FAQs from “JW Modifier and SAD Demystified” Webinars

Questions on New CMS Pharmaceutical Policieschange-compass_620x200

Now available for replay and handouts download.

Now available for replay and handouts download.

“Finally Friday!” hosted a presentation by Bill Malm on Friday, May 20, providing an educational review of the newest Transmittals concerning the reporting and billing of drug wastage and so-called “self-administered drugs” (SAD). The Special Edition Finally Friday! segment lasted a full 110 minutes and it is now freely available for replay, along with all the recommended handouts.

Many viewers posed questions to us before, during and after the original webinar. Below is a compilation of the questions and our answers.

Be sure to keep in mind that these are answers given “to the best of our knowledge at this time.”


We must caveat these answers as “educational” and do not constitute guidance.  ONLY CMS, your MAC or commercial payor can provide source determinations and guidance. Please confirm all answers with these parties prior to proceeding with any decisions or internal policy determinations.

We also offer the document for download, and grant a Creative Commons License for the document.

Also, if you choose to download our PDF of these answers, you are accepting that this is for education and not for guidance of management decisions.

FAQs Document in PDF Format


Download the PDF

[FAQs from “JW Modifier and SAD Demystified” Webinars v052716]


How to Use This Document:

Our collective opinion is that, in light of the operational and compliance issues involved, and the short time-frame granted for implementation, we highly recommend two key tasks, for every facility:

  1. Consult your legal staff, and be sure to involve them, even after implementation.
  2. Consult with your MAC and/or CMS – be specific in your questions.
If you choose to have an aggressive interpetation of a CMS policy, you should ask this question: And then what?

If you choose to have an aggressive interpetation of a CMS policy, you should ask this question: And then what happens?

We suggest that caution is perhaps (at least) less costly than any aggressive interpretation of the policies discussed.

To that end, and in light of some comments we’ve received on our webinar, we suggest that providers should be overly cautious when offered guidance from outside sources. One might be wise to ask the question, “if your guidance is in error, will you pay any costs we incur as a result of taking your advice?” We suspect that answers are more conservative when one’s neck is on the line.

Finally, please be aware that JW may also apply to your commercial payors’ policy guidance, and you may need to implement their policies into your use of the modifier for those claims.


Questions and Answers:

  1. Will the JW modifier be required on outpatients for all single-dose drug/biologics even if we are not asking for payment of the discarded amount?
  • Yes – the JW modifier is to be consistently applied on all pharmaceuticals that are non-CAP single dose vials for which you did not utilize the whole.
  1. There are some medications that are more cost effective and efficient for the hospital to purchase as a single-dose vial and then split the dose between multiple patients instead of purchasing multi-dose vial. Will you still require the waste to be reported on that particular vial or would it be considered a multi-dose if split between multiple patients? If we are to bill waste on those, how would we do that?
  • Single dose is as it is packaged and while common practice is to split it into a multiple dose you may not charge when this is done as it results in an overpayment.  You must purchase the smallest single dose vial available for the order and then bill the wastage.   Alternatively, if you want to break a single dose into uses for multiple patients, then billing of the drug would not be allowed unless it was a packaged drug.
  1. Does the JW modifier apply to all part B claims which would include part B inpatient? Or only outpatient claims including observation and ED?
  • While not specifically written the regulations specify Part B Non-Cap Single dose vials therefore it would be reasonable to assume it applies to all part b drugs regardless of the status.
  1. Does the JW modifier requirement apply to only HCPCS coded drugs?
  • It would appear to only apply to HCPCS coded drugs but be sure to include the “unlisted hcpcs” codes as necessary.
  1. If the JW modifier requirement applies to all HCPCS coded drugs, is it all HCPCS coded drugs or is it dependent upon the payable status?
  • It is all HCPCS coded drugs that are Part B, Non-Cap, Single dose / single unit
  1. Does the JW modifier requirement apply to wasted blood products?
  • We did not find any guidance that included blood products – does appear to apply to blood at all
  • The regulations talk about Part B pharmaceuticals, non-cap, single dose / single unit drug or biological
  1. Does the JW modifier requirement apply to wasted nuclear medicine isotopes?
  • You will need to consult your MAC for explicit guidance
  1. Does the JW modifier requirement apply to brachytherapy seeds?
  • You will need to consult your MAC for explicit guidance
  1. Is there a specific area in the medical record the administered/discarded amount should be documented?
  • You will need to consult your MAC for explicit guidance
  1. Is there a specific way this documentation should be stated?
  • JW describes wastage – some MACs may apply it to isotopes – you will need to consult your MAC for further guidance
  • The exact method of documentation will be both for commercial and Medicare – please follow the MAC guidelines and/or your commercial guidelines which will be more stringent
  1. Does this apply to drugs given in the OR on outpatients?
  • Applies to all Part B drugs, non-cap single dose
  1. Does this apply to implanted biologicals used in the OR? We understand that implanted biologicals in the OR are considered implanted devices and would be billed with a device C-code if the product does not have a pass-through HCPCS.
  • We did not find any guidance on this but it would seem to follow OPPS instructions for implantable biologics – please consult your MAC for confirmation
  1. Does this apply to skin substitute biologicals used in the OR?
  1. Does this apply to policy packaged and non-separately reimbursable drugs?
  • CMS has referenced to specific providers that “packaged drugs” do not apply for the JW modifier. This is not at this time written guidance, and CMS has stated verbally that further guidance would come from the MAC. This does make sense, as OPPS is very specific on policy packaged and non-separately reimbursable drugs. Additionally, the manuals describe HCPCS coding as required for separately payable but it is only recommended for non-separately payable drugs. The concern would be that institutions who use a 250 packaged revenue may fail to submit the HCPCS code that would allow edits to work properly. Stay tuned for further guidance from either CMS or your friendly neighborhood MAC.
  1. Can you provide the Novitas region H medical record documentation requirements for SVD wastage and the use of modifier JW?
  • Hospitals should seek guidance directly from their MAC. Even in our conversations with CMS, we were unable to get answers, and were instead told to expect further guidance from the MACs. That said, we have not seen any documentation requirements published by Novitas for Jurisdiction H, as of May 26 2016.
  1. Can you suggest the best method to provide feedback to CMS regarding all this, especially regarding two months not being enough time for large medical centers to implement the reporting and documentation requirements?
  • One of our listeners spoke briefly with Felecia Eggelston at CMS, who is listed as one of the Pre-Implementation Contacts at the end of CMS Transmittal 3508 (JW Modifier). When questioned about what the best method would be for providers to provide feedback regarding 2 months not being enough time for large medical centers to implement the reporting and documentation requirements, Ms. Eggelston said such feedback can be emailed to the following address: sec303aspdata@cms.hhs.gov  (corrected on 5/27/2016 4pm EDT)Here is more from our listener:

    “I asked if there had been any discussion within CMS to push back the implementation date. She was very nice but said she wasn’t at liberty to discuss that. I also asked if CMS was going to respond to questions previously posed, such as how providers are to split the charge between the administered and wasted amounts; she said our Intermediaries should be able to provide that type of detailed direction.

    “I’d appreciate others spreading the word and emailing the above address with feedback and a request to push back the implementation date so that we have time to get more information and figure out the operational aspects of implementation.”

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