(Medicare Claims Processing Manual)

60.3.2 - Tracer Codes Required for Positron Emission Tomography ( PET ) Scans  (Rev.10881; Issued: 08- 06-2021; Effective: 09- 07-2021; Implementation: 09- 07- 2021)   An applicable tracer/radiopharmaceutical code, along with an applicable Current Procedural Technology (CPT) code, is necessary for claims processing of any Positron Emission Tomography (PET) scan services. While there are a number of PET tracers already bi llable for a diverse number of medical indications, there have been, and may be in the future, additional PET indications that might require a new PET tracer. Under those circumstances, the process to request/approve/implement a new code could be time- intensive. To help alleviate inordinate spans of time between when a national coverage determination is made, or when the Food and Drug Administration (FDA) approves a particular radiopharmaceutical for an oncologic indication already approved by the Centers for Medicare & Medicaid Services (CMS), and when it can be fully  implemented via valid claims processing, CMS has created two new PET radiopharmaceutical unclassified tracer codes that can be used temporarily. This time period would be pending the creation/approval/implementation of permanent CPT codes that would later specifically define their function by CMS in official instructions.  Effective with dates of service on or after January 1, 2018, the following Healthcare Common Procedure Coding System (HCPCS) codes shall be used ONLY AS NECESSARY FOR AN INTERIM PERIOD OF TIME under the circumstances explained here. Specifically, there are two circumstances that would warrant use of the  CPT Code  Description  78814  Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization; limited area (e.g., chest, head/neck)  78815  Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization; skull base to mid -thigh  78816  Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization; whole body     below codes: (1) After FDA approval of a PET oncologic indication, or, (2) after CMS approves coverage of a new PET indication, and ONLY if either of those situations requires the use of a dedicated PET radiopharmaceutical/tracer that is currently non - existent. Once permanent replacement codes are officially implemented by CMS, use of the temporary code for that particular indication will simultaneously be discontinued. NOTE: The following two codes were effective as of January 1, 2017, with the January 2017 quarterly HCPCS update.   A9597 -  Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified  A9598 -  Positron emission tomography radiopharmaceutical, diagnostic, for non- tumor identification, not otherwise classified   Effective for claims with dates of service on and after January 1, 2018, when PET tracer code A9597 or A9598 are present on a claim, that claim must also include:  -an appropriate PET HCPCS code, either  78429, 78430, 78431, 78432, 78433, 78434, 78459, 78491, 78492, 78608, 78811, 78812, 78813, 78814, 78815, or 78816, -if tumor -related, either the - PI or - PS modifier as appropriate,  -if clinical trial, registry, or study -related outside of NCD220.6.17, PET for Solid Tumors, clinical trial modifier Q0,  -if clinical trial, registry, or study -related, all claims require the 8 -digit clinical trial number, -if Part A OP and clinical trial, registry, or study -related outside of NCD220.6.17, PET for Solid Tumors, also include condition code 30 and ICD -10 diagnosis Z00.6. Effective for claims with dates of service on and after January 1, 2018, A/Medicare Administrative Contractors (MACs) shall line -item deny, and B/MACs shall line -item reject, PET claims for A9597 or A9598 that don't include the elements noted above as appropriate.  Contractors shall use the following messaging when line -item denying (Part A) or line - item rejecting (Part B) PET claims containing HCPCS A9597 or A9598:  Remittance Advice Remark Codes (RARC) N386  Claim Adjustment Reason Code (CARC) 50, 96, and/or 119. Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file).  (The above new verbiage will supersede any existing verbiage in chapter 13, section 60.3.2.)   60.3.3 - Denial Messages for Noncovered PET Services  (Rev. 3650, Issued: 11- 10-16, Effective: 02 -10-17, Implementation: 02- 10-17)  The A/B MAC denies claims for noncovered procedure code, such as 78609.  The contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy.  This CARC/RARC combination is compliant with CAQH CORE Business Scenario Three.   Group Code: CO  CARC: 96  RARC: N386  MSN: 16.10  60.4 - PET Scans for Imaging of the Perfusion of the Heart Using Rubidium 82 (Rb 82) (Rev. 223, Issued: 07- 02-04) (Effective/Implementation: Not Applicable)  For dates of service on or after March 14, 1995, Medicare covers one PET scan for imaging of the perfusion of the heart using Rubidium 82 (Rb 82), provided that the following conditions are met:    The PET is done at a PET imaging center with a PET scanner that has been approved by the FDA;    The PET scan is a rest alone or rest with pharmacologic stress PET scan, used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease, using Rb 82; and   Either the PET scan is used in place of, but not in addition to, a single photon emission computed tomography (SPECT) or the PET scan is used following a SPECT that was found inconclusive.   60.5 - Expanded Coverage of PET Scan for Solitary Pulmonary Nodules (SPNs)  (Rev. 223, Issued: 07- 02-04) (Effective/Implementation: Not Applicable)  For dates of service on or after January 1, 1998, Medicare expanded PET scan coverage to include characterization of solitary pulmonary nodules (SPNs).  60.6 - Expanded Coverage of PET Scans Effective for Services on or after July 1, 1999 (Rev. 223, Issued: 07- 02-04) (Effective/Implementation: Not Applicable)  Effective for services performed on or after July 1, 1999, Medicare expanded coverage of PET scans to include the evaluation of recurrent colorectal cancer in patients with rising levels of carinoembryonic antigen (CEA), for the staging of lymphoma (both H odgkins and non- Hodgkins) when the PET scan substitutes for a gallium scan or lymphangiogram, and for the staging of recurrent melanoma prior to surgery, provided certain conditions are met. All three indications are covered only when using the radiopharma ceutical FDG - (2-[flourine -18]-fluoro- 2-deoxy- D-glucose), and are further predicated on the legal availability of FDG for use in such scans.   60.7 - Expanded Coverage of PET Scans Effective for Services on or After July 1, 2001 (Rev. 223, Issued: 07- 02-04) (Effective/Implementation: Not Applicable)  See the Medicare National Coverage Determinations Manual, section 220.6, for specific coverage criteria for PET Scans. Coverage is expanded for PET scans to include the following effective July 1, 2001:    Scans performed with dedicated full -ring scanners will be covered. Gamma camera systems with at least a 1 inch thick crystal are eligible for coverage in addition to those already approved by CMS (FDA approved);    The provider must maintain on file the doctors referral and documentation that the procedure involved:   o Only FDA approved drugs and devices and,  o Did not involve investigational drugs, or procedures using investigational drugs, as determined by the FDA;    The ordering physician is responsible for certifying the medical necessity of the study according to the conditions.  The physician must have documentation in the beneficiarys medical record to support the referral supplied to the PET scan provider.   The following is a brief summary of the expanded coverage as of July 1, 2001:    PET is covered for diagnosis, initial staging and restaging of non -small cell lung cancer (NSCLC).    Usage of PET for colorectal cancer has been expanded to include diagnosis, staging, and restaging.    Usage of PET for the initial staging, and restaging of both Hodgkins and non- Hodgkins disease.    Usage of PET for the diagnosis, initial staging, and restaging of melanoma.  (PET Scans are NOT covered for the evaluation of regional nodes.)    Medicare covers PET for the diagnosis, initial staging, and restaging of esophageal cancer.    Usage of PET for Head and Neck Cancers. (PET scans for head and neck cancer is NOT covered for central nervous system or thyroid cancers.)    Usage of PET following an inconclusive single photon emission computed tomography (SPECT) only for myocardial viability.  In the event that a patient has received a SPECT and the physician finds the results to be inconclusive, only then may a PET scan be ordered utilizing the proper documentation.   Usage of PET for pre -surgical evaluation for patients with refractory seizures.  NOTE:   Effective January 1, 2002, the definitions of HCPCS Codes G0210 through G0230 have been updated to properly reflect the type of PET scanner used.   60.8 - Expanded Coverage of PET Scans for Breast Cancer Effective for Dates of Service on or After October 1, 2002  (Rev. 527, Issued: 04- 15-05, Effective: 01 -28-05, Implementation: 04- 18-05)  Effective for dates of service on or after October 1, 2002, Medicare will cover FDG PET as an adjunct to other imaging modalities for staging and restaging for locoregional, recurrence or metastasis of breast cancer.  Monitoring treatment of a locally advanced breast cancer tumor and metastatic breast cancer when a change in therapy is contemplated is also covered as an adjunct to other imaging modalities.  The baseline PET study for monitoring should be done under the code for staging or restaging.   Medicare continues to have a national non- coverage determination for initial diagnosis of breast cancer and initial staging of axillary lymph nodes.  Medicare coverage now includes PET as an adjunct to standard imaging modalities for staging patients with distant metastasis or restaging patients with locoregional recurrence or metastasis of breast cancer; as an adjunct to standard imaging modalities for monitoring for women with locally advanced and metastatic breast cancer when a change in therapy is conte mplated.   CPT Codes for PET Scans Performed on or After October 1, 2002 for Breast Cancer   Contractors shall advise providers to use the appropriate CPT code from section 60.3.1 for covered breast cancer indications for services performed on or after January 28, 2005.  NOTE:  The NCD Manual contains a description of coverage.  FDG Positron Emission Tomography is a minimally invasive diagnostic procedure using positron camera [tomograph] to measure the decay of radioisotopes such as FDG.  The CMS determined that the benefit cate gory for the requested indications fell under 1861(s)(3)  of the Act diagnostic service.  60.9 - Coverage of PET Scans for Myocardial Viability  (Rev.10881; Issued: 08- 06-2021; Effective: 09- 07-2021; Implementation: 09- 07- 2021)     FDG PET is covered for the determination of myocardial viability following an inconclusive single photon computed tomography test (SPECT) from July 1, 2001, through September 30, 2002. Only full ring scanners are covered as the scanning medium for this service from July 1, 2001, through December 31, 2001. However, as of January 1, 2002, full and partial ring scanners are covered for myocardial viability following an inconclusive SPECT.