LaboratoryPathology Specialty Manual by tck21090



        Cahaba Government Benefit Administrators, LLC
                                      Medicare Part B
             Alabama • Georgia • Tennessee • Mississippi
                                             June 2010
This instructional material was prepared as a service to the public and is not intended to
grant rights or impose obligations. This instructional material may contain references or
links to statutes, regulations or other policy materials. The information provided is only
intended to be a general summary. It is not intended to take the place of either the written
law or regulations. We encourage readers to review the specific statutes, regulations and
other interpretive materials for a full and accurate statement of their contents.

Cahaba GBA, LLC, their employees, and their staff make no representation, warranty, or
guarantee that this compilation of Medicare information is error-free, nor that the use of
this manual will prevent differences of opinion or disputes with the Medicare Contractor
as to the codes that are accepted or the amounts that will be paid to providers of services,
and will bear no responsibility for the results or consequences of the use of this manual.

The information in this handbook is date-sensitive, and portions of the handbook may not
be accurate or relevant due to changes in policies, procedures, and regulations. Users are
urged to refer to the CMS website and the Cahaba GBA, LLC website for the most
current Medicare policies, procedures and regulations.

Welcome to the Laboratory/Pathology Specialty Manual. Cahaba Government Benefit
Administrators (GBA), LLC, has developed this educational material to assist Medicare
Part B providers in locating laws, regulations, policies and other guidelines directly
related to your specialty.

CMS Internet Online Manual System (IOM)
Several of the website links in this manual will direct you to the Center’s for Medicare
and Medicaid Services (CMS) website to help assure that you will have the most current
information. In 2003, CMS transformed the CMS Program Manuals into a web user-
friendly presentation and renamed it the CMS Internet Online Manual System.

The CMS Internet Online Manual System is used by CMS program components,
partners, contractors, and State Survey Agencies to administer CMS programs. It offers
day-to-day operating instructions, policies, and procedures based on statutes, regulations,
guidelines, models and directives. The direct link to the CMS Internet Online Manual
System is

On the following page, you will locate several website links to various educational
materials. When you locate a topic that you would like to review and the reference is to
the CMS Internet Online Manual, please note the section number and click on the website
link. The website link will take you directly to the CMS Internet Online Manual,
publication and chapter. Scroll down and review the appropriate section number. After
reviewing, you will need to close the website link and return to this specialty manual.

Laboratory/Pathology Specialty Manual
Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15

Section 80            Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and
                     Other Diagnostic
Section 80.1          Clinical Laboratory Services
Section 80.1.1        Certification Changes
Section 80.1.2        Carrier Contacts With Independent Clinical Laboratories
Section 80.1.3        Independent Laboratory Service to a Patient in the Patient’s Home or
                     an Institution
Section 80.4          Coverage of Portable X-Ray Services Not Under the Direct
                     Supervision of a Physician
Section 80.4.1        Diagnostic X-Ray Tests
Section 80.4.2        Applicability of Health and Safety Standards
Section 80.4.3        Scope of Portable X-Ray Benefit
Section 80.4.4        Exclusions From Coverage as Portable X-Ray Services
Section 80.4.5        Electrocardiograms
Section 80.6          Requirements for Ordering and Following Orders for Diagnostic
Section 80.6.1        Definitions
Section 80.6.2        Interpreting Physician Determines a Different Diagnostic Test is
Section 80.6.3        Rules for Testing Facility to Furnish Additional Tests
Section 80.6.4        Rules for Testing Facility Interpreting Physician to Furnish Different
                     or Additional Tests
Section 80.6.5        Surgical/Cytopathology Exception
Section 90            X-Ray, Radium, and Radioactive Isotope Therapy
Section 100           Surgical Dressings, Splints, Casts, and Other Devices Used for
                     Reductions of Fractures and Dislocations

Pub. 100-03, National Coverage Determinations Manual, Chapter 1, Part 3
Section 190         Pathology and Laboratory
Section 190.1        Histocompatibility Testing
Section 190.2        Diagnostic Pap Smears
Section 190.3        Cytogenetic Studies
Section 190.4        Electron Microscope
Section 190.5 -     Sweat Test
Section 190.6        Hair Analysis
Section 190.7        Human Tumor Stem Cell Drug Sensitivity Assays
Section 190.8        Lymphocyte Mitogen Response Assays
Section 190.9        Serologic Testing for Acquired Immunodeficiency Syndrome (AIDS)
Section 190.10       Laboratory Tests - CRD Patients

Section 190.11        Home Prothrombin Time/International Normalized Ratio (PT/INR)
                     Monitoring for Anticoagulation Management – (Effective March 19,
Section 190.12        Urine Culture, Bacterial
Section 190.13        Human Immunodeficiency Virus (HIV) Testing (Prognosis Including
Section 190.14        Human Immunodeficiency Virus (HIV) Testing (Diagnosis)
Section 190.15        Blood Counts
Section 190.16        Partial Thromboplastin Time (PTT)
Section 190.17       Prothrombin Time (PT)
Section 190.18        Serum Iron Studies
Section 190.19        Collagen Crosslinks, Any Method
Section 190.20        Blood Glucose Testing
Section 190.21        Glycated Hemoglobin/Glycated Protein
Section 190.22        Thyroid Testing
Section 190.23        Lipid Testing
Section 190.24       Digoxin Therapeutic Drug Assay
Section 190.25        Alpha-fetoprotein
Section 190.26        Carcinoembryonic Antigen
Section 190.27       Human Chorionic Gonadotropin
Section 190.28       Tumor Antigen by Immunoassay – CA 125
Section 190.29        Tumor Antigen by Immunoassay CA 15-3/CA 27.29
Section 190.30        Tumor Antigen by Immunoassay CA 19-9
Section 190.31        Prostate Specific Antigen
Section 190.32        Gamma Glutamyl Transferase
Section 190.33        Hepatitis Panel/Acute Hepatitis Panel
Section 190.34        Fecal Occult Blood Test

Pub. 100-04, Medicare Claims Processing Manual, Chapter 16
Section 10          Background
Section 10.1        Definitions
Section 10.2        General Explanation of Payment
Section 20          Calculation of Payment Rates – Clinical Laboratory Test Fee
Section 20.1        Initial Development of Laboratory Fee Schedules
Section 20.2        Annual Fee Schedule Updates
Section 30          Special Payment Considerations
Section 30.1        Mandatory Assignment for Laboratory Tests
Section 30.1.1      Rural Health Clinics
Section 30.2        Deductible and Coinsurance Application for Laboratory Tests
Section 30.3        Method of Payment for Clinical Laboratory Tests – Place of
                    Service Variation
Section 30.4        Payment for Review of Laboratory Test Results by Physician
Section 40          Billing for Clinical Laboratory Tests
Section 40.1        Laboratories Billing for Referred Tests

Pub. 100-04, Medicare Claims Processing Manual, Chapter 16 (continued)

Section 40.1.1     Paper Claim Submission to Carriers
Section 40.1.2     Electronic Claim Submission to Carriers
Section 40.2       Payment Limit for Purchased Services
Section 40.4.1     Which Contractor to Bill for Laboratory Services Furnished to a
                   Medicare Beneficiary in a Skilled Nursing Facility (SNF)
Section 40.5       Rural Health Clinic (RHC) Billing
Section 50.1       Referring Laboratories
Section 50.2       Carrier Claims Processing – Physicians
Section 50.2.1     Assignment Required
Section 50.3.1     Hospital-Leased Laboratories
Section 50.3.2     Hospital Laboratory Services Furnished to Nonhospital Patients
Section 50.4       Reporting of Pricing Localities for Clinical Laboratory Services
Section 50.5       Jurisdiction of Laboratory Claims
Section 50.5.1     Jurisdiction of Referral Laboratory Services
Section 50.5.2     Examples of Reference Laboratory Jurisdiction Rules
Section 50.5.3     Recurring Update Notification Containing New Pricing File
                   Names and Retrieval Dates
Section 60.1       Specimen Collection Fee
Section 60.1.1     Physician Specimen Drawing
Section 60.1.2     Independent Laboratory Specimen Drawing
Section 60.1.3     Specimen Drawing for Dialysis Patients
Section 60.1.4     Coding Requirements for Specimen Collection
Section 60.2       Travel Allowance
Section 70.1       Clinical Laboratory Improvement Amendments (CLIA) –
Section 70.2       Billing (CLIA)
Section 70.3       Verifying CLIA Certification
Section 70.4       CLIA Numbers
Section 70.5       CLIA Categories and Subcategories
Section 70.6       Certificate for Physician-Performed Microscopy Procedures
Section 70.8       Certificate of Waiver
Section 70.9       CLIA License or Licensure Exemption
Section 70.10      CLIA Number Submitted on Form CMS-1500
Section 70.11      Reasons for Denial – Physician Office Laboratories Out-of-
Section 80         Issues Related to Specific Tests
Section 80.1       Screening Services
Section 80.2       Anatomic Pathology Services
Section 80.2.1     Technical Component (TC) of Physician Pathology Services to
                   Hospital Patients
Section 80.3       National Minimum Payment Amounts for Cervical or Vaginal
                   Smear Clinical Laboratory Tests
Section 80.4       Oximetry
Section 90         Automated Profile Tests and Organ/Disease Oriented Panels

Pub. 100-04, Medicare Claims Processing Manual, Chapter 16 (continued)

Section 90.1          Laboratory Tests Utilizing Automated Equipment
Section 90.1.1        Automated Test Listing
Section 90.2          Organ or Disease Oriented Panels
Section 90.3          Claims Processing Requirements for Panel and Profile Tests
Section 90.3.1        History Display (Contractors)
Section 90.3.2        Medicare Secondary Payer (MSP)
Section 90.4          Evaluating the Medical Necessity for Laboratory Panel CPT Codes
Section 90.5          Special Processing Considerations
Section 100           CPT Codes Subject to and Not Subject to the Clinical Laboratory
                      Fee Schedule
Section 100.2         Laboratory Tests Never Subject to the Fee Schedule
Section 100.3         Procedures Not Subject to Fee Schedule When Billed With Blood
Section 100.4         Not Otherwise Classified Clinical Laboratory Tests
Section 100.5.1       Tests Performed More Than Once on the Same Day
Section 100.6         Pricing Modifiers
Section 110.1         Coordination between Carriers and FIs/RRB
Section 110.2         Coordination with Medicaid
Section 110.3         Coordination with FIs and Providers
Section 110.4         Carrier Contacts with Independent Clinical Laboratories
Section 120           Clinical Laboratory Services Based on the Negotiated Rulemaking
Section 120.1         Negotiated Rulemaking Implementation
Section 120.2         Implementation and Updates of Negotiated National Coverage
                      Determinations (NCDs) for Clinical Diagnostic Laboratory

Pub. 100-04, Medicare Claims Processing Manual, Chapter 30
Section 40.3        Advance Beneficiary Notice Standards

CMS - Beneficiary Notice Initiative (BNI)
      BNI Overview
      Fee for Service Revised Advanced Beneficiary Notice of Noncoverage (ABN)

CMS – Laboratory National Coverage Determinations (NCDs)

CMS – Local Coverage Determinations (LCDs)

CMS – Clinical Laboratory Improvement Amendments (CLIA)
     How to Apply for a CLIA Certificate
     CLIA Brochures

New Waived Tests – Medicare Learning Network Matters Article (MM 6906)

Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded
from Clinical Laboratory Improvement Amendments (CLIA) Edits

National Correct Coding Initiatives Edits

Medically Unlikely Edits (MUE)

Cahaba GBA – Fee Schedules

Clinical Lab Fee Schedule

Clinical Laboratory Fee Schedule (CLFS) – Medical Travel Allowance Fees for
Collection of Specimens

Medicare B Newsline Articles
Pathology and Laboratory: B-type Natriuretic Peptide (BNP) Testing

Place of Service (POS) and Date of Service (DOS) Instructions for Interpretation of
Diagnostic Tests

Clinical Laboratory Fee Schedule (CLFS) - Special Instructions for Specific Test Codes
(CPT Code 80100, CPT Code 80101, CPT Code 80101QW, G0430, G0430QW, and

Diagnostic Procedures/Laboratory Modifiers

Claim Rejection for Procedure Code Requires Referring

Medicare Leaning Network (MLN) Matters Articles

MM6964         Changes to the Laboratory National Coverage Determination (NCD) Edit
               Software for July 2010

MM6698         Signature Guidelines for Medical Review Purposes

MM6864         Clinical Laboratory Fee Schedule (CLFS) - Medicare Travel Allowance
               Fees for Collection of Specimens

MM6852         Clinical Laboratory Fee Schedule (CLFS) - Special Instructions for
               Specific Test Codes (CPT Code 80100, CPT Code 80101, CPT Code
               80101QW, G0430, G0430QW, and G0431QW)

MM6813         Legislation to Allow Independent Laboratory Billing for the Technical
               Component of Physician Pathology Services for Hospital Inpatients and

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