The battle between pharma and PBMs over copays intensifies
By bringing regulatory considerations from longstanding governmental rules on how employer-based health insurance is managed, a Washington advocacy group is fighting the adoption of copay accumulators. The group, the Alliance for the Adoption of Innovations in Medicine, is not itself litigating on behalf of industry, but is firing a warning shot that litigation could be in store for employers and insurers.
In a just-released report, “Employers Beware: Understanding the Costs and Liability Risks of Health Insurance Copay Accumulator Programs,” the group offers a pair of arguments against accumulator programs: they might be illegal under a variety of federal rules, including the Affordable Care Act, Employee Retirement Income Security Act (ERISA), and the Federal Trade Commission Act; and, by limiting employee/patient access to medicines, the accumulator programs might worsen the health of those patients.
Copay accumulator programs, which have been around for about a year, set up a mechanism whereby employers (and/or their PBMs) exclude copays from the calculation of a patient’s annual deductible, while collecting the copay support (from manufacturers) that the patient presents when obtaining a prescription, thus negating the value of the copay assistance for that patient. They are the latest salvo in the long-running battle between manufacturers (who want patients to have access to their drugs, despite high copay costs) and PBMs (who want to steer patients to lower-cost medicines by charging higher copays or requiring coinsurance from the patient).
The Alliance’s argument is that federal law (the ACA) mandates a maximum deductible for insured lives (which could be exceeded if copay assistance is not counted as part of the deductible), and that the programs may, in effect, be denying access to patients for needed drugs in a discriminatory manner. The language that some insurance programs use to describe the programs might be an intentional form of deceiving (or at least confusing) patients; the accumulator programs have labels like “Out of Pocket Protection Program” or “Benefit Plan Protection Program” that sound like they are saving patients money, rather than causing more patient expense. There are federal rules on plain-language descriptions of what employer health plans offer.
Accumulator programs “not only limit access to necessary treatment for employees who take prescription medications, they also can place employers at risk for liability,” says the Alliance. “Ultimately, these programs may result in increased costs for the employer. Moreover, legislative action limiting copay accumulator programs is also foreseeable.” According to data cited by the Alliance, 17% of multistate employers already have an accumulator program in place, and 56% are considering adoption in 2019 or 2020. If the legalistic arguments carry any water with employers, the Alliance’s recommendation is that employers simply not adopt the program, or ensure that, among plans offered to employees, at least one excludes the program.
The Alliance (www.AimedAlliance.org) is a nonprofit supported, in part, by numerous pharma companies, as well as “collaborations” with a variety of patient-advocacy groups. It has previously tackled restrictions on physician prescribing practices and patient access issues.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.
Operating Without a Commercial Blueprint: Empowering the Field for Niche Therapy Launches
October 24th 2024How emerging biotech companies can create fruitful partnerships between home office commercial teams and the field force to enable this intelligence gathering, while driving commercial success.