Heartsbreath Test for Heart Transplant Rejection

On December 8, 2008, CMS issued a decision memorandum in response to a formal request for Menssana Research, Inc., to consider national coverage of the Heartsbreath Test as an adjunct to a 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 did 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. They concluded that the Heartsbreath Test is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act, and is non-covered.

Key Points of CR 6366

• Effective for claims with dates of service on and after December 8, 2008, the Heartsbreath test CPT Code 0085T, is nationally non-covered.
• For beneficiaries who choose to have this procedure anyway, providers should issue an Advance Beneficiary Notice (ABN).
• For claims already processed with dates of service between December 8, 2008, and April 1, 2009, contractors will not search their files, but may go back and adjust claims that are brought to their attention.