(Medicare Claims Processing Manual)

 CMS -1500 paper form- place in Field 19 (preceded by CT).   In addition to the clinical trial number, claims should include:   If ICD -9-CM is applicable,  ICD-9 diagnosis code V70.7   If ICD -10-CM is applicable,  ICD -10 diagnosis code Z00.6 (in either the primary/secondary positions)   HCPCS modifier Q0 or Q1 as appropriate  Practitioner claims submitted without a clinical trial number shall be returned as unprocessable using the following messages:  CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.)   RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number for FDA -approved clinical trial services.   RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information.   Group Code-Contractual Obligation (CO)  Routine Costs Submitted by Institutional Providers  All Institutional Clinical Trial Claims   Effective for clinical trial claims received after April 1, 2008, (regardless of the date of service) providers can begin to report an 8-digit clinical trial number.  The reporting of this number is voluntary thru December 31, 2013.  Refer to CR 5790 for more information regarding the 8-digit number.  To bill the 8- digit clinical trial number, institutional providers shall code value code D4 ---where the value code amount equals the 8 -digit clinical trial number.  Below are the claim locators in which to bill the 8 -digit number:   837 institutional claim format-Loop 2300 REF02 (REF01=P4)   Paper CMS -1450 value code D4  NOTE:   Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. Institutional claims submitted without a clinical trial number shall be return to providers.   NOTE:  The Q1 modifier is line item specific and must be used to identify items and services that constitute medically necessary routine patient care or treatment of complications arising from a Medicare beneficiarys participation in a Medicare- covered clinical trial.  Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the clinical management of the patient are not covered and may not be billed using the Q1 modifier.  Items and services that a re not covered by Medicare by virtue of a statutory exclusion or lack of a benefit category also may not be billed using the Q1 modifier.  When billed in conjunction with the V70.7/Z00.6 diagnosis code, t he Q1 modifier will serve as the providers attestation that the service meets the Medicare coverage criteria (i.e., was furnished to a beneficiary who is participating in a Medicare qualifying clinical trial and represents routine patient care, including complications associated with qualifying trial participation).   Inpatient Clinical Trial Claims   Institutional providers billing clinical trial service(s) must report ICD -9 diagnosis code V70.7 if ICD -9 is applicable or, i f ICD -10-CM is applicable, ICD -10 diagnosis code Z006 in either the primary or secondary position  and a condition code 30 regardless of whether all services are related to the clinical trial or not.   NOTE:   HCPCS codes are not reported on inpatient claims.  Therefore, the HCPCS modifier requirements (i.e., Q0/Q1) as outlined in the outpatient clinical trial section immediately below, are not applicable to inpatient clinical trial claims.   Outpatient Clinical Trial Claims   On all outpatient clinical trial claims, providers need to do the following:  Report condition code 30,  Report ICD -9 diagnosis code V70.7, if ICD -9-CM is applicable, in the primary or secondary position;   Report ICD -10 diagnosis code Z00.6, if ICD-10-CM is applicable,  in the primary or secondary position; and   Identify all lines that contain an investigational item/service with a HCPCS modifier of:  o Q0 for dates of service on or after 1/1/08    Identify all lines that contain a routine service with a HCPCS modifier of:  o Q1 for dates of service on or after 1/1/08.   For clinical trial billing requirements for patients enrolled in a managed care plan, please refer to Section 69.9 of this chapter.   69.7 - Reserved for Future Use  (Rev. 1418, Issued: 01- 18-08, Effective: 01 -01-08, Implementation: 04- 07-08)  69.8 - Handling Erroneous Denials of Qualifying Clinical Trial Services  (Rev. 487, Issued: 03- 04-05, Effective and Implementation: N/A)   If a service Medicare covers was billed with the appropriate clinical trial coding but was inadvertently denied (e.g., for medical necessity or utilization) and is subsequently brought to your attention, adjust the denied claim.  If the denied services wer ent properly coded as clinical trial services, instruct the provider to resubmit the service on a new claim with appropriate clinical trial coding.   69.9 - Billing and Processing Fee for Service Claims for Covered Clinical Trial Services Furnished to Managed Care Enrollees (Rev. 1723, Issued: 05- 01-09, Effective: 10 -01-09, Implementation: 10- 05-09)  For dates of service on or after September 19, 2000, and until notified otherwise by CMS, Medicare contractors will pay for covered clinical trial services furnished to beneficiaries enrolled in managed care plans.  Providers who furnish covered clinical trial services to managed care beneficiaries must be enrolled with Medicare in order to bill on a fee -for-service basis.  Providers that wish to bil l fee for service but have not enrolled with Medicare must contact their local carrier, intermediary, regional home health intermediary or National Supplier Clearinghouse, as appropriate, to obtain an enrollment application.  Determine payment for covered clinical trial services furnished to beneficiaries enrolled in managed care plans in accordance with applicable fee for service rules, except that beneficiaries are not responsible for the Part A or Part B deductibles (i.e., a ssume the Part A or Part B deductible has been met).  Managed care enrollees are liable for the coinsurance amounts applicable to services paid under Medicare fee for service rules.   The clinical trial coding requirements for managed care enrollee claims are the same as those for regular Medicare fee for service claims.  However, for beneficiaries enrolled in a managed care plan, institutional providers must not bill outpatient clinica l trial services and non -clinical trial services on the same claim.  If covered outpatient services unrelated to the clinical trial are rendered during the same day/stay, the provider must split- bill so that ONLY the clinical trial services are contained o n a single claim and billed as fee -for-service (this allows the Medicare claims processing system to not apply deductible when the patient is found to be in a managed care plan).  Any outpatient services unrelated to the clinical trial should be billed to the managed care plan.   69.10 - CWF Editing Of Clinical Trial Claims For Managed Care Enrollees  (Rev. 487, Issued: 03- 04-05, Effective and Implementation: N/A)   Submit clinical trial services for managed care enrollees to CWF for payment approval. CWF will not reject clinical trial claims for managed care enrollees when all services on the claim transaction record are coded as clinical trial services and the date( s) of service is (are) on or after September 19, 2000.  In addition, CWF will not apply Part B deductible to clinical trial claims for managed care enrollees (i.e., CWF will process clinical trial services for managed care enrollees as if the Part B deduct ible has already been met).   69.11 - Resolution of CWF UR 5232 Rejects  (Rev. 487, Issued: 03- 04-05, Effective and Implementation: N/A)   If you send a claim transaction to CWF that includes both clinical and non -clinical trial services for a managed care enrollee, the entire claim will be rejected with the UR 5232 error code. When you receive a UR 5232 error code split the claim and resubmi t the clinical trial portion to CWF.  Process the non- clinical trial portion of the rejected claims in the same manner that other non -clinical trial fee for service claims for managed care enrollees are handled.   70 - Billing Requirements for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health (NIH) Clinical Trial  (Rev. 986, Issued: 06- 16-06, Effective: 05 -01-06, Implementation: 07- 31-06)  For services performed on or after October 1, 2004, Medicare will cover islet cell transplantation for patients with Type I diabetes who are participating in an NIH sponsored clinical trial.  See Pub 100 -04 (National Coverage Determinations Manual) section 260.3.1 for complete coverage policy.   The islet cell transplant may be done alone or in combination with a kidney transplant.  Islet recipients will also need immunosuppressant therapy to prevent rejection of the transplanted islet cells.  Routine follow -up care will be necessary for each trial patient.  See Pub 100- 04, section 310 for further guidance relative to routine care.  All other uses for islet cell services will remain non -covered.   70.1 - Healthcare Common Procedure Coding System (HCPCS) Codes for Carriers  (Rev. 261, Issued: 07- 30-04, Effective: 10 -01-04, Implementation: 10- 04-04)  G0341:  Percutaneous islet cell transplant, includes portal vein catheterization and infusion  Short Descriptor:  Percutaneous islet cell trans   Type of Service:  2  G0342:  Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion   Short Descriptor:  Laparoscopy islet cell trans   Type of Service:  2  G0343:  Laparotomy for islet cell transplant, includes portal vein catheterization and infusion  Short Descriptor:  Laparotomy islet cell transp   Type of Service:  2  70.2 - Applicable Modifier for Islet Cell Transplant Claims for Carriers  (Rev. 986, Issued: 06- 16-06, Effective: 05 -01-06, Implementation: 07- 31-06)  Carriers shall instruct physicians to bill using the above procedure code(s) with modifier QR (Item or service provided in a Medicare- specified study)  for all claims for islet cell transplantation and routine follow -up care related to this service.   70.3 - Special Billing and Payment Requirements for Carriers (Rev. 261, Issued: 07- 30-04, Effective: 10 -01-04, Implementation: 10- 04-04)  Payment and pricing information will be on the October 2004 update of the Medicare Physician Fee Schedule Database (MPFSDB).  Pay for islet cell transplants on the basis of the MPFS.  Deductible and coinsurance apply for fee -for-service beneficiaries.   70.4 - Special Billing and Payment Requirements for A/B MACs (A)  (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21)    If ICD -10 is applicable, ICD -10-PCS codes for the clinical trial are: