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"If you're having trouble paying for your medications, Drug Company X may be able to help."

You may have heard sentences like this at the end of pharmaceutical ads on television, and some clinicians may wonder what exactly the companies do to help their patients. The help usually comes in the form of what drugmakers call a "copay coupon" or copay assistance card for, say, $50 that the patient can present at the pharmacy counter to lower the amount they have to pay for their prescription.

Insurers are notified when their patients use copay coupons, and many of them use the data to compile "copay accumulator" records for enrollees. Often, insurers won't allow the money paid by drugmakers to count toward the patient's deductible or out-of-pocket costs.

These rules can be confusing for patients, who may be unaware of the practice. "They think they've met the total amount and then they're surprised when the plan says, 'We've accumulated all those coupons and they don't count for out-of-pocket costs,'" Jennifer Graff, vice president for policy research at the National Pharmaceutical Council (NPC), said during a phone interview at which a public relations person was present. The NPC is a health policy research organization funded by pharmaceutical firms.

"The way it works is really damaging to patients," agreed Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. "Patients don't know this is happening, and they're picking up the drug thinking their copay assistance is counting, and all of a sudden they get stuck with a $1,000 bill," he said in a phone interview. "The insurance companies are double-billing because they're collecting all that coupon money and now they're collecting from the patient ... They're growing, and it's really bad policy."

The Insurer View

Not surprisingly, the health insurers have a different view of the situation. "Copay coupon programs are a marketing scheme leveraged by Big Pharma to keep drug costs high for everyone," said David Allen, spokesman for America's Health Insurance Plans (AHIP), a lobbying group for the health insurance industry, in an email to 乌鸦传媒. "Manufacturers may use coupons to steer patients toward more expensive medications, even when there might be a less costly but equally effective option (generic) available. Meanwhile, health insurance providers foot the bill for the entire treatment cost, which ultimately gets passed on to consumers and employers in the form of higher premiums."

"The bottom line is this: there is only one entity that makes drugs unaffordable or inaccessible -- pharmaceutical manufacturers," he added. "Patients should not be paying such high prices for their medications. The true issue remains that drug pricing continues to skyrocket, with no clear explanation on how those prices are set. Copay coupon programs hide the true impact of rising prescription drug costs."

Need for Transparency

Regardless of how one feels about copay accumulators, "plans need to be transparent, at least, and tell patients the policy," said Schmid. "I started looking at 2021 plans and they bury the policy in plan documents," although one insurer whose policy Schmid looked at did put it on the "Summary of Benefits" page.

Copay accumulators have spawned varying reactions from states and the federal government. Although a few states -- including Virginia, West Virginia, Illinois, Arizona, and Georgia -- have banned their use, the Trump administration did exactly the opposite when it came to plans on the Affordable Care Act's insurance exchanges, said Graff. "In the exchanges, CMS [the Centers for Medicare & Medicaid Services] came out and said, 'You can include accumulators and it can count against the patients' ... It's the opposite of what states have done. That's this interesting back-and-forth and challenge between what's going on at the state and federal level."

The accumulators "can help insurers better reflect actual patient out-of-pocket costs," said Allen, of AHIP. "If patients do pay more for branded drugs, it will only be because pharmaceutical manufacturers impose limits on the amount of copay assistance they are willing to provide. There is no reason any patient should face higher out-of-pocket costs for branded drugs unless the pharmaceutical manufacturer arbitrarily decides to cut off copay assistance to patients."

"Insurance providers stand on the side of the patient," he added. "The point is not us receiving more or fewer copays."

Copay accumulators also play a role in the Medicaid program, where drugmakers are required to offer state Medicaid plans their "best price" for prescription drugs -- that is, they can't offer a lower drug price to private insurers. "The Medicaid 'best price' is determined by lots of different factors, and if the drug company provides a certain amount of money to the patient -- copay assistance -- that does not get deducted from the best price, but if it goes to the insurance company ... it does affect the best price."

However, in a recent on the issue, CMS gave drugmakers 2 years to determine which copay accumulators should and should not be deducted. "While we are thankful that HHS [Department of Health and Human Services] is not immediately implementing this policy that would endanger copay assistance programs that patients rely on to afford their medications, particularly during the COVID pandemic, we still question the policy and will work with the next administration to revisit it," said Schmid.

Use on the Medical Side

Although copay accumulators are most well-known for their use with drugs that patients buy at the pharmacy, one large insurer recently considered using them for drugs administered in a doctor's office or hospital, which are often prohibitively expensive for patients.

"We were able to have some one-on-one phone calls with them to walk them through what the patient impact would look like," explained Chris Phillips, MD, a rheumatologist in solo practice in Paducah, Kentucky, and chair of the insurance subcommittee of the American College of Rheumatology. The insurer later decided not to go through with the program. "The optimist in me would like to believe that they didn't understand how the patient would be negatively impacted, and when they understood that, they put a pause on that," he said.

One of the difficulties with the program would have been that the physicians themselves would have had to notify the insurer when the copay assistance was used -- since insurers don't automatically know that when it comes to doctors' offices -- "so they could ding patients for that and have it not count toward their deductible," said Phillips. "There is a bit of a moral quandary there because our first oath is to do no harm, so if we're put in a position to have to do this report, it's not only administratively burdensome logistically, but also potentially damaging for our patients." He noted that copay assistance programs are widely used. For example, in his own practice, "for every patient who has a typical commercial plan with deductibles and out-of-pocket maximums, if they're receiving treatment in the office, they're using a copay assistance program."

Graff and Schmid said they are both hoping the Biden administration will address issues around the cost of prescription drugs. "There needs to be a focus on patient out-of-pocket costs," said Graff. "Patients can't take medications they can't afford, and it creates downstream consequences."

Schmid agreed. "High deductibles are just so high, and they have co-insurance and high cost-sharing on top of it," he said. "That's what they need to get a handle on. We wouldn't have to worry so much about coupons if that was taken care of."

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