The Centers for Medicare and Medicaid Services (CMS) recently announced that effective January 1, 2014, reporting of an 8-digit clinical trial number on claims will become mandatory. The clinical trial number, which has been voluntarily reported since January 18, 2008, will be a requirement for the payment of claims that include items and services provided in clinical trials that qualify for Medicare coverage as outlined in the Medicare National Coverage Determination (NCD) Manual.
For institutional claims, the 8-digit clinical trial number must be reported on the claim in addition to:
- Condition code 30
- ICD-9 code of V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions)
- Modifier Q0 and/or Q1, as appropriate (outpatient claims only)
For professional claims, the 8-digit clinical trial number preceded by the 2 alpha characters of CT must be reported on the claim in addition to:
- ICD-9 code of V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions)
- Modifier Q0 and/or Q1, as appropriate (outpatient claims only)
Medicare Part B clinical trial/registry/study claims that contain a date of service on or after January 1, 2014 will not be paid if the 8-digit clinical trial number is not appropriately completed. Implementation of this new requirement can heavily affect the billing staff if a proactive stance is not taken. Additionally, over the last several years, the government has identified proper reporting of clinical trial services as a significant risk area. If your facility or providers participate in clinical trial services, we recommend reviewing your internal clinical trial billing process, including how such items and services are identified and communicated to billing staff to ensure compliant and accurate reporting.
To view this Change Request in its entirety, go to the following link: http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2758CP.pdf
HC Healthcare Consulting has a team comprised of consultants Certified in Healthcare Compliance along with coders, certified fraud examiners, statisticians and physician consultants. We have extensive expertise in coding and billing compliance and regularly assist hospitals with ongoing auditing, education and corrective action needs.
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