(Medicare National Coverage Determinations Manual)

Medicare National Coverage Determinations Manual  Chapter 1, Part 2 (Sections 90  160.26) Coverage Determinations   Table of Contents  (Rev. 1 2299, 10-12-23)  Transmittals for Chapter 1, Part 2   90 - Genetics  90.1  Pharmacogenomic Testing to Predict Warfarin Responsiveness (Effective August 3, 2009)           90.2 Next-Generation Sequencing for Patients with Advanced Cancer  100 - Gastrointestinal System 100.1 - Bariatric Surgery for Treatment of Co -morbid Conditions Related to Morbid Obesity (Effective September 24, 2013) 100.2 - Endoscopy  100.3 - 24-Hour Ambulatory Esophegeal pH Monitoring 100.4 - Esophageal Manometry 100.5 - Diagnostic Breath Analyses  100.6 - Gastric Freezing  100.7 - Colonic Irrigation  100.8  Intestinal Bypass Surgery (RETIRED)  100.9 - Implantation of Anti- Gastroesophageal Reflux Device (RETIRED)  100.10 - Injection Sclerotherapy for Esophageal Variceal Bleeding  100.11  Gastric Balloon for Treatment of Obesity  (RETIRED)  100.12 - Gastrophotography 100.13 - Laproscopic Cholecystectomy  100.14  Surgery for Diabetes (RETIRED ) 110 - Hematology/Immunology/Oncology 110.1 - Hyperthermia for Treatment of Cancer  110.2 - Certain Drugs Distributed by the National Cancer Institute  110.3 - Anti -Inhibitor Coagulant Complex (AICC)  110.4 - Extracorporeal Photopheresis  110.5 - Granulocyte Transfusions  110.6 - Scalp Hypothermia During Chemotherapy to Prevent Hair Loss  110.7 - Blood Transfusions  110.8 - Blood Platelet Transfusions                            110.8.1 - Stem Cell Transplantation (RETIRED) 110.9 - Antigens Prepared for Sublingual Administration 110.10 - Intravenous Iron Therapy  110.11 - Food Allergy Testing and Treatment  110.12 - Challenge Ingestion Food Testing 110.13 - Cytotoxic Food Tests  110.14 - Apheresis (Therapeutic Pheresis)  110.15 - Ultrafiltration, Hemoperfusion and Hemofiltration  110.16 -  Nonselective (Random) Transfusions and Living Related Donor Specific Transfusions (DST) in Kidney Transplantation 110.17 -  Anti -cancer Chemotherapy for Colorectal Cancer (Effective January 28, 2005)  110.18 -  Aprepitant  for Chemotherapy- Induced Emesis  110.19  Abarelix for the Treatment of Prostate Cancer (Effective March 15, 2005)  (RETIRED)  110.20 -  Blood Brain Barrier Osmotic Disruption for Treatment of Brain Tumors (Effective March 20, 2007)  110.21 -  Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions  110.22  Autologous Cellular Immunotherapy Treatment (Effective June 30, 2011)  110.23 -  Stem Cell Transplantation (Formerly 110.8.1) (Various Effective Dates Below)  110.24 -  Chimeric Antigen Receptor (CAR) T -cell therapy  120 -  Infectious Diseases  130 -  Mental Health  130.1 -  Inpatient Hospital Stays for the Treatment of Alcoholism 130.2 -  Outpatient Hospital Services for Treatment of Alcoholism 130.3 -  Chemical Aversion Therapy for Treatment of Alcoholism  130.4 -  Electrical Aversion Therapy for Treatment of Alcoholism  130.5 -  Treatment of Alcoholism and Drug Abuse in a Freestanding Clinic  130.6 -  Treatment of Drug Abuse (Chemical Dependency)  130.7 -  Withdrawal Treatments for Narcotic Addictions  130.8 -  Hemodialysis for Treatment of Schizophrenia  140 -  Miscellaneous Surgical Procedures  140.1 -  Abortion 140.2 -  Breast Reconstruction Following Mastectomy 140.4 -  Plastic Surgery to Correct Moon Face"  140.5 -  Laser Procedures  140.6  Wrong Surgical or Other Invasive Procedure Performed on a Patient (Effective January 15, 2009)  140.7  Surgical or Other Invasive Procedure Performed on the Wrong Body Part (Effective January 15, 2009)  140.8  Surgical or Other Invasive Procedure Performed on the Wrong Patient (Effective January 15, 2009)  140.9 -  Gender Reassignment Surgery for Gender Dysphoria  150 -  Musculoskeletal  System  150.1 -  Manipulation 150.2 -  Osteogenic Stimulator  150.3 -  Bone (Mineral) Density Studies  (Effective January 1, 2007)  150.5 -  Diathermy Treatment  150.6 -  Vitamin B12 Injections to Strengthen Tendons, Ligaments, etc., of the Foot  150.7 -  Prolotherapy, Joint Sclerotherapy, and Ligamentous Injections with Sclerosing Agents  150.8 -  Fluidized Therapy Dry Heat for Certain Musculoskeletal Disorders  150.9 -  Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee (Effective June 11, 2004)  150.10 -  Lumbar Artificial Disc Replacement (LADR) (Effective August 14, 2007)  150.11  Thermal Intradiscal Procedures (Effective September 29, 2008)  150.12  Collagen Meniscus Implant (Effective May 25, 2010)  150.13 -  Percutaneous Image- guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) (Various Effective Dates Below)  150.20  Reserved for Future Use  160 -  Nervous System  160.1 -  Induced Lesions of Nerve Tracts  160.2 -  Treatment of Motor Function Disorders with Electric Nerve Stimulation  160.4 -  Stereotactic Cingulotomy as a Means of Psychosurgery (RETIRED)  160.5 -  Stereotaxic Depth Electrode Implantation 160.6 -  Carotid Sinus Nerve Stimulator  (RETIRED)  160.7 -  Electrical Nerve Stimulators  160.7.1 -  Assessing Patients Suitability for Electrical Nerve Stimulation Therapy  160.8 -  Electroencephalographic Monitoring During Surgical Procedures Involving the Cerebral Vasculature  160.9  Electroencephalographic (EEG) Monitoring During Open- Heart Surgery  (RETIRED)  160.10 -  Evoked Response Tests  160.12 -  Neuromuscular Electrical Stimulator (NMES)  160.13 -  Supplies Used in the Delivery of Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation (NMES)  160.14 -  Invasive Intracranial Pressure Monitoring 160.15 -  Electrotherapy for Treatment of Facial Nerve Palsy (Bells Palsy)  160.16 -  Vertebral Axial Decompression (VAX -D) 160.17 -  L-Dopa  160.18 -  Vagus Nerve Stimulation  (VNS)  160.19 -  Phrenic Nerve Stimulator  160.20 -  Transfer Factor for Treatment of Multiple Sclerosis  160.21 -  Telephone Transmission of EEGs  160.22 -  Ambulatory EEG Monitoring (RETIRED)  160.23 -  Sensory Nerve Conduction Threshold Tests (sNCTs)  160.24  Deep Brain Stimulation for Essential Tremor and Parkinsons Disease  160.25 -  Multiple Electroconvulsive Therapy (MECT)  160.26 -  Cavernous Nerves Electrical Stimulation With Penile Plethysmography -  Effective August 24, 2006 160.27  Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)      90 - Genetics  (Rev. 1, 10- 03-03)  No coverage determinations   90.1 - Pharmacogenomic Testing to Predict Warfarin Responsiveness  (Effective August 3, 2009)  (Rev. 111, Issued: 12- 18-09, Effective: 08 -03-09, Implementation: 04- 05-10)  A. General   Warfarin sodium is an orally administered anticoagulant drug that is marketed most commonly as Coumadin. (The Food and Drug Administration (FDA) approved labeling for Coumadin includes a Black Box Warning dating back to 2007.)  Anticoagulant drugs are sometimes referred to as blood thinners by the lay public.  Warfarin affects the vitamin K -dependent clotting factors II, VII, IX, and X.  Warfarin is thought to interfere with clotting factor synthesis by inhibition of the C1 subunit of the vitamin K epoxide reductase (VKORC1) enzyme complex, thereby reducing the regeneration of vitamin K1 epoxide.  The elimination of warfarin is almost entirely by metabolic conversion to inactive metabolites by cytochrome P450 (CYP) enzymes in liver cells.  CYP2C9 is the pr incipal cytochrome P450 enzyme that modulates the anticoagulant activity of warfarin.  From results of clinical studies, genetic variation in the CYP2C9  and/or VKORC1  genes can, in concert with clinical factors, predict how each individual responds to warf arin.  Pharmacogenomics denotes the study of how an individual's genetic makeup, or genotype, affects the body's response to drugs.  Pharmacogenomics as a science examines associations among variations in genes with individual responses to a drug or medication.  In application, pharmacogenomic results (i.e., information on the patients genetic variations) can contribute to predicting a patients response to a given drug: good, bad, or none at all.  Pharmacogenomic testing of CYP2C9  or VKORC1  alleles to predict a patients response to warfarin occurs ideally prior to initiation of the drug.  This would be an once -in-a-lifetime test, absent any reason to believe that the patients personal genetic characteristics would change over time.  Although such pharmacogenomi c testing would be used to attempt to better approximate the best starting dose of warfarin, it would not eliminate the need for periodic PT/INR testing, a standard diagnostic test for coagulation activity and for assessing how a patient is reacting to a w arfarin dose.   Nationally Covered Indications   Effective August 3, 2009, the Centers for Medicare & Medicaid Services (CMS) believes that the available evidence supports that coverage with evidence development (CED) under 1862(a)(1)(E) of the Social Security Act (the Act) is appropriate for pharmacoge nomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness by any method, and is therefore covered only when provided to Medicare beneficiaries who are candidates for anticoagulation therapy with warfarin who:   1. Have not been previously tested for CYP2C9 or VKORC1 alleles; and   2. Have received fewer than five days of warfarin in the anticoagulation regimen for which the testing is ordered; and   3. Are enrolled in a prospective, randomized, controlled clinical study when that study meets the following standards.   A clinical study seeking Medicare payment for pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness provided to the Medicare beneficiary who is a candidate for anticoagulation therapy with warfarin pursuant to CED must addr ess one or more aspects of the following question:   Prospectively, in Medicare-aged subjects whose warfarin therapy management includes pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin response, what is the frequency and severity of the following outcomes, compared to subjects whose warfarin therapy management does not include pharmacogenomic testing?   Major hemorrhage  Minor hemorrhage  Thromboembolism related to the primary indication for anticoagulation  Other thromboembolic event  Mortality   The study must adhere to the following standards of scientific integrity and relevance to the Medicare population:  a. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants health outcomes.  b. The research study is well -supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.  c. The research study does not unjustifiably duplicate existing studies.  d. The research study design is appropriate to answer the research question being asked in the study.