evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: The Routine Costs of Investigational Chemotherapy Drugs Studied In a Qualifying Clinical Trial (A53784)
CMS National Coverage PolicyCMS Internet-Only Manual (IOM), Pub 100-04, Medicare Claims Processing Manual, Chapter 32, 69.5CMS Internet-Only Manual (IOM), Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 310.1Article TextPalmetto GBA has been receiving claims for chemotherapy drugs billed as if the drug is a covered charge, when the drug is utilized as the investigational item in a qualifying clinical trial. Generally the investigational item, in this case chemotherapy drugs, used in a qualifying clinical trial is provided free of charge by research sponsors andmay not be billed to be paid by Medicare, and providers are not required to submit the charge to Medicare.Refer to the CMS Internet-Only Manual (IOM), Pub 100-04, Medicare Claims Processing Manual, Chapter 32, 69.5 for general billing requirements for qualifying clinical trials.If the chemotherapy drug(s) is administered for an investigational indication and is billed to Medicare in the course of an outpatient clinical trial, the drug(s) should be billed as a noncovered service (even if the drug is covered by Medicare for other indications) with condition code 30, the Q0 (zero) modifier and diagnosis code Z00.6 (examination of participant or control in clinical research program) included on the claim.Routine costs of clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trialsare covered by Medicare. The CMS Internet-Only Manual (IOM), Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 310.1 includes a description ofcovered routine coststhat are included in a qualifying clinical trial.
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Medicare Claims Processing Manual  Chapter 32  Billing Requirements for Special Services   Table of Contents   (Rev. 1 2533; Issued:  03-07-24)     Transmittals for Chapter 32  10- Diagnostic Blood Pressure Monitoring 10.1 - Ambulatory Blood Pressure Monitoring (ABPM) Billing Requirements 11 - Wound Treatments 11.1  Electrical Stimulation  11.2  Electromagnetic Therapy  11.3  Autologous Platelet-Rich Plasma (PRP) for Chronic Non-Healing Wounds  11.3.1  Policy  11.3.2  Healthcare Common Procedure Coding System (HCPCS) Codes and Diagnosis Coding 11.3.3  Types of Bill (TOB)  11.3.5 - Place of Service (POS) for Professional Claims  11.3.6  Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RARCs), Claim Adjustment Reason Codes (CARCs) and Group Codes  12 -  Counseling to Prevent Tobacco Use
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12.1 -  Counseling to Prevent Tobacco Use HCPCS and Diagnosis Coding 12.2 - Counseling to Prevent Tobacco Use A/B MAC (B) Billing Requirements  12.3 - A/B MAC (A)  Billing Requirements  12.4 - Remittance Advice (RA) Notices  12.5 - Medicare Summary Notices (MSNs)  12.6 - Post-Payment Review for Counseling To Prevent Tobacco Use Services  12.7 - Common Working File (CWF) Inquiry  12.8 - Provider Access to Counseling To Prevent Tobacco Use Services Eligibility Data  20  Billing Requirements for Coverage of Kidney Disease Patient Education Services  20.1  Additional Billing Requirements Applicable to Claims Submitted to Fiscal Intermediaries (FIs)  20.2 - Healthcare Common Procedure Coding System (HCPCS) Procedure Codes and Applicable Diagnosis Codes  20.3 - Medicare Summary Notices (MSNs) and Claim Adjustment Reason Codes (CARCs)  20.4 - Advance Beneficiary Notice (ABN) Information 30 - Hyperbaric Oxygen (HBO) Therapy  30.1  Billing Requirements for HBO Therapy for the Treatment of Diabetic Wounds of the Lower Extremities  30.2 Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Application of Oxygen)  40  Sacral Nerve Stimulation  40.1  Coverage Requirements  40.2  Billing Requirements  40.2.1  Healthcare Common Procedural Coding System (HCPCS)  40.2.2  Payment Requirements for Test Procedures   (HCPCS Codes 64585, 64590 and 64595)  40.2.3  Payment Requirements for Device Codes A4290, E0752 and E0756
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40.2.4 -  Payment Requirements for Codes C1767, C1778, C1820, C1883 and  C1897  40.3  Bill Types  40.4  Revenue Codes  40.5 -  Claims Editing  50  Deep Brain Stimulation for Essential Tremor and Parkinsons Disease  50.1  Coverage Requirements  50.2  Billing Requirements  50.2.1  Part A Intermediary Billing Procedures  50.3  Payment Requirements  50.3.1 -  Part A Payment Methods  50.3.2  Bill Types  50.3.3  Revenue Codes  50.4  Allowable Codes  50.4.1  Allowable Covered Diagnosis Codes  50.4.2 -  Allowable Covered Procedure Codes  50.4.3  Healthcare Common Procedure Coding System (HCPCS)  50.5  Ambulatory Surgical Centers  50.6  Claims Editing for Intermediaries  50.7  Remittance Advice Notice for A/B MACs (A)  50.8  Medicare Summary Notices (MSN) Messages for Intermediaries  50.9  Provider Notification 60  Coverage and Billing for Home Prothrombin Time (PT/INR) Monitoring for Home Anticoagulation Management  60.1  Coverage Requirements  60.2  Intermediary Payment Requirements  60.2.1  Part A Payment Methods  60.3  Intermediary Billing Procedures  60.3.1  Bill Types  60.3.2  Revenue Codes  60.4  Intermediary Allowable Codes  60.4.1  Allowable Covered Diagnosis Codes  60.4.2  Healthcare Common Procedure Coding System (HCPCS) for Intermediaries  60.5
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 Carrier Billing Instructions  60.5.1 -  HCPCS for Carriers  60.5.2  Applicable Diagnosis Codes for A/B MACs (B)  60.6  Carrier Claims Requirements  60.7  Carrier Payment Requirements  60.8  Carrier and Intermediary General Claims Processing Instructions  60.12 -  Coverage for PET Scans for Dementia and Neurodegenerative Diseases  60.8.1  Remittance Advice Notices  60.8.2  Medicare Summary Notice (MSN) Messages  66 - National Coverage Determination (NCDs) services that are considered a significant cost for Medicare Advantage.   66.1  Institutional Billing for National Coverage Determination (NCDs) services that are considered a significant cost for Medicare Advantage  66.2  Services Identified as having Significant Cost for Medicare Advantage  67 - No Cost Claims  67.1 -  Practitioner Billing for No Cost Items  67.2 -  Institutional Billing for No Cost Items  67.2.1 -  Billing No Cost Items Due to Recall, Replacement, or Free Sample  68 - Investigational Device Exemption (IDE) Studies  68.1 -  Billing Requirements for Providers Billing for Routine Care Items and Services in Category A IDE Studie  68.2 -  Billing Requirements for Providers Billing for Category B IDE Devices and Routine Care Items and Services in Category B IDE Studies  68.4  Billing Requirements for Providers Billing Routine Costs of Clinical Trials Involving a Category B IDE  69 - Qualifying Clinical Trails  69.1 -  General  69.2 -  Payment for Qualifying Clinical Trial Services  69.3 -  Medical Records Documentation Requirements  69.4 -  Local Medical Review Policy  69.5 -  Billing Requirements -  General  69.6 -  Requirements for Billing Routine Costs of Clinical Trials  69.7 -  Reserved for Future Use  69.8 -  Handling Erroneous Denials of Qualifying Clinical Trial Services  69.9 -  Billing and  Processing Fee for Service Claims for Covered Clinical Trial Services Furnished to Managed Care Enrollees  69.10 -  CWF Editing Of Clinical Trial Claims For Managed Care Enrollees  69.11 -  Resolution of CWF UR 5232 Rejects  70 - Billing Requirements for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health (NIH) Clinical Trial 70.1 -  Healthcare Common Procedure Coding System (HCPCS) Codes for Carriers  70.2 -  Applicable Modifier for Islet Cell Transplant Claims for Carriers  70.3 -  Special Billing and Payment Requirements for Carriers  70.4 -  Special Billing and Payment Requirements for A/B MACs (A)
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Codes for Carriers  70.2 -  Applicable Modifier for Islet Cell Transplant Claims for Carriers  70.3 -  Special Billing and Payment Requirements for Carriers  70.4 -  Special Billing and Payment Requirements for A/B MACs (A)  70.5 -  Special Billing and Payment Requirements Medicare Advantage (MA) Beneficiaries  80  Billing of the Diagnosis and Treatment of Peripheral Neuropathy with Loss of Protective Sensation in People with Diabetes  80.1 -  General Billing Requirements  80.2 -  Applicable HCPCS Codes  80.3 -  Diagnosis Codes  80.4 -  Payment  80.5 -  Applicable Revenue Codes  80.6 -  Editing Instructions for A/B MACs (A)  80.7 -  CWF General Information  80.8 -  CWF Utilization Edits  90 - Stem Cell Transplantation  90.1 -  General  90.2 -  HCPCS and Diagnosis Coding -  ICD -9-CM Applicable  90.2.1 -  HCPCS and Diagnosis Coding for Stem Cell Transplantation -  ICD-10-CM Applicable  90.3 -  Non -Covered Conditions  90.4 -  Edits  90.5 -  Suggested MSN and RA Messages  90.6 -  Clinical Trials for Allogeneic Hematopoietic Stem Cell Transplantation  (HSCT) for Myelodysplastic Syndrome (MDS)  100  Billing Requirements for Expanded Coverage of Cochlear Implantation 100.1 A/B MACs (Part A)   Billing Procedures  100.1.1  Applicable Bill Types  100.1.2  Special Billing Requirements for A/B MACs (A) for Inpatient Billing  100.2   A/B MACs (Part A) Payment Requirements  100.3  A/B MACs (Part B) Billing  Procedures  100.4  Healthcare Common Procedural Coding System (HCPCS)  100.5  Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs),   Group Codes, and Medicare Summary Notice (MSN) Messages  110 -  Coverage and Billing for Ultrasound Stimulation for Nonunion Fracture Healing 110.1 -  Coverage Requirements  110.2 -  Intermediary Billing Requirements  110.3 -  Bill Types  110.4 -  Carrier and Intermediary Billing Instructions  110.5 -  DMERC Billing Instructions  120 -  Presbyopia -Correcting (P -C IOLS) and Astigmatism- Correcting Intraocular Lenses (A -C IOLs) (General
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Billing Instructions  110.5 -  DMERC Billing Instructions  120 -  Presbyopia -Correcting (P -C IOLS) and Astigmatism- Correcting Intraocular Lenses (A -C IOLs) (General Policy Information)  120.1 -  Payment for Services and Supplies  120.2 -  Coding and General Billing Requirements  120.3 -  Provider Notification Requirements  120.4 -  Beneficiary Liability  130 -  External Counterpulsation (ECP) Therapy  130.1 -  Billing and Payment Requirements  130.2 -  Special Intermediary Billing and Payment Requirements  140 140 -  Cardiac Rehabilitation (CR) Programs, Intensive Cardiac Rehabilitation (ICR) Programs, and Pulmonary Rehabilitation (PR) Programs  On or After January 1, 2024
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140.1  CR Program Services Furnished On or Before Dec. 31, 2009  140.1.1 -  Coding Requirements for CR Services Furnished On or Before Dec. 31, 2009              140.2   CR Program  Services  Effective for Dates of Service  On or After  January  1, 2024
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140.2.1  Coding Requirements for CR Services Furnished On or After January 1, 2010  140.2.2 -  Claims Processing Requirements for Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Services Furnished On or After January 1, 2010 140.2.2.1  Correct Place of Service (POS) Codes for CR and ICR Services on Professional Claims  140.2.2.2  Requirements for CR and ICR Services on Institutional Claims  140.2.2.3  Frequency Edits for CR and ICR Claims  140.2.2.4  Edits for CR Services Exceeding 36 Sessions  140.2.2.5  Edits for ICR Services Exceeding 126 Days and 72 Sessions  140.2.2.6  Supplier Specialty Code 31 Requirements for ICR Claims  140.3  ICR Program Services  Effective for Dates of Service On or After January 1, 2024 140.3.1  Coding Requirements for ICR Services Furnished On or After January 1, 2010  140.4  PR Program Services Effective for Dates of Service On or After January 1, 2024 140.4.1  Coding Requirements for PR Services Furnished On or After January 1, 2010  140.4.2 -  Claims Processing Requirements for Pulmonary Rehabilitation (PR) Services Furnished On or After January 1, 2010  140.4.2.1  Correct Place of Service (POS) Codes for PR Services on Professional Claims  140.4.2.2  Requirements for PR Services on Institutional Claims  140.4.2.3  Daily Frequency Edits for PR Claims  140.4.2.4  Edits for PR Services Exceeding 36 Sessions  140.4.2.5  Edits for PR Services Exceeding 72 Sessions  150 -  Billing Requirements for Bariatric Surgery for Morbid Obesity  150.1 -  General  150.2 -  HCPCS Procedure Codes for Bariatric Surgery  150.3 -  ICD Procedure Codes for Bariatric Surgery for Treatment of Co -Morbid Conditions Related to Morbid Obesity (A/MACs only)  150.4 -  ICD Diagnosis Codes for Bariatric Surgery 150.5 -  ICD Diagnosis Codes for BMI  35 150.5.1  ICD Codes for Type II Diabetes Mellitus Complication  150.6 -  Claims Guidance for Payment  150.7 -  Medicare Summary Notices (MSNs) and Claim Adjustment Reason Codes  150.8 -  B/MAC Billing Requirements  150.9 -
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 ICD Codes for Type II Diabetes Mellitus Complication  150.6 -  Claims Guidance for Payment  150.7 -  Medicare Summary Notices (MSNs) and Claim Adjustment Reason Codes  150.8 -  B/MAC Billing Requirements  150.9 -  Advance Beneficiary Notice and HINN Information 160  PTA for Implanting the Carotid Stent  160.1  Category B Investigational Device Exemption (IDE) Study Coverage  160.2  Post -Approval Study Coverage  160.2.1  Carotid Artery Stenting (CAS) Post -Approval Extension Studies  160.3  Carotid Artery Stenting (CAS) With Embolic Protection Coverage  160.4  510k Post -Approval Extension Studies using 510k- Cleared Embolic Protection Devices during Carotid Artery Stenting (CAS) Procedures  161 -  Intracranial PTA With Stenting  170 -  Billing Requirements for L umbar Artificial Disc Replacement  170.1 -  General  170.2 -  Carrier Billing Requirements  170.3 -  A/B MAC (A) Billing Requirements  170.4 -  Reasons for Denial and Medicare Summary Notice (MSN), Claim Adjustment Reason Code Messages  and Remittance Advice Remark Code  170.5 -  Advance Beneficiary Notice (ABN and Hospital Issued Notice of Noncoverage (HINN) Information 180  Cryosurgery of the Prostate Gland  180.1  Coverage Requirements  180.2  Billing Requirements  180.3  Payment Requirements  180.4 -  Claim Adjustment Reason Codes, Remittance Advice Remark Codes, Group Codes, and Medicare Summary Notice Messages  180.5  Additional CWF and Contractor Requirements  190  Billing Requirements for Extracorporeal Photopheresis  190.1 -  Applicable Intermediary Bill Types  190.2 -  Healthcare Common Procedural Coding System (HCPCS), Applicable Diagnosis Codes and Procedure Code  190.3 -  Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RAs) and Claim Adjustment Reason Coded 190.4 -  Advance Beneficiary Notice and Hospital Issued Notice of Noncoverage Information  200 -  Billing Requirements for Vagus Nerve Stimulation (VNS)  200.1 -  General  200.2 -  ICD-9 Diagnosis Codes for Vagus Nerve Stimulation (Covered since DOS on and after July 1, 1999)  200.3 -  Carrier/MAC Billing Requirements  200.4 -  Fiscal Intermediary Billing Requirements  200.5 -  Medicare Summary Notice (MSN), Remittance Advice Remark
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Nerve Stimulation (Covered since DOS on and after July 1, 1999)  200.3 -  Carrier/MAC Billing Requirements  200.4 -  Fiscal Intermediary Billing Requirements  200.5 -  Medicare Summary Notice (MSN), Remittance Advice Remark Code (RARC) and Claims Adjustment Reason Code (CARC) Messages  200.6 -  Advance Beneficiary Notice and HINN Information 210  Billing Requirements for Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea (OSA)  220  Billing Requirements for Thermal Intradiscal Procedures (TIPs) Claims  220.1 -  General  220.2 -  Contractors, A/B Medicare Administrative Contractors (MACs)  220.3 -  Medicare Summary Notice (MSN), Claim Adjustment Reason Code (CARC), and Remittance Advise Remark Code (RARC)  220.4 -  Advanced Beneficiary Notice (ABN)  230 -  Billing Wrong Surgical or Other Invasive Procedures Performed on a Patient, Surgical or Other Invasive Procedures Performed on the Wrong Body Part, and Surgical or Other Invasive Procedures Performed on the Wrong Patient  240  Special Instructions for Certain Claims with a Gender/Procedure Conflict 240.1 -  Billing Instructions for Institutional Providers  240.2  Billing Instructions for Physicians and Non- Physician Practitioners  250  Pharmacogenomic Testing for Warfarin Response  250.1  Coverage Requirements  250.2  Billing Requirements  250.3  Payment Requirements  260  Dermal Injections for Treatment of Facial Lipodystophy Syndrome (FLS)  260.1  Policy  260.2  Billing Instructions  260.2.1  Hospital Billing Instructions  260.2.2.  Practitioner Billing Instructions  260.3  Claims Processing System Editing  270 -  Claims Processing for Implantable Automatic Defibrillators  270.1 -  Coding Requirements for Implantable Automatic Defibrillators  270.2 -  Billing Requirements for Patients Enrolled in a Data Collection System 280  Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer  280.1 -  Policy  280.2  Healthcare Common Procedure Coding System (HCPCS) Codes and Diagnosis Coding 280.3 -  Types of Bill (TOB) and Revenue Codes  280.4 -  Payment Method 280.5 -  Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RARCs), Claims Adjustment Reason Codes (CARCs), and Group Codes  290 -  Transcatheter Aortic Valve Replacement (TAVR) Furnished on
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-  Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RARCs), Claims Adjustment Reason Codes (CARCs), and Group Codes  290 -  Transcatheter Aortic Valve Replacement (TAVR) Furnished on or After May 1, 2012  290.1 -  Coding Requirements for TAVR Furnished on or After May 1, 2012, through December 31, 2012  290.1.1-  Coding Requirements for TAVR Services Furnished On or After January 1, 2013 290.2 -  Claims Processing Requirements for TAVR Services on Professional Claims  290.3 -  Claims Processing Requirements for TAVR Services on Inpatient Hospital Claims  290.4 -  Claims Processing Requirements for TAVR Services for Medicare Advantage (MA) Plan Participants  300 -  Billing Requirements for Ocular Photodynamic Therapy (OPT) with Verteporfin 300.1 -  Coding Requirements for OPT with Verteporfin 300.2 -  Claims Processing Requirements for OPT with Verteporfin Services on Professional Claims and Outpatient Facility Claims  300.3 -  Claims Processing Requirements for OPT with Verteporfin Services on Inpatient Facility Claims  300.4 -  Medicare Summary Notice (MSN) and Remittance Advice (RA)  Messages  310 -  Transesophageal Doppler Used for Cardiac Monitoring 310.1  Coding Requirements for Transesophageal Doppler Cardiac Monitoring Furnished Before October 1, 2012 310.2  Coding Requirements for Transesophageal Doppler Monitoring Furnished On or After October 1, 2012  310.3  Correct Place of Service (POS) Code for Transesophageal Doppler Cardiac Monitor Services on Professional Claims  320 -  Artificial Hearts and Related Devices  320.1  Coding Requirements for Artificial Hearts Furnished Before May 1, 2008 320.2  Coding Requirements for Artificial Hearts Furnished After May 1, 2008 320.3  Ventricular Assist Devices (VADs)  320.3.1  Postcardiotomy 320.3.2  Bridge - to-Transplantation (BTT)  320.3.3  Other  320.3.4  Replacement Accessories and Supplies for External VADs or Any VAD
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330  Percutaneous Image- guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)   330.1  Claims Processing Requirements for Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) on Professional Claims  330.2 -  Claims Processing Requirements for PILD for Outpatient Facilities  340  Transcatheter Mitral Valve Repair (TMVR)  340.1  Coding Requirements for TMVR for Mitral Valve TEER  Claims Furnished on or After August 7, 2014  340.2  Claims Processing Requirements for Mitral Valve TEER  Services on Professional Claims  340.3 -  Claims Processing Requirements for Mitral Valve TEER  Services on Inpatient Hospital Claims  340.4 -  Claims Processing Requirements for  Mitral Valve TEER  Services for Medicare Advantage (MA) Plan Participants  350 -  Emergency and Foreign Hospital Services  350.1 -  Services Rendered By Nonparticipating Providers  350.2 -  Establishing an Emergency  350.3 -  Qualifications of an Emergency Services Hospital  350.4 -  Coverage Requirements for Emergency Hospital Services Furnished Outside of the United States  350.5 -  Services Furnished in a Foreign Hospital Nearest to Beneficiary's U.S. Residence  350.6 -  Coverage of Physician and Ambulance Services Furnished Outside U.S. 350.7 -  Claims for Services Furnished in Canada to Qualified Railroad Retirement Beneficiaries  350.8 -  Claims from Hospital- Leased Laboratories Not Meeting Conditions of Participation  350.9 -  Nonemergency Part B Medical and Other Health Services  350.10 -  Elections to Bill for Services Rendered By Nonparticipating Hospitals  350.11 -  Processing Claims  350.11.1 -  Contractors Designated to Process Foreign Claims  350.11.2 -  Contractor Processing Guidelines  350.11.3 -  Medicare Approved Charges for Services Rendered in Canada or Mexico  350.11.4 -  Accessibility Criteria  350.11.5 -  Medical Necessity  350.11.6 -  Time Limitation on Emergency and Foreign Claims  350.11.7 -  Payment Denial for Medicare Services Furnished to Alien Beneficiaries Who Are Not Lawfully Present in the United States  350.12 -  Appeals on Claims for Emergency and Foreign Services  360 -  Payment for Services Received By Nonparticipating Providers  360.1 -  Payment for Services from Foreign Hospitals  360.1.1 -  Attending Physician's Statement and Documentation of Medicare Emergency  360.2 -  Designated Contractors  360.3 -  Model
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360 -  Payment for Services Received By Nonparticipating Providers  360.1 -  Payment for Services from Foreign Hospitals  360.1.1 -  Attending Physician's Statement and Documentation of Medicare Emergency  360.2 -  Designated Contractors  360.3 -  Model Letters, Nonparticipating Hospital and Emergency Claims  360.3.1 -  Model Letter to Nonparticipating Hospital That Elected to Bill For Current Year  360.3.2 -  Model Letter to Nonparticipating Hospital That Did Not Elect to Bill for Current Year  360.3.3 -  Model Letter to Nonparticipating Hospital That Requests to Bill the Program  360.3.4 -  Full Denial -  Hospital -Filed or Beneficiary -Filed Emergency Claim 360.3.5 -  Partial Denial -  Hospital -Filed or Beneficiary -Filed Emergency Claim  360.3.6 -  Denial -  Military Personnel/Eligible Dependents  360.3.7 -  Full Denial -  Shipboard Claim -  Beneficiary filed  360.3.8 -  Full Denial -  Foreign Claim -  Beneficiary Filed  370 -  Microvolt T -wave Alternans (MTWA)  370.1 -  Coding and Claims Processing for MTWA  370.2 -  Messaging for MTWA  380--Leadless Pacemakers