evekhm/cms_iom_500 huggingface dataset:
(Medicare Claims Processing 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.
(Medicare Claims Processing Manual)
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)
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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).
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
 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
(Medicare Claims Processing Manual)
 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.
(Medicare Claims Processing Manual)
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:
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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: