Clinical Diagnostic Laboratory Services - cms.gov

1 Clinical Diagnostic Laboratory Services Health & Human Services Department Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 CMS Email Point of Contact: TDD Fu Associates, Ltd. Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report January 2013 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report This is CMS Logo. Fu Associates, Ltd. *January 13 Changes Red ii January 2013 NCD Manual Changes Date Reason Release Change Edit 1 The following section represents NCD Manual updates for January *01/01/13 *There were no CR updates for January 2013.

2 The following section represents NCD Manual updates for October 2012. 10/01/12 There were no CR updates for October 2012. The following section represents NCD Manual updates for July 2012. 07/01/12 There were no CR updates for July 2012. The following section represents NCD Manual updates for April 2012. 04/01/12 ICD-9-cm code range and descriptors revised Disorders of the orbit, except Other exophthalmic conditions (underlining in original) 2012200 Endocrine exophthalmos Deformity of orbit Enophthalmos Retained (old) foreign body following penetrating wound of orbit Orbital cysts; myopathy of extraocular muscles Other orbital disorders Unspecified disorder of orbit ( ) Blood Counts The following section represents NCD Manual updates for January 2012.

3 01/01/12 Per CR 7621 add ICD-9-CM codes and to the list of ICD-9-CM codes that are covered by Medicare for the Prothrombin Time (PT) ( ) NCD. Transmittal # 2344 2012100 Chest pain, unspecified Precordial pain ( ) Prothrombin Time (PT) Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report This is CMS Logo. Fu Associates, Ltd. *January 13 Changes Red iii January 2013 Date Reason Release Change Edit 01/01/12 Per CR 7621 delete ICD-9-CM codes and from the list of ICD-9-CM codes that are covered by Medicare for the Alpha-fetoprotein ( ) NCD.

4 Transmittal # 2344 2012100 Hypertrophic obstructive cardiomyopathy Other hypertrophic cardiomyopathy ( ) Alpha-fetoprotein Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report This is CMS Logo. Fu Associates, Ltd. *January 13 Changes Red iv January 2013 Table of Contents Manual Changes .. ii Table of Contents .. iv Introduction .. 1 Non-covered ICD-9-CM Codes for All NCD Edits .. 4 Reasons for Denial for All NCD Edits .. 6 Coding Guidelines for All NCD Edits .. 7 Additional Coding Guidelines .. 8 - Urine Culture, Bacterial.

5 12 - Human Immunodeficiency Virus (HIV)Testing (Prognosis Including Monitoring) 18 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis) .. 20 - Blood Counts .. 28 - Partial Thromboplastin Time (PTT) .. 39 - Prothrombin Time (PT) .. 50 - Serum Iron Studies .. 65 - Collagen Crosslinks, Any 77 - Blood Glucose Testing .. 80 - Glycated Hemoglobin/Glycated Protein .. 87 - Thyroid Testing .. 91 - Lipids Testing .. 99 - Digoxin Therapeutic Drug Assay .. 106 - Alpha-fetoprotein .. 111 - Carcinoembryonic Antigen .. 114 - Human Chorionic Gonadotropin.

6 117 - Tumor Antigen by Immunoassay CA 125 .. 119 - Tumor Antigen by Immunoassay CA 15-3/CA .. 121 - Tumor Antigen by Immunoassay CA 19-9 .. 123 - Prostate Specific Antigen .. 125 - Gamma Glutamyl Transferase .. 128 - Hepatitis Panel/Acute Hepatitis Panel .. 140 - Fecal Occult Blood Test .. 144 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report This is CMS Logo. *January 13 Changes Red Fu Associates, Ltd. 1 January 2013 Introduction Background Section 4554(b)(1) of the Balanced Budget Act of 1997 (BBA), Public Law 105-33, mandated the use of a negotiated rulemaking committee to develop national coverage and administrative policies for Clinical Diagnostic Laboratory Services payable under Medicare Part B by January 1, 1999.

7 This provision requires that these national coverage policies be designed to promote program integrity and national uniformity and simplify administrative requirements with respect to Clinical Diagnostic Laboratory Services in connection with the following: Beneficiary information required to be submitted with each claim or order for Laboratory Services ; The medical condition for which a Laboratory test is reasonable and necessary (within the meaning of section 1862(a)(1)(A) of the Social Security Act); The appropriate use of procedure codes in billing for a Laboratory test, including the unbundling of Laboratory Services ; The medical documentation that is required by a Medicare contractor at the time a claim is submitted for a Laboratory test (in accordance with section 1833(e) of the Act); Record keeping requirements in addition to any information required to be submitted with a claim, including physicians obligations regarding these requirements.

8 Procedures for filing claims and for providing remittances by electronic media; and Limitations on frequency of coverage for the same Services performed on the same individual. On March 10, 2000, a proposed rule was published in the Federal Register (65 FR 13082) that set forth uniform national coverage and administrative policies for Clinical Diagnostic Laboratory Services . These proposed policies reflected the consensus of the Negotiated Rulemaking Committee. The final rule, published in the Federal Register on November 23, 2001 (66 FR 58788), addresses the public comments received on the proposed rule.

9 The final rule established the national coverage and administrative policies for Clinical Diagnostic Laboratory Services payable under Medicare Part B. It promotes Medicare program integrity and national uniformity, and simplifies administrative requirements for Clinical Diagnostic Services . There are 23 national coverage determinations included in the final rule listed below: Culture, Bacterial, Urine Human Immunodeficiency Virus Testing (Prognosis including monitoring) Human Immunodeficiency Virus Testing (Diagnosis) Blood Counts Partial Thromboplastin Time Prothrombin Time Serum Iron Studies Collagen Crosslinks, Any Method Blood Glucose Testing Glycated Hemoglobin/Glycated Protein Thyroid Testing Lipids Digoxin Therapeutic Drug Assay Alpha-fetoprotein Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report This is CMS Logo.

10 *January 13 Changes Red Fu Associates, Ltd. 2 January 2013 Carcinoembryonic Antigen Human Chorionic Gonadotropin Tumor Antigen by Immunoassay - CA125 Tumor Antigen by Immunoassay CA 15-3/CA Tumor Antigen by Immunoassay CA 19-9 Prostate Specific Antigen Gamma Glutamyl Transferase Hepatitis Panel/Acute Hepatitis Panel Fecal Occult Blood What Is a National Coverage Policy? Part B of title XVIII of the Social Security Act (the Act) provides for Supplementary Medical Insurance (SMI) for certain Medicare beneficiaries, specifying what health care items or Services will be covered by the Medicare Part B program.