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JW Modifier FAQ and Drug List Download

 

As of Jan 1st, 2017, CMS requires hospitals to report the JW Modifier on Part B drug claims for drugs and biologicals discarded or not administered. We’ve compiled this collection of frequently asked questions, we hope you find it useful.

Disclaimer: This FAQ and report was prepared by Craneware for informational and educational purposes only; it is not legal advice or a legal document, and should not be relied upon. The document serves as a general summary of our current understanding of the JW Modifier requirements, it is not guaranteed to be complete, correct, timely or current, and Craneware Inc., Craneware Insights or Craneware PLC bears no responsibility or liability for the results or consequences of the use or reliance on the information in this presentation. No portion or element of this document may be reproduced, in whole or in part without the express written consent of Craneware Inc. or its associated companies.

JW Modifier FAQ


Q: How can Craneware help with JW Modifier requirements?

Top Five drug HCPCS by Revenue: Free Report

If you would like to know which drugs you should be focusing on at your facility, please request a free custom report for your facility. Using CMS and proprietary Craneware intelligence analytics, Craneware has created a complimentary report which calculates your hospital or health system’s top five drug HCPCS by revenue. These five HCPCS will likely be an excellent area of focus for ensuring compliance with the new JW modifier requirements. The report also contains a summary of the new requirements and recommended action steps. This report is provided at no cost and we do not share your information with other vendors or businesses.

Pharmacy ChargeLink®

Pharmacy ChargeLink allows hospitals and health systems to bridge the gap between pharmacy and finance so you can more efficiently maintain the necessary data and capture the appropriate requirements through your business processes. Pharmacy ChargeLink lets you know immediately whether a drug is single-dose or multi-dose, its HCPCS codes and status indicators, and a plethora of other information around acquisition cost and markup to ensure your organization is staying price competitive.


Q: Does Pharmacy ChargeLink help identify a new JW requiring drug the first day it is purchased?

A: Yes, that information is immediately available in the application. Pharmacy ChargeLink captures purchased drugs, including specialty drugs and drugs which may be missing from your formulary. The tool also provides a filter to take you directly to those drugs that would be included for the JW modifier requirements.


Q: How is the Pharmacy Chargelink single-dose / multi-dose column populated?

A: We have a proprietary catalog maintained by our pharmacy team, which is compared against all the drugs you are purchasing. We evaluate each drug at the NDC level for single-dose or multi-dose identification.


Q: Do you know how to obtain the list of single-dose vial packages?

Q: Is there a list of drugs where the JW modifier is accepted or is common?

Q: Where can I find addendum B to get to the list of drugs with status indicator G & K?

Q: Do you have a link to the G,K, and N status indicator lists for CMS?

A: Addendum B is available on the OPPS Website. Filter G and K status indicators for a rough list of drugs where JW modifier would be accepted. However, single-dose vs. multi-dose is difficult to identify without a tool like Pharmacy ChargeLink.


Q: Are patients responsible for the 20% coinsurance for the waste that is billed?

Q: Does Medicare pass along costs associated with institutional billing for JW modifiers to the patient? Or is the entirety of the charge paid by Medicare without patient personal responsibility?

A: Subregulatory guidance does not directly address coinsurance. However, limitation on liability provisions in section 1879 of the Social Security Act imply that the beneficiary is NOT responsible for coinsurance on the drug waste that is billed. Under 1879 of the Act, a beneficiary is not responsible for payment of the Part B deductible or coinsurance for items or services that are not reasonable or necessary to diagnose or treat the illness or injury, nor to improve the functioning of a malformed body member. It is our understanding that in a recent informal query to CMS on this issue during an open door forum, CMS officials stated that the beneficiary is not responsible for coinsurance on items or services that were not rendered. Therefore, since the patient did not receive the wasted medication, they would not be responsible for coinsurance.


Q: As a Critical Access Hospital, we have the G and K medications set up to document waste, but we cannot get clarification on if we have to use it for all part B medications and if so, not all have CMS billing units. What do we do for these medications?

Q: There seems to be varying interpretations around the requirements for Critical Access Hospital submissions on JW modifiers? Is it only G and K status indicator drugs or all single dose vials in CAHs since drugs are separately billable in CAH settings?

A: Our understanding is that CAHs are only required to comply with JW modifier reporting for the HCPCS codes classified as G and K drugs under the OPPS. However, this should not be taken as an official answer until we can confirm this directly with CMS.


Q: Do you have recommendations for billing and documentation for example the waste for Ciprofloxacin Otic Suspension (OTIPRIO) if the dose is 0.2 mL and the nurses is taking 1 mL from Pyxis?

A: OTIPRIO is supplied as an otic suspension of 6% (60 mg/mL) ciprofloxacin. Per the package insert, each single-patient use vial contains 1 mL, but because of the poloxamer and thermosensitive properties of OTIPRIO, only two 0.1 mL doses (one per ear) can be withdrawn from a single-patient use vial. The dose administered for a single patient is 0.2 mL total. The package insert indicates the nurse withdraws 0.3 mL of the suspension into the syringe for each ear (0.6 mL total). There is an additional 0.2 mL of product wasted for each ear when the nurse primes the syringe. The 0.2 mL of OTIPRIO that is administered converts to two billing units of J7342 Installation, ciprofloxacin otic suspension, 6 mg. The nurse would document that after withdrawing 0.3 mL of medication into each syringe (two syringes for a bilateral procedure) there was 0.4 mL of unused medication in the vial that was discarded. Additionally, the nurse would document 0.2 mL of medication was wasted when priming each syringe (0.4 mL total). Total wasted product of 0.8 mL or 48 mg is billed with J7342JW with 8 billing units.


Q: At our facility we do not use overfill. Is it necessary in that case that waste of overfill be documented?

A: You are only required to document the amount of waste that represents the quantity up to the amount of the drug as indicated on the vial or package label. In the presentation, we suggested that for specific drugs that are vulnerable to audit scrutiny (i.e., ophthalmic drugs sold in single-use vials with enough overfill for “multi-dosing”) a simple best practice to assemble the documentation required for passing a potential audit would be to include notation in your documentation regarding the discarded overfill such as, “Manufacturer overfill was appropriately discarded.”


Q: Does this only apply to G and K codes, or ALL single dose vials?

A: The JW modifier only apples to those drugs designated with status indicator of G or K in Addendum B that are supplied in single-dose vials. Packaged drugs suppled in single-dose vials are not subject to JW reporting.


Q: If pharmacy prepares a 139 mg dose using a 100 mg vial and a 40 mg vial and the billing unit is 1 mg then the claim will have 3 lines: qty 100, qty 39 and waste qty 1. Is it acceptable to have a claim with 3 lines in this case?

A: The claim should contain one line item for the amount of drug administered and a second line item for the amount of drug discarded. In this case, 139 billing units administered on the first claim line and 1 billing unit with the JW modifier reported on the second claim line for the amount of drug discarded.


Q: If we use part of a multi dose vial for one patient and we don’t have other patients to use the remaining, how do we bill the waste?

A: Billing for unused portions of multi-dose vials and/or using the JW modifier for drugs supplied in a multi-dose vial is not allowed.


Q: If you have a drug set up with a one multiplier and the unit is one, but the patient only receives 50% of the unit, do you not report waste since you can’t report a fraction and report one?

A. The amount wasted and identified with the JW modifier must be at least equal to one billing unit. For example, if the HCPCS code is reportable in 10mg increments and you administered 7mg of a 10mg SDV, report one billing unit without a separate line for the amount wasted. Example: HCPCS J9280 – Mitomycin comes in single dose vials which are 5 mg and one billable unit = 5 mg. If the ordered and administered dose is 7.5 mg of the drug the JW modifier would not be used in this instance. You would use one line of coding with 2 units of J9280, with wastage described in the medical record. The billable unit is 5 mg, so the wastage of 2.5 mg cannot be coded on a separate line, since it is less than the billable unit.


Q: Rituxan has a billing unit of 100 mg. We frequently use doses NOT rounded to the nearest hundred mg (i.e., 860 mg). Does this mean we can only bill for 8 units and can’t bill for the waste since it is not a full unit of waste?

A: The units billed must correspond with the smallest dose (vial) available for purchase from the manufacturer(s) that could provide the appropriate dose for the patient. Rituxan is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials. Providers can use the 500 mg vials; however, the wastage calculation must be based off the 100 mg vial as the 100 mg vial is the smallest vial size available for the medication. Additionally, the amount wasted and identified with the JW modifier must be at least equal to one billing unit. For J9310, the billable unit is 100 mg. If the ordered and administered dose is 860 mg, the billable amount is 9 units of J9310, since providers are allowed to round up. The wastage of 40 mg cannot be reported on a separate line with the JW modifier, since it is less than the billable unit.


Q: Is it acceptable to report waste for medications with status indicator of N?

CMS has indicated the JW modifier does not apply to drugs assigned status indicator N. It is unclear whether claims will process appropriately if the JW modifier is appended to a HCPCS code that is designated as a packaged drug under status indicator N.


Q: When preparing Alteplase, we usually draw up the bolus from the vial and the remainder of the infusion from the same vial then waste the remainder. How can this be handled with the JW modifier without creating fraud and without charging the patient for two vials?

A: Some hospitals set this up as two separate orders—one order for the bolus dose and a separate order for the continuous infusion. As an example, for a stroke patient, if the SDV is 100 mg and the total dose ordered is 70 mg, the t-PA bolus order would be 7 mg (10% of the ordered dose) and the continuous infusion order would be 63 mg. In this example, on the claim the charge quantity for J2997 should be 70 units for the t-PA administered and 30 units with the JW modifier for the discarded t-PA. Given the high cost of t-PA it may be advisable to stop these claims for manual review before billing.


Q: What about product shortages?

Q: There is always Oncology Meds size vials that are backordered or unavailable. Any direction from CMS when the correct sequence of vials cannot be used to compound a chemo and reporting waste and charging?

A: CMS has not directly addressed this issue. WPS Medicare provided this response in their FAQ:

Question: There are occasions when, due to drug shortages and the unavailability of a drug in a smaller dose vial, a provider may need to bill a larger vial than needed. How should providers document this in order to receive proper reimbursement?

WPS Answer: Medicare would consider the above scenario as a rare and unusual circumstance. The Centers for Medicare & Medicaid Services (CMS) encourages physicians, hospitals and other providers to schedule patients in such a way that they can use drugs or biologicals most efficiently, in a clinically appropriate manner.

By using “most efficiently” in this reference, it is inferred that it would be expected that the physician has made a good faith effort to minimize the unused portion of the drug or biological in how he or she scheduled patients and how he or she ordered, accepted, stored, and used the drug or biological.

To meet Medicare coverage requirements, the provider will need to document the amount administered and the amount wasted in the patient’s medical record. In addition, documentation must show the higher dosage vial was the only one available. If requested, the provider should be able to produce evidence showing the good faith effort to monitor the availability of the lower dose vial during ongoing ordering and acquisition processes.


Q: When it’s said that JW isn’t required for status indicator N drugs, is the waste documentation still needed

A: Since you are not billing for waste on status “N” drugs, it is not necessary to document waste.


Q: You indicated not to bill waste from multi-use. What do you do for expiring drugs from multi-use? My understanding is that you could bill the waste to the last patient for whom the drug was used.

A: Wastage due to expiration of a multi-use vial is not billable. CMS removed previous examples of billing the last patient for the unused portion of a multi-use vial (due to expiration) from Section 40 of Chapter 17 of the Medicare Claims Processing (MCP) Manual. The current Medicare policy does not extend coverage to any amount of the drug discarded from a multi-use vial. Medicare will reimburse only for the amount of the drug that is given to each patient. You should not separately report any amount discarded at the end of the shelf life. Providers should check to make sure their systems can correctly calculate and bill for only the administered portion of a multi-dose/multiuse vial or package.


Q: Do you still need to add a JW modifier if the amount of medication being wasted is below the HCPCS code increment?

A: The amount wasted and identified with the JW modifier must be at least equal to one billing unit.

Example: HCPCS J9280 – Mitomycin comes in single dose vials which are 5 mg and one billable unit = 5 mg. If the ordered and administered dose is 7.5 mg of the drug the JW modifier would not be used in this instance. You would use one line of coding with 2 units of J9280, with wastage described in the medical record. The billable unit is 5 mg, so the wastage of 2.5 mg cannot be coded on a separate line, since it is less than the billable unit.

If, on the other hand, a HCPCS code is reportable in 10 mg increments, and you administered 70 mg from a 100 mg SDV, you may report seven billing units as administered, and on a separate line report 3 billing units with the JW modifier appended to the HCPCS to indicate the drug amount discarded.


Q: Not all hospital patients are inpatient status. We have no system way in pharmacy system to differentiate who to bill waste on and who not to. Is it ok to bill waste the same across the board to all patient types?

Q: For hospital setting, when should we bill JW? JW is NOT required for INPATIENT setting (medication used to treat inpatient and medications from automated dispensing machines)? On one slide, it said that JW is NOT required for INPATIENT setting?

A: In the hospital setting the JW modifier is only reported on outpatient claims. For OPPS hospitals that includes outpatient bill types 131 and Part B inpatient bill type 121, but JW is never reported on inpatient bill type 111.


Q: WPS and Paragon told us to do full amount on given line and 0.01 on JW wasted line? I have heard both, how do I clarify?

Follow the specific instructions of your MAC.


Q: If a patient starts an infusion but cannot tolerate treatment, is it OK to charge for the eligible waste remaining from the infusion? For example, a 50mL IVPB contains 2 HCPCS Units of a drug & the patient receives 10ML-can we charge for the 1 unit of waste?

A: The unused portion of the drug/biologic not administered is considered to be waste. If the waste volume can be accurately quantified, any billing units that are properly documented as discarded are eligible for JW modifier reporting. In situations where the discarded drug cannot be quantified, the JW modifier is not required.


Q: If an IV Piggyback back containing 100mg drug in 100 ml solution is prepared by Pharmacy and the bag is hung on a patient to run over 1 hour, but the infusion is stopped after 30 minutes then does the amount of drug not infused need be submitted as waste?

A: The unused portion of the drug/biologic not administered is considered to be waste. If the waste volume can be accurately quantified, any billing units that are properly documented as discarded are eligible for JW modifier reporting. In situations where the discarded drug cannot be quantified, the JW modifier is not required.


Q: Is reporting the JW modifier mandatory, or is it optional? Can we choose to not report waste?

Q: Is it mandatory to use the JW Modifier if we are not concerned about being reimbursed for waste. We are a very small surgery center?

Q: Just to verify as a CAH, if a med is billed for the dose administered, they will not be out of compliance if they choose not to utilize the JW modifier?

A: On questions about potential compliance risk in choosing not to bill for any waste with the JW modifier you would need to check with your legal counsel. Based on FAQ #4, our understanding is that if you bill discarded drugs to any other payor besides Medicare then the JW modifier is mandated by Medicare. If you choose not to bill discarded drugs to any other payor then JW reporting is not required by Medicare. This interpretation should be confirmed with your MAC or directly with CMS. The rationale behind the CMS JW modifier requirement is to identify where the Medicare Program can make substantial savings by packaging medications in sizes that conform more closely to patient weight and dosing needs. So drugs where the dollars associated with waste are insignificant are unlikely to become the target of future audits. The biggest risk for audit take-backs is billing for waste that is not substantiated in the documentation or billing waste for multiuse vials.


Q: Has there been any discussions that this would be a regulation the Trump administration rolls back?

A. Not that we are aware of, it’s probably too early to tell before Rep. Price is confirmed as the new HHS Secretary. We will continue to closely monitor the President Trump’s twitter feed…
follow us at https://twitter.com/craneware!


Q: How do you bill PuraPly with JW if there is not NDC per the vendor

A: Since PuraPly is designated with status indicator G, it is eligible for JW modifier reporting for waste. Specific examples of billing for waste with the JW modifier and a model documentation form can be found at the following link: http://www.puraplyam.com/wp-content/uploads/NGS-PuraPly-LCD-2017.pdf

Product waste documentation requirements include the following:

  • Location of ulcer
  • Number of square centimeters applied
  • Number of square centimeters discarded
  • Reason for wastage
  • Date and time product was discarded
  • Name, licensure, and signature of the person who wasted the product
  • Manufacture’s serial/lot/batch number

Q: What commercial payors are requiring JW?

A: We have seen numerous commercial payors’ policies that require the JW modifier for wastage. You should verify each private payors’ requirements for reporting discarded drugs.


Q: On low cost J-coded items, can we opt out of waste billing like Ondansetron

A: Ondansetron (J2405) is designated as status “N” and is not subject to JW modifier reporting. On questions about potential liability in choosing only to bill waste for expensive drugs you would need to check with your legal counsel. The rationale behind the CMS JW modifier requirement is to identify where the Medicare Program can make substantial savings by packaging medications in sizes that conform more closely to patient weight and dosing needs. So drugs where the dollars associated with waste are insignificant are unlikely to become the target of future audits. The biggest risk for audit take-backs is billing for waste that is not substantiated in the documentation or billing waste for multiuse vials.


Q: 340B accumulation is generally based off charge data. If you do not charge for waste on a status indicator of N, it impacts 340B accumulation – do you have a solution for this scenario?

A: No, we don’t really know. In the FAQs, CMS states 340B providers are not exempt from reporting the JW modifier. The issue you describe may have been overlooked by CMS and should be brought to the agencies’ attention.


Q: Is billing for the JW waste adequate documentation?

A: No, the waste volume has to be properly documented. You must be able to substantiate the amount of waste charged to Medicare in the patient record. If the waste is not documented and the reason for waste not apparent in the patient record, it could raise medical necessity questions if audited.


Q: If our Pharmacy system is not capable of charging two different vial size CDM’s on a given dose to achieve the least waste can you just bill the one CDM that comes the closest? Opdivo is prime example of where this could happen?

A: CMS expects providers to administer medications in the most cost-effective manner, utilizing the most cost effective vial and/or combination of vial sizes in order to minimize waste. Drug units billed must reflect the volume of the actual vials utilized for the infusion.


Q: Trying to figure out the documentation of waste… Example- Remicade dose is 550 mg. Pharmacy makes it & nurse gives it. On the bill J code is 550 mg used and 50 mg wasted. Can the waste be assumed since it is only available in 100 mg vials?

A: The HCPCS code for Remicade is J1745 (infliximab, one unit per 10 mgs infused). One service unit is billed for each 10-milligrams of Remicade (infliximab). Remicade is supplied in 100 mg single-use vials. Therefore, the billing quantity will be 10 units of J1745 for each vial infused. If the patient required a 550 mg dose of Remicade, you would report 55 units administered with J1745 on the first claim line and 5 units discarded with J1745JW on the second claim line.


Q: We’ve typically been told that the billable quantity must be whole numbers when reporting on the bill. If this is still valid, how do you suggest rounding the billable quantities when the JW modifier is involved…should waste always be rounded down

A: The following provides an example of rounding: Rituxan is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials. For J9310, the billable unit is 100 mg. The most cost effective vial size must be used. If the ordered and administered dose is 860 mg, the billable amount is 9 units of J9310, since providers are allowed to round up. The wastage of 40 mg cannot be reported on a separate line with the JW modifier, since it is less than the billable unit.


Q: We are a Critical Access Hospital and when we bill outpatient claims it is on an 851 TOB. We are in the J5 for a MAC in Iowa. On our claims most of the drug waste would be reported with a 250 revenue code and Medicare does not let us put HCPCS codes on them.

A: CMS may have overlooked this issue. As you have correctly pointed out, CAHs are not mandated to use 0636 for billing drugs. So if you have set up your entire CDM using 250 and no HCPCS then JW modifier reporting creates a huge administrative burden. This issue needs to be raised with your MAC and CMS.


Q: We’ve chosen to focus specifically in our outpatient infusion center and focus on high cost items and focus on billing for waste of these items. When you mention mandatory, are we subject to focusing on this in capacity and billing for high cost items? Are we subject to liability in not billing for all JW modifiers?

A: Focusing on the infusion center and other expensive drugs is a practical approach. The rationale behind the CMS JW modifier requirement is to identify where the Medicare Program can make substantial savings by packaging medications in sizes that conform more closely to patient weight and dosing needs. So drugs where the dollars associated with waste are insignificant are unlikely to become the target of future audits. The biggest risk for audit take-backs is billing for waste that is not substantiated in the documentation or billing waste for multiuse vials. On questions about potential liability in choosing only to bill waste for expensive drugs you would need to check with your legal counsel.


Q: What are the specifics on waste documentation, can it be done in the charging tool that is connected to the patient financial number for each visit?

A: In the FAQs, CMS said it’s acceptable to use atomatic calculations from software as documentation of discarded drugs and that it doesn’t dictate how doses are calculated.


Q: What if you are only billing for the amount used? If you are not billing for the amount wasted, are you still required to add the JW modifier with that waste?

A: If rounded up amount includes entire amount of the drug to be billed (including administered and wasted amounts), no additional billing for wasted amount should be made


Q: What is the expectation if no drug is wasted? 140 mg dose. Pharmacy used a 40 mg vial and a 100 mg vial to compound.

A: The JW modifier only applies if there is drug wasted. If there is no unused drug, you bill for the amount administered.


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