evekhm/cms_iom_500 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.
Article - Billing and Coding: Rezum® System for Benign Prostatic (A56083)
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 - Billing and Coding: Chemotherapy (A56141)
CMS National Coverage PolicyCMSInternet-Only Manual, Pub 100-02, Chapter 15,50.4.1 Approved Use of Drug and 50.4.5 Off Label Use of Anti-Cancer Drugs and BiologicalsTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article Text
Article - Billing and Coding: Chemotherapy (A56141)
The purpose of this article is to provide billing guidance for chemotherapeutic agents, that are usually billed as incident to medications under Part B. This article provides the information which must be included in box 19 of the CMS-1500 Claim Form or the electronic equivalent for Part B or in the remarks field (Field Locator 80) of the CMS- 1450 (UB-04) Claim Form or the electronic equivalent for Part A in order to process the claim.Palmetto GBA expects that providers identify off-label uses by the use of the KX modifier appended to the CPT/HCPCS code for the drug. These off-label uses must be supported by clinical research under the conditions identified in this section. Peer-reviewed medical literature may appear in scientific, medical, and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased, independent experts prior to publication. In-house publications of entities whose business relates to the manufacture, sale, or distribution of pharmaceutical products are excluded from consideration. Abstracts (including meeting abstracts) are excluded from consideration. Such usages will be subject to review at the discretion of Palmetto GBA. For review of medications under these considerations, please submit full articles, not abstracts, for consideration.The JW modifier is required for wastage in single dose vials; this modifier does not apply to multidose vials.This article applies only to those medications that have designated J codes. For those medications that have not been provided J codes use CPT C9399 using the instructions found in the published article A55913 Correct Billing and Coding for Hospital Outpatient Drugs and Biologicals Under the Outpatient Prospective Payment System (OPPS). For those medications that have not been provided J codes and are being billed under Part B use the appropriate NOC code (J9999 Not otherwise classified, antineoplastic drugs; J3490 Unclassified drugs; J3590 Unclassified biologics). Administration coding for these drugs is addressed in the Billing and Coding of Drug and Biological Infusions A55297 article.
Article - Billing and Coding: Chemotherapy (A56141)
It is noted that some drugs have approvals for specific forms of the cancers, such as estrogen receptor positivity in breast cancers. If the approved indications require that level of specificity, it is expected that the coded diagnosis will include the additional codes (Z codes on occasion) that improve the specificity to the level shown in the FDA (or other) approval.Per the manual, Medicare limits coverage to those indications listed in the FDA label as approved, or in the NCCN Guidelines listing as category 2B or higher or in the additional approved compendia listed in the manual per the rating or recommendation level assigned for each of those compendia. As new agents and indications are approved, general coverage guidelines are found in the CMS Internet-Only Manual, Pub 100-02, Chapter 15, 50.4.1 Approved Use of Drug and  50.4.5 Off Label Use of Anti-Cancer Drugs and Biologicals.Other off-label indications may be approved as noted above with the KX modifier.
Article - Billing and Coding: Pulmonary Rehabilitation Services (A56152)
CMS National Coverage PolicyN/AArticle TextWe are providing clarification of coverage and documentation requirements for pulmonary rehabilitation services based on Noridian medical review findings. Pulmonary rehabilitation services are covered by Medicare as either: a) Individual component services when medical necessity requirements are met or as; b) Pulmonary Rehabilitation Program services when specific program requirements are met.A. Individual ComponentsThese services must be provided by a qualified clinician, i.e., physician, non-physician practitioner (NPP), respiratory therapist (RT), physical therapist (PT), occupational therapist (OT) or appropriately supervised/qualified therapist assistant (physical therapist assistant (PTA) or occupational therapist assistant (OTA)).Ifallthe Pulmonary Rehabilitation Program requirements listed in Section B below arenotmet, individual pulmonary rehabilitation components are still payable, using the GXXXX or 97XXX codes, when the documentation supports:It is tailored to meet the individual patients specific needs based on a thorough evaluation.It is at a level of complexity that requires a qualified clinician to perform.It is medically reasonable and necessary for the treatment of an individual patients acute/exacerbated pulmonary condition.These services must be billed as follows:Use HCPCS G0237-G0239Services are provided under a physician plan of care by incident-to staff or RT. Note: Incident-to services cannot be provided by a PTA and/or OTA.Inclusive services that are not separately billable include - pulse oximetry, counseling, education, and the 6-minute walk test.Therapy modifiers and revenue codes should not be coded (GP/GO and 42x/43x).Use CPT 97xxx CodesServices are provided under a therapy plan of care by a physician/NPP/incident-to or by PT or OT.Inclusive services that are not separately billable include - pulse oximetry, counseling, education, and the 6-minute walk test.Therapy modifiers and revenue codes should be coded as applicable, GP/GO and 42x/43x).B. Pulmonary Rehabilitation (PR) Programs - effective on or after January 1, 2010
Article - Billing and Coding: Pulmonary Rehabilitation Services (A56152)
B. Pulmonary Rehabilitation (PR) Programs - effective on or after January 1, 2010All requirements of the CMS Internet Only Manual (IOM)Medicare Benefit Policy Manual,Publication 100-02,Chapter 15, Section 231and IOMMedicare Claims Processing Manual,Publication 100-4,Chapter 32, Section 140.4and National Coverage Determination (NCD)Pulmonary Rehabilitation Services 240.8must be fulfilled. Programs must provide a comprehensive, evidence-based multidisciplinary intervention for patients with chronic respiratory impairment.Medicare covers Pulmonary Rehabilitation Program services for:Moderate to very severe COPD (defined as GOLD classification II, III and IV), when referred by the physician treating the chronic respiratory disease.As perthe 2022 Physician Fee Schedule Final Rule (86 FR 65244 dated November 19, 2021), CMS finalized revisions to the conditions of coverage for pulmonary rehabilitation (PR) specified at 42 Code of Federal Register 410.47. These revisions included coverage forconfirmed or suspected COVID-19 and experience persistent symptoms that include respiratory dysfunction for at least four weeks (effective January 1, 2022).Note: Additional medical indications for coverage for Pulmonary Rehabilitation Program services may be established through an NCD.Medicare will pay for a maximum of 2 one-hour sessions per day, for up to 36 sessions for up to 36 weeks for Pulmonary Rehabilitation Program services when documentation supports thatallof the following program requirements are met:Physician has ordered and prescribed exercise and aerobic exercise combined with other types of exercise (such as conditioning, breathing retraining, step, and strengthening) as determined to be appropriate for individual patients by a physician and is provided at each treatment session.An individualized plan of careplan detailing how components are utilized for each patientis initially established by the physician as well as reviewed and signed by the physician every 30 days.Services must be provided only in the following place of service (POS): 11 (physicians office), 19 (Off-Campus Outpatient Hospital or 22 (On-Campus Outpatient Hospital). All settings must have a physician immediately available and accessible for medical consultations and emergencies at all times when program services are being furnished.Physicians acting as the supervising physician must possess all of the following: