(Medicare Claims Processing Manual)

Contractors shall accept claims for these services with the appropriate CPT code listed in section 60.3.1.  Refer to Pub. 100- 03, section 220.6.17, for complete coverage guidelines for this new PET oncology indication.  The implementation date for these CPT codes will be April 18, 2005.  Also see section 60.17, of this chapter for further claims processing instructions for cervical cancer indications.   60.14 - Billing Requirements for PET Scans for Non -Covered Indications  (Rev. 527, Issued: 04- 15-05, Effective: 01 -28-05, Implementation: 04- 18-05)  For services performed on or after January 28, 2005, contractors shall accept claims with the following HCPCS code for non- covered PET indications:    -  G0235:  PET imaging, any site not otherwise specified  Short Descriptor:  PET not otherwise specified  Type of Service:  4  NOTE:   This code is for a non- covered service.   60.15 - Billing Requirements for CMS - Approved Clinical Trials and Coverage With Evidence Development Claims for PET Scans for Neurodegenerative Diseases, Previously Specified Cancer Indications, and All Other Cancer Indications Not Previously Specified  (Rev. 3227, Issued: 04- 02-15, Effective; ASC -X12: January 1, 2012 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Tumors:  June 11, 2013, ICD -10: Upon Implementation of ICD -10 Implementation: ASC X12: November 10, 2014 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Tumors:  May 19, 2014 -  MAC Non -Shared System Edits; July 7, 2014 -  CWF development/testing, FISS requirement development; October 6, 2014 -  CWF, FISS, MCS Shared System Edits), ICD -10: Upon Implementation of ICD -10)  A/B MACs (A and B)   Effective for services on or after January 28, 2005, contractors shall accept and pay for claims for Positron Emission Tomography (PET) scans for lung cancer, esophageal cancer, colorectal cancer, lymphoma, melanoma, head & neck cancer, breast cancer, thyroid cancer, soft tissue sarcoma, brain cancer, ovarian cancer, pancreatic cancer, small cell lung cancer, and testicular cancer, as well as for neurodegenerative diseases and all other cancer indications not previously mentioned in this chapter, if these scans were performed as part of a Centers for Medicare & Medicaid (CMS) -approved clinical trial. (See Pub. 100- 03, National Coverage Determinations (NCD) Manual, sections 220.6.13 and 220.6.17.)   Contractors shall also be aware that PET scans for all cancers not previously specified at Pub. 100- 03, NCD Manual, section 220.6.17, remain nationally non- covered unless performed in conjunction with a CMS -approved clinical trial.   Effective for dates of service on or after June 11, 2013, Medicare has ended the coverage with evidence development (CED) requirement for FDG (2 -[F18] fluoro -2-deoxy- D-glucose) PET and PET/computed tomography (CT) and PET/magnetic resonance imaging (MRI) f or all oncologic indications contained in section 220.6.17 of the NCD Manual.  Modifier - Q0 (Investigational clinical service provided in a clinical research study that is in an approved clinical research study) or - Q1 (routine clinical service provided in a clinical research study that is in an approved clinical research study) is no longer mandatory for  these services when performed  on or after  June 11, 2013.  A/B MACs (B) Only   A/B MACs (B) shall pay claims for PET scans for beneficiaries participating in a CMS -approved clinical trial submitted with an appropriate current procedural terminology (CPT) code from section 60.3.1 of this chapter and modifier Q0/Q1 for services performed on or after January 1, 2008, through June 10, 2013.  (NOTE:  Modifier QR (Item or service provided in a Medicare specified study) and QA (FDA investigational device exemption) were replaced by modifier Q0 effective January 1, 2008.)  Modifier QV (item o r service provided as routine care in a Medicare qualifying clinical trial) was replaced by modifier Q1 effective January 1, 2008.)  Beginning with services performed on or after June 11, 2013, modifier Q0/Q1 is no longer required for PET FDG services.   A/B MACs (A) Only   In order to pay claims for PET scans on behalf of beneficiaries participating in a CMS -approved clinical trial, A/B MACs (A) require providers to submit claims with, if ICD -9-CM is applicable, ICD -9 code V70.7; if ICD -10-CM is applicable, ICD -10 code Z00.6 in the primary/secondary diagnosis position using the ASC X12 837 institutional claim format or on Form CMS -1450, with the appropriate principal diagnosis code and an appropriate CPT code from section 60.3.1.  Effective for PET scan claims for dates of service on or after January 28, 2005, through December 31, 2007, A/B MACs (A)  shall accept claims with the QR, QV, or QA modifier on other than inpatient claims.  Effective for services on or after January 1, 2008, through June 10, 2013, modifier Q0 replaced the -QR and QA modifier, modifier Q1 replaced the QV modifier.  Modifier Q0/Q1 is  no longer required for  services performed  on or after  June 11, 2013.  60.16 - Billing and Coverage Changes for PET Scans Effective for Services on or After April 3, 2009  (Rev. 3650, Issued: 11- 10-16, Effective: 02 -10-17, Implementation: 02- 10-17)  A.  Summary of Changes   Effective for services on or after April 3, 2009, Medicare will not cover  the use of FDG PET imaging to determine  initial treatment strategy  in patients with adenocarcinoma of the prostate.   Medicare will also not cover FDG PET imaging for subsequent treatment strategy for tumor types other than breast, cervical, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, myeloma, non- small cell lung, and ovarian, unless the FDG PET is provided under the coverage with evidence development (CED) paradigm ( billed with modifier - Q0/-Q1, see section 60.15 of this chapter).   Medicare will cover FDG PET imaging for initial treatment strategy  for myeloma.   Effective for services performed on or after June 11, 2013, Medicare has ended the CED requirement for FDG PET and PET/CT and PET/MRI for all oncologic indications contained in section 220.6.17 of the NCD Manual.   Effective for services  on or after  June 11, 2013, the Q0/Q1 modifier is no longer required.  Beginning with services performed on or after June 11, 2013, contractors shall pay for up to three (3) FDG PET scans when used to guide subsequent management of anti -tumor treatment strategy (modifier PS) after completion of initial anti- cancer therapy (modifier PI) for the exact same cancer diagnosis.   Coverage of any additional FDG PET scans (that is, beyond 3) used to guide subsequent management of anti -tumor treatment strategy after completion of initial anti- tumor therapy for the same cancer diagnosis will be determined by the A/B MACs (A or B).  Claims will include the KX modifier indicating the coverage criteria is met for coverage of four or more FDG PET scans for subsequent treatment strategy for the same cancer diagnosis under this NCD.  A different cancer diagnosis whether submitted with a PI or a PS modifier will begin the count of one initial and three subsequent FDG PET scans not requiring the KX modifier and four or more FDG PET scans for subsequent treatment strategy for the same can cer diagnosis requiring the KX modifier.   NOTE:   The presence or absence of an initial treatment strategy claim in a beneficiarys record does not impact the frequency criteria for subsequent treatment strategy claims for the same cancer diagnosis.   NOTE:   Providers please refer to the following link for a list of appropriate diagnosis codes, http://cms.gov/medicare/coverage/determinationprocess/downloads/petforsolidtumorsoncologicdxcodesattachment_NCD220_6_17.pdf   For further information regarding the changes in coverage, refer to Pub.100 -03, NCD Manual, section 220.6.17.  B.  Modifiers for PET Scans   Effective for claims with dates of service on or after April 3, 2009, the following modifiers have been created for use to inform for the  initial treatment strategy  of biopsy- proven or strongly suspected tumors or subsequent treatment strategy  of cancerous tumors:   PI Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing.  Short descriptor:  PET tumor init tx strat   PS Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary's treatment physician determines that the PET study is needed to inform subsequent anti -tumor strategy.   Short descriptor:  PS -  PET tumor subsq tx strategy  C.  Billing for A/B MACs (A and B)   Effective for claims with dates of service on or after April 3, 2009, contractors shall accept FDG PET claims billed to inform initial treatment strategy  with the following CPT codes AND modifier PI: 78608, 78811, 78812, 78813, 78814, 78815, 78816.  Effective for claims with dates of service on or after April 3, 2009, contractors shall accept FDG PET claims with modifier PS for the subsequent treatment strategy  for solid tumors using a CPT code above AND a cancer diagnosis code.   Contractors shall also accept FDG PET claims billed to inform initial treatment strategy or subsequent treatment strategy  when performed under CED with one of the PET or PET/CT CPT codes above AND modifier PI OR modifier PS AND  a cancer diagnosis code AND modifier Q0/Q1.  Effective for services  performed on or after June 11, 2013, the CED requirement has ended and modifier Q0/Q1, along with condition code 30 (institutional claims only), or ICD -9 code V70.7, (both institutional and practitioner claims) are n o longer required.   D.  Medicare Summary Notices, Remittance Advice Remark Codes, and Claim Adjustment Reason Codes   Effective for dates of service on or after April 3, 2009, contractors shall return as unprocessable/return to provider claims that do not include the PI modifier with one of the PET/PET/CT CPT codes listed in subsection C. above when billing for the initial treatment strategy  for solid tumors in accordance with Pub.100- 03, NCD Manual, section 220.6.17.  In addition, contractors shall return as unprocessable/return to provider claims that do not include the PS modifier with one of the CPT codes listed in subsection C. above when billing for the subsequent treatment strategy for solid tumors in accordance with Pub.100- 03, NCD Manual, section 220.6.17.  The contractor shall use the following remittance advice messages and associated codes when returning claims under this policy.  This CARC/RARC combination is compliant with CAQH CORE Business Scenario Two.   Group Code: CO  CARC: 4  RARC: MA130  MSN: N/A  Effective for claims with dates of service on or after April 3, 2009, through June 10, 2013, contractors shall return as unprocessable/return to provider FDG PET claims billed to inform initial treatment strategy or subsequent treatment strategy  when performed under CED without one of the PET/PET/CT CPT codes listed in subsection C. above AND modifier PI OR modifier PS AND a cancer diagnosis code AND modifier Q0/Q1.   The contractor shall use the following remittance advice messages and associated codes when returning claims under this policy.  This CARC/RARC combination is compliant with CAQH CORE Business Scenario Two.   Group Code: CO  CARC: 4  RARC: MA130  MSN: N/A  Effective April 3, 2009, contractors shall deny claims with ICD -9/ICD -10 diagnosis code 185/C61 for FDG PET imaging for the initial treatment strategy  of patients with adenocarcinoma of the prostate.