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Local Coverage Determination (LCD)

Frequency of Laboratory Tests

L35099

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L35099
Original ICD-9 LCD ID
Not Applicable
LCD Title
Frequency of Laboratory Tests
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL35099
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 11/07/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
02/19/2016
Notice Period End Date
04/06/2016

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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.

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

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 may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations:

  • CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
    • Chapter 6, Section 20.4 Outpatient Diagnostic Services
    • Chapter 15, Section 80.1 Clinical Laboratory Services
  • CMS IOM Publication 100-03, National Coverage Determination Manual, Chapter 1, Part 3, Sections 190.20 Blood Glucose Testing, 190.21 Glycated Hemoglobin/Glycated Protein, 190.22 Thyroid Testing, and 190.23 Lipid Testing
  • CMS IOM Publication 100-04, Medicare Claims Processing Manual,
    • Chapter 16, Laboratory Services
    • Chapter 23, Section 10 Reporting ICD Diagnosis and Procedure codes and Section 40 Clinical Diagnostic Laboratory Fee Schedule
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Federal Register References:

  • 42 CFR, Section 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests
  • 42 CFR, Section 411.15 Particular services excluded from coverage
  • 42 CFR, Section 410.38 Durable medical equipment: Scope and conditions

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.

History/Background and/or General Information

Sections 42 CFR 410.32 and 411.15 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 410.38). Routine glucose monitoring of diabetics is never covered in an SNF, whether the beneficiary 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.

Limitations

The following are the pertinent laboratory tests for which frequency limitations will be specified, noting that lipid, thyroid, glycated hemoglobin/glycated protein, and glucose testing frequencies apply to analytes from the laboratory National Coverage Determination (NCD) via negotiated rulemaking:

  • Lipids
  • Thyroid testing
  • Glucose testing
  • Glycated hemoglobin/glycated protein

This LCD imposes frequency limitations. For frequency limitations please refer to the Utilization Guidelines section below.

Notice: 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. Refer to Billing and Coding: Frequency of Laboratory Tests, A56420, for applicable CPT codes and diagnosis codes.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements of this LCD.
Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
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Contractor Advisory Committee (CAC) Meetings
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Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
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Contact for Comments on Proposed LCD

Coding Information

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Revenue Codes

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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 Group 1 Codes:

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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 Group 1 Codes:

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Additional ICD-10 Information

General Information

Associated Information


Refer to Local Coverage Article: Billing and Coding: Frequency of Laboratory Tests, A56420, for all coding information.


Documentation Requirements

  1. All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The medical record documentation must support the medical necessity of the services as stated in this policy.


Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

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 for Exceeding the LCD Maximum." Refer to Billing and Coding: Frequency of Laboratory Tests, A56420, for CPT codes and a link to the NCDs for applicable ICD-10 codes. Lipid, thyroid, glycated hemoglobin/glycated protein, and glucose testing frequencies apply to analytes from the laboratory National Coverage Determination (NCD).

 

Type of Lab Test (CPT Code) LCD Frequency Limit (Per Beneficiary Per Provider) Acceptable Reasons for Exceeding the LCD Maximum
Lipids No more than every two months for any test (e.g., triglycerides, LDL cholesterol), whether in a panel or separately ordered
  • Inability to stabilize lipid-lowering drug dosing
  • Adverse reaction to lipid-lowering drug
  • Pancreatitis
  • Monitoring of acitretin (i.e., Soriatane) therapy

Thyroid testing

 Four times a year for most patients, except for selected endocrine presentations
  • Inability to stabilize thyroid medication dosing
  • Thyrotoxicosis
  • Concurrent endocrinopathies
  • Hypothyroidism

 
Glycated hemoglobin / glycolated protein Once per month as discussed in NCD 190.21
  • No diagnoses are to exceed this frequency but unusual circumstances can be reviewed in the appeals process.
Glucose testing Once per month
  • Type I or Type II Diabetes with hyperglycemia/complications


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

Contractor is not responsible for the continued viability of websites listed.

Original JH ICD-9 Source L32731, Frequency of Laboratory Tests

“Frequency of Laboratory Tests,” TrailBlazer Health Enterprises LCD, (00400) L20354, (00900) L14227.

Other Contractor Local Coverage Determinations

Contractor Medical Directors
Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
11/07/2019 R8

LCD revised and published on 11/07/2019. Consistent with CMS Change Request 10901, the entire coding section has been removed from the LCD and placed into the related Billing and Coding Article, A56420. All CPT codes and coding information within the text of the LCD has been placed in the Billing and Coding Article.
  • Other (CMS Change Request 10901)
03/28/2019 R7

LCD revised and published on 03/28/2019. The IOM Citation section was revised to add applicable manual reference and to remove the reference to NCCI since coding and billing information has been moved to the companion article. All billing and coding related information has been moved to companion article Billing and Coding: Frequency of Laboratory Tests, A56420, consistent with CMS Change Request (CR) 10901. There has been no change in content to the LCD.
  • Other (Change in LCD process per CMS CR 10901)
02/08/2018 R6

LCD revised and published on 02/08/2018. Per LCD Annual review, updates were made to the references in the “CMS National Coverage Policy” section. No change was made to the LCD coverage content.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; therefore, not all the fields included on the LCD are applicable as noted in this policy.
  • Other (LCD Annual Review)
10/01/2017 R5

LCD revised and published on 10/05/2017 effective for dates of service on and after 10/01/2017 to reflect the ICD-10 Annual Code Updates.  The following ICD-10 code(s) have been added to the table in the Utilization Guidelines section in the row titled “Thyroid testing: 84436, 84439, 84443, 84479”: E11.10, E11.11, I50.810, I50.811, I50.812, I50.813,  I50.814, I50.82, I50.83, I50.84, I50.89.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; therefore, not all the fields included on the LCD are applicable as noted in this policy.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2016 R4 LCD revised and published on 09/29/2016 effective for dates of service on and after 10/01/2016 to reflect the annual ICD-10 code update. The following ICD-10 codes listed in the Lipids row have been deleted; K85.0-K85.3, and K85.8. The following ICD-10 codes listed in the Thyroid row have been deleted; E10.321, E10.329, E10.331, E10.339, E10.341, E10.349, E10.351, E10.359, E11.321, E11.329, E11.331, E11.339, E11.341, E11.349, E11.351, E11.359, E13.321, E13.329, E13.331, E13.339, E13.341, E13.349, E13.351, E13.359, E78.0, F32.8, and F34.8. The following ICD-10 codes have been added to the Lipid testing row; K85.00, K85.01, K85.02, K85.10, K85.11, K85.12, K85.20, K85.21, K85.22, K85.30, K85.31, K85.32, K85.80, K85.81, K85.82, K85.90, K85.91, and K85.92. The following ICD-10 codes have been added to the Thyroid testing row; E10.3211, E10.3212, E10.3213, E10.3291, E10.3292, E10.3293, E10.3311, E10.3312, E10.3313, E10.3391, E10.3392, E10.3393, E10.3411, E10.3412, E10.3413, E10.3491, E10.3492, E10.3493, E10.3511, E10.3512, E10.3513, E10.3591, E10.3592, E10.3593, E11.3211, E11.3212, E11.3213, E11.3291, E11.3292, E11.3293, E11.3311, E11.3312, E11.3313, E11.3391, E11.3392, E11.3393, E11.3411, E11.3412, E11.3413, E11.3491, E11.3492, E11.3493, E11.3511, E11.3512, E11.3513, E11.3591, E11.3592, E11.3593, E13.3211, E13.3212, E13.3213, E13.3291, E13.3292, E13.3293, E13.3311, E13.3312, E13.3313, E13.3391, E13.3392, E13.3393, E13.3411, E13.3412, E13.3413, E13.3491, E13.3492, E13.3493, E13.3511, E13.3512, E13.3513, E13.3591, E13.3592, E13.3593, E78.00, F32.89, F34.81, and F34.89.
  • Revisions Due To ICD-10-CM Code Changes
04/07/2016 R3 LCD revised and published on 04/07/2016. In Indications, Limitations, and/or Medical Necessity section of LCD, chapter and section clarification made to CMS IOM 100-08 reference and notation added that italicized and/or quoted material is excerpted from the American Medical Association Current Procedural Terminology (CPT) codes. In Utilization Guidelines section, CPT codes listed in the Utilization Guidelines table italicized.
  • Other (Clarifications)
04/07/2016 R2 LCD posted for notice on 02/19/2016 to become effective 04/07/2016.

09/17/2015 DL35099 Draft LCD posted for comments
  • Creation of Uniform LCDs With Other MAC Jurisdiction
10/01/2015 R1 LCD revised and published on 05/14/2015 to correct typographical error in the diagnosis code area for thyroid testing.
  • Typographical Error
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11/01/2019 11/07/2019 - N/A Currently in Effect You are here
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