(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              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 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   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  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)     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.)  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);   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).   For Clinical Diagnostic Laboratory services denied due to frequency edits, the contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy.   This CARC/RARC combination is compliant with CAQH CORE Business Scenario Three.   Group Code: CO or PR  CARC: 151  RARC: N/A  MSN: N/A  20 - Calculation of Payment Rates - Clinical Laboratory Test Fee Schedules  (Rev. 4479; Issued: 12- 20-19 Effective: 01 -23-20, Implementation: 01- 23-20)  Section 216 of Public Law 113- 93, the Protecting Access to Medicare Act of 2014, added section 1834A to the Social Security Act (the Act). This provision requires extensive revisions to the payment and coverage methodologies for clinical laboratory tests  paid under the clinical laboratory fee schedule (CLFS). The Centers for Medicare & Medicaid Services (CMS) published CMS -1621- F Medicare Clinical Diagnostic Laboratory Tests Payment System, on June 23, 2016, which implemented the provisions of the new legislation.