Summary Of Evidence

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Analysis of Evidence

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Compliance with the provisions in this policy 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 (42 CFR §410.33) as published in the Federal Register, Vol. 62, number 211, October 31, 1997. Please refer to CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 35, Section 10, for General Coverage Payment Policies.

This local coverage determination (LCD) addresses the structure, approved services, and credentialing requirements for an IDTF. Diagnostic testing performed in an IDTF must follow the supervision and credentialing guidelines set forth in this LCD and in the companion Local Coverage Article, A53252, Independent Diagnostic Testing Facility (IDTF). All enrolling IDTFs must meet the supervising physician qualification/proficiency requirements and technician qualification requirements at the time of their enrollment. See Local Coverage Article, A53252 IDTF, for complete credentialing information.

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 42 CFR §410.33 for additional information on IDTF requirements.

• *Performs only diagnostic tests by licensed, certified non-physician personnel under appropriate physician supervision;
• The sole purpose is to furnish diagnostic testing;
• Is not engaged in any form of patient treatment; and
• Is properly enrolled with Medicare as an IDTF and approved for the specific tests to be provided.

*Please refer to CMS IOM Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in LCDs for information regarding services ordered and furnished by qualified personnel. Services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

Coverage

• Medicare will cover diagnostic tests performed by an IDTF 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).
• IDTFs are required to report the exact CPT/HCPCS codes/procedures they intend to perform when enrolling with the CMS-855B form. If an IDTF which is already enrolled wants to perform additional CPT or HCPCS code tests that were not originally specified on its CMS-855B and that are for procedure types and supervision levels similar to its previously allowed codes, the contractor shall have the IDTF amend its CMS-855B to add the additional codes and equipment listing. A new site visit is not required. However, if the enrolled IDTF will be performing CPT or HCPCS codes for different types of procedures, or with different supervision levels, a new site visit is required. Claims submitted with procedure codes not reported on the CMS-855B form and reviewed by the contractor will be denied.
• By definition, therapeutic procedures and interventions are not allowed to be performed by an IDTF. Independent Diagnostic Testing Facilities may not perform therapeutic, intra-operative or ablation procedures. Please refer to CMS IOM Pub. 100-04, Chapter 35, Section 50 Therapeutic Procedures.
• IDTFs are not an extension of any outpatient facility and should not perform procedures such as removal of foreign body from the esophagus, placement of gastrointestinal tubes, dilatation of strictures, pain management or trans-catheter therapies, to name a few. Therefore, any physician services and/or surgical procedures best provided in acute care facilities, ambulatory surgical centers, or a physician office are not included in the CPT/HCPCS codes for IDTFs.
• Please refer to CMS IOM Pub. 100-04, Chapter 35, Section 30 for information regarding diagnostic tests subject to the anti-markup payment limitation.
• Please refer to CMS IOM Pub. 100-04, Chapter 1, §10 for more information regarding claims filing jurisdiction.

 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. Please refer to Local Coverage Article, A53252 IDTF, for covered additional services.
• 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. 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.
• At the time that the IDTF requests contractor approval to perform the tests, the IDTF must identify all such items/services that it intends to bill in conjunction with specific tests.
• Each IDTF will have a specific and unique list of CPT/HCPCS codes for which it can be paid by the contractor, and it is the responsibility of the IDTF to obtain specific contractor approval to bill each CPT/HCPCS code that it intends to bill.

 Ordering of Tests

• For information regarding ordering of tests performed by an IDTF, please refer to the following:
• CMS IOM Pub. 100-04, Chapter 35, Section 20
• 42 CFR §410.33
• 42 CFR §410.32
• Although all procedures performed by the IDTF must be specifically ordered in writing by the practitioner treating the beneficiary as described in the above regulations, the mere fact that the test(s) were properly ordered does not reflect or imply Medicare coverage for these services. Medical necessity must be apparent and statutory exclusions, national and local coverage determinations (LCDs) apply.
• As noted in the regulations referenced above, 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.
• Please refer to CMS IOM Pub. 100-02, Chapter 15, Section 80.6 Requirements for Ordering and Following Orders for Diagnostic Tests for information on acceptable forms of communication for an order.
• An IDTF may perform the service based on the verbal order of the treating physician; however, the IDTF must obtain an order that is written, dated, and signed by the treating physician before a claim is submitted for the service. In any case, it is expected that a hard copy of the physician’s order be available to Medicare upon request.

Multi-State Entities

• For information regarding multi-state entities for an IDTF that operates across State Boundaries, please refer to the following:
• 42 CFR §410.33
• CMS IOM Pub. 100-04, Chapter 1, Section 10.1.1, Part A. Multiple Offices and/or Part B. Service Provided at a Place of Service Other than Home or Office
• Note that an IDTF must enroll with the Contractor that has jurisdiction in the area where the beneficiary will receive the technical services of the procedure.

Physician Supervision

Please refer to 42 CFR §410.33 for information regarding physician supervision requirements for furnishing the technical component of diagnostic tests for Medicare beneficiaries who are not a hospital inpatient or outpatient.

Please refer to CMS IOM Pub. 100-02, Chapter 15, Section 80 and 42 CFR §410.32(b) for supervision requirements of diagnostic tests including reference to SSA 1861(r) for the definition of physician. 

Exceptions:

Please refer to 42 CFR §410.33 for exceptions for diagnostic tests, payable under the Physician Fee Schedule, that are not required to be furnished in accordance with the ordering and supervising requirements.

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 the equipment used to perform tests and the qualifications of non-physician personnel who use the equipment.

Not every supervising physician has to be responsible for all these functions. These responsibilities may be divided among the supervising physicians. For example, one supervising physician may be responsible only for the operation and calibration of the equipment, while other supervising physicians are responsible for test supervision and/or the qualifications of the non-physician personnel. 

Consistent with the supervising physician proficiency requirements in 42 CFR § 410.33, Novitas requires the supervising physician to meet the qualification requirements as listed in the Local Coverage Article, A53252, IDTF.

Please refer to CMS IOM Pub. 100-02, Chapter 15, Section 80 for the definitions of General, Direct, and Personal supervision.

For additional information specific to IDTF and supervision requirements, please refer to 42 CFR §410.33.

General Supervision - There is no physical distance limitation between where the test is performed and where the supervisory physician is located. When a remote supervisory physician is responsible for general supervision of the IDTF, written documentation indicating how he/she has fulfilled the requirements of general supervision must be made available upon request.

*Note: The minimal level of physician supervision, which applies to ALL diagnostic tests, with the exceptions cited above, is “general supervision”. 

The basic requirement is that all the supervising functions 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. A different physician may supervise the test at each location. The supervising physicians only have to meet the proficiency standards for the tests they are supervising.

Supervising physicians do not have to be employees of the IDTF. They may be contracted physicians for each location served by the IDTF.

The level of physician supervision required for diagnostic procedures can be found in the Medicare Physician Fee Schedule Database (MPFSDB). 

Non-Physician Personnel

Please refer to the following regulations regarding non-physician personnel.

• 42 CFR §410.33
• CMS IOM Pub. 100-02, Chapter 15, Sections 80.2, 80.3, 190

It is expected that non-physician personnel must maintain an active status in order for the diagnostic tests to be covered. The only exception to this is 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 non-physician personnel credentialing requirements are listed in Local Coverage Article, A53252, IDTF.

The IDTF technicians do not have to be employees of the IDTF. They can be contracted by the IDTF. All enrolling IDTFs must meet the applicable technician licensure, certification or credentialing requirements at the time of their enrollment.

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:

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 are 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 (CMS Change Request 4280, dated 01/27/06).

Novitas will consider a diagnostic cardiac catheterization performed in an IDTF as medically reasonable and necessary when all the following criteria are met:

• Performed by a *qualified physician as defined below; AND
• 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
• Performed with the assistance of a Registered Nurse (RN) with Advanced Cardiac Life Support (ACLS) certification; OR
• 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 II training as outlined by the ACC/AHA Task Force 10.

** Accepted Accreditation Organizations for Cardiac Catheterization Labs:

• Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (Now known as the Joint Commission)
• 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.

Select cardiac catheterization procedure codes and the supervising physician and technician qualification requirements as stated above may be found in Local Coverage Article, A53252, IDTF.

Limitations:

Left heart catheterization performed using transapical puncture or transseptal puncture through intact septum 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, Medicare may reimburse 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.

This LCD and companion Article A53252, IDTF (including physician supervision requirements and technician requirements) will be updated when new CPT codes are released or with a valid reconsideration to this LCD. The reconsideration process can be found on the Medical Policy page on the Novitas website. It is the requirement of the provider to be aware of changes as their profile in Provider Enrollment may change and an application for new procedure codes will be required.

NOTE: IDTFs who have been given procedure privileges in the past but not included in the article will have their profile updated against the new list included in the article when requesting addition of procedures.

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.