Bea Lipsky shuffled into her wellness coach’s office one morning this fall and parked her walker by the wall. Lipsky, 89, had had a trying year, enduring a hernia operation and two emergency room visits for heart problems. She’s losing her hearing, and recently gave up her dream of riding in a hot air balloon for her 90th birthday.
That day, though, she was filled with pride: She told her coach she’d achieved her goals for the year, including attending her grandson’s wedding in China.
Lipsky spent two months training, doing leg curls and riding a stationary bicycle, to build up the strength to make it through a 10-day trip to China, accompanied by an aide. “It was absolutely divine,” she told coach Susan Flashner-Fineman, who works at the Orchard Cove retirement community in Canton, where Lipsky has lived for the past four years.
Lipsky’s check-ins with Flashner-Fineman are part of a wellness coaching program, Vitalize 360, that Orchard Cove started eight years ago in collaboration with the Kendal nonprofit senior living organization in Pennsylvania.
When seniors arrive at Orchard Cove, a coach measures their health and wellness in an hourlong, one-on-one session, assessing common problems for seniors, like loneliness, pain and distress. The coach also asks about seniors’ families, friendships, and spiritual life. Then the seniors meet with their coach every year before their physical checkup with a doctor, to talk about what matters most to them. The coaches, who come from a variety of backgrounds, including fitness, social work and chaplaincy, help seniors set goals for the year — which could be physical, social, intellectual or spiritual. These goals become the focus for the senior’s medical team, and the seniors follow up with their coaches every three months to stay on track.
Wellness coaching aims to rethink how we treat aging, said Aline Russotto, Orchard Cove’s executive director. “We used to be at our very best when somebody was in crisis,” she said.
But Orchard Cove staff think they can help residents live healthier and happier lives by shifting the focus away from “fixing what’s broken,” said Russotto, to “living your best day every single day until the end.”
Dr. Atul Gawande, author of “Being Mortal” and an expert on end-of-life care, calls the Vitalize 360 approach “transformative.” It recognizes that “even as you may have health issues and frailty and the difficulties that can come with aging … people have lives worth living. And in fact have a lot more life worth living,” he said.
When young people become disabled, others often help them find ways to contribute to the world, he noted, but that is much less true for older people.
“I see it as the kind of thing that you’d like to see go populationwide,” Gawande said. “You’d like to make it routine.”
Since the program started at Orchard Cove, fitness participation — the proportion of residents who exercise at least three times a week — has more than doubled, from 30 to 77 percent, and one study found participants felt significantly less depressed than a control group, with a notable jump in the number who said they felt “delighted with life.”
The program itself has spread to 35 communities in 12 states, reaching more than 2,600 older adults in independent or assisted living. Since existing staff can be retrained to serve as coaches, the program isn’t costly, though there is an annual fee for training and data-tracking software.
Flashner-Fineman, who spent a decade as Orchard Cove’s fitness director, travels to new sites several times a year to run a three-day training to teach new coaches the skills they’ll need to work with patients and run standardized assessments. She and her colleagues also train health professionals, leadership and other staff on how to orient their care around seniors’ goals.
At Orchard Cove, where the average age is almost 90, Flashner-Fineman coaches a wide range of seniors, including younger, healthy residents, like 74-year-old Janet Donnoe, a retired consultant.
In a recent visit, an energetic Donnoe announced “great progress” on her fitness goals. She now gets up at 5 a.m. on Tuesdays to drive off-campus for nearly two hours of aqua “boot camp” and weight training. Flashner-Fineman asked if Donnoe, who moved there recently, is making time to meet her neighbors, too.
Programs like this have emerged because seniors are living longer and defying predictions of cognitive and functional decline, said John Morris, a researcher at the Institute for Aging Research at Hebrew SeniorLife, which operates Orchard Cove. Morris designed the assessment tool that Vitalize 360 uses and is helping retirement communities track participants’ wellness.
Esther Adler, a 93-year-old poet, writer and former Hebrew school teacher, moved to Orchard Cove in 2012, a few years after her husband died. She set a goal to “be a productive person” but didn’t know exactly how.
After learning about her background in an extensive intake interview, staff invited her to start teaching Hebrew to patients on the skilled nursing floor. Adler discovered their memories were too short for language lessons, and started teaching Bible lessons and prayers instead — a practice she has continued for three years.
Adler, who also finds purpose in writing poetry and helping neighbors through hospice, has proved resilient amid physical setbacks: She broke her pelvis last year when she tripped in the lobby of a hotel room in Poland, the night before the premiere of a documentary about her life.
“They thought I would never walk,” Adler said. “Here I am, I’m walking.”
Lipsky, despite her successful trip to China, confessed she feels “hesitant” about the year ahead. “I’m not as active as I’d like to be,” she said. As she spoke, her right hand started shaking — a new symptom she hadn’t yet told her doctor about.
But Lipsky lit up talking about achieving another goal, finding a new way to cope with loss. She sat with her granddaughter two weeks before and dialed up a medium on Skype to try to communicate with her husband, Sidney, who died three years earlier.
“She breathed in our energy — on the computer!” Lipsky said. “It was eerie. We felt like he was there.”
She said it helped the family grieve and brought her happiness. Since the experience, she said, “our lives haven’t been the same.”
In the year ahead, she plans to attend another wedding, this time in Canada, and continue “finding unexpected things that bring me joy.”
Tuesday's Senate hearing, the third in a series, comes as Americans across the political spectrum say lowering the price of prescription drugs is a top priority.
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 — 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 FDA’s 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 isn’t 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.
Leapfrog Group called the lawsuit from Saint Anthony's Hospital an 'eleventh hour gambit to turn back the clock on a disappointing safety grade based.'
CHICAGO — For two years, Saint Anthony Hospital here has celebrated its top-rated “A” grade from the national Leapfrog Group that evaluates hospital safety records. But this fall, when executives opened a preview of their score, they got an unwelcome surprise: a “C.”
Hospitals take their ratings seriously, despite hospital industry experts’ skepticism about their scientific methodology and studies showing that scores may not have a huge influence on patient behavior. In a highly competitive market, no one wants to be a “C”-rated safety hospital any more than a “C”-rated restaurant for cleanliness.
So, the hospital didn’t take its new grade sitting down. It sued the ratings group for defamation, alleging that the grade was based on data that Leapfrog knew to be inaccurate.
“If Leapfrog publishes a ‘C’ grade for Saint Anthony as part of its Fall 2017 Hospital Survey Grades, it will erase years of improvements at the hospital and irreparably degrade the public perception of the hospital,” according to the complaint, which was filed in the Circuit Court of Cook County, Ill. “Saint Anthony competes with other hospitals in the immediate area, including one down the street, and one of the most important ways Saint Anthony recently has been able to distinguish itself is the high safety grades it receives from Leapfrog.”
In a response filed to the court on Tuesday, Leapfrog called Saint Anthony’s lawsuit an "eleventh hour gambit to turn back the clock on a disappointing safety grade based in part on the data that [the hospital] itself provided and certified, and which Leapfrog simply used in accordance with its long-established processes."
Leapfrog is one of a number of organizations, including U.S. News and World Report, Healthgrades and Consumer Reports, that score hospitals based on whether they meet certain quality measures. Based in Washington, D.C., Leapfrog’s scores are a combination of 27 measures of quality from government data and an independent survey to evaluate things like infections, deaths among surgical patients and how well doctors communicate.
About 50 percent of hospitals participate in Leapfrog’s survey; the others are evaluated based only on publicly available data. Leapfrog’s mission is to help hospitals improve in weak areas and to give patients useful information.
Hospitals are quick to tout good grades on advertising and banners.
Saint Anthony’s complaint appears to be the first time a hospital has sued a rating agency over a contested grade. But in an era when hospitals are brands and patients are customers hoping to make rational purchases for care, such grades and rating systems are likely to face more scrutiny and new pushback.
“In highly competitive markets, hospitals are likely to see poor grades as a challenge, and I think many will be tempted to sue the rating agencies,” said Ashish Jha, a professor at the Harvard T.H. Chan School of Public Health.
Jha, who was on a committee that helped set standards when Leapfrog was established, said he was heartened that hospitals are reacting to data, whatever the impetus. “If they’re going to use that as motivation to get better, that’s perfect,” he said. “As a patient, you don’t care why a hospital is investing in safety, you just care that they are.”
It is unclear to what extent grades influence patient decisions. A Pew Research Center survey from 2012, for example, found that only 14 percent of internet users consulted online rankings or reviews of hospitals or medical facilities.
But Saint Anthony hospital executives insist Leapfrog’s score has an enormous effect on their bottom line. “We have seen, for better or worse, that people are paying a great deal of attention — not only our patients but also our stakeholders, vendors and politicians,” said Dr. Eden Takhsh, the hospital’s chief quality officer. Such scores have also influenced them to focus on improving certain quality metrics, such as rates of sepsis and central line infections.
Leapfrog’s scores are plastered across every newspaper in town, he said. Based on their past “A” grades, Takhsh said, Saint Anthony has been approached by both the University of Chicago and Northwestern, two much larger teaching hospitals in Chicago, to form partnerships in pediatrics and neurology. Both hospitals offered to send their physicians to Saint Anthony to provide subspecialty care, which would provide the small community hospital with more patients and prestige.
A “C” grade could threaten those partnerships. “These organizations don’t want to partner with someone with low quality because it hurts them,” said Takhsh.
Dr. Karl Bilimoria, a professor at Northwestern University in Chicago, said it’s unclear whether ratings ought to have so much influence. “These ratings systems are overall not very good,” he said. “Most of them use data that are generated for billing, so they’re not particularly accurate.”
Major ratings systems “frequently conflict,” because they use different criteria, he said: “A hospital can be rated best on one of them and be rated poorly on another.” Saint Anthony, for example, was rated three out of five stars on Medicare’s Hospital Compare website during the same period that it received an “A” from Leapfrog. The hospital was not included in U.S. News and World Report’s top 22 hospitals in Chicago.
Hospitals can choose to advertise the rating that makes them look best. Patients may be impressed by a hospital’s “Top Hospital” banner but never see the lower scores.
Some ratings groups charge for the display. Leapfrog charges $5,500-$17,600 for a hospital to use its emblem in advertising, depending on the hospital’s size. Others, such as U.S. News and World Report’s “Best Hospitals” program, also levies a fee, but Consumer Reports does not.
The ratings systems differ widely on how they compile their scores, and some are more focused on the quality of care than others. “Leapfrog is the best and the only publicly reported rating focused exclusively on safety. It was developed by top experts and uses the very best publicly available data,” said Leapfrog CEO and President Leah Binder. “Our reviews are scrupulous.”
Saint Anthony’s lawsuit hinges on the question of how its physicians order medications, which Saint Anthony believes was the principal reason for their lower grade. The grade was wrong, the hospital claims, because it is based on an inaccurate assessment that physicians prescribed medications electronically only 50 to 74 percent of the time. Saint Anthony maintains that its physicians in fact prescribe electronically 95 percent of the time. The hospital contacted Leapfrog several times to fix the error, according to the lawsuit, but Leapfrog declined.
Leapfrog has removed Saint Anthony’s grade for now, but will likely repost it pending further investigation, noting that the electronic ordering issue was unlikely to fully explain the “C” grade. “There’s clearly some very poor and sloppy reporting from this hospital,” said Binder.
Dr. Karen Joynt Maddox, an assistant professor at the Washington University School of Medicine in St. Louis, said that the dispute underlines the weaknesses of the ratings information available to patients. “This whole field is way behind where it needs to be,” especially given the proliferation of “consumer-driven” high-deductible plans, she said, adding: “there’s a vacuum in terms of consumer-friendly information.”
Sen. Susan Collins (R-Maine), whose vote was pivotal in pushing the GOP tax bill forward last week, thought she had a deal to bolster health care protections in exchange for her support.
But it’s now far from clear that her strategy to shore up part of the Affordable Care Act will prevail or that her deal would produce the results she anticipates.
The tax bill repeals the ACA’s fines for the “individual mandate,” which requires most people to have health insurance or pay a fine. Collins said she would vote for it if Senate Republicans promised to allow a vote on two other health bills.
One would reinstate payments to insurers in order to cover discounts that the ACA requires those insurers to provide to their lowest-income enrollees for out-of-pocket costs. President Donald Trump ended those “cost-sharing reduction” payments in October. The bill that Collins supports would extend the payments for two years.
The other bill she supports would provide temporary funding for “reinsurance” pools, which help insurers pay claims for the sickest – and most expensive – customers. Reinsurance would help bring down premium costs for everyone else.
Before the tax vote, Collins said in a statement she was “deeply concerned that the repeal of the individual mandate would almost certainly lead to further increases in the cost of health insurance premiums – premiums that are already too expensive under the ACA.” Senate Majority Leader Mitch McConnell (R-Ky.) said on the floor that he would support Collins’ demands.
McConnell added that he would seek to restore the cost-sharing subsidies, “ideally prior to the adoption of any final tax reform conference agreement and certainly before the end of the year.” He also said he would “support passage of your bill” to create the reinsurance program, with the same timing.
But it’s nowhere near that easy.
The tax bill is now the subject of final negotiations between the House and the Senate. First, even if the bills pass the Senate, there is little to suggest that the House Republicans would go along. On Tuesday, House Speaker Paul Ryan (R-Wis.) reportedly told other House leaders he was not a party to Collins’ health care deal with McConnell. Ryan had previously expressed opposition to restoring the cost-sharing payments.
In response to Ryan, Collins on Thursday signaled that she might not vote for the tax bill’s final passage.
But would Collins’ changes offset the elimination of the mandate? Some analysts question whether the bill restoring the federal cost-sharing subsidy payments could actually do more harm than good.
“It’s a mess,” said insurance industry consultant Robert Laszewski. Many states allowed insurers to raise premiums to make up for the loss of the federal cost-sharing reduction payments. So passing the law now, at least for 2018, would require insurers to make refunds to individuals and the federal government for those overpayments.
“It’s certainly too late to affect premiums for 2018,” agreed Aviva Aron-Dine, a former Obama administration health official at the Center on Budget and Policy Priorities, a progressive think tank. “It’s also too late to help with market disruption for 2018.”
Open enrollment for 2018 coverage on the federal marketplace ends Dec. 15, although some state-run exchanges have later deadlines.
One irony, Aron-Dine noted, is that state regulators have dealt with the loss of the federal payments in such a way that many customers can get unexpectedly large discounts on premiums, including bronze-level plans for no monthly premium or gold-level plans cheaper than the mid-level silver ones.
Going back to the original payment system, she said, would result in “a whole group of people who would actually see higher premiums.”
In addition, the tax bill’s elimination of the federal health law’s individual mandate penalty would also raise premium costs – beyond the expected yearly increases – by an average of 10 percent, according to the Congressional Budget Office. That’s because the CBO estimates that about 13 million people would give up their coverage by 2027. Fewer people buying insurance means that the insurance pools would have larger numbers of sicker enrollees and would be more expensive for insurers, who would likely raise premiums.
Industry analysts also predict that the loss of the mandate could disrupt the marketplace enough to drive out some insurers.
The elimination of the mandate penalties is permanent, but Collins’ bill would fund the cost-sharing and reinsurance programs for only two years. Because of that, said Timothy Jost, a former law professor and expert on the health law, “I don’t think it’s going to be much of a carrot” to encourage insurers to stay in the individual market.
Analysts were more upbeat about the potential impact of the reinsurance program. The program would be similar to one that existed in the first years of the health law, “and it did in fact reduce premiums by about 10 percent,” Jost said.
But in order to set up such reinsurance programs and be eligible for funding, states would have to apply for special waivers under the health law. Federal officials have been slow about approving those.
“States would have to get their act together politically,” said Jost. “And the money might run out before [the federal government] gets to your state.”
At least one organization thinks Collins is onto something.
The consulting firm Avalere Health estimated this week that the combination of funding the cost-sharing reductions and funding a new reinsurance program would offset the impact of the mandate repeal – at least temporarily.
“Funding CSRs and funding reinsurance is expected to decrease average premiums in the market by more than the 10 percent [increase] CBO is projecting” for getting rid of the mandate fines, said Chris Sloan, a co-author of the study.
But he warned that when the funding runs out, “we’re back where we started.”
While the nation grapples with soaring prices of drugs, dozens of cities, counties and school districts across the country have quietly found a solution they say protects their budgets and saves workers money.
Schenectady County, N.Y., is on track to pay 20 percent less on prescription drugs for its employees this year than in 2003.
Flagler County, Fla., expects to save nearly $200,000 in 2017 on brand-name medicines for its 800 workers, its total drug costs having fallen by 10 percent since last year.
Kokomo, Ind., has found a way to save so much money buying drugs that it offers employees a 90-day supply of dozens of popular brand-name medicines for free.
While the nation grapples with soaring prices of drugs, dozens of cities, counties and school districts across the country have quietly found a solution they say protects their budgets and saves workers money: They are helping their employees buy medicines from pharmacies in Canada and overseas, where prices are up to 80 percent cheaper.
“We love it … it’s a win-win for us and our employees,“ said Anita Stoker, benefits and wellness manager for Flagler County, on Florida’s northeastern coast, which in 2015 started offering its employees a program to get drugs from pharmacies in Canada, England, Australia and New Zealand.
The numbers are growing, even though the U.S. Food and Drug Administration says the practice of importing prescription drugs is illegal and is stepping up enforcement, with raids on stores that helped people order overseas, and even visiting some customers’ homes to collect evidence of illegal purchases.
So far, the FDA has made no move to shut down these employee benefit programs — a few dating back over a decade, but most far more recent.
Asked about its view of the programs, an agency spokeswoman said: “The FDA does not comment on its compliance or enforcement strategy regarding specific FDA-regulated products. When non-compliance with FDA regulations is found, the agency may take, and has taken, a variety of advisory, administrative and judicial actions depending on the violations identified.”
The FDA doesn’t prosecute consumers buying medicines from foreign pharmacies for personal use, although — if detected — such packages are intercepted at the border as contraband and their contents returned or destroyed.
But signaling it may be stepping up enforcement — at least against middlemen who facilitate the practice — the FDA in October raided nine Central Florida storefronts that helped a mostly senior population buy drugs from Canada and other countries. The stores don’t stock any medicines but assist consumers in ordering drugs from foreign pharmacies. Criminal investigators warned the store’s owners they were operating illegally and could face fines or jail time. They were not shut down.
Bill Hepscher, co-owner of Canadian MedStore, which owns six of the nine storefronts visited by the FDA, defends his practice, saying he’s only helping consumers do what the FDA says they can do without fear of government prosecution. He said it’s not fair that his stores get targeted for assisting consumers while municipalities across the country are doing the same thing for their employees. This includes the school district in Pasco County, where Hepscher has one of his stores.
Bill Hepscher, co-owner of the Canadian MedStore, outside his Lakeland, Fla., location. Six of the nine stores that federal agents searched in October are owned by Canadian MedStore. (Phil Galewitz/KHN)
Congress has passed legislation legalizing the importation of prescription drugs several times in the past 20 years, but both Democratic and Republican administrations have opted not to implement it. The FDA has said reimporting medicines from outside the United States is dangerous because of the possibility that medications are counterfeit, mislabeled or otherwise unsafe — a view vigorously supported by the industry.
The pharmaceutical industry applauded the recent FDA raids. “We welcome the FDA’s action to crack down on drug importation schemes,” said Holly Campbell, a spokeswoman for PhRMA.
But rising drug prices have given this reimportation idea new life — in Congress and in practice.
In hearings last week, Sen. Rand Paul (R-Ky.) said he would oppose the nomination of Alex Azar, a former drug company CEO, as head of Health and Human Services unless Azar commits to implementing an importation plan. Told by Azar that the problem was guaranteeing safety, Paul replied: “That’s b.s. The American people think it’s b.s. that you can’t buy drugs from Europe or from Canada or Mexico or other places.”
A growing number of city and county officials argue that their employees should have the option to buy less expensive drugs and that helping them do so doesn’t violate any laws.
In recent years, millions of Americans have driven over the border to Canada and Mexico or used the internet to buy medicines from foreign pharmacies for personal use.
A Kaiser Family Foundation poll in 2016 found that 8 percent of respondents said they or someone in their household had imported a drug at some point, a figure that would translate to about 19 million adults in the U.S. based on current Census population estimates.
In the early 2000s, several states, including Maine and Illinois, briefly maintained websites to help residents buy drugs from Canada. The programs were discontinued, amid opposition from federal authorities, the pharmaceutical industry and GOP politicians. Now, cities, counties and school districts are stepping in.
Consumers need a doctor’s prescription just as they would to buy medicine from their local pharmacy.
Drugs ordered from overseas often come with the same packaging as in the U.S. CanaRx, based in Windsor, Ontario, and ElectRx, based in Detroit, says it vets the pharmacies (generally in Canada, England and Australia) to ensure customers get the real product. Counties, cities and schools — as well as a growing number of private companies — contract with one of these companies for online service.
These companies do not sell to individuals. They sell only a three-month supply of medicine and do not provide drugs that are available as generics in the U.S.
The price savings for common medicines outside the U.S. can be huge, since other nations negotiate prices with drug manufacturers or allow cheaper generic equivalents to be sold more rapidly.
Take Canadian MedStore, for example. It sells a 90-day supply of Januvia for $83, imported from England. The same supply of the diabetes drug can cost $423 in the U.S. An Advair Diskus, which goes for $417 in the U.S., MedStore gets from New Zealand and sells for $96. Xarelto, a popular blood thinner, costs $89 per month imported from England, versus $485 a month in the U.S.
Companies selling drugs from Canada and overseas say the FDA’s safety concerns are unjustified. The recent FDA raids on Hepscher’s Florida storefronts followed a sting operation in which undercover agents purchased medicines from overseas — all of which proved in testing to contain the ingredients matching the medicines ordered.
But FDA spokeswoman Lyndsay Meyer said: “The ones that we found and tested may have been [safe], but that doesn’t mean that they all were. We do believe that it’s unsafe. You never know what you’re going to get or how they were stored — it’s a gamble. And importantly, it’s prohibited under federal law.”
Cities and counties that facilitate online ordering from overseas often do so on the advice of their insurance brokers. “In this day and age, when it’s common for employers to see a 20 or 30 percent annual increase in drug costs, we are seeing a negative drug trend in Flagler County — that’s unheard of,” said Sherry Bugnet, an account executive with The Bailey Group, an insurance broker in St. Augustine, Fla.
Schenectady County, N.Y., has worked with CanaRx for over a decade to allow employees to buy drugs overseas, saving more than $10 million during that period, with no complaints; prescriptions involve no copay if the service is used. The few times drugs were confiscated at an international mail-processing facility by customs officials, CanaRx merely re-sent the shipment.
“It helps us keep our tax rate down and helps us give cost-of-living increases to employees,” said Chris Gardner, a county attorney who helped start the program, through which he has ordered medicines for cholesterol and blood pressure.
Since 2012, Kokomo, Ind., has let its employees get brand-name drugs with no copayment if they order from Canada and overseas through ElectRx. “Our employees like it, and it’s very simple and easy to use. Their doctor fills out a prescription, they send it in, and the medication goes right to their home,” said Kathy Horton, director of human resources for the city, about 60 miles north of Indianapolis.
Encouraged by the successes in other parts of Florida, Patricia Howard, senior manager for benefits and risk at Pasco County Schools, said the county in July started offering the international pharmacy option to its 9,600 employees and dependents to buy brand-name drugs.
Employees pay zero for their first 90-day order, then $10 for each 90-day refill. About 75 workers have used the program.
Other parts of Florida will soon join in. Both the Palm Beach County Clerk & Comptroller and the city of Sarasota are set to unveil similar programs in January. ”I have no questions about the legality, as that’s already been vetted,” said April Bryan, the city’s general manager of human resources.
Carmen Catizone, executive director of the National Association of Boards of Pharmacy, a nonprofit association that promotes safe pharmacy practices, said: “If cities and counties have done their due diligence to ensure their employees are getting drugs from reputable sources, then there is nothing wrong with it,” he said. “If not, they could be playing Russian roulette.”
Although people over age 52 still account for the largest share of chronic hepatitis C cases, the highest number of new infections occurs among people in their 20s.
This story by KHN Sacramento correspondent Pauline Bartolone aired Dec. 1, 2017, on Here & Now.
UKIAH, Calif. — Once a week, Dr. Diana Sylvestre puts her medical expertise to use in a rickety old house frequented by drug users in this small Northern California city.
She sets up in a stuffy office no bigger than a walk-in closet, just feet from a room where people who shoot heroin or methamphetamine drop off used needles and pick up clean ones. The needle exchange and Sylvestre’s makeshift clinic are under the same roof, part of a program run by the Mendocino County AIDS/Viral Hepatitis Network.
Sylvestre comes here in part to treat young drug users, people who are often homeless or suffering from mental illness, many of them newly infected with hepatitis C. She doesn't see many of them at a hepatitis C clinic she runs in Oakland.
“They are the ones who are spreading hepatitis C,” she said. “They're the ones who have the high-risk behaviors.”
The opioid addiction crisis has engendered an unfortunate side effect — an epidemic of new hepatitis C infections, mainly among young people who share infected needles. Although people over age 52 still account for the largest share of chronic hepatitis C cases, the highest number of new infections occurs among people in their 20s.
In California, newly reported cases shot up 55 percent among men in their 20s and 37 percent for women in that age range from 2007 to 2015, the California Department of Public Health (CDPH) said.
The wave of hepatitis C infections among young people is “cause for alarm,” said John Ward, the CDC’s viral hepatitis director. The agency is studying the best ways to treat this population, he said, adding that a new “front of attack” is needed. Health experts and doctors like Sylvestre say that battle may be best waged outside traditional health care settings, in places frequented by young drug users.
At the needle exchange in Ukiah, caseworkers give $7 Subway gift cards to people who agree to be tested for hepatitis C. Those who test positive can visit Sylvestre and try to qualify for expensive new medications that wipe out the virus. Drug users can also get help for their substance abuse.
Patient advocates say this kind of on-site treatment is an anomaly in California, where only a few needle exchanges offer such services.
Treating young drug users is not easy, Sylvestre said. Their lives are chaotic, which makes it difficult to start or continue their medication. “They're frequently homeless; they have untreated mental illness,” she said. “They aren't the most reliable people in the world.”
The surge in hepatitis C cases among young people doesn’t surprise 28-year-old Stephanie Clarizio of San Francisco. She injected heroin for about six years, starting in her home town of Atlanta. Clarizio said many of her friends who used intravenous drugs there knew about the risk of hepatitis C, and many of them contracted the virus.
“Everyone kind of knows about it,” Clarizio said. “You just don’t care.”
Clarizio had hepatitis C for a couple of years before she was cured in San Francisco while in rehab for heroin addiction.
Experts and government officials say they’re concerned about the surge among young people, who are more challenging to treat because many of them do not regularly see a doctor.
Many people who have been recently infected don’t experience symptoms of the viral disease. Left untreated, hepatitis C can cause severe liver damage or cancer later in life.
While the baby boomer generation, defined by the CDC as those people born between 1945 and 1965, still accounts for three-quarters of chronic cases, University of California-Berkeley epidemiologist Art Reingold suggests the public health response should target the newly infected population.
“The prevention opportunity is much greater” when treating the younger generation, Reingold explained. “If you’re working on a group that’s already got [75 percent] of the people infected, your opportunity to prevent new infections is much smaller.”
Dr. Heidi Bauer, chief of the sexually transmitted diseases control branch at the state Department of Public Health, said she encourages local health departments and community-based organizations to be creative about treating the younger population.
“We ask for people to think beyond that baby boomer box,” Bauer said. Public health organizations “can take their services on the road, so to speak, and they can make an extra effort to reach populations that may be more at risk.”
Dr. Sylvestre has been doing just that for more than a year. “If they're not going to show up in our medical facilities, we need to go out where they are there,” she said.
Ashley Greene, a 29-year-old resident of Eureka, Calif., said treating young drug users for hepatitis C at needle exchanges is a good strategy. Greene recently recovered from the disease, which she said she contracted injecting cocaine as a teenager. She also used heroin on and off until 2011.
Greene feels much more energetic, clear-minded and optimistic about life since she was cured of hepatitis C, and she supports anything that educates young drug users about treatment, she said.
Not all will be ready for treatment, but at least “you can lead them to water,” she said.
The perverse incentives of the health care payment system have long made it far more lucrative to treat severe, dangerous asthma attacks than to prevent them.
BALTIMORE — Keyonta Parnell has had asthma most of his young life, but it wasn’t until his family moved to the 140-year-old house here on Lemmon Street two years ago that he became one of the health care system’s frequent customers.
“I call 911 so much since I’ve been living here, they know my name,” said the 9-year-old’s mother, Darlene Summerville, who calls the emergency medical system her “best friend.”
Summerville and her family live in the worst asthma hot spot in Baltimore: ZIP code 21223, where decrepit houses, rodents and bugs trigger the disease and where few community doctors work to prevent asthma emergencies. One mom there wields a BB gun to keep rats from her asthmatic child.
Residents of this area visit hospitals for asthma flare-ups at more than four times the rate of people from the city’s wealthier neighborhoods, according to data analyzed by Kaiser Health News and the University of Maryland’s Capital News Service.
Baltimore paramedic crews make more asthma-related visits per capita in 21223 than anywhere else in the city, according to fire department records. It is the second-most-common ZIP code among patients hospitalized for asthma, which, when addressed properly, should never require emergency visits or hospitalization.
The supreme irony of the localized epidemic is that Keyonta’s neighborhood in southwest Baltimore is in the shadow of prestigious medical centers — Johns Hopkins, whose researchers are international experts on asthma prevention, and the University of Maryland Medical Center.
Both receive massive tax breaks in return for providing “community benefit,” a poorly defined federal requirement that they serve their neighborhoods. Under Maryland’s ambitious effort to control medical costs, both are supposed to try to improve residents’ health outside the hospital and prevent admissions.
But like hospitals across the country, the institutions have done little to address the root causes of asthma. The perverse incentives of the health care payment system have long made it far more lucrative to treat severe, dangerous asthma attacks than to prevent them.
Hopkins, UMMC and other hospitals collected $84 million over the three years ending in 2015 to treat acutely ill Baltimore asthma patients as inpatients or in emergency rooms, according to the news organizations’ analysis of statewide hospital data. Hopkins and a sister hospital received $31 million of that.
Executives at Hopkins and UMMC acknowledge that they should do more about asthma in the community but note that there are many competing problems: diabetes, drug overdoses, infant mortality and mental illness among the homeless.
Science has shown it’s relatively easy and inexpensive to reduce asthma attacks: Remove rodents, carpets, bugs, cigarette smoke and other triggers. Deploy community doctors to prescribe preventive medicine and health workers to teach patients to use it.
Ben Carson, secretary of the Department of Housing and Urban Development, who saw hundreds of asthmatic children from low-income Baltimore during his decades as a Hopkins neurosurgeon, said that the research on asthma triggers is unequivocal. “It’s the environment — the moist environments that encourage the mold, the ticks, the fleas, the mice, the roaches,” he said in an interview.
Research showing that removing household triggers reduces asthma attacks “is unequivocal,” says Ben Carson, a former Johns Hopkins neurosurgeon and now secretary of the Department of Housing and Urban Development. “The cost of not taking care of people is probably greater than the cost of taking care of them.” (Katherine Gilyard/KHN)
As the leader of HUD, he says he favors reducing asthma risks in public housing as a way of cutting expensive hospital visits. The agency is discussing ways to finance pest removal, moisture control and other remediation in places asthma patients live, a spokeswoman said.
“The cost of not taking care of people is probably greater than the cost of taking care of them” by removing triggers, Carson said, adding, “It depends on whether you take the short-term view or the long-term view.”
That drives the total annual cost of asthma care, including medicine and office visits, well over $50 billion.
Keyonta lives in a two-bedroom row house on the 1900 block of Lemmon Street, which some residents call the “Forgetabout Neighborhood,” about a mile from UMMC and 3 miles from Hopkins.
Reporters spent months interviewing patients and parents and visiting homes in 21223, a multiracial community where the average household income of $38,911 is lower than in all but two other ZIP codes in Maryland.
To uncover the impact of asthma, the news organizations analyzed every Maryland inpatient and emergency room case over more than three years through a special agreement with the state commission that sets hospital rates and collects such data. The records did not include identifying personal information.
For each emergency room visit to treat Baltimore residents for asthma, according to the data, hospitals were paid $871, on average. For each inpatient case, the average revenue was $8,698. In one recent three-year period, hospitals collected $6.1 million for treating just 50 inpatients, the ones most frequently ill with asthma, each of whom visited the hospital at least 10 times.
Lemmon Street’s trash piles and vacant homes harbor rodents and insects that can set off asthma flare-ups. (Doug Kapustin for KHN)
Darlene Summerville partly blames a moldy dirt basement for triggering her children’s asthma flare-ups. (Doug Kapustin for KHN)
Hopkins’ own research shows that shifting dollars from hospitals to Lemmon Street and other asthma hot spots could more than pay for itself. Half the cost of one admission — a few thousand dollars — could buy air purifiers, pest control, visits by community health workers and other measures proven to slash asthma attacks and hospital visits by frequent users.
“We love” these ideas, and “we think it’s the right thing to do,” said Patricia Brown, a senior vice president at Hopkins in charge of managed care and population health. “We know who these people are. . . . This is doable, and somebody should do it.”
But converting ideas to action hasn’t happened at Hopkins or much of anywhere else.
One of the few hospitals making a substantial effort, Children’s National Health System in Washington, D.C., has found that its good work comes at a price to its bottom line.
Children’s sends asthma patients treated in the emergency room to follow-up care at a clinic that teaches them and their families how to take medication properly and remove home triggers. The program, begun in the early 2000s, cut emergency room use and other unscheduled visits by those patients by 40 percent, a study showed.
While recognizing that it decreases potential revenue, hospital managers fully support the program, said Dr. Stephen Teach, the pediatrics chief who runs it.
“‘Asthma visits and admissions are down again, and it’s all your fault!’” Children’s chief executive likes to tease him, Teach said. “And half his brain is actually serious, but the other half of his brain is celebrating the fact that the health of the children of the District of Columbia is better.”
The Close-Up View
Half of the 32 row houses on Summerville’s block of Lemmon Street are boarded up, occupied only by the occasional heroin user. At least 10 people on the block had asthma late last year, according to interviews with residents then.
“We have mold in our house” and a leaky roof, said Tracy Oates, 42, who lived across the street from Summerville. “That is really big trouble as far as triggering asthma.”
Two of her children have the disease. “I don’t even want to stay here,” she said. “I’m looking for a place.”
Shadawnna Fews, 30, lived with her asthmatic toddler on Stricker Street, a few blocks east. She kept a BB gun to pick off rats that doctors said can set off her son’s wheezing.
Delores Jackson, 56, who lived on Wilkens Avenue, a few blocks south of Lemmon Street, said she had been to the hospital for asthma three times in the previous month.
All three of Summerville’s kids have asthma. Before moving to Lemmon Street two years ago, she remembers, Keyonta’s asthma attacks rarely required medical attention.
But their new house contained a clinical catalog of asthma triggers.
The moldy basement has a dirt floor. Piles of garbage in nearby vacant lots draw vermin: mice, which are among the worst asthma triggers, along with rats. Summerville, 37, kept a census of invading insects: gnats, flies, spiders, ants, grasshoppers, “little teeny black bugs,” she laughed.
Often she smokes inside the house.
The state hospital data show that about 25 Marylanders die annually from acute asthma, their airways so constricted and blocked by mucus that they suffocate.
Keyonta missed dozens of school days last year because of his illness, staying home so often that Summerville had to quit her cooking job to care for him. Without that income, the family nearly got evicted last fall and again in January. The rent is $750.
About a third of Baltimore high school students report they have had asthma, causing frequent absences and missed learning, said Dr. Leana Wen, Baltimore’s health commissioner.
With numbers like that, West Baltimore’s primary care clinics, which treat a wide range of illnesses, are insufficient, as is the city health department’s asthma program, whose three employees visit homes of asthmatic children to demonstrate how to take medication and reduce triggers.
The program, which an analysis by Wen’s office showed cut asthma symptoms by 89 percent, “is chronically underfunded,” she said. “We’re serving 200 children [a year], and there are thousands that we could expand the program to.”
‘The Hospital Instead Of The Classroom’
The federal government paid for $1.3 billion in asthma-related research over the past decade, of which $205 million went to Hopkins, records show. The money supports basic science as well as many studies showing that modest investments in community care and home remediation can improve lives and save money.
“Getting health care providers to pay for home-based interventions is going to be necessary if we want to make a dent in the asthma problem,” said Patrick Breysse, a former Hopkins official, who as director of the National Center for Environmental Health at the Centers for Disease Control and Prevention is one of the country’s top public health officials.
Other factors can trigger asthma: outdoor air pollution and pollen, in particular. But eliminating home-based triggers could reduce asthma flare-ups by 44 percent, one study showed.
Perhaps no better place exists to try community asthma prevention than Maryland. By guaranteeing hospitals’ revenue each year, the state’s unique rate-setting system encourages them to cut admissions with preventive care, policy authorities say.
But Hopkins, UMMC and their corporate parents, whose four main Baltimore hospitals together collect some $5 billion in revenue a year, have so far limited their community asthma prevention to small, often temporary efforts, often financed by somebody else’s money.
UMMC’s Breathmobile program, which visits Baltimore schools dispensing asthma treatment and education, depends on outside grants and could easily be expanded with the proper resources, said its medical director, Dr. Mary Bollinger. “The need is there, absolutely,” she said.
Hopkins runs “Camp Superkids,” a weeklong, sleep-away summer session for children with asthma that costs participants $400, although it awards scholarships to low-income families. It’s also conducting yet another study — testing referral to follow-up care for emergency room asthma patients, which Children’s National long ago showed was effective.
But no hospital has invested substantially in home remediation to eliminate triggers, a proven strategy supported by the HUD secretary and promoted by Green and Healthy Homes Initiative, a Baltimore nonprofit that works to reduce asthma and lead poisoning.
“We either go forward to do what has been empirically shown to work, or we continue to bury our heads in the sand and kids will continue to go to the hospital instead of the classroom,” said Ruth Ann Norton, the nonprofit’s chief executive.
Hopkins and UMMC say they do plenty to earn their community benefit tax breaks.
“It’s always a challenge to say, ‘Where do we start first?’” said Dana Farrakhan, a senior vice president at UMMC whose duties include community health improvement.
Among other initiatives, UMMC takes credit for working with city officials to sharply reduce infant mortality by working with expectant mothers. The organization’s planned outpatient center will include health workers to help people reduce home asthma triggers, Farrakhan said.
“What we do is perhaps not sufficiently focused,” Brown of Hopkins said. At the same time, “we have to have revenue,” she said. “We’re a business.”
After months of waiting, Summerville considered herself lucky to get an appointment with the city health department’s asthma program.
One of its health workers came to the house late last year. She supplied mousetraps and mattress and pillow covers to control mites and other triggers. She helped force Summerville’s landlord to fix holes in the ceiling and floor.
She urged Summerville to stop smoking inside and gave medication lessons, which uncovered that Summerville had mixed up a preventive inhaler with the medicine used for Keyonta’s flaring symptoms.
“The asthma lady taught me what I needed to know to keep them healthy,” Summerville said of her family.
That was late in 2016. Since then, Summerville said last month, she hasn’t called an ambulance.
METHODOLOGY:
Kaiser Health News and the University of Maryland’s Capital News Service obtained data held by the Maryland Health Services Cost Review Commission on every hospital inpatient and emergency room case in the state from mid-2012 to mid-2016 — some 10 million cases. The anonymized data did not include identifying personal information.
The news organizations measured asthma costs by calculating total charges for cases in which asthma was the principal diagnosis. Maryland’s hospital rate-setting system ensures that such listed charges are very close to equaling the payments collected.
To determine asthma prevalence, reporters calculated the per capita rate of hospital visits with asthma as a principal diagnosis — a method frequently used by health departments and researchers. This may exaggerate asthma prevalence in low-income ZIP codes such as 21223, because of those communities’ tendency to use hospital services at greater rates.
However, the data also point to high asthma rates in 21223 and other low-income Baltimore communities — for example, asthma prevalence within the population of all hospital patients in a ZIP code.
One proposal calls for hospitals to guarantee their work. If patients experience certain avoidable complications up to 90 days after surgery, then they they don't have to pay.
Linda Radach has had six hip replacement operations since 2006, three on each side. Osteoarthritis was the reason she needed surgery in the first place, but replacing her hips in some ways only worsened her troubles.
Following two of the procedures, the implanted metal socket didn’t integrate with the bone of her own hip socket and was loose, causing excruciating pain. Most recently, the titanium metal ball in her hip corroded.
The surgical complications were bad enough, but after one of the operations, Radach, 63, also developed cellulitis, a bacterial skin infection that if left untreated can turn deadly.
Having to pay for medical mistakes added insult to injury, said Radach, who explained that each surgery typically cost her about $5,000 out-of-pocket.
“Nobody should come out of the hospital with an infection,” she said. “Why does any patient pay for a medical error like that? … Because that’s the way the system is set up.”
Now Radach, who lives in Seattle, is trying to change that system. She is a patient advocate with the Dr. Robert Bree Collaborative, a program established by the state Legislature to improve the quality and cost-effectiveness of care.
One recommendation is that patients shouldn’t have to pay for their care if they experience certain avoidable complications up to 90 days after surgery. A participating hospital would guarantee its work, or patients would be off the hook for the copayment or would get that money back.
“I think the warranty is something that really resonates with patients,” said Ginny Weir, program director for the Bree Collaborative. “They think, ‘If something goes wrong in the hospital, I know that I’d be taken care of financially if any of these things happened.”
Guarantees Rare In Medicine
You wouldn’t pay a mechanic for a faulty muffler or a restaurant for spoiled food. If you did, you would expect a refund. But the same arrangement between buyer and seller hasn’t historically existed in medical care.
Some argue that maybe it should. “Medicine is certainly not like making widgets, but there is a production process to it,” said Dr. Ezekiel Emanuel, chairman of the Department of Medical Ethics and Health Policy at the University of Pennsylvania. He advocated for the government to test a 90-day money-back guarantee in the Medicare program in his 2014 book, “Reinventing American Health Care.”
“There are things you can do that are in your control that reduce the error rate and improve quality,” he added. “A guarantee makes people [more motivated to adopt] this kind of process.”
Examples of health care systems offering money-back guarantees are thin. The one notable exception is Geisinger Health System in central Pennsylvania, which pioneered health care warranties. Since Geisinger offered its first 90-day warranty in 2006 for coronary artery bypass graft surgery, the ProvenCare program has added other procedures, including hip and knee replacement and lumbar spine surgery.
ProvenCare aims to ensure that providers use evidence-based best practices to improve patient outcomes and reduce avoidable hospital readmissions. In the past five years, for example, the health system’s 30-day readmission rate for coronary artery bypass graft surgery has declined from 10.2 percent to 4.4 percent, according to Geisinger figures.
Under ProvenCare, if patients are hospitalized or need other follow-up care for complications that could have been avoided in that 90-day window, Geisinger absorbs the cost to both patient and health insurer.
Two years ago, the health system expanded its money-back promise to include customer satisfaction measures related to care. The new program, ProvenExperience, deals with patient complaints about poor staff communication, difficulty making appointments, a long wait to be seen in the emergency department, bad food or construction noise, for example.
“I thought, what if we put it all together?” said Dr. David Feinberg, Geisinger’s president and CEO. “I know we’re really good at anticoagulation, but are we really good at transitions of care? Are we really good at the phones?”
When Kim Walsh, 52, had her thyroid removed at a Geisinger facility in Wilkes-Barre in 2015, the surgery went extremely well. Her hospital stay, not so much. Assigned to a room without a bathroom, Walsh had to hike down three hallways in her hospital gown to a restroom located just off a public hallway. When she got there, there was no toilet paper and there was urine on the seat.
“I was so angry,” she said. After she complained, a patient advocate came to her room and told her to call her when she got the bill. Walsh was never charged her $785 copayment.
Misplaced Priorities?
Although no one would argue that paying attention to quality is a mistake, some believe that “mint-on-the-pillow” efforts could distract people from focusing on what really matters: The quality of the medical care they receive.
“We start to emphasize parking, nice meals, but we’re not really paying attention to how good the care is,” said Arthur Caplan, director of the division of medical ethics at New York University.
Others argue that focusing on patient experiences helps capture the caring dimension of health care.
“These kinds of things matter a lot to feeling you’ve gotten health care that’s personalized for you, and that your experiences and interactions are taken seriously,” said Rachel Grob, director of national initiatives at the University of Wisconsin’s Center for Patient Partnerships.
In Washington, the Bree Collaborative warranty is one element in a larger effort to reform how doctors and hospitals get paid. The group recommends “bundled payments” for some surgeries that cover a whole “episode of care,” from preoperative doctor visits through postoperative rehabilitation. The collaborative recommends bundled payments and warranties for five types of surgery: total knee and total hip replacements, lumbar fusion operations, coronary artery bypass and bariatric surgery.
To date, though, there have been no warranty claims under the Bree program. Participation by employers and hospitals in the bundled payment and warranty model is voluntary. The first contract that includes a financial warranty started in January and covers public employees who receive a total hip or total knee replacement at Virginia Mason Medical Center in Seattle, Weir said.
In addition to its Bree work, Virginia Mason incorporates bundled payments with limited warranties for some of its larger, more progressive employer clients, said Dr. Robert Mecklenburg, medical director at the Virginia Mason Center for Health Care Solutions.
The motive behind the Bree Collaborative is to reduce avoidable hospital readmissions by aligning payment for care with quality rather than the number of services provided, Weir said. These themes have cropped up with growing frequency in health care, adopted to varying degrees by health care providers, employers and government health care programs like Medicare.
The Bree warranty covers very specific complications that are considered directly related to the operation. For hip and knee replacements, for example, hospitals that participate would agree to hold patients and health plans harmless financially if the patients got pneumonia, sepsis or had a heart attack within seven days of the surgery. Within 30 days, the warranty would cover wound infections, surgical site bleeding and pulmonary embolisms. Patients and insurers would be protected for up to 90 days if they develop an infection around the artificial joint or if the joint suffers a mechanical failure.
If a complication arises during the warranty time frame that is directly attributable to the initial procedure, the Bree warranty recommends that there would be no charge for hospitalization related to that care, even if care extended beyond the warranty period, Weir said.
The collaborative is revising its current recommendations, Weir said. One change will be to eliminate “death” from the list of 30-day complications under the warranty.
“You can’t really warranty against death,” she said.
Had a hip replacement warranty been in place when Radach had her surgeries, she would likely have saved a lot of money.
Radach believes that surgical warranties should be even more comprehensive than Bree recommends, holding manufacturers responsible for the production of safe and effective devices. For now, she said, the current warranty is reasonable.
“Starting with a warranty for the procedure itself and the hospital care is a good start,” she said.
Health plans, medical practices, and some Medicaid programs increasingly offer financial incentives to motivate Medicaid patients to engage in more preventive care and make healthier lifestyle choices.
Patricia Alexander knew she needed a mammogram but just couldn’t find the time.
“Every time I made an appointment, something would come up,” said Alexander, 53, who lives in Moreno Valley, Calif.
Over the summer, her doctor’s office, part of Vantage Medical Group, promised her a $25 Target gift card if she got the exam. Alexander, who’s insured through Medi-Cal, California’s version of the Medicaid program for lower-income people, said that helped motivate her to make a new appointment — and keep it.
Health plans, medical practices and some Medicaid programs are increasingly offering financial incentives to motivate Medicaid patients to engage in more preventive care and make healthier lifestyle choices.
They are following the lead of private insurers and employers that have long rewarded people for healthy behavior such as quitting smoking or maintaining weight loss. Such changes in health-related behavior can lower the cost of care in the long run.
“We’ve seen incentive programs be quite popular in the insurance market, and now we are seeing those ramp up in the Medicaid space as well,” said Robert Saunders, research director at the Margolis Center for Health Policy at Duke University.
Medicaid patients who agree to be screened for cancer, attend health-related classes or complete health risk surveys can get gift cards, cash, gym memberships, pedometers or other rewards. They may also get discounts on their out-of-pocket health care costs or bonus benefits such as dental care.
Under the Affordable Care Act, 10 states received grants totaling $85 million to test the use of financial rewards as a way to reduce the risk of chronic disease among their Medicaid populations. During the five-year demonstration, states used the incentives to encourage people to enroll in diabetes prevention, weight management, smoking cessation and other preventive programs. The states participating were California, Connecticut, Hawaii, Minnesota, Montana, Nevada, New Hampshire, New York, Texas and Wisconsin.
Medi-Cal, for example, offered gift cards and nicotine replacement therapy to people who called the state’s smoking cessation line. Minnesota’s Medicaid program handed out cash to people who attended a diabetes prevention class and completed bloodwork.
An evaluation of these programs, released in April, showed that incentives help persuade Medicaid beneficiaries to take part in such preventive activities. Participants said gift cards and other rewards also helped them achieve their health goals. But the evaluators weren’t able to show that the programs prevented chronic disease or saved Medicaid money. That’s in part because those benefits could take years to manifest, according to the evaluation.
Overall, research on the effectiveness of financial incentives for the Medicaid population has been mixed. A report this year by the Center on Budget and Policy Priorities found that they can induce people to keep an appointment or attend a class but are less likely to yield long-term behavior changes, such as weight loss. And in some cases, the report said, incentives are given to people to get exams they would have gotten anyway.
The center’s report also found that penalties, including ones that limit coverage for people who don’t engage in healthful behaviors, were not effective. Instead, they can result in increased use of emergency rooms by restricting access to other forms of care, the report said.
Some of the biggest factors preventing Medicaid patients from adopting healthful behaviors are related not to medical care but to their circumstances, said Charlene Wong, a pediatrician and health policy researcher at Duke University.
That makes administering incentive programs more complicated. Even recruiting and enrolling participants has been a challenge for some states that received grants through the Affordable Care Act.
“The thing that is most likely to help Medicaid beneficiaries utilize care appropriately is actually just giving them access to that care — and that includes providing transportation and child care,” said Hannah Katch, one of the authors of the report by the Center on Budget and Policy Priorities. Another barrier is being able to take time off work to go to the doctor.
But health plans are eager to offer patients financial incentives because it can bring their quality scores up and attract more enrollees. And medical groups, which may receive fixed payments per patient, know they can reduce their costs — and increase their profits — if their patients are healthier.
Providing incentives to plans and medical groups has created a business opportunity for some companies. Gift Card Partners has been selling gift cards to Medicaid health plans for about five years, said CEO Deb Merkin. She said health insurers that serve Medicaid patients want to improve their quality metrics, and they can do that by giving incentives and getting patients to the doctor.
“It is things like that that are so important to get them to do the right thing so that it saves money in the long run,” she said.
Agilon Health, based in Long Beach, Calif., runs incentive programs and other services for several California medical groups that care for Medi-Cal patients. The medical groups contract with the company, which provides gift cards to patients who get mammograms, cervical cancer exams or childhood immunizations. People with diabetes also receive gift cards if they get their eyes examined or blood sugar checked. And the company offers bonuses to doctors if their Medicaid patients embrace healthier behaviors.
The incentives for patients are “massively important for the Medicaid population, because the gaps in care are historically so prevalent,” said Ron Kuerbitz, CEO of Agilon. Those gaps are a big factor pushing up costs for Medicaid patients, because if they don’t get preventive services, they may be more likely to need costlier specialty care later, Kuerbitz said.
Emma Alcanter, who lives in Temecula, Calif., received a gift card from her doctor’s office after getting a mammogram late this summer. Alcanter, 56, had noticed a lump in her breast but waited about two years before getting it checked, despite reminders from her doctor’s office. “I was scared they were going to find cancer,” she said.
Alcanter finally decided to get screened after her first grandchild was born. The gift card was an added bonus, and Alcanter said it showed her doctors cared about her. Her mammogram revealed that the lump wasn’t cancer, and she plans to use the gift card to buy a present for her grandson.
State lawmakers passed sweeping changes in the 1990s that consigned association health plans to near extinction. The Trump administration aims now to revive them.
Just a few decades ago, small businesses in California often banded together to buy health insurance on the premise that a bigger pool of enrollees would get them a better deal.
California’s dairy farmers did it; so did car dealers and accountants.
But after a string of these “association health plans” went belly up, sometimes in the wake of fraud, state lawmakers passed sweeping changes in the 1990s that consigned them to near extinction.
Now, President Donald Trump wants to promote a renaissance of these health plans and make it easier for them to operate across state lines — with less regulation. In a recent executive order, Trump directed the Department of Labor to look into ways to “allow more small businesses to avoid many of the [Affordable Care Act’s] costly requirements.”
Because the plans would do business in more than one state, they could “figure out a way to pull back some authority states have,” said Kevin Lucia, senior research professor at Georgetown University’s Center on Health Insurance Reforms.
That does not sit well in California, where key state policymakers warn that weaker regulation of these plans could destabilize the small-employer and individual markets, which have gained important consumer protections under the ACA and state health laws — including minimum benefit levels.
“President Trump is trying to loosen those rules, and return us to the bad old days” that were disastrous for consumers, said California Insurance Commissioner Dave Jones. Tens of thousands of consumers were “left in the lurch” without insurance when their associations folded, and millions of dollars in medical claims went unpaid, he said.
In the 1980s and 1990s, association plan failures hit a number of small businesses, affecting employees across industries. Thousands of farmworkers suffered when a plan created by Sherman Oaks-based Sunkist Growers collapsed. When Irvine-based Rubell-Helms Insurance Services went out of business, it reportedly left $10 million in medical claims unpaid.
In 1995, California banned a common form of health care associations known as multiple employer welfare arrangements, or MEWAs, in which small businesses jointly purchased health coverage in the same way Trump is now proposing. The plans that already existed at the time could remain in business as long as they met certain financial requirements.
That ban followed “decades of bad experience,” said Jones.
But some business groups say that these plans offer companies flexibility in the face of state regulations that add cost and administrative burdens.
“Small-business owners are being pummeled,” said Tom Scott, California director of the National Federation of Independent Business. The looser regulations could save businesses thousands of dollars a year, he said.
Still, California lawmakers said they will do everything they can to prevent these plans from bypassing state regulations.
State Sen. Ed Hernandez (D-West Covina), chairman of the Senate Health Committee, said he will consider legislation to ban the sale of policies that don’t meet minimum benefit requirements.
“I’m committed to do everything I can to make sure we don’t go backward to having skinny plans in the state,” he said. Consumers need to be guaranteed coverage with robust health benefits and a cap on out-of-pocket expenses, he added.
Policy experts say the impact of Trump’s plan will depend on the precise details, which are still being considered by the Department of Labor. But Trump has suggested he wants the association plans to be treated the same as large-employer insurance, which would free them from regulations that govern the benefits they offer.
Supporters of the idea argue that the greater flexibility on benefits, plus the bargaining clout that comes with size, would lower the cost of these plans, providing relief to small employers hit by rising health care costs and state taxes.
“It’s very, very easy and it’s very competitive,” said Jack Stoughton, CEO of Los Angeles-based Stoughton Printing Co., which produces 12-inch record jackets for vinyl records by bands such as Led Zeppelin and Wilco.
His workers receive health benefits through one of the few remaining MEWAs in California.
The plan “saves me money; it certainly saves me time,” he said.
But Beth Capell, a longtime health care consumer lobbyist, said these cheaper plans compromise the quality of health coverage for small-business employees and individuals.
“There was a fairly concerted outcry” to get rid of association health plans in the 1990s, and they should not be resurrected, Capell said. “They were a bad idea then; they are a bad idea now. It [feels] like déjà vu all over again.”
Deborah Kelch, director of the Insure the Uninsured Project in Sacramento, said state officials banned new MEWAs in the 1990s because they feared the associations would siphon off healthy people, leaving many small businesses with sicker and costlier enrollees — and higher premiums. The legislative changes from the 1990s helped ensure that the remaining MEWAs stayed afloat, she said.
Today, only four MEWAs remain in California, covering about 150,000 employees and their dependents. The enrollees say the model works.
Stoughton’s employees have received health benefits through a MEWA since the mid-1990s.
His roughly 50 workers have a choice of three insurance carriers — Kaiser Permanente, Health Net and Blue Shield — and the association acts as an intermediary between the employees and the insurers. (Kaiser Health News is not affiliated with Kaiser Permanente.)
The Printing Industries Association Inc. of Southern California, a trade association for printers, administers the insurance for Stoughton’s business. That allows him to limit his human resources staff to half of a full-time employee, he said.
“We want to be able to concentrate on what we do. We don’t want to shop around” for health insurance, he said.
The greatest number of association health plan members in California are in agriculture. Two farm trade groups, UnitedAg and Western Growers, offer farmers health care that they say caters to their unique workforce, which includes a large number of Spanish-speaking immigrants.
Kirti Mutatkar, CEO of UnitedAg, which covers 700 agricultural businesses and 43,000 members through its association, says her company doesn’t offer “cookie-cutter” health coverage.
UnitedAg offers free telemedicine and 10 free clinic visits in some of its plans, she said. It has bilingual customer support services and a network of doctors in Mexico. The members of the board include UnitedAg health plan enrollees, who have a say in what their health coverage looks like.
“This model works unbelievably well for us,” said A.J. Cisney, general manager of Rancho Guadalupe, which grows fruit and broccoli on California’s Central Coast. “If UnitedAg could take their brand of administering health care to other areas, I can’t see the downside.”
But that would be anathema to actuaries and health insurers, who worry about competing with more lightly regulated plans. They say the proliferation of such plans could undermine consumer protections and increase the potential for the kind of health insurance fraud that plagued many of the old association plans.
But Scott, of the National Federation of Independent Business, does not believe past is necessarily prologue.