SUPERSEDED Local Coverage Determination (LCD)

Independent Diagnostic Testing Facility (IDTF)

L33910

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Proposed LCD
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33910
Original ICD-9 LCD ID
Not Applicable
LCD Title
Independent Diagnostic Testing Facility (IDTF)
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 05/13/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Independent Diagnostic Testing Facility (IDTF). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Independent Diagnostic Testing Facility (IDTF) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site. 

Internet Only Manual (IOM) Citations:  

  • CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
    • Chapter 15, Section 60 Services and Supplies Furnished Incident To a Physician’s/NPP’s Professional Service, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
  • CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
    • Chapter 1, Part 4, Section 240.4.1 Sleep Testing for Obstructive Sleep Apnea (OSA)
  • CMS IOM Publication 100-04, Medicare Claims Processing Manual,
    • Chapter 1, Section 10 Jurisdiction for Claims, Section 30.2 Assignment of Provider’s Right to Payment
    • Chapter 23, Section 20.9 National Correct Coding Initiative (CCI)
    • Chapter 35 Independent Diagnostic Testing Facility (IDTF)
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 3, Section 3.4.1.2 Not Otherwise Classified (NOC) Codes
    • Chapter 10, Section 10.2.2, I. Independent Diagnostic Testing Facilities (IDTFs)
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:  

  • Title XVIII of the Social Security Act, Section 1861(r) defines the term physician.
  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. 
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. 

Federal Register References: 

  • CFR, Title 42, Volume 2, Chapter IV, Part 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions and Part 410.33 Independent diagnostic testing facility. 

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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 (42CFR§410.33) 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.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

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Associated Information
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Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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Revenue Codes

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Please refer to the related Local Coverage Article: Billing and Coding: Independent Diagnostic Testing Facility (IDTF) (A57807) for documentation requirements, utilization parameters and all coding information as applicable.

Sources of Information

First Coast Service Options, Inc. reference LCD number – L29330

American Association of Electrodiagnostic Technologists (AAET)

American Board of Registration of Electroencephalographic and Evoked Potential

American College of Cardiology/American Heart Association Guidelines for Coronary Angiography: Executive Summary and Recommendations. (1999). A report of the ACC/AHA task force on practice guidelines (committee on coronary angiography). Developed in collaboration with the society for cardiac angiography and interventions. Circulation, 99, 2345-2357.

American Registry of Diagnostic Medical Sonographers (ARDMS)

American Registry of Magnetic Resonance Imaging Technologists (ARMRIT)

Bashore, T., Bates, E., Berger, P., Clark, D., Cusma, J., Dehmer, G., Kern, M., Laskey, W., O’Laughlin, M., Oesterle, S., Popma, J. (2001). Cardiac catheterization laboratory standards: a report of the American college of cardiology task force on clinical expert consensus documents (ACC/SCA&I committee to develop an expert consensus document on catheterization laboratory standards. J Am Coll Cardiol, 37(8), 2170-2214.

Board of Registered Polysomnographic Technologists (BRPT)

Cardiovascular Credentialing International (CCI)

Joint Commission on Allied Health Personnel in Ophthalmology (JCAHPO)

National Board for Respiratory Care (NBRC)

Nuclear Medicine Technology Certification Board (NMTCB)

Pepine, C., Babb, J., Briner, J., Douglas, J., Jacobs, A., Johnson, W., & Vetrovec, G. (2008). Task Force 3: Training in Cardiac Catheterization and Interventional Cardiology.

The American Registry of Radiologic Technologists (ARRT)

The Board of Certification of the Ophthalmic Photographers’ Society

Bibliography

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Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
05/13/2021 R4

LCD revised and published on 05/13/2021 to update IOM 100-08 Chapter 15 to Chapter 10 in the Citations section and throughout the Coverage Guidance section per CR11700 and CR11917. Minor formatting changes made throughout the coding section.

  • Other (CMS Change Requests 11700 and 11917)
11/25/2019 R3

Revision Number: 3
Publication: November 2019 Connection
LCR B2019-034

Explanation of Revision: Based on Change Request (CR) 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes”, “Revenue Codes”, “CPT/HCPCS Codes”, “ICD-10 Codes that Support Medical Necessity”, “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. In addition, the Social Security Act, Code of Federal Regulations, and IOM reference sections were updated. Also, the CMS IOM language has been removed from the LCD and instead, the IOM citation related to this language is referenced. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

Furthermore, based on review of the newly created billing and coding article CPT code 74283 is being removed as it is not appropriate for an IDTF to perform a therapeutic service. The effective date of this revision is for claims processed on or after November 25, 2019.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Other (Revision based on CR 10901)
01/22/2019 R2

Revision Number: 2
Publication: February 2019 Connection
LCR B2019-005

Explanation of Revision: Based on a review of the LCD, grammatical and formatting errors were corrected throughout the LCD. The effective date of this revision is based on process date. Also, it was determined that some of the italicized language in the “Coverage Indications, Limitations, and/or Medical Necessity” and “Documentation Requirements” sections of the LCD do not represent direct quotations from some of the CMS sources listed in the LCD; therefore, this LCD is being revised to assure consistency with the CMS sources. The effective date of this revision is based on date of service. In addition, based on CR 10901, the “CMS National Coverage Policy” and “Coverage Indications, Limitations, and/or Medical Necessity” sections of the LCD were revised to update the section number for Pub. 100-08, Chapter 13 from 13.5.1 to 13.5.4. The effective date of this revision is for claims processed on or after 01/08/2019, for dates of service on or after 09/26/2018.

01/22/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Other (Revisions based on review)
01/01/2017 R1 Explanation of Revision: Annual 2017 HCPCS Update. LCD was revised to add CPT codes 36901, 76706, and 92242. Additionally, LCD was revised to delete CPT/HCPCS codes G0389, 75791, 77051, 77052, 77055, 77056, 77057, and 93965. The effective date of this revision is based on date of service.
  • Revisions Due To CPT/HCPCS Code Changes
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04/12/2024 05/13/2021 - 04/04/2024 Retired View
05/07/2021 05/13/2021 - N/A Superseded You are here
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