LCD/NCD Portal

L29195 INDEPENDENT DIAGNOSTIC TESTING FACILITY (IDTF)

 

 

01/01/2011

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

• Effective for diagnostic procedures performed on or after March 15, 1999, carriers will pay for diagnostic procedures under the physician fee schedule only when performed by

o a physician,

o  a group practice of physicians,

o an approved supplier of portable x-ray services,

o a nurse practitioner, or

o a clinical nurse specialist when he or she performs a test he or she is authorized by the State to perform, or

o an independent diagnostic testing facility (IDTF).

• This local coverage determination (LCD) addresses the structure, approved services, credentialing requirements and coding and billing for an IDTF.

o Diagnostic testing performed in an IDTF must follow the supervision and credentialing guidelines set forth in this LCD.

o 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

o physician’s office,

o group practices,

o Multi-specialty clinics or groups.

• Required Characteristics of an IDTF:

o It may be in a fixed location or be a mobile entity or supplied by an individual non-physician practitioner

o Is independent of a physician’s office or hospital; however, these rules apply when an IDTF furnishes diagnostic procedures in a physician’s office

o  *Performs only diagnostic tests by licensed, certified non-physician personnel under appropriate physician supervision

o The sole purpose is to furnish diagnostic testing

o Is not engaged in any form of patient treatment;

and

o Is properly enrolled with Medicare as an IDTF and approved for the specific tests to be provided.

o *The CMS On-line Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.1) outlines that "reasonable and necessary" services are "ordered and/or 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.

o If an IDTF which is already enrolled wants to perform additional CPT or HCPCS code tests that are 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 and a new site visit is not required.

o 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.

o 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.

o Independent Diagnostic Testing Facilities may not perform therapeutic, intra-operative or ablation procedures.

o 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.

o 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.

 

 

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.

o 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.

o The additional items or services may not be listed on the IDTF CPT/HCPCS code table.

o 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.

o 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.

o 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

 

• All procedures performed by the IDTF must be specifically ordered in writing by the physician who is treating the beneficiary, or a non-physician practitioner, nurse practitioner, clinical nurse specialist, or physician assistant, as defined in §1861(s)(2)(K) of the Act, who furnishes, pursuant to State law, a consultation or treats a beneficiary for a specific medical problem, and who uses the results of a diagnostic test in the management of the beneficiary’s specific medical problem, as noted in 42CFR410.32.

• The order must specify the diagnosis or other basis for the testing.

o The supervising physician for the IDTF may not order tests to be performed by the IDTF, unless the IDTF’s supervising physician is in fact the beneficiary’s treating physician with a prior relationship to the patient.

o  The IDTF may not add any procedures based on internal protocols without a written order from the treating physician.

• Although all procedures performed by the IDTF must be specifically ordered in writing by the practitioner treating the beneficiary as noted above, the mere fact that the test(s) were properly ordered does not reflect or imply Medicare coverage for these services.

o Medical necessity must be apparent and statutory exclusions, national and local coverage determinations (LCDs) apply.

o As noted 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.

o An order may include the following forms of communication:

 a) A written document signed by the treating physician/practitioner, which is hand-delivered, mailed, or faxed to the testing facility; (No signature is required on orders for clinical diagnostic tests paid on the basis of the clinical laboratory fee schedule, the physician fee schedule, or for physician pathology services)

 b) A telephone call by the treating physician/practitioner or his/her office to the testing facility; or c) An electronic mail by the treating physician/practitioner or his/her office to the testing facility.

o Note: If the order is communicated via telephone, both the treating physician/practitioner or his/her office, and the testing facility must document the telephone call in their respective copies of the beneficiary’s medical records.

 While a physician order is not required to be signed, the physician must clearly document, in the medical record, his or her intent that the test be performed.

• 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.

o In any case, it is expected that a hard copy of the physician’s order be available to Medicare upon request.

 

 

Multi-State Entities

 

• An IDTF that operates across State boundaries must:

o Maintain documentation that the supervising physicians and technicians are licensed and certified in each of the States in which it operates.

o The technicians must be licensed and/or nationally certified for each state in which they provide services;

And

o Operate in compliance with all applicable Federal, State, and local licensure and regulatory requirements with regard to the health and safety of patients.

o The point of the actual delivery of service should be reported as 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 the diagnostic test contains a home based and a facility based component, and the IDTF reads or monitors the test, the IDTF is considered the place of service.

 Note that an IDTF must enroll with the carrier that has jurisdiction in the area where the beneficiary will receive the technical services of the procedure.

• Physician Supervision

o This section describes the levels of physician supervision required for furnishing the technical component of diagnostic tests for Medicare beneficiaries who are not a hospital inpatient or outpatient.

 Diagnostic tests covered under the physician fee schedule, with certain exceptions listed in the regulation, have to be performed under the supervision of an individual meeting the definition of a physician.

  Nurse practitioners, clinical nurse specialists, and physician assistants are not defined as physicians under 1861(r) of the Act.

 Therefore they may not function as supervisory physicians under the diagnostic tests benefit.

o Exceptions: The following diagnostic tests, payable under the Physician Fee Schedule, are not required to be furnished in accordance with the ordering and supervising requirements as outlined in this document.

 Diagnostic mammography procedures, which are regulated by the Food and Drug Administration.

 Diagnostic tests personally furnished by a qualified audiologist as defined in section 1861(ll)(3) of the Act.

 Diagnostic psychological testing services personally furnished by a clinical psychologist or a qualified independent psychologist.

 Diagnostic tests personally performed by a physical therapist who is certified by the American Board of Physical Therapy Specialties as a qualified electrophysiologic clinical specialist and permitted to provide the service under State law.

o 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.

o 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.

o Each supervising physician must be limited to providing supervision to no more than three IDTF sites.

 The IDTF supervising physician is responsible for the overall operation and administration of the IDTFs, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations.

o In the case of a procedure requiring the direct or personal supervision of a physician, the IDTF’s supervising physician must personally furnish this level of supervision whether the procedure is performed in the IDTF or, in the case of mobile services, at the remote location.

o The supervising physician must evidence proficiency in the performance and interpretation of each type of diagnostic procedure performed by the IDTF (42 CFR 410.33). In this regard, FCSO Medicare requires the supervising physician to meet the qualification requirements as listed in the attached Credentialing Matrix.

o General supervision means the procedure is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure.

 Under general supervision, the training of the non-physician personnel who actually performs the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician.

 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”.

o Direct supervision means that the physician must be present in the suite/facility and immediately available to furnish assistance and direction throughout the performance of the procedure.

 In the case of procedures requiring direct supervision, the supervising physician may oversee concurrent procedures.

o Personal supervision means the physician must be in attendance in the room during the performance of the procedure.

• All diagnostic tests payable under the physician fee schedule must be performed under the supervision of a physician with the exception of certain procedures personally performed by qualified independent psychologists, clinical psychologists, qualified audiologists and physical therapists that are certified as qualified electrophysiologic clinical specialists.

• The basic requirement is that all the supervising functions be properly met at each location, regardless of the number of physicians involved.

o This is particularly applicable to mobile IDTF units that are allowed to use different supervising physicians at different locations.

o A different physician may supervise the test at each location.

o 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.

o 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).

• Tests Personally Performed by a Physician

o 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.

• Non-Physician Personnel

o All non-physician personnel used by the IDTF to perform tests must demonstrate the basic qualifications to perform the tests in question and have appropriate 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.

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

o 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 contactor does not establish a credentialing service but the contractor is authorized to determine which organizations it recognizes.

o For example, the use of the word “national” in the organization’s name does not, in itself, meet Medicare standards for national credentialing.

 The technicians do not have to be employees of the IDTF. They can be contracted by the IDTF.

 Non-physician practitioners may not supervise diagnostic testing performed by others.

 Audiologists, psychologists and physical therapists, may personally perform certain diagnostic tests without physician supervision and bill using their own provider number.

 Physician supervision of any type is not required for diagnostic tests performed by nurse practitioners or clinical nurse specialists when they are authorized by the State to perform such tests and the testing is within the scope of their practice. (They must bill under their own number.)

 Physician assistants require general physician supervision for the performance of diagnostic tests permitted within the scope of their practice authorized by their state.

 The supervising physician and non-physician personnel credentialing requirements are listed in the LCD attachment ‘Credentialing Matrix’.

o 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.

o 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:

o 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).

o 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 facilites (CMS Change Request 4280, dated 01/27/07 – http://www.cms.hhs.gov/Transmittals/downloads/R46NCD.pdf).

• FCSO will consider a diagnostic cardiac catheterization performed in an IDTF as medically reasonable and necessary when all criteria in LCD 93501 Cardiac Catheterization and the following criteria are met:

o Performed by a *qualified physician as defined below;

AND

o 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

o Performed with the assistance of a Registered Nurse (RN) with Advanced Cardiac Life Support (ACLS) certification;

OR

o Performed in an IDTF accredited by an **approved accreditation organization as a cardiac catheterization lab.

o *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).

o 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.

o 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.

• The following cardiac catheterization procedure codes have been added to the IDTF LCD ‘Coding Guidelines’ attachment under the ‘Credentialing Matrix’, along with the supervising physician and technician qualification requirements as stated above:

o 93530,

o 93531,

o 93532,

o 93533,

o 93561,

o 93562,

o 93571 and

o 93572.

 

 

Limitations:

 

• Cardiac catheterization procedure code 93462 is not considered safe when performed in an independent diagnostic testing facility setting and therefore, are not covered.

• Patients having a cardiac catheterization performed in an IDTF must be in stable condition and at the lowest risk for complications.

o 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.

o The codes and equipment should be listed on Attachment 2, Section 1 of Enrollment Application Form CMS-855B.

 

 

CPT/HCPCS Codes

 

See LCD Attachment

XX000 Not Applicable

 

ICD-9 Codes that Support Medical Necessity

 

N/A

XX000 Not Applicable

 

 

Documentation Requirements

 

• Medical record documentation maintained by the IDTF must include the information listed below and be available to Medicare upon request:

o Written order from the treating physician

o Hard copy documentation of the test results and interpretation; and

o The medical necessity (reason) for performing the diagnostic test(s).

• Documentation may be requested from the billing provider of the diagnostic test.

o If such documentation is insufficient to establish the medical necessity of the diagnostic test contractors may, but are not required to, request documentation from a third party (the ordering or treating provider).

o In the event the third party request is ignored or is insufficient to establish the medical necessity of the diagnostic test, coverage will be denied (CMS Manual System, Pub 100-08, Chapter 3, Section 3.4.1.2).

• The IDTF must maintain documentation to demonstrate the required physician supervision requirements were met.

o Also, the IDTF must maintain documentation of sufficient physician resources during all hours of operations to assure that the required physician supervision is furnished.

• Multi-state entities must maintain evidence that supervising physicians are licensed to practice in the State(s) where the diagnostic tests are performed and the technicians performing the diagnostic test(s) are credentialed appropriately in each state in which services are performed in accordance with requirements outlined in this LCD.

• Documentation maintained by the IDTF must support that the personnel performing the diagnostic test(s) have the training and proficiency as evidenced by current licensure or certification as outlined in this LCD.

o This documentation must contain verification by the supervising physician(s).

Treatment Logic

• 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.

 

 

Sources of Information and Basis for Decision

 

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)

 

The American Registry of Radiologic Technologists (ARRT)

 

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.

 

The Board of Certification of the Ophthalmic Photographers’ Society

 

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. Retreived August 18, 2008, from www.acc.org

 

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

 

AMA CPT / ADA CDT Copyright Statement

 

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

CMS LCD INDEPENDENT DIAGNOSTIC TESTING FACILITY (IDTF)