwise - that the supervising physician in question supervises for all codes listed in

Section 2 of the IDTF attachment. If Question E2 is completed, the contractor shall ensure that

all codes listed in Section 2 are covered through the use of multiple supervising physicians.

The contractor no longer needs to contact each supervisory physician by telephone or otherwise

to verify that the physician: (1) actually exists (e.g., is not using a false or inactive physician

number); (2) indeed signed the attestation; and (3) is aware of the physician’s responsibilities.

If the physician is enrolled with a different contractor, the contractor shall contact the latter

contractor and obtain the listed telephone number of the physician.

P. IDTF - Changes of Supervising Physicians

If a supervising physician is being added or changed, the updated information must be reported

via a Form CMS-855B change request. To perform services as a supervising physician, the new

supervising physician must have met all requirements at the time any tests were performed.

If the contractor receives notification from a supervising physician that the latter is no longer

supervising tests at the IDTF, the contractor shall request from the supplier a Form CMS-855B

change of information. If the IDTF did not have another supervising physician listed on the

current application, the IDTF must submit a change of information adding a new supervising

physician. If the IDTF does not provide this information, the contractor shall proceed with non-compliance revocation procedures as noted in section 10.4.7 et seq. of this chapter.

Q. Desk and Site Reviews

All initial and revalidating IDTF applicants shall receive: (1) a thorough desk review; and (2) a

mandatory site visit prior to the contractor’s approval of the application. The general purposes of

these reviews are to determine whether:

• The information listed on Attachment 2 of the Form CMS-855B is correct, verifiable, and in

accordance with all IDTF regulatory and enrollment requirements.

• To the extent applicable, the IDTF meets the criteria outlined in sections 10.6.20(A) and

10.6.20(B) of this chapter.

• The IDTF meets the supplier standards in 42 CFR § 410.33.

The contractor shall order the site visit through PECOS. The NSVC will perform the site visit.

The contractor shall not make a final decision regarding the application prior to the completion

of the NSVC’s site visit and the contractor’s review of the results.

R. Mobile Units

Mobile units must list their geographic service areas in Section 4 of the Form CMS-855B. Based

on the information furnished therein, the NSVC will generally perform the site visit via one of

the following methods: (1) the mobile unit visits the office of the NSVC (or some other agreed-to

location) for inspection; (2) the NSVC visits the mobile unit’s base of operations to inspect the

unit; or (3) the NSVC obtains an advance schedule of the locations at which the IDTF will be

performing services and conducts the site visit at one of those locations.

Units performing CPT-4 or HCPCS code procedures that require direct or personal supervision

mandate special attention. To this end, the contractor shall maintain a listing of all mobile IDTFs

that perform procedure codes that require such levels of supervision. The contractor shall also

discuss with the applicant and all supervising physicians listed:

• How they will perform these types of supervision on a mobile basis;

• What their responsibilities are; and

• That a patient’s physician who is performing direct or personal supervision for the IDTF on

the patient should be aware of the prohibition concerning physician self-referral for testing

(in particular, this concerns potentially illegal compensation to the supervisory physician

from the IDTF).

S. Addition of Codes

An enrolled IDTF that wants to perform additional CPT-4 or HCPCS codes must submit a Form

CMS-855B change request. If the additional procedures are of a type and supervision level

similar to those previously reported (e.g., an IDTF that performs MRIs for shoulders wants to

perform MRIs for hips), a new site visit is typically not required, though the contractor reserves

the right to request that the NSVC perform one.

If, however, the enrolled IDTF wants to perform additional procedures that are not similar to

those previously reported (e.g., an IDTF that conducts sleep studies wants to perform ultrasound

tests or skeletal x-rays), the contractor shall order an NSVC site visit through PECOS. All IDTF

claims for the additional procedures shall be suspended until the IDTF: (1) passes all enrollment

requirements for the additional procedures (e.g., supervisory physician, non-physician personnel,

equipment); and (2) presents evidence that all requirements for the new procedures were met

when the tests were actually performed.

If the enrolled IDTF (1) originally listed only general supervision codes, (2) was only reviewed

for general supervision tests, and (3) now wants to perform tests that require direct or personal

supervision, the contractor shall promptly suspend all payments for all codes other than those

requiring general supervision. The contractor shall order an NSVC site visit through PECOS.

All IDTF claims for the additional procedures shall be suspended until the IDTF: (1) passes all

enrollment requirements for the additional procedures (e.g., supervisory physician, non-physician personnel, equipment); and (2) presents evidence that all requirements for the new

procedures were met when the tests were actually performed.

In the situations described in the two previous paragraphs, the contractor shall not approve the

application prior to the completion of the NSVC’s site visit and the contractor’s review of the

results.

T. IDTF That Performs Diagnostic Mammography

If an IDTF performs diagnostic mammography services, it must have a Food and Drug

Administration certification to perform the mammography. However, an entity that only

performs diagnostic mammography services should not be enrolled as an IDTF. Rather, it

should be separately enrolled as a mammography screening center.

U. IDTF Ownership of CLIA Laboratory

An IDTF may not perform or bill for CLIA tests. However, an entity with one tax identification

number may own both an IDTF and an independent CLIA laboratory. In such a situation, they

should be separately enrolled and advised to bill separately. The contractor shall also advise its

claims unit to ensure that the CLIA codes are not being billed under the IDTF provider number.

V. Denials and Revocations for Non-Compliance with IDTF Supplier Standards

Pursuant to 42 CFR §§ 424.530(a)(1)/(18) and 424.535(a)(1)/(23), an IDTF’s enrollment may be

denied or revoked if it violates any applicable standard in § 410.33(g). The contractor shall

abide by the following in such situations:

1. (a)(1) – Prior approval unnecessary

For violations of any of the following supplier standards in § 410.33(g), the contractor shall deny

or revoke enrollment under, respectively, §§ 424.530(a)(1) or 424.535(a)(1). Prior PEOG

approval is unnecessary. Corrective action plan (CAP) rights under §§ 424.530(a)(1) or

424.535(a)(1) apply.

• § 410.33(g)(1) through (g)(6) as well as (g)(8) through (17).

2. (a)(1) and (a)(23) – Prior approval unnecessary

For violations of the following supplier standard in § 410.33(g), the contractor shall deny or

revoke enrollment under, respectively, §§ 424.530(a)(1) or 424.535(a)(23). Prior PEOG

approval is unnecessary. CAP rights under §§ 424.530(a)(1) apply but no CAP rights apply for §

424.535(a)(23) revocations.

• § 410.33(g)(7)