Changes to Tests, CLIA for Medicare

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  • April 5, 2010
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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.
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.

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No Responses to “Changes to Tests, CLIA for Medicare”

  1. Randi Brazer says:

    As of April 1, 2010:
    For code G0431 QW:
    1- Are there MUE edits and where are they published?
    2-Does the code G0431 require a modifier?
    3-Should each drug class tested be submitted line item or in total units?
    Your interpretation of these new coding guidelines is greatly appreciated.
    Randi Brazer

  2. stevens says:

    Medicare is denying G0431 stating ” The number of days or Units of service exceeds our acceptable maximum”. We billed 12 units and Medicare says that we can only bill a max of 9 units. I can’t find any information about the number of units allowed with G0431. Anybody have anything?

  3. Jenny Harrison says:

    Just spoke to a Medicare rep. My Go431 denied also based on units not medically necessary. Medicare rep could not tell me the amount of units allowed because for this CPT codes the MUE is not listed (medically unlikely edit) I was told I had to send a redermination letter in with office notes and Medicare would decide if all 11 units were necessary. I told her this is not right, to change a code and then not supply the information needed to get claim paid. Randi…G0431 does require QW modifier, submit total units and MUE is not published for this code. Steve…..how did you find out it was 9 units ? Did you appeal a denial ? Thank you.

  4. Alex says:

    Anybody got any information about the maximum allowable units of G0431……

  5. Jennifer says:

    We’ve been told by Trailblazer that Medicare will only allow one unit for the G0431 even though our physician is performing a 10 panel test.

  6. Jenny Harrison says:

    Finally received payment from Medicare on G0431 QW. They did pay on 9 units, allowed $177.48. Not sure if this would be the same for everyone across the board. If anyone needs billing services please feel free to contact me. Good luck !

  7. Chris says:

    Jenny Harrison, You say that you got paid on nine units!!! Is this true. Hope so, I am sitting on about $250K worth of billing that has been rejected. Did you bill one line with 9 units or nine seperate lines on one date of service with one unit per line??????????????? If you or anyone has an answer, Please contact me at :christopher@cplaboratoriesinc.comcastbiz.net

  8. Jenny Harrison says:

    Hi Christopher,
    I sent you an email. Let me know if you received it.

  9. Chris says:

    Hi Jennifer, yes I did and sent a reply (2) with a couple of questions. THANK you very much!!

  10. Justin says:

    I am not a billing expert at all, and I need help with a question. Please bare with me…
    Lets say that medicare is the secondary payer and that Blue Cross is the primary.
    What if you bill 80101 QW to Blue Cross, and have a balance that needs to be billed as G0430 QW to Medicare. How does Medicare want that billed. I believe it is called Medicare Secondary Payer (MSP).
    Any help or better understanding would be greatly appreciated!!!

  11. Arthur says:

    Jenny,
    Can you also let me know how you billed the 9 units? One line w/9 units? Nine lines w/ unit? Also, did you use modifier QW?
    Any help is very much appreciated.
    My email address is: arthur.webb@yahoo.com

  12. Randi B says:

    With all due respect- can you please let us “all” know how you got the 9 units paid? This blog should be helpful to us all- we are trying to work together to get paid the right way! Thanks!!!!

  13. Kenneth says:

    Hello fellow folks, going out of your figurative tree’s over our lastest in a long line of US Government boondoggles,
    This is “all” I know:
    1. If you or your billing client is a “CLIA Waived” lab, you must bill under code; G0431 QW. The “QW” is the modifier that lets Medicare know that you or your client is a “CLIA Waived” lab.
    2. The “arbitrarily” decided upon maximum number of units (drug panels) that they are paying on is; nine (9).
    3. If you bill anything over nine (9) units/panels on a single billing line, the entire claim WILL be REJECTED under reason code CO-151; “Payment adjusted because payer deems the information submitted does not support this many/frequency of service.”
    4. If you or your client is performing anything above a nine (9) unit/panel screening you must do the following to get paid for thoses additional unit/panels: Some MAC’s have a process that allows you to appeal anything over the nine (9)units over the phone. Others DO NOT. In Florida, you must submitt the entire batch of claims with 10, 11 or 12 units per billing line of service. You will recieve a REJECTION under CO-151 for all claims over nine (9) units. Before you get the rejection though, search your MAC’s website for a “Redetermination Form”. It is a interactive, print only pdf form. You will be required to fill one out for each claim (patient) that you are billing over the nine (9) units per billing line. Check the box that says “The service was medically necessary”. In the narrative box list what the patients diagnosis is that makes the screening “medically reasonable and necessary” and refer to the April 1, 2010 LCD (L30574). List the bullet point (word for word and refer to the LCD) that best fits this patients medical necessity for the screening. (You can search your MAC’s website for this LCD or enter the following web address in your browser now: http://www.cms.gov/mcd/results_index.asp?from=%27Imrpcontractor%27&contractor=197&name=First+Coast+Service+Options%2C+Inc%2E+%2809102%2C+MAC+%2D+Part+B%29&letter_range=3&retired= This is the Florida (FCSO) LCD.
    Then click on L30574. All of the other MAC’s should have this same notice in their “List of LCDs” section on their websites.
    You will need to include copies of all the documentation necessary, i.e. doctors scripts, diagnosis, medical history, ect.
    For those who are billing as a “:CLIA NON-WAIVED” facility, do not add the “QW” modifier. In Florida and in most areas, you can still only bill the nine (9) units and must follow the same appeals process to get paid over that.
    The background on this change is: that since 2007, there has been an 86% increase in the number of “CLIA Waived” clinical laboratories and (no offense intended-don’t shoot the messanger) but most of these have been Physicians Labs that are part of Pain Management Clinic. Once again…don’t shoot the messenger…, but here in Florida, it is all over the News. We have hundreds of “Pain Clinics” that have sprung up and are at best…and I quote: “shaddy operators”. They are servicing people that come from all over the southeastern US. These “people” show up with an MRI, get drug screened and blood tested and then leave 45 minutes later with 60 to 120 Oxy’s. All billed to Medicare. They then repeat this two or four more times at other “Clinics”, sometimes in the same day (I have seen some of their “Statements of Benefits”)and return back to their home state. They then SELL these Oxy’s at $80.00 PER PILL!!! I also have it on very good authority from a contact in the US Attorney’s Office that EVERYONE who is a Medicare approved Provider, Non-Waived lab that bills with the “QW” is being “Flagged” for further investigation. Those of us who are legit and have all their figurative ducks in a row should be fine…but the US Attorey’s Office and the FTC WILL be going after the “shaddy operators”.
    Good luck to all of you who are legit and being swept up in this dragnet. To the “others”…here’s hoping you get everything you so deserve!!!

  14. Jenny Harrison says:

    Hi everyone !!!
    Thank you Kenneth for all your information !
    Justin- I believe that if you bill BS as primary and Medicare is secondary that you may not get paid the balance from Medicare. The only reason I am thinking this is because when Medicare decided they would no longer accept Consult codes, I had the same concerns. A Medicare rep actually told me I would have to CHANGE the code (ex:99204) in order for Medicare to pay the secondary balance on a consult code. When I come across this situation I will call Medicare and see what they tell me.
    Arthur- I billed 9 units on 1 line. G0431 9 units. Now Medicare did pay on 11 units for 1 claim. They broke this up by paying 9 units on 1 line and 2 on another. I did send a claim like this G0431 QW 9 units and G0431 2 units to see if they would pay 11 units total again.

  15. Arthur says:

    Jenny,
    Thank you sooo much for your help. I’m sitting on about $150,000 in denials that I can now start resubmitting. Heading to my coffee maker. It’s going to be a long night.
    thank you again for your help.

  16. Jenny Harrison says:

    Your welcome Arthur. Let me know how you make out. You might want to see if you can correct your denied claims through Medicare phone appeals. I am in Maryland and I can have my units corrected right over the phone. However this is not the case in all states.

  17. Melody says:

    Jenny,
    From reading above, how did you bill the 11 units in order to have them paid? We perform a 12 panel test. Would this be a G0431 9-units and on a 2nd line G0431 3-units?
    Any help is greatly appreciated.

  18. Jenny Harrison says:

    Hi Melody,
    I went back and looked at my Medicare EOB. The claims that paid the addtl 2 units were billed as DAYS not UNITS. That was an error on our end. This was on only 2 claims. The rest did pay on 9 units. I called Medicare and asked if we split the charge into 2 lines would they pay additional units ? He was not sure. He said there is an MUE (Medically unlikely Edit) with G0431 QW, where according to medicare it is unlikely there would be a need to bill over 9 units, that is why it appears they are only allowing 9 units.
    Now he did say I could try to bill the addtl units, which I did on one patient to see if it would pay. If not Medicare will have to be billed at 9 units and your commerical claims can still be billed 12 or 11 units. Unfortunately some of this is trial and error.

  19. Melody says:

    Thanks, Jenny. This is such a crazy process. I do appreciate your help.

  20. Sandra says:

    What is the method for these UDS test? Are you all using analyzers? We have a 12 panel test cup and we were told we can only bill 1 unit with G0430 QW @ $19.72 Can anyone help me

  21. Sam says:

    Hi Friends,
    I have billed CPT G0430 with 10 units and my claims got denied as CO-151, later on i have corrected it and sent with 9 units now MCR is saying that only 1 unit is payable at 1 test. My company is billing under Pain management as “CLIA NON-WAIVED”.
    Now please let me know what should i do to get my claims paid?

  22. Carol says:

    Sam,
    The G0430 can only be billed at 1 unit. Use G0431 with a QW modifier at 9 units. If you have additional units bill a second line item with the G0431 and a 59 modifier as stated above.

  23. bryan says:

    as per medicare do they have documents to show the MUE for CPT G0431 can be billed with 9 units.
    We billed g0431 with 9units without modifier do they require QW modifier always. Please advise.

  24. Chris says:

    All of my claims billed with DOS prior to 7/1/2010 were billed 9 units on one lie G0431QW and 1 units on line two. Those were paid. All claims billed for DOSon or after 7/1/2009 were paid differently. Line 1 with 9 unit was denied CO151 and with remarks code REM 365: Exceds maximum number allowed. Line two with 1 unit was paid at: $19.72. Has anyone else come across this and is that it…just 1 unit at $19.72 for dip cards CLIA Waived Labs. Is anyone billing for Non-Waived Labs without the QW modifier??? Are Non-Waived drug screens getting paid for all 10 units done on a table top anaylizer???

  25. mypoct.com says:

    Please keep in mind the device being used has now been HCPCS coded as if they were DME. The products used are reviewed and approved by medicare. If you are using a cup or any device that houses more than one drug you must bill G0430QW as all these devices have been assigned that code. IF you are using a single panel device and dipping each drug class one time then you can bill G0431QW for each drug class. I would suggest making sure the device is on the publicized list. Phamatech is the only company with numerous drug classes available.
    Also remember there must be supporting documentation in the file as to why you are testing for each drug. If the patient is on OPI and you are testing for PCP there should be a reason for it. We are not billing experts and only offer our opinion.

  26. Cathy says:

    We have billed Trailblazers the G0431-QW (8) units and are being denied, so I don’t understand how anyone is getting (9) units paid. What Medicare supplier is this being filed to?
    Is anyone else having problems with Trailblazer Medicare and how many units are they being paid for?
    Thanks

  27. LANCE says:

    One thing that has not been addressed in this forum is the fact G0431 requires single strip testing and not a cup with mulitple strips built in. I work directly for a lab and we provide a specially packed kit for medicare testing only that include single strips for each drug class that are required when billing the G0431. If you are using a cup with strips built in, you must bill the G0430 and that reimburses $20.83. Our clients use strips and do bill with modifers and get paid for more than 9 units.
    We also have introduced an anlayzer that will effectively eliminate the need to mess with all these changes with the CLIA waived tests. Our analyzer will test for up to 16 panels and can test 40 specimens at a time or it can do a stat test. This is working absolutely terrific for our larger clients and the billing headaches are substantially reduced.

  28. Shae says:

    Lance or anyone else that can help us !!! We are a CLIA certified clinic. We are billing with the G0431 with 9 units. Now medicare is denying stating that they will not allow that many units. So we tryed billing G0431 4 units on the first line and on the second line 5 units with a modifier 76. Medicare paid for the first line at 78.88 and allowed 0.00 for the second line. So PLEASE if anyone can help us please responed. Thanks so much Shae !!!!!!!

  29. LANCE says:

    Hi Shae. Shoot me your contact info at terpsfan9999@yahoo.com and I’ll be glad to help you. Thx.

  30. Jill says:

    I am also having issues billing 9 units for G0430. I was told by medicare I would have to file a redetermination form. Has the magic number changed again? arg.

  31. Shae says:

    LANCE I HAVE SENT YOU AN EMAIL !!!!!!!!!!

  32. Jana says:

    Is anyone billing G0431QW for commercial yet replacing the 80101QW?

  33. Randi says:

    I have sent you an e-mail Lance – Hope to hear from you soon!

  34. Cathy says:

    We are billing some Commerical carriers with the G0431. I have talked to BCBS, First Health/Coventry and United Healthcare and they are saying that they will accept either code.

  35. Chad says:

    Hi,
    I am with a pain managment practice in Oklahoma (medicare trailblazer). I am being denied with mediare trailblazer when billing G0431 and 5 units when using test strips (CO-151 medically unlikely number of units).
    I have been told to bill G0431 with 1 unit and 5 lines (it pays this way). Is this appropriate and any actual mediare documents to go by.
    I am a clia waived lab. Thank you for any and all help. I do not want to buy an analyzer if I do not need to but also want to get paid. I was told if I get to a moderate compelxity lab status I can bill for 10 strips but have no documents to back this up. Thanks ahead of time.
    cowensx2@gmail.com

  36. SRINIVAS says:

    I AM BILLING MEDICARE FOR 8 UNITS OF G0431 AND MEDICARE IS REJECTING AS C0151. DOES ANY BODY HAVE AN ANSWER AS TO HOW MANY MAX UNITS ARE REIMBURSABLE AND IN WHICH FASHION THAT NEED TO BE BILLED

  37. Deana says:

    I am having trouble billing 6 units with the G0430QW getting the CO151. HELP! Medicare will not tell me the units. Does anyone know how to get these claims paid?? Any help would be greatly appreciated!
    Thanks,

  38. TenaK says:

    I have received several denials on the G0431 being billed as follows:
    G0431 QW 1 unit
    G0431 QW Mod 59 5 units.
    I was advised to bill this way as of July 1, 2010 however they are still coming back as denied.
    I called a “friend” and was advised they are not going to pay for multiple units, i.e. 5,6,9 but to try and bill this way.
    G0430 QW 1 unit
    G0431 QW 1 unit
    G0431 QW Mod 59 1 unit
    Even though you are testing for muiltple drugs on a patient they still consider it ONE test.
    I hope this information helps but please advise of any new information on this process.
    Thanks!

  39. CLIAwaived,Inc says:

    CLIAwaived,Inc. (www.cliawaived.com) will be hosting a call/webcast entitled “ASK the EXPERTS” on many of these topics in early September. The first call is open to both CLIAwaived.com customers and non customers. There will be a series of calls throughout the fall regarding these topics for CLIAwaived.com customers. To join the call or get on the evite list send an email to info@cliawaived.com.

  40. Jodi says:

    So up until July 1 Medicare was paying for G0431QW up to 9 units. Starting July 1 all claims of G0431QW came back denied. After talking to my Medicare rep, I was told that anything above 1 unit required medical documentation, I have been sending all my G0431 claims out by paper with notes attached. I have not received any payments on these yet, however I have not received any denials yet either. As far as those asking about G0430 being denied, G0430 can ONLY be billed X 1 unit, and will only be paid at ONE unit, this would be the code you would use for a multi panel cup etc. If you are using individual strips then the code you should be billing is G0431.

  41. Cheryl says:

    I have researched and found that the new limit on medicare drug screen is 4 units; and I have billed the Alcohol separate; substance abuse 4 drugs + alcohol, G0431 x4 and 82055 x1. Has anyone tried this billing method and been paid since July 1, 2010??

  42. Jodi says:

    Just spoke to my supplier of cups/strips, he states that as of July 1 CMS lowered aloowed units from 9 to 4, I will be sending all future claims as G0431X4 and see what happens. We do not test acohol. so I’m not sure if it will work like that or not.

  43. Sam says:

    Does anyone have documentation from CMS directly on the reimbursement being lowered from 9 drugs to 4 drugs?

  44. Jodi says:

    No, no documentation, just word of mouth. 🙁

  45. Cheryl says:

    No, no documentation directly from CMS.

  46. LMA says:

    There is no documentation from CMS. It’s a question of trial and error. We talked to CMS and they said they would not publish how to get reimbursed for more than 4 units but it is possible. Most of this can be avoided by upgrading your lab from CLIA waived to Mod Complex and using an analyzer. No more cups, strips, or you follow a specific protocol everyday. It makes your whole drug testing program more legit. You should be doing at least 200 tests/month to make this a smart business decision for the practice.

  47. PTS says:

    Some experts have said if you used individual strips for medicare after 3/31/10 there could be ramifications. Medicare is looking into 59 mod issues also. Analyzers are working and legit. Any questions email me.

  48. Melissa says:

    I am also trying to figure out how to bill these new G-codes. We used to bill 80101 X 9 on one line but of course cannot now. We have to bill thru Administar Federal and they are now denying ours for the N362 Max units. Since I am seeing that most people are billing x4 would this work for us to try?
    G0431 X 4
    G0431-59 X 1
    G0431-59 X 1 (5 times)
    or should we be bundling the last 5 units such as
    G0431 X 4
    G0431-59 X 5
    Thanks for all your help!

  49. Eva says:

    If you have an analyzer how many units can you bill? and do you still use the same code G0431?

  50. LMA says:

    eva. i know two practices that are receiving reimbursement for 12 units for G0431 that are using an analyzer. all indications are that the CLIA waived devices will only be reimbursed a small flat rate in 2011. for those practices with high volumes and a large mix of medicare, this will make a negative impact on your revenue stream.
    if you need help in finding a company offering an analyzer and upgrading your license, shoot me an email and i’ll be glad to help. email: terpsfan9999@yahoo.com

  51. mypoct.com 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
    info@mypoct.com

  52. TenaK says:

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

  53. 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.

  54. 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

  55. Leslie Johnson says:

    See Palmetto, OH (also true for SC & WV) http://www.palmettogba.com/palmetto/providers.nsf/DocsCat/Providers~Ohio%20Part%20B%20Carrier~Browse%20by%20Specialty~Lab~86VH8B8231?OpenDocument&navmenu=Browse%5Eby%5ESpecialty%7C%7C%7C%7C&Click=
    “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: http://www.cms.gov/MLNMattersArticles/downloads/MM6852.pdf
    “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.
    http://www.cignagovernmentservices.com/partb/education/pdf/ACT_minutes_09-23-10.pdf
    Effective for services performed on or after 10/01/2010, First Coast has a new LCD: http://www.cms.gov/mcd/viewlcd.asp?lcd_id=30574&lcd_version=8&show=all
    Here’s National Gov’t Services for Upstate NY: http://www.cms.gov/mcd/viewlcd.asp?lcd_id=28145&lcd_version=38&basket=lcd%3A28145%3A38%3AQualitative+Drug+Screening%3AMAC+%2D+Part+B%3ANational+Government+Services%7C%7C+Inc%2E+%2813282%29%3A
    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

  56. 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.

  57. 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?

  58. JJP says:

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

  59. 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.

  60. 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 stethomps@hotmail.com.

  61. Steve Thompson says:

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

  62. 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: stethomps@hotmail.com.

  63. 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!

  64. Sandy says:

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

  65. 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,
    Stacy
    (Billing Manager)

  66. I HAVE FILED 4 TIMES TO MEDICARE AND HAVE BEEN DENIED. I HAVE BEEN TOLD THAT YOU CAN ONLY BILL MEDICARE FOR 5 UNITS says:

    THIS IS HOW I WAS TOLD TO FILE
    G0431 QWX4
    G0431 QW59
    DOES ANYONE KNOW IF THIS IS CORRECT OR NOT.

  67. 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 –
    Angela
    Billing Co.

  68. 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?

  69. erum says:

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

  70. 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!!!!!!!!!

  71. 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!!!
    Angela

  72. BlueChair says:

    erum and angela. where are your offices?
    we are still getting reimbursement for all 12 units in TX and OK.

  73. 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.

  74. ANGIE says:

    I JUST HAD ONE THAT PAID.BILLED TOTAL OF 6 UNITS
    G0431 – 2
    GO431- 2 QW,59
    G0431- 2 QW, 59
    I HOPE THIS HELPS

  75. 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)

  76. 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
    thanks
    Stacy
    Billing Manager
    stlynnfl@yahoo.com

  77. Kaybe says:

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

  78. FAITH says:

    I AM IN DELAWARE AND HAVE BILLED:
    G0431QW WITH 8 UNITS AND HAVE DENIED TOO MAN UNITS ON SAME DAY CAN ANY HELP?

  79. 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.

  80. 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.

  81. Stacey T says:

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

  82. 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…..
    Thanks!

  83. 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 🙂

  84. samantha P says:

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

  85. 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 CODEMAP.com

  86. 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.

  87. 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 jblair@castlemedical.com. Thanks!

  88. 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?

  89. KATHY STOVER says:

    BILLING G0431 MUST BE BILLED 1 EACH LINE UP TO A TOTAL OF 9 A MODIFYER 91 GOES ON ALL LINES UNDER THE FIRST ONE. IF YOU ALREADY BILLED MEDICARE YOU WILL HAVE TO SEND IN AN APPEAL CANNOT REBILL

  90. Kumar says:

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

  91. Chris says:

    DOES THIS SOUND LIKE YOU OR YOUR BUSINESS SITUATION!!
    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.
    THIS IS NOT A JOKE OR SCAM!
    Anyone interested contact me at: chawgleg2@yahoo.com
    Serious inquiries ON THE BUSINESS ONLY PLEASE.

  92. 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?

  93. 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

  94. 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.

  95. 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.
    ????????????

  96. Kerry says:

    I am in the state of florida and I an trying to bill for toxicologies.
    Please help with codes.
    got_therapy@yahoo.com

  97. 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.

  98. 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