LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Genetic Testing for Hypercoagulability / Thrombophilia

A54894

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A54894
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Article Title
Response to Comments: MolDX: Genetic Testing for Hypercoagulability / Thrombophilia
Article Type
Response to Comments
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06/16/2016
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Noridian’s Response to Provider Recommendations (for comment period ending 08/10/2015).

Response To Comments

Number Comment Response
1 1. LCD ignores fact that MTHFR is associated with homocysteinuria. The commenter notes that it is rare that a typical Medicare beneficiary would be tested for homocystinuria, the commenter notes young children may be qualify for Medicare, and the appropriate diagnosis and treatment makes a huge difference in the prognosis of homocystinuria. The commenter notes that MTHFR sequencing should not be done in the evaluation of thrombophilia. Agreement acknowledged.
2 2. Factor V Leiden (FVL) - Long-term anticoagulation. Commenter notes that Long-term anticoagulation should be considered in individuals homozygous for FVL or with multiple thrombophilic disorders; “potential benefits from long-term warfarin may outweigh the bleeding risks”, and cites Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. American College of Chest Physicians; Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008b;133:454S–545S. [PubMed] It must be emphasized that there currently no data from prospective, randomized, controlled trials specifically designed to address the optimal duration of anticoagulation therapy in patients with specific hypercoagulable states. Any decision regarding the ideal duration of therapy must take into account the estimates of VTE recurrence for a given disorder, the nature of the index VTE, and the risk of bleeding associated with prolonged oral anticoagulation.
3 3. Prophylactic anticoagulation Because the initial thrombosis in factor V Leiden heterozygotes occurs in association with other circumstantial risk factors in 50% of cases, a short course of prophylactic anticoagulation during exposure to hemostatic stresses may prevent some of these episodes. Prophylactic anticoagulation should be considered in high-risk clinical settings such as surgery, pregnancy, or prolonged immobilization, although currently no evidence confirms the benefit of primary prophylaxis for all asymptomatic carriers. Decisions regarding prophylactic anticoagulation should be based on a risk/benefit assessment in each individual case. Factors that may influence decisions about the indication for and duration of anticoagulation include age, family history, and other coexisting risk factors. Recommendations for prophylaxis at the time of surgery and other high-risk situations are available in consensus guidelines [Geerts et al 2008].” Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. American College of Chest Physicians; Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133:381S–453S. [PubMed]. This policy does not address the need for or against prophylactic anticoagulation therapy. The policy addresses the appropriateness of FVL, F2 and MTHFR genetic testing.
4 4. Genetic Testing for Thrombophilia Commenter states that EGAPP statement included “the recommendations do not extend to patients with other risk factors for thrombosis, such as contraceptive use, as the evidence review that serves as the basis for the recommendations focused primarily on idiopathic VTE.” The policy specifically addresses the “other” risk factors such as contraceptive use. However, initiation of oral anticoagulation for primary VTE prophylaxis in asymptomatic carriers of any hypercoagulable state has not been advised, mainly because the annual absolute risk of idiopathic VTE is low or not high enough to be favorably balanced against the annual risk of oral anticoagulation-related major and fatal hemorrhage. However, because most VTEs (50-70%) in patients with a predisposition to hypercoagulability occur following a situational risk factor, such as major or orthopedic surgery, aggressive VTE prophylaxis should be prescribed to asymptomatic carriers of hypercoagulable states during high-risk situations. Many physicians justify hypercoagulability state testing because, if an abnormality is found, prescription of long-term oral anticoagulation is believed to be more appropriate than the recommended 3- to 6-month course. However, there are no data from prospective, randomized, controlled trials specifically designed to address the optimal duration of anticoagulation in patients with specific hypercoagulable states.
5 5. ACOG Clinical Management Guidelines The commenter agrees with the ACOG guidelines, but states that ACOG includes screening for thrombophilia when the results will affect pregnancy/postpartum management and suggest avoiding screening when treatment is indicated because of patient-specific risk factors. Testing for hypercoagulable states is best performed in stages by individuals with specific training in hematology/oncology, hematopathology or coagulation disorders. Highest yielding assays (screening tests) should be performed first, and if positive, should be followed by appropriate confirmatory tests. If screening test results are negative and sufficient suspicion exists, less common disorders can be tested for. Specific testing for FVL is not necessary if the test result for APC-R is negative. Prothrombin G20210A mutation detection by PCR is preferred over prothrombin activity level quantification because the latter does not sufficiently differentiate carriers from non-carriers of the mutation. Activity assays for antithrombin, protein C, and protein S are initially preferred because they will be abnormal in both type I (quantitative) and type II (qualitative) deficiencies. If activity assay results are normal, there is no benefit to pursuing antigenic testing.
6 6. Testing is reasonable in asymptomatic women planning a pregnancy The commenter specifies that genetic testing is reasonable in an asymptomatic woman planning a pregnancy who have a first degree relative with a history of a high-risk thrombophilia. A Medicare benefit applies only to patients with signs or symptoms of disease. An asymptomatic individual is not eligible for testing under Medicare.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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