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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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Non-Autologous Blood-Derived Products for Chronic Non-Healing Wounds
Provider Types Affected
Physicians, providers and suppliers submitting claims to Medicare carriers, fiscal intermediaries (FIs) and/or regional home health intermediaries (RHHIs) for chronic non-healing wound related services furnished to Medicare beneficiaries.
Impact on Providers
This article is based on Change Request (CR) 5123 which instructs Medicare contractors (carriers, FIs, and RHHIs) that claims submitted for becaplermin, a self-administered, non-autologous growth factor for chronic, non-healing, subcutaneous wounds, will remain noncovered.
Becaplermin, Healthcare Common Procedure Coding System (HCPCS) S0157, is nationally noncovered because it is usually self-administered by the patient.
Background
After releasing a national noncoverage determination (NCD) on Autologous Blood-Derived Products for Chronic Non-Healing Wounds in December of 2003, an error was printed in the NCD Manual. To correct that error, the Centers for Medicare & Medicaid Services (CMS) is revising section 270.3 of the National Coverage Determinations (NCD) Manual (Publication 100-03, Chapter 1, Part 3, “Blood-Derived Products for Chronic Non-Healing Wounds”) to accurately reflect the payment policy for non-autologous blood derived products for chronic non-healing wounds, effective April 27, 2006.
In this revision, the following sentence is being deleted:
“Coverage for treatments utilizing becaplermin, a non-autologous growth factor for chronic non-healing subcutaneous non-healing wounds, will remain at local carrier discretion. Becaplermin is approved by the Food and Drug Administration.” |
The correct statement should read:
“Coverage for treatments utilizing becaplermin, a non-autologous growth factor for chronic non-healing subcutaneous wounds, will remain nationally noncovered under Part B based on §1861(s)(2)(A) and §1861(s)(2)(B) because this product is usually self-administered by the patient.” |
While CMS makes every effort to provide accurate and complete information, the erroneous coverage statement printed in the NCD Manual regarding non-autologous blood-derived products was not intended, and is not part of the Decision Memorandum (DM) posted on December 15, 2003. Non-autologous blood-derived products are not in the same class as the products referred to in the December 15, 2003 DM.
NCDs are binding on all carriers, FIs, quality improvement organizations, health maintenance organizations, qualified independent contractors, the Medicare Appeals Council, and administrative law judges (ALJs) (see 42 CFR 405.1060)(a)(4), effective May 1, 2005). An NCD that expands coverage is also binding on a Medicare advantage organization. In addition, an ALJ may not review an NCD (see section 1869(f)(1)(A)(i) of the Social Security Act). |
Additional Information
CR5123 is the official instruction issued to your Medicare carrier or FI/RHHI regarding changes mentioned in this article. There are two transmittals for CR5123. Transmittal 59, containing the NCD revision, is available at http://www.cms.hhs.gov/Transmittals/downloads/R59NCD.pdf  on the CMS Web site. Transmittal 977, containing the Medicare claims processing instructions, is at http://www.cms.hhs.gov/Transmittals/downloads/R977CP.pdf on the CMS Web site.
If you have questions please contact your Medicare carrier/FI/RHHI 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: MM5123
Related Change Request (CR) #: 5123
Related CR Release Date: June 9, 2006
Effective Date: April 27, 2006
Related CR Transmittal #: R977CP and R59NCD
Implementation Date: July 10, 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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