Local Coverage Determination for Assays for …

1 Contractor NameContract TypeContract NumberJurisdictionState(s)Novitas Solutions, and B MAC04111 - MAC AJ - HColoradoNovitas Solutions, and B MAC04112 - MAC BJ - HColoradoNovitas Solutions, and B MAC04211 - MAC AJ - HNew MexicoNovitas Solutions, and B MAC04212 - MAC BJ - HNew MexicoNovitas Solutions, and B MAC04311 - MAC AJ - HOklahomaNovitas Solutions, and B MAC04312 - MAC BJ - HOklahomaNovitas Solutions, and B MAC04411 - MAC AJ - HTexasNovitas Solutions, and B MAC04412 - MAC BJ - HTexasNovitas Solutions, and B MAC04911 - MAC AJ - HColoradoNew MexicoOklahomaTexasNovitas Solutions, and B MAC07101 - MAC AJ - HArkansasNovitas Solutions, and B MAC07102 - MAC BJ - HArkansasNovitas Solutions.

2 And B MAC07201 - MAC AJ - HLouisianaNovitas Solutions, and B MAC07202 - MAC BJ - HLouisianaNovitas Solutions, and B MAC07301 - MAC AJ - HMississippiNovitas Solutions, and B MAC07302 - MAC BJ - HMississippiNovitas Solutions, and B MAC12101 - MAC AJ - LDelawareNovitas Solutions, and B MAC12102 - MAC BJ - LDelawareNovitas Solutions, and B MAC12201 - MAC AJ - LDistrict of ColumbiaNovitas Solutions, and B MAC12202 - MAC BJ - LDistrict of ColumbiaNovitas Solutions, and B MAC12301 - MAC AJ - LMarylandNovitas Solutions, and B MAC12302 - MAC BJ - LMarylandNovitas Solutions, and B MAC12401 - MAC AJ - LNew JerseyNovitas Solutions, and B MAC12402 - MAC BJ - LNew JerseyNovitas Solutions, and B MAC12501 - MAC AJ - LPennsylvaniaNovitas Solutions, and B MAC12502 - MAC BJ - LPennsylvaniaNovitas Solutions, and B MAC12901 - MAC AJ - LDistrict of ColumbiaDelawareMarylandNew JerseyPennsylvaniaLCD IDL34914 LCD TitleAssays for Vitamins and Metabolic FunctionOriginal Effective DateFor services performed on or after 10/01/2015 Revision Effective DateFor services performed on or after 10/01/2016 Local Coverage Determination (LCD): Assays for Vitamins and Metabolic Function (L34914)Links in PDF documents are not guaranteed to work.

3 To follow a web link, please use the MCD InformationBack to TopLCD InformationDocument InformationPrinted on 1/12/2017. Page 1 of 20 AMA CPT / ADA CDT / AHA NUBC Copyright StatementCPT only copyright 2002-2017 American MedicalAssociation. All Rights Reserved. CPT is a registeredtrademark of the American Medical FARS/DFARS Apply to Government Use. Feeschedules, relative value units, conversion factorsand/or related components are not assigned by theAMA, are not part of CPT, and the AMA is notrecommending their use. The AMA does not directly orindirectly practice medicine or dispense medicalservices. The AMA assumes no liability for datacontained or not contained Code on Dental Procedures and Nomenclature(Code) is published in Current Dental Terminology(CDT).

4 Copyright American Dental Association. Allrights reserved. CDT and CDT-2016 are trademarks ofthe American Dental Manual. OFFICIAL UB-04 DATA SPECIFICATIONSMANUAL, 2014, is copyrighted by American HospitalAssociation ( AHA ), Chicago, Illinois. No portion ofOFFICIAL UB-04 MANUAL may be reproduced, sorted ina retrieval system, or transmitted, in any form or byany means, electronic, mechanical, photocopying,recording or otherwise, without prior express, writtenconsent of AHA. Health Forum reserves the right tochange the copyright notice from time to time uponwritten notice to Ending DateN/ARetirement DateN/ANotice Period Start Date06/16/2016 Notice Period End Date08/03/2016 Medicare Benefit Policy Manual Pub.

5 100-02. Chapter 6, Section Outpatient Diagnostic Services andChapter 15, Section Clinical Laboratory Services. Medicare National Coverage Determinations Manual Pub. 100-03, Chapter 1, Part 4, Section for use in the Treatment of Carnitine Deficiency in ESRD Patients. Medicare Claims Processing Manual Pub. 100-04, Chapter 16 Laboratory Services and Chapter 23,Section 10 Reporting ICD Diagnosis and Procedure codes and Section 40 Clinical Diagnostic Laboratory FeeSchedule. Correct Coding Initiative Medicare Contractor Beneficiary and Provider Communications Manual , Chapter 5 Correct Coding Initiative. Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall bemade for items or services which are not reasonable and necessary for the diagnosis or treatment ofillness or injury.

6 Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physicalexaminations. Title XVIII of the Social Security Act, Section 1862(a)(1)(D) states that no payment shall be made for anyservices that are considered investigational or experimental. Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to anyprovider for any claim that lacks the necessary information to process the National Coverage Policy This LCD supplements but does not replace, modify or supersede existing Medicareapplicable National Coverage Determinations (NCDs) or payment policy rules and regulations for vitamins andmetabolic function assay services.

7 Federal statute and subsequent Medicare regulations regarding provision andpayment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policyrules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or otherhealth practice professions acts, definitions and/or scopes of practice. All providers who report services forMedicare payment must fully understand and follow all existing laws, regulations and rules for Medicare paymentfor vitamins and metabolic function assay services and must properly submit only valid claims for them. Pleasereview and understand them and apply the medical necessity provisions in the policy within the context of themanual rules.

8 Relevant CMS manual instructions and policies regarding vitamins and metabolic function assayservices are found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:Social Security Act (Title XVIII) Standard References:Printed on 1/12/2017. Page 2 of 20 Assays of selenium (84255) Functional intracellular analysis (84999) Total antioxidant function (84999) Assays of vitamin testing, not otherwise classified* (84591) Noncovered as described above (84255, 84999, 84591) Diagnosis to procedure limitations only (86352) Frequency limitations* only (82180, 84252, 84425, 84446, 84590, 84597) Diagnosis to procedure and frequency limitations* (82306, 82652, 82379, 82607, 82746, 83090, 84207,85385, 83698) Coverage GuidanceCoverage Indications, Limitations, and/or Medical NecessityNotice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) asif they are covered.

9 When billing for non-covered services, use the appropriate with the provisions in this policy may be monitored and addressed through post payment dataanalysis and subsequent medical review generally considers vitamin assay panels (more than one vitamin assay ) a screening procedure andtherefore, non-covered. Similarly, Assays for micronutrient testing for nutritional deficiencies that include multipletests for vitamins, minerals, antioxidants and various metabolic functions are never necessary. Medicarereimburses for covered clinical laboratory studies that are reasonable and necessary for the diagnosis ortreatment of an illness. Many vitamin deficiency problems can be determined from a comprehensive history andphysical examination.

10 Any diagnostic evaluation should be targeted at the specific vitamin deficiency suspectedand not a general screen. Most vitamin deficiencies are nutritional in origin and may be corrected withsupplemented vitamin deficiencies are suggested by specific clinical findings. The presence of those specific clinical findingsmay prompt laboratory testing for evidence of a deficiency of that specific vitamin. Certain other clinical statesmay also lead to vitamin deficiencies (malabsorption syndromes, etc).Limitations:For Medicare beneficiaries, screening tests are governed by statute. Vitamin or micronutrient testing may not beused for routine a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensureadequate replacement has been accomplished.