Many oncologists oppose white bags because they prefer to be able to adjust doses during a visit based on lab reports taken that day.
The rise of white bags is wreaking havoc on patients and has spurred legislation in several states, according to 2 experts who said their oncology practices refused to participate in the practice. With the white bags, Pharmacy Benefit Managers (PBMs) require that certain expensive drugs be shipped from their own specialty pharmacies to practices, where clinicians then administer the drugs to patients, assuming the drugs arrive safely and that no change in dose is necessary.
But the real problem, according to a third expert on Friday’s panel on PBM practices at the National Comprehensive Cancer Network’s (NCCN) annual meeting, is that payers are determined to do something about rising drug costs.
Michael Kolodziej, MD, who was a longtime medical oncologist and then an executive at Aetna/CVS before joining ADVI, noted that oncologists did not create the “buy and bill” reimbursement system, in which they receive 6 % of the average sale price. medications they administer. The optics of this method are “problematic,” he said, especially with so many expensive new cancer drugs approved through the FDA’s fast track. Payers, he said, are skeptical of the value of some treatments; indeed, over the past year, some pharmaceutical companies have withdrawn indications after confirmatory trials have failed.
“Payers don’t like it,” Kolodziej said. “And, oh, by the way, neither does the federal government.”
Kolodziej was joined by Kathy W. Oubre, MS, Pontchartrain Cancer Center, Kenneth M. Komorny, PharmD, BCPS, Moffitt Cancer Center, and Michael I. Rabin, MBA, MPA, City of Hope National Medical Center, who served in as moderator.
Oubre explained the difference between white bags and transparent bags, in which a supplier’s in-house specialist pharmacy prepares a medicine and administers it during a patient visit, which oncologists prefer, because the doses can be adjusted based on lab reports taken that day. Brown bagging, another cost-saving practice, involves shipping drugs directly to the patient. In some cases, the patient is expected to bring the medications to the oncologist for administration. Documented cases include patients leaving medication in their car instead of putting it in the fridge.
Patient safety. Oubre and Komorny raised safety and chain of custody issues that have been reported to pharmacy boards and professional associations, such as the Community Oncology Alliance. These include medications shipped to the wrong address, medications left on loading docks without temperature control, or medication shipments interrupted due to weather events.
Komorny said delays in shipping a patient’s granulocyte colony-stimulating factor are extremely dangerous. “In these cases, the patients missed that rescue medication when the medication was due,” he said. “Failing to receive this drug when due could lead to significant complications, including neutropenic fever, which of course has a higher mortality rate.”
“All of these issues negatively affect the patient, leading to delays in care,” Oubre said. “And, if it’s a dose reduction, you’re talking about additional copays for that patient.”
Frustration over the cost. Noting that the issue might be sensitive to some NCCN member institutions, Kolodziej explained that payers are frustrated with hospitals that inflate the cost of oncology drugs. He cited both a report paid for by the pharmaceutical industry which found that hospitals mark up drug prices by an average of 500%, and data which shows that more than half of hospitals are now participating in the 340B program, which allows them to participate in drug discounts. purchasing programs while charging full price to payers.
The combination is not durable, he said, and that is why white bags exist. Kolodziej noted that he did not forbid the practice – he did not allow it when he practiced. But the policy is a way for vertically integrated payers and PBMs to cut costs, by controlling the service site. Staged edits are another tactic. “The thing is, all of these policies can be executed now because they can control pharmaceutical benefits internally,” he said.
It might be in the best interests of oncologists to adopt a phase-out of purchase and billing for something similar to a plan advocated by former American Medical Association president Barbara McAneny, MD, who pays oncologists for the actual services they provide with administrative fees for the drugs they administer.
“I think most of us would agree that we would like to get paid for the work we do,” Kolodziej said. “The question is, how do we get from point A to point B?”
Legislation. In his home state of Louisiana, Oubre successfully advocated for a law that says payers cannot refuse to reimburse providers for approved physician-administered drugs and services “even if those services are obtained in out-of-network pharmacies,” according to the summary. Oubre has since pushed for similar laws in other states, and governors of politically diverse states like Michigan, New York and Texas have signed laws.
At the federal level, she is working with bipartisan sponsors on the TACT Act, which requires patients to receive their oral cancer drugs within 72 hours, allowing situations such as obtaining financial support, which are “understandable and acceptable “.
Hospital responsibility. Komorny sought to help NCCN members with ties to institutional pharmacies understand the laws and regulations that apply to white bags, as the real-life situations that community oncology has experienced – and potential liability – will only grow as this practice becomes more widespread.
“As this practice is extended to hospitals, hospital pharmacies should be aware of how this practice could affect hospital regulations that must be followed,” he said. CMS accreditation by the Joint Commission requires several standards that hospitals must follow, including 9 specific standards related to medication management, 10 standards adopted in March 2001 to prevent drug diversion, and 5 standards developed in May 2007 that involve preparation under appropriate supervision and sterile conditions. Separately, the FDA has supply chain requirements that must be met to prevent counterfeiting.
Komorny described the detailed measures taken to ensure temperature control in sunny Florida.
“In the pharmacy, we store these medicines in temperature-controlled storage units monitored 24 hours a day, 365 days a year. Electronically, these units record the temperature every 5 minutes, average these 3 temperatures every 15 minutes and document this average over 15 minutes continuously. If there is a deviation from the recommended range, we are alerted and take action,” he said.
Hospitals, he said, must follow the same regulations — and are expected to maintain those standards with all drugs from unaffiliated pharmacies. The rules state that the hospital must remove any vials that are damaged or stored outside of FDA-recommended temperature ranges.
An unaffiliated specialty pharmacy will receive, store, compound and ship medications via third party shipping companies. “As we only got hold of this medicine at the very end, it is impossible for us to ensure proper storage or protection against contamination or counterfeiting. Instances of delayed shipments and receipt of boxes containing room temperature freezer packs, as well as medications that should have been refrigerated, are not uncommon,” Komorny said.
It is for reasons like this that Moffitt and Pontchartrain will not allow white bagging. Komorny described some scenarios that raised serious patient safety issues around chain of custody and dosing, some of which involve the transfer of data for the prescription itself, as well as legal questions about whether the pharmacy hospital would have to assume additional levels of responsibility to get a medicine to a patient. Sometimes insurers try to avoid this by bagging the drugs to the patient. But Komorny warned that if something goes wrong, the hospital pharmacy and possibly the individual pharmacist could violate state laws.
And yet, if a fill is missed, there is a chance that the state board of pharmacy will discipline the pharmacy or pharmacist. “Hospital brown bags are becoming very popular with insurance companies,” Komorny said. “Regulatory and legal white bag compliance can be impossible for pharmacies in the healthcare system to meet.”
“At the end of the day, it’s not the insurance company and PBM or even the specialty pharmacy that’s going to be accountable to regulatory bodies, including the pharmacy board, it’s going to be your hospital and your pharmacy that be held accountable,” he said.