CMS Pub. 100-04, ch. 35
Table of Contents (Rev. 4473, 12-06-19)
(Rev. 1506; Issued: 05-16-08; Effective/Implementation Date: 06-16-08)
Effective for diagnostic procedures performed on or after March 15, 1999, A/B MACs (B) will pay for diagnostic procedures under the physician fee schedule only when performed by a physician, a group practice of physicians, an approved supplier of portable x-ray services, a nurse practitioner, or a clinical nurse specialist when he or she performs a test he or she is authorized by the State to perform, or an independent diagnostic testing facility (IDTF). An IDTF may be a fixed location or a mobile entity. It is independent of a physician's office or hospital.
Refer to the Medicare Program Integrity Manual, Pub. 100-08, chapter 10, for information concerning provider enrollment and instructions regarding entities that must enroll as and bill for diagnostic procedures as an independent diagnostic testing facility (IDTF).
(Rev. 1506; Issued: 05-16-08; Effective/Implementation Date: 06-16-08)
Consistent with 42 CFR 410. 33(a)(1), an IDTF is one 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.
(Rev. 4473, Issued: 12-6-19; Effective: 3-9-20; Implementation: 3-9-20)
Nothing in this document or in the Medicare Enrollment Application, (CMS-855B) or the Internet-based Provider Enrollment, Chain and Ownership System shall be construed or interpreted to authorize billing by an IDTF, physician, physician group practice, or any other entity that would otherwise violate the physician self-referral prohibition set forth in §1877 of the Social Security Act and related regulations. A/B MACs (Part B) must deny claims submitted in violation of §1877 and demand refunds of any payments that have been made in violation of §1877.
Consistent with 42 CFR 410.32(a), the supervisory physician for the IDTF, whether or not for a mobile unit, may not order tests to be performed by the IDTF, unless the supervisory physician is the patient's treating physician and is not otherwise prohibited from referring to the IDTF. The supervisory physician is the patient's treating physician if he or she furnishes a consultation or treats the patient for a specific medical problem and uses the test results in the management of the patient's medical problem.
If an IDTF wants to bill for an interpretation performed by a physician who does not share a practice with the IDTF, the IDTF must meet certain conditions concerning the
anti-markup payment limitation. If a physician working for an IDTF (or a party related to the IDTF through common ownership or control as described in 42 CFR §413.17) does not order the technical component or professional component of a diagnostic test (excluding clinical diagnostic laboratory tests), it would not be subject to the anti-markup payment limitation. (See Pub. 100-04, chapter 1, §30.2.9)
Transtelephonic and electronic monitoring services (e.g., 24 hour ambulatory EKG monitoring, pacemaker monitoring and cardiac event detection) may perform some of their services without actually seeing the patient. Most but not all of these billing codes are 93012, 93014, 93040, 93224, 93225, 93226, 93232, 93230, 93231, 93233, 93236, 93270, 93271, 93731, 93733, 93736, 95953, 95956. These monitoring service entities should be classified as IDTFs and must meet all IDTF requirements. We currently do not have specific certification standards for their technicians; technician credentialing requirements for them are at A/B MAC (Part B) discretion. They do require a supervisory physician who performs General Supervision. Final enrollment of a transtelephonic or electronic monitoring service as an IDTF requires a site visit.
For any entity that lists and will bill codes 93012, 93014, 93268, 93270, 93271, 93272, the A/B MAC (Part B) must make a written determination that the entity actually has a person available on a 24 hour basis to answer telephone inquiries. Use of an answering service in lieu of the actual person is not acceptable. The person performing the attended monitoring should be listed in Section 3 of Attachment 2 of Form CMS-855B. The qualifications of the person are at the A/B MAC (Part B)'s discretion. The A/B MAC (Part B) shall check that the person is available by attempting to contact the applicant during non-standard business hours. In Particular, at least one of the contact calls should be made between midnight and 6:00 AM. If the applicant does not meet the availability standard they should receive a denial.
Slide Preparation Facilities and Radiation Therapy Centers are not IDTFs. Slide preparation facilities are entities that provide slide preparation services and other kinds of services that are payable through the technical component of the surgical pathology service. These entities do not provide the professional component of surgical pathology services or other kinds of laboratory tests. The services that they provide are recognized by A/B MACs (Part B) for payment, as codes in the surgical pathology code range (88300) to (88399) with a technical component value under the physician fee schedule. The services provided by these entities are usually ordered by and reviewed by a dermatologist. Slide preparation facilities generally only have one or two people performing this service.
All enrolled Slide Preparation Facilities must enroll separately with their Medicare contractor. Radiation therapy centers provide therapeutic services and therefore are not IDTFs. Radiation therapy centers must enroll separately with their Medicare contractor.
(Rev. 4473, Issued: 12-6-19; Effective: 3-9-20; Implementation: 3-9-20)
Global billing is acceptable when both the TC and 26 modifier are performed by the same entity and both the TC and the 26 modifier are furnished within the same Medicare Physician Fee Schedule (MPFS) payment locality. The TC and 26 may be furnished in different locations as long as they are furnished within the same MPFS payment locality.
If the global diagnostic test code is billed, report the name, address and NPI of the location where the technical component was furnished in Items 32 and 32a (or the 837P electronic claim equivalent). See Pub. 100-04, chapter 1, §80.3.2.1.2 and 80.3.2.1.3 for more information regarding what is required in Items 32 and 32a.
(Rev. 4473, Issued: 12-6-19; Effective: 3-9-20; Implementation: 3-9-20)
When the TC and 26 modifier are billed separately (not billed globally), report the name, address and NPI of the location where each component was performed. If the billing provider has an enrolled practice location at the address where the service was performed, the billing provider/supplier may report their own name, address and NPI in Items 32 and 32a (or the 837P electronic claim equivalent).
If the professional component service was performed at an unusual or infrequently used location, the location of the provider's/supplier's closest Medicare-enrolled practice location may be used in Item 32.
The NPI in Item 32a must correspond to the entity identified in Item 32 (no matter if it is the group, hospital, the IDTF, or the individual physician). The only exception for Medicare claims is when a service is performed out of jurisdiction and is subject to the anti-markup or a reference lab service. See Pub. 100-04, chapter 1, § 30.2.9 and chapter 16, §40.1 for instructions specific to anti-markup and reference lab, respectively.
See, Pub. 100-04, chapter 1, §80.3.2.1.2 and 80.3.2.1.3 for more information regarding what is required in Items 32 and 32a.
(Rev. 1506; Issued: 05-16-08; Effective/Implementation Date: 06-16-08)
All procedures performed by the IDTF must be specifically ordered in writing by the physician or practitioner who is treating the beneficiary, that is, the physician who is furnishing a consultation or treating a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. (Nonphysician practitioners may order tests as set forth in CFR 410.32(a)(3).)
The order must specify the diagnosis or other basis for the testing. 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. That is, the physician in question had a relationship with the beneficiary prior to the performance of the testing and is treating the beneficiary for a specific medical problem. The IDTF may not add any procedures based on internal protocols without a written order from the treating physician.
(Rev. 4473, Issued: 12-6-19; Effective: 3-9-20; Implementation: 3-9-20)
In most instances, physicians working for an IDTF do not order diagnostic tests because such tests are generally ordered by the patient's treating physician. If a physician working for an IDTF does not order a diagnostic test, the test is not subject to the anti-markup payment limitation. However, if a physician working for an IDTF (or a physician financially related to the IDTF through common ownership or control) orders a diagnostic test payable under the Medicare Physician Fee Schedule (MPFS), the anti-markup payment limitation may apply (depending on whether the performing physician or other supplier meets the 'sharing a practice' requirements). For additional information, see Pub. 100-04, chapter 1, §30.2.9.
If a physician working for an IDTF (or a physician financially related to the IDTF through common ownership or control) orders and the IDTF bills for a diagnostic test that is performed by another physician or supplier, the performing physician or other supplier must be enrolled in the Medicare program. No formal reassignment is necessary; however, reassigned diagnostic testing services may also be subject to the anti-markup payment limitation.
The billing entity must report using the ASC X12 837 professional claim format or on the Form CMS-1500 the name, NPI, and address of the performing physician or other supplier. The acquisition price of the either the technical component or professional component of the diagnostic test must also be reported on the claim.
Effective for claims with dates of service on or after January 25, 2005, A/B MACs (Part B) must accept and process claims for diagnostic tests subject to the anti-markup payment limitation billed by suppliers (including laboratories, physicians, and independent diagnostic testing facilities [IDTFs]) enrolled in the A/B MAC's (Part B) jurisdiction, for services furnished anywhere in the United States. For services furnished outside the A/B MAC (Part B) jurisdiction in which the billing entity is enrolled, the billing entity must submit its own NPI with the name, address, and ZIP code of the performing physician or other supplier in the appropriate data field. (The billing physician or other supplier should maintain a record of the performing physician or other supplier's NPI in the clinical record for auditing purposes.) Effective April 1, 2005, A/B MACs (Part B) must price claims for diagnostic tests that are subject to the anti-markup payment limitation based on the ZIP Code of the location where the service was rendered, using a CMS-supplied abstract file containing the HCPCS codes that are payable under the MPFS as an anti-markup test for the calendar year. From April 1, 2005, through December 31, 2013, this was done using a CMS-supplied abstract file containing the HCPCS codes that are
payable under the MPFS as an anti-markup test for the calendar year. Beginning January 1, 2014, A/B MACs (Part B) began using the Purchased Diagnostic Test Indicator for the HCPCS codes that are payable under the MPFS as an anti-markup test for the calendar year. A/B MACs (Part B) must pay the lesser of: (a) the net acquisition price, (b) the billing entity’s actual charge, or (c) the fee schedule amount as if the test was billed by the performing supplier.
Effective for claims submitted with a receipt date on and after October 1, 2015, the billing physician or supplier must report the name, address, and NPI of the performing physician or supplier in Item 32a on anti-markup and reference laboratory claims, even if the performing physician or supplier is enrolled in a different A/B MAC (Part B) jurisdiction. See Pub. 100-04, Chapter 1, §10.1.1 for more information regarding claims filing jurisdiction.
NOTE: As with all services payable under the MPFS, the ZIP Code is used to determine the appropriate payment locality and corresponding fee that is used to price the service that is subject to the anti-markup payment limitation. When a ZIP Code crosses county lines, CMS uses the dominant locality to determine the corresponding fee.
Effective for dates of service May 23, 2008 and later, IDTF’s must submit the NPI assigned to the ordering physician using the ASC X12 837 professional claim format or, for paper claims, on the Form CMS-1500.
If an IDTF wants to bill for an interpretation performed by an independent practitioner off the premises of the IDTF, the IDTF must meet the conditions shown in IOM Pub. 100-04, Chapter 1, §30.2.9.
An IDTF shall not be allowed to bill for any CPT or HCPCS codes that are solely therapeutic.
| Rev # | Issue Date | Subject | Impl Date | CR# |
|---|---|---|---|---|
| 12/06/2019 | Update to Medicare Claims Processing Manual, Chapters 1, 23 and 35 | 03/09/2020 | 10882 | |
| R3255CP | 05/08/2015 | Correction to the Multi-Carrier System (MCS) Editing on the Service Location National Provider Identifier (NPI) Reported for Anti-Markup and Reference Laboratory Claims | 10/05/2015 | 9150 |
| R3103CP | 11/03/2014 | Reporting the Service Location National Provider Identifier (NPI) on Anti-Markup and Reference Laboratory Claims | 04/06/2015 | 8806 |
| R3098CP | 10/21/2014 | Reporting the Service Location National Provider Identifier (NPI) on Anti-Markup and Reference Laboratory Claims – Rescinded and replaced by Transmittal 3103 | 04/05/2014 | 8806 |
| R3047CP | 08/22/2014 | Reporting the Service Location National Provider Identifier (NPI) on Anti-Markup and Reference Laboratory Claims – Rescinded and replaced by Transmittal 3098 | 01/05/2014 | 8806 |
| R2994CP | 07/25/2014 | Update to Pub. 100-04, Chapter 35 to Provide Language-Only Changes for Updating ASC X12 | 08/25/2014 | 8769 |
| R1987CP | 06/11/2010 | Correction to the Claims Processing Internet Only Manual (IOM) to Reinstate Previous Instructions Regarding Payment Jurisdiction for Reassigned Services | 08/12/2010 | 6923 |
| R1931CP | 03/12/2010 | Revision of the Internet Only Manual (IOM) to Remove References to “Purchased Diagnostic Test” and Replace With Language Consistent With the Anti-Markup Rule | 06/14/2010 | 6627 |
| R1504CP | 05/15/2008 | New Chapter for Independent Diagnostic Testing Facilities (IDTF) | 06/16/2008 | 5815 |
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