Debbie Liebermann Health Care Policy Liason Send questions to: DebbieL@thml.com Inforamtion from the Indiana Carrier Advisory Committee (CAC) meeting held June 25, 2007 in Indianapolis For hospital laboratories that have an outreach program (non-patients) and independent clinical laboratories, three new Local Coverage Determinations (LCD’s) are being developed for implementation. The new draft LCDs are: Acid Phosphatase, Homocysteine Level (serum), and Erythrocyte Sedimentation Rate (ESR) and may be accessed on the Medical Policy/Current LCDs page of the National Government Services (formerly Adminastar Federal carrier or fiscal intermediary) web site at www.ngsmedicare.com . They are also available on the CMS Medicare coverage database at www.cms.hhs.gov/mcd. . Acid Phosphatase: The new policy establishes NO COVERAGE for Prostatic Acid Phosphatase (CPT code 84066) and defines the ICD-9 CM diagnosis codes for which total acid phosphatase (CPT code 84060) is considered “reasonable and necessary”. Rationale for 84066: “Since the introduction of prostate specific antigen (PSA) the use of prostatic acid phosphatase has declined and is no longer routinely used for screening or staging of prostate cancer as it seldom provides additional useful information.” In addition, “The clinical accuracy of prostatic acid phosphatase assay is problematic. The assay is not organ specific, and levels measured are influenced by diurnal fluctuations, prostate examinations prior to blood sampling, and enzyme instability if not handled properly prior to testing.” Indications for 84060: Gaucher’s disease, myeloid leukemias, hyperparathyroidism, and osteitis deformans. Implementation Date for Carriers: August 15, 2007 Implementation Date for Intermediaries: Not available Homocysteine Level, Serum: The proposed policy establishes a limit of ONCE IN A LIFETIME for Homocysteine (CPT code 83090). Indications for 83090: Elevated serum levels of the amino acid Homocysteine are associated with increased risk of cardiovascular and cerebrovascular disease events as well as an increased risk of osteoporosis. Treatment has consisted of supplementation with vitamin B6, B12 and folic acid. Although vitamin supplementation lowers serum Homocysteine levels, there are no studies that demonstrate this reduces the risk for cardiovascular or cerebrovascular events or osteoporosis. Therefore: Homocysteine levels will be covered by Medicare to confirm Vitamin B12 or folate deficiency. In the absence of evidence that treatment of hyperhomocysteinemia reduces cardiovascular events, this test can only be covered in patients with known vascular disease or risk thereof (based upon abnormal lipid metabolism, high blood pressure or diabetes mellitus) for the purpose of risk stratification. In this circumstance it will be covered only once per lifetime. Utilization Guidelines: When used for atherosclerotic cardiovascular disease risk stratification, measurement of serum homocysteine is considered to be medically necessary only once in a lifetime. Implementation Date for Carriers: Proposed 12/01/2007 Implementation Date for Intermediaries: Proposed 12/01/2007 Erythrocyte Sedimentation Rate (ESR): CPT codes affected are 85651 and 85652. No information is available at this time for the Indiana policy although it will be modeled after the New Jersey policy. Indications: It is most often used as a gauge for determining the progress of an inflammatory disorder caused by infection, autoimmune mechanisms, or connective tissue disease. Frequency limitation will be once per week.