Contractor Information. LCD Information. FUTURE Local Coverage Determination (LCD): Frequency of Laboratory Tests (L35099) Document Information

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1 FUTURE Local Coverage Determination (LCD): Frequency of Laboratory Tests (L35099) Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. Please note: Future Effective Date. Contractor Information Contractor Name Novitas Solutions, Inc. Contract Number Contract Type A and B MAC Jurisdiction J - H LCD Information Document Information L35099 Original ICD-9 LCD ID L32731 LCD Title Frequency of Laboratory Tests LCD ID AMA CPT / ADA CDT / AHA NUBC Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Jurisdiction Texas Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 10/01/2015 Revision Ending Date Retirement Date Notice Period Start Date Notice Period End Date Printed on 9/21/2015. Page 1 of 7

2 UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS MANUAL, 2014, is copyrighted by American Hospital Association ( AHA ), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL may be reproduced, sorted in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior express, written consent of AHA. Health Forum reserves the right to change the copyright notice from time to time upon written notice to Company. CMS National Coverage Policy This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for laboratory services. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for laboratory services and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies regarding laboratory services are found in the following Internet-Only Manuals (IOMs) published on the CMS Web site: Medicare Benefit Policy Manual Pub National Coverage Determination Manual Pub , Chapter 1, Section 190. National Coverage Determination Manual at Correct Coding Initiative Medicare Contractor Beneficiary and Provider Communications Manual Pub , Chapter 5. Social Security Act (Title XVIII) Standard References, Sections: 1862(a)(1)(A) Medically Reasonable & Necessary. 1862(a)(1)(D) Investigational or Experimental. 1862(a)(7) Screening (Routine Physical Checkups). 1833(e) Incomplete Claim. Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier. Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits. Sections 42 CFR and specify that for a laboratory service to be reasonable and necessary, it must not only be ordered by the physician, but the ordering physician must also use the result in the management of the beneficiary s specific medical problem. Implicitly, the laboratory result must be reported to the physician promptly for the physician to use the result and instruct continuation or modification of patient care; this includes the physician s order for another laboratory service. Compliance program guidance for laboratory services sets forth conditions under which a physician s order for a repeat laboratory service can qualify as an order for another covered laboratory service. A standing order is not acceptable documentation for a covered laboratory service. A glucose monitoring laboratory service must be performed in accordance with laboratory service coverage criteria including the order and clear use of a laboratory result prior to a similar subsequent laboratory order to qualify for separate payment under the Medicare laboratory benefit. Please note there are some specific relevant Medicare requirements with respect to glucose monitoring. Medicare Part B may pay for a glucose monitoring device and related disposable supplies under its durable medical equipment benefit if the equipment is used in the home or in an institution that is used as a home. A hospital or Skilled Nursing Facility (SNF) is not considered a home under this benefit (Section 1861(h) of the Social Security Act, 42 CFR ). Routine glucose monitoring of diabetics is never covered in an SNF, whether the beneficiary Printed on 9/21/2015. Page 2 of 7

3 is in a covered Part A stay or not. Glucose monitoring may only be covered when it meets all the conditions of a covered laboratory service, including use by the physician in modifying the patient s treatment. The following are the pertinent laboratory tests for which frequency limitations will be specified, noting that lipid, thyroid and glucose testing frequencies apply to analytes from the laboratory National Coverage Determination (NCD) via negotiated rulemaking: Lipids. Thyroid testing. Glucose testing. Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. As published in CMS IOM , , to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is: Safe and effective. Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, that meet the requirements of the clinical trials NCD are considered reasonable and necessary). Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is: Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member. Furnished in a setting appropriate to the patient's medical needs and condition. Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient's medical needs. At least as beneficial as an existing and available medically appropriate alternative. Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient 014x Hospital - Laboratory Services Provided to Non-patients 018x Hospital - Swing Beds 021x Skilled Nursing - Inpatient (Including Medicare Part A) 022x Skilled Nursing - Inpatient (Medicare Part B only) Printed on 9/21/2015. Page 3 of 7

4 023x Skilled Nursing - Outpatient 071x Clinic - Rural Health 072x Clinic - Hospital Based or Independent Renal Dialysis Center 085x Critical Access Hospital Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. Note: The contractor has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all the CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub , Claims Processing Manual, for further guidance. 030X Laboratory - General Classification CPT/HCPCS Codes Group 1 Paragraph: Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. Group 1 Codes: Lipid panel Assay bld/serum cholesterol Reagent strip/blood glucose Glucose blood test Assay of lipoprotein Assay of blood lipoprotein Assay of total thyroxine Assay of free thyroxine Assay thyroid stim hormone Assay of triglycerides Assay of thyroid (t3 or t4) ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: The CPT/HCPCS codes included in this LCD will be subjected to procedure to diagnosis editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary. Medicare is establishing the following limited coverage for CPT/HCPCS codes 80061, 82465, 82948, 82962, 83718, 83721, 84436, 84439, 84443, and 84479: Covered for: Refer to the NCDs for the procedure code list of ICD-10-CM codes that do not support medical necessity at: Group 1 Codes: ICD-10 Codes Description XX000 Not Applicable Printed on 9/21/2015. Page 4 of 7

5 ICD-10 Codes that DO NOT Support Medical Necessity ICD-10 Additional Information General Information Associated Information Documentation Requirements Documentation supporting medical necessity should be legible, maintained in the patient s medical record and made available to Medicare upon request. Refer to Appendices Utilization Guidelines Please note the Utilization Guidelines below only apply to diagnostic laboratory testing. The Utilization Guidelines below summarizes certain frequencies beyond which Medicare would consider further tests neither reasonable nor necessary. To support equitable implementation of such frequency limits, they will be applied on a per-beneficiary, per-provider basis to account for patients who may need to see different providers to best accommodate their needs. Certain tests may exceed the stated frequencies when accompanied by a diagnosis fitting the description in the column marked Acceptable Reasons (ICD-10-CM Codes) for Exceeding the LCD Maximum. Type of Lab Test (CPT Code) Lipids: Thyroid testing: LCD Frequency Limit (Per Beneficiary Per Provider) No more than every two months for any test (e.g., triglycerides, LDL cholesterol), whether in a panel or separately ordered Four times a year for most patients, except for selected endocrine presentations Acceptable Reasons (ICD-10-CM Codes) for Exceeding the LCD Maximum Inability to stabilize lipid-lowering drug dosing (Z79.899). Adverse reaction to lipid-lowering drug (Z79.899). Pancreatitis (B25.2, K85.0-K85.3, K85.8-K86.1). Inability to stabilize thyroid medication dosing. Thyrotoxicosis. Concurrent endocrinopathies. Hypothyroidism. Printed on 9/21/2015. Page 5 of 7

6 Type of Lab Test (CPT Code) LCD Frequency Limit (Per Beneficiary Per Provider) Acceptable Reasons (ICD-10-CM Codes) for Exceeding the LCD Maximum (Codes pertaining to the above bullets: D34, D51.0, D53.9, D64.9, D89.82, D89.89, E00.0-E00.2, E00.9, E01.8, E02, E03.0-E03.3, E03.8-E03.9, E05.00-E05.01, E E05.11, E05.20-E05.21, E05.30-E05.31, E05.40-E05.41, E05.80-E05.81, E E05.91, E06.0-E06.5, E06.9, E10.10-E10.11, E10.21-E10.22, E10.29, E10.311, E10.319, E10.321, E10.329, E10.331, E10.339, E10.341, E10.349, E10.351, E10.359, E10.36, E10.39-E10.44, E10.49, E10.51-E10.52, E10.59, E10.610, E10.618, E E10.622, E10.628, E10.630, E10.638, E10.641, E E10.65, E10.69, E10.8-E11.01, E11.21-E11.22, E11.29, E11.311, E11.319, E11.321, E11.329, E11.331, E11.339, E11.341, E11.349, E11.351, E E11.36, E E11.44, E11.49-E11.52, E11.59, E11.610, E11.618, E E11.622, E E11.630, E11.638, E11.641, E E11.65, E11.69, E11.8-E11.9, E E13.01, E13.10-E13.11, E13.21-E13.22, E13.29, E13.311, E13.319, E13.321, E13.329, E13.331, E13.339, E13.341, E13.349, E13.351, E E13.36, E E13.44, E13.49, E13.51-E13.52, E13.59, E13.610, E13.618, E E13.622, E13.628, E13.630, E13.638, E13.641, E E13.65, E13.69, E13.8-E13.9, E20.0 -E20.1, E20.8-E20.9, E23.0, E23.6, E25.0, E25.8-E25.9, E27.1-E27.40, E27.49, E78.0, E78.2, E83.50-E83.52, E83.59, E87.0-E87.1, E89.0, E89.2, E89.6, F03.90, F05, F30.10-F30.13, F30.2-F30.4, F30.8-F31.0, F31.10-F31.13, F31.2, F F31.32, F31.4-F31.5, F31.60-F31.64, F31.70-F31.78, F31.81, F31.89-F32.5, F32.8- F33.3, F33.40-F33.42, F33.8-F33.9, F34.8-F34.9, F39, F41.0-F41.1, F41.3, F41.8- F41.9, G73.7, H H02.536, H02.539, H H02.846, H02.849, H05.89, I47.1, I48.0, I48.2, I48.91, I49.2, I50.20-I50.23, I50.30-I50.33, I50.40-I50.43, I50.9, J91.8, K56.0, K56.7, N94.4-N94.6, Q38.2, R00.0, R00.2, R07.0, R40.0- R40.1, R40.4, R63.4-R63.5, R94.6, Z79.899) Glucose testing: Once per month Type I or Type II Diabetes with hyperglycemia/complications (E10.65, E10.8, E11.65, E11.8). Notice: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services. Sources of Information and Basis for Decision Other Contractor Local Coverage Determinations Original JH ICD-9 Source L32731, Frequency of Laboratory Tests Frequency of Laboratory Tests, TrailBlazer Health Enterprises LCD, (00400) L20354, (00900) L Novitas Solutions, Inc. JH Local Coverage Determination (LCD) Consolidation Narrative Justification Most Clinically Appropriate LCD LCDs Compared: L26817, Frequency of Laboratory Tests, TrailBlazer, CO, NM, OK, TX - A/B CMD Rationale: This is an LCD which represents a substantive area of Medicare program vulnerability importance, and, as such, this single MAC LCD should be extended to all of JH. In addition, this current LCD has a robust procedure-todiagnosis coding edit structure, which is well-correlated with text on clinical indications/limitations, and the LCD is also formatted to be Medical Review-friendly in the event of necessary post-pay reviews. L26817 is the most clinically appropriate LCD. Printed on 9/21/2015. Page 6 of 7

7 Revision History Information Please note: Most Revision History entries effective on or before 01/24/2013 display with a Revision History Number of "R1" at the bottom of this table. However, there may be LCDs where these entries will display as a separate and distinct row. Revision History Date 10/01/2015 R1 Revision History Number Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Revision History Explanation LCD revised and published on 05/14/2015 to correct typographical error in the diagnosis code area for thyroid testing. Reason(s) for Change Typographical Error Public Version(s) Updated on 05/07/2015 with effective dates 10/01/ Updated on 04/02/2014 with effective dates 10/01/ Keywords Read the LCD Disclaimer Printed on 9/21/2015. Page 7 of 7