MLN Matters Number: MM6366 Revised
Related Change Request (CR) #: 6366
Related CR Release Date: March 12, 2009
Effective Date: December 8, 2008
Related CR Transmittal #: R1697CP and R99NCD
Implementation Date: April 6, 2009
Note: This article was revised on March 12, 2009, to reflect a revised transmittal related to CR 6366. The CR release date, transmittal number (see above), and the Web address for accessing that transmittal were changed. All other information remains the same.
Provider Types Affected
Providers submitting claims to Palmetto GBA for Heartsbreath testing services provided to Medicare beneficiaries.
Provider Action Needed
This article is based on Change Request (CR) 6366 and alerts providers that the Centers for Medicare & Medicaid Services (CMS) determined that the Heartsbreath Test is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act, and is non-covered for dates of service on or after December 8, 2008. See the Background and Additional Information Sections of this article for further details regarding this issue.
Background
On December 8, 2008, CMS issued a decision memorandum in response to a formal request from Menssana Research, Inc., to consider national coverage of the Heartsbreath test as an adjunct to the heart biopsy to detect grade 3 heart transplant rejection in patients who have had a heart transplant within the last year and an endomyocardial biopsy in the prior month. CMS determined that the evidence does not adequately define the technical characteristics of the test nor demonstrate that Heartsbreath testing to predict heart transplant rejection improves health outcomes in Medicare beneficiaries.
Key Points of CR 6366
- Effective for claims with dates of service on and after December 8, 2008, the Heartsbreath test used to predict heart transplant rejection is nationally non-covered. This coverage change to Current Procedural Terminology (CPT) Code 0085T, Breath test for heart transplant rejection, will be effective with the April 1, 2009, quarterly update of the Medicare Physician Fee Schedule Database.
- Effective with the April 1, 2009, quarterly update of the Integrated Outpatient Code Editor, CPT code 0085T, Breath test for heart transplant rejection, is no longer payable by Medicare
- When denying claims for CPT code 0085T, Medicare contractors will use:
- Medicare Summary Notice (MSN) message 16.10: Medicare does not pay for this item or service
- Claim Adjustment Reason Code 50: These are non-covered services because this is not deemed a medical necessity by the payer
- Claim Adjustment Remark Code MA 51: Missing/Incomplete/Invalid Procedure Code(s); and
- N386: This decision was based on an NCD. A NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.hhs.gov/mcd/search.asp.
- For beneficiaries who choose to have this procedure, providers shall issue an Advance Beneficiary Notice (ABN) indicating that Medicare issued a NCD at section 260.10 of the NCD Manual stating that the Heartsbreath test is not reasonable and necessary for Medicare beneficiaries. Medicare never pays for this test and the beneficiary would be held financially liable. (Beginning March 1, 2009, the ABN-G will no longer be valid and providers must issue the revised ABN (CMS-R-131.)
- Medicare Contractors will include the Group Code CO (contractor obligation) or PR (provider responsibility) depending on liability on the Remittance Advice Notice
Additional Information
The official instruction (CR 6366) was issued to Palmetto GBA via two transmittals. The first conveys the revised claims processing instructions and is available at www.cms.hhs.gov/Transmittals/downloads/R1683CP.pdf (PDF, 130 KB). The second transmittal conveys the change to the National Coverage Determinations Manual and that transmittal is at
www.cms.hhs.gov/Transmittals/downloads/R99NCD.pdf (PDF, 110 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).
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. CPT only copyright 2008 American Medical Association.