In part 1 of this article, we reviewed the increasing problems that patients encounter adhering to a medication regimen in the era of extremely high prices for medications. We also evaluated the programs those pharmaceutical manufacturers have developed for patients to afford medications that the manufacturers themselves have priced so high.
In part 2 of the article below, we focus on a response by pharmaceutical manufacturers to reduce costs—programs called accumulators and maximizers. Pharmacy benefit managers (PBMs) have long pursued a series of strategies to reduce spending on medications, in particular prior authorization, rebate negotiations, tiered formularies, and lowest-cost site of care. Accumulators and maximizers are among the more recent tools developed to reduce costs for their payer clients.
As noted in part 1, manufacturers’ copayment assistance is designed to bridge the beneficiary to the out-of-pocket maximum, after which any medication is free to the beneficiary but still costly to the payer. This undermines any financial incentives (such as tiering) that the PBM can set up to promote use of generic medications when they are available.
An accumulator program re-introduces those incentives via a multistep mechanism. At the time the patient presents to the retail pharmacy and uses the copayment coupon, the retail pharmacy (which contracts with the PBM) enters the amount of the coupon in the adjudication system. The PBM notes this part of the transaction and deducts the value of the coupon so that it does not “accumulate” against the deductible. (The pharmaceutical assistance program also notes the value of the coupon, as the programs do put limits on the amount of assistance available.) The beneficiary still avoids the copayment cost at least until she hits the limits on the copayment program, when the coupon ceases to become available and the patient has to begin to pay, reinstating the original incentives.
From the payer’s point of view—either the self-insured employer or the insurer—the effect is financially salutary. Some pharmaceutical firm funds help pay for the initial costs of the medication. But eventually, the deductible and copayments come back into play and promote consumerism. Yet, as the coupon limits come into play, the beneficiary faces challenges from out-of-pocket spending, and adherence can drop.
Accumulators are most common in the commercial setting, where the federal government has set some rules since the passage of the Affordable Care Act (ACA). The government appears to have been of two minds about accumulators. Under rules published as part of the Notice of Benefit and Payment Parameters (NBPP) in 2020, the Department of Health and Human Services had permitted self-funded plans to exclude value of copayment coupons from beneficiaries’ cost-sharing limits only when the medication involved had an appropriate generic alternative. This was sensible in that the most reasonable role for accumulators was to re-establish the incentives that drive patients toward lower-cost and equally effective generic alternatives to brand-name drugs, which most data indicate lowers cost and improves health. However, this was modified with 2021 NBPP, which allowed all the value of a manufacturer’s drug assistance program to be excluded for all drugs, whether or not there was a generic alternative—thereby broadening the reach of the accumulator strategy.
Since copayment assistance is intended to reduce individual patient costs and boost pharmaceutical firm revenue, it should not be surprising that pharmaceutical trade groups and patient advocacy organizations have pushed for federal legislation to block accumulators. Federal legislation has now been introduced by a bipartisan group in the US House of Representatives, the Help Ensure Lower Patient Copays Act (HELP Copays Act). At the state level, by the spring of 2022, local advocacy had led to 15 states and Puerto Rico basically prohibiting the accumulator strategy, requiring that any payment in the form of a coupon made to the patient be applied to the out-of-pocket cost-sharing requirement. Of course, these requirements apply only to fully insured employers; self-insured employers (the overwhelming majority of employers) are shielded from state oversight by the Employee Retirement Income Security Act (ERISA).
With efforts being made to undermine accumulators, PBMs have not rested in their efforts to counter copayment assistance. The newer copayment maximizer strategy is even more potent. Taking a “if you cannot beat them, join them” approach, the program is offered to the self-insured client, which then creates financial drivers to sign up individual employees. Once a patient is in the program and prescribed a drug that is part of the program, the copayment is set at 1/12th of the maximum allowed under a particular drug’s copayment program. In addition, the PBM works with the self-insured client to designate target drugs as non-essential benefits, hence the ACA out-of-pocket maximum is waived for those drugs. The copayment relief is then sought monthly. This allows the self-insured client to essentially drain all the copay assistance available, reducing its costs substantially.
The copayment maximizers are applied to a select group of very expensive medications that generally are adjudicated through the PBM systems (most importantly, not Part B medications). The program has several clear benefits over the accumulator. First, it does not create the accumulator “cliff” when patients are suddenly exposed to unsupported copayments. Second, it is designed to take advantage of the entire copayment assistance program, all of which goes to lower costs for the client. The maximizer does not reinstate the deductible after the copayment assistance programs limits are reached. In some circumstances, the accumulator may be more effective for reducing costs, but many employers appear to believe that that is outweighed by the adherence benefits of a maximizer program.
All three of the largest PBMs have designed maximizer programs, and they are quite similar in their details. For example, Optum describes its maximizer program as applying to a list of 200 drugs, representing more than 90 percent of copayment assistance. The medication must be dispensed from the Optum Specialty Pharmacy. The program spreads the coupon assistance over 12 months. The member simply accesses the coupon program and applies it all year long. From that viewpoint, the customer experience seems quite smooth.
Overall, the maximizer programs must be seen by clients of the PBM as an advance over the accumulator programs: They do not have the adherence cliff, and they lower costs for the ultimate payer especially, for medications that have no generic competition. And there is reason to believe that maximizers are working. First, there has been tremendous growth in the short life of the program, with 6 percent of employers using them in 2018, rising to 45 percent by 2021. Second, there is some evidence of effectiveness. One PBM reported that clients that used the maximizer program experienced a specialty drug cost trend of negative 12.5 percent; those not using it who had an average trend of positive 7.4 percent. Those numbers are astounding to industry insiders who have become used to a decade of double-digit increases in spending on specialty drugs. Such major shifts in revenue will generally prompt litigation, and they have.
The Legal Proceedings
Litigation on accumulators was originally touched off by the Centers of Medicare and Medicaid Services’ (CMS’s) decision to address accumulator programs as part of the Medicaid Best Price rule. This rule requires manufacturers to give the Medicaid the lowest price it offers to any other business, such as health plans or PBMs. It sets the floor for pricing discounts.
On December 31, 2020, in the last months of the Trump administration, CMS proposed changes in the rule, known as the Medicaid Drug Rebate Program. The proposal essentially declared that any copayment assistance for medication costs reclaimed through an accumulator by the PBM on behalf of a self-insured employer or health plan would count as a discount, thus lowering the best price and the amount that Medicaid would have to pay for the medications. CMS took the position that the accumulators’ effect on copayment assistance was a matter of the manufacturer paying the ultimate payer and thus fell under the definitions set out by the original Best Price Rule and its 2016 revisions.
Commenters on the proposed rule countered, noting that the original rule had explicitly designated certain entities (insurers, wholesalers, and so forth) as the appropriate discount obtainers. Patients were not designated. So, commenters saw the new rulemaking as inappropriate. They also argued that if the new CMS rule stood, the entire structure of the copayment assistance endeavor by pharmaceutical firms would be put at risk as unaffordable. CMS acknowledged this and expected there would have to be changes in patient assistance programs overall, but clearly believed that this evolution was probable. The possibility of evolution and change did not seem unwarranted, as the accumulators and maximizers themselves were part of an evolutionary process in addressing the costs of drugs.
The Pharmaceutical Research and Manufacturers of America—the lobbying group representing the pharmaceutical industry—sued on May 21, 2021, seeking injunctive relief to have the rulemaking halted. The legal argument was that the new rule was inconsistent with the original Medicaid Best Price rule. Notably, however, the brief’s posture was one of patient protection, noting that the accumulator could harm adherence. Not surprisingly, Amitabh Chandra, Evan Flack, and Ziad Obermeyer’s recent paper on the health effects of cost sharing was prominently cited.
Particularly interesting was the amicus brief submitted by the wholesaler, McKesson Corporation, which also operates one of the widely used pharmacy “switches.” Switches are the electronic backbone that links payers, PBMs, and retail pharmacies in a seamless adjudication process. McKesson noted that CMS failed to address the key point that the PBM accumulator process is invisible to the drug manufacturers. The new rule did not require the PBMs to share any information about who qualifies for and uses an accumulator. McKesson found preposterous CMS’s suggestion that pharmaceutical manufacturers should do their accounting outside of the electronic adjudication process. McKesson hinted that such an approach might force a lowering in the Medicaid Best Price for any drug that has a copayment assistance program, ultimately reaching the maximum of the program’s benefit, even for patients on the target drug who have not availed themselves of the program. The latter would be extremely expensive for pharmaceutical firms.
The case was recently decided by Judge Carl Nichols in the District of Columbia Federal District Court. He granted the manufacturers’ request for summary judgement and granted injunctive relief, halting the rulemaking. He relied on the argument raised by McKesson that manufacturers would be unable to calculate exactly how much copayment assistance was going directly to the payers. More importantly, he concluded that the original Medicare Best Price rule was rather clear and was never intended to include payments that went “through” patients on their way to the insurer/employer. Judge Nichols broadly accepted the Pharmaceutical Research and Manufacturers of America’s (PhRMA’s) view of the accumulator programs, writing, “Seeking to pocket for themselves at least some of the assistance, commercial health insurers have devised schemes known as accumulator adjustment programs.”
Of course, another way of interpreting the accumulator programs is that they are a way for the payer of health care (insurer or employer) to reduce the costs of very expensive drugs to patients and the health care system. Central to the PBM business model are programs that reduce costs for their clients (insurers and employers)—many payers are struggling with managing high spending on prescription drugs, which currently account for about one in every seven health care dollars in the US. Patient assistance programs were pharmaceutical companies’ response to PBM cost-sharing programs such as tiered pricing, and the accumulators and maximizers were the PBMs’ answer back.
Judge Nichols ruling did not address the ongoing operation of accumulator programs. Rather it only, for the time being, stayed CMS’s efforts to lower Medicaid drug prices by treating the copayment assistance as a discount for health plans. However, it was an important victory for pharmaceutical companies and their patient assistance programs; had the CMS rule been enacted, many manufacturers might have thought seriously about the ongoing viability of such programs.
Meanwhile, patients remain at the mercy of this “great game” between manufacturers on one hand and health plans and PBMs on the other. As noted in the first part of this article, while financial impediments to adherence have not been a focus of health services research until recently, a growing number of studies have identified “irrational” patient behavior in the face of high cost sharing. One has to fear for the effects on adherence. The best approach for patients would be to create ways to lower the overall costs of medications to align with their clinical value, but pharmaceutical manufacturers have fought hard against any effort at the state or federal level to rein in their ability to freely set prices. With spending on medication continuing to increase, employers and insurers, the ultimate payers, must continue to rely on the more recondite tools of PBMs.
Accumulators are not the only target of recent litigation. In May 2022, the patient assistance program operated by Johnson & Johnson, known as Johnson & Johnson Health Care Systems (JJHCS), sued the company that manages the maximizer program for Express Scripts (SaveOn SP). In the request for a jury trial, JJHCS alleged that SaveOn SP tortiously interfered with the copayment assistance program that JJHCS operated and also engaged in deceptive business practices. This complaint is just the beginning of the litigation, but the complaint provides insight into how manufacturers view maximizer programs.
The complaint frames the entire structure of SaveOn SP to be a surreptitious effort to extract inflated amounts of copayment assistance for the benefit of the insurer/employer. It presses hard against the strategy of declaring certain drugs as non-essential. The Affordable Care Act requires that a certain number of medications in every drug class be covered, but so long as that number of drugs are covered, all others in the class may be considered non-essential. The maximizer program requires the employer to declare some drugs as non-covered, hence the out-of-pocket limit no longer applies to those drugs.
JJHCS’s complaint alleges that this manipulation of the list of required drugs by the maximizer program is simply a matter of taking advantage of a loophole in the law. That seems a stretch, but the definition of essential benefits for drugs in the ACA is thin, and employers can take advantage of it to limit what will be covered by the insurance they provide. Indeed, some employers are interested, at the time they specify their benefit structure for their ERISA plan, in excluding coverage entirely for certain classes of treatments, such as gene therapy. As prices of drugs continue to increase, such exclusions could become more common.
Quoting from SaveOn SP’s own marketing materials, the JJHCS complaint makes it clear that the maximizer program was designed to extract as much benefit as possible for the insurer from the manufacturer’s copayment assistance program: Specific drugs are targeted; the SaveOn SP program also enrolls the beneficiary after careful outreach. JJHCS argues that this is all inappropriate, in that they offer the copayment assistance only insofar as it is not associated with any other outside programs. This appears to be the primary basis for the tortious interference claim.
As suggested in the previous section, the program appears to work for SaveOn SP and its clients. Given the impressively high costs of today’s specialty drugs, the dollar amounts extracted from the assistance programs are startling. For example, the average amount of JJHCS assistance pulled per prescription fill for Uptravi, a medication to treat pulmonary artery hypertension, was $418. For a person on the SaveOn SP program, the amount pulled per prescription fill was $5,000. For Stelara, used to treat plaque psoriasis, the similar amounts were $1,171 per fill for patients not in the SaveOn SP program, $4,301 within the program. The complaint validates SaveOn SP claims that relatively small clients can save hundreds of thousands of dollars using the program. These kinds of figures help explain the fast growth of maximizers.
The new litigation over accumulators and maximizers neatly sets up the policy issues surrounding them. If one believes that the patient assistance programs funded by pharmaceutical manufacturers are mainly efforts to promote more use of very expensive drugs by countering cost-sharing programs, then the accumulators and maximizers are a creative answer that checks the manufacturers’ efforts. If, by contrast, one perceives the patient assistance funds as intended to improve access to medications for patients stranded by their under-insurance, then it is the PBM programs that are problematic.
Research shows that brand-name prescription drug launch prices have been increasing exponentially over the past decade and are generally not connected with the clinical benefits those drugs offer to patients. Until more systemic reforms rein in pharmaceutical manufacturers’ ability to set drug prices at such levels, accumulator and maximizer programs will be among the tools PBMs deploy on behalf of the payers in the system (insurers and employers) to ensure that they can continue to cover expensive but useful drugs, rather than simply walking away from coverage. Therefore, the next steps in these two streams of litigation will be watched closely.
The back and forth reflected in the litigation reveals exactly how irrational our system for pricing of drugs has become. Pharmaceutical manufacturers name their price, then provide their own discounts in the form of patient assistance. Benefit managers then design programs to access greater amounts of such assistance to reduce the premium pressure that high prices create for the payers in the market. All of this requires a great deal of administrative costs, not to mention the costs of litigation as the adversaries push their programs ever harder. Sooner or later, a government intervention will be needed to address the root problem: What level of drug prices can US patients and the health care system afford? Until then, these same battles between payers and manufacturers will continue.
Troyen Brennan was previously employed by CVS Health and has stock and stock options in a number of health insurance companies. Aaron Kesselheim has had grants from Arnold Ventures.