(Medicare Claims Processing Manual)

Effective January 1, 2014, if the Category B IDE device is provided at no cost, outpatient prospective payment system (OPPS) providers must report a token charge in the covered charge field along with condition code 53 and Value Code FD. For more information on billing no cost items under the OPPS, refer to Chapter 4, 20.6.9 and 61.3.1 of this manual.  Practitioner Billing   Routine Costs  Practitioners shall submit claims for the routine costs of a clinical trial involving a Category B IDE device by billing according to the clinical trial billing instructions found in section 69.6 of this chapter.  Category B Device   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. Providers report the 8-digit number on the following claims locators:   837 professional claim format (do not use CT on the electronic claim) or,   CMS -1500 paper form- place in Field 19 (preceded by CT).   In addition to the clinical trial number, claims shall include (in either the primary/secondary positions):   If ICD -9-CM is applicable, ICD-9 diagnosis code V70.7   If ICD -10-CM is applicable, ICD-10 diagnosis code Z00.6    HCPCS modifier Q0 or Q1 as appropriate  Claims submitted without a clinical trial number shall be returned as unprocessable reporting 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)  Effective for dates of service on or before December 31, 2007, practitioners must bill the Category B IDE device on a line with a QA modifier (FDA IDE) along with the IDE number.  However, effective for dates of service on or after January 1, 2008, practitioners will no longer bill a QA modifier to identify a Category B device.  Instead, practitioners will bill a Q0 modifier (numeral 0 versus the letter O) (Investigational clinical service provided in a clinical research study that is in an approved clinical research study) along with the IDE number.  The following table shows the designated field locations to report the Category B IDE number on institutional and practitioner claims:   Data  CMS -1450  CMS -1500  837 institutional claim format and 837 professional claim format  IDE #  Revenue Code Description field  Item 23  Segment 2300,  REF02(REF01=LX)   Contractors will validate the IDE number for the Category B device when modifier Q0 is submitted on the claim along with the IDE number.  Claims containing an invalid IDE number will be returned to the provider using the following messages:  RARC MA50:  Missing/incomplete/invalid Investigational Device Exemption Number for FDA approved clinical trial services.   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.  69 - Qualifying Clinical Trials  (Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)  69.1  General  (Rev. 1147, Issued: 01- 05-07, Effective: 11-06-06, Implementation: 02-05-07)  The CMS has issued a National Coverage Determination (NCD) which allows Medicare coverage for the routine costs of qualifying clinical trial services as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. The coverage requirements for routine costs of qualifying clinical trial services are contained in The National Coverage Determinations Manual, Section 310.1.  69.2 - Payment for Qualifying Clinical Trial Services  (Rev.  2998, Issued: 07- 25-14, Effective: Upon implementation of ICD-10; 01-01-12 - ASC X12, Implementation: 08-25-2014 - ASC X12; Upon Implementation of ICD -10) For dates of service on or after September 19, 2000, pay for covered services furnished to beneficiaries participating in qualifying clinical trials.  Payment is based on the payment methodology applicable for the service that was furnished (e.g., physicia n fee schedule, lab fee schedule, durable medical equipment fee schedule, reasonable charge, etc.). With the exception of managed care enrollees, applicable deductibles and coinsurance rules apply to clinical trial items and services.  The Part A and Part B deductibles are assumed to be met for covered clinical trial services billed on a fee service basis for managed care enrollees.   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.  This is the number assigned by the National Library of Medicine (NLM) ClinicalTrials.gov Web site when a new study appears in the NLM Clinical Trials data base. This number is listed prominently on each specific studys page and is always preceded by the letters NCT. Contractors verify the validity of a trial/study/registry by consulting CMSs clinical trials/registry web site at: http://www.cms.gov/Medicare/Medicare- General -Information/MedicareApprovedFacilitie/index.html.  NOTE:   Contractors shall ensure value code D4/amount data from their internal claims processing is mapped/populated to the 837 institutional claim format for a coordination of benefits 837 institutional claim.   69.3 - Medical Records Documentation Requirements (Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)   The billing provider must include in the beneficiary's medical record the following information: trial name, sponsor, and sponsor-assigned protocol number. This information does not need to be submitted with the claim but must be provided if requested for medical review.   69.4 - Local Medical Review Policy (Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)  Do not develop new or revised LMRPs for clinical trial services.  Clinical trial services that meet the requirements of the NCD are considered reasonable and necessary.   69.5 - Billing Requirements  General  (Rev. 2955, Issued: 05- 14-14, Effective, 01-01-14, Implementation, 01- 06-14)   Instruct practitioners and institutional providers to enter clinical trial and non -clinical trial services on separate line items when billing both types of services on the same claim. For services that require a Certificate of Medical Necessity (CMN), continue to require CMNs. Items and services provided free-of-charge by research sponsors generally may not be billed to be paid by Medicare, and providers are not required to submi t the charge to Medicare.  If it is necessary for a provider to show the items and services that are provided free-of- charge in order to receive payment for the covered routine costs (e.g. administration of a non- covered chemotherapeutic agent), providers are instructed to submit such charges as non- covered at the time of entry, while also assuring that the beneficiary is not held liable.  This instruction applies to all hospitals including hospitals located in Maryland under the jurisdiction of the Health Services Cost Review Commission (HSCRC).   For OPPS claims, providers must report a token charge for a no cost item in the covered charge field along with the applicable HCPCS modifier (i.e., modifier FB) appended to the procedure code that reports the service provided to furnish the no cost i tem, in instances when claims processing edits require that certain devices be billed with their associated procedures.  For more information on billing no cost items under the OPPS, refer to Chapter 4, 20.6.9 and 61.3.1 of this manual.  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.   Future updates will be issued in a Recurring Update Notification.  69.6 - Requirements for Billing Routine Costs of Clinical Trials  (Rev.  2998, Issued: 07- 25-14, Effective: Upon implementation of ICD-10; 01-01-12 - ASC X12, Implementation: 08-25-2014 - ASC X12; Upon Implementation of ICD -10)  Routine Costs Submitted by Practitioners/Suppliers   Claims with dates of service on or after January 1, 2008:   HCPCS modifier Q1 (numeral 1 instead of the letter i) ; and,    If ICD -9-CM is applicable, ICD-9 diagnosis code V70.7 (Examination of participant in clinical trial) reported as the secondary diagnosis (effective September 19, 2000, diagnosis code V70.7 can be reported as either primary or secondary).   If ICD -10-CM is applicable, ICD-10 diagnosis code Z00.6  CMS covers costs of healthy volunteers in a qualified clinical trial if it meets the following conditions:    The trial is not designed exclusively to test toxicity or disease pathophysiology.   The trial must have therapeutic intent.    If the trial has therapeutic interventions, it must enroll patients with diagnosed disease rather than healthy volunteers.   If the trial is studying diagnostic interventions, it may enroll healthy patients in order to have a proper control group.  Effective for claims processed after September 28, 2009, with dates of service on or after January 1, 2008, claims submitted with modifier Q1 shall be returned as unprocessable if ICD-9-CM code V70.7 (if ICD-9 is applicable) or ICD-10-CM code Z00.6 (if ICD-10- CM is applicable) is not submitted on the claim.   Contractors shall return the following messages:  Claims adjustment Reason Code 16: Claim/service lacks information which is needed for adjudication.  As least one Remark Code must be provided (may be comprised of either the Remittance Advice Code or NCPDP Reject Reason Code).   Remittance Advice Remark Code M76: Missing/incomplete/invalid diagnosis or condition.  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 through December 31, 2013.  Refer to change request (CR) 5790 for more information regarding the 8-digit number.  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. Providers report the 8-digit number on the following claims locators:   837 professional claim format-Loop 2300 REF02 (REF01=P4) (do not use CT on the electronic claim); or    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