evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) (A56178)
Article TextThis article contains coding and other guidelines that complement the local coverage determination (LCD) forPercutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF).Provisions in this article and the LCD only address Vertebral Augmentation for Osteoporotic Vertebral Compression Fracture (VCF). Coverage will remain available for medically necessary procedures for other conditions not included in this article/LCD.Coding GuidelinesProcedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.The diagnosis code(s) must best describe the patient's condition for which the service was performed.All services/procedures performed on the same day for the same beneficiary by the physician/provider should be billed on the same claim.Specific Coding GuidelinesNo separate payment for venography performed during the operative session may be allowed and it should not be separately billed.Documentation RequirementsThe patient's medical record must contain documentation that fully supports the medical necessity for services included within the related LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.
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 Meeting
Article - New Local Coverage Determination (LCD) Request Process (A56198)
Informal 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
Article - Billing and Coding: Molecular Pathology Procedures (A56199)
CMS National Coverage PolicyN/AArticle TextThis article contains coding and other guidelines that complement the Local Coverage Determination (LCD) for Molecular Pathology Procedures.Specific Coding of Molecular Testing PanelsThe submission of claims using individual gene CPT codes, when either 5-50 or >50 gene panels are ordered, is considered incorrect coding. Correct coding requires that when a panel code is ordered, it should be billed, rather than the individual gene codes. CPT code 81445, 81449, 81450, or 81451 should be billed when 5 to 50 genes are ordered.CPT code 81455, or 81456, should be billed when 51 or greater genes are ordered for molecular biomarkers.Please refer to Local Coverage Determination L37810 Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms and the associated Article A56867.When a panel with greater than one or less than five genes is ordered, use the corresponding existing panel CPT code or CPT code 81479 if none exists.Coding InformationCoding guidance in this article is categorized into four, distinct CPT/HCPCS sections: CPT/HCPCS section-Group1-Tier 1 Covered Codesfor which limited coverage may be provided for the genetic tests and for which specific ICD-10-CM diagnosis to CPT procedure groupings may be listed CPT/ HCPCS section-Group 2-Tier 1 Codes that require Individual Reviewfor which coverage may be provided for the genetic tests submitted, if documentation supports medical necessity, and for which specific ICD-10-CM diagnosis to CPT procedure groupings may be listed. CPT/HCPCS section-Group 3-Tier 1 Non-covered Codesfor which genetic testing is unlikely to impact therapeutic decision-making in the clinical management of the patient and will be denied automatically as not medically necessary. CPT/HCPCS section-Group 4-Tier 2/NOC Covered Code/Gene Combinationsfor which limited coverage may be provided for specific genes listed in the Group 4 paragraph;Tier 2/NOC Individual Review Code/Gene Combinations;Tier 2/NOC Non-covered Code/Gene Combinations.Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.
Article - Billing and Coding: Molecular Pathology Procedures (A56199)
For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.
Article - Billing and Coding: Molecular Pathology Procedures (A56199)
The diagnosis code(s) must best describe the patient's condition for which the service was performed.Modifier 91Please use Modifier 91 as appropriate, based on the Medicare Claims Processing Manual Chapter 16, Laboratory Services Section 100.5.1. Modifier 91 may be is used"to indicate that a test was performed more than once on the same day forthe same patient., only when it is necessary to obtain multiple results in the course of treatment."Documentation RequirementsDocumentation must be adequate to verify that coverage guidelines listed above have been met. Thus, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed. The laboratory or billing provider must have on file the physician requisition which sets forth the diagnosis or condition (ICD-10-CM code) that warrants the test(s).Examples of documentation requirements of the ordering physician/nonphysician practitioner (NPP) include, but are not limited to, history and physical or exam findings that support the decision making, problems/diagnoses, relevant data (e.g., lab testing, imaging results).Documentation requirements of the performing laboratory (when requested) include, but are not limited to, lab accreditation, test requisition, test record/procedures, reports (preliminary and final), and quality control record.Documentation requirements for LDT(s)/protocols (when requested) include diagnostic test/assay, lab/manufacturer, names of comparable assays/services (if relevant), description of assay, analytical validity evidence, clinical validity evidence, and clinical utility.Providers are required to code to specificity however, if CPT 81479 (unlisted molecular pathology procedure) is used the documentation must clearly identify the unique molecular pathology procedure performed. When multiple procedure codes are submitted on a claim (unique and/or unlisted) the documentation supporting each code should be easily identifiable. If on review the contractor cannot link a billed code to the documentation, these services will be denied based on Title XVIII of the Social Security Act, 1833(e). For these tests, the ordering provider must provide to the laboratory copies of the signed informed consent documentation.When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary.Utilization Guidelines
Article - Billing and Coding: Molecular Pathology Procedures (A56199)
Screening services such as pre-symptomatic genetic tests and services used to detect an undiagnosed disease or disease predisposition are not a Medicare benefit and are not covered. Similarly, Medicare may not reimburse the costs of tests/examinations that assess the risk of a condition unless the risk assessment clearly and directly affects the management of the patient.A specific genetic test may only be performed once in a lifetime per beneficiary for inherited conditions; however, when medically reasonable and necessary, genetic testing may be done on acquired conditions such as malignancies (including separate malignancies developing at different times) as they are treated and are being followed, in order to assess response or other relevant clinical criteria. Likewise, there are situations where medical record and literature documentation are able to demonstrate that serial testing can be reasonably predicted to provide additional clinically useful information. When the record documents that this information, such as confirmed significant response to current therapy, is likely to assist in modifying treatment, serial testing can be considered reasonable and necessary and eligible for coverage.
(Medicare Claims Processing Manual)
Medicare Claims Processing Manual  Chapter 16 - Laboratory Services   Table of Contents  (Rev.  12443; Issued: 01-04-24)   Transmittals for Chapter 16  10 - Background 10.1 - Definitions  10.2 - General Explanation of Payment  20 - Calculation of Payment Rates - Clinical Laboratory Test Fee Schedules  20.1 - Initial Development of Laboratory Fee Schedules  20.2 - Annual Fee Schedule Updates   20.3 Clinical Laboratory Fee Schedule Based on Protecting Access to Medicare
(Medicare Claims Processing Manual)
Act (PAMA) of 2014  30 - Special Payment Considerations  30.1 - Mandatory Assignment for Laboratory Tests  30.1.1 - Rural Health Clinics  30.2 - Deductible and Coinsurance Application for Laboratory Tests  30.3 - Method of Payment for Clinical Laboratory Tests - Place of Service Variation  30.4 - Payment for Review of Laboratory Test Results by Physician  40 - Billing for Clinical Laboratory Tests  40.1 - Laboratories Billing for Referred Tests  40.1.1 - Claims Information and Claims Forms and Formats  40.1.1.1 - Paper Claim Submission to A/B MACs (B)  40.1.1.2 - Electronic Claim Submission to A/B MACs (B)  40.2 - Payment Limit for Purchased Services  40.3 - Hospital Billing Under Part B  40.3.1 - Critical Access Hospital (CAH) Outpatient Laboratory Service  40.4 - Special Skilled Nursing Facility (SNF) Billing Exceptions for Laboratory Tests  40.4.1 - Which A/B MAC  (A) or (B) to Bill for Laboratory Services Furnished to a Medicare Beneficiary in a Skilled Nursing Facility (SNF)  40.5 - Rural Health Clinic (RHC) Billing  40.6 - Billing for End Stage Renal Disease (ESRD) Related Laboratory Tests  40.6.1 - Automated Multi- Channel Chemistry (AMCC) Tests for ESRD Beneficiaries  40.6.2 - Claims Processing for Separately Billable Tests for ESRD Beneficiaries  40.6.2.1 - Separately Billable ESRD Laboratory Tests Furnished by Hospital- Based Facilities  40.6.2.2 - Reserved  40.6.2.3 - Skilled Nursing Facility (SNF) Consolidated Billing (CB) Editing and Separately Billed ESRD Laboratory Test Furnished to Patients of Renal Dialysis Facilities  40.7 - Billing for Noncovered Clinical Laboratory Tests  40.8 - Date of Service (DOS) for Clinical Laboratory and Pathology Specimens  50 - A/B MAC (B)  Claims Processing  50.1 - Referring Laboratories  50.2 - Physicians  50.2.1 - Assignment Required 50.3 - Hospitals  50.3.1 - Hospital- Leased Laboratories  50.3.2 - Hospital Laboratory Services Furnished to Nonhospital Patients  50.4 - Reporting of Pricing Localities for Clinical Laboratory Services  50.5 - Jurisdiction of Laboratory Claims  50.5.1 - Jurisdiction of Referral Laboratory Services
(Medicare Claims Processing Manual)
Leased Laboratories  50.3.2 - Hospital Laboratory Services Furnished to Nonhospital Patients  50.4 - Reporting of Pricing Localities for Clinical Laboratory Services  50.5 - Jurisdiction of Laboratory Claims  50.5.1 - Jurisdiction of Referral Laboratory Services 50.5.2 - Examples of Independent Laboratory Jurisdiction 60 - Specimen Collection Fee and Travel Allowance  60.1 - Specimen Collection Fee  60.1.1- Independent Laboratory Specimen Drawing
(Medicare Claims Processing Manual)
60.1.2 Coding Requirements For Specimen Collection  60.1.3 - Specimen Drawing for Dialysis Patients  60.1.4 - Coding Requirements for Specimen Collection 60.2 - Travel Allowance  70 - Clinical Laboratory Improvement Amendments (CLIA) Requirements  70.1 - Background  70.2 - Billing  70.3 - Verifying CLIA Certification  70.4 - CLIA Numbers  70.5 - CLIA Categories and Subcategories  70.6 - Certificate for Provider -Performed Microscopy Procedures  70.7 - Deleted - Held for Expansion 70.8 - Certificate of Waiver  70.9 - HCPCS Subject To and Excluded From CLIA Edits  70.10 - CLIA Number Submitted on Claims from Independent Labs  70.10.1 - Physician Notification of Denials  70.11 - Reasons for Denial - Physician Office Laboratories Out -of-Compliance  80 - Issues Related to Specific Tests  80.1 - Screening Services  80.2 - Anatomic Pathology Services  80.2.1 - Technical Component (TC) of Physician Pathology Services to Hospital Patients  80.3 - National Minimum Payment Amounts for Cervical or Vaginal Smear Clinical Laboratory Tests  80.4 - Oximetry  90 - Automated Profile Tests and Organ/Disease Oriented Panels  90.1 - Laboratory Tests Utilizing Automated Equipment  90.1.1 - Automated Test Listing  90.2 - Organ or Disease Oriented Panels  90.3 - Claims Processing Requirements for Panel and Profile Tests  90.3.1 - History Display  90.3.2 - Medicare Secondary Payer  90.4 - Evaluating the Medical Necessity for Laboratory Panel CPT Codes  90.5 -  Special Processing Considerations  100 -  CPT Codes Subject to and Not Subject to the Clinical Laboratory Fee Schedule  100.1 -  Deleted - Held for Expansion  100.2 -  Laboratory Tests Never Subject to the Fee Schedule  100.3 -  Procedures Not Subject to Fee Schedule When Billed With Blood Products  100.4 -  Not Otherwise Classified Clinical Laboratory Tests  100.5 -  Other Coding Issues  100.5.1 -  Tests Performed More Than Once on the Same Day  100.6 -  Pricing Modifiers  110 -  Coordination Between A/B MACs (B)  and Other Entities  110.1 -  Coordination Between A/B MACs (B)  and A/B MACs (A) /RRB  110.2 -  Coordination With Medicaid  110.3 -  Coordination With A/B MACs (A)  and Providers  110.4 -  A/B MAC (B)  Contacts With Independent Clinical Laboratories
(Medicare Claims Processing Manual)
MACs (A) /RRB  110.2 -  Coordination With Medicaid  110.3 -  Coordination With A/B MACs (A)  and Providers  110.4 -  A/B MAC (B)  Contacts With Independent Clinical Laboratories  120- Clinical Laboratory Services Based on the Negotiated Rulemaking 120.1 -  Negotiated Rulemaking Implementation  120.2 -  Implementation and Updates of Negotiated National Coverage Determinations (NCDs) or Clinical Diagnostic Laboratory Services  Exhibit 1-  List of Diagnostic Tests that are Considered End Stage Renal Disease (ESRD)
(Medicare Claims Processing Manual)
10 - Background  (Rev. 1, 10-01-03) B3-2070, B3-2070.1, B3 -4110.3, B3-5114  Diagnostic X-ray, laboratory, and other diagnostic tests, including materials and the services of technicians, are covered under the Medicare program.  Some clinical laboratory procedures or tests require Food and Drug Administration (FDA) approval before coverage is provided.  A diagnostic laboratory test is considered a laboratory service for billing purposes, regardless of whether it is performed in:   A physicians office, by an independent laboratory;   By a hospital laboratory for its outpatients or nonpatients;   In a rural health clinic; or    In an HMO or Health Care Prepayment Plan (HCPP) for a patient who is not a member.  When a hospital laboratory performs laboratory tests for nonhospital patients, the laboratory is functioning as an independent laboratory, and still bills the A/B MAC (A).  Also, when physicians and laboratories perform the same test, whether manually or w ith automated equipment, the services are deemed similar.   Laboratory services furnished by an independent laboratory are covered under SMI if the laboratory is an approved Independent Clinical Laboratory.  However, as is the case of all diagnostic services, in order to be covered these services must be related to  a patients illness or injury (or symptom or complaint) and ordered by a physician.  A small number of laboratory tests can be covered as a preventive screening service.  See the Medicare Benefit Policy Manual, Chapter 15, for detailed coverage requirements.   See the Medicare Program Integrity Manual, Chapter 10, for laboratory/supplier enrollment guidelines.  See the Medicare State Operations Manual for laboratory/supplier certification requirements.   10.1 - Definitions  (Rev. 85, 02-06-04) B3-2070.1, B3-2070.1.B, RHC-406.4  Independent Laboratory - An independent laboratory is one that is independent both of an attending or consulting physicians office and of a hospital that meets at least the requirements to qualify as an emergency hospital as defined in 1861(e) of the Social Security Act (the Act.)  (See the Medicare Benefits Policy Manual, Chapter 15, for detailed discussion.)
(Medicare Claims Processing Manual)
of the Social Security Act (the Act.)  (See the Medicare Benefits Policy Manual, Chapter 15, for detailed discussion.)  Physician Office Laboratory - A physician office laboratory is a laboratory maintained by a physician or group of physicians for performing diagnostic tests in connection with the physician practice.  Clinical Laboratory - See the Medicare Benefits Policy Manual, Chapter 15.   Qualified Hospital Laboratory - A qualified hospital laboratory is one that provides some clinical laboratory tests 24 hours a day, 7 days a week, to serve a hospitals emergency room that is also available to provide services 24 hours a day, 7 days a week.  For the qualified hospital laboratory to meet this requirement, the hospital must have physicians physically present or available within 30 minutes through a medical staff call roster to handle emergencies 24 hours a day, 7 days a week; and hospital laboratory technologists must be on duty or on call at all times to provide testing for the emergency room.  "Hospital Outpatient -  See the Medicare Benefit Policy Manual, Chapter 2.   Referring laboratory - A Medicare- approved laboratory that receives a specimen to be tested and that refers the specimen to another laboratory for performance of the laboratory test.  Reference laboratory  - A Medicare- enrolled laboratory that receives a specimen from another, referring laboratory for testing and that actually performs the test.   Billing laboratory -  The laboratory that submits a bill or claim to Medicare.   Service  - A clinical diagnostic laboratory test.  Service and test are synonymous.  Test -  A clinical diagnostic laboratory service.  Service and test are synonymous.  CLIA  - The Clinical Laboratory Improvement Act and CMS implementing regulations and processes.  Certification  - A laboratory that has met the standards specified in the CLIA.   Draw Station -  A place where a specimen is collected but no Medicare- covered clinical laboratory testing is performed on the drawn specimen.   Medicare -approved laboratory -  A laboratory that meets all of the enrollment standards as a Medicare provider including the certification by a CLIA certifying authority.  10.2 - General Explanation of Payment  (Rev.  3510, Issued: 04- 29-16, Effective:  10-01-16, Implementation; 10- 03-16)   Outpatient laboratory services can be paid in different ways:    Physician Fee Schedule;    101 percent of reasonable cost (critical access hospitals (CAH) only);
(Medicare Claims Processing Manual)
Outpatient laboratory services can be paid in different ways:    Physician Fee Schedule;    101 percent of reasonable cost (critical access hospitals (CAH) only);   NOTE: When the CAH bills a 14X bill type for a non- patient laboratory specimen, the CAH is paid under the fee schedule.    Laboratory Fee Schedule;    Outpatient Prospective Payment System, (OPPS) except for most hospitals in the State of Maryland that are subject to a waiver; or    Reasonable Charge   Annually, CMS distributes a list of codes and indicates the payment method. Carriers, FIs, and A/B MACs pay as directed by this list. Neither deductible nor coinsurance applies to HCPCS codes paid under the laboratory fee schedule.  The majority of outpati ent laboratory services are paid under the laboratory fee schedule or the OPPS.   Carriers, FIs and A/B MACs are responsible for applying the correct fee schedule for payment of clinical laboratory tests. FIs/AB MACs must determine which hospitals meet the criteria for payment at the 62 percent fee schedule. Only sole community hospital s with qualified hospital laboratories are eligible for payment under the 62 percent fee schedule. Generally, payment for diagnostic laboratory tests that are not subject to the clinical laboratory fee schedule is made in accordance with the reasonable charge or physician fee schedule methodologies (or at 101 percent of reasonable cost for CAHs).