Corporate Compliance

Note from the instructor: CMS clarifies billing guidelines on proper billing for drugs in a single-dose or single-use vial, including billing for discarded drugs

Medicare Insider, April 15, 2014

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This week’s note from the instructor is written by Judith Kares, JD, regulatory specialist for HCPro.
 
During a recent Medicare Bootcamp® – Hospital Version session, we had a lively discussion on updated CMS guidelines for proper billing of discarded outpatient drugs. Some of you may have missed this update, since it was included in a supplemental section that was added to Special Edition MLN Matters Article SE1316. This MLN Matters articleinitially focused on correct billing of several anti-cancer drugs administered in the outpatient setting. CMS emphasized the importance of hospitals and other facility and professional providers billing units of these drugs based upon the dosage included in their long descriptors. 
 
The information in the supplemental section, however, provided guidance regarding the proper billing for drugs generally. It also provided clarification on proper billing for drugs contained in a single-dose or use vial, including billing for discarded drugs (those amounts that remain in the single-use vial after the patient has received an appropriate dose for his condition). 
 
General Medicare billing guidelines for oupatient drugs covered under Part B
 
When reporting covered drugs administered to patients in the outpatient setting, CMS reminded both facility and professional healthcare providers to do both of the following:
 
  • Ensure that the amounts of those drugs are accurately reported in terms of the dosage specified in the long descriptors for the applicable HCPCS codes.
  • Report units in multiples of the dosage included in the long HCPCS descriptor. (If the dosage given is not a multiple of the number provided in the HCPCS code description, the provider should round up to the nearest whole number in order to express the number as a multiple.)
                                                                                                                                             
Special Medicare billing guidelines for outpatient drugs covered under Part B contained in a single-dose or use vial, including discarded drugs
 
In certain circumstances (outlined below) Medicare will pay not only for the amount of drug in a single-use vial appropriately administered to a patient, but also for the left over amount that is discarded:
 
  1. The vial must be a single-use vial. (Multi-use vials are not subject to payment for any discarded amounts of the drug.)
  2. 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.
  3. The left-over amount must actually be discarded and may not be used for another patient, regardless of whether or not that other patient has Medicare.
 
CMS reminded providers to carefully document relevant information regarding discarded drugs in the patient’s medical record, including the actual dose administered, the exact amount wasted and the total amount the vial is labeled to contain. In addition, if the Medicare contractor requires discarded drugs to be reported with the JW modifier on a separate line, the total number of discarded units reported should not include amounts of the drug also included on the administered line, due to the rounding up of units.
 
Consistency with other guidance
 
These clarifications are not entirely consistent with prior guidance set out in the Medicare Claims Processing Manual, Chapter 17, Section 40, which reads in pertinent part, as follows:
 
When a physician, hospital or other provider or supplier must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label.
 
There is no mention in this prior guidance that 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.”
 
These clarifications do appear to be consistent, however, with the CDC definition and guidelines for a single-dose or single-use vial, which can be found on the CMS website
 
What is a single-dose or single-use vial?
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case/procedure/injection.  Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative.
 
Can single-dose or single-use vials be used for more than one patient?
No. Vials that are labeled as single-dose or single-use should be used for a single patient and single case/procedure/injection. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients [
3, 6-9].

Even if a single-dose or single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use on the same patient.

To prevent unnecessary waste or the temptation to use contents from single-dose or single-use vials for more than one patient, healthcare personnel should select the smallest vial necessary for their needs when making purchasing decisions.
 
Provider follow-up                                                                                                            
 
Hospitals and other healthcare facility and professional providers are encouraged to review the above-referenced MLN Matters article. There are two excellent examples included that demonstrate how these rules should be applied. Clearly, Medicare is concerned with proper administration of drugs in a single-use dose or vial, as well as proper reporting of related discarded drugs, for both patient safety and cost containment reasons. Healthcare providers will need to gather together relevant hospital staff, with representatives from clinical, pharmaceutical, billing and compliance staff, at a minimum, to develop and implement appropriate policies to assure that both concerns are addressed. 

 



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