LCD Reference Article Response To Comments Article

Response to Comments: Testing for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II prothrombin, and MTHFR)

A54586

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A54586

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Response to Comments: Testing for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II prothrombin, and MTHFR)

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The following are comments received by CGS Administrators during the open comment period, 06/17/2015 to 08/03/2015, for draft DL35984 MoPath: Testing for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II Prothrombin and MTHFR).

Response To Comments

Number	Comment	Response
1	Coverage, Indications and Limitations The draft LCD states “This is a non-coverage policy for genetic testing for thrombophilia resulting from mutations in the Factor V Leiden, the Prothrombin, or the MTHFR genes. Genetic testing for these genes for all other risk factors, signs, symptoms, diseases, or conditions, including cardiovascular risk assessment, are non-covered.” This ignores the fact that mutations in MTHFR are associated with homocystinuria (http://omim.org/entry/236250). While it is rare that a typical Medicare beneficiary (age 65 or older) would be tested for homocystinuria, there are circumstances in which young children may qualify for Medicare benefits, and appropriate diagnosis and treatment makes a huge difference in the prognosis of homocystinuria. In addition, the fact that children and adults <65 years old sometimes qualify for Medicare is relevant to other topics (e.g. pregnancy risks). There are also mild manifestations of every genetic disorder, including homocystinuria, which could result in an adult age 65 or older requiring this diagnostic test. For example, management of homocystinuria, even at late age, can reduce the risk of stroke. Moreover, there is good evidence that MTHFR sequencing should not be done in the evaluation of thrombophilia, therefore, we agree that excluding this test specifically for thrombophilia evaluation is reasonable.	Despite many earlier publications suggesting a link between MTHFR polymorphisms and a risk for a wide spectrum of obstetric and cardiovascular complications, it is now accepted that MTHFR genotype alone is not associated with VTE. There is no clinical indication for MTHFR genotyping in any population (Hickey, 2013). In the rare situation when MTHFR may be indicated, claims will deny and can be appealed with the medical record justifying the specific need for MTHFR testing and the management change that would result from the test result.
2	Factor V Leiden Long-term anticoagulation should be considered in individuals homozygous for the factor V Leiden mutation or with multiple thrombophilic disorders [Kearon et al 2008b]. In these individuals at high risk for recurrence, the potential benefits from long-term warfarin may outweigh the bleeding risks.” 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].” ° Prophylactic anticoagulation during pregnancy is not routinely recommended in asymptomatic heterozygous women with no history of thrombosis. These women should be warned about potential thrombotic complications, counseled about the risks and benefits of anticoagulation during pregnancy, and offered a four- to six-week course of anticoagulation after delivery, as the greatest thrombotic risk is in the initial postpartum period [Bates et al 2008]. ° Prophylactic anticoagulation is recommended for women with a factor V Leiden allele and a history of unprovoked VTE. Unfractionated or low molecular-weight heparin should be given during pregnancy, followed by a four- to six-week course of anticoagulation post-partum [Duhl et al 2007, Bates et al 2008]. ° Prophylactic anticoagulation should be considered for heterozygous women with a prior estrogen-related thrombosis who are also at an increased risk for recurrence [Pabinger et al 2005, Bates et al 2008]. ° Prophylactic anticoagulation also should be considered for asymptomatic women with homozygous factor V Leiden or double heterozygosity for factor V Leiden and the prothrombin 20210G>A mutation, or with other combined thrombophilic defects, especially those with circumstantial risk factors (obesity, immobilization, multiple gestation) [Barbour 2001, Bates et al 2008].”	The American College of Chest Physicians (ACCP) notes the following recommendations: In person with asymptomatic thrombophilia (e.g., without a previous history of VTE), ACCP recommends against the long-term daily use of mechanical or pharmacologic thromboprophylaxis to prevent VTE; For pregnant women with no prior history of VTE who are known to be homozygous for factor V Leiden or the prothrombin 20210A mutation and have a positive family history for VTE, we suggest antepartum prophylaxis with prophylactic or intermediatedose low molecularweight heparin (LMWH) and postpartum prophylaxis for 6 weeks with prophylactic or intermediatedose LMWH or vitamin K antagonists (VKAs) targeted at INR 2.0 to 3.0 rather than no prophylaxis; For all pregnant women with prior VTE, we suggest postpartum prophylaxis for 6 weeks with prophylactic or intermediatedose LMWH or VKAs targeted at INR 2.0 to 3.0 rather than no prophylaxis; For pregnant women at low risk of recurrent VTE (single episode of VTE associated with a transient risk factor not related to pregnancy or use of estrogen), we suggest clinical vigilance antepartum rather than antepartum prophylaxis; For pregnant women at moderate to high risk of recurrent VTE (single unprovoked VTE, pregnancy or estrogenrelated VTE, or multiple prior unprovoked VTE not receiving longterm anticoagulation), we suggest antepartum prophylaxis with prophylactic or intermediatedose LMWH rather than clinical vigilance or routine care. The population for which genetic testing results have direct implications for treatment is pregnant women with a previous history of VTE associated with a transient risk factor (e.g., surgery, trauma). These women would typically not be treated with antepartum anticoagulation prophylaxis unless they were found to have a genotype associated with a high risk of VTE recurrence (FVL homozygosity, F2 G20210A homozygosity, or compound heterozygosity for FVL and F2 G20210A). Genetic testing for these patients is indicated. There may also be benefit to screening pregnant women with a family history of known thrombophilia, as those women found to have a high risk genotype would be offered antenatal prophylactic anticoagulant therapy even in the absence of a personal history of VTE. However, the Medicare benefit applies only to patients with signs and symptoms of disease and does not include screening in asymptomatic patients. The American College of Medical Genetics (ACMG) Practice Guidelines (2001, reaffirmed 2006) does not recommend FVL testing as: A general population screen; A routine initial test during pregnancy or prior to the use of oral contraceptives, hormone replacement therapy (HRT) or selective estrogen receptor modulators (SERMs); A prenatal or newborn test, or as a routine test in asymptomatic children; A routine initial test in individuals (under age 50) with unexplained arterial thrombosis in the absence of other risk factors for atherosclerotic vascular disease. However, the ACMG does recommend Factor V Leiden testing for pregnant women with venous thrombosis or women taking oral contraceptives with venous thrombosis. By extension, women on HRT or SERMs with venous thrombosis are considered candidates for thrombophilia testing. ACMG indicates that testing may be considered in patients with venous thrombosis, age over 50, except when active malignancy is present. Medicare will not add thrombophilia testing for pregnant women to the policy because they likely represent a very small group of potential patients. Claims submitted on this limited Medicare population will deny per the policy, but should be appealed for coverage with submission of medical records supporting the necessity for testing and the management changes resulting from the testing results.
3	Genetic Testing for Thrombophilia A. The draft LCD states, “During the previous 5 years, a number of guidelines and/or position statements on testing for thrombophilia have been published. In 2011, The Evaluation of Genomic Applications in Practice and Prevention Working Groups (EGAPP) addressed genetic testing for FVL and PT mutations. The expert consensus recommended, a) There is no evidence that knowledge of FVL/PT mutation status in patients with VTE affects anticoagulation treatment to avoid recurrence; b) There is convincing evidence that anticoagulation beyond three months reduces recurrence of VTE, regardless of mutation status and; c) There is no evidence that knowledge of FVL/PT mutation status among symptomatic family members of patients with VTE leads to anticoagulation aimed at avoiding initial episodes of VTE (See note).” The EGAPP statement does include this line: “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.” While the EGAPP statement doesn’t cite any evidence for benefit of FVL/PT testing in the setting of additional risk factors, it should be emphasized that there is a lack of evidence against benefit, and one should not confuse ‘lack of evidence for benefit’ with ‘evidence for lack of benefit.’ The commenter agrees with the American Congress of Obstetricians and Gynecologists (ACOG) clinical management guidelines outlined in this draft LCD. However, ACOG guidelines also state that screening for thrombophilia when the results will affect pregnancy/postpartum management and suggests avoiding screening when treatment is indicated because of patient-specific risk factors. (See "Screening for inherited thrombophilia in asymptomatic individuals" and "Deep vein thrombosis and pulmonary embolism in pregnancy: Prevention".) For example, screening is appropriate in women with history of VTE associated with a nonrecurrent risk factor, such as femoral fracture, surgery, or prolonged immobilization, because those with no hereditary thrombophilic defect are at low risk for recurrent thrombosis and do not require antepartum thromboprophylaxis, whereas those with a thrombophilic defect are at higher risk of VTE during pregnancy; the magnitude of risk and management depend on the defect [57]. Women with a past history of idiopathic (unprovoked) or recurrent VTE are at relatively high risk of recurrent thrombosis and should receive thromboprophylaxis antepartum regardless of thrombophilia status. For women with a prior VTE associated with estrogen-progestin contraceptive use or pregnancy, we would recommend prophylactic anticoagulation whether or not a thrombophilic defect is identified. Nevertheless, we would screen such women for hereditary thrombophilia, particularly if there was a family history of VTE. If a high-risk thrombophilic defect such as antithrombin (AT) deficiency was identified, treatment with higher-intensity prophylactic anticoagulation (eg, more than a single daily dose of enoxaparin 40 mg subcutaneously) and AT concentrate in the peripartum period would be reasonable. Testing is also reasonable in asymptomatic (no prior VTE) women planning a pregnancy who have a first degree relative with a history of a high-risk thrombophilia [9]. Identification of a heritable thrombophilic defect in the relative can narrow the laboratory evaluation to determine whether or not the woman carries the specific defect. The rationale for such testing is that antepartum and postpartum prophylaxis may be indicated if the asymptomatic patient is found to be a carrier of one of the more highly thrombogenic defects (eg, AT deficiency, double heterozygosity or homozygosity for FVL and PGM). Postpartum thromboprophylaxis may be indicated if the asymptomatic patient is a carrier of one of the less thrombogenic defects (eg, heterozygous FVL) in the presence of other risk factors (eg, cesarean delivery, prolonged immobilization) or has a symptomatic first-degree relative with VTE before age 50 years [58,59]. (See "Management of inherited thrombophilia".) The American Society of Hematology (ASH), recommends against thrombophilia testing in adult patients diagnosed with venous thromboembolism (VTE) in the context of a major transient VTE risk factor such as surgery, trauma or prolonged immobility. In this scenario, thrombophilia testing does not influence duration or intensity of treatment. However, this recommendation is in regards to VTE associated with major risk factors. “Major transient risk factors” are NOT the following: contraceptives, pregnancy, hormonal therapy, airline travel, minor surgery (arthroscopic surgeries, etc.) or partial immobility (boot immobilizer, etc.). Patients who develop VTE associated with such minor VTE risk factors may be candidates for thrombophilia testing. Such patients should seek guidance from an expert in VTE. The ACOG does advocate testing in women with several predisposing risk factors. Their guidelines state that asymptomatic women with a family history of venous thrombosis should be tested if a thromboembolic event in a first-degree relative was unprovoked, or provoked by pregnancy, COCP exposure or a minor risk factor. The result will be more informative if the first-degree relative has a known thrombophilia. Finally, work-up for thrombophilia is a complex process and is arrived at by a process of elimination. The mutation status is one of several factors that can be ruled out at a relatively low cost and can help guide the diagnosis and treatment of not only the patient but female family members who are considering contraceptive use.	Screening and testing of asymptomatic women/individuals with or without a family history of VTE is not a Medicare benefit. Citations provided by commenters: Barbour LA. ACOG practice bulletin. Thrombembolism in pregnancy. Int J Gynaecol Obstet. 2001;75:203–12. [PubMed] Bates SM, Greer IA, Pabinger I, Sofaer S, Hirsh J. American College of Chest Physicians; Venous thromboembolism, thrombophilia, antithrombotic therapy, and pregnancy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133:844S–86S. [PubMed] Duhl AJ, Paidas MJ, Ural SH, Branch W, Casele H, Cox-Gill J, Hamersley SL, Hyers TM, Katz V, Kuhlmann R, Nutescu EA, Thorp JA, Zehnder JL. Pregnancy and Thrombosis Working Group; Antithrombotic therapy and pregnancy: consensus report and recommendations for prevention and treatment of venous thromboembolism and adverse pregnancy outcomes. Am J Obstet Gynecol. 2007;197:457. [PubMed] 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] 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] Pabinger I, Nemes L, Rintelen C, Koder S, Lechler E, Loreth RM, Kyrle PA, Scharrer I, Sas G, Lechner K, Mannhalter C, Ehrenforth S. Pregnancy- associated risk for venous thromboembolism and pregnancy outcome in women homozygous for factor V Leiden. Hematol J. 2000;1:37–41. [PubMed]

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Response to Comments: Testing for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II prothrombin, and MTHFR)

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