Billing Requirements for Providers Billing Routine Costs of Clinical Trials Involving a

68.4 – Billing Requirements for Providers Billing Routine Costs of Clinical Trials Involving a Category B IDE (Rev. 12571; Issued: 04-11-24) Effective: 10-11-23; Implementation: 05-13-24) As noted above in section 68.2, of this chapter, providers shall first notify their contractor of the IDE device trial before submitting claims for Category B IDE devices and the routine costs of clinical trials involving Category B IDE devices. Once the contractor notifies the provider that all required information for the IDE has been furnished, the provider may bill Category B IDE claims. When billing for Category B IDEs, providers shall bill for the device and all related procedures. The Category B IDE device and the routine costs associated with its use are eligible for payment under Medicare. (Payment for the device may not exceed the Medicare-approved amount for a comparable device that has been already FDA-approved.) Institutional Inpatient Billing Routine Costs Institutional providers 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 §69.6 of this chapter. Category B Device Institutional providers must bill the Category B IDE number on a 0624 revenue code line with charges in the covered charges field. Hospital inpatient providers should not bill for the Category B IDE device if receiving the device free- of-charge. Institutional Outpatient Billing Routine Costs Institutional providers 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 On a 0624 revenue code line, institutional providers must bill the following for Category B IDE devices for which they incur a cost: • Category B IDE device HCPCS code, if applicable. • Appropriate HCPCS modifier: • Q0 or Q1 as appropriate for claims with dates of service on or after January 1, 2014; or • Q0 (numeral 0 versus the letter O) modifier for claims with dates of service on or after January 1, 2008; or • QA modifier for claims with dates of service prior to January 1, 2008. • Category B IDE number • Charges for the device billed as covered charges NOTE: For claims prior to 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 the applicable HCPCS modifier (i.e., modifier –FB) appended to the procedure code that reports the service to furnish the device, 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. 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.” Claims that are submitted without the ‘Q0’ modifier will be returned with the following messages: CARC 16 - Claim/service lacks information or has submission/billing error(s). Usage: Do not use this code for claims attachment(s)/other documentation. At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N822 – Missing procedure modifier(s).