Provider Action Needed
This article is based on Change Request (CR) 5790 that notifies providers and suppliers that Medicare claims forms will be modified to accommodate the 8-digit clinical trial number for Medicare claims. Reporting this number is voluntary and claims submitted without the clinical trial number will be paid the same as claims containing a number. While reporting is voluntary, the number will assist the Centers for Medicare & Medicaid Services (CMS) in informing beneficiaries about the availability of clinical trials and to use claims information to inform coverage decisions. Be sure your billing staff is aware of this rule.
Background
The purpose of CR 5790 is to instruct providers and suppliers on new, voluntary reporting for placing a clinical trial number on claims for items and services provided in clinical trials that are qualified for coverage as specified in the Medicare National Coverage Determination Manual, Publication 100-03, section 310.1. That publication is available at www.cms.hhs.gov/Manuals/IOM/list.asp. The clinical trial number that the CMS is requesting to be voluntarily reported is the number assigned by the National Library of Medicine (NLM) Clinical Trials Data Bank when a new study is registered by a sponsor or investigator. Information regarding NLM clinical trials is available at http://clinicaltrials.gov/.
CMS will use this number to identify all items and services provided to beneficiaries during their participation in a clinical trial. Furthermore, this identifier will permit CMS to meet the recommendations of the 2000 Institute of Medicine report that led to the Executive Memorandum to increase participation of Medicare beneficiaries in clinical trials and the development and implementation of the CMS clinical trials policy.
Recommendations from The White House Executive Memorandum included:
- Tracking Medicare payments
- Ensuring that the information gained from the research is used to inform coverage decisions
- Making certain that the research focuses on issues of importance to the Medicare population
- Enabling CMS to better inform Medicare beneficiaries about the clinical studies available for their participation
Key Points
- Claims submitted without the clinical trial number will be paid the same as claims containing a number
- Institutional clinical trial claims are identified through the presence of all of the following elements:
- Value Code D4 and corresponding 8-digit clinical trial number (when present on the claim)
- ICD-9 diagnosis code V70.7
- Condition Code 30
- HCPCS modifier Q1: outpatient claims only. (See MM 5805 related to CR 5805 for more information regarding HCPCS modifier Q1)
- Practitioner/DME clinical trial claims are identified through the presence of all of the following elements:
- ICD-9 diagnosis code V70.7
- HCPCS modifier Q1
- 8-digit clinical trial number (when present on the claim)
- On institutional claims, the 8-digit numeric clinical trial number should be placed in the value amount of value code D4 on the paper claim UB-40 (Form Locators 39-41) or in Loop 2300, HI – Value Information segment, qualifier BE on the 837I
- On professional claims, the clinical trial registry number should be preceded by the two alpha characters of 'CT' and placed in Field 19 of the paper Form CMS-1500 or it should be entered WITHOUT the 'CT' prefix in the electronic 837P in Loop 2300 REF02(REF01=P4)
Additional Information
You may see the official instruction, CR 5790 (PDF, 263 KB) issued to your Medicare A/B MAC, FI, DME/MAC or carrier. You may see the article related to the HCPCS modifier Q1, MM 5805 (PDF, 65 KB).
If you have questions, please contact our Provider Contact Center at our toll-free number (866) 332-7025 (Ohio and West Virginia) or (888) 828-2092 (South Carolina Part B).