LCD Reference Article Response To Comments Article

Response to Comments: Urine Drug Testing

A59581

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Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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Source Article ID
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Article ID
A59581
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Urine Drug Testing
Article Type
Response to Comments
Original Effective Date
12/24/2023
Revision Effective Date
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Revision Ending Date
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CMS National Coverage Policy

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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Urine Drug Testing LCD. The official notice period for the final LCD begins on November 9, 2023, and the final determination will become effective on December 24, 2023.

Response To Comments

Number Comment Response
1

One commenter stated: Low risk should be tested 4 times a year.

Moderate to high- should be tested 8 to 12 times a year. These medications are addictive and should have a high expectation of monitoring- especially for those who have chronic pain and are not a candidate for surgery.

The bottom line is- if we don’t test appropriately abuse will not be discovered timely.

NGS disagrees. As noted in the LCD, the frequency of testing is based on national recommendations listed in the bibliography. In addition the policy notes:

Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical situations in which changes in prescribed medications may be needed, such as:

  • Patient response to prescribed medication suddenly changes;
  • Patient side effect profile changes;
  • To assess for possible drug-drug interactions;
  • Change in patient’s medical condition or behavior;
  • Patient admits to use of illicit or non-prescribed controlled substance.

Also, LCDs are based on the best available medical evidence, not personal experience. The submitter failed to submit any peer-reviewed medical literature published on PubMed to support this.

2

The American Clinical Laboratory Association noted:

“…specific documentation requirements often lead to inefficiencies and difficulties in obtaining this information from the ordering practitioner. ACLA-member laboratories make significant efforts to educate ordering clinicians on coverage requirements and comply with records requests related to the adjudication of claims. However, laboratories often struggle to obtain medical documentation from health care practitioners to support the medical necessity of tests that they perform pursuant to the health care practitioners’ orders and for which the laboratories submit claims.

“The ordering health care provider creates and maintains the documentation about a patient encounter that supports the medical necessity of a test, yet the performing laboratory’s reimbursement is at stake when the documentation is not produced or is insufficient.”

NGS disagrees. The submission of appropriate documentation is a National Medicare requirement found in multiple places in the Internet Only Manuals and in other Federal sources:

100-01 Medicare General Information, Eligibility, and Entitlement Chapter 1 - General Overview

60.4 - Statutory Obligations of Practitioners and Other Persons (Rev. 1, 09-11-02) It is the obligation of any health care practitioner or other person who furnishes or orders health care items or services that may be reimbursed under Medicare, to ensure that to the extent of his or her authority, those services are:

  • Furnished economically and only when and to the extent medically necessary;
  • Of a quality that meets professionally recognized standards of health care; and
  • Supported by evidence of the medical necessity and quality of the services in the form and fashion that the reviewing PRO may reasonably require (including copies of the necessary documentation) to ensure that the practitioner or other person is meeting the obligations imposed by Section 1156(a) of the Act.

IOM 100-08 Medicare Program Integrity Manual, Chapter 3, Sections, 3.2.3.3 and 3.2.3.7

3.2.3.7 - Special Provisions for Lab Additional Documentation Requests

When the MACs, CERT, RACs, and UPICs send an ADR for a lab service, the following documentation shall be requested from the billing lab:

  • The order for the service billed (including sufficient information to allow the reviewer to identify and contact the ordering provider);
  • Verification of accurate processing of the order and submission of the claim; and
  • Diagnostic or other medical information supplied to the lab by the ordering provider, including any diagnosis codes or narratives.

The contractor shall deny the claim if a benefit category, statutory exclusion, or coding issue is in question, or send an ADR to the ordering provider in order to determine medical necessity. The contractor shall review information from the lab and find it insufficient before the ordering provider is contacted. The contractor shall send an ADR to the ordering provider that shall include sufficient information to identify the claim in question. If the documentation received does not demonstrate that the service was reasonable and necessary, the contractor shall deny the claim.

Social Security Act §1156 (ssa.gov)

OBLIGATIONS OF HEALTH CARE PRACTITIONERS AND PROVIDERS OF HEALTH CARE SERVICES; SANCTIONS AND PENALTIES; HEARINGS AND REVIEW

Sec. 1156. [42 U.S.C. 1320c–5] (a) It shall be the obligation of any health care practitioner and any other person (including a hospital or other health care facility, organization, or agency) who provides health care services for which payment may be made (in whole or in part) under this Act, to assure, to the extent of his authority that services or items ordered or provided by such practitioner or person to beneficiaries and recipients under this Act—

(1) will be provided economically and only when, and to the extent, medically necessary;

(2) will be of a quality which meets professionally recognized standards of health care; and

(3) will be supported by evidence of medical necessity and quality in such form and fashion and at such time as may reasonably be required by a reviewing quality improvement[230] organization in the exercise of its duties and responsibilities.

U.S. Code Title 42 Chapter 7 SUBCHAPTER XI Part B

42 U.S. Code § 1320c–5 - Obligations of health care practitioners and providers of health care services; sanctions and penalties; hearings and review

(a) Assurances regarding services and items ordered or provided by practitioner or provider

It shall be the obligation of any health care practitioner and any other person (including a hospital or other health care facility, organization, or agency) who provides health care services for which payment may be made (in whole or in part) under this chapter, to assure, to the extent of his authority that services or items ordered or provided by such practitioner or person to beneficiaries and recipients under this chapter—

(1) will be provided economically and only when, and to the extent, medically necessary;

(2) will be of a quality which meets professionally recognized standards of health care; and

(3) will be supported by evidence of medical necessity and quality in such form and fashion and at such time as may reasonably be required by a reviewing quality improvement organization in the exercise of its duties and responsibilities.

 

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L39611 - Urine Drug Testing
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Public Versions
Updated On Effective Dates Status
11/03/2023 12/24/2023 - N/A Currently in Effect You are here

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