MLN Matters® Number: MM6431 Revised
Related Change Request (CR) #: 6431
Related CR Release Date: June 26, 2009
Effective Date: For claims with dates of service on or after January 1, 2008 and processed after September 28, 2009
Related CR Transmittal #: R1761CP
Implementation Date: September 28, 2009
Note: This article was revised on June 29, 2009, to reflect a revised CR 6431, issued by the Centers for Medicare & Medicaid Services (CMS) on June 26, 2009. The transmittal number, CR release date (see above), and the Web address for accessing CR 6431 have changed. In addition, the implementation date was changed to September 28, 2009. All other information is the same.
Provider Types Affected
Physicians and non-physician practitioners submitting claims to Palmetto GBA for clinical trials.
Provider Action Needed
This article is based on Change Request (CR) 6431 that alerts providers that they should continue to report the International Classification of Diseases diagnosis code V70.7 (Examination of participant in clinical trial) on clinical trial claims. It is no longer necessary to make a distinction between a diagnostic and therapeutic clinical trial service on the claim.
Background
CR 6431 revises the Medicare Claims Processing Manual, Chapter 32, Section 69.6 (Requirements for Billing Routine Costs of Clinical Trails). The revised manual section is attached to CR 6431. The Centers for Medicare & Medicaid Services (CMS) is clarifying that there no longer remains a need to make a distinction between a diagnostic versus therapeutic clinical trial service on the claim.
If the QV or Q1 HCPCS modifier is billed and diagnosis code V70.7 is submitted by practitioners as a secondary rather than the primary diagnosis, Palmetto GBA will not consider the service as having been furnished to a diagnostic trial volunteer. Instead, they will process the service as a therapeutic clinical trial service.
- Effective for claims processed 90 days after issuance of CR 6431 with service dates on or after January 1, 2008, claims submitted with either the QV or the Q1 HCPCS modifier will be returned as unprocessable if the diagnosis code V70.7 is not submitted on the claim
- Providers will see the following messages from their Medicare contractor with the returned claim:
- Claims adjustment Reason Code 16 – Claim/service lacks information which is needed for adjudication; and
- As least one Remark Code, which may be comprised of either:
- The Remittance Advice Code (M76, Missing/incomplete/invalid diagnosis or condition) or
- National Council for Prescription Drug Programs Reject Reason Code
Note: Healthcare Common Procedure Coding System (HCPCS) codes are not reported on inpatient claims. Therefore, the HCPCS modifier requirements (i.e., QV or Q1) as outlined in the outpatient clinical trial section immediately below, are not applicable to inpatient clinical trial claims.
On all outpatient clinical trial claims, providers need to do the following:
- Report condition code 30
- Report a secondary diagnosis code of V70.7 and
- Identify all lines that contain an investigational item/service with a HCPCS modifier of
- QA/QR for dates of service before January 1, 2008 or
- Q0 for dates of service on or after January 1, 2008
- Identify all lines that contain a routine service with a HCPCS modifier of:
- QV for dates of service before January 1, 2008 or
- Q1 for dates of service on or after January 1, 2008
Additional Information
If you have questions, please contact our Provider Contact Center at our toll-free (866) 332-7025 (Ohio and West Virginia) or (888) 828-2092 (South Carolina Part B).
Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents.