evekhm/cms_iom_3000 huggingface dataset:
Article - Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors (A56072)

CMS National Coverage PolicyN/AArticle TextIn May, 2017, the FDA granted accelerated approval for the use of Keytruda for treatment of patients with unresectable or metastatic solid tumors having either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) biomarkers. Keytruda, a human PD-1 blocking antibody, is indicated for the treatment of metastatic melanoma, non-small cell lung cancer, recurrent or metastatic head and neck squamous cancer, advanced/metastatic urothelial cancer and classical Hodgkins lymphoma.This contractor will allow one of the following:dMMR by immunohistochemistry (IHC),orMSI by PCR,orMulti-gene NGS panel inclusive of MSI microsatellite loci, and MLH1, MSH2, MSH6 and PMS2 genesTesting by one of the above methodologies is reasonable and necessary if testing for dMMR or MSI has not previously been performed on the patients tumor sample. A multi-gene NGS panel inclusive of MSI microsatellite loci and MLH1, MSH2, MSH6 and PMS2 gene is reasonable and necessary. A multi-gene NGS panel and separate MSI by PCR will be denied as not reasonable and necessary. If testing is performed by NGS, the test must be a properly designed and appropriately validated assay demonstrating 95% concordance to the reference method (MSI by PCR).To report a dMMR service, please submit the following claim information:CPTcode 88342  One (1) unit of serviceCPTcode 88341  Three (3) units of serviceTo report a MSI service, please submit the following claim information:CPTcode 81301  One (1) unit of serviceTo report by NGS, please submit the following claim information:CPTcode 81479  One (1) unit of service
Article - Billing and Coding: In Vitro Chemosensitivity & Chemoresistance Assays (A56073)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.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.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1, Clinical Laboratory Services.CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, 50.5 Jurisdiction of Laboratory Claims, 60.1.2 Independent Laboratory Specimen Drawing, 60.2. Travel AllowanceCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, 10 Reporting ICD Diagnosis and Procedure CodesArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for In Vitro Chemosensitivity & Chemoresistance Assays L37630.To receive a CSRA denial, please submit the following claim information:CPTcodeAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifier
Article - Billing and Coding: Rezum® System for Benign Prostatic (A56083)

CMS National Coverage PolicyN/AArticle TextOn August 27, 2015, the FDA cleared for marketing the Rezum System to relieve lower urinary tract symptoms secondary to benign prostatic hyperplasia. This procedure involves the transurethral injection of steam into the prostate. Once injected, the steam condenses to water, imparting convective energy to the tissue, causing cell death and damage. The technology uses radiofrequency (RF) to boil the water to create the steam that is injected, but does not impart radiofrequency directly to the prostate tissue.Rezum received FDA 510(k) clearance on February 27, 2018. Available evidence has shown that the Rezum procedure for treatment of BPH is reasonable and necessary. The procedure is covered for FDA approved indications if the appropriate criteria are met.For Medicare Billing: Hospital Outpatient Setting or Ambulatory Surgical Center:Effective January 1, 2019, claims billed for procedures involving Rezum should be coded as CPT 53854.Documentation must be included in the remarks field (Field Locator 80) on the UB-04 (CMS 1450 form) or the equivalent 5010 electronic claimsPhysicians Office:Effective January 1, 2019claims billed for procedures involving Rezum should be coded as CPT 53854.Documentation must be included in Box 19 on the CMS 1500 form or the electronic equivalent to indicate that the Rezum procedure was performed.NOTE: Claims for procedures involving Rezum steam injection should NOT be coded as CPT 53852 because the technology does not apply radiofrequency energy to the prostate. Prostatic tissue destruction is accomplished via steam generated by RF, not by the RF itself.Sources of Information:1. McVary KT, Gange SN, Gittelman MC, et al. Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study.J Sex Med.2016;13(6):924-933.2. McVary KT, Gange SN, Gittelman MC, et al. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.J Urol. 2016;195(5):1529-1538.3. Dixon CM, Rijo Cedano E, Pacik D, et al. Efficacy and Safety of Rezum System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.Urology. 2015;86(5):1042-1047.4. Mynderse LA, Hanson D, Robb RA, et al. Rezum System Water Vapor Treatment for Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: Validation of Convective Thermal Energy Transfer and Characterization With Magnetic Resonance Imaging and 3-Dimensional Renderings.Urology. 2015;86(1):122-127.5. Dixon CM, Rijo Cedano E, Pacik D, et al.Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia.Research and Reports in Urology.2016;8:207216.
Article - Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors (A56103)

CMS National Coverage PolicyN/AArticle TextIn May, 2017, the FDA granted accelerated approval for the use of Keytruda for treatment of patients with unresectable or metastatic solid tumors having either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) biomarkers. Keytruda, a human PD-1 blocking antibody, is indicated for the treatment of metastatic melanoma, non-small cell lung cancer, recurrent or metastatic head and neck squamous cancer, advanced/metastatic urothelial cancer and classical Hodgkins lymphoma.This contractor will allow one of the following:dMMR by immunohistochemistry (IHC),orMSI by PCR,orMulti-gene NGS panel inclusive of MSI microsatellite loci, and MLH1, MSH2, MSH6 and PMS2 genesTesting by one of the above methodologies is reasonable and necessary if testing for dMMR or MSI has not previously been performed on the patients tumor sample. A multi-gene NGS panel inclusive of MSI microsatellite loci and MLH1, MSH2, MSH6 and PMS2 gene is reasonable and necessary. A multi-gene NGS panel and separate MSI by PCR will be denied as not reasonable and necessary. If testing is performed by NGS, the test must be a properly designed and appropriately validated assay demonstrating 95% concordance to the reference method (MSI by PCR).To report a dMMR service, please submit the following claim information:CPT code 88342  One (1) unit of serviceCPT code 88341  Three (3) units of serviceTo report a MSI service, please submit the following claim information:CPT code 81301  One (1) unit of serviceTo report by NGS, please submit the following claim information:CPT code 81479  One (1) unit of service
Article - Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors (A56104)

CMS National Coverage PolicyN/AArticle TextIn May, 2017, the FDA granted accelerated approval for the use of Keytruda for treatment of patients with unresectable or metastatic solid tumors having either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) biomarkers. Keytruda, a human PD-1 blocking antibody, is indicated for the treatment of metastatic melanoma, non-small cell lung cancer, recurrent or metastatic head and neck squamous cancer, advanced/metastatic urothelial cancer and classical Hodgkins lymphoma.This contractor will allow one of the following:dMMR by immunohistochemistry (IHC),orMSI by PCR,orMulti-gene NGS panel inclusive of MSI microsatellite loci, and MLH1, MSH2, MSH6 and PMS2 genesTesting by one of the above methodologies is reasonable and necessary if testing for dMMR or MSI has not previously been performed on the patients tumor sample. A multi-gene NGS panel inclusive of MSI microsatellite loci and MLH1, MSH2, MSH6 and PMS2 gene is reasonable and necessary. A multi-gene NGS panel and separate MSI by PCR will be denied as not reasonable and necessary. If testing is performed by NGS, the test must be a properly designed and appropriately validated assay demonstrating 95% concordance to the reference method (MSI by PCR).To report a dMMR service, please submit the following claim information:CPT code 88342  One (1) unit of serviceCPT code 88341  Three (3) units of serviceTo report a MSI service, please submit the following claim information:CPT code 81301  One (1) unit of serviceTo report by NGS, please submit the following claim information:CPT code 81479  One (1) unit of service
Article - Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors (A56106)

CMS National Coverage PolicyN/AArticle TextIn May, 2017, the FDA granted accelerated approval for the use of Keytruda for treatment of patients with unresectable or metastatic solid tumors having either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) biomarkers. Keytruda, a human PD-1 blocking antibody, is indicated for the treatment of metastatic melanoma, non-small cell lung cancer, recurrent or metastatic head and neck squamous cancer, advanced/metastatic urothelial cancer and classical Hodgkins lymphoma.This contractor will allow one of the following:dMMR by immunohistochemistry (IHC),orMSI by PCR,orMulti-gene NGS panel inclusive of MSI microsatellite loci, and MLH1, MSH2, MSH6 and PMS2 genesTesting by one of the above methodologies is reasonable and necessary if testing for dMMR or MSI has not previously been performed on the patients tumor sample. A multi-gene NGS panel inclusive of MSI microsatellite loci and MLH1, MSH2, MSH6 and PMS2 gene is reasonable and necessary. A multi-gene NGS panel and separate MSI by PCR will be denied as not reasonable and necessary. If testing is performed by NGS, the test must be a properly designed and appropriately validated assay demonstrating 95% concordance to the reference method (MSI by PCR).To report a dMMR service, please submit the following claim information:CPTcode 88342  One (1) unit of serviceCPTcode 88341  Three (3) units of serviceTo report a MSI service, please submit the following claim information:CPTcode 81301  One (1) unit of serviceTo report by NGS, please submit the following claim information:CPTcode 81479  One (1) unit of service
Article - Non-Payment for Prefabricated Splints (A56112)

CMS National Coverage PolicyN/AArticle TextNoridian has noted that providers have been advised by some coding sources to report a splint application code for the application of "off the shelf" or pre-packaged splints.  While it may be appropriate to bill for the actual splint, Noridian strongly disagrees with the advice to bill separately for the application of these splints.  The application of the pre-packaged splint is a packaged service when performed on the same day as an E/M service or other procedure but, in no case, may this type of splint application be separately billed.The CPT codes: 29105, 29125, 29126, 29130, 29131, 97760, 97799 are not appropriate to bill in addition to a splint code that has a "fitting" included in the descriptor. Be aware that a large range of "L" codes do include "fitting" in the descriptor
Article - Billing and Coding: Billing Limitations for Pharmacies (A56119)

CMS National Coverage PolicyN/AArticle TextMedicare Part B has limitations on pharmacy billing. There are two Specialty codes that may be used by pharmacies, each with limitations.Specialty 73 is for Mass Immunization Roster Billers and Specialty A5 (formerly Specialty 87) is for Pharmacy.Specialty 73 may only bill for influenza or pneumococcal immunizations and their administration codes.Specialty A5 may only bill for patient supplies of hemophilia factor products. Mass Immunizers must roster bill assigned claims and may only bill for immunizations.Neither specialty 73 nor A5 may bill for drugs that are administered incident to a physician service; these must be billed by the physician. Also, none of these may bill for hepatitis B vaccine since this requires a physician order. Suppliers of oral immunosuppressive drugs, oral anti-cancer drugs, oral anti-nausea drugs and diabetes testing supplies must be enrolled as DME suppliers and submit their bills to the DME MAC.Beginning October 22, 2018 only these codes will be allowed when billed by these specialties.Specialty 73 - Mass ImmunizersInfluenza Vaccine90653-90668, 90630, 90672-90674, 90682-90689, 90756not all are currently active/available; see annual Change Request (CR).Pneumococcal Vaccine90670, 90732Vaccine AdministrationG0008, G0009Specialty A5 - PharmacyHemophilia Clotting Factors (J7170, J7180-J7195, J7198-J7212, J7214)Certain other suppliers are also enrolled as Specialty A5 such as Cochlear Implant suppliers.
Article - Billing and Coding: Billing Limitations for Pharmacies (A56124)

CMS National Coverage PolicyN/AArticle TextMedicare Part B has limitations on pharmacy billing. There are two Specialty codes that may be used by pharmacies, each with limitations.Specialty 73 is for Mass Immunization Roster Billers and Specialty A5 (formerly Specialty 87) is for Pharmacy.Specialty 73 may only bill for influenza or pneumococcal immunizations and their administration codes.Specialty A5 may only bill for patient supplies of hemophilia factor products. Mass Immunizers must roster bill assigned claims and may only bill for immunizations.Neither specialty 73 nor A5 may bill for drugs that are administered incident to a physician service; these must be billed by the physician. Also, none of these may bill for hepatitis B vaccine since this requires a physician order. Suppliers of oral immunosuppressive drugs, oral anti-cancer drugs, oral anti-nausea drugs and diabetes testing supplies must be enrolled as DME suppliers and submit their bills to the DME MAC.Beginning October 22, 2018 only these codes will be allowed when billed by these specialties.Specialty 73 - Mass ImmunizersInfluenza Vaccine90653-90668, 90630, 90672-90674, 90682-90689, 90756not all are currently active/available; see annual Change Request (CR).Pneumococcal Vaccine90670, 90732Vaccine AdministrationG0008, G0009Specialty A5 - PharmacyHemophilia Clotting Factors (J7170, J7180-J7195, J7198-J7212, J7214)Certain other suppliers are also enrolled as Specialty A5 such as Cochlear Implant suppliers.
Article - Low frequency, non-contact, non-thermal ultrasound (CPT code 97610) (A56175)

CMS National Coverage PolicyN/AArticle TextLow frequency, non-contact, non-thermal ultrasound (CPT code 97610) describes a system employed in wound care that uses continuous low frequency ultrasonic energy to atomize a liquid and deliver continuous low frequency ultrasound to the wound bed. MIST therapy or other similar products are included in the payment for the treatment of the same wound with other active wound care management CPT codes (97597, 97598, 97602, 97607, 97608) or wound debridement CPT codes (e.g., CPT codes 11042-11047, 97597, 97598). Effective November 1, 2018, MIST Therapy or other similar treatments would be separately billable if other active wound management and/or wound debridement is NOT performed.
Article - New Local Coverage Determination (LCD) Request Process (A56198)

CMS National Coverage PolicyN/AArticle TextThe requirements in this article are based on instructions found in CMS Publication 100-08,Medicare Program Integrity Manual, Chapter 13, Section 13.2, 13.2.2.2, 13.2.2.3, and 13.2.1.1.New LCD Request ProcessThe New LCD Request Process is a mechanism by which interested parties within a contractors jurisdiction can request a new LCD. New LCD requests will be considered from:Beneficiaries residing or receiving care in a contractors jurisdiction;Health care professionals doing business in a contractors jurisdiction; andAny interested party doing business in a contractors jurisdiction.The materials received will be reviewed within 60 calendar days from receipt and a determination will be made as to whether the request is complete or incomplete.Valid Request CriteriaThe request is in writing and can be sent to the MAC via e-mail, facsimile or written letter;The request clearly identifies the statutorily-defined Medicare benefit category to which the requestor believes the item or service falls under and provides a rationale justifying the assignment;The request shall identify the language that the requestor wants in an LCD;The request shall include a justification supported by peer- reviewed evidence. Full copies of published evidence to be considered shall be included and failure to include same invalidates the request;The request shall include information that addresses the relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service;andThe request shall include information that fully explains the design, purpose, and/or method, as appropriate, of using the item or service for which the request is made.If the request is valid, NGS will follow the LCD process as outlined in CMS Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.2 or notify the requestor why the request is invalid.Health Disparities Analysis (Recommended)Requestors are strongly encouraged to include an analysis of any relevant peer-reviewed medical literature that quantifies and/or describes any health disparities related to the New LCD request, and how the requested change may impact health disparities.Requests for Informal MeetingInformal meetings may be held, so that interested parties in the MACs jurisdiction can informally discuss ONLY potential LCD requests.The meetings are for educational purposes only and are not pre-decisional negotiations.These meetings are permitted but are not required and the process allows requestors to communicate via conference call or in-person meeting before submitting a formal request for a new LCD.These meetings will ensure that all relevant evidence needed for review for coverage is submitted with the request for a formal review.Requests for development of a new LCD, or for informal meetings should be submitted to the e-mail address below.Submission MethodsE-MailNGSnewlcdrequest@anthem.comFax(317)595-4334Attention: New LCD RequestMailNational Government Services, Inc.Medical Policy UnitAttention: New LCD RequestP.O. Box 7108Indianapolis, IN 46207-7108
(Medicare Claims Processing Manual)

Transmittals Issued for this Chapter  Rev #  Issue Date  Subject  Impl Date  CR#  R12443CP  01/04/2024  Clinical Laboratory Fee Schedule  Medicare Travel Allowance Fees for Collection of Specimens and New Updates for 2024  02/07/2024  13503  R11778CP  01/06/2023  Clinical Laboratory Fee Schedule  Medicare Travel Allowance Fees for Collection of Specimens and New Updates for 2023 01/23/2023  13071  R11463CP  06/23/2022  Internet Only Manual Update to Publication 100-04, Chapter 16, Sections 70.5, 70.8, and 70.9 to Remove References to the Clinical Laboratory Improvement Amendments (CLIA) Files  07/25/2022  12766  R11184CP  01/14/2022  Clinical Laboratory Fee Schedule  Medicare Travel Allowance Fees for Collection of Specimens 02/02/2022  12593  R10615CP  03/09/2021  Clinical Laboratory Fee Schedule  Medicare Travel Allowance Fees for Collection of Specimens  03/19/2021  12140 R10341CP  09/04/2020  Internet Only Manual Update to Pub. 100-04, Chapter 16, Section 60.1.2 and Pub. 100-04, Chapter 26, Section 10.4, Item 19 10/06/2020  11935 R4495CP  01/17/2020  Clinical Laboratory Fee Schedule  Medicare Travel Allowance Fees for Collection of Specimens  02/18/2020  11641  12/20/2019  Internet Only Manual Update to Pub 100-04, Chapter 16, Section 40.8  Laboratory Date of Service Policy  01/23/2020  11574  12/20/2019  Internet Only Manual Update to Add New and Revise Sections of Publication 100-04, Chapter 16 01/23/2020  11553 R4299CP  05/03/2019  Re-implementation of the AMCC Lab Panel Claims Payment System Logic  10/07/2019  11248 Rev #  Issue Date  Subject  Impl Date  CR#  R4227CP  02/01/2019  Independent Laboratory Billing of Laboratory Tests for End- Stage Renal Disease (ESRD) Beneficiaries and the Sunset of the CB Modifier 07/01/2019  11061 R4199CP  01/11/2019  Clinical Laboratory Fee Schedule  Medicare Travel Allowance Fees for Collection of Specimens 02/12/2019  11146 R4112CP  11/01/2018  Temporary Transitional Payment for Home Infusion Therapy Services for CYs 2019 and 2020 01/07/2019  10836 R4000CP  03/16/2018  Internet Only Manual Update to Pub 100-04, Chapter 16, Section 40.8 - Date of Service Policy  07/02/2018  10419 R3942CP  12/22/2017  Clinical Laboratory Fee Schedule  Medicare Travel Allowance Fees for Collection of Specimens  01/22/2018  10448 R3875CP  10/06/2017  Internet Only Manual Update to Pub. 100 -04, Chapter 16, to update Clinical Lab Fee Schedule Layout