Medicare Part B local coverage determination (LCD) comment summary

LCD Number


Contractor Name

First Coast Service Options, Inc.

Contractor Number

09102 - Florida
09202 - Puerto Rico
09302 - U.S. Virgin Islands

Contractor Type

MAC Part B

LCD Title

Qualitative Drug Screening

AMA CPT Copyright Statement

CPT codes, descriptions, and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

Start Date of Comment Period:


End Date of Comment Period:


Comments received:

Comment #1:    There is a state regulation for when qualitative drug screening (QDS) has to be performed.  The “Limitations” section of the LCD needs to be clearer in regards to codes allowed,

Contractor response:    This LCD addresses two issues, reasonable and necessary (R&N) and coding.  In regard to R&N, the documentation in the medical record must support the medical necessity of the test. We are aware of Florida state law that addresses regulations for pain clinics.  However, Contractors cannot create a screening benefit.

The issues with coding include the codes in the LCD are not specific to urine testing, and the intent of the LCD is to address the point of service testing (physician’s office) and that the billing should not be more than one unit of the equivalent of HCPCS code G0430 as opposed to multiple units of G0431 based on 2010 code descriptors.  CMS has changed the applicable codes for 2011 and the LCD will be revised to reflect this.


Comment #2:    Respiratory failure should be a covered diagnosis for this LCD. It is more appropriate that acidosis (ICD-9-CM code 276.2).  Many overdoses will end up intubated initially when a patient has respiratory acidosis.

Contractor response:    FCSO agrees this diagnosis code should be included in the covered ICD-9-CM codes in the LCD and will add diagnosis code 518.81 (Acute respiratory failure).


Comment #3:    A comment was made stating the proposed point of service limitation to the equivalent of CPT code 80100 or HCPCS code G0430 billed for one unit along with deeming multiple units HCPCS code G0431 not reasonable and necessary is not congruent with the Pain Clinic Standard of Care set by SB 2272 which was passed into law Oct. 2, 2010 by the State of FL. Reimbursement for CPT code G0431 or HCPCS code 80101 for each drug tested, which includes testing for urine sample adulteration, should be allowed. The pain physician should be covered for all urine drug tests required by law.

 Contractor response:    As noted in contractor response # 1, contractors cannot create a screening benefit.  Therefore, any urine drug test must be reasonable and necessary for each patient and supported in the documentation. Also, CMS changed the coding for some of the codes in the LCD. Of course FCSO will address any further clarification from CMS


Comment #4:    It was asked if the immunoassay would be covered in the office at a higher level of reimbursement. 

Contractor response:    The 2011 applicable HCPCS codes and pricing for laboratory fee schedule will be posted by CMS in the near future.  


Comment #5:      Will FCSO consider credentialing pain clinics?

Contractor response:    Credentialing is not an issue for this LCD and FCSO does not have the jurisdiction to do that. 


Comment #6:      Several comments were made about the standard of care (SOC) and that the SOC for urine drug testing is evolving.   The current LCD does not differentiate between the place of service and /or types of laboratories providing the testing, nor does it differentiate between the types of testing instruments that are being utilized.  There are two types of providers – those who perform testing in a physician’s office and those who perform moderately complex testing in a clinical laboratory.  These two service types should not be held to the same guidelines or reimbursement rates as the complexities of the services provided are different. It is recommended that FCSO recognize the differences in the place of service where the testing is performed, and reimburse accordingly for these services when finalizing the language of the LCD.  Also, a recommendation was made to change the last paragraph under the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD to read as follows:

·         “For management of patients under treatment of substance abuse or management of patients with chronic pain, there are multiple types of medically necessary testing, which, in concert with each other, comprise an emerging standard of care for urine drug testing (UDT). This configuration includes POC dipstick/cup testing, POC instrumented testing and reference/independent laboratory instrumented testing.”

Contractor response:     This language will not be adopted.  As far as the other comments, the intent of the LCD was to address point of service urine drug testing given it is the most frequently utilized qualitative drug testing in the office setting.  The language in the LCD will be modified to reflect this intent as well as the changes in the 2011 HCPCS codes.  Contractors do not have discretion to create codes or descriptors and the 2011 HCPCS/CPT codes will be incorporated in this LCD.  Pending further changes from CMS, the 2011 applicable codes distinguish between high complexity test method vs. CLIA waived or moderate complexity test.  Both codes are per patient encounter.  


Comment #7:    There were multiple comments related to the coding statements in the LCD and their pricing impacts.  For example, the LCD erroneously extends beyond its purview and puts forward a standard of care for physicians treating chronic pain patients.  It is not the purpose of an LCD to set standards for quality of care, or to ensure completeness of medical record documentation, or to act as a quality monitor.  It is not intended to prescribe medical practice or bar physicians from practicing in the best interest of their patients.  However, the LCD does just that – it obstructs pain management physicians from practicing pain management medicine in accordance with the Standards set forth by the FL Board of Medicine. 

This LCD is attempting to set the “standard of care” for point of service qualitative drug screening (QDS) and linking it to a specific billing methodology, without any consideration as to the method of point of service QDS utilized in testing of the specimen.  It appears CLIA drug screening, at point of service, via an immunoassay analyzer in a moderately complex physician’s office laboratory (POL) will soon be subject to the same reimbursement criteria being applied to CLIA-waived point of service testing.

It is requested that FCSO recognize the benefits of QDS performed in a CLIA moderately complex testing environment and allow for appropriate reimbursement based upon CPT code G0431 one unit for each analyte tested.

Contractor response:       As noted in response to comment # 6, language in the LCD has been amended and reference to standard of care has been removed.  The LCD addresses point of service urine drug testing given it is the most frequently utilized qualitative drug testing in the office setting.  There is no restriction on the physician’s ability to order medically reasonable and necessary reference lab tests.  As noted previously, the LCD addresses reasonable and necessary indications of Qualitative Drug Screening because the contractor cannot create a Medicare screening (preventive services) benefit.  Also, as noted in # 6 above, CMS changed the codes and descriptors.  Pending further changes from CMS, the 2011 applicable codes distinguish between high complexity test method vs. CLIA waived or moderate complexity test.  Both codes are per patient encounter.