Norma Smith was diagnosed with stage-three cancer in December.

In Smith’s case, that’s the last stage of her blood cancer, multiple myeloma, which had spread extensively.

As it attacked cells in Smith’s bone marrow, an important part of the immune system, the 62-year-old was eager to start treatments to stop it. What happened instead in the months that followed was Smith’s pharmacy denying and delaying chemotherapy treatments prescribed by Smith’s medical doctor over and over again.

Smith, a retired special education teacher in Fresno, and her husband, Rodney, a retired school psychologist and director of special education, consider their “very expensive” health insurance coverage to be “the best.”

But that insurance didn’t ensure Smith would get the drugs she needed when facing CVS Specialty Pharmacy – the pharmacy their insurance required them to use. Cancer drugs prescribed by Smith’s oncologist were denied because they didn’t follow the standard protocol sequence of medications that Smith’s pharmacy benefit manager, CVS Caremark, had in their guidelines.

That means pharmacy benefit managers have the authority to trump a doctor’s medical judgment without seeing patients or knowing their full medical history, and without accountability for the consequences of what happens to sick people.

Smith is among thousands of documented cases of patients who have been denied needed medications in this way. Doctors and other medical professionals say these denials are only expected to get worse as the country’s largest health insurance companies and pharmacies are increasingly joining forces.

These elusive middlemen with the authority to deny doctors’ prescriptions based on company policies are sometimes referred to as PBMs for short. Doctors and patients believe they are causing life-threatening problems for people like Smith.

The role PBMs play in health care is being examined in some proposed legislation related to costly pharmaceutical drugs and patients’ access to medications.

“Every time we want to make a change (to medications), we have to go through this whole process where someone – and we don’t know who it is – someone has the right and authority to override my judgment and what the patient needs,” said Smith’s oncologist, Dr. Ravi Rao, of cCare Cancer Center in Fresno, “and that person is functioning without us having a recourse to it. He can do whatever he wants, he or she, and I can’t call them and say, ‘Hey, by the way, what you’re saying doesn’t make sense,’ because they are hiding behind all these processes, and we are struggling here.”

Trouble getting cancer drugs, chemotherapy

CVS Caremark denied cancer medications prescribed by Rao for Smith several times over the past seven months. Each denial resulted in challenging delays. In the worst instance, Smith waited nearly two months for a cancer drug her doctor ordered.

Rao said Smith’s health had deteriorated so much by the spring that she could have easily died. At one point she was nearly bedridden, using a walker to get to and from the bathroom.

“This whole process has been extremely painful,” Rao said, “extremely traumatic for the patient and her family.”

Smith’s story is “an example of how bad things can get” for cancer patients who require different medications than what pharmacy benefit managers consider standard protocol.

“You are making us practice medicine based on some policy or guideline written by someone else,” Rao said. “So if you are a patient who has something slightly unusual – and Norma is very unusual in her disease – if I say, ‘Hmm, you know what, this disease is strange. We cannot follow the textbook guidelines that are laid down by any agency,’ I’m out of luck.”

It wasn’t always so hard to get medications. Rao said for many years, insurance companies would often ask for prior authorizations, but the process was somewhat streamlined. “There were delays by a little bit, but not by a whole lot.”

Those delays increased significantly because of pharmacy benefit managers, hired in response to rising drug prices, Rao said. They act as “one more layer of bureaucracy to go through before we can give the patient the drug.”

Those cancer drugs for Smith include chemotherapy infusions and injections she receives at cCare, along with pills she receives in the mail. A pharmacy benefit manager is involved with authorizing all of that.

“Now if this was an isolated incident by a company that was unusual, that would be one thing, but this happens to be a very common problem that we’re facing,” Rao said. “Especially over the last three to four years this whole PBM issue has become a huge issue, and when I talked about this to my colleagues, everyone has similar horror stories. And when I speak to my colleagues in other states, it appears that this is a problem all over the country.”

PBMs can work for a number of different entities. In Smith’s case, she’s dealing with CVS Caremark, the prescription benefit management subsidiary of CVS Health, which controls what pills she receives from a CVS Specialty Pharmacy and the drugs she receives via infusions and injections at cCare.

And her insurance – a plan through Anthem Blue Cross that costs around $500 a month – requires she use CVS.

But customers can’t actually visit a CVS Specialty Pharmacy, according to CVS. Cancer pills are either mailed to a patient’s home or shipped to a regular CVS store for pickup.

“My husband would call and be on the phone for five and six hours trying to advocate for me,” Smith said, “trying to find out how he could work the system so he could get the needed drug for me so that I would live.

“I’m a human being. I’m not a used car. I have feelings. I’m a person. I want to live. I want to spend time with my grandchildren. I want to quilt. I want to do things. I want to live.”

Timeline of denials

The first cancer drug Smith received was a standard, first-tier chemotherapy medication that she was able to get relatively quickly. Unfortunately, she had to stop taking it after a couple weeks in January because she had a life-threatening allergic reaction, including trouble breathing and a severe head-to-toe rash.

Rao recommended she be switched to another cancer drug, which was denied by the PBM. She was without needed medicine for nearly two months while her case was on “review” before receiving new medication.

As she waited, her cancer grew and her liver function deteriorated. She has a rare kind of myeloma that mainly involves her liver. She started losing a lot of weight and getting very sick.

“I wanted to shift her to a related drug that does not have that reaction, and the insurance company flatly refused; the PBM refused,” Rao said. “I spoke to someone at the PBM and they faxed me a protocol, basically saying that, ‘You do drug combination A first, you go to drug combination B, and only then will you get drug C,’ and what I was asking for was drug C. And so I told the family, ‘Well, this is their policy, so let’s go with drug combination B.’ “

By the time Smith received her second chemotherapy drug – in March – her cancer was much worse. That “drug combination B” that her pharmacy required she take next wasn’t effective. During this time, her liver also began to fail, Rao said.

Her cancer counts were much higher than when she was first diagnosed. Myeloma cells make a protein called light chains, Rao explained, and during this time they had increased to about 3,200. A normal number for someone in remission is 20.

Rao asked again for the drug he wanted for Smith. It was approved, but only in combination with another drug he didn’t want.

“The combination that was their protocol wasn’t what I thought was right because of her deteriorating liver and kidney functions,” Rao said. “And again, that led to another few weeks of back and forth, during which time I was giving her just half the treatment I was planning on giving her.”

Rao was eventually able to get the whole treatment he wanted, but Smith had another severe reaction and had to stop taking it. She needed to be switched a third time to another drug combination.

“That combination included a drug they had authorized in January, but because I was using it in a sort of unusual combination – and that was based on clinical reasoning – that reasoning did not fit in with what they thought should be the third-line drug combination, they again said no. Then it took another week or so, and this time the patient’s husband had learned the nuances of the process. He knew who to call, so I’m pretty sure he pushed a lot of buttons there and, finally, it got authorized.”

Rodney Smith said he had to go all the way up to a top appeals board supervisor before the drugs his wife needed were approved.

The PBMs’ protocol “was used to override my clinical judgment each time,” Rao said. “Each time they said no, the patient suffered as a result, and it led to the decline in her status by the time that we got to the right treatment.”

Since Smith has been taking her newest medications, her health is distinctly better.

Smith said it “took practically an act of God” to get the medications her doctor wanted. She credits the persistence and knowledge of her husband and doctor in keeping her from dying earlier this year. She knows many other cancer patients aren’t as fortunate.

Pharmacy benefit managers vs. doctors: Who is accountable?

These pharmacy denials are also incredibly frustrating for doctors trying to save patients’ lives.

“Unless I prove to the insurance company that this patient is not going to respond, then I’m out of luck,” Rao said. “Now unfortunately, the only way that we might get proof is if the patient gets much worse clinically. What if Norma’s liver had failed in the meanwhile? I can never talk to the person who made the policy. I don’t have access to someone to say, ‘Hey, can you please change your policy?’ The system is completely opaque. We have no idea who is making the decision.”

Rao said one of the strangest denials he received was after requesting a standard drug for a patient with stage-four kidney cancer and tumors in his liver.

“So we get a phone call here to my staff saying that the pharmacist – not the doctor, but the pharmacist – to the PBM called and said they are denying the drug.”

The reason given: The patient should have surgery to remove his kidney first.

“I thought it was a joke,” Rao said.

Rao called that pharmacist about the decision.

“In that particular instance, I got really upset,” Rao said. “I said, ‘The patient is too sick for surgery, and the surgeon has said no.’ They said, ‘Please fax me the surgeon’s note saying the patient is not a surgery candidate before we approve it.’

“Now, is that someone who is second-guessing me, or is it someone who is practicing medicine? And who and why is that person practicing medicine without seeing the patient?

“What if I had sent the patient for surgery and the patient had a bad complication and died from it – who is responsible? Me or the surgeon, not that person on the phone, who has zero responsibility. They have all the power but zero responsibility.”

Rao later learned from his colleagues that they had received the same drug denials for their kidney cancer patients.

“That’s because if the PBM pharmacist or who is in charge says no, well guess what? They’ll save money there,” Rao said. “The money comes out from a different pot. So the patient goes and gets surgery done, it comes out from a different part of the insurance. It’s almost like within the insurance company, they have created little fiefdoms, and each fiefdom is fighting with the others to say no to money that will come out of their pot.”

CVS Health response

CVS Health provided an emailed statement about what happened to Smith:

“We are committed to delivering better patient experiences at lower overall costs,” wrote Mike DeAngelis, senior director of corporate communications at CVS Health.

“As part of that, for these types of therapies, payers (i.e. insurance plans, employers, etc.) often opt to employ utilization management strategies, including prior authorization, which can help ensure that patients access the most clinically appropriate and cost effective medication, and that the medication is used in line with a drug’s indication(s) and the clinical guidelines.

“In this case, we worked with the patient’s doctor and insurer to gain necessary approvals for the required prior authorization and we delivered all medications that were prescribed by her doctor.”

Rao agreed that CVS did eventually deliver medications, “at least if the meaning of ‘delivered’ is construed narrowly.”

“CVS did, eventually – but belatedly – get these life-saving drugs to my patient,” Rao said. “It is as if a fireman sat around watching a house burn, and then finally by acting at the last minute, put out the fire and then says, ‘See, I did my job.’ ”

But to get CVS to act, Rao said, it took “tremendous effort” since PBMs’ medical decisions seem “to have taken precedence over the physician’s clinical judgment.”

Rao said the drugs he wanted for Smith “were clearly prescribed completely in accordance with the drugs’ labels and were completely indicated for this patient’s condition, so it was not as if we were using them off-label, which necessitated so much extra effort.

“If my patient had been less motivated, did not have a husband who was able to go above and beyond most people, and if my office had not been as diligent as we were, this patient may have likely died waiting for CVS to come through.”

On its website, CVS Health says it is “pioneering a bold new approach to total health” that includes “a leading pharmacy benefits manager with approximately 94 million plan members.”

That pharmacy benefits manager, CVS Caremark, was described on the website this way: “We work with employers, health insurance companies, the government and other health benefit program sponsors to design and administer prescription coverage plans and keep pharmacy costs low.”

Growing monopolies

Sitting at his wife’s side in a chemotherapy clinic in July, Rodney Smith talked about how “insurance is not the problem here, it’s just getting the medication. I have the insurance.”

His wife’s doctor interjected.

“Actually, insurance is part of the problem,” Rao said.

A number of insurance companies have purchased PBMs that delay the process, Rao said.

“The longer you don’t get the drug, the more money they save,” Rao said. “The other issue that happens is they say, ‘Well, you can only go through our PBM.’”

So it’s “playing a game,” Rao continued, where a patient receives an authorization from insurance and thinks “it is someone else’s fault that they are saying no – but both are owned by the same entity.”

Ted Okon, chief executive officer of Community Oncology Alliance, has become an expert in understanding this complicated system. He’s testified before Congress on cancer issues and is frequently on Capitol Hill discussing cancer care.

Okon’s oncology alliance, a Washington-based, nonprofit advocacy group that lobbies for federal legislation and has its own political action committee, has documented thousands of stories like Smith’s to advocate for patients and medical professionals struggling to get needed medications.

Rao’s oncology office, cCare, is a member of Community Oncology Alliance, an association of community cancer clinics. Okon and Rao share similar concerns about PBMs and the mergers of insurance companies and pharmacies.

“Especially in the last three to four years, this has been a growing problem,” Okon said. “Unfortunately, I think it’s going to get worse and the reason I say that is, number one, we’ve seen massive mergers in the PBM industry to get us where we are today. We have PBMs that account for at least 80% of prescription drugs now.”

Okon listed the country’s three largest health insurance-plus-pharmacy pairs – accounting for “monopolistic control” of approximately 80% of prescription drugs in the U.S.

1. CVS Health owns Aetna.

2. Cigna owns Express Scripts.

3. UnitedHealth Group owns OptumRx.

Insurance companies can require a patient only use certain pharmacies, as happened to Smith.

“Part of the problem now is that the free market is not happening,” Rao said. “Everyone talks about capitalism at work. This is capitalism not at work. The drug companies and insurance companies and the PBMs are tying things up. There is a vertical integration happening.”

Okon said part of the problem is PBMs also receive “sweetheart deals” – rebate arrangements on the drug manufacturer side that can guide drug selection based on profitability rather than what’s most appropriate for a patient.

“For example, a pharmacy benefit manager will draft a list of approved drugs, called a formulary, for an insurance company,” wrote the Los Angeles Times in a story last year about Cigna purchasing Express Scripts. “The pharmacy benefit manager will go to a drug company and offer to include that company’s drug on its list. In return, the drug company might agree to offer a rebate — say, $10 less on a $100 drug. The customer, however, would still pay $100, and doesn’t see any direct benefit from the rebate.”