Denied

denied

Six weeks after Donnette Smith’s doctor prescribed a new medication to help lower her cholesterol, a letter arrived in the mail. It was from her insurance company, explaining that they were denying coverage of that drug.

So her doctor prescribed a competing drug. Again, insurance denied coverage.

At this point, Smith was livid.

“How dare my insurance company have someone who doesn’t know me just look at my chart and deny coverage?” Smith says.

Her insurer says coverage is denied until she’s tried all the alternatives, which are statins, the longtime standard of care for patients with high cholesterol. But Smith has tried them, for years, despite the side effects they cause for her, including leg pain and muscle weakness. For now, her cardiologist has taken her off of statins while they battle it out with Smith’s insurance company. It’s a battle they’ve been fighting for a year, while her LDL creeps higher.

“They’re playing Russian roulette with my life,” Smith says.

This is a life-threatening gamble more and more patients face because medications, especially brand name and specialty drugs, are increasingly difficult to access.

“It’s gotten to the point where as physicians, we often feel we are working for the insurance companies rather than working on our own, solely with the patients’ best interests at heart,” says Seth Baum, M.D., president of the American Society for Preventative Cardiology, chief medical officer of ExcelMedical Clinical Trials and medical director of Women’s Preventive Cardiology at Boca Raton Regional Hospital.

Yet despite the many roadblocks in their way, patients do have some options they can pursue — both individually and collectively — if they have the time, stamina and gumption.

The Problem with Pricing

What’s causing all this hand-wringing? It’s complicated, to put it mildly. To get a sense of just how complicated, consider the players involved. ere are the drug companies, who set their own prices (this is not the case in all countries). There are payers, including Medicare and commercial insurers. And then there are pharmacy benefit managers (PBMs). These are the third parties that manage prescription drug programs for Medicare Part D, commercial health plans, and employer plans. And there are, of course, the physicians and patients, who are caught in the middle.

Now consider pricing. Once a drug company sets a price for a medication, health plans and their representative PBMs (Express Scripts, CVS Caremark, Optum and Prime erapeutics are the big ones) often negotiate discounts ranging from 30% to 55%, according to an analysis by Berkley Research Group.

But these reduced rates are not consistently shared with commercially insured patients, a study by Amundsen Consulting, a division of QuintilesIMS, found. Instead, cost-sharing (patients’ out-of-pocket costs for deductibles and coinsurance) for nearly one in five brand medicines and more than one in three specialty medicines is based on list price — not the discounted rate the PBM or insurance company pays.

“The patient may be paying hundreds or thousands more than the insurer in some cases. It’s important for patients to be able to benefit from the discounts and rebates that are negotiated,” says Holly Campbell, senior director of public affairs at The Pharmaceutical Research and Manufacturers of America (PhRMA).

Patients with high cost sharing are less likely to take their prescribed medication and are more likely to delay or forego treatment, which puts them at a higher risk for emergency room visits, avoidable hospitalizations and poorer health outcomes, according to another QuintilesIMS study.

Also trending in the pharmaceutical world: PBMs will exclude drugs from their formularies if they deem the price to be too high. So, patients can pay full price for the drug. (In Smith’s case, this would mean paying thousands of dollars a month for the medication she was prescribed.) Or, they can ask their doctor to prescribe a di erent drug, which may not be as effective as what was originally prescribed.

Other Barriers to Access

Insurance companies also restrict access to drugs through other methods. Prior authorization, for example, requires doctors to fill out additional paperwork, sometimes up to 17 pages, about the patient and his need for the medication.

Step therapy, also known as “fail first,” is also becoming more common. Drugs are typically divided into tiers based on cost. With step therapy, insurance companies require a patient to begin with a medication on the lowest (cheapest) tier.

The patient cannot receive medication on a higher tier until the physician submits documented proof that the lower tier was ineffective for the patient. These requirements can lead to negative long-term results for patients. As a result, some state legislatures are restricting step therapy.

‘If This Stent Closes, I’m Gone’

Heart patients like Donnette Smith are feeling the pain.

In 2015, the FDA approved a new class of cholesterol-lowering drugs to treat patients with high cholesterol. These were widely regarded as game-changers for patients who have high cholesterol, especially those who don’t respond to statins, and those who, like Smith, can’t tolerate them.

But these new medications cost upwards of $14,000 per year. As a result, insurance companies deny coverage of them approximately 80% of the time when they’re first prescribed. Final approval rates are between 25% and 50% for commercial and Medicare patients respectively, according to a 2016 Symphony study.

“This is supposed to be about the patient and not the money,” Dr. Baum says. “When an insurance company puts a drug on formulary, they’re obligated to provide that drug to patients when a physician prescribes the drug if it’s written as the FDA recommends, but that’s rarely happening in this case.”

Smith says she has met all the criteria her insurance company requires, and they still will not approve coverage of the drug.

“I’ve tried all the medication combinations,” Smith says. “I’ve been a heart patient my entire life. My chest has been open five times. I’ve had valve replacement three times, and I have a shunt in now for my damaged valve. I have five stents already. I watch my diet and exercise, and the insurance company won’t let me have the medication I need. Something has to be done, not just for me, but for all the patients out there.

“[The insurance company is] making me wait. My cholesterol is climbing. I already have five stints. If one of those stints closes, I’m gone.”

Outright denials of coverage are occurring more frequently, and a lengthy appeals process increases obstacles.

“Denials are typically incongruous with the data we have already presented insurance companies,” says Dr. Baum, who is not involved with Smith’s care. “The payers are acting as though they aren’t practicing medicine when they make these decisions — but they really are. Patients can have heart attacks, stroke or death waiting on medications we prescribed.”

Appealing coverage denials creates problems in doctors’ offices, too. “It’s eroding our ability to treat patients because we’re spending so much time dealing with the bureaucracy of getting them the medication we want them on,” Dr. Baum says. “I still prescribe the same way. I just spend a lot of time battling the payers. At other practices where physicians don’t have as much time per patient, some physicians have just given up. They won’t prescribe the drugs because they know they’ll be denied.”

Drug makers also acknowledge the danger in limiting access to drugs.

“Amgen remains concerned that many patients are experiencing barriers to accessing Repatha, despite their physician’s treatment recommendations,” says Kristen Davis, spokesperson for Amgen, makers of Repatha and Corlanor. “Up to now, payers and pharmacy benefit managers have been preventing appropriate patients from gaining access to Repatha with onerous utilization management criteria, rejecting patients with no meaningful clinical difference from those who are approved.”

What You Can Do Individually

Though the hurdles are high, patients do have some options for getting over them.

For starters, choose a health care plan that covers your prescriptions. Make a list of medications you and your family take, and ensure they’re covered before selecting a plan. Ask the insurance company which prescriptions require fail first and which require prior authorization. Also, don’t focus solely on premiums. Try to gather information on your projected total costs, including out-of-pocket expenses.

Campbell, with the Pharmaceutical Research and Manufacturers of America, notes that it’s difficult to calculate out-of-pocket information when selecting a plan from the federal health exchange. A third-party calculator like the one at www.PuttingPatientsFirst.net can provide a more comprehensive view of a patient’s expected expenses.

If insurance does not cover the medications you need or your copays or deductibles are too high, drug manufacturers’ patient assistance programs can help.

To find such programs, you can head to PhRMA’s Partnership for Prescription Assistance (PPA) site, www.PPARX.org. It includes information on 475 public and private assistance programs. Input your medication and income info, and it will match you with different programs you’re eligible for. It then links you to the programs to apply.

Though manufacturers’ programs are included on the PPA site, you can also contact the drug makers directly. Their assistance takes on various forms, from free medication to copay coupons.

(Sano Patient Connection, Entresto Central and Amgen Safety Net Foundation are examples of drug makers’ assistance programs.)

What You Can Do Collectively

If your insurance denies coverage for a drug your physician prescribes, work with your physician to appeal it. Also, call your insurance company and speak to them about the issue.

“Patients need to become their own advocates,” Dr. Baum says. “They need to contact their insurance company and say, ‘I want this medication my doctor prescribed.’ It starts a clock on everything, and it’ll be documented because the patient called. Insurance companies don’t have to keep record of a doctor calling.”

If that doesn’t work, Dr. Baum suggests contacting the state insurance commis- sioner to have them evaluate the situation.

“We’re really fighting hard to try to change this trend. The more involved the patients are, the more vocal they are, the more likely it’ll be that we succeed. Speak to your congressmen and say, ‘Enough! The doctors should be in control, not the insurance companies,’” Dr. Baum says.

Smith is doing all of the above and encourages other patients to do the same. “Go to your local representatives, make some noise and demand your rights,” she says. “It shouldn’t be this hard for your physician to prescribe you a medication. You’ve got to know your body and your issues, and you’ve got to be willing to speak up.

“We’re going to keep hammering at that wall until we knock it down and everyone has access to the medication they need,” Smith says. “We have to stick together and be a voice for those out there who don’t have a voice or are afraid to use it. We aren’t stopping. We aren’t giving up until we break it down.”

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