waste?

Catching up on what’s crucial!

The Waste REFUND Act

The infrastructure bill that passed on Nov. 15, 2021, garnered much media attention for its focus on bridges and other long-neglected systems. But did you know that the bill also includes a drug waste provision that, if not addressed adequately by your revenue cycle team, could lead to failed audits and charges of healthcare fraud?

Fortunately, there are four key questions you can use to determine how to accurately bill for drug waste and ensure compliance, along with several other tools detailed below.

First, a bit more background. The portion of the infrastructure bill (H.R. 3684) that you need to pay attention to is the drug waste provision from the Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act of 2021 (S. 1287). The act requires manufacturers to rebate the amount wasted back to CMS effective Jan. 1, 2023 (see Sec. 90004). This concept was first introduced in 2019 by Sens. Dick Durbin (D-Ill.) and Rob Portman (R-Ohio) in a bipartisan bill designed to reduce egregious wasted spending on discarded medications that are the result of excessively large, single-use drug vials.

The bill requires drug companies/ manufacturers to reimburse Medicare for certain wasted medications. It specifically states that these medications are certain single-dose container or single-use package drugs payable under Part B of the Medicare program. The intent is to provide refunds with respect to discarded amounts of such drugs— for example, wasted medications that include leftover portions of drugs packaged in single-use containers.

Keep in mind, however, that three pharmaceutical categories are excluded: • a drug or biological that is either a radiopharmaceutical or an imaging agent; • a drug or biological approved by the

FDA for which dosage and admin-

istration instructions included in the labeling require filtration during the drug preparation process, prior to dilution and administration, and require that any unused portion of such drug after the filtration process be discarded after the completion of such filtration process; and • a drug or biological approved by the

FDA on or after the date of enactment of this subsection and with respect to which payment has been made under this part for fewer than 18 months.

Further provisions require HHS to

aggregate the total amount of discarded Part B drugs quarterly using Medicare Part B claims and calculate refunds using the ASP (or WAC if ASP is not available). The drug manufacturer will be required to provide a rebate to HHS for the total amount of discarded medication recorded, above a 10% low-volume threshold. Noncompliance to provide a timely rebate could incur civil monetary penalties under this act.

More details on S. 1287 and H.R. 3684 can be found at the Congress. gov website (bit.ly/35ZG4Jo and bit. ly/3spjqBH, respectively). For the latter, see Sec. 90004, which requires certain single-dose container or singleuse package drugs payable under Part B of the Medicare program to provide refunds with respect to discarded amounts of such drugs.

Compliance audits are a guarantee! These could be audits of the manufacturer’s compliance, as well as audits of health systems’ activities related to the accuracy of the aggregated amount calculated, comparisons of billed doses and billed wastage with the number of units sold, or any untold number of other methods of determining data accuracy and ruling out fraud.

Given the potential for audits, this is a good time to review your waste billing program. Medicare created the ability to bill for expensive waste in the outpatient area shortly after moving to the concept of “billing units representing actual dose given” for reimbursement and away from the “whole vial” method of billing under OPPS. Medicare does not mandate billing for waste, but makes it possible to recoup some lost dollars if you choose to bill for them. How does this work? That’s where answering those four questions comes in: 1. Is the drug being used for a Medicare outpatient? 2. Are you using a single-dose vial/ package? 3. Does the product have an HCPCS code? 4. Does the code include an SI G or SI K designation?

If yes, proceed to waste billing. If no, then there’s nothing to do.

It’s also important to avoid pitfalls when coding for drug waste. For example, the actions in the IV prep area must match what’s billed and charted in the EHR! Don’t file build in such a way that the computer automatically processes waste billing on order entry without knowing exactly what’s happening to the drug. Never create an auto-bill situation that doesn’t represent true actions. Consider this potentially tricky filebuild scenario: The drug vial contains 1 g of medication. The infusion center uses 500 mg for each of two patients. Nothing was actually wasted. But without a careful file build, you could have created a situation where your revenue cycle department would assume that two vials had been used and erroneously process two waste charges. This would constitute fraud.

Zero-priced products are another potential pitfall. These medications— typically patient assistance and whitebagged/specialty pharmacy drugs— don’t qualify for waste billing. Since there’s no charge for these products because you didn’t buy them, there cannot be any waste billed. Staff must understand the difference, know when a zero-priced product is being used and use the correct line item on order entry.

It’s also important to understand your system’s limitations. For instance, you may be able to file build such that the computer will calculate the amount given and amount wasted, but how does this information become a line on the MAR for the nurse to chart the waste? And how does this information get converted into a waste line bill with the appropriate modifier that accompanies the drug line bill so that the two are charged together on the same day? Documentation must be in the patient chart; automated dispensing records or other internal pharmacy records aren’t sufficient. If you’re trying to charge for waste for something that comes out of an automated dispensing cabinet, you’ll need to work out how this is consistently charted in the medical record, if that is even possible.

Here’s another important tip: Don’t forget about revenue cycle orientation. Waste billing means that there are two lines of billing for the same patient on the same day with the waste identified by the JW modifier. This goes completely against the hard stops that have been built into many of the revenue cycle processes that prevent this from happening. Have you worked with your revenue cycle team to resolve this issue? ■

“Reimbursement Matters” is a tool for maintaining your health system’s fiscal health. Please email the author at bonniekirschenbaum@ gmail.com with suggestions on reimbursement issues that you would like to see covered. Bonnie Kirschenbaum, MS, FASHP, FCSHP

A Reimbursement Lexicon

ASP, average sales price; CDM, charge description master; CMS, Centers for Medicare & Medicaid Services; EHR, electronic health record; HCPCS, Healthcare Common Procedure Coding System; HHS, Department of Health and Human Services; MAR, medication administration record; OPPS, Outpatient Prospective Payment System; PDM, pharmacy drug master; SI, status indicator; WAC, wholesale acquisition cost

3 Trigger Points To Measure Your Progress

1. Candidate Drugs

Success: Eligible SI G + K drugs identified, updated quarterly Fail Point: Pharmacy unaware of how to do this

2. Billing Unit Conversions

Success: Crosswalk accurate, CDM/PDM built to accommodate required charting Fail Point: Pharmacy not following up

3. Reality Matches Billing

Success: Clinician actions match charting and billing Fail Point: Pharmacy opted for “robo-billing.” Billing person has no idea of what clinician or IV prep area actually did

See Module 4 of the Reimbursement Tool Kit (www.pharmacypracticenews.com/ToolKit) for more details. e details.

FDA NEWS

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Tebentafusp-tebn is the first T-cell receptor (TCR) therapeutic to receive regulatory approval from the FDA and the first BiTE approved to treat a solid tumor, Immunocore said in a press release. It also is the only therapy approved to treat this rare form of ocular melanoma, the company said (bit.ly/3uaTXyt).

“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” John Kirkwood, MD, the director of the Melanoma Center at the University of Pittsburgh Hillman Cancer Center, said in the press release. “The approval … represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offers hope to those with this aggressive form of cancer.”

The approval was based on a phase 3 trial of 378 human leukocyte antigen (HLA)-A*02:01–positive adults who received tebentafusp-tebn or the investigator’s choice of therapy with single-agent dacarbazine, ipilimumab or pembrolizumab, according to results published in The New England Journal of Medicine (2021;385[13]:1196-1206).

Overall survival at one year was 73% in the tebentafusp-tebn group and 59% in the control group (hazard ratio [HR] for death, 0.51; 95% CI, 0.37-0.71; P<0.001). Progression-free survival at six months was 31% in the tebentafusptebn group compared with 19% (HR for disease progression or death, 0.73; 95% CI, 0.58-0.94; P=0.01).

Serious adverse reactions include cytokine release syndrome (CRS); skin reactions such as rash, pruritus and cutaneous edema; and elevations in liver enzymes, Immunocore said. Other common side effects include fatigue, nausea, hypotension, dry skin, headache and vomiting.

Tebentafusp-tebn is a new class of BiTE therapy that specifically targets the lineage antigen glycoprotein 100 via an anti–cluster-of-differentiation 3 immune-activating effector function, Immunocore said. The compound is an example of Immunocore’s proprietary TCR technology, which generates bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules, according to the company.

“Based on the demonstrated mechanism of T-cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune ‘cold’ low mutation rate tumors,” Immunocore said.

“The approval of tebentafusp-tebn is very exciting, because it represents the first treatment for patients with unresectable or metastatic uveal melanoma, a devastating disease,” said Lisa Holle, PharmD, BCOP, a clinical professor of pharmacy practice in the Department of Pharmacy Practice, University of Connecticut School of Medicine, in Storrs. “Incorporating this new medication, however, into patient care will require education of the healthcare team, especially for those who may not be familiar with BiTE therapies,” added Dr. Holle, a member of the Pharmacy Practice News editorial board.

BiTE therapies can cause CRS, “which can be very serious and even lifethreatening, requiring close monitoring for at least 16 hours the first three infusions,” Dr. Holle said. “This represents a challenge for infusion rooms, which typically are not operating for that length of time on a daily basis. Thus, observation in an inpatient setting may be needed.”

She added that “a trained healthcare team should be available with access to the appropriate medications and equipment to manage CRS. Pharmacists should ensure that patients are euvolemic prior to starting therapy, as well.”

Other potential toxicities, Dr. Holle noted, include skin reactions, “which are common but often can be managed with antihistamines and topical corticosteroids, and elevations in hepatic enzymes, which should be monitored closely during therapy.”

For more news on BiTE therapy, see page 17

FDA Warns of Strangulation Risk From Tubes

By PPN News Staff

Enteral feeding set tubing can become wrapped around a child’s neck, causing strangulation or death, the FDA warned pharmacists, parents and other healthcare professionals.

The warning comes after the FDA received reports of two toddlers younger than 24 months who died after being strangled by the tubing last year, the agency said.

“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” the FDA said. “It is also possible that some cases have not been reported to the FDA.”

The FDA recommends pharmacists and other healthcare workers share the warning with colleagues and pediatric patient caregivers to ensure they are taking appropriate measures to protect patients, including following protocols to monitor medical line safety.

Adverse events related to enteral feeding set tubing can be reported to the FDA’s MedWatch system online (bit. ly/34SQE4f).

“Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices,” the FDA said.

The agency added it is working with device manufacturers to evaluate the risk in pediatric patients and to create strategies to minimize patient risk.

Almost 190,000 pediatric patients— 40% of all users—rely on feeding tubes for nutrition in the United States, according to a 2017 study (Nutr Clin Pract 2017;32[6]:799-805).

Find more information, including safety tips and other resources, on the Feeding Tube Awareness Foundation website (www.feedingtubeawareness.org).