Laboratory Tests Chronic Renal Deficiency (CRD) Patients (NCD )

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Policy Number 190.10 Approved By UnitedHealthcare Medicare Reimbursement Policy Committee Current Approval Date 03/26/2014 IMPORTANT NOTE ABOUT THIS REIMBURSEMENT POLICY This policy is applicable to UnitedHealthcare Medicare Advantage Plans offered by UnitedHealthcare and its affiliates. You are responsible for submission of accurate claims. This reimbursement policy is intended to ensure that you are reimbursed based on the code or codes that correctly describe the health care services provided. UnitedHealthcare reimbursement policies use Current Procedural Terminology (CPT *), Centers for Medicare and Medicaid Services (CMS), or other coding guidelines. References to CPT or other sources are for definitional purposes only and do not imply any right to reimbursement. This reimbursement policy applies to all health care services billed on CMS 1500 forms and, when specified, to those billed on UB04 forms (CMS 1450). Coding methodology, industry-standard reimbursement logic, regulatory requirements, benefits design and other factors are considered in developing reimbursement policy. This information is intended to serve only as a general resource regarding UnitedHealthcare s reimbursement policy for the services described and is not intended to address every aspect of a reimbursement situation. Accordingly, UnitedHealthcare may use reasonable discretion in interpreting and applying this policy to health care services provided in a particular case. Further, the policy does not address all issues related to reimbursement for health care services provided to UnitedHealthcare enrollees. Other factors affecting reimbursement may supplement, modify or, in some cases, supersede this policy. These factors may include, but are not limited to: legislative mandates, the physician or other provider contracts, and/or the enrollee s benefit coverage documents. Finally, this policy may not be implemented exactly the same way on the different electronic claims processing systems used by UnitedHealthcare due to programming or other constraints; however, UnitedHealthcare strives to minimize these variations. UnitedHealthcare may modify this reimbursement policy at any time by publishing a new version of the policy on this Website. However, the information presented in this policy is accurate and current as of the date of publication. *CPT copyright 2010 (or such other date of publication of CPT) American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Proprietary information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Table of Contents Application...1 Summary...2 Overview...2 Reimbursement Guidelines...3 CPT/HCPCS Codes...3 References Included (but not limited to):...5 CMS NCD(s)...5 CMS LCD(s)...5 CMS Benefit Policy Manual...5 CMS Claims Processing Manual...5 UnitedHealthcare Medicare Advantage Coverage Summaries...5 UnitedHealthcare Reimbursement Policies...5 UnitedHealthcare Medical Policies...5 MLN Matters...5 History...5 Application This reimbursement policy applies to services reported using the Health Insurance Claim Form CMS-1500 or its electronic equivalent or its successor form, and services reported using facility claim form CMS-1450 or its Proprietary information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Page 1

electronic equivalent or its successor form. This policy applies to all products, all network and non-network physicians, and other health care professionals. The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing UnitedHealthcare. It is not enough to link the procedure code to a correct, payable ICD-9-CM diagnosis code. The diagnosis must be present for the procedure to be paid. Compliance with the provisions in this policy is subject to monitoring by pre-payment review and/or post-payment data analysis and subsequent medical review. The effective date of changes/additions/deletions to this policy is the committee meeting date unless otherwise indicated. CPT codes and descriptions are copyright 2010 American Medical Association (or such other date of publication of CPT). All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS restrictions apply to Government use. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. Current Dental Terminology (CDT), including procedure codes, nomenclature, descriptors, and other data contained therein, is copyright by the American Dental Association, 2002, 2004. All rights reserved. CDT is a registered trademark of the American Dental Association. Applicable FARS/DFARS apply. Summary Overview Laboratory tests are essential to monitor the progress of CRD patients. The following list and frequencies of tests constitute the level and types of routine laboratory tests that are covered. Bills for other types of tests are considered non-routine. Routine tests at greater frequencies must include medical justification. Nonroutine tests generally are justified by the diagnosis. A. The routinely covered regimen includes the following tests: 1. Per Dialysis o All hematocrit or hemoglobin and clotting time tests furnished incident to dialysis treatments. 2. Per Week o Prothrombin time for patients on anticoagulant therapy o Serum Creatinine 3. Per Week or Thirteen Per Quarter o BUN 4. Monthly o CBC o Serum Calcium o Serum Potassium o Serum Chloride o Serum Bicarbonate o Serum Phosphorous o Total Protein o Serum Albumin o Alkaline Phosphatase o AST, SGOT o LDH B. Guidelines for tests other than those routinely performed include: 1. Serum Aluminum - one every 3 months 2. Serum Ferritin - one every 3 months C. The following tests for hepatitis B are covered when patients first enter a dialysis facility: 1. Hepatitis B surface antigen (HBsAg) 2. Anti-HBs Proprietary information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Page 2

Frequency of Screening Vaccination Status Serologic Status HBsAG Patients Anti-HBs Patients Unvaccinated Susceptible Monthly Semiannually Unvaccinated HBsAg Carrier Annually None Unvaccinated Anti-HBs-Positive 1 None Annually Vaccinated Anti-HBs-Positive 1 None Annually Vaccinated Low Level or No Anti- Monthly Semiannually HBs 1 At least 10 sample ration units by radioimmunoassay or positive by enzyme immunoassay Patients who are in the process of receiving hepatitis B vaccines, but have not received the complete series, should continue to be routinely screened as susceptible. Between one and six months after the third dose, all vaccines should be tested for anti-hbs to confirm their response to the vaccine. Patients who have a level of anti-hbs of at least 10 sample ratio units (SRUs) by radioimmunoassay (RIA) or who are positive by enzyme immunoassay (EIA) are considered adequate responders to vaccine and need only be tested for anti-hbs annually to verify their immune status. If anti-hbs drops below 10 SRUs by RIA or is negative by EIA, a booster dose of hepatitis B vaccine should be given. D. Laboratory tests are subject to the normal coverage requirements. If the laboratory services are performed by a free-standing facility; be sure it meets the conditions of coverage for independent laboratories. Reimbursement Guidelines Coverage of future testing in these patients depends on their serologic status and on whether they have been successfully immunized against hepatitis B virus. The following table summarizes the frequency of serologic surveillance for hepatitis B. Tests furnished according to this table do not require additional documentation and are paid separately because payment for maintenance dialysis treatments does not take them into account. CPT/HCPCS Codes Code Description 80047 Basic metabolic panel (Calcium, ionized) This panel must include the following: Calcium, ionized (82330) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Potassium (84132) Sodium (84295) Urea Nitrogen (BUN) (84520) (Non-covered When Submitted With Screening 80048 Basic metabolic panel (Calcium, total) This panel must include the following: Calcium, total (82310) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Potassium (84132) Sodium (84295) Urea nitrogen (BUN) (84520) (Non-covered When Submitted With Screening 80050 General health panel This panel must include the following: Comprehensive metabolic panel (80053) Blood count, complete (CBC), automated and automated differential WBC count (85025 or 85027 and 85004) OR Blood count, complete (CBC), automated (85027) and appropriate manual differential WBC count (85007 or 85009) Thyroid stimulating hormone (TSH) (84443) (Never Covered) 80051 Electrolyte panel This panel must include the following: Carbon dioxide (bicarbonate) (82374) Chloride (82435) Potassium (84132) Sodium (84295) (Non-covered When Submitted With Screening 80053 Comprehensive metabolic panel This panel must include the following: Albumin (82040) Bilirubin, total (82247) Calcium, total (82310) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Phosphatase, alkaline (84075) Potassium (84132) Protein, total (84155) Sodium (84295) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST) (SGOT) (84450) Urea nitrogen (BUN) (84520). (Non-covered When Submitted With Screening ) Proprietary information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Page 3

80069 Renal function panel This panel must include the following: Albumin (82040) Calcium, total (82310) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Phosphorus inorganic (phosphate) (84100) Potassium (84132) Sodium (84295) Urea nitrogen (BUN) (84520) (Non-covered When Submitted With Screening 80074 Acute hepatitis panel This panel must include the following: Hepatitis A antibody (HAAb), IgM antibody (86709) Hepatitis B core antibody (HBcAb), IgM antibody (86705) Hepatitis B surface antigen (HBsAg) (87340) Hepatitis C antibody (86803) (Lab NCD Dx Criteria Must Be Met) 80076 Hepatic function panel This panel must include the following: Albumin (82040) Bilirubin, total (82247) Bilirubin, direct (82248) Phosphatase, alkaline (84075) Protein, total (84155) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST) (SGOT) (84450) (Non-covered When Submitted With Screening 82040 Albumin; serum, plasma or whole blood. (Non-covered When Submitted With Screening 82108 Aluminum (*Non-covered When Submitted With Screening 82310 Calcium; total (*Non-covered When Submitted With Screening 82374 Carbon dioxide (bicarbonate). (Non-covered When Submitted With Screening 82435 Chloride; blood. (Non-covered When Submitted With Screening 82565 Creatinine; blood. (Non-covered When Submitted With Screening 82575 Creatinine; clearance (Non-covered When Submitted With Screening 82728 Ferritin (Lab NCD Dx Criteria Must Be Met) 83615 Lactate dehydrogenase (LD), (LDH) (Non-covered When Submitted With Screening 83625 Lactate dehydrogenase (LD), (LDH); isoenzymes, separation and quantitation. (Noncovered When Submitted With Screening 84075 Phosphatase, alkaline. (Non-covered When Submitted With Screening 84100 Phosphorus inorganic (phosphate) (Non-covered When Submitted With Screening 84132 Potassium; serum, plasma or whole blood. (Non-covered When Submitted With Screening 84155 Protein, total, except by refractometry; serum, plasma or whole blood. (Non-covered When Submitted With Screening 84295 Sodium; serum, plasma or whole blood. (Non-covered When Submitted With Screening 84450 Transferase; aspartate amino (AST) (SGOT). (Non-covered When Submitted With Screening 84520 Urea nitrogen; quantitative. (Non-covered When Submitted With Screening 84525 Urea nitrogen; semiquantitative (eg, reagent strip test) (Non-covered When Submitted With Screening 85014 Blood count; hematocrit (Hct). (Lab NCD Dx Criteria Must Be Met) 85018 Blood count; hemoglobin (Hgb) (Lab NCD Dx Criteria Must Be Met) 85025 Blood count; complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) and automated differential WBC count (Lab NCD Dx Criteria Must Be Met) 85027 Blood count; complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count). (Lab NCD Dx Criteria Must Be Met) Proprietary information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Page 4

85610 Prothrombin time (Lab NCD Dx Criteria Must Be Met) 85611 Prothrombin time; substitution, plasma fractions, each (Non-covered When Submitted With Screening 86706 Hepatitis B surface antibody (HBsAb) (Non-covered When Submitted With Screening 87340 Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple-step method; hepatitis B surface antigen (HBsAg) (Lab NCD Dx Criteria Must Be Met) 87341 Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple-step method; hepatitis B surface antigen (HBsAg) neutralization (Lab NCD Dx Criteria Must Be Met) References Included (but not limited to): CMS NCD(s) NCD 190.10 Laboratory Tests - CRD Patients Reference NCDs are numerous: See the Lab NCD Index CMS LCD(s) Numerous LCDs CMS Benefit Policy Manual Chapter 15, 80.1- Clinical Laboratory Services CMS Claims Processing Manual Chapter 16; 20 Calculation of Payment Rates, 30 Special Payment Considerations, 40 Billing for Clinical Laboratory Tests, 70 Clinical Laboratory Improvement Amendments (CLIA) Requirements UnitedHealthcare Medicare Advantage Coverage Summaries Dialysis Services Laboratory Tests and Services UnitedHealthcare Reimbursement Policies Preventive Lab Services UnitedHealthcare Medical Policies Hepatitis Screening MLN Matters Article MM8572, January 2014 Update of the Hospital Outpatient Prospective Payment System (OPPS) History Date Revisions 09/08/2014 Removed all GA/GY modifier language from document 03/26/2014 Annual review for MRP Committee presentation and approval 03/27/2013 Annual review for MRP Committee presentation and approval 12/14/2011 Administrative updates Proprietary information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Page 5