The president was expected to sign two bills Wednesday that ban clauses that prohibit pharmacists from telling customers when they can save money by paying the pharmacy’s lower cash price.

This article first appeared October 10, 2018 on Kaiser Health News.

By Susan Jaffe

For years, most pharmacists couldn't give customers even a clue about an easy way to save money on prescription drugs. But the restraints are coming off.

When the cash price for a prescription is less than what you would pay using your insurance plan, pharmacists will no longer have to keep that a secret.

President Donald Trump was expected to sign two bills Wednesday that ban "gag order" clauses in contracts between pharmacies and insurance companies or pharmacy benefit managers — those firms that negotiate prices for employers and insurers with drugstores and drugmakers. Such provisions prohibit pharmacists from telling customers when they can save money by paying the pharmacy's lower cash price instead of the price negotiated by their insurance plan.

The bills — one for Medicare and Medicare Advantage beneficiaries and another for commercial employer-based and individual policies— were passed by Congress in nearly unanimous votes last month. A spokesman for Sen. Susan Collins (R-Maine) said her office had been told the president would sign the bills Wednesday. The White House declined to comment.

"Americans deserve to know the lowest drug price at their pharmacy, but 'gag clauses' prevent your pharmacist from telling you!" Trump wrote on Twitter three weeks ago, shortly before the Senate voted on the bills. "I support legislation that will remove gag clauses.” The change was one of the proposals included in Trump's blueprint to cut prescription drug prices issued in May.

Ronna Hauser, vice president of payment policy and regulatory affairs at the National Community Pharmacists Association, said many members of her group "say a pharmacy benefit manager will call them with a warning if they are telling patients it's less expensive" without insurance. She said pharmacists could be fined for violating their contracts and even dropped from insurance networks.

According to research published in JAMA in March, people with Medicare Part D drug insurance overpaid for prescriptions by $135 million in 2013. Copayments in those plans were higher than the cash price for nearly 1 in 4 drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33 percent.

Yet some critics say eliminating gag orders doesn't address the causes of high drug prices. "As a country, we're spending about $450 billion on prescription drugs annually," said Steven Knievel, who works on drug price issues for Public Citizen, a consumer advocacy group. The modest savings gained by paying the cash price "is far short of what needs to happen to actually deliver the relief people need."

After the president signs the legislation affecting commercial insurance contracts, gag order provisions will immediately be prohibited, said a spokesman for Collins, who co-authored the bill. The bill affecting Medicare beneficiaries wouldn’t take effect until Jan. 1, 2020.

But there's a catch: Under the new legislation, pharmacists will not be required to tell patients about the lower cost option. If they don't, it's up to the customer to ask.

The Pharmaceutical Care Management Association, a trade group representing pharmacy benefit managers, said gag orders are increasingly rare. The association supported the legislation. Some insurers have also said their contracts don't include these provisions. Yet two members of Congress have encountered them at the pharmacy counter.

At a hearing on the gag order ban, Collins said she watched a couple leave a Bangor, Maine, pharmacy without their prescription because they couldn't afford the $111 copayment and the pharmacist did not advise them about saving money by paying directly for the medicine. When she asked him how often that happens, he said every day.

"Banning gag clauses will make it easier for more Americans to afford their prescription drugs because pharmacists will be able to proactively notify consumers if a less expensive option may be available,” she said last week.

When Rep. Debbie Dingell (D-Mich.) went to a Michigan pharmacy to pick up a prescription recently, she was told it would cost $1,300. "After you peeled me off the ceiling, I called the doctor and screamed and talked to the pharmacist," she recalled during a hearing last month. "I'm much more aggressive than many in asking questions," she admitted, and ended up saving $1,260 after she learned she could get an equivalent drug for $40.

While the legislation removes gag orders, it doesn't address how patients who pay the cash price outside their insurance plan can apply that expense toward meeting their policy's deductible.

But for Medicare beneficiaries there is a little-known rule — not found in the "Medicare & You" handbook or on its website —that helps people with Medicare Part D or Medicare Advantage coverage. If they pay the lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation to their plan, insurers must count it toward patients’ out-of-pocket expenses.

The total of those expenses are important because that amount affects the drug coverage gap commonly called the “doughnut hole.” (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)

And beneficiaries don't have to wait until the gag order ban takes effect in two years.

The Medicare rule also says that if a senior asks about a lower price for a prescription, the pharmacist can answer.

Rep. Buddy Carter (R-Ga.), a pharmacist who sponsored the Medicare gag order bill, said he wasn’t surprised by the bipartisan support for the legislation. "High prescription drug costs affect everyone," he said.

Their preferences for fast service, connectivity, and price transparency are upending the time-honored model of office-based primary care.

This article first appeared October 09, 2018 on Kaiser Health News.

By Sandra G. Boodman

Calvin Brown doesn't have a primary care doctor — and the peripatetic 23-year-old doesn't want one.

Since his graduation last year from the University of San Diego, Brown has held a series of jobs that have taken him to several California cities. "As a young person in a nomadic state," Brown said, he prefers finding a walk-in clinic on the rare occasions when he's sick.

"The whole 'going to the doctor' phenomenon is something that's fading away from our generation," said Brown, who now lives in Daly City outside San Francisco. "It means getting in a car [and] going to a waiting room." In his view, urgent care, which costs him about $40 per visit, is more convenient — "like speed dating. Services are rendered in a quick manner."

Brown's views appear to be shared by many millennials, the 83 million Americans born between 1981 and 1996 who constitute the nation's biggest generation. Their preferences — for convenience, fast service, connectivity and price transparency — are upending the time-honored model of office-based primary care.

Many young adults are turning to a fast-growing constellation of alternatives: retail clinics carved out of drugstores or big-box retail outlets, free-standing urgent care centers that tout evening and weekend hours, and online telemedicine sites that offer virtual visits without having to leave home. Unlike doctors' offices, where charges are often opaque and disclosed only after services are rendered, many clinics and telemedicine sites post their prices.

A national poll of 1,200 randomly selected adults conducted in July by the Kaiser Family Foundation for this story found that 26 percent said they did not have a primary care provider. There was a pronounced difference among age groups: 45 percent of 18- to 29-year-olds had no primary care provider, compared with 28 percent of those 30 to 49, 18 percent of those 50 to 64 and 12 percent age 65 and older. (Kaiser Health News is an editorially independent program of the foundation.)

A 2017 survey by the Employee Benefit Research Institute, a Washington think tank, and Greenwald and Associates yielded similar results: 33 percent of millennials did not have a regular doctor, compared with 15 percent of those age 50 to 64.

"There is a generational shift," said Dr. Ateev Mehrotra, an internist and associate professor in the Department of Health Care Policy at Harvard Medical School. "These trends are more evident among millennials, but not unique to them. I think people's expectations have changed. Convenience [is prized] in almost every aspect of our lives," from shopping to online banking.

So is speed. Younger patients, Mehrotra noted, are unwilling to wait a few days to see a doctor for an acute problem, a situation that used to be routine. "Now," Mehrotra said, "people say, 'That's crazy, why would I wait that long?'"

Until recently, the after-hours alternative to a doctor's office for treatment of a strep throat or other acute problem was a hospital emergency room, which usually meant a long wait and a big bill.

Luring Millennials

For decades, primary care physicians have been the doctors with whom patients had the closest relationship, a bond that can last years. An internist, family physician, geriatrician or general practitioner traditionally served as a trusted adviser who coordinated care, ordered tests, helped sort out treatment options and made referrals to specialists.

But some experts warn that moving away from a one-on-one relationship may be driving up costs and worsening the problem of fragmented or unnecessary care, including the misuse of antibiotics.

A recent report in JAMA Internal Medicine found that nearly half of patients who sought treatment at an urgent care clinic for a cold, the flu or a similar respiratory ailment left with an unnecessary and potentially harmful prescription for antibiotics, compared with 17 percent of those seen in a doctor's office. Antibiotics are useless against viruses and may expose patients to severe side effects with just a single dose.

"I've seen many people who go to five different places to be treated for a UTI [urinary tract infection] who don't have a UTI," said Dr. Janis Orlowski, a nephrologist who is chief health care officer at the Association of American Medical Colleges, or AAMC. "That's where I see the problem of not having some kind of continuous care."

"We all need care that is coordinated and longitudinal," said Dr. Michael Munger, president of the American Academy of Family Physicians, who practices in Overland Park, Kan. "Regardless of how healthy you are, you need someone who knows you." The best time to find that person, Munger and others say, is before a health crisis, not during one.

And that may mean waiting weeks. A 2017 survey by physician search firm Merritt Hawkins found that the average wait time for a new-patient appointment with a primary care doctor in 15 large metropolitan areas is 24 days, up from 18.5 days in 2014.

While wait times for new patients may reflect a shortage of primary care physicians — in the view of the AAMC — or a maldistribution of doctors, as other experts argue, there is no dispute that primary care alternatives have exploded. There are now more than 2,700 retail clinics in the United States, most in the South and Midwest, according to Rand Corp. researchers.

Connecting With Care

To attract and retain patients, especially young adults, primary care practices are embracing new ways of doing business.

Many are hiring additional physicians and nurse practitioners to see patients more quickly. They have rolled out patient portals and other digital tools that enable people to communicate with their doctors and make appointments via their smartphones. Some are exploring the use of video visits.

Mott Blair, a family physician in Wallace, N.C., a rural community 35 miles north of Wilmington, said he and his partners have made changes to accommodate millennials, who make up a third of their practice.

"We do far more messaging and interaction through electronic interface," he said. "I think millennials expect that kind of connectivity." Blair said his practice has also added same-day appointments.

Although walk-in clinics may be fine as an option for some illnesses, few are equipped to provide holistic care, offer knowledgeable referrals to specialists or help patients decide whether they really need, say, knee surgery, he noted. Primary care doctors "treat the whole patient. We're tracking things like: Did you get your mammogram? Flu shot? Pap smear? Eye exam?"

Dr. Nitin Damle, an internist and past president of the American College of Physicians, said that young people develop diabetes, hypertension and other problems "that require more than one visit."

"We know who the best and most appropriate specialists in the area are," said Damle, an associate clinical professor of medicine at Brown University in Providence, R.I. "We know who to go to for asthma, allergies, inflammatory bowel disease."

Marquenttha Purvis, 38, said her primary care doctor was instrumental in helping arrange treatment for her stage 2 breast cancer last year. "It was important because I wouldn't have been able to get the care I needed" without him, said Purvis, who lives in Richmond, Va.

Sometimes the fragmented care that can result from not having a doctor has serious consequences.

Orlowski cites the case of a relative, a 40-year-old corporate executive with excellent medical insurance. The man had always been healthy and didn't think he needed a primary care physician.

"Between treating himself and then going to outpatient clinics," he spent nearly a year battling a sore throat that turned out to be advanced throat cancer, she said.

For patients without symptoms or a chronic condition such as asthma or high blood pressure, a yearly visit to a primary care doctor may not be necessary. Experts no longer recommend the once-sacrosanct annual physical for people of all ages.

"Not all access has to be with you sitting on an exam table," Munger said. "And I may not need to see you more than every three years. But I should be that first point of contact."

Convenience Is Paramount

Caitlin Jozefcyk, 30, a high school history teacher in Sparta, N.J., uses urgent care when she's sick. She dumped her primary care doctor seven years ago because "getting an appointment was so difficult" and he routinely ran 45 minutes behind schedule. During her recent pregnancy, she saw her obstetrician.

Jozefcyk knows she's not building a relationship with a physician — she sees different doctors at the center — but "really likes the convenience" and extended hours.

Digital access is also important to her. "I can make appointments directly through an app, and prescriptions are sent directly to the pharmacy," she said.

After years of going to an urgent care center or, when necessary, an emergency room, Jessica Luoma, a 29-year-old stay-at-home mother in San Francisco, recently decided to find a primary care doctor.

"I'm very healthy, very active," said Luoma, who has been treated for a kidney infection and a miscarriage.

Luoma said her husband pushed her to find a doctor after the insurance offered by his new employer kicked in.

"He's a little more 'safety first' than me," she said. "I figured, 'Why not?' — just in case."

The strategies involve repurposing two obscure and rarely deployed workarounds in patent law. These ideas also are finding traction among some major health industry players.

This article first appeared October 05, 2018 on Kaiser Health News.

By Shefali Luthra

In the drug pricing battle, progressive lawmakers such as Sen. Bernie Sanders (I-Vt.) and patients' rights activists rarely find themselves in step with the health industry's big players.

But in a twist, these usually at-odds actors are championing similar tactics to tame prescription drug prices.

The strategies involve repurposing two obscure and rarely deployed workarounds in patent law that, in different ways, empower the federal government to take back patents and license them to other companies. The first is known as "march-in rights." The second is generally referred to as Section 1498 because of its location in the U.S. Code.

Sanders has in recent years pointed to these steps as useful tools in the drug-pricing debate.

As an indicator of how high the stakes have become, these ideas also are finding traction among some major health industry players — most notably, two large trade groups that represent health plans and the "middlemen" companies that negotiate drug coverage.

"It used to be the case that everyone played nicely with one another, and now as prices have gone up, the knives have come out," said Jacob Sherkow, a law professor at New York University who focuses on intellectual property and the pharmaceutical industry.

The push for march-in rights gained momentum this past summer, when activists launched a campaign challenging the patent for Truvada, the HIV treatment by Gilead Sciences that has been shown to reduce the risks of contracting HIV when taken daily as a preventive.

Initially, patient advocates focused mainly on shaming insurance companies into providing better coverage of that pill, also known as pre-exposure prophylaxis, or PrEP, because it is taken before someone is exposed to the virus. But they soon found themselves targeting a frustration that insurance happened to share: the drug's list price.

James Krellenstein, co-founder of the PrEP4All Collaboration, an advocacy group, was part of that campaign. Health plans had put barriers in place to limit access to the drug, he said. But they, too, were worried about Truvada's escalating price.

"You can't scale up to a level you need to unless we deal with the pricing problem," he said.

Now, as insurers signal they might adopt an approach similar to that of the campaign, he voiced skepticism. On the one hand, the support could benefit their cause. At the same time, "they have their interests, and that's not the interests of public health," Krellenstein said.

Still, in Washington, the influence of groups like America's Health Insurance Plans (AHIP), which is the largest trade association for health insurers, and the Pharmaceutical Care Management Association (PCMA), which represents those middlemen companies known as pharmacy benefit managers (PBMs), could add political credibility to these long-shot ideas.

President Donald Trump has said curbing prescription drug costs is a high priority. But, as congressional action seems increasingly unlikely, these two approaches offer another possible path forward.

They are "already part of a law that is intact. … An option the administration can take now," said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

AHIP says the Department of Health and Human Services should lean on a federal statute that lets the government take over drug patents and grant them to other manufacturers, as long as it adequately compensates the original patent holder.

Meanwhile, PCMA is pressing the administration to use the "march-in rights" championed by HIV activists. Provided under the 1980 Bayh-Dole Act, they empower the government to rescind a drug's patent and let other companies develop versions of it. This applies only if government funding helped develop a drug, and it can be invoked only in specific circumstances, including a threat to public health or safety.

"Everybody is feeling the heat, and I think that is the reason you're seeing this interest in using the tools that exist," said Amy Kapczynski, professor at Yale Law School who has written extensively about drug patents.

But opposition is strong among drugmakers.

"Policies should spur competition and new innovations to meet patient needs, not disincentivize them such as the use of 1498 and march-in could do," said Priscilla VanDerVeer, a spokeswoman for the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, a trade and lobbying group.

Gilead, which manufactures Truvada, has a similar stance.

"We believe that there is no rationale or precedent for the government to exercise march-in or other [intellectual property] rights related to Truvada for PrEP," said Ryan McKeel, a spokesman for Gilead. The company's other efforts to make the drug "available for health and safety needs," he added, "clearly satisfy" the company's legal requirements.

And the potential for march-in authority is still theoretical. It has never been used, despite at least five petitions to the National Institutes of Health, three of which cited high drug prices.

Section 1498 was used to negotiate lower drug prices in the 1960s and '70s, but has since faded. In 2001, during the nation's anthrax scare, the Department of Health and Human Services threatened to invoke it to procure more of the antibiotic used to treat the deadly bacterial disease, according to contemporaneous reports. Last year, Louisiana's health secretary unsuccessfully tried to use it to ease the toll pricey hepatitis C medications exerted on the state's Medicaid program.

NIH Director Francis Collins remains skeptical, repeatedly saying that a drug's price doesn't constitute a health or safety concern within the agency's jurisdiction.

HHS Secretary Alex Azar, speaking at a June Senate hearing, described march-in, also known as "compulsory licensing," as a "socialist" approach.

But health pans and other payers, increasingly squeezed by fast-climbing prices, are undeterred — touting this kind of intervention as a "market-based solution."

"The trends of drug prices in this country suggest that we all collectively need to find new approaches — including new approaches that are available under existing law — to try to change this trend," said Mark Hamelburg, AHIP's senior vice president of federal programs.

Kaiser Permanente, the health system and insurance provider, called for leveraging Section 1498 in a public comment submitted to HHS about its strategy to bring down drug prices. In a similar filing, Humana, a major insurer, pointed to "existing law [that] allows for actions around patents," singling out march-in rights.

Humana did not respond to requests for comment. Both PCMA and Kaiser Permanente declined to comment beyond their statements. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Nonetheless, experts say there are serious sticking points.

Neither of these legal provisions would be a sweeping solution. And both require administration buy-in.

"They're only as effective as the government's willingness to pursue them," said Robin Feldman, a law professor at the University of California-Hastings.

Simply taking a patent doesn't bring down prices, either. There are other ways manufacturers gain favorable market positioning for specific drugs, said Rachel Sachs, an associate law professor at Washington University in St. Louis who tracks drug-pricing laws.

And creating an opening for generics is only one step. Another drugmaker would still need to create a competing product, gain approval and make it available. Then, theoretically, market competition can kick in.

Finally, there's no guarantee such savings would benefit consumers, argued Nicholson Price, an assistant professor at the University of Michigan Law School. Insurance plans or PBMs could simply bargain greater discounts on drugs and pocket the money. (AHIP says any savings should be passed on.)

That's the fundamental question, Krellenstein said.

"Is this going to be more armor in the fighting [between payers and drug companies]?" he said. "Or is it actually going to be a dramatic reform that actually results in real changes, that actually makes it easier for Americans to access the medications they need?"