Patient Protection

An unlikely alliance is tackling everything from cannabis to pharmacy benefit reform.
By Katie King Posted on November 15, 2022

Leader’s Edge sat down with Michael Barnes, counsel to Aimed Alliance and managing attorney at Sequel Health Law, to discuss everything from prescription drug transparency and  mental health parity to employer liability related to cannabis.

Aimed Alliance brings together stakeholders ranging from pharmaceutical companies and wellness providers to chronic disease associations. Which issues have proved the most challenging to find consensus and how have you solved for that?
One of the greatest challenges Aimed Alliance confronts is in encouraging employers, health insurers and pharmacy benefit managers (PBMs) to recognize the value in implementing patient protections like those established under the Affordable Care Act (ACA).

Step therapy provides a helpful example. Requiring documentation that an insured consumer and his or her healthcare provider have considered and ruled out the use of a less expensive healthcare product or service, can help ensure that a treatment is medically necessary, and can reduce healthcare spending. But step therapy policies often strictly require insured consumers to “fail first” on alternative treatments before the insurer or PBM will cover the prescribed treatment.

Frustratingly, health insurers and PBMs have largely refused to adopt protections like reasonable limitations on benefit utilization policies. For example, New York implemented a step therapy law in 2017 that obliges health plans to grant a step therapy exception if the patient has already tried and failed to experience intended clinical outcomes while using the required medication. Despite this obligation, almost half (46%) of New York healthcare providers who responded to an Aimed Alliance survey indicated that patients are required to try and fail to experience results on the same medication more than once “every time” or “most times.”

We are now working with New York patient advocates and state legislators to support the introduction, passage and implementation of a robust step therapy law. Essential elements of such a law include prohibiting requirements that patients (1) step through off-label drugs; (2) try and fail on more than one drug; and (3) go through step therapy for longer than 30 days. Additionally, step therapy approvals should remain valid for at least 12 months. We intend for a stronger New York step therapy law to serve as a model for other states.

Many of your supporters are drug manufacturers. How are you working with them on furthering transparency in the prescription drug industry?
Since its inception in 2013, Aimed Alliance has encouraged drug and device manufacturers, distributors, health insurers, PBMs and pharmacies to voluntarily adopt and implement pricing strategies that are fair and transparent, support patient access to healthcare, and in the case of manufacturers, enable further research and development.

We have seen progress in recent years on the part of drug makers. For example, some have voluntarily pledged to limit price increases or provide transparency around pricing decisions.

The Alliance advocates on nonmedical switching practices. What’s the relationship between prescription drug coverage and mental health parity here?
Non-medical switching is a common health insurer or PBM practice that requires stable patients to switch treatments for financial rather than medical reasons. Non-medical switching can occur by a health plan excluding the medically necessary medication from coverage, elevating the drug to a higher cost tier, or otherwise limiting access to a treatment or increasing the patient’s out-of-pocket costs. A 2022 survey by the Alliance for Mental Health Care Access (AMHCA) found that one in three patients with mental health conditions who responded were forced to pause, change or completely stop their mental health medication because their insurer stopped covering it.

Non-medical switching and mental health parity violations are similar in that both practices can negatively impact the stability of patients with a mental health condition or substance use disorder. As a result, they may be more likely to experience a recurrence or worsening of symptoms and higher corresponding healthcare costs. The AMHCA survey also found that one in five respondents with mental health conditions required a visit to the hospital or emergency department due to a change in how their medication was covered.

There are state laws that have proposed that insurance cover non-FDA approved cannabis products as health benefits or through workers comp. What state and federal activity are you tracking right now regarding this issue that’s relevant to employers?
Requiring health insurance plans to cover non-FDA-approved cannabis products would be in direct conflict with federal laws, such as the Employee Retirement Income Security Act of 1974 (ERISA) and the Food, Drug and Cosmetic Act (FDCA).

We’ve identified occupational health and safety risks and legal implications of proposals to require health insurance and workers compensation plans to cover non-FDA-approved cannabis products that could specifically impact employers. For example, employers could be exposed to criminal liability under controlled substance laws and tort liability through lawsuits for negligence.

How do you see this issue evolving from an insurance coverage perspective moving forward?
We anticipate that state legislators will continue to introduce bills to mandate that health insurance and workers compensation plans cover non-FDA-approved cannabis products. If states pass laws requiring coverage of non-FDA-approved cannabis products, employers should challenge those laws in court.

At the federal level, the Medical Marijuana and Cannabidiol Research Expansion Act would remove barriers to medical research into the cannabis plant, CBD and other cannabinoids. The bill has been approved by the House but has not been approved by the Senate. We do not expect the Senate to pass the bill during this Congress.

President Biden recently asked the Secretary of Health and Human Services and Attorney General to review how marijuana is scheduled under federal law. Given that marijuana has not been approved by the FDA as a prescription medication, it is not likely that the substance will be down-scheduled through the administrative process.

Some of your work proposes implementing consumer protections and safety requirements for CBD products. How did you come to focus on this issue in particular?
The FDA-approved prescription medication Epidiolex is the only cannabis-derived drug that is legal under federal law. The FDA has asked Congress for new authority to regulate consumer CBD products. In the meantime, many consumers remain unaware that non-FDA-approved cannabis products could cause impairment or contain contaminants, such as pesticides.

In a 2021 National Safety Council survey, 21% of employees were not aware that consumer CBD products can cause impairment. In that same survey, 77% of employers were concerned about non-FDA-approved, potentially psychoactive CBD products having a negative impact on their workforce.

The risks of employee impairment are especially high in positions involving tasks that could affect the safety and health of the employee or others, such as dispensing pharmaceuticals, carrying a firearm, or handling hazardous materials. Employee impairment in the workplace could translate to a workers compensation issue.

You recently wrote an amicus brief in a consumer protection lawsuit about patient access to medications. Can you talk through your approach and why the Alliance flagged this issue?
We, along with six other patient advocacy organizations, zeroed in on this issue when Johnson & Johnson filed a complaint against SaveOnSP, a specialty medication administrator that sets consumer copays for Johnson & Johnson’s specialty medications.

Many health insurers now engage third-party companies to administer specialty medication benefits and require consumers who need specialty medications to go through the third-party company to access their medications.

For example, if a drug manufacturer provides a patient $12,000 a year (or $1,000 a month) in assistance for a specialty medication, the insurer will artificially inflate the patient’s medication copay to $1,005 per month. But, if the individual enrolls in the third-party specialty medication program, the patient’s copay will be $5, and the insurer will collect the $1,000 of manufacturer assistance each month.

Typically, if a consumer does not enroll in the third-party specialty medication program, the consumer is told he or she must pay 30% to 70% of the medication cost as coinsurance. On top of that, the value of the manufacturer copay assistance received ($12,000 per year), as well as the value of the consumer’s out-of-pocket copayments ($60), does not count toward the patient’s deductible or annual out-of-pocket limit.

Katie King Vice President, Health Policy & Strategy, The Council Read More

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