Effective July 1, 2019, HCPCS code J9031 BCG (intravesical) per instillation will be discontinued and replaced with the new code J9030 BCG live intravesical, 1 mg. This change will allow more accurate coding and billing if a provider uses less than a whole vial of BCG (50 mg) for one patient.
As BCG is a single-use vial, any unused portion should be discarded, and the JW modified used to note for billing purposes the amount discarded. However, in light of the current BCG shortage, groups such as the American Urological Association (AUA), American Association of Clinical Urologists (AACU), Bladder Cancer Advocacy Network (BCAN), Society of Urologic Oncology (SUO), the Large Urology Group Practice Association (LUGPA) and the Urology Care Foundation (UCF), have proposed split-vial dosing (vs. discarding unused solution) as an option to maximize patient access to this important therapy. (Read more.)
"If your practice is considering split-vial dosing for your patients during this shortage situation, it's imperative that you take into account the regulatory and billing concerns and that you get consent from patients when doing so," said AUA Coding and Reimbursement Committee Chair Dr. Jonathan Rubenstein. "It's also important to be aware that not all insurers are allowing split-billing."
FDA: Per FDA labeling, a single-dose vial (SDV) is approved for use on a single patient for a single procedure or injection. SDVs typically lack an antimicrobial preservative, in contrast to a multiple dose vial (MDV), which typically contains a preservative to help limit the growth of bacteria. Although MDVs can be used for more than one patient when aseptic technique is followed, ideally even MDVs are used for only one patient. (more information here). The concern associated with using a single-dose vial for multiple doses is the risk of an unintended break in sterility due to multiple passes into a vial that does not contain an antimicrobial preservative, which may lead to contamination and infection of subsequent patients. There have been reports in the past of bacterial and viral infection outbreaks when a single-dose container has been used for more than one patient. The FDA believes that consistent use of correct package type terms and discard statements for injectable medical products for human use will promote their proper use and provide a foundation for educational efforts to reduce the transmission of blood borne pathogens. BCG is labeled as a "single-dose vial" and therefore the FDA recommends following labeling. The FDA points out that their guidance does not establish legally enforceable responsibilities, but provides recommendations that may be superseded by specific regulatory or statutory requirements.
CDC: The Centers for Disease Control and Prevention's guidelines similarly call for medications labeled as "single-dose" or "single-use" to be used for only one patient. The CDC notes that this practice protects patients from potentially life-threatening infections that can occur from unintended contamination, and notes that multiple outbreaks have been reported resulting from healthcare personnel using single-dose or single-use vials for multiple patients. These outbreaks can cause extensive harm to patients, and can be associated with significant healthcare and legal expenses
Concerns have been raised about whether these guidelines and related policies contribute to drug shortages and increased medical costs. The CDC recognizes the problem of drug shortages; however, such shortages are often a result of manufacturing, shipping, and other issues unrelated to the above guidelines. The CDC does state that "Shortages of some essential medications may warrant implementation of meticulously applied practice and quality standards to subdivide contents of single-dose/single-use vials. In these cases, qualified healthcare personnel may repackage medication from a previously unopened single-dose/single-use vial into multiple single-use vehicles (e.g., syringes). This should only be performed under ISO Class 5 conditions in accordance with standards in United States Pharmacopeia General Chapter 797, Pharmaceutical Compounding – Sterile Preparations, as well as the manufacturer's recommendations pertaining to safe storage of that medication outside of its original container."
Joint Commission: The Joint Commission states that organizations must comply with the original product manufacturer's intended use and notes that dozens of recent outbreaks have been associated with reuse of single-dose vials and misuse of multiple-dose vials. Read more.
CMS: CMS has a policy where unused portions of the single use vial would be subject to the Discarded Drug Policy (see section 40). CMS has stated that "The appropriate clinical use of drug products, including sterile products, depends on numerous factors, including, but not limited to: approved labeling, State law, the setting in which the product is prepared and used (including interpretive guidelines used during survey and certification), how the product is stored, sterility, and chemical stability. These factors are outside CMS's purview, and instead depend on laws and regulations that are in the jurisdiction of states or other federal agencies. In contrast, our Medicare payment policies neither encourage nor prohibit the use or administration of more than one dose from a single-use vial to one or more beneficiaries."
State regulations: The administration of medications falls under local state jurisdiction and regulations. It is important to check with your state to ensure you are not violating state law.
It is important to check with the patient's insurance company for their rules regarding BCG billing. Having a new J code does not mean that insurers or your local Medicare Contractor will allow partial or split billing of BCG. While CMS has stated that their policy allows billing for less than a full vial of BCG, they did state that, ultimately, the Medicare Administrative Contractors will determine payment or not. Medicare has stated that their payment policy does not provide guidance about whether a single use vial can or should be used for more than one dose of a drug
Patients must be made aware that they are receiving a less than full dose of BCG and its potential implications.
The new J code for BCG that will be activated on July 1, 2019 facilitates greater accuracy and transparency with respect to BCG billing. However, it does not mitigate the federal (CMS, FDA, CDC, Joint Commission) and state regulatory constraints that could be implicated by splitting a vial of BCG to multiple patients, not does it mitigate payment concerns and the need for patient consent.
Dr. Rubenstein added, "The AUA is actively monitoring rules and policies that will help you stay aware of the concerns and risks involved."
For more information, or if you have questions, please contact PaymentPolicy@AUAnet.org