Changes in infusion drug insurance coverage jeopardize ‘hard-won’ disease control

An increasing number of insurance carriers are cutting out infusion centers and small practices for the delivery of infusion medications, and the impact on patient care could be profound.

“We handle a lot of calls from patients and for patients,” Ashley Neal, senior manager of prior authorizations at Articularis Healthcare, a South Carolina-based rheumatology practice, told Healio. “When insurance carriers stop covering buy-and-bill, we try to explain the change to the patients and let them know what their options are.”

This “buy-and-bill” process is when the provider purchases the medication, stores it at their clinic or practice, and bills the third-party payer for reimbursement after the patient has been treated. Many patients in private rheumatology practices are comfortable with this system, even if they do not completely understand it.

However, when their insurance carrier mandates a change in medication or medication procurement, such as through a specialty pharmacy, patients may have concerns, according to Karen McKerihan, MSN, NP-C, director of infusion services at Articularis Healthcare, and president of the Rheumatology Nurses Society.

“When an infusion patient’s insurance changes and mandates that we switch from buy-and-bill to a self-injectable or hospital infusion center, or home infusion through specialty pharmacy, it often impacts the cost to the patient,” she said. “That makes a huge difference for them.”

Cost is not the only issue. Logistical changes in medication delivery can often result in a patient missing doses.

“They have been working for years, adhering to their medications, to get hard-won control of their disease,” McKerihan said. “When you throw in these complications, it can shatter that, sometimes in a matter of days.”

The most common alternative to buy-and-bill is “white bagging,” through the patient’s specialty pharmacy. This is where the medication is sent directly from the specialty pharmacy to the location where the drug will be administered. In this instance, the only reimbursement the physician’s office can recoup is the cost of administration, despite the massive amount of time dedicated to obtaining authorization and ensuring the medication arrives on time for the patient’s infusion, to say nothing of the nursing time and chair time for the actual infusion.

A similar, but rarer, approach is “brown bagging.” Here, the specialty pharmacy sends the medication directly to the patient, who then must take it to a provider for infusion.

However, no matter what color the bag, patient concerns abound. According to both McKerihan and Neal, ongoing communication is critical to helping patients manage these potential shifts in coverage and the associated delays.

Stuck holding the bag

Each of the infusible medication delivery systems has its own advantages and disadvantages for both patients and providers.

Although buy-and-bill is generally the preferred method for most rheumatology practices, it can cause complications for physicians. Most practices purchase drug quantities based on upcoming infusion appointments, with the plan to infuse those patients soon. This helps avoid a situation where a practice is forced to maintain an expensive inventory of drugs for a prolonged period of time.

“However, when patients miss their appointments and the inventory is not closely managed, the medication, particularly ones that aren’t used frequently, can expire, and then you are stuck with the cost,” McKerihan said.

This issue may not be so problematic for high-volume centers with big budgets, but letting doses go unused can make or break a small practice with slimmer profit margins.

Meanwhile, the main concern with white bagging is that it can lead to delayed or missed treatments, according to McKerihan.

“The feedback we hear is that the process of receiving a patient’s drug from the specialty pharmacy is fraught with delays, mishandling or mismanagement, and patients do not get their medications on time,” she said. “This obviously can have a big impact on how their condition is managed.”

Delays can have dire consequences for patients.

“They have so much anxiety about losing control of their disease and their symptoms,” McKerihan said. “Some patients can miss a dose or go a week or two without an exacerbation of their symptoms. Other patients go 3 or 4 days and they feel it.”

Stopping and starting medications can also be problematic, McKerihan added.

“Immunogenicity is a concern,” she said. “If a patient is introduced to a molecule, and then there is a lapse or delay, the reintroduction of the molecule runs the risk of the patient developing antibodies to it. This increases the risk for infusion reactions or loss of efficacy.”

Brown bagging is beset with similar concerns, alongside the unique wrinkle of inserting the patient into the drug supply chain. Here, the medication is delivered to the patient’s home, adding a degree of uncertainty regarding how it will be stored and handled.

Specialty pharmacies may also send an amount of medication that does not allow for accurate dosing per the patient’s weight. Another potential issue arises when a drug has vials of several dose sizes, and the wrong combination of vials is sent, leading to drug waste. These problems can then cascade into delayed treatment or under dosing, according to Neal.

‘Pain, confusion and trepidation’

Often, insurance coverage of biologic medications can be complicated, obtuse and frustrating. Moreover, understanding its various processes and rules does not always mitigation confusion or concerns. A prime example is when an insurance company mandates a switch from an originator product to a biosimilar.

“If the patient thinks they are receiving ‘Remicade’ (infliximab, Janssen) but then see that their infusion label says ‘Inflectra’ (infliximab-dyyb, Pfizer), or another biosimilar, it can cause panic, confusion and trepidation,” McKerihan said.

She added that education is critical at every twist and turn of a patient’s infusion medication journey.

“When drug changes are mandated by insurance companies, we try to call all the affected patients to discuss the change,” McKerihan said. “We give them opportunities to ask us questions. If they want to see the doctor to talk it through, we make an appointment.”

Trust is critical in these situations.

“The nurse’s relationship with the patient is key to this whole thing,” McKerihan said. “We can be a stabilizing force through insurance mandated changes.”

However, she was quick to note that embracing and accepting change are two different things. In addition, there are ways rheumatology providers can advocate to minimize the incidence of insurers changing course at their own discretion.

‘There is power in numbers’

Although many clinicians feel powerless in the face of the U.S. health care system, McKerihan said she believes that with enough will, advocacy can be effective. For the average provider, this can involve making a phone call or writing an email to a legislator. However, there are other tactics with broader ambitions.

“Employers in health systems should allow their employees who are passionate about this to be involved,” McKerihan said. “If they are willing to go to the statehouse or Capitol Hill, let them go.”

According to Neal, the American College of Rheumatology, the Coalition of State Rheumatology Organizations (CSRO), the National Organization of Rheumatology Managers (NORM) and other such collectives all offer ways for practitioners to make their voices heard and to volunteer.

“These organizations can help increase your voice and push relevant legislation along,” she said.

Such organizations can also help smaller practices communicate across state lines, organize and improve their power to stand up against insurance practices they disagree with, according to McKerihan.

“Recently, one of our employer-funded plans suggested we round down doses of a particular drug that comes in 50 mg vial sizes to the nearest vial,” she said.

For example, if the patient’s weight required a 255 mg dose, the practice was to deliver a 250 mg dose to eliminate the 45 mg “waste” that would have occurred with proper dosing.

“When we got wind of this, one of our physicians reached out to CSRO,” McKerihan said.

It did not take long for CSRO to issue a letter to bring awareness to other practitioners about this trend.

“They were able to shed light on this new tactic, empowering practitioners to look for it and help fight this trend before it became more widespread,” McKerihan said. “There is value in communicating with larger organizations about these issues. There is power in numbers. A small practice being part of a larger group has a voice.”