Changes to Tests, CLIA for Medicare

The Centers for Medicare & Medicaid Services (CMS) provides special instructions for the proper use of CPT® codes 80100, 80101, 80101-QW, and HCPCS Level II codes G0430, G0430-QW, G0431, and G0431-QW as of April 1. The instructions impact both the lab fee schedule and list of waived tests.

Effective Jan. 1, two new G codes were established – G0430 Drug screen, qualitative; multiple drug classes other than chromatographic method, each procedure and G0431 Drug screen, qualitative; single drug class method (eg, immunoassay, enzyme assay), each drug class – as it had come to CMS’ attention that some companies were using questionable billing practices concerning CPT® codes 80100 and 80101. The G codes are meant to operate in place of and alongside 80100 Drug screen, qualitative; multiple drug classes chromatographic method, each procedure and 80101 Single drug class method (eg, immunoassay, enzyme assay), each drug class.

Clinical laboratories requiring a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver had been utilizing 80101-QW. Effective April 1, however, clinical laboratories requiring a CLIA certificate of waiver should use G0430-QW  and G0431-QW to bill correctly, whether the performed drug screen test is for a single drug class or multiple drug classes. The modifier QW CLIA waived test should be appended to codes used for CLIA waived tests.

2016 HCPCS Level

For purposes of the Clinical Laboratory Fee Schedule (CLFS), beginning April 1, when performing a qualitative drug screening test for multiple drug classes that use chromatographic methods, 80100 is the appropriate code to bill. New test code G0430 was created to limit the billing to one time per procedure and to remove the method’s (chromatographic) limitation when it’s not used in the performance of the test. As a result, when a clinical laboratory not requiring a CLIA certificate of waiver performs a qualitative drug screening test for multiple drug classes not using chromatographic methods, new test code G0430 is the appropriate code to bill. When a clinical laboratory requiring a CLIA certificate of waiver performs a qualitative drug screening test for multiple drug classes not using chromatographic methods, G0430-QW is the appropriate code to bill. New test code G0431 is a direct replacement for 80101. For purposes of the CLFS, beginning April 1, new test code G0431 should be utilized by those clinical laboratories that do not require a CLIA certificate of waiver. Clinical laboratories requiring a CLIA certificate of waiver should utilize new test code G0431-QW.

Effective April 1, code 80101 will no longer be covered by Medicare, and code 80101-QW will be deleted.

98 Responses to “Changes to Tests, CLIA for Medicare”

  1. says:

    UPDATE: PLEASE read the new CMS document regarding new codes for drug testing. G0430 QW is being replaced by 801XX and GXXX1 is being introduced to replace G0431QW. Analyzers could be obsolete come January 1 as the new code states per specimen, regardless of the number of classes and other than chromatographic. If you haven’t seen this document email me and I will send you one. Good luck, Keith

  2. TenaK says:

    G0431 with 4 units is denying as too many units now.

  3. JJP says:

    Keith. great point about the new codes for 2011. with all the push to thwart drug abuse, diversion, and compliance—restricting reimbursement for physicians to properly treat their patients seems to be a step backwards. however, we are talking about the government here. the fate of analyzer has yet to be determined. i would imagine the steps needed to upgrade your CLIA license and the strict guidelines needed to keep your license is something being highly considered amongst the thinktankers. many physicians do all kinds of testing as CLIA lab in their practice. the new code states per specimen meaning a practice will have to get multiple specimens in order to be reimbursed for multiple panels. talk about opening a door!! wow…. i can’t imagine the fraud that’s going to come from this one.

  4. Randi says:

    Keith- can you provide the link to the CMS document regarding the new coding- I am not seeing that on First Coast- thanks

  5. Leslie Johnson says:

    See Palmetto, OH (also true for SC & WV)

    “For HCPCS code G0431, only one test per episode of care will be allowed because Palmetto GBA does not consider multiple individual tests to be medically necessary when a single testing item to screen for all drug classes is available.”

    Per CMS:
    “G0431 – Drug screen, qualitative; single drug class method (e.g., immunoassay, enzyme assay), each drug class; and

    G0431QW – Drug screen, qualitative; single drug class method (e.g., immunoassay, enzyme assay), each drug class.”

    Cigna Gov’t Services – see page 4 – Directs us to use single-line item billing with an appropriate modifier when more than a single test is performed.

    Effective for services performed on or after 10/01/2010, First Coast has a new LCD:

    Here’s National Gov’t Services for Upstate NY:

    Don’t forget, we have to make sure our diagnoses match the procedures. I know we’re talking about per-unit billing here but it’s something we need to look at as well.

    The descriptor of the code: “each” . If you see “each” on any other CPT code, what do you do? Do you code it per quantity or do you code it per line-item w/Modifier -59?

    L J

  6. JJP says:

    keith. i read the new 2011 regs. the G0431 code is clearly states that it will pay for 5 classes for those using an “immunoassay or enzyme assay”. this is an anlayzer using liquid reagents. the reason is state as follows:

    “By setting the payment at a multiple of five (5) times the price of testing for one drug of
    abuse, we are recognizing that multiple drugs are often tested through one specimen and
    that the high complexity tests that are performed in the laboratory setting require more
    resources than the simple dipstick test kit tests performed outside the laboratory setting”.

    i’m confident the analyzer will be around for a while.

  7. Jennifer says:

    Trying to code G0431 with the correct modifiers and units has been fun. We have changed how we are billing 3 times in the past 2 months. We recently billed the line with 4 units with the QW and the next line with 2 units QW59, that denied. The only way we have found they will pay is code each line with 1 unit per line. This is very frustrating, they will pay it for a while then start denying, which is why we have had to change it so many times. Is anyone else still having problems with this? Has anyone found a way that works for longer than a couple of weeks?

  8. JJP says:

    Jennifer. What state are you in? This makes a difference.

  9. CCPM says:

    We’re a pain practice in New Orleans and we are getting denials on G0431. Any help from a practice in LA on how many units you are being paid and how you are billing would be great. Thx.

  10. Steve Thompson says:

    These 2011 proposed changes are confusing, and potentially pose a risk to Moderately and Waived Complexity laboratories. However, I do agree with JJP and I think the analyzers will be around, but at this time, I see two solid problems with the proposed 2011 changes, and I suggest caution. I am actually suggesting to my clients to postpone an analyzer purchase until Jan 1st (or until we know more information), and to continue to bill G0431QW x 9 with an approved POCT.

    1. The proposed changes dose not say that 80101 will be reimbursed 5 units, the proposal claims that the reimbursement for 80101 will be equal to G0430 x5. I interpret this mean that 80101 will be billed as one unit with a reimbursement of around $105.00. The issue with 80101 is these proposed changes are suggesting this cpt code is to be used exclusively for “Highly Complex Laboratories” , or to use the terminology in the proposal as “Highly Complex Confirmatory Drugs of Abuse Screening”. Which of course creates another series of questions for the reference laboratory; the question of most concern is will additional GC/MS confirmatory testing will be considered non-billable? Which is what I suspect.

    2. The second issue I see with these changes is the new G Code to replace G0430 is proposed to be billed at one unit for Moderate Complexity and Waived laboratories qualitative testing. Or, overlapping the testing methods to be billed under this same new G Code. We are still unsure of what the reimbursement will be for the Code (although I suspect around $20). The proposal specifically mentions: Dips, Cups, Cartridge, and Reader Tests. The issue here is many cartridge and reader instruments are classified as Moderate Complexity, but in reality; requiring little or more skill and expertise to perform then an instant device. Thus being, this new G Code will close this loop hole. The main question is will a Moderately Complex laboratory be able to bill a reagent based immunoassay screen under the new proposed 80101 cpt code, and this is still unanswered?

    The big issue is the proposal is suggesting setting reimbursements based on CLIA Complexity; which I do not believe that this is permitable under the ACT. Reimbursements will have to be set based on the testing methods and instrumentation to be compliant. However, with the verbiage used, (or Highly Complex Confirmatory Screening) suggests that the 80101 cpt code will be used not only for immunoassay and/or enzyme screening, but the sole reimbursement for any addition confirmatory testing as well. If this is the case, then of course a Moderately Complex facility would be unable to bill using this code, regardless of the screening method?

    I hope this helps some of you? I am the CEO of Pain Management Diagnostics, and we provide numerous consulting and ancillary services to Pain Management Providers, with of course laboratory testing being one of them. I’ll be happy to discuss this further if anyone wishes more information, or to share their insights. My personal email is

  11. Steve Thompson says:

    CPPM, contact me at I have a solution that is CLIA waived and still billable at G0431QW x 9.

  12. Steve Thompson says:

    Jennifer, the only way that I have seen that works is G0431QW x 1, on nine seperate lines.

    I would strongly recommend against using the 59 or 91 modifiers; that is just inviting the OIG into your practice. Also, note there are only 2 instant products available that are CLIA waived and approved for G0431QW billing. It is important that you are using one of these POCT if you are billing G0431QW. If you are using a test product that is approved to bill G0430QW, and are billing G0431QW x 9, then of course you are at risk of being required to pay back the reimbursements and other sanctions. Feel free to e-mail me if you have any other questions:

  13. EuGenett says:

    I just spoke to a representative at Medicare this morning she stated as of October 1, 2010 the number of units to bill for the G0431 code changed. She stated she does know how many units providers can bill but she is not at liberty to disclose that information. I billed my claims with 9 units (4 units then 5 additional units listed as one unit per line) they only paid for the 5 units the date of service was 092610. She said that I would have to submit a redetermination form for each patient and submit medical notes to support medical necessity for any additional units. She also stated that this code does not have to be billed on seperate lines just bill on one line with the number of units. I billed several October claims with 9 units on one line and they all denied CO-151.

    I have to say that I recently received an eob denial and the correspondence stated that “for this procedure only “4” units can be billed and medical notes are needed for review is more than “4” units are billed. I hope this was helpful to all you fellow billers out there!

  14. Sandy says:

    What is the current reimbursement for BCBS of Minnesota using 80101QW?

  15. Stacy says:

    Hi Everyone.

    My office….We have been back and forth with medicare about the G0431.
    For medicare ONLY
    This is how I code and bill out.
    g0431 QW 4 units
    g0431 QW 59 1 unit
    g0431 QW 59 1 unit
    g0431 QW 59 1 unit
    g0431 QW 59 1 unit
    g0431 QW 59 1 unit

    but make sure you use V58.69 only in each line, nothing else. ONLY use this dx.

    Medicare will pay all 9 units but all other payors will pay 11 units, hope this helps
    PS But if you hear anything better, please share.

    Thank You,
    (Billing Manager)



    G0431 QWX4
    G0431 QW59


  17. Angela says:

    Stacy – I understand that you coded and billed out 9 units as stated above, but have you received payment on these? If you have, what medicare contractor do you use.

    Your information is a great help. I think that if the DX is different than v58.69 it may get denied, is that correct?

    Thanks –
    Billing Co.

  18. Margie Nichole Baeza says:

    I am wanting to know if you can bill the 80100 and the 80101 x #of units on the same day. if so how would it be coded?

  19. erum says:

    is anyone in ct, becasue this is all too much confusion

  20. erum says:

    i have a physician office lab and have an analyzer that i use in the office. we are sitting on probably 100,000 dollars in rejections from medicare. we keep changing the number we bill and we keep getting denials. we billed as few as 6 units and still were denied. what should i do, help!!!!!!!!!

  21. Angela says:

    I tried the G0341QW x4 and G0341QW x1 came back Denied. This is for the Trailblazer Medicare area.

    Spoke with the supplier for our POCT CUPS. He said that Medicare is paying only x1 on the G0341 QW. If this doesn’t work – I don’t know what will. It looks like everyone is trying many different ways to get paid, but has had no luck.

    If someone is getting paid for more than x1 in the Trailblazer Medicare area, let us know!!!

  22. BlueChair says:

    erum and angela. where are your offices?

    we are still getting reimbursement for all 12 units in TX and OK.

  23. Judy says:

    I have been getting rejections from BCBS. We just started billing UDS and would like to know how to bill this correctly. We were told to bill G0430QW one time for a pay out of 20.83. We are testing for 12 drug types. If we are suppose to bill 80101QW do I use 9 units on the first line and 3 units on second line with a 59 modifer? Also what is the price per unit.

  24. ANGIE says:

    G0431 – 2
    GO431- 2 QW,59
    G0431- 2 QW, 59

  25. Kaybe says:

    G0431 QW X 2
    G0431 QW 76 X 4
    G0431 QW 76 X 4

    For 10 units (no more than 4 per line)

  26. Stacy says:

    This is how I bill out G0431 for MEDICARE ONLY:

    My reimbursement from medicare-

    Proc/Rev Code, Mods Billed Amount Allowed Amount Deduct Amount CoIns Amount CoPay Amount Late Filing Red. Other Adjusts Adjust Codes Provider Paid Remark Codes
    12/15/2010 12/15/2010 1639101744 1 99213 $403.00 $67.20 $0.00 $13.44 $0.00 $0.00 $335.80 CO-45 $53.76
    12/15/2010 12/15/2010 1639101744 4 G0431,QW $156.00 $78.88 $0.00 $0.00 $0.00 $0.00 $77.12 CO-45 $78.88
    12/15/2010 12/15/2010 1639101744 1 G0431,QW,59 $39.00 $19.72 $0.00 $0.00 $0.00 $0.00 $19.28 CO-45 $19.72
    12/15/2010 12/15/2010 1639101744 1 G0431,QW,59 $39.00 $19.72 $0.00 $0.00 $0.00 $0.00 $19.28 CO-45 $19.72
    12/15/2010 12/15/2010 1639101744 1 G0431,QW,59 $39.00 $19.72 $0.00 $0.00 $0.00 $0.00 $19.28 CO-45 $19.72
    12/15/2010 12/15/2010 1639101744 1 G0431,QW,59 $39.00 $19.72 $0.00 $0.00 $0.00 $0.00 $19.28 CO-45 $19.72
    12/15/2010 12/15/2010 1639101744 1 G0431,QW,59 $39.00 $19.72 $0.00 $0.00 $0.00 $0.00 $19.28 CO-45 $19.72
    SERVICE LINE TOTALS: $754.00 $244.68 $0.00 $13.44 $0.00 $0.00 $509.32 $231.24

    I copied this from my edi- medicare payment on a OV and UDS

    any questions, please contact me
    Billing Manager

  27. Kaybe says:

    Rules changed again after 12-31-2010. Here we go again…

  28. FAITH says:


  29. Brenda says:

    Has anyone figured out the way we are suppose to be billing the G0431 after 12/31/2010? We are trying to bill ten units and we were getting paid billing the units as 4, 3 and 3 prior to December but we are now getting rejections. This is so frustrating.

  30. Linda P says:

    I havn’t billed any yet but make sure you look at the new code 80104.

    I am doing the confirmation testing on UDS and was wondering if anyone has billed (2010) claims using the G0431 x 1 and then used the 80102 x 10 or how ever many you are doing? We are not a QW facility.

  31. Stacey T says:

    Bill 4xG0431 got denial start 1-1-2011. Anyone know how to bill, How many unit can bill after 2011?

  32. Crystal Miller says:

    I have billed out the G0431 x 4, G0431 59-QW x 4 and G0431 59-QW x 4 and still receiving denials….can someone please help me1! We have several thousands of dollars just sitting there not getting paid…

    I have seen this scenario on the AAPC but its denying with a CO-151 and N362 and we are using V58.69 as the dx…..


  33. Sandra says:

    I use to bill to Medicare procedure G0431 QW x 4, G0431 QW 59 x1, G0431 QW 59 x1 and as of 1.1.2011 the line for procedure G0431 QW x 4 have been denied…I need help, please!!!

    Thanks :)

  34. samantha P says:

    Medicare will only pay one unit now. It has to be billed G0434QW X 1

  35. Chris says:

    Samantha P is correct!!!!!! For Dates of Service (Urine collected) after 1/1/2011, The gravy-train on cheap dip cup/cards reimbursing $197.00 has run out. As of Jan. 1, 2011, CMS now says that if you are using POS devices (Cards/Cups) you ONLY, and I repeat…ONLY… get paid one time per paitent encounter. No more x4 or x10 with a 59 Mod. That means if your using a card/cup and testing for ONE or FOUR or TWELVE different drug classes…you get paid $20.00 PERIOD. The new code on waived POS devices (Cards/Cups) is G0434QW and it pays on average $20.00. The only way around this is to become a moderate or high complexity lab (NOT A CLIA WAIVED LAB) which means you invest in an Anylizer and the professional staff (MD of Pathology Lab Director and licensed Medical Technoligist to operate the Anilyzer). Then and only then will medicare reimburse under G0431 but the new reimbursment fee for that code is $102.00 per patient encounter regardless of the amount of drug classes tested for. This has been coming for many months. Check out

  36. mrizzkhan says:

    I have agreed with chris, That’s how medicare is paying now only one unit per period regardless of units we are billing 4, 5, 9 or 12 and the description for G0431 has been changed in 2011 to perform this service your need professional staff and equipment, There is only one way out now to save the reimbursement.

  37. JBlair says:

    If anyone is doing the moderate screens and running confirmations I have some questions about coding and pricing. Any help would be appreciated. You can email me at Thanks!

  38. Peggy Sears says:

    can anyone tell me if you know just WHAT each of these drug screenings are actaully looking for and/or measuring? Or if you know where I can look to find this information the G0431-QW59 and G0431-QW?

  39. KATHY STOVER says:


  40. Kumar says:

    CPT code G0431 how can we billed to medicare please help me

  41. Chris says:


    You are a POL Pain Clinic in Florida that has just a CLIA Certificate of Waiver. Prior to the end of 2010, you were using dip cup/cards for your drug screening. You went from billing and getting paid ($236.64) on 12 drug classes per sample, to getting paid ($177.48) for 9 drug classes in May and June. Then after July 1, 2010 you only got paid ($78.88) on 4 drug classes.

    Then low and behold… JANUARY 1, 2011…CMS issued new code G0434QW for dip cup/cards which pays only ($20.44) and changed the definition of G0431 to read “High Complexity Test” and eliminated G0431QW all together. You’ either knew or found out that a “Immunoassay Drug screening Analyzer” is NOT considered a “High Complexity Test” but a “Moderate Complexity Test”. And no one can quite figure out what a “High Complexity” Qualitative Drug Screen is, as a Highly Complex tests are not “Qualitative Drug Screens” but generally thought of as a “Quantitative” test done via GC or LC/MS instruments.

    What do you do? How do you go from simply billing G0434QW and getting paid just $20.44 back to the newly defined G0431 code that incidentally now only pays you $102.33 per sample? You may have been told by a sales rep for an Analyzer company that you should upgrade your POL to a Moderate Complexity Lab, Hire the staff necessary to operate the lab and purchase or contract for an Analyzer.

    This will NOT be enough to get paid under G0431. Most all of the manufactures of these instruments also sell you a “Reagent Contract” with their instruments. Sounds good, doesn’t it? IT”S NOT. If you use reagents that are made for that machine by the machines manufacture…those tests are considered to be FDA approved and therefore by the new definition, only considered to be “Moderately Complex”, not “Highly Complex” tests. Confused?

    What is an easy and fast way around these problems? How do you regain the lost revenue for your POL Pain Management Business in Florida without waiting the 6 Month average time to become a Accredited and State Licensed Lab in Florida by AHCA?

    Here’s how: I have had a Laboratory in business in South Florida since 2004. It is has recently become a COLA Accredited (just receiving COLA’s award of excellence) and State of Florida (AHCA) Licensed High Complexity Clinical Laboratory and… it is for sale. It does not come with any contracts. It is available with, or without the “High Complexity Analyzer” (COLA and AHCA certified). The Analyzer is less than 10 months old and has Reagent and Service contracts. Additionally, the business has both Medicare (FCSO) and Florida Medicaid provider number(s). The Corporation, its provider numbers, COLA Accreditation and its State (AHCA) License are all transferable to anyone who is “Eligible” under CMS to own a Medicare Provider number.


    Anyone interested contact me at:
    Serious inquiries ON THE BUSINESS ONLY PLEASE.

  42. EVA says:

    I am from New Jersey,not CLIA waived laboratory,we have screen for 10 drugs,but medicare only allowed one unit for G0431.How we can bill in order to get reimbursement?

  43. NANCY says:

    I am billing Medicare with V58.69 as primary diagnosis. Do I need a scondary dx as well? Medicare has denied not deemed “medical necessity”. I have the LCD and it does not indicate that a secondary dx is needed unless your patient is in a drug tx program. Can anyone help? Thanks

  44. Tammy says:

    I received notice from UHC recently requesting thousands of dollars in refund for G0431 for the first quarter of 2011. We billed G0431 x 9 with Moderate Lab Certificate. Has anyone had this issue come up or does anyone know where I can look for the MUE’s for this time period.

  45. Kerry says:

    I am trying to get paid for UA’s in my private practice. The code I am using is G0431 QW.

    The insurance compnaies denied the claim.


  46. Kerry says:

    I am in the state of florida and I an trying to bill for toxicologies.

    Please help with codes.

  47. Michelle says:

    Attn: Kerry

    this is an old deleted code .. G0431 QW .. try using G0434 QW both ways and see if this should help .. with the QW and without .. you can also use 80101 QW for commercials only .. please let me know if this helps you out.

  48. LoyAnn says:

    When you are billing the G0431 to Medicare, is there a yearly limit on who many you can bill? I do not think there is and I believe my staff is confusing the number of times in a day you can bill verses a yearly limit. Any help is greatly appreciated!.

    Thank You

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