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Local Coverage Determinations, LCD, Local policies, Implantable Continuous Glucose Monitors (I-CGM), DL38662

Use this page to view details for the Local Coverage Determination for Implantable Continuous Glucose Monitors (I-CGM).

PROPOSED

Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38662)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38787&ver=7

lcd-38787-7-1.txt

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38787

lcd

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3fdf4f93-0fc4-438b-881e-787283128588

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Implantable Continuous Glucose Monitors (I-CGM). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Implantable Continuous Glucose Monitors (I-CGM) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Coverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.Covered IndicationsI-CGMs are class III medical devices that require premarket approval by the FDA. In order to be considered reasonable and necessary, the FDA approved indication must include use as a therapeutic CGM.1The FDA recently approved expanding the indications of an implantable CGM product to replace fingerstick blood glucose measurements for diabetes treatment decisions.Therapeutic I-CGMs are considered reasonable and necessary by Medicare when all of the following coverage criteria (1-4) are met:The beneficiary has diabetes mellitus (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); and,The beneficiarys treating practitioner has concluded that the beneficiary (or beneficiarys caregiver) has sufficient training using the I-CGM prescribed as evidenced by providing a prescription; and,The I-CGM is prescribed in accordance with its FDA indications for use; and,The beneficiary for whom a CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:The beneficiary is insulin-treated; or,The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following:Recurrent (more than one) level 2 hypoglycemic events (glucose <54mg/dL (3.0mmol/L)) that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or,A history of one level 3 hypoglycemic event (glucose <54mg/dL (3.0mmol/L)) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia.CGM Continued CoverageEvery six (6) months following the initial prescription of the CGM, the treating practitioner conducts an in-person or Medicare-approved telehealth visit with the beneficiary to document adherence to their CGM regimen and diabetes treatment plan.LimitationsI-CGM devices will not be considered reasonable and necessary for short-term (72 hours to 1 week) diagnostic use.Exception:For those beneficiaries who have previously met the coverage criteria for a non-implantable therapeutic continuous glucose monitor through the Medicare DME benefit and subsequently choose to switch to the implantable device, they may do so with a provider order. However, all other coverage criteria above must be fulfilled in order for Medicare payment.General InformationAssociated InformationPlease refer to the related Billing and Coding Article: Implantable Continuous Glucose Monitors (I-CGM) (DA58127) for documentation and utilization requirements as applicable.Sources of InformationN/ABibliography

Local Coverage Determinations, LCD, Local policies, Implantable Continuous Glucose Monitors (I-CGM), DL38662

Use this page to view details for the Local Coverage Determination for Implantable Continuous Glucose Monitors (I-CGM).

PROPOSED

Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38662)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38787&ver=7

lcd-38787-7-1.txt

1

38787

lcd

7

ae521d60-63ce-4b1b-88b1-9779ad95d4b9

General InformationAssociated InformationPlease refer to the related Billing and Coding Article: Implantable Continuous Glucose Monitors (I-CGM) (DA58127) for documentation and utilization requirements as applicable.Sources of InformationN/ABibliographyDepartment of Health and Human Services. Centers for Medicare & Medicaid Services. CMS Rulings. CMS-1682-R. Accessed August 16, 2023,https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/CMS-Rulings-Items/CMS1682RSapra A, Bhandari P. Diabetes. StatPearls Publishing. Accessed August 9, 2023,https://www.ncbi.nlm.nih.gov/books/NBK551501/Centers for Disease Control and Prevention (CDC). What is Diabetes? Accessed August 10, 2023,https://www.cdc.gov/diabetes/basics/diabetes.htmlCenters for Disease Control and Prevention (CDC). Prevalence of Both Diagnosed and Undiagnosed Diabetes. Accessed August 10, 2023,https://www.cdc.gov/diabetes/data/statistics-report/diagnosed-undiagnosed-diabetes.htmlAmerican Diabetes Association (ADA). Economic Costs of Diabetes in the U.S. in 2017.Diabetes Care. May 2018;41(5):917-928. doi:10.2337/dci18-0007American Diabetes Association (ADA). Standards of Care in Diabetes-2023 Abridged for Primary Care Providers.Clin Diabetes. Winter 2022;41(1):4-31. doi:10.2337/cd23-as01Solano L. Seven facts you need to know about continuous glucose monitors.Jaapa. Sep 1 2022;35(9):41-45. doi:10.1097/01.JAA.0000854536.09072.5eAdolfsson P, Parkin CG, Thomas A, Krinelke LG. Selecting the Appropriate Continuous Glucose Monitoring System - a Practical Approach.Eur Endocrinol. Apr 2018;14(1):24-29. doi:10.17925/ee.2018.14.1.24Cowart K. A Review of the First Long-term Implantable Continuous Glucose Monitoring System Available in the United States.J Diabetes Sci Technol. Jan 2021;15(1):160-166. doi:10.1177/1932296819890865Heinemann L, Schoemaker M, Schmelzeisen-Redecker G, et al. Benefits and Limitations of MARD as a Performance Parameter for Continuous Glucose Monitoring in the Interstitial Space.J Diabetes Sci Technol. Jan 2020;14(1):135-150. doi:10.1177/1932296819855670Freckmann G. Basics and use of continuous glucose monitoring (CGM) in diabetes therapy. 2020;44(2):71-79. Journal of Laboratory Medicine. doi:doi:10.1515/labmed-2019-0189Barnard KD, Kropff J, Choudhary P, et al. Acceptability of Implantable Continuous Glucose Monitoring Sensor.J Diabetes Sci Technol. May 2018;12(3):634-638. doi:10.1177/1932296817735123Boscari F, Vettoretti M, Amato AML, et al. Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor.Nutr Metab Cardiovasc Dis. Feb 8 2021;31(2):650-657. doi:10.1016/j.numecd.2020.09.006Boscari F, Vettoretti M, Cavallin F, et al. Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance.J Endocrinol Invest. Jan 2022;45(1):115-124. doi:10.1007/s40618-021-01624-2Christiansen MP, Klaff LJ, Bailey TS, Brazg R, Carlson G, Tweden KS. A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study.Diabetes Technol Ther. May 2019;21(5):231-237. doi:10.1089/dia.2019.0020Christiansen MP, Klaff LJ, Brazg R, et al. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.Diabetes Technol Ther. Mar 2018;20(3):197-206. doi:10.1089/dia.2017.0142Dehennis A, Mortellaro MA, Ioacara S. Multisite Study of an Implanted Continuous Glucose Sensor Over 90 Days in Patients With Diabetes Mellitus.J Diabetes Sci Technol. Jul 29 2015;9(5):951-6. doi:10.1177/1932296815596760Fokkert M, van Dijk PR, Edens MA, et al. Performance of the Eversense versus the Free Style Libre Flash glucose monitor during exercise and normal daily activities in subjects with type 1 diabetes mellitus.BMJ Open Diabetes Res Care. Aug 2020;8(1)doi:10.1136/bmjdrc-2020-001193Garg SK, Liljenquist D, Bode B, et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study.Diabetes Technol Ther. Feb 2022;24(2):84-92. doi:10.1089/dia.2021.0182Jafri RZ, Balliro CA, El-Khatib F, et al. A Three-Way Accuracy Comparison of the Dexcom G5, Abbott Freestyle Libre Pro, and Senseonics Eversense Continuous Glucose Monitoring Devices in a Home-Use Study of Subjects with Type 1 Diabetes.Diabetes Technol Ther. Nov 2020;22(11):846-852. doi:10.1089/dia.2019.0449Kropff J, Choudhary P, Neupane S, et al. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial.Diabetes Care. Jan 2017;40(1):63-68. doi:10.2337/dc16-1525Mortellaro M, DeHennis A. Performance characterization of an abiotic and fluorescent-based continuous glucose monitoring system in patients with type 1 diabetes.Biosens Bioelectron. Nov 15 2014;61:227-31. doi:10.1016/j.bios.2014.05.022Sanchez P, Ghosh-Dastidar S, Tweden KS, Kaufman FR. Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor.Diabetes Technol Ther. Dec 2019;21(12):677-681. doi:10.1089/dia.2019.0234Tweden KS, Deiss D, Rastogi R, Addaguduru S, Kaufman FR. Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor over Multiple Sensor Insertion and Removal Cycles.Diabetes Technol Ther. May 2020;22(5):422-427. doi:10.1089/dia.2019.0342Wang X, Ioacara S, DeHennis A. Long-Term Home Study on Nocturnal Hypoglycemic Alarms Using a New Fully Implantable Continuous Glucose Monitoring System in Type 1 Diabetes.Diabetes Technol Ther. Nov 2015;17(11):780-6. doi:10.1089/dia.2014.0375American Diabetes Association (ADA). Understanding A1C. A1c Does it All. Accessed August 16, 2023,https://diabetes.org/diabetes/a1cIrace C, Cutruzzol A, Nuzzi A, et al. Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes.Diabetes Obes Metab. Jul 2020;22(7):1056-1061. doi:10.1111/dom.13993Renard E, Riveline JP, Hanaire H, Guerci B. Reduction of clinically important low glucose excursions with a long-term implantable continuous glucose monitoring system in adults with type 1 diabetes prone to hypoglycaemia: the France Adoption Randomized Clinical Trial.Diabetes Obes Metab. May 2022;24(5):859-867. doi:10.1111/dom.14644American Diabetes Association (ADA). CGM & Time in Range. Accessed June 6, 2023,https://diabetes.org/tools-support/devices-technology/cgm-time-in-range#:~:text=What%20is%20time%20in%20range,mg%2FdL%20for%20most%20people.Deiss D, Irace C, Carlson G, Tweden KS, Kaufman FR. Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study.Diabetes Technol Ther. Jan 2020;22(1):48-52. doi:10.1089/dia.2019.0159Fonseca VA, Grunberger G, Anhalt H, et al. CONTINUOUS GLUCOSE MONITORING: A CONSENSUS CONFERENCE OF THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY.Endocr Pract. Aug 2016;22(8):1008-21. doi:10.4158/ep161392.CsNational Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management. Accessed August 16, 2023,https://www.nice.org.uk/guidance/ng28Wada E, Onoue T, Kobayashi T, et al. Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial.BMJ Open Diabetes Res Care. Jun 2020;8(1)doi:10.1136/bmjdrc-2019-001115American Diabetes Association Professional Practice Committee. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2022.Diabetes Care. Jan 1 2022;45(Suppl 1):S97-s112. doi:10.2337/dc22-S007Holt RIG, DeVries JH, Hess-Fischl A, et al. The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).Diabetes Care. 2021;44(11):2589-2625. doi:10.2337/dci21-0043Grunberger G, Sherr J, Allende M, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus.Endocr Pract. Jun 2021;27(6):505-537. doi:10.1016/j.eprac.2021.04.008Deiss D, Szadkowska A, Gordon D, et al. Clinical Practice Recommendations on the Routine Use of Eversense, the First Long-Term Implantable Continuous Glucose Monitoring System.Diabetes Technol Ther. May 2019;21(5):254-264. doi:10.1089/dia.2018.0397U.S. Food & Drug Administration (FDA). Approval Order - Eversense Continuous Glucose Monitoring System. Accessed August 16, 2023,https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160048A.pdfGehlaut RR, Dogbey GY, Schwartz FL, Marling CR, Shubrook JH. Hypoglycemia in Type 2 DiabetesMore Common Than You Think: A Continuous Glucose Monitoring Study.J Diabetes Sci Technol. Apr 27 2015;9(5):999-1005. doi:10.1177/193229681558105240. Munshi MN, Segal AR, Suhl E, et al. Frequent hypoglycemia among elderly patients with poor glycemic control.Arch Intern Med. Feb 28 2011;171(4):362-4. doi:10.1001/archinternmed.2010.539

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39116

Use this page to view details for the Local Coverage Determination for Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39116)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39115&ver=5

lcd-39115-5-1.txt

1

39115

lcd

5

dea4c7a5-102e-4b0f-9e01-e64c653c7e01

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) addresses services that are determined to be investigational or experimental.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 16, 10 General Exclusions from CoverageCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, 30A Physicians ServicesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 30, 50.3.1 Mandatory ABN UsesCoverage Indications, Limitations, and/or Medical NecessityThis is a NON-coverage policy for allamniotic membrane, amniotic fluid or other placental-derived productinjections and/or applications as a means of managing musculoskeletal injuries, joint conditions, and all other conditions not stated below.This guidance does NOT include discussion on burns, wounds or ophthalmic conditions.NOTE: For information on stem cell transplantation please see CMS National Coverage Determination 110.23 Stem Cell TransplantationIntroductionAmniotic and placental-derived products are reported to possess certain beneficial characteristics. These products have been proposed as a source of stem cells. Stem cells, by definition, have the capability to differentiate into any cell of an organism as well as the capability of self-renewal.1In addition, the extracellular matrix (ECM) of placental and amniotic-based tissues are rich in collagen, glycoproteins, proteoglycans, fibroblasts, as well as many cytokines and growth factors thought to promote healing with a lower risk of low immunologic reaction.Based on these characteristics, amniotic and placental-derived products are currently being studied and marketed as allografts to serve as:scaffolds for tissue engineeringmembrane covering for certain burns, wounds, and ophthalmic corneal injuriesmicronized/particulate products suspended in an aqueous material to be applied topically or injected into joints, tendons, ligamentsapplications or injections performed intra-operatively to promote post-operative healingThese amniotic and placental-derived products are further being investigated for a multitude of indications, including but not limited to musculoskeletal conditions involving joint pain and back pain, chronic pain in general, dental conditions, alopecia, wounds, burns, and a plethora of others. In the quest to find alternative treatments for certain musculoskeletal conditions, the emergence of a class of substances being marketed as orthobiologics has become more prevalent in the pharmaceutical market. Orthobiologics are biological products aimed at treating musculoskeletal conditions purported to heal injury/trauma, slow degenerative processes and affect regeneration of tissues.2The result ideally would be decreased pain and increased function. One such category of orthobiologics involves the incorporation of human amniotic and placental-derived products.The amniotic and placental-derived products are obtained from the placenta of donors, usually, immediately post C-section at full term and screened for transmittable diseases. These products are made up of varying combinations of amniotic membrane, amniotic fluid, chorionic membrane, umbilical cord, umbilical cord blood, and what is known as Whartons jelly.3Definitions:ThePlacentais a multi-layered circulatory temporary organ that supplies food and oxygen to the fetus during pregnancy.The multiple layers of the placenta include the:Amnion- the innermost membrane that surrounds the fetus during gestationChorion- outermost membrane that surrounds the fetus during gestationAmniotic fluidis the fluid surrounding the fetus within the amnion.Umbilical cordis the vascular conduit connecting the fetus to the placenta comprised of the umbilical vein, arteries, allantois and yolk sac embedded in Whartons jelly.Whartons Jellyis a gelatinous soft connective tissue derived from extra-embryonic mesoderm within the umbilical cord.4Theamniotic membraneitself is divided into three histologic layers:A singleepithelial layerA thickbasement membraneAnavascular stromal (mesenchymal) layer5.6,7,8The avascular stromal layer is further divided into three layers:6,7,8TheCompact layerThe middleFibroblast layerTheSpongy layerTheSpongy Layer, loosely connected to the chorionic membrane, is highly concentrated with proteoglycans and glycoproteins including hyaluronic acid, as well as type I, III, and IV collagen.5,6,8,9Themiddle Fibroblast layeris made up of type I, III, V, and VI collagen.6,8,9TheCompact layerthat sits adjacent to the basement membrane is composed of collagen Types I, III, V, and VI, along with fibronectin.5,9Thebasement membraneanchors the epithelial layer (ref 13) and contains collagen Types IV, V and VII, fibronectin, laminin, and hyaluronic acid.6,10Adjacent to the basement membrane and in immediate contact with amniotic fluid is the single layer of epithelial cells.Amniotic epithelial cellsproduce type III and IV collagen, glycoproteins such as laminin and fibronectin, which become the basement membrane.5The amniotic membranes purpose is to house and physically protect the fetus, but additional functions include regulation of the pH of the amniotic fluid, transportation of water and soluble material between the mother and fetus, and the synthesis of numerous growth factors and cytokines. The amniotic membrane also secretes anti-inflammatory proteins. All of this results in these tissues having anti-inflammatory, anti-microbial, anti-fibroblastic, and non-immunogenic properties.Amniotic products have been asserted to be a source of stem cells. Both the amniotic epithelial layer (maternal derived cells) and mesenchymal (avascular stromal) layer derived from the embryonic mesoderm contain their respective stem cells that can differentiate into multiple cell lines, including myocytes, osteocytes, and chondrocytes.8,9Amniotic fluid also is found to contain amniotic mesenchymal stem cells.7The chorionic membrane adjacent to the mothers endometrium during development of the fetus. Umbilical cord, Whartons jelly, and umbilical cord blood have also been found to contain mesenchymal stem cells.7,11Under normal conditions, placental tissues are collected via aseptic technique during cesarean section. Protocols vary as to how the tissues are harvested, prepared, preserved and stored. Testing is also required to ensure these tissues do not carry any communicable diseases transmissible from donor to recipient.Because the spongy layer loosely connects the amniotic membrane to the chorionic membrane, these two layers are easily separated upon blunt dissection at initial harvesting.10Other than ease of separation between amniotic and chorionic membranes, the following steps in processing the tissues into the desired form vary, based on the portions of the placental tissues extracted, sterilization processes (if any) undertaken, and method of preservation utilized. Common methods of preservation include cryopreservation, lyophilization (freeze-drying), glycerol-preservation, (gamma)-sterilization, low heat dehydration, and vitrification.5,8,9,10A process called Decellularization may be used in which the layer of amniotic epithelial cells is removed from the collected amniotic membrane, leaving behind the valuable extracellular matrix components. Removal of all cellular components is thought to lessen the possibility of eliciting an immune response.3,10Different decellularization processes are available. Eventual preparation of sheets, particulate suspensions, liquids, or gels allows the final marketed product.Depending on the methods utilized, the processing of placental and amniotic-based tissues will affect the viability of cellular components, growth factors, and other valuable properties for which these tissues are promoted. To date, there are significant differences that exist in the processing of different placental and amniotic-based tissue products.3,5Lack of consistency and standardization within propriety manufacturing (preparation) processes precludes determination and comparison of the final product form, characteristics, properties, and components.The Food and Drug Administration (FDA), under Sect. 361 of the Public Health Service Act (regulated by the Centers for Biologics Evaluation and Research CBER, an arm of the FDA) oversees the therapeutic use of "Human cells or tissue products" or HCT/Ps. Once these types products are harvested, their process and handling will determine whether the products fall under Section 361 guidance or default to the more regulated section 351 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act. The regulatory pathway for pre-market FDA approval of new drugs, devices and/or biological products, requires registration as a (NDA) New Drug application, an (IND) Investigational New Drug application, or a (BLA) Biologics License Approval.8,9,12,13If a human cells or tissue product should meet Section 361 FDA requirements, the product will not require FDA pre-market review and approval. To meet Section 361 FDA regulatory requirements, the placental/amniotic-based tissue product must meet the following 4 criteria: The HCT/P is:Minimally ManipulatedIntended for Homologous Use (as reflected by the labeling, advertising, or other indications of the manufacturers objective intent)The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/PEither:The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; orThe HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:Is for autologous use;Is for allogeneic use in a first-degree or second-degree blood relative; orIs for reproductive use12Due to the ongoing development of new products and clinical trials, the field of FDA regulatory requirements is fluid and evolving. It is the expectation that the respective Medicare Administrative Contractor will continue to follow any guidance and insight as it is brought forward by the FDA.Lack of standard formulation, dose, frequency of administration, and standard of care in treatment with these products further complicates regulation and guidance determinations.Despite this lack of standardization, numerous amniotic and placental-derived products have been released for use in treatment of musculoskeletal conditions. These conditions include, but are not limited to tendon/ligament injuries, musculoskeletal injuries, cartilage damage, osteoarthritis, (or pain related of these conditions) as well as an adjunctive to orthopedic surgical treatments. Due to the lack of component standardization, the remainder of this LCD will use the term amniotic and placental-derived products to mean ANY product derived from ANY combination of amniotic membrane/chorion/placenta/Whartons jelly/umbilical cord/amniotic fluid/umbilical cord blood.Although amniotic and placental-derived products are marketed to treat certain musculoskeletal conditions, there is limited support for safety and efficacy from human clinical trials available.All injectable amniotic and/or placental-derived products fall under FDA section 551 of the Federal Food, Drug, and Cosmetic Act. Promotion relating to novel indication or evidence of new intended use may constitute labeling, adulteration, or misbranding of the drug or device if such dissemination fails to comply with section 551 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A manufacturers failure to exercise due diligence in submitting the clinical studies necessary for the approval of a new use as subject of information disseminated under this part or in beginning or completing such clinical studies shall be deemed a failure to comply with section 551 of the act and the requirement of this part. Use of any amniotic and/or placental-derived products that have not met the requirements of section 551 of the Federal Food, Drug, and Cosmetic Act will be denied per Medicare Benefit Policy Manual 100-2 Chapter 15 Section 50.4.1 and associated services will also be denied per Medicare Benefit Policy Manual 100-2 Chapter 16 Section 180.General InformationAssociated InformationN/ASources of InformationN/ABibliographyZakrzewski W, Dobrzynski M, Szymonowicz M, and Rybak Z. Stem Cells: Past, Present, and Future. Stem Cell Research & Therapy 2019 10:68.doi:10.1186/s13287-019-1165-5Dhillon MS, Behera P, Patel S, and Shetty V. Orthobiologics and Platelet Rich Plasma. Indian J of Orthop. 2014 Jan-Feb; 48(1):1-9.doi:10.4103/0019-5413.125477

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39116

Use this page to view details for the Local Coverage Determination for Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39116)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39115&ver=5

lcd-39115-5-1.txt

1

39115

lcd

5

0b07354d-16f0-4e33-b5b4-75016e643c0e

General InformationAssociated InformationN/ASources of InformationN/ABibliographyZakrzewski W, Dobrzynski M, Szymonowicz M, and Rybak Z. Stem Cells: Past, Present, and Future. Stem Cell Research & Therapy 2019 10:68.doi:10.1186/s13287-019-1165-5Dhillon MS, Behera P, Patel S, and Shetty V. Orthobiologics and Platelet Rich Plasma. Indian J of Orthop. 2014 Jan-Feb; 48(1):1-9.doi:10.4103/0019-5413.125477Sultan AA, Piuzzi NS, Mont MA. Nonoperative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of Literature. Clin J Sport Med. Jul 2020;30(4):383-389. doi:10.1097/jsm.0000000000000684Gabbe SG, Niebyl JR, Simpson JL, et al. Obstetricsnormal and problem pregnancies. 5th ed. Philadelphia: Churchill Livingstone; 2007.Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the Amniotic Membrane for Potential use in Tissue Engineering. European Cells and Materials. Vol. 15 2008. Pg 88-99.doi:10.22203/ecm.v015a07Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. PMID: 32076938McIntyre JA, Jones IA, Danilkovich A, Vangsness CT Jr.McIntyre JA, et al. The Placenta: Applications in Orthopaedic Sports Medicine. Am J Sports Med. 2018 Jan;46(1):234-247.

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39116

Use this page to view details for the Local Coverage Determination for Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39116)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39115&ver=5

lcd-39115-5-1.txt

1

39115

lcd

5

7f3290b1-2f7f-4501-b1ba-acc370b82268

Gabbe SG, Niebyl JR, Simpson JL, et al. Obstetricsnormal and problem pregnancies. 5th ed. Philadelphia: Churchill Livingstone; 2007.Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the Amniotic Membrane for Potential use in Tissue Engineering. European Cells and Materials. Vol. 15 2008. Pg 88-99.doi:10.22203/ecm.v015a07Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. PMID: 32076938McIntyre JA, Jones IA, Danilkovich A, Vangsness CT Jr.McIntyre JA, et al. The Placenta: Applications in Orthopaedic Sports Medicine. Am J Sports Med. 2018 Jan;46(1):234-247.Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34.Hannon CP, Yanke AB, Farr J. Amniotic Tissue Modulation of Knee Pain-A Focus on Osteoarthritis. J Knee Surg. 2019 Jan;32(1):26-36. doi:10.1055/s-0038-1676370Leal-Marin S, Kern T, Hofmann N, Pogozhykh O, Framme C, Brgel M, Figueiredo C, Glasmacher B, Gryshkov O. Human Amniotic Membrane: A review on tissue engineering, application, and storage. J Biomed Mater Res. 2021;118. doi.org/10.1002/jbm.b.34782Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. Nov 2019;32(11):1143-1154. doi:10.1055/s-0039-1696672FDA Guidance for Industry and Food and Drug Administration Staff. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. 2020 July.Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. 2007 Aug.Gellhorn A.C., Han A. The use of dehydrated human amnion/chorion membrane allograft injection for the treatment of tendinopathy or arthritis: a case series involving 40 patients.PM&R. 2017;9(12):1236-1243. doi:10.1016/j.pmrj.2017.04.011Buck D. Amniotic umbilical cord particulate for discogenic pain.Am. Osteopath. Assoc.2019;119(12):814-819. doi:10.7556/jaoa.2019.138Ross A, Gambrill V, Main C. Clinical outcomes of amniotic membrane/umbilical cord particulate in spinal disorders: a retrospective study.J Pain Res. 2022;15:3971-3979. doi:10.2147/JPR.S375201, 10.2147/JPR.S375201Ackley JF, Kolosky M, Gurin D, Hampton R, Masin R, Krahe D. Cryopreserved amniotic membrane and umbilical cord particulate matrix for partial rotator cuff tears: A case series. Medicine (Baltimore). Jul 2019;98(30):e16569. doi:10.1097/md.0000000000016569Aufiero, D, Sampson, S, Onishi, K, and Bemden, V. Treatment of medial and lateral elbow tendinosis with an injectable amniotic membrane allografta retrospective case series.J Pain Relief. 2016;5(3):242.Quinet MT, Raghavan M, Morris E, et al. Effectiveness of amniotic fluid injection in the treatment of trigger finger: a pilot study.Journal of Hand Surgery Global Online. 2020;2(5):301-305.Cazzell S., Stewart J., Agnew P.S., et al Randomized controlled trial of micronized dehydrated human amnion/chorion membrane (dHACM) injection compared to placebo for the treatment of plantar fasciitis.Foot Ankle Int. 2018;39(10):1151-1161. doi:10.1177/1071100718788549Zelen C.M., Poka A., Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis - A feasibility study.Foot Ankle Int. 2013;34(10):1332-1339. doi:10.1177/1071100713502179Hanselman A.E., Tidwell J.E., Santrock R.D. Cryopreserved human amniotic membrane injection for plantar fasciitis: A randomized, controlled, double-blind pilot study.Foot Ankle Int. 2015;36(2):151-158. doi:10.1177/1071100714552824Matthews M, Betrus CJ, Klein EE, et al. Comparison of Regenerative Injection Therapy and Conventional Therapy for Proximal Plantar Fasciitis.J Foot Ankle Surg. 2022;doi:10.1053/j.jfas.2022.11.010, 10.1053/j.jfas.2022.11.010Nakagawa H, Sung K, Ashkani-Esfahani S, et al. Plantar fasciitis: a comparison of ultrasound-guided fasciotomy with or without amniotic membrane allograft injection.Med. 2022;17(12):931-940. doi:10.2217/rme-2022-0094Werber B: Amniotic tissues for the treatment of chronic plantar fasciosis and Achilles tendinosis.J Sports Med(Hindawi Publ Corp) 2015;2015:219896Lullove E. A flowable placental tissue matrix allograft in lower extremity injuries: a pilot study. 2015;7:e275.Spector JE, Hubbs B, Kot K, et al. Micronized dehydrated human amnion/chorion membrane injection in the treatment of chronic Achilles tendinitis.J Am Podiatr Med Assoc. 2021;111(6)doi:10.7547/19-170, 10.7547/19-170Gomoll A.H., Farr J., Cole B.J., et al. Safety and efficacy of an amniotic suspension allograft injection over 12 months in a single-blinded, randomized controlled trial for symptomatic osteoarthritis of the knee.J. Arthrosc. Relat. Surg.2021;37:22462257. doi: 10.1016/j.arthro.2021.02.044.elik D, oban , Kilioglu . Minimal clinically important difference of commonly used hip-, knee-, foot-, and ankle-specific questionnaires: a systematic review.J Clin Epidemiol. 2019;113:44-57. doi:10.1016/j.jclinepi.2019.04.017McCarthy M Jr, Chang CH, Pickard AS, et al. Visual analog scales for assessing surgical pain.J Am Coll Surg. 2005;201(2):245-252. doi:10.1016/j.jamcollsurg.2005.03.034Landorf KB, Radford JA, Hudson S. Minimal important difference (MID) of two commonly used outcome measures for foot problems.J Foot Ankle Res2010;3(1):7.Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale.Ann Emerg Med2001;38(6):633-638.Alden KJ, Harris S, Hubbs B, et al. Micronized dehydrated human amnion chorion membrane injection in the treatment of knee osteoarthritis a large retrospective case series.J Knee Surg. 2021;34(8):841-845. doi:10.1055/s-0039-3400951, 10.1055/s-0039-3400951Castellanos R, Tighe S. Injectable amniotic membrane/umbilical cord particulate for knee osteoarthritis: a prospective, single-center pilot study.Pain Med. 2019;20(11):2283-2291. doi:10.1093/pm/pnz143Mead OG, Mead LP. Intra-articular injection of amniotic membrane and umbilical cord particulate for the management of moderate to severe knee osteoarthritis.Res. Rev.2020;12:161170. doi: 10.2147/ORR.S272980.Natali S, Farinelli L, Screpis D, et al. Human amniotic suspension allograft improves pain and function in knee osteoarthritis: a prospective not randomized clinical pilot study.Clin. Med. 2022;11(12)doi:10.3390/jcm11123295,10.3390/jcm11123295Meadows MC, Elisman K, Nho SJ, et al. A single injection of amniotic suspension allograft is safe and effective for treatment of mild to moderate hip osteoarthritis: a prospective study. 2022;38:325331. doi: 10.1016/j.arthro.2021.04.034.Guimaraes JDS, Arcanjo FL, Leporace G, et al Effects of therapeutic interventions on pain due to plantar fasciitis: A systematic review and meta-analysis.Rehabil. 2022;no pagination. doi:10.1177/02692155221143865Zaffagnini M, Boffa A, Andriolo L, et al. Orthobiologic injections for the treatment of hip osteoarthritis: a systematic review.J Clin Med. 2022;11(22):6663. Published 2022 Nov 10. doi:10.3390/jcm11226663Aratikatla A, Maffulli N, Rodriguez HC, et al. Allogenic perinatal tissue for musculoskeletal regenerative medicine applications: a systematic review protocol. J. Orthop. Surg.2022;17(1):307. doi:10.1186/s13018-022-03197-z,10.1186/s13018-022-03197-zSultan AA, Samuel LT, Roth A, et al. Operative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of the Literature.Surg Technol Int.2019;34:397-402.McIntyre JA, Jones IA, Danilkovich A, Vangsness CT. The placenta: applications in orthopaedic sports medicine.J. Sports Med. 2018;46(1):234-247. doi:10.1177/0363546517697682Tsikopoulos K, Vasiliadis HS, Mavridis D. Injection therapies for plantar fasciopathy ('plantar fasciitis'): A systematic review and network meta-analysis of 22 randomised controlled trials.J. Sports Med. 2016;50(22):1367-1375. doi:10.1136/bjsports-2015-095437Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials.BMJ. 2019;366:l4898. Published 2019 Aug 28. doi:10.1136/bmj.l4898Schnemann H, Brozek J, Guyatt G, Oxman A, editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013.The GRADE Working Group, 2013. Available fromguidelinedevelopment.org/handbook.

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39118

Use this page to view details for the Local Coverage Determination for Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39117&ver=4

lcd-39117-4-1.txt

1

39117

lcd

4

8574a7d6-0452-4199-9bd2-16660aa4fe77

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) addresses services that are determined to be investigational or experimental.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 16, 10 General Exclusions from CoverageCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, 30A Physicians ServicesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 30, 50.3.1 Mandatory ABN UsesCoverage Indications, Limitations, and/or Medical NecessityThis is a NON-coverage policy for allamniotic membrane, amniotic fluid or other placental-derived productinjections and/or applications as a means of managing musculoskeletal injuries, joint conditions, and all other conditions not stated below.This guidance does NOT include discussion on burns, wounds or ophthalmic conditions.NOTE: For information on stem cell transplantation please see CMS National Coverage Determination 110.23 Stem Cell TransplantationIntroductionAmniotic and placental-derived products are reported to possess certain beneficial characteristics. These products have been proposed as a source of stem cells. Stem cells, by definition, have the capability to differentiate into any cell of an organism as well as the capability of self-renewal.1In addition, the extracellular matrix (ECM) of placental and amniotic-based tissues are rich in collagen, glycoproteins, proteoglycans, fibroblasts, as well as many cytokines and growth factors thought to promote healing with a lower risk of low immunologic reaction.Based on these characteristics, amniotic and placental-derived products are currently being studied and marketed as allografts that serve as:scaffolds for tissue engineeringmembrane covering certain burns, wounds, and ophthalmic corneal injuriesmicronized/particulate products suspended in an aqueous material to be applied topically or injected into joints, tendons, ligamentsapplications or injections performed intra-operatively to promote post-operative healingThese amniotic and placental-derived products are further being investigated for a multitude of indications, including but not limited to musculoskeletal conditions involving joint pain and back pain, chronic pain in general, dental conditions, alopecia, wounds, burns, and a plethora of others. In the quest to find alternative treatments for certain musculoskeletal conditions, the emergence of a class of substances being marketed as orthobiologics has become more prevalent in the pharmaceutical market. Orthobiologics are biological products aimed at treating musculoskeletal conditions purported to heal injury/trauma, slow degenerative processes and affect regeneration of tissues.2The end result ideally would be decreased pain and increased function. One such category of orthobiologics involves incorporation of human amniotic and placental-derived products.The amniotic and placental-derived products are obtained from the placenta of donors, usually immediately post C-section at full term and screened for transmittable diseases. These products are made up of varying combinations of amniotic membrane, amniotic fluid, chorionic membrane, umbilical cord, umbilical cord blood, and what is known as Whartons jelly.3Definitions:ThePlacentais a multi-layered circulatory temporary organ that supplies food and oxygen to the fetus during pregnancy.The multiple layers of the placenta include the:Amnion- the innermost membrane that surrounds the fetus during gestationChorion- outermost membrane that surrounds the fetus during gestationAmniotic fluidis the fluid surrounding the fetus within the amnion.Umbilical cordis the vascular conduit connecting the fetus to the placenta comprised of the umbilical vein, arteries, allantois and yolk sac embedded in Whartons jelly.Whartons Jellyis a gelatinous soft connective tissue derived from extra-embryonic mesoderm within the umbilical cord.4Theamniotic membraneitself is divided into 3 histologic layers:A singleepithelial layerA thickbasement membraneAnavascular stromal (mesenchymal) layer5.6,7,8The avascular stromal layer is further divided into 3 layers:6,7,8TheCompact layerThe middleFibroblast layerTheSpongy layerTheSpongy Layer, loosely connected to the chorionic membrane, is highly concentrated with proteoglycans and glycoproteins including hyaluronic acid, as well as type I, III, and IV collagen.5,6,8,9Themiddle Fibroblast layeris made up of type I, III, V, and VI collagen.6,8,9TheCompact layerthat sits adjacent to the basement membrane is composed of collagen Types I, III, V, and VI, along with fibronectin.5,9Thebasement membraneanchors the epithelial layer (ref 13) and contains collagen Types IV, V and VII, fibronectin, laminin, and hyaluronic acid.6,10Adjacent to the basement membrane and in immediate contact with amniotic fluid is the single layer of epithelial cells.Amniotic epithelial cellsproduce type III and IV collagen, glycoproteins such as laminin and fibronectin, which become the basement membrane.5The amniotic membranes purpose is to house and physically protect the fetus, but additional functions include regulation of the pH of the amniotic fluid, transportation of water and soluble material between the mother and fetus, and the synthesis of numerous growth factors and cytokines. The amniotic membrane also secretes anti-inflammatory proteins. All of this results in these tissues having anti-inflammatory, anti-microbial, anti-fibroblastic, and non-immunogenic properties.Amniotic products have been asserted to be a source of stem cells. Both the amniotic epithelial layer (maternal derived cells) and mesenchymal (avascular stromal) layer derived from the embryonic mesoderm contain their respective stem cells that can differentiate into multiple cell lines including myocytes, osteocytes, and chondrocytes.8,9Amniotic fluid also is found to contain amniotic mesenchymal stem cells.7The chorionic membrane connected adjacent to the mothers endometrium during development of the fetus. Umbilical cord, Whartons jelly, and umbilical cord blood have also been found to contain mesenchymal stem cells.7,11Under normal conditions, placental tissues are collected via aseptic technique during cesarean section. Protocols vary as to how the tissues are harvested, prepared, preserved and stored. Testing is also required to ensure these tissues do not carry any communicable diseases transmissible from donor to recipient.Because the spongy layer loosely connects the amniotic membrane to the chorionic membrane, these two layers are easily separated upon blunt dissection at initial harvesting.10Other than ease of separation between amniotic and chorionic membranes, the following steps in processing the tissues into the desired form vary, based on the portions of the placental tissues extracted, sterilization processes (if any) undertaken, and method of preservation utilized. Common methods of preservation include cryopreservation, lyophilization (freeze-drying), glycerol-preservation, (gamma)-sterilization, low heat dehydration, and vitrification.5,8,9,10A process called Decellularization may be used in which the layer of amniotic epithelial cells is removed from the collected amniotic membrane, leaving behind the valuable extracellular matrix components. Removal of all cellular components is thought to lessen the possibility of eliciting an immune response.3,10Different decellularization processes are available. Eventual preparation of sheets, particulate suspensions, liquids, or gels allows the final marketed product.Depending on the methods utilized, the processing of placental and amniotic-based tissues will affect the viability of cellular components, growth factors, and other valuable properties for which these tissues are promoted. To date, there are significant differences that exist in the processing of different placental and amniotic-based tissue products.3,5Lack of consistency and standardization within propriety manufacturing (preparation) processes precludes determination and comparison of the final product form, characteristics, properties, and components.The Food and Drug Administration (FDA), under Sect. 361 of the Public Health Service Act (regulated by the Centers for Biologics Evaluation and Research CBER, an arm of the FDA) oversees the therapeutic use of Human cells or tissue products or HCT/Ps. Once these types of products are harvested, their process and handling will determine whether the products fall under Section 361 guidance or default to the more regulated section 351 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act. The regulatory pathway for pre-market FDA approval of new drugs, devices and/or biological products, requires registration as a (NDA) New Drug application, an (IND) Investigational New Drug application, or a (BLA) Biologics License Approval.8,9,12,13If a human cells or tissue product should meet Section 361 FDA requirements, the product will not require FDA pre-market review and approval. To meet Section 361 FDA regulatory requirements, the placental/amniotic-based tissue product must meet the following 4 criteria: The HCT/P is:Minimally ManipulatedIntended for Homologous Use (as reflected by the labeling, advertising, or other indications of the manufacturers objective intent)The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/PEither:The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; orThe HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:Is for autologous use;Is for allogeneic use in a first-degree or second-degree blood relative; orIs for reproductive use12Due to the ongoing development of new products and clinical trials, the field of FDA regulatory requirements is fluid and evolving. It is the expectation that the respective Medicare Administrative Contractor will continue to follow any guidance and insight as it is brought forward by the FDA.Lack of standard formulation, dose, frequency of administration, and standard of care in treatment with these products further complicates regulation and guidance determinations.Despite this lack of standardization, numerous amniotic and placental-derived products have been released for use in treatment of musculoskeletal conditions. These conditions include, but are not limited to tendon/ligament injuries, musculoskeletal injuries, cartilage damage, osteoarthritis, (or pain related of these conditions) as well as an adjunctive to orthopedic surgical treatments. Due to the lack of component standardization, the remainder of this LCD will use the term amniotic and placental-derived products to mean ANY product derived from ANY combination of amniotic membrane/chorion/placenta/Whartons jelly/umbilical cord/amniotic fluid/umbilical cord blood.Although amniotic and placental-derived products are marketed to treat certain musculoskeletal conditions, there is limited support for safety and efficacy from human clinical trials available.All injectable amniotic and/or placental-derived products fall under FDA section 551 of the Federal Food, Drug, and Cosmetic Act. Promotion relating to novel indication or evidence of new intended use may constitute labeling, adulteration, or misbranding of the drug or device if such dissemination fails to comply with section 551 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A manufacturers failure to exercise due diligence in submitting the clinical studies necessary for the approval of a new use as subject of information disseminated under this part or in beginning or completing such clinical studies shall be deemed a failure to comply with section 551 of the act and the requirement of this part. Use of any amniotic and/or placental-derived products that have not met the requirements of section 551 of the Federal Food, Drug, and Cosmetic Act will be denied per Medicare Benefit Policy Manual 100-2 Chapter 15 Section 50.4.1 and associated services will also be denied per Medicare Benefit Policy Manual 100-2 Chapter 16 Section 180.General InformationAssociated InformationN/ASources of InformationN/ABibliographyZakrzewski W, Dobrzynski M, Szymonowicz M, and Rybak Z. Stem Cells: Past, Present, and Future. Stem Cell Research & Therapy 2019 10:68.doi:10.1186/s13287-019-1165-5Dhillon MS, Behera P, Patel S, and Shetty V. Orthobiologics and Platelet Rich Plasma. Indian J of Orthop. 2014 Jan-Feb; 48(1):1-9.doi:10.4103/0019-5413.125477

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39118

Use this page to view details for the Local Coverage Determination for Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39117&ver=4

lcd-39117-4-1.txt

1

39117

lcd

4

5f9a3773-2622-4f16-9a8e-410520b009c3

General InformationAssociated InformationN/ASources of InformationN/ABibliographyZakrzewski W, Dobrzynski M, Szymonowicz M, and Rybak Z. Stem Cells: Past, Present, and Future. Stem Cell Research & Therapy 2019 10:68.doi:10.1186/s13287-019-1165-5Dhillon MS, Behera P, Patel S, and Shetty V. Orthobiologics and Platelet Rich Plasma. Indian J of Orthop. 2014 Jan-Feb; 48(1):1-9.doi:10.4103/0019-5413.125477Sultan AA, Piuzzi NS, Mont MA. Nonoperative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of Literature. Clin J Sport Med. Jul 2020;30(4):383-389. doi:10.1097/jsm.0000000000000684Gabbe SG, Niebyl JR, Simpson JL, et al. Obstetricsnormal and problem pregnancies. 5th ed. Philadelphia: Churchill Livingstone; 2007.Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the Amniotic Membrane for Potential use in Tissue Engineering. European Cells and Materials. Vol. 15 2008. Pg 88-99.doi:10.22203/ecm.v015a07Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. PMID: 32076938McIntyre JA, Jones IA, Danilkovich A, Vangsness CT Jr.McIntyre JA, et al. The Placenta: Applications in Orthopaedic Sports Medicine. Am J Sports Med. 2018 Jan;46(1):234-247.

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39118

Use this page to view details for the Local Coverage Determination for Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39117&ver=4

lcd-39117-4-1.txt

1

39117

lcd

4

5707518f-7a48-46aa-91aa-624425e8971f

Gabbe SG, Niebyl JR, Simpson JL, et al. Obstetricsnormal and problem pregnancies. 5th ed. Philadelphia: Churchill Livingstone; 2007.Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the Amniotic Membrane for Potential use in Tissue Engineering. European Cells and Materials. Vol. 15 2008. Pg 88-99.doi:10.22203/ecm.v015a07Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. PMID: 32076938McIntyre JA, Jones IA, Danilkovich A, Vangsness CT Jr.McIntyre JA, et al. The Placenta: Applications in Orthopaedic Sports Medicine. Am J Sports Med. 2018 Jan;46(1):234-247.Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34.Hannon CP, Yanke AB, Farr J. Amniotic Tissue Modulation of Knee Pain-A Focus on Osteoarthritis. J Knee Surg. 2019 Jan;32(1):26-36. doi:10.1055/s-0038-1676370Leal-Marin S, Kern T, Hofmann N, Pogozhykh O, Framme C, Brgel M, Figueiredo C, Glasmacher B, Gryshkov O. Human Amniotic Membrane: A review on tissue engineering, application, and storage. J Biomed Mater Res. 2021;118. doi.org/10.1002/jbm.b.34782Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. Nov 2019;32(11):1143-1154. doi:10.1055/s-0039-1696672FDA Guidance for Industry and Food and Drug Administration Staff. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. 2020 July.Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. 2007 Aug.Gellhorn A.C., Han A. The use of dehydrated human amnion/chorion membrane allograft injection for the treatment of tendinopathy or arthritis: a case series involving 40 patients.PM&R. 2017;9(12):1236-1243. doi:10.1016/j.pmrj.2017.04.011Buck D. Amniotic umbilical cord particulate for discogenic pain.Am. Osteopath. Assoc.2019;119(12):814-819. doi:10.7556/jaoa.2019.138Ross A, Gambrill V, Main C. Clinical outcomes of amniotic membrane/umbilical cord particulate in spinal disorders: a retrospective study.J Pain Res. 2022;15:3971-3979. doi:10.2147/JPR.S375201, 10.2147/JPR.S375201Ackley JF, Kolosky M, Gurin D, Hampton R, Masin R, Krahe D. Cryopreserved amniotic membrane and umbilical cord particulate matrix for partial rotator cuff tears: A case series. Medicine (Baltimore). Jul 2019;98(30):e16569. doi:10.1097/md.0000000000016569Aufiero, D, Sampson, S, Onishi, K, and Bemden, V. Treatment of medial and lateral elbow tendinosis with an injectable amniotic membrane allografta retrospective case series.J Pain Relief. 2016;5(3):242.Quinet MT, Raghavan M, Morris E, et al. Effectiveness of amniotic fluid injection in the treatment of trigger finger: a pilot study.Journal of Hand Surgery Global Online. 2020;2(5):301-305.Cazzell S., Stewart J., Agnew P.S., et al Randomized controlled trial of micronized dehydrated human amnion/chorion membrane (dHACM) injection compared to placebo for the treatment of plantar fasciitis.Foot Ankle Int. 2018;39(10):1151-1161. doi:10.1177/1071100718788549Zelen C.M., Poka A., Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis - A feasibility study.Foot Ankle Int. 2013;34(10):1332-1339. doi:10.1177/1071100713502179Hanselman A.E., Tidwell J.E., Santrock R.D. Cryopreserved human amniotic membrane injection for plantar fasciitis: A randomized, controlled, double-blind pilot study.Foot Ankle Int. 2015;36(2):151-158. doi:10.1177/1071100714552824Matthews M, Betrus CJ, Klein EE, et al. Comparison of Regenerative Injection Therapy and Conventional Therapy for Proximal Plantar Fasciitis.J Foot Ankle Surg. 2022;doi:10.1053/j.jfas.2022.11.010, 10.1053/j.jfas.2022.11.010Nakagawa H, Sung K, Ashkani-Esfahani S, et al. Plantar fasciitis: a comparison of ultrasound-guided fasciotomy with or without amniotic membrane allograft injection.Med. 2022;17(12):931-940. doi:10.2217/rme-2022-0094Werber B: Amniotic tissues for the treatment of chronic plantar fasciosis and Achilles tendinosis.J Sports Med(Hindawi Publ Corp) 2015;2015:219896Lullove E. A flowable placental tissue matrix allograft in lower extremity injuries: a pilot study. 2015;7:e275.Spector JE, Hubbs B, Kot K, et al. Micronized dehydrated human amnion/chorion membrane injection in the treatment of chronic Achilles tendinitis.J Am Podiatr Med Assoc. 2021;111(6)doi:10.7547/19-170, 10.7547/19-170Gomoll A.H., Farr J., Cole B.J., et al. Safety and efficacy of an amniotic suspension allograft injection over 12 months in a single-blinded, randomized controlled trial for symptomatic osteoarthritis of the knee.J. Arthrosc. Relat. Surg.2021;37:22462257. doi: 10.1016/j.arthro.2021.02.044.elik D, oban , Kilioglu . Minimal clinically important difference of commonly used hip-, knee-, foot-, and ankle-specific questionnaires: a systematic review.J Clin Epidemiol. 2019;113:44-57. doi:10.1016/j.jclinepi.2019.04.017McCarthy M Jr, Chang CH, Pickard AS, et al. Visual analog scales for assessing surgical pain.J Am Coll Surg. 2005;201(2):245-252. doi:10.1016/j.jamcollsurg.2005.03.034Landorf KB, Radford JA, Hudson S. Minimal important difference (MID) of two commonly used outcome measures for foot problems.J Foot Ankle Res2010;3(1):7.Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale.Ann Emerg Med2001;38(6):633-638.Alden KJ, Harris S, Hubbs B, et al. Micronized dehydrated human amnion chorion membrane injection in the treatment of knee osteoarthritis a large retrospective case series.J Knee Surg. 2021;34(8):841-845. doi:10.1055/s-0039-3400951, 10.1055/s-0039-3400951Castellanos R, Tighe S. Injectable amniotic membrane/umbilical cord particulate for knee osteoarthritis: a prospective, single-center pilot study.Pain Med. 2019;20(11):2283-2291. doi:10.1093/pm/pnz143Mead OG, Mead LP. Intra-articular injection of amniotic membrane and umbilical cord particulate for the management of moderate to severe knee osteoarthritis.Res. Rev.2020;12:161170. doi: 10.2147/ORR.S272980.Natali S, Farinelli L, Screpis D, et al. Human amniotic suspension allograft improves pain and function in knee osteoarthritis: a prospective not randomized clinical pilot study.Clin. Med. 2022;11(12)doi:10.3390/jcm11123295,10.3390/jcm11123295Meadows MC, Elisman K, Nho SJ, et al. A single injection of amniotic suspension allograft is safe and effective for treatment of mild to moderate hip osteoarthritis: a prospective study. 2022;38:325331. doi: 10.1016/j.arthro.2021.04.034.Guimaraes JDS, Arcanjo FL, Leporace G, et al Effects of therapeutic interventions on pain due to plantar fasciitis: A systematic review and meta-analysis.Rehabil. 2022;no pagination. doi:10.1177/02692155221143865Zaffagnini M, Boffa A, Andriolo L, et al. Orthobiologic injections for the treatment of hip osteoarthritis: a systematic review.J Clin Med. 2022;11(22):6663. Published 2022 Nov 10. doi:10.3390/jcm11226663Aratikatla A, Maffulli N, Rodriguez HC, et al. Allogenic perinatal tissue for musculoskeletal regenerative medicine applications: a systematic review protocol. J. Orthop. Surg.2022;17(1):307. doi:10.1186/s13018-022-03197-z,10.1186/s13018-022-03197-zSultan AA, Samuel LT, Roth A, et al. Operative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of the Literature.Surg Technol Int.2019;34:397-402.McIntyre JA, Jones IA, Danilkovich A, Vangsness CT. The placenta: applications in orthopaedic sports medicine.J. Sports Med. 2018;46(1):234-247. doi:10.1177/0363546517697682Tsikopoulos K, Vasiliadis HS, Mavridis D. Injection therapies for plantar fasciopathy ('plantar fasciitis'): A systematic review and network meta-analysis of 22 randomised controlled trials.J. Sports Med. 2016;50(22):1367-1375. doi:10.1136/bjsports-2015-095437Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials.BMJ. 2019;366:l4898. Published 2019 Aug 28. doi:10.1136/bmj.l4898Schnemann H, Brozek J, Guyatt G, Oxman A, editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013.The GRADE Working Group, 2013. Available fromguidelinedevelopment.org/handbook.

Local Coverage Determinations, LCD, Local policies, Colon Capsule Endoscopy (CCE), DL38571

Use this page to view details for the Local Coverage Determination for Colon Capsule Endoscopy (CCE).

PROPOSED

Proposed LCD - Colon Capsule Endoscopy (CCE) (DL38571)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39122&ver=3

lcd-39122-3-1.txt

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39122

lcd

3

865fe06e-8fab-4ac7-9bf8-9e2364f248ee

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Code of Federal Regulations:42 CFR 410.32 indicates that diagnostic tests may only be ordered by a treating physician (or other treating practitioner acting within the scope of their license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapterCMS Publications:CMS Publication 100-04,Medicare Claims Processing Manual, Chapter 23: 10.1 - 10.1.7 ICD-10-CM Coding for Diagnostic Tests.Coverage Indications, Limitations, and/or Medical NecessityDiagnostic and/or surveillance* (performed for signs/symptoms of disease) colon capsule colonoscopy (CCE) is medically necessary for the detection of colon polyps when EITHER of the following criteria are met:Secondary procedure after an incomplete diagnostic optical colonoscopy (OC) with adequate preparation, and a complete evaluation of the colon was not technically possible (1,2) whenEITHERof the following criteria are metDetection or surveillance of colon polyp(s)ORDiagnostic procedure whenANYof the following criteria are met (3):Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical)ORMultitarget Stool DNA (sDNA) Test positiveORBlood-based biomarker colorectal cancer screening test positiveOROther evidence of lower GI bleed in hemodynamically stable patientsPrimary procedure in patients with major risks for OC or moderate sedation as indicated from an evaluation of the patient by a board certified or board eligible gastroenterologist, a surgeon trained in endoscopy, or a physician with equivalent endoscopic training whenEITHERof the following criteria are met:Surveillance of colon polyp(s) in previously diagnosed patientsORDiagnostic procedure whenANYof the following criteria are met (3):Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical)ORMultitarget Stool DNA (sDNA) Test positiveORBlood-based biomarker colorectal cancer screening test positiveOROther evidence of lower GI bleed in hemodynamically stable patientsExclusion Criteria (NONE of the below are allowed)Known or suspected gastrointestinal obstruction, stricture, or fistulaCardiac pacemaker or another implanted electro-medical device if the CCE device is contraindicated due to emission of a radiofrequency or other interfering signalSwallowing disorderKnown contraindication or allergy to any medication or preparation agent used before or during the procedureMay not be done in conjunction with CT Colonography (CTC)CCE is not a Medicare Benefit for colorectal cancer screening, regardless of family history or other risk factors for the development of colonic disease* Cancer Diagnostic strategies refer to the measures taken to investigate persons with symptoms suspicious for malignancy or as a result of positive screening tests. Cancer Surveillance refers to the interval utilization of diagnostic strategies in people with previously detected cancerous or pre-cancerous lesions. Cancer Screening strategies refer to those measures taken to diagnose cancerous and pre-cancerous lesions in asymptomatic people with no previous history of such.General InformationAssociated InformationN/ASources of InformationN/ABibliographyFDA approves PillCam COLON as follow-up test.Cancer Discov.2014;4(4):380-381.PillCam COLON 2 Capsule Endoscopy System (K153466). https://www.accessdata.fda.gov/cdrh_docs/pdf15/K153466.pdf. Accessed 2/28/20.National Coverage Determination (NCD) for Colorectal Cancer Screening Tests (210.3).National Coverage Decision. Accessed 6/01/21.Rex DK, Adler SN, Aisenberg J, et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population.Gastroenterology.2015;148(5):948-957 e942.Rondonotti E, Borghi C, Mandelli G, et al. Accuracy of capsule colonoscopy and computed tomographic colonography in individuals with positive results from the fecal occult blood test.Clin Gastroenterol Hepatol.2014;12(8):1303-1310.Spada C, Hassan C, Barbaro B, et al. Colon capsule versus CT colonography in patients with incomplete colonoscopy: a prospective, comparative trial.Gut. 2015;64(2):272-281.Holleran G, Leen R, OMorain C, McNamara DJE. Colon capsule endoscopy as possible filter test for colonoscopy selection in a screening population with positive fecal immunology.Endoscopy.2014;46(06):473-478.Kobaek-Larsen M, Kroijer R, Dyrvig AK, et al. Back-to-back colon capsule endoscopy and optical colonoscopy in colorectal cancer screening individuals.Colorectal Dis.2018;20(6):479-485.Morikawa T, Kato J, Yamaji Y, et al. Sensitivity of immunochemical fecal occult blood test to small colorectal adenomas.Am J Gastroenterol.2007;102(10):2259.Morgan DR, Malik PR, Romeo DP, Rex DK. Initial US evaluation of second-generation capsule colonoscopy for detecting colon polyps.BMJ Open Gastroenterol.2016;3(1):e000089.Spada C, Hassan C, Munoz-Navas M, et al. Second-generation colon capsule endoscopy compared with colonoscopy.Gastrointest Endosc.2011;74(3):581-589 e581.Eliakim R, Yassin K, Niv Y, et al. Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy.Endoscopy.2009;41(12):1026-1031.Parodi A, Vanbiervliet G, Hassan C, et al. Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer.Gastrointest Endosc.2018;87(3):695-704.Voska M, Zavoral M, Grega T, et al. Accuracy of Colon Capsule Endoscopy for Colorectal Neoplasia Detection in Individuals Referred for a Screening Colonoscopy.Gastroenterol Res Pract.2019;2019:5975438.Ohmiya N, Hotta N, Mitsufuji S, et al. Multicenter feasibility study of bowel preparation with castor oil for colon capsule endoscopy.Dig Endosc.2019;31(2):164-172.Blanes-Vidal V, Nadimi ES, Buijs MM, Baatrup GJIjocd. Capsule endoscopy vs. colonoscopy vs. histopathology in colorectal cancer screening: matched analyses of polyp size, morphology, and location estimates.Int J Colorectal Dis. 2018;33(9):1309-1312.Health Quality O. Colon Capsule Endoscopy for the Detection of Colorectal Polyps: An Evidence-Based Analysis.Ont Health Technol Assess Ser.2015;15(14):1-39.Spada C, Pasha SF, Gross SA, et al. Accuracy of First- and Second-Generation Colon Capsules in Endoscopic Detection of Colorectal Polyps: A Systematic Review and Meta-analysis.Clin Gastroenterol Hepatol.2016;14(11):1533-1543 e1538.Enns RA, Hookey L, Armstrong D, et al. Canadian Clinical Practice Guidelines for the Use of Video Capsule Endoscopy.Gastroenterology.2017;152(3):497-514.Institute E. PillCam Colon 2 Capsule Endoscopy System (Medtronic plc) for Detecting Colon Polyps. .Hayes- Colon Capsule Endoscopy for Colorectal Cancer Screening, Diagnosis and Surveillance. 2019.Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: Recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer.Gastrointest Endosc.2017;86(1):18-33.Hussey M, Holleran G, Stack R, Moran N, Tersaruolo C, McNamara D. Same-day colon capsule endoscopy is a viable means to assess unexplored colonic segments after incomplete colonoscopy in selected patients.United European Gastroenterol J.2018;6(10):1556-1562.

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39139

Use this page to view details for the Local Coverage Determination for Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39139)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39138&ver=5

lcd-39138-5-1.txt

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39138

lcd

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a00c8a26-aeb7-404b-bd16-0e14b8a217db

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) addresses services that are determined to be investigational or experimental.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 16, 10 General Exclusions from CoverageCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, 30A Physicians ServicesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 30, 50.3.1 Mandatory ABN UsesCoverage Indications, Limitations, and/or Medical NecessityThis is a NON-coverage policy for allamniotic membrane, amniotic fluid or other placental-derived productinjections and/or applications as a means of managing musculoskeletal injuries, joint conditions, and all other conditions not stated below.This guidance does NOT include discussion on burns, wounds or ophthalmic conditions.NOTE: For information on stem cell transplantation please see CMS National Coverage Determination 110.23 Stem Cell TransplantationIntroductionAmniotic and placental-derived products are reported to possess certain beneficial characteristics. These products have been proposed as a source of stem cells. Stem cells, by definition, have the capability to differentiate into any cell of an organism as well as the capability of self-renewal.1In addition, the extracellular matrix (ECM) of placental and amniotic-based tissues are rich in collagen, glycoproteins, proteoglycans, fibroblasts, as well as many cytokines and growth factors thought to promote healing with a lower risk of low immunologic reaction.Based on these characteristics, amniotic and placental-derived products are currently being studied and marketed as allografts to serve as:scaffolds for tissue engineeringmembrane covering for certain burns, wounds, and ophthalmic corneal injuriesmicronized/particulate products suspended in an aqueous material to be applied topically or injected into joints, tendons, ligamentsapplications or injections performed intra-operatively to promote post-operative healingThese amniotic and placental-derived products are further being investigated for a multitude of indications, including but not limited to musculoskeletal conditions involving joint pain and back pain, chronic pain in general, dental conditions, alopecia, wounds, burns, and a plethora of others. In the quest to find alternative treatments for certain musculoskeletal conditions, the emergence of a class of substances being marketed as orthobiologics has become more prevalent in the pharmaceutical market. Orthobiologics are biological products aimed at treating musculoskeletal conditions purported to heal injury/trauma, slow degenerative processes and affect regeneration of tissues.2The result ideally would be decreased pain and increased function. One such category of orthobiologics involves the incorporation of human amniotic and placental-derived products.The amniotic and placental-derived products are obtained from the placenta of donors, usually, immediately post C-section at full term and screened for transmittable diseases. These products are made up of varying combinations of amniotic membrane, amniotic fluid, chorionic membrane, umbilical cord, umbilical cord blood, and what is known as Whartons jelly.3Definitions:ThePlacentais a multi-layered circulatory temporary organ that supplies food and oxygen to the fetus during pregnancy.The multiple layers of the placenta include the:Amnion- the innermost membrane that surrounds the fetus during gestationChorion- outermost membrane that surrounds the fetus during gestationAmniotic fluidis the fluid surrounding the fetus within the amnion.Umbilical cordis the vascular conduit connecting the fetus to the placenta comprised of the umbilical vein, arteries, allantois and yolk sac embedded in Whartons jelly.Whartons Jellyis a gelatinous soft connective tissue derived from extra-embryonic mesoderm within the umbilical cord.4Theamniotic membraneitself is divided into three histologic layers:A singleepithelial layerA thickbasement membraneAnavascular stromal (mesenchymal) layer5.6,7,8The avascular stromal layer is further divided into three layers:6,7,8TheCompact layerThe middleFibroblast layerTheSpongy layerTheSpongy Layer, loosely connected to the chorionic membrane, is highly concentrated with proteoglycans and glycoproteins including hyaluronic acid, as well as type I, III, and IV collagen.5,6,8,9Themiddle Fibroblast layeris made up of type I, III, V, and VI collagen.6,8,9TheCompact layerthat sits adjacent to the basement membrane is composed of collagen Types I, III, V, and VI, along with fibronectin.5,9Thebasement membraneanchors the epithelial layer (ref 13) and contains collagen Types IV, V and VII, fibronectin, laminin, and hyaluronic acid.6,10Adjacent to the basement membrane and in immediate contact with amniotic fluid is the single layer of epithelial cells.Amniotic epithelial cellsproduce type III and IV collagen, glycoproteins such as laminin and fibronectin, which become the basement membrane.5The amniotic membranes purpose is to house and physically protect the fetus, but additional functions include regulation of the pH of the amniotic fluid, transportation of water and soluble material between the mother and fetus, and the synthesis of numerous growth factors and cytokines. The amniotic membrane also secretes anti-inflammatory proteins. All of this results in these tissues having anti-inflammatory, anti-microbial, anti-fibroblastic, and non-immunogenic properties.Amniotic products have been asserted to be a source of stem cells. Both the amniotic epithelial layer (maternal derived cells) and mesenchymal (avascular stromal) layer derived from the embryonic mesoderm contain their respective stem cells that can differentiate into multiple cell lines, including myocytes, osteocytes, and chondrocytes.8,9Amniotic fluid also is found to contain amniotic mesenchymal stem cells.7The chorionic membrane adjacent to the mothers endometrium during development of the fetus. Umbilical cord, Whartons jelly, and umbilical cord blood have also been found to contain mesenchymal stem cells.7,11Under normal conditions, placental tissues are collected via aseptic technique during cesarean section. Protocols vary as to how the tissues are harvested, prepared, preserved and stored. Testing is also required to ensure these tissues do not carry any communicable diseases transmissible from donor to recipient.Because the spongy layer loosely connects the amniotic membrane to the chorionic membrane, these two layers are easily separated upon blunt dissection at initial harvesting.10Other than ease of separation between amniotic and chorionic membranes, the following steps in processing the tissues into the desired form vary, based on the portions of the placental tissues extracted, sterilization processes (if any) undertaken, and method of preservation utilized. Common methods of preservation include cryopreservation, lyophilization (freeze-drying), glycerol-preservation, (gamma)-sterilization, low heat dehydration, and vitrification.5,8,9,10A process called Decellularization may be used in which the layer of amniotic epithelial cells is removed from the collected amniotic membrane, leaving behind the valuable extracellular matrix components. Removal of all cellular components is thought to lessen the possibility of eliciting an immune response.3,10Different decellularization processes are available. Eventual preparation of sheets, particulate suspensions, liquids, or gels allows the final marketed product.Depending on the methods utilized, the processing of placental and amniotic-based tissues will affect the viability of cellular components, growth factors, and other valuable properties for which these tissues are promoted. To date, there are significant differences that exist in the processing of different placental and amniotic-based tissue products.3,5Lack of consistency and standardization within propriety manufacturing (preparation) processes precludes determination and comparison of the final product form, characteristics, properties, and components.The Food and Drug Administration (FDA), under Sect. 361 of the Public Health Service Act (regulated by the Centers for Biologics Evaluation and Research CBER, an arm of the FDA) oversees the therapeutic use of "Human cells or tissue products" or HCT/Ps. Once these types products are harvested, their process and handling will determine whether the products fall under Section 361 guidance or default to the more regulated section 351 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act. The regulatory pathway for pre-market FDA approval of new drugs, devices and/or biological products, requires registration as a (NDA) New Drug application, an (IND) Investigational New Drug application, or a (BLA) Biologics License Approval.8,9,12,13If a human cells or tissue product should meet Section 361 FDA requirements, the product will not require FDA pre-market review and approval. To meet Section 361 FDA regulatory requirements, the placental/amniotic-based tissue product must meet the following 4 criteria: The HCT/P is:Minimally ManipulatedIntended for Homologous Use (as reflected by the labeling, advertising, or other indications of the manufacturers objective intent)The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/PEither:The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; orThe HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:Is for autologous use;Is for allogeneic use in a first-degree or second-degree blood relative; orIs for reproductive use12Due to the ongoing development of new products and clinical trials, the field of FDA regulatory requirements is fluid and evolving. It is the expectation that the respective Medicare Administrative Contractor will continue to follow any guidance and insight as it is brought forward by the FDA.Lack of standard formulation, dose, frequency of administration, and standard of care in treatment with these products further complicates regulation and guidance determinations.Despite this lack of standardization, numerous amniotic and placental-derived products have been released for use in treatment of musculoskeletal conditions. These conditions include, but are not limited to tendon/ligament injuries, musculoskeletal injuries, cartilage damage, osteoarthritis, (or pain related of these conditions) as well as an adjunctive to orthopedic surgical treatments. Due to the lack of component standardization, the remainder of this LCD will use the term amniotic and placental-derived products to mean ANY product derived from ANY combination of amniotic membrane/chorion/placenta/Whartons jelly/umbilical cord/amniotic fluid/umbilical cord blood.Although amniotic and placental-derived products are marketed to treat certain musculoskeletal conditions, there is limited support for safety and efficacy from human clinical trials available.All injectable amniotic and/or placental-derived products fall under FDA section 551 of the Federal Food, Drug, and Cosmetic Act. Promotion relating to novel indication or evidence of new intended use may constitute labeling, adulteration, or misbranding of the drug or device if such dissemination fails to comply with section 551 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A manufacturers failure to exercise due diligence in submitting the clinical studies are necessary for the approval of a new use as subject of information disseminated under this part or in beginning or completing such clinical studies shall be deemed a failure to comply with section 551 of the act and the requirement of this part. Use of any amniotic and/or placental-derived products that have not met the requirements of section 551 of the Federal Food, Drug, and Cosmetic Act will be denied per Medicare Benefit Policy Manual 100-2 Chapter 15 Section 50.4.1 and associated services will also be denied per Medicare Benefit Policy Manual 100-2 Chapter 16 Section 180.General InformationAssociated InformationN/ASources of InformationN/ABibliographyZakrzewski W, Dobrzynski M, Szymonowicz M, and Rybak Z. Stem Cells: Past, Present, and Future. Stem Cell Research & Therapy 2019 10:68.doi:10.1186/s13287-019-1165-5Dhillon MS, Behera P, Patel S, and Shetty V. Orthobiologics and Platelet Rich Plasma. Indian J of Orthop. 2014 Jan-Feb; 48(1):1-9.doi:10.4103/0019-5413.125477

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39139

Use this page to view details for the Local Coverage Determination for Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39139)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39138&ver=5

lcd-39138-5-1.txt

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39138

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ab95b35b-8cc3-4457-bdd3-31f3a4b60669

General InformationAssociated InformationN/ASources of InformationN/ABibliographyZakrzewski W, Dobrzynski M, Szymonowicz M, and Rybak Z. Stem Cells: Past, Present, and Future. Stem Cell Research & Therapy 2019 10:68.doi:10.1186/s13287-019-1165-5Dhillon MS, Behera P, Patel S, and Shetty V. Orthobiologics and Platelet Rich Plasma. Indian J of Orthop. 2014 Jan-Feb; 48(1):1-9.doi:10.4103/0019-5413.125477Sultan AA, Piuzzi NS, Mont MA. Nonoperative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of Literature. Clin J Sport Med. Jul 2020;30(4):383-389. doi:10.1097/jsm.0000000000000684Gabbe SG, Niebyl JR, Simpson JL, et al. Obstetricsnormal and problem pregnancies. 5th ed. Philadelphia: Churchill Livingstone; 2007.Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the Amniotic Membrane for Potential use in Tissue Engineering. European Cells and Materials. Vol. 15 2008. Pg 88-99.doi:10.22203/ecm.v015a07Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. PMID: 32076938McIntyre JA, Jones IA, Danilkovich A, Vangsness CT Jr.McIntyre JA, et al. The Placenta: Applications in Orthopaedic Sports Medicine. Am J Sports Med. 2018 Jan;46(1):234-247.

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39139

Use this page to view details for the Local Coverage Determination for Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39139)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39138&ver=5

lcd-39138-5-1.txt

1

39138

lcd

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dc982d40-5a4c-4053-a76c-232c92ebeda1

Gabbe SG, Niebyl JR, Simpson JL, et al. Obstetricsnormal and problem pregnancies. 5th ed. Philadelphia: Churchill Livingstone; 2007.Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the Amniotic Membrane for Potential use in Tissue Engineering. European Cells and Materials. Vol. 15 2008. Pg 88-99.doi:10.22203/ecm.v015a07Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. PMID: 32076938McIntyre JA, Jones IA, Danilkovich A, Vangsness CT Jr.McIntyre JA, et al. The Placenta: Applications in Orthopaedic Sports Medicine. Am J Sports Med. 2018 Jan;46(1):234-247.Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34.Hannon CP, Yanke AB, Farr J. Amniotic Tissue Modulation of Knee Pain-A Focus on Osteoarthritis. J Knee Surg. 2019 Jan;32(1):26-36. doi:10.1055/s-0038-1676370Leal-Marin S, Kern T, Hofmann N, Pogozhykh O, Framme C, Brgel M, Figueiredo C, Glasmacher B, Gryshkov O. Human Amniotic Membrane: A review on tissue engineering, application, and storage. J Biomed Mater Res. 2021;118. doi.org/10.1002/jbm.b.34782Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. Nov 2019;32(11):1143-1154. doi:10.1055/s-0039-1696672FDA Guidance for Industry and Food and Drug Administration Staff. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. 2020 July.Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. 2007 Aug.Gellhorn A.C., Han A. The use of dehydrated human amnion/chorion membrane allograft injection for the treatment of tendinopathy or arthritis: a case series involving 40 patients.PM&R. 2017;9(12):1236-1243. doi:10.1016/j.pmrj.2017.04.011Buck D. Amniotic umbilical cord particulate for discogenic pain.Am. Osteopath. Assoc.2019;119(12):814-819. doi:10.7556/jaoa.2019.138Ross A, Gambrill V, Main C. Clinical outcomes of amniotic membrane/umbilical cord particulate in spinal disorders: a retrospective study.J Pain Res. 2022;15:3971-3979. doi:10.2147/JPR.S375201, 10.2147/JPR.S375201Ackley JF, Kolosky M, Gurin D, Hampton R, Masin R, Krahe D. Cryopreserved amniotic membrane and umbilical cord particulate matrix for partial rotator cuff tears: A case series. Medicine (Baltimore). Jul 2019;98(30):e16569. doi:10.1097/md.0000000000016569Aufiero, D, Sampson, S, Onishi, K, and Bemden, V. Treatment of medial and lateral elbow tendinosis with an injectable amniotic membrane allografta retrospective case series.J Pain Relief. 2016;5(3):242.Quinet MT, Raghavan M, Morris E, et al. Effectiveness of amniotic fluid injection in the treatment of trigger finger: a pilot study.Journal of Hand Surgery Global Online. 2020;2(5):301-305.Cazzell S., Stewart J., Agnew P.S., et al Randomized controlled trial of micronized dehydrated human amnion/chorion membrane (dHACM) injection compared to placebo for the treatment of plantar fasciitis.Foot Ankle Int. 2018;39(10):1151-1161. doi:10.1177/1071100718788549Zelen C.M., Poka A., Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis - A feasibility study.Foot Ankle Int. 2013;34(10):1332-1339. doi:10.1177/1071100713502179Hanselman A.E., Tidwell J.E., Santrock R.D. Cryopreserved human amniotic membrane injection for plantar fasciitis: A randomized, controlled, double-blind pilot study.Foot Ankle Int. 2015;36(2):151-158. doi:10.1177/1071100714552824Matthews M, Betrus CJ, Klein EE, et al. Comparison of Regenerative Injection Therapy and Conventional Therapy for Proximal Plantar Fasciitis.J Foot Ankle Surg. 2022;doi:10.1053/j.jfas.2022.11.010, 10.1053/j.jfas.2022.11.010Nakagawa H, Sung K, Ashkani-Esfahani S, et al. Plantar fasciitis: a comparison of ultrasound-guided fasciotomy with or without amniotic membrane allograft injection.Med. 2022;17(12):931-940. doi:10.2217/rme-2022-0094Werber B: Amniotic tissues for the treatment of chronic plantar fasciosis and Achilles tendinosis.J Sports Med(Hindawi Publ Corp) 2015;2015:219896Lullove E. A flowable placental tissue matrix allograft in lower extremity injuries: a pilot study. 2015;7:e275.Spector JE, Hubbs B, Kot K, et al. Micronized dehydrated human amnion/chorion membrane injection in the treatment of chronic Achilles tendinitis.J Am Podiatr Med Assoc. 2021;111(6)doi:10.7547/19-170, 10.7547/19-170Gomoll A.H., Farr J., Cole B.J., et al. Safety and efficacy of an amniotic suspension allograft injection over 12 months in a single-blinded, randomized controlled trial for symptomatic osteoarthritis of the knee.J. Arthrosc. Relat. Surg.2021;37:22462257. doi: 10.1016/j.arthro.2021.02.044.elik D, oban , Kilioglu . Minimal clinically important difference of commonly used hip-, knee-, foot-, and ankle-specific questionnaires: a systematic review.J Clin Epidemiol. 2019;113:44-57. doi:10.1016/j.jclinepi.2019.04.017McCarthy M Jr, Chang CH, Pickard AS, et al. Visual analog scales for assessing surgical pain.J Am Coll Surg. 2005;201(2):245-252. doi:10.1016/j.jamcollsurg.2005.03.034Landorf KB, Radford JA, Hudson S. Minimal important difference (MID) of two commonly used outcome measures for foot problems.J Foot Ankle Res2010;3(1):7.Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale.Ann Emerg Med2001;38(6):633-638.Alden KJ, Harris S, Hubbs B, et al. Micronized dehydrated human amnion chorion membrane injection in the treatment of knee osteoarthritis a large retrospective case series.J Knee Surg. 2021;34(8):841-845. doi:10.1055/s-0039-3400951, 10.1055/s-0039-3400951Castellanos R, Tighe S. Injectable amniotic membrane/umbilical cord particulate for knee osteoarthritis: a prospective, single-center pilot study.Pain Med. 2019;20(11):2283-2291. doi:10.1093/pm/pnz143Mead OG, Mead LP. Intra-articular injection of amniotic membrane and umbilical cord particulate for the management of moderate to severe knee osteoarthritis.Res. Rev.2020;12:161170. doi: 10.2147/ORR.S272980.Natali S, Farinelli L, Screpis D, et al. Human amniotic suspension allograft improves pain and function in knee osteoarthritis: a prospective not randomized clinical pilot study.Clin. Med. 2022;11(12)doi:10.3390/jcm11123295,10.3390/jcm11123295Meadows MC, Elisman K, Nho SJ, et al. A single injection of amniotic suspension allograft is safe and effective for treatment of mild to moderate hip osteoarthritis: a prospective study. 2022;38:325331. doi: 10.1016/j.arthro.2021.04.034.Guimaraes JDS, Arcanjo FL, Leporace G, et al Effects of therapeutic interventions on pain due to plantar fasciitis: A systematic review and meta-analysis.Rehabil. 2022;no pagination. doi:10.1177/02692155221143865Zaffagnini M, Boffa A, Andriolo L, et al. Orthobiologic injections for the treatment of hip osteoarthritis: a systematic review.J Clin Med. 2022;11(22):6663. Published 2022 Nov 10. doi:10.3390/jcm11226663Aratikatla A, Maffulli N, Rodriguez HC, et al. Allogenic perinatal tissue for musculoskeletal regenerative medicine applications: a systematic review protocol. J. Orthop. Surg.2022;17(1):307. doi:10.1186/s13018-022-03197-z,10.1186/s13018-022-03197-zSultan AA, Samuel LT, Roth A, et al. Operative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of the Literature.Surg Technol Int.2019;34:397-402.McIntyre JA, Jones IA, Danilkovich A, Vangsness CT. The placenta: applications in orthopaedic sports medicine.J. Sports Med. 2018;46(1):234-247. doi:10.1177/0363546517697682Tsikopoulos K, Vasiliadis HS, Mavridis D. Injection therapies for plantar fasciopathy ('plantar fasciitis'): A systematic review and network meta-analysis of 22 randomised controlled trials.J. Sports Med. 2016;50(22):1367-1375. doi:10.1136/bjsports-2015-095437Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials.BMJ. 2019;366:l4898. Published 2019 Aug 28. doi:10.1136/bmj.l4898Schnemann H, Brozek J, Guyatt G, Oxman A, editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013.The GRADE Working Group, 2013. Available fromguidelinedevelopment.org/handbook.

Local Coverage Determinations, LCD, Local policies, Pneumatic Compression Devices, DL33829

Use this page to view details for the Local Coverage Determination for Pneumatic Compression Devices.

PROPOSED

Proposed LCD - Pneumatic Compression Devices (DL33829)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39169&ver=7

lcd-39169-7-1.txt

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39169

lcd

7

7ef9bcae-8e77-469e-8fe9-68c9b3b59f61

CMS National Coverage PolicyCMS Pub. 100-03, (Medicare National Coverage Determinations Manual), Chapter 1, Section 280.6Coverage Indications, Limitations, and/or Medical NecessityFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act 1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.PRESCRIPTIONSPrescriptions for Pneumatic Compression Devices (PCDs) (E0650, E0651, E0652, E0675, E0676) are limited to Physicians (MD, DO, DPM) and physician extenders (NP, PA, CNS) to the extent allowed by their applicable state scope-of-practice and other license requirements. Providers must use care because the treatment of lymphedema, chronic venous insufficiency with ulceration and complications related to the treatment of these conditions by use of PCDs, commonly require consideration of diagnoses and management of systemic conditions. In no event should a provider order PCDs or PCD appliances that are to be used for or are to be applied to areas of the body that fall outside of their state scope of practice and other license limitations.DEFINITIONSFor Medicare DMEPOS reimbursement purposes the following definitions are used in this policy.Edema:Edema is a non-specific term for the accumulation of fluid in tissue, most often in the extremities. There are numerous causes for edema, ranging from systemic disorders (e.g. congestive heart failure) to local conditions (e.g. post-surgery, congenital abnormalities). (Examples are not all-inclusive.)Lymphedema, as discussed below, is just one group of conditions that can be a cause of accumulation of fluid in the tissue. Lymphedema arises from disorders of the lymphatic system. It is essential to rule out other causes of edema in order to diagnose lymphedema. Edema from other causes is not classified as lymphedema for purposes of Medicare reimbursement for PCDs (E0650, E0651, E0652).Primary lymphedema:Primary lymphedema is a disorder of the lymphatic system that occurs on its own. It is inherited and uncommon. Examples (not all-inclusive) are:Congenital lymphedema due to lymphatic aplasia or hypoplasiaMilroy's disease, an autosomal dominant familial form of congenital lymphedemaLymphedema praecoxLymphedema tardaSecondary lymphedema:Secondary lymphedema is a disorder of lymphatic flow that is caused by some other disease or condition. It is more common than primary lymphedema. It is most commonly caused by surgery (especially lymph node dissection, such as for breast cancer), radiation therapy (especially axillary or inguinal), trauma, lymphatic obstruction by tumor, and, in developing countries, lymphatic filariasis. Secondary lymphedema may also result from compression of the lymphatic and venous channels resulting from leakage of fluid into interstitial tissues in patients with chronic venous insufficiency (CVI). (See below)Chronic Venous Insufficiency (CVI)Lymphedema may also be caused by CVI when fluid leaks into the tissues from the venous system. CVI of the lower extremities is a condition caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in the veins. Signs of CVI include hyperpigmentation, stasis dermatitis, chronic edema, and venous stasis ulcers. The incidence of lymphedema from CVI is not well established.Peripheral Arterial Disease (PAD)PAD is a circulatory problem in which narrowed arteries reduce blood flow to limbs, resulting in compromised blood flow to the distal tissue and failure to keep up with oxygen demands.GENERALPCDs coded as E0650, E0651, E0652 are used only in the treatment of lymphedema or CVI with venous stasis ulcers. Reimbursement for these items is based upon the criteria in the following sections. PCD coded as E0675 is used in the treatment of PAD. Claims for E0675 will be denied as not reasonable and necessary as outlined below.I - LYMPHEDEMAA PCD coded as E0650 or E0651 is covered for both primary and secondary lymphedema in beneficiaries with chronic and severe lymphedema when all of the following three requirements are met:The beneficiary has a diagnosis of lymphedema as defined above, andThe beneficiary has persistence of chronic and severe lymphedema as identified by the documented presence of at least one of the following clinical findings:Marked hyperkeratosis with hyperplasia and hyperpigmentation,Papillomatosis cutis lymphostatica,Deformity of elephantiasis,Skin breakdown with persisting lymphorrhea,Detailed measurements over time confirming the persistence of the lymphedema with a history evidencing a likely etiology, andIn addition to this documented persistence, the lymphedema is then documented to be unresponsive to other clinical treatment over the course of a required four-week trial. (See below for trial guidelines.)A PCD coded as E0650 or E0651 used to treat lymphedema that does not meet all of the requirements above is not eligible for reimbursement. Claims will be denied as not reasonable and necessary.A PCD coded as E0650 or E0651 used to treat edema from causes other than lymphedema is not eligible for reimbursement. Claims will be denied as not reasonable and necessary.A PCD coded as E0652 is not covered for the treatment of lymphedema of the extremities alone even if the criteria in this section are met. Claims will be denied as not reasonable and necessary. Refer below to the sections III - LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN and PCD Code Selection for additional information about the limited coverage for PCD coded as E0652.Four-Week Trial for LymphedemaA four-week trial of conservative therapy demonstrating failed response to treatment is required. The four-week trial of conservative therapy must include all of the following:Regular and compliant use of an appropriate compression bandage system or compression garment to provide adequate graduated compressionAdequate compression is defined as (1) sufficient pressure at the lowest pressure point to cause fluid movement, and (2) sufficient pressure across the gradient (from highest to lowest pressure point) to move fluid from distal to proximal. The compression used must not create a tourniquet effect at any point.The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression starting with a minimum of 30 mmHg distally.Regular exerciseElevation of the limbWhen available, manual lymphatic drainage is a key component of conservative treatment as is appropriate medication treatment when there is concurrent congestive heart failure.At the end of the four-week trial, if there has been improvement, then reimbursement for a PCD is not justified. Where improvement has occurred, the trial of conservative therapy must be continued with subsequent reassessment at intervals at least a week apart. Only when no significant improvement has occurred in the most recent four weeks and the coverage criteria above are still met, may the lymphedema be considered unresponsive to conservative therapy, and coverage for a PCD considered.The medical necessity determination for a PCD by the treating practitioner must include symptoms and objective findings, including measurements, to establish the severity of the condition.The documentation by thetreatingpractitionerof the medical necessity of a PCD must include:The patients diagnosis and prognosis;Symptoms and objective findings, including measurements which establish the severity of the condition;The reason the device is required, including the treatments which have been tried and failed; andThe clinical response to an initial treatment with the deviceAt a minimum, re-assessments conducted for a trial must include detailed measurements, obtained in the same manner and with reference to the same anatomic landmarks, prior to and at the conclusion of the various trials and therapy, with bilateral comparisons where appropriate.The trial of conservative therapy must be documented in the beneficiarys medical record before prescribing any type of PCD (E0650, E0651, E0652). This assessment may be performed by thetreatingpractitioneror any other licensed/certified medical professional (LCMP) directly involved in the beneficiarys lymphedema treatment. The LCMP may not have any financial relationship with the DMEPOS supplier providing the device. If the assessment is performed by an LCMP, thetreatingpractitionermust receive and review the report of the evaluation. In addition, thetreatingpractitionermust sign and date the report, and state concurrence or disagreement with the assessment. The signature date must be on or before the prescription date.II - CHRONIC VENOUS INSUFFICIENCY (CVI) WITH VENOUS STASIS ULCERSA PCD coded as E0650 or E0651 is covered for the treatment of CVI of the lower extremities only if the patient has all of the following:Edema in the affected lower extremityOne or more venous stasis ulcer(s)The ulcer(s) have failed to heal after a six-month trial of conservative therapy directed by thetreatingpractitioner. (See below for trial guidelines.)A PCD coded as E0650 or E0651 used to treat CVI that does not meet all of the requirements above is not eligible for reimbursement. Claims will be denied as not reasonable and necessary.A PCD coded as E0650 or E0651 used to treat ulcers in locations other than the lower extremity or ulcers and wounds from other causes is not eligible for reimbursement. Claims will be denied as not reasonable and necessary.A PCD coded as E0652 is not covered for the treatment of CVI even if the criteria in this section are met. Claims will be denied as not reasonable and necessary. Refer below to the sections III - LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN and PCD Code Selection for additional information about the limited coverage for PCD coded as E0652.Six-Month Trial for CVIA six-month trial of conservative therapy demonstrating failed response to treatment is required. The six-month trial of conservative therapy must include all of the following:Compliant use of an appropriate compression bandage system or compression garment to provide adequate graduated compressionAdequate compression is defined as (1) sufficient pressure at the lowest pressure point to cause fluid movement and (2) sufficient pressure across the gradient (from highest to lowest pressure point) to move fluid from distal to proximal. The compression used must not create a tourniquet effect at any point.The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression starting with a minimum of 30 mmHg distally.Medications as appropriate (e.g. diuretics and/or other treatment of congestive heart failure)Regular exerciseElevation of the limbAppropriate wound care for the ulcer (including sharp debridement where appropriate)At the end of the six-month trial, if there has been improvement, then reimbursement for a PCD is not reasonable and necessary. Where improvement has occurred, the trial of conservative therapy must be continued with subsequent reassessments. When no significant improvement has occurred for a continuous period of six months and the coverage criteria above are still met, then the use of a PCD to treat CVI is eligible for reimbursement.The trial of conservative therapy must be documented in the beneficiarys medical record before prescribing any type of PCD (E0650, E0651, E0652). This assessment may be performed by thetreatingpractitioneror any other licensed/certified medical professional (LCMP) directly involved in the beneficiarys CVI treatment. The LCMP may not have any financial relationship with the DMEPOS supplier providing the device. If the assessment is performed by an LCMP, thetreatingpractitionermust receive and review the report of the evaluation. In addition, thetreatingpractitionermust sign and date the report, and state concurrence or disagreement with the assessment. The signature date must be on or before the prescription date.III - LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMENA segmented, calibrated gradient PCD (E0652) is only covered when the individual has unique characteristics which prevent them from receiving adequate satisfactory pneumatic compression treatment using a nonsegmented device along with a segmented appliance or compression device without manual control of the pressure in each chamber.A PCD coded as E0652, is covered for the treatment of lymphedema extending onto the chest, trunk and/or abdomen when all of the following are met:

Local Coverage Determinations, LCD, Local policies, Pneumatic Compression Devices, DL33829

Use this page to view details for the Local Coverage Determination for Pneumatic Compression Devices.

PROPOSED

Proposed LCD - Pneumatic Compression Devices (DL33829)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39169&ver=7

lcd-39169-7-1.txt

1

39169

lcd

7

89565652-a393-414e-956a-05cfe3e5b95e

The beneficiary has lymphedema of an extremity as defined aboveThe coverage criteria for an E0650 or E0651 are metThe beneficiary has lymphedema extending onto the chest, trunk and/or abdomen that extends past the limits of a standard compression sleeve, and the chest, trunk and/or abdominal lymphedema has failed to improve with a four-week trial. (See below for trial guidelines.)A PCD coded as E0652 used to treat lymphedema extending onto the chest, trunk and/or abdomen that does not meet all of the requirements above is not eligible for reimbursement. Claims will be denied as not reasonable and necessary.A PCD coded as E0652 used to treat lymphedema not extending onto the chest, trunk and/or abdomen or CVI is not eligible for reimbursement. Claims will be denied as not reasonable and necessary.Four-Week Trial for Lymphedema Extending Onto the Chest, Trunk and/or AbdomenA four-week trial of conservative therapy demonstrating failed response to treatment with and E0650 or E0651 is required. The four-week trial of conservative therapy must include all of the following:At least four weeks of regular, daily, multiple-hour home usage of the E0650 or E0651 after careful, in-person fitting, training and supervision by a technician who is skilled in and who regularly and successfully uses the appliance providedCompliant use of an appropriate compression bandage system or compression garment to provide adequate graduated compressionAdequate compression is defined as (1) sufficient pressure at the lowest pressure point to cause fluid movement and (2) sufficient pressure across the gradient (from highest to lowest pressure point) to move fluid from distal to proximal. The compression used must not create a tourniquet effect at any point.The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression starting with a minimum of 30 mmHg distally.Regular exerciseElevation where appropriateManual lymphatic drainage (where available) and self-manual lymphatic drainage (MLD) for at least 30 minutes per dayEvaluation of diet and implementation of any necessary changeMedications as appropriate (e.g. diuretics and/or other treatment of congestive heart failure)Correction (where possible) of anemia and/or hypoproteinemiaAt the end of the four-week trial, if there has been improvement of the lymphedema extending onto the chest, trunk and/or abdomen, then reimbursement for an E0652 is not justified. Where improvement has occurred, the trial of conservative therapy must be continued with subsequent reassessment at intervals at least a week apart. When and only when no significant improvement has occurred in the most recent four weeks and the coverage criteria above are still met, an E0652 is eligible for reimbursement.The trial of conservative therapy must be documented in the beneficiarys medical record before prescribing any type of PCD (E0650, E0651, E0652). This assessment may be performed by thetreatingpractitioneror any other licensed/certified medical professional (LCMP) directly involved in the beneficiarys lymphedema treatment. The LCMP may not have any financial relationship with the DMEPOS supplier providing the device. If the assessment is performed by an LCMP, thetreatingpractitionermust receive and review the report of the evaluation. In addition, thetreatingpractitionermust sign and date the report, and state concurrence or disagreement with the assessment. The signature date must be on or before the prescription date.IV PERIPHERAL ARTERY DISEASE (PAD)A PCD coded as E0675 to treat PAD is not eligible for reimbursement. There is insufficient evidence to demonstrate that reimbursement is justified. Claims for E0675 will be denied as not reasonable and necessary.V DEEP VENOUS THROMBOSIS (DVT) PREVENTIONA PCD coded as E0676 is used only for prevention of venous thrombosis. Refer to the related Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section for information about lack of a Medicare benefit for devices used for prophylaxis of venous thrombosis.ACCESSORIESPCD related accessories (E0655, E0656, E0657, E0660, E0665, E0666, E0667, E0668, E0669, E0670, E0671, E0672, E0673) are eligible for reimbursement only when the appropriate, related base PCDs (E0650, E0651, E0652, E0675) meets the applicable coverage criteria for that type of PCD. If the base PCD is not covered, related accessories are not eligible for reimbursement. Claims for related items will be denied as not reasonable and necessary.PCD CODE SELECTION (E0650, E0651, E0652, E0675, E0676)A PCD coded as E0650 or E0651 is used for lymphedema or CVI. An E0650 compressor with a segmented appliance/sleeve (E0671, E0672, E0673) is considered functionally equivalent to an E0651 compressor with a segmented appliance/sleeve (E0667, E0668, E0669).A segmented, calibrated gradient PCD (E0652) is only covered when the individual has unique characteristics which prevent them from receiving adequate satisfactory pneumatic compression treatment using a nonsegmented device along with a segmented appliance or compression device without manual control of the pressure in each chamber.The only unique characteristics identified in the clinical literature that requires the use of an E0652 device is lymphedema extending onto the chest, trunk and/or abdomen which has remained unresponsive to all other therapies.A PCD coded as E0675 is used only for peripheral artery disease. Other PCD codes are not used for this condition.A PCD coded as E0676 is used only for prevention of venous thrombosis. Refer to the related Policy Article NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section for information about lack of a Medicare benefit for devices used for prophylaxis of venous thrombosis.GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.General InformationAssociated InformationDOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider". It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include thetreatingpractitionersoffice records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSItems covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MiscellaneousAppendicesUtilization GuidelinesRefer to Coverage Indications, Limitations, and/or Medical NecessitySources of InformationN/ABibliography

Local Coverage Determinations, LCD, Local policies, Pneumatic Compression Devices, DL33829

Use this page to view details for the Local Coverage Determination for Pneumatic Compression Devices.

PROPOSED

Proposed LCD - Pneumatic Compression Devices (DL33829)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39169&ver=7

lcd-39169-7-1.txt

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39169

lcd

7

a468a46e-35aa-48e4-aa68-71ebe2585c78

Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). European Journal of Vascular and Endovascular Surgery. 2007;33(1): S1-S75. doi: 10.1016/j.ejvs.2006.09.024Schainfeld RM. Management of peripheral arterial disease and intermittent claudication. J Am Board Fam Pract. Nov-Dec 2001;14(6):443-50.Kavros SJ, Delis KT, Turner NS, et al. Improving limb salvage in critical ischemia with intermittent pneumatic compression: a controlled study with 18-month follow-up. J Vasc Surg. Mar 2008;47(3):543-9. doi: 10.1016/j.jvs.2007.11.043Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. Jan 2007;45 Suppl S: S5-67. doi: 10.1016/j.jvs.2006.12.037Oresanya L, Mazzei M, Bashir R, et al. Systematic review and meta-analysis of high-pressure intermittent limb compression for the treatment of intermittent claudication. J Vasc Surg. Feb 2018;67(2):620-628 e2. doi: 10.1016/j.jvs.2017.11.044Alvarez OM, Wendelken ME, Markowitz L, Comfort C. Effect of High-pressure, Intermittent Pneumatic Compression for the Treatment of Peripheral Arterial Disease and Critical Limb Ischemia in Patients Without a Surgical Option. Wounds. Nov 2015;27(11):293-301.Labropoulos N, Leon LR, Jr., Bhatti A, et al. Hemodynamic effects of intermittent pneumatic compression in patients with critical limb ischemia. J Vasc Surg. Oct 2005;42(4):710-6. doi: 10.1016/j.jvs.2005.05.051Louridas G, Saadia R, Spelay J, et al. The ArtAssist Device in chronic lower limb ischemia. A pilot studies. Int Angiol. Mar 2002;21(1):28-35.Berni A, Tromba L, Falvo L, et al. Randomized study on the effects of different strategies of intermittent pneumatic compression for lower limb claudication. G Chir. Jun-Jul 2009;30(6-7):269-73.Kakkos SK, Geroulakos G, Nicolaides AN. Improvement of the walking ability in intermittent claudication due to superficial femoral artery occlusion with supervised exercise and pneumatic foot and calf compression: a randomised controlled trial. Eur J Vasc Endovasc Surg. Aug 2005;30(2):164-75. doi: 10.1016/j.ejvs.2005.03.011Delis KT, Nicolaides AN. Effect of intermittent pneumatic compression of foot and calf on walking distance, hemodynamics, and quality of life in patients with arterial claudication: a prospective randomized controlled study with 1-year follow-up. Ann Surg. Mar 2005;241(3):431-41. doi: 10.1097/01.sla.0000154358.83898.26Ramaswami G, D'Ayala M, Hollier LH, Deutsch R, McElhinney AJ. Rapid foot and calf compression increases walking distance in patients with intermittent claudication: results of a randomized study. J Vasc Surg. May 2005;41(5):794-801. doi: 10.1016/j.jvs.2005.01.045van den Houten MM, Gommans LN, van der Wees PJ, Teijink JA. Minimally Important Difference of the Absolute and Functional Claudication Distance in Patients with Intermittent Claudication. Eur J Vasc Endovasc Surg. Mar 2016;51(3):404-9. doi: 10.1016/j.ejvs.2015.11.008McGinigle KL, Minc SD. Disparities in amputation in patients with peripheral arterial disease. Surgery. Jun 2021;169(6):1290-1294. doi: 10.1016/j.surg.2021.01.025Newhall K, Spangler E, Dzebisashvili N, Goodman DC, Goodney P. Amputation Rates for Patients with Diabetes and Peripheral Arterial Disease: The Effects of Race and Region. Ann Vasc Surg. Jan 2016; 30:292-8 e1. doi: 10.1016/j.avsg.2015.07.040Pandit V, Nelson P, Kempe K, et al. Racial and ethnic disparities in lower extremity amputation: Assessing the role of frailty in older adults. Surgery. Dec 2020;168(6):1075-1078. doi: 10.1016/j.surg.2020.07.015O'Donnell TFX, Powell C, Deery SE, et al. Regional variation in racial disparities among patients with peripheral artery disease. J Vasc Surg. Aug 2018;68(2):519-526. doi: 10.1016/j.jvs.2017.10.090Goodney PP, Holman K, Henke PK, et al. Regional intensity of vascular care and lower extremity amputation rates. J Vasc Surg. Jun 2013;57(6):1471-79, 1480 e1-3; discussion 1479-80. doi: 10.1016/j.jvs.2012.11.068Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. Mar 21 2017;135(12):e726-e779. doi:10.1161/CIR.0000000000000471Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. Jun 2019;69(6S):3S-125S e40. doi: 10.1016/j.jvs.2019.02.016Abu Dabrh AM, Steffen MW, Asi N, et al. Nonrevascularization-based treatments in patients with severe or critical limb ischemia. J Vasc Surg. 2015;62(5):1330-9. e13. doi: 10.1016/j.jvs.2015.07.069Andersen CA, Daab LJ, Le TD, Green DM, Tyminski RL, Ponticello M, Marmolejo V. Treatment of Nonreconstructable Critical Limb Ischemia With Ischemic Wounds Utilizing a Noninvasive Intermittent Pneumatic Compression Device Monitored With Fluorescence Angiography. Wounds. 2018 Jul;30(7):191-196.Bin Azizi, ZA. Determining the Optimum Intermittent Pneumatic Compression Stimulus for Lower Limb Venous Emptying Using Direct Pressure Measurements [dissertation]. London, UK: University of London; 1996.Breu FX, Zelikovski A, Loberman Z, Rauh G. Efficacy and safety of a new pneumatic compression device for peripheral arterial disease with intermittent claudication: A prospective, randomized, multi-center clinical trial: a prospective, randomized, multi-center clinical trial. Phlebologie. 2014; 43:5-11Chang ST, Hsu JT, Chu CM, Pan KL, Jang SJ, Lin PC, Hsu HC, Huang KC. Using intermittent pneumatic compression therapy to improve quality of life for symptomatic patients with infrapopliteal diffuse peripheral obstructive disease. Circ J. 2012;76(4):971-6. doi: 10.1253/circj. cj-11-1229.Delis KT. The case for intermittent pneumatic compression of the lower extremity as a novel treatment in arterial claudication. Perspect Vasc Surg Endovasc Ther. 2005 Mar;17(1):29-42.Delis KT, Azizi ZA, Stevens RJ, Wolfe JH, Nicolaides AN. Optimum intermittent pneumatic compression stimulus for lower-limb venous emptying. Eur J Vasc Endovasc Surg. 2000 Mar;19(3):261-9.Delis KT, Husmann MJ, Cheshire NJ, Nicolaides AN. Effects of intermittent pneumatic compression of the calf and thigh on arterial calf inflow: a study of normals, claudicants, and grafted arteriopaths. Surgery. 2001 Feb;129(2):188-95.Delis KT, Husmann MJ, Nicolaides AN, Wolfe JH, Cheshire NJ. Enhancing foot skin blood flux in peripheral vascular disease using intermittent pneumatic compression: controlled study on claudicants and grafted arteriopaths. World J Surg. 2002;26(7):861-866.Delis KT, Husmann MJ, Szendro G, Peters NS, Wolfe JH, Mansfield AO. Haemodynamic effect of intermittent pneumatic compression of the leg after infrainguinal arterial bypass grafting. Br J Surg. 2004 Apr;91(4):429-34.Delis KT, Nicolaides AN, Stansby G. Effect of posture on popliteal artery hemodynamics. Arch Surg. 2000 Mar;135(3):265-9.Delis KT, Nicolaides AN, Wolfe JH, Stansby G. Improving walking ability and ankle brachial pressure indices in symptomatic peripheral vascular disease with intermittent pneumatic foot compression: a prospective controlled study with one-year follow-up. J Vasc Surg. 2000 Apr;31(4):650-61.Delis, KT, Slimani, G, Hafez, HM, Nicolaides, AN. Enhancing Venous Outflow in the Lower Limb with Intermittent Pneumatic Compression. A Comparative Haemodynamic Analysis on the Effect of Foot vs. Calf vs. Foot and Calf Compression. Eur J Vasc Endovasc Surg. 2000 Mar;19(3):250-60.Eton, D, Guolin, Z, Tong, HC, Elsorady, M, Syed, ZA. Enhancing neovascularization in chronic limb-threatening ischemia. J Vasc Surg. 2015; June Suppl: 106SEton D, Yu H. Enhanced cell therapy strategy to treat chronic limb-threatening ischemia. J Vasc Surg. 2010 Jul;52(1):199-204.Eze AR, Cisek PL, Holland BS, Comerota AJ Jr, Verramasuneni R, Comerota AJ. The contributions of arterial and venous volumes to increased cutaneous blood flow during leg compression. Ann Vasc Surg. 1998 Mar;12(2):182-6.Eze AR, Comerota AJ, Cisek PL, Holland BS, Kerr RP, Veeramasuneni R, Comerota AJ Jr. Intermittent calf and foot compression increases lower extremity blood flow. Am J Surg. 1996 Aug;172(2):130-4; discussion 135.Feuerhake IL, Henneberg EW, Hgh A. Intermitterende pneumatisk kompressions-behandling ved underekstremitetsiskmi uden kirurgiske behandlingstilbud [The use of intermittent pneumatic compression for critical limb ischaemia without vascular surgery reconstruction]. Ugeskr Laeger. 2016;178(11): V12150982.Gardner, AMN, Fox, RH. The Return of Blood to the Heart. London: John Libbey; 1989.GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. McMaster University, 2020 (developed by Evidence Prime, Inc.). Available from gradepro.org.Guarneri,G, Tiengo, A. Haemorrologic and Clotting Alterations in the Pathogenesis of the Diabetic Foot. In Faglia, E, Giuffrida, G, Oriani, G, ed. The Ischaemic Diabetic Foot. Milano, Italy: Kurtis. 1999: 17-23.Husmann M, Willenberg T, Keo HH, Spring S, Kalodiki E, Delis KT. Integrity of venoarteriolar reflex determines level of microvascular skin flow enhancement with intermittent pneumatic compression. J Vasc Surg. 2008 Dec;48(6):1509-13.

Local Coverage Determinations, LCD, Local policies, Pneumatic Compression Devices, DL33829

Use this page to view details for the Local Coverage Determination for Pneumatic Compression Devices.

PROPOSED

Proposed LCD - Pneumatic Compression Devices (DL33829)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39169&ver=7

lcd-39169-7-1.txt

1

39169

lcd

7

0ff85399-0697-4e51-94ef-924b3a54dfba

Feuerhake IL, Henneberg EW, Hgh A. Intermitterende pneumatisk kompressions-behandling ved underekstremitetsiskmi uden kirurgiske behandlingstilbud [The use of intermittent pneumatic compression for critical limb ischaemia without vascular surgery reconstruction]. Ugeskr Laeger. 2016;178(11): V12150982.Gardner, AMN, Fox, RH. The Return of Blood to the Heart. London: John Libbey; 1989.GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. McMaster University, 2020 (developed by Evidence Prime, Inc.). Available from gradepro.org.Guarneri,G, Tiengo, A. Haemorrologic and Clotting Alterations in the Pathogenesis of the Diabetic Foot. In Faglia, E, Giuffrida, G, Oriani, G, ed. The Ischaemic Diabetic Foot. Milano, Italy: Kurtis. 1999: 17-23.Husmann M, Willenberg T, Keo HH, Spring S, Kalodiki E, Delis KT. Integrity of venoarteriolar reflex determines level of microvascular skin flow enhancement with intermittent pneumatic compression. J Vasc Surg. 2008 Dec;48(6):1509-13.Ishibashi, H, Ohta, T, Hosaka, M, Sugimoto, I, Nehei, T, Kawanishi, J. Intermittent Pneumatic Compression Therapy for Chronically Ischemic Legs. In Iwai, T, Ohta, T, Sasajima, T, Ishibashi, H, and Nishikimi, N, ed. Breakthrough in the Treatment for Critical Limb Ischemia in Japan. Japanese Society for Limb Salvage Research. 2004: 65-71.Jolissaint, J, Shah, SK, Martin, MC, Raffetto, JD, McPhee, JT. Risk Prediction of 30-day mortality after lower extremity major amputation. New England Society for Vascular Surgery. Dec 2019 70(6): 1868-1875.Labropoulos N, Watson WC, Mansour MA, Kang SS, Littooy FN, Baker WH. Acute effects of intermittent pneumatic compression on popliteal artery blood flow. Arch Surg. 1998 Oct;133(10):1072-5.Levin SR, Arinze N, Siracuse JJ. Lower extremity critical limb ischemia: A review of clinical features and management. Trends Cardiovasc Med. 2020 Apr;30(3):125-130.Liu K, Chen LE, Seaber AV, Urbaniak JR. Influences of inflation rate and duration on vasodilatory effect by intermittent pneumatic compression in distant skeletal muscle. J Orthop Res. 1999 May;17(3):415-20.Louridas, G. A Randomized, Placebo-Controlled Limb Salvage Trial Using the ArtAssist Pneumatic Compression Device. Winnipeg Vascular and Endovascular Symposium. Winnipeg, Canada; April 2006.Manfredini F, Malagoni AM, Felisatti M, Mandini S, Lamberti N, Manfredini R, Mascoli F, Basaglia N, Zamboni P. Acute oxygenation changes on ischemic foot of a novel intermittent pneumatic compression device and of an existing sequential device in severe peripheral arterial disease. BMC Cardiovasc Disord. 2014 Mar 31; 14:40.Mehta T, Venkata Subramaniam A, Chetter I, McCollum P. Assessing the validity and responsiveness of disease-specific quality of life instruments in intermittent claudication. Eur J Vasc Endovasc Surg. 2006 Jan;31(1):46-52.Mentias A, Qazi A, McCoy K, Wallace R, Vaughan-Sarrazin M, Girotra S. Trends in Hospitalization, Management, and Clinical Outcomes Among Veterans with Critical Limb Ischemia. Circ Cardiovasc Interv. 2020 Feb;13(2): e008597.Montori VM, Kavros SJ, Walsh EE, Rooke TW. Intermittent compression pump for nonhealing wounds in patients with limb ischemia. The Mayo Clinic experience (1998-2000). Int Angiol. 2002 Dec;21(4):360-6.Moran PS, Teljeur C, Harrington P, Ryan M. A systematic review of intermittent pneumatic compression for critical limb ischaemia. Vasc Med. 2015;20(1):41-50. doi:10.1177/1358863X14552096Pawlaczyk K, Gabriel M, Urbanek T, Dzieciuchowicz L, Krasinski Z, Gabriel Z, Olejniczak-Nowakowska M, Stanisic M. Effects of Intermittent Pneumatic Compression on Reduction of Postoperative Lower Extremity Edema and Normalization of Foot Microcirculation Flow in Patients Undergoing Arterial Revascularization. Med Sci Monit. 2015 Dec 21; 21:3986-92.Pfizenmaier DH 2nd, Kavros SJ, Liedl DA, Cooper LT. Use of intermittent pneumatic compression for treatment of upper extremity vascular ulcers. Angiology. 2005 Jul-Aug;56(4):417-22.Schnemann H, Brozek J, Guyatt G, Oxman A, editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from guidelinedevelopment.org/handbook.Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366: l4898. Published 2019 Aug 28. doi:10.1136/bmj. l4898Sultan S, Esan O, Fahy A. Nonoperative active management of critical limb ischemia: initial experience using a sequential compression biomechanical device for limb salvage. Vascular. 2008 May-Jun;16(3):130-9. doi: 10.2310/6670.2008.00021.Sultan S, Hamada N, Soylu E, Fahy A, Hynes N, Tawfick W. Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral vascular disease. J Vasc Surg. 2011 Aug;54(2):440-6; discussion 446-7. doi: 10.1016/j.jvs.2011.02.057.Tawfick WA, Hamada N, Soylu E, Fahy A, Hynes N, Sultan S. Sequential compression biomechanical device versus primary amputation in patients with critical limb ischemia. Vasc Endovascular Surg. 2013 Oct;47(7):532-9.van Bemmelen PS, Mattos MA, Faught WE, Mansour MA, Barkmeier LD, Hodgson KJ, Ramsey DE, Sumner DS. Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. J Vasc Surg. 1994 Jun;19(6):1052-8.van Bemmelen PS, Weiss-Olmanni J, Ricotta JJ. Rapid intermittent compression increases skin circulation in chronically ischemic legs with infra-popliteal arterial obstruction. Vasa. 2000 Feb;29(1):47-52.van Bemmelen PS, Choudry RG, Salvatore MD, Goldenberg M, Goldman BI, Blebea J. Long-term intermittent compression increases arteriographic collaterals in a rabbit model of femoral artery occlusion. Eur J Vasc Endovasc Surg. 2007 Sep;34(3):340-6.van Bemmelen P, Char D, Giron F, Ricotta JJ. Angiographic improvement after rapid intermittent compression treatment [ArtAssist] for small vessel obstruction. Ann Vasc Surg. 2003 Mar;17(2):224-8.van Bemmelen PS, Gitlitz DB, Faruqi RM, et al. Limb salvage using high-pressure intermittent compression arterial assist device in cases unsuitable for surgical revascularization. Arch Surg. 2001;136(11):1280-1286.Williams KJ, Babber A, Ravikumar R, Davies AH. Non-Invasive Management of Peripheral Arterial Disease. Adv Exp Med Biol. 2017; 906:387-406. doi:10.1007/5584_2016_129Zaki M, Elsherif M, Tawfick W, El Sharkawy M, Hynes N, Sultan S. The Role of Sequential Pneumatic Compression in Limb Salvage in Non-reconstructable Critical Limb Ischemia. Eur J Vasc Endovasc Surg. 2016 Apr;51(4):565-71. doi: 10.1016/j.ejvs.2015.12.025.Zaleska MT, Olszewski WL, Ross J. The long-term arterial assist intermittent pneumatic compression generating venous flow obstruction is responsible for improvement of arterial flow in ischemic legs. PLoS One. 2019 Dec 11;14(12): e0225950.

Local Coverage Determinations, LCD, Local policies, MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer, DL38586

Use this page to view details for the Local Coverage Determination for MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer.

PROPOSED

Proposed LCD - MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DL38586)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39347&ver=3

lcd-39347-3-1.txt

1

39347

lcd

3

a0215b34-bbd6-40aa-b7bc-53368fc54729

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 Code of Federal Regulations (CFR) 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityThis contractor will cover molecular diagnostic tests for use in a beneficiary with bladder cancer when all of the following conditions are met:The beneficiary is being actively managed for bladder cancer.The beneficiary is within the population and has the indication for which the test was developed and is covered. The lab providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use.At least 1of the 2 criteria are met:The patient is a candidate for multiple potential treatments, which could be considered to have varied or increasing levels of intensity based on a consensus guideline, and the physician and patient must decide among these treatments.ORb. The patient is a candidate for multiple therapies, and the test has shown that it predicts response to a specific therapy among accepted therapy options based on nationally recognized society consensus guidelines (i.e., National Comprehensive Cancer Network [NCCN], American Society of Clinical Oncology [ASCO], Society of Urologic Oncology [SUO], or American Urological Association [AUA]).The test demonstrates analytical validity including both analytical and clinical validations. If the test relies on an algorithm (which may range in complexity from a threshold determination of a single numeric value to a complex mathematical or computational function), the algorithm must be validated in a cohort that is not a development cohort for the algorithm.The test has demonstrated clinical validity and utility, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision (in 4. above) in a clearly defined population.The test successfully completes a Molecular Diagnostic Services Program (MolDX)technical assessment that ensures the test is reasonable and necessary as described in 4. and 5. above.General InformationAssociated InformationN/ASources of InformationN/ABibliographySiegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021.CA Cancer J Clin.2021;71(1):7-33.Flaig TW, Spiess PE, Agarwal N, et al. Bladder cancer, version 3.2020, NCCN clinical practice guidelines in oncology.J Natl Compr Canc Netw.2020;18(3): 329-354.Svatek RS, Shariat SF, Novara G, et al. Discrepancy between clinical and pathological stage: external validation of the impact on prognosis in an international radical cystectomy cohort.BJU Int.2011;107(6):898-904.U.S. Food and Drug Administration (FDA).Balversa prescribing information. Accessed April 20, 2022.Helpap B. Morphology and therapeutic strategies for neuroendocrine tumors of the genitourinary tract.Cancer.2002;95(7):1415-1420.Ali SZ, Reuter VE, Zakowski MF. Small cell neuroendocrine carcinoma of the urinary bladder: a clinicopathologic study with emphasis on cytologic features.Cancer.1997;79(2):356-361.National Cancer Institute. Cancer Stat Facts: Bladder Cancer.https://seer.cancer.gov/statfacts/html/urinb.htmlAccessed April 20, 2022.Seiler R, Ashab HAD, Erho N, et al. Impact of molecular subtypes in muscle-invasive bladder cancer on predicting response and survival after neoadjuvant chemotherapy.Eur Urol.2017;72(4):544-554.Lotan Y, Boorjian SA, Zhang J, et al. Molecular subtyping of clinically localized urothelial carcinoma reveals lower rates of pathological upstaging at radical cystectomy among luminal tumors.Eur Urol.2019;76(2):200-206.Batista da Costa J, Gibb EA, Bivalacqua TJ, et al. Molecular characterization of neuroendocrine-like bladder cancer.Clin Cancer Res.2019;25(13):3908-3920.Fryback DG, Thornbury JR. The efficacy of diagnostic imaging.Med Decis Making.1991;11(2):88-94.Centers for Disease Control and Prevention. ACCE Model List of 44 Targeted Questions Aimed at a Comprehensive Review of Genetic Testing.https://www.cdc.gov/genomics/gtesting/acce/acce_proj.htm. Accessed April 20, 2022.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Bladder Cancer, Version 6.2021.https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed April 20, 2022.Ross JS, Wang K, Khaira D, et al. Comprehensive genomic profiling of 295 cases of clinically advanced urothelial carcinoma of the urinary bladder reveals a high frequency of clinically relevant genomic alterations.Cancer. 2016;122(5):702-711.Mori K, Abufaraj M, Mostafaei H, et al. A systemic review and meta-analysis of variant histology in urothelial carcinoma of the bladder treated with radical cystectomy.J Urol.2020;204(6):1129-1140.US Food and Drug Administration (FDA). Prescribing Information. BALVERSA (erdafitinib). 2020.https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212018s001lbl.pdf. Accessed April 20, 2022.Loriot Y, Necchi A, Park SH, et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma.N Engl J Med.2019;381(4):338-348.

Local Coverage Determinations, LCD, Local policies, Genetic Testing for Oncology, DL39365

Use this page to view details for the Local Coverage Determination for Genetic Testing for Oncology.

PROPOSED

Proposed LCD - Genetic Testing for Oncology (DL39365)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39364&ver=23

lcd-39364-23-1.txt

1

39364

lcd

23

91bd5b6f-bfce-46e7-81d4-b4aba3e7bebb

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for genetic testing for oncology. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for genetic testing for oncology and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.4.5 Off Label Use of Anti-Cancer Drugs and Biologicals, Section 80.1 Clinical Laboratory Services and Section 280 Preventive and Screening ServicesCMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Part 2, Section 90.2 Next-Generation Sequencing for Patients with Advanced CancerChapter 1, Part 4, Section 210.3 Colorectal Cancer Screening TestsCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Code of Federal Regulations (CFR) References:CFR, Title 42, Volume 2, Chapter IV, Part 410.32(d)(3) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCoverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationWith advancement in science and technology comes the ability to incorporate genetic testing for oncology biomarkers into clinical care, with the goal of improved patient outcomes. The scope of this LCD is DNA and RNA genetic testing in the practice of oncology in the Medicare population.As defined by the Food and Drug Administration (FDA) and National Institutes of Health (NIH) Biomarker Working Group, a biomarker is A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, orbiological responses to an exposure or intervention, including therapeutic interventions, and may include molecular, histologic, radiographic, or physiologic characteristics.1 (p.45)Cancer is a disease caused by changes or alterations to a persons genome. Some genetic changes or alterations can be inherited (also known as germline mutations). About 5-10% of all cancer diagnoses result from germline mutations, and over 50 hereditary cancer syndromes are known. Other cancer-causing (oncogenic) genetic changes or alterations result from acquired genetic damage (also known as somatic mutations). Somatic mutations can arise in numerous scenarios, including exposure to chemicals that alter DNA (carcinogens) or ultraviolet (UV) radiation from the sun.2Biomarker testing is a part of personalized laboratory medicine (also known as precision medicine). Precision medicine is a tailored approach to medical care and treatment. Because each patient has a unique combination of genetic changes, and therefore, a unique pattern of biomarkers, precision medicine for oncology involves the use of biomarker testing to pinpoint the disease management needs of individual patients (and avoid the use of treatments which are unlikely to be successful).3Much of this testing involves direct evaluation of the genetics of the malignancy through various testing methodologies. These methodologies can include high level genetic evaluations such as karyotyping (analysis of chromosomes) to more detailed evaluations such as identifying specific pathogenic point variations (analysis of specific nucleotide changes).Additionally, testing may be used to check for a single biomarker or multiple biomarkers at the same time via a multigene test or panel.3As a result, the growing compendium of products described as biomarkers requires careful evaluation to determine what testing configurations are medically reasonable and necessary under Medicare.Biomarkers for oncology can be generally classified into four functional types4:Diagnosticbiomarkers detect or confirm the presence of a disease or conditionPrognosticbiomarkers provide information about the likely course of a disease process and potential patient outcomes if left untreatedPredictivebiomarkers forecast a patients response and/or benefit to a specific treatmentTherapeuticbiomarkers identify potential targets for a medical intervention (e.g., targeted drug therapy)In certain circumstances, genetic testing for oncology biomarkers in patients with the corresponding appropriate medical condition could have the potential to assist patient management in the Medicare population. However, given the complexity and rapidly expanding knowledge in this topic area, there is also a potential for testing that does not help the patient or leads to confusion. In order for services to be considered medically reasonable and necessary, they must impact the management of the patient. Specialized clinical expertise in oncology in addition to advanced knowledge in both genetic variation and effect on gene function is required to facilitate optimal outcomes for patients.DefinitionsActionable usedescribes a scenario when the genotype information identified via genetic testing may lead to selection of or avoidance of a specific intervention.Analytical validationis a process intended to determine if a test, tool, or instrument has acceptable technical performance (sensitivity, specificity, accuracy, precision, etc.). Analytical validation is an assessment of the tests technical performance (that it measures what it was intended to measure), not its usefulness or clinical significance.1Clinical validityis defined as the ability of a test to classify a patients specific circumstance into a diagnostic, prognostic, or predictive functional category. It should be noted that clinical validity is not a fixed value.5Clinical utilitycan be defined as the ability of a test to provide information related to the patients care and management, and thus, its ability to inform treatment decisions.5Covered IndicationsThree evidence-based databases and/or knowledge bases have been identified as valid and reliable sources. Note that a specific genetic test may be listed in one database or knowledge base, but not others; therefore, providers may choose to utilize guidelines from any of the three databases/knowledge bases. However,for services to be considered medically reasonable and necessary, #1 below is required regardless of which guidelines are utilized.Genetic testing for oncology will be considered medically reasonable and necessary if:The provider has either established a diagnosis of cancer or found significant evidence to create suspicion for cancer in their patient via a clinical evaluation and abnormal results (cancer or suspicious for cancer) from histologic and/or cytologic examination. If then, as a next step in the clinical management of the patient, genetic testing would directly impact the management of the patients condition, the testing would be indicated.AND ONE OF THE FOLLOWING:The evidence for the gene-disease association is evaluated by the evidence-based, transparent, peer-reviewed process of the National Institutes of Health (NIH) sponsored Clinical Genome Resource (ClinGen)6and is determined to demonstrate actionability in clinical decision making,meeting the criteria for all 5 categories below.At leastoneof the items listed under each of the categories (severity, likelihood of disease, effectiveness, nature of the intervention, and validity) must be satisfied:Disease severity equal to:Sudden death (Level 3), orPossible death or major morbidity (Level 2), orModest morbidity (Level 1)Likelihood of disease equal to:Substantial evidence of a >40% chance (Level 3A), orModerate evidence of a >40% chance (Level 3B)Effectiveness equal to:Substantial evidence of a highly effective intervention (Level 3A), orModerate evidence of a highly effective intervention (Level 3B), orSubstantial evidence of a moderately effective intervention (Level 2A), orModerate evidence of a moderately effective intervention (Level 2B)Nature of the intervention is equal to:Low risk/medically acceptable/low intensity (Level 3), orModerately acceptable/risk/intensive (Level 2)Validity of the gene-disease relationship equal to:Definitive, orStrong, orModerateORThe evidence for the intervention is evaluated by the National Comprehensive Cancer Network (NCCN)7and is determined to demonstrate actionability in clinical decision making, meeting the following metric:Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate (Category 1), orBased upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate (Category 2A)ORThe evidence for the intervention is evaluated by the Memorial Sloan Kettering Cancer Center-sponsored Oncology Knowledge Base (OncoKB)8and is determined to demonstrate actionability in clinical decision making, meeting one of the following metrics:For therapeutic use cases:The intervention is an FDA-recognized biomarker predictive of response to an FDA-approved drug in this indication (Level 1)ORThe intervention is a standard care biomarker recommended by the NCCN or other professional guidelines predictive of response to an FDA-approved drug in this indication (Level 2)ORThe intervention is a standard care biomarker predictive of resistance to an FDA-approved drug in this indication (Level R1)For diagnostic use cases:The intervention is an FDA and/or professional guideline-recognized biomarker required for diagnosis in this indication (Level Dx1)ORThe intervention is an FDA and/or professional guideline-recognized biomarker that supports diagnosis in this indication (Level Dx2)For prognostic use cases:The intervention is an FDA and/or professional guideline-recognized biomarker prognostic in this indication based on a well-powered study (or studies) (Level Px1)ORThe intervention is an FDA and/or professional guideline-recognized biomarker prognostic in this indication based on a single study or multiple small studies (Level Px2)LimitationsThe following are considered not medically reasonable and necessary:A genetic test where either analytical validity, clinical validity, or clinical utility has not been established.Interventions with levels of evidence not identified by either ClinGen, NCCN, or OncoKB as demonstrating actionability in clinical decision making as noted in Covered Indications.Genetic testing in patients who do not have either an established diagnosis of cancer or substantiated suspicion of cancer as determined by a clinical evaluation and abnormal results (cancer or suspicious for cancer) from histologic and/or cytologic examination.Genetic testing of asymptomatic patients for the purposes of screening the patient or their relatives.Repetitions of the same genetic test on the same genetic material.Genetic tests for hereditary cancer syndromes, which are considered germline testing, may only be performed once per beneficiarys lifecycle.Provider QualificationsThe following provider qualification requirements must be met for the service to be considered medically reasonable and necessary.The ordering provider of a genetic test for a patient with an established diagnosis of cancer or substantiated suspicion of cancer:Must be the treating clinician who is responsible for the management of the patients cancer; and,Understands how the test result will impact the patients condition; and,Has presented this information to the patient eliciting patient understanding.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Genetic Testing for Oncology (DA59125) for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationContractor Medical DirectorsPrivate Insurer PoliciesOther Contractor PoliciesBibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Co-published by National Institutes of Health (US), Bethesda (MD).The Genetics of Cancer. National Cancer Institute website. https://www.cancer.gov/about-cancer/causes-prevention/genetics. Published October 12, 2017. Accessed January 5, 2022 to April 7, 2022.Biomarker Testing for Cancer Treatment. National Cancer Institute website. https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment. Published October 5, 2017. Accessed January 5, 2022 to April 7, 2022.Califf RM. Biomarker definitions and their applications.Exp Biol Med (Maywood).2018;243(3):213-221. doi:10.1177/1535370217750088Joseph L, Cankovic M, Caughron S, et al. The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology.J Mol Diagn. 2016;18(5):605-619. doi:10.1016/j.jmoldx.2016.05.007

Local Coverage Determinations, LCD, Local policies, Genetic Testing for Oncology, DL39365

Use this page to view details for the Local Coverage Determination for Genetic Testing for Oncology.

PROPOSED

Proposed LCD - Genetic Testing for Oncology (DL39365)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39364&ver=23

lcd-39364-23-1.txt

1

39364

lcd

23

aa3724b3-1e48-4488-9e07-0eeb574554f2

FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Co-published by National Institutes of Health (US), Bethesda (MD).The Genetics of Cancer. National Cancer Institute website. https://www.cancer.gov/about-cancer/causes-prevention/genetics. Published October 12, 2017. Accessed January 5, 2022 to April 7, 2022.Biomarker Testing for Cancer Treatment. National Cancer Institute website. https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment. Published October 5, 2017. Accessed January 5, 2022 to April 7, 2022.Califf RM. Biomarker definitions and their applications.Exp Biol Med (Maywood).2018;243(3):213-221. doi:10.1177/1535370217750088Joseph L, Cankovic M, Caughron S, et al. The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology.J Mol Diagn. 2016;18(5):605-619. doi:10.1016/j.jmoldx.2016.05.007ClinGen. Explore the clinical relevance of genes & variants. https://www.clinicalgenome.org. Published May 2021. Updated January 2, 2022. Accessed January 5, 2022 to April 7, 2022.National Comprehensive Cancer Network (NCCN). Biomarkers Compendium. https://www.nccn.org/compendia-templates/compendia/biomarkers-compendium. Accessed January 5, 2022 to April 7, 2022.Chakravarty D, Gao J, Phillips SM, et al. OncoKB: A Precision Oncology Knowledge Base.JCO Precision Oncology. 2017;(1):1-16. doi:10.1200/po.17.00011Institute of Medicine (US) Committee to Advise the Public Health Service on Clinical Practice Guidelines, Field MJ, Lohr KN, eds.Clinical Practice Guidelines: Directions for a New Program. Washington (DC): National Academies Press (US); 1990.Development and Update of Guidelines. National Comprehensive Cancer Network website. https://www.nccn.org/guidelines/guidelines-process/development-and-update-of-guidelines. Accessed January 5, 2022 to April 7, 2022.Birkeland ML, McClure JS. Optimizing the Clinical Utility of Biomarkers in Oncology: The NCCN Biomarkers Compendium.Arch Pathol Lab Med. 2015;139(5):608-611. doi:10.5858/arpa.2014-0146-RAPoonacha TK, Go RS. Level of scientific evidence underlying recommendations arising from the National Comprehensive Cancer Network clinical practice guidelines.J Clin Oncol. 2011;29(2):186191. doi:10.1200/JCO.2010.31.6414Genetic Database Recognition Decision Summary for ClinGen Expert Curated Human Variant Data. US Food & Drug Administration. https://www.fda.gov/media/119313/download. Accessed January 5, 2022 to April 7, 2022.Hunter JE, Irving SA, Biesecker LG, et al. A standardized, evidence-based protocol to assess clinical actionability of genetic disorders associated with genomic variation.Genet Med. 2016 Dec;18(12):1258-1268. doi:10.1038/gim.2016.40FDA Recognition of Public Human Genetic Variant Databases. US Food & Drug Administration.FDA. https://www.fda.gov/medical-devices/precision-medicine/fda-recognition-public-human-genetic-variant-databases. Published online October 7, 2021. Accessed January 5, 2022 to April 7, 2022.Strande NT, Riggs ER, Buchanan AH, et al. Evaluating the Clinical Validity of Gene-Disease Associations: An Evidence-Based Framework Developed by the Clinical Genome Resource.The American Journal of Human Genetics.2017 Jun 1;100(6):895-906. doi:10.1016/j.ajhg. 2017.04.015Berg JS, Foreman AK, O'Daniel JM, et al. A semiquantitative metric for evaluating clinical actionability of incidental or secondary findings from genome-scale sequencing.Genet Med. 2016;18(5):467-475. doi:10.1038/gim.2015.104Genetic Database Recognition Decision Summary for OncoKB. US Food & Drug Administration. https://www.fda.gov/media/152847/download. Accessed January 5, 2022 to April 7, 2022.FDA Fact Sheet. US Food & Drug Administration. https://www.oncokb.org/levels#version=FDA_NGS. Updated March 29, 2022. Accessed January 5, 2022 to April 7, 2022.

Local Coverage Determinations, LCD, Local policies, Genetic Testing for Oncology, DL39367

Use this page to view details for the Local Coverage Determination for Genetic Testing for Oncology.

PROPOSED

Proposed LCD - Genetic Testing for Oncology (DL39367)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39366&ver=10

lcd-39366-10-1.txt

1

39366

lcd

10

db94fda9-d55a-40fd-8f87-54ede121a545

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for genetic testing for oncology. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for genetic testing for oncology and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.4.5 Off Label Use of Anti-Cancer Drugs and Biologicals, Section 80.1 Clinical Laboratory Services and Section 280 Preventive and Screening ServicesCMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Part 2, Section 90.2 Next-Generation Sequencing for Patients with Advanced CancerChapter 1, Part 4, Section 210.3 Colorectal Cancer Screening TestsCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Code of Federal Regulations (CFR) References:CFR, Title 42, Volume 2, Chapter IV, Part 410.32(d)(3) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCoverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationWith advancement in science and technology comes the ability to incorporate genetic testing for oncology biomarkers into clinical care, with the goal of improved patient outcomes. The scope of this LCD is DNA and RNA genetic testing in the practice of oncology in the Medicare population.As defined by the Food and Drug Administration (FDA) and National Institutes of Health (NIH) Biomarker Working Group, a biomarker is A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, orbiological responses to an exposure or intervention, including therapeutic interventions, and may include molecular, histologic, radiographic, or physiologic characteristics.1 (p.45)Cancer is a disease caused by changes or alterations to a persons genome. Some genetic changes or alterations can be inherited (also known as germline mutations). About 5-10% of all cancer diagnoses result from germline mutations, and over 50 hereditary cancer syndromes are known. Other cancer-causing (oncogenic) genetic changes or alterations result from acquired genetic damage (also known as somatic mutations). Somatic mutations can arise in numerous scenarios, including exposure to chemicals that alter DNA (carcinogens) or ultraviolet (UV) radiation from the sun.2Biomarker testing is a part of personalized laboratory medicine (also known as precision medicine). Precision medicine is a tailored approach to medical care and treatment. Because each patient has a unique combination of genetic changes, and therefore, a unique pattern of biomarkers, precision medicine for oncology involves the use of biomarker testing to pinpoint the disease management needs of individual patients (and avoid the use of treatments which are unlikely to be successful).3Much of this testing involves direct evaluation of the genetics of the malignancy through various testing methodologies. These methodologies can include high level genetic evaluations such as karyotyping (analysis of chromosomes) to more detailed evaluations such as identifying specific pathogenic point variations (analysis of specific nucleotide changes).Additionally, testing may be used to check for a single biomarker or multiple biomarkers at the same time via a multigene test or panel.3As a result, the growing compendium of products described as biomarkers requires careful evaluation to determine what testing configurations are medically reasonable and necessary under Medicare.Biomarkers for oncology can be generally classified into four functional types4:Diagnosticbiomarkers detect or confirm the presence of a disease or conditionPrognosticbiomarkers provide information about the likely course of a disease process and potential patient outcomes if left untreatedPredictivebiomarkers forecast a patients response and/or benefit to a specific treatmentTherapeuticbiomarkers identify potential targets for a medical intervention (e.g., targeted drug therapy)In certain circumstances, genetic testing for oncology biomarkers in patients with the corresponding appropriate medical condition could have the potential to assist patient management in the Medicare population. However, given the complexity and rapidly expanding knowledge in this topic area, there is also a potential for testing that does not help the patient or leads to confusion. In order for services to be considered medically reasonable and necessary, they must impact the management of the patient. Specialized clinical expertise in oncology in addition to advanced knowledge in both genetic variation and effect on gene function is required to facilitate optimal outcomes for patients.DefinitionsActionable usedescribes a scenario when the genotype information identified via genetic testing may lead to selection of or avoidance of a specific intervention.Analytical validationis a process intended to determine if a test, tool, or instrument has acceptable technical performance (sensitivity, specificity, accuracy, precision, etc.). Analytical validation is an assessment of the tests technical performance (that it measures what it was intended to measure), not its usefulness or clinical significance.1Clinical validityis defined as the ability of a test to classify a patients specific circumstance into a diagnostic, prognostic, or predictive functional category. It should be noted that clinical validity is not a fixed value.5Clinical utilitycan be defined as the ability of a test to provide information related to the patients care and management, and thus, its ability to inform treatment decisions.5Covered IndicationsThree evidence-based databases and/or knowledge bases have been identified as valid and reliable sources. Note that a specific genetic test may be listed in one database or knowledge base, but not others; therefore, providers may choose to utilize guidelines from any of the three databases/knowledge bases. However,for services to be considered medically reasonable and necessary, #1 below is required regardless of which guidelines are utilized.Genetic testing for oncology will be considered medically reasonable and necessary if:The provider has either established a diagnosis of cancer or found significant evidence to create suspicion for cancer in their patient via a clinical evaluation and abnormal results (cancer or suspicious for cancer) from histologic and/or cytologic examination. If then, as a next step in the clinical management of the patient, genetic testing would directly impact the management of the patients condition, the testing would be indicated.AND ONE OF THE FOLLOWING:The evidence for the gene-disease association is evaluated by the evidence-based, transparent, peer-reviewed process of the National Institutes of Health (NIH) sponsored Clinical Genome Resource (ClinGen)6and is determined to demonstrate actionability in clinical decision making,meeting the criteria for all 5 categories below.At leastoneof the items listed under each of the categories (severity, likelihood of disease, effectiveness, nature of the intervention, and validity) must be satisfied:Disease severity equal to:Sudden death (Level 3), orPossible death or major morbidity (Level 2), orModest morbidity (Level 1)Likelihood of disease equal to:Substantial evidence of a >40% chance (Level 3A), orModerate evidence of a >40% chance (Level 3B)Effectiveness equal to:Substantial evidence of a highly effective intervention (Level 3A), orModerate evidence of a highly effective intervention (Level 3B), orSubstantial evidence of a moderately effective intervention (Level 2A), orModerate evidence of a moderately effective intervention (Level 2B)Nature of the intervention is equal to:Low risk/medically acceptable/low intensity (Level 3), orModerately acceptable/risk/intensive (Level 2)Validity of the gene-disease relationship equal to:Definitive, orStrong, orModerateORThe evidence for the intervention is evaluated by the National Comprehensive Cancer Network (NCCN)7and is determined to demonstrate actionability in clinical decision making, meeting the following metric:Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate (Category 1), orBased upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate (Category 2A)ORThe evidence for the intervention is evaluated by the Memorial Sloan Kettering Cancer Center-sponsored Oncology Knowledge Base (OncoKB)8and is determined to demonstrate actionability in clinical decision making, meeting one of the following metrics:For therapeutic use cases:The intervention is an FDA-recognized biomarker predictive of response to an FDA-approved drug in this indication (Level 1)ORThe intervention is a standard care biomarker recommended by the NCCN or other professional guidelines predictive of response to an FDA-approved drug in this indication (Level 2)ORThe intervention is a standard care biomarker predictive of resistance to an FDA-approved drug in this indication (Level R1)For diagnostic use cases:The intervention is an FDA and/or professional guideline-recognized biomarker required for diagnosis in this indication (Level Dx1)ORThe intervention is an FDA and/or professional guideline-recognized biomarker that supports diagnosis in this indication (Level Dx2)For prognostic use cases:The intervention is an FDA and/or professional guideline-recognized biomarker prognostic in this indication based on a well-powered study (or studies) (Level Px1)ORThe intervention is an FDA and/or professional guideline-recognized biomarker prognostic in this indication based on a single study or multiple small studies (Level Px2)LimitationsThe following are considered not medically reasonable and necessary:A genetic test where either analytical validity, clinical validity, or clinical utility has not been established.Interventions with levels of evidence not identified by either ClinGen, NCCN, or OncoKB as demonstrating actionability in clinical decision making as noted in Covered Indications.Genetic testing in patients who do not have either an established diagnosis of cancer or substantiated suspicion of cancer as determined by a clinical evaluation and abnormal results (cancer or suspicious for cancer) from histologic and/or cytologic examination.Genetic testing of asymptomatic patients for the purposes of screening the patient or their relatives.Repetitions of the same genetic test on the same genetic material.Genetic tests for hereditary cancer syndromes, which are considered germline testing, may only be performed once per beneficiarys lifecycle.Provider QualificationsThe following provider qualification requirements must be met for the service to be considered medically reasonable and necessary.The ordering provider of a genetic test for a patient with an established diagnosis of cancer or substantiated suspicion of cancer:Must be the treating clinician who is responsible for the management of the patients cancer; and,Understands how the test result will impact the patients condition; and,Has presented this information to the patient eliciting patient understanding.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Genetic Testing for Oncology (DA59123) for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationContractor Medical DirectorsPrivate Insurer PoliciesOther Contractor PoliciesBibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Co-published by National Institutes of Health (US), Bethesda (MD).The Genetics of Cancer. National Cancer Institute website. https://www.cancer.gov/about-cancer/causes-prevention/genetics. Published October 12, 2017. Accessed January 5, 2022 to April 7, 2022.Biomarker Testing for Cancer Treatment. National Cancer Institute website. https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment. Published October 5, 2017. Accessed January 5, 2022 to April 7, 2022.Califf RM. Biomarker definitions and their applications.Exp Biol Med (Maywood).2018;243(3):213-221. doi:10.1177/1535370217750088Joseph L, Cankovic M, Caughron S, et al. The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology.J Mol Diagn. 2016;18(5):605-619. doi:10.1016/j.jmoldx.2016.05.007

Local Coverage Determinations, LCD, Local policies, Genetic Testing for Oncology, DL39367

Use this page to view details for the Local Coverage Determination for Genetic Testing for Oncology.

PROPOSED

Proposed LCD - Genetic Testing for Oncology (DL39367)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39366&ver=10

lcd-39366-10-1.txt

1

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lcd

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FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Co-published by National Institutes of Health (US), Bethesda (MD).The Genetics of Cancer. National Cancer Institute website. https://www.cancer.gov/about-cancer/causes-prevention/genetics. Published October 12, 2017. Accessed January 5, 2022 to April 7, 2022.Biomarker Testing for Cancer Treatment. National Cancer Institute website. https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment. Published October 5, 2017. Accessed January 5, 2022 to April 7, 2022.Califf RM. Biomarker definitions and their applications.Exp Biol Med (Maywood).2018;243(3):213-221. doi:10.1177/1535370217750088Joseph L, Cankovic M, Caughron S, et al. The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology.J Mol Diagn. 2016;18(5):605-619. doi:10.1016/j.jmoldx.2016.05.007ClinGen. Explore the clinical relevance of genes & variants. https://www.clinicalgenome.org. Published May 2021. Updated January 2, 2022. Accessed January 5, 2022 to April 7, 2022.National Comprehensive Cancer Network (NCCN). Biomarkers Compendium. https://www.nccn.org/compendia-templates/compendia/biomarkers-compendium. Accessed January 5, 2022 to April 7, 2022.Chakravarty D, Gao J, Phillips SM, et al. OncoKB: A Precision Oncology Knowledge Base.JCO Precision Oncology. 2017;(1):1-16. doi:10.1200/po.17.00011Institute of Medicine (US) Committee to Advise the Public Health Service on Clinical Practice Guidelines, Field MJ, Lohr KN, eds.Clinical Practice Guidelines: Directions for a New Program. Washington (DC): National Academies Press (US); 1990.Development and Update of Guidelines. National Comprehensive Cancer Network website. https://www.nccn.org/guidelines/guidelines-process/development-and-update-of-guidelines. Accessed January 5, 2022 to April 7, 2022.Birkeland ML, McClure JS. Optimizing the Clinical Utility of Biomarkers in Oncology: The NCCN Biomarkers Compendium.Arch Pathol Lab Med. 2015;139(5):608-611. doi:10.5858/arpa.2014-0146-RAPoonacha TK, Go RS. Level of scientific evidence underlying recommendations arising from the National Comprehensive Cancer Network clinical practice guidelines.J Clin Oncol. 2011;29(2):186191. doi:10.1200/JCO.2010.31.6414Genetic Database Recognition Decision Summary for ClinGen Expert Curated Human Variant Data. US Food & Drug Administration. https://www.fda.gov/media/119313/download. Accessed January 5, 2022 to April 7, 2022.Hunter JE, Irving SA, Biesecker LG, et al. A standardized, evidence-based protocol to assess clinical actionability of genetic disorders associated with genomic variation.Genet Med. 2016 Dec;18(12):1258-1268. doi:10.1038/gim.2016.40FDA Recognition of Public Human Genetic Variant Databases. US Food & Drug Administration.FDA. https://www.fda.gov/medical-devices/precision-medicine/fda-recognition-public-human-genetic-variant-databases. Published online October 7, 2021. Accessed January 5, 2022 to April 7, 2022.Strande NT, Riggs ER, Buchanan AH, et al. Evaluating the Clinical Validity of Gene-Disease Associations: An Evidence-Based Framework Developed by the Clinical Genome Resource.The American Journal of Human Genetics.2017 Jun 1;100(6):895-906. doi:10.1016/j.ajhg. 2017.04.015Berg JS, Foreman AK, O'Daniel JM, et al. A semiquantitative metric for evaluating clinical actionability of incidental or secondary findings from genome-scale sequencing.Genet Med. 2016;18(5):467-475. doi:10.1038/gim.2015.104Genetic Database Recognition Decision Summary for OncoKB. US Food & Drug Administration. https://www.fda.gov/media/152847/download. Accessed January 5, 2022 to April 7, 2022.FDA Fact Sheet. US Food & Drug Administration. https://www.oncokb.org/levels#version=FDA_NGS. Updated March 29, 2022. Accessed January 5, 2022 to April 7, 2022.

Local Coverage Determinations, LCD, Local policies, MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer, DL38647

Use this page to view details for the Local Coverage Determination for MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer.

PROPOSED

Proposed LCD - MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DL38647)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39370&ver=4

lcd-39370-4-1.txt

1

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4

96451a56-80d7-4905-a6c8-ce58c6ce655c

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 Code of Federal Regulations (CFR) 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityThis contractor will cover molecular diagnostic tests for use in a beneficiary with bladder cancer when all of the following conditions are met:The beneficiary is being actively managed for bladder cancer.The beneficiary is within the population and has the indication for which the test was developed and is covered. The lab providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use.At least 1 of the 2 criteria are met:The patient is a candidate for multiple potential treatments, which could be considered to have varied or increasing levels of intensity based on a consensus guideline, and the physician and patient must decide among these treatments.ORThe patient is a candidate for multiple therapies, and the test has shown that it predicts response to specific therapy among accepted therapy options based on nationally recognized consensus guidelines.The test demonstrates analytical validity including both analytical and clinical validations. If the test relies on an algorithm (which may range in complexity from a threshold determination of a single numeric value to a complex mathematical or computational function), the algorithm must be validated in a cohort that is not a development cohort for the algorithm.The test has demonstrated clinical validity and utility, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision (in 4. above) in a clearly defined population.The test successfully completes a Molecular Diagnostic Program (MolDX) technical assessment that ensures the test is reasonable and necessary as described in 4 and 5 above.General InformationAssociated InformationN/ASources of InformationN/ABibliographySiegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021.CA Cancer J Clin.2021;71(1):7-33.Flaig TW, Spiess PE, Agarwal N, et al. Bladder cancer, version 3.2020, NCCN clinical practice guidelines in oncology.J Natl Compr Canc Netw.2020;18(3): 329-354.Svatek RS, Shariat SF, Novara G, et al. Discrepancy between clinical and pathological stage: external validation of the impact on prognosis in an international radical cystectomy cohort.BJU Int.2011;107(6):898-904.U.S. Food and Drug Administration (FDA).Balversa prescribing information. Accessed April 20, 2022.Helpap B. Morphology and therapeutic strategies for neuroendocrine tumors of the genitourinary tract.Cancer.2002;95(7):1415-1420.Ali SZ, Reuter VE, Zakowski MF. Small cell neuroendocrine carcinoma of the urinary bladder: a clinicopathologic study with emphasis on cytologic features.Cancer.1997;79(2):356-361.National Cancer Institute. Cancer Stat Facts: Bladder Cancer.https://seer.cancer.gov/statfacts/html/urinb.htmlAccessed April 20, 2022.Seiler R, Ashab HAD, Erho N, et al. Impact of molecular subtypes in muscle-invasive bladder cancer on predicting response and survival after neoadjuvant chemotherapy.Eur Urol.2017;72(4):544-554.Lotan Y, Boorjian SA, Zhang J, et al. Molecular subtyping of clinically localized urothelial carcinoma reveals lower rates of pathological upstaging at radical cystectomy among luminal tumors.Eur Urol.2019;76(2):200-206.Batista da Costa J, Gibb EA, Bivalacqua TJ, et al. Molecular characterization of neuroendocrine-like bladder cancer.Clin Cancer Res.2019;25(13):3908-3920.Fryback DG, Thornbury JR. The efficacy of diagnostic imaging.Med Decis Making.1991;11(2):88-94.Centers for Disease Control and Prevention. ACCE Model List of 44 Targeted Questions Aimed at a Comprehensive Review of Genetic Testing.https://www.cdc.gov/genomics/gtesting/acce/acce_proj.htm. Accessed April 20, 2022.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Bladder Cancer, Version 6.2021.https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed April 20, 2022.Ross JS, Wang K, Khaira D, et al. Comprehensive genomic profiling of 295 cases of clinically advanced urothelial carcinoma of the urinary bladder reveals a high frequency of clinically relevant genomic alterations.Cancer. 2016;122(5):702-711.Mori K, Abufaraj M, Mostafaei H, et al. A systemic review and meta-analysis of variant histology in urothelial carcinoma of the bladder treated with radical cystectomy.J Urol.2020;204(6):1129-1140.US Food and Drug Administration (FDA). Prescribing Information. BALVERSA (erdafitinib). 2020.https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212018s001lbl.pdf. Accessed April 20, 2022.Loriot Y, Necchi A, Park SH, et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma.N Engl J Med.2019;381(4):338-348.

Local Coverage Determinations, LCD, Local policies, MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer, DL38649

Use this page to view details for the Local Coverage Determination for MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer.

PROPOSED

Proposed LCD - MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DL38649)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39371&ver=4

lcd-39371-4-1.txt

1

39371

lcd

4

7c7c3c48-c13c-4462-a4df-da71a5e25999

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 Code of Federal Regulations (CFR) 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityThis contractor will cover molecular diagnostic tests for use in a beneficiary with bladder cancer when all of the following conditions are met:The beneficiary is being actively managed for bladder cancer.The beneficiary is within the population and has the indication for which the test was developed and is covered. The lab providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use.At least 1 of the 2 criteria are met:The patient is a candidate for multiple potential treatments, which could be considered to have varied or increasing levels of intensity based on a consensus guideline, and the physician and patient must decide among these treatments.ORThe patient is a candidate for multiple therapies, and the test has shown that it predicts response to a specific therapy among accepted therapy options based on nationally recognized consensus guidelines.The test demonstrates analytical validity including both analytical and clinical validations. If the test relies on an algorithm (which may range in complexity from a threshold determination of a single numeric value to a complex mathematical or computational function), the algorithm must be validated in a cohort that is not a development cohort for the algorithm.The test has demonstrated clinical validity and utility, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision (in 4. above) in a clearly defined population.The test successfully completes a Molecular Diagnostic Program (MolDX) technical assessment that ensures the test is reasonable and necessary as described in 4 and 5 above.General InformationAssociated InformationN/ASources of InformationN/ABibliographySiegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021.CA Cancer J Clin.2021;71(1):7-33.Flaig TW, Spiess PE, Agarwal N, et al. Bladder cancer, version 3.2020, NCCN clinical practice guidelines in oncology.J Natl Compr Canc Netw.2020;18(3): 329-354.Svatek RS, Shariat SF, Novara G, et al. Discrepancy between clinical and pathological stage: external validation of the impact on prognosis in an international radical cystectomy cohort.BJU Int.2011;107(6):898-904.U.S. Food and Drug Administration (FDA).Balversa prescribing information. Accessed April 20, 2022.Helpap B. Morphology and therapeutic strategies for neuroendocrine tumors of the genitourinary tract.Cancer.2002;95(7):1415-1420.Ali SZ, Reuter VE, Zakowski MF. Small cell neuroendocrine carcinoma of the urinary bladder: a clinicopathologic study with emphasis on cytologic features.Cancer.1997;79(2):356-361.National Cancer Institute. Cancer Stat Facts: Bladder Cancer.https://seer.cancer.gov/statfacts/html/urinb.htmlAccessed April 20, 2022.Seiler R, Ashab HAD, Erho N, et al. Impact of molecular subtypes in muscle-invasive bladder cancer on predicting response and survival after neoadjuvant chemotherapy.Eur Urol.2017;72(4):544-554.Lotan Y, Boorjian SA, Zhang J, et al. Molecular subtyping of clinically localized urothelial carcinoma reveals lower rates of pathological upstaging at radical cystectomy among luminal tumors.Eur Urol.2019;76(2):200-206.Batista da Costa J, Gibb EA, Bivalacqua TJ, et al. Molecular characterization of neuroendocrine-like bladder cancer.Clin Cancer Res.2019;25(13):3908-3920.Fryback DG, Thornbury JR. The efficacy of diagnostic imaging.Med Decis Making.1991;11(2):88-94.Centers for Disease Control and Prevention. ACCE Model List of 44 Targeted Questions Aimed at a Comprehensive Review of Genetic Testing.https://www.cdc.gov/genomics/gtesting/acce/acce_proj.htm. Accessed April 20, 2022.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Bladder Cancer, Version 6.2021.https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed April 20, 2022.Ross JS, Wang K, Khaira D, et al. Comprehensive genomic profiling of 295 cases of clinically advanced urothelial carcinoma of the urinary bladder reveals a high frequency of clinically relevant genomic alterations.Cancer. 2016;122(5):702-711.Mori K, Abufaraj M, Mostafaei H, et al. A systemic review and meta-analysis of variant histology in urothelial carcinoma of the bladder treated with radical cystectomy.J Urol.2020;204(6):1129-1140.US Food and Drug Administration (FDA). Prescribing Information. BALVERSA (erdafitinib). 2020.https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212018s001lbl.pdf. Accessed April 20, 2022.Loriot Y, Necchi A, Park SH, et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma.N Engl J Med.2019;381(4):338-348.

Local Coverage Determinations, LCD, Local policies, MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma, DL39389

Use this page to view details for the Local Coverage Determination for MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma.

PROPOSED

Proposed LCD - MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DL39389)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39388&ver=3

lcd-39388-3-1.txt

1

39388

lcd

3

ce981418-8687-482f-a73b-02db47969c3f

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary42 CFR 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityThe purpose of this test is to assist dermatopathologists to arrive at the correct diagnosis of melanoma versus non-melanoma when examining skin biopsies.This Medicare contractor will provide limited coverage for molecularDeoxyribonucleic acid (DNA)/Ribonucleic acid(RNA) assays that aid in the diagnosis or exclusion of melanoma from a biopsy when ALL of the following clinical conditions are met:The test is ordered by a board-certified or board-eligible dermatopathologistThe specimen is a primary (non-metastatic, non-re-excision specimen) cutaneous melanocytic neoplasm for which the diagnosis is equivocal/uncertain (i.e., clear distinction between benign or malignant cannot be achieved using clinical and/or histopathological features alone) despite the performance of standard-of-care test procedures and relevant ancillary tests (i.e., immunohistochemical stains)The specimen includes an area representative of the lesion or portion of the lesion that is suspicious for malignancyThe patient may be subjected to additional intervention, such as re-excision and/or sentinel lymph node biopsy, as a result of the diagnostic uncertaintyThe patient has not been tested with the same or similar assay for the same clinical indicationThe test is validated for use in the intended-use population and is performed according to its stated intended-useThe test demonstrates Analytical and Clinical Validity (AV and CV) and Clinical Utility (CU) and undergoes a technical assessment (TA) by MolDxto demonstrate compliance of the service with this policyTests that demonstrate similar indicated uses and equivalent or superior performance to covered tests may similarly be covered under this policy.General InformationAssociated InformationN/ASources of InformationN/ABibliographyAmerican Cancer Society. Key statistics for melanoma skin cancer.https://www.Cancer.Org/cancer/melanoma-skin-cancer/about/key-statistics.Html. Accessed 02/28/2022.American Cancer Society. Survival rates for melanoma skin cancer.https://www.Cancer.Org/cancer/melanoma-skin-cancer/detection-diagnosis-staging/survival-rates-for-melanoma-skin-cancer-by-stage.Html. Accessed 02/28/2022.Shoo BA, Sagebiel RW, Kashani-Sabet M. Discordance in the histopathologic diagnosis of melanoma at a melanoma referral center.Journal of the American Academy of Dermatology.2010;62(5):751-756.Veenhuizen KC, De Wit PE, Mooi WJ, Scheffer E, Verbeek AL, Ruiter DJ. Quality assessment by expert opinion in melanoma pathology: Experience of the pathology panel of the dutch melanoma working party.The Journal of Pathology.1997;182(3):266-272.Ronen S, Al-Rohil RN, Keiser E, et al. Discordance in diagnosis of melanocytic lesions and its impact on clinical management.Arch Pathol Lab Med.2021;145(12):1505-1515.Piepkorn MW, Longton GM, Reisch LM, et al. Assessment of second-opinion strategies for diagnoses of cutaneous melanocytic lesions.JAMA Network Open.2019;2(10):e1912597.Tosteson ANA, Tapp S, Titus LJ, et al. Association of second-opinion strategies in the histopathologic diagnosis of cutaneous melanocytic lesions with diagnostic accuracy and population-level costs.JAMA Dermatology.2021;157(9):1102-1106.Elder DE, Piepkorn MW, Barnhill RL, et al. Pathologist characteristics associated with accuracy and reproducibility of melanocytic skin lesion interpretation.Journal of the American Academy of Dermatology.2018;79(1):52-59.e55.Farmer ER, Gonin R, Hanna MP. Discordance in the histopathologic diagnosis of melanoma and melanocytic nevi between expert pathologists.Human Pathology.1996;27(6):528-531.Cerroni L, Barnhill R, Elder D, et al. Melanocytic tumors of uncertain malignant potential: Results of a tutorial held at the XXIX symposium of the International Society of Dermatopathology in Graz, October 2008.The American Journal of Surgical Pathology.2010;34(3):314-326.Hawryluk EB, Sober AJ, Piris A, et al. Histologically challenging melanocytic tumors referred to a tertiary care pigmented lesion clinic.Journal of the American Academy of Dermatology.2012;67(4):727-735.McGinnis KS, Lessin SR, Elder DE, et al. Pathology review of cases presenting to a multidisciplinary pigmented lesion clinic.Archives of Dermatology.2002;138(5):617-621.Warf MB, Flake DD II, Adams D, et al. Analytical validation of a melanoma diagnostic gene signature using formalin-fixed paraffin-embedded melanocytic lesions.Biomarkers in Medicine.2015;9(5):407-416.Clarke LE, Warf MB, Flake DD II, et al. Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma.Journal of Cutaneous Pathology.2015;42(4):244-252.Clarke LE, Flake DD II, Busam K, et al. An independent validation of a gene expression signature to differentiate malignant melanoma from benign melanocytic nevi.Cancer.2017;123(4):617-628.Ko JS, Matharoo-Ball B, Billings SD, et al. Diagnostic distinction of malignant melanoma and benign nevi by a gene expression signature and correlation to clinical outcomes.Cancer Epidemiology, Biomarkers & Prevention: A Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology.2017;26(7):1107-1113.Cockerell CJ, Tschen J, Evans B, et al. The influence of a gene expression signature on the diagnosis and recommended treatment of melanocytic tumors by dermatopathologists.Medicine.2016;95(40):e4887.Cockerell C, Tschen J, Billings SD, et al. The influence of a gene-expression signature on the treatment of diagnostically challenging melanocytic lesions.Personalized Medicine.2017;14(2):123-130.Clarke LE, Mabey B, Flake DD II, et al. Clinical validity of a gene expression signature in diagnostically uncertain neoplasms.Personalized Medicine.2020;17(5):361-371.Estrada SI, Cleaver NJ, Depcik-Smith N, et al. Development and validation of a diagnostic 35-gene expression profile test for ambiguous or difficult-to-diagnose suspicious pigmented skin lesions.SKIN J Cutaneous Med.2020;4(6):506-522.Minca EC, Al-Rohil RN, Wang M, et al. Comparison between melanoma gene expression score and fluorescence in situ hybridization for the classification of melanocytic lesions.Modern Pathology: An Official Journal of the United States and Canadian Academy of Pathology, Inc.2016;29(8):832-843.Farberg AS, Ahmed Kl, Bailey CN, et al. A 35-gene expression profile test for use in suspicious pigmented lesions impacts clinical management decisions of dermatopathologists and dermatologists.SKIN J Cutaneous Med.2020;4(6):523-533.North JP, Vemula SS, Bastian BC. Molecular Diagnostics for Melanoma: Methods and Protocols, in Methods in Molecular Biology. Vol. 1102. Thurin and Marincola (eds), Springer Science+Business Media 2014.Daz A, Valera A, Carrera C, et al. Pigmented spindle cell nevus: Clues for differentiating it from spindle cell malignant melanoma. A comprehensive survey including clinicopathologic, immunohistochemical, and fish studies.The American Journal of Surgical Pathology.2011;35(11):1733-1742.Absolo A, Vargas MT, Ros-Martn JJ, Trigo I, Arjona A, Gonzlez-Cmpora R. Application of fluorescence in situ hybridization as a diagnostic tool in melanocytic lesions, using paraffin wax-embedded tissues and imprint-cytology specimens.Clinical and Experimental Dermatology.2012;37(8):838-843.Clemente C, Bettio D, Venci A, et al. A fluorescence in situ hybridization (fish) procedure to assist in differentiating benign from malignant melanocytic lesions.Pathologica.2009;101(5):169-174.Gerami P, Jewell SS, Morrison LE, et al. Fluorescence in situ hybridization (fish) as an ancillary diagnostic tool in the diagnosis of melanoma.The American Journal of Surgical Pathology.2009;33(8):1146-1156.Gerami P, Li G, Pouryazdanparast P, et al. A highly specific and discriminatory fish assay for distinguishing between benign and malignant melanocytic neoplasms.The American Journal of Surgical Pathology.2012;36(6):808-817.Bastian BC, LeBoit PE, Hamm H, Brcker EB, Pinkel D. Chromosomal gains and losses in primary cutaneous melanomas detected by comparative genomic hybridization.Cancer Research.1998;58(10):2170-2175.Bastian BC, Olshen AB, LeBoit PE, Pinkel D. Classifying melanocytic tumors based on DNA copy number changes.The American Journal of Pathology.2003;163(5):1765-1770.Wang L, Rao M, Fang Y, et al. A genome-wide high-resolution array-cgh analysis of cutaneous melanoma and comparison of array-cgh to fish in diagnostic evaluation.J Mol Diagn.2013;15(5):581-591.Gaiser T, Kutzner H, Palmedo G, et al. Classifying ambiguous melanocytic lesions with fish and correlation with clinical long-term follow up.Modern Pathology: An Official Journal of the United States and Canadian Academy of Pathology, Inc.2010;23(3):413-419.Lezcano C, Jungbluth AA, Nehal KS, Hollmann TJ, Busam KJ. Prame expression in melanocytic tumors.The American Journal of Surgical Pathology.2018;42(11):1456-1465.Lezcano C, Jungbluth AA, Busam KJ. Comparison of immunohistochemistry for prame with cytogenetic test results in the evaluation of challenging melanocytic tumors.The American Journal of Surgical Pathology.2020;44(7):893-900.Ferris LK, Jansen B, Ho J, et al. Utility of a noninvasive 2-gene molecular assay for cutaneous melanoma and effect on the decision to biopsy.JAMA Dermatology.2017;153(7):675-680.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Melanoma - Cutaneous. Version 1.2022-dec 3, 2021. Melanoma_1_2021_101220.pdf.

Local Coverage Determinations, LCD, Local policies, Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers, DL35041

Use this page to view details for the Local Coverage Determination for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.

PROPOSED

Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39448&ver=6

lcd-39448-6-1.txt

1

39448

lcd

6

d67aeb10-39f9-408e-8598-9bdbcc012727

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for skin substitutes for the treatment of diabetic foot ulcers and venous leg ulcers. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for skin substitutes for the treatment of diabetic foot ulcers and venous leg ulcers and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.4.1 Approved Use of DrugCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 17, Section 40 Discarded Drugs and BiologicalsCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Code of Federal Regulations (CFR) References:CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue-based productsCoverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationThis LCD addresses the medically reasonable and necessary threshold for coverage of skin replacement surgery for application of skin substitute grafts for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).Application of skin substitute grafts for wound care indications other than for DFU or VLU are not addressed by this LCD. Use of skin substitute grafts must meet the medically reasonable and necessary threshold for coverage and these devices must be used in accordance with their approved United States (U.S.) Food and Drug Administration (FDA) intended use.Chronic wounds of the lower extremities, including venous stasis ulcers, DFUs and pressure sores, are a major public health problem. While lower extremity ulcers have numerous causes such as burns, trauma, mixed venous-arterial disease, immobility, and vasculitis, nutritional or other neuropathy, over 90% of the lesions in the U.S. are related to venous stasis disease and diabetic neuropathy.1-3Generally, depending on the purpose of the product and how it functions, skin substitutes are regulated by the FDA premarket approval (PMA) process, FDA 510(k) premarket notification process, or the FDA regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Although skin substitutes have attributes of both biologicals and devices, the current position is that these products are best characterized as surgical supplies or devices because of their required surgical application and their similarity to other surgical supplies. It has been noted that there are instances in which certain products might have a wound healing indication but may not necessarily meet the definition of skin substitutes. Therefore, FDA classification and indication alone does not determine if a product meets the definition of skin substitute and/or meets the medically reasonable and necessary threshold for coverage.Amniotic/chorionic-based products are HCT/Ps as defined in 21 CFR 1271.3(d) and must meet criteria in 21 CFR 1271 and 361 of the Public Health Service Act (PHS Act). The HCT/Ps not regulated under 361 are regulated as drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. In order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product's intended use.4-6Standard treatment of lower extremity ulcers (e.g., DFUs and/or VLUs) may include mechanical offloading, infection control, mechanical compression, limb elevation, debridement of necrotic tissue, management of systemic disease and medications, nutrition assessment, tissue perfusion and oxygenation, and counseling on the risk of continued tobacco use. In addition, maintenance of a moist wound environment through appropriate dressings facilitates development of healthy granulation tissue and epithelialization and thus may potentiate complete healing at a wound site. Dressings are an integral part of wound management by not only maintaining a moist environment but by stopping contamination and absorbing exudate.7-12Despite advancements in various synthetic occlusive dressings some ulcers fail to heal. The development of skin substitutes has been employed as an adjunct to established wound care methods to increase the chances of healing.1,13Chronic wounds and frequently recurring wounds related to DFUs and VLUs are a challenge to treat effectively. Chronic wounds may be unresponsive to initial therapy or persist despite additional care. A wound that has not healed within one to three months may be considered chronic and the application of a skin substitute graft, an advanced treatment modality, may be considered medically reasonable and necessary for certain patients.1-3Patients receiving skin replacement surgery with a skin substitute graft should be under the care of a physician/non-physician practitioner (NPP) for the treatment of their systemic disease process (e.g., diabetes mellitus, chronic venous insufficiency, and/or peripheral vascular disease). It is imperative that their systemic disease be monitored/treated in order to ensure adequate healing of the wound site.3,9It is the expectation that a specific skin substitute graft product will be used for the episode of skin replacement surgery for wound care (defined as 12 weeks from the first application of a skin substitute graft) assuming its use is not in conflict with the FDA assessments (e.g., indications, contraindications, how supplied and directions for use, etc.) and/or the American Association of Tissue Banks (AATB) approved use and assuming there is one related wound. Repeat application of a skin substitute graft within the 12-week episode of skin replacement surgery for wound care may be appropriate per the package insert based on wound re-assessment and must be supported in the medical record documentation for that encounter. Additional applications of a skin substitute product beyond the 12-week episode of skin replacement wound care are not expected if the wound has responded to the skin replacement surgery with epithelialization and other progression. This LCD does not endorse particular products for separate payment. The medical record documentation must support the medical necessity for skin replacement surgery and that the product is being used within its approved FDA indications.Covered IndicationsIf the patient meets all of the criteria as outlined in this LCD, application of a skin substitute graft for lower extremity DFU or VLU is considered medically reasonable and necessary for the following:The presence of a chronic, non-infected DFU having failed to respond to documented conservative wound care measures (outlined below) for greater than four weeks with documented compliance.7The presence of a chronic, non-infected VLU having failed to respond to documented conservative wound care measures (outlined below) for greater than four weeks with documented compliance.10For purposes of this LCD, conservative wound care measures include, but are not limited to2,7-12:Comprehensive patient assessment (history, exam, Ankle-Brachial Index [ABI]) and diagnostic tests as indicated) and implemented treatment plan.For patients with a DFU - assessment of Type 1 vs. Type 2 diabetes and management history with attention to certain comorbidities (e.g., vascular disease, neuropathy, osteomyelitis), review of current blood glucose levels/hemoglobin A1c (HbA1c), diet and nutritional status, activity level, physical exam that includes assessment of skin and wound, ABI, and check of off-loading device or assessment of appropriate footwear.3For patients with a VLU - assessment of clinical history (prior ulcers, thrombosis risks), physical exam (edema, skin changes), ABI, diagnostic testing to verify superficial or deep venous reflux, perforator incompetence, and chronic (or acute) venous thrombosis. In this regard, venous duplex ultrasound is recommended to confirm the Clinical class, Etiology, Anatomy, and Pathophysiology (CEAP) classification and categorize the patients chronic venous disorder to guide the analysis of management alternatives. The Venous Clinical Severity Score (VCSS) is used to assess changes in response to therapy.An implemented treatment plan demonstrating all of the following:Debridement as appropriate.Some form of offloading for DFUs and some form of compression for VLUs.Infection control.Management of exudate - maintenance of a moist environment (moist saline gauze, other classic dressings, bioactive dressing, etc.).Patient is a nonsmoker or has refrained from smoking for at least 6 weeks prior to planned skin replacement surgery or has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation.The skin substitute graft is applied to an ulcer that has failed to respond to documented conservative wound care measures. Failed response is defined as an ulcer that has increased in size or depth, or no change in baseline size or depth, or no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing). Documentation of response requires measurements of the initial ulcer, measurements at the completion of at least four weeks of conservative wound care measures, and measurements immediately prior to placement of the skin substitute graft for a DFU. For VLUs, conservative wound care measures must continue for no less than four weeks and include on-going compression therapy.7,10,13The medical record documentation specifically addresses the circumstances regarding why the wound has failed to respond to standard wound care treatment of greater than four weeks and references the specific interventions that have failed based on the prior wound evaluation. The record must include an updated medication history, review of pertinent medical problems that may have arisen since the previous wound evaluation, and explanation of the planned skin replacement surgery with choice of skin substitute graft product. The procedure risks and complications must also be reviewed and documented.7,10,13-14Skin substitute grafts utilized per the approved FDA intended use.The patient is under the care of a qualified physician/NPP for their underlying chronic condition.3,9LimitationsThe following are considered not medically reasonable and necessary1-3,9-10:Greater than two applications of a specific skin substitute graft product within the episode of skin replacement surgery for wound care (defined as 12 weeks from the first application of a skin substitute graft).The expectation is treatment will consist of the fewest repeat applications and amount of product to heal the wound. It is expected that products are used per the labeling. It is not expected that every ulcer, in every patient will require the maximum number of applications listed on the product label. This utilization pattern may be subject to focused medical review.Switching skin substitute graft products in a 12-week episode of skin replacement surgery for wound care. Exceptions should be rare and may be considered on appeal when the medical necessity of the change is clearly documented in the medical record.Application of a skin substitute graft product beyond 12-weeks.Repeat applications of skin substitute grafts when a previous application was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer, or no change in baseline size or depth and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing).Application of skin substitute grafts in patients with inadequate control of underlying conditions or exacerbating factors, or other contraindications (e.g., uncontrolled diabetes, active infection, active Charcot arthropathy of the ulcer extremity, active vasculitis).Use of surgical preparation services (for example, debridement), in conjunction with routine, simple and/or repeat skin replacement surgery with a skin substitute graft.Excessive wastage (discarded amount).The skin substitute graft must be used in an efficient manner utilizing the smallest package size available for purchase from the manufacturer that could provide the appropriate amount for the patient.All liquid skin substitute products for wound care.15Refer to the CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 for Human-derived products regulated as human cells, tissues, or cellular or tissue-based product (HCT/P) for additional limitations.Provider QualificationsServices provided within the LCD coverage indications will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117) for documentation requirements, utilization parameters and all coding information as applicable.Sources of Information

Local Coverage Determinations, LCD, Local policies, Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers, DL35041

Use this page to view details for the Local Coverage Determination for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.

PROPOSED

Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39448&ver=6

lcd-39448-6-1.txt

1

39448

lcd

6

1d828dd6-b8d8-4e04-b78e-6dc14c7f0f77

All liquid skin substitute products for wound care.15Refer to the CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 for Human-derived products regulated as human cells, tissues, or cellular or tissue-based product (HCT/P) for additional limitations.Provider QualificationsServices provided within the LCD coverage indications will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117) for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationN/ABibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.Pourmoussa A, Gardner DJ, Johnson MB, Wong AK. An update and review of cell-based wound dressings and their integration into clinical practice.Ann Transl Med. 2016 Dec;4(23):457. doi:10.21037/atm.2016.12.44.Snyder DL, Sullivan N, Margolis DJ, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Program Project ID No. WNDT0818. (Prepared by the ECRI Institute-Penn Medicine Evidence-based Practice Center under Contract No. HHSA 290-2015-00005-I) Rockville, MD:Agency for Healthcare Research and Quality. February 2020. http://www.ahrq.gov/research/findings/ta/index.html. Accessed April 27, 2021.Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds.Adv Wound Care. 2015 Sep 1;4(9):560-582. doi:10.1089/wound.2015.0635.U.S. Food and Drug Administration. Premarket Notification 510(k).Division of Industry and Consumer Education.March 2020. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k. Accessed December 9, 2021.U.S. Food and Drug Administration. FDA announces comprehensive regenerative medicine policy framework.FDA News Release. 2017 Nov 15. https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework. Accessed April 27, 2021.U.S. Food and Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use-Guidance for Industry and Food and Drug Administration Staff.Center for Biologics Evaluation and Research.Center for Devices and Radiological Health. Office of Combination Products. July 2020. https://www.fda.gov/media/109176/download. Accessed December 9, 2021.Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine.J Vasc Surg. 2016 Feb;63(2 Suppl):3S-21S. doi:10.1016/j.jvs.2015.10.003.Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines.Wound Repair Regen. 2016 Jan-Feb;24(1):112-26. doi:10.1111/wrr.12391.Marston W, Tang J, Kirsner RS, Ennis W. Wound Healing Society 2015 update on guidelines for venous ulcers.Wound Repair Regen. 2016 Jan-Feb;24(1):136-44. doi:10.1111/wrr.12394.O'Donnell TF Jr, Passman MA, Marston WA, et al; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.J Vasc Surg. 2014 Aug;60(2 Suppl):3S-59S. doi:10.1016/j.jvs.2014.04.049.Rayman G, Vas P, Dhatariya K, et al. International Working Group on the Diabetic Foot (IWGDF). Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update).Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3283. doi:10.1002/dmrr.3283.Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update).Diabetes Metab Res Rev.2020 Mar;36 Suppl 1:e3266. doi:10.1002/dmrr.3266.Agency for Healthcare Research and Quality (AHRQ). Evidence-based Practice Center Technical Brief Protocol. Project Title: Skin Substitutes for Treating Chronic Wounds. 2018 (rev 2019). https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/skin-substitute_0.pdf. Accessed April 20, 2021.Nathoo R, Howe N, Cohen G. Skin substitutes: an overview of the key players in wound management.J Clin Aesthet Dermatol. 2014;7(10):44-48.U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. July 2021. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies. Accessed February 16, 2022.Santema TB, Poyck PPC, Ubbink DT. Skin grafting and tissue replacement for treating foot ulcers in people with diabetes.Cochrane Database of Systematic Reviews. 2016, Issue 2. Art. No.: CD011255. doi:10.1002/14651858.CD011255.pub2.Jones JE, Nelson EA, Al-Hity A. Skin grafting for venous leg ulcers.Cochrane Database of Systematic Reviews2013, Issue 1. Art. No.: CD001737. doi:10.1002/14651858.CD001737.pub4.Barbul A, Gurtner GC, Gordon H, Bakewell K, Carter MJ. Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions.Wound Repair Regen. 2020 Jan;28(1):81-89. doi:10.1111/wrr.12767.Cazzell S, Vayser D, Pham H, et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator.Wound Repair Regen. 2017 May;25(3):483-497. doi:10.1111/wrr.12551.Driver VR, Lavery LA, Reyzelman AM, et al. A clinical trial of Integra Template for diabetic foot ulcer treatment.Wound Repair Regen. 2015 Nov-Dec;23(6):891-900. doi:10.1111/wrr.12357.Lavery LA, Fulmer J, Shebetka KA, et al; Grafix Diabetic Foot Ulcer Study Group. The efficacy and safety of Grafix) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial.Int Wound J.2014 Oct;11(5):554-60. doi:10.1111/iwj.12329.Sanders L, Landsman AS, Landsman A, et al. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft.Ostomy Wound Manage. 2014 Sep;60(9):26-38.Zelen CM, Orgill DP, Serena T, et al. A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers.Int Wound J. 2017 Apr;14(2):307-315. doi:10.1111/iwj.12600.Cazzell S. A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers.Wounds. 2019 Mar;31(3):68-74.Harding K, Sumner M, Cardinal M. A prospective, multicentre, randomised controlled study of human fibroblast-derived dermal substitute (Dermagraft) in patients with venous leg ulcers.Int Wound J. 2013 Apr;10(2):132-7. doi:10.1111/iwj.12053.Snyder DL, Sullivan N, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Report Project ID No. HCPR0610. (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No. HHSA 290-2007-10063) Rockville, MD:Agency for Healthcare Research and Quality. December 2012. https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf. Accessed June 11, 2021.

Local Coverage Determinations, LCD, Local policies, Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers, DL36377

Use this page to view details for the Local Coverage Determination for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.

PROPOSED

Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39451&ver=5

lcd-39451-5-1.txt

1

39451

lcd

5

83e212da-8835-4c3f-80c5-627b3c4b59d4

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for skin substitutes for the treatment of diabetic foot ulcers and venous leg ulcers. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for skin substitutes for the treatment of diabetic foot ulcers and venous leg ulcers and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.4.1 Approved Use of DrugCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 17, Section 40 Discarded Drugs and BiologicalsCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Code of Federal Regulations (CFR) References:CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue-based productsCoverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationThis LCD addresses the medically reasonable and necessary threshold for coverage of skin replacement surgery for application of skin substitute grafts for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).Application of skin substitute grafts for wound care indications other than for DFU or VLU are not addressed by this LCD. Use of skin substitute grafts must meet the medically reasonable and necessary threshold for coverage and these devices must be used in accordance with their approved United States (U.S.) Food and Drug Administration (FDA) intended use.Chronic wounds of the lower extremities, including venous stasis ulcers, DFUs and pressure sores, are a major public health problem. While lower extremity ulcers have numerous causes such as burns, trauma, mixed venous-arterial disease, immobility, and vasculitis, nutritional or other neuropathy, over 90% of the lesions in the U.S. are related to venous stasis disease and diabetic neuropathy.1-3Generally, depending on the purpose of the product and how it functions, skin substitutes are regulated by the FDA premarket approval (PMA) process, FDA 510(k) premarket notification process, or the FDA regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Although skin substitutes have attributes of both biologicals and devices, the current position is that these products are best characterized as surgical supplies or devices because of their required surgical application and their similarity to other surgical supplies. It has been noted that there are instances in which certain products might have a wound healing indication but may not necessarily meet the definition of skin substitutes. Therefore, FDA classification and indication alone does not determine if a product meets the definition of skin substitute and/or meets the medically reasonable and necessary threshold for coverage.Amniotic/chorionic-based products are HCT/Ps as defined in 21 CFR 1271.3(d) and must meet criteria in 21 CFR 1271 and 361 of the Public Health Service Act (PHS Act). The HCT/Ps not regulated under 361 are regulated as drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. In order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product's intended use.4-6Standard treatment of lower extremity ulcers (e.g., DFUs and/or VLUs) may include mechanical offloading, infection control, mechanical compression, limb elevation, debridement of necrotic tissue, management of systemic disease and medications, nutrition assessment, tissue perfusion and oxygenation, and counseling on the risk of continued tobacco use. In addition, maintenance of a moist wound environment through appropriate dressings facilitates development of healthy granulation tissue and epithelialization and thus may potentiate complete healing at a wound site. Dressings are an integral part of wound management by not only maintaining a moist environment but by stopping contamination and absorbing exudate.7-12Despite advancements in various synthetic occlusive dressings some ulcers fail to heal. The development of skin substitutes has been employed as an adjunct to established wound care methods to increase the chances of healing.1,13Chronic wounds and frequently recurring wounds related to DFUs and VLUs are a challenge to treat effectively. Chronic wounds may be unresponsive to initial therapy or persist despite additional care. A wound that has not healed within one to three months may be considered chronic and the application of a skin substitute graft, an advanced treatment modality, may be considered medically reasonable and necessary for certain patients.1-3Patients receiving skin replacement surgery with a skin substitute graft should be under the care of a physician/non-physician practitioner (NPP) for the treatment of their systemic disease process (e.g., diabetes mellitus, chronic venous insufficiency, and/or peripheral vascular disease). It is imperative that their systemic disease be monitored/treated in order to ensure adequate healing of the wound site.3,9It is the expectation that a specific skin substitute graft product will be used for the episode of skin replacement surgery for wound care (defined as 12 weeks from the first application of a skin substitute graft) assuming its use is not in conflict with the FDA assessments (e.g., indications, contraindications, how supplied and directions for use, etc.) and/or the American Association of Tissue Banks (AATB) approved use and assuming there is one related wound. Repeat application of a skin substitute graft within the 12-week episode of skin replacement surgery for wound care may be appropriate per the package insert based on wound re-assessment and must be supported in the medical record documentation for that encounter. Additional applications of a skin substitute product beyond the 12-week episode of skin replacement wound care are not expected if the wound has responded to the skin replacement surgery with epithelialization and other progression. This LCD does not endorse particular products for separate payment. The medical record documentation must support the medical necessity for skin replacement surgery and that the product is being used within its approved FDA indications.Covered IndicationsIf the patient meets all of the criteria as outlined in this LCD, application of a skin substitute graft for lower extremity DFU or VLU is considered medically reasonable and necessary for the following:The presence of a chronic, non-infected DFU having failed to respond to documented conservative wound care measures (outlined below) for greater than four weeks with documented compliance.7The presence of a chronic, non-infected VLU having failed to respond to documented conservative wound care measures (outlined below) for greater than four weeks with documented compliance.10For purposes of this LCD, conservative wound care measures include, but are not limited to2,7-12:Comprehensive patient assessment (history, exam, Ankle-Brachial Index [ABI]) and diagnostic tests as indicated) and implemented treatment plan.For patients with a DFU - assessment of Type 1 vs. Type 2 diabetes and management history with attention to certain comorbidities (e.g., vascular disease, neuropathy, osteomyelitis), review of current blood glucose levels/hemoglobin A1c (HbA1c), diet and nutritional status, activity level, physical exam that includes assessment of skin and wound, ABI, and check of off-loading device or assessment of appropriate footwear.3For patients with a VLU - assessment of clinical history (prior ulcers, thrombosis risks), physical exam (edema, skin changes), ABI, diagnostic testing to verify superficial or deep venous reflux, perforator incompetence, and chronic (or acute) venous thrombosis. In this regard, venous duplex ultrasound is recommended to confirm the Clinical class, Etiology, Anatomy, and Pathophysiology (CEAP) classification and categorize the patients chronic venous disorder to guide the analysis of management alternatives. The Venous Clinical Severity Score (VCSS) is used to assess changes in response to therapy.An implemented treatment plan demonstrating all of the following:Debridement as appropriate.Some form of offloading for DFUs and some form of compression for VLUs.Infection control.Management of exudate - maintenance of a moist environment (moist saline gauze, other classic dressings, bioactive dressing, etc.).Patient is a nonsmoker or has refrained from smoking for at least 6 weeks prior to planned skin replacement surgery or has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation.The skin substitute graft is applied to an ulcer that has failed to respond to documented conservative wound care measures. Failed response is defined as an ulcer that has increased in size or depth, or no change in baseline size or depth, or no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing). Documentation of response requires measurements of the initial ulcer, measurements at the completion of at least four weeks of conservative wound care measures, and measurements immediately prior to placement of the skin substitute graft for a DFU. For VLUs, conservative wound care measures must continue for no less than four weeks and include on-going compression therapy.7,10,13The medical record documentation specifically addresses the circumstances regarding why the wound has failed to respond to standard wound care treatment of greater than four weeks and references the specific interventions that have failed based on the prior wound evaluation. The record must include an updated medication history, review of pertinent medical problems that may have arisen since the previous wound evaluation, and explanation of the planned skin replacement surgery with choice of skin substitute graft product. The procedure risks and complications must also be reviewed and documented.7,10,13-14Skin substitute grafts utilized per the approved FDA intended use.The patient is under the care of a qualified physician/NPP for their underlying chronic condition.3,9LimitationsThe following are considered not medically reasonable and necessary1-3,9-10:Greater than two applications of a specific skin substitute graft product within the episode of skin replacement surgery for wound care (defined as 12 weeks from the first application of a skin substitute graft).The expectation is treatment will consist of the fewest repeat applications and amount of product to heal the wound. It is expected that products are used per the labeling. It is not expected that every ulcer, in every patient will require the maximum number of applications listed on the product label. This utilization pattern may be subject to focused medical review.Switching skin substitute graft products in a 12-week episode of skin replacement surgery for wound care. Exceptions should be rare and may be considered on appeal when the medical necessity of the change is clearly documented in the medical record.Application of a skin substitute graft product beyond 12-weeks.Repeat applications of skin substitute grafts when a previous application was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer, or no change in baseline size or depth and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing).Application of skin substitute grafts in patients with inadequate control of underlying conditions or exacerbating factors, or other contraindications (e.g., uncontrolled diabetes, active infection, active Charcot arthropathy of the ulcer extremity, active vasculitis).Use of surgical preparation services (for example, debridement), in conjunction with routine, simple and/or repeat skin replacement surgery with a skin substitute graft.Excessive wastage (discarded amount).The skin substitute graft must be used in an efficient manner utilizing the smallest package size available for purchase from the manufacturer that could provide the appropriate amount for the patient.All liquid skin substitute products for wound care.15Refer to the CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 for Human-derived products regulated as human cells, tissues, or cellular or tissue-based product (HCT/P) for additional limitations.Provider QualificationsServices provided within the LCD coverage indications will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA57680) for documentation requirements, utilization parameters and all coding information as applicable.Sources of Information

Local Coverage Determinations, LCD, Local policies, Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers, DL36377

Use this page to view details for the Local Coverage Determination for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.

PROPOSED

Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39451&ver=5

lcd-39451-5-1.txt

1

39451

lcd

5

37d1e883-b53c-4b04-8605-f655c7357d3b

All liquid skin substitute products for wound care.15Refer to the CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 for Human-derived products regulated as human cells, tissues, or cellular or tissue-based product (HCT/P) for additional limitations.Provider QualificationsServices provided within the LCD coverage indications will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA57680) for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationN/ABibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.Pourmoussa A, Gardner DJ, Johnson MB, Wong AK. An update and review of cell-based wound dressings and their integration into clinical practice.Ann Transl Med. 2016 Dec;4(23):457. doi:10.21037/atm.2016.12.44.Snyder DL, Sullivan N, Margolis DJ, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Program Project ID No. WNDT0818. (Prepared by the ECRI Institute-Penn Medicine Evidence-based Practice Center under Contract No. HHSA 290-2015-00005-I) Rockville, MD:Agency for Healthcare Research and Quality. February 2020. http://www.ahrq.gov/research/findings/ta/index.html. Accessed April 27, 2021.Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds.Adv Wound Care. 2015 Sep 1;4(9):560-582. doi:10.1089/wound.2015.0635.U.S. Food and Drug Administration. Premarket Notification 510(k).Division of Industry and Consumer Education.March 2020. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k. Accessed December 9, 2021.U.S. Food and Drug Administration. FDA announces comprehensive regenerative medicine policy framework.FDA News Release. 2017 Nov 15. https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework. Accessed April 27, 2021.U.S. Food and Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use-Guidance for Industry and Food and Drug Administration Staff.Center for Biologics Evaluation and Research. Center for Devices and Radiological Health. Office of Combination Products. July 2020. https://www.fda.gov/media/109176/download. Accessed December 9, 2021.Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine.J Vasc Surg. 2016 Feb;63(2 Suppl):3S-21S. doi:10.1016/j.jvs.2015.10.003.Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines.Wound Repair Regen. 2016 Jan-Feb;24(1):112-26. doi:10.1111/wrr.12391.Marston W, Tang J, Kirsner RS, Ennis W. Wound Healing Society 2015 update on guidelines for venous ulcers.Wound Repair Regen. 2016 Jan-Feb;24(1):136-44. doi:10.1111/wrr.12394.O'Donnell TF Jr, Passman MA, Marston WA, et al; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.J Vasc Surg. 2014 Aug;60(2 Suppl):3S-59S. doi:10.1016/j.jvs.2014.04.049.Rayman G, Vas P, Dhatariya K, et al. International Working Group on the Diabetic Foot (IWGDF). Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update).Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3283. doi:10.1002/dmrr.3283.Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update).Diabetes Metab Res Rev.2020 Mar;36 Suppl 1:e3266. doi:10.1002/dmrr.3266.Agency for Healthcare Research and Quality (AHRQ). Evidence-based Practice Center Technical Brief Protocol. Project Title: Skin Substitutes for Treating Chronic Wounds. 2018 (rev 2019). https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/skin-substitute_0.pdf. Accessed April 20, 2021.Nathoo R, Howe N, Cohen G. Skin substitutes: an overview of the key players in wound management.J Clin Aesthet Dermatol. 2014;7(10):44-48.U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. July 2021. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies. Accessed February 16, 2022.Santema TB, Poyck PPC, Ubbink DT. Skin grafting and tissue replacement for treating foot ulcers in people with diabetes.Cochrane Database of Systematic Reviews. 2016, Issue 2. Art. No.: CD011255. doi:10.1002/14651858.CD011255.pub2.Jones JE, Nelson EA, Al-Hity A. Skin grafting for venous leg ulcers.Cochrane Database of Systematic Reviews2013, Issue 1. Art. No.: CD001737. doi:10.1002/14651858.CD001737.pub4.Barbul A, Gurtner GC, Gordon H, Bakewell K, Carter MJ. Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions.Wound Repair Regen. 2020 Jan;28(1):81-89. doi:10.1111/wrr.12767.Cazzell S, Vayser D, Pham H, et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator.Wound Repair Regen. 2017 May;25(3):483-497. doi:10.1111/wrr.12551.Driver VR, Lavery LA, Reyzelman AM, et al. A clinical trial of Integra Template for diabetic foot ulcer treatment.Wound Repair Regen. 2015 Nov-Dec;23(6):891-900. doi:10.1111/wrr.12357.Lavery LA, Fulmer J, Shebetka KA, et al; Grafix Diabetic Foot Ulcer Study Group. The efficacy and safety of Grafix) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial.Int Wound J.2014 Oct;11(5):554-60. doi:10.1111/iwj.12329.Sanders L, Landsman AS, Landsman A, et al. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft.Ostomy Wound Manage. 2014 Sep;60(9):26-38.Zelen CM, Orgill DP, Serena T, et al. A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers.Int Wound J. 2017 Apr;14(2):307-315. doi:10.1111/iwj.12600.Cazzell S. A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers.Wounds. 2019 Mar;31(3):68-74.Harding K, Sumner M, Cardinal M. A prospective, multicentre, randomised controlled study of human fibroblast-derived dermal substitute (Dermagraft) in patients with venous leg ulcers.Int Wound J. 2013 Apr;10(2):132-7. doi:10.1111/iwj.12053.Snyder DL, Sullivan N, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Report Project ID No. HCPR0610. (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No. HHSA 290-2007-10063) Rockville, MD:Agency for Healthcare Research and Quality. December 2012. https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf. Accessed June 11, 2021.

Local Coverage Determinations, LCD, Local policies, Molecular Pathology Procedures, DL35000

Use this page to view details for the Local Coverage Determination for Molecular Pathology Procedures.

PROPOSED

Proposed LCD - Molecular Pathology Procedures (DL35000)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39503&ver=5

lcd-39503-5-1.txt

1

39503

lcd

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e9e2059c-5830-431d-9e19-fdb9ec329d60

CMS National Coverage PolicyN/ACoverage Indications, Limitations, and/or Medical NecessityMolecular pathology procedures have broad clinical and research applications. The following examples of applications may not be relevant to a Medicare beneficiary or may not meet a Medicare benefit category and/or reasonable and necessary threshold for coverage. Such examples include Genetic Testing and Genetic Counseling (when applicable) for: Disease Risk, Carrier Screening, Hereditary Cancer Syndromes, Gene Expression Profiling for certain cancers, Prenatal Diagnostic testing, Diagnosis and Monitoring Non-Cancer Indications, and Several Pharmacogenomic applications.This Local Coverage Determination (LCD) addresses the circumstances under which the item or service may be reasonable and necessary. For laboratory services, a service may be reasonable and necessary if the service is safe and effective; and appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis of the patient's condition; furnished in a setting appropriate to the patient's medical needs and condition; ordered and furnished by qualified personnel; one that meets, but does not exceed, the patient's medical need; and is at least as beneficial as an existing and available medically appropriate alternative.Many applications of the molecular pathology procedures are not covered services given lack of benefit category (e.g., preventive service or screening for a genetic abnormality in the absence of a suspicion of disease) and/or failure to the reasonable and necessary threshold for coverage (e.g., based on quality of clinical evidence and strength of recommendation or when the results would not reasonably be used in the management of a beneficiary). Furthermore, payment of claims in the past (based on stacking codes) or in the future (based on the new code series) is not a statement of coverage since the service may not have been audited for compliance with program requirements and documentation supporting the reasonable and necessary testing for the beneficiary. Certain molecular pathology procedures may be subject to prepayment medical review (records requested) and paid claims must be supportable, if selected, for post payment audit by the MAC or other contractors. Molecular pathology tests for diseases or conditions that manifest severe signs or symptoms in newborns and in early childhood or that result in early death (e.g., Canavan disease) could be subject to automatic denials since these tests are not usually relevant to a Medicare beneficiary.This LCD gives general guidance to the medically reasonable and necessary applications of the Molecular Pathology Procedures and Genomic Sequencing Procedures, described in Current Procedural Terminology (CPT).Coding guidance is provided inMolecular Pathology Procedures Article A56199, attached below.Indications:Molecular pathology procedures (Tier1 and Tier 2) may be eligible for coverage whenALLof the following criteria are met:Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are unavailable or results are clearly equivocal; ANDAvailability of a clinically valid test, based on published peer reviewed medical literature; ANDTesting assay(s) are Food and Drug Administration (FDA) approved/cleared or if LDT (lab developed test) or LDT protocol or FDA modified test(s) the laboratory documentation should support assay(s) of analytical validity and clinical utility; ANDResults of the testing must directly impact treatment or management of the Medicare beneficiary; ANDFor testing panels, including but not limited to, multiple genes or multiple conditions, and in cases where a tiered approach/method is clinically available, testing would be covered ONLY for the number of genes or test that are reasonable and necessary to obtain necessary information for therapeutic decision making; ANDIndividual has not previously received genetic testing for the disease/condition. (In general, diagnostic genetic testing for a disease should be performed once in a lifetime.) Exceptions include clinical scenarios whereby repeat testing of somatically-acquired mutations (for example, pre- and post- therapy) may be required to inform appropriate therapeutic decision-making.Limitations:Any procedures required prior to cell lysisshould be reported separately and utilization must be clearly supported based on the application and clinical utility. Such claims may be subject to prepayment medical review.The medically necessary interpretation and report of a molecular pathology test, written by a pathologist, which is above and beyond the report of standard laboratory results may not be reported by Non- physician practitioners (e.g., PhD, scientists etc.); only physicians are eligible to reportthis service.Testing for quality assurance component of the service is not separately billable.Indications and Limitations of CoverageABL1(ABL proto-oncogene 1, non-receptor tyrosine kinase) (eg, acquired imatinib tyrosine kinase inhibitor resistance), gene analysis, variants in the kinase domain is considered medically necessary in patients with acute lymphoblasic leukemia (ALL) and chronic myeloid leukemia (CML) to guide therapeutic decision making.ATP7Bis considered medically necessary in patients with symptoms of Wilsons disease to guide therapeutic decision making.BCR/ABLis indicated in patients with suspected CML with either persistent, unexplained leukocytosis or thrombocytosis. BCR/ABL is considered medically necessary in the evaluation of individuals with chronic myelogenous leukemia or BCR-ABL positive acute lymphoblastic leukemia to evaluate treated individuals who manifest suboptimal response to initial tyrosine kinase inhibitor therapy or loss of response to tyrosine kinase inhibitor therapy.BLM(Bloom syndrome, RecQ helicase-like)(e.g. Bloom syndrome) gene analysis, 2281 del6ins7 variant is considered medically necessary for a beneficiary who may have Bloom syndrome to confirm diagnosis and guide medical decision-making.BRAFgene analysis is considered medically necessary for patients who have malignant melanoma, non-small cell lung cancer, hairy cell leukemia, or metastatic colorectal cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical presentation.BRCA1 and BRCA2genetic testing is considered medically necessary for a beneficiary with a current diagnosis or a personal history of a cancer associated with the BRCA mutation who meets one or more of the criteria found in the most recent version of the NCCN guidelines for Genetic/Familial High-Risk Assessment: Breast and Ovarian or other evidence based guideline addressing genetic testing, and the results will be used to benefit the individual tested in terms of potential to guide therapeutic decision making.Cardiology (heart transplant), mRNA, gene expression profiling by real-time quantitative PCR of 20 genes (11 content and 9 housekeeping), utilizing subtraction of peripheral blood, algorithm reported as rejection risk score is considered medically necessary for heart transplant patients to guide therapeutic decision-making.CEBPA(CCAAT/enhancer binding protein [C/EBP], alpha) (eg, acute myeloid leukemia), full gene sequence is considered medically necessary in patients with acute myelogenous leukemia (AML) to guide therapeutic decision making.CALR(calreticulin) (eg, myeloproliferative disorders), gene analysis, common variants in exon 9 is considered medically necessary in the initial diagnostic work-up of BCR-ABL negative, JAK2-negative adults with clinical, laboratory, or pathological findings suggesting polycythemia vera (PV), essential thrombocythemia (ET) or primary myelofibrosis (PMF).CCND1/IGH(BCL1/IgH, t)(eg, mantle cell lymphoma) translocation analysis, major breakpoint, qualitative and quantitative, if performed is considered medical necessary for patients who have non- Hodgkins lymphoma to guide therapeutic decision-making.CFTR(cystic fibrosis transmembrane conductance regulator) (e.g.cystic fibrosis) gene analysis, common variants (e.g. ACMG/ACOG guidelines) is considered medically necessary for a beneficiary who has or may have cystic fibrosis to guide therapeutic decision-making.Chimerism analysisto identify appropriate donors and monitor engraftment success or disease reoccurrence is considered medically necessary.CYP2C619-cytochrome P450 CYP2C6 19-cytochrome P450 Based on the FDAs Black Box warning for clopidogrel, the effectiveness of clopidogrel is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. CYP2C619 genotyping may be medically necessary once per lifetime to identify individuals:Who are poor metabolizers of clopidogrel, so that alternative treatment or treatment strategies can be consideredWho are poor metabolizers of clopidogrel with acute coronary syndrome or who are undergoing percutaneous coronary interventionCYP2C9(cytochrome P450, family 2, subfamily D polypeptide 9) (e.g., drug metabolism), gene analysis, is only considered medically necessary for individuals who have relapsing forms of multiple sclerosis, and require CYP2C9 genotyping for dosing in accordance with the FDA prescribing information for Mayzent. CYP2C9 testing must include the *1, *2, and *3 alleles that are necessary to safely dose the FDA-approved drug Mayzent.CYP2D6(cytochrome P450, family 2, subfamily D polypeptide 6) (e.g., drug metabolism), gene analysis, is only considered medically necessary for individuals with Huntingtons disease for whom doses of tetrabenazine greater than 50 mg per day are being considered, and for testing prior to the initiation of CerdelgaTM(eliglustat) for Gauchers disease.EGFR(epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) [when specified as EGFR mutation analysis testing] EGFR testing is considered medically necessary as a technique to predict treatment response for individuals with non-small cell lung cancer undergoing treatment with EGFR tyrosine kinase inhibitor (TKI) therapy (for example, erlotinib [Tarceva ], gefitinib [Iressa ], or afatinib [Gilotrif ]).F2gene (prothrombin coagulation factor II) andF5gene (coagulation factor V) The F2 and F5 genetic tests are not considered to be clinically efficacious; therefore, testing is not medically necessary.FLT3is considered medically necessary in patients with acute myeloid leukemia (AML) to guide therapeutic decision making.Gene Testing for Warfarin ResponsePharmacogenomic Testing for Warfarin Response, gene testing onCYP2C9 and/or VKORC1see NCD 90.1 for coverage information.HFE(hemochromatosis)(hereditary hemochrosis) gene analysis, common variants (e.g. C282Y, H63D) is considered medically necessary in patients with iron overload of uncertain etiology (e.g. when the test is used to avoid liver biopsy in someone when the ferritin and the transferrin saturation are elevated greater than 45%). The genotyping of patients with iron overload of uncertain etiology is allowed only once per lifetime.HLAClass I or II typing is considered medically necessary when one of the following indications is met:Transplantation:Standard of care determination of HLA matching for solid organ transplant (donor/recipient). Solid organ transplant registries include both serological HLA testing (e.g., crossmatch) and genomic molecular DNA typing. Family members, or unrelated living donors or cadaveric donors who donate bone marrow or a solid organ are HLA tested pre-transplant to determine compatibility with the potential recipients.Standard of care determination of HLA matching for solid organ transplant (donor/recipient). Solid organ transplant registries include both serological HLA testing (e.g., crossmatch) and genomic molecular DNA typing. Family members, or unrelated living donors or cadaveric donors who donate bone marrow or a solid organ are HLA tested pre-transplant to determine compatibility with the potential recipients.Standard of care identification of determination of HLA matching for hematopoietic stem cell/bone marrow transplantation -allele-level typing will provide clinical guidance for the HLA-A,B,C Class I and DRB1, DQB1,DPB1, and DQA1 Class II loci in the average transplant program because it is well established that mismatches at certain HLA loci between donor-recipients are closely linked to the risk of graft versus host disease. Potential marrow donors may enroll with a national registry such as the United States National Marrow Donor Program or the Canadian Blood Services registry.Disease Association:Standard of care testing to diagnose certain HLA related diseases/conditions when the testing is supported by the clinical literature and is informative for the direct management of a patient bearing a certain allele(s). It is not expected that more than one test would be required in a given beneficiarys lifetime. Possible covered indications when standard laboratory testing (tissue typing) not adequate:HLA-B*27 for the diagnosis of certain cases of symptomatic patients with presumed ankylosing spondylitis or related inflammatory disease. HLA-B*27 is covered for ankylosing spondylitis in cases where other methods of diagnosis would not be appropriate or have yielded inconclusive results (NCD 190.1).In the work-up of certain patients with an unclear diagnosis of celiac disease and gluten hypersensitivity usually related to ambiguous standard laboratory results and/or inconsistent biopsy results (e.g., HLA-DQ2 by HLA-DQB1*02 and of DQ8 by HLA-DQB1*0302).Pharmacogenetics:Standard of care testing to diagnose certain HLA related drug hypersensitivity reactions when the testing is supported by the clinical literature and is informative for the direct management of a patient bearing a certain allele(s) associated to fatal skin drug reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis). It is not expected that more than one test would be required in a given beneficiarys lifetime. Possible covered indications:

Local Coverage Determinations, LCD, Local policies, Molecular Pathology Procedures, DL35000

Use this page to view details for the Local Coverage Determination for Molecular Pathology Procedures.

PROPOSED

Proposed LCD - Molecular Pathology Procedures (DL35000)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39503&ver=5

lcd-39503-5-1.txt

1

39503

lcd

5

51d1e213-3147-46dd-981a-f59ff15c5925

Pharmacogenetics:Standard of care testing to diagnose certain HLA related drug hypersensitivity reactions when the testing is supported by the clinical literature and is informative for the direct management of a patient bearing a certain allele(s) associated to fatal skin drug reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis). It is not expected that more than one test would be required in a given beneficiarys lifetime. Possible covered indications:HLA B*5701 when testing performed prior to the initiation of an abacavir-containing regime in the treatment of HIV Infection.HLA-B*1502 when genotyping may be useful for risk stratification when the testing is performed prior to the initiation of carbamazepine therapy in the treatment of patients at high risk of having this allele. HLA-B*1502 occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians.Identification of HLA compatible platelets for transfusion when standard typing is not adequate.HUMAN PLATELET ANTIGEN 1-15as genotyping for human platelet antigens is important for identifying woman at risk for neonatal alloimmune thrombocytopenia (NAIT). Post-transfusion purpura is an immune reaction against human platelet antigens, often occurring when a woman is sensitized during pregnancy, then subsequently receives a transfusion. There are few Medicare beneficiaries for whom this testing will be clinically actionable.IGH@ (Immunoglobulin heavy chain locus) is considered medically necessary for acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and lymphoma, B-cell to guide therapeutic decision making.JAK2 V617Fgenotyping is considered medically necessary in the initial diagnostic work-up of BCR-ABL negative, JAK2-negative adults with clinical, laboratory, or pathological findings suggesting myeloproliferative neoplasm (MPN) (polycythemia vera (PV), essential thrombocythemia (ET) or primary myelofibrosis (PMF)) or a myelodysplastic syndrome (MDS). Note: JAK2 (exons 12 and 13) (reported with 81403) is medically necessary in individuals for whom PV is a strong consideration.JAK2(Janus kinase 2) (eg, myeloproliferative disorder), exon 12 sequence and exon 13 sequence is considered medically necessary in the initial work-up of BCR-ABL and JAK2 (V617F variant) negative adults with clinical, laboratory, or pathological findings suggesting polycythemia vera.KIT(v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, gastrointestinal stromal tumor [GIST], acute myeloid leukemia, melanoma), gene analysis, targeted sequence analysis (eg, exons 8, 11, 13, 17, 18) is considered medically necessary in patients who have GIST, acute myeloid leukemia (AML) or melanoma to guide therapeutic decision making.KIT(v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, mastocytosis), gene analysis, D816 variant(s) is considered medically necessary in patients who have mastocytosis to guide therapeutic decision making.KRASgene analysis, variants in codons 12 and 13, is considered medically necessary in patients with colorectal cancer or non-small cell lung cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical presentation.KRAS(Kirsten rat sarcoma viral oncogene homolog) (e.g., carcinoma) gene analysis; additional variant(s) (e.g., codon 61, codon 146) is considered medically necessary in patients with colorectal cancer or non-small cell lung cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical presentation.MEN1(multiple endocrine neoplasia 1) (eg, multiple endocrine neoplasia type 1, Wermer syndrome), duplication/deletion and CPT code 81405 MEN1 (multiple endocrine neoplasia 1) e.g. multiple endocrine neoplasia type 1, Wermer syndrome), duplication/deletion analysis) are considered medically necessary in patients with multiple endocrine neoplasia to guide therapeutic decision-making.METproto-oncogene, receptor tyrosine kinase, is considered medically necessary in patients with non-small cell lung cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individuals specific clinical presentation.MGMT(O-6-methylguanine-DNA methyltransferase) (e.g., glioblastoma multiforme), methylation analysis) is considered medically necessary in patients with malignant brain neoplasm to guide therapeutic decision making.MPL(myeloproliferative leukemia virus oncogene, thrombopoietin receptor, TPOR) (eg, myeloproliferative disorder), common variants (eg, W515A, W515K, W515L, W515R) is considered medically necessary in the initial work-up of BCR-ABL negative, JAK2 negative, and CALR negative adults with clinical, laboratory, or pathological findings suggesting thrombocytosis, essential thrombocythemia (ET), or primary myelofibrosis (PMF).MPL(myeloproliferative leukemia virus oncogene, thrombopoietin receptor, TPOR) (eg, myeloproliferative disorder), exon 10 sequence is considered medically necessary in the initial work-up of BCR-ABL negative, JAK2 negative, and CALR negative adults with clinical, laboratory, or pathological findings suggesting thrombocytosis, essential thrombocythemia (ET), or primary myelofibrosis (PMF).MTHFR(5,10-methyenetetrahydrofolate reductase) (e.g. hereditary hypercoaguability), gene analysis, common variants(e.g., EG, 677T, 1298C) is not considered to be clinically efficacious; therefore, testing is not medically necessary.Microsatellite instability analysis(e.g., hereditary non-polyposis colorectal cancer, Lynch syndrome) of markers for mismatch repair deficiency (e.g. BAT25, BAT26), includes comparison of neoplastic and normal tissue and is considered medically necessary in individuals who have colorectal cancer (CRC) diagnosed at less than or equal to 70 years of age, and those greater than 70 years who meet the revised Bethesda Lynch Syndrome (LS) guidelines to guide therapeutic decision-making. Despite the high penetrance of CRC and endometrial cancer and recommendations of consideration for screening unaffected first-degree relatives following diagnosis of an LS proband, testing of genetic carriers who are unaffected with a Lynch- related cancer is not a Medicare benefit, and is statutorily excluded from coverage.MSI testing is also required by FDA for the clinical use of Keytruda (pembrolizumab) in a restricted population of patients. These are patients who have unresectable or metastatic solid tumors who have progressed following prior treatment and have no satisfactory alternative options. When Keytruda (pembrolizumab) is a potential clinically appropriate therapeutic choice, MSI testing is medically necessary in these patients. Because this is a wide-ranging population of advanced cancer patients, ICD-10 specificity is impractical, therefore use an ICD-10 appropriate for the tumor type and location.MYD88genetic test is considered medically necessary in patients with Marginal Zone Lymphoma (MZL), Waldenstroms Macroglobulinemia (WM) and Lymphoplasmacytic Lymphoma (LPL) to guide therapeutic decision-making.NPM1 (nucleophosmin) is considered medically necessary in patients with acute myeloid leukemia (AML) to guide therapeutic decision making.NRAS(neuroblastoma RAS viral [v-ras] oncogene homolog) (e.g., colorectal carcinoma), gene analysis, variants in exon 2 (e.g., codons 12 and 13) and exon 3 (e.g., codon 61) is considered medically necessary in patients with colorectal cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical presentation.Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score is considered medically necessary to guide therapeutic decision-making in patients with the following findings:estrogen-receptor positive, node-negative carcinoma of the breastestrogen-receptor positive micrometastases of carcinoma of the breast, andestrogen-receptor positive breast carcinoma with 1-3 positive nodes.PDGFRA(platelet-derived growth factor receptor, alpha polypeptide) (e.g., gastrointestinal stromal tumor [GIST]), gene analysis, targeted sequence analysis (eg, exons 12, 18) is considered medically necessary in patients with PDGFRA-associated chronic eosinophilic leukemia or GIST caused by mutations in the PDGFRA gene to guide therapeutic decision making.PML/RARALPHA, (T(15;17)), (PROMYELOCYTIC LEUKEMIA/RETINOIC ACID RECEPTOR ALPHA) (EG, PROMYELOCYTIC LEUKEMIA) TRANSLOCATION ANALYSIS; COMMON BREAKPOINTS (EG, INTRON 3 AND INTRON 6), QUALITATIVE OR QUANTITATIVE is considered medically necessary in patients with promyelocytic leukemia.Prosigna Breast Cancer Prognostic Gene Signature Assayis considered medically necessary in patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:A prognostic indicator for distant recurrence-free survival at 10 years in post- menopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.A prognostic indicator for distant recurrence-free survival at 10 years in post- menopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 positive nodes}, Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with 4 or more positive nodesRARS(SF3B1 mutation) is considered medically necessary in patients with Myelodysplastic Syndrome to guide therapeutic decision-making.RET(ret-proto-oncogene) is considered medically necessary in patients with medullary CA of thyroid, multiple endocrine neoplasia, pheochromocytoma, and parathyroid tumors) to guide therapeutic decision making.ROSproto-oncogene 1, receptor tyrosine kinase, is considered medically necessary in patients with non-small cell lung cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individuals specific clinical presentation.SERPINA1(serpin peptidase inhibitor, clade A, alpha-1- antiproteinase, antitrypsin, member 1) (e.g., antitrypsin deficiency), gene analysis, common variants (e.g. *S and *Z) is considered medically necessary for patients who have antitrypsin deficiency to guide therapeutic decision-making.Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5-50 genes (EG, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed is considered not medically necessary except when used to guide treatment decision making in individuals with non-small cell lung cancer (please refer to LCD L36376).TP53(tumor protein 53) (e.g. tumor samples), targeted sequence analysis of 2-5 exons, and CPT code 81405 TP53 (tumor protein 53) (e.g. Li-Fraumeni syndrome, tumor samples), full gene sequence or targeted sequence analysis of >5 exons are considered medically necessary in individuals who have Acute Myelogenous Leukemia, chronic lymphocytic leukemia (CLL), or Myelodysplastic Disease to guide therapeutic decision-making.TRB@ (T CELL antigen receptor, BETA) (e.g., leukemia and lymphoma), gene rearrangement analysis to detect abnormal cloning population(s); using amplification methodology is considered necessary to guide therapeutic decision-making for individuals with acute lymphoid leukemia, aplastic anemia, and T cell prolymphocytic leukemia.TRG@ (T CELL antigen receptor, GAMMA ) (e.g., leukemia and lymphoma), gene rearrangement analysis , evaluation to detect abnormal cloning population(s) are considered medically necessary to guide therapeutic decision-making for individuals with acute lymphoid leukemia, aplastic anemia, and T cell prolymphocytic leukemia and mastocytosis.Tier 2 Covered Gene/Gene CombinationsLimited coverage may be provided for specific genes reported below:ACEATP7B (ATPase, Cu++ transporting, beta polypeptide)CCND1/IGHCBFB-MYH11CDKN2A (cyclin-dependent kinase inhibitor 2A)E2A/PBX1EML4-ALKETV6-RUNX1EWSR1/ERGEWSR1/FLI1EWSR1/WT1F11coagulation factor XIF13BF5F7F8 (coagulation factor VIII)FGBFIP1L1-PDGFRFOXO1/PAX3

Local Coverage Determinations, LCD, Local policies, Molecular Pathology Procedures, DL35000

Use this page to view details for the Local Coverage Determination for Molecular Pathology Procedures.

PROPOSED

Proposed LCD - Molecular Pathology Procedures (DL35000)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39503&ver=5

lcd-39503-5-1.txt

1

39503

lcd

5

4b26d659-3764-410f-92d3-967e7576aeb0

TRG@ (T CELL antigen receptor, GAMMA ) (e.g., leukemia and lymphoma), gene rearrangement analysis , evaluation to detect abnormal cloning population(s) are considered medically necessary to guide therapeutic decision-making for individuals with acute lymphoid leukemia, aplastic anemia, and T cell prolymphocytic leukemia and mastocytosis.Tier 2 Covered Gene/Gene CombinationsLimited coverage may be provided for specific genes reported below:ACEATP7B (ATPase, Cu++ transporting, beta polypeptide)CCND1/IGHCBFB-MYH11CDKN2A (cyclin-dependent kinase inhibitor 2A)E2A/PBX1EML4-ALKETV6-RUNX1EWSR1/ERGEWSR1/FLI1EWSR1/WT1F11coagulation factor XIF13BF5F7F8 (coagulation factor VIII)FGBFIP1L1-PDGFRFOXO1/PAX3FOXO1/PAX7MEN1 (multiple endocrine neoplasia 1) (eg, multiple endocrine neoplasia type 1, Wermer syndrome), duplication/deletionMEN1 (multiple endocrine neoplasia 1) (eg, multiple endocrine neoplasia type 1, Wermer syndrome), full gene sequenceMUTYH (mutY homolog [E.coli])NPM/ALKPAX8/PPARGPRSS1 (protease, serine, 1 [trypsin 1])RARS (SF3B1RUNX1/RUNX1T1TP53 (tumor protein 53) (e.g. tumor samples), targeted sequence analysis of 2-5 exonsTP53 (tumor protein 53) (e.g. Li-Fraumeni syndrome, tumor samples), full gene sequence or targeted sequence analysis of >5 exonsVHL (von Hippel-Lindau tumor suppressor)Tier 2 Individual Review Codes/Gene CombinationsAny genetic test reported with a Tier 2 CPT code, not listed above or below, is subject to individual review.Tier 2 Non-covered Codes/Gene CombinationsThe following individual Tier 2 genetic tests are unlikely to impact therapeutic decision-making, directly impact treatment, outcome and/or clinical management in the care of the beneficiary and will be denied as not medically necessary (Please note that this list of non-covered genes is not exhaustive, and the fact that a specific gene is not mentioned does not mean it is covered. In addition, many genes have several names that are used. The most common names have been used in this policy):ABCC8ACADMACADS (acyl-CoA dehydrogenase)ACADVL (acyl-CoA dehydrogenase, very long chain)ADRB2AGTR1AIRE (APSI)AKT1ANG (angiogenin, ribonuclease, RNase A family, 5)APOEAQP2 (aquaporin 2 [collecting duct])AR (androgen receptor)ARX (aristaless related homeobox)ATN1BTD (biotinidase)C9orf72CASR (CAR, EIG8, extracellular calcium-sensing receptor, FHH, FIH, GPRC2A, HHC, HHC1, NSHPT, PCAR1)CAV3 (caveolin 3) (eg, CAV3-related distal myopathy, limb-girdle muscular dystrophy type 1C), full gene sequenceCBS (cystathionine-beta-synthase)CCR5CDKL5 (cyclin-dependent kinase-like 5)CFH/ARMS2Chromosome 18q-CLRN1CLRN1 (clarin 1)CYP1B1 (cytochrome P450, family 1, subfamily B, polypeptide 1)CYP21A2 (cytochrome P450, family 21, subfamily A, polypeptide2)CYP21A2DEK/NUP214DLAT (dihydrolipoamide S-acetyltransferase)DLD (dihydrolipoamide dehydrogenase)DMPK (dystrophia myotonica-protein kinase (DM gene and DM1)DMPK (dystrophia myotonica-protein kinase)DYT1 (TOR1A)EGR2 (early growth response 2) (eg, Charcot-Marie-Tooth)F8 (coagulation factor VIII)F8 (coagulation factor VIII)FGFR2 (fibroblast growth factor receptor 2) (2 EXONS)FGFR3FGFR3FGFR3 (fibroblast growth factor receptor 3) (4 EXONS)FGFR3 (fibroblast growth factor receptor 3) one exonFKRP (Fukutin related protein)FOXG1 (forkhead box G1)FSHMD1A (facioscapulohumeral muscular dystrophy 1A)FSHMD1A (facioscapulohumeral muscular dystrophy 1A)FXN (frataxin)GALT (galactose-1-phosphate uridylyltransferase)GALT (galactose-1-phosphate uridylyltransferase)GJB1 (gap junction protein, beta 1) (eg, Charcot-Marie-Tooth X-linked), full gene sequenceH19HADHA (hydroxyacyl-CoA dehydrogenase/3-ketoacyl-CoA thiolase/enoyl-CoA hydratase [trifunctional protein] alpha subunit)HAX1 (HAX1_HUMAN, HCLS1- associated protein X-1, HCLSBP1, HS1-associating protein X-1, HS1 binding protein, HS1-binding protein 1, HS1BP1, HSP1BP-1)HEXA (hexosaminidase A, alpha polypeptide)HNF1B (HNF1 homeobox B)HRAS (v-Ha-ras Harvey rat sarcoma viral oncogene homolog Costello syndrome)HRAS (v-Ha-ras Harvey rat sarcoma viral oncogene homolog)HTT (huntingtin)IL28BIVDKCNJ10 (potassium inwardly-rectifying channel, subfamily J, member 10)KCNQ10T1 (KCNQ1 overlapping transcript 1)KIF6Level 8 Molecular Pathology ProceduresLevel 9 Molecular Pathology ProceduresLMNA (lamin A/C)LPA intron 25 genotypeMEFV (Mediterranean fever) (eg, familial Mediterranean fever)MEG3/DLK1MEK1MLH1MLL/AFFMPZ (myelin protein zero)MT-ATP6MT-ND4, MT-ND6MT-ND5 mitochondrially encoded tRNA leucine 1 [UUA/G] mitochondrially encoded NADH dehydrogenase 5)MT-RNR1 (mitochondrially encoded 12S RNA)MT-RNR1 (mitochondrially encoded 12S RNA)MT-TK (mitochondrially encoded tRNA lysine)MT-TL1MT-TS1MT-TS1 (mitochondrially encoded tRNA serine 1)MUTYH (mutY homolog [E. coli])NF2 (neurofibromin 2 [merlin])NSD1 (nuclear receptor binding SET domain protein 1)PAH (phenylalanine hydroxylase)PAX2 (paired box 2)PDHA1 (pyruvate dehydrogenase [lipoamide] alpha1)PIK3C, PI3Ks, PI(3)Ks, PI-3KsPOLG (polymerase [DNA directed], gamma)PRKAG2 (protein kinase, AMP-activated, gamma 2 non-catalytic subunit)PRSS1 (protease, serine, 1 [trypsin 1])PTPN11 (protein tyrosine phosphatase, non-receptor type 11)RET (ret-proto-oncogene) (eg, Hirschsprung disease), full gene sequenceSCA1SDA2SLC25A4 (solute carrier family 25 [mitochondrial carrier; adenine nucleotide translocation]SLC9A6 (solute carrier family 9 [sodium/hydrogen exchanger] member 6)SMN1SMN1 (survival of motor neuron 1, telomeric)SMN1/SMN2 (survival of motor neuron 1, telomeric/survival of motor neuron 2, centromeric)SOS1 (son of sevenless homolog 1)SPG4TAZ (tafazzin)TOR1ATRDTSC1 (tuberous sclerosis 1)TSC2 (tuberous sclerosis 2)UBE3A (ubiquitin protein ligase)UPD (Uniparental disomy)VEGFR2 (CD309, FLK1, VEGFR)VWF (von Willebrand factor)General InformationAssociated InformationN/ASources of InformationAgency for Healthcare Research and Quality (AHRQ). Update for horizon scans of genetic tests currently available for clinical use in cancers. 2011. Tufts Evidence-based Practice Center.American Medical Association. Current procedural terminology (CPT) professional edition 2013.Centers for Disease Control and Prevention (CDC). Genomic testing: Genomic tests by level of evidence. 2013. http://www.cdc.gov/genomics/gtesting/Current Procedural Terminology (CPT), 2015 American Medical Association.Hampel H, Frankel WL, Martin E, et al. Screening for the Lynch syndrome (hereditary nonpolyposis colorectal cancer).New England Journal of Medicine.2005;352(18):1851-60.LCDs and policies from other Medicare contractors and private insurersLoupakis, F, Ruzzo A, Cremolini C, et al. KRAS codon 61, 146, and BRAF mutations predict resistance to cetuximab and irinotecan in KRAS codon 12 and 13, wild type metastatic colorectal cancer.BR J Cancer, 2009.101(4):p.715-721.Schmeler KM, Lynch HT, Chen L, et al. Prophylactic surgery to reduce the risk of gynecologic cancers in Lynch syndrome.New England Journal of Medicine.2006;354(3):261-269.Secretarys Advisory Committee on Genetics, Health, and Society. U.S. system of oversight of genetic testing: A response to the charge of the secretary of health and human services.Department of Health and Human Services.2008. http://www4.od.nih.gov/oba/sacghs/reports/SACGHS_oversight_report.pdfU.S. Preventive Services Task Force. Genetic risk assessment and BRCA mutation testing for breast and ovarian cancer susceptibility: Recommendation statement. 2005. http://www.uspreventiveservicestaskforce.org/uspstf05/brcagen/brcagenrs.htm.Vaughn, CP, Zobell SD, Furtado LV, et al. Frequency of KRAS, BRAF, and NRAS Mutations in Colorectal Cancer.Genes Chromosomes Cancer, 2011, 50(5): p. 307-312.Mesa R, Jamieson C, Bhatia R, et al. Myeloproliferative Neoplasms. NCCN Clinical Practice Guidelines in Oncology. 2017;Version 2.2018.BibliographyNCCN Clinical Practice Guidelines in Oncology: Chronic Myeloid Leukemia Version 3.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia Version 1.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Myeloproliferative Neoplasms Version 2.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes Version 2.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers NCCN V1.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas Version 3.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia Version 1.2018. 2018.MacDermott RP. 6-mercaptopurine (6-MP) metabolite monitoring and TPMT testing in patients with inflammatory bowel disease. 2017.UpToDateWyles DL. Predictors of response to antiviral therapy for chronic hepatitis C virus infection.UpToDateReconsideration Request-CPT Code 0007M March 2017

Local Coverage Determinations, LCD, Local policies, Molecular Pathology Procedures, DL35000

Use this page to view details for the Local Coverage Determination for Molecular Pathology Procedures.

PROPOSED

Proposed LCD - Molecular Pathology Procedures (DL35000)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39503&ver=5

lcd-39503-5-1.txt

1

39503

lcd

5

9f73ca04-b743-4965-824f-0068ac1febe9

BibliographyNCCN Clinical Practice Guidelines in Oncology: Chronic Myeloid Leukemia Version 3.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia Version 1.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Myeloproliferative Neoplasms Version 2.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes Version 2.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers NCCN V1.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas Version 3.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia Version 1.2018. 2018.MacDermott RP. 6-mercaptopurine (6-MP) metabolite monitoring and TPMT testing in patients with inflammatory bowel disease. 2017.UpToDateWyles DL. Predictors of response to antiviral therapy for chronic hepatitis C virus infection.UpToDateReconsideration Request-CPT Code 0007M March 2017Bodei L, Kidd M, Modlin IM, Severi S, Drozdov I, Nicolini S, Kwekkeboom DJ, Krenning EP, Baum RP, Paganelli G. Measurement of circulating transcripts and gene cluster analysis predicts and defines therapeutic efficacy of Peptide Receptor Radionuclide Therapy (PRRT) in neuroendocrine tumors.EJNMMI. 2016;43:839-851.Pavel M, Jann H, Prasad V, Drozdov I, Modlin IM, Kidd M. NET blood transcript analysis defines the crossing of the clinical Rubicon: when stable disease becomes progressive.Neuroendocrinology. 2017;104:180-182.Modlin IM, Frilling AF, Salem RR, Alaimo D, Drymousis P, Wasan HS, Callahan S, Faiz O, Weng L, Teixeira NS, Bodei L, Drozdov I, Kidd M. Blood measurements of neuroendocrine gene transcripts defines the effectiveness of surgical resection and ablation strategies.Surgery.2016;159:336-347.Cwikla JB, Bodei L, Cwikla A, Sankowski A, Alaimo D, Modlin IM, Kidd M. Gene Transcript analysis in advanced gastroenteropancreatic neuroendocrine tumors treated with somatostatin analogs defines stable and progressive disease.J Clin Endocrinol Metabolism. 2015;100:E1437-1445.Peczkowska M, Cwikla J, Kidd M, Lewczuk A, Kolasinska-Cwikla A, Niec D, Michalowska I, Prejbisz A, Januszewicz A, Chiarelli J, Bodei L, Modlin I. The clinical utility of circulating neuroendocrine gene transcript analysis in well-differentiated paragangliomas and pheochromocytomas.Eur J Endocrinol. 2017;176:143-157.Modlin IM, Drozdov I, Bodei L, Kidd M. Blood transcript analysis and metastatic recurrent small bowel carcinoid management. BMCCancer. 2014;14:564.Reconsideration Request- CPT Code 0007MJuly 2017Verbeek WH, Korse CM, Tesselaar ME. GEP-NETs UPDATE: Secreting gastro-enteropancreatic neuroendocrine tumours and biomarkers.Eur J Endocrinol. 2016;174(1):R1-7.Oberg K, Modlin IM, De Herder W, et al. Consensus on biomarkers for neuroendocrine tumour disease.Lancet Oncol. 2015;16(9):e435-e446.Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors. NCT02948946.https://clinicaltrials.gov/ct2/show/study/NCT02948946Aetna Number: 0352. Tumor Markers.http://www.aetna.com/cpb/medical/data/300_399/0352.htmlReconsideration Request- IGH and TP53 October 20221. NCCN Biomarker Compendium , accessed October 20, 2022

Local Coverage Determinations, LCD, Local policies, Special Histochemical Stains and Immunohistochemical Stains, DL35986

Use this page to view details for the Local Coverage Determination for Special Histochemical Stains and Immunohistochemical Stains.

PROPOSED

Proposed LCD - Special Histochemical Stains and Immunohistochemical Stains (DL35986)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39504&ver=6

lcd-39504-6-1.txt

1

39504

lcd

6

ae323c08-add5-4a5d-a659-1b65f84ba922

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 Code of Federal Regulations (CFR) 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.6.5 Surgical/Cytopathology ExceptionCoverage Indications, Limitations, and/or Medical NecessityThis policy does not designate specific special histochemical stains (aka special stains) and/or immunohistochemical (IHC) stains that should be used in the differential diagnosis of tissues or neoplasms because this information is readily available in textbooks and various scientific publications. This policy identifies the medically necessary criteria for the use of special stains and/or IHC stains and addresses, based on claims review, the scenarios that may be driving medically unnecessary over-utilization or incorrect billing of these services including:Reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine hematoxylin and eosin (H&E) stain by the pathologist, orUse of special stains and/or IHC stains without clinical evidence that the stain is actionable or provides the treating physician with information that changes patient management, orUse of added stains when the diagnosis is already known based on morphologic evaluation of the primary stain.The surgical pathology report is expected to designate the specific block(s) upon which IHC testing is performed, the reason and results for IHC testing, the specific markers, and whether single antibody(ies) or a cocktail of antibodies is utilized. A statement alone in the pathology report that states IHC confirms the diagnosis will not be covered as reasonable and necessary.General InformationAssociated InformationN/ASources of InformationN/ABibliographyAllred DC, Carlson RW, Berry DA, et al. NCCN task force report: estrogen receptor and progesterone receptor testing in breast cancer by immunohistochemistry.Journal of the National Comprehensive Cancer Network.2009;7(Suppl_6):S-1-S-21.Burstein HJ, Mangu PB, Somerfield MR, et al. American Society of Clinical Oncology clinical practice guideline update on the use of chemotherapy sensitivity and resistance assays.J Clin Oncol.2011;29(24):3328-3330.CAP. College of American Pathology Cancer Protocol Templates.https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates, 11/2/2020.Fitzgibbons PL, Dillon DA, Alsabeh R, et al. Template for reporting results of biomarker testing of specimens from patients with carcinoma of the breast.Archives of Pathology.2014;138(5):595-601.Allison KH, Hammond MEH, Dowsett M, et al. Estrogen and progesterone receptor testing in breast cancer: ASCO/CAP guideline update.Journal of Clinical Oncology.2020;38(12):1346-1366.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Breast Cancer Version 4.2022. 2022;https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf, 11/10/2022.Harbeck N, Rastogi P, Martin M, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study.Annals of oncology : official journal of the European Society for Medical Oncology.2021;32(12):1571-1581.Nielsen TO, Leung SCY, Rimm DL, et al. Assessment of Ki67 in Breast Cancer: Updated Recommendations From the International Ki67 in Breast Cancer Working Group.Journal of the National Cancer Institute.2021;113(7):808-819.Martinez AP, Cohen C, Hanley KZ, Li XB. Estrogen Receptor and Cytokeratin 5 Are Reliable Markers to Separate Usual Ductal Hyperplasia From Atypical Ductal Hyperplasia and Low-Grade Ductal Carcinoma In Situ.Archives of pathology & laboratory medicine.2016;140(7):686-689.Batts KP, Ketover S, Kakar S, et al. Appropriate use of special stains for identifying Helicobacter pylori: recommendations from the Rodger C. Haggitt Gastrointestinal Pathology Society.The American journal of surgical pathology2013;37(11):e12-e22.Chitkara Y. Upfront special staining for Helicobacter pylori in gastric biopsy specimens is not indicated.American journal of clinical pathology.2015;143(1):84-88.Wright CL, Kelly JK. The use of routine special stains for upper gastrointestinal biopsies.The American journal of surgical pathology2006;30(3):357-361.Hartman DJ, Owens SR. Are routine ancillary stains required to diagnose Helicobacter infection in gastric biopsy specimens? An institutional quality assurance review.American journal of clinical pathology.2012;137(2):255-260.Smith SB, Snow AN, Perry RL, Qasem SA. Helicobacter pylori: to stain or not to stain?American journal of clinical pathology.2012;137(5):733-738.Mvundura M, Grosse SD, Hampel H, Palomaki GE. The cost-effectiveness of genetic testing strategies for Lynch syndrome among newly diagnosed patients with colorectal cancer.Genetics in Medicine.2010;12(2):93-104.EGAPP. Recommendations from the EGAPP Working Group: genetic testing strategies in newly diagnosed individuals with colorectal cancer aimed at reducing morbidity and mortality from Lynch syndrome in relatives.Genetics in medicine : official journal of the American College of Medical Genetics.2009;11(1):35-41.Morais CL, Han JS, Gordetsky J, et al. Utility of PTEN and ERG immunostaining for distinguishing high grade PIN and intraductal carcinoma of the prostate on needle biopsy.The American journal of surgical pathology.2015;39(2):169.Epstein JI, Egevad L, Humphrey PA, Montironi R, Group IIiDUP. Best practices recommendations in the application of immunohistochemistry in the prostate: report from the International Society of Urologic Pathology consensus conference.The American journal of surgical pathology2014;38(8):e6-e19.Varma M, Jasani B. Diagnostic utility of immunohistochemistry in morphologically difficult prostate cancer: review of current literature.Histopathology.2005;47(1):1-16.Lotan TL, Gurel B, Sutcliffe S, et al. PTEN protein loss by immunostaining: analytic validation and prognostic indicator for a high risk surgical cohort of prostate cancer patients.Clinical cancer research.2011;17(20):6563-6573.Shah RB. Clinical applications of novel ERG immunohistochemistry in prostate cancer diagnosis and management.Advances in anatomic pathology2013;20(2):117-124.van Leenders G, van der Kwast TH, Grignon DJ, et al. The 2019 International Society of Urological Pathology (ISUP) Consensus Conference on Grading of Prostatic Carcinoma.The American journal of surgical pathology.2020;44(8):e87-e99.Travis WD, Brambilla E, Noguchi M, et al. Diagnosis of lung cancer in small biopsies and cytology: implications of the 2011 International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society classification.Archives of Pathology.2013;137(5):668-684.Pelosi G, Rindi G, Travis WD, Papotti M. Ki-67 antigen in lung neuroendocrine tumors: unraveling a role in clinical practice.Journal of thoracic oncology.2014;9(3):273-284.North American Neuroendocrine tumor society NANETS Guidelines 2022 edition.https://nanets.net/images/guidelines/21513_NANETS_2022_Guidelines_Compendium.pdf, 11/11/2022.National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer Version 3.2014.https://www.nccn.org/guidelines/category_1, 11/2/2020.

Local Coverage Determinations, LCD, Local policies, Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkins and Non-Hodgkins Lymphoma with B-cell or T-cell Origin, DL39513

Use this page to view details for the Local Coverage Determination for Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin.

PROPOSED

Proposed LCD - Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39513)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39512&ver=3

lcd-39512-3-1.txt

1

39512

lcd

3

5fa2920d-0516-4828-b6e0-f8bbcf51770d

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member.CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2,110.23 Stem Cell TransplantationCMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 310.1 Routine Costs in Clinical TrialsCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 3, 90.3 Stem Cell TransplantationCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing, Chapter 32, 90 Stem Cell Transplantation and 90.1 GeneralCoverage Indications, Limitations, and/or Medical NecessityStem celltransplantation is a process in which stem cellsare harvested from either a patients (autologous) or donors (allogeneic) bone marrow or peripheral blood for intravenous infusion. Autologousstem celltransplantation (AuSCT) is a technique for restoring stemcells using the patient's own previously stored cells. AuSCT must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a procedure in which a portion of a healthy donor's stem cells or bone marrow is obtained and prepared for intravenous infusion. Hematopoietic stem cells are multi-potent cells that give rise to all the blood cell types; these stem cells form blood and immune cells. A hematopoietic stem cell is a cell isolated from blood or bone marrow that can renew itself, differentiate to a variety of specialized cells, can mobilize out of the bone marrow into circulating blood, and can undergo programmed cell death, called apoptosis - a process by which cells that are unneeded or detrimental will self-destruct.The Centers for Medicare & Medicaid Services (CMS) has clarified that bone marrow and peripheral blood stem cell transplantation is a process which includes mobilization, harvesting, and transplant of bone marrow or peripheral blood stem cells and the administration of high dose chemotherapy or radiotherapy prior to the actual transplant. When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage.NCD 110.23 Stem Cell Transplantation covers allo-HSCT for the following conditions, when reasonable and necessary:LeukemiaAplastic AnemiaSevere Combined Immunodeficiency disease (SCID)Wiskott-Aldrich SyndromeAllo-HSCTis covered for Medicare beneficiaries with the following indications only when participating in approved prospective clinical studies meeting specific criteria under the Coverage with Evidence Development (CED) paradigm:Myelodysplastic SyndromesMultiple myeloma with Durie-Salmon Stage II or III disease, or International Staging System (ISS) Stage II or Stage III diseaseMyelofibrosis (MF) with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary disease; orSickle cell disease (SCD) that is severe and symptomatic(Please refer to CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual,Chapter 1, Part 2, 110.23 Stem Cell Transplantation)Per the NCD,all other indications forstemcelltransplantation not otherwise noted as covered or non-covered remain at local Medicare Administrative Contractor (MAC) discretion.This policy describes additional locally covered indications for allo-HSCT for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphomas with B-cell or T-cell origin that are medically necessary in patients for whom there are no other curative intent options.Documentation to support the reasonable and necessary nature of allo-HSCTs must speak to the serious illness of the patient, the reasons why the patient is considered to have relapsed or refractory disease, relevant clinical contextual information such as age, frailty, performance status, cardiopulmonary function, any associated organ dysfunction that could impact complications or recovery, screening for infectious diseases that could impact transplant care, nutritional status and patient specific psychosocial and financial support structures. Risk assessment scoring, such as the European Society for Blood and Bone Marrow Transplantation (EBMT) or the HCT Comorbidity Index (HCT-CI), should be strongly considered and in the case of any nationally covered indications per NCD 110.23 would of course be required.General InformationAssociated InformationN/ASources of InformationAmerican Society of HematologyAmerican Society for Transplantation and Cellular TherapyBibliographyShah NN, Ahn KW, Litovich C, et al. Outcomes for Medicare-age eligible NHL patients receiving RIC allogeneic transplantation: A CIBMTR analysis.Blood Advances.2018;2(8):933-940.Muffly L, Pasquini MC, Martens M, et al. Increasing use of allogeneic hematopoietic cell transplantation in patients aged 70 years and older in the United States.Blood. 2017;130(9):1156-1164.Majhail NS, Farnia SH, Carpenter PA, et al. Indications for autologous and allogeneic hematopoietic cell transplantation: Guidelines from the American society for blood and marrow transplantation.Biol Blood Marrow Transplant. 2015:21(11):1863-1869.Kharfan-Dabaja MA, Kumar A, Ayala E, et al. Clinical practice recommendations on indication and timing of hematopoietic cell transplantation in mature t cell and nk/t cell lymphomas: An international collaborative effort on behalf of the guidelines committee of the American society for blood and marrow transplantation.Biol Blood Marrow Transplant. 2017;23(11):1826-1838.DSouza A, Lee S, Zhu X, Pasquini M. Current use and trends in hematopoietic cell transplantation in the United States.Biol Blood Marrow Transplant. 2017;23(9):1417-1421.Kanate AS, Majhail NS, Savani BN, et al. Indications for Hematopoietic cell transplantation and immune effector cell therapy: Guidelines from the American society for transplantation and cellular therapy.Biol Blood Marrow Transplant.2020;26:1247-1256.Deeg HJ, Sandmaier BM. Determining eligibility for allogeneic hematopoietic transplantation. In: Rosmarin AG, ed.UpToDate.2022.Khouri IF, Champlin RE. Nonmyeloablative allogeneic stem cell transplantation for non-hodgkin lymphoma.Cancer J.2012;18(5):457-462.Bellei M, Foss FM, Shustov AR, et al. The outcome of peripheral T-cell lymphoma patients failing first-line therapy: A report from the prospective, international t-Cell project.Haematologica. 2018;103(7):1191-1197.

Local Coverage Determinations, LCD, Local policies, Cataract Surgery in Adults, DL34203

Use this page to view details for the Local Coverage Determination for Cataract Surgery in Adults.

PROPOSED

Proposed LCD - Cataract Surgery in Adults (DL34203)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39514&ver=5

lcd-39514-5-1.txt

1

39514

lcd

5

37917cc3-7071-4f2b-a408-d2903b604a09

CMS National Coverage PolicyTitle XVIII of the Social Security Act 1862(a)(7) excludes routine physical examinations.Title XVIII of the Social Security Act, 1862 (a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1833(e) prohibits Medicare Payment for any claim which lacks the necessary information to process the claim.Code of Federal Regulations 42 CFR CH.IV [411.15(b)(2)&(3)and(o)(1)&(2)] Services excluded from coverageCode of Federal Regulations 42 CFR CH. IV [416.65] Covered surgical proceduresCMS Manual System, Pub 100-03,Medicare National Coverage Determinations Manual,Chapter 1, Part 1, 80.10, Phaco-Emulsification Procedure-Cataract ExtractionCMS Manual System, Pub 100-04,Medicare Claims Processing ManualChapter 12, 40.6, 40.7, Claims for Multiple Surgeries, Claims for Bilateral SurgeriesCoverage Indications, Limitations, and/or Medical NecessityCataract is defined as an opacity or loss of optical clarity of the crystalline lens. Cataract development follows a continuum extending from minimal changes in the crystalline lens to the extreme stage of total opacity. Cataracts may be due to a variety of causes. Age-related cataract (senile cataract) is the most common type found in adults. Other types are pediatric (both congenital and acquired), traumatic, toxic and secondary (meaning the result of another disease process) cataract.Most cataracts are not visible to the naked eye until they become dense enough (mature or hypermature) to cause blindness. However, a cataract at any stage of development can be observed through a sufficiently dilated pupil using a slit lamp biomicroscope. In settings where this instrument is unavailable (e.g., skilled nursing facility), a direct ophthalmoscope can be used to assess the degree to which the fundus reflectivity (red reflex) is impaired by the ocular media. There is no scientifically proven medical (i.e., non-surgical) treatment for cataracts.In general, cataract surgery is performed to alleviate visual impairments attributable to lens opacity. There are uncommon situations when lens extraction becomes medically necessary for anatomic rather than optical reasons. These include lens induced angle closure (e.g., microspherophakia) and lens subluxation (e.g., Marfan syndrome). In other situations, cataract extraction might be medically indicated with relatively less opacity because of intolerable optical imbalance. Most commonly, this would be due to surgically induced anisometropia (a significant difference in refractive errors between the eyes) or aniseikonia (a difference in magnification as a result of prior lens extraction in the one eye). Some patients may elect lens removal and replacement primarily for refractive benefits to reduce their dependence on spectacles. Such elective procedures are not medically necessary and are called refractive lens exchanges to distinguish them from medically indicated cataract surgery. Finally, advanced cataracts may need to be removed to properly visualize, treat, and monitor retinal disease, apart from the patients visual symptoms and potential.This policy statement defines the medical necessity for cataract and other lens extraction in adults, and specifies the required documentation of the preoperative evaluation necessary to justify the procedure.MEDICAL NECESSITYLens extraction is considered medically necessary and therefore covered by Medicare when one (or more) of the following conditions or circumstances are documented in the medical record (see Documentation Requirements):Cataract causing symptomatic (i.e., causing the patient to seek medical attention) impairment of visual function not correctable with a tolerable change in glasses or contact lenses resulting in the patient's inability to function satisfactorily while performing Activities of Daily Life including, but not limited to reading, viewing television, driving, or meeting vocational or recreational needs.Concomitant intraocular disease (e.g., diabetic retinopathy or intraocular tumor) requiring monitoring or treatment that is prevented by the presence of cataract.Lens-induced disease threatening vision or ocular health (including, but not limited to, phacomorphic or phacolytic glaucoma).High probability of accelerating cataract development as a result of a concomitant or subsequent procedure (e.g., pars plana vitrectomy, iridocyclectomy, procedure for ocular trauma) and treatments such as external beam irradiation.Cataract interfering with the performance of vitreoretinal surgery.Intolerable anisometropia or aniseikonia uncorrectable with glasses or contact lenses that exists as a result of lens extraction in the first eye (despite satisfactorily corrected monocular visual acuity.Any circumstances not listed may be considered based on the standard of care and other factors related to medical necessity at redetermination.Surgery is not deemed to be medically necessary purely on the basis of lens opacity in the absence of symptoms.Visual AcuityThe Snellen visual acuity chart is an excellent way of measuring distance refractive error (e.g., myopia, hyperopia, astigmatism) in healthy eyes, and is in wide clinical use. However, testing only with high contrast letters viewed in dark room conditions will underestimate the functional impairments caused by some cataracts in common real-life situations such as day or nighttime glare conditions, poor contrast environments or reading, halos and starbursts at night, and impaired optical quality causing monocular diplopia and ghosting.While a single arbitrary objective measure might be desirable a specific Snellen visual acuity alone can neither rule in nor rule out the need for surgery. Visual acuity should be considered in the context of the patients visual impairment and other ocular findings.Specialized Ophthalmic TestingFor circumstances where the placement of an intraocular lens (IOL) is anticipated, A-scan ultrasound testing or partial coherence interferometry, keratometry (may be from corneal topography), and IOL calculations and selection would be anticipated to be performed.Additional ancillary testing as appropriate in the establishment or exclusion of medical necessity. This should be directed by specific patient complaint or symptom where possible.Certain testing wouldnotbe anticipated to be required in a pre-operative workup when performing routine cataract surgery. These include, but are not limited to:B-Scan/Ultrasound of the Posterior SegmentGlare TestingBrightness Acuity TestingLow-contrast visual acuity testingContrast sensitivity testingPotential vision testingFormal visual fieldsFluorescein angiographyExternal photographyCorneal pachymetry/specular microscopySpecialized color vision testsElectrophysiological testsHowever, there may be legitimate reasons to perform these tests. For example (other reasonable examples are possible):a.B-scan ultrasound testing would be medically necessary to assess such structures for the purpose of surgical decision-making in circumstances where an adequate view of the intraocular structures cannot be obtained because of dense cataract,b.Glaretesting/brightnessacuitytestingwouldbemedicallynecessaryinapatientwithacomplaintofdifficultydrivingatnight,andc.Corrected Snellen visual acuity testing under low-contrast conditions or formal contrast sensitivity testing would be medically necessary to uncover or demonstrate functional impairments correlated with the patient's symptoms.In general, any performed ancillary testing must be conducted so as not to deliberately bias the decision toward the performance of surgery (e.g., glare testing done on abnormally high settings inconsistent with the instructions of the testing devices manufacturer, etc.), and must have results and indications of medical necessary properly documented (see Documentation Requirements).Second Eye SurgeryShould a significant cataract also be present in the second eye, as supported byCataract in the Adult Eye,a Preferred Practice Pattern by the American Academy of Ophthalmology, except in special circumstances, surgery is generally not performed in both eyes at the same time because of the potential for bilateral visual loss.In the more common situation where surgery is performed sequentially in the other eye on separate days for bilateral visually symptomatic cataracts the appropriate interval between the first-eye surgery and second-eye surgery is influenced by several factors:The patient's visual needsThe patient's preferencesVisual function in the second eyeThe medical and refractive stability of the first eyeThe need to restore binocular vision and resolve anisometropia,An adequate interval of time has elapsed to evaluate and treat early postoperative complications in first eye, such as endophthalmitis; and/orLogistical and travel considerations of the patient.The patient and the ophthalmologist should discuss the benefits, risks, need, and timing of second-eye surgery when they have had the opportunity to evaluate the results of surgery on the first eye, taking into account the above factors.If the decision to perform cataract extraction in both eyes is made prior to the first (sequential) cataract extraction, the documentation must support the medical necessity for each procedure to be performed.Complex Cataract SurgeryNote that a procedure coded as Complex Cataract Surgery must meet all other requirements for Cataract Surgery as outlined in the Billing and Coding Article A57195General InformationAssociated InformationN/ASources of InformationAmerican Academy of Ophthalmology. Cataract and Anterior Segment Panel. Cataract in the Adult Eye Preferred Practice Pattern. San Francisco, CA. 2016.Gayer S, Zuleta J. Perioperative Management of the Elderly Undergoing Eye Surgery.Clinics in Geriatric Medicine.2008;24(4):687-700.Yanoff M, Duker JS.Yanoff & Duker:Ophthalmology.3rd ed. Mosby, An Imprint of Elsevier. 2008.American Academy of Ophthalmology, American Society of Cataract and Refractive Surgery, et al. Utilization, Appropriate Care, and Quality of Life for Patients with Cataracts.Ophthalmology.2006;113(10):1878-82.BibliographyN/A

Local Coverage Determinations, LCD, Local policies, Cataract Surgery in Adults, DL37027

Use this page to view details for the Local Coverage Determination for Cataract Surgery in Adults.

PROPOSED

Proposed LCD - Cataract Surgery in Adults (DL37027)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39515&ver=5

lcd-39515-5-1.txt

1

39515

lcd

5

ee39c884-3ff2-4f35-a4ce-b3469c3d0ab8

CMS National Coverage PolicyTitle XVIII of the Social Security Act 1862(a)(7) excludes routine physical examinations.Title XVIII of the Social Security Act, 1862 (a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1833(e) prohibits Medicare Payment for any claim which lacks the necessary information to process the claim.Code of Federal Regulations 42 CFR CH.IV [411.15(b)(2)&(3)and(o)(1)&(2)] Services excluded from coverageCode of Federal Regulations 42 CFR CH. IV [416.65] Covered surgical proceduresCMS Manual System, Pub 100-03,Medicare National Coverage Determinations Manual,Chapter 1, Part 1, 80.10, Phaco-Emulsification Procedure-Cataract ExtractionCMS Manual System, Pub 100-04,Medicare Claims Processing ManualChapter 12, 40.6, 40.7, Claims for Multiple Surgeries, Claims for Bilateral SurgeriesCoverage Indications, Limitations, and/or Medical NecessityCataract is defined as an opacity or loss of optical clarity of the crystalline lens. Cataract development follows a continuum extending from minimal changes in the crystalline lens to the extreme stage of total opacity. Cataracts may be due to a variety of causes. Age-related cataract (senile cataract) is the most common type found in adults. Other types are pediatric (both congenital and acquired), traumatic, toxic and secondary (meaning the result of another disease process) cataract.Most cataracts are not visible to the naked eye until they become dense enough (mature or hypermature) to cause blindness. However, a cataract at any stage of development can be observed through a sufficiently dilated pupil using a slit lamp biomicroscope. In settings where this instrument is unavailable (e.g., skilled nursing facility), a direct ophthalmoscope can be used to assess the degree to which the fundus reflectivity (red reflex) is impaired by the ocular media. There is no scientifically proven medical (i.e., non-surgical) treatment for cataracts.In general, cataract surgery is performed to alleviate visual impairments attributable to lens opacity. There are uncommon situations when lens extraction becomes medically necessary for anatomic rather than optical reasons. These include lens induced angle closure (e.g., microspherophakia) and lens subluxation (e.g., Marfan syndrome). In other situations, cataract extraction might be medically indicated with relatively less opacity because of intolerable optical imbalance. Most commonly, this would be due to surgically induced anisometropia (a significant difference in refractive errors between the eyes) or aniseikonia (a difference in magnification as a result of prior lens extraction in the one eye). Some patients may elect lens removal and replacement primarily for refractive benefits to reduce their dependence on spectacles. Such elective procedures are not medically necessary and are called refractive lens exchanges to distinguish them from medically indicated cataract surgery. Finally, advanced cataracts may need to be removed to properly visualize, treat, and monitor retinal disease, apart from the patients visual symptoms and potential.This policy statement defines the medical necessity for cataract and other lens extraction in adults, and specifies the required documentation of the preoperative evaluation necessary to justify the procedure.MEDICAL NECESSITYLens extraction is considered medically necessary and therefore covered by Medicare when one (or more) of the following conditions or circumstances are documented in the medical record (see Documentation Requirements):Cataract causing symptomatic (i.e., causing the patient to seek medical attention) impairment of visual function not correctable with a tolerable change in glasses or contact lenses resulting in the patient's inability to function satisfactorily while performing Activities of Daily Life including, but not limited to reading, viewing television, driving, or meeting vocational or recreational needs.Concomitant intraocular disease (e.g., diabetic retinopathy or intraocular tumor) requiring monitoring or treatment that is prevented by the presence of cataract.Lens-induced disease threatening vision or ocular health (including, but not limited to, phacomorphic or phacolytic glaucoma).High probability of accelerating cataract development as a result of a concomitant or subsequent procedure (e.g., pars plana vitrectomy, iridocyclectomy, procedure for ocular trauma) and treatments such as external beam irradiation.Cataract interfering with the performance of vitreoretinal surgery.Intolerable anisometropia or aniseikonia uncorrectable with glasses or contact lenses that exists as a result of lens extraction in the first eye (despite satisfactorily corrected monocular visual acuity.Any circumstances not listed may be considered based on the standard of care and other factors related to medical necessity at redetermination.Surgery is not deemed to be medically necessary purely on the basis of lens opacity in the absence of symptoms.Visual AcuityThe Snellen visual acuity chart is an excellent way of measuring distance refractive error (e.g. myopia, hyperopia, astigmatism) in healthy eyes, and is in wide clinical use. However, testing only with high contrast letters viewed in dark room conditions will underestimate the functional impairments caused by some cataracts in common real-life situations such as day or nighttime glare conditions, poor contrast environments or reading, halos and starbursts at night, and impaired optical quality causing monocular diplopia and ghosting.While a single arbitrary objective measure might be desirable a specific Snellen visual acuity alone can neither rule in nor rule out the need for surgery. Visual acuity should be considered in the context of the patients visual impairment and other ocular findings.Specialized Ophthalmic TestingFor circumstances where the placement of an intraocular lens (IOL) is anticipated, A-scan ultrasound testing or partial coherence interferometry, keratometry (may be from corneal topography), and IOL calculations and selection would be anticipated to be performed.Additional ancillary testing as appropriate in the establishment or exclusion of medical necessity. This should be directed by specific patient complaint or symptom where possible.Certain testing wouldnotbe anticipated to be required in a pre-operative workup when performing routine cataract surgery. These include, but are not limited to:B-Scan/Ultrasound of the Posterior SegmentGlare TestingBrightness Acuity TestingLow-contrast visual acuity testingContrast sensitivity testingPotential vision testingFormal visual fieldsFluorescein angiographyExternal photographyCorneal pachymetry/specular microscopySpecialized color vision testsElectrophysiological testsHowever, there may be legitimate reasons to perform these tests. For example (other reasonable examples are possible):a.B-scan ultrasound testing would be medically necessary to assess such structures for the purpose of surgical decision-making in circumstances where an adequate view of the intraocular structures cannot be obtained because of dense cataract,b.Glaretesting/brightnessacuitytestingwouldbemedicallynecessaryinapatientwithacomplaintofdifficultydrivingatnight,andc.Corrected Snellen visual acuity testing under low-contrast conditions or formal contrast sensitivity testing would be medically necessary to uncover or demonstrate functional impairments correlated with the patient's symptoms.In general, any performed ancillary testing must be conducted so as not to deliberately bias the decision toward the performance of surgery (e.g., glare testing done on abnormally high settings inconsistent with the instructions of the testing devices manufacturer, etc.), and must have results and indications of medical necessary properly documented (see Documentation Requirements).Second Eye SurgeryShould a significant cataract also be present in the second eye, as supported byCataract in the Adult Eye,a Preferred Practice Pattern by the American Academy of Ophthalmology, except in special circumstances, surgery is generally not performed in both eyes at the same time because of the potential for bilateral visual loss.In the more common situation where surgery is performed sequentially in the other eye on separate days for bilateral visually symptomatic cataracts the appropriate interval between the first-eye surgery and second-eye surgery is influenced by several factors:The patient's visual needsThe patient's preferencesVisual function in the second eyeThe medical and refractive stability of the first eyeThe need to restore binocular vision and resolve anisometropia,An adequate interval of time has elapsed to evaluate and treat early postoperative complications in first eye, such as endophthalmitis; and/orLogistical and travel considerations of the patient.The patient and the ophthalmologist should discuss the benefits, risks, need, and timing of second-eye surgery when they have had the opportunity to evaluate the results of surgery on the first eye, taking into account the above factors.If the decision to perform cataract extraction in both eyes is made prior to the first (sequential) cataract extraction, the documentation must support the medical necessity for each procedure to be performed.Complex Cataract SurgeryNote that a procedure coded as Complex Cataract Surgery must meet all other requirements for Cataract Surgery as outlined in Billing and Coding Article A57196General InformationAssociated InformationN/ASources of InformationAmerican Academy of Ophthalmology. Cataract and Anterior Segment Panel. Cataract in the Adult Eye Preferred Practice Pattern. San Francisco, CA. 2016.Gayer S, Zuleta J. Perioperative Management of the Elderly Undergoing Eye Surgery.Clinics in Geriatric Medicine.2008;24(4):687-700.Yanoff M, Duker JS.Yanoff & Duker:Ophthalmology.3rd ed. Mosby, An Imprint of Elsevier. 2008.American Academy of Ophthalmology, American Society of Cataract and Refractive Surgery, et al. Utilization, Appropriate Care, and Quality of Life for Patients with Cataracts.Ophthalmology.2006;113(10):1878-82.BibliographyNA

Local Coverage Determinations, LCD, Local policies, Transcranial Magnetic Stimulation (TMS), DL37086

Use this page to view details for the Local Coverage Determination for Transcranial Magnetic Stimulation (TMS).

PROPOSED

Proposed LCD - Transcranial Magnetic Stimulation (TMS) (DL37086)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39516&ver=4

lcd-39516-4-1.txt

1

39516

lcd

4

56bd15b0-035c-4aa9-b2b3-5578d66972c2

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA) 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.Social Security Act:1862 (a) (1)(A) Medically Reasonable & Necessary1862 (a) (1)(D) & (E) Investigational or ExperimentalCoverage Indications, Limitations, and/or Medical NecessityTranscranial Magnetic Stimulation (TMS) is a non-invasive method of brain stimulation. The technique involves placement of a small electromagnetic coil over the scalp and applying a rapidly alternating current through the coil wire which produces a magnetic field that passes unimpeded through the brain. Depending on stimulation parameters (frequency, intensity, pulse duration, stimulation site), repetitive TMS (rTMS) to specific cortical regions can either increase or decrease the excitability of the affected brain structures. The procedure is usually carried out in an outpatient setting and does not require anesthesia or analgesia.When used as an antidepressant therapy, TMS produces a clinical benefit without the systemic side effects attendant with standard oral medications. TMS does not have adverse effects on cognition. Unlike electroconvulsive therapy (ECT), rTMS does not induce amnesia or seizures.Indications for CoverageTMS may be covered if prescribed and administered by a licensed physician under direct supervision who is trained and experienced in the use of repetitive transcranial magnetic stimulation. Outpatient rTMS may be indicated for patients with DSM-IV defined Major Depressive Disorder who have failed to benefit from initial treatment of their depression.Initial TreatmentLeft Prefrontal rTMS of the brain is considered medically necessary for use in an adult who has a confirmed diagnosis of severe Major Depressive Disorder (MDD) single or recurrent episode; andOne or more of the following:Resistance to treatment with psychopharmacologic agents as evidenced by a lack of a clinically significant response to one trial of psychopharmacologic agents in the current depressive episode from at least two different agent classes. Each agent in the treatment trial must have been administered at an adequate course of mono- or poly- drug therapy; orInability to tolerate psychopharmacologic agents as evidenced by two trials of psychopharmacologic agents from at least two different agent classes, with distinct side effects; orHistory of response to rTMS in a previous depressive episode; orIf patient is currently receiving electro-convulsive therapy, rTMS may be considered reasonable and necessary as a less invasive treatment option.ANDA trial of an evidence-based psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration without significant improvement in depressive symptoms as documented by standardized rating scales that reliably measure depressive symptoms.ANDThe order for treatment (or retreatment) is written by a psychiatrist (MD or DO) who has examined the patient and reviewed the record. The physician will have experience in administering TMS therapy. The treatment shall be given under direct supervision of this physician (physician present in the area but does not necessarily personally provide the treatment).Coverage LimitationsThe benefits of TMS use must be carefully considered against the risk of potential side effects in patients with any of the following:Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence); orPresence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; orNeurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system, orPresence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items including, but not limited to a cochlear implant, implanted cardiac defibrillator (ICD), pacemaker, Vagus nerve stimulator (VNS), or metal aneurysm clips or coils, staples or stents. (Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with TMS).All other uses of Transcranial Magnetic Stimulation are considered experimental or investigational and are not allowed reimbursement per Statute XVIII, 1862 (a) (1)(D) & (E).RetreatmentRetreatment may be considered for patients who met the guidelines for initial treatment and subsequently developed relapse of depressive symptoms if the patient responded to prior treatments as evidenced by a greater than 50% improvement in standard rating scale measurements for depressive symptoms.All other uses of TMS therapy are considered investigational or experimental and remain non-covered services.General InformationAssociated InformationN/ASources of InformationOther Contractors LCDsBibliographyClinical TMS Society: Coverage Guidance for TMS for OCD. 2021; https://www.clinicaltmssociety.org/news/2021-02/ctmss-recommended-ocd-policy. Accessed Nov. 11, 2021.Perera MPN, Mallawaarachchi S, Miljevic A, Bailey NW, Herring SE, Fitzgerald PB. Repetitive Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Meta-analysis of Randomized, Sham-Controlled Trials. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021;6(10):947-960.Liang K, Li H, Bu X, et al. Efficacy and tolerability of repetitive transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder in adults: a systematic review and network meta-analysis. Transl Psychiatry. 2021;11(1):332.Homan S, Muscat W, Joanlanne A, et al. Treatment effect variability in brain stimulation across psychiatric disorders: A meta-analysis of variance. Neuroscience and biobehavioral reviews. 2021;124:54-62.Acevedo N, Bosanac P, Pikoos T, Rossell S, Castle D. Therapeutic Neurostimulation in Obsessive-Compulsive and Related Disorders: A Systematic Review. Brain sciences. 2021;11(7).Bijanki KR, Pathak YJ, Najera RA, et al. Defining functional brain networks underlying obsessive-compulsive disorder (OCD) using treatment-induced neuroimaging changes: a systematic review of the literature. Journal of neurology, neurosurgery, and psychiatry. 2021;92(7):776-786.Rapinesi C, Kotzalidis GD, Ferracuti S, Sani G, Girardi P, Del Casale A. Brain Stimulation in Obsessive-Compulsive Disorder (OCD): A Systematic Review. Curr Neuropharmacol. 2019;17(8):787-807.Marques RC, Vieira L, Marques D, Cantilino A. Transcranial magnetic stimulation of the medial prefrontal cortex for psychiatric disorders: a systematic review. Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999). 2019;41(5):447-457.Zhou DD, Wang W, Wang GM, Li DQ, Kuang L. An updated meta-analysis: Short-term therapeutic effects of repeated transcranial magnetic stimulation in treating obsessive-compulsive disorder. J Affect Disord. 2017;215:187-196.Euser AM, Stapert AF, Oosterhoff M, van Balkom IDC, Figee M. [Transcranial magnetic stimulation in obsessive compulsive disorder: a systematic review]. Tijdschr Psychiatr. 2017;59(10):617-625.Trevizol AP, Shiozawa P, Cook IA, et al. Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: An Updated Systematic Review and Meta-analysis. The journal of ECT. 2016;32(4):262-266.Ma ZR, Shi LJ. Repetitive transcranial magnetic stimulation (rTMS) augmentation of selective serotonin reuptake inhibitors (SSRIs) for SSRI-resistant obsessive-compulsive disorder (OCD): a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2014;7(12):4897-4905.Rehn S, Eslick GD, Brakoulias V. A Meta-Analysis of the Effectiveness of Different Cortical Targets Used in Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Obsessive-Compulsive Disorder (OCD). Psychiatr Q. 2018;89(3):645-665.Berlim MT, Neufeld NH, Van den Eynde F. Repetitive transcranial magnetic stimulation (rTMS) for obsessive-compulsive disorder (OCD): an exploratory meta-analysis of randomized and sham-controlled trials. J Psychiatr Res. 2013;47(8):999-1006.Martin JL, Barbanoj MJ, Perez V, Sacristan M. Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder. Cochrane Database Syst Rev. 2003(3):CD003387.Fontenelle LF, Coutinho ES, Lins-Martins NM, Fitzgerald PB, Fujiwara H, Yucel M. Electroconvulsive therapy for obsessive-compulsive disorder: a systematic review. J Clin Psychiatry. 2015;76(7):949-957.Lusicic A, Schruers KR, Pallanti S, Castle DJ. Transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: current perspectives. Neuropsychiatr Dis Treat. 2018;14:1721-1736.Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018;11(1):158-165.Carmi L, Tendler A, Bystritsky A, et al. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019;176(11):931-938.Elbeh KAM, Elserogy YMB, Khalifa HE, Ahmed MA, Hafez MH, Khedr EM. Repetitive transcranial magnetic stimulation in the treatment of obsessive-compulsive disorders: Double blind randomized clinical trial. Psychiatry Res. 2016;238:264-269.Dutta P, Dhyani M, Garg S, et al. Efficacy of intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS) in Obsessive Compulsive Disorder: A Randomized Placebo Controlled Study. Psychiatry Res. 2021;298:113784.Badawy AA, El Sawy H. Efficacy of repetitive transcranial magnetic stimulation in the management of obsessive compulsive disorder.NICE: Transcranial magnetic stimulation for obsessive-compulsive disorder | Interventional Procedures Guidance. 2020; https://www.nice.org.uk/guidance/ipg676/resources/transcranial-magnetic-stimulation-for-obsessivecompulsive-disorder-pdf-1899874288332997. Accessed Nov. 10, 2021.UpToDate: Technique for performing transcranial magnetic stimulation (TMS). https://www.uptodate.com/contents/technique-for-performing-transcranial-magnetic-stimulation-tms/print?search=Transcranial%20Magnetic%20Stimulation%20&source=search_result&selectedTitle=2~71&usage_type=default&display_rank=2. Accessed Nov. 10, 2021.ECRI Clinical Evidence Assessment: Transcranial Magnetic Stimulation for Treating Adults with Obsessive-compulsive Disorder. 2021; https://www.ecri.org/components/Hotline/Pages/210287.aspx. Accessed Nov. 11, 2021.Social Security Administration. Social Security Act 1862. Exclusions From Coverage and Medicare as Secondary Payer. Compilation Of The Social Security Laws 2021; Accessed 3/11/22.

Local Coverage Determinations, LCD, Local policies, Transcranial Magnetic Stimulation (TMS), DL37086

Use this page to view details for the Local Coverage Determination for Transcranial Magnetic Stimulation (TMS).

PROPOSED

Proposed LCD - Transcranial Magnetic Stimulation (TMS) (DL37086)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39516&ver=4

lcd-39516-4-1.txt

1

39516

lcd

4

76907ba2-c0cc-4b80-ba23-4b3b0a93106f

Additional literature reviewed but not citedRepetitive Transcranial Magnetic - StimulationPosition Statement 79. 2018; https://www.ranzcp.org/news-policy/policy-and-advocacy/position-statements/repetitive-transcranial-magnetic-stimulation. Accessed Nov. 23, 2021.Hamani C, Pilitsis J, Rughani AI, et al. Deep brain stimulation for obsessive-compulsive disorder: systematic review and evidence-based guideline sponsored by the American Society for Stereotactic and Functional Neurosurgery and the Congress of Neurological Surgeons (CNS) and endorsed by the CNS and American Association of Neurological Surgeons. Neurosurgery. 2014;75(4):327-333; quiz 333.Reddy JYC, Sundar AS, Narayanaswamy JC, Math SB. Clinical practice guidelines for Obsessive-Compulsive Disorder. Indian J Psychiatry. 2017;59(Suppl 1):S74-S90.Koran LM, Hanna GL, Hollander E, Nestadt G, Simpson HB. Practice Guideline for the Treatment of Patients with Obessive-Compulsive Disorder. 2007; https://psychiatryonline.org/guidelines. Accessed Nov. 24, 2021.Katzman MA, Bleau P, Blier P, Chokka P, Kjernisted K, Van Ameringen MJBp. Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders. 2014;14(1):1-83.Rossi S, Antal A, Bestmann S, et al. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines.Clinical Neurophysiology. 2021;132(1):269-306.Allan CL, Herrmann LL, Ebmeier KP. Transcranial Magnetic Stimulation in Management of Mood Disorders.Neuropsychobiology. 2011;64(3)163-9.

Local Coverage Determinations, LCD, Local policies, Transcranial Magnetic Stimulation (TMS), DL37088

Use this page to view details for the Local Coverage Determination for Transcranial Magnetic Stimulation (TMS).

PROPOSED

Proposed LCD - Transcranial Magnetic Stimulation (TMS) (DL37088)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39517&ver=3

lcd-39517-3-1.txt

1

39517

lcd

3

f9b48fa4-edaf-4027-b790-74460574bc58

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA) 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.Social Security Act:1862 (a) (1)(A) Medically Reasonable & Necessary1862 (a) (1)(D) & (E) Investigational or ExperimentalCoverage Indications, Limitations, and/or Medical NecessityTranscranial Magnetic Stimulation (TMS) is a non-invasive method of brain stimulation. The technique involves placement of a small electromagnetic coil over the scalp and applying a rapidly alternating current through the coil wire which produces a magnetic field that passes unimpeded through the brain. Depending on stimulation parameters (frequency, intensity, pulse duration, stimulation site), repetitive TMS (rTMS) to specific cortical regions can either increase or decrease the excitability of the affected brain structures. The procedure is usually carried out in an outpatient setting and does not require anesthesia or analgesia.When used as an antidepressant therapy, TMS produces a clinical benefit without the systemic side effects attendant with standard oral medications. TMS does not have adverse effects on cognition. Unlike electroconvulsive therapy (ECT), rTMS does not induce amnesia or seizures.Indications for CoverageTMS may be covered if prescribed and administered by a licensed physician under direct supervision who is trained and experienced in the use of repetitive transcranial magnetic stimulation. Outpatient rTMS may be indicated for patients with DSM-IV defined Major Depressive Disorder who have failed to benefit from initial treatment of their depression.Initial TreatmentLeft Prefrontal rTMS of the brain is considered medically necessary for use in an adult who has a confirmed diagnosis of severe Major Depressive Disorder (MDD) single or recurrent episode; andOne or more of the following:Resistance to treatment with psychopharmacologic agents as evidenced by a lack of a clinically significant response to one trial of psychopharmacologic agents in the current depressive episode from at least two different agent classes. Each agent in the treatment trial must have been administered at an adequate course of mono- or poly- drug therapy; orInability to tolerate psychopharmacologic agents as evidenced by two trials of psychopharmacologic agents from at least two different agent classes, with distinct side effects; orHistory of response to rTMS in a previous depressive episode; orIf patient is currently receiving electro-convulsive therapy, rTMS may be considered reasonable and necessary as a less invasive treatment option.ANDA trial of an evidence-based psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration without significant improvement in depressive symptoms as documented by standardized rating scales that reliably measure depressive symptoms.ANDThe order for treatment (or retreatment) is written by a psychiatrist (MD or DO) who has examined the patient and reviewed the record. The physician will have experience in administering TMS therapy. The treatment shall be given under direct supervision of this physician (physician present in the area but does not necessarily personally provide the treatment).Coverage LimitationsThe benefits of TMS use must be carefully considered against the risk of potential side effects in patients with any of the following:Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence); orPresence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; orNeurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system, orPresence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items including, but not limited to a cochlear implant, implanted cardiac defibrillator (ICD), pacemaker, Vagus nerve stimulator (VNS), or metal aneurysm clips or coils, staples or stents. (Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with TMS).All other uses of Transcranial Magnetic Stimulation are considered experimental or investigational and are not allowed reimbursement per Statute XVIII, 1862 (a) (1)(D) & (E).RetreatmentRetreatment may be considered for patients who met the guidelines for initial treatment and subsequently developed relapse of depressive symptoms if the patient responded to prior treatments as evidenced by a greater than 50% improvement in standard rating scale measurements for depressive symptoms.All other uses of TMS therapy are considered investigational or experimental and remain non-covered services.General InformationAssociated InformationN/ASources of InformationOther Contractors LCDsBibliographyClinical TMS Society: Coverage Guidance for TMS for OCD. 2021; https://www.clinicaltmssociety.org/news/2021-02/ctmss-recommended-ocd-policy. Accessed Nov. 11, 2021.Perera MPN, Mallawaarachchi S, Miljevic A, Bailey NW, Herring SE, Fitzgerald PB. Repetitive Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Meta-analysis of Randomized, Sham-Controlled Trials. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021;6(10):947-960.Liang K, Li H, Bu X, et al. Efficacy and tolerability of repetitive transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder in adults: a systematic review and network meta-analysis. Transl Psychiatry. 2021;11(1):332.Homan S, Muscat W, Joanlanne A, et al. Treatment effect variability in brain stimulation across psychiatric disorders: A meta-analysis of variance. Neuroscience and biobehavioral reviews. 2021;124:54-62.Acevedo N, Bosanac P, Pikoos T, Rossell S, Castle D. Therapeutic Neurostimulation in Obsessive-Compulsive and Related Disorders: A Systematic Review. Brain sciences. 2021;11(7).Bijanki KR, Pathak YJ, Najera RA, et al. Defining functional brain networks underlying obsessive-compulsive disorder (OCD) using treatment-induced neuroimaging changes: a systematic review of the literature. Journal of neurology, neurosurgery, and psychiatry. 2021;92(7):776-786.Rapinesi C, Kotzalidis GD, Ferracuti S, Sani G, Girardi P, Del Casale A. Brain Stimulation in Obsessive-Compulsive Disorder (OCD): A Systematic Review. Curr Neuropharmacol. 2019;17(8):787-807.Marques RC, Vieira L, Marques D, Cantilino A. Transcranial magnetic stimulation of the medial prefrontal cortex for psychiatric disorders: a systematic review. Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999). 2019;41(5):447-457.Zhou DD, Wang W, Wang GM, Li DQ, Kuang L. An updated meta-analysis: Short-term therapeutic effects of repeated transcranial magnetic stimulation in treating obsessive-compulsive disorder. J Affect Disord. 2017;215:187-196.Euser AM, Stapert AF, Oosterhoff M, van Balkom IDC, Figee M. [Transcranial magnetic stimulation in obsessive compulsive disorder: a systematic review]. Tijdschr Psychiatr. 2017;59(10):617-625.Trevizol AP, Shiozawa P, Cook IA, et al. Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: An Updated Systematic Review and Meta-analysis. The journal of ECT. 2016;32(4):262-266.Ma ZR, Shi LJ. Repetitive transcranial magnetic stimulation (rTMS) augmentation of selective serotonin reuptake inhibitors (SSRIs) for SSRI-resistant obsessive-compulsive disorder (OCD): a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2014;7(12):4897-4905.Rehn S, Eslick GD, Brakoulias V. A Meta-Analysis of the Effectiveness of Different Cortical Targets Used in Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Obsessive-Compulsive Disorder (OCD). Psychiatr Q. 2018;89(3):645-665.Berlim MT, Neufeld NH, Van den Eynde F. Repetitive transcranial magnetic stimulation (rTMS) for obsessive-compulsive disorder (OCD): an exploratory meta-analysis of randomized and sham-controlled trials. J Psychiatr Res. 2013;47(8):999-1006.Martin JL, Barbanoj MJ, Perez V, Sacristan M. Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder. Cochrane Database Syst Rev. 2003(3):CD003387.Fontenelle LF, Coutinho ES, Lins-Martins NM, Fitzgerald PB, Fujiwara H, Yucel M. Electroconvulsive therapy for obsessive-compulsive disorder: a systematic review. J Clin Psychiatry. 2015;76(7):949-957.Lusicic A, Schruers KR, Pallanti S, Castle DJ. Transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: current perspectives. Neuropsychiatr Dis Treat. 2018;14:1721-1736.Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018;11(1):158-165.Carmi L, Tendler A, Bystritsky A, et al. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019;176(11):931-938.Elbeh KAM, Elserogy YMB, Khalifa HE, Ahmed MA, Hafez MH, Khedr EM. Repetitive transcranial magnetic stimulation in the treatment of obsessive-compulsive disorders: Double blind randomized clinical trial. Psychiatry Res. 2016;238:264-269.Dutta P, Dhyani M, Garg S, et al. Efficacy of intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS) in Obsessive Compulsive Disorder: A Randomized Placebo Controlled Study. Psychiatry Res. 2021;298:113784.Badawy AA, El Sawy H. Efficacy of repetitive transcranial magnetic stimulation in the management of obsessive compulsive disorder.NICE: Transcranial magnetic stimulation for obsessive-compulsive disorder | Interventional Procedures Guidance. 2020; https://www.nice.org.uk/guidance/ipg676/resources/transcranial-magnetic-stimulation-for-obsessivecompulsive-disorder-pdf-1899874288332997. Accessed Nov. 10, 2021.UpToDate: Technique for performing transcranial magnetic stimulation (TMS). https://www.uptodate.com/contents/technique-for-performing-transcranial-magnetic-stimulation-tms/print?search=Transcranial%20Magnetic%20Stimulation%20&source=search_result&selectedTitle=2~71&usage_type=default&display_rank=2. Accessed Nov. 10, 2021.ECRI Clinical Evidence Assessment: Transcranial Magnetic Stimulation for Treating Adults with Obsessive-compulsive Disorder. 2021; https://www.ecri.org/components/Hotline/Pages/210287.aspx. Accessed Nov. 11, 2021.Social Security Administration. Social Security Act 1862. Exclusions From Coverage and Medicare as Secondary Payer. Compilation Of The Social Security Laws 2021; Accessed 3/11/22.

Local Coverage Determinations, LCD, Local policies, Transcranial Magnetic Stimulation (TMS), DL37088

Use this page to view details for the Local Coverage Determination for Transcranial Magnetic Stimulation (TMS).

PROPOSED

Proposed LCD - Transcranial Magnetic Stimulation (TMS) (DL37088)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39517&ver=3

lcd-39517-3-1.txt

1

39517

lcd

3

5d52f813-8f73-41e4-bac0-e58842fa2396

Additional literature reviewed but not citedRepetitive Transcranial Magnetic - StimulationPosition Statement 79. 2018; https://www.ranzcp.org/news-policy/policy-and-advocacy/position-statements/repetitive-transcranial-magnetic-stimulation. Accessed Nov. 23, 2021.Hamani C, Pilitsis J, Rughani AI, et al. Deep brain stimulation for obsessive-compulsive disorder: systematic review and evidence-based guideline sponsored by the American Society for Stereotactic and Functional Neurosurgery and the Congress of Neurological Surgeons (CNS) and endorsed by the CNS and American Association of Neurological Surgeons. Neurosurgery. 2014;75(4):327-333; quiz 333.Reddy JYC, Sundar AS, Narayanaswamy JC, Math SB. Clinical practice guidelines for Obsessive-Compulsive Disorder. Indian J Psychiatry. 2017;59(Suppl 1):S74-S90.Koran LM, Hanna GL, Hollander E, Nestadt G, Simpson HB. Practice Guideline for the Treatment of Patients with Obessive-Compulsive Disorder. 2007; https://psychiatryonline.org/guidelines. Accessed Nov. 24, 2021.Katzman MA, Bleau P, Blier P, Chokka P, Kjernisted K, Van Ameringen MJBp. Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders. 2014;14(1):1-83.Rossi S, Antal A, Bestmann S, et al. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines.Clinical Neurophysiology. 2021;132(1):269-306.Allan CL, Herrmann LL, Ebmeier KP. Transcranial Magnetic Stimulation in Management of Mood Disorders.Neuropsychobiology. 2011;64(3)163-9.

Local Coverage Determinations, LCD, Local policies, Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinsons Disease, DL37729

Use this page to view details for the Local Coverage Determination for Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease.

PROPOSED

Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37729)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39524&ver=9

lcd-39524-9-1.txt

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39524

lcd

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310da42a-caf5-4e18-babd-af114c3e2053

CMS National Coverage PolicyLanguage quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1862(a)(1)(D) refers to limitations on items or devices that are investigational or experimental.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Coverage Indications, Limitations, and/or Medical NecessityThis LCD addresses use of Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for the treatment of idiopathic essential tremor (ET) patients including Tremor Dominant Parkinson's disease (TDPD) patients with medication-refractory tremor.MRgFUS unilateral thalamotomy is considered medically reasonable and necessary in patients with all four of the following criteria:medication refractory ET (defined as refractory to at least two trials of medical therapy, including at least one first-line agent)moderate to severe postural or intention tremor of the dominant handor another nationally accepted clinical measure of tremor severitydisabling ET (defined by a score of 2 on any of the eight items in the disability subsection of the CRST or another nationally accepted clinical measure of tremor severity)nota candidate for DBS (e.g., advanced age, anticoagulant therapy,surgical comorbidities,or has failed Deep Brain Stimulation (DBS), but has no retained cranial implants)Limitations (not covered):Treatment of head or voice tremorBilateral thalamotomyAn advanced neurodegenerative conditionUnstable cardiac diseaseDepression sufficiently severe to compromise beneficiarys ability to provide informed consent and limit likely clinical benefit of the treatmentSevere cognitive impairment (such as may be defined by a score of <24 on the MiniMental State Examination)A skull density ratio (SDR) (the ratio of cortical to cancellous bone) <0.40MRI contraindicatedGeneral InformationAssociated InformationN/ASources of InformationN/ABibliographyTarsy D, Shih L. Surgical treatment of essentialtremor. http://www.uptodate.com/contents/surgical-treatment-of-essential-tremor. Accessed 3/7/2018.Louis ED. Treatment of medically refractory essential tremor.N Engl J Med.2016;375;8:792-793.FDA approval ExAblate Neuro. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038a.pdf. Accessed 3/5/2018.Jeanmonod D, Werner B, Morel A, et al. Transcranial magnetic resonance imagingguided focused ultrasound: noninvasive central lateral thalamotomy for chronic neuropathic pain.Neurosurg Focus.2012;32(1):1-11.Lipsman N, Schwartz ML, Huang Y, et al. MR-guided focused ultrasound thalamotomy for essential tremor: a proof-of-concept study.Lancet Neurol.2013;12(5):462-468.Elias WJ, Huss D, Voss T, et al. A pilot study of focused ultrasound thalamotomy for essential tremor.N Engl J Med.2013;369:640-648.Wintermark M, Druzgal J, Huss DS, et al. Imaging findings in MR imaging-guided focused ultrasound treatment for patients with essential tremor.Am J Neuroradiol.2014;35(5):891-896.Chang WS, Jung HH, Kweon EJ, Zadicario E, Rachmilevitch I, Chang JW. Unilateral magnetic resonance guided focused ultrasound thalamotomy for essential tremor: practices and clinicoradiological outcomes.J Neurol Neurosurg Psychiatry.2015;86(3):257-264.Huss DS, Dallapiazza RF, Shah BB, Harrison MB, Diamond J, Elias WJ. Functional assessment and quality of life in essential tremor with bilateral or unilateral DBS and focused ultrasound thalamotomy.Mov Disord.2015;30(14):1937-1943.Jung HH, Chang WS, Rachmilevitch I, Tlusty T, Zadicario E, Chang JW. Different magnetic resonance imaging patterns after transcranial magnetic resonanceguided focused ultrasound of the ventral intermediate nucleus of the thalamus and anterior limb of the internal capsule in patients with essential tremor or obsessive-compulsive disorder.J Neurosurg.2015;122:162-168.Gallay MN, Moser D, Rossi F, et al. Incisionless transcranial MR-guided focused ultrasound in essential tremor: cerebellothalamic tractotomy.J Ther Ultrasound.2016;4:5. DOI 10.1186/s40349-016-0049-8.Elias WJ, Lipsman N, Ondo WG, et al. A randomized trial of focused ultrasound thalamotomy for essential tremor.N Engl J Med.2016;375;8:730-739.Alterman RL. A trial of focused ultrasound thalamotomy for essential tremor.N Engl J Med.2016;375;22:2201-2203.Novitas LCD Services That Are Not Reasonable and Necessary (L35094).Noridian LCD Non Covered Services (L36219).First Coast Service Options LCD Noncovered Services (DL33777).Palmetto GBA LCD Non-Covered Category III CPT Codes (DL34555).BCBSMA Policy Number 243. Magnetic Resonance-Guided Focused Ultrasound. https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam-assets/243%20MRI-Guided%20Focused%20Ultrasound%20-%20MRgFUS%20prn.pdf. Accessed 2/1/2022.Aetna Policy Number 0153. Thalamotomy. http://www.aetna.com/cpb/medical/data/100_199/0153.html. Accessed 3/5/2018.UnitedHealthcare Guideline Number MPG043.05. Category III CPT Codes. UnitedHealthCareOnline.Category III CodesAnthem Policy Number MED.00057. MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications. https://www.empireblue.com/dam/medpolicies/ebcbs/active/policies/mp_pw_a050053.html. Accessed 2/1/2022.Ravikumar VK, Parker JJ, Hornbeck TS, et al. Cost-effectiveness of focused ultrasound, radiosurgery, and DBS for essential tremor.Mov Disord.2017;32(8):1165-1173.Kim M, Jung NY, Park CK, Chang WS, Jung HH, Chang JW. Comparative Evaluation of Magnetic Resonance-Guided Focused Ultrasound Surgery for Essential Tremor.Stereotact Funct Neurosurg.2017;95(4):279-286.Zesiewicz TA, Elble R, Louis ED, et al. Practice parameter: therapies for essential tremor: report of the Quality Standards Subcommittee of the American Academy of Neurology.Neurology.2005;64(12):2008-2020.Zesiewicz TA, Elble RJ, Louis ED, et al. Evidence-based guideline update: treatment of essential tremor: report of the Quality Standards subcommittee of the American Academy of Neurology.Neurology.2011;77(19):1752-1755.Schuurman PR, Bosch DA, Bossuyt PM, et al. A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor.N Engl J Med.2000;342(7):461-468.

Local Coverage Determinations, LCD, Local policies, Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinsons Disease, DL37729

Use this page to view details for the Local Coverage Determination for Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease.

PROPOSED

Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37729)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39524&ver=9

lcd-39524-9-1.txt

1

39524

lcd

9

88391009-824f-4067-85b2-8382cbe6c4c7

Zesiewicz TA, Elble RJ, Louis ED, et al. Evidence-based guideline update: treatment of essential tremor: report of the Quality Standards subcommittee of the American Academy of Neurology.Neurology.2011;77(19):1752-1755.Schuurman PR, Bosch DA, Bossuyt PM, et al. A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor.N Engl J Med.2000;342(7):461-468.Chang JW, Chang KP, Lipsman N, et al. A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: results of the 2-year follow-up.ANN NEUROL2018;83:107-114.P.S. Fishman,W.J. Elias,P. Ghanouni, R. Gwinn, N. Lipsman, M. Schwartz, J. W. Chang, T. Taira, V. Krishna, A. Rezai, K. Yamada, K. Igase, R. Cosgrove, H. Kashima, M.G.Kaplitt, T.S. Tierney, and H.M. Eisenberg, "Neurological adverse event profile of magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor,"Moy Disord, vol. 33, no. 5, pp. 843-847-, May 2018.Krishna V, Sammartino, F, Cosgrove R, et al.Tremor Outcomes Improve with Experience in Focused Ultrasound Thalamotomy. In press.Moosa S, Martnez-Fernndez R, Elias WJ, Del Alamo M, Eisenberg HM, Fishman PS. The role of high-intensity focused ultrasound as a symptomatic treatment for Parkinsons disease.Mov Disord. 2019;34(9):1243-1251. doi:10.1002/mds.27779Ahmed N, Gandhi D, Melhem ER, Frenkel V. MRI guided focused ultrasound-mediated delivery of therapeutic cells to the brain: A review of the state-of-the-art methodology and future applications.Front Neurol. 2021;12:669449. doi:10.3389/fneur.2021.669449Lin F, Wu D, Yu J, et al. Comparison of efficacy of deep brain stimulation and focused ultrasound in parkinsonian tremor: a systematic review and network meta-analysis.J Neurol Neurosurg Psychiatry. 2021;92(4):434-443. doi:10.1136/jnnp-2020-323656Schreglmann SR, Krauss JK, Chang JW, Bhatia KP, Kgi G. Functional lesional neurosurgery for tremor: a systematic review and meta-analysis.J Neurol Neurosurg Psychiatry. 2018;89(7):717-726. doi:10.1136/jnnp-2017-316302Xu Y, He Q, Wang M, et al. Safety and efficacy of magnetic resonance imaging-guided focused ultrasound neurosurgery for Parkinsons disease: a systematic review.Neurosurg Rev. 2021;44(1):115-127. doi:10.1007/s10143-019-01216-yLennon JC, Hassan I. Magnetic resonance-guided focused ultrasound for Parkinsons disease since ExAblate, 2016-2019: a systematic review.Neurol Sci. 2021;42(2):553-563. doi:10.1007/s10072-020-05020-1Ge Y, Wang Z, Gu F, et al. Clinical application of magnetic resonance-guided focused ultrasound in Parkinsons disease: a meta-analysis of randomized clinical trials.Neurol Sci. 2021;42(9):3595-3604. doi:10.1007/s10072-021-05443-4Magara A, Bhler R, Moser D, Kowalski M, Pourtehrani P, Jeanmonod D. First experience with MR-guided focused ultrasound in the treatment of Parkinsons disease.J Ther Ultrasound. 2014;2(1):11. doi:10.1186/2050-5736-2-11Schlesinger I, Eran A, Sinai A, et al. MRI Guided Focused Ultrasound Thalamotomy for Moderate-to-Severe Tremor in Parkinsons Disease. Parkinsons Disease.; 2015.Zaaroor M, Sinai A, Goldsher D, Eran A, Nassar M, Schlesinger I. Magnetic resonanceguided focused ultrasound thalamotomy for tremor: a report of 30 Parkinsons disease and essential tremor cases.J Neurosurg. 2018;128(1):202-210. doi:10.3171/2016.10.jns16758Fasano A, Llinas M, Munhoz RP, Hlasny E, Kucharczyk W, Lozano AM. MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes.Neurology. 2017;89(8):771-775. doi:10.1212/WNL.0000000000004268Bond AE, Shah BB, Huss DS, et al. Safety and efficacy of focused ultrasound thalamotomy for patients with medication-refractory, tremor-dominant Parkinson disease: A randomized clinical trial.JAMA Neurol. 2017;74(12):1412-1418. doi:10.1001/jamaneurol.2017.3098Martnez-Fernndez R, Rodrguez-Rojas R, Del lamo M, et al. Focused ultrasound subthalamotomy in patients with asymmetric Parkinsons disease: a pilot study.Lancet Neurol. 2018;17(1):54-63. doi:10.1016/S1474-4422(17)30403-9Ito H, Fukutake S, Yamamoto K, Yamaguchi T, Taira T, Kamei T. Magnetic resonance imaging-guided focused ultrasound thalamotomy for Parkinsons disease.Intern Med. 2018;57(7):1027-1031. doi:10.2169/internalmedicine.9586-17Iacopino DG, Gagliardo C, Giugno A. Preliminary experience with a transcranial magnetic resonance- guided focused ultrasound surgery system integrated with a 1.5- T MRI unit in a series of patients with essential tremor and Parkinsons disease.Neurosurg Focus. 2018;44.Fasano A, De Vloo P, Llinas M, et al. Magnetic resonance imaging-guided focused ultrasound thalamotomy in Parkinson tremor: Reoperation after benefit decay.Mov Disord. 2018;33(5):848-849. doi:10.1002/mds.27348Jung NY, Park CK, Kim M. The efficacy and limits of magnetic resonance guided focused ultrasound pallidotomy for Parkinsons disease: a phase I clinical trial.J Neurosurg. 2018:1-9.Sperling SA, Shah BB, Barrett MJ, et al. Focused ultrasound thalamotomy in Parkinson disease: Nonmotor outcomes and quality of life: Nonmotor outcomes and quality of life.Neurology. 2018;91(14):e1275-e1284. doi:10.1212/WNL.0000000000006279Ito H, Fukutake S, Yamamoto K, et al. Magnetic resonance imaging-guided focused ultrasound thalamotomy for Parkinsons disease with cardiac pacemaker: A case report.Mov Disord Clin Pract. 2018;5(3):339-340. doi:10.1002/mdc3.12578Gallay MN, Moser D, Rossi F, et al. MRgFUS pallidothalamic tractotomy for chronic therapy-resistant Parkinsons disease in 51 consecutive patients: Single center experience.Front Surg. 2019;6:76. doi:10.3389/fsurg.2019.00076Martnez-Fernndez R, Mez-Mir JU, Rodrguez-Rojas R, et al. Randomized trial of focused ultrasound subthalamotomy for Parkinsons disease.N Engl J Med. 2020;383(26):2501-2513. doi:10.1056/NEJMoa2016311Yamamoto K, Ito H, Fukutake S, et al. Focused ultrasound thalamotomy for tremor-dominant Parkinsons disease: A prospective 1-year follow-up study.Neurol Med Chir (Tokyo). 2021;61(7):414-421. doi:10.2176/nmc.oa.2020-0370Food and Drug Administration. Exablate Model 4000 Types 1.0 and 1.1 System Summary of Safety and Effectiveness Data. December 16, 2018. Accessed 11/07/2022. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038S006B.pdfNational Government Services, Inc. Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Tremor.LCDL37421. Revised effective date 4/01/2018. Accessed 11/07/2022.Pouratian N, Baltuch G, Elias WJ, Gross R. American Society for stereotactic and Functional Neurosurgery position statement on magnetic resonance-guided focused ultrasound for the management of essential tremor.Neurosurgery. 2020;87(2):E126-E129. doi:10.1093/neuros/nyz510Wisconsin Physicians Service Insurance Corp. Category III Codes. LCD L35490. Revised effective date 6/12/2022. Accessed 11/07/2022.Palmetto GBA. Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor.LCDL37761.Revised effective date 8/13/2020. Accessed 11/07/2022.CGS Administrators, LLC. Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the treatment of neurologic conditions.LCDL37790. Revised effective date 6/12/2022. Accessed 11/07/2022.Parkinsons Disease. Medical Policy Bulletin 0307. Revised effective date 9/16/2022. Accessed 11/07/2022.MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications. Medical Policy MED.00057. Revised effective date 9/16/2022. Accessed 11/07/2022.Blue Cross Blue ShieldLA. Magnetic Resonance-Guided Focused Ultrasound. Policy 00180. Revised effective date 1/10/2022. Accessed 11/07/2022.Blue Cross Blue ShieldNC. MRI-Guided Focused Ultrasound (MRgFUS). Medical Policy. Revised effective date 5/2022. Accessed 11/07/2022.Magnetic ResonanceGuided Focused Ultrasound. Medical Policy 7.01.109. Revised effective date 8/22/2022. Accessed 11/07/2022.Magnetic Resonance (MR) Guided Focused Ultrasound (MRgFUS) and High Intensity Focused Ultrasound (HIFU) Ablation. Surgery Policy 139. Revised effective date 12/01/2021. Accessed 11/07/2022.Tufts Health Plan. Medical Necessity Guidelines: Noncovered Investigational Services. Revised effective date 10/01/2022. Accessed 11/07/2022.Wellmark. MRI-Guided High-Intensity Focused Ultrasound (MRgFUS) Ablation. Medical Policy 04.01.09. Revised effective date 1/2022. Accessed 11/07/2022.Deuschl G, Antonini A, Costa J, et al. European Academy of Neurology/Movement Disorder Society-European section guideline on the treatment of Parkinsons disease: I. invasive therapies.Mov Disord. 2022;37(7):1360-1374. doi:10.1002/mds.29066ECRI. ExAblate Neuro (InSightec, Inc.) for Treating Tremor-dominant Parkinson Disease. Plymouth Meeting (PA):2020 Jul 23. (Clinical Evidence Assessment).Chou KL, Tarsey D. Device-assisted and lesioning procedures for Parkinson disease. UpToDate. Updated 10/13/2022. Accessed 11/07/2022. https://www.uptodate.com/contents/device-assisted-and-lesioning-procedures-for-parkinson-disease?search=deep%20brain%20stimulation%20parkinsons&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H3670506581Ghanouni P, Pauly KB, Elias WJ, et al. Transcranial MRI-Guided Focused Ultrasound: A Review of the Technologic and Neurologic Applications.AJR Am J Roentgenol. 2015;205:150.Na YC, Chang WS, Jung HH, et al. Unilateral magnetic resonance-guided focused ultrasound pallidotomy for Parkinson disease.Neurology. 2015;85:549.

Local Coverage Determinations, LCD, Local policies, Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinsons Disease, DL37738

Use this page to view details for the Local Coverage Determination for Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease.

PROPOSED

Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37738)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39525&ver=8

lcd-39525-8-1.txt

1

39525

lcd

8

2c7d76c2-7a04-4206-aa4a-e0d32193c483

CMS National Coverage PolicyLanguage quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1862(a)(1)(D) refers to limitations on items or devices that are investigational or experimental.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Coverage Indications, Limitations, and/or Medical NecessityThis LCD addresses use of Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for the treatment of idiopathic essential tremor (ET) patients including Tremor Dominant Parkinson's disease (TDPD) patients with medication-refractory tremor.MRgFUS unilateral thalamotomy is considered medically reasonable and necessary in patients with all four of the following criteria:medication refractory ET (defined as refractory to at least two trials of medical therapy, including at least one first-line agent)moderate to severe postural or intention tremor of the dominant hand or another nationally accepted clinical measure of tremor severitydisabling ET (defined by a score of 2 on any of the eight items in the disability subsection of the CRST or another nationally accepted clinical measure of tremor severity)not a candidate for DBS (e.g., advanced age, anticoagulant therapy, surgical comorbidities, or has failed Deep Brain Stimulation (DBS), but has no retained cranial implants)Limitations (not covered):Treatment of head or voice tremorBilateral thalamotomyAn advanced neurodegenerative conditionUnstable cardiac diseaseDepression sufficiently severe to compromise beneficiarys ability to provide informed consent and limit likely clinical benefit of the treatmentSevere cognitive impairment (such as may be defined by a score of <24 on the MiniMental State Examination)A skull density ratio (SDR) (the ratio of cortical to cancellous bone) <0.40MRI contraindicatedGeneral InformationAssociated InformationN/ASources of InformationN/ABibliographyTarsy D, Shih L. Surgical treatment of essential t tremor. http://www.uptodate.com/contents/surgical-treatment-of-essential-tremor. Accessed 3/7/2018.Louis ED. Treatment of medically refractory essential tremor.N Engl J Med.2016;375;8:792-793.FDA approval ExAblate Neuro. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038a.pdf. Accessed 3/5/2018.Jeanmonod D, Werner B, Morel A, et al. Transcranial magnetic resonance imagingguided focused ultrasound: noninvasive central lateral thalamotomy for chronic neuropathic pain.Neurosurg Focus.2012;32(1):1-11.Lipsman N, Schwartz ML, Huang Y, et al. MR-guided focused ultrasound thalamotomy for essential tremor: a proof-of-concept study.Lancet Neurol.2013;12(5):462-468.Elias WJ, Huss D, Voss T, et al. A pilot study of focused ultrasound thalamotomy for essential tremor.N Engl J Med.2013;369:640-648.Wintermark M, Druzgal J, Huss DS, et al. Imaging findings in MR imaging-guided focused ultrasound treatment for patients with essential tremor.Am J Neuroradiol.2014;35(5):891-896.Chang WS, Jung HH, Kweon EJ, Zadicario E, Rachmilevitch I, Chang JW. Unilateral magnetic resonance guided focused ultrasound thalamotomy for essential tremor: practices and clinicoradiological outcomes.J Neurol Neurosurg Psychiatry.2015;86(3):257-264.Huss DS, Dallapiazza RF, Shah BB, Harrison MB, Diamond J, Elias WJ. Functional assessment and quality of life in essential tremor with bilateral or unilateral DBS and focused ultrasound thalamotomy.Mov Disord.2015;30(14):1937-1943.Jung HH, Chang WS, Rachmilevitch I, Tlusty T, Zadicario E, Chang JW. Different magnetic resonance imaging patterns after transcranial magnetic resonanceguided focused ultrasound of the ventral intermediate nucleus of the thalamus and anterior limb of the internal capsule in patients with essential tremor or obsessive-compulsive disorder.J Neurosurg.2015;122:162-168.Gallay MN, Moser D, Rossi F, et al. Incisionless transcranial MR-guided focused ultrasound in essential tremor: cerebellothalamic tractotomy.J Ther Ultrasound.2016;4:5. DOI 10.1186/s40349-016-0049-8.Elias WJ, Lipsman N, Ondo WG, et al. A randomized trial of focused ultrasound thalamotomy for essential tremor.N Engl J Med.2016;375;8:730-739.Alterman RL. A trial of focused ultrasound thalamotomy for essential tremor.N Engl J Med.2016;375;22:2201-2203.Novitas LCD Services That Are Not Reasonable and Necessary (L35094).Noridian LCD Non Covered Services (L36219).First Coast Service Options LCD Noncovered Services (DL33777).Palmetto GBA LCD Non-Covered Category III CPT Codes (DL34555).BCBSMA Policy Number 243. Magnetic Resonance-Guided Focused Ultrasound.https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam-assets/243%20MRI-Guided%20Focused%20Ultrasound%20-%20MRgFUS%20prn.pdf.Accessed 2/1/2022.Aetna Policy Number 0153. Thalamotomy. http://www.aetna.com/cpb/medical/data/100_199/0153.html. Accessed 3/5/2018.UnitedHealthcare Guideline Number MPG043.05. Category III CPT Codes. UnitedHealthCareOnline.Category III CodesAnthem Policy Number MED.00057. MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications.https://www.empireblue.com/dam/medpolicies/ebcbs/active/policies/mp_pw_a050053.html.Accessed 2/1/2022.Ravikumar VK, Parker JJ, Hornbeck TS, et al. Cost-effectiveness of focused ultrasound, radiosurgery, and DBS for essential tremor.Mov Disord.2017;32(8):1165-1173.Kim M, Jung NY, Park CK, Chang WS, Jung HH, Chang JW. Comparative Evaluation of Magnetic Resonance-Guided Focused Ultrasound Surgery for Essential Tremor.Stereotact Funct Neurosurg.2017;95(4):279-286.Zesiewicz TA, Elble R, Louis ED, et al. Practice parameter: therapies for essential tremor: report of the Quality Standards Subcommittee of the American Academy of Neurology.Neurology.2005;64(12):2008-2020.Zesiewicz TA, Elble RJ, Louis ED, et al. Evidence-based guideline update: treatment of essential tremor: report of the Quality Standards subcommittee of the American Academy of Neurology.Neurology.2011;77(19):1752-1755.Schuurman PR, Bosch DA, Bossuyt PM, et al. A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor.N Engl J Med.2000;342(7):461-468.

Local Coverage Determinations, LCD, Local policies, Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinsons Disease, DL37738

Use this page to view details for the Local Coverage Determination for Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease.

PROPOSED

Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37738)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39525&ver=8

lcd-39525-8-1.txt

1

39525

lcd

8

b5a25427-dce8-4132-b508-afc2e4cf2fb9

Zesiewicz TA, Elble RJ, Louis ED, et al. Evidence-based guideline update: treatment of essential tremor: report of the Quality Standards subcommittee of the American Academy of Neurology.Neurology.2011;77(19):1752-1755.Schuurman PR, Bosch DA, Bossuyt PM, et al. A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor.N Engl J Med.2000;342(7):461-468.Chang JW, Chang KP, Lipsman N, et al. A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: results of the 2-year follow-up.ANN NEUROL2018;83:107-114.P.S. Fishman, W.J. Elias, P. Ghanouni, R. Gwinn, N. Lipsman, M. Schwartz, J. W. Chang, T. Taira, V. Krishna, A. Rezai, K. Yamada, K. Igase, R. Cosgrove, H. Kashima, M.G.Kaplitt, T.S. Tierney, and H.M. Eisenberg, "Neurological adverse event profile of magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor,"Moy Disord, vol. 33, no. 5, pp. 843-847-, May 2018.Krishna V, Sammartino, F, Cosgrove R, et al.Tremor Outcomes Improve with Experience in Focused Ultrasound Thalamotomy. In press.Moosa S, Martnez-Fernndez R, Elias WJ, Del Alamo M, Eisenberg HM, Fishman PS. The role of high-intensity focused ultrasound as a symptomatic treatment for Parkinsons disease.Mov Disord. 2019;34(9):1243-1251. doi:10.1002/mds.27779Ahmed N, Gandhi D, Melhem ER, Frenkel V. MRI guided focused ultrasound-mediated delivery of therapeutic cells to the brain: A review of the state-of-the-art methodology and future applications.Front Neurol. 2021;12:669449. doi:10.3389/fneur.2021.669449Lin F, Wu D, Yu J, et al. Comparison of efficacy of deep brain stimulation and focused ultrasound in parkinsonian tremor: a systematic review and network meta-analysis.J Neurol Neurosurg Psychiatry. 2021;92(4):434-443. doi:10.1136/jnnp-2020-323656Schreglmann SR, Krauss JK, Chang JW, Bhatia KP, Kgi G. Functional lesional neurosurgery for tremor: a systematic review and meta-analysis.J Neurol Neurosurg Psychiatry. 2018;89(7):717-726. doi:10.1136/jnnp-2017-316302Xu Y, He Q, Wang M, et al. Safety and efficacy of magnetic resonance imaging-guided focused ultrasound neurosurgery for Parkinsons disease: a systematic review.Neurosurg Rev. 2021;44(1):115-127. doi:10.1007/s10143-019-01216-yLennon JC, Hassan I. Magnetic resonance-guided focused ultrasound for Parkinsons disease since ExAblate, 2016-2019: a systematic review.Neurol Sci. 2021;42(2):553-563. doi:10.1007/s10072-020-05020-1Ge Y, Wang Z, Gu F, et al. Clinical application of magnetic resonance-guided focused ultrasound in Parkinsons disease: a meta-analysis of randomized clinical trials.Neurol Sci. 2021;42(9):3595-3604. doi:10.1007/s10072-021-05443-4Magara A, Bhler R, Moser D, Kowalski M, Pourtehrani P, Jeanmonod D. First experience with MR-guided focused ultrasound in the treatment of Parkinsons disease.J Ther Ultrasound. 2014;2(1):11. doi:10.1186/2050-5736-2-11Schlesinger I, Eran A, Sinai A, et al. MRI Guided Focused Ultrasound Thalamotomy for Moderate-to-Severe Tremor in Parkinsons Disease. Parkinsons Disease.; 2015.Zaaroor M, Sinai A, Goldsher D, Eran A, Nassar M, Schlesinger I. Magnetic resonanceguided focused ultrasound thalamotomy for tremor: a report of 30 Parkinsons disease and essential tremor cases.J Neurosurg. 2018;128(1):202-210. doi:10.3171/2016.10.jns16758Fasano A, Llinas M, Munhoz RP, Hlasny E, Kucharczyk W, Lozano AM. MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes.Neurology. 2017;89(8):771-775. doi:10.1212/WNL.0000000000004268Bond AE, Shah BB, Huss DS, et al. Safety and efficacy of focused ultrasound thalamotomy for patients with medication-refractory, tremor-dominant Parkinson disease: A randomized clinical trial.JAMA Neurol. 2017;74(12):1412-1418. doi:10.1001/jamaneurol.2017.3098Martnez-Fernndez R, Rodrguez-Rojas R, Del lamo M, et al. Focused ultrasound subthalamotomy in patients with asymmetric Parkinsons disease: a pilot study.Lancet Neurol. 2018;17(1):54-63. doi:10.1016/S1474-4422(17)30403-9Ito H, Fukutake S, Yamamoto K, Yamaguchi T, Taira T, Kamei T. Magnetic resonance imaging-guided focused ultrasound thalamotomy for Parkinsons disease.Intern Med. 2018;57(7):1027-1031. doi:10.2169/internalmedicine.9586-17Iacopino DG, Gagliardo C, Giugno A. Preliminary experience with a transcranial magnetic resonance- guided focused ultrasound surgery system integrated with a 1.5- T MRI unit in a series of patients with essential tremor and Parkinsons disease.Neurosurg Focus. 2018;44.Fasano A, De Vloo P, Llinas M, et al. Magnetic resonance imaging-guided focused ultrasound thalamotomy in Parkinson tremor: Reoperation after benefit decay.Mov Disord. 2018;33(5):848-849. doi:10.1002/mds.27348Jung NY, Park CK, Kim M. The efficacy and limits of magnetic resonance guided focused ultrasound pallidotomy for Parkinsons disease: a phase I clinical trial.J Neurosurg. 2018:1-9.Sperling SA, Shah BB, Barrett MJ, et al. Focused ultrasound thalamotomy in Parkinson disease: Nonmotor outcomes and quality of life: Nonmotor outcomes and quality of life.Neurology. 2018;91(14):e1275-e1284. doi:10.1212/WNL.0000000000006279Ito H, Fukutake S, Yamamoto K, et al. Magnetic resonance imaging-guided focused ultrasound thalamotomy for Parkinsons disease with cardiac pacemaker: A case report.Mov Disord Clin Pract. 2018;5(3):339-340. doi:10.1002/mdc3.12578Gallay MN, Moser D, Rossi F, et al. MRgFUS pallidothalamic tractotomy for chronic therapy-resistant Parkinsons disease in 51 consecutive patients: Single center experience.Front Surg. 2019;6:76. doi:10.3389/fsurg.2019.00076Martnez-Fernndez R, Mez-Mir JU, Rodrguez-Rojas R, et al. Randomized trial of focused ultrasound subthalamotomy for Parkinsons disease.N Engl J Med. 2020;383(26):2501-2513. doi:10.1056/NEJMoa2016311Yamamoto K, Ito H, Fukutake S, et al. Focused ultrasound thalamotomy for tremor-dominant Parkinsons disease: A prospective 1-year follow-up study.Neurol Med Chir (Tokyo). 2021;61(7):414-421. doi:10.2176/nmc.oa.2020-0370Food and Drug Administration. Exablate Model 4000 Types 1.0 and 1.1 System Summary of Safety and Effectiveness Data. December 16, 2018. Accessed 11/07/2022. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038S006B.pdfNational Government Services, Inc. Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Tremor.LCDL37421. Revised effective date 4/01/2018. Accessed 11/07/2022.Pouratian N, Baltuch G, Elias WJ, Gross R. American Society for stereotactic and Functional Neurosurgery position statement on magnetic resonance-guided focused ultrasound for the management of essential tremor.Neurosurgery. 2020;87(2):E126-E129. doi:10.1093/neuros/nyz510Wisconsin Physicians Service Insurance Corp. Category III Codes. LCD L35490. Revised effective date 6/12/2022. Accessed 11/07/2022.Palmetto GBA. Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor.LCDL37761.Revised effective date 8/13/2020. Accessed 11/07/2022.CGS Administrators, LLC. Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the treatment of neurologic conditions.LCDL37790. Revised effective date 6/12/2022. Accessed 11/07/2022.Parkinsons Disease. Medical Policy Bulletin 0307. Revised effective date 9/16/2022. Accessed 11/07/2022.MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications. Medical Policy MED.00057. Revised effective date 9/16/2022. Accessed 11/07/2022.Blue Cross Blue ShieldLA. Magnetic Resonance-Guided Focused Ultrasound. Policy 00180. Revised effective date 1/10/2022. Accessed 11/07/2022.Blue Cross Blue ShieldNC. MRI-Guided Focused Ultrasound (MRgFUS). Medical Policy. Revised effective date 5/2022. Accessed 11/07/2022.Magnetic ResonanceGuided Focused Ultrasound. Medical Policy 7.01.109. Revised effective date 8/22/2022. Accessed 11/07/2022.Magnetic Resonance (MR) Guided Focused Ultrasound (MRgFUS) and High Intensity Focused Ultrasound (HIFU) Ablation. Surgery Policy 139. Revised effective date 12/01/2021. Accessed 11/07/2022.Tufts Health Plan. Medical Necessity Guidelines: Noncovered Investigational Services. Revised effective date 10/01/2022. Accessed 11/07/2022.Wellmark. MRI-Guided High-Intensity Focused Ultrasound (MRgFUS) Ablation. Medical Policy 04.01.09. Revised effective date 1/2022. Accessed 11/07/2022.Deuschl G, Antonini A, Costa J, et al. European Academy of Neurology/Movement Disorder Society-European section guideline on the treatment of Parkinsons disease: I. invasive therapies.Mov Disord. 2022;37(7):1360-1374. doi:10.1002/mds.29066ECRI. ExAblate Neuro (InSightec, Inc.) for Treating Tremor-dominant Parkinson Disease. Plymouth Meeting (PA):2020 Jul 23. (Clinical Evidence Assessment).Chou KL, Tarsey D. Device-assisted and lesioning procedures for Parkinson disease. UpToDate. Updated 10/13/2022. Accessed 11/07/2022. https://www.uptodate.com/contents/device-assisted-and-lesioning-procedures-for-parkinson-disease?search=deep%20brain%20stimulation%20parkinsons&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H3670506581Ghanouni P, Pauly KB, Elias WJ, et al. Transcranial MRI-Guided Focused Ultrasound: A Review of the Technologic and Neurologic Applications.AJR Am J Roentgenol. 2015;205:150.Na YC, Chang WS, Jung HH, et al. Unilateral magnetic resonance-guided focused ultrasound pallidotomy for Parkinson disease.Neurology. 2015;85:549.

Local Coverage Determinations, LCD, Local policies, Enteral Nutrition, DL38955

Use this page to view details for the Local Coverage Determination for Enteral Nutrition.

PROPOSED

Proposed LCD - Enteral Nutrition (DL38955)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39533&ver=9

lcd-39533-9-1.txt

1

39533

lcd

9

be929f5f-5349-4f98-acd6-79e31d81ae54

CMS National Coverage PolicyN/ACoverage Indications, Limitations, and/or Medical NecessityFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act 1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.Enteral nutrition is covered for a beneficiary who requires feedings via an enteral access device to provide sufficient nutrients to maintain weight and strength commensurate with the beneficiary's overall health status and has a permanent:full or partial non-function or disease of the structures that normally permit food to reach the small bowel; OR,disease that impairs digestion and/or absorption of an oral diet, directly or indirectly, by the small bowel.Refer to the LCD-related Policy Article for the definition of test of permanence.Adequate nutrition must not be possible by dietary adjustment and/or oral supplements.Typical examples of conditions associated with non-function or disease of the structures that permit food from reaching the small bowel that qualify for coverage are head and neck cancer with reconstructive surgery and central nervous system disease leading to interference with the neuromuscular mechanisms of ingestion of such severity that the beneficiary cannot be maintained with oral feeding (not all inclusive).Typical examples of conditions associated with impaired digestion and/or absorption of an oral diet by the small bowel that may qualify for coverage include inflammatory bowel disease, surgical resection of small bowel, cystic fibrosis, chronic pancreatitis, and advanced liver disease (not all inclusive).If the coverage requirements for enteral nutrition are met, medically necessary nutrients, administration supplies, and equipment are covered.For coverage of the following scenarios, see the LCD-related Policy Article:Enteral nutrition for temporary impairmentsEnteral nutrition for beneficiaries with a functioning gastrointestinal tract whose need for enteral nutrition is not due to reasons related to the non-function or disease of the structures that normally permit food to reach the small bowelOrally administered enteral nutrition products, related supplies and equipmentNUTRIENTSEnteral formulas consisting of semi-synthetic intact protein/protein isolates (B4150 or B4152) are appropriate for the majority of beneficiaries requiring enteral nutrition.The medical necessity for special enteral formulas (B4149, B4153, B4154, B4155, B4157, B4161, and B4162) must be justified in each beneficiary. If a special enteral nutrition formula is provided and if the medical record does not document why that item is medically necessary, it will be denied as not reasonable and necessary. (Refer to theLCD-related Policy Article for policy specific documentation requirements.)EQUIPMENT AND SUPPLIESEnteral nutrition may be administered by syringe, gravity, or pump. Some enteral beneficiaries may experience complications associated with syringe or gravity method of administration.If a pump (B9002) is ordered, there must be documentation in the beneficiary's medical record to justify its use (e.g., gravity feeding is not satisfactory due to reflux and/or aspiration, severe diarrhea, dumping syndrome, administration rate less than 100 ml/hr, blood glucose fluctuations, circulatory overload, gastrostomy/jejunostomy tube used for feeding). If the medical necessity of the pump is not documented, the pump will be denied as not reasonable and necessary.In-line digestive enzyme cartridges (B4105) are reasonable and necessary for beneficiaries who:meet the coverage criteria for enteral nutrition; AND,have a diagnosis of Exocrine Pancreatic Insufficiency (EPI) (refer to the Group 1 Codes in the LCD-related Policy Article for applicable diagnoses).More than two in-line digestive enzyme cartridges (B4105) per day will be denied as not reasonable and necessary.The feeding supply allowance (B4034, B4035, and B4036) must correspond with the method of enteral nutrition administration (syringe, pump, gravity). If a feeding supply kit does not correspond with the method in which the enteral nutrition is being administered, then the feeding supply kit will be denied as not reasonable and necessary.For dates of service prior to January 1, 2023, the feeding supply allowance (B4034, B4035, and B4036) must correspond to the method of administration indicated in question 5 of the DME Information Form (DIF). If it does not correspond, it will be denied as not reasonable and necessary.If a pump supply allowance (B4035) is provided and if the medical necessity of the pump is not documented, it will be denied as not reasonable and necessary.The codes for feeding supply allowances (B4034, B4035, and B4036) are specific to the route of administration. Claims for more than one type of kit code delivered on the same date or provided on an ongoing basis will be denied as not reasonable and necessary.Enteral feeding supply kit allowances (B4034, B4035, and B4036), are all-inclusive, with the exception of B4105 in-line digestive enzyme cartridge. Separate billing for any item including an item using a specific HCPCS code, if one exists, or B9998 (ENTERAL SUPPLIES, NOT OTHERWISE CLASSIFIED) will be denied as unbundling.Refer to theLCD-related Policy Article CODING GUIDELINES section for additional information about enteral feeding supply allowances.More than three nasogastric tubes (B4081, B4082, and B4083), or one gastrostomy/jejunostomy tube (B4087 or B4088) every three months is not reasonable and necessary.GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.REFILL REQUIREMENTSFor DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioner that any changed or atypical utilization is warranted.Regardless of utilization, a supplier must not dispense more than a 1-month quantity at a time.Supply allowance HCPCS codes (B4034, B4035, and B4036) are daily allowances which are considered all-inclusive and therefore refill requirements are not applicable to these HCPCS codes. Refer to the Coding Guidelines section in theLCD-related Policy Articlefor further clarification.General InformationAssociated InformationDOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider. It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSItems covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MiscellaneousAppendicesUtilization GuidelinesRefer to Coverage Indications, Limitations and/or Medical NecessitySources of InformationReserved for future use.BibliographyN/A

Local Coverage Determinations, LCD, Local policies, Parenteral Nutrition, DL38953

Use this page to view details for the Local Coverage Determination for Parenteral Nutrition.

PROPOSED

Proposed LCD - Parenteral Nutrition (DL38953)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39539&ver=6

lcd-39539-6-1.txt

1

39539

lcd

6

42389c7f-9f2f-4335-98f3-079441085a26

CMS National Coverage PolicyN/ACoverage Indications, Limitations, and/or Medical NecessityFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act 1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.Parenteral nutrition is the provision of nutritional requirements intravenously and is covered for beneficiaries who qualify under the Prosthetic Device Benefit defined in the MedicareBenefit Policy Manual(CMS Pub. 100-02), Chapter 15, Section 120.When nutritional support other than the oral route is necessary, enteral nutrition (EN) is usually initially preferable to parenteral nutrition for the following reasons: (1) In a fluid restricted beneficiary, EN permits delivery of all necessary nutrients in a more concentrated volume than parenteral nutrition; (2) EN allows for safer home delivery of nutrients; and (3) EN lowers the risk of Central Line-Associated Bloodstream Infections (CLABSI).For parenteral nutrition to be considered reasonable and necessary, the treating practitioner must document that enteral nutrition has been considered and ruled out, tried andbeen found ineffective, or that EN exacerbates gastrointestinal tract dysfunction. The beneficiary must have (a) a condition involving the small intestine and/or its exocrine glands which significantly impairs the absorption of nutrients or (b) disease of the stomach and/or intestine which is a motility disorder and impairs the ability of nutrients to be transported through and absorbed by the gastrointestinal (GI) system. The beneficiary must have a permanent impairment. Please refer to the LCD-related Policy Article for further guidance regarding the test of permanence.The treating practitioner is required to evaluate the beneficiary within 30 days prior to initiation ofparenteral nutrition.If the treating practitioner does not see the beneficiary within this timeframe, they must document the reason why and describe what other monitoring methods were used to evaluate the beneficiary's parenteral nutrition needs. There must be documentation in the medical record supporting the clinical diagnosis.GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.If the coverage requirements for parenteral nutritional therapy are met under the prosthetic device benefit provision, related supplies, equipment and nutrients are also covered.No more than one month's supply of parenteral nutrients, equipment or supplies is allowed for one month's prospective billing. Claims submitted retroactively, however, may include multiple months.Services associated with the administration of parenteral nutrition in a beneficiarys home are addressed in the Non-Medical Necessity Coverage and Payment Rules section located in the LCD-related Policy Article.NUTRIENTS:A total caloric daily intake of 20-35 cal/kg/day is considered reasonable and necessary to achieve or maintain appropriate body weight. The treating practitioner must document the medical necessity for a caloric intake outside this range in an individual beneficiary.The treating practitioner must document the medical necessity for protein orders outside of the range of 0.8-2.0 gm/kg/day (B4168, B4172, B4176, B4178), dextrose concentration less than 10% (B4164, B4180), or lipid use per month in excess of the product-specific, FDA-approved dosing recommendations (B4185, B4187).Special nutrient formulas, HCPCS codes B5000, B5100, and B5200 are produced to meet the unique nutrient needs for specific disease conditions. The beneficiarys medical record must adequately document the specific condition and the necessity for the special nutrient.REFILL REQUIREMENTSFor DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioner that any changed or atypical utilization is warranted.Regardless of utilization, a supplier must not dispense more than a 1-month quantity at a time.Supply allowance HCPCS codes (B4220, B4222 and B4224) are daily allowances which are considered all-inclusive and therefore refill requirements are not applicable to these HCPCS codes. Refer to the Coding Guidelines section in the LCD-related Policy Article for further clarification.General InformationAssociated InformationDOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioners office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSItems covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MiscellaneousAppendicesUtilization GuidelinesRefer to Coverage Indications, Limitations, and/or Medical NecessitySources of InformationN/ABibliographyN/A

Local Coverage Determinations, LCD, Local policies, Osteogenesis Stimulators, DL33796

Use this page to view details for the Local Coverage Determination for Osteogenesis Stimulators.

PROPOSED

Proposed LCD - Osteogenesis Stimulators (DL33796)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39540&ver=6

lcd-39540-6-1.txt

1

39540

lcd

6

ce0b7e08-edb9-4c30-89dc-458c047c7f1e

CMS National Coverage PolicyCMS Pub. 100-03 (Medicare National Coverage Determination Manual), Chapter 1, Section 150.2Coverage Indications, Limitations, and/or Medical NecessityFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act 1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.A non-spinal electrical osteogenesis stimulator (E0747) is covered only if any of the following criteria are met:Nonunion of a long bone fracture (see Appendices section) defined as radiographic evidence that fracture healing has ceased for three or more months prior to starting treatment with the osteogenesis stimulator, orFailed fusion of a joint other than in the spine where a minimum of nine months has elapsed since the last surgery, orCongenital pseudarthrosis.Nonunion of a long bone fracture must be documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days, each including multiple views of the fracture site, and with a written interpretation by a treating practitioner stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs.A non-spinal electrical osteogenesis stimulator will be denied as not medically necessary if none of the criteria above are met.A spinal electrical osteogenesis stimulator (E0748) is covered only if any of the following criteria are met:Failed spinal fusion where a minimum of nine months has elapsed since the last surgery, orFollowing a multilevel spinal fusion surgery (see Appendices section), orFollowing spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site.A spinal electrical osteogenesis stimulator will be denied as not medically necessary if none of the criteria above are met.An ultrasonic osteogenesis stimulator (E0760) is covered only if all of the following criteria are met:Nonunion of a fracture documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days. Each radiograph set must include multiple views of the fracture site accompanied by a written interpretation by a treating practitioner stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs; andThe fracture is not of the skull or vertebrae; andThe fracture is not tumor related.An ultrasonic osteogenesis stimulator will be denied as not medically necessary if any of the criteria above are not met.Use of an ultrasonic osteogenesis stimulator for the treatment of a fresh fracture or delayed union will be denied as not medically necessary.Ultrasound conductive coupling gel is covered and separately payable if an ultrasonic osteogenesis stimulator is covered.An ultrasonic osteogenesis stimulator will be denied as not medically necessary if it is used with other noninvasive osteogenesis stimulators.GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.REFILL REQUIREMENTSFor DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioners that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a three (3)-month quantity at a time.General InformationAssociated InformationDOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider. It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSItems covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MISCELLANEOUSAPPENDICESA multilevel spinal fusion is one which involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc).A long bone is limited to a clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal, or metatarsal.UTILIZATION GUIDELINESRefer to Coverage Indications, Limitations and/or Medical NecessitySources of InformationN/ABibliographyNA

Local Coverage Determinations, LCD, Local policies, Seat Lift Mechanisms, DL33801

Use this page to view details for the Local Coverage Determination for Seat Lift Mechanisms.

PROPOSED

Proposed LCD - Seat Lift Mechanisms (DL33801)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39541&ver=5

lcd-39541-5-1.txt

1

39541

lcd

5

ced24dbd-a49d-4b55-afb9-edcef207776c

CMS National Coverage PolicyCMS Pub. 100-03, Chapter 1, Section 280.4Coverage Indications, Limitations, and/or Medical NecessityFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act 1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.A seat lift mechanism is covered if all of the following criteria are met:The beneficiary must have severe arthritis of the hip or knee or have a severe neuromuscular disease.The seat lift mechanism must be a part of the treating practitioners course of treatment and be prescribed to effect improvement, or arrest or retard deterioration in the beneficiary's condition.The beneficiary must be completely incapable of standing up from a regular armchair or any chair in their home. (The fact that a beneficiary has difficulty or is even incapable of getting up from a chair, particularly a low chair, is not sufficient justification for a seat lift mechanism. Almost all beneficiaries who are capable of ambulating can get out of an ordinary chair if the seat height is appropriate and the chair has arms.)Once standing, the beneficiary must have the ability to ambulate.Coverage of seat lift mechanisms is limited to those types which operate smoothly, can be controlled by the beneficiary, and effectively assist a beneficiary in standing up and sitting down without other assistance. Excluded from coverage is the type of lift which operates by spring release mechanism with a sudden, catapult-like motion and jolts the beneficiary from a seated to a standing position.Thepractitioner ordering the seat lift mechanism must be the treating practitioner or a consultingpractitionerfor the disease or condition resulting in the need for a seat lift. The practitioner's record must document that all appropriate therapeutic modalities (e.g., medication, physical therapy) have been tried and failed to enable the beneficiary to transfer from a chair to a standing position.GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.General InformationAssociated InformationDOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include thetreating practitionersoffice records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSItems covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MISCELLANEOUSAPPENDICESUTILIZATION GUIDELINESRefer to Coverage Indications, Limitations and/or Medical NecessitySources of InformationReserved for future use.BibliographyNA

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39575

Use this page to view details for the Local Coverage Determination for Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39575)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39574&ver=3

lcd-39574-3-1.txt

1

39574

lcd

3

a79ee3e8-6e7b-45e1-a923-7d31557ab810

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) addresses services that are determined to be investigational or experimental.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 16, 10 General Exclusions from CoverageCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, 30A Physicians ServicesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 30, 50.3.1 Mandatory ABN UsesCoverage Indications, Limitations, and/or Medical NecessityThis is a NON-coverage policy for allamniotic membrane, amniotic fluid or other placental derived productinjections and/or applications as a means of managing musculoskeletal injuries, joint conditions, and all other conditions not stated below.This guidance does NOT include discussion on burns, wounds or ophthalmic conditions.NOTE: For information on stem cell transplantation please see CMS National Coverage Determination 110.23 Stem Cell TransplantationIntroductionAmniotic and placental derived products are reported to possess certain beneficial characteristics. These products have been identified as a source of stem cells. Stem cells, by definition, have the capability to differentiate into any cell of an organism as well as the capability of self-renewal.1In addition, the extracellular matrix (ECM) of placental and amniotic-based tissues are rich in collagen, glycoproteins, proteoglycans, fibroblasts, as well as many cytokines and growth factors thought to promote healing with a lower risk of low immunologic reaction.Based on these characteristics, amniotic and placental derived products are currently being studied and heavily marketed as allografts to serve as:scaffolds for tissue engineeringmembrane covering for certain burns, wounds, and ophthalmic corneal injuriesmicronized/particulated products suspended in an aqueous material to be applied topically or injected into joints, tendons, ligamentsapplications or injections performed intra-operatively to promote post-operative healingThese amniotic and placental-derived products are further being investigated for a multitude of indications, including but not limited to musculoskeletal conditions involving joint pain and back pain, chronic pain in general, dental conditions, alopecia, wounds, burns, and a plethora of others. In the quest to find alternative treatments for certain musculoskeletal conditions, the emergence of a class of substances being marketed as orthobiologics has become more prevalent in the pharmaceutical market. Orthobiologics are biological products aimed at treating musculoskeletal conditions purported to heal injury/trauma, slow degenerative processes and affect regeneration of tissues.2The result ideally would be decreased pain and increased function. One such category of orthobiologics involves the incorporation of human amniotic and placental-derived products.The amniotic and placental-derived products are obtained from the placenta of donors, usually, immediately post C-section at full term and screened for transmittable diseases. These products are made up of varying combinations of amniotic membrane, amniotic fluid, chorionic membrane, umbilical cord, umbilical cord blood, and what is known as Whartons jelly.3Definitions:ThePlacentais a multi-layered circulatory temporary organ that supplies food and oxygen to the fetus during pregnancy.The multiple layers of the placenta include the:Amnion- the innermost membrane that surrounds the fetus during gestationChorion- outermost membrane that surrounds the fetus during gestationAmniotic fluidis the fluid surrounding the fetus within the amnion.Umbilical cordis the vascular conduit connecting the fetus to the placenta comprised of the umbilical vein, arteries, allantois and yolk sac embedded in Whartons jelly.Whartons Jellyis a gelatinous soft connective tissue derived from extra-embryonic mesoderm within the umbilical cord.4Theamniotic membraneitself is divided into 3 histologic layers:A singleepithelial layerA thickbasement membraneAnavascular stromal (mesenchymal) layer5.6,7,8The avascular stromal layer is further divided into 3 layers:6,7,8TheCompact layerThe middleFibroblast layerTheSpongy layerTheSpongy Layer, loosely connected to the chorionic membrane, is highly concentrated with proteoglycans and glycoproteins including hyaluronic acid, as well as type I, III, and IV collagen.5,6,8,9Themiddle Fibroblast layeris made up of type I, III, V, and VI collagen.6,8,9TheCompact layerthat sits adjacent to the basement membrane is composed of collagen Types I, III, V, and VI, along with fibronectin.5,9Thebasement membraneanchors the epithelial layer (ref 13) and contains collagen Types IV, V and VII, fibronectin, laminin, and hyaluronic acid.6,10Adjacent to the basement membrane and in immediate contact with the amniotic fluid is the single layer of epithelial cells.Amniotic epithelial cellsproduce type III and IV collagen, glycoproteins such as laminin and fibronectin, which in turn form become the basement membrane.5The amniotic membranes purpose is to house and physically protect the fetus, but additional functions include regulation of the pH of the amniotic fluid, transportation of water and soluble material between the mother and fetus, and the synthesis of numerous growth factors and cytokines. The amniotic membrane also secretes anti-inflammatory proteins. All of this results in these tissues having anti-inflammatory, anti-microbial, anti-fibroblastic, and non-immunogenic properties.Amniotic products have been asserted to be a source of stem cells. Both the amniotic epithelial layer (maternal derived cells) and mesenchymal (avascular stromal) layer derived from the embryonic mesoderm contain their respective stem cells that can differentiate into multiple cell lines, including myocytes, osteocytes, and chondrocytes.8,9Amniotic fluid also is found to contain amniotic mesenchymal stem cells.7The chorionic membrane adjacent to the mothers endometrium during the development of the fetus. Umbilical cord, Whartons jelly, and umbilical cord blood have also been found to contain mesenchymal stem cells.7,11Under normal conditions, placental tissues are collected via aseptic technique during cesarean section. Protocols vary as to how the tissues are harvested, prepared, preserved, and stored. Testing is also required to ensure these tissues do not carry any communicable diseases transmissible from donor to recipient.Because the spongy layer loosely connects the amniotic membrane to the chorionic membrane, these two layers are easily separated upon blunt dissection at initial harvesting.10Other than ease of separation between amniotic and chorionic membranes, the following steps in processing the tissues into the desired form vary, based on the portions of the placental tissues extracted, sterilization processes (if any) undertaken, and method of preservation utilized. Common methods of preservation include cryopreservation, lyophilization (freeze-drying), glycerol-preservation, (gamma)-sterilization, low heat dehydration, and vitrification.5,8,9,10A process called Decellularization may be used in which the layer of amniotic epithelial cells is removed from the collected amniotic membrane, leaving behind the valuable extracellular matrix components. Removal of all cellular components is thoughtto lessen the possibility of eliciting an immune response.3,10Different decellularization processes are available. Eventual preparation of sheets, particulate suspensions, liquids, or gels allows the final marketed product.Depending on the methods utilized, the processing of placental and amniotic-based tissues will affect the viability of cellular components, growth factors, and other valuable properties for which these tissues are promoted. To date, there are significant differences that exist in the processing of different placental and amniotic-based tissue products.3,5Lack of consistency and standardization within proprietary manufacturing (preparation) processes precludes determination and comparison of the final product form, characteristics, properties, and components.The Food and Drug Administration (FDA), under Sect. 361 of the Public Health Service Act (regulated by the Centers for Biologics Evaluation and Research CBER, an arm of the FDA) oversees the therapeutic use of Human cells or tissue products or HCT/Ps. Once these types of products are harvested, their process and handling will determine whether the products fall under Section 361 guidance or default to the more regulated section 351 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act. The regulatory pathway for pre-market FDA approval of new drugs, devices and/or biological products, requires registration as a (NDA) New Drug application, an (IND) Investigational New Drug application, or a (BLA) Biologics License Approval.8,9,12,13If a human cells or tissue product should meet Section 361 FDA requirements, the product will not require FDA pre-market review and approval. To meet Section 361 FDA regulatory requirements, the placental/amniotic-based tissue product must meet the following four criteria: The HCT/P isMinimally ManipulatedIntended for Homologous Use (as reflected by the labeling, advertising, or other indications of the manufacturers objective intent)The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/PEither:The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; orThe HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:Is for autologous use;Is for allogeneic use in a first-degree or second-degree blood relative; orIs for reproductive use12Due to the ongoing development of new products and clinical trials, the field of FDA regulatory requirements is fluid and evolving. It is the expectation that the respective Medicare Administrative Contractor will continue to follow any guidance and insight as it is brought forward by the FDA.Lack of standard formulation, dose, or frequency of administration, and standard of care in treatment with these products further complicates regulation and guidance determinations.Despite this lack of standardization, numerous amniotic and placental-derived products have been released for use in treatment of musculoskeletal conditions. These conditions include, but are not limited to tendon/ligament injuries, musculoskeletal injuries, cartilage damage, osteoarthritis, (or pain related to these conditions) as well as adjunctive to orthopedic surgical treatments. Due to the lack of component standardization, the remainder of this LCD will use the term amniotic and placental-derived products to mean ANY product derived from ANY combination of amniotic membrane/chorion/placenta/Whartons jelly/umbilical cord/amniotic fluid/umbilical cord blood.Although amniotic and placental-derived products are marketed to treat certain musculoskeletal conditions, there is limited support for safety and efficacy from human clinical trials available.All injectable amniotic and/or placental-derived products fall under FDA section 551 of the Federal Food, Drug, and Cosmetic Act. Promotion relating to novel indication or evidence of new intended use may constitute labeling, adulteration, or misbranding of the drug or device if such dissemination fails to comply with section 551 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A manufacturers failure to exercise due diligence in submitting the clinical studies necessary for the approval of a new use as subject of information disseminated under this part or in beginning or completing such clinical studies shall be deemed a failure to comply with section 551 of the act and the requirement of this part. Use of any amniotic and/or placental-derived products that have not met the requirements of section 551 of the Federal Food, Drug, and Cosmetic Act will be denied per Medicare Benefit Policy Manual 100-2 Chapter 15 Section 50.4.1 and associated services will also be denied per Medicare Benefit Policy Manual 100-2 Chapter 16 Section 180.General InformationAssociated InformationN/ASources of InformationN/ABibliography

Local Coverage Determinations, LCD, Local policies, Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound, DL39575

Use this page to view details for the Local Coverage Determination for Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound.

PROPOSED

Proposed LCD - Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39575)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39574&ver=3

lcd-39574-3-1.txt

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39574

lcd

3

5f754ec2-5e74-42e0-ad04-60f8bb31171e

Associated InformationN/ASources of InformationN/ABibliographyZakrzewski W, Dobrzynski M, Szymonowicz M, Rybak Z. Stem cells: past, present, and future.Stem Cell Research & Therapy2019 10:68. doi:10.1186/s13287-019-1165-5Dhillon MS, Behera P, Patel S, and Shetty V. Orthobiologics and platelet rich plasma.Indian J of Orthop. 2014;48(1):1-9. doi:10.4103/0019-5413.125477Sultan AA, Piuzzi NS, Mont MA. Nonoperative applications of placental tissue matrix in orthopaedic sports injuries: a review of literature.Clin J Sport Med. 2020;30(4):383-389. doi:10.1097/jsm.0000000000000684Gabbe SG, Niebyl JR, Simpson JL, et al. Obstetricsnormal and problem pregnancies. 5th ed. Philadelphia: Churchill Livingstone; 2007.Niknejad H, Peirovi H, Jorjani M, et al. Properties of the amniotic membrane for potential use in tssue engineering.European Cells and Materials. Vol. 15 2008. Pg 88-99. doi:10.22203/ecm.v015a07Huddleston HP, Cohn MR, Haunschild ED, et al. Amniotic product treatments: clinical and basic science evidence.Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. PMID: 32076938McIntyre JA, Jones IA, Danilkovich A, et al. The placenta: applications in orthopaedic sports medicine.Am J Sports Med. 2018;46(1):234-247.Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human amniotic membrane-derived products in sports medicine: basic science, early results, and potential clinical applications.Am J Sports Med. 2016;44(9):2425-34.Hannon CP, Yanke AB, Farr J. Amniotic tissue modulation of knee pain-a focus on osteoarthritis.J Knee Surg. 2019;32(1):26-36. doi:10.1055/s-0038-1676370Leal-Marin S, Kern T, Hofmann N, et al. Human amniotic membrane: a review on tissue engineering, application, and storage.J Biomed Mater Res. 2021;118. doi.org/10.1002/jbm.b.34782Farr J, Gomoll AH, Yanke AB, et al. A randomized controlled single-blind study demonstrating superiority of amniotic suspension allograft injection over hyaluronic acid and saline control for modification of knee osteoarthritis symptoms.J Knee Surg. 2019;32(11):1143-1154. doi:10.1055/s-0039-1696672FDA Guidance for Industry and Food and Drug Administration Staff. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. 2020 July.Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. 2007 Aug.Gellhorn A.C., Han A. The use of dehydrated human amnion/chorion membrane allograft injection for the treatment of tendinopathy or arthritis: a case series involving 40 patients.PM&R. 2017;9(12):1236-1243. doi:10.1016/j.pmrj.2017.04.011Buck D. Amniotic umbilical cord particulate for discogenic pain.Am. Osteopath. Assoc.2019;119(12):814-819. doi:10.7556/jaoa.2019.138Ross A, Gambrill V, Main C. Clinical outcomes of amniotic membrane/umbilical cord particulate in spinal disorders: a retrospective study.J Pain Res. 2022;15:3971-3979. doi:10.2147/JPR.S375201, 10.2147/JPR.S375201Ackley JF, Kolosky M, Gurin D, et al. Cryopreserved amniotic membrane and umbilical cord particulate matrix for partial rotator cuff tears: a case series.Medicine(Baltimore). 2019;98(30):e16569. doi:10.1097/MD.0000000000016569, 10.1097/MD.0000000000016569Aufiero, D, Sampson, S, Onishi, K, and Bemden, V. Treatment of medial and lateral elbow tendinosis with an injectable amniotic membrane allografta retrospective case series.J Pain Relief. 2016;5(3):242.Quinet MT, Raghavan M, Morris E, et al. Effectiveness of amniotic fluid injection in the treatment of trigger finger: a pilot study.Journal of Hand Surgery Global Online. 2020;2(5):301-305.Cazzell S., Stewart J., Agnew P.S., et al Randomized controlled trial of micronized dehydrated human amnion/chorion membrane (dHACM) injection compared to placebo for the treatment of plantar fasciitis.Foot Ankle Int. 2018;39(10):1151-1161. doi:10.1177/1071100718788549Zelen C.M., Poka A., Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis - A feasibility study.Foot Ankle Int. 2013;34(10):1332-1339. doi:10.1177/1071100713502179Hanselman A.E., Tidwell J.E., Santrock R.D. Cryopreserved human amniotic membrane injection for plantar fasciitis: A randomized, controlled, double-blind pilot study.Foot Ankle Int. 2015;36(2):151-158. doi:10.1177/1071100714552824Matthews M, Betrus CJ, Klein EE, et al. Comparison of Regenerative Injection Therapy and Conventional Therapy for Proximal Plantar Fasciitis.J Foot Ankle Surg. 2022;doi:10.1053/j.jfas.2022.11.010, 10.1053/j.jfas.2022.11.010Nakagawa H, Sung K, Ashkani-Esfahani S, et al. Plantar fasciitis: a comparison of ultrasound-guided fasciotomy with or without amniotic membrane allograft injection.Med. 2022;17(12):931-940. doi:10.2217/rme-2022-0094Werber B: Amniotic tissues for the treatment of chronic plantar fasciosis and Achilles tendinosis.J Sports Med(Hindawi Publ Corp) 2015;2015:219896Lullove E. A flowable placental tissue matrix allograft in lower extremity injuries: a pilot study. 2015;7:e275.Spector JE, Hubbs B, Kot K, et al. Micronized dehydrated human amnion/chorion membrane injection in the treatment of chronic Achilles tendinitis.J Am Podiatr Med Assoc. 2021;111(6)doi:10.7547/19-170, 10.7547/19-170Gomoll A.H., Farr J., Cole B.J., et al. Safety and efficacy of an amniotic suspension allograft injection over 12 months in a single-blinded, randomized controlled trial for symptomatic osteoarthritis of the knee.J. Arthrosc. Relat. Surg.2021;37:22462257. doi: 10.1016/j.arthro.2021.02.044.elik D, oban , Kilioglu . Minimal clinically important difference of commonly used hip-, knee-, foot-, and ankle-specific questionnaires: a systematic review.J Clin Epidemiol. 2019;113:44-57. doi:10.1016/j.jclinepi.2019.04.017McCarthy M Jr, Chang CH, Pickard AS, et al. Visual analog scales for assessing surgical pain.J Am Coll Surg. 2005;201(2):245-252. doi:10.1016/j.jamcollsurg.2005.03.034Landorf KB, Radford JA, Hudson S. Minimal important difference (MID) of two commonly used outcome measures for foot problems.J Foot Ankle Res2010;3(1):7.Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale.Ann Emerg Med2001;38(6):633-638.Alden KJ, Harris S, Hubbs B, et al. Micronized dehydrated human amnion chorion membrane injection in the treatment of knee osteoarthritis a large retrospective case series.J Knee Surg. 2021;34(8):841-845. doi:10.1055/s-0039-3400951, 10.1055/s-0039-3400951Castellanos R, Tighe S. Injectable amniotic membrane/umbilical cord particulate for knee osteoarthritis: a prospective, single-center pilot study.Pain Med. 2019;20(11):2283-2291. doi:10.1093/pm/pnz143Mead OG, Mead LP. Intra-articular injection of amniotic membrane and umbilical cord particulate for the management of moderate to severe knee osteoarthritis.Res. Rev.2020;12:161170. doi: 10.2147/ORR.S272980.Natali S, Farinelli L, Screpis D, et al. Human amniotic suspension allograft improves pain and function in knee osteoarthritis: a prospective not randomized clinical pilot study.Clin. Med. 2022;11(12)doi:10.3390/jcm11123295,10.3390/jcm11123295Meadows MC, Elisman K, Nho SJ, et al. A single injection of amniotic suspension allograft is safe and effective for treatment of mild to moderate hip osteoarthritis: a prospective study. 2022;38:325331. doi: 10.1016/j.arthro.2021.04.034.Guimaraes JDS, Arcanjo FL, Leporace G, et al Effects of therapeutic interventions on pain due to plantar fasciitis: A systematic review and meta-analysis.Rehabil. 2022;no pagination. doi:10.1177/02692155221143865Zaffagnini M, Boffa A, Andriolo L, et al. Orthobiologic injections for the treatment of hip osteoarthritis: a systematic review.J Clin Med. 2022;11(22):6663. Published 2022 Nov 10. doi:10.3390/jcm11226663Aratikatla A, Maffulli N, Rodriguez HC, et al. Allogenic perinatal tissue for musculoskeletal regenerative medicine applications: a systematic review protocol. J. Orthop. Surg.2022;17(1):307. doi:10.1186/s13018-022-03197-z,10.1186/s13018-022-03197-zSultan AA, Samuel LT, Roth A, et al. Operative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of the Literature.Surg Technol Int.2019;34:397-402.McIntyre JA, Jones IA, Danilkovich A, Vangsness CT. The placenta: applications in orthopaedic sports medicine.J. Sports Med. 2018;46(1):234-247. doi:10.1177/0363546517697682Tsikopoulos K, Vasiliadis HS, Mavridis D. Injection therapies for plantar fasciopathy ('plantar fasciitis'): A systematic review and network meta-analysis of 22 randomised controlled trials.J. Sports Med. 2016;50(22):1367-1375. doi:10.1136/bjsports-2015-095437Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials.BMJ. 2019;366:l4898. Published 2019 Aug 28. doi:10.1136/bmj.l4898Schnemann H, Brozek J, Guyatt G, Oxman A, editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013.The GRADE Working Group, 2013. Available fromorg/handbook.

Local Coverage Determinations, LCD, Local policies, Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH), DL38378

Use this page to view details for the Local Coverage Determination for Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH).

PROPOSED

Proposed LCD - Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH) (DL38378)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39576&ver=3

lcd-39576-3-1.txt

1

39576

lcd

3

9e45e3e5-1b87-4ac4-a56f-e6bd945f330b

CMS National Coverage PolicyN/ACoverage Indications, Limitations, and/or Medical NecessityThis LCD addresses use of the fluid jet system treatment of lower urinary tract symptoms attributable to benign prostatic hyperplasia (LUTS/BPH).Treatment for LUTS/BPH treatment will be considered reasonable and necessary when performedONCEin patients with the following:Indications includingALLof the following :Prostate volume of 30-150 cc by transrectal ultrasound (TRUS)1,2Persistent moderate to severe symptoms despite maximal medical management includingALLof the following:International Prostate Symptom Score (IPSS) 121Maximum urinary flow rate (Qmax) of 15 mL/s (voided volume greater than 125 cc)1Failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)Only treatment using an FDA approved/cleared device will be considered reasonable and necessary.LimitationsThe following are considered not reasonable and necessary:Body mass index 42kg/m2Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines4) or a prostate specific antigen (PSA)>10 ng/mL unless the patient has had a negative prostate biopsy within the last 6 months.Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum3Active urinary tract or systemic infection5Treatment for chronic prostatitis3Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture3Damaged external urinary sphincter3Known allergy to device materials5Inability to safely stop anticoagulants or antiplatelet agents preoperatively.5General InformationAssociated InformationN/ASources of InformationN/ABibliographyGilling P BN, Bidair, M, et al. . Threeyear outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial.Can J Urol.2020;27(1).Desai Mea. Aquablation for benign prostatic hyperplasia in large prostates (80-150cc):2-year results.Can J Urol.2020;27(2):10147-10153.Nguyen DD BN, Bidair M, Gilling P, Anderson P, Zorn KC, et al. . Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates. .BJU Int2020;125(1):112-122.Carroll PR KPJ, Andriole G, et al. . NCCN Guidelines Insights Prostate Cancer Early Detection, Version 2.J Natl Compr Canc Netw.2016;14(5):509-519.FDA. FDA Approval: De Nova Classification Request for AQUABEAM System. Accessed 7/2/19.Gilling P, Anderson P, Tan A. Aquablation of the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year Results.Journal of Urology.2017;197(6):1565-1572.Hwang EC, Jung JH, Borofsky M, Kim MH, Dahm P. Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.Cochrane Database of Systematic Reviews.2019;2:CD013143.Taktak S, Jones P, Haq A, Rai BP, Somani BK. Aquablation: a novel and minimally invasive surgery for benign prostate enlargement.Therapeutic Advances in Urology.2018;10(6):183-188.Nickel JC AL, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH): 2018 update.CAn Urol Assoc J.2018;12:303-312.Desai M, Bidair M, Bhojani N, et al. WATER II (80150 mL) procedural outcomes. 2019;123(1):106-112.Chung ASJ, Woo HH. Update on minimally invasive surgery and benign prostatic hyperplasia.Asian Journal of Urology.2018;5(1):22-27.Sturch P WH, McNicholas T, Muir G. Ejaculatory dysfunction after treatment for lower urinary tract symptoms: retrograde ejaculation or retrograde thinking? .BJU Int2015;115(2):186-197.Zorn KC, Goldenberg SL, Paterson R, So A, Elterman D, Bhojani N. Aquablation among novice users in Canada: A WATER II subpopulation analysis.Canadian Urological Association Journal.2019;13(5):E113-E118.Gilling P, Barber N, Bidair M, et al. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation vs. Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia.Journal of Urology.2018;199(5):1252-1261.Gilling PJ, Barber N, Bidair M, et al. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes.Urology.2019;125:169-173.Gilling P, Barber N, Bidair M, et al. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. 2019;36(6):1326-1336.Gilling, P.J., et al.,Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH.Can J Urol, 2022.29(1): p. 10960-10968.Desai M, Bidair M, Zorn KC, et al. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial.BJU International.2019;08:08.Bhojani N, Bidair M, Zorn KC, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results.Urology.2019;129:1-7.Bach T, Giannakis I, Bachmann A, et al. Aquablation of the prostate: single-center results of a non-selected, consecutive patient cohort.World J Urol.2018.Thorsten Bach PG, Albert El Hajj, Paul Anderson, Neil Barber. First Multi-Center All-Comers Study for the Aquablation Procedure.J Clin Med2020;9(603).Giulio R, Sebastiano C, Giorgio B, et al. Aquabeam System for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique.International journal of impotence research.2019:1.Kasivisvanathan V, Hussain M. Aquablation versus transurethral resection of the prostate: 1 year United States - cohort outcomes.Canadian Journal of Urology.2018;25(3):9317-9322.Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc).Advances in Therapy.2018;35(6):832-838.Yafi FA, Tallman CT, Seard ML, Jordan ML. Aquablation outcomes for the U.S. cohort of men with LUTS due to BPH in large prostates (80-150 cc).International Journal of Impotence Research.2018;30(5):209-214.Kasraeian, A., et al.,Aquablation for BPH: United States single-center experience.The Canadian Journal of Urology, 2020.27(5): p. 10379.Labban, M., et al.,Aquablation for benign prostatic obstruction: Single center technique evolution and experience.Investigative and Clinical Urology, 2021.62(2): p. 210.Bach, T., et al.,First multi-center all-comers study for the aquablation procedure.Journal of Clinical Medicine, 2020.9(2): p. 603.(AUA) AUA. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019, 2020). 2020. Accessed 8/26/2020.Lerner, L. B., McVary, K. T., Barry, M. J., Bixler, B. R., Dahm, P., Das, A. K., ... & Wilt, T. J. (2021). Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline part IIsurgical evaluation and treatment.The Journal of urology,206(4), 818-826.Gravis S, Cornu JN, Gratze, C, et al. EAU Guidelines: Management of Non-neurogenic Male LUTS; Chapter 5.3: Surgical Management. 2020: Disease Management. 2019. Accessed 9/14/2020.NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia. Accessed 8/1/2019.

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL36029

Use this page to view details for the Local Coverage Determination for Urine Drug Testing.

PROPOSED

Proposed LCD - Urine Drug Testing (DL36029)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39580&ver=4

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CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A). Allows coverage and payment for only those services that are considered to be reasonable and necessary.42 CFR 410.32(a). Order diagnostic tests.42 CFR 411.15(k)(1). Particular Services excluded from coverage.CMS On-Line Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.0, 80.1.1, 80.1.2. Clinical Laboratory services.CMS Internet Only Manuals, Pub 100-02 Medicare Beneficiary Policy Manual chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityPurposeUrine drug testing (UDT) provides timely, objective, and actionable information to clinicians by identifying the presence or absence of drugs of potential abuse in the body to assist the clinician in making treatment decisions1.This policy details:The appropriate indications and allowed number of UDTs billed over time for safe medication management of prescribed substances in risk stratified pain management patients and/or in identifying and treating substance use disorders (SUDs);Designates documentation, by the clinician caring for the beneficiary in the beneficiarys medical record, of medical necessity for, and testing ordered on an individual patient basis;Provides an overview of presumptive UDT and definitive UDT testing by various methodologies.This policy addresses UDT for Medicare patients only.DefinitionsAs used in this document, the following terminology relates to the basic forms of UDT:Presumptive/Qualitative Drug Testing(hereafter called "presumptive" UDT) - Covered when medically necessary to immediately determine the presence or absence of drugs or drug classes in a urine sample; results expressed as negative or positive or as a numerical result; includes competitive immunoassays (IA) and thin layer chromatography2.Definitive/Quantitative/Confirmation(hereafter called definitive UDT) - Covered when clinically indicated and medically reasonable and necessary based on this LCD to identify specific medications, illicit substances, and metabolites; reports the results of analytes absent or present typically in concentrations such as ng/mL; definitive methods include but are not limited to GC-MS and LC-MS/MS testing methods only2.Specimen Validity Testing- Urine specimen testing to ensure that it is consistent with normal human urine and has not been adulterated or substituted, may include, but is not limited to pH, specific gravity, oxidants, and creatinine. This however is quality assurance, not a Medicare benefit, and thus not separately payable by Medicare.Immunoassay (IA)- Ordered by clinicians primarily to identify the presence or absence of drug classes and some specific drugs; biochemical tests that measure the presence above a cutoff level of a substance (drug) with the use of an antibody; read by photometric technology2.Point of Care Testing (POCT)- Covered when medically necessary by clinicians caring for the beneficiary for immediate test results for the immediate management of the beneficiary; available when the beneficiary and physician are in the same location; IA test method that primarily identifies drug classes and a few specific drugs; platform consists of cups, dipsticks, cassettes, or strips; read by the human eye, or read by instrument assisted direct optical observation3.Standing Orders- Test request for a specific patient representing repetitive testing to monitor a condition or disease for a limited number of sequential visits; individualized orders for certain patients for pre-determined tests based on historical use, risk, and community trend patient profiles; clinician can alter the standing order. Note: A profile is developed based on specific characteristics of a specific patient, while a panel is a general non-specific group of tests that may have unnecessary tests for the specific patient being treated.Blanket Orders- Test request that is not for a specific patient; rather, it is an identical order for all patients in a clinicians practice without individualized decision making at every visit.Reflex Testing- Laboratory testing that is performed "reflexively" after initial test results to identify further diagnostic information essential to patient care. This testing is not necessarily based on a specific physician's order.Drug Testing MethodsThe Clinical Laboratory Improvement Amendments (CLIA) regulates laboratory testing and requires clinical labs to be certified by their State as well as the Center for Medicare & Medicaid Services (CMS) before they can accept human samples for diagnostic testing3. Multiple types of CLIA certificates may be obtained based on the complexity of testing a lab conducts. CLIA levels of complexity (CLIA-waived, moderate complexity, and high complexity) are addressed only as they correspond to the Healthcare Common Procedure Coding System (HCPCS) code description in the related billing and coding article.A. Presumptive Testing Methods1. Presumptive UDT:A presumptive UDT that consists of various platforms including cards, dipsticks, cassettes, and cups based on qualitative competitive immunoassay methodology with one or more analytes in the test. A presumptive IA test detects the presence of the amount of drug/substance present in urine above a predetermined cut-off value and may be read by direct optical observation or by instrument assisted direct optical observation.A positive test result is reported when the concentration of drug is above the cutoff; a negative is reported when the concentration of drug is below the cut-off. Positive test results are presumptive but not necessarily definitive due to sensitivity and cross-reactivity limitations4. Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen3. The accuracy of the results of a presumptive UDT will depend on the testing environment, type of test, the drug being tested for, and training of the individual conducting the test. This type of test should only be used when results are needed immediately.2. Presumptive UDT by Instrumented Chemistry Analyzers:Chemistry analyzers with IA UDT technology can be used in an office or clinical laboratory setting. This test provides less immediate test results. At no time is IA technology by chemistry analyzer analysis considered confirmatory (definitive) testing.A presumptive positive IA test detects the presence of a drug/substance in urine at or above the cut-off value. If the concentration of the drug is below the cut-off, the result will be negative. Presumptive positive tests are not always true positives due to sensitivity, specificity, and cross-reactivity limitations. Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen3.Food and Drug Administration (FDA) approved/cleared test platforms are available in the marketplace as well as laboratory developed tests (LDTs) such as modified FDA approved/ cleared and non-FDA approved/cleared platforms and/or reagents. LDTs generally have been modified to test at a lower cutoff in order to detect substances that would have been missed at a higher cutoff. For example, an FDA labeled cutoff may be 300 ng/mL and the LDT cutoff for the same drug may be 100 ng/mL3.Presumptive UDT can be carried out at any validated cut-off concentration. Lowering of the cut-off concentration provides more stringent cutoffs for illicit drugs. LDTs may include non-FDA cleared tests not available in CLIA-waived or moderate complexity tests (e.g., tramadol, tapentadol, carisoprodol, fentanyl, zolpidem). Lowering the cutoff increases the possibility of detecting a drug when the test has been modified from the recipe of the manufacturer.3. Limitations of Presumptive UDT:Presumptive UDT testing is limited due to:Primarily screens for drug classes rather than specific drugs, and therefore, the practitioner may not be able to determine if a different drug within the same class is causing the positive result;Produces erroneous results due to cross-reactivity with other compounds or does not detect all drugs within a drug class5;Given that not all prescription medications or synthetic/analog drugs are detectable and/or have assays available, it is unclear as to whether other drugs are present when some tests are reported as positive;Cut-off may be too high to detect presence of a drug5.These limitations may mean that presumptive testing is insufficient for certain clinical needs.An IA involves an antibody that reacts best with the stimulating drug and reacts to a lesser extent (cross-reactive) or not at all with other drugs in the drug class. While presumptive tests vary in their ability to detect illicit drugs such as tetrahydrocannabinol (THC), cocaine, 3,4-methylenedioxy-N-methylamphetamine (MDMA; ecstasy), and phencyclidine (PCP), they may not be optimal tests for many prescription drugs, such as: opiates, barbiturates, benzodiazepines, and opioids.For example, opiate reagents are formulated from morphine. Consequently, the cross-reactivity for other opioids and opiates varies based on the manufacturer and lot number. The semisynthetic opioids, hydromorphone and hydrocodone, may contribute to a positive presumptive result, while the semisynthetic opioids, oxycodone and oxymorphone, will not typically be detected even at a 300 ng/mL cutoff. Synthetic opioids, such as fentanyl, meperidine, and methadone, will not be detected by current opiate IA testing. Consequently, a positive opiate result by IA normally necessitates more specific identification of the substance(s) that account for the positive result, and a negative result does not rule out the presence of opiates or opioids6.Presumptive UDT reagents for benzodiazepine are typically formulated for oxazepam, a metabolite of diazepam (Valium) and chlordiazepoxide (Librium), the main benzodiazepines prescribed twenty years ago. However, many of the more than 10 benzodiazepines that are currently available do not cross-react with IA benzodiazepine reagents. In particular, clonazepam and lorazepam give false negative results with presumptive IA tests and may necessitate more specific identification to account for the negative result. Similarly, a positive screening test result may require definitive UDT to identify the specific drug(s).Synthetic/analog or designer drugs manufactured to elude law enforcement require definitive testing for detection. Most commercially available IA reagents fail to detect designer drugs such as psychedelic phenethylamines even at very high concentrations.In summary, presumptive IA UDT is often unable to identify specific drugs within many drug classes, particularly within the amphetamine, barbiturate, benzodiazepine, tricyclic antidepressants, and opiate/opioid drug classes. Drugs such as buprenorphine, amphetamines, benzodiazepines, and cocaine/heroin may yield false negative IA results due to low cross-reactivity or non-reactivity, and drugs such as fentanyl, carisoprodol, tramadol, tapentadol, and synthetic designer drugs cannot be detected by presumptive IA. Therefore, it may be medically necessary for clinicians to utilize definitive UDT when the presumptive tests for these drugs are negative1,5.B. Definitive UDT:Gas Chromatography coupled with Mass Spectrometry (GC-MS) and Liquid Chromatography coupled with Mass Spectrometry (LC-MS/MS) are complex technologies that use the separation capabilities of gaseous or liquid chromatography with the analytical capabilities of mass spectrometry. These methodologies require the competency of on-site highly trained experts in this technology and interpretation of results. While these tests require different sample preparation and analytical runs, they identify specific drugs, metabolites, and most illicit substances and report the results as absent or present typically in concentrations of ng/mL2.Quantification should not be used to determine adherence with a specific dosage or time of dose of a pain medication or illicit drug for clinical purposes. Rather, the use of quantitative drug data may be important for many reasons such as in a differential patient assessment1. For example, when several opioids are present in the urine of a patient prescribed a single opioid, quantification may help the clinician decide whether the presence of the other opioids is consistent with metabolism of the prescribed opioid, opioid contamination during manufacturing, or if more than 1 drug within a class is being used.Quantification may also provide information in the setting of illicit drug use. Serial creatinine-corrected quantitative values may assist in the differential assessment of ongoing drug use or cessation of drug use with continued drug excretion1.GC-MSGC-MS can only be performed on molecules that are volatile. If the test drug is not volatile in its own right, it must be modified or derivatized to a volatile form. To derivatize, the test drug must be extracted from the urine, eluted from the extraction device, concentrated, and then reacted with a chemical reagent to make a volatile product. Each drug class may require a different derivatizing agent. For patients on multiple classes of medications, laboratories using GC procedures must make different volatile derivatives in order to perform comprehensive testing. Since a GC column may not be able to separate more than one class of compounds, multiple chromatographic runs on different column types may be required to monitor multiple drug classes1. Newer GC-MS instruments often use tandem systems. GC-MS methodology allows for the testing of multiple substances but differs in ease of run.LC-MS/MS

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL36029

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Proposed LCD - Urine Drug Testing (DL36029)

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GC-MSGC-MS can only be performed on molecules that are volatile. If the test drug is not volatile in its own right, it must be modified or derivatized to a volatile form. To derivatize, the test drug must be extracted from the urine, eluted from the extraction device, concentrated, and then reacted with a chemical reagent to make a volatile product. Each drug class may require a different derivatizing agent. For patients on multiple classes of medications, laboratories using GC procedures must make different volatile derivatives in order to perform comprehensive testing. Since a GC column may not be able to separate more than one class of compounds, multiple chromatographic runs on different column types may be required to monitor multiple drug classes1. Newer GC-MS instruments often use tandem systems. GC-MS methodology allows for the testing of multiple substances but differs in ease of run.LC-MS/MSLC-MS/MS is roughly 100 times more sensitive and selective, involves fewer human steps, provides quicker turn-around time, uses less specimen volume, and can test for a larger number of substances simultaneously when compared to GC-MS1. After sample preparation, it is injected into the LC-MS/MS. The sample has to undergo hydrolysis to break the glucuronide bond that frees the drug and drug metabolites. Hydrolysis is followed by multiple additional steps including protein precipitation, centrifugation, and purification. Deuterium-labeled isotopic internal standards are added to quantify the drugs and drug metabolites.The sample is injected when the mobile phase is flowing through the chromatographic column. Each drug and drug metabolite interacts with the mobile phase and stationary phase differently and moves at different speeds depending on their chemical properties. In other words, each analyte elutes at different times. Specific drugs and metabolites are identified by their retention time and quantified against isotopic internal standards for each drug and metabolite. Each drug peak has a minimum of 2 mass transmissions to be compared to drug standards (calibrators) to ensure identification.CLIA-Certified Laboratories-Informational onlyCLIA specifies quality standards for proficiency testing, facility administration, general laboratory systems, pre-analytic, analytic, and post-analytic systems, onsite supervision requirements, personnel qualifications and responsibilities, quality control, and quality assessment3.High complexity laboratories must ensure that testing is carried out by onsite qualified, trained personnel using validated reliable methods compliant with regulatory procedures (42 CFR Part 493). Both GC-MS and LC-MS/MS require a quality program to monitor the quality and audit the competency of the staff. LC-MS/MS instrument maintenance must be performed daily as well as the validation of instrument performance prior to patient specimens. Final review and approval of GC-MS and LC-MS/MS results must be performed by a qualified clinical laboratory scientist as defined in 42 CFR Part 493.1489 (Testing Personnel Qualifications). A GC-MS or LC-MS/MS laboratory must have a qualified laboratory director, qualified physician, or qualified clinical laboratory scientist, as provided in 42 CFR 493.1443 (Laboratory Director Qualifications).Purpose of UDT:Presumptive UDT may be ordered by the clinician caring for a beneficiary when it is necessary to rapidly obtain and/or integrate results into clinical assessment and treatment decisions.Definitive UDT is considered reasonable and necessary when the clinical information supplied supports the definitive testing as in:Identify a specific substance or metabolite that is inadequately detected by a presumptive UDT screen;Definitively identify specific drugs in a large family of drugs;Identify a specific substance or metabolite that is not detected by presumptive UDT such as fentanyl, meperidine, synthetic cannabinoids, and other synthetic/analog drugs;Identify drugs when a definitive concentration of a drug is needed to guide management (e.g., discontinuation of THC use according to a treatment plan);Identify a negative, or confirm a positive, presumptive UDT result that is inconsistent with a patients self-report, presentation, medical history, or current prescribed pain medication plan;Rule out an error as the cause of a presumptive UDT result;Identify non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; andUse in a differential assessment of medication efficacy, side effects, or drug-drug interactions.Definitive UDT may be reasonable and necessary based on patient specific indications, including historical use, medication response, and clinical assessment, when accurate results are necessary to make clinical decisions1.To establish that a test is reasonable and necessary,the clinicians rationale for the definitive UDT and the tests ordered must be documented in the patients medical record.Drug Testing PanelsPresumptive UDT PanelsPresumptive UDT typically involves testing for multiple analytes based on the specific beneficiary's clinical history and risk assessment and must be documented in the medical record. May be ordered as a panel and billed a "Per Patient encounter" regardless of the number of analytes tested.B. Definitive UDT PanelsPhysician-directed definitive profile testing is reasonable and necessary when ordered for a particular patientbased upon historical use, clinical findings, and community trends. However, the same physician-defined profile is not reasonable and necessary for every patient in a physicians practice.Definitive UDT orders should be individualized based on clinical history and risk assessment and must be documented in the medical record.Specimen TypeUrine or oral fluid is the preferred biologic specimen for testing because of the ease of collection, storage, and cost-effectiveness1. UDT cannot detect the dosage of drug ingested/used, the time of use, or the means of delivery (intravenous vs. oral vs. inhaled). Detection time of a substance in urine is typically 1-3 days depending on the drug, rate of metabolism, and rate of excretion. Lipid-soluble drugs, such as marijuana, may remain in body fat and be detected upwards of a week or more.Ethanol is not discussed in this LCD:Note: Ethanol is a known drug of abuse but is routinely tested in blood, not urine. In addition, the DEA Resource Guide8states that alcohol is exempt from control by the Controlled Substances Act (CSA).Covered Indications for UDTGroup A Symptomatic patients, Multiple drug ingestion, and/or Patients with unreliable historyA patient who presents in a variety of medical settings with signs or symptoms of substance use toxicity will be treated presumptively to stabilize the patient while awaiting presumptive, then definitive testing to determine the cause(s) of the presentation. The need for definitive UDT is based upon presumptive test findings, responses to medical interventions, and treatment plan1. A presumptive UDT should be performed as part of the evaluation and management of a patient who presents in an emergency room or urgent care setting with any 1 of the following:Coma;Altered mental status in the absence of a clinically defined toxic syndrome or toxidrome;Severe or unexplained cardiovascular instability (cardiotoxicity);Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome or toxidrome;Seizures with an undetermined history;To provide antagonist to specific drug.The presumptive findings, definitive drug tests ordered, and reasons for the testing must be documented in the patients medical record.Group B - Diagnosis and treatment for substance abuse or dependenceA patient in active treatment for a SUD or monitoring across different phases of recovery may undergo medical management for a variety of medical conditions. A physician who is writing prescriptions for medications to treat either the SUD or other conditions may need to know if the patient is taking substances which can interact with prescribed medications or taking prescribed medications as expected1. The risk of drug-drug interactions is inherent to the patient and may be compounded by prescribed medications. UDT is a medically necessary and useful component of chemical dependency diagnosis and treatment. The UDT result influences treatment and level of care decisions3.Ordered tests and testing methods (presumptive and/or definitive) must match the stage of screening, treatment, or recovery; the documented history; and Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis. For patients with no known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using presumptive UDT. For patients with known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using definitive UDT. For patients with a diagnosed SUD, the clinician should perform random UDT at random intervals to properly monitor the patient3. Testing profiles must be determined by the clinician based on the following medical necessity guidance criteria:Patient history, physical examination, and previous laboratory findings;Stage of treatment or recovery;Suspected abused substance;Substances that may present high risk for additive or synergistic interactions with prescribed medication (e.g., benzodiazepines, alcohol).The patients medical recordmust include an appropriate number of UDTs billed over time based on the stage of screening, treatment, or recovery9and the rationale for the drugs/drug classes ordered; and the results must be documented in the medical record and used to direct care3.1. Maximum Number of Allowed Presumptive UDTs for SUDThe number of UDTs billed over time must meet medical necessity and be documented in the patients medical record9.For patients with0 to 30 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 30 days. More than 3 presumptive UDTs a rolling 30 days is not reasonable and necessary and is not covered by Medicare.2. Maximum Number of Allowed Definitive UDTs for SUDDepending on the patients specific substance use history, definitive UDT to accurately determine the specific drugs in the patients system may be necessary. Definitive testing may be ordered when accurate and reliable results are necessary to integrate treatment decisions and clinical assessment. The number of UDTs billed over time and the rationale for definitive UDT must be documented in the patients medical record.For patients with0 to 30 consecutive days of abstinence, definitive UDT is not to exceed 1 definitive UDT in a rolling 7 days More than 1 definitive UDT in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence,definitive UDT is not to exceed 3 definitive UDTs in a rolling 30 days. More than 3 definitive UDTs in a rolling 30 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 days of consecutive abstinence, definitive UDT is not to exceed 3 definitive UDTs in a rolling 90 days. More than 3 definitive UDTs in a rolling 90 days is not reasonable and necessary and is not covered by Medicare.Group C - Treatment for patients on chronic opioid/opiate therapy (COT).A physician who is writing prescriptions for medications to treat chronic pain can manage a patient better if the physician knows whether the patient is consuming another medication or substance, which could suggest the possibility of SUD or lead to drug-drug interactions. Additionally, UDT may help the physician monitor for medication adherence, diversion, efficacy, side effects, and patient safety in general11. A broad cross section of the general population will develop either cancer pain syndrome or non-cancer pain which will require prolonged or chronic opioid therapy for management with normal risk of addiction inherent to the substance(s) exposed12.COT UDT Testing Objectives:Identifies absence of prescribed medication and potential for abuse, misuse, and diversion;Identifies undisclosed substances, unsanctioned prescription medication, or illicit substances;Identifies substances that contribute to adverse events or drug-drug interactions;Provides objectivity to the treatment plan11;Reinforces therapeutic compliance with the patient;Provides additional documentation demonstrating compliance with patient evaluation and monitoring13;Provides diagnostic information to help assess individual patient response to medications (e.g., metabolism, side effects, drug-drug interaction, etc.) over time for ongoing management of prescribed medications.Medical Necessity Guidance:Criteria to establish medical necessity for UDT must be based on patient-specific elements identified during the clinical assessment, and documented by the clinician in the patients medical record and minimally include the following elements:14Patient history, physical examination, and previous laboratory findings;Current treatment plan;Prescribed medication(s);Risk assessment plan.National pain organizations, physician societies, and the Federation of State Medical Boards15recommend a practical management approach to definitive UDT for COT. The number of UDTs billed over time beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patients medical record. Recommendations for the ordering of presumptive and definitive UDT for patients on COT are as follows:COT Baseline Testing:Depending on the patients specific circumstances, initial presumptive and/or definitive COT patient testing may include amphetamine/ methamphetamine, barbiturates, benzodiazepines, cocaine, methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinol, opioids, opiates, heroin, and synthetic/analog or designer drugs.COT Monitoring Testing:

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL36029

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Proposed LCD - Urine Drug Testing (DL36029)

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Medical Necessity Guidance:Criteria to establish medical necessity for UDT must be based on patient-specific elements identified during the clinical assessment, and documented by the clinician in the patients medical record and minimally include the following elements:14Patient history, physical examination, and previous laboratory findings;Current treatment plan;Prescribed medication(s);Risk assessment plan.National pain organizations, physician societies, and the Federation of State Medical Boards15recommend a practical management approach to definitive UDT for COT. The number of UDTs billed over time beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patients medical record. Recommendations for the ordering of presumptive and definitive UDT for patients on COT are as follows:COT Baseline Testing:Depending on the patients specific circumstances, initial presumptive and/or definitive COT patient testing may include amphetamine/ methamphetamine, barbiturates, benzodiazepines, cocaine, methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinol, opioids, opiates, heroin, and synthetic/analog or designer drugs.COT Monitoring Testing:Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, self-escalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern16. As part of the clinical evaluation of the patient, the provider should inquire about prescription compliance and potential issues of abuse or diversion such as lost prescriptions, early refill requests, or requests for escalating dose of medication16. The number of UDTs billed over time must be based on the individuals risk potential1. Appropriate number of UDTs billed over time based on risk is listed in the table below14.The clinician should perform random UDT at random intervals to properly monitor a patient17.UDT testing does not have to be associated with an office visit.Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this documents guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.UDT Frequency Based on Risk Assessment and Stratification*:Testing must be based on clinicians documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.Risk GroupBaselineFrequency of TestingLow RiskPrior to Initiation of COTPresumptive and definitive UDTnot to exceed 2 times each in a rolling 365 days for prescribed medications, non- prescribed medications that may pose a safety risk if taken with prescribed medications, and illicit substances based on patient history, clinical presentation, and/or community usage.Moderate RiskPrior to Initiation of COTPresumptive and definitive UDTnot to exceed 2 times each in a rolling 180 days for prescription medications, non- prescribed medication that may pose a safety risk if taken with prescribed medications, and illicit substances, based on patient history, clinical presentation, and/or community usage.High RiskPrior to Initiation of COTPresumptive and definitive UDTnot to exceed 3 times each in a rolling 90 days for prescribed medications, non-prescribed medications that may pose a safety risk if mixed with prescribed and illicit substances based on patient history, clinical presentation and/or community usage.*Note: Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical situations in which changes in prescribed medications may be needed, such as:Patient response to prescribed medication suddenly changes;Patient side effect profile changes;To assess for possible drug-drug interactions;Change in patients medical condition or behavior;Patient admits to use of illicit or non-prescribed controlled substance.Opioid Risk Tool:The patients risk category must be clearly defined in the medical record and is essential in determining number of UDTs billed over time and medical necessity.This TOOL is to be used as a suggestion for defining Risk and this document is just an example and other tools accepted by the Opioid Use treating community may be used. Example, accepted by SAMHSA (Substance Abuse and Mental Health Services Administration)The Opioid Risk Tool (ORT)18is a brief, self-report screening tool designed for use with adult patients in primary care settings to assess risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain15,16. Patients categorized as high-risk are at increased likelihood of future abusive drug-related behavior14. The ORT can be administered and scored in less than 1 minute and has been validated in both male and female patients, but not in non-pain populations. This tool should be administered to patients upon an initial visit prior to beginning opioid therapy for pain management. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse15, 18.Mark each box that appliesFemaleMaleFamily history of substance abuseAlcoholIllegal drugsRx drugsPersonal history of substance abuseAlcoholIllegal drugsRx drugsAge between 16-45 yearsHistory of preadolescent sexual abusePsychological diseaseADD, OCD, bipolar, schizophreniaDepressionScoring totalsOther Covered ServicesReflex Testing by Reference Laboratories since reference laboratories do not have access to patient-specific data, reflex testing under the following circumstances is reasonable and necessary:To verify a presumptive positive UDT using definitive methods that include but are not limited to GC-MS or LC-MS/MS before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician; orTo confirm the absence of prescribed medications when a negative result is obtained by presumptive UDT in the laboratory for a prescribed medication listed by the ordering clinician.When medical record documentation that is individualized for a particular patient satisfies medical necessity requirements found elsewhere in this LCD (e.g., risk assessment, frequency), direct to definitive UDT without a presumptive UDT may be reasonable and necessary.Definitive testing to confirm a negative presumptive UDT result, upon the order of the clinician, is reasonable and necessary in the following circumstances:The result is inconsistent with a patients self-report, presentation, medical history, or current prescribed medication plan (should be present in the sample);Following a review of clinical findings, the clinician suspects use of a substance that is inadequately detected or not detected by a presumptive UDT; orWhen there is an unexpected negative presumptive UDT result, and it is clinically imperative to know if it is truly positive or negative; the medical record should state such.Definitive testing to confirm a presumptive UDT positive result, upon the order of the clinician, is reasonable and necessary when the result is inconsistent with the expected result, a patients self-report, presentation, medical history, or current prescribed medication plan.Non-Covered Services-therefore not reasonable and necessary servicesBlanket Orders-same orders for all patients in a health care providers practice.Reflex definitive UDT is not reasonable and necessary when presumptive testing is performed at point of care because the clinician may have sufficient information to manage the patient. If the clinician is not satisfied, he/she must determine the clinical appropriateness of and order specific subsequent definitive testing (e.g., the patient admits to using a particular drug, or the IA cut-off is set at such a point that is sufficiently low that the physician is satisfied with the presumptive test result).Routine standing orders for all patients in a physicians practice are not reasonable and necessary.It is not reasonable and necessary for a physician to perform presumptive POCT and order presumptive IA testing from a reference laboratory. In other words, Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a physician to perform presumptive IA testing and order presumptive IA testing from a reference laboratory. Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to definitive testing without a specific physicians order for the presumptive testing.IA testing, regardless of whether it is qualitative or semi-quantitative (numerical), may not be used to confirm or definitively identify a presumptive test result obtained by cups, dipsticks, cards, cassettes, or other IA testing methods. Definitive UDT provides specific identification and/or quantification typically by GC-MS or LC-MS/MS. Semi-Quantitative is defined as a numerical estimation of the approximate concentrations.Drug testing of 2 different specimen types from the same patient on the same date of service for the same drugs/metabolites/analytes.UDT for medico-legal and/or employment purposes or to protect a physician from drug diversion charges.Specimen validity testing including, but not limited to, pH, specific gravity, oxidants, creatinine.General InformationAssociated InformationN/ASources of InformationOther Contractor(s)' PoliciesBibliographyDuPont RL, Shea CL, Barthwell AG, et al. DRUG TESTING: A White Paper of the American Society of Addiction Medicine (ASAM). American Society of Addiction Medicine. White Paper. 2013.Gourlay DL, Heit HA, Caplan YH. Urine drug testing in clinical practice. The art and science of patient care. 2015(6):1-30SAMHSA, Clinical DRUG TESTING in Primary Care, Rockville, MD: SAMHSA; 2012. Technical Assistance Publication (TAP) 32, HHS publication (SMA) 12-4668.Agency Medical Directors Group. Interagency guideline on opioid dosing for chronic non-cancer pain: An educational aid to improve care and safety with opioid therapy 2010 Update.Melanson Stacy EF, Baskin LB. Interpretation and utility of drug of abuse immunoassays: lessons from laboratory drug testing surveys. Arch Pathol Lab Med. 2010;134:736-739.Standridge JB, Adams SM. Urine drug screening: a valuable office procedure. American Family Physician. 2010;81(5):635-640.American Medical Association, CPT 2021 Professional Edition, 26 November 2020, ISBN: 1640160493.Drug Enforcement Administration, U.S. Department of Justice, Drugs of Abuse: A DEA Resource Guide, 2020 Edition.Jannetto PJ, Bratanow NC, Clark WA, et al. Executive Summary: American Association of Clinical Chemistry Laboratory Medicine Practice GuidelineUsing Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. The Journal of Applied Laboratory Medicine. 2018;2(4):489526.https://doi.org/10.1373/jalm.2017.023341AMA Report 2 of the Council on Science and Public Health (I-08): Improving Medical Practice and Patient/Family Education to Reverse the Epidemic of Nonmedical Prescription Drug Use and Addiction.American Academy of Pain Medicine, Guideline Statement, Use of Opioids for the Treatment of Chronic Pain, March 2013.Passik SD, Kirsh KL, Casper D. Addiction-related assessment tools and pain management: instruments for screening, treatment planning and monitoring compliance. Pain Med. 2008;9:S145-S166.Jones T, McCoy D, Moore TM, Browder, JH, Daffron S. Urine drug testing as an evaluation of risk management strategies. Practical Pain Management. 2010;10(5):26-30.Chou R, Fanciullo GJ. Opioid Treatment Guidelines; Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J Pain. 2009; 10(2): 113-130.Federation of State Medical Boards (FSMB), Model Policy for the Use of Opioid Analgesics for the Treatment of Chronic Pain, July 2013.Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clinic Proceedings. 2009;84(7):593-601.Centers for Disease Control and Prevention. Unintentional Drug Poisoning in the United States. July 2010.Webster LR, Webster R. Predicting aberrant behaviors in Opioid-treated patients: preliminary validation of the Opioid risk tool. Pain Med. 2005;6(6):432.Additional literature reviewed but not citedMichna, E. et al. Urine toxicology screening among chronic pain patients of opioid therapy: frequency and predictability of abnormal findings. Clin J Pain. 2007;23(2):173-179.

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39580&ver=4

lcd-39580-4-1.txt

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39580

lcd

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Additional literature reviewed but not citedMichna, E. et al. Urine toxicology screening among chronic pain patients of opioid therapy: frequency and predictability of abnormal findings. Clin J Pain. 2007;23(2):173-179.Barthwell, A. Principles for Urine DRUG TESTING in Addiction Medicine. CLAAD June 23, 2014.Centers for Disease Control: Policy Impact: Prescription Painkiller Overdose Deaths. July 2013.Institute for Clinical Systems Improvement (ICSI). Guideline for the assessment and management of chronic pain. November 2011.Jackman RP, Purvis JM. Chronic nonmalignant pain in primary care.American Family Physician.2008; 78(10):1155-1162.Jamison RN, Ross EL, Michna E, Chen LQ, Holcomb C, Wasan AD. Substance misuse treatment for high-risk chronic pain patients on opioid therapy: a randomized trial.Pain.2010; 150(3):390-400.Jones T, Moore T, et al. A comparison of various risk screening methods in predicting discharge from opioid treatment.Clin J Pain.2012;28(2):93-100.University of Washington, Division of Pain Medicine, Urine DRUG TESTING Interpretive Algorithm for Monitoring Opioid Treatment (adapted from the Washington Agency Medical Directors Group Opioid Treatment Guidelines 2010).Trescot AM, Standiford H. Opioids in the management of chronic non-cancer pain: an update on American Society of the Interventional Pain Physicians' (ASIPP) guidelines.AFP.2008;11:S5-S61.Jones T, Moore TM. Preliminary data on a new risk assessment tool: the brief risk interview.Journal of Opioid Management.2013; 9(1):19-27.Jones T, Moore TM, Levy J, Browder JH, Daffron S, Passik SD. A comparison of various risk screening methods for patients receiving opioids for chronic pain management.Clinical Journal of Pain.2012; 28(2):93-100.Jones T, Passik SD. A comparison of methods of administering the opioid risk tool.Journal of Opioid Management.2011; 7(5): 347-352.Mallya A., Purnell AL, Svrakic DM, et al. Witnesses versus unwitnessed random urine tests in the treatment of opioid dependence.Am J Addict.2013; 22(2):175-177.Moore TM, Jones T, Browder JH, Daffron S, Passik SD. A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids of chronic pain management.Pain Medicine.2009; 10(8):1426-1433.Nafziger AN, Bertino JS. Utility and application of urine drug testing in chronic pain management with opioids.Clin J Pain.2009;25(1)73-79.Nicholson B, Passik S. Management of chronic non-cancer pain in the primary care setting.SMJ. 2007;100(10):1028-1034.Passik S, Jones T. Risk assessment 2.0.PainWeek Journal. 2013; 1(3): 5-9.Reisfield GM, Wasan AD, Jamison RN. The prevalence and significance of cannabis uses in patients prescribed chronic opioid therapy: a review of the extant literature.Pain Med. 2009; 10(8):1434-1441.Schneider J, Miller A. Urine drug tests in a private chronic pain practice.PPM.January/February 2008.

Local Coverage Determinations, LCD, Local policies, MolDX: Molecular Biomarker Testing for Risk Stratification of Cutaneous Squamous Cell Carcinoma, DL39585

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Proposed LCD - MolDX: Molecular Biomarker Testing for Risk Stratification of Cutaneous Squamous Cell Carcinoma (DL39585)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39584&ver=3

lcd-39584-3-1.txt

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39584

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CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary.42 CFR 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityCurrent molecular biomarker tests that risk stratify individuals with cutaneous squamous cell carcinoma (cSCC) are non-covered by this contractor.General InformationAssociated InformationN/ASources of InformationN/ABibliographyLomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of wordwide incidence of nonmelanoma skin cancer.Br J Dermatol.2012;166(5):1069-1080. doi: 10.1111/j.1365-2133.2012.10830.xSchmults CD, Blitzblau R, Aasi SZ, et al. NCCN Guidelinesinsights: squamous cell skin cancer, version 1.2022.J Natl Compr Canc Netw. 2021;19(12):1382-1394. doi:10.6004/jnccn.2021.0059Muzic JG, Schmitt AR, Wright AC, et al. Incidence and trends of basal cell carcinoma and cutaneous squamous cell carcinoma: a population-based study in Olmsted County, Minnesota, 2000 to 2010.Mayo Clin Proc. 2017;92(6):890-898. doi:10.1016/j.mayocp.2017.02.015Karia PS, Han J, Schmults CD. Cutaneous squamous cell carcinoma: estimated incidence of disease, nodal metastasis, and deaths from disease in the United States, 2012.J Am Acad Dermatol. 2013;68(6):957-966. doi:10.1016/j.jaad.2012.11.037Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: incidence, risk factors, diagnosis, and staging.J Am Acad Dermatol. 2018;78(2):237-247. doi:10.1016/j.jaad.2017.08.059Waldman A, Schmults C. Cutaneous squamous cell carcinoma.Hematol Oncol Clin North Am. 2019;33(1):1-12. doi:10.1016/j.hoc.2018.08.001Stang A, Khil L, Kajter H, et al. Incidence and mortality for cutaneous squamous cell carcinoma: comparison across three continents.J Eur Acad Dermatol Venereol. 2019;33 Suppl 8(Suppl 8):6-10. doi:10.1111/jdv.15967NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Squamous Cell Skin Cancer. Version 1.2023.https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed April 18, 2023.Xiang F, Lucas R, Hales S, Neale R. Incidence of nonmelanoma skin cancer in relation to ambient UV radiation in white populations, 1978-2012: empirical relationships.JAMA Dermatol. 2014;150(10):1063-1071. doi:10.1001/jamadermatol.2014.762Juzeniene A, Grigalavicius M, Baturaite Z, Moan J. Minimal and maximal incidence rates of skin cancer in Caucasians estimated by use of sigmoidal UV dose-incidence curves.Int J Hyg Environ Health. 2014;217(8):839-844. doi:10.1016/j.ijheh.2014.06.002Rowe DE, Carroll RJ, Day CL Jr. Prognostic factors for local recurrence, metastasis, and survival rates in squamous cell carcinoma of the skin, ear, and lip. Implications for treatment modality selection.J Am Acad Dermatol. 1992;26(6):976-990. doi:10.1016/0190-9622(92)70144-5Eroglu A, Berberoglu U, Berreroglu S. Risk factors related to locoregional recurrence in squamous cell carcinoma of the skin.J Surg Oncol. 1996;61(2):124-130. doi:10.1002/(SICI)1096-9098(199602)61:2<124::AID-JSO6>3.0.CO;2-EMullen JT, Feng L, Xing Y, et al. Invasive squamous cell carcinoma of the skin: defining a high-risk group.Ann Surg Oncol. 2006;13(7):902-909. doi:10.1245/ASO.2006.07.022Schmults CD, Karia PS, Carter JB, Han J, Qureshi AA. Factors predictive of recurrence and death from cutaneous squamous cell carcinoma: a 10-year, single-institution cohort study.JAMA Dermatol. 2013;149(5):541-547. doi:10.1001/jamadermatol.2013.2139Oh Y, Zheng Z, Kim KY, et al. A nomogram combining clinical factors and biomarkers for predicting the recurrence of high-risk cutaneous squamous cell carcinoma.BMC Cancer. 2022;22(1):1126.Roscher I, Falk RS, Vos L, et al. Validating 4 staging systems for cutaneous squamous cell carcinoma using population-based data: a nested case-control study.JAMA Dermatol. 2018;154(4):428-434. doi:10.1001/jamadermatol.2017.6428Nelson TG, Ashton RE. Low incidence of metastasis and recurrence from cutaneous squamous cell carcinoma found in a UK population: do we need to adjust our thinking on this rare but potentially fatal event?.J Surg Oncol. 2017;116(6):783-788. doi:10.1002/jso.24707Matsumoto A, Li JN, Matsumoto M, Pineider J, Nijhawan RI, Srivastava D. Factors predicting outcomes of patients with high-risk squamous cell carcinoma treated with Mohs micrographic surgery.J Am Acad Dermatol. 2021;85(3):588-595. doi:10.1016/j.jaad.2021.01.063Thompson AK, Kelley BF, Prokop LJ, Murad MH, Baum CL. Risk factors for cutaneous squamous cell carcinoma recurrence, metastasis, and disease-specific death: a systematic review and meta-analysis.JAMA Dermatol. 2016;152(4):419-428. doi:10.1001/jamadermatol.2015.4994Baum CL, Wright AC, Martinez JC, et al. A new evidence-based risk stratification system for cutaneous squamous cell carcinoma into low, intermediate, and high risk groups with implications for management.J Am Acad Dermatol. 2018;78(1):141-147. doi:10.1016/j.jaad.2017.07.031Farasat S, Yu SS, Neel VA, et al. A new American Joint Committee on Cancer staging system for cutaneous squamous cell carcinoma: creation and rationale for inclusion of tumor (T) characteristics.J Am Acad Dermatol. 2011;64(6):1051-1059. doi:10.1016/j.jaad.2010.08.033Lydiatt WM, Patel SG, O'Sullivan B, et al. Head and neck cancers-major changes in the American Joint Committee on Cancer eighth edition cancer staging manual.CA Cancer J Clin. 2017;67(2):122-137. doi:10.3322/caac.21389Karia PS, Jambusaria-Pahlajani A, Harrington DP, Murphy GF, Qureshi AA, Schmults CD. Evaluation of American Joint Committee on Cancer, International Union Against Cancer, and Brigham and Women's Hospital tumor staging for cutaneous squamous cell carcinoma.J Clin Oncol. 2014;32(4):327-334. doi:10.1200/JCO.2012.48.5326Stratigos AJ, Garbe C, Dessinioti C, et al. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: part 1. epidemiology, diagnostics and prevention.Eur J Cancer. 2020;128:60-82. doi:10.1016/j.ejca.2020.01.007Brunner M, Ng BC, Veness MJ, Clark JR. Comparison of the AJCC N staging system in mucosal and cutaneous squamous head and neck cancer.Laryngoscope. 2014;124(7):1598-1602. doi:10.1002/lary.24549Ruiz ES, Karia PS, Besaw R, Schmults CD. Performance of the American Joint Committee on Cancer Staging Manual, 8th Edition vs the Brigham and Women's Hospital Tumor Classification System for cutaneous squamous cell carcinoma.JAMA Dermatol. 2019;155(7):819-825. doi:10.1001/jamadermatol.2019.0032Patel VA, McCullum C, Sparks AD, Schmults CD, Arron ST, Jambusaria-Pahlajani A. Cutaneous squamous cell carcinoma staging may influence management in users: a survey study.Cancer Med. 2022;11(1):94-103. doi:10.1002/cam4.4426Stevens JS, Murad F, Smile TD, et al. CLO22-085: A dual-center retrospective cohort validation of the 2021 NCCN risk stratification for cutaneous squamous cell carcinoma.J Natl Compr Canc Netw. 2022;20(3.5):CLO22-085-CLO22-085. doi:10.6004/jnccn.2021.7281Venables ZC, Tokez S, Hollestein LM, et al. Validation of four cutaneous squamous cell carcinoma staging systems using nationwide data.Br J Dermatol. 2022;186(5):835-842. doi:10.1111/bjd.20909Caueto J, Burguillo J, Moyano-Bueno D, et al. Comparing the eighth and the seventh editions of the American Joint Committee on Cancer staging system and the Brigham and Women's Hospital alternative staging system for cutaneous squamous cell carcinoma: implications for clinical practice.J Am Acad Dermatol. 2019;80(1):106-113.e2. doi:10.1016/j.jaad.2018.06.060Puebla-Tornero L, Corchete-Snchez LA, Conde-Ferreirs A, et al. Performance of Salamanca refinement of the T3-AJCC8 versus the Brigham and Women's Hospital and Tbingen alternative staging systems for high-risk cutaneous squamous cell carcinoma.J Am Acad Dermatol. 2021;84(4):938-945. doi:10.1016/j.jaad.2020.12.020Conde-Ferreirs A, Corchete LA, Puebla-Tornero L, et al. Definition of prognostic subgroups in the T3 stage of the eighth edition of the American Joint Committee on Cancer staging system for cutaneous squamous cell carcinoma: tentative T3 stage subclassification.J Am Acad Dermatol. 2021;85(5):1168-1177. doi:10.1016/j.jaad.2020.03.088

Local Coverage Determinations, LCD, Local policies, MolDX: Molecular Biomarker Testing for Risk Stratification of Cutaneous Squamous Cell Carcinoma, DL39585

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Proposed LCD - MolDX: Molecular Biomarker Testing for Risk Stratification of Cutaneous Squamous Cell Carcinoma (DL39585)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39584&ver=3

lcd-39584-3-1.txt

1

39584

lcd

3

8c5bd828-0aee-4cb5-8cff-719b84b15bb1

Jambusaria-Pahlajani A, Kanetsky PA, Karia PS, et al. Evaluation of AJCC tumor staging for cutaneous squamous cell carcinoma and a proposed alternative tumor staging system.JAMA Dermatol. 2013;149(4):402-410. doi:10.1001/jamadermatol.2013.2456Karia PS, Morgan FC, Califano JA, Schmults CD. Comparison of tumor classifications for cutaneous squamous cell carcinoma of the head and neck in the 7th vs 8th edition of the AJCC cancer staging manual.JAMA Dermatol. 2018;154(2):175-181. doi:10.1001/jamadermatol.2017.3960Wysong A, Newman JG, Covington KR, et al. Validation of a 40-gene expression profile test to predict metastatic risk in localized high-risk cutaneous squamous cell carcinoma.J Am Acad Dermatol. 2021;84(2):361-369. doi:10.1016/j.jaad.2020.04.088Amin MB, Edge S, Green F, et al., eds.AJCC Cancer Staging Manual.8thed. Springer; 2018.Burns C, Kubicki S, Nguyen QB, et al. Advances in cutaneous squamous cell carcinoma management.Cancers (Basel). 2022;14(15):3653.Work Group; Invited Reviewers, Kim JYS, et al. Guidelines of care for the management of cutaneous squamous cell carcinoma.J Am Acad Dermatol. 2018;78(3):560-578. doi:10.1016/j.jaad.2017.10.007Schmitt AR, Brewer JD, Bordeaux JS, Baum CL. Staging for cutaneous squamous cell carcinoma as a predictor of sentinel lymph node biopsy results: meta-analysis of American Joint Committee on Cancer criteria and a proposed alternative system.JAMA Dermatol. 2014;150(1):19-24. doi:10.1001/jamadermatol.2013.6675Ross AS, Schmults CD. Sentinel lymph node biopsy in cutaneous squamous cell carcinoma: a systematic review of the English literature.Dermatol Surg. 2006;32(11):1309-1321. doi:10.1111/j.1524-4725.2006.32300.xDurham AB, Lowe L, Malloy KM, et al. Sentinel lymph node biopsy for cutaneous squamous cell carcinoma on the head and neck.JAMA Otolaryngol Head Neck Surg. 2016;142(12):1171-1176. doi:10.1001/jamaoto.2016.1927Gore SM, Shaw D, Martin RC, et al. Prospective study of sentinel node biopsy for high-risk cutaneous squamous cell carcinoma of the head and neck.Head Neck. 2016;38 Suppl 1:E884-E889. doi:10.1002/hed.24120Renzi C, Caggiati A, Mannooranparampil TJ, et al. Sentinel lymph node biopsy for high risk cutaneous squamous cell carcinoma: case series and review of the literature.Eur J Surg Oncol. 2007;33(3):364-369. doi:10.1016/j.ejso.2006.10.017Kwon S, Dong ZM, Wu PC. Sentinel lymph node biopsy for high-risk cutaneous squamous cell carcinoma: clinical experience and review of literature.World J Surg Oncol. 2011;9:80. doi:10.1186/1477-7819-9-80Ahmed MM, Moore BA, Schmalbach CE. Utility of head and neck cutaneous squamous cell carcinoma sentinel node biopsy: a systematic review.Otolaryngol Head Neck Surg. 2014;150(2):180-187. doi:10.1177/0194599813511949Fukushima S, Masuguchi S, Igata T, et al. Evaluation of sentinel node biopsy for cutaneous squamous cell carcinoma.J Dermatol. 2014;41(6):539-541. doi:10.1111/1346-8138.12508Takahashi A, Imafuku S, Nakayama J, Nakaura J, Ito K, Shibayama Y. Sentinel node biopsy for high-risk cutaneous squamous cell carcinoma.Eur J Surg Oncol. 2014;40(10):1256-1262. doi:10.1016/j.ejso.2014.05.009Maruyama H, Tanaka R, Fujisawa Y, Nakamura Y, Ito S, Fujimoto M. Availability of sentinel lymph node biopsy for cutaneous squamous cell carcinoma.J Dermatol. 2017;44(4):431-437. doi:10.1111/1346-8138.13577Tejera-Vaquerizo A, Garca-Doval I, Llombart B, et al. Systematic review of the prevalence of nodal metastases and the prognostic utility of sentinel lymph node biopsy in cutaneous squamous cell carcinoma.J Dermatol. 2018;45(7):781-790. doi:10.1111/1346-8138.14342Likhacheva A, Awan M, Barker CA, et al. Definitive and postoperative radiation therapy for basal and squamous cell cancers of the skin: executive summary of an American Society for Radiation Oncology clinical practice guideline.Pract Radiat Oncol. 2020;10(1):8-20. doi:10.1016/j.prro.2019.10.014Farberg AS, Fitzgerald AL, Ibrahim SF, et al. Current methods and caveats to risk factor assessment in cutaneous squamous cell carcinoma (cSCC): a narrative review.Dermatol Ther (Heidelb). 2022;12(2):267-284. doi:10.1007/s13555-021-00673-yKamiya S, Kato J, Kamiya T, et al. Association between PD-L1 expression and lymph node metastasis in cutaneous squamous cell carcinoma.Asia Pac J Clin Oncol. 2020;16(2):e108-e112. doi:10.1111/ajco.13102Garca-Pedrero JM, Martnez-Camblor P, Diaz-Coto S, et al. Tumor programmed cell death ligand 1 expression correlates with nodal metastasis in patients with cutaneous squamous cell carcinoma of the head and neck.J Am Acad Dermatol. 2017;77(3):527-533. doi:10.1016/j.jaad.2017.05.047Slater NA, Googe PB. PD-L1 expression in cutaneous squamous cell carcinoma correlates with risk of metastasis.J Cutan Pathol. 2016;43(8):663-670. doi:10.1111/cup.12728Amoils M, Kim J, Lee C, et al. PD-L1 expression and tumor-infiltrating lymphocytes in high-risk and metastatic cutaneous squamous cell carcinoma.Otolaryngol Head Neck Surg. 2019;160(1):93-99. doi:10.1177/0194599818788057Maly CJ, Cumsky HJL, Costello CM, et al. Prognostic value of inositol polyphosphate-5-phosphatase expression in recurrent and metastatic cutaneous squamous cell carcinoma.J Am Acad Dermatol. 2020;82(4):846-853. doi:10.1016/j.jaad.2019.08.027Cumsky HJL, Costello CM, Zhang N, et al. The prognostic value of inositol polyphosphate 5-phosphatase in cutaneous squamous cell carcinoma.J Am Acad Dermatol. 2019;80(3):626-632.e1. doi:10.1016/j.jaad.2018.10.018Chen MK, Cai MY, Luo RZ, et al. Overexpression of p300 correlates with poor prognosis in patients with cutaneous squamous cell carcinoma.Br J Dermatol. 2015;172(1):111-119. doi:10.1111/bjd.13226Campos MA, Macedo S, Fernandes M, et al. TERT promoter mutations are associated with poor prognosis in cutaneous squamous cell carcinoma.J Am Acad Dermatol. 2019;80(3):660-669.e6. doi:10.1016/j.jaad.2018.08.032Xu R, Cai MY, Luo RZ, Tian X, Han JD, Chen MK. The expression status and prognostic value of xancer stem cell biomarker CD133 in cutaneous squamous cell carcinoma.JAMA Dermatol. 2016;152(3):305-311. doi:10.1001/jamadermatol.2015.3781Piipponen M, Nissinen L, Riihil P, et al. p53-Regulated long noncoding RNA PRECSIT promotes progression of cutaneous squamous cell carcinoma via STAT3 signaling.Am J Pathol. 2020;190(2):503-517. doi:10.1016/j.ajpath.2019.10.019Ch'ng S, Low I, Ng D, et al. Epidermal growth factor receptor: a novel biomarker for aggressive head and neck cutaneous squamous cell carcinoma.Hum Pathol. 2008;39(3):344-349. doi:10.1016/j.humpath.2007.07.004Caueto J, Cardeoso E, Garca JL, et al. Epidermal growth factor receptor expression is associated with poor outcome in cutaneous squamous cell carcinoma.Br J Dermatol. 2017;176(5):1279-1287. doi:10.1111/bjd.14936Arron ST, Wysong A, Hall MA, et al. Gene expression profiling for metastatic risk in head and neck cutaneous squamous cell carcinoma.Laryngoscope Investig Otolaryngol. 2022;7(1):135-144. doi:10.1002/lio2.724Ibrahim SF, Kasprzak JM, Hall MA, et al. Enhanced metastatic risk assessment in cutaneous squamous cell carcinoma with the 40-gene expression profile test.Future Oncol. 2022;18(7):833-847. doi:10.2217/fon-2021-1277Borman S, Wilkinson J, Meldi-Sholl L, et al. Analytical validity of DecisionDx-SCC, a gene expression profile test to identify risk of metastasis in cutaneous squamous cell carcinoma (SCC) patients.Diagn Pathol. 2022;17(1):32. doi:10.1186/s13000-022-01211-wFarberg AS, Hall MA, Douglas L, et al. Integrating gene expression profiling into NCCN high-risk cutaneous squamous cell carcinoma management recommendations: impact on patient management.Curr Med Res Opin. 2020;36(8):1301-1307. doi:10.1080/03007995.2020.1763284Arron ST, Blalock TW, Guenther JM, et al. Clinical considerations for integrating gene expression profiling into cutaneous squamous cell carcinoma management.J Drugs Dermatol. 2021;20(6):5s-s11. doi:10.36849/JDD.2021.6068Au JH, Hooper PB, Fitzgerald AL, Somani AK. Clinical utility of the 40-gene expression profile (40-GEP) test for improved patient management decisions and disease-related outcomes when combined with current clinicopathological risk factors for cutaneous squamous cell carcinoma (cSCC): Case Series.Dermatol Ther (Heidelb). 2022;12(2):591-597. doi:10.1007/s13555-021-00665-yLitchman GH, Fitzgerald AL, Kurley SJ, Cook RW, Rigel DS. Impact of a prognostic 40-gene expression profiling test on clinical management decisions for high-risk cutaneous squamous cell carcinoma.Curr Med Res Opin. 2020;36(8):1295-1300. doi:10.1080/03007995.2020.176328Rebeca T, Giselle P, Litchman GH, Rigel DS. Impact of gene expression profile testing on the management of squamous cell carcinoma by dermatologists.J Drugs Dermatol. 2019;18(10):980-984.Saleeby R, Bielinksi K, Fitzgerald A, Siegel J, Ibrahim S. A prospective, multi-center clinical utility study demonstrates that the 40-gene expression profile (40-GEP) test impacts clinical management for Medicare-eligible patients with high-risk cutaneous squamous cell carcinoma (cSCC).SKIN The Journal of Cutaneous Medicine.2022;6(6):482-496.

Local Coverage Determinations, LCD, Local policies, MolDX: Molecular Biomarker Testing for Risk Stratification of Cutaneous Squamous Cell Carcinoma, DL39585

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39584&ver=3

lcd-39584-3-1.txt

1

39584

lcd

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634bc69a-4e2f-4d84-b5c7-5492f2dd985b

Litchman GH, Fitzgerald AL, Kurley SJ, Cook RW, Rigel DS. Impact of a prognostic 40-gene expression profiling test on clinical management decisions for high-risk cutaneous squamous cell carcinoma.Curr Med Res Opin. 2020;36(8):1295-1300. doi:10.1080/03007995.2020.176328Rebeca T, Giselle P, Litchman GH, Rigel DS. Impact of gene expression profile testing on the management of squamous cell carcinoma by dermatologists.J Drugs Dermatol. 2019;18(10):980-984.Saleeby R, Bielinksi K, Fitzgerald A, Siegel J, Ibrahim S. A prospective, multi-center clinical utility study demonstrates that the 40-gene expression profile (40-GEP) test impacts clinical management for Medicare-eligible patients with high-risk cutaneous squamous cell carcinoma (cSCC).SKIN The Journal of Cutaneous Medicine.2022;6(6):482-496.Hooper PB, Farberg AS, Fitzgerald AL, et al. Real-world evidence shows clinicians appropriately use the prognostic 40-gene expression profile (40-GEP) test for high-risk cutaneous squamous cell carcinoma (cSCC) patients.Cancer Invest. 2022;40(10):911-922. doi:10.1080/07357907.2022.2116454Tokez S, Venables ZC, Hollestein LM, et al. Risk factors for metastatic cutaneous squamous cell carcinoma: refinement and replication based on 2 nationwide nested case-control studies.J Am Acad Dermatol. 2022;87(1):64-71. doi:10.1016/j.jaad.2022.02.056Part II head and neck. In: Amin MB, Edge S, Green F, et al., eds.AJCC Cancer Staging Manual. 8thed. Springer; 2018.Levine DE, Karia PS, Schmults CD. Outcomes of patients with multiple cutaneous squamous cell carcinomas: a 10-year single-institution cohort study.JAMA Dermatol. 2015;151(11):1220-1225. doi:10.1001/jamadermatol.2015.1702Eigentler TK, Leiter U, Hfner HM, Garbe C, Rcken M, Breuninger H. Survival of patients with cutaneous squamous cell carcinoma: results of a prospective cohort study.J Invest Dermatol. 2017;137(11):2309-2315. doi:10.1016/j.jid.2017.06.025Brantsch KD, Meisner C, Schnfisch B, et al. Analysis of risk factors determining prognosis of cutaneous squamous-cell carcinoma: a prospective study.Lancet Oncol. 2008;9(8):713-720. doi:10.1016/S1470-2045(08)70178-5Roozeboom MH, Lohman BG, Westers-Attema A, et al. Clinical and histological prognostic factors for local recurrence and metastasis of cutaneous squamous cell carcinoma: analysis of a defined population.Acta Derm Venereol. 2013;93(4):417-421. doi:10.2340/00015555-1501Harb JN, Owens AL, Potter KM, Montuno M, De Jesus RO, Konda S. Resident rounds part III: case report: metastatic cutaneous squamous cell carcinoma in an African American female.J Drugs Dermatol. 2017;16(1):81-84.Harb JN, Owens AL, Potter KM, Montuno M, De Jesus RO, Konda S. Resident rounds part III: case report: metastatic cutaneous squamous cell carcinoma in an African American female.J Drugs Dermatol. 2017;16(1):81-84.Agbai ON, Buster K, Sanchez M, et al. Skin cancer and photoprotection in people of color: a review and recommendations for physicians and the public.J Am Acad Dermatol. 2014;70(4):748-762. doi:10.1016/j.jaad.2013.11.038Bradford PT. Skin cancer in skin of color.Dermatol Nurs. 2009;21(4):170-178.Battie C, Gohara M, Verschoore M, Roberts W. Skin cancer in skin of color: an update on current facts, trends, and misconceptions.J Drugs Dermatol. 2013;12(2):194-198.

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL36668

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PROPOSED

Proposed LCD - Urine Drug Testing (DL36668)

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lcd-39586-9-1.txt

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CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A). Allows coverage and payment for only those services that are considered to be reasonable and necessary.42 CFR 410.32(a). Order diagnostic tests.42 CFR 411.15(k)(1). Particular Services excluded from coverage.CMS On-Line Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.0, 80.1.1, 80.1.2. Clinical Laboratory services.CMS Internet Only Manuals, Pub 100-02 Medicare Beneficiary Policy Manual chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification Changes.Coverage Indications, Limitations, and/or Medical NecessityPurposeUrine drug testing (UDT) provides timely, objective, and actionable information to clinicians by identifying the presence or absence of drugs of potential abuse in the body to assist the clinician in making treatment decisions.1This policy details:The appropriate indications and allowed number of UDTs billed over time for safe medication management of prescribed substances in risk stratified pain management patients and/or in identifying and treating substance use disorders (SUDs);Designates documentation, by the clinician caring for the beneficiary in the beneficiarys medical record, of medical necessity for, and testing ordered on an individual patient basis;Provides an overview of presumptive UDT and definitive UDT testing by various methodologies.This policy addresses UDT for Medical patients only.DefinitionsAs used in this document, the following terminology relates to the basic forms of UDT:Presumptive/Qualitative Drug Testing(hereafter called "presumptive" UDT) - Covered when medically necessary to immediately determine the presence or absence of drugs or drug classes in a urine sample; results expressed as negative or positive or as a numerical result; includes competitive immunoassays (IA) and thin layer chromatography.2Definitive/Quantitative/Confirmation(hereafter called definitive UDT) - Covered when clinically indicated and medically reasonable and necessary based on this LCD to identify specific medications, illicit substances, and metabolites; reports the results of analytes absent or present typically in concentrations such as ng/mL; definitive methods include but are not limited to GC-MS and LC-MS/MS testing methods only.2Specimen Validity Testing- Urine specimen testing to ensure that it is consistent with normal human urine and has not been adulterated or substituted, may include, but is not limited to pH, specific gravity, oxidants and creatinine. This however is quality assurance, not a Medicare benefit, and thus not separately payable by Medicare.Immunoassay (IA)- Ordered by clinicians primarily to identify the presence or absence of drug classes and some specific drugs; biochemical tests that measure the presence above a cutoff level of a substance (drug) with the use of an antibody; read by photometric technology.2Point of Care Testing (POCT)- Covered when medically necessary by clinicians caring for the beneficiary for immediate test results for the immediate management of the beneficiary; available when the beneficiary and physician are in the same location; IA test method that primarily identifies drug classes and a few specific drugs; platform consists of cups, dipsticks, cassettes, or strips; read by the human eye, or read by instrument assisted direct optical observation.3Standing Orders- Test request for a specific patient representing repetitive testing to monitor a condition or disease for a limited number of sequential visits; individualized orders for certain patients for pre-determined tests based on historical use, risk and community trend patient profiles; clinician can alter the standing order.Note: A profile is developed based on specific characteristics of a specific patient, while a panel is a general non-specific group of tests that may have unnecessary tests for the specific patient being treated.Blanket Orders- Test request that is not for a specific patient; rather, it is an identical order for all patients in a clinicians practice without individualized decision making at every visit.Reflex Testing- Laboratory testing that is performed "reflexively" after initial test results to identify further diagnostic information essential to patient care. This testing is not necessarily based on a specific physician's order.Drug Test MethodsThe Clinical Laboratory Improvement Amendments (CLIA) regulates laboratory testing and requires clinical labs to be certified by their State as well as the Centers for Medicare & Medicaid (CMS) before they can accept human samples for diagnostic testing.3Multiple types of CLIA certificates may be obtained based on the complexity of testing a lab conducts. CLIA levels of complexity (CLIA-waived, moderate complexity, and high complexity) are addressed only as they correspond to the Healthcare Common Procedure Coding System (HCPCS) code description in the related billing and coding article.A. Presumptive Testing Methods:Presumptive UDT:A presumptive UDT consist of various platforms including cards, dipsticks, cassettes and cups based on qualitative competitive immunoassay methodology with one or more analytes in the test. A presumptive IA test detects the presence of the amount of drug/substance present in urine above a predetermined cut-off value and may be read by direct optical observation or by instrument assisted direct optical observation.A positive test result is reported when the concentration of drug is above the cutoff; a negative is reported when the concentration of drug is below the cut-off. Positive test results are presumptive but not necessarily definitive due to sensitivity and cross-reactivity limitations.4Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen.3The accuracy of the results of a presumptive UDT will depend on the testing environment, type of test, the drug being tested for, and training of the individual conducting the test. This type of test should only be used when results are needed immediately.Presumptive UDT by Instrumented Chemistry Analyzers: 80307Chemistry analyzers with IA UDT technology can be used in an office or clinical laboratory setting. This test provides less immediate test results. At no time is IA technology by chemistry analyzer analysis considered confirmatory (definitive) testing.A presumptive positive IA test detects the presence of a drug/substance in urine at or above the cut-off value. If the concentration of the drug is below the cut-off, the result will be negative. Presumptive positive tests are not always true positives due to sensitivity, specificity, and cross-reactivity limitations. Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen.3Food and Drug Administration (FDA) approved/cleared test platforms are available in the marketplace as well as laboratory developed tests (LDTs) such as modified FDA approved/cleared and non-FDA approved/cleared platforms and/or reagents. LDTs generally have been modified to test at a lower cutoff in order to detect substances that would have been missed at a higher cutoff. For example, a FDA labeled cutoff may be 300 ng/mL and the LDT cutoff for the same drug may be a 100 ng/mL.3Presumptive UDT can be carried out at any validated cut-off concentration. Lowering of the cut-off concentration provides more stringent cutoffs for illicit drugs. LDTs may include non-FDA cleared tests not available in CLIA-waived or moderate complexity tests (e.g. tramadol, tapentadol, carisoprodol, fentanyl, zolpidem). Lowering the cutoff increases the possibility of detecting a drug when the test has been modified from the recipe of the manufacturer.Limitations of Presumptive UDT:Presumptive UDT testing is limited due to:Primarily screens for drug classes rather than specific drugs, and therefore, the practitioner may not be able to determine if a different drug within the same class is causing the positive result;Produces erroneous results due to cross-reactivity with other compounds or does not detect all drugs within a drug class5;Given that not all prescription medications or synthetic/analog drugs are detectable and/or have assays available, it is unclear as to whether other drugs are present when some tests are reported as positive;Cut-off may be too high to detect presence of a drug.5These limitations may mean that presumptive testing is insufficient for certain clinical needs.An IA involves an antibody that reacts best with the stimulating drug and reacts to a lesser extent (cross-reactive) or not at all with other drugs in the drug class. While presumptive tests vary in their ability to detect illicit drugs such as tetrahydrocannabinol (THC), cocaine, 3,4-methylenedioxy-N-methylamphetamine (MDMA; ecstasy), and phencyclidine (PCP), they may not be optimal tests for many prescription drugs, such as: opiates, barbiturates, benzodiazepines and opioids.For example, opiate reagents are formulated from morphine. Consequently, the cross-reactivity for other opioids and opiates varies based on the manufacturer and lot number. The semisynthetic opioids, hydromorphone and hydrocodone, may contribute to a positive presumptive result, while the semisynthetic opioids, oxycodone and oxymorphone, will not typically be detected even at 300 ng/mL cutoff. Synthetic opioids, such as fentanyl, meperidine and methadone, will not be detected by current opiate IA testing. Consequently, a positive opiate result by IA normally necessitates more specific identification of the substance(s) that account for the positive result, and a negative result does not rule out the presence of opiates or opioids.6Presumptive UDT reagents for benzodiazepine are typically formulated for oxazepam, a metabolite of diazepam (Valium) and chlordiazepoxide (Librium), the main benzodiazepines prescribed twenty years ago. However, many of the more than 10 benzodiazepines that are currently available do not cross-react with IA benzodiazepine reagents. In particular, clonazepam and lorazepam give false negative results with presumptive IA tests and may necessitate more specific identification to account for the negative result. Similarly, a positive screening test result may require definitive UDT to identify the specific drug(s).Synthetic/analog or designer drugs manufactured to elude law enforcement require definitive testing for detection. Most commercially available IA reagents fail to detect designer drugs, such as psychedelic phenethylamines even at very high concentrations.In summary, presumptive IA UDT is often unable to identify specific drugs within many drug classes, particularly within the amphetamine, barbiturate, benzodiazepine, tricyclic antidepressants, and opiate/opioid drug classes. Drugs such as buprenorphine, amphetamines, benzodiazepines, and cocaine/heroin yield false negative IA results due to low cross-reactivity or non-reactivity, and drugs such as fentanyl, carisoprodol, tramadol, tapentadol and synthetic designer drugs cannot be detected by presumptive IA. Therefore, it may be medically necessary for clinicians to utilize definitive UDT when the presumptive tests for these drugs are negative.1,5B.Definitive UDT:Gas Chromatography coupled with Mass Spectrometry (GC-MS) and Liquid Chromatography coupled with Mass Spectrometry (LC-MS/MS) are complex technologies that use the separation capabilities of gaseous or liquid chromatography with the analytical capabilities of mass spectrometry. These methodologies require the competency of on-site highly trained experts in this technology and interpretation of results. While these tests require different sample preparation and analytical runs, they identify specific drugs, metabolites, and most illicit substances and report the results as absent or present typically in concentrations of ng/mL.2Quantification should not be used to determine adherence with a specific dosage or time of dose of a pain medication or illicit drug for clinical purposes. Rather, the use of quantitative drug data may be important for many reasons such as in a differential patient assessment.1For example, when several opioids are present in the urine of a patient prescribed a single opioid, quantification may help the clinician decide whether the presence of the other opioids is consistent with metabolism of the prescribed opioid, opioid contamination during manufacturing, or if more than 1 drug within a class is being used.Quantification may also provide information in the setting of illicit drug use. Serial creatinine-corrected quantitative values may assist in the differential assessment of ongoing drug use or cessation of drug use with continued drug excretion.1GC-MSGC-MS can only be performed on molecules that are volatile. If the test drug is not volatile in its own right, it must be modified or derivatized to a volatile form. To derivatize, the test drug must be extracted from the urine, eluted from the extraction device, concentrated, and then reacted with a chemical reagent to make a volatile product. Each drug class may require a different derivatizing agent. For patients on multiple classes of medications, laboratories using GC procedures must make different volatile derivatives in order to perform comprehensive testing. Since a GC column may not be able to separate more than one class of compounds, multiple chromatographic runs on different column types may be required to monitor multiple drug classes.1Newer GC-MS instruments often use tandem systems. GC-MS methodology allows for the testing of multiple substances but differs in ease of run.LC-MS/MSLC-MS/MS is roughly 100 times more sensitive and selective, involves fewer human steps, provides quicker turn-around time, uses less specimen volume, and can test for a larger number of substances simultaneously when compared to GC-MS.1After sample preparation, it is injected into the LC-MS/MS. The sample has to undergo hydrolysis to break the glucuronide bond that frees the drug and drug metabolites. Hydrolysis is followed by multiple additional steps including protein precipitation, centrifugation and purification. Deuterium-labeled isotopic internal standards are added to quantify the drugs and drug metabolites.

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL36668

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PROPOSED

Proposed LCD - Urine Drug Testing (DL36668)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39586&ver=9

lcd-39586-9-1.txt

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The sample is injected when the mobile phase is flowing through the chromatographic column. Each drug and drug metabolite interacts with the mobile phase and stationary phase differently and moves at different speeds depending on their chemical properties. In other words, each analyte elutes at different times. Specific drugs and metabolites are identified by their retention time and quantified against isotopic internal standards for each drug and metabolite. Each drug peak has a minimum of 2 mass transmissions to be compared to drug standards (calibrators) to ensure identification.CLIA-Certified Laboratories-Informational onlyCLIA specifies quality standards for proficiency testing, facility administration, general laboratory systems, pre-analytic, analytic and post-analytic systems, onsite supervision requirements, personnel qualifications and responsibilities, quality control, and quality assessment.3High complexity laboratories must ensure that testing is carried out by onsite qualified, trained personnel using validated reliable methods compliant with regulatory procedures (42 CFR Part 493). Both GC-MS and LC-MS/MS require a quality program to monitor the quality and audit the competency of the staff. LC-MS/MS instrument maintenance must be performed daily as well as the validation of instrument performance prior to patient specimens. Final review and approval of GC-MS and LC-MS/MS results must be performed by a qualified clinical laboratory scientist as defined in 42 CFR Part 493.1489 (Testing Personnel Qualifications). A GC-MS or LC-MS/MS laboratory must have a qualified laboratory director, qualified physician, or qualified clinical laboratory scientist, as provided in 42 CFR 493.1443 (Laboratory Director Qualifications).Purpose of UDT:Presumptive UDT may be ordered by the clinician caring for a beneficiary when it is necessary to rapidly obtain and/or integrate results into clinical assessment and treatment decisions.Definitive UDT is considered reasonable and necessarywhen the clinical information supplied supports the definitive testing as in:Identify a specific substance or metabolite that is inadequately detected by a presumptive UDT screen;Definitively identify specific drugs in a large family of drugs;Identify a specific substance or metabolite that is not detected by presumptive UDT such as fentanyl, meperidine, synthetic cannabinoids and other synthetic/analog drugs;Identify drugs when a definitive concentration of a drug is needed to guide management (e.g., discontinuation of THC use according to a treatment plan);Identify a negative, or confirm a positive, presumptive UDT result that is inconsistent with a patients self-report, presentation, medical history, or current prescribed pain medication plan;Rule out an error as the cause of a presumptive UDT result;Identify non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; andUse in a differential assessment of medication efficacy, side effects, or drug-drug interactions.Definitive UDT may be reasonable and necessary based on patient specific indications, including historical use, medication response, and clinical assessment, when accurate results are necessary to make clinical decisions.1To establish that a test is reasonable and necessary,the clinicians rationale for the definitive UDT and the tests ordered must be documented in the patients medical record.Drug Testing PanelsPresumptive UDT PanelsPresumptive UDT typically involves testing for multiple analytes based on the specific beneficiary's clinical history and risk assessment and must be documented in the medical record. May be ordered as a panel and billed a "Per Patient encounter" regardless of the number of analytes tested.Definitive UDT PanelsPhysician-directed definitive profile testing is reasonable and necessary when ordered for a particular patientbased upon historical use, clinical findings, and community trends.However, the same physician-defined profile is not reasonable and necessary for every patient in a physicians practice.Definitive UDT orders should be individualized based on clinical history and risk assessment, and must be documented in the medical record.Specimen TypeUrine or oral fluid is the preferred biologic specimen for testing because of the ease of collection, storage, and cost-effectiveness.1UDT cannot detect the dosage of drug ingested/used, the time of use, or the means of delivery (intravenous vs. oral vs. inhaled). Detection time of a substance in urine is typically 1-3 days depending on the drug, rate of metabolism, and rate of excretion. Lipid-soluble drugs, such as marijuana, may remain in body fat and be detected upwards of a week or more.Ethanol is not discussed in this LCD:Note: Ethanol is a known drug of abuse but is routinely tested in blood, not urine. In addition, the DEA Resource Guide8states that alcohol is exempt from control by the Controlled Substances Act (CSA). Ethanol is not under discussion in this LCD.Covered Indications for UDTGroup A Symptomatic patients, Multiple drug ingestion, and/or Patients with unreliable historyA patient who presents in a variety of medical settings with signs or symptoms of substance use toxicity will be treated presumptively to stabilize the patient while awaiting presumptive, then definitive testing to determine the cause(s) of the presentation. The need for definitive UDT is based upon presumptive test findings, responses to medical interventions, and treatment plan.1A presumptive UDT should be performed as part of the evaluation and management of a patient who presents in an emergency room or urgent care setting with any 1 of the following:Coma;Altered mental status in the absence of a clinically defined toxic syndrome or toxidrome;Severe or unexplained cardiovascular instability (cardiotoxicity);Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome or toxidrome;Seizures with an undetermined history;To provide antagonist to specific drug.The presumptive findings, definitive drug tests ordered, and reasons for the testing must be documented in the patient's medical record.Group B - Diagnosis and treatment for substance abuse or dependenceA patient in active treatment for a SUD or monitoring across different phases of recovery may undergo medical management for a variety of medical conditions. A physician who is writing prescriptions for medications to treat either the SUD or other conditions may need to know if the patient is taking substances which can interact with prescribed medications or taking prescribed medications as expected.1The risk of drug-drug interactions is inherent to the patient and may be compounded by prescribed medications. UDT is a medically necessary and useful component of chemical dependency diagnosis and treatment. The UDT result influences treatment and level of care decisions.3Ordered tests and testing methods (presumptive and/or definitive) must match the stage of screening, treatment, or recovery; the documented history; and Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis. For patients with no known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using presumptive UDT. For patients with known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using definitive UDT. For patients with a diagnosed SUD, the clinician should perform random UDT at random intervals in order to properly monitor the patient.3Testing profiles must be determined by the clinician based on the following medical necessity guidance criteria:Patient history, physical examination, and previous laboratory findings;Stage of treatment or recovery;Suspected abused substance;Substances that may present high risk for additive or synergistic interactions with prescribed medication (e.g., benzodiazepines, alcohol).The patients medical recordmust include an appropriate number of UDTs billed over time based on the stage of screening, treatment, or recovery10; the rationale for the drugs/drug classes ordered; and the results must be documented in the medical record and used to direct care.3Maximum Number of Allowed Presumptive UDTs for SUDThe number of UDTs billed over time must meet medical necessity and be documented in the patients medical record.9For patients with0 to 30 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days. More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days. More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 30 days. More than 3 presumptive UDTs in a rolling 30 days is not reasonable and necessary and is not covered by Medicare.Maximum Number of Allowed Definitive UDTs for SUD:Depending on the patients specific substance use history, definitive UDT to accurately determine the specific drugs in the patients system may be necessary. Definitive testing may be ordered when accurate and reliable results are necessary to integrate treatment decisions and clinical assessment. The number of UDTs billed over time and the rationale for definitive UDT must be documented in the patients medical record.For patients with0 to 30 consecutive days of abstinence, definitive UDT is not to exceed 1 definitive UDT in a rolling 7 days. More than 1 definitive UDT in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence, definitive UDT is not to exceed 3 definitive UDTs in a rolling 30 days. More than 3 definitive UDTs in a rolling 30 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 days of consecutive abstinence, definitive UDT is not to exceed 3 definitive UDTs in a rolling 90 days. More than 3 definitive UDTs in a rolling 90 days is not reasonable and necessary and is not covered by Medicare.Group C - Treatment for patients on chronic opioid therapy (COT).A physician who is writing prescriptions for medications to treat chronic pain can manage a patient better if the physician knows whether the patient is consuming another medication or substance, which could suggest the possibility of SUD or lead to drug-drug interactions. Additionally, UDT may help the physician monitor for medication adherence, diversion, efficacy, side effects, and patient safety in general.11A broad cross section of the general population will develop either cancer pain syndrome or non-cancer pain which will require prolonged or chronic opioid therapy for management with normal risk of addiction inherent to the substance(s) exposed.12COT UDT Testing Objectives:Identifies absence of prescribed medication and potential for abuse, misuse, and diversion;Identifies undisclosed substances, unsanctioned prescription medication, or illicit substances;Identifies substances that contribute to adverse events or drug-drug interactions;Provides objectivity to the treatment plan11;Reinforces therapeutic compliance with the patient;Provides additional documentation demonstrating compliance with patient evaluation and monitoring13;Provide diagnostic information to help assess individual patient response to medications (e.g., metabolism, side effects, drug-drug interaction, etc.) over time for ongoing management of prescribed medications.Medical Necessity Guidance:Criteria to establish medical necessity for UDT must be based on patient-specific elements identified during the clinical assessment, and documented by the clinician in the patients medical record and minimally include the following elements14:Patient history, physical examination, and previous laboratory findings;Current treatment plan;Prescribed medication(s);Risk assessment plan.National pain organizations, physician societies, and the Federation of State Medical Boards15recommend a practical management approach to definitive UDT for COT. The number of UDTs billed overt time beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patients medical record. Recommendations for the ordering of presumptive and definitive UDT for patients on COT are as follows:3.COT Baseline Testing:Depending on the patients specific circumstances, initial presumptive and/or definitive COT patient testing may include amphetamine/ methamphetamine, barbiturates, benzodiazepines, cocaine, methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinol, opioids, opiates, heroin, and synthetic/analog or designer drugs.4.COT Monitoring Testing:Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, self-escalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern.16As part of the clinical evaluation of the patient, the provider should inquire about prescription compliance and potential issues of abuse or diversion such as lost prescriptions, early refill requests, or requests for escalating dose of medication.16The number of UDTs billed over time must be based on the individuals risk potential.1Appropriate number of UDTs billed over time based on risk is listed in the table below.14The clinician should perform random UDT at random intervals to properly monitor a patient.17UDT testing does not have to be associated with an office visit.Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this documents guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.UDT Frequency Based on Risk Assessment and Stratification*:Testing must be based on clinicians documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.Risk GroupBaselineFrequency of Testing

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL36668

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Proposed LCD - Urine Drug Testing (DL36668)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39586&ver=9

lcd-39586-9-1.txt

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Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, self-escalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern.16As part of the clinical evaluation of the patient, the provider should inquire about prescription compliance and potential issues of abuse or diversion such as lost prescriptions, early refill requests, or requests for escalating dose of medication.16The number of UDTs billed over time must be based on the individuals risk potential.1Appropriate number of UDTs billed over time based on risk is listed in the table below.14The clinician should perform random UDT at random intervals to properly monitor a patient.17UDT testing does not have to be associated with an office visit.Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this documents guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.UDT Frequency Based on Risk Assessment and Stratification*:Testing must be based on clinicians documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.Risk GroupBaselineFrequency of TestingLow RiskPrior toInitiation ofCOTPresumptive and definitive UDT not to exceed 2 times each in a rolling 365 days for prescribed medications, non-prescribed medications that may pose a safety risk if taken with prescribed medications, and illicit substances based on patient history, clinical presentation, and/or community usage.Moderate RiskPrior toInitiation ofCOTPresumptive and definitive UDT not to exceed 2 times each in a rolling 180 days for prescription medications, non-prescribed medication that may pose a safety risk if taken with prescribed medications, and illicit substances, based on patient history, clinical presentation, and/or community usage.High RiskPrior to Initiation of COTPresumptive and definitive UDT not to exceed 3 times each in a rolling 90 days for prescribed medications, non-prescribed medications that may pose a safety risk if mixed with prescribed and illicit substances based on patient history, clinical presentation and/or community usage.*Note: Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical situations in which changes in prescribed medications may be needed, such as:Patient response to prescribed medication suddenly changes;Patient side effect profile changes;To assess for possible drug-drug interactions;Change in patients medical condition or behavior;Patient admits to use of illicit or non-prescribed controlled substance.Opioid Risk Tool:The patients risk category must be clearly defined in the medical record and is essential in determining number of UDTs billed over time and medical necessity.This TOOL is to be used as a suggestion for defining Risk and this document is just an example and other tools accepted by the Opioid Use treating community may be used. Example, accepted by SAMHSA (Substance Abuse and Mental Health Services Administration)The Opioid Risk Tool (ORT)18is a brief, self-report screening tool designed for use with adult patients in primary care settings to assess risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain.15,16Patients categorized as high-risk are at increased likelihood of future abusive drug-related behavior.14The ORT can be administered and scored in less than 1 minute and has been validated in both male and female patients, but not in non-pain populations. This tool should be administered to patients upon an initial visit prior to beginning opioid therapy for pain management. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse.15, 18Mark each box that appliesFemaleMaleFamily history of substance abuseAlcoholIllegal drugsRx drugsPersonal history of substance abuseAlcoholIllegal drugsRx drugsAge between 16-45 yearsHistory of preadolescent sexual abusePsychological diseaseADD, OCD, bipolar, schizophreniaDepressionScoring totalsOther Covered ServicesReflex Testing by Reference Laboratories since reference laboratories do not have access to patient-specific data, reflex testing under the following circumstances is reasonable and necessary:To verify a presumptive positive UDT using definitive methods that include but are not limited to GC-MS or LC-MS/MS before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician; orTo confirm the absence of prescribed medications when a negative result is obtained by presumptive UDT in the laboratory for a prescribed medication listed by the ordering clinician.When medical record documentation that is individualized for a particular patient satisfies medical necessity requirements found elsewhere in this LCD (e.g., risk assessment, frequency), direct to definitive UDT without a presumptive UDT may be reasonable and necessary.Definitive testing to confirm a negative presumptive UDT result, upon the order of the clinician, is reasonable and necessary in the following circumstances:The result is inconsistent with a patients self-report, presentation, medical history, or current prescribed medication plan (should be present in the sample);Following a review of clinical findings, the clinician suspects use of a substance that is inadequately detected or not detected by a presumptive UDT; orWhen there is an unexpected negative presumptive UDT result, and it is clinically imperative to know if it is truly positive or negative; the medical record should state such.Definitive testing to confirm a presumptive UDT positive result, upon the order of the clinician, is reasonable and necessary when the result is inconsistent with the expected result, a patients self-report, presentation, medical history, or current prescribed medication plan.Non-Covered ServicesBlanket Orders-same orders for all patients in a health care provider's practice.Reflex definitive UDT is not reasonable and necessary when presumptive testing is performed at point of care because the clinician may have sufficient information to manage the patient. If the clinician is not satisfied, he/she must determine the clinical appropriateness of and order specific subsequent definitive testing (e.g., the patient admits to using a particular drug, or the IA cut-off is set at such a point that is sufficiently low that the physician is satisfied with the presumptive test result).Routine standing orders for all patients in a physicians practice are not reasonable and necessary.It is not reasonable and necessary for a physician to perform presumptive POCT and order presumptive IA testing from a reference laboratory. In other words, Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a physician to perform presumptive IA testing and order presumptive IA testing from a reference laboratory. Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to definitive testing without a specific physicians order for the presumptive testing.IA testing, regardless of whether it is qualitative or semi-quantitative (numerical), may not be used to confirm or definitively identify a presumptive test result obtained by cups, dipsticks, cards, cassettes or other IA testing methods. Definitive UDT provides specific identification and/or quantification typically by GC-MS or LC-MS/MS. Semi-Quantitative is defined as a numerical estimation of the approximate concentrations.Drug testing of 2 different specimen types from the same patient on the same date of service for the same drugs/metabolites/analytes.UDT for medico-legal and/or employment purposes or to protect a physician from drug diversion charges.Specimen validity testing including, but not limited to, pH, specific gravity, oxidants, creatinine.General InformationAssociated InformationN/ASources of InformationOther Contractor(s)' PoliciesBibliographyDuPont RL, Shea CL, Barthwell AG, et al. DRUG TESTING: A White Paper of the American Society of Addiction Medicine (ASAM). American Society of Addiction Medicine. White Paper. 2013.Gourlay DL, Heit HA, Caplan YH. Urine drug testing in clinical practice. The art and science of patient care. 2015(6):1-30SAMHSA, Clinical DRUG TESTING in Primary Care, Rockville, MD: SAMHSA; 2012. Technical Assistance Publication (TAP) 32, HHS publication (SMA) 12-4668.Agency Medical Directors Group. Interagency guideline on opioid dosing for chronic non-cancer pain: An educational aid to improve care and safety with opioid therapy 2010 Update.Melanson Stacy EF, Baskin LB. Interpretation and utility of drug of abuse immunoassays: lessons from laboratory drug testing surveys. Arch Pathol Lab Med. 2010;134:736-739.Standridge JB, Adams SM. Urine drug screening: a valuable office procedure. American Family Physician. 2010;81(5):635-640.American Medical Association, CPT 2021 Professional Edition, 26 November 2020, ISBN: 1640160493.Drug Enforcement Administration, U.S. Department of Justice, Drugs of Abuse: A DEA Resource Guide, 2020 Edition.Jannetto PJ, Bratanow NC, Clark WA, et al. Executive Summary: American Association of Clinical Chemistry Laboratory Medicine Practice GuidelineUsing Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. The Journal of Applied Laboratory Medicine. 2018;2(4):489526.https://doi.org/10.1373/jalm.2017.023341AMA Report 2 of the Council on Science and Public Health (I-08): Improving Medical Practice and Patient/Family Education to Reverse the Epidemic of Nonmedical Prescription Drug Use and Addiction.American Academy of Pain Medicine, Guideline Statement, Use of Opioids for the Treatment of Chronic Pain, March 2013.Passik SD, Kirsh KL, Casper D. Addiction-related assessment tools and pain management: instruments for screening, treatment planning and monitoring compliance. Pain Med. 2008;9:S145-S166.Jones T, McCoy D, Moore TM, Browder, JH, Daffron S. Urine drug testing as an evaluation of risk management strategies. Practical Pain Management. 2010;10(5):26-30.Chou R, Fanciullo GJ. Opioid Treatment Guidelines; Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J Pain. 2009; 10(2): 113-130.Federation of State Medical Boards (FSMB), Model Policy for the Use of Opioid Analgesics for the Treatment of Chronic Pain, July 2013.Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clinic Proceedings. 2009;84(7):593-601.Centers for Disease Control and Prevention. Unintentional Drug Poisoning in the United States. July 2010.Webster LR, Webster R. Predicting aberrant behaviors in Opioid-treated patients: preliminary validation of the Opioid risk tool. Pain Med. 2005;6(6):432.Additional literature reviewed but not citedMichna, E. et al. Urine toxicology screening among chronic pain patients of opioid therapy: frequency and predictability of abnormal findings. Clin J Pain. 2007;23(2):173-179.Barthwell, A. Principles for Urine DRUG TESTING in Addiction Medicine. CLAAD June 23, 2014.Centers for Disease Control: Policy Impact: Prescription Painkiller Overdose Deaths. July 2013.Institute for Clinical Systems Improvement (ICSI). Guideline for the assessment and management of chronic pain. November 2011.Jackman RP, Purvis JM. Chronic nonmalignant pain in primary care.American Family Physician.2008; 78(10):1155-1162.Jamison RN, Ross EL, Michna E, Chen LQ, Holcomb C, Wasan AD. Substance misuse treatment for high-risk chronic pain patients on opioid therapy: a randomized trial.Pain.2010; 150(3):390-400.Jones T, Moore T, et al. A comparison of various risk screening methods in predicting discharge from opioid treatment.Clin J Pain.2012;28(2):93-100.University of Washington, Division of Pain Medicine, Urine DRUG TESTING Interpretive Algorithm for Monitoring Opioid Treatment (adapted from the Washington Agency Medical Directors Group Opioid Treatment Guidelines 2010).Trescot AM, Standiford H. Opioids in the management of chronic non-cancer pain: an update on American Society of the Interventional Pain Physicians' (ASIPP) guidelines.AFP.2008;11:S5-S61.Jones T, Moore TM. Preliminary data on a new risk assessment tool: the brief risk interview.Journal of Opioid Management.2013; 9(1):19-27.

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Proposed LCD - Urine Drug Testing (DL36668)

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Jones T, Moore TM, Levy J, Browder JH, Daffron S, Passik SD. A comparison of various risk screening methods for patients receiving opioids for chronic pain management.Clinical Journal of Pain.2012; 28(2):93-100.Jones T, Passik SD. A comparison of methods of administering the opioid risk tool.Journal of Opioid Management.2011; 7(5): 347-352.Mallya A., Purnell AL, Svrakic DM, et al. Witnesses versus unwitnessed random urine tests in the treatment of opioid dependence.Am J Addict.2013; 22(2):175-177.Moore TM, Jones T, Browder JH, Daffron S, Passik SD. A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids of chronic pain management.Pain Medicine.2009; 10(8):1426-1433.Nafziger AN, Bertino JS. Utility and application of urine drug testing in chronic pain management with opioids.Clin J Pain.2009;25(1)73-79.Nicholson B, Passik S. Management of chronic non-cancer pain in the primary care setting.SMJ. 2007;100(10):1028-1034.Passik S, Jones T. Risk assessment 2.0.PainWeek Journal. 2013; 1(3): 5-9.Reisfield GM, Wasan AD, Jamison RN. The prevalence and significance of cannabis uses in patients prescribed chronic opioid therapy: a review of the extant literature.Pain Med. 2009; 10(8):1434-1441.Schneider J, Miller A. Urine drug tests in a private chronic pain practice.PPM.January/February 2008.

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Proposed LCD - Urine Drug Testing (DL36707)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39587&ver=6

lcd-39587-6-1.txt

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CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A). Allows coverage and payment for only those services that are considered to be reasonable and necessary.42 CFR 410.32(a). Order diagnostic tests.42 CFR 411.15(k)(1). Particular Services excluded from coverage.CMS On-Line Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.0, 80.1.1, 80.1.2. Clinical Laboratory services.CMS Internet Only Manuals, Pub 100-02 Medicare Beneficiary Policy Manual chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification Changes.Coverage Indications, Limitations, and/or Medical NecessityPurposeUrine drug testing (UDT) provides timely, objective, and actionable information to clinicians by identifying the presence or absence of drugs of potential abuse in the body to assist the clinician in making treatment decisions.1This policy details:The appropriate indications and allowed number of UDTs billed over time for safe medication management of prescribed substances in risk stratified pain management patients and/or in identifying and treating substance use disorders (SUDs);Designates documentation, by the clinician caring for the beneficiary in the beneficiarys medical record, of medical necessity for, and testing ordered on an individual patient basis;Provides an overview of presumptive UDT and definitive UDT testing by various methodologies.This policy addresses UDT for Medical patients only.DefinitionsAs used in this document, the following terminology relates to the basic forms of UDT:Presumptive/Qualitative Drug Testing(hereafter called "presumptive" UDT) -Covered when medically necessary to immediately determine the presence or absence of drugs or drug classes in a urine sample; results expressed as negative or positive or as a numerical result; includes competitive immunoassays (IA) and thin layer chromatography.2Definitive/Quantitative/Confirmation(hereafter called definitive UDT) -Covered when clinically indicated and medically reasonable and necessary based on this LCD to identify specific medications, illicit substances, and metabolites; reports the results of analytes absent or present typically in concentrations such as ng/mL; definitive methods include but are not limited to GC-MS and LC-MS/MS testing methods only.2Specimen Validity Testing-Urine specimen testing to ensure that it is consistent with normal human urine and has not been adulterated or substituted, may include, but is not limited to pH, specific gravity, oxidants and creatinine. This however is quality assurance, not a Medicare benefit, and thus not separately payable by Medicare.Immunoassay (IA)-Ordered by clinicians primarily to identify the presence or absence of drug classes and some specific drugs; biochemical tests that measure the presence above a cutoff level of a substance (drug) with the use of an antibody; read by photometric technology.2Point of Care Testing (POCT)-Covered when medically necessary by clinicians caring for the beneficiary for immediate test results for the immediate management of the beneficiary; available when the beneficiary and physician are in the same location; IA test method that primarily identifies drug classes and a few specific drugs; platform consists of cups, dipsticks, cassettes, or strips; read by the human eye, or read by instrument assisted direct optical observation.3Standing Orders-Test request for a specific patient representing repetitive testing to monitor a condition or disease for a limited number of sequential visits; individualized orders for certain patients for pre-determined tests based on historical use, risk and community trend patient profiles; clinician can alter the standing order.Note: A profile is developed based on specific characteristics of a specific patient, while a panel is a general non-specific group of tests that may have unnecessary tests for the specific patient being treated.Blanket Orders-Test request that is not for a specific patient; rather, it is an identical order for all patients in a clinicians practice without individualized decision making at every visit.Reflex Testing-Laboratory testing that is performed "reflexively" after initial test results to identify further diagnostic information essential to patient care. This testing is not necessarily based on a specific physician's order.Drug Test MethodsThe Clinical Laboratory Improvement Amendments (CLIA) regulates laboratory testing and requires clinical labs to be certified by their State as well as the Centers for Medicare & Medicaid (CMS) before they can accept human samples for diagnostic testing.3Multiple types of CLIA certificates may be obtained based on the complexity of testing a lab conducts. CLIA levels of complexity (CLIA-waived, moderate complexity, and high complexity) are addressed only as they correspond to the Healthcare Common Procedure Coding System (HCPCS) code description in the related billing and coding article.A. Presumptive Testing Methods:Presumptive UDT:A presumptive UDT consist of various platforms including cards, dipsticks, cassettes and cups based on qualitative competitive immunoassay methodology with one or more analytes in the test. A presumptive IA test detects the presence of the amount of drug/substance present in urine above a predetermined cut-off value, and may be read by direct optical observation or by instrument assisted direct optical observation.A positive test result is reported when the concentration of drug is above the cutoff; a negative is reported when the concentration of drug is below the cut-off. Positive test results are presumptive but not necessarily definitive due to sensitivity and cross-reactivity limitations.4Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen.3The accuracy of the results of a presumptive UDT will depend on the testing environment, type of test, the drug being tested for, and training of the individual conducting the test. This type of test should only be used when results are needed immediately.Presumptive UDT by Instrumented Chemistry Analyzers: 80307Chemistry analyzers with IA UDT technology can be used in an office or clinical laboratory setting. This test provides less immediate test results. At no time is IA technology by chemistry analyzer analysis considered confirmatory (definitive) testing.A presumptive positive IA test detects the presence of a drug/substance in urine at or above the cut-off value. If the concentration of the drug is below the cut-off, the result will be negative. Presumptive positive tests are not always true positives due to sensitivity, specificity, and cross-reactivity limitations. Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen.3Food and Drug Administration (FDA) approved/cleared test platforms are available in the marketplace as well as laboratory developed tests (LDTs) such as modified FDA approved/cleared and non-FDA approved/cleared platforms and/or reagents. LDTs generally have been modified to test at a lower cutoff in order to detect substances that would have been missed at a higher cutoff. For example, a FDA labeled cutoff may be 300 ng/mL and the LDT cutoff for the same drug may be a 100 ng/mL.3Presumptive UDT can be carried out at any validated cut-off concentration. Lowering of the cut-off concentration provides more stringent cutoffs for illicit drugs. LDTs may include non-FDA cleared tests not available in CLIA-waived or moderate complexity tests (e.g. tramadol, tapentadol, carisoprodol, fentanyl, zolpidem). Lowering the cutoff increases the possibility of detecting a drug when the test has been modified from the recipe of the manufacturer.Limitations of Presumptive UDT:Presumptive UDT testing is limited due to:Primarily screens for drug classes rather than specific drugs, and therefore, the practitioner may not be able to determine if a different drug within the same class is causing the positive result;Produces erroneous results due to cross-reactivity with other compounds or does not detect all drugs within a drug class5;Given that not all prescription medications or synthetic/analog drugs are detectable and/or have assays available, it is unclear as to whether other drugs are present when some tests are reported as positive;Cut-off may be too high to detect presence of a drug.5These limitations may mean that presumptive testing is insufficient for certain clinical needs.An IA involves an antibody that reacts best with the stimulating drug and reacts to a lesser extent (cross-reactive) or not at all with other drugs in the drug class. While presumptive tests vary in their ability to detect illicit drugs such as tetrahydrocannabinol (THC), cocaine, 3,4-methylenedioxy-N-methylamphetamine (MDMA; ecstasy), and phencyclidine (PCP), they may not be optimal tests for many prescription drugs, such as: opiates, barbiturates, benzodiazepines and opioids.For example, opiate reagents are formulated from morphine. Consequently, the cross-reactivity for other opioids and opiates varies based on the manufacturer and lot number. The semisynthetic opioids, hydromorphone and hydrocodone, may contribute to a positive presumptive result, while the semisynthetic opioids, oxycodone and oxymorphone, will not typically be detected even at 300 ng/mL cutoff. Synthetic opioids, such as fentanyl, meperidine and methadone, will not be detected by current opiate IA testing. Consequently, a positive opiate result by IA normally necessitates more specific identification of the substance(s) that account for the positive result, and a negative result does not rule out the presence of opiates or opioids.6Presumptive UDT reagents for benzodiazepine are typically formulated for oxazepam, a metabolite of diazepam (Valium) and chlordiazepoxide (Librium), the main benzodiazepines prescribed twenty years ago. However, many of the more than 10 benzodiazepines that are currently available do not cross-react with IA benzodiazepine reagents. In particular, clonazepam and lorazepam give false negative results with presumptive IA tests and may necessitate more specific identification to account for the negative result. Similarly, a positive screening test result may require definitive UDT to identify the specific drug(s).Synthetic/analog or designer drugs manufactured to elude law enforcement require definitive testing for detection. Most commercially available IA reagents fail to detect designer drugs, such as psychedelic phenethylamines even at very high concentrations.In summary, presumptive IA UDT is often unable to identify specific drugs within many drug classes, particularly within the amphetamine, barbiturate, benzodiazepine, tricyclic antidepressants, and opiate/opioid drug classes. Drugs such as buprenorphine, amphetamines, benzodiazepines, and cocaine/heroin yield false negative IA results due to low cross-reactivity or non-reactivity, and drugs such as fentanyl, carisoprodol, tramadol, tapentadol and synthetic designer drugs cannot be detected by presumptive IA. Therefore, it may be medically necessary for clinicians to utilize definitive UDT when the presumptive tests for these drugs are negative.1,5B.Definitive UDT:Gas Chromatography coupled with Mass Spectrometry (GC-MS) and Liquid Chromatography coupled with Mass Spectrometry (LC-MS/MS) are complex technologies that use the separation capabilities of gaseous or liquid chromatography with the analytical capabilities of mass spectrometry. These methodologies require the competency of on-site highly trained experts in this technology and interpretation of results. While these tests require different sample preparation and analytical runs, they identify specific drugs, metabolites, and most illicit substances and report the results as absent or present typically in concentrations of ng/mL.2Quantification should not be used to determine adherence with a specific dosage or time of dose of a pain medication or illicit drug for clinical purposes. Rather, the use of quantitative drug data may be important for many reasons such as in a differential patient assessment.1For example, when several opioids are present in the urine of a patient prescribed a single opioid, quantification may help the clinician decide whether the presence of the other opioids is consistent with metabolism of the prescribed opioid, opioid contamination during manufacturing, or if more than 1 drug within a class is being used.Quantification may also provide information in the setting of illicit drug use. Serial creatinine-corrected quantitative values may assist in the differential assessment of ongoing drug use or cessation of drug use with continued drug excretion.1GC-MSGC-MS can only be performed on molecules that are volatile. If the test drug is not volatile in its own right, it must be modified or derivatized to a volatile form. To derivatize, the test drug must be extracted from the urine, eluted from the extraction device, concentrated, and then reacted with a chemical reagent to make a volatile product. Each drug class may require a different derivatizing agent. For patients on multiple classes of medications, laboratories using GC procedures must make different volatile derivatives in order to perform comprehensive testing. Since a GC column may not be able to separate more than one class of compounds, multiple chromatographic runs on different column types may be required to monitor multiple drug classes.1Newer GC-MS instruments often use tandem systems. GC-MS methodology allows for the testing of multiple substances but differs in ease of run.LC-MS/MSLC-MS/MS is roughly 100 times more sensitive and selective, involves fewer human steps, provides quicker turn-around time, uses less specimen volume, and can test for a larger number of substances simultaneously when compared to GC-MS.1After sample preparation, it is injected into the LC-MS/MS. The sample has to undergo hydrolysis to break the glucuronide bond that frees the drug and drug metabolites. Hydrolysis is followed by multiple additional steps including protein precipitation, centrifugation and purification. Deuterium-labeled isotopic internal standards are added to quantify the drugs and drug metabolites.

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL36707

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Proposed LCD - Urine Drug Testing (DL36707)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39587&ver=6

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The sample is injected when the mobile phase is flowing through the chromatographic column. Each drug and drug metabolite interacts with the mobile phase and stationary phase differently and moves at different speeds depending on their chemical properties. In other words, each analyte elutes at different times. Specific drugs and metabolites are identified by their retention time and quantified against isotopic internal standards for each drug and metabolite. Each drug peak has a minimum of 2 mass transmissions to be compared to drug standards (calibrators) to ensure identification.CLIA-Certified Laboratories-Informational onlyCLIA specifies quality standards for proficiency testing, facility administration, general laboratory systems, pre-analytic, analytic and post-analytic systems, onsite supervision requirements, personnel qualifications and responsibilities, quality control, and quality assessment.3High complexity laboratories must ensure that testing is carried out by onsite qualified, trained personnel using validated reliable methods compliant with regulatory procedures (42 CFR Part 493). Both GC-MS and LC-MS/MS require a quality program to monitor the quality and audit the competency of the staff. LC-MS/MS instrument maintenance must be performed daily as well as the validation of instrument performance prior to patient specimens. Final review and approval of GC-MS and LC-MS/MS results must be performed by a qualified clinical laboratory scientist as defined in 42 CFR Part 493.1489 (Testing Personnel Qualifications). A GC-MS or LC-MS/MS laboratory must have a qualified laboratory director, qualified physician, or qualified clinical laboratory scientist, as provided in 42 CFR 493.1443 (Laboratory Director Qualifications).Purpose of UDT:Presumptive UDT may be ordered by the clinician caring for a beneficiary when it is necessary to rapidly obtain and/or integrate results into clinical assessment and treatment decisions.Definitive UDT is considered reasonable and necessary when the clinical information supplied supports the definitive testing as in:Identify a specific substance or metabolite that is inadequately detected by a presumptive UDT screen;Definitively identify specific drugs in a large family of drugs;Identify a specific substance or metabolite that is not detected by presumptive UDT such as fentanyl, meperidine, synthetic cannabinoids and other synthetic/analog drugs;Identify drugs when a definitive concentration of a drug is needed to guide management (e.g., discontinuation of THC use according to a treatment plan);Identify a negative, or confirm a positive, presumptive UDT result that is inconsistent with a patients self-report, presentation, medical history, or current prescribed pain medication plan;Rule out an error as the cause of a presumptive UDT result;Identify non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; andUse in a differential assessment of medication efficacy, side effects, or drug-drug interactions.Definitive UDT may be reasonable and necessary based on patient specific indications, including historical use, medication response, and clinical assessment, when accurate results are necessary to make clinical decisions.1To establish that a test is reasonable and necessary,the clinicians rationale for the definitive UDT and the tests ordered must be documented in the patients medical record.Drug Testing PanelsPresumptive UDT PanelsPresumptive UDT typically involves testing for multiple analytes based on the specific beneficiary's clinical history and risk assessment and must be documented in the medical record. May be ordered as a panel and billed a "Per Patient encounter" regardless of the number of analytes tested.Definitive UDT PanelsPhysician-directed definitive profile testing is reasonable and necessary when ordered for a particular patientbased upon historical use, clinical findings, and community trends.However, the same physician-defined profile is not reasonable and necessary for every patient in a physicians practice.Definitive UDT orders should be individualized based on clinical history and risk assessment, and must be documented in the medical record.Specimen TypeUrine or oral fluid is the preferred biologic specimen for testing because of the ease of collection, storage, and cost-effectiveness.1UDT cannot detect the dosage of drug ingested/used, the time of use, or the means of delivery (intravenous vs. oral vs. inhaled). Detection time of a substance in urine is typically 1-3 days depending on the drug, rate of metabolism, and rate of excretion. Lipid-soluble drugs, such as marijuana, may remain in body fat and be detected upwards of a week or more.Ethanol is not discussed in this LCD:Note:Ethanol is a known drug of abuse but is routinely tested in blood, not urine. In addition, the DEA Resource Guide8states that alcohol is exempt from control by the Controlled Substances Act (CSA). Ethanol is not under discussion in this LCD.Covered Indications for UDTGroup A Symptomatic patients, Multiple drug ingestion and/or Patients with unreliable historyA patient who presents in a variety of medical settings with signs or symptoms of substance use toxicity will be treated presumptively to stabilize the patient while awaiting presumptive, then definitive testing to determine the cause(s) of the presentation. The need for definitive UDT is based upon presumptive test findings, responses to medical interventions, and treatment plan.1A presumptive UDT should be performed as part of the evaluation and management of a patient who presents in an emergency room or urgent care setting with any 1 of the following:Coma;Altered mental status in the absence of a clinically defined toxic syndrome or toxidrome;Severe or unexplained cardiovascular instability (cardiotoxicity);Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome or toxidrome;Seizures with an undetermined history;To provide antagonist to specific drug.The presumptive findings, definitive drug tests ordered, and reasons for the testing must be documented in the patient's medical record.Group B - Diagnosis and treatment for substance abuse or dependenceA patient in active treatment for a SUD or monitoring across different phases of recovery may undergo medical management for a variety of medical conditions. A physician who is writing prescriptions for medications to treat either the SUD or other conditions may need to know if the patient is taking substances which can interact with prescribed medications or taking prescribed medications as expected.1The risk of drug-drug interactions is inherent to the patient and may be compounded by prescribed medications. UDT is a medically necessary and useful component of chemical dependency diagnosis and treatment. The UDT result influences treatment and level of care decisions.3Ordered tests and testing methods (presumptive and/or definitive) must match the stage of screening, treatment, or recovery; the documented history; and Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis. For patients with no known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using presumptive UDT. For patients with known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using definitive UDT. For patients with a diagnosed SUD, the clinician should perform random UDT at random intervals in order to properly monitor the patient.3Testing profiles must be determined by the clinician based on the following medical necessity guidance criteria:Patient history, physical examination, and previous laboratory findings;Stage of treatment or recovery;Suspected abused substance;Substances that may present high risk for additive or synergistic interactions with prescribed medication (e.g., benzodiazepines, alcohol).The patients medical recordmust include an appropriate number of UDTs billed over time based on the stage of screening, treatment, or recovery10; the rationale for the drugs/drug classes ordered; and the results must be documented in the medical record and used to direct care.3Maximum Number of Allowed Presumptive UDTs for SUD:The number of UDTs billed over time must meet medical necessity and be documented in the patients medical record.9For patients with0 to 30 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days. More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days. More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 30 days. More than 3 presumptive UDTs in a rolling 30 days is not reasonable and necessary and is not covered by Medicare.Maximum Number of Allowed Definitive UDTs for SUD:Depending on the patients specific substance use history, definitive UDT to accurately determine the specific drugs in the patients system may be necessary. Definitive testing may be ordered when accurate and reliable results are necessary to integrate treatment decisions and clinical assessment. The number of UDTs billed over time and the rationale for definitive UDT must be documented in the patients medical record.For patients with0 to 30 consecutive days of abstinence, definitive UDT is not to exceed 1 definitive UDT in a rolling 7 days. More than 1 definitive UDT in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence, definitive UDT is not to exceed 3 definitive UDTs in a rolling 30 days. More than 3 definitive UDTs in a rolling 30 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 days of consecutive abstinence, definitive UDT is not to exceed 3 definitive UDTs in a rolling 90 days. More than 3 definitive UDTs in a rolling 90 days is not reasonable and necessary and is not covered by Medicare.Group C - Treatment for patients on chronic opioid therapy (COT).A physician who is writing prescriptions for medications to treat chronic pain can manage a patient better if the physician knows whether the patient is consuming another medication or substance, which could suggest the possibility of SUD or lead to drug-drug interactions. Additionally, UDT may help the physician monitor for medication adherence, diversion, efficacy, side effects, and patient safety in general.11A broad cross section of the general population will develop either cancer pain syndrome or non-cancer pain which will require prolonged or chronic opioid therapy for management with normal risk of addiction inherent to the substance(s) exposed.121. COT UDT Testing Objectives:Identifies absence of prescribed medication and potential for abuse, misuse, and diversion;Identifies undisclosed substances, unsanctioned prescription medication, or illicit substances;Identifies substances that contribute to adverse events or drug-drug interactions;Provides objectivity to the treatment plan11;Reinforces therapeutic compliance with the patient;Provides additional documentation demonstrating compliance with patient evaluation and monitoring13;Provide diagnostic information to help assess individual patient response to medications (e.g., metabolism, side effects, drug-drug interaction, etc.) over time for ongoing management of prescribed medications.Medical Necessity Guidance:Criteriato establish medical necessity for UDT must be based on patient-specific elements identified during the clinical assessment, and documented by the clinician in the patients medical record and minimally include the followingelements14:Patient history, physical examination, and previous laboratory findings;Current treatment plan;Prescribed medication(s);Risk assessment plan.National pain organizations, physician societies, and the Federation of State Medical Boards15recommend a practical management approach to definitive UDT for COT. The number of UDTs billed overt time beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patients medical record. Recommendations for the ordering of presumptive and definitive UDT for patients on COT are as follows:3.COTBaseline Testing:Depending on the patients specific circumstances, initial presumptive and/or definitive COT patient testing may include amphetamine/ methamphetamine, barbiturates, benzodiazepines, cocaine, methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinol, opioids, opiates, heroin, and synthetic/analog or designer drugs.4.COTMonitoring Testing:Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, self-escalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern.16As part of the clinical evaluation of the patient, the provider should inquire about prescription compliance and potential issues of abuse or diversion such as lost prescriptions, early refill requests, or requests for escalating dose of medication.16The number of UDTs billed over time must be based on the individuals risk potential.1Appropriate number of UDTs billed over time based on risk is listed in the table below.14The clinician should perform random UDT at random intervals to properly monitor a patient.17UDT testing does not have to be associated with an office visit.Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this documents guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.UDT Frequency Based on Risk Assessment and Stratification*:Testing must be based on clinicians documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.Risk GroupBaselineFrequency of Testing

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL36707

Use this page to view details for the Local Coverage Determination for Urine Drug Testing.

PROPOSED

Proposed LCD - Urine Drug Testing (DL36707)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39587&ver=6

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Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, self-escalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern.16As part of the clinical evaluation of the patient, the provider should inquire about prescription compliance and potential issues of abuse or diversion such as lost prescriptions, early refill requests, or requests for escalating dose of medication.16The number of UDTs billed over time must be based on the individuals risk potential.1Appropriate number of UDTs billed over time based on risk is listed in the table below.14The clinician should perform random UDT at random intervals to properly monitor a patient.17UDT testing does not have to be associated with an office visit.Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this documents guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.UDT Frequency Based on Risk Assessment and Stratification*:Testing must be based on clinicians documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.Risk GroupBaselineFrequency of TestingLow RiskPrior toInitiation ofCOTPresumptive and definitive UDT not to exceed 2 times each in a rolling 365 days for prescribed medications, non-prescribed medications that may pose a safety risk if taken with prescribed medications, and illicit substances based on patient history, clinical presentation, and/or community usage.Moderate RiskPrior toInitiation ofCOTPresumptive and definitive UDT not to exceed 2 times each in a rolling 180 days for prescription medications, non-prescribed medication that may pose a safety risk if taken with prescribed medications, and illicit substances, based on patient history, clinical presentation, and/or community usage.High RiskPrior to Initiation of COTPresumptive and definitive UDT not to exceed 3 times each in a rolling 90 days for prescribed medications, non-prescribed medications that may pose a safety risk if mixed with prescribed and illicit substances based on patient history, clinical presentation and/or community usage.*Note: Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical situations in which changes in prescribed medications may be needed, such as:Patient response to prescribed medication suddenly changes;Patient side effect profile changes;To assess for possible drug-drug interactions;Change in patients medical condition or behavior;Patient admits to use of illicit or non-prescribed controlled substance.Opioid Risk Tool:The patients risk category must be clearly defined in the medical record and is essential in determining number of UDTs billed over time and medical necessity.This TOOL is to be used as a suggestion for defining Risk and this document is just an example and other tools accepted by the Opioid Use treating community may be used. Example, accepted by SAMHSA (Substance Abuse and Mental Health Services Administration)The Opioid Risk Tool (ORT)18is a brief, self-report screening tool designed for use with adult patients in primary care settings to assess risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain.15,16Patients categorized as high-risk are at increased likelihood of future abusive drug-related behavior.14The ORT can be administered and scored in less than 1 minute and has been validated in both male and female patients, but not in non-pain populations. This tool should be administered to patients upon an initial visit prior to beginning opioid therapy for pain management. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse.15, 18Mark each box that appliesFemaleMaleFamily history of substance abuseAlcoholIllegal drugsRx drugsPersonal history of substance abuseAlcoholIllegal drugsRx drugsAge between 16-45 yearsHistory of preadolescent sexual abusePsychological diseaseADD, OCD, bipolar, schizophreniaDepressionScoring totalsOther Covered ServicesReflex Testing by Reference Laboratories since reference laboratories do not have access to patient-specific data, reflex testing under the following circumstances is reasonable and necessary:To verify a presumptive positive UDT using definitive methods that include but are not limited to GC-MS or LC-MS/MS before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician; orTo confirm the absence of prescribed medications when a negative result is obtained by presumptive UDT in the laboratory for a prescribed medication listed by the ordering clinician.When medical record documentation that is individualized for a particular patient satisfies medical necessity requirements found elsewhere in this LCD (e.g., risk assessment, frequency), direct to definitive UDT without a presumptive UDT may be reasonable and necessary.Definitive testing to confirm a negative presumptive UDT result, upon the order of the clinician, is reasonable and necessary in the following circumstances:The result is inconsistent with a patients self-report, presentation, medical history, or current prescribed medication plan (should be present in the sample);Following a review of clinical findings, the clinician suspects use of a substance that is inadequately detected or not detected by a presumptive UDT; orWhen there is an unexpected negative presumptive UDT result, and it is clinically imperative to know if it is truly positive or negative; the medical record should state such.4. Definitive testing to confirm a presumptive UDT positive result, upon the order of the clinician, is reasonable and necessary when the result is inconsistent with the expected result, a patients self-report, presentation, medical history, or current prescribed medication plan.Non-Covered ServicesBlanket Orders-same orders for all patients in a health care provider's practice.Reflex definitive UDT is not reasonable and necessary when presumptive testing is performed at point of care because the clinician may have sufficient information to manage the patient. If the clinician is not satisfied, he/she must determine the clinical appropriateness of and order specific subsequent definitive testing (e.g., the patient admits to using a particular drug, or the IA cut-off is set at such a point that is sufficiently low that the physician is satisfied with the presumptive test result).Routine standing orders for all patients in a physicians practice are not reasonable and necessary.It is not reasonable and necessary for a physician to perform presumptive POCT and order presumptive IA testing from a reference laboratory. In other words, Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a physician to perform presumptive IA testing and order presumptive IA testing from a reference laboratory. Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to definitive testing without a specific physicians order for the presumptive testing.IA testing, regardless of whether it is qualitative or semi-quantitative (numerical), may not be used to confirm or definitively identify a presumptive test result obtained by cups, dipsticks, cards, cassettes or other IA testing methods. Definitive UDT provides specific identification and/or quantification typically by GC-MS or LC-MS/MS. Semi-Quantitative is defined as a numerical estimation of the approximate concentrations.Drug testing of 2 different specimen types from the same patient on the same date of service for the same drugs/metabolites/analytes.UDT for medico-legal and/or employment purposes or to protect a physician from drug diversion charges.Specimen validity testing including, but not limited to, pH, specific gravity, oxidants, creatinine.General InformationAssociated InformationN/ASources of InformationOther Contractor(s)' PoliciesBibliographyDuPont RL, Shea CL, Barthwell AG, et al. DRUG TESTING: A White Paper of the American Society of Addiction Medicine (ASAM). American Society of Addiction Medicine. White Paper. 2013.Gourlay DL, Heit HA, Caplan YH. Urine drug testing in clinical practice. The art and science of patient care. 2015(6):1-30SAMHSA, Clinical DRUG TESTING in Primary Care, Rockville, MD: SAMHSA; 2012. Technical Assistance Publication (TAP) 32, HHS publication (SMA) 12-4668.Agency Medical Directors Group. Interagency guideline on opioid dosing for chronic non-cancer pain: An educational aid to improve care and safety with opioid therapy 2010 Update.Melanson Stacy EF, Baskin LB. Interpretation and utility of drug of abuse immunoassays: lessons from laboratory drug testing surveys. Arch Pathol Lab Med. 2010;134:736-739.Standridge JB, Adams SM. Urine drug screening: a valuable office procedure. American Family Physician. 2010;81(5):635-640.American Medical Association, CPT 2021 Professional Edition, 26 November 2020, ISBN: 1640160493.Drug Enforcement Administration, U.S. Department of Justice, Drugs of Abuse: A DEA Resource Guide, 2020 Edition.Jannetto PJ, Bratanow NC, Clark WA, et al. Executive Summary: American Association of Clinical Chemistry Laboratory Medicine Practice GuidelineUsing Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. The Journal of Applied Laboratory Medicine. 2018;2(4):489526.https://doi.org/10.1373/jalm.2017.023341AMA Report 2 of the Council on Science and Public Health (I-08): Improving Medical Practice and Patient/Family Education to Reverse the Epidemic of Nonmedical Prescription Drug Use and Addiction.American Academy of Pain Medicine, Guideline Statement, Use of Opioids for the Treatment of Chronic Pain, March 2013.Passik SD, Kirsh KL, Casper D. Addiction-related assessment tools and pain management: instruments for screening, treatment planning and monitoring compliance. Pain Med. 2008;9:S145-S166.Jones T, McCoy D, Moore TM, Browder, JH, Daffron S. Urine drug testing as an evaluation of risk management strategies. Practical Pain Management. 2010;10(5):26-30.Chou R, Fanciullo GJ. Opioid Treatment Guidelines; Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J Pain. 2009; 10(2): 113-130.Federation of State Medical Boards (FSMB), Model Policy for the Use of Opioid Analgesics for the Treatment of Chronic Pain, July 2013.Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clinic Proceedings. 2009;84(7):593-601.Centers for Disease Control and Prevention. Unintentional Drug Poisoning in the United States. July 2010.Webster LR, Webster R. Predicting aberrant behaviors in Opioid-treated patients: preliminary validation of the Opioid risk tool. Pain Med. 2005;6(6):432.Additional literature reviewed but not citedMichna, E. et al. Urine toxicology screening among chronic pain patients of opioid therapy: frequency and predictability of abnormal findings. Clin J Pain. 2007;23(2):173-179.Barthwell, A. Principles for Urine DRUG TESTING in Addiction Medicine. CLAAD June 23, 2014.Centers for Disease Control: Policy Impact: Prescription Painkiller Overdose Deaths. July 2013.Institute for Clinical Systems Improvement (ICSI). Guideline for the assessment and management of chronic pain. November 2011.Jackman RP, Purvis JM. Chronic nonmalignant pain in primary care.American Family Physician.2008; 78(10):1155-1162.Jamison RN, Ross EL, Michna E, Chen LQ, Holcomb C, Wasan AD. Substance misuse treatment for high-risk chronic pain patients on opioid therapy: a randomized trial.Pain.2010; 150(3):390-400.Jones T, Moore T, et al. A comparison of various risk screening methods in predicting discharge from opioid treatment.Clin J Pain.2012;28(2):93-100.University of Washington, Division of Pain Medicine, Urine DRUG TESTING Interpretive Algorithm for Monitoring Opioid Treatment (adapted from the Washington Agency Medical Directors Group Opioid Treatment Guidelines 2010).Trescot AM, Standiford H. Opioids in the management of chronic non-cancer pain: an update on American Society of the Interventional Pain Physicians' (ASIPP) guidelines.AFP.2008;11:S5-S61.Jones T, Moore TM. Preliminary data on a new risk assessment tool: the brief risk interview.Journal of Opioid Management.2013; 9(1):19-27.

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL36707

Use this page to view details for the Local Coverage Determination for Urine Drug Testing.

PROPOSED

Proposed LCD - Urine Drug Testing (DL36707)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39587&ver=6

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Jones T, Moore TM, Levy J, Browder JH, Daffron S, Passik SD. A comparison of various risk screening methods for patients receiving opioids for chronic pain management.Clinical Journal of Pain.2012; 28(2):93-100.Jones T, Passik SD. A comparison of methods of administering the opioid risk tool.Journal of Opioid Management.2011; 7(5): 347-352.Mallya A., Purnell AL, Svrakic DM, et al. Witnesses versus unwitnessed random urine tests in the treatment of opioid dependence.Am J Addict.2013; 22(2):175-177.Moore TM, Jones T, Browder JH, Daffron S, Passik SD. A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids of chronic pain management.Pain Medicine.2009; 10(8):1426-1433.Nafziger AN, Bertino JS. Utility and application of urine drug testing in chronic pain management with opioids.Clin J Pain.2009;25(1)73-79.Nicholson B, Passik S. Management of chronic non-cancer pain in the primary care setting.SMJ. 2007;100(10):1028-1034.Passik S, Jones T. Risk assessment 2.0.PainWeek Journal. 2013; 1(3): 5-9.Reisfield GM, Wasan AD, Jamison RN. The prevalence and significance of cannabis uses in patients prescribed chronic opioid therapy: a review of the extant literature.Pain Med. 2009; 10(8):1434-1441.Schneider J, Miller A. Urine drug tests in a private chronic pain practice.PPM.January/February 2008.

Local Coverage Determinations, LCD, Local policies, External Upper Limb Tremor Stimulator Therapy, DL39591

Use this page to view details for the Local Coverage Determination for External Upper Limb Tremor Stimulator Therapy.

PROPOSED

Proposed LCD - External Upper Limb Tremor Stimulator Therapy (DL39591)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39590&ver=7

lcd-39590-7-1.txt

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dcf0ec30-14d4-4be4-8bd1-657e9e8d736d

CMS National Coverage PolicyN/ACoverage Indications, Limitations, and/or Medical NecessityFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act 1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.An external upper limb tremor stimulator of the peripheral nerves of the wrist (K1018) and related supplies and accessories (K1019) will be denied as not reasonable and necessary.GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.General InformationAssociated InformationDOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider. It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSRefer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MiscellaneousAppendicesN/AUtilization GuidelinesRefer to Coverage Indications, Limitations and/or Medical NecessitySources of InformationN/ABibliographyBhatia KP, Bain P, Bajaj N, et al. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society.Mov Disord.2018;33(1):75-87.Louis ED, Ottman R. How many people in the USA have essential tremor? Deriving a population estimate based on epidemiological data.Tremor Other Hyperkinet Mov (N Y). 2014;4:259.Louis ED. The Roles of Age and Aging in Essential Tremor: An Epidemiological Perspective.Neuroepidemiology. 2019;52(1-2):111-118.Lin PT, Ross EK, Chidester P, et al. Noninvasive neuromodulation in essential tremor demonstrates relief in a sham-controlled pilot trial.Mov Disord. 2018;33(7):1182-1183.Pahwa R, Dhall R, Ostrem J, et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor.Neuromodulation. 2019.Yu JY, Rajagopal A, Syrkin-Nikolau J, et al. Transcutaneous Afferent Patterned Stimulation Therapy Reduces Hand Tremor for One Hour in Essential Tremor Patients.Frontiers in neuroscience. 2020;14:530300.Isaacson SH, Peckham E, Tse W, et al. Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.Tremor Other Hyperkinet Mov (N Y). 2020;10:29.Brillman S, Colletta K, Borucki S, et al. Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor. 2022;12(1).Zesiewicz T, Elble R, Louis E, et al. Evidence-based guideline update: treatment of essential tremor: report of the Quality Standards subcommittee of the American Academy of Neurology. 2011;77(19):1752-1755.Lyons KE, Ott K. R., Shill, H. Essential Tremor in Adult Patients. http://eguideline.guidelinecentral.com/i/1380755-essential-tremor-advisory-ietf/0? 2021. Accessed January 12, 2023Sterne JAC SJ, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng H-Y, Corbett MS, Eldridge SM, Hernn MA, Hopewell S, Hrbjartsson A, Junqueira DR, Jni P, Kirkham JJ, Lasserson T, Li T, McAleenan A, Reeves BC, Shepperd S, Shrier I, Stewart LA, Tilling K, White IR, Whiting PF, Higgins JPT. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.Sterne JAC HM, Reeves BC, Savovic J, Berkman ND, Viswanathan M, Henry D, Altman DG, Ansari MT, Boutron I, Carpenter JR, Chan AW, Churchill R, Deeks JJ, Hrbjartsson A, Kirkham J, Jni P, Loke YK, Pigott TD, Ramsay CR, Regidor D, Rothstein HR, Sandhu L, Santaguida PL, Schnemann HJ, Shea B, Shrier I, Tugwell P, Turner L, Valentine JC, Waddington H, Waters E, Wells GA, Whiting PF, Higgins JPT. ROBINS-I: a tool for assessing risk of bias in non-randomized studies of interventions. BMJ 2016; 355; i4919; doi: 10.1136/bmj.i4919.GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. McMaster University, 2015 (developed by Evidence Prime, Inc.). gradepro.org. (Accessed May 1, 2020).

Local Coverage Determinations, LCD, Local policies, Respiratory Care, DL34149

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PROPOSED

Proposed LCD - Respiratory Care (DL34149)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39604&ver=4

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a9d2cb6b-95b7-4789-8121-b0d6b2e54fa9

CMS National Coverage PolicyLanguage quoted from the Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Title XVIII of the Social Security Act, 1861(cc)(1) discusses CORF facility services.Title XVIII of the Social Security Act, 1861(s)(2)(B) provides coverage of services incident to physicians services furnished to hospital patients.Title XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 CFR 485.70-CORF personnel qualifications- lists qualifications for respiratory therapists.Federal Register: December 31, 2002 (Volume 67, Number 251) p 79999-80000 Final rule revisions to payment policies specific to G0237-G0239CMS Manual System, Pub 100-02,Medicare Benefit Policy Manual, Chapter 6, 20.4-20.4.1CMS Manual System, Pub 100-02,Medicare Benefit Policy Manual, Chapter 8, 50.8.2CMS Manual System, Pub 100-02,Medicare Benefit Policy Manual, Chapter 12, 10, 20, 20.1, 20.2, 30, 30.1, and 40.5CMS Manual System, Pub 100-03,Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 240.7 and 240.8CMS Manual System, Pub 100-20, One Time Notification, Transmittal 477, dated April 24, 2009, Change Request 6338Coverage Indications, Limitations, and/or Medical NecessityRespiratory care (respiratory therapy) is defined as those services prescribed by a physician or a non-physician practitioner for the assessment and diagnostic evaluation, treatment, management, and monitoring of patients with deficiencies and abnormalities of cardiopulmonary function.Monitoring is defined as the periodic checking of the equipment in actual use to ascertain proper functioning; real time tracking the individuals condition to assure that he/she is receiving effective respiratory therapy services; and periodic evaluation of the patients progress in improvement of respiratory function.Respiratory care (respiratory therapy) services may include but are not limited to the following:application techniques to support oxygenation and ventilation in an acute illness (e.g., establish/maintain artificial airway, ventilatory therapy, precise delivery of oxygen concentrations, aid in removal of secretions from pulmonary tree)therapeutic use/monitoring of medicinal gases, pharmacologically active mists and aerosols, and equipment (e.g., resuscitators, ventilators)bronchial hygiene therapy (e.g., deep breathing, coughing exercises, IPPB, postural drainage, chest percussion/vibration, and nasotracheal/endotracheal suctioning)diagnostic tests ordered by and for the evaluation by a physician or NPP (e.g., pulmonary function test, spirometry, and blood gas analyses etc.)pulmonary rehabilitation techniques (e.g., exercise conditioning, breathing retraining, and patient education regarding management of patients respiratory problems) andperiodic assessment of the patient for the effectiveness of respiratory therapy services.For Pulmonary Rehabilitation services, please refer to Noridian's Billing and Coding: Pulmonary Rehabilitation Services Local Coverage Article under Related Documents at the end of this policy.The above services may be performed by respiratory therapists, physical therapists, nurses, and other qualified personnel as described by relevant state practice acts. Documentation in the medical record must clearly support the need for respiratory therapy services to be separately reimbursed.Respiratory care (respiratory therapy) services can be considered reasonable and necessary for the diagnosis and treatment of a specific illness or injury. The service provided must be consistent with the severity of the patients documented illness and must be reasonable in terms of modality, amount, frequency, and duration of treatment. The treatment must be generally accepted by the professional community as safe and effective for the purpose used, and recognized standards of care should not be violated.Medicare coverage of respiratory care (respiratory therapy) provided as outpatient hospital or extended care services depends on the determination by the attending physician (as part of his/her plan of treatment) that for the safe and effective administration of such services the procedures or exercises in question need to be performed by a respiratory therapist, physical therapists, nurses, and other qualified personnel as described by relevant state practice acts as listed above. In addition, Medicare may cover postural drainage and pulmonary exercises furnished by a respiratory therapist as incident to a physician's professional service.Instructing a patient in the use of equipment, breathing exercises, etc. may be considered reasonable and necessary for the treatment of the patients condition and can usually be given to a patient during the course of treatment by any of the health personnel involved, (e.g., physician, nurse, respiratory care practitioner or other qualified personnel).These educational instructions are bundled into the covered service and separate payment is not made.Separate billing for one-on-one education is rarely necessary and is usually only reasonable at the start of the treatment plan. Initially, for outpatient care where a series of visits provides an individualized physical conditioning and exercise program using proper breathing techniques separate billing for one-on-one intervention is both reasonable and necessary. Provision of more information than is ordinarily provided during the course of a treatment (e.g., extensive theoretical background in the pathology, etiology, and physiological effects of the disease) is not considered reasonable and necessary. Group sessions that only offer generalized (i.e., non-individualized) education and training are not covered.Therapeutic procedures with an individualized physical conditioning and exercise program using proper breathing techniques can be considered for a patient with activity limitations. Breathing retraining, energy conservation, and relaxation techniques are often used. Ventilatory muscle training (VMT) may be considered reasonable and necessary in a very select population of pulmonary patients who demonstrate significantly decreased respiratory muscle strength and who remain symptomatic despite optimal therapy. Routine exercise, or any exercise, without a documented need for skilled care, is not covered.Pulmonary Function TestsPulmonary Function Tests (PFTs) are a broad range of diagnostic procedures that measure two components of the respiratory system's functional status: 1) the mechanical ability to move air in and out of the lungs, and 2) the effectiveness of providing oxygen to the body and removing carbon dioxide.Pulmonary function tests are divided into five general areas:Spirometry,Lung Volume,Diffusion Capacity,Lung compliance, andPulmonary Studies during Exercise Testing.General indications for any of the pulmonary function tests include:To determine the presence of lung disease or abnormality of lung function;To determine the type of abnormality;To determine the extent of abnormality;To determine the extent of disability due to abnormal lung function, andTo determine and evaluate one or more courses of therapy in the treatment of the particular condition.General limitations for any of the pulmonary function tests include:All diagnostic tests payable by Medicare must be ordered by a treating physician and used in patient care. Community standards always apply.The various modalities to assess pulmonary function must be used in a purposeful and logical sequence.Tests performed as components rather than a single test will be denied.Medicare does not cover screening tests.Medicare coverage excludes routine (screening) tests for asymptomatic patients with or without high risk of lung disease (e.g., prolonged smoking history). It also excludes studies as part of a routine exam, and studies as part of an epidemiological survey.Medical necessity is an overriding requirement for Medicare coverage of diagnostic testing.When a diagnosis or evaluation can be made clinically or when test results are not necessary to manage the patient's disease, then Pulmonary Function Testing is not reasonable and necessary. In addition, on routine visits for other medical conditions, when a patient claims to be stable or does not report clinically meaningful changes in pulmonary status, a physical exam and interview confirm this, repeat testing is unlikely to be necessary. Noridian has found that in many patients routine use of PFTs at each office visit is not a necessary and reasonable clinical practice and as such, cannot be reimbursed.Providers should pay particular attention to guidelines for the usage of the CPT codes relative to Medicare's standards of reasonable and necessary care found in the Billing and Coding article attached under Related Local Coverage Documents below.1. Spirometry:Spirometryis performed by having the patient breathe into a mouthpiece that is connected to an instrument called a spirometer. The spirometer records the amount of air and the rate that it is breathed in and out over a specified amount of time (approximately 10 seconds). Some of the test measurements are obtained by normal breathing and other measurements require forced inhalation and exhalation.Spirometry is most useful for assessing obstructive lung diseases such as asthma and chronic obstructive pulmonary disease (COPD).Refer to the Billing and Coding article attached under Related Local Coverage Documents below for the CPT codes for Spirometry. Routine and/or repetitive billing for unnecessary batteries of tests is not clinically reasonable.Specific indications for spirometry include:Diagnostic indications:Detect the presence or absence of lung dysfunction suggested by history or clinically significant physical signs and symptoms,Detect the presence or absence of lung dysfunction suggested by other abnormal diagnostic tests (e.g., radiography, arterial blood gas analysis).Monitoring indications:Quantify the severity of known lung disease,Assess the change in lung function over time,Assess the change in lung function following administration of or a change in therapy,Assess the risk for surgical procedures known to affect lung function.Limitations to performing spirometry are:Routine or repetitive batteries of tests are not clinically reasonable.In many scenarios, simple spirometry is a mainstay of pulmonary function testing and is usually sufficient to differentiate between obstructive and restrictive disorders and evaluate their severity. Extensive testing may often not be necessary for adequate clinical assessment.Post-bronchodilator spirometry is used to evaluate the reversible component of bronchospasm and to determine if the patient is a bronchodilator therapy candidate. Claims for spirometry will be subject to medical review as follows: there are clinical signs and symptoms consistent with bronchospasm; or spirometry without bronchodilator is abnormal; or reversibility or nonreversibility of bronchospasm has not been demonstrated. Repeat studies are covered only with clinically significant change, necessitating adjustment/augmentation of therapy, appropriately documented.General clinical contraindications to spirometry include: hemoptysis of unknown origin, pneumothorax, unstable cardiovascular status, thoracic/abdominal or cerebral aneurysms, recent eye surgery, recent thoracic or abdominal surgery, and presence of acute disease processes that interfere with test performance.2. Lung volumeThe entire lung volume is not measured by simple spirometry because it is larger than the air quantity exhaled/inhaled. Lung volume is measured when a person breathes nitrogen or helium gas through a tube for a specified period of time. The change in concentration of the gas in a chamber attached to the tube is measured before and after test breathing, allowing estimation of the lung volume. Measures include total lung capacity, residual volume, and functional residual capacity.Lung volume tests are most useful for assessing restrictive lung diseases such as those caused by scarring inside the lungs or by abnormalities in the ribcage or muscles of the chest wall.CPT codes for lung volume determination may be added when clinically relevant (see Section 4).Indications for a lung volume test are as follows, when consistent with community standards of reasonable clinical practice:Evaluation of the type and degree of pulmonary dysfunction,Evaluation of dyspnea, cough, and other symptoms,Early detection of lung dysfunction,Follow-up and response to therapy,Preoperative evaluation,Track pulmonary disease progression,Assess the effectiveness of therapy for pulmonary conditions,Pre and post-op evaluations for Lung Volume Reduction Surgery (LVRS).Limitations to performing a lung volume test are:Functional Residual Capacity (FRC) may be artificially high if the measurement is taken at a higher lung volume secondary to pain or anxiety,Subject cooperation is necessary,A complete evaluation may require the use of inhaled gases,Repetitive testing of total lung volume is not usually clinically necessary.3. Diffusion CapacityDiffusion capacity is measured when a person breathes in a measured amount of carbon monoxide for a very short time (often just one breath). While breathing out, the concentration of carbon monoxide is measured. The difference in the amount of carbon monoxide inhaled and the amount exhaled allows estimation of how rapidly gases can travel from the lungs into the blood.Diffusion capacity tests are most useful for the assessment of how well the lung tissues transfer oxygen from the air inside the lungs, across thin membranes, into the blood.Indications for diffusion capacity (DLCO) are as follows, when consistent with community standards of reasonable clinical practice:

Local Coverage Determinations, LCD, Local policies, Respiratory Care, DL34149

Use this page to view details for the Local Coverage Determination for Respiratory Care.

PROPOSED

Proposed LCD - Respiratory Care (DL34149)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39604&ver=4

lcd-39604-4-1.txt

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39604

lcd

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87a52ee8-05c4-48f1-9258-e815d39a6176

Evaluation of the type and degree of pulmonary dysfunction,Evaluation of dyspnea, cough, and other symptoms,Early detection of lung dysfunction,Follow-up and response to therapy,Preoperative evaluation,Track pulmonary disease progression,Assess the effectiveness of therapy for pulmonary conditions,Pre and post-op evaluations for Lung Volume Reduction Surgery (LVRS).Limitations to performing a lung volume test are:Functional Residual Capacity (FRC) may be artificially high if the measurement is taken at a higher lung volume secondary to pain or anxiety,Subject cooperation is necessary,A complete evaluation may require the use of inhaled gases,Repetitive testing of total lung volume is not usually clinically necessary.3. Diffusion CapacityDiffusion capacity is measured when a person breathes in a measured amount of carbon monoxide for a very short time (often just one breath). While breathing out, the concentration of carbon monoxide is measured. The difference in the amount of carbon monoxide inhaled and the amount exhaled allows estimation of how rapidly gases can travel from the lungs into the blood.Diffusion capacity tests are most useful for the assessment of how well the lung tissues transfer oxygen from the air inside the lungs, across thin membranes, into the blood.Indications for diffusion capacity (DLCO) are as follows, when consistent with community standards of reasonable clinical practice:Evaluate and follow up parenchymal lung diseases associated with dusts or drug reactions or Sarcoidosis,Evaluate and follow up emphysema and cystic fibrosis,Differentiate between chronic bronchitis, emphysema, and asthma in patient with obstructive patterns,Evaluate the pulmonary involvement in systemic diseases (e.g., rheumatoid arthritis, systemic lupus),Help in the evaluation of some types of cardiovascular disease (e.g., primary pulmonary hypertension, pulmonary edema, acute or recurrent thromboembolism),Predict arterial desaturation during exercise in chronic obstructive pulmonary disease,Evaluate and quantify the disability associated with interstitial lung disease,Evaluate the effects of chemotherapy agents or other drugs known to induce pulmonary dysfunction,Evaluate hemorrhagic disorders.Limitations to performing a diffusion capacity test are:Mental confusion or muscular incoordination preventing the subject from adequately performing the maneuver,Single breath DLCO requires breath holding at maximal inhalation. Some patients may be limited by syncopal symptoms triggered by an associated Valsalva or Muller maneuver which may slow the heart rate.4. Lung ComplianceLung compliance studies are performed only when all other PFTs give equivocal results or results which must be confirmed by additional lung compliance testing. Lung compliance measures the elastic recoil/stiffness of the lungs. It is more invasive than other PFTs, because the patient is required to swallow an esophageal balloon.5. Pulmonary Studies during Exercise Testing:Pulmonary stress testing is done in two (2) forms.The simple pulmonary stress testing is a test that allows quantification of workload and heart rate activity, while measuring the degree of oxygen desaturation. This test is undertaken to measure the degree of hypoxemia or desaturation that occurs with exertion. It is also used to optimize titration of supplemental oxygen for the correction of hypoxemia.A more complex protocol involves the measurements of oxygen uptake, CO2 production, and O2. Indications for this protocol include the following:To distinguish between cardiac and pulmonary causes for dyspnea;To determine the need for and dose of ambulatory oxygen;To assist in developing a safe exercise prescription for patients with cardiovascular or pulmonary disease;To predict the morbidity of lung resection; orTo titrate optimal settings in selected patients who have physiologic pacemakers.Qualifications of personnelPersonnel who perform all pulmonary function tests should have verifiable training in all aspects of spirometry, lung volume, diffusion capacity, lung compliance, and pulmonary exercise testing, including equipment operation, quality control, and test outcomes relative to diagnosis and medical history.This A/B MAC would anticipate that clinical practices with heavy emphasis on extensive batteries of complex pulmonary function tests and primary focus on treating severe pulmonary disease would often be managed by pulmonologists or by other physicians with specialized experience in respiratory disorders, and that such pulmonary testing centers would often have staff with specific training in respiratory therapy (for example, associate degree in respiratory therapy, licensure as a Respiratory Care Practitioner, or National Board of Respiratory Care (NBRC) certification).According to National Regulations, clinics which are (a) not physician owned and which are (b) billing Medicare primarily for diagnostic tests may be required to enroll as IDTFs. For example, a nonphysician owner who establishes a diagnostic PFT clinic by leasing office space, equipment, and hiring technicians, and hires a retired ophthalmologist to provide off-site (general) supervision of diagnostic testing without treatment would be more appropriately enrolled as an IDTF.General InformationAssociated InformationN/ASources of InformationAmerican Association of Respiratory Care (AARC) website http://www.aarc.org- information about accredited respiratory care programs and online CRCE (continuing respiratory care education).Filart RA, Bach JR. Pulmonary physical medicine interventions for elderly patients with muscular dysfunction.Clinics in Geriatric Medicine.2003; 19(1):189-204.International Classification of Functioning, Disability and Health (ICF).Geneva: World Health Organization; 2001. http://www.who.int/classifications/icf/en/Mahler DA, Fierro-Carrion G, Baird JC. Evaluation of dyspnea in the elderly.Clinics in Geriatric Medicine.2003;19(1):19-33. Describes that the prevalence of dyspnea in the elderly could be as high as 38% and raises the question of how much of this is related to obesity and deconditioning as opposed to actual pulmonary impairments.Taiwo OA, Cain HC. Pulmonary impairment and disability.Clinics in Chest Medicine.2002;23(4):841-851. Describes the role of both PFTs and CPET in the evaluation of pulmonary impairments.Commission of Accreditation of Allied Health Education Programs. Available at: www.caahep.org Accessed 03/13/2012.Cystic-L. PFTs Explained For You. Available at:www.cystic-l.org/handbook/html/pft_s_explained_for_you.htm Accessed 03/13/2012.Puritan Bennett. Reimbursement: Spirometry. Available at: http://www.puritanbennett.com/remb/spirometry.aspx Accessed 03/13/2012.Respiratory Care Board of California. Available at:www.rcb.ca.gov/applicants/education_regs.shtml Accessed 03/13/2012. www.rcb.ca.gov/licensees/scopeofprac.shtml Accessed 03/13/2013.University of Maryland Medical Center. Pulmonary Function Tests. Available at: www.umm.edu/ency/article/003853 Accessed 03/13/2013.WebMD Health. Lung Function Tests. Available at:www.webmd.com Accessed 3/13/2013.This contractors prior LCDs Pulmonary Function Tests, (L10375, L10412) which will be retired once this policy becomes effective.Other contractors LCDs including Healthnow (L3929, in particular for pulmonary exercise testing), BCBS Arkansas (L13428), and Trailblazer (L11908).Contractor Medical DirectorBibliographyNA

Local Coverage Determinations, LCD, Local policies, Respiratory Care, DL37293

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PROPOSED

Proposed LCD - Respiratory Care (DL37293)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39605&ver=3

lcd-39605-3-1.txt

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f9e700be-8129-4403-88eb-333e594fba25

CMS National Coverage PolicyLanguage quoted from the Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Title XVIII of the Social Security Act, 1861(cc)(1) discusses CORF facility services.Title XVIII of the Social Security Act, 1861(s)(2)(B) provides coverage of services incident to physicians services furnished to hospital patients.Title XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 CFR 485.70-CORF personnel qualifications- lists qualifications for respiratory therapists.Federal Register: December 31, 2002 (Volume 67, Number 251) p 79999-80000 Final rule revisions to payment policies specific to G0237-G0239CMS Manual System, Pub 100-02,Medicare Benefit Policy Manual, Chapter 6, 20.4-20.4.1CMS Manual System, Pub 100-02,Medicare Benefit Policy Manual, Chapter 8, 50.8.2CMS Manual System, Pub 100-02,Medicare Benefit Policy Manual, Chapter 12, 10, 20, 20.1, 20.2, 30, 30.1, and 40.5CMS Manual System, Pub 100-03,Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 240.7 and 240.8CMS Manual System, Pub 100-20, One Time Notification, Transmittal 477, dated April 24, 2009, Change Request 6338Coverage Indications, Limitations, and/or Medical NecessityRespiratory care (respiratory therapy) is defined as those services prescribed by a physician or a non-physician practitioner for the assessment and diagnostic evaluation, treatment, management, and monitoring of patients with deficiencies and abnormalities of cardiopulmonary function.Monitoring is defined as the periodic checking of the equipment in actual use to ascertain proper functioning; real time tracking the individuals condition to assure that he/she is receiving effective respiratory therapy services; and periodic evaluation of the patients progress in improvement of respiratory function.Respiratory care (respiratory therapy) services may include but are not limited to the following:application techniques to support oxygenation and ventilation in an acute illness (e.g., establish/maintain artificial airway, ventilatory therapy, precise delivery of oxygen concentrations, aid in removal of secretions from pulmonary tree)therapeutic use/monitoring of medicinal gases, pharmacologically active mists and aerosols, and equipment (e.g., resuscitators, ventilators)bronchial hygiene therapy (e.g., deep breathing, coughing exercises, IPPB, postural drainage, chest percussion/vibration, and nasotracheal/endotracheal suctioning)diagnostic tests ordered by and for the evaluation by a physician or NPP (e.g., pulmonary function test, spirometry, and blood gas analyses etc.)pulmonary rehabilitation techniques (e.g., exercise conditioning, breathing retraining, and patient education regarding management of patients respiratory problems) andperiodic assessment of the patient for the effectiveness of respiratory therapy services.For PulmonaryRehabilitation services, please refer to Noridian's Billing and Coding: Pulmonary Rehabilitation ServicesLocal Coverage Article under Related Documents at the end of this policy.The above services may be performed by respiratory therapists, physical therapists, nurses, and other qualified personnel as described by relevant state practice acts. Documentation in the medical record must clearly support the need for respiratory therapy services to be separately reimbursed.Respiratory care (respiratory therapy) services can be considered reasonable and necessary for the diagnosis and treatment of a specific illness or injury. The service provided must be consistent with the severity of the patients documented illness and must be reasonable in terms of modality, amount, frequency, and duration of treatment. The treatment must be generally accepted by the professional community as safe and effective for the purpose used, and recognized standards of care should not be violated.Medicare coverage of respiratory care (respiratory therapy) provided as outpatient hospital or extended care services depends on the determination by the attending physician (as part of his/her plan of treatment) that for the safe and effective administration of such services the procedures or exercises in question need to be performed by a respiratory therapist, physical therapists, nurses, and other qualified personnel as described by relevant state practice acts as listed above. In addition, Medicare may cover postural drainage and pulmonary exercises furnished by a respiratory therapist as incident to a physician's professional service.Instructing a patient in the use of equipment, breathing exercises, etc. may be considered reasonable and necessary for the treatment of the patients condition and can usually be given to a patient during the course of treatment by any of the health personnel involved, (e.g., physician, nurse, respiratory care practitioner or other qualified personnel).These educational instructions are bundled into the covered service and separate payment is not made.Separate billing for one-on-one education is rarely necessary and is usually only reasonable at the start of the treatment plan. Initially, for outpatient care where a series of visits provides an individualized physical conditioning and exercise program using proper breathing techniques separate billing for one-on-one intervention is both reasonable and necessary. Provision of more information than is ordinarily provided during the course of a treatment (e.g., extensive theoretical background in the pathology, etiology, and physiological effects of the disease) is not considered reasonable and necessary. Group sessions that only offer generalized (i.e., non-individualized) education and training are not covered.Therapeutic procedures with an individualized physical conditioning and exercise program using proper breathing techniques can be considered for a patient with activity limitations. Breathing retraining, energy conservation, and relaxation techniques are often used. Ventilatory muscle training (VMT) may be considered reasonable and necessary in a very select population of pulmonary patients who demonstrate significantly decreased respiratory muscle strength and who remain symptomatic despite optimal therapy. Routine exercise, or any exercise, without a documented need for skilled care, is not covered.Pulmonary Function TestsPulmonary Function Tests (PFTs) are a broad range of diagnostic procedures that measure two components of the respiratory systems functional status: 1) the mechanical ability to move air in and out of the lungs, and 2) the effectiveness of providing oxygen to the body and removing carbon dioxide.Pulmonary function tests are divided into five general areas:Spirometry,Lung Volume,Diffusion Capacity,Lung compliance, andPulmonary Studies during Exercise Testing.General indications for any of the pulmonary function tests include:To determine the presence of lung disease or abnormality of lung function,To determine the type of abnormality,To determine the extent of abnormality,To determine the extent of disability due to abnormal lung function, andTo determine and evaluate one or more courses of therapy in the treatment of the particular condition.General limitations for any of the pulmonary function tests include:All diagnostic tests payable by Medicare must be ordered by a treating physician and used in patient care. Community standards always apply.The various modalities to assess pulmonary function must be used in a purposeful and logical sequence.Tests performed as components rather than as a single test will be denied.Medicare does not cover screening tests.Medicare coverage excludes routine (screening) tests for asymptomatic patients with or without high risk of lung disease (e.g., prolonged smoking history). It also excludes studies as part of a routine exam, and studies as part of an epidemiological survey.Medical necessity is an overriding requirement for Medicare coverage of diagnostic testing.When a diagnosis or evaluation can be made clinically or when test results are not necessary to manage the patients disease, then Pulmonary Function Testing is not reasonable and necessary. In addition, on routine visits for other medical conditions, when a patient claims to be stable or does not report clinically meaningful changes in pulmonary status, and physical exam and interview confirm this, repeat testing is unlikely to be necessary. Noridian has found that in many patients routine use of PFTs at each office visit is not a necessary and reasonable clinical practice and as such, cannot be reimbursed.Providers should pay particular attention to guidelines for the usage of the CPT codes relative to Medicares standards of reasonable and necessary care found in the Billing and Coding article attached under Related Local Coverage Documents below.1. SpirometrySpirometry is performed by having the patient breathe into a mouthpiece that is connected to an instrument called a spirometer. The spirometer records the amount of air and the rate that it is breathed in and out over a specified amount of time (approximately 10 seconds). Some of the test measurements are obtained by normal breathing and other measurements require forced inhalation and exhalation.Spirometry is most useful for assessing obstructive lung diseases such as asthma and chronic obstructive pulmonary disease (COPD).Refer to the Billing and Coding article attached under Related Local Coverage Documents below for the CPT codes for Spirometry. Routine and/or repetitive billing for unnecessary batteries of tests is not clinically reasonable.Specific indications for spirometry include:Diagnostic indications:Detect the presence or absence of lung dysfunction suggested by history or clinically significant physical signs and symptoms,Detect the presence or absence of lung dysfunction suggested by other abnormal diagnostic tests (e.g., radiography, arterial blood gas analysis).Monitoring indications:Quantify the severity of known lung disease,Assess the change in lung function over time,Assess the change in lung function following administration of or a change in therapy,Assess the risk for surgical procedures known to affect lung function.Limitations to performing spirometry are:Routine or repetitive batteries of tests are not clinically reasonable.In many scenarios, simple spirometry is a mainstay of pulmonary function testing and is usually sufficient to differentiate between obstructive and restrictive disorders and evaluate their severity. Extensive testing may often not be necessary for adequate clinical assessment.Post-bronchodilator spirometry is used to evaluate the reversible component of bronchospasm and to determine if the patient is a bronchodilator therapy candidate. Claims for spirometry will be subject to medical review as follows: there are clinical signs and symptoms consistent with bronchospasm; or spirometry without bronchodilator is abnormal; or reversibility or nonreversibility of bronchospasm has not been demonstrated. Repeat studies are covered only with clinically significant change, necessitating adjustment/augmentation of therapy, appropriately documented.General clinical contraindications to spirometry include: hemoptysis of unknown origin, pneumothorax, unstable cardiovascular status, thoracic/abdominal or cerebral aneurysms, recent eye surgery, recent thoracic or abdominal surgery, and presence of acute disease processes that interfere with test performance.2. Lung VolumeThe entire lung volume is not measured by simple spirometry because it is larger than the air quantity exhaled/inhaled. Lung volume is measured when a person breathes nitrogen or helium gas through a tube for a specified period of time. The change in concentration of the gas in a chamber attached to the tube is measured before and after test breathing, allowing estimation of the lung volume. Measures include total lung capacity, residual volume, and functional residual capacity.Lung volume tests are most useful for assessing restrictive lung diseases such as those caused by scarring inside the lungs or by abnormalities in the ribcage or muscles of the chest wall.CPT codes for lung volume determination may be added when clinically relevant (see Section 4).Indications for a lung volume test are as follows, when consistent with community standards of reasonable clinical practice:Evaluation of the type and degree of pulmonary dysfunction,Evaluation of dyspnea, cough, and other symptoms,Early detection of lung dysfunction,Follow-up and response to therapy,Preoperative evaluation,Track pulmonary disease progression,Assess the effectiveness of therapy for pulmonary conditions,Pre and post-op evaluations for Lung Volume Reduction Surgery (LVRS).Limitations to performing a lung volume test are:Functional Residual Capacity (FRC) may be artificially high if the measurement is taken at a higher lung volume secondary to pain or anxiety,Subject cooperation is necessary,A complete evaluation may require the use of inhaled gases,Repetitive testing of total lung volume is not usually clinically necessary.3. Diffusion CapacityDiffusion capacity is measured when a person breathes in a measured amount of carbon monoxide for a very short time (often just one breath). While breathing out, the concentration of carbon monoxide is measured. The difference in the amount of carbon monoxide inhaled and the amount exhaled allows estimation of how rapidly gases can travel from the lungs into the blood.Diffusion capacity tests are most useful for the assessment of how well the lung tissues transfer oxygen from the air inside the lungs, across thin membranes, into the blood.Indications for diffusion capacity (DLCO) are as follows, when consistent with community standards of reasonable clinical practice:

Local Coverage Determinations, LCD, Local policies, Respiratory Care, DL37293

Use this page to view details for the Local Coverage Determination for Respiratory Care.

PROPOSED

Proposed LCD - Respiratory Care (DL37293)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39605&ver=3

lcd-39605-3-1.txt

1

39605

lcd

3

dd8c199b-2539-4735-93a2-9a190e07cff7

Evaluation of the type and degree of pulmonary dysfunction,Evaluation of dyspnea, cough, and other symptoms,Early detection of lung dysfunction,Follow-up and response to therapy,Preoperative evaluation,Track pulmonary disease progression,Assess the effectiveness of therapy for pulmonary conditions,Pre and post-op evaluations for Lung Volume Reduction Surgery (LVRS).Limitations to performing a lung volume test are:Functional Residual Capacity (FRC) may be artificially high if the measurement is taken at a higher lung volume secondary to pain or anxiety,Subject cooperation is necessary,A complete evaluation may require the use of inhaled gases,Repetitive testing of total lung volume is not usually clinically necessary.3. Diffusion CapacityDiffusion capacity is measured when a person breathes in a measured amount of carbon monoxide for a very short time (often just one breath). While breathing out, the concentration of carbon monoxide is measured. The difference in the amount of carbon monoxide inhaled and the amount exhaled allows estimation of how rapidly gases can travel from the lungs into the blood.Diffusion capacity tests are most useful for the assessment of how well the lung tissues transfer oxygen from the air inside the lungs, across thin membranes, into the blood.Indications for diffusion capacity (DLCO) are as follows, when consistent with community standards of reasonable clinical practice:Evaluate and follow up parenchymal lung diseases associated with dusts or drug reactions or Sarcoidosis,Evaluate and follow up emphysema and cystic fibrosis,Differentiate between chronic bronchitis, emphysema, and asthma in patient with obstructive patterns,Evaluate the pulmonary involvement in systemic diseases (e.g., rheumatoid arthritis, systemic lupus),Help in the evaluation of some types of cardiovascular disease (e.g., primary pulmonary hypertension, pulmonary edema, acute or recurrent thromboembolism),Predict arterial desaturation during exercise in chronic obstructive pulmonary disease,Evaluate and quantify the disability associated with interstitial lung disease,Evaluate the effects of chemotherapy agents or other drugs known to induce pulmonary dysfunction,Evaluate hemorrhagic disorders.Limitations to performing a diffusion capacity test are:Mental confusion or muscular incoordination preventing the subject from adequately performing the maneuver,Single breath DLCO requires breath holding at maximal inhalation. Some patients may be limited by syncopal symptoms triggered by an associated Valsalva or Muller maneuver which may slow the heart rate.4. Lung ComplianceLung compliance studies are performed only when all other PFTs give equivocal results or results which must be confirmed by additional lung compliance testing. Lung compliance measures the elastic recoil/stiffness of the lungs. It is more invasive than other PFTs, because the patient is required to swallow an esophageal balloon.5. Pulmonary Studies during Exercise TestingPulmonary stress testing is done in two (2) forms.The simple pulmonary stress testing is a test that allows quantification of workload and heart rate activity, while measuring the degree of oxygen desaturation. This test is undertaken to measure the degree of hypoxemia or desaturation that occurs with exertion. It is also used to optimize titration of supplemental oxygen for the correction of hypoxemia.A more complex protocol involves the measurements of oxygen uptake, CO2 production, and O2. Indications for this protocol include the following:To distinguish between cardiac and pulmonary causes for dyspnea;To determine the need for and dose of ambulatory oxygen;To assist in developing a safe exercise prescription for patients with cardiovascular or pulmonary disease;To predict the morbidity of lung resection; orTo titrate optimal settings in selected patients who have physiologic pacemakers.Qualifications of personnelPersonnel who perform all pulmonary function tests should have verifiable training in all aspects of spirometry, lung volume, diffusion capacity, lung compliance, and pulmonary exercise testing, including equipment operation, quality control, and test outcomes relative to diagnosis and medical history.This A/B MAC would anticipate that clinical practices with heavy emphasis on extensive batteries of complex pulmonary function tests and primary focus on treating severe pulmonary disease would often be managed by pulmonologists or by other physicians with specialized experience in respiratory disorders, and that such pulmonary testing centers would often have staff with specific training in respiratory therapy (for example, associate degree in respiratory therapy, licensure as a Respiratory Care Practitioner, or National Board of Respiratory Care (NBRC) certification).According to National Regulations, clinics which are (a) not physician owned and which are (b) billing Medicare primarily for diagnostic tests may be required to enroll as IDTFs. For example, a nonphysician owner who establishes a diagnostic PFT clinic by leasing office space, equipment, and hiring technicians, and hires a retired ophthalmologist to provide off-site (general) supervision of diagnostic testing without treatment would be more appropriately enrolled as an IDTF.General InformationAssociated InformationN/ASources of InformationAmerican Association of Respiratory Care (AARC) website http://www.aarc.org- information about accredited respiratory care programs and online CRCE (continuing respiratory care education).Filart RA, Bach JR. Pulmonary physical medicine interventions for elderly patients with muscular dysfunction.Clinics in Geriatric Medicine.2003; 19(1):189-204.International Classification of Functioning, Disability and Health (ICF).Geneva: World Health Organization; 2001. http://www.who.int/classifications/icf/en/Mahler DA, Fierro-Carrion G, Baird JC. Evaluation of dyspnea in the elderly.Clinics in Geriatric Medicine.2003;19(1):19-33. Describes that the prevalence of dyspnea in the elderly could be as high as 38% and raises the question of how much of this is related to obesity and deconditioning as opposed to actual pulmonary impairments.Taiwo OA, Cain HC. Pulmonary impairment and disability.Clinics in Chest Medicine.2002;23(4):841-851. Describes the role of both PFTs and CPET in the evaluation of pulmonary impairments.Commission of Accreditation of Allied Health Education Programs. Available at: www.caahep.org Accessed 3/13/2012.Cystic-L. PFTs Explained For You. Available at:www.cystic-l.org/handbook/html/pft_s_explained_for_you.htm Accessed 03/13/2012.Puritan Bennett. Reimbursement: Spirometry. Available at: http://www.puritanbennett.com/remb/spirometry.aspx Accessed 03/13/2012.Respiratory Care Board of California. Available at:www.rcb.ca.gov/applicants/education_regs.shtml Accessed 03/13/2012. www.rcb.ca.gov/licensees/scopeofprac.shtml Accessed 03/13/2013.University of Maryland Medical Center. Pulmonary Function Tests. Available at: www.umm.edu/ency/article/003853 Accessed 03/13/2013.WebMD Health. Lung Function Tests. Available at:www.webmd.com Accessed 3/13/2013.This contractors prior LCDs Pulmonary Function Tests, (L10375, L10412) which will be retired once this policy becomes effective.Other contractors LCDs including Healthnow (L3929, in particular for pulmonary exercise testing), BCBS Arkansas (L13428), and Trailblazer (L11908).Contractor Medical DirectorBibliographyNA

Local Coverage Determinations, LCD, Local policies, Transurethral Waterjet Ablation of the Prostate, DL38705

Use this page to view details for the Local Coverage Determination for Transurethral Waterjet Ablation of the Prostate.

PROPOSED

Proposed LCD - Transurethral Waterjet Ablation of the Prostate (DL38705)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39606&ver=7

lcd-39606-7-1.txt

1

39606

lcd

7

b527b627-c4a2-4f75-b1c8-fecbdeed8649

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations forTransurethral Waterjet Ablation of the Prostate.Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment forTransurethral Waterjet Ablation of the Prostateand must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 14, Section 10 Coverage of Medical DevicesCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 23, Section 30 Services paid under the Medicare Physicians Fee ScheduleCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Coverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationBenign prostatic hyperplasia (BPH) is a histological diagnosis characterized by an increased number of epithelial and stromal cells in the prostate. It is common in men over the age of 40, and the incidence increases with age. In the United States, 8 million men older than 50 years old suffer from BPH. In many cases BPH is asymptomatic, however, symptoms may occur with prostate enlargement and compression of the urethra leading to bothersome lower urinary tract symptoms (LUTS), including voiding symptoms such as hesitancy, weak stream, straining, prolonged voiding, and storage symptoms (frequency, urgency, and nocturia). LUTS/BPH can have a significant impact on the quality of life and can cause serious complications such as infections, bleeding, calculus formation, urinary retention and decline of renal function when untreated.1First line treatment generally consists of treatment with medications such as alpha blockers, PDE5 Inhibitors, or finasteride/dutasteride. If treatment with medications is not successful, surgical options may then be considered. Transurethral resection of the prostate (TURP) and open simple prostatectomy (OSP) are the standard surgical treatments for LUTS/BPH and are highly effective and provide improved outcomes in urinary functions. However, neither TURP nor OSP are without considerable perioperative complication and morbidity.2Recently, new minimally invasive surgeries have emerged as alternatives for the resection of the prostate to manage LUTS in men with BPH. One such surgery is transurethral waterjet ablation which is minimally invasive; water based surgical therapy that combines image guidance and robotics to remove prostatic tissue.3The system works by pumping high pressure saline (500 to 8000 pounds per square [PSI]) through a probe nozzle to cut and dissect tissue at predetermined system parameters.3Covered IndicationsTreatment for LUTS/BPH treatment will be considered reasonable and necessary when performedONCEin patients with the following:Indications includingALLof the following:Prostate volume of 30-150 cc by transrectal ultrasound (TRUS)4,5Persistent moderate to severe symptoms despite maximal medical management includingALLof the following:International Prostate Symptom Score (IPSS) 124Maximum urinary flow rate (Qmax) of 15 mL/s4(voided volume greater than 125 cc)Failure, contraindication or intolerance to at least three months of conventionalmedical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)2. Onlytreatment using an FDA approved/cleared device will be considered reasonable and necessary.LimitationsThe following are considered not reasonable and necessary:Body mass index 42kg/m26Knownor suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines7) or a prostate specific antigen (PSA) >10 ng/mL unless the patient has had a negative prostate biopsy within the last 6 months.Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum6Active urinary tract or systemic infection8Treatment for chronic prostatitis6Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture6Damaged external urinary sphincter6Known allergy to device materials8Inability to safely stop anticoagulants or antiplatelet agents preoperatively.8Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the relatedBilling and Coding Article: Article Title (A58227) for documentation and utilization requirements as applicable.Sources of InformationContractor Medical Directors Waterjet Ablation WorkgroupBibliographyZorn KC, Goldenberg SL, Paterson R, So A, Elterman D, Bhojani N. Aquablation among novice users in Canada: A WATER II subpopulation analysis.JCan Urol Assoc2019;13(5):E113-E118.Chung ASJ, Woo HH. Update on minimally invasive surgery and benign prostatic hyperplasia.Asian J Urol. 2018;5(1):22-27.Hwang_EC, Jung_JH, Borofsky_M, Kim_MH, Dahm_P. Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.Cochrane Database of Systematic Reviews2019, Issue 2. Art. No.: CD013143.Gilling P, Barber N, Bidair, M, et al. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial.Can J Urol. February 2020; 27(1):10072-10079.Desai M, Bidair M, Bhojani N et al. Aqablation for benign prostatic hyperplasia in large prostate (80-150 cc): 2-year results.Can J Urol.2020; 27(2): 10147-10153.Nguyen DD, Barber N, Bidair M, Gilling P, Anderson P, Zorn KC, et al. Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates.BJU Int.2020;125(1):112-122.Carroll PR, Kellogg Parsons J, Andriole G, et al. NCCN GuidelinesInsights Prostate Cancer Early Detection, Version 2.2016 Featured Updates to the NCCN Guidelines JNatl Compr Canc Netw2016;14(5):509519.FDA Approval: DeNovoClassification Request for AQUABEAM System. Accessed 7/2/19].Gilling P, Barber N, Bidair M, et al. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes.Urol.2019;125:169-173.Gilling P, Barber N, Bidair M, et al. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained.Adv Ther. March 8, 2019.AUA Guidelines: Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019). 2019.Nickel JC, Aaron L, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms /benign prostatic hyperplasia (MLUTS/BPH): 2018 update.Can Urol Assoc J.2018; 12:303-312.NICE Transurethral water jet ablation for LUTS caused by BPH. 2018Taktak S, Jones P, Haq A, Rai BP, Somani BK. Aquablation: a novel and minimally invasive surgery for benign prostate enlargement.Ther Adv Urol 2018, Vol. 10(6): 183188.Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, et al. WATER II (80150 mL) procedural outcomes.BJU Int2019;123(1):106-112.Sturch P, Woo HH, McNicholas T, Muir G. Ejaculatory dysfunction after treatment for lower urinary tract symptoms: retrograde ejaculation or retrograde thinking?BJU Int.2015;115(2):186-187.Bjojani N, Bidair M, Zorn KC, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150cc): 1-year Results.Urology Gold Journal.May 2019.Misrai V, Rijo E, Zorn KC, Barry-Delongchamps N, Descazeaud A. Waterjet Ablation Therapy for Treating Benign Prostatic Obstruction in Patients with Small- to Medium-size Glands: 12-month Results of the First French Aquablation Clinical Registry.Eur Urol(2019).Kasivisvanathan V, Hussain M. Aquablation versus transurethral resection of the prostate: 1 year United States - cohort outcomes.Can J Urol.2018;25(3):9317-9322.Kasraeian, A., et al., Aquablation for BPH: United States single-center experience. The Canadian Journal of Urology, 2020. 27(5): p. 10379.Labban, M., et al., Aquablation for benign prostatic obstruction: Single center technique evolution and experience. Investigative and Clinical Urology, 2021. 62(2): p. 210.Bach, T., et al., First multi-center all-comers study for the aquablation procedure. Journal of Clinical Medicine, 2020. 9(2): p. 603.(AUA) AUA. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019, 2020). 2020. Accessed 8/26/2020.Lerner, L. B., McVary, K. T., Barry, M. J., Bixler, B. R., Dahm, P., Das, A. K., ... & Wilt, T. J. (2021). Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline part IIsurgical evaluation and treatment. The Journal of urology, 206(4), 818-826.Gravis S, Cornu JN, Gratze, C, et al. EAU Guidelines: Management of Non-neurogenic Male LUTS; Chapter 5.3: Surgical Management. 2020: Disease Management. 2019. Accessed 9/14/2020.NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia. Accessed 8/1/2019.

Local Coverage Determinations, LCD, Local policies, Transurethral Waterjet Ablation of the Prostate, DL38707

Use this page to view details for the Local Coverage Determination for Transurethral Waterjet Ablation of the Prostate.

PROPOSED

Proposed LCD - Transurethral Waterjet Ablation of the Prostate (DL38707)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39607&ver=4

lcd-39607-4-1.txt

1

39607

lcd

4

48f23336-4648-4d39-89ee-89db9f081c2d

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations forTransurethral Waterjet Ablation of the Prostate.Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment forTransurethral Waterjet Ablation of the Prostateand must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 14, Section 10 Coverage of Medical DevicesCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 23, Section 30 Services paid under the Medicare Physicians Fee ScheduleCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Coverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationBenign prostatic hyperplasia (BPH) is a histological diagnosis characterized by an increased number of epithelial and stromal cells in the prostate. It is common in men over the age of 40, and the incidence increases with age. In the United States, 8 million men older than 50 years old suffer from BPH. In many cases BPH is asymptomatic, however, symptoms may occur with prostate enlargement and compression of the urethra leading to bothersome lower urinary tract symptoms (LUTS), including voiding symptoms such as hesitancy, weak stream, straining, prolonged voiding, and storage symptoms (frequency, urgency, and nocturia). LUTS/BPH can have a significant impact on the quality of life and can cause serious complications such as infections, bleeding, calculus formation, urinary retention and decline of renal function when untreated.1First line treatment generally consists of treatment with medications such as alpha blockers, PDE5 Inhibitors, or finasteride/dutasteride. If treatment with medications is not successful, surgical options may then be considered. Transurethral resection of the prostate (TURP) and open simple prostatectomy (OSP) are the standard surgical treatments for LUTS/BPH and are highly effective and provide improved outcomes in urinary functions. However, neither TURP nor OSP are without considerable perioperative complication and morbidity.2Recently, new minimally invasive surgeries have emerged as alternatives for the resection of the prostate to manage LUTS in men with BPH. One such surgery is transurethral waterjet ablation which is minimally invasive; water based surgical therapy that combines image guidance and robotics to remove prostatic tissue.3The system works by pumping high pressure saline (500 to 8000 pounds per square [PSI]) through a probe nozzle to cut and dissect tissue at predetermined system parameters.3Covered IndicationsTreatment for LUTS/BPH treatment will be considered reasonable and necessary when performedONCEin patients with the following:Indications includingALLof the following:Prostate volume of 30-150 cc by transrectal ultrasound (TRUS)4,5Persistent moderate to severe symptoms despite maximal medical management includingALLof the following:International Prostate Symptom Score (IPSS) 124Maximum urinary flow rate (Qmax) of 15 mL/s4(voided volume greater than 125 cc)Failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)2. Onlytreatment using an FDA approved/cleared device will be considered reasonable and necessary.LimitationsThe following are considered not reasonable and necessary:Body mass index 42kg/m26Knownor suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines7) or a prostate specific antigen (PSA) >10 ng/mL unless the patient has had a negative prostate biopsy within the last 6 months.Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum6Active urinary tract or systemic infection8Treatment for chronic prostatitis6Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture6Damaged external urinary sphincter6Known allergy to device materials8Inability to safely stop anticoagulants or antiplatelet agents preoperatively.8Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Billing and Coding Article: Article Title (A58229) for documentation and utilization requirements as applicable.Sources of InformationContractor Medical Directors Waterjet Ablation WorkgroupBibliographyZorn KC, Goldenberg SL, Paterson R, So A, Elterman D, Bhojani N. Aquablation among novice users in Canada: A WATER II subpopulation analysis.JCan Urol Assoc2019;13(5):E113-E118.Chung ASJ, Woo HH. Update on minimally invasive surgery and benign prostatic hyperplasia.Asian J Urol. 2018;5(1):22-27.Hwang_EC, Jung_JH, Borofsky_M, Kim_MH, Dahm_P. Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.Cochrane Database of Systematic Reviews2019, Issue 2. Art. No.: CD013143.Gilling P, Barber N, Bidair, M, et al. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial.Can J Urol. February 2020; 27(1):10072-10079.Desai M, Bidair M, Bhojani N et al. Aqablation for benign prostatic hyperplasia in large prostate (80-150 cc): 2-year results.Can J Urol.2020; 27(2): 10147-10153.Nguyen DD, Barber N, Bidair M, Gilling P, Anderson P, Zorn KC, et al. Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates.BJU Int.2020;125(1):112-122.Carroll PR, Kellogg Parsons J, Andriole G, et al. NCCN GuidelinesInsights Prostate Cancer Early Detection, Version 2.2016 Featured Updates to the NCCN Guidelines JNatl Compr Canc Netw2016;14(5):509519.FDA Approval: DeNovoClassification Request for AQUABEAM System. Accessed 7/2/19].Gilling P, Barber N, Bidair M, et al. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes.Urol.2019;125:169-173.Gilling P, Barber N, Bidair M, et al. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained.Adv Ther. March 8, 2019.AUA Guidelines: Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019). 2019.Nickel JC, Aaron L, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms /benign prostatic hyperplasia (MLUTS/BPH): 2018 update.Can Urol Assoc J.2018; 12:303-312.NICE Transurethral water jet ablation for LUTS caused by BPH. 2018Taktak S, Jones P, Haq A, Rai BP, Somani BK. Aquablation: a novel and minimally invasive surgery for benign prostate enlargement.Ther Adv Urol 2018, Vol. 10(6): 183188.Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, et al. WATER II (80150 mL) procedural outcomes.BJU Int2019;123(1):106-112.Sturch P, Woo HH, McNicholas T, Muir G. Ejaculatory dysfunction after treatment for lower urinary tract symptoms: retrograde ejaculation or retrograde thinking?BJU Int.2015;115(2):186-187.Bjojani N, Bidair M, Zorn KC, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150cc): 1-year Results.Urology Gold Journal.May 2019.Misrai V, Rijo E, Zorn KC, Barry-Delongchamps N, Descazeaud A. Waterjet Ablation Therapy for Treating Benign Prostatic Obstruction in Patients with Small- to Medium-size Glands: 12-month Results of the First French Aquablation Clinical Registry.Eur Urol(2019).Kasivisvanathan V, Hussain M. Aquablation versus transurethral resection of the prostate: 1 year United States - cohort outcomes.Can J Urol.2018;25(3):9317-9322.Kasraeian, A., et al., Aquablation for BPH: United States single-center experience. The Canadian Journal of Urology, 2020. 27(5): p. 10379.Labban, M., et al., Aquablation for benign prostatic obstruction: Single center technique evolution and experience. Investigative and Clinical Urology, 2021. 62(2): p. 210.Bach, T., et al., First multi-center all-comers study for the aquablation procedure. Journal of Clinical Medicine, 2020. 9(2): p. 603.(AUA) AUA. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019, 2020). 2020. Accessed 8/26/2020.Lerner, L. B., McVary, K. T., Barry, M. J., Bixler, B. R., Dahm, P., Das, A. K., ... & Wilt, T. J. (2021). Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline part IIsurgical evaluation and treatment. The Journal of urology, 206(4), 818-826.Gravis S, Cornu JN, Gratze, C, et al. EAU Guidelines: Management of Non-neurogenic Male LUTS; Chapter 5.3: Surgical Management. 2020: Disease Management. 2019. Accessed 9/14/2020.NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia. Accessed 8/1/2019.

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL39611

Use this page to view details for the Local Coverage Determination for Urine Drug Testing.

PROPOSED

Proposed LCD - Urine Drug Testing (DL39611)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39610&ver=3

lcd-39610-3-1.txt

1

39610

lcd

3

a09f7c82-c4c5-4c10-b501-8a25d2210c0b

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A). Allows coverage and payment for only those services that are considered to be reasonable and necessary.42 CFR 410.32(a). Order diagnostic tests.42 CFR 411.15(k)(1). Particular Services excluded from coverage.CMS On-Line Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.0, 80.1.1, 80.1.2. Clinical Laboratory services.CMS Internet Only Manuals, Pub 100-02 Medicare Beneficiary Policy Manual chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification Changes.Coverage Indications, Limitations, and/or Medical NecessityPurposeUrine drug testing (UDT) provides timely, objective, and actionable information to clinicians by identifying the presence or absence of drugs of potential abuse in the body to assist the clinician in making treatment decisions.1This policy details:The appropriate indications and allowed number of UDTs billed over time for safe medication management of prescribed substances in risk stratified pain management patients and/or in identifying and treating substance use disorders (SUDs);Designates documentation, by the clinician caring for the beneficiary in the beneficiarys medical record, of medical necessity for, and testing ordered on an individual patient basis;Provides an overview of presumptive UDT and definitive UDT testing by various methodologies.This policy addresses UDT for Medical patients only.DefinitionsAs used in this document, the following terminology relates to the basic forms of UDT:Presumptive/Qualitative Drug Testing(hereafter called "presumptive" UDT) - Covered when medically necessary to immediately determine the presence or absence of drugs or drug classes in a urine sample; results expressed as negative or positive or as a numerical result; includes competitive immunoassays (IA) and thin layer chromatography.2Definitive/Quantitative/Confirmation(hereafter called definitive UDT) - Covered when clinically indicated and medically reasonable and necessary based on this LCD to identify specific medications, illicit substances, and metabolites; reports the results of analytes absent or present typically in concentrations such as ng/mL; definitive methods include but are not limited to GC-MS and LC-MS/MS testing methods only.2Specimen Validity Testing- Urine specimen testing to ensure that it is consistent with normal human urine and has not been adulterated or substituted, may include, but is not limited to pH, specific gravity, oxidants and creatinine. This however is quality assurance, not a Medicare benefit, and thus not separately payable by Medicare.Immunoassay (IA)- Ordered by clinicians primarily to identify the presence or absence of drug classes and some specific drugs; biochemical tests that measure the presence above a cutoff level of a substance (drug) with the use of an antibody; read by photometric technology.2Point of Care Testing (POCT)- Covered when medically necessary by clinicians caring for the beneficiary for immediate test results for the immediate management of the beneficiary; available when the beneficiary and physician are in the same location; IA test method that primarily identifies drug classes and a few specific drugs; platform consists of cups, dipsticks, cassettes, or strips; read by the human eye, or read by instrument assisted direct optical observation.3Standing Orders- Test request for a specific patient representing repetitive testing to monitor a condition or disease for a limited number of sequential visits; individualized orders for certain patients for pre-determined tests based on historical use, risk and community trend patient profiles; clinician can alter the standing order.Note: A profile is developed based on specific characteristics of a specific patient, while a panel is a general non-specific group of tests that may have unnecessary tests for the specific patient being treated.Blanket Orders- Test request that is not for a specific patient; rather, it is an identical order for all patients in a clinicians practice without individualized decision making at every visit.Reflex Testing- Laboratory testing that is performed "reflexively" after initial test results to identify further diagnostic information essential to patient care. This testing is not necessarily based on a specific physician's order.Drug Test MethodsThe Clinical Laboratory Improvement Amendments (CLIA) regulates laboratory testing and requires clinical labs to be certified by their State as well as the Centers for Medicare & Medicaid (CMS) before they can accept human samples for diagnostic testing.3Multiple types of CLIA certificates may be obtained based on the complexity of testing a lab conducts. CLIA levels of complexity (CLIA-waived, moderate complexity, and high complexity) are addressed only as they correspond to the Healthcare Common Procedure Coding System (HCPCS) code description in the related billing and coding article.A. Presumptive Testing Methods:Presumptive UDT:A presumptive UDT consist of various platforms including cards, dipsticks, cassettes and cups based on qualitative competitive immunoassay methodology with one or more analytes in the test. A presumptive IA test detects the presence of the amount of drug/substance present in urine above a predetermined cut-off value and may be read by direct optical observation or by instrument assisted direct optical observation.A positive test result is reported when the concentration of drug is above the cutoff; a negative is reported when the concentration of drug is below the cut-off. Positive test results are presumptive but not necessarily definitive due to sensitivity and cross-reactivity limitations.4Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen.3The accuracy of the results of a presumptive UDT will depend on the testing environment, type of test, the drug being tested for, and training of the individual conducting the test. This type of test should only be used when results are needed immediately.Presumptive UDT by Instrumented Chemistry Analyzers: 80307Chemistry analyzers with IA UDT technology can be used in an office or clinical laboratory setting. This test provides less immediate test results. At no time is IA technology by chemistry analyzer analysis considered confirmatory (definitive) testing.A presumptive positive IA test detects the presence of a drug/substance in urine at or above the cut-off value. If the concentration of the drug is below the cut-off, the result will be negative. Presumptive positive tests are not always true positives due to sensitivity, specificity, and cross-reactivity limitations. Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen.3Food and Drug Administration (FDA) approved/cleared test platforms are available in the marketplace as well as laboratory developed tests (LDTs) such as modified FDA approved/cleared and non-FDA approved/cleared platforms and/or reagents. LDTs generally have been modified to test at a lower cutoff in order to detect substances that would have been missed at a higher cutoff. For example, a FDA labeled cutoff may be 300 ng/mL and the LDT cutoff for the same drug may be a 100 ng/mL.3Presumptive UDT can be carried out at any validated cut-off concentration. Lowering of the cut-off concentration provides more stringent cutoffs for illicit drugs. LDTs may include non-FDA cleared tests not available in CLIA-waived or moderate complexity tests (e.g. tramadol, tapentadol, carisoprodol, fentanyl, zolpidem). Lowering the cutoff increases the possibility of detecting a drug when the test has been modified from the recipe of the manufacturer.Limitations of Presumptive UDT:Presumptive UDT testing is limited due to:Primarily screens for drug classes rather than specific drugs, and therefore, the practitioner may not be able to determine if a different drug within the same class is causing the positive result;Produces erroneous results due to cross-reactivity with other compounds or does not detect all drugs within a drug class5;Given that not all prescription medications or synthetic/analog drugs are detectable and/or have assays available, it is unclear as to whether other drugs are present when some tests are reported as positive;Cut-off may be too high to detect presence of a drug.5These limitations may mean that presumptive testing is insufficient for certain clinical needs.An IA involves an antibody that reacts best with the stimulating drug and reacts to a lesser extent (cross-reactive) or not at all with other drugs in the drug class. While presumptive tests vary in their ability to detect illicit drugs such as tetrahydrocannabinol (THC), cocaine, 3,4-methylenedioxy-N-methylamphetamine (MDMA; ecstasy), and phencyclidine (PCP), they may not be optimal tests for many prescription drugs, such as: opiates, barbiturates, benzodiazepines and opioids.For example, opiate reagents are formulated from morphine. Consequently, the cross-reactivity for other opioids and opiates varies based on the manufacturer and lot number. The semisynthetic opioids, hydromorphone and hydrocodone, may contribute to a positive presumptive result, while the semisynthetic opioids, oxycodone and oxymorphone, will not typically be detected even at 300 ng/mL cutoff. Synthetic opioids, such as fentanyl, meperidine and methadone, will not be detected by current opiate IA testing. Consequently, a positive opiate result by IA normally necessitates more specific identification of the substance(s) that account for the positive result, and a negative result does not rule out the presence of opiates or opioids.6Presumptive UDT reagents for benzodiazepine are typically formulated for oxazepam, a metabolite of diazepam (Valium) and chlordiazepoxide (Librium), the main benzodiazepines prescribed twenty years ago. However, many of the more than 10 benzodiazepines that are currently available do not cross-react with IA benzodiazepine reagents. In particular, clonazepam and lorazepam give false negative results with presumptive IA tests and may necessitate more specific identification to account for the negative result. Similarly, a positive screening test result may require definitive UDT to identify the specific drug(s).Synthetic/analog or designer drugs manufactured to elude law enforcement require definitive testing for detection. Most commercially available IA reagents fail to detect designer drugs, such as psychedelic phenethylamines even at very high concentrations.In summary, presumptive IA UDT is often unable to identify specific drugs within many drug classes, particularly within the amphetamine, barbiturate, benzodiazepine, tricyclic antidepressants, and opiate/opioid drug classes. Drugs such as buprenorphine, amphetamines, benzodiazepines, and cocaine/heroin yield false negative IA results due to low cross-reactivity or non-reactivity, and drugs such as fentanyl, carisoprodol, tramadol, tapentadol and synthetic designer drugs cannot be detected by presumptive IA. Therefore, it may be medically necessary for clinicians to utilize definitive UDT when the presumptive tests for these drugs are negative.1,5B.Definitive UDT:Gas Chromatography coupled with Mass Spectrometry (GC-MS) and Liquid Chromatography coupled with Mass Spectrometry (LC-MS/MS) are complex technologies that use the separation capabilities of gaseous or liquid chromatography with the analytical capabilities of mass spectrometry. These methodologies require the competency of on-site highly trained experts in this technology and interpretation of results. While these tests require different sample preparation and analytical runs, they identify specific drugs, metabolites, and most illicit substances and report the results as absent or present typically in concentrations of ng/mL.2Quantification should not be used to determine adherence with a specific dosage or time of dose of a pain medication or illicit drug for clinical purposes. Rather, the use of quantitative drug data may be important for many reasons such as in a differential patient assessment.1For example, when several opioids are present in the urine of a patient prescribed a single opioid, quantification may help the clinician decide whether the presence of the other opioids is consistent with metabolism of the prescribed opioid, opioid contamination during manufacturing, or if more than 1 drug within a class is being used.Quantification may also provide information in the setting of illicit drug use. Serial creatinine-corrected quantitative values may assist in the differential assessment of ongoing drug use or cessation of drug use with continued drug excretion.1GC-MSGC-MS can only be performed on molecules that are volatile. If the test drug is not volatile in its own right, it must be modified or derivatized to a volatile form. To derivatize, the test drug must be extracted from the urine, eluted from the extraction device, concentrated, and then reacted with a chemical reagent to make a volatile product. Each drug class may require a different derivatizing agent. For patients on multiple classes of medications, laboratories using GC procedures must make different volatile derivatives in order to perform comprehensive testing. Since a GC column may not be able to separate more than one class of compounds, multiple chromatographic runs on different column types may be required to monitor multiple drug classes.1Newer GC-MS instruments often use tandem systems. GC-MS methodology allows for the testing of multiple substances but differs in ease of run.LC-MS/MSLC-MS/MS is roughly 100 times more sensitive and selective, involves fewer human steps, provides quicker turn-around time, uses less specimen volume, and can test for a larger number of substances simultaneously when compared to GC-MS.1After sample preparation, it is injected into the LC-MS/MS. The sample has to undergo hydrolysis to break the glucuronide bond that frees the drug and drug metabolites. Hydrolysis is followed by multiple additional steps including protein precipitation, centrifugation and purification. Deuterium-labeled isotopic internal standards are added to quantify the drugs and drug metabolites.

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The sample is injected when the mobile phase is flowing through the chromatographic column. Each drug and drug metabolite interacts with the mobile phase and stationary phase differently and moves at different speeds depending on their chemical properties. In other words, each analyte elutes at different times. Specific drugs and metabolites are identified by their retention time and quantified against isotopic internal standards for each drug and metabolite. Each drug peak has a minimum of 2 mass transmissions to be compared to drug standards (calibrators) to ensure identification.CLIA-Certified Laboratories-Informational onlyCLIA specifies quality standards for proficiency testing, facility administration, general laboratory systems, pre-analytic, analytic and post-analytic systems, onsite supervision requirements, personnel qualifications and responsibilities, quality control, and quality assessment.3High complexity laboratories must ensure that testing is carried out by onsite qualified, trained personnel using validated reliable methods compliant with regulatory procedures (42 CFR Part 493). Both GC-MS and LC-MS/MS require a quality program to monitor the quality and audit the competency of the staff. LC-MS/MS instrument maintenance must be performed daily as well as the validation of instrument performance prior to patient specimens. Final review and approval of GC-MS and LC-MS/MS results must be performed by a qualified clinical laboratory scientist as defined in 42 CFR Part 493.1489 (Testing Personnel Qualifications). A GC-MS or LC-MS/MS laboratory must have a qualified laboratory director, qualified physician, or qualified clinical laboratory scientist, as provided in 42 CFR 493.1443 (Laboratory Director Qualifications).Purpose of UDT:Presumptive UDT may be ordered by the clinician caring for a beneficiary when it is necessary to rapidly obtain and/or integrate results into clinical assessment and treatment decisions.Definitive UDT is considered reasonable and necessarywhen the clinical information supplied supports the definitive testing as in:Identify a specific substance or metabolite that is inadequately detected by a presumptive UDT screen;Definitively identify specific drugs in a large family of drugs;Identify a specific substance or metabolite that is not detected by presumptive UDT such as fentanyl, meperidine, synthetic cannabinoids and other synthetic/analog drugs;Identify drugs when a definitive concentration of a drug is needed to guide management (e.g., discontinuation of THC use according to a treatment plan);Identify a negative, or confirm a positive, presumptive UDT result that is inconsistent with a patients self-report, presentation, medical history, or current prescribed pain medication plan;Rule out an error as the cause of a presumptive UDT result;Identify non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; andUse in a differential assessment of medication efficacy, side effects, or drug-drug interactions.Definitive UDT may be reasonable and necessary based on patient specific indications, including historical use, medication response, and clinical assessment, when accurate results are necessary to make clinical decisions.1To establish that a test is reasonable and necessary,the clinicians rationale for the definitive UDT and the tests ordered must be documented in the patients medical record.Drug Testing PanelsPresumptive UDT PanelsPresumptive UDT typically involves testing for multiple analytes based on the specific beneficiary's clinical history and risk assessment and must be documented in the medical record. May be ordered as a panel and billed a "Per Patient encounter" regardless of the number of analytes tested.Definitive UDT PanelsPhysician-directed definitive profile testing is reasonable and necessary when ordered for a particular patientbased upon historical use, clinical findings, and community trends.However, the same physician-defined profile is not reasonable and necessary for every patient in a physicians practice.Definitive UDT orders should be individualized based on clinical history and risk assessment, and must be documented in the medical record.Specimen TypeUrine or oral fluid is the preferred biologic specimen for testing because of the ease of collection, storage, and cost-effectiveness.1UDT cannot detect the dosage of drug ingested/used, the time of use, or the means of delivery (intravenous vs. oral vs. inhaled). Detection time of a substance in urine is typically 1-3 days depending on the drug, rate of metabolism, and rate of excretion. Lipid-soluble drugs, such as marijuana, may remain in body fat and be detected upwards of a week or more.Ethanol is not discussed in this LCD:Note: Ethanol is a known drug of abuse but is routinely tested in blood, not urine. In addition, the DEA Resource Guide8states that alcohol is exempt from control by the Controlled Substances Act (CSA). Ethanol is not under discussion in this LCD.Covered Indications for UDTGroup A Symptomatic patients, Multiple drug ingestion, and/or Patients with unreliable historyA patient who presents in a variety of medical settings with signs or symptoms of substance use toxicity will be treated presumptively to stabilize the patient while awaiting presumptive, then definitive testing to determine the cause(s) of the presentation. The need for definitive UDT is based upon presumptive test findings, responses to medical interventions, and treatment plan.1A presumptive UDT should be performed as part of the evaluation and management of a patient who presents in an emergency room or urgent care setting with any 1 of the following:Coma;Altered mental status in the absence of a clinically defined toxic syndrome or toxidrome;Severe or unexplained cardiovascular instability (cardiotoxicity);Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome or toxidrome;Seizures with an undetermined history;To provide antagonist to specific drug.The presumptive findings, definitive drug tests ordered, and reasons for the testing must be documented in the patient's medical record.Group B - Diagnosis and treatment for substance abuse or dependenceA patient in active treatment for a SUD or monitoring across different phases of recovery may undergo medical management for a variety of medical conditions. A physician who is writing prescriptions for medications to treat either the SUD or other conditions may need to know if the patient is taking substances which can interact with prescribed medications or taking prescribed medications as expected.1The risk of drug-drug interactions is inherent to the patient and may be compounded by prescribed medications. UDT is a medically necessary and useful component of chemical dependency diagnosis and treatment. The UDT result influences treatment and level of care decisions.3Ordered tests and testing methods (presumptive and/or definitive) must match the stage of screening, treatment, or recovery; the documented history; and Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis. For patients with no known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using presumptive UDT. For patients with known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using definitive UDT. For patients with a diagnosed SUD, the clinician should perform random UDT at random intervals in order to properly monitor the patient.3Testing profiles must be determined by the clinician based on the following medical necessity guidance criteria:Patient history, physical examination, and previous laboratory findings;Stage of treatment or recovery;Suspected abused substance;Substances that may present high risk for additive or synergistic interactions with prescribed medication (e.g., benzodiazepines, alcohol).The patients medical recordmust include an appropriate number of UDTs billed over time based on the stage of screening, treatment, or recovery10; the rationale for the drugs/drug classes ordered; and the results must be documented in the medical record and used to direct care.3Maximum Number of Allowed Presumptive UDTs for SUDThe number of UDTs billed over time must meet medical necessity and be documented in the patients medical record.9For patients with0 to 30 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days. More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days. More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 30 days. More than 3 presumptive UDTs in a rolling 30 days is not reasonable and necessary and is not covered by Medicare.Maximum Number of Allowed Definitive UDTs for SUD:Depending on the patients specific substance use history, definitive UDT to accurately determine the specific drugs in the patients system may be necessary. Definitive testing may be ordered when accurate and reliable results are necessary to integrate treatment decisions and clinical assessment. The number of UDTs billed over time and the rationale for definitive UDT must be documented in the patients medical record.For patients with0 to 30 consecutive days of abstinence, definitive UDT is not to exceed 1 definitive UDT in a rolling 7 days. More than 1 definitive UDT in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence, definitive UDT is not to exceed 3 definitive UDTs in a rolling 30 days. More than 3 definitive UDTs in a rolling 30 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 days of consecutive abstinence, definitive UDT is not to exceed 3 definitive UDTs in a rolling 90 days. More than 3 definitive UDTs in a rolling 90 days is not reasonable and necessary and is not covered by Medicare.Group C - Treatment for patients on chronic opioid therapy (COT).A physician who is writing prescriptions for medications to treat chronic pain can manage a patient better if the physician knows whether the patient is consuming another medication or substance, which could suggest the possibility of SUD or lead to drug-drug interactions. Additionally, UDT may help the physician monitor for medication adherence, diversion, efficacy, side effects, and patient safety in general.11A broad cross section of the general population will develop either cancer pain syndrome or non-cancer pain which will require prolonged or chronic opioid therapy for management with normal risk of addiction inherent to the substance(s) exposed.12COT UDT Testing Objectives:Identifies absence of prescribed medication and potential for abuse, misuse, and diversion;Identifies undisclosed substances, unsanctioned prescription medication, or illicit substances;Identifies substances that contribute to adverse events or drug-drug interactions;Provides objectivity to the treatment plan11;Reinforces therapeutic compliance with the patient;Provides additional documentation demonstrating compliance with patient evaluation and monitoring13;Provide diagnostic information to help assess individual patient response to medications (e.g., metabolism, side effects, drug-drug interaction, etc.) over time for ongoing management of prescribed medications.Medical Necessity Guidance:Criteria to establish medical necessity for UDT must be based on patient-specific elements identified during the clinical assessment, and documented by the clinician in the patients medical record and minimally include the following elements14:Patient history, physical examination, and previous laboratory findings;Current treatment plan;Prescribed medication(s);Risk assessment plan.National pain organizations, physician societies, and the Federation of State Medical Boards15recommend a practical management approach to definitive UDT for COT. The number of UDTs billed overt time beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patients medical record. Recommendations for the ordering of presumptive and definitive UDT for patients on COT are as follows:3.COT Baseline Testing:Depending on the patients specific circumstances, initial presumptive and/or definitive COT patient testing may include amphetamine/ methamphetamine, barbiturates, benzodiazepines, cocaine, methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinol, opioids, opiates, heroin, and synthetic/analog or designer drugs.4.COT Monitoring Testing:Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, self-escalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern.16As part of the clinical evaluation of the patient, the provider should inquire about prescription compliance and potential issues of abuse or diversion such as lost prescriptions, early refill requests, or requests for escalating dose of medication.16The number of UDTs billed over time must be based on the individuals risk potential.1Appropriate number of UDTs billed over time based on risk is listed in the table below.14The clinician should perform random UDT at random intervals to properly monitor a patient.17UDT testing does not have to be associated with an office visit.Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this documents guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.UDT Frequency Based on Risk Assessment and Stratification*:Testing must be based on clinicians documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.Risk GroupBaselineFrequency of Testing

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Proposed LCD - Urine Drug Testing (DL39611)

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Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, self-escalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern.16As part of the clinical evaluation of the patient, the provider should inquire about prescription compliance and potential issues of abuse or diversion such as lost prescriptions, early refill requests, or requests for escalating dose of medication.16The number of UDTs billed over time must be based on the individuals risk potential.1Appropriate number of UDTs billed over time based on risk is listed in the table below.14The clinician should perform random UDT at random intervals to properly monitor a patient.17UDT testing does not have to be associated with an office visit.Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this documents guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.UDT Frequency Based on Risk Assessment and Stratification*:Testing must be based on clinicians documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.Risk GroupBaselineFrequency of TestingLow RiskPrior toInitiation ofCOTPresumptive and definitive UDT not to exceed 2 times each in a rolling 365 days for prescribed medications, non-prescribed medications that may pose a safety risk if taken with prescribed medications, and illicit substances based on patient history, clinical presentation, and/or community usage.Moderate RiskPrior toInitiation ofCOTPresumptive and definitive UDT not to exceed 2 times each in a rolling 180 days for prescription medications, non-prescribed medication that may pose a safety risk if taken with prescribed medications, and illicit substances, based on patient history, clinical presentation, and/or community usage.High RiskPrior to Initiation of COTPresumptive and definitive UDT not to exceed 3 times each in a rolling 90 days for prescribed medications, non-prescribed medications that may pose a safety risk if mixed with prescribed and illicit substances based on patient history, clinical presentation and/or community usage.*Note: Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical situations in which changes in prescribed medications may be needed, such as:Patient response to prescribed medication suddenly changes;Patient side effect profile changes;To assess for possible drug-drug interactions;Change in patients medical condition or behavior;Patient admits to use of illicit or non-prescribed controlled substance.Opioid Risk Tool:The patients risk category must be clearly defined in the medical record and is essential in determining number of UDTs billed over time and medical necessity.This TOOL is to be used as a suggestion for defining Risk and this document is just an example and other tools accepted by the Opioid Use treating community may be used. Example, accepted by SAMHSA (Substance Abuse and Mental Health Services Administration)The Opioid Risk Tool (ORT)18is a brief, self-report screening tool designed for use with adult patients in primary care settings to assess risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain.15,16Patients categorized as high-risk are at increased likelihood of future abusive drug-related behavior.14The ORT can be administered and scored in less than 1 minute and has been validated in both male and female patients, but not in non-pain populations. This tool should be administered to patients upon an initial visit prior to beginning opioid therapy for pain management. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse.15, 18Mark each box that appliesFemaleMaleFamily history of substance abuseAlcoholIllegal drugsRx drugsPersonal history of substance abuseAlcoholIllegal drugsRx drugsAge between 16-45 yearsHistory of preadolescent sexual abusePsychological diseaseADD, OCD, bipolar, schizophreniaDepressionScoring totalsOther Covered ServicesReflex Testing by Reference Laboratories since reference laboratories do not have access to patient-specific data, reflex testing under the following circumstances is reasonable and necessary:To verify a presumptive positive UDT using definitive methods that include but are not limited to GC-MS or LC-MS/MS before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician; orTo confirm the absence of prescribed medications when a negative result is obtained by presumptive UDT in the laboratory for a prescribed medication listed by the ordering clinician.When medical record documentation that is individualized for a particular patient satisfies medical necessity requirements found elsewhere in this LCD (e.g., risk assessment, frequency), direct to definitive UDT without a presumptive UDT may be reasonable and necessary.Definitive testing to confirm a negative presumptive UDT result, upon the order of the clinician, is reasonable and necessary in the following circumstances:The result is inconsistent with a patients self-report, presentation, medical history, or current prescribed medication plan (should be present in the sample);Following a review of clinical findings, the clinician suspects use of a substance that is inadequately detected or not detected by a presumptive UDT; orWhen there is an unexpected negative presumptive UDT result, and it is clinically imperative to know if it is truly positive or negative; the medical record should state such.Definitive testing to confirm a presumptive UDT positive result, upon the order of the clinician, is reasonable and necessary when the result is inconsistent with the expected result, a patients self-report, presentation, medical history, or current prescribed medication plan.Non-Covered ServicesBlanket Orders-same orders for all patients in a health care provider's practice.Reflex definitive UDT is not reasonable and necessary when presumptive testing is performed at point of care because the clinician may have sufficient information to manage the patient. If the clinician is not satisfied, he/she must determine the clinical appropriateness of and order specific subsequent definitive testing (e.g., the patient admits to using a particular drug, or the IA cut-off is set at such a point that is sufficiently low that the physician is satisfied with the presumptive test result).Routine standing orders for all patients in a physicians practice are not reasonable and necessary.It is not reasonable and necessary for a physician to perform presumptive POCT and order presumptive IA testing from a reference laboratory. In other words, Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a physician to perform presumptive IA testing and order presumptive IA testing from a reference laboratory. Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to definitive testing without a specific physicians order for the presumptive testing.IA testing, regardless of whether it is qualitative or semi-quantitative (numerical), may not be used to confirm or definitively identify a presumptive test result obtained by cups, dipsticks, cards, cassettes or other IA testing methods. Definitive UDT provides specific identification and/or quantification typically by GC-MS or LC-MS/MS. Semi-Quantitative is defined as a numerical estimation of the approximate concentrations.Drug testing of 2 different specimen types from the same patient on the same date of service for the same drugs/metabolites/analytes.UDT for medico-legal and/or employment purposes or to protect a physician from drug diversion charges.Specimen validity testing including, but not limited to, pH, specific gravity, oxidants, creatinine.General InformationAssociated InformationN/ASources of InformationOther Contractor(s)' PoliciesBibliographyDuPont RL, Shea CL, Barthwell AG, et al. DRUG TESTING: A White Paper of the American Society of Addiction Medicine (ASAM). American Society of Addiction Medicine. White Paper. 2013.Gourlay DL, Heit HA, Caplan YH. Urine drug testing in clinical practice. The art and science of patient care. 2015(6):1-30SAMHSA, Clinical DRUG TESTING in Primary Care, Rockville, MD: SAMHSA; 2012. Technical Assistance Publication (TAP) 32, HHS publication (SMA) 12-4668.Agency Medical Directors Group. Interagency guideline on opioid dosing for chronic non-cancer pain: An educational aid to improve care and safety with opioid therapy 2010 Update.Melanson Stacy EF, Baskin LB. Interpretation and utility of drug of abuse immunoassays: lessons from laboratory drug testing surveys. Arch Pathol Lab Med. 2010;134:736-739.Standridge JB, Adams SM. Urine drug screening: a valuable office procedure. American Family Physician. 2010;81(5):635-640.American Medical Association, CPT 2021 Professional Edition, 26 November 2020, ISBN: 1640160493.Drug Enforcement Administration, U.S. Department of Justice, Drugs of Abuse: A DEA Resource Guide, 2020 Edition.Jannetto PJ, Bratanow NC, Clark WA, et al. Executive Summary: American Association of Clinical Chemistry Laboratory Medicine Practice GuidelineUsing Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. The Journal of Applied Laboratory Medicine. 2018;2(4):489526.https://doi.org/10.1373/jalm.2017.023341AMA Report 2 of the Council on Science and Public Health (I-08): Improving Medical Practice and Patient/Family Education to Reverse the Epidemic of Nonmedical Prescription Drug Use and Addiction.American Academy of Pain Medicine, Guideline Statement, Use of Opioids for the Treatment of Chronic Pain, March 2013.Passik SD, Kirsh KL, Casper D. Addiction-related assessment tools and pain management: instruments for screening, treatment planning and monitoring compliance. Pain Med. 2008;9:S145-S166.Jones T, McCoy D, Moore TM, Browder, JH, Daffron S. Urine drug testing as an evaluation of risk management strategies. Practical Pain Management. 2010;10(5):26-30.Chou R, Fanciullo GJ. Opioid Treatment Guidelines; Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J Pain. 2009; 10(2): 113-130.Federation of State Medical Boards (FSMB), Model Policy for the Use of Opioid Analgesics for the Treatment of Chronic Pain, July 2013.Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clinic Proceedings. 2009;84(7):593-601.Centers for Disease Control and Prevention. Unintentional Drug Poisoning in the United States. July 2010.Webster LR, Webster R. Predicting aberrant behaviors in Opioid-treated patients: preliminary validation of the Opioid risk tool. Pain Med. 2005;6(6):432.Additional literature reviewed but not citedMichna, E. et al. Urine toxicology screening among chronic pain patients of opioid therapy: frequency and predictability of abnormal findings. Clin J Pain. 2007;23(2):173-179.Barthwell, A. Principles for Urine DRUG TESTING in Addiction Medicine. CLAAD June 23, 2014.Centers for Disease Control: Policy Impact: Prescription Painkiller Overdose Deaths. July 2013.Institute for Clinical Systems Improvement (ICSI). Guideline for the assessment and management of chronic pain. November 2011.Jackman RP, Purvis JM. Chronic nonmalignant pain in primary care.American Family Physician.2008; 78(10):1155-1162.Jamison RN, Ross EL, Michna E, Chen LQ, Holcomb C, Wasan AD. Substance misuse treatment for high-risk chronic pain patients on opioid therapy: a randomized trial.Pain.2010; 150(3):390-400.Jones T, Moore T, et al. A comparison of various risk screening methods in predicting discharge from opioid treatment.Clin J Pain.2012;28(2):93-100.University of Washington, Division of Pain Medicine, Urine DRUG TESTING Interpretive Algorithm for Monitoring Opioid Treatment (adapted from the Washington Agency Medical Directors Group Opioid Treatment Guidelines 2010).Trescot AM, Standiford H. Opioids in the management of chronic non-cancer pain: an update on American Society of the Interventional Pain Physicians' (ASIPP) guidelines.AFP.2008;11:S5-S61.Jones T, Moore TM. Preliminary data on a new risk assessment tool: the brief risk interview.Journal of Opioid Management.2013; 9(1):19-27.

Local Coverage Determinations, LCD, Local policies, Urine Drug Testing, DL39611

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Proposed LCD - Urine Drug Testing (DL39611)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39610&ver=3

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Jones T, Moore TM, Levy J, Browder JH, Daffron S, Passik SD. A comparison of various risk screening methods for patients receiving opioids for chronic pain management.Clinical Journal of Pain.2012; 28(2):93-100.Jones T, Passik SD. A comparison of methods of administering the opioid risk tool.Journal of Opioid Management.2011; 7(5): 347-352.Mallya A., Purnell AL, Svrakic DM, et al. Witnesses versus unwitnessed random urine tests in the treatment of opioid dependence.Am J Addict.2013; 22(2):175-177.Moore TM, Jones T, Browder JH, Daffron S, Passik SD. A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids of chronic pain management.Pain Medicine.2009; 10(8):1426-1433.Nafziger AN, Bertino JS. Utility and application of urine drug testing in chronic pain management with opioids.Clin J Pain.2009;25(1)73-79.Nicholson B, Passik S. Management of chronic non-cancer pain in the primary care setting.SMJ. 2007;100(10):1028-1034.Passik S, Jones T. Risk assessment 2.0.PainWeek Journal. 2013; 1(3): 5-9.Reisfield GM, Wasan AD, Jamison RN. The prevalence and significance of cannabis uses in patients prescribed chronic opioid therapy: a review of the extant literature.Pain Med. 2009; 10(8):1434-1441.Schneider J, Miller A. Urine drug tests in a private chronic pain practice.PPM.January/February 2008.

Local Coverage Determinations, LCD, Local policies, Urinary Biomarkers for Chronic Pain Management, DL39616

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Proposed LCD - Urinary Biomarkers for Chronic Pain Management (DL39616)

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lcd-39615-10-1.txt

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ab754ebf-5637-43b1-bdfb-703fba9f8cb5

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) Investigational or Experimental42 Code of Federal Regulations (CFR) 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic TestsCMS Internet-Only Manuals, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories.CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, 50.5 Jurisdiction of Laboratory Claims.Coverage Indications, Limitations, and/or Medical NecessityFor this policy:Urinary biomarker laboratory tests for chronic pain are non-covered by this contractor.BackgroundChronic pain is a significant problem that is complex and challenging to treat. The mechanisms of chronic pain are not well understood, and the lack of objective diagnostic tests adds to this challenge. Research to develop biomarkers for chronic pain is of interest as this may provide guidance for drug development and clinical practice. A biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathological processes or pharmacological responses to a therapeutic intervention(Biomarker Definitions Working Group, 2001).1Biomarkers aim to help diagnose, aid in prognosis and evaluation of treatment responses and can inform rational drug development. There are no specific biomarkers for chronic pain.1Commercially available at the time of this LCD includes a novel, pain algorithmic based biomarker test panel called Foundation Pain Index (FPI) was developed by Ethos Laboratories, Newport, KY to evaluate biomarkers of systemic inflammation, oxidative stress, neurotransmitter turnover, and micronutrient status. The test includesanalysis of 11 endogenous analytes (methylmalonic acid, xanthurenic acid, homocysteine, pyroglutamic acid, vanilmandelate, 5- hydroxyindoleacetic acid, hydroxymethylglutarate, ethylmalonate, 3- hydroxypropyl mercapturic acid (3- HPMA), quinolinic acid, kynurenic acid), LC- MS/MS collected via urine sample. An algorithm is used to report a pain-index score with likelihood of atypical biochemical function associated with pain. The concept is based on emerging research that nutrition-based interventions could reduce the severity and intensity of pain and that nearly all neurogenerative diseases appear to have an underlying diet-induced, pro-inflammatory state that can be mitigated if diagnosed.2General InformationAssociated InformationN/ASources of InformationN/ABibliographyBorsook D, Becerra L, Hargreaves R. Biomarkers for chronic pain and analgesia. Part 1: the need, reality, challenges, and solutions.Discovery medicine.2011;11(58):197-207.Peabody J, Paculdo D, Tamondong-Lachica D, Cabaluna IT, Gunn J. Randomized Trial on the Clinical Utility of a Novel Biomarker Panel to Identify Treatable Determinants of Chronic Pain.Diagnostics (Basel).2020;10(8).Hagedorn JM, Gunn J, Budwany R, DSouza RS, Chakravarthy K, Deer TR. How Well Do Current Laboratory Biomarkers Inform Clinical Decision-Making in Chronic Pain Management?Journal of Pain Research.2021:3695-3710.Aroke EN, Powell-Roach KL. The Metabolomics of Chronic Pain Conditions: A Systematic Review.Biol Res Nurs.2020;22(4):458-471.McDonagh MS, Selph SS, Buckley DI, et al. Nonopioid pharmacologic treatments for chronic pain. 2020.David Tauben BRS. Approach to the management of chronic non-cancer pain in adults.https://www.uptodate.com/. Published 2023. Accessed 5/12/2023.Gunn J, Hill MM, Cotten BM, Deer TR. An Analysis of Biomarkers in Patients with Chronic Pain.Pain Physician.2020;23(1):E41-E49.Amirdelfan K, Pope JE, Gunn J, et al. Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study.Pain Ther.2020;9(2):511-529.GRADEpro GDT: GRADEpro Guideline Development [Software]. McMaster University and Evidence Prime, 2022. Available from gradepro.org. Accessed May 12, 2023.Schnemann H BJ, Guyatt G, Oxman A, editors. The GRADE Working Group. GRADE handbook for grading quality of evidence and strength of recommendations. Available from guidelinedevelopment.org/handbook. Published 2013. Accessed 5/12/2023.Practice Guidelines for Chronic Pain Management: An Updated Report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine*.Anesthesiology.2010;112(4):810-833.Jannetto PJ, Langman LJ. Using clinical laboratory tests to monitor drug therapy in pain management patients.The Journal of Applied Laboratory Medicine.2018;2(4):471-472.Argoff CE, Alford DP, Fudin J, et al. Rational Urine Drug Monitoring in Patients Receiving Opioids for Chronic Pain: Consensus Recommendations.Pain Medicine.2017;19(1):97-117.Carville S, Constanti M, Kosky N, Stannard C, Wilkinson C, Guideline C. Chronic pain (primary and secondary) in over 16s: summary of NICE guidance.BMJ.2021;373:n895.Lambert M. ICSI releases guideline on chronic pain assessment and management.American family physician.2010;82(4):434.

Local Coverage Determinations, LCD, Local policies, Intraosseous Basivertebral Nerve Ablation, DL39642

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Proposed LCD - Intraosseous Basivertebral Nerve Ablation (DL39642)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39641&ver=4

lcd-39641-4-1.txt

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39641

lcd

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4864b711-59c6-4b38-8b96-79cbc709923b

CMS National Coverage PolicySection 1862(a)(1)(A) of Title XVIII of the Social Security Act excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1833(e) of Title XVIII of the Social Security Act prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS Manual System. Publication 100-2, Medicare Benefit Policy Manual, Chapter 15, 80 describes coverage for physician supervision of diagnostic x-ray, lab and other diagnostic tests.Coverage Indications, Limitations, and/or Medical NecessityCovered IndicationsThermal ablation of the intraosseous Basivertebral Nerve (BVN) is considered medically reasonable and necessary for the treatment of Chronic Low Back Pain (CLBP) in patient who meet ALL the following criteria for coverage and reimbursement.Individual is skeletally mature and has had CLBP for at least 6 months, with lower back pain as the dominant symptom.Has failed to adequately improve despite documented non-surgical management, to include at least 3 or more of the following modalities:Avoidance of activities that aggravate pain.Course of physical therapy or professionally directed therapeutic exercise program.Chiropractic manipulationCognitive therapyPharmacotherapy, including narcotic and non-narcotic analgesics, muscle relaxants, neuroleptics, and anti-inflammatories.Injection therapy of epidural or facet joint implicated pain sources in the region of concernType 1 or Type 2 Modic changes on MRI: Endplate hyposensitivity (Type 1) or hyperintensity (Type 2) on T1 images plus hyperintensity on T2 images (Type1) involving the endplates between L3 and S1Absence of non-vertebral pathology by physical, history, radiologic or clinical assessment including, but not limited to, fracture, tumor, infection, deformity, trauma, or post-surgical change which could explain or contribute to symptoms or complaints.Screening, evaluation, and diagnosis by a multidisciplinary team to include psychological and physical assessment.LimitationsThermal ablation of the Intraosseous Basivertebral nerve (BVN) is considered contraindicated with any of the following and precluded from coverage and reimbursement by Medicare:Skeletal immaturity (<18 years of age)Evidence on imaging (MRI, flexion/extension radiographs, CT) suggesting alternative etiology for LBP symptoms, including, but not limited to, lumbar spinal stenosis, spondylolisthesis, segmental instability, disc herniation, degenerative scoliosis, facet arthropathy or effusion with clinically suspected facet joint pain.Metabolic bone disease (e.g., osteoporosis with T score<-2.5), treatment of spine fragility fracture, trauma/compression fracture, or spinal primary or metastatic tumor.Active Spine or Systemic InfectionNeurogenic claudication, lumbar radiculopathy, radicular pain, nerve impingement or compression (e.g., NHP, stenosis), as primary symptoms.Patients with severe cardiac or pulmonary compromise, systemic vulnerability to bleeding, or concern for further compromise of existing disease.Patients with implantable pulse generators (e.g., pacemakers, defibrillators, or neurostimulator) and other electronic implants, unless type specific precautions are taken to maintain patient safety.Generalized systemic disease or complaints from which BVN pain cannot be differentiated from other aspects of the patients condition (e.g., morbid obesity, fibromyalgia, rheumatologic disease)Previous history of BVN ablation at the level of treatment.Treatment of more than 4 vertebral bodies per patient lifetime, within the confines of L3-S1 vertebral bodies.Retreatment of a single vertebral body with BVN ablation within the patients lifetime.Ongoing use or abuse of addictive medications without evidence of potential weaning or decreasing use with treatment of this and other causes of chronic pain.General InformationDefinitionsChronic Pain/Chronic Low Back Pain: Pain lasting longer than three months in the same location, seemingly resistant to conservative measures.Conservative Measures/ Non-surgical Managment: Any single or combination use of medication, physical therapeutic regimens, psychological or cognitive therapy designed by a qualified health care provider to affect relief of a disability or disease, based on a patients needs and physical findings. Incidental encounters are not considered therapeutic unless prescribed and monitored for defined purpose, time and frequency by a qualified practitioner.Functional impairment: A physical, functional or physiologic impairment causing deviation from the normal function of a tissue, organ or body member, resulting in a significant limitation or impairment of the capacity to move, coordinate actions or perform physical activities, demonstrated by difficulty performing physical and motor tasks, independent movement or basic life functions.Radicular pain or radiculopathy: pain radiating or identified in the path and distribution or dermatomal pattern of a named spinal nerve. Pain that is localized and does not travel in the distribution of an identified spinal nerve and remains axial in location is considered to have a non-radicular pattern.Spinal stenosis:Narrowing of the central spinal canal and /or the foraminal openings through which nerve or neural tissue are located, causing compression and irritation of the involved neural structures. A wide range of symptoms may be present, contributing to back and extremity pain and dysfunction.General InformationAssociated InformationDocumentation RequirementsMethods used for measurement of pain and/or disability must be documented in the medical record. Acceptable scales include, but are not limited to, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment and Pain Disability Assessment Scale (PDAS) Oswestry disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OWS) Quebec Back Pain Disability Scare (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS) and the PROMIS profile domains to assess function.Complete history and physician exam, including laboratory and imaging findings and abnormalities.Patient assessment for pain and related conditions that may contribute to the complaint by a qualified health care provider trained in assessment of spinal and paraspinal disorders with relevant medical history including duration, treatments considered as well as documentation of success and failure of treatments prescribed.Treatments and procedures utilized for pain control including pertinent evaluation, medications, imaging and testing. Must include MRI documentation and reports demonstrating Modic changes (Type 1 or 2) in the L3-S1 vertebral body endplates.Provider assessment with order or recommendation for treatment including indication, method, and associated medications and therapies prescribed with provider signature and date. Patient acknowledgement of method, potential adverse effects and expected outcome, with consent for treatment.Provider qualificationsMedicare considers BasiVertebral Nerve (BVN) ablation reasonable and necessary when furnished in accordance with the accepted standards of medical practice, furnished in a setting appropriate to the patients medical needs and condition, meets but does not exceed the patients medical need, and when ordered and furnished by qualified personnel, meeting the requirements of this LCD. Patient safety and consideration for coverage and reimbursement mandate that all provisions specified in the CMS policy manuals be followed.BVN ablation services must be performed in a place of service demonstrating the appropriate equipment (e.g., fluoroscopy, CT, medical emergency equipment). It is expected that all clinical staff maintain appropriate training and credentials to support their role as first responders to potential medical emergencies.Procedures listed and included in this LCD do not constitute anesthesia services. Evaluation, methods and techniques specified are not considered routine for surgical or perioperative anesthesia. Procedures to remedy pain emanating from the BasiVertebral Nerve constitute surgical intervention of a diseased body part, for which evaluation, diagnosis and management must be established by a medical provider trained in the specific discipline. It is expected that all providers of BVN ablative services are appropriately trained and credentialed by a formal residency/ fellowship program accredited by a nationally recognized organization or post-graduate training course accredited by an established national credentialing body in a relevant specialty.*Services will be considered medically reasonable and necessary only if both of the following criteria are met:All aspects of the procedure and its related care are within the scope of practice of the providers professional licensure; andAll procedures are performed by appropriately trained providers in the appropriate setting. Patient safety and quality of care mandate that healthcare professionals who perform injections or ablative techniques for treatment of specific nerve maladies and dysfunction are appropriately trained and are competent to perform all aspects of these procedures safely and effectively. The core curriculum of any training program should include the performance and management of the procedures addressed in this policy with documentation of trainee competency assessment by formal examination and case history document review.*Health care providers performing intraosseous BVN nerve ablation must be appropriately trained and credentials by a formal residency or fellowship training program recognized in the United States or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program. At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics, proficiency in evaluation, diagnosis and management of diseases necessitating the procedures, technical performance of the procedure and performing and interpreting medically reasonable imaging modalities required for procedure performance (imaging technique, contrast material use, and image interpretation) as well as the evaluation, diagnosis and management of potential complications from the intervention. If a procedure requires facility credentialing or privilege approval when performed in an inpatient or outpatient hospital setting, the provider must possess those credentials to receive reimbursement for that procedure when performed in a healthcare facility or elsewhere. Only those settings with immediate availability of equivalent support services and personnel as those in a hospital will be considered appropriate place of service for purposes of Medicare reimbursement.Reimbursement for procedures utilizing imaging may be made to providers who meet training requirements for the procedures in this policy when permitted under relevant state professional practice acts. In addition, all providers who seek Medicare payment for the procedures included in this policy must meet any applicable federal, state, or local licensing requirements and statutes for owning, operating, handling, or utilizing ionizing radiation, and relevant imaging equipment, materials, and contrast.Utilization GuidelinesAll aspects of evaluation and treatment must be documented in the patients chart, to include time, date and signature of the providing clinician and made available to Medicare on request.All medications, and equipment utilized in the procedure must be documented at the time of the procedure, including name, identification/ serial number, dose, route of administration and site of administration. Therapeutic equipment including type, brand name, energy level attained and method of deployment must be documented in the patients record, including pertinent identifying imaging used for deployment. All documentation must be made available to Medicare on request.No payment will be made for procedures not performed with appropriate imaging (fluoroscopic or computerized tomography) with formal report or reproduced images documented in the patient record and made available to Medicare on request.It is not expected that anesthesia for the procedure will require other than administration of local anesthetizing agents at the site of entrance, with addition mild sedation. The rationale for the use of higher levels of sedation or general anesthesia should be documented in the patients record, without which denial of claim reimbursement may be made.The injection of medications other than agents recognized as local anesthetics are not considered reasonable or medically appropriate at the site of administration of this procedure and will result in claim denial as inconsistent with patient safety. This specifically applies to the use of steroids, anti-inflammatories, biologics and any form of pharmaceutical not specifically designated as a local anesthetic agent.Sources of InformationN/ABibliography

Local Coverage Determinations, LCD, Local policies, Intraosseous Basivertebral Nerve Ablation, DL39642

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Proposed LCD - Intraosseous Basivertebral Nerve Ablation (DL39642)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39641&ver=4

lcd-39641-4-1.txt

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a9962b52-3c40-4160-8ba2-84d1ddf22115

Sources of InformationN/ABibliographyConger A, Schuster NM, Cheng DS, et al. The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Neurotomy for the Treatment of Chronic Low Back Pain in Patients with Modic Changes: A Systematic Review.Pain Med. 2021;22(5):1039-1054. doi:10.1093/pm/pnab040*ECRI Institute. Clinical Evidence Assessment. Intracept intraosseous nerve ablation system (Relievant Medsystems, Inc.) for treating low-back pain. October 2020b.Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study.Eur Spine J. 2018;27(5):1146-1156. doi:10.1007/s00586-018-5496-1Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study.Int J Spine Surg. 2019;13(2):110-119. Published 2019 Apr 30. doi:10.14444/6015Fischgrund JS, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study.Eur Spine J. 2020;29(8):1925-1934. doi:10.1007/s00586-020-06448-x*Jarvinen J, Karppinen J, Niinimki J, et al. Association between changes in lumbar Modic changes and low back symptoms over a two-year period.BMC Musculoskelet Disord.2015;16:98.*Jensen TS, Karppinen J, Sorensen JS, Niinimki J, Leboeuf-Yde C. Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain.Eur Spine J.2008;17(11):14071422.Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.Spine J. 2019;19(10):1620-1632. doi:10.1016/j.spinee.2019.05.598Kim HS, Adsul N, Yudoyono F, et al. Transforaminal Epiduroscopic Basivertebral Nerve Laser Ablation for Chronic Low Back Pain Associated with Modic Changes: A Preliminary Open-Label Study.Pain Res Manag. 2018;2018:6857983. Published 2018 Aug 14. doi:10.1155/2018/6857983*Koreckij T, Kreiner S, Khalil J, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results.NASSJ. 2021;8:100089-100098.Lorio M, Clerk-Lamalice O, Beall DP, Julien T. International Society for the Advancement of Spine Surgery Guideline-Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain.Int J Spine Surg. 2020;14(1):18-25. Published 2020 Feb 29. doi:10.14444/7002*Luoma K, Vehmas T, Kerttula L, Gronblad M, Rinne E. Chronic low back pain in relation to Modic changes, bony endplate lesions, and disc degeneration in a prospective MRI study.Eur Spine J.2016;25(9):2873-2881.Macadaeg K, Truumees E, Boody B, et al. A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results [published correction appears in N Am Spine Soc J. 2020 Dec 01;4:100039].N Am Spine Soc J. 2020;3:100030. Published 2020 Sep 18. doi:10.1016/j.xnsj.2020.100030Markman JD, Rhyne AL, Sasso RC, et al. Association Between Opioid Use and Patient-Reported Outcomes in a Randomized Trial Evaluating Basivertebral Nerve Ablation for the Relief of Chronic Low Back Pain.Neurosurgery. 2020;86(3):343-347. doi:10.1093/neuros/nyz093*Michalik A, Conger A, Smuck M, Maus TP, McCormick ZL. Intraosseous basivertebral nerve radiofrequency ablation for the treatment of vertebral body endplate low back pain: current evidence and future directions.Pain Medicine.2021;22(S1):S24-S30.North American Spine Society (NASS). Basivertebral nerve ablation: defining appropriate coverage positions.North American Spine Society. 2023;spine.orgSayed D, Naidu RK, Patel KV, et al. Best practice guidelines on the diagnosis and treatment of vertebrogenic pain with basivertebral nerve ablation from the American Society of Pain and Neuroscience.JPR. 2022;15:28012819.*Smuck M, Khalil J, Barrette K, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results.Reg Anesth Pain Med. 2021;0:1-11.Truumees E, Macadaeg K, Pena E, et al. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.Eur Spine J. 2019;28(7):1594-1602. doi:10.1007/s00586-019-05995-2

Local Coverage Determinations, LCD, Local policies, Intraosseous Basivertebral Nerve Ablation, DL39644

Use this page to view details for the Local Coverage Determination for Intraosseous Basivertebral Nerve Ablation.

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Proposed LCD - Intraosseous Basivertebral Nerve Ablation (DL39644)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39643&ver=4

lcd-39643-4-1.txt

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39643

lcd

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8024e922-61e5-41bd-adc5-bb3c865c61b2

CMS National Coverage PolicySection 1862(a)(1)(A) of Title XVIII of the Social Security Act excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1833(e) of Title XVIII of the Social Security Act prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS Manual System. Publication 100-2, Medicare Benefit Policy Manual, Chapter 15, 80 describes coverage for physician supervision of diagnostic x-ray, lab and other diagnostic tests.Coverage Indications, Limitations, and/or Medical NecessityCovered IndicationsThermal ablation of the intraosseous Basivertebral Nerve (BVN) is considered medically reasonable and necessary for the treatment of Chronic Low Back Pain (CLBP) in patient who meet ALL the following criteria for coverage and reimbursement.Individual is skeletally mature and has had CLBP for at least 6 months, with lower back pain as the dominant symptom.Has failed to adequately improve despite documented non-surgical management, to include at least 3 or more of the following modalities:Avoidance of activities that aggravate pain.Course of physical therapy or professionally directed therapeutic exercise program.Chiropractic manipulationCognitive therapyPharmacotherapy, including narcotic and non-narcotic analgesics, muscle relaxants, neuroleptics, and anti-inflammatories.Injection therapy of epidural or facet joint implicated pain sources in the region of concernType 1 or Type 2 Modic changes on MRI: Endplate hyposensitivity (Type 1) or hyperintensity (Type 2) on T1 images plus hyperintensity on T2 images (Type1) involving the endplates between L3 and S1Absence of non-vertebral pathology by physical, history, radiologic or clinical assessment including, but not limited to, fracture, tumor, infection, deformity, trauma, or post-surgical change which could explain or contribute to symptoms or complaints.Screening, evaluation, and diagnosis by a multidisciplinary team to include psychological and physical assessment.LimitationsThermal ablation of the Intraosseous Basivertebral nerve (BVN) is considered contraindicated with any of the following and precluded from coverage and reimbursement by Medicare:Skeletal immaturity (<18 years of age)Evidence on imaging (MRI, flexion/extension radiographs, CT) suggesting alternative etiology for LBP symptoms, including, but not limited to, lumbar spinal stenosis, spondylolisthesis, segmental instability, disc herniation, degenerative scoliosis, facet arthropathy or effusion with clinically suspected facet joint pain.Metabolic bone disease (e.g., osteoporosis with T score<-2.5), treatment of spine fragility fracture, trauma/compression fracture, or spinal primary or metastatic tumor.Active Spine or Systemic InfectionNeurogenic claudication, lumbar radiculopathy, radicular pain, nerve impingement or compression (e.g., NHP, stenosis), as primary symptoms.Patients with severe cardiac or pulmonary compromise, systemic vulnerability to bleeding, or concern for further compromise of existing disease.Patients with implantable pulse generators (e.g., pacemakers, defibrillators, or neurostimulator) and other electronic implants, unless type specific precautions are taken to maintain patient safety.Generalized systemic disease or complaints from which BVN pain cannot be differentiated from other aspects of the patients condition (e.g., morbid obesity, fibromyalgia, rheumatologic disease)Previous history of BVN ablation at the level of treatment.Treatment of more than 4 vertebral bodies per patient lifetime, within the confines of L3-S1 vertebral bodies.Retreatment of a single vertebral body with BVN ablation within the patients lifetime.Ongoing use or abuse of addictive medications without evidence of potential weaning or decreasing use with treatment of this and other causes of chronic pain.General InformationDefinitionsChronic Pain/Chronic Low Back Pain: Pain lasting longer than three months in the same location, seemingly resistant to conservative measures.Conservative Measures/ Non-surgical Managment: Any single or combination use of medication, physical therapeutic regimens, psychological or cognitive therapy designed by a qualified health care provider to affect relief of a disability or disease, based on a patients needs and physical findings. Incidental encounters are not considered therapeutic unless prescribed and monitored for defined purpose, time and frequency by a qualified practitioner.Functional impairment: A physical, functional or physiologic impairment causing deviation from the normal function of a tissue, organ or body member, resulting in a significant limitation or impairment of the capacity to move, coordinate actions or perform physical activities, demonstrated by difficulty performing physical and motor tasks, independent movement or basic life functions.Radicular pain or radiculopathy: pain radiating or identified in the path and distribution or dermatomal pattern of a named spinal nerve. Pain that is localized and does not travel in the distribution of an identified spinal nerve and remains axial in location is considered to have a non-radicular pattern.Spinal stenosis:Narrowing of the central spinal canal and /or the foraminal openings through which nerve or neural tissue are located, causing compression and irritation of the involved neural structures. A wide range of symptoms may be present, contributing to back and extremity pain and dysfunction.General InformationAssociated InformationDocumentation RequirementsMethods used for measurement of pain and/or disability must be documented in the medical record. Acceptable scales include, but are not limited to, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment and Pain Disability Assessment Scale (PDAS) Oswestry disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OWS) Quebec Back Pain Disability Scare (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS) and the PROMIS profile domains to assess function.Complete history and physician exam, including laboratory and imaging findings and abnormalities.Patient assessment for pain and related conditions that may contribute to the complaint by a qualified health care provider trained in assessment of spinal and paraspinal disorders with relevant medical history including duration, treatments considered as well as documentation of success and failure of treatments prescribed.Treatments and procedures utilized for pain control including pertinent evaluation, medications, imaging and testing. Must include MRI documentation and reports demonstrating Modic changes (Type 1 or 2) in the L3-S1 vertebral body endplates.Provider assessment with order or recommendation for treatment including indication, method, and associated medications and therapies prescribed with provider signature and date. Patient acknowledgement of method, potential adverse effects and expected outcome, with consent for treatment.Provider qualificationsMedicare considers BasiVertebral Nerve (BVN) ablation reasonable and necessary when furnished in accordance with the accepted standards of medical practice, furnished in a setting appropriate to the patients medical needs and condition, meets but does not exceed the patients medical need, and when ordered and furnished by qualified personnel, meeting the requirements of this LCD. Patient safety and consideration for coverage and reimbursement mandate that all provisions specified in the CMS policy manuals be followed.BVN ablation services must be performed in a place of service demonstrating the appropriate equipment (e.g., fluoroscopy, CT, medical emergency equipment). It is expected that all clinical staff maintain appropriate training and credentials to support their role as first responders to potential medical emergencies.Procedures listed and included in this LCD do not constitute anesthesia services. Evaluation, methods and techniques specified are not considered routine for surgical or perioperative anesthesia. Procedures to remedy pain emanating from the BasiVertebral Nerve constitute surgical intervention of a diseased body part, for which evaluation, diagnosis and management must be established by a medical provider trained in the specific discipline. It is expected that all providers of BVN ablative services are appropriately trained and credentialed by a formal residency/ fellowship program accredited by a nationally recognized organization or post-graduate training course accredited by an established national credentialing body in a relevant specialty.*Services will be considered medically reasonable and necessary only if both of the following criteria are met:All aspects of the procedure and its related care are within the scope of practice of the providers professional licensure; andAll procedures are performed by appropriately trained providers in the appropriate setting. Patient safety and quality of care mandate that healthcare professionals who perform injections or ablative techniques for treatment of specific nerve maladies and dysfunction are appropriately trained and are competent to perform all aspects of these procedures safely and effectively. The core curriculum of any training program should include the performance and management of the procedures addressed in this policy with documentation of trainee competency assessment by formal examination and case history document review.*Health care providers performing intraosseous BVN nerve ablation must be appropriately trained and credentials by a formal residency or fellowship training program recognized in the United States or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program. At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics, proficiency in evaluation, diagnosis and management of diseases necessitating the procedures, technical performance of the procedure and performing and interpreting medically reasonable imaging modalities required for procedure performance (imaging technique, contrast material use, and image interpretation) as well as the evaluation, diagnosis and management of potential complications from the intervention. If a procedure requires facility credentialing or privilege approval when performed in an inpatient or outpatient hospital setting, the provider must possess those credentials to receive reimbursement for that procedure when performed in a healthcare facility or elsewhere. Only those settings with immediate availability of equivalent support services and personnel as those in a hospital will be considered appropriate place of service for purposes of Medicare reimbursement.Reimbursement for procedures utilizing imaging may be made to providers who meet training requirements for the procedures in this policy when permitted under relevant state professional practice acts. In addition, all providers who seek Medicare payment for the procedures included in this policy must meet any applicable federal, state, or local licensing requirements and statutes for owning, operating, handling, or utilizing ionizing radiation, and relevant imaging equipment, materials, and contrast.Utilization GuidelinesAll aspects of evaluation and treatment must be documented in the patients chart, to include time, date and signature of the providing clinician and made available to Medicare on request.All medications, and equipment utilized in the procedure must be documented at the time of the procedure, including name, identification/ serial number, dose, route of administration and site of administration. Therapeutic equipment including type, brand name, energy level attained and method of deployment must be documented in the patients record, including pertinent identifying imaging used for deployment. All documentation must be made available to Medicare on request.No payment will be made for procedures not performed with appropriate imaging (fluoroscopic or computerized tomography) with formal report or reproduced images documented in the patient record and made available to Medicare on request.It is not expected that anesthesia for the procedure will require other than administration of local anesthetizing agents at the site of entrance, with addition mild sedation. The rationale for the use of higher levels of sedation or general anesthesia should be documented in the patients record, without which denial of claim reimbursement may be made.The injection of medications other than agents recognized as local anesthetics are not considered reasonable or medically appropriate at the site of administration of this procedure and will result in claim denial as inconsistent with patient safety. This specifically applies to the use of steroids, anti-inflammatories, biologics and any form of pharmaceutical not specifically designated as a local anesthetic agent.Sources of InformationN/ABibliography

Local Coverage Determinations, LCD, Local policies, Intraosseous Basivertebral Nerve Ablation, DL39644

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PROPOSED

Proposed LCD - Intraosseous Basivertebral Nerve Ablation (DL39644)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39643&ver=4

lcd-39643-4-1.txt

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Sources of InformationN/ABibliographyConger A, Schuster NM, Cheng DS, et al. The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Neurotomy for the Treatment of Chronic Low Back Pain in Patients with Modic Changes: A Systematic Review.Pain Med. 2021;22(5):1039-1054. doi:10.1093/pm/pnab040*ECRI Institute. Clinical Evidence Assessment. Intracept intraosseous nerve ablation system (Relievant Medsystems, Inc.) for treating low-back pain. October 2020b.Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study.Eur Spine J. 2018;27(5):1146-1156. doi:10.1007/s00586-018-5496-1Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study.Int J Spine Surg. 2019;13(2):110-119. Published 2019 Apr 30. doi:10.14444/6015Fischgrund JS, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study.Eur Spine J. 2020;29(8):1925-1934. doi:10.1007/s00586-020-06448-x*Jarvinen J, Karppinen J, Niinimki J, et al. Association between changes in lumbar Modic changes and low back symptoms over a two-year period.BMC Musculoskelet Disord.2015;16:98.*Jensen TS, Karppinen J, Sorensen JS, Niinimki J, Leboeuf-Yde C. Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain.Eur Spine J.2008;17(11):14071422.Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.Spine J. 2019;19(10):1620-1632. doi:10.1016/j.spinee.2019.05.598Kim HS, Adsul N, Yudoyono F, et al. Transforaminal Epiduroscopic Basivertebral Nerve Laser Ablation for Chronic Low Back Pain Associated with Modic Changes: A Preliminary Open-Label Study.Pain Res Manag. 2018;2018:6857983. Published 2018 Aug 14. doi:10.1155/2018/6857983*Koreckij T, Kreiner S, Khalil J, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results.NASSJ. 2021;8:100089-100098.Lorio M, Clerk-Lamalice O, Beall DP, Julien T. International Society for the Advancement of Spine Surgery Guideline-Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain.Int J Spine Surg. 2020;14(1):18-25. Published 2020 Feb 29. doi:10.14444/7002*Luoma K, Vehmas T, Kerttula L, Gronblad M, Rinne E. Chronic low back pain in relation to Modic changes, bony endplate lesions, and disc degeneration in a prospective MRI study.Eur Spine J.2016;25(9):2873-2881.Macadaeg K, Truumees E, Boody B, et al. A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results [published correction appears in N Am Spine Soc J. 2020 Dec 01;4:100039].N Am Spine Soc J. 2020;3:100030. Published 2020 Sep 18. doi:10.1016/j.xnsj.2020.100030Markman JD, Rhyne AL, Sasso RC, et al. Association Between Opioid Use and Patient-Reported Outcomes in a Randomized Trial Evaluating Basivertebral Nerve Ablation for the Relief of Chronic Low Back Pain.Neurosurgery. 2020;86(3):343-347. doi:10.1093/neuros/nyz093*Michalik A, Conger A, Smuck M, Maus TP, McCormick ZL. Intraosseous basivertebral nerve radiofrequency ablation for the treatment of vertebral body endplate low back pain: current evidence and future directions.Pain Medicine.2021;22(S1):S24-S30.North American Spine Society (NASS). Basivertebral nerve ablation: defining appropriate coverage positions.North American Spine Society. 2023;spine.orgSayed D, Naidu RK, Patel KV, et al. Best practice guidelines on the diagnosis and treatment of vertebrogenic pain with basivertebral nerve ablation from the American Society of Pain and Neuroscience.JPR. 2022;15:28012819.*Smuck M, Khalil J, Barrette K, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results.Reg Anesth Pain Med. 2021;0:1-11.Truumees E, Macadaeg K, Pena E, et al. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.Eur Spine J. 2019;28(7):1594-1602. doi:10.1007/s00586-019-05995-2

Local Coverage Determinations, LCD, Local policies, MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers, DL39648

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Proposed LCD - MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers (DL39648)

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lcd-39647-3-1.txt

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e7ce2b9e-1ad0-4195-bc6c-9ae3fd9f6a07

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary.42 CFR 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityThis is a coverage policy for gene expression profile tests that assess risk or predict therapeutic response in men who have an established diagnosis of castration resistant or metastatic prostate cancer.Such testing is considered reasonable and necessary to help guide treatment decisions in men with prostate cancer and a life expectancy such that they are candidates for prostate cancer treatment according to the most recent nationally recognized guidelines at the time of testing or based on FDA labelling of drugs and biologics available as potential treatment options.The scope of this policy includes gene expression profile tests regardless of methodology. It is exclusive of targeted and comprehensive genomic profiles (CGP) by next generation sequencing (NGS) and single biomarker expression analyses.Coverage criteria:1. BOTH of the following criteria must be met:The beneficiary is being actively managed for castration resistant or metastatic (hormone sensitive or castration resistant) prostate cancer.The beneficiary is within the population and has the indication for which the test was developed and validated.2. At least 1 of the following criteria are met:The patient is a candidate for more than one management option, which could be considered to have varied, or increasing/decreasing levels of intensity based on a nationally recognized consensus guideline, and the physician and patient must decide among these treatments ORThe patient is a candidate for more than one management option, and the test has shown that it predicts response to a specific therapy among accepted therapy options based on nationally recognized consensus guidelines and/or FDA labelling.3. The patient has not been tested with the same or similar test for prostate cancer.4. The patient has not received pelvic radiation or androgen deprivation therapy (ADT) prior to the biopsy or prostate resection specimen on which the test will be performed.The only exception to this is for men who are nave to secondary systemic therapies (that could be given after ADT monotherapy) AND at least 1 of the following is true:a. They do not have other standard-of-care drug-targetable gene alterations to guide systemic therapy, as defined in nationally recognized guidelines ORb. They have other standard-of-care drug-targetable gene alterations to guide systemic therapy, as defined in nationally recognized guidelines but they are not eligible for those therapies for another reason.The test demonstrates analytical validity (AV), clinical validity (CV) and clinical utility (CU), establishing a clear and significant biological/ molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management in a clearly defined population.Clinical validity of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population.If the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm.Testing must be performed according to Clinical Laboratory Improvement Amendments (CLIA) and/or Food and Drug Administration (FDA) regulations in an accredited laboratory.The lab providing the test is responsible for clearly indicating to treating physicians the population and indication(s) for test use.The test successfully completes a Molecular Diagnostic Services Program (MolDX) Technical Assessment that ensures that AV, CV, and CU criteria set in this policy are met to establish the test as Reasonable and Necessary.Genomic expression profile tests that demonstrate equivalent or superior analytical and clinical validity to those covered by this contractor will be considered reasonable and necessary for the same indications.General InformationAssociated InformationN/ASources of InformationN/ABibliography

Local Coverage Determinations, LCD, Local policies, MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers, DL39648

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Proposed LCD - MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers (DL39648)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39647&ver=3

lcd-39647-3-1.txt

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39647

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f7c57aa7-8502-42d6-94b4-da9097277a65

Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023.CA Cancer J Clin. 2023;73(1):17-48. doi:10.3322/caac.21763Basourakos SP, Gulati R, Vince RA Jr, et al. Harm-to-benefit of three decades of prostate cancer screening in black men.NEJM Evid. 2022;1(6).Awasthi S, Grass GD, Torres-Roca J, et al. Genomic testing in localized prostate cancer can identify subsets of African Americans with aggressive disease.J Natl Cancer Inst. 2022;114(12):1656-1664. doi:10.1093/jnci/djac162Siegel DA, O'Neil ME, Richards TB, Dowling NF, Weir HK. Prostate cancer incidence and survival, by stage and race/ethnicity - United States, 2001-2017.MMWR Morb Mortal Wkly Rep. 2020;69(41):1473-1480. doi:10.15585/mmwr.mm6941a1Dai C, Heemers H, Sharifi N. Androgen signaling in prostate cancer.Cold Spring Harb Perspect Med. 2017;7(9):a030452.Sweeney CJ, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer.N Engl J Med. 2015;373(8):737-746. doi:10.1056/NEJMoa1503747James ND, Sydes MR, Clarke NW, et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial.Lancet. 2016;387(10024):1163-1177. doi:10.1016/S0140-6736(15)01037-5Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer.N Engl J Med. 2017;377(4):352-360. doi:10.1056/NEJMoa1704174Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy.N Engl J Med. 2014;371(5):424-433. doi:10.1056/NEJMoa1405095Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al. ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer.J Clin Oncol. 2019;37(32):2974-2986. doi:10.1200/JCO.19.00799NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Prostate Cancer. Version 1.2023.Virgo KS, Rumble RB, de Wit R, et al. Initial management of noncastrate advanced, recurrent, or metastatic prostate cancer: ASCO guideline update.J Clin Oncol. 2021;39(11):1274-1305. doi:10.1200/JCO.20.03256Lowrance W, Dreicer R, Jarrard DF, et al. Updates to advanced prostate cancer: AUA/SUO guideline (2023).J Urol. 2023;209(6):1082-1090. doi:10.1097/JU.0000000000003452Cancer Genome Atlas Research Network. The molecular taxonomy of primary prostate cancer.Cell. 2015;163(4):1011-1025. doi:10.1016/j.cell.2015.10.025Robinson D, Van Allen EM, Wu YM, et al. Integrative clinical genomics of advanced prostate cancer.Cell. 2015;161(5):1215-1228. doi:10.1016/j.cell.2015.05.001Ryan S, Jenkins MA, Win AK. Risk of prostate cancer in Lynch syndrome: a systematic review and meta-analysis.Cancer Epidemiol Biomarkers Prev. 2014;23(3):437-449. doi:10.1158/1055-9965.EPI-13-1165Castro E, Goh C, Olmos D, et al. Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer.J Clin Oncol. 2013;31(14):1748-1757. doi:10.1200/JCO.2012.43.1882Messina C, Cattrini C, Soldato D, et al. BRCA mutations in prostate cancer: prognostic and predictive implications.J Oncol. 2020;2020:4986365. doi:10.1155/2020/4986365de Bono J, Mateo J, Fizazi K, et al. Olaparib for metastatic castration-resistant prostate cancer.N Engl J Med. 2020;382(22):2091-2102. doi:10.1056/NEJMoa1911440Gillette CM, Yette GA, Cramer SD, Graham LS. Management of advanced prostate cancer in the precision oncology era.Cancers (Basel). 2023;15(9):2552. doi:10.3390/cancers15092552Pritchard CC, Mateo J, Walsh MF, et al. Inherited DNA-repair gene mutations in men with metastatic prostate cancer.N Engl J Med. 2016;375(5):443-453. doi:10.1056/NEJMoa1603144Erho N, Crisan A, Vergara IA, et al. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy.PLoS One. 2013;8(6):e66855.Kim HL, Li P, Huang HC, et al. Validation of the Decipher Test for predicting adverse pathology in candidates for prostate cancer active surveillance.Prostate Cancer Prostatic Dis. 2019;22(3):399-405. doi:10.1038/s41391-018-0101-6Spratt DE, Yousefi K, Deheshi S, et al. Individual patient-level meta-analysis of the performance of the decipher genomic classifier in high-risk men after prostatectomy to predict development of metastatic disease.J Clin Oncol. 2017;35(18):1991-1998.Srlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications.Proc Natl Acad Sci U S A. 2001;98(19):10869-10874. doi:10.1073/pnas.191367098Wallden B, Storhoff J, Nielsen T, et al. Development and verification of the PAM50-based Prosigna breast cancer gene signature assay.BMC Med Genomics. 2015;8:54.Parker JS, Mullins M, Cheang MC, et al. Supervised risk predictor of breast cancer based on intrinsic subtypes.J Clin Oncol. 2009;27(8):1160-1167. doi:10.1200/JCO.2008.18.1370Choi W, Porten S, Kim S, et al. Identification of distinct basal and luminal subtypes of muscle-invasive bladder cancer with different sensitivities to frontline chemotherapy.Cancer Cell. 2014;25(2):152-165. doi:10.1016/j.ccr.2014.01.009Zhao SG, Chang SL, Erho N, et al. Associations of luminal and basal subtyping of prostate cancer with prognosis and response to androgen deprivation therapy.JAMA Oncol. 2017;3(12):1663-1672. doi:10.1001/jamaoncol.2017.0751Zhao SG, Chen WS, Das R, et al. Clinical and genomic implications of luminal and basal subtypes across carcinomas.Clin Cancer Res. 2019;25(8):2450-2457. doi:10.1158/1078-0432.CCR-18-3121Spratt DE, Alshalalfa M, Fishbane N, et al. Transcriptomic heterogeneity of androgen receptor activity defines ade novolow ar-active subclass in treatment nave primary prostate cancer.Clin Cancer Res. 2019;25(22):6721-6730. doi:10.1158/1078-0432.CCR-19-1587Kyriakopoulos CE, Chen YH, Carducci MA, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized phase III E3805 CHAARTED trial.J Clin Oncol. 2018;36(11):1080-1087. doi:10.1200/JCO.2017.75.3657Hamid AA, Huang HC, Wang V, et al. Transcriptional profiling of primary prostate tumor in metastatic hormone-sensitive prostate cancer and association with clinical outcomes: correlative analysis of the E3805 CHAARTED trial.Ann Oncol. 2021;32(9):1157-1166. doi:10.1016/j.annonc.2021.06.003Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer.N Engl J Med. 2018;378(15):1408-1418. doi:10.1056/NEJMoa1715546Feng FY, Thomas S, Saad F, et al. Association of molecular subtypes with differential outcome to apalutamide treatment in nonmetastatic castration-resistant prostate cancer.JAMA Oncol. 2021;7(7):1005-1014. doi:10.1001/jamaoncol.2021.1463Aggarwal R, Rydzewski NR, Zhang L, et al. Prognosis associated with luminal and basal subtypes of metastatic prostate cancer.JAMA Oncol. 2021;7(11):1644-1652. doi:10.1001/jamaoncol.2021.3987Alumkal JJ, Sun D, Lu E, et al. Transcriptional profiling identifies an androgen receptor activity-low, stemness program associated with enzalutamide resistance.Proc Natl Acad Sci U S A. 2020;117(22):12315-12323. doi:10.1073/pnas.1922207117Zhang D, Park D, Zhong Y, et al. Stem cell and neurogenic gene-expression profiles link prostate basal cells to aggressive prostate cancer.Nat Commun. 2016;7:10798.Coleman IM, DeSarkar N, Morrissey C, et al. Therapeutic implications for intrinsic phenotype classification of metastatic castration-resistant prostate cancer.Clin Cancer Res. 2022;28(14):3127-3140. doi:10.1158/1078-0432.CCR-21-4289Labrecque MP, Coleman IM, Brown LG, et al. Molecular profiling stratifies diverse phenotypes of treatment-refractory metastatic castration-resistant prostate cancer.J Clin Invest. 2019;129(10):4492-4505.Beltran H, Prandi D, Mosquera JM, et al. Divergent clonal evolution of castration-resistant neuroendocrine prostate cancer.Nat Med. 2016;22(3):298-305. doi:10.1038/nm.4045Kumar A, Coleman I, Morrissey C, et al. Substantial interindividual and limited intraindividual genomic diversity among tumors from men with metastatic prostate cancer.Nat Med. 2016;22(4):369-378. doi:10.1038/nm.4053Aryee MJ, Liu W, Engelmann JC, et al. DNA methylation alterations exhibit intraindividual stability and interindividual heterogeneity in prostate cancer metastases.Sci Transl Med. 2013;5(169):169ra10. doi:10.1126/scitranslmed.3005211Liu W, Laitinen S, Khan S, et al. Copy number analysis indicates monoclonal origin of lethal metastatic prostate.Nat Med. 2009;15(5):559-565. doi:10.1038/nm.1944Sathianathen NJ, Philippou YA, Kuntz GM, et al. Taxane-based chemohormonal therapy for metastatic hormone-sensitive prostate cancer.Cochrane Database Syst Rev. 2018;10(10):CD012816.

Local Coverage Determinations, LCD, Local policies, MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers, DL39648

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Proposed LCD - MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers (DL39648)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39647&ver=3

lcd-39647-3-1.txt

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39647

lcd

3

256d9632-3865-40db-a3bc-ad475bcf1f6f

Kumar A, Coleman I, Morrissey C, et al. Substantial interindividual and limited intraindividual genomic diversity among tumors from men with metastatic prostate cancer.Nat Med. 2016;22(4):369-378. doi:10.1038/nm.4053Aryee MJ, Liu W, Engelmann JC, et al. DNA methylation alterations exhibit intraindividual stability and interindividual heterogeneity in prostate cancer metastases.Sci Transl Med. 2013;5(169):169ra10. doi:10.1126/scitranslmed.3005211Liu W, Laitinen S, Khan S, et al. Copy number analysis indicates monoclonal origin of lethal metastatic prostate.Nat Med. 2009;15(5):559-565. doi:10.1038/nm.1944Sathianathen NJ, Philippou YA, Kuntz GM, et al. Taxane-based chemohormonal therapy for metastatic hormone-sensitive prostate cancer.Cochrane Database Syst Rev. 2018;10(10):CD012816.Nowakowska MK, Ortega RM, Wehner MR, Nead KT. Association of second-generation antiandrogens with cognitive and functional toxic effects in randomized clinical trials: a systematic review and meta-analysis [published online ahead of print, 2023 May 25].JAMA Oncol. 2023;e230998. doi:10.1001/jamaoncol.2023.0998Fizazi K, Foulon S, Carles J, et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 22 factorial design.Lancet. 2022;399(10336):1695-1707. doi:10.1016/S0140-6736(22)00367-1Smith MR, Hussain M, Saad F, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer.N Engl J Med. 2022;386(12):1132-1142. doi:10.1056/NEJMoa2119115Riaz IB, Naqvi SAA, He H, et al. First-line systemic treatment options for metastatic castration-sensitive prostate cancer: a living systematic review and network meta-analysis.JAMA Oncol. 2023;9(5):635-645. doi:10.1001/jamaoncol.2022.7762Hoeh B, Garcia CC, Wenzel M, et al. Triplet or doublet therapy in metastatic hormone-sensitive prostate cancer: updated network meta-analysis stratified by disease volume [published online ahead of print, 2023 Apr 11].Eur Urol Focus. 2023;S2405-4569(23)00094-9. doi:10.1016/j.euf.2023.03.024Ramaswamy A, Proudfoot JA, Ross AE, Davicioni E, Schaeffer EM, Hu JC. Prostate cancer tumor volume and genomic risk.Eur Urol Open Sci. 2023;48:90-97.Thysell E, Khn L, Semenas J, et al. Clinical and biological relevance of the transcriptomic-based prostate cancer metastasis subtypes MetA-C.Mol Oncol. 2022;16(4):846-859. doi:10.1002/1878-0261.13158Sutera P, Deek MP, Van der Eecken K, et al. Genomic biomarkers to guide precision radiotherapy in prostate cancer.Prostate. 2022;82 Suppl 1(Suppl 1):S73-S85. doi:10.1002/pros.24373

Local Coverage Determinations, LCD, Local policies, MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules, DL39650

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PROPOSED

Proposed LCD - MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (DL39650)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39649&ver=5

lcd-39649-5-1.txt

1

39649

lcd

5

16ec51c0-a560-49d3-9d85-6f4ccb49abf5

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary.42 CFR 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityThis contractor will cover molecular diagnostic tests for use in a beneficiary with an indeterminate or suspicious thyroid nodule when all the following criteria are met:The patient:Has not been tested with the same or similar assay for the same clinical indication AND:Has an indeterminate thyroid nodule as defined by Bethesda categories III-IV ORHas a Bethesda category V nodule for which molecular testing may aid in further stratifying the type of malignancy.The results of the test will be used to aid in surgical decision making after a consideration of clinical, radiographic and cytologic features.The beneficiary is within the population and has the indication for which the test was developed. The laboratory providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use.The test demonstrates analytical validity, including both analytical and clinical validation, on a cohort of patients appropriate for its intended use. If the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm.The test has demonstrated clinical validity and utility in peer-reviewed, published literature, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision in a clearly defined population.The test successfully completes a technical assessment that ensures the test is reasonable and necessary as described above.The performance characteristics of the test have been demonstrated to be as good or better than currently covered services.NOTE: Next Generation Sequencing (NGS) performed to identify genetic variants in samples classified as malignant is not within the scope of this policy but may fall under other established policies.General InformationAssociated InformationN/ASources of InformationN/ABibliography

Local Coverage Determinations, LCD, Local policies, MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules, DL39650

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PROPOSED

Proposed LCD - MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (DL39650)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39649&ver=5

lcd-39649-5-1.txt

1

39649

lcd

5

0b83020e-9e91-4d51-abb8-f2dd7a0b7992

National Cancer Institute Surveillance, Epidemiology, and End Results Program (SEER) Cancer Stat Facts: Thyroid Cancer. Accessed 6/26/2023.https://seer.cancer.gov/statfacts/html/thyro.htmlChen DW, Yeh MW. Disparities in thyroid care.Endocrinol Metab Clin North Am. 2022;51(2):229-241. doi:10.1016/j.ecl.2021.11.017Henley SJ, Ward EM, Scott S, et al. Annual report to the nation on the status of cancer, part I: national cancer statistics.Cancer.2020;126(10):2225-2249. doi:10.1002/cncr.32802Lorusso L, Cappagli V, Valerio L, et al. Thyroid cancers: from surgery to current and future systemic therapies through their molecular identities.Int J Mol Sci. 2021;22(6):3117. doi:10.3390/ijms22063117Chernock RD, Hagemann IS. Molecular pathology of hereditary and sporadic medullary thyroid carcinomas.Am J Clin Pathol. 2015;143(6):768-777. doi:10.1309/AJCPHWACTTUYJ7DDMolinaro E, Romei C, Biagini A, et al. Anaplastic thyroid carcinoma: from clinicopathology to genetics and advanced therapies.Nat Rev Endocrinol. 2017;13(11):644-660. doi:10.1038/nrendo.2017.76Davies L, Welch HG. Current thyroid cancer trends in the United States.JAMA Otolaryngol Head Neck Surg. 2014;140(4):317-322. doi:10.1001/jamaoto.2014.1Hoang JK, Nguyen XV, Davies L. Overdiagnosis of thyroid cancer: answers to five key questions.Acad Radiol. 2015;22(8):1024-1029. doi:10.1016/j.acra.2015.01.019Kitahara CM, Sosa JA. Understanding the ever-changing incidence of thyroid cancer.Nat Rev Endocrinol. 2020;16(11):617-618. doi:10.1038/s41574-020-00414-9Lim H, Devesa SS, Sosa JA, Check D, Kitahara CM. Trends in thyroid cancer incidence and mortality in the United States, 1974-2013.JAMA. 2017;317(13):1338-1348. doi:10.1001/jama.2017.2719Vaccarella S, Franceschi S, Bray F, Wild CP, Plummer M, Dal Maso L. Worldwide thyroid cancer epidemic? The increasing impact of overdiagnosis.N Engl J Med. 2016;375(7):614-617. doi:10.1056/NEJMp1604412Lee M, Powers AE, Morris LGT, Marti JL. Reversal in thyroid cancer incidence trends in the United States, 2000-2017.Thyroid. 2020;30(8):1226-1227. doi:10.1089/thy.2020.0321Megwalu UC, Moon PK. Thyroid cancer incidence and mortality trends in the United States: 2000-2018.Thyroid. 2022;32(5):560-570. doi:10.1089/thy.2021.0662Nikiforov YE, Seethala RR, Tallini G, et al. Nomenclature revision for encapsulated follicular variant of papillary thyroid carcinoma: a paradigm shift to reduce overtreatment of indolent tumors.JAMA Oncol. 2016;2(8):1023-1029. doi:10.1001/jamaoncol.2016.0386Haugen BR, Sawka AM, Alexander EK, et al. American Thyroid Association guidelines on the management of thyroid nodules and differentiated Thyroid Cancer Task Force review and recommendation on the proposed renaming of encapsulated follicular variant papillary thyroid carcinoma without invasion to noninvasive follicular thyroid neoplasm with papillary-like nuclear features.Thyroid. 2017;27(4):481-483. doi:10.1089/thy.2016.0628Haugen BR, Alexander EK, Bible KC, et al. 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer: The American Thyroid Association Guidelines Task Force on thyroid nodules and differentiated thyroid ancer.Thyroid. 2016;26(1):1-133. doi:10.1089/thy.2015.0020Tessler FN, Middleton WD, Grant EG, et al. ACR Thyroid Imaging, Reporting and Data System (TI-RADS): white paper of the ACR TI-RADS committee.J Am Coll Radiol. 2017;14(5):587-595. doi:10.1016/j.jacr.2017.01.046Kitahara CM, Pfeiffer RM, Sosa JA, Shiels MS. Impact of overweight and obesity on US papillary thyroid cancer incidence trends (1995-2015).J Natl Cancer Inst. 2020;112(8):810-817. doi:10.1093/jnci/djz202Ginzberg SP, Soegaard Ballester JM, Wirtalla CJ, et al. Insurance-based disparities in guideline-concordant thyroid cancer care in the era of de-escalation.J Surg Res. 2023;289:211-219. doi:10.1016/j.jss.2023.03.046Radhakrishnan A, Reyes-Gastelum D, Abrahamse P, et al. Physician specialties involved in thyroid cancer diagnosis and treatment: implications for improving health care disparities.J Clin Endocrinol Metab. 2022;107(3):e1096-e1105. doi:10.1210/clinem/dgab781Ginzberg SP, Soegaard Ballester JM, Wirtalla CJ, et al. Racial and ethnic disparities in appropriate thyroid cancer treatment, before and after the release of the 2015 American Thyroid Association Guidelines.Ann Surg Oncol. 2023;30(5):2928-2937. doi:10.1245/s10434-023-13158-3White C, Weinstein MC, Fingeret AL, et al. Is less more? A microsimulation model comparing cost-effectiveness of the revised American Thyroid Association's 2015 to 2009 Guidelines for the management of patients with thyroid nodules and differentiated thyroid Cancer.Ann Surg. 2020;271(4):765-773. doi:10.1097/SLA.0000000000003074Cibas ES, Ali SZ. The 2017 Bethesda system for reporting thyroid cytopathology.Thyroid. 2017;27(11):1341-1346. doi:10.1089/thy.2017.0500Padmanabhan V, Marshall CB, Akdas Barkan G, et al. Reproducibility of atypia of undetermined significance/follicular lesion of undetermined significance category using the Bethesda system for reporting thyroid cytology when reviewing slides from different institutions: a study of interobserver variability among cytopathologists.Diagn Cytopathol. 2017;45(5):399-405. doi:10.1002/dc.23681Kuzan TY, Guzelbey B, Turan Guzel N, Kuzan BN, Cakir MS, Canbey C. Analysis of intra-observer and inter-observer variability of pathologists for non-benign thyroid fine needle aspiration cytology according to Bethesda System categories.Diagn Cytopathol. 2021;49(7):850-855. doi:10.1002/dc.24756Papaleontiou M, Hughes DT, Guo C, Banerjee M, Haymart MR. Population-based assessment of complications following surgery for thyroid cancer.J Clin Endocrinol Metab. 2017;102(7):2543-2551. doi:10.1210/jc.2017-00255National Comprehensive Cancer Network. Thyroid Carcinoma (Version 2.2023). Accessed 6/26/2023.https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdfAlexander EK, Kennedy GC, Baloch ZW, et al. Preoperative diagnosis of benign thyroid nodules with indeterminate cytology.N Engl J Med. 23 2012;367(8):705-715. doi:10.1056/NEJMoa1203208Borowczyk M, Szczepanek-Parulska E, Olejarz M, et al. Evaluation of 167 gene expression classifier (GEC) and ThyroSeq v2 diagnostic accuracy in the preoperative assessment of indeterminate thyroid nodules: bivariate/HROC meta-analysis.Endocr Pathol. 2019;30(1):8-15. doi:10.1007/s12022-018-9560-5Silaghi CA, Lozovanu V, Georgescu CE, et al. Thyroseq v3, Afirma GSC, and microRNA panels versus previous molecular tests in the preoperative diagnosis of indeterminate thyroid nodules: a systematic review and meta-analysis.Front Endocrinol(Lausanne).2021;12:649522. doi:10.3389/fendo.2021.649522Vargas-Salas S, Martinez JR, Urra S, et al. Genetic testing for indeterminate thyroid cytology: review and meta-analysis.Endocr Relat Cancer.2018;25(3):R163-R177. doi:10.1530/ERC-17-0405Al-Qurayshi Z, Deniwar A, Thethi T, et al. Association of malignancy prevalence with test properties and performance of the gene expression classifier in indeterminate thyroid nodules.JAMA Otolaryngol Head Neck Surg. 2017;143(4):403-408. doi:10.1001/jamaoto.2016.3526Marti JL, Avadhani V, Donatelli LA, et al. Wide inter-institutional variation in performance of a molecular classifier for indeterminate thyroid Nodules.Ann Surg Oncol. 2015;22(12):3996-4001. doi:10.1245/s10434-015-4486-3Valderrabano P, Hallanger-Johnson JE, Thapa R, Wang X, McIver B. Comparison of postmarketing findings vs the initial clinical validation findings of a thyroid nodule gene expression classifier: a systematic review and meta-analysis.JAMA Otolaryngol Head Neck Surg. 2019;145(9):783-792. doi:10.1001/jamaoto.2019.1449Nikiforov YE, Ohori NP, Hodak SP, et al. Impact of mutational testing on the diagnosis and management of patients with cytologically indeterminate thyroid nodules: a prospective analysis of 1056 FNA samples.J Clin Endocrinol Metab. 2011;96(11):3390-3397. doi:10.1210/jc.2011-1469Nikiforov YE, Carty SE, Chiosea SI, et al. Highly accurate diagnosis of cancer in thyroid nodules with follicular neoplasm/suspicious for a follicular neoplasm cytology by ThyroSeq v2 next-generation sequencing assay.Cancer. 2014;120(23):3627-3634. doi:10.1002/cncr.29038Nikiforov YE, Carty SE, Chiosea SI, et al. Impact of the multi-gene ThyroSeq next-generation sequencing assay on cancer diagnosis in thyroid nodules with atypia of undetermined significance/follicular lesion of undetermined significance cytology.Thyroid. 2015;25(11):1217-1223. doi:10.1089/thy.2015.0305Marcadis AR, Valderrabano P, Ho AS, et al. Interinstitutional variation in predictive value of the ThyroSeq v2 genomic classifier for cytologically indeterminate thyroid nodules.Surgery. 2019;165(1):17-24. doi:10.1016/j.surg.2018.04.062Taye A, Gurciullo D, Miles BA, et al. Clinical performance of a next-generation sequencing assay (ThyroSeq v2) in the evaluation of indeterminate thyroid nodules.Surgery. 2018;163(1):97-103. doi:10.1016/j.surg.2017.07.032Valderrabano P, Khazai L, Leon ME, et al. Evaluation of ThyroSeq v2 performance in thyroid nodules with indeterminate cytology.Endocr Relat Cancer. 2017;24(3):127-136. doi:10.1530/ERC-16-0512

Local Coverage Determinations, LCD, Local policies, MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules, DL39650

Use this page to view details for the Local Coverage Determination for MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules.

PROPOSED

Proposed LCD - MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (DL39650)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39649&ver=5

lcd-39649-5-1.txt

1

39649

lcd

5

b1e84fee-ad62-4fa7-a0b7-bc7dd35e0fdf

Marcadis AR, Valderrabano P, Ho AS, et al. Interinstitutional variation in predictive value of the ThyroSeq v2 genomic classifier for cytologically indeterminate thyroid nodules.Surgery. 2019;165(1):17-24. doi:10.1016/j.surg.2018.04.062Taye A, Gurciullo D, Miles BA, et al. Clinical performance of a next-generation sequencing assay (ThyroSeq v2) in the evaluation of indeterminate thyroid nodules.Surgery. 2018;163(1):97-103. doi:10.1016/j.surg.2017.07.032Valderrabano P, Khazai L, Leon ME, et al. Evaluation of ThyroSeq v2 performance in thyroid nodules with indeterminate cytology.Endocr Relat Cancer. 2017;24(3):127-136. doi:10.1530/ERC-16-0512Patel KN, Angell TE, Babiarz J, et al. Performance of a genomic sequencing classifier for the preoperative diagnosis of cytologically indeterminate thyroid nodules.JAMA Surg. 2018;153(9):817-824. doi:10.1001/jamasurg.2018.1153Nikiforova MN, Mercurio S, Wald AI, et al. Analytical performance of the ThyroSeq v3 genomic classifier for cancer diagnosis in thyroid nodules.Cancer. 15 2018;124(8):1682-1690. doi:10.1002/cncr.31245Lee E, Terhaar S, McDaniel L, et al. Diagnostic performance of the second-generation molecular tests in the assessment of indeterminate thyroid nodules: a systematic review and meta-analysis.Am J Otolaryngol. 2022;43(3):103394. doi:10.1016/j.amjoto.2022.103394Patel J, Klopper J, Cottrill EE. Molecular diagnostics in the evaluation of thyroid nodules: Current use and prospective opportunities.Front Endocrinol(Lausanne).2023;14:1101410. doi:10.3389/fendo.2023.1101410Livhits MJ, Zhu CY, Kuo EJ, et al. Effectiveness of molecular testing techniques for diagnosis of indeterminate thyroid nodules: a randomized clinical trial.JAMA Oncol. 2021;7(1):70-77. doi:10.1001/jamaoncol.2020.5935Kim NE, Raghunathan RS, Hughes EG, et al. Bethesda III and IV thyroid nodules managed nonoperatively after molecular testing with Afirma GSC or Thyroseq v3.J Clin Endocrinol Metab. 2023; dgad181. doi:10.1210/clinem/dgad181Kim M, Kim BH. Current guidelines for management of medullary thyroid carcinoma.Endocrinol Metab (Seoul). 2021;36(3):514-524. doi:10.3803/EnM.2021.1082Tao Y, Wang F, Shen X, et al. BRAF V600E status sharply differentiates lymph node metastasis-associated mortality risk in papillary thyroid cancer.J Clin Endocrinol Metab. 2021;106(11):3228-3238.Wells SA, Jr., Asa SL, Dralle H, et al. Revised American Thyroid Association guidelines for the management of medullary thyroid carcinoma.Thyroid. 2015;25(6):567-610.Yip L. Molecular markers for thyroid cancer diagnosis, prognosis, and targeted therapy.J Surg Oncol. 2015;111(1):43-50.Najafian A, Noureldine S, Azar F, et al. RAS Mutations, and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangements are also prevalent in benign thyroid lesions: implications thereof and a systematic review.Thyroid. 2017;27(1):39-48.Guan H, Toraldo G,.Thyroid. 2020;30(4):536-547.Patel KN, Yip L, Lubitz CC, et al. The American Association of Endocrine Surgeons Guidelines for the Definitive Surgical Management of Thyroid Disease in Adults.Ann Surg. 2020;271(3):e21-e93.

Local Coverage Determinations, LCD, Local policies, Trigger Point Injections (TPI), DL39656

Use this page to view details for the Local Coverage Determination for Trigger Point Injections (TPI).

PROPOSED

Proposed LCD - Trigger Point Injections (TPI) (DL39656)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39655&ver=7

lcd-39655-7-1.txt

1

39655

lcd

7

ac4294ad-e94e-4007-974e-cb4bd6f52033

CMS National Coverage PolicyItalicizedfont represents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national language/wording.Title XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) Investigational or ExperimentalIOM Citations:CMS IOM Publication 100-08,Medicare Program Integrity Manual,~ Chapter 13, 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Code of Federal Regulations (CFR) References:CFR, Title 42, Ch. IV, 410.74 Physician assistants services, 410.75 Nurse practitioners services and 410.76 Clinical nurse specialists services.NCDsNCD 30.3.3 Acupuncture for Chronic Low Back PainCoverage Indications, Limitations, and/or Medical NecessityInitial Trigger Point InjectionTrigger point injections (TPI) will be considered medically reasonable and necessary to treat myofascial pain caused by trigger points when all the following requirements are met:There is a focal area of pain in the skeletal muscle.There is clinical evidence of a trigger point defined as pain in a skeletal muscle that is associated with at least 2 of the following findings: the presence of a hyperirritable spot and/or taut band identified by palpation and possible referred painANDThe physical examination identifies a focal hypersensitive bundle or nodule of muscle fiber harder than normal consistency with or without a local twitch response and referred painANDNon-invasive conservative therapy is not successful as first line treatmentORmovement of a joint or limb is limited or blockedORthe TPI is necessary for diagnostic confirmation.Subsequent TPIRepeat Trigger point injections in previously injected trigger points will be considered medically reasonable and necessary to treat myofascial pain syndrome when all the following requirements are met:There is a positive pain response from the most recent TPI defined as providing consistent minimum of 50% relief of primary (index) pain after the TPI measured by the SAME pain scale* at baseline and post-injectionANDConsistent pain relief from the most recent previous TPI lasting at least 6 weeks1ANDThe myofascial pain has reoccurred and is causing objective functional limitations measured by a functional scale obtained at baseline and after TPI which demonstrated at least 50% improvement from the previous TPI.*Note: The scales used to measure pain and/or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OSW), Quebec Back Pain Disability Scale (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.Limitations: No more than three (3) TPI sessions will be reimbursed per rolling 12 months.Requirements:Patients should be part of an ongoing conservative treatment program and documentation to support the patient is actively participating in a rehabilitation program, home exercise program or functional restoration program is in the medical record.There should be at least 6 weeks duration before TPI is repeated in the same location.Trigger point primary index pain must be measured prior to the injection at the beginning of the session.The post procedure pain level must be measured after the TPI at the conclusion of the session using the same scale* utilized at baseline.When documenting the percentage of pain relief from the primary (index) pain compared to the post-injection pain levels, it is insufficient to report only a percentage of pain relief and/or a nonspecific statement of the duration of pain relief. The documentation should include a specific assessment of the duration of relief being consistent or inconsistent with the agent used for the injection and the specific dates the measurements were obtained using the SAME pain scale* used at baseline.When documenting the ability to perform previously painful movements and activities of daily living (ADLs) it is insufficient to provide a vague or nonspecific statement regarding the improvement of previously painful movements and activities of daily living (ADLs). The documentation should include a functional assessment to show clinically meaningful improvement with painful movements and ADLs, if this metric is used to justify the efficacy of the TPI Providers should use established and measurable goals and objective scales to assess functionality and ADLs measures.Limitations:A TPI involves the use of a local anesthetic and does not include injections of biologics (e.g., platelet rich plasma, stem cells, amniotic fluid, etc.) and/or any other injectates.It is not considered medically reasonable and necessary to perform TPI into multiple muscle groups in different anatomical regions during the same session.It is not considered medically reasonable and necessary to perform multiple blocks (ESI, sympathetic blocks, facet blocks etc.) during the same session as TPI.Trigger points injections for treatment of headache, neck pain or low back pain in absence of actual trigger points, diffuse muscle pain, a chronic pain syndrome, lumbosacral canal stenosis, fibromyalgia, non-malignant multifocal musculoskeletal pain, complex regional pain syndrome, sexual dysfunction/ pelvic pain, whiplash, neuropathic pain, and hemiplegic shoulder painare considered investigational and therefore are not considered medically reasonable and necessary.Use of fluoroscopy or MRI guidance for performance of TPI is not considered reasonable and necessary.The use of ultrasound guidance for the performance of TPI is considered investigational.Trigger point injections used on a routine basis, e.g., on a regular periodic and continuous basis, for patients with chronic non-malignant pain syndromes are not considered medically necessary.Provider Qualifications:The Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers.Patient safety and quality of care mandate that healthcare professionals who perform TPI injections/procedures for chronic pain (not surgical anesthesia) are appropriately trained and/or credentialed by a formal residency/fellowship program and/or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this policy. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings.2All aspects of care must be within the provider's medical licensure and scope of practice. Reimbursement for procedures utilizing imaging techniques may be made to providers who meet training requirements for the procedures in this policy only if their respective state allows such in their practice act and formally licenses or certifies the practitioner to use and interpret these imaging modalities (ionizing radiation and associated contrast material, magnetic resonance imaging, ultrasound). At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure, and utilization of the required associated imaging modalities.General InformationAssociated InformationN/ASources of InformationN/ABibliography

Local Coverage Determinations, LCD, Local policies, Trigger Point Injections (TPI), DL39656

Use this page to view details for the Local Coverage Determination for Trigger Point Injections (TPI).

PROPOSED

Proposed LCD - Trigger Point Injections (TPI) (DL39656)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39655&ver=7

lcd-39655-7-1.txt

1

39655

lcd

7

41d63793-d807-404e-91d5-abe42ec1fed4

Manchikanti L, Singh V, Kloth D, et al. Interventional techniques in the management of chronic pain: Part 2. Pain Physician 2001;4(1):24Title XVIII of the Social Security Act: Sec. 1861.(s)(2) Part E-Miscellaneous Provisions: Definitions of Services I e. Secondary.https://www.ssa.gov/OP_Home/ssact/title18/1861.htm#ft495.Borg-Stein J, Stein J. Trigger points and tender points: one and the same? Does injection treatment help? Rheum Dis Clin North Am 1996;22(2):305-22 doi: 10.1016/s0889-857x(05)70274-x[published Online First: Epub Date]|.Fernndez-de-Las-Peas C, Dommerholt J. International consensus on diagnostic criteria and clinical considerations of myofascial trigger points: a Delphi study. Pain Medicine 2018;19(1):142-50Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. American family physician 2002;65(4):653Shankar H, Reddy S. Two-and three-dimensional ultrasound imaging to facilitate detection and targeting of taut bands in myofascial pain syndrome. Pain medicine 2012;13(7):971-75Ball A, Perreault T, Fernndez-de-Las-Peas C, Agnone M, Spennato J. Ultrasound Confirmation of the Multiple Loci Hypothesis of the Myofascial Trigger Point and the Diagnostic Importance of Specificity in the Elicitation of the Local Twitch Response. Diagnostics (Basel) 2022;12(2) doi: 10.3390/diagnostics12020321[published Online First: Epub Date]|.Lewis J, Tehan P. A blinded pilot study investigating the use of diagnostic ultrasound for detecting active myofascial trigger points. Pain 1999;79(1):39-44Rha D-w, Shin JC, Kim Y-K, Jung JH, Kim YU, Lee SC. Detecting local twitch responses of myofascial trigger points in the lower-back muscles using ultrasonography. Archives of physical medicine and rehabilitation 2011;92(10):1576-80. e1Sikdar S, Shah JP, Gebreab T, et al. Novel applications of ultrasound technology to visualize and characterize myofascial trigger points and surrounding soft tissue. Archives of physical medicine and rehabilitation 2009;90(11):1829-38Cojocaru MC, Cojocaru IM, Voiculescu VM, Cojan-Carlea NA, Dumitru VL, Berteanu M. Trigger pointsultrasound and thermal findings. J Med Life 2015;8(3):315-8Kang JJ, Kim J, Park S, Paek S, Kim TH, Kim DK. Feasibility of Ultrasound-Guided Trigger Point Injection in Patients with Myofascial Pain Syndrome. Healthcare (Basel) 2019;7(4) doi: 10.3390/healthcare7040118[published Online First: Epub Date]|.Botwin KP, Sharma K, Saliba R, Patel BC. Ultrasound-guided trigger point injections in the cervicothoracic musculature: a new and unreported technique. Pain Physician 2008;11(6):885-9Quintner JL, Bove GM, Cohen ML. A critical evaluation of the trigger point phenomenon. Rheumatology 2014;54(3):392-99 doi: 10.1093/rheumatology/keu471[published Online First: Epub Date]|.Shipton B, Sagar S, Mall JK. Trigger Point Management. Am Fam Physician 2023;107(2):159-64Ahmed S, Subramaniam S, Sidhu K, et al. Effect of Local Anesthetic Versus Botulinum Toxin-A Injections for Myofascial Pain Disorders: A Systematic Review and Meta-Analysis. Clin J Pain 2019;35(4):353-67 doi: 10.1097/AJP.0000000000000681[published Online First: Epub Date]|.Nouged E, Dajani J, Ku B, Al-Eryani K, Padilla M, Enciso R. Local Anesthetic Injections for the Short-Term Treatment of Head and Neck Myofascial Pain Syndrome: A Systematic Review with Meta-Analysis. Journal of Oral & Facial Pain & Headache 2019;33(2)Lugo LH, Garca H, Rogers H, Plata JA. Treatment of myofascial pain syndrome with lidocaine injection and physical therapy, alone or in combination: a single blind, randomized, controlled clinical trial. BMC musculoskeletal disorders 2016;17(1):1-11Xie P, Qin B, Yang F, et al. Lidocaine Injection in the Intramuscular Innervation Zone Can Effectively Treat Chronic Neck Pain Caused by MTrPs in the Trapezius Muscle. Pain Physician 2015;18(5):E815-26Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg 2021;79(1):88 e1-88 e9 doi: 10.1016/j.joms.2020.09.013[published Online First: Epub Date]|.Barad M, Ailani J, Hakim SM, Kissoon NR, Schuster NM. Percutaneous Interventional Strategies for Migraine Prevention: A Systematic Review and Practice Guideline. Pain Med 2022;23(1):164-88 doi: 10.1093/pm/pnab236[published Online First: Epub Date]|.Sabatke S, Scola RH, Paiva ES, Kowacs PA. Injection of trigger points in the temporal muscles of patients with miofascial syndrome. Arq Neuropsiquiatr 2015;73(10):861-6 doi: 10.1590/0004-282X20150135[published Online First: Epub Date]|.Karadas O, Inan LE, Ulas U, Odabasi Z. Efficacy of local lidocaine application on anxiety and depression and its curative effect on patients with chronic tension-type headache. Eur Neurol 2013;70(1-2):95-101 doi: 10.1159/000350619[published Online First: Epub Date]|.Baron EP, Cherian N, Tepper SJ. Role of greater occipital nerve blocks and trigger point injections for patients with dizziness and headache. Neurologist 2011;17(6):312-7 doi: 10.1097/NRL.0b013e318234e966[published Online First: Epub Date]|.Ashkenazi A, Blumenfeld A, Napchan U, et al. Peripheral nerve blocks and trigger point injections in headache management - a systematic review and suggestions for future research. Headache 2010;50(6):943-52 doi: 10.1111/j.1526-4610.2010.01675.x[published Online First: Epub Date]|.Venancio Rde A, Alencar FG, Jr., Zamperini C. Botulinum toxin, lidocaine, and dry-needling injections in patients with myofascial pain and headaches. Cranio 2009;27(1):46-53 doi: 10.1179/crn.2009.008[published Online First: Epub Date]|.Boelens OBA, Scheltinga MR, Houterman S, Roumen RM. Randomized clinical trial of trigger point infiltration with lidocaine to diagnose anterior cutaneous nerve entrapment syndrome. Br J Surg 2013;100(2):217-21 doi: 10.1002/bjs.8958[published Online First: Epub Date]|.Oor JE, Unlu C, Hazebroek EJ. A systematic review of the treatment for abdominal cutaneous nerve entrapment syndrome. Am J Surg 2016;212(1):165-74 doi: 10.1016/j.amjsurg.2015.12.013[published Online First: Epub Date]|.Boelens OB, Scheltinga MR, Houterman S, Roumen RM. Management of anterior cutaneous nerve entrapment syndrome in a cohort of 139 patients. Ann Surg 2011;254(6):1054-8 doi: 10.1097/SLA.0b013e31822d78b8[published Online First: Epub Date]|.Staal JB, de Bie RA, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low back pain: an updated Cochrane review. Spine (Phila Pa 1976) 2009;34(1):49-59 doi: 10.1097/BRS.0b013e3181909558[published Online First: Epub Date]|.Watters WC, 3rd, Resnick DK, Eck JC, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 13: injection therapies, low-back pain, and lumbar fusion. J Neurosurg Spine 2014;21(1):79-90 doi: 10.3171/2014.4.SPINE14281[published Online First: Epub Date]|.Di Cesare A, Giombini A, Di Cesare M, Ripani M, Vulpiani MC, Saraceni VM. Comparison between the effects of trigger point mesotherapy versus acupuncture points mesotherapy in the treatment of chronic low back pain: a short term randomized controlled trial. Complement Ther Med 2011;19(1):19-26 doi: 10.1016/j.ctim.2010.11.002[published Online First: Epub Date]|.Kocak AO, Ahiskalioglu A, Sengun E, Gur STA, Akbas I. Comparison of intravenous NSAIDs and trigger point injection for low back pain in ED: A prospective randomized study. Am J Emerg Med 2019;37(10):1927-31 doi: 10.1016/j.ajem.2019.01.015[published Online First: Epub Date]|.Saeidian SR, Pipelzadeh MR, Rasras S, Zeinali M. Effect of trigger point injection on lumbosacral radiculopathy source. Anesth Pain Med 2014;4(4):e15500 doi: 10.5812/aapm.15500[published Online First: Epub Date]|.Khoshnazar SS, Farpour HR, Shahriarirad R. A comparison between effectiveness of gluteal trigger point and epidural steroid injection in lumbosacral canal stenosis patients: a randomized clinical trial. Br J Neurosurg 2022:1-7 doi: 10.1080/02688697.2022.2033698[published Online First: Epub Date]|.Chou R, Atlas S. Subacute and chronic low back pain: Nonsurgical interventional treatment. Secondary Subacute and chronic low back pain: Nonsurgical interventional treatment 2016.www.uptodate.com.Peloso PM, Khan M, Gross AR, et al. Pharmacological Interventions Including Medical Injections for Neck Pain: An Overview as Part of the ICON Project. 2013;7(Suppl 4):473-93 doi: 10.2174/1874325001307010473[published Online First: Epub Date]|.Freeman MD, Nystrom A, Centeno C. Chronic whiplash and central sensitization; an evaluation of the role of a myofascial trigger points in pain modulation. J Brachial Plex Peripher Nerve Inj 200923(4):2 doi: 10.1186/1749-7221-4-2.[published Online First: Epub Date]|.Staud R, Weyl E, Bartley E, Price D, Robinson M. Analgesic and anti-hyperalgesic effects of muscle injections with lidocaine or saline in patients with fibromyalgia syndrome. European Journal of Pain 2014;18(6):803-12Hong CZ, Hsueh TC. Difference in pain relief after trigger point injections in myofascial pain patients with and without fibromyalgia. Arch Phys Med Rehabil 1996;77(11):1161-6 doi: 10.1016/s0003-9993(96)90141-0[published Online First: Epub Date]|.Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA 2004;292(19):2388-95 doi: 10.1001/jama.292.19.2388[published Online First: Epub Date]|.

Local Coverage Determinations, LCD, Local policies, Trigger Point Injections (TPI), DL39656

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PROPOSED

Proposed LCD - Trigger Point Injections (TPI) (DL39656)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39655&ver=7

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39655

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f569afbb-aa4e-4984-b29d-fda48db9e4f1

Freeman MD, Nystrom A, Centeno C. Chronic whiplash and central sensitization; an evaluation of the role of a myofascial trigger points in pain modulation. J Brachial Plex Peripher Nerve Inj 200923(4):2 doi: 10.1186/1749-7221-4-2.[published Online First: Epub Date]|.Staud R, Weyl E, Bartley E, Price D, Robinson M. Analgesic and anti-hyperalgesic effects of muscle injections with lidocaine or saline in patients with fibromyalgia syndrome. European Journal of Pain 2014;18(6):803-12Hong CZ, Hsueh TC. Difference in pain relief after trigger point injections in myofascial pain patients with and without fibromyalgia. Arch Phys Med Rehabil 1996;77(11):1161-6 doi: 10.1016/s0003-9993(96)90141-0[published Online First: Epub Date]|.Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA 2004;292(19):2388-95 doi: 10.1001/jama.292.19.2388[published Online First: Epub Date]|.Scott NA, Guo B, Barton PM, Gerwin RD. Trigger point injections for chronic non-malignant musculoskeletal pain: a systematic review. Pain Medicine 2009;10(1):54-69Zoorob D, South M, Karram M, et al. A pilot randomized trial of levator injections versus physical therapy for treatment of pelvic floor myalgia and sexual pain. Int Urogynecol J 2015;26(6):845-52 doi: 10.1007/s00192-014-2606-4[published Online First: Epub Date]|.Patil S, Daniel G, Vyas R, et al. Neuromuscular treatment approach for women with chronic pelvic pain syndrome improving pelvic pain and functionality. Neurourol Urodyn 2022;41(1):220-28 doi: 10.1002/nau.24799[published Online First: Epub Date]|.Ratmansky M, Defrin R, Soroker N. A randomized controlled study of segmental neuromyotherapy for post-stroke hemiplegic shoulder pain. J Journal of rehabilitation medicine 2012;44(10):830-36Terlemez R, Ercalik T. Effect of piriformis injection on neuropathic pain. Agri 2019;31(4):178-82 doi: 10.14744/agri.2019.34735[published Online First: Epub Date]|.American Society of Anesthesiologists Task Force on Chronic Pain Management: Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology 2010;112(4):810-33Practice Guidelines for Chronic Pain Management: An Updated Report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine*. Anesthesiology 2010;112(4):810-33 doi: 10.1097/ALN.0b013e3181c43103[published Online First: Epub Date]|.Hegmann K TR, Anderson G etal. . ACOEM GUIDELINES: Invasive Treatments for Low Back Disorders. JOEM 2021;63(4):e215-e41NASS. Diagnosis and Treatment of Low Back Pain. Secondary Diagnosis and Treatment of Low Back Pain 2020.https://www.spine.org/.

Local Coverage Determinations, LCD, Local policies, Peripheral Venous Ultrasound, DL35451

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PROPOSED

Proposed LCD - Peripheral Venous Ultrasound (DL35451)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39659&ver=13

lcd-39659-13-1.txt

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2e3fdea4-be96-4f75-a3c3-bfc9a289b8e0

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for peripheral venous ultrasound. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for peripheral venous ultrasound and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic TestsCMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD)Manual, Chapter 1,Part 1, Section 20.14 PlethysmographyPart 4, Section 220.5 Ultrasound Diagnostic ProceduresCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 13, Radiology Services and Other Diagnostic Procedures, Section 10 ICD Coding for Diagnostic Tests and Section 20 Payment Conditions for Radiology ServicesCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in LCDsSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Coverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationNon-invasive vascular diagnostic studies utilize ultrasonic Doppler and physiologic principles to assess irregularities in blood flow in the venous system. Vascular studies include patient care required to perform the studies, supervision of the studies and interpretation of study results with copies for patient records of hard copy output with analysis of all data, including bidirectional vascular flow or imaging when provided. (AMA 2023 CPT book, page 788)For the purpose of this LCD, we utilize the general term Venous Ultrasound which includes the following terminology: ultrasound doppler venous studies, compression ultrasound, whole leg ultrasound, limited ultrasound, two point ultrasound or two region ultrasound, and three point ultrasound or three region ultrasound.DefinitionsUltrasound doppler venous studies Combines B-mode imaging of the deep and superficial veins with pulsed Doppler assessment of flow direction with provocative maneuvers.1Compression ultrasound Venous compression is applied every two centimeters or less in the transverse (short-axis) plane with adequate pressure on the skin to completely obliterate the normal vein lumen. The fullest visible extent of the common femoral, femoral, popliteal, and posterior tibial and peroneal veins must be scanned by an optimal grayscale compression technique. The deep femoral vein should also be examined at the confluence with the femoral vein. The great saphenous vein is examined at the saphenofemoral junction.2Compression ultrasound (US) evaluates the compressibility, or lack thereof, of a venous segment to diagnose thrombosis and is commonly coupled with a color Doppler to assess blood flow. Compression US may be limited to the proximal leg veins (usually popliteal-trifurcation and more proximally).3Whole leg ultrasound Extended imaging including the calf veins.4Defined as an examination of both the proximal and distal deep venous system of the leg, including the femoral veins, the popliteal vein, the posterior and anterior tibial vein, and the peroneal vein. It may include the muscular veins (gastrocnemius or soleus).5Compression US evaluates the compressibility, or lack thereof, of a venous segment to diagnose thrombosis and is commonly coupled with a color Doppler to assess blood flow. Compression US may be performed on the entire leg (whole-leg US).3Whole-leg venous ultrasound or complete venous ultrasound is extended imaging of inferior vena cava, iliac and femoral veins, and calf veins.6Limited ultrasound Defined as either a two-point or (extended) proximal approach. The two-point technique includes an examination of two venous segments, i.e. the common femoral vein at the level of the inguinal ligament and the popliteal in the popliteal fossa. The (extended) proximal strategy examines additional segments off the proximal venous system, and may include the common and superficial femoral veins, the popliteal vein, and sometimes includes the confluence of the deep calf veins (i.e. calf trifurcation). Limited compression ultrasonography (CUS) comprises either a single or a serial examination in which a second assessment is performed after 5 to 10 days.5Two point ultrasound or two region ultrasound is a limited protocol that has compression of the femoral and popliteal regions. It is sometimes described as 2-point ultrasound, but this term is misleading because the proper protocol is two areas rather than two compressions.7For two point compression ultrasound scanning the deep vein patency is only assessed in two venous territories (usually the common femoral vein and the popliteal vein).8Two-point/two region compression venous ultrasonography or limited compression venous ultrasonography examines the popliteal and common femoral veins only.6Three point ultrasound or three region ultrasound tests the compressibility of the common femoral vein (CFV), superficial femoral vein (SFV) and the popliteal vein (PV), as well as detects isolated SFV thrombosis of lower extremity deep vein thrombosis.9For three point compression ultrasound scanning the deep vein patency is only assessed in three venous territories (usually the common femoral vein, the popliteal vein, and the femoral vein).8Covered IndicationsDeep Vein Thrombosis (DVT)Due to the risk of DVT associated with pulmonary embolism (PE), objective testing of venous function is considered medically reasonable and necessary in any of the following situations:To evaluate clinical signs or symptoms suggestive of acute or new onset DVT such as extremity swelling, tenderness, or erythema. Both clinical evaluation and objective tests are required to make a diagnosis for venous thromboembolism (VTE). Wells score is a validated clinical decision rule to estimate the pretest probability for acute DVT in ambulatory settings.3,4,6,7,8,10,11,12,13ORInvestigation for DVT as the source of a suspected or confirmed PE.2,10,14ORTo follow-up patients with known venous thrombosis on therapy and who undergo a clinical change and where a change in the thrombus burden will alter treatment.2,14Chronic Venous InsufficiencyChronic venous insufficiency is impaired venous return which may cause lower extremity symptoms. Objective testing of venous function is considered medically reasonable and necessary in any one of the following situations:Evaluation of Postthrombotic (Postphlebitic) Syndrome (PTS) in patients with symptoms of PTS (e.g., chronic leg pain, leg heaviness, leg swelling, leg itching or ulcers on the leg).8,15OREvaluation of suspected valvular incompetence in patients with symptomatic chronic venous insufficiency or symptomatic varicose veins (e.g., significant pain or edema of the lower leg, ulceration, itching, aching, thickening and discoloration) suspected to be secondary to venous insufficiency in order to confirm this diagnosis prior to treatment.1,16,17,18ORPost-procedural assessment of venous ablation.2,14,19,20Note:Additional coverage information pertinent to the treatment of varicose veins and ablation therapy is located in JH/JL LCD L34924, Treatment of Chronic Venous Insufficiency of the Lower Extremities and JN LCD L38720 Treatment of Chronic Venous Insufficiency of the Lower Extremities.Preoperative ExaminationsVenous ultrasound studies are considered medically reasonable and necessary for select preoperative examinations that meet criteria for coverage as follows:Bypass surgeryVenous ultrasound of extremity veins including responses to compression and other maneuvers; unilateral or limited study is indicated for the preoperative examination of potential harvest vein grafts to be utilized during bypass surgery. This service is considered medically reasonable and necessary when the results of the study are needed to locate suitable graft vessels.14,21,22LimitationsThe following are considered not medically reasonable and necessary:Objective testing of peripheral venous function for any one of the following11,14:Asymptomatic varicose veinsRoutine screening testsVenous ultrasound performed when the results will have no impact on the decision for further diagnostic or therapeutic procedures or will not provide any unique diagnostic information that would impact patient management. For example, if it is evident from the findings of the history and physical examination that the patient is going to proceed to angiography, then venous ultrasounds are not reasonable and necessary.11,14Imaging while on adequate anticoagulation is unwarranted unless it will change the patients treatment.2,7,23Performance of multiple duplex scans and multiple duplex plus noninvasive physiologic studies of the upper and lower extremities on the same day. There may be rare occurrences where this may be appropriate. In such circumstances, individual consideration will be made on redetermination.In the outpatient setting in non-active cancer patients, if the clinical decision score (Wells score) is less than two, a positive D-dimer must be obtained prior to ordering an ultrasound.4,6,7,13Please refer to NCD 20.14, for a list of plethysmography methods that are not covered.Provider QualificationsServices will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.Please see CMS IOM Publication 100-02,Medicare Benefit Policy Manual, Chapter 15, Section 80, for supervision definitions and requirements for diagnostic tests.Note:For services performed in an Independent Diagnostic Testing Facility (IDTF), please refer to LCD L35448, Independent Diagnostic Testing Facility (IDTF), and related Local Coverage Article A53252, Independent Diagnostic Testing Facility (IDTF), for additional information.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationRefer to the Local Coverage Article: Billing and Coding: Peripheral Venous Ultrasound, DA52993, for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationContractor Medical DirectorsBibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.

Local Coverage Determinations, LCD, Local policies, Peripheral Venous Ultrasound, DL35451

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Proposed LCD - Peripheral Venous Ultrasound (DL35451)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39659&ver=13

lcd-39659-13-1.txt

1

39659

lcd

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12ed3938-3dde-4ab9-a024-394c22a20357

Eberhardt RT, Raffetto JD. Chronic Venous Insufficiency.Circulation. 2014;130(4):333-346.American Institute of Ultrasound in Medicine. AIUM Practice Parameter for the Performance of a Peripheral Venous Ultrasound Examination.J Ultrasound Med. 2020;39:E49-E56.Bhatt M, Braun C, Patel P, et al. Diagnosis of deep vein thrombosis of the lower extremity: a systematic review and meta-analysis of test accuracy.Blood Advances. 2020;4(7):1250-1264.Chopard R, Albertsen I, Piazza G. Diagnosis and Treatment of Lower Extremity Venous Thrombembolism.JAMA. 2020;234;1765-1776.Kraaijpoel N, Carrier M, Le Gal G, et al. Diagnostic accuracy of three ultrasonography strategies for deep vein thrombosis of the lower extremity: A systemic review and meta-analysis.PLoS ONE. 2020;15(2):1-16.Mazzolai L, Aboyans V, Ageno W et al. Diagnosis and management of acute deep vein thrombosis: a joint consensus document from the European Society of Cardiology working groups of aorta and peripheral vascular diseases and pulmonary circulation and right ventricular function.European Heart Journal. 2018;39:4208-4218.Needleman L., Cronan J., Lilly M., et al. Ultrasound for Lower Extremity Deep Venous Thrombosis: Multidisciplinary Recommendations From the Society of Radiologist in Ultrasound Consensus Conference.Circulation. 2018;137:1505-1515.Kakkos S, Gohel M, Baekgaard N et al. European Society for Vascular Surgery (ESVS) 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis.Eur J Vasc Endovas Surg. 2021;61:9-82.Lee J, Lee S, Yun S. Comparison of 2-point and 3-point point-of-care ultrasound techniques for deep vein thrombosis at the emergency department A meta-analysis.Medicine. 2019;98(22):1-11.Society for Ultrasound. Lower Extremity Venous Duplex Evaluation for Thrombosis.Vascular Professional Performance Guideline. 2019:1-8.American Institute of Ultrasound in Medicine. AIUM Practice Parameter for the Performance of Point-of-Care Ultrasound Examinations.J Ultrasound Med. 2019;38:833-849.Karande GY, Hedgire SS, Sanchez Y, et al. Advanced imaging in acute and chronic deep vein thrombosis.Cardiovasc Diagnosis and Therapy. 2016; Dec 6(6):493-507.Silveira P, Ip I, Goldhaber S, et al. Performance of Wells Score for Deep Vein Thrombosis in the Inpatient Setting.JAMA Inter Med. 2015;175(7):1112-7.ACR-AIUM-SPR-SRU Practice Parameter for the Performance of Peripheral Venous Ultrasound Examination.American College of Radiology. Revised 2019 (Resolution 29):1-11.Society for Vascular Surgery. Lower Extremity Venous Disease and Treatment of Post-Thrombotic Syndrome. https://vascular.org/pmg/vascular-conditions/lower-extremity-venous-disease-and-treatment-post-thrombotic-syndrome. 2023. Accessed April 18, 2023.Society for Ultrasound. Lower Extremity Venous Duplex Evaluation for Insufficiency.Vascular Professional Performance Guideline. 2019:1-8.Raetz J, Wilson M, Collins K. Varicose Veins: Diagnosis and Treatment.American Family Physician. 2019;99:682-688.Spiridon M, Corduneanu D. Chronic Venous Insufficiency: a Frequently Underdiagnosed and Undertreated Pathology.Maedica. 2017; Jan 12(1):59-61.Healy d, Kimura S, Power D, et al. A Systematic Review and Meta-analysis of Thrombotic Events Following Endovenous Thermal Ablation of the Great Saphenous Vein.Eur J Vasc Endovasc Surg. 2018;56:410-424.Itoga N, Rothenberg K, Deslarzes-Dubuis C, et al. Incidence and Risk Factors for Deep Vein Thrombosis after Radiofrequency and Laser Ablation of the Lower Extremity Veins.Ann Vasc Surg. 2020;62:45-50.Linni K, Mader N, Aspalter M, et al. Ultrasonic vein mapping prior to infrainguinal autogenous bypass grafting reduces postoperative infections and admissions.Journal of Vascular Surgery. 2012;56(1):126-133.Media A, Rajendran R, Kimose H, et al. Effect of preoperative ultrasound mapping of the saphenous vein on leg wound complications after coronary artery bypass surgery: a systematic review.The Cardiothoracic Surgeon. 2022;30(21);1-9.Ortel T, Neumann I, Ageno W, et al. American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism.Blood Advances. 2020;4(19):4693-4738.Nasra K, Negussie E. Sonography Vascular Peripheral Vein Assessment, Protocols, And Interpretation. 2023 Feb 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing.2023.Andrade A, Tyroch A, McLean S, et al.Trauma patients warrant upper and lower extremity venous duplex ultrasound surveillance.J Emerg Trauma Shock. 2017;10(2):60-63.Guirguis-Blake JM, Evans CV, Redmon N, Lin JS. Screening for peripheral artery disease using the ankle-brachial index: updated evidence report and systematic review for the US Preventative Services Task Force.JAMA. 2018;320(2):184-196.Gerhard-Herman MD, Gornick HL, Barret C, Barshes NR, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.Circulation.2017;135(12):1-64.Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, and abdominal aortic): a collaborative report from the American Association of Vascular Surgery/Society for Vascular Surgery, Society of Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines.Circulation. 2006;113(11):e4634.Hwang JY. Doppler ultrasonography of the lower extremity arteries: anatomy and scanning guidelines.Ultrasonography. 2017 Apr;36(2):111-119.Duplex Ultrasound: Medlineplus medical encyclopedia. MedlinePlus. https://medlineplus.gov/ency/article/003433.htm. Updated March 21 2022. Accessed January 12, 2022.Ultrasound- Venous (Extremities). RadiologyInfo.org. https://www.radiologyinfo.org/en/info/venousus. Reviewed February 5, 2019. Accessed February 05, 2019.Kabnick LS, Scovell S. Overview of lower extremity chronic venous disease. UpToDate. https://www.uptodate.com/contents/overview-of-lower-extremity-chronic-venous- disease. Updated September 22, 2020.Mark A, Joseph L. Arterial Diseases of the Extremities. In Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 19e 302:Arterial Diseases of the Extremities. McGraw Hill; 2014.Yadav MK, Mohaammed AKM, Puramadathil V, Geetha D, Unni M. Lower extremities arteries.Cardiovasc. Diagn. Ther. 2019 Aug;9(Suppl 1):S174-S182.Mayo Clinic. Peripheral artery disease (PAD). https://www.mayoclinic.org/diseases- conditions/peripheral-artery-disease/diagnosis-treatment/drc-203505631. 2022.Patel SK, Surowiec SM. Venous Insufficiency. [Updated 2021 Aug 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from https://www.ncbi.nlm.nih.gov/books/NBK430975/.Varicose Veins- Treatment. NHS. https://www.nhs.uk/conditions/varicose- veins/treatment/. Reviewed May 07, 2020.Deep Vein Thrombosis (DVT). Mayo Clinic. https://www.mayoclinic.org/diseases- conditions/deep-vein-thrombosis/symptoms-causes/syc-20352557. Accessed December 22, 2020.Hirsh J, Hull RD, Raskob GE. Clinical features and diagnosis of venous thrombosis.J Am Coll Cardiol. 1986;8(6 Suppl B):114B-127B.Diagnosis and Treatment of Venous Thromboembolism. Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/dvt/diagnosis-treatment.html. February 07, 2020.Criqui MH, Langer RD, Fronek A, et al. Mortality over a period of 10 years in patients with peripheral arterial disease.N. Engl. J. Med. 1992;326(6):381.Shutze WP, Kane K, et al. The effect of wavelength of endothermal heat-induces thrombosis incidence after endovenous laser ablation.Journal of Vascular Surgery Venous and Lymphatic Disorders. 2016;4(1):36-44.Ryer E, Elmore J, Garvin R, et al. Value of delayed duplex ultrasound assessment after endothermal ablation of the great saphenous vein.Journal of Vascular Surgery, 2016;64(2):446-451.Leng GC, Fowkes FG, Lee AJ, Dunbar J, Housely R, Ruckley CV. Use of ankle pressure index to predict cardiovascular events and death: a cohort study.BMJ. 1996;313(7070):1440.Nicolaides AN; Cardiovascular Disease Educational and Research Trust; European Society of Vascular Surgery; ,The International Angiology Scientific Activity Congress Organization; International Union of Angiology; Union Internationale de Phlebologie at the Abbaye des Vaux de Cernay. Investigation of chronic venous insufficiency: A consensus statement (France, March 5-9, 1997).Circulation. 2000;102(20):E126-E163.McDermott MM, Kerwin DR, Liu K, et al. Prevalence and significance of unrecognized lower extremity peripheral arterial disease in general medicine practice.J Gen Intern Med. 2001;16(6):384390.AbuRahma AF, Adams E, AbuRahma, et al. Critical analysis and limitations of resting ankle-brachial index in the diagnosis of symptomatic peripheral arterial disease patients and the role of diabetes mellitus and chronic kidney disease.J. Vasc. Surg. 2020;71(3):937-945.Hur KY, Jun JE, Choi YJ, et al. Color Doppler Ultrasonography Is a Useful Tool for Diagnosis of Peripheral Artery Disease in Type 2 Diabetes Mellitus Patients with Ankle-Brachial Index 0.91 to 1.40.Diabetes Metab J. 2018;42(1):63-73.Heit J, Spencer F, White R. The Epidemiology of Venous Thromboembolism.J Thromb Thrombolysis. 2016;41(1):3-14.Bell E, Lutsey P, Basu S et al. Lifetime Risk of Venous Thromboembolism in Two Cohort Studies.The American Journal of Medicine, 2016;129(3):339.e19-339.e26.Farah M, Nayfeh T, Urtecho M, et al. A systematic review supporting the Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society guidelines on the management of varicose veins.J Vasc Surg Venous Lymphat Disord. 2022;10(5):1155-1171.

Local Coverage Determinations, LCD, Local policies, Peripheral Venous Ultrasound, DL35451

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PROPOSED

Proposed LCD - Peripheral Venous Ultrasound (DL35451)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39659&ver=13

lcd-39659-13-1.txt

1

39659

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13

b41d1ab0-b055-4db4-8e0d-af5fc87dc135

Hur KY, Jun JE, Choi YJ, et al. Color Doppler Ultrasonography Is a Useful Tool for Diagnosis of Peripheral Artery Disease in Type 2 Diabetes Mellitus Patients with Ankle-Brachial Index 0.91 to 1.40.Diabetes Metab J. 2018;42(1):63-73.Heit J, Spencer F, White R. The Epidemiology of Venous Thromboembolism.J Thromb Thrombolysis. 2016;41(1):3-14.Bell E, Lutsey P, Basu S et al. Lifetime Risk of Venous Thromboembolism in Two Cohort Studies.The American Journal of Medicine, 2016;129(3):339.e19-339.e26.Farah M, Nayfeh T, Urtecho M, et al. A systematic review supporting the Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society guidelines on the management of varicose veins.J Vasc Surg Venous Lymphat Disord. 2022;10(5):1155-1171.Gloviczki P, Lawrence P, Wasan S et al. The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology.J. Vasc Surg Venous Lymphat Disord. 2023;11(2):231-261.ACR-SPR-SRU Practice Parameter for the Performing and Interpreting Diagnostic Ultrasound Examinations.American College of Radiology. Revised 2017 (Resolution 32):1-6.

Local Coverage Determinations, LCD, Local policies, Peripheral Venous Ultrasound, DL35451

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PROPOSED

Proposed LCD - Peripheral Venous Ultrasound (DL35451)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39659&ver=13

lcd-39659-13-1.txt

1

39659

lcd

13

7b0b0ef6-0949-4208-82f4-79ed35c0625d

American Institute of Ultrasound in Medicine. AIUM Practice Parameter for Documentation of an Ultrasound Examination.2020.J Ultrasound Med;39:E1-E4.

Local Coverage Determinations, LCD, Local policies, Peripheral Venous Ultrasound, DL33693

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39660&ver=10

lcd-39660-10-1.txt

1

39660

lcd

10

d65eda28-1884-4aa2-9bca-d0d3dd3d03bb

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for peripheral venous ultrasound. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for peripheral venous ultrasound and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic TestsCMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD)Manual, Chapter 1,Part 1, Section 20.14 PlethysmographyPart 4, Section 220.5 Ultrasound Diagnostic ProceduresCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 13 Radiology Services and Other Diagnostic Procedures, Section 10 ICD Coding for Diagnostic Tests and Section 20 Payment Conditions for Radiology ServicesCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in LCDsSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Coverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationNon-invasive vascular diagnostic studies utilize ultrasonic Doppler and physiologic principles to assess irregularities in blood flow in the venous system. Vascular studies include patient care required to perform the studies, supervision of the studies and interpretation of study results with copies for patient records of hard copy output with analysis of all data, including bidirectional vascular flow or imaging when provided. (AMA 2023 CPT book, page 788)For the purpose of this LCD, we utilize the general term Venous Ultrasound which includes the following terminology: ultrasound doppler venous studies, compression ultrasound, whole leg ultrasound, limited ultrasound, two point ultrasound or two region ultrasound, and three point ultrasound or three region ultrasound.DefinitionsUltrasound doppler venous studies Combines B-mode imaging of the deep and superficial veins with pulsed Doppler assessment of flow direction with provocative maneuvers.1Compression ultrasound Venous compression is applied every two centimeters or less in the transverse (short-axis) plane with adequate pressure on the skin to completely obliterate the normal vein lumen. The fullest visible extent of the common femoral, femoral, popliteal, and posterior tibial and peroneal veins must be scanned by an optimal grayscale compression technique. The deep femoral vein should also be examined at the confluence with the femoral vein. The great saphenous vein is examined at the saphenofemoral junction.2Compression ultrasound (US) evaluates the compressibility, or lack thereof, of a venous segment to diagnose thrombosis and is commonly coupled with a color Doppler to assess blood flow. Compression US may be limited to the proximal leg veins (usually popliteal-trifurcation and more proximally).3Whole leg ultrasound Extended imaging including the calf veins.4Defined as an examination of both the proximal and distal deep venous system of the leg, including the femoral veins, the popliteal vein, the posterior and anterior tibial vein, and the peroneal vein. It may include the muscular veins (gastrocnemius or soleus).5Compression US evaluates the compressibility, or lack thereof, of a venous segment to diagnose thrombosis and is commonly coupled with a color Doppler to assess blood flow. Compression US may be performed on the entire leg (whole-leg US).3Whole-leg venous ultrasound or complete venous ultrasound is extended imaging of inferior vena cava, iliac and femoral veins, and calf veins.6Limited ultrasound Defined as either a two-point or (extended) proximal approach. The two-point technique includes an examination of two venous segments, i.e. the common femoral vein at the level of the inguinal ligament and the popliteal in the popliteal fossa. The (extended) proximal strategy examines additional segments off the proximal venous system, and may include the common and superficial femoral veins, the popliteal vein, and sometimes includes the confluence of the deep calf veins (i.e. calf trifurcation). Limited compression ultrasonography (CUS) comprises either a single or a serial examination in which a second assessment is performed after 5 to 10 days.5Two point ultrasound or two region ultrasound is a limited protocol that has compression of the femoral and popliteal regions. It is sometimes described as 2-point ultrasound, but this term is misleading because the proper protocol is two areas rather than two compressions.7For two point compression ultrasound scanning the deep vein patency is only assessed in two venous territories (usually the common femoral vein and the popliteal vein).8Two-point/two region compression venous ultrasonography or limited compression venous ultrasonography examines the popliteal and common femoral veins only.6Three point ultrasound or three region ultrasound tests the compressibility of the common femoral vein (CFV), superficial femoral vein (SFV) and the popliteal vein (PV), as well as detects isolated SFV thrombosis of lower extremity deep vein thrombosis.9For three point compression ultrasound scanning the deep vein patency is only assessed in three venous territories (usually the common femoral vein, the popliteal vein, and the femoral vein).8Covered IndicationsDeep Vein Thrombosis (DVT)Due to the risk of DVT associated with pulmonary embolism (PE), objective testing of venous function is considered medically reasonable and necessary in any of the following situations:To evaluate clinical signs or symptoms suggestive of acute or new onset DVT such as extremity swelling, tenderness, or erythema. Both clinical evaluation and objective tests are required to make a diagnosis for venous thromboembolism (VTE). Wells score is a validated clinical decision rule to estimate the pretest probability for acute DVT in ambulatory settings.3,4,6,7,8,10,11,12,13ORInvestigation for DVT as the source of a suspected or confirmed PE.2,10,14ORTo follow-up patients with known venous thrombosis on therapy and who undergo a clinical change and where a change in the thrombus burden will alter treatment.2,14Chronic Venous InsufficiencyChronic venous insufficiency is impaired venous return which may cause lower extremity symptoms. Objective testing of venous function is considered medically reasonable and necessary in any one of the following situations:Evaluation of Postthrombotic (Postphlebitic) Syndrome (PTS) in patients with symptoms of PTS (e.g., chronic leg pain, leg heaviness, leg swelling, leg itching or ulcers on the leg).8,15OREvaluation of suspected valvular incompetence in patients with symptomatic chronic venous insufficiency or symptomatic varicose veins (e.g., significant pain or edema of the lower leg, ulceration, itching, aching, thickening and discoloration) suspected to be secondary to venous insufficiency in order to confirm this diagnosis prior to treatment.1,16,17,18ORPost-procedural assessment of venous ablation.2,14,19,20Note:Additional coverage information pertinent to the treatment of varicose veins and ablation therapy is located in JH/JL LCD L34924, Treatment of Chronic Venous Insufficiency of the Lower Extremities and JN LCD L38720 Treatment of Chronic Venous Insufficiency of the Lower Extremities.Preoperative ExaminationsVenous ultrasound studies are considered medically reasonable and necessary for select preoperative examinations that meet criteria for coverage as follows:Bypass surgeryVenous ultrasound of extremity veins including responses to compression and other maneuvers; unilateral or limited study is indicated for the preoperative examination of potential harvest vein grafts to be utilized during bypass surgery. This service is considered medically reasonable and necessary when the results of the study are needed to locate suitable graft vessels.14,21,22LimitationsThe following are considered not medically reasonable and necessary:Objective testing of peripheral venous function for any one of the following11,14:Asymptomatic varicose veinsRoutine screening testsVenous ultrasound performed when the results will have no impact on the decision for further diagnostic or therapeutic procedures or will not provide any unique diagnostic information that would impact patient management. For example, if it is evident from the findings of the history and physical examination that the patient is going to proceed to angiography, then venous ultrasounds are not reasonable and necessary.11,14Imaging while on adequate anticoagulation is unwarranted unless it will change the patients treatment.2,7,23Performance of multiple duplex scans and multiple duplex plus noninvasive physiologic studies of the upper and lower extremities on the same day. There may be rare occurrences where this may be appropriate. In such circumstances, individual consideration will be made on redetermination.In the outpatient setting in non-active cancer patients, if the clinical decision score (Wells score) is less than two, a positive D-dimer must be obtained prior to ordering an ultrasound.4,6,7,13Please refer to NCD 20.14, for a list of plethysmography methods that are not covered.Provider QualificationsServices will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.Please see CMS IOM Publication 100-02,Medicare Benefit Policy Manual, Chapter 15, Section 80, for supervision definitions and requirements for diagnostic tests.Note:For services performed in an Independent Diagnostic Testing Facility (IDTF), please refer to LCD L33910, Independent Diagnostic Testing Facility (IDTF), and related Local Coverage Article A57807, Independent Diagnostic Testing Facility (IDTF), for additional information.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationRefer to the Local Coverage Article: Billing and Coding: Peripheral Venous Ultrasound, DA57125, for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationContractor Medical DirectorsBibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.

Local Coverage Determinations, LCD, Local policies, Peripheral Venous Ultrasound, DL33693

Use this page to view details for the Local Coverage Determination for Peripheral Venous Ultrasound.

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Proposed LCD - Peripheral Venous Ultrasound (DL33693)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39660&ver=10

lcd-39660-10-1.txt

1

39660

lcd

10

450634fe-9d62-4830-a53a-66ba71eeea2e

Eberhardt RT, Raffetto JD. Chronic Venous Insufficiency.Circulation. 2014;130(4):333-346.American Institute of Ultrasound in Medicine. AIUM Practice Parameter for the Performance of a Peripheral Venous Ultrasound Examination.J Ultrasound Med. 2020;39:E49-E56.Bhatt M, Braun C, Patel P, et al. Diagnosis of deep vein thrombosis of the lower extremity: a systematic review and meta-analysis of test accuracy.Blood Advances. 2020;4(7):1250-1264.Chopard R, Albertsen I, Piazza G. Diagnosis and Treatment of Lower Extremity Venous Thrombembolism.JAMA. 2020;234;1765-1776.Kraaijpoel N, Carrier M, Le Gal G, et al. Diagnostic accuracy of three ultrasonography strategies for deep vein thrombosis of the lower extremity: A systemic review and meta-analysis.PLoS ONE. 2020;15(2):1-16.Mazzolai L, Aboyans V, Ageno W et al. Diagnosis and management of acute deep vein thrombosis: a joint consensus document from the European Society of Cardiology working groups of aorta and peripheral vascular diseases and pulmonary circulation and right ventricular function.European Heart Journal. 2018;39:4208-4218.Needleman L., Cronan J., Lilly M., et al. Ultrasound for Lower Extremity Deep Venous Thrombosis: Multidisciplinary Recommendations From the Society of Radiologist in Ultrasound Consensus Conference.Circulation. 2018;137:1505-1515.Kakkos S, Gohel M, Baekgaard N et al. European Society for Vascular Surgery (ESVS) 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis.Eur J Vasc Endovas Surg. 2021;61:9-82.Lee J, Lee S, Yun S. Comparison of 2-point and 3-point point-of-care ultrasound techniques for deep vein thrombosis at the emergency department A meta-analysis.Medicine. 2019;98(22):1-11.Society for Ultrasound. Lower Extremity Venous Duplex Evaluation for Thrombosis.Vascular Professional Performance Guideline. 2019:1-8.American Institute of Ultrasound in Medicine. AIUM Practice Parameter for the Performance of Point-of-Care Ultrasound Examinations.J Ultrasound Med. 2019;38:833-849.Karande GY, Hedgire SS, Sanchez Y, et al. Advanced imaging in acute and chronic deep vein thrombosis.Cardiovasc Diagnosis and Therapy. 2016; Dec 6(6):493-507.Silveira P, Ip I, Goldhaber S, et al. Performance of Wells Score for Deep Vein Thrombosis in the Inpatient Setting.JAMA Inter Med. 2015;175(7):1112-7.ACR-AIUM-SPR-SRU Practice Parameter for the Performance of Peripheral Venous Ultrasound Examination.American College of Radiology. Revised 2019 (Resolution 29):1-11.Society for Vascular Surgery. Lower Extremity Venous Disease and Treatment of Post-Thrombotic Syndrome. https://vascular.org/pmg/vascular-conditions/lower-extremity-venous-disease-and-treatment-post-thrombotic-syndrome. 2023. Accessed April 18, 2023.Society for Ultrasound. Lower Extremity Venous Duplex Evaluation for Insufficiency.Vascular Professional Performance Guideline. 2019:1-8.Raetz J, Wilson M, Collins K. Varicose Veins: Diagnosis and Treatment.American Family Physician. 2019;99:682-688.Spiridon M, Corduneanu D. Chronic Venous Insufficiency: a Frequently Underdiagnosed and Undertreated Pathology.Maedica. 2017; Jan 12(1):59-61.Healy d, Kimura S, Power D, et al. A Systematic Review and Meta-analysis of Thrombotic Events Following Endovenous Thermal Ablation of the Great Saphenous Vein.Eur J Vasc Endovasc Surg. 2018;56:410-424.Itoga N, Rothenberg K, Deslarzes-Dubuis C, et al. Incidence and Risk Factors for Deep Vein Thrombosis after Radiofrequency and Laser Ablation of the Lower Extremity Veins.Ann Vasc Surg. 2020;62:45-50.Linni K, Mader N, Aspalter M, et al. Ultrasonic vein mapping prior to infrainguinal autogenous bypass grafting reduces postoperative infections and admissions.Journal of Vascular Surgery. 2012;56(1):126-133.Media A, Rajendran R, Kimose H, et al. Effect of preoperative ultrasound mapping of the saphenous vein on leg wound complications after coronary artery bypass surgery: a systematic review.The Cardiothoracic Surgeon. 2022;30(21);1-9.Ortel T, Neumann I, Ageno W, et al. American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism.Blood Advances. 2020;4(19):4693-4738.Nasra K, Negussie E. Sonography Vascular Peripheral Vein Assessment, Protocols, And Interpretation. 2023 Feb 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing.2023.Andrade A, Tyroch A, McLean S, et al.Trauma patients warrant upper and lower extremity venous duplex ultrasound surveillance.J Emerg Trauma Shock. 2017;10(2):60-63.Guirguis-Blake JM, Evans CV, Redmon N, Lin JS. Screening for peripheral artery disease using the ankle-brachial index: updated evidence report and systematic review for the US Preventative Services Task Force.JAMA. 2018;320(2):184-196.Gerhard-Herman MD, Gornick HL, Barret C, Barshes NR, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.Circulation.2017;135(12):1-64.Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, and abdominal aortic): a collaborative report from the American Association of Vascular Surgery/Society for Vascular Surgery, Society of Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines.Circulation. 2006;113(11):e4634.Hwang JY. Doppler ultrasonography of the lower extremity arteries: anatomy and scanning guidelines.Ultrasonography. 2017 Apr;36(2):111-119.Duplex Ultrasound: Medlineplus medical encyclopedia. MedlinePlus. https://medlineplus.gov/ency/article/003433.htm. Updated March 21 2022. Accessed January 12, 2022.Ultrasound- Venous (Extremities). RadiologyInfo.org. https://www.radiologyinfo.org/en/info/venousus. Reviewed February 5, 2019. Accessed February 05, 2019.Kabnick LS, Scovell S. Overview of lower extremity chronic venous disease. UpToDate. https://www.uptodate.com/contents/overview-of-lower-extremity-chronic-venous- disease. Updated September 22, 2020.Mark A, Joseph L. Arterial Diseases of the Extremities. In Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 19e 302:Arterial Diseases of the Extremities. McGraw Hill; 2014.Yadav MK, Mohaammed AKM, Puramadathil V, Geetha D, Unni M. Lower extremities arteries.Cardiovasc. Diagn. Ther. 2019 Aug;9(Suppl 1):S174-S182.Mayo Clinic. Peripheral artery disease (PAD). https://www.mayoclinic.org/diseases- conditions/peripheral-artery-disease/diagnosis-treatment/drc-203505631. 2022.Patel SK, Surowiec SM. Venous Insufficiency. [Updated 2021 Aug 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from https://www.ncbi.nlm.nih.gov/books/NBK430975/.Varicose Veins- Treatment. NHS. https://www.nhs.uk/conditions/varicose- veins/treatment/. Reviewed May 07, 2020.Deep Vein Thrombosis (DVT). Mayo Clinic. https://www.mayoclinic.org/diseases- conditions/deep-vein-thrombosis/symptoms-causes/syc-20352557. Accessed December 22, 2020.Hirsh J, Hull RD, Raskob GE. Clinical features and diagnosis of venous thrombosis.J Am Coll Cardiol. 1986;8(6 Suppl B):114B-127B.Diagnosis and Treatment of Venous Thromboembolism. Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/dvt/diagnosis-treatment.html. February 07, 2020.Criqui MH, Langer RD, Fronek A, et al. Mortality over a period of 10 years in patients with peripheral arterial disease.N. Engl. J. Med. 1992;326(6):381.Shutze WP, Kane K, et al. The effect of wavelength of endothermal heat-induces thrombosis incidence after endovenous laser ablation.Journal of Vascular Surgery Venous and Lymphatic Disorders. 2016;4(1):36-44.Ryer E, Elmore J, Garvin R, et al. Value of delayed duplex ultrasound assessment after endothermal ablation of the great saphenous vein.Journal of Vascular Surgery, 2016;64(2):446-451.Leng GC, Fowkes FG, Lee AJ, Dunbar J, Housely R, Ruckley CV. Use of ankle pressure index to predict cardiovascular events and death: a cohort study.BMJ. 1996;313(7070):1440.Nicolaides AN; Cardiovascular Disease Educational and Research Trust; European Society of Vascular Surgery; ,The International Angiology Scientific Activity Congress Organization; International Union of Angiology; Union Internationale de Phlebologie at the Abbaye des Vaux de Cernay. Investigation of chronic venous insufficiency: A consensus statement (France, March 5-9, 1997).Circulation. 2000;102(20):E126-E163.McDermott MM, Kerwin DR, Liu K, et al. Prevalence and significance of unrecognized lower extremity peripheral arterial disease in general medicine practice.J Gen Intern Med. 2001;16(6):384390.AbuRahma AF, Adams E, AbuRahma, et al. Critical analysis and limitations of resting ankle-brachial index in the diagnosis of symptomatic peripheral arterial disease patients and the role of diabetes mellitus and chronic kidney disease.J. Vasc. Surg. 2020;71(3):937-945.Hur KY, Jun JE, Choi YJ, et al. Color Doppler Ultrasonography Is a Useful Tool for Diagnosis of Peripheral Artery Disease in Type 2 Diabetes Mellitus Patients with Ankle-Brachial Index 0.91 to 1.40.Diabetes Metab J. 2018;42(1):63-73.Heit J, Spencer F, White R. The Epidemiology of Venous Thromboembolism.J Thromb Thrombolysis. 2016;41(1):3-14.Bell E, Lutsey P, Basu S et al. Lifetime Risk of Venous Thromboembolism in Two Cohort Studies.The American Journal of Medicine, 2016;129(3):339.e19-339.e26.Farah M, Nayfeh T, Urtecho M, et al. A systematic review supporting the Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society guidelines on the management of varicose veins.J Vasc Surg Venous Lymphat Disord. 2022;10(5):1155-1171.

Local Coverage Determinations, LCD, Local policies, Peripheral Venous Ultrasound, DL33693

Use this page to view details for the Local Coverage Determination for Peripheral Venous Ultrasound.

PROPOSED

Proposed LCD - Peripheral Venous Ultrasound (DL33693)

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https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39660&ver=10

lcd-39660-10-1.txt

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39660

lcd

10

f6a7faf0-e086-4b08-9d4b-55001d2abfb0

Hur KY, Jun JE, Choi YJ, et al. Color Doppler Ultrasonography Is a Useful Tool for Diagnosis of Peripheral Artery Disease in Type 2 Diabetes Mellitus Patients with Ankle-Brachial Index 0.91 to 1.40.Diabetes Metab J. 2018;42(1):63-73.Heit J, Spencer F, White R. The Epidemiology of Venous Thromboembolism.J Thromb Thrombolysis. 2016;41(1):3-14.Bell E, Lutsey P, Basu S et al. Lifetime Risk of Venous Thromboembolism in Two Cohort Studies.The American Journal of Medicine, 2016;129(3):339.e19-339.e26.Farah M, Nayfeh T, Urtecho M, et al. A systematic review supporting the Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society guidelines on the management of varicose veins.J Vasc Surg Venous Lymphat Disord. 2022;10(5):1155-1171.Gloviczki P, Lawrence P, Wasan S et al. The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology.J. Vasc Surg Venous Lymphat Disord. 2023;11(2):231-261.ACR-SPR-SRU Practice Parameter for the Performing and Interpreting Diagnostic Ultrasound Examinations.American College of Radiology. Revised 2017 (Resolution 32):1-6.

Local Coverage Determinations, LCD, Local policies, Peripheral Venous Ultrasound, DL33693

Use this page to view details for the Local Coverage Determination for Peripheral Venous Ultrasound.

PROPOSED

Proposed LCD - Peripheral Venous Ultrasound (DL33693)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39660&ver=10

lcd-39660-10-1.txt

1

39660

lcd

10

5ead1ebc-9c80-4e7b-9f81-6159bbbe6d80

American Institute of Ultrasound in Medicine. AIUM Practice Parameter for Documentation of an Ultrasound Examination.2020.J Ultrasound Med;39:E1-E4.

Local Coverage Determinations, LCD, Local policies, Fluid Jet System Treatment for LUTS/BPH, DL38367

Use this page to view details for the Local Coverage Determination for Fluid Jet System Treatment for LUTS/BPH.

PROPOSED

Proposed LCD - Fluid Jet System Treatment for LUTS/BPH (DL38367)

html

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39669&ver=4

lcd-39669-4-1.txt

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39669

lcd

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20a1e593-c4eb-40bc-b9df-e94743739278

CMS National Coverage PolicyLanguage quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1862(a)(1)(D) refers to limitations on items or devices that are investigational or experimental.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS Publications:CMS Publication 100-02,Medicare Benefit Policy Manual, Chapter 14,10 Coverage of Medical DevicesCMS Publication 100-04,Medicare Claims Processing Manual, Chapter 23,30 Services paid under the Medicare Physicians Fee ScheduleCMS Publication 100-08,Medicare Program Integrity Manual, Chapter 13,5.1 Reasonable and necessary provisions in LCDs7.1 Evidence supporting LCDs.Coverage Indications, Limitations, and/or Medical NecessityThis LCD addresses use of the fluid jet system treatment of lower urinary tract symptoms attributable to benign prostatic hyperplasia (LUTS/BPH).IndicationsTreatment for LUTS/BPH will be considered reasonable and necessary when performedONCEin patients with the following:Indications includingALLof the following:Prostate volume of 30-150 cc by transrectal ultrasound (TRUS)1,2Persistent moderate to severe symptoms despite maximal medical management includingALLof the following:International Prostate Symptom Score (IPSS) 121Maximum urinary flow rate (Qmax) of 15 mL/s (voided volume greater than 125 cc)1Failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)Only treatment using an FDA approved/cleared device will be considered reasonable and necessary.LimitationsThe following are considered not reasonable and necessary:Body mass index 42kg/m2Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines4) or a prostate specific antigen (PSA) >10ng/mL unless the patient has had a negative prostate biopsy within the last 6 months.Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum3Active urinary tract or systemic infection5Treatment for chronic prostatitis3Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture3Damaged external urinary sphincter3Known allergy to device materials5Inability to safely stop anticoagulants or antiplatelet agents preoperatively.5General InformationAssociated InformationN/ASources of InformationN/ABibliographyGilling P, Barber N, Bidair, M, et al. Threeyear outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial.Can J Urol.2020;27(1).Desai Mea. Aquablation for benign prostatic hyperplasia in large prostates (80-150cc):2-year results.Can J Urol.2020;27(2):10147-10153.Nguyen DD BN, Bidair M, Gilling P, Anderson P, Zorn KC, et al. Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates.BJU Int2020;125(1):112-122.Carroll PR, Parsons JK, Andriole G, et al. NCCN Guidelines Insights Prostate Cancer Early Detection, Version 2.J Natl Compr Canc Netw.2016;14(5):509-519.FDA. FDA Approval: De Nova Classification Request for AQUABEAM System.https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170024.pdf. Accessed accessed 7/2/19.Gilling P, Anderson P, Tan A. Aquablation of the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year Results.Journal of Urology.2017;197(6):1565-1572.Hwang EC, Jung JH, Borofsky M, Kim MH, Dahm P. Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.Cochrane Database of Systematic Reviews.2019;2:CD013143.Taktak S, Jones P, Haq A, Rai BP, Somani BK. Aquablation: a novel and minimally invasive surgery for benign prostate enlargement.Therapeutic Advances in Urology.2018;10(6):183-188.Nickel JC, Aaron L, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH): 2018 update.CAn Urol Assoc J.2018;12:303-312.Desai M, Bidair M, Bhojani N, et al. WATER II (80150 mL) procedural outcomes. 2019;123(1):106-112.Chung ASJ, Woo HH. Update on minimally invasive surgery and benign prostatic hyperplasia.Asian Journal of Urology.2018;5(1):22-27.Sturch P, Woo HH, McNicholas T, Muir G. Ejaculatory dysfunction after treatment for lower urinary tract symptoms: retrograde ejaculation or retrograde thinking? .BJU Int2015;115(2):186-197.Zorn KC, Goldenberg SL, Paterson R, So A, Elterman D, Bhojani N. Aquablation among novice users in Canada: A WATER II subpopulation analysis.Canadian Urological Association Journal.2019;13(5):E113-E118.Gilling P, Barber N, Bidair M, et al. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation vs. Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia.Journal of Urology.2018;199(5):1252-1261.Gilling PJ, Barber N, Bidair M, et al. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes.Urology.2019;125:169-173.Gilling P, Barber N, Bidair M, et al. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. 2019;36(6):1326-1336.Desai M, Bidair M, Zorn KC, et al. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial.BJU International.2019;08:08.Bhojani N, Bidair M, Zorn KC, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results.Urology.2019;129:1-7.Bach T, Giannakis I, Bachmann A, et al. Aquablation of the prostate: single-center results of a non-selected, consecutive patient cohort.World J Urol.2018.Bach T, Gilling P, El Hajj A, Anderson P, Barber N. First Multi-Center All-Comers Study for the Aquablation Procedure.J Clin Med2020;9(603).Giulio R, Sebastiano C, Giorgio B, et al. Aquabeam System for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique.International journal of impotence research.2019:1.Kasivisvanathan V, Hussain M. Aquablation versus transurethral resection of the prostate: 1 year United States - cohort outcomes.Canadian Journal of Urology.2018;25(3):9317-9322.Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc).Advances in Therapy.2018;35(6):832-838.Yafi FA, Tallman CT, Seard ML, Jordan ML. Aquablation outcomes for the U.S. cohort of men with LUTS due to BPH in large prostates (80-150 cc).International Journal of Impotence Research.2018;30(5):209-214.AUA. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019, 2020). 2020;https://www.auanet.org/guidelines/benign-prostatic-hyperplasia-(bph)-guideline. Accessed 8/26/2020.Gravis S, Cornu JN, Gratze, C, et al. EAU Guidelines: Management of Non-neurogenic Male LUTS; Chapter 5: Disease Management. 2019;https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts/#5. Accessed 9/14/2020.NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia.https://www.nice.org.uk/Guidance/IPG629. Accessed accessed 8/1/2019.Labban, M., et al., Aquablation for benign prostatic obstruction: Single center technique evolution and experience.Investigative and ClinicalUrology, 2021. 62(2): p. 210.Bach, T., et al., First multi-center all-comers study for the aquablation procedure.Journal of Clinical Medicine, 2020.9(2): p. 603.