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First Edition: December 12, 2017

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Experts Tell Congress How To Cut Drug Prices

The nation’s most influential science advisory group will tell Congress today that the U.S. pharmaceutical market is not sustainable and needs to change.

“Drugs that are not affordable are of little value and drugs that do not exist are of no value,” said Norman Augustine, chair of the National Academies of Sciences, Engineering and Medicine’s committee on drug pricing and former CEO of Lockheed Martin Corp.

The report, “Making Medicines Affordable: A National Imperative,” identifies eight steps to cut drug prices. It also provides a list of specific “implementation actions” for various federal agencies, including Congress, the Federal Trade Commission and the U.S. Departments of Justice and Health and Human Services.

Today’s hearing, which is the third in a series by the Senate Health, Education, Labor and Pensions committee, comes as Americans across the political spectrum say lowering the price of prescription drugs is a top priority. Yet, while individual states have passed laws for more transparency and price controls and President Donald Trump has publicly called for lower drug prices, Congress has stalled.

So, will the committee’s recommendations spur action? Kaiser Health News takes the political temperature, talks to experts and rates their chances:


Recommendation No. 1: Allow the federal government to negotiate drug prices

Current law prohibits the U.S. Health and Human Services Secretary from directly negotiating drug prices and the committee says that’s ridiculous.

The committee recommends Medicare and other agencies negotiate which drugs are placed on a list of covered drugs and, when necessary, exclude some drugs. This is not a new idea.

Some states are already restricting high-priced drugs in Medicaid, the state-federal insurance program for low-income Americans. But federal efforts to change Medicare are more complicated.

Just two months ago, top House Democrats introduced another Medicare negotiation bill. But don’t hold your breath, Trump hasn’t responded to multiple letters sent from Rep. Elijah Cummings (D-Md.) — including one after the most recent bill was introduced in late October. That bill hasn’t moved past the health subcommittee.


Recommendation No. 2: Speed approvals of safe and effective generics and biosimilars

This recommendation has a strong ally at the Food and Drug Administration.

Commissioner Scott Gottlieb announced a “drug competition action plan” in June and followed it up two months ago with a new set of policies aimed at speeding the drug approval process for complex generics. More changes are expected too, as Gottlieb wrote in his blog post “if consumers are priced out of the drugs they need, that’s a public health concern that FDA should address.”

But the pharmaceutical world knows which games to play to keep competition at bay. The committee specifically recommends the U.S. Department of Justice and the Federal Trade Commission should watch for anti-competitive tactics, such as pay-for-delay and extending exclusivity protections. The U.S. Supreme Court weighed in on pay-for-delay, saying settlements between brand-name drug makers and generic rivals warranted antitrust review, The total number of these deals has fallen in recent years.

To further encourage generic approvals, Congress could include several proposed bills, such as the so-called CREATES Act, in a final year-end package, said Chip Davis, president of the generics and biosimilars lobby Association for Accessible Medicines.

“People are starting to pay more attention” to anticompetitive patent tactics, Davis said.


Recommendation No. 3: Transparency

The committee takes direct aim at drug prices by saying that Congress should make manufacturers and insurers disclose drug prices, as well as the rebates and discounts they negotiate. It also asks that HHS curate and publicly report the information.

States have taken the lead on price transparency with Vermont the first to pass a law, which requires an annual report on up to 15 drugs that cost the state a lot of money and have seen price spikes. In Congress, Sen. Ron Wyden (D-Ore.), introduced a bill in June that would impose price-reporting requirements on some drugs. It now sits in the Senate finance committee. The pharmaceutical industry has fended off most price disclosure efforts in the past.

Notably, the committee also recommends that nonprofits in the pharmaceutical sector — such as patient groups â disclose all sources of income in their tax filings. That’s a move that would reveal exactly how much the pharmaceutical companies are supporting advocacy groups.


Recommendation No. 4:  Discourage the pharmaceuticual industry’s direct-to-consumer advertising 

The U.S. is only one of two developed countries in the world to allow direct-to-consumer pharmaceutical advertising (the other is New Zealand and doctors there have called for a ban). And U.S. taxpayers support the tax breaks with a deduction that politicians have tried to eliminate in the past.

Now, the committee recommends Congress eliminate the tax deduction pharmaceutical companies are allowed to take on direct-to-consumer advertising.

This is an idea that should have wide support. Polls show that most Americans favor banning the ads and federal lawmakers have tried to change the rules on so-called DTC for years. The American Medical Association called for a ban on pharmaceutical advertising directly to patients in 2015, saying there were concerns that the ads were driving up demand for expensive drugs. The FDA provides guidance for the advertising and, in August, FDA Commissioner Gottlieb said he may reduce the number of risks manufacturers must reveal when advertising a medicine.

In a sign of just how entrenched the tax break is in D.C. politics, Sen. Dick Durbin (D- Ill.) introduced a bill last month that doesn’t eliminate the break but takes a step to rein in the advertising. Durbin’s bill would require manufacturers to provide the wholesale price of a drug in their advertisements.


Recommendation No. 5: Limit what Medicare enrollees pay for drugs

The committee ticks off a to-do list for Congress when it comes to what older Americans and those with disabilities are paying for drugs.

Their recommendations include asking Congress to establish limits on total annual out-of-pocket costs for Medicare Part D enrollees and telling Congress to make sure the Centers for Medicare and Medicaid Services efforts to guarantee enrollee cost-sharing is based on the real price of the drug as well as how well the drug works.

Turns out, there is already some limited movement on this one.

Medicare allows negotiations between the corporate insurers and pharmacy benefit managers who help administer the Part D program. CMS announced last month that it is exploring how to pass on the behind-the-scenes manufacturer rebates to patients, though it warns premiums may rise if they make this move.


Recommendation No. 6: Increasing oversight of a very specific federal drug discount program

The committee is stepping into a hot-button political issue by recommending increased transparency and oversight of a program that Congress created in 1992.

The program, known as 340B, requires pharmaceutical companies to sell drugs at steep discounts to hospitals and clinics that serve high volumes of low-income patients. Congress held two hearings this year, questioning who is benefiting from the discounts and the Centers for Medicare and Medicaid Services recently announced it was slashing Medicare reimbursement to some hospitals enrolled in the program.

Hospitals are fighting back, filing a lawsuit over the reimbursement cut. The committee, echoing concerns from House Republicans, recommends making sure the program helps “aid vulnerable populations.”


Recommendation No. 7: Revise the Orphan Drug Act

The committee wants to make sure the 1983 Orphan Drug Act helps patients with rare diseases.

The law, intended to spur development of medicines for rare diseases, provides financial incentives for drugmakers such as seven years of market exclusivity for drugs that treat a specific condition that affects fewer than 200,000 people.

The program has been under fire this year after Kaiser Health News, whose investigation is cited by the committee, reported that approved drugs often gamed this system and won won blockbuster sales for more common diseases. The Government Accountability Office has begun an investigation into the program after receiving a request from top Republican senators and FDAâs announced a “modernization” plan for the agency this summer.

The committee’s requests include limiting the number of exclusivity periods a drug can receive and making sure drugs that win the financial incentives really do treat rare disease. Finally, the committee says HHS should obtain favorable concessions on launch prices, annual price increases,” and more.


Recommendation No. 8: Make sure doctors prescribe drugs for the right reasons

Medical practices, hospitals and doctors should “substantially” tighten restrictions on office visits by pharma employees, and the acceptance of free samples, the committee recommends.

This isnât the first time the national group has recommended controlling drug samples and visits. In 2009, the then Institute of Medicine said doctors and medical schools should stop taking free drug samples. It may have worked — to some extent. A study this year found that academic medical centers that limited visits saw changes in prescribing patterns.

Now, the National Academies committee says doctors in private practice should also stop taking free samples and welcoming pharmaceutical visits. The AMA, which is nation’s largest membership group doctors, supports physicians using samples on a voluntary basis, particularly for uninsured patients.

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Sign-Up Deadline Is Friday, But Some People May Get Extra Time

Open enrollment on the federal health law’s marketplace ends Friday, and most people who want a plan for next year need to meet the deadline.

But some consumers who miss the cutoff could be surprised to learn they have the opportunity to enroll later.

“While a lot of people will be eligible … I am still worried that a lot of consumers won’t know it,” said Shelby Gonzales, a senior policy analyst at the Center on Budget and Policy Priorities.

Under the health law, people are entitled to a special enrollment period (SEP) when they have specific changes in their lives, such as losing other health insurance, getting married or having a child, or when they have a change in income that affects their eligibility for premium tax credits or cost-sharing reduction subsidies. Those special enrollment periods generally last at least 60 days.

Other circumstances can also qualify customers for a special enrollment period. But this year, consumer advocates are focused on two that could affect a substantial number of people: consumers whose 2017 marketplace policies are being discontinued in 2018 and people affected by the hurricanes that ravaged Texas, parts of the Southeastern United States and Puerto Rico.

It’s not clear how many consumers this will affect. In past years, people who sign up during an SEP made up a tiny fraction of overall marketplace enrollment. In the spring of 2016, 11.1 million people had a marketplace plan. Meanwhile, roughly 1.6 million signed up through a special enrollment period during 2015, according to the federal Centers for Medicare & Medicaid Services (CMS).

The majority of people who use a special enrollment period do so because they’ve lost coverage under another plan. This applies to people who lose their job-based coverage as well as those with marketplace plans whose insurer discontinues their plan for the upcoming year.

Between 2014 and 2018 the average number of issuers per state declined from 5 to 3.5, according to the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.) Several big name companies, including Anthem, Aetna and Humana, dramatically pulled back in their 2018 offerings.

A growing proportion of people will likely qualify for SEPs now because of a loss of marketplace coverage, insurance analysts say.

People who are eligible for that special enrollment period have up to 60 days after their coverage ends on Dec. 31 to sign up for a new marketplace plan. Meeting the regular Dec. 15 sign-up deadline is preferable because it allows coverage to start Jan 1. But eligible people who miss that date can apply through the marketplace for an SEP that will allow them to sign up until the end of February.

Even if the marketplace automatically re-enrolls customers in a plan that’s similar to the one that ended, they’re entitled to an SEP to pick a new plan, said Karen Pollitz, a senior fellow at the Kaiser Family Foundation.

But people shouldn’t count on getting a clear explanation of what the SEP is or how it works, said Pollitz, who has reviewed the consumer notices related to plan discontinuations.

“The notices are not what they could be,” she said.

Gonzales concurs.

“The bottom line here is many consumers experienced a discontinuation of their plan this year,” she said. “Notices are complicated, and these consumers in particular are going to get several notices which may result in more confusion, and it will not be easily understood by many what an SEP is or how and/or when to activate it.”

This year, there are also special enrollment periods for people who were affected by the hurricanes that slopped across all or parts of Texas, Florida, Georgia, Puerto Rico and elsewhere last fall.

The special enrollment period for 2018 applies to people who live in or move from counties designated by the Federal Emergency Management Agency as hurricane disaster areas. It gives them an extra two weeks, from Dec. 16 to Dec. 31, to sign up for January coverage. Officials said they’ll consider extending the timeframe if necessary.

To take advantage of the special enrollment period, people must request it through the healthcare.gov call center. They’ll be asked to attest that they resided in an affected area, but they won’t have to provide proof.

Consumer advocates who work on outreach for enrollment and help people sign up for coverage aren’t yet talking up the SEPs, said Gonzales.

“They want one clear message for everyone: Open enrollment ends Dec. 15,” she said. Starting Dec. 16, these groups will start getting the word out for people who have missed the deadline and may not realize they may have other options.

Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.

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An Overlooked Epidemic: Older Americans Taking Too Many Unneeded Drugs

Consider it America’s other prescription drug epidemic.

For decades, experts have warned that older Americans are taking too many unnecessary drugs, often prescribed by multiple doctors, for dubious or unknown reasons. Researchers estimate that 25 percent of people ages 65 to 69 take at least five prescription drugs to treat chronic conditions, a figure that jumps to nearly 46 percent for those between 70 and 79. Doctors say it is not uncommon to encounter patients taking more than 20 drugs to treat acid reflux, heart disease, depression or insomnia or other disorders.

Unlike the overuse of opioid painkillers, the polypharmacy problem has attracted little attention, even though its hazards are well documented. But some doctors are working to reverse the trend.

At least 15 percent of seniors seeking care annually from doctors or hospitals have suffered a medication problem; in half of these cases, the problem is believed to be potentially preventable. Studies have linked polypharmacy to unnecessary death. Older patients, who have greater difficulty metabolizing medicines, are more likely to suffer dizziness, confusion and falls. And the side effects of drugs are frequently misinterpreted as a new problem, triggering more prescriptions, a process known as a prescribing cascade.

The glide path to overuse can be gradual: A patient taking a drug to lower blood pressure develops swollen ankles, so a doctor prescribes a diuretic. The diuretic causes a potassium deficiency, resulting in a medicine to treat low potassium. But that triggers nausea, which is treated with another drug, which causes confusion, which in turn is treated with more medication.

For many patients, problems arise when they are discharged from the hospital on a host of new medications, layered on top of old ones.

Alice Cave, who divides her time between Alexandria, Va., and Tucson, Ariz., discovered this when she traveled to Cheyenne, Wyo., after her 87-year-old aunt was sent home following treatment for a stroke in 2015.

Before her hospitalization, Cave said, her aunt, a retired telephone company employee whose vision is impaired by glaucoma, had been taking seven drugs per day. Five new ones were added in the hospital, Cave said.

âShe came home and had a huge bag of pills, half of which she was already taking, plus pages and pages of instructions,” she said. Some were supposed to be taken with food, some on an empty stomach. Cave said she spent several hours sorting the medications into a giant blue pill box. “It was crazy and scary.”

Cave said she felt helpless to do much; her aunt’s doctors didn’t question the need for more drugs.

When Shannon Brownlee’s mother was taken to an emergency room recently to determine whether her arm pain might signal a heart attack (it didn’t) a cardiologist prescribed five new drugs — including an opioid €” to the small dose of a diuretic she had been taking to control her blood pressure.

Brownlee, senior vice president of the Lown Institute, a Boston-based group that seeks to improve health care quality by reducing unnecessary treatment, said that when her brother questioned the necessity of so many new drugs for a woman in her late 80s, the specialist replied frostily, “I don’t see anything wrong with prescribing lots of medication to older people.”

Bring The Pill Bottles

“This problem has gotten worse because the average American is on a lot more medications than 15 years ago,” said cardiologist Rita Redberg, a professor of medicine at the University of California at San Francisco.

Studies bolster Redberg’s contention: A 2015 report found that the share of Americans of all ages who regularly took at least five prescription drugs nearly doubled between 2000 and 2012, from 8 percent to 15 percent. University of Michigan researchers recently reported that the percentage of people older than 65 taking at least three psychiatric drugs more than doubled in the nine years beginning in 2004. Nearly half of those taking the potent medications, which include antipsychotic drugs used to treat schizophrenia, had no mental health diagnosis.

Redberg and other doctors are trying to counter the blizzard of prescriptions through a grass-roots movement called â€deprescribing” — systematically discontinuing medicines that are inappropriate, duplicative or unnecessary.

Interest in deprescribing, which was pioneered in Canada and Australia, is growing in the United States, bolstered by physician-led efforts, such as the five-year-old Choosing Wisely campaign. The Beers Criteria, a list of overused and potentially unsafe drugs for seniors first published in 1991, has been followed by other tools aimed at curbing unnecessary drug use.

“Lots of different medications get started for reasons that are never supported by evidence,€ said Redberg, editor in chief of JAMA Internal Medicine. “In general, we like the idea of taking a pillâ a lot better than non-drug measures, such as improved eating habits or exercise.

“That’s what we were taught as physicians: to prescribe drugs,” said Ranit Mishori, a professor of family medicine at Georgetown University and a proponent of deprescribing. âWe are definitely not taught how to take people off meds.

Kathryn McGrath, a Philadelphia geriatrician, said she tries to begin every appointment with a review of medications, which she asks patients to bring with them. “I think having the pill bottles” is much more powerful than a list, said McGrath, who has written about how to deprescribe safely.

Although support is growing, deprescribing faces formidable obstacles.

Among them, experts say, is a paucity of research about how best to do it, relentless advertising that encourages consumers to ask their doctors for new drugs, and a strong disinclination – baked into the culture of medicine — to countermand what another physician has ordered. Time constraints play a significant role. So do performance measures that are viewed as a mandate to prescribe drugs even when they make virtually no sense, such as giving statins to terminally ill patients.

A Reluctance To Overrule

“There’s a reluctance to tinker or change things too much,” said University of Michigan geriatric psychiatrist Donovan Maust, who labels the phenomenon “clinical inertia.” When inheriting a new patient, Maust said, doctors tend to assume that if a colleague prescribed a drug, there must be a good reason for it — even if they don’t know what it is. Maust said he tries to combat inertia by writing time-limited orders for medication.

He recently began treating a man in his 80s with dementia who was taking eight psychiatric drugs — each of which can cause significant side effects and most of which had been prescribed for undetermined reasons.

“It’s very typical to see a patient who has a few episodes of reflux and is then put on a [proton pump inhibitor, or PPI] and a few years later are still taking it,” said Georgetown™s Mishori. Many experts say the heartburn drugs are overprescribed, and studies have linked their long-term use to fractures, dementia and premature death.

œThis is a cultural problem and an awareness problem exacerbated by the fragmentation of care,” said Brownlee, the author of “Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer.” Many doctors, she added, have never heard of deprescribing.

Before his death several years ago, doctors advised Brownleeâs father, a hospice patient, to continue taking a statin, along with several other medications. None would improve or extend his life, and all had potentially harmful side effects.

Rx: What For?

Older people taking lots of medication was what Canadian pharmacist Barbara Farrell encountered when she began working at a geriatric hospital in Ottawa nearly two decades ago. Her experience, she said, was a catalyst for the Canadian Deprescribing Network, a consortium of researchers, physicians, pharmacists and health advocates she co-founded. The group seeks to drastically reduce inappropriate medication use among Canadian seniors by 2020.

Farrell, a clinical scientist at the Bruyere Research Institute, has also helped write guidelines, used by doctors in the United States and other countries, to safely deprescribe certain classes of widely used drugs, including proton pump inhibitors and sedatives.

“I’ve found a lot of receptivity” to the guidelines among physicians, Farrell said. “We know there are pockets around Canada and the world where they’re being implemented.”

One of Farrell™s most memorable successes involved a woman in her late 70s who was using a wheelchair and was nearly comatose.

“She would literally slide out of her chair,” Farrell recalled. The woman was taking 27 drugs four times per day and had been diagnosed with dementia and a host of other ailments.

After reviewing her medications, Farrell and her colleagues were able to weed out duplicative and potentially harmful drugs and reduce the doses of others. A year later, the woman was “like a different person”: She was able to walk with a cane and live mostly independently, and she reported that her doctor said she did not have dementia after all.

When Farrell asked another patient why she was taking thyroid medication, the woman replied that her doctor had prescribed it for weight loss after her last pregnancy — in 1955.

“The patients I see are the tip of the iceberg,” Farrell said.

One way to facilitate deprescribing, Farrell said, is to require doctors to record why a drug is being prescribed, a proposal the deprescribing network has made to Canadian health officials. A recent study by a team from the Boston VA Healthcare System found strong support among doctors for this concept.

While some doctors are reluctant to discontinue medications, patients can be wary, too.

“They may say, I tried stopping my sleeping pill and I couldn’t sleep the next night, so I figured I needed it,’” Farrell said. ” Nobody explained to them that rebound insomnia, which can occur after stopping sleeping pills, lasts three to five days.â

Mishori said that she deprescribes only one medication at a time so she can detect any problem that arises from that change. And, she adds, “I never take people off of a medication without doing something else.” In the case of heartburn drugs, she might first recommend taking the drug only when needed, not continuously. Or she might suggest a safer alternative, such as an over-the-counter antacid tablet.

Maust, the geriatric psychiatrist, recommends that doctors actively focus on “the big picture” and carefully weigh whether the benefits of a drug outweigh its risks.

“In geriatrics,” he said, “less is more.

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Viewpoints: The Move To ‘Trumpcare’; GOP’s Threat To Medicare; Opioid Epidemic’s Hidden Threat

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Health Officials, Hospitals On High Alert As Wildfires Burn Across California

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State Highlights: Doctor Allowed To Continue To Work At Mass. Health Center Despite Allegations; Troubled Texas Psych Hospital Blasted In Report

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Buckle Up, This Flu Season Could Be Long And Vicious

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Groundbreaking Drugs Could Revolutionize Cancer Treatment. But There’s One Big Hold-Up.

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Looking To Compare Prices For Health Care? The Internet Is Not Your Friend

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