Compliance with the provisions in this LCD may be monitored and addressed
through post payment data analysis and subsequent medical review audits.

**History/Background and/or General Information**

An Independent Diagnostic Testing Facility (IDTF) is an entity independent of
a hospital or physician's office in which diagnostic tests are performed. It
was created by regulation (42CFR410.33) as published in the Federal Register,
Vol. 62, number 211, October 31, 1997.  
  
This local coverage determination (LCD) addresses the structure, approved
services, credentialing requirements and coding and billing for an IDTF.
Diagnostic testing performed in an IDTF must follow the supervision and
credentialing guidelines set forth in this LCD. All enrolling IDTFs must meet
the supervising physician qualification/proficiency requirements and
technician qualification requirements at the time of their enrollment.  
  
IDTF regulations in this LCD do not apply to approved portable x-ray suppliers
or to procedures (e.g., pathology and laboratory) furnished in a physician's
office, group practices, multi-specialty clinics or groups.

  
**Required Characteristics of an IDTF:**

Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33
Independent diagnostic testing facility, CMS IOM Publication 100-04, _Medicare
Claims Processing Manual_ , Chapter 35, Section 50 Therapeutic Procedures, and
CMS IOM Publication 100-08, _Medicare Program Integrity Manual_ , Chapter 10
Medicare Enrollment.

**  
Covered Indications**

Diagnostic tests performed by an IDTF will be covered when the procedures are
medically necessary and the criteria in this LCD are met. **The procedures in
this document are also subject to applicable National and Local Coverage
Determinations (LCDs).**  

Please refer to CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 10 Medicare Enrollment regarding the Form CMS-855B
enrollment application.

Please refer to CMS IOM Publication 100-04, _Medicare Claims Processing
Manual_ , Chapter 35, Section 50 Therapeutic Procedures.

**  
Additional Services/Supplies  **

Additional services/items (e.g., radiopharmaceutical agents, special contrast
agents, medications, etc.) related to, or generally considered required for,
performing a diagnostic test are also payable to an IDTF if they are commonly
separately reimbursed to a physician in a physician's office setting. An IDTF
can bill these practitioner services when they are performed by a qualified
practitioner in accordance with coverage, payment and general billing rules,
and in accordance with the reassignment of benefit and purchased test rules.

These additional services/items which are necessary for the performance of
specific diagnostic tests may be billed by an IDTF if approval is granted by
the contractor for the IDTF to bill for the specific test(s) that require such
items/services. The additional items or services may not be listed on the IDTF
CPT/HCPCS code table. For example, some procedures require an injection of a
joint for arthrography and would be allowed if the procedure is integral to
the diagnostic test the IDTF is permitted to perform. However, an IDTF is not
allowed to bill for surgical procedures that are clearly not related to, or
required for a diagnostic test.

**  
Ordering of Tests  **

Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(d)
Ordering of tests and CMS IOM Publication 100-04, Medicare Claims Processing
Manual, Chapter 35, Section 20 Ordering of Test.

Although all procedures performed by the IDTF must be specifically ordered in
writing by the practitioner treating the beneficiary as noted in the CFR,
Title 42, Volume 2, Chapter IV, Part 410.33(d), the mere fact that the test(s)
were properly ordered does not reflect or imply coverage for these services.
Medical necessity must be apparent and statutory exclusions, national and
local coverage determinations (LCDs) apply.

As noted in the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(d), the
results of any diagnostic test performed by the IDTF must actually be used in
the management of the beneficiary's specific medical problem. If a
beneficiary's medical care will not be significantly altered by the results of
a test performed by an IDTF, even if properly ordered, it will not be paid.
Similarly, any test performed by an IDTF must be in an appropriate place of
service.

**  
Multi-State Entities  **

Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(e) Multi-
State entities.

**  
Physician Supervision**

Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(a)(2)
Exceptions, Part 410.33(b) Supervising physician, CMS IOM Publication 100-02,
_Medicare Benefit Policy Manual_ , Chapter 15, Section 80 Requirements for
Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, and CMS
IOM Publication 100-08, _Medicare Program Integrity Manual_ , Chapter 10,
Section 10.2.2, I. Independent Diagnostic Testing Facilities (IDTFs), Parts 13
and 14.

It is required that the supervising physician meet the qualification
requirements as listed in the Credentialing Matrix found in Local Coverage
Article: Billing and Coding: Independent Diagnostic Testing Facility (IDTF)
(A57807).

***Note: The minimal level of physician supervision, which applies to ALL
diagnostic tests, with the exceptions cited in the CFR, Title 42, Volume 2,
Chapter IV, Part 410.33(a)(2), is "general supervision".**

**  
Tests Personally Performed by a Physician  **

Physician supervision of any type is not required for diagnostic tests
personally performed by a physician when they are authorized by the State to
perform such tests and the testing is within the scope of their practice. In
this case, technician requirements would not apply since the qualified
physician is performing the test.

**  
Nonphysician Personnel  **

Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(a)
General rule, Part 410.33(c) Nonphysician personnel, CMS IOM Publication
100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80 Requirements
for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, and
CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 10,
Section 10.2.2, I. Independent Diagnostic Testing Facilities (IDTFs), Parts
10-12.

It is expected that nonphysician personnel must maintain an active status in
order for the diagnostic tests to be covered.

When a Medicare payable diagnostic test is not subject to State license or
certification of the technician performing the test, and no generally accepted
national credentialing body exists. In that instance, the technician should be
listed and the IDTF should submit as an attachment any education/credentialing
and/or experience that the person has.

The contractor does not establish a credentialing service but the contractor
is authorized to determine which organizations it recognizes. For example, the
use of the word "national" in the organization's name does not, in itself,
meet Medicare standards for national credentialing.

The supervising physician and nonphysician personnel credentialing
requirements are listed in the Credentialing Matrix found in Local Coverage
Article: Billing and Coding: Independent Diagnostic Testing Facility (IDTF)
(A57807).

**Note:** For all credentialed technologists, licensed personnel and personnel
in which no credentialing or licensing board is available, it is a requirement
that the individual demonstrate proficiency in the service one is performing.
This must be documented and verified by the supervising physician.

**  
Requirements for Cardiac Catheterization Procedures Performed in an IDTF:  **

Effective for services performed on or after January 12, 2006, CMS repealed
section 20.25, titled Cardiac Catheterization in Other than a Hospital
Setting, of publication 100-03 ( _Medicare National Coverage Determinations
(NCD) Manual_ ). Therefore, determinations of coverage for cardiac
catheterization when performed outside the hospital setting is at the
discretion of the local Medicare contractor through their local coverage
determinations (LCDs).

The original language from section 20.25 of publication 100-03 required that
Medicare contractors, in consultation with the Peer Review Organizations
(PROs), renamed Quality Improvement Organizations (QIOs), review freestanding
Cardiac Catheterization facilities to determine that procedures can be
performed safely. This function of the QIOs is no longer in their scope of
work as their focus has shifted to include other functions. It is now at the
contractor's discretion through LCDs to make decisions regarding the coverage
of Cardiac Catheterization in freestanding facilities.

A diagnostic cardiac catheterization performed in an IDTF will be considered
as medically reasonable and necessary when the following criteria are met:

  1. Performed by a *qualified physician as defined below; AND
  2. Performed with the assistance of a cardiology technologist credentialed as follows:
    * Credentialed by The American Registry of Radiologic Technologists (ARRT) as a Cardiac-Interventional Radiographer (ARRT: CI); OR
    * Credentialed by Cardiovascular Credentialing International (CCI) as a Cardiovascular Invasive Specialist (CCI: RCIS); AND 
  3. Performed with the assistance of a Registered Nurse (RN) with Advanced Cardiac Life Support (ACLS) certification; OR 
  4. Performed in an IDTF accredited by an **approved accreditation organization as a cardiac catheterization lab. 

*Training Requirements for Physicians Performing Cardiac Catheterizations in an IDTF: 

The American College of Cardiology (ACC) and the American Heart Association
(AHA) have issued joint guidelines on training in cardiac catheterization and
interventional cardiology. Providers who perform diagnostic catheterization
services in an IDTF setting must have a minimum of Level 2 training as
outlined by the ACC/AHA Task Force 3.

** Accepted Accreditation Organizations for Cardiac Catheterization Labs:

  * Joint Commission on Accreditation of Healthcare Organizations (JCAHO) 
  * Accreditation Association for Ambulatory Health Care (AAAHC). 

This procedure must always be performed under personal physician supervision,
which means the physician must be present in the room while the entire cardiac
catheterization is being performed.

The IDTF must have a formal relationship with a tertiary hospital for the
emergency transfer of patients, have equipment for intubation and ventilatory
support, and have quality assurance and quality improvement programs in place.
In addition, the physicians must be able to perform endotracheal intubations
and insert an intra-aortic balloon pump.

**  
Limitations:  **

Left heart catheterization by transseptal puncture through intact septum or by
transapical puncture is not considered safe when performed in an independent
diagnostic testing facility setting and therefore, is not covered.

Patients having a cardiac catheterization performed in an IDTF must be in
stable condition and at the lowest risk for complications. Higher risk
patients include those with recent myocardial infarction (MI) with post-
infarction ischemia, class IV cardiac disease, refractory unstable angina, and
New York Heart Association (NYHA) Class III or IV heart failure, among others.

As a reminder, reimbursement may be made to IDTFs only for procedure codes for
which they are approved, based on equipment and personnel requirements, IDTFs
are required to submit a list of all procedure codes performed by the facility
to Medicare Provider Enrollment. The codes and equipment should be listed on
Attachment 2, Section 1 of Enrollment Application Form CMS-855B.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity
Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.

**Notice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.