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MIR-2006-8AB, August 2006
MLN Matters. . .Information for Medicare Providers
(Issued by the Centers for Medicare & Medicaid Services)
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Payment for Islet Cell Transplantation in NIH-Sponsored Clinical Trials
Provider Types Affected
Physicians, suppliers, and providers billing Medicare contractors (carriers and fiscal intermediaries (FIs))
Provider Action Needed
Impact to You
The Centers for Medicare & Medicaid Services (CMS) is updating the modifier used for claims for islet cell transplantation and for routine follow-up care related to the transplantation in NIH-sponsored clinical trials.
What You Need to Know
Please note that effective for islet cell transplantation and routine follow-up services related to the islet cell transplantation on or after May 1, 2006, the QV modifier is no longer valid. The QR modifier (item or service provided in a Medicare-specified study) will replace the QV modifier for services on or after May 1, 2006.
What You Need to Do
Refer to the Background and Additional Information sections of this article for more information. Be ready to use the new QR modifier for payment of islet cell transplantation and routine follow-up care when appropriate.
Background
As a result of section 733 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) (P.L. 108-173), for services performed/discharges on or after October 1, 2004, Medicare covers islet cell transplantation for patients with Type I diabetes who are participating in an NIH-sponsored clinical trial. The islet cell transplantation may be done alone or in combination with kidney transplantation.
Additional Information
Effective for services on or after May 1, 2006, Medicare will accept the QR modifier for payment on claims for patients who participate in an NIH-sponsored clinical trial in conjunction with:
- Islet cell transplantation; and
- Routine follow-up care related to islet cell transplantation, when:
- Performed in an outpatient department of a hospital; and
- Billed on type of bill (TOB) 13X or 85X.
For additional information, please refer to MM3385, “MMA-Billing Requirements for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health (NIH) Clinical Trial,” which can be found at http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM3385.pdf  on the CMS Web site. Also, refer to the Medicare National Coverage Determinations Manual, publication 100-03, Chapter 1, Part 4, Section 260.3.1 “Islet Cell Transplantation in the Context of a Clinical Trial (Effective October 1, 2004),”located at http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf on the CMS Web site.
CR5140 is the official instruction issued to your Medicare carrier or FI regarding changes mentioned in this article, and the manual attachment to CR5140, the Medicare Claims Processing Manual, Publication 100-4, Chapter 32, “Billing Requirements for Special Services,” Section 70 “Billing Requirements for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health (NIH) Clinical Trial.” CR5140 may be found at http://www.cms.hhs.gov/Transmittals/downloads/R986CP.pdf on the CMS Web site.
If you have questions, please contact your Medicare carrier or FI at their toll-free number, which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.pdf on the CMS Web site.
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.
MLN Matters Number: MM5140
Pub. 100-4, Transmittal# R986CP, CR# 5140
Related CR Release Date: June 16, 2006
Effective Date: May 1, 2006
Implementation Date: July 31, 2006
Do you have your NPI? National Provider Identifiers (NPIs) will be required on claims sent on or after May 23, 2007. Every health care provider needs to get an NPI. Learn more about the NPI and how to apply for an NPI by visiting http://www.cms.hhs.gov/NationalProvIdentStand/  on the CMS Web site.
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