Site of Care Restrictions: There Are Risks and Rewards, but for Whom?

In this issue, a case report by authors Jordan Krumanocker, PharmD, CPP, BCACP; and Geena Eglin, PharmD, BCACP, CSP, CPP, describes an infusion reaction during treatment with evinacumab-dgnb (Evkeeza; Regeneron Pharmaceuticals, Inc), a monoclonal antibody approved for the treatment of homozygous familial hypercholesterolemia.¹ This is a relatively new drug that is rarely used and has little published experience related to the safety of this treatment and what clinicians should expect when initiating therapy. While this article is noteworthy for expanding awareness of the potential risks of evinacumab infusions, I find it even more valuable for the concerns it highlights relating to alternative sites of care, especially for the first infusion of an infrequently used drug.

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In this case report, the female patient was forced by payer policy to receive this drug at home for the first time, likely being administered by a home care nurse who had no experience whatsoever with this drug. The drug was also provided by a specialty pharmacy that otherwise had no relationship with this patient, for the sake of presumably saving the payer some money. After experiencing an acute infusion-related reaction, the patient was rushed to an emergency department to receive treatment for the adverse effect. Fortunately, the patient made a full recovery. However, the question remains: Is at-home administration really a safe strategy for the first infusion of a drug with which the health care professionals involved have little to no experience? Also, more importantly, this drug is no longer considered to be a treatment option for this patient, who is likely destined to suffer from premature vascular disease due to under-treated familial hyperlipidemia. Further, there is a reasonable chance that if she had therapy initiated in a proper setting involving a multidisciplinary team that was familiar with managing infusion reactions, she could have been supported through the infusion and allowed to receive future doses of the drug with proper precautions in place. Saving a few dollars by using an alternative site of care may have destined this patient to ineffective treatment options and premature onset of cardiovascular disease.

This case report raises the question: How did we get to a point where payers will rationalize forcing patients into alternative sites of care to receive often complex therapies from people who otherwise have no therapeutic relationship with the patient? It is certainly not welcomed by the specialty team ultimately responsible for the treatment decisions and the patient outcomes resulting from those decisions, and it is not a safe thing for the patient. It is recognized that for patient convenience and perhaps lower out-of-pocket costs, the use of home infusion or alternative treatment centers may be an option, but that determination should be based on shared decision-making between the patient and their care team. That shared decision-making should include an assessment of the risk inherent to the treatment involved, previous tolerance of the therapy, and any patient-specific factors. For the case reported in this issue, it is highly unlikely anyone would have considered giving the first infusion of a new drug with little safety data in the patient’s home to be a clinically sound plan. If the reaction had been more severe and the patient had been seriously harmed or died because of delays in emergency treatment, it would have been a tragedy with much of the liability likely coming back to those who ordered the treatment and not those who wrote the restrictive payer policy.

Plain and simple, the alternative site of care challenge comes down to money. I have sat through several meetings in which a policy is explained on the basis that health centers, especially academic health centers, are paid too much to provide this care and that it can be provided at a much lower cost in a strip mall infusion center or the patient’s home. The health centers defend their costs based on overhead and availability of comprehensive services for managing all levels of complexity of infusion therapy; however, one thing that is not fully discussed during these meetings is that health centers are paid higher rates for infusion because the payers have agreed contractually to those rates. The payer representatives present it as though they are forced to pay a higher cost billed by the provider, when they are only required to pay what they contractually agreed. Why would a payer agree to terms that on the surface are disadvantageous to the payer and their employer clients? It is certainly not because their contract negotiators are naive or dim. Provider agreements with large medical centers are very complex, and there is a lot of “horse trading” that is involved. The payer wants commodity rates for common admissions, procedures, and tests to establish community rates for those high-volume charges. Further, to ensure complex services are available in the community, there are often concessions for specialized care or lower volume tests and procedures. From the health systems’ perspective, this allows the losses on commodity cases to be made up on specialty cases and overall have a sustainable financial position.

Once the ink on the contract is dry, all too often payer policy changes start to occur that cherry-pick options from the medical center, such as infusion and high-cost diagnostic procedures, that are profitable. The stand-alone infusion centers or diagnostic centers are not in the same position of being able to negotiate losers and winners across a broad spectrum of services and therefore must negotiate more competitive rates for the narrow spectrum of services they provide. This cherry-picking on the part of payers is disingenuous and violates the spirit, if not necessarily the letter, of a payer-provider contract.

Many health centers have decided to respond by getting into the community-based infusion center business to compete with stand-alone infusion centers. However, this approach runs the risk of unnecessarily duplicating resources in order to not lose business, which, in the big picture, further increases the cost of health care. Others have negotiated lower rates for lower complexity infusion services to remove the financial incentive to shift patients to stand-alone treatment centers, but many payer policies have been written in a way to exclude any health system–owned infusion sites from consideration.

Currently, it is not entirely clear what the best answer is, but payers and providers need to come to the table to make sure there are safe approaches that balance good care with reasonable costs. Furthermore, if infusion care is not one of the concessions the payers are willing to make in complex payer agreements, that should be defined at the negotiation table and not picked out of the agreement after the deal is finalized.