Now that it's upending the way you play music, cook, shop, hear the news and check the weather, the friendly voice emanating from your Amazon Alexa-enabled smart speaker is poised to wriggle its way into all things health care.
Amazon has big ambitions for its devices. It thinks Alexa, the virtual assistant inside them, could help doctors diagnose mental illness, autism, concussions and Parkinson's disease. It even hopes Alexa will detect when you're having a heart attack.
At present, Alexa can perform a handful of health care-related tasks: "She" can track blood glucose levels, describe symptoms, access post-surgical care instructions, monitor home prescription deliveries and make same-day appointments at the nearest urgent care center.
Amazon has partnered with numerous health care companies, including several in California, to let consumers and employees use Alexa for health care purposes. Workers at Cigna Corp. can manage their health improvement goals and earn wellness incentives with Alexa. And Alexa helps people who use Omron Healthcare's blood pressure monitor, HeartGuide, track their readings.
But a flood of new opportunities are emerging since Alexa won permission to use protected patient health records controlled under the U.S. privacy law known as the Health Insurance Portability and Accountability Act (HIPAA).
Before, Alexa had been limited to providing generic responses about medical conditions. Now that it can transmit private patient information, Amazon has extended its Alexa Skills Kit, the software development tools used to add functions. Soon, the virtual assistant will be able to send and receive individualized patient records, allowing health care companies to create services for consumers to use at home.
Amazon's efforts in this domain are important because, with its 100 million smart devices in use worldwide, it could radically change the way consumers get health information and even treatment — and not just tech-savvy consumers. Analysts expect 55% of U.S. households will have smart speakers by 2022.
Some of Alexa's new skills depend on a little-understood feature of the devices: They listen to every sound around them. They have to in order to be ready to respond to a request, like "Alexa, how many tablespoons in a half-pint?" or "Put carrots on the shopping list."
University of Washington researchers recently published a study in which they taught Alexa and two other devices — an iPhone 5s and a Samsung Galaxy S4 — to listen for so-called agonal breathing, the distinct gasping sounds that are an early warning sign in about half of all cardiac arrests. These devices correctly identified agonal breathing in 97% of instances, while registering a false positive only 0.2% of the time.
Earlier research had shown that a machine learning system could recognize cardiac arrest during 911 emergency calls more accurately and far faster than human dispatchers could.
Amazon, which declined to comment for this article, holds a patent on an acoustic technology that recognizes and could act on significant audio interruptions. Combined with patented technology from the University of Washington that differentiates coughs and sneezes from other background noises, for example, Alexa could discern when someone is ill and suggest solutions.
Because Amazon also holdspatents on monitoring blood flow and heart rate through an Alexa-enabled camera, Alexa could send vitals to a doctor's office before you head to your appointment and continue to monitor your condition after you get home.
"It opens possibilities to deliver care at a distance," said Dr. Sandhya Pruthi, lead investigator for several breast cancer prevention trials at the Mayo Clinic, which has been on the front lines of using voice assistants in health care. "Think about people living in small towns who aren't always getting access to care and knowing when to get health care," she said. "Could this be an opportunity, if someone had symptoms, to say, 'It's time for this to get checked out'?"
A growing number of clinics, hospitals, home health care providers and insurers have begun experimenting with products using Alexa:
Livongo, a Mountain View, Calif.-based startup focused on managing chronic diseases, sells an Alexa-connected blood glucose monitor that can help diabetes patients track their condition.
Home health care provider Libertana Home Health, based in Sherman Oaks, Calif., created an Alexa skill that lets elderly or frail residents connect with caregivers, set up reminders about medications, report their weight and blood pressure, and schedule appointments.
Cedars-Sinai Medical Center in Los Angeles put Amazon devices loaded with a plug-in called Aivainto more than 100 rooms to connect patients with staff and to provide hands-free television controls. Unlike a static call button, the voice-controlled device can tell nurses why a patient needs help and can then tell the patient the status of their request.
Boston Children's Hospital, which offered the first Alexa health care software with an educational tool called Kids MD, now uses Alexa to share post-surgical recovery data between a patient's home and the hospital.
Many medical technology companies are tantalized by the possibilities offered by Alexa and similar technologies for an aging population. A wearable device could transmit information about falls or an uneven gait. Alexa could potentially combat loneliness. It is learning how to make conversation.
"Alexa can couple a practical interaction around health care with an interaction that can engage the patient, even delight the patient," said elder care advocate Laurie Orlov.
It and other voice assistants might also help bring some relief to doctors and other medical practitioners who commonly complain that entering medical information into electronic health records is too time-consuming and detracts from effective interactions with patients.
This technology could work in the background to take notes on doctor-patient meetings, even suggesting possible treatments. Several startup companies are working on such applications.
One such company is Suki, based in Redwood City, Calif., which bills itself as "Alexa for doctors." Its artificial intelligence software listens in on interactions between doctors and patients to write up medical notes automatically.
Amazon devices will need to excel at conversational artificial intelligence, capable of relating an earlier phrase to a subsequent one, if it is to remain dominant in homes.
In a 2018 interviewon Amazon's corporate blog, Rohit Prasad, a company vice president who is head scientist for Amazon Alexa, described Alexa's anticipated evolution using "federated learning" that lets algorithms make themselves smarter by incorporating input from a wide variety of sources.
"With these advances, we will see Alexa become more contextually aware in how she recognizes, understands and responds to requests from users," Prasad said.
Even some Republicans who supported legislation in committee warned they may not back the sweeping package in a full Senate vote. They object in particular to a provision that would cap drug prices paid by Medicare based on the rate of inflation.
This article was published by Kaiser Health News on Thursday, July 25, 2019.
The fight between policymakers intent on lowering prescription drug prices and the drugmakers who keep raising them intensified Thursday, as a slew of Republican senators threatened to side with manufacturers against legislation supported by their own committee chairman and president.
But even some Republicans who supported it warned they may not back the sweeping package of proposals in a full Senate vote. They object in particular to a provision that would cap drug prices paid by Medicare based on the rate of inflation.
Other obstacles have piled up. Wyden announced that Democrats, who provided most of the bill's support in committee, would not allow a Senate vote without the Republicans agreeing to hold votes on cementing insurance protections for people with preexisting conditions. Democrats have complained for months that GOP efforts to kill the Affordable Care Act will leave people with these medical problems without any recourse to get affordable health care. Democrats also want to empower federal health officials to negotiate drug prices.
Here are the three major problems revealed in Thursday's hearing.
Many Senate Republicans disagree with President Donald Trump about how to lower drug prices.
Some of Trump's efforts to reduce Americans' drug costs took a beating Thursday. They were criticized — by members of his own party — for putting too much power in the hands of government.
Despite urging from White House and federal health officials to support the legislation, 13 of the committee's 15 Republicans voted to remove its controversial proposal to prevent drug prices from rising faster than inflation under Medicare. Their attempt failed, barely.
Medicaid already uses this strategy, requiring drugmakers to pay the government a rebate if the prices it pays outpace inflation, and Medicaid tends to pay lower prices on drugs than Medicare. The HHS inspector general has said Medicare could collect billions of dollars from the drug industry if it did the same. But many Republicans strongly oppose any government interference in private markets or price setting.
Sen. Patrick Toomey (R-Pa.), who introduced the amendment to remove the proposal, said it wasn't necessary because seniors would be protected from paying too much by another proposal in the bill to cap out-of-pocket expenses.
"It's my view that we should not use this sledgehammer of a universal price control, imported from Medicaid, to deal with that relatively narrow problem and to disrupt a program that's working very well," Toomey said, mentioning Medicare's popularity.
Grassley said the inflation caps would help relieve taxpayers from covering Medicare's skyrocketing drug costs.
And having played a key role in 2003 creating Medicare's prescription drug program, called Medicare Part D, he took issue with the idea that his latest bill would harm the program: "I wrote it, so you ought to know that I want to protect it," Grassley said.
Most of the Republicans also backed an amendment to block a proposal being considered by the Trump administration to tie drug prices here to those paid in other developed nations, which narrowly failed. While Grassley said he, too, opposes the administration's proposal, he did not want the issue to hold up his own bill and so voted against the amendment.
Grassley also said he is not comfortable with empowering federal health officials to negotiate drug prices, as Wyden said he would like to see considered. But Grassley noted that the issue isn't going away: Trump campaigned on the idea, which White House officials have been discussing with House Democratic leaders as part of a plan expected to be released in September.
But that may not be enough, Grassley suggested: "I don't think that you're going to get 60 votes in the United States Senate."
Critics in Congress are using some of the same misleading arguments as drugmakers.
Smelling trouble, pharmaceutical executives met with Trump at the White House on Wednesday evening to voice their opposition to the Grassley-Wyden bill.
In a statement after their meeting, PhRMA, the industry's lobbying group, called it "the wrong approach to lowering drug prices" and said it "imposes harmful price controls in Medicare Part D."
PhRMA claimed the bill would "siphon more than $150 billion from researching and developing new medicines." (Experts say most innovation now happens at academic institutions, not pharmaceutical companies.) It said the Medicare Payment Advisory Commission, a panel that advises Congress, had found "it will only benefit 2% of Medicare patients starting in 2022." (A Bloomberg Law reporter said a commission official told her it had not analyzed the bill.) The lobbying group asserted the bill would "result in money going to the federal treasury instead of seniors." (The money collected by the new rebates would go into the Supplemental Medical Insurance trust fund, which pays for health services for Medicare beneficiaries.)
The flaws in PhRMA's claims did not stop critics from echoing some of them. Sen. Robert Menendez (D-N.J.), whose state is home to several drugmakers, said the bill's savings should go to patients and not into "some fund" where patients would not see it. (He nonetheless voted to advance the bill.)
And Republicans decried the bill's "price controls" — even as Grassley and Wyden explained that the inflation caps would do nothing to the list prices set by drugmakers, only slow price increases once they were on the market.
In one exchange, Sen. John Cornyn (R-Texas) questioned Phillip Swagel, the director of the Congressional Budget Office, about who would pay more under the legislation's inflation caps. "If you cut the subsidy," he said, referring to what the government pays drugmakers, "doesn't somebody else's cost have to go up?"
"In this case, the out-of-pocket spending would go down. The premiums would go down. The federal spending would go down," Swagel replied. "The drug manufacturer, they would see lower price increases than they might have seen without this provision."
"So they would have to eat that cost?" Cornyn asked.
"We would see them, as you put it, eating some of that cost, and they might change their overall pricing as well," Swagel said.
Saying there was "sufficient uncertainty" about how the caps would work, Cornyn then asked to be added as a co-sponsor of the amendment opposing that change.
Democrats, who unanimously voted to advance the bill, may still kill it.
Wyden opened with an unusual declaration as he discussed the legislation he and Grassley had spent months crafting: If Republican leaders do not allow votes on amendments that would protect preexisting conditions and empower federal health officials to negotiate drug prices, Democrats will oppose moving forward on it.
In short, he threatened his own bill.
"We're certainly not going to sit quietly by while protections for preexisting conditions are wiped out," Wyden said. "We're not going to sit by while opportunities for seniors to use their bargaining power in Medicare are frittered away."
Democrats slammed Republicans during the 2018 midterm election for not doing enough to protect those with preexisting conditions, especially since Republican attorneys general have sued to void the entire Affordable Care Act. It looks like Democrats are warming up that argument for 2020.
During one tense exchange Thursday, Sen. Bob Casey (D-Pa.) fired back at Cornyn for claiming Republicans have a plan to protect patients should the ACA be thrown out.
"How the hell can you say that you support protections when you have all the power and a bill did not pass that would support the Affordable Care Act?" Casey said. "You've had eight years of bellyaching about it, and you haven't done a damn thing about it."
As the hearing went on, Democrats praised the bipartisan legislation at hand but listed other proposals they would like to see, including the revival of the Trump administration's now-defunct rebate rule. That would have forced the pharmacy benefit managers who negotiate drug prices for government health plans to refund some of those discounts to customers. (Grassley, for his part, asked Wyden to work with him on incorporating the proposal into their legislation.)
Still, Grassley referred to the opposition among his own Republican colleagues as his "most vexing problem." At one point, when Sen. John Thune (R-S.D.) gently suggested that stripping out the inflation caps would leave them with "a big, bipartisan margin on this bill coming out of here," Grassley didn't miss a beat.
"It could get us a unanimous vote in this committee, but it would also leave the taxpayers with $50 billion more cost," he said before calling on the next senator.
A Tennessee couple has dedicated the last years of their working lives to helping people with Type 2 diabetes control and even reverse the condition with diet and exercise.
In a former church parsonage in Grundy County, Tenn., Karen Wickham ladled out her lentil stew as people arrived for an evening health education class.
Wickham and her husband, Steve, are white-haired, semi-retired nurses who have dedicated the last years of their working lives to helping people with Type 2 diabetes control and even reverse the condition with diet and exercise.
Wendy Norris is in the group, and she has brought along her father and daughter. Since her diagnosis several years ago, Norris said, her doctor prescribed insulin shots and told her to watch what she ate.
She recalled thinking at the time, "Well, what does that mean?"
The Wickhams have set out to answer that question in Tennessee's Grundy County, which ranks loweston the scale of residents' health. Grundy's population of 13,000 has the shortest life expectancy in the state and an elevated rate of diabetes (16% of adults), which can eventually result in blindness, kidney failure or amputations.
Norris said trying to overhaul her diet by herself was confusing and difficult. And when things didn't change, the doctor just kept increasing her dosage of insulin.
But then Norris lost her health insurance. The injectable insulin cost her hundreds of dollars a month — money she simply didn't have.
"I felt like I was stuck having to take three or four shots a day [for] the rest of my life," she said. She enrolled in one of the six-week seminars the Wickhams offer and is seeing results in how many shots she needs: "I've got it down to one already."
With slide presentations, the Wickhams explain the difference between sucrose and glucose, and the science behind the fact that certain foods, like potatoes, spike blood sugar, while sweet potatoes don't. They preach eating as much fiber as a stomach can stand, and dropping almost every kind of sweetened beverage.
And they demonstrate ways to burn all those calories. Steve even invented the "Beersheba Boogie" — after the Grundy town of Beersheba Springs — asking participants to raise their knees and pump their fists while marching in place.
Support for Hard changes
All the workshop participants have to find a way to get active at home or in a rugged state park nearby because there's no gym anywhere in the county. There's not a proper grocery store anywhere nearby either, so healthy cooking can become a real chore.
These communitywide obstacles reveal why it can be a struggle for people to maintain their health in rural America. But the Wickhams are working to overcome those barriers.
During one education session, as participants shared their latest health stats, Steve called out: "Her blood sugar is going down! Give her a hand."
If it sounds like a revival meeting, it kind of is. Steve and Karen Wickham say they are compelled in this work by their Christian faith as Seventh-day Adventists — a denomination known for a focus on health. They first moved to Grundy County to take care of ailing parents, and once settled in their scenic mountain retreat, they grew disturbed by the suffering they saw in their neighbors.
"I think God holds us responsible for living in the middle of this people and doing nothing," Steve Wickham said.
Many people think of Type 2 diabetes as practically incurable, though it has long been known that the condition can be reversed with weight loss and exercise. But research shows people need lots of help to change their lifestyle, and they rarely get it.
"I had taken care of diabetic patients for so long, and I knew the progression," Karen said. "If you truly want the people to get better, you have to treat it with lifestyle interventions."
Those changes can be hard to start and even harder to maintain.
"Nobody, actually, will make all of the lifestyle changes that we recommend," Steve said. "But if you're making the kind of choices that lead you to a healthier lifestyle, then you get better."
A more hopeful message
Along with their lifestyle counseling, the Wickhams always give a disclaimer, advising people to consult with their doctors. They also acknowledge that their seminars are not yet "evidence-based" or backed by peer-reviewed scientific literature.
But there are studies showing that people with blood sugar levels in the "prediabetes" range can get back to normal blood sugar by losing 5% of their body weight.
And weight loss and exercise havealready been shown to lower hemoglobin A1c levels, a test physicians use to monitor a patient's blood sugar over two to three months.
In addition,new research fromDr. Roy Taylor of Newcastle University in England shows promise for true remission.
"Doctors tell their patients, 'You've got a lifelong condition. We know it's going to steadily get worse.' Then they turn around and their patients aren't losing weight or doing exercise, but they've given them this utterly depressing message," he said.
Taylor's research finds that by losing 30 pounds or so, Type 2 diabetes can be reversed in the early stages.
Ultimately, Taylor hopes, better nutrition will become the preferred response to high blood sugar in the next decade.
"I think the main headwinds [against progress] are just conceptual ones — of scientists and doctors believing this is an irreversible condition because of what we've seen," he said.
Even the American Diabetes Association has beenchanging its views. The advocacy group has a new position on reversal:
"If a patient wishes to aim for remission of Type 2 diabetes, particularly within six years of diagnosis, evidence-based weight management programs are often successful."
Dr. John Buse, chief of endocrinology at the University of North Carolina medical school, helped write the new position on reversal.
"We've known, literally since the 17th century, that diet is the key to managing diabetes," he said.
But it's hard to write a prescription for a lifestyle change.
"Doctors don't have the time to do it well, so we have often used the sort of short shrift," he said. "'Eat less carbohydrates and walk every day' … that has basically no impact."
The Wickhams are doing their part to add to the scientific data, tracking the blood sugar of the participants in their program. And the anecdotal, short-term evidence they've gathered is resonating far beyond Grundy County. They've been traveling more and more lately.
The couple just sold their retirement home so they can say "yes" to all the invitations they've received, mostly from Seventh-day Adventist groups, to present their program to other communities around the country.
As Wei Wei Lee sat with her doctor to discuss starting a family, she felt a "distance" between them. The physician was busy on the computer and focused on the screen.
"It just didn't feel very personal," Lee said. "I didn't feel heard."
It seemed as though keeping a record of the conversation was more important to the doctor than making a connection with Lee.
It wasn't the experience she wanted, but she could relate: Lee is Dr. Wei Wei Lee, a primary care physician with the University of Chicago Medicine.
When she first started using electronic health records (EHRs) in the exam room, Lee struggled too. She would apologize to patients for not giving them her full attention. And Lee spent valuable patient time trying to toggle between tasks on the computer, she said.
Today, Lee studies the influence of electronic health records on the doctor-patient relationship. She's interested in improving physicians' "computer-side manner."
Electronic health records can help reduce medical errors, but when not used well they can strain the doctor-patient relationship.
But medical providers — and patients — can learn skills to keep communication flowing even when there's a screen in the room, Lee said.
KHN spoke with Lee about her survey of patients at the University of Chicago Medicine. Lee found that the vast majority of them were satisfied with doctors using computers in the exam room. But some people felt the focus of their appointments had shifted away from them. And the medical provider's body language sometimes made communication more difficult:
In the past, the patient could be the center of attention through that visit. Now, the physician is really dividing their attention between putting in orders and working in the computer without paying full attention to the patient. So, eye contact, having a back to the patient, awkward silences while the doctor is looking up something in the computer — all these can cause challenging communication issues for patients.
Those "awkward silences" can have consequences, Lee said.
Most patients want to go to the doctor to feel that they're heard and really be able to talk to the doctor about what's bothering them. When the computer is not used well, often it can make that patient less likely to go back to that physician if they felt like there was a disconnect in the way that they communicated. Other things that can happen are medical errors. If the doctor is more distracted during that visit, they may put in wrong orders for medications or not record a part of the history that is pertinent.
Lee and colleagues developed strategies to help physicians better relate to their patients while also working with a computer. There's now a curriculum to teach clinicians how to use EHRs in a "patient-centered" way.
A lot of it has to do with behaviors and skills that are not rocket science. For example, starting off the visit completely technology-free. Greeting your patient. Honoring that golden minute. Establishing rapport and conversation in that first minute can really go a long way. And then another thing that's been found to be very helpful is screen-sharing.
So what does effective screen-sharing look like? Instead of placing the computer between the patient and doctor, the physician can move his or her chair next to the patient so they are sitting side by side, Lee suggested. Then, the computer is positioned in front of both of them — to form a triangle.And if a computer is still getting in the way of conversation, Lee says patients shouldn't hesitate to speak up. Her team developed a comic using a simple ABC mnemonic to teach people those skills. Ask To See The Screen. Become Involved. Call For Attention.
I think speaking up and calling for that attention is a way to continue to build that relationship with their doctor because it may be a behavior that the physicians aren't aware of. There may be times when they're talking about a sensitive topic or issues that have come up that they want the physician's undivided attention. In those moments, I think it's OK to say, "Is it OK if we just talk without the computer for a few minutes?"
I think that goes a long way to also just signaling to the physician that there is something that the patient really finds important.
ST. LOUIS — In many ways, Essence Group Holdings Corp. is a homegrown health care success story.
Founded locally, it has grown into a broader company backed by a major Silicon Valley investor. Essence now boasts Medicare Advantage plans for seniors with some 60,000 members in Missouri and across the Mississippi River in Illinois. It ranks among the city's top 35 privately held companies, according to the St. Louis Business Journal. And market research firm PitchBook Data values the company at over $1.64 billion.
But a recent audit by the federal Health and Human Services inspector general, along with a whistleblower lawsuit, have put the St. Louis health care standout under scrutiny. Medicare officials also are conducting a separate audit of Essence.
The same growth and use of big data that attracted venture capital cash are getting a renewed look from government officials who estimate that Medicare Advantage plans nationwide overcharge taxpayers nearly $10 billion annually.
The April audit of Essence — the first in a series of upcoming audits scrutinizing some Medicare Advantage plans across the United States — revealed that the St. Louis company could not substantiate fees for dozens of patients diagnosed with stroke or depression.
The government pays privately run insurance plans like Essence using a formula called a "risk score" that is designed to pay higher rates for sicker clients and less for patients who are in good health.
"There's great temptation to push the envelope on risk scores without the supporting documentation in the medical files, especially for depressive disorders," said former Sen. Claire McCaskill, a Missouri Democrat who now works as a political analyst. While in office, McCaskill in 2015 called for an investigation into overbilling practices by insurers running Medicare Advantage plans.
In the Essence audit of 218 cases, HHS found dozens of instances in which the health plan reported patients had an acute stroke — meaning the patients had strokes that year — when they actually had suffered strokes only in past years. HHS also discovered that Essence had charged Medicare for major depressive disorder diagnoses for several enrollees, but that the doctors had not recommended a treatment plan, indicating the patients likely had a less severe form of depression. In five cases, HHS couldn't find any medical records to support payments for a diagnosis of acute stroke or major depressive disorder diagnoses.
Essence denied wrongdoing but agreed to refund $158,904 that Medicare paid for those patients who were reviewed in the audit and committed to correcting any other errors.
Medicare Advantage: The Next Silicon Valley Frontier
Essence is part of the Medicare Advantage boom — such plans now treat more than 22.6 million U.S. seniors, about 1 in 3 people on Medicare. And with that growth, the money has followed — top investors, including Google, have poured more than $1 billion dollars into health care companies that have Medicare Advantage aspirations.
Essence's medical technology arm, Lumeris, which helps power its Medicare Advantage plans, is key to those ambitions. And last year Lumeris received a commitment of $266 million over the next 10 years from Cerner, a leading electronic medical records firm. Cerner declined to comment for this story on its investment.
Essence, and companies like it, are venture capital darlings because they draw deeply on data mining by entities such as Lumeris to hone health care delivery and cut costs.
But Essence now finds itself in the middle of a national reckoning with the government, which is attempting to reduce overbilling by the Medicare Advantage industry that it says costs taxpayers up to $10 billion a year. Previous efforts to claw back such overpayments have been delayed by an onslaught of lobbying efforts by private insurers.
More Overcharging Alleged In Lawsuit
The Missouri whistleblower suitalleges Essence, Lumeris and its local partner, Lester E. Cox Medical Centers, used data-mining software to identify patients for an "enhanced encounter" that jacked up the patients' risk scores to boost Medicare payments. The suit was unsealed in January after being filed in 2017 by Branson, Mo., family doctor Charles Rasmussen.
In his lawsuit, Rasmussen said he worked for Cox from 2013 through August 2017 and treated more than 2,000 patients there. He and his lawyers declined to comment on the case.
After a training session on "enhanced" coding practices, one doctor wrote to Cox officials in an email that was quoted in the suit. The doctor said the Essence team had used the case of an 86-year-old patient that the doctor described as "pretty healthy for looking sick on paper" as an example of a potential coding "opportunity." The doctor wrote that the man's care likely cost less than $2,000 a year, but Essence's "enhanced" coding techniques could "capture around $11,000 from Medicare."
The lawsuit alleges: "Because of this fraud, hundreds of millions of taxpayers' dollars have been siphoned from the United States."
The case is pending in federal court in Springfield, Mo. On July 15, a judge denied Essence and Cox's joint motion to dismiss the case.
Essence and Lumeris denied the whistleblower's allegations in a statement to Kaiser Health News. Lumeris spokesman Marcus Gordon said the allegations were "wholly without merit." In the emailed statement, he said the companies would "continue to vigorously defend against these baseless claims," adding that its programs "result in higher quality care and better health outcomes for our members."
In a written statement, Cox Media Relations Manager Kaitlyn McConnell said the company had reviewed the allegations. "We adamantly deny them, and believe we are fully compliant with the law."
McConnell added: "As always, patients are our top priority, and we will continue to focus on providing quality and compassionate health care to the communities we serve."
St. Louis Roots, Ambition For Beyond
Essence grew in 2007 after St. Louis physician and software designer Dr. Thomas Doerr and his venture capitalist brother, John Doerr, an early backer of Amazon and Google, invested in the company.
Good national press followed, much of it noting the company's commitment to developing innovative medical software to improve patient care and cut costs. Neither of the Doerr brothers would comment for this article.
In December 2015, Medicare awarded Essence a5-star rating, a coveted indicator of high-quality medical care.
That helped make the plans popular for customers in Missouri, said Stacey Childs, the regional liaison for CLAIM, the state's health insurance assistance program. She credited its A+ ranking with the Better Business Bureau and high star rankings year after year for helping create a swell of excitement when Essence expanded to the Springfield area of Missouri in 2015.
And its Lumeris-powered technology is growing nationally, including partnerships with Stanford Health Carein California and medical groups in Florida and Louisiana. It also has been deployed to other regions, bolstered by Cerner's investment for a joint program managing Medicare Advantage plans called the "Maestro Advantage," according to the partnership's website.
Coding Questions
But Rasmussen, the Missouri whistleblower, alleges that Lumeris software played a role in overcharging Medicare.
The lawsuit alleges physicians were encouraged to examine high-risk patients the medical software identified for "Enhanced Encounter" appointments — even sending recommendations for some patients who were in hospice — to re-evaluate their risk scores.
Physicians were paid $100 to examine patients for each of those encounters, according to the suit. On its website,Lumeris has saidthose appointments create "new cash flows to enhance physician incentives and increase the level of physician engagement."
In a statement to KHN, Taylor Griffin, a spokesman for Essence, said: "We compensate physicians for the substantial extra time and effort to meet with our members and gather information essential to delivering better care. It is a program designed around capturing the health status of the member and not on capturing codes."
At least one Essence-affiliated doctor has questioned the ethics of the initiative, according to court documents. "All I have heard about since we signed on with Essence is about coding to get paid more," the unidentified doctor alleged in an email to Cox officials. "This is doing little to enhance these patients' care."
For the North Carolina Cherokee, self-governance has meant adopting an integrated care model that not only improves patients' health, but also is tailor-made for the needs of the tribe.
This article was first published on Monday, July 22, 2019 in Kaiser Health News.
CHEROKEE, N.C. — Light pours through large windows and glass ceilings of the Cherokee Indian Hospital onto a fireplace, a waterfall and murals. Rattlesnake Mountain, which the Cherokee elders say holds ancient healing powers, is visible from most angles. The hospital's motto — "Ni hi tsa tse li" or "It belongs to you" — is written in Cherokee syllabary on the wall at the main entrance.
"It doesn't look like a hospital, and it doesn't feel like a hospital," Kristy Nations said on a recent visit to pick up medications at the pharmacy. "It actually feels good to be here."
Profits from the tribe's casino have helped the 12,000 members of the Eastern Band of Cherokee Indians opt out of the troubled U.S. government-run Indian Health Service. They are part of an expanding experiment in decentralization, in which about 20% of federally recognized tribes in Oklahoma, California, Arizona and elsewhere have been granted permission to take full control of their health care.
For the North Carolina Cherokee, self-governance has meant adopting an integrated care model designed by Alaska Natives to deliver care that not only improves patients' health, but also is tailor-made for the needs of the tribe. It has meant the opening of a 20-bed state-of-the-art facility in 2015 and the construction of an 18-bed mental health clinic scheduled to open in October 2020.
The hospital is a "medical home for our people," said Casey Cooper, the hospital's CEO who is a member of the tribe.
Half of the Indian Health Service budget is now managed by Indian tribes to various degrees. But while full control has worked out well for tribes with resources like the Eastern Cherokee, they are one of just a few bright spots in an otherwise dire medical landscape. It remains to be seen how widely this model can be applied.
"Not all tribal communities have access to the economic opportunities that we have," Cooper said. "Some tribes are in these desolate, remote locations where there are no natural resources or economic development opportunities. I get that."
Self-Governing To Change The Narrative
The U.S is legally obligated to offer health services to all members of the 573 federally recognized tribes. Yet the federal Indian Health Service, which currently provides direct care to about 2.2 million out of the nation's estimated 3.7 million American Indians and Alaska Natives, is chronically underfunded. The current IHS budget is about $5.4 billion, yet the National Indian Health Board estimates the total level of need to be nearly $37 billion.
American Indians are more than twice as likely to get diabetes and six times as likely to get tuberculosis than the average U.S. population. Mental illness, and especially substance abuse, runs high in Indian Country. Native Americans are more likely to commit suicide than any other ethnic or racial group.
Health disparities are particularly harsh in the Northern Plains region. In the Dakotas, average life expectancy among American Indians is 20 years less than among white Americans.
"You do not have to cross an ocean to find Third World health conditions," said Dr. Donald Warne, a professor of public health at the University of North Dakota and an Oglala Lakota tribesman. "You can find them right here, in the heartland of the United States."
One particularly grim example is the Rosebud Indian Reservation in South Dakota. In 2015, the Centers for Medicare & Medicaid Services found safety violations at the local IHS hospital so severe that they shut down the emergency room for six months. During this time, at least five patients died en route to other hospitals located sometimes 100 or more miles away. Since then, the situation has only slightly improved.
"The Indian Health Service respects tribal sovereignty and is committed to tribal self-governance," said IHS spokesman Joshua Barnett. "IHS recognizes that tribal leaders and members are in the best position to understand the health care needs and priorities of their communities."
Self-governance also allows tribes to be eligible for Medicare, Medicaid, private-sector health insurance, partnerships with larger health systems and even federal grants that are designed for underserved communities — all which can be limited for the IHS.
"Generally speaking, tribally operated health care systems tend to run more efficiently, more effectively and with higher quality of care than IHS-managed systems," said Warne.
Money Makes A Difference
The Cherokee Indian Hospital is lucky to be supported by a tribe that's economically thriving due to gambling revenues, according to Cooper. The Qualla Boundary is home to Harrah's Cherokee Casino Resort. It's a unique situation, said Indian health expert Warne, as most reservation casinos don't make huge profits.
The hospital's annual budget has grown from $20 million to over $80 million within the past 17 years. The largest sources are third-party reimbursements, mostly from Medicaid and Medicare, at $27.4 million, followed by IHS contributions and tribal funding.
In 2012, the hospital decided to implement a new, patient-centered approach called the Nuka System of Care, created by the Southcentral Foundation, a nonprofit health provider owned and led by Alaska Natives. A Cherokee delegation visited a Nuka program to see how it could be tailored to their culture and health needs.
"An integrated approach is more consistent with traditional healing," Warne said. Since "we don't separate our physical, mental, spiritual and emotional health the way we do in modern specialized health care."
At Cherokee Indian Hospital, patients are assigned a team, which typically includes a primary care physician or a family nurse practitioner as well as a nutritionist, a pharmacist and a behavioral health specialist.
Rebuilding their health care prompted the need for the new hospital. Gambling revenue covered most of the costs for the $82 million facility. "The old building was outdated and inefficient," said Cooper, "a constant reminder of the paternalistically provided Indian Health Service."
The new hospital's main concourse — called Riverwalk — tells stories from Cherokee legend through graphics of a winding river, fish and turtles inlaid in the terrazzo floor. Signs are written in English and Cherokee. A literal translation of the emergency room sign is "Get better in a hurry," and the dental suite is "the place that gives you a big smile."
Patients can receive dialysis, acupuncture, massage therapy and chiropractic care. The ambulance bay, surgical suite and in-patient unit are located out of patients' view to reduce anxiety and stress.
"The building really is one big strategic tool," Cooper said.
Nations, the patient visiting recently, remembers the old days when she and her family, many of them dealing with diabetes and some on dialysis, used to wait for hours in the former hospital, a dark space dubbed "the bunker."
The 46-year-old said that she'd typically see different providers every visit. "And every time I would have to tell my story over and over and over." Now, she feels somewhat accountable to her care team — and more motivated to make and keep appointments.
"Back then, if my provider had wanted me to see a nutritionist, for example, I would have probably said, 'Whatever,' and forgotten about it," she said.
"We're trying to build a relationship with our patients," said Richard Bunio, the Cherokee Indian Hospital's clinical director who is Canadian and married to a tribe member. He noted that Native Americans generally have suffered a lot of historical trauma, leading to deeply rooted mistrust of mainstream medicine.
By quality measures, including the widely used Healthcare Effectiveness Data and Information Set, the hospital has recently performed in the top quartile for blood pressure control, blood sugar control and several cancer screenings. Also, Cooper added that in the past four years the diabetes rate in the community has leveled.
Could It Work Everywhere?
It is uncertain if self-governance would work for tribes such as the Rosebud Sioux or the Oglala Lakota on the Pine Ridge Indian Reservation, where geographic isolation, poverty and a lack of resources make new health care investments difficult.
"It's a huge challenge, but it's possible," said Warne, adding that philanthropy or partnerships with an academic health system might help finance such projects.
Not too long ago, tribal officials from South Dakota visited the Cherokee Indian Hospital. Despite their geographic and socioeconomic challenges, Cooper said, he believes self-determination is essential for their future. "Self-determination works. Self-determination is the right thing. And self-determination is the catalyst to restoring the health of our communities."
Yet many of the South Dakota tribal leaders remain skeptical. They are concerned that self-determination would let the federal government off the hook from its responsibility to provide health services.
Therefore, the Rosebud Sioux took a different route. Instead of just parting ways with the IHS, they sued the federal government for violating treaties. The case is pending in court.
The headlines about presidential candidate Joe Biden's new health care plan called it "a nod to the past" and "Affordable Care Act 2.0." That mostly refers to the fact that the former vice president has specifically repudiated many of his Democratic rivals' calls for a "Medicare for All" system and instead sought to build his plan on the ACA's framework.
Sen. Bernie Sanders, one of Biden's opponents in the primary race and the key proponent of the Medicare for All option, has criticized Biden's proposal, complaining that it is just "tinkering around the edges" of a broken health care system.
Still, the proposal put forward by Biden last week is much more ambitious than Obamacare — and, despite its incremental label, would make some very controversial changes. "I would call it radically incremental," said Chris Jennings, a political health strategist who worked for Presidents Bill Clinton and Barack Obama and who has consulted with several of the current Democratic candidates.
Republicans who object to other candidates' Medicare for All plans find Biden's alternative just as displeasing.
"No matter how much Biden wants to draw distinctions between his proposals and single payer, his plan looks suspiciously like "SandersCare Lite," wroteformer congressional aide and conservative commentator Chris Jacobs.
Biden's plan is built on expanding the ACA to reduce costs for patients and consumers, similar to what Hillary Clinton campaigned on in 2016. It would do things Democrats have called for repeatedly since the ACA was passed. Among them is a provision to that would "uncap" federal help to pay for health insurance premiums — assistance that is now available only to those with incomes below 400% of the poverty level, or about $50,000 for an individual. Under Biden's plan, no one would be required to pay more than 8.5% of their income toward health insurance premiums. The plan also proposes to make coverage more affordable to use by effectively lowering deductibles and copayments.
But it includes several proposals that Congress has failed repeatedly to enact, including some that were part of the original debate over the ACA. It also has some initiatives that are so expansive, it is hard to imagine them passing Congress — even if Democrats sweep the presidency and both chambers of Congress in 2020.
Here are some of the more controversial pieces of the Biden health plan:
Public Option
Although many of the Democratic presidential candidates have expressed varying degrees of support for a Medicare for All plan, nearly all have also endorsed creating a government-sponsored health plan, known colloquially as a "public option," that would be available to people why buy their own health insurance. In other words, it would apply to those who don't get insurance through their job or qualify for other government programs, like Medicare or Medicaid.
A public option was included in the version of the ACA that passed the House in 2009. But it could not muster the 60 votes needed to pass the Senate over GOP objections — even though the Democrats had 60 votes at the time.
Biden's public option, however, would be available to many more people than the 20 million or so in the current individual insurance market. According to the document put out by the campaign, it would be available to those who don't like or can't afford their employer insurance, and to small businesses.
Most controversial, though, is that the 2.5 million people ineligible for either Medicaid or private insurance subsidies because their states have chosen not to expand Medicaid would be automatically enrolled in the new public option, at no cost to them or the states where they live. Also included automatically in the public option would be another 2 million people with low incomes who currently are eligible for ACA coverage subsidies but would also be eligible for expanded Medicaid.
That part of Biden's proposal has prompted charges that the 14 states that have so far chosen not to expand Medicaid would save money compared with those that have expanded, because expansion states have to pay 10% of the cost of that new population.
Jennings, the Democratic health strategist, argued that's unavoidable because it's the population that needs coverage most. "If you're not going to have everyone get a plan right away, you need to make sure those who are most vulnerable do," he said.
Abortion
The Biden plan calls for eliminating the "Hyde Amendment," an annual rider to the spending bill for the Department of Health and Human Services that forbids the use of federal funds to pay for abortions. Biden recently ran into some difficulty when his position on Hyde was unclear.
But the plan also calls for federal abortion funding. "[T]he public option will cover contraception and a woman's constitutional right to choose," said the document.
In 2010, the Affordable Care Act very nearly failed to become law after an intraparty fight between Democrats who supported and opposed abortion funding. Abortion opponents wanted firm guarantees in permanent law that no federal funds would ever be used for abortion; abortion-rights supporters called that a deal breaker. Eventually,a shaky compromise was reached.
And while it is true that there are now far fewer Democrats who oppose abortion in Congress than there were in 2010, the idea of even a Democratic-controlled Congress voting for federal abortion funding seems far-fetched. The current Democratic-led House has declined even to include a repeal of the Hyde Amendment in this year's HHS spending bill, because it could not get through the GOP-controlled Senate or get signed by President Donald Trump.
Undocumented Immigrants
When Obama said in a speech to Congress in September 2009 that people not in the U.S. legally would be ineligible for federal help purchasing insurance, it prompted the infamous "You lie!" shout from Rep. Joe Wilson (R-S.C.).
Today, all the Democratic candidates say they would provide coverage to undocumented residents. There is no mention of them specifically in the plan posted on Biden's website, although a campaign official told Politico that undocumented people would be able to purchase plans on the health insurance exchanges but would not qualify for subsidies.
Still, in his speech unveiling the plan at an AARP-sponsored candidate forum in Iowa, Biden did not address this issue of immigrants' health care. He said only that his plan would expand funding for community health centers, which serve patients regardless of ability to pay or immigration status, and that people here without legal authority would be able to obtain coverage in emergencies, which is already law.
When Michael Howard arrived for a checkup with his lung specialist, he was worried about how his body would cope with the heat and humidity of a Boston summer.
"I lived in Florida for 14 years, and I moved back because the humidity was just too much," Howard told pulmonologist Dr. Mary Rice as he settled into an exam room chair at a Beth Israel Deaconess HealthCare clinic.
Howard, 57, has chronic obstructive pulmonary disease (COPD), a progressive lung disease that can be exacerbated by heat and humidity. Even inside a comfortable, climate-controlled room, his oxygen levels worried Rice.
Howard reluctantly agreed to try using portable oxygen, resigned to wearing the clear plastic tubes looped over his ears and inserted into his nostrils. He assured Rice he has an air conditioner and will stay inside on extremely hot days. The doctor and patient agreed that Howard should take his walks in the evenings to be sure he gets enough exercise without overheating.
Then Howard turned to Rice with a question she didn't encounter in medical school: "Can I ask you: Last summer, why was it so hot?"
Rice, who studies air pollution, was ready.
"The overall trend of the hotter summers that we're seeing [is] due to climate change," Rice said.
In June, the American Medical Association, American Academy of Pediatrics and American Heart Association were among a long list of medical and public health groups that issued a call to action asking the U.S. government, business and leaders to recognize climate change as a health emergency.
The World Health Organization calls climate change "the greatest health challenge of the 21st century," and a dozen U.S.medical societies urge action to limit global warming.
Some medical societies provide patients with information that explains the related health risks. But none have guidelines on how providers should talk to patients about climate change.
There is no concrete list of "do's" — as in wear a seat belt, use sunscreen and get exercise — or "don'ts" — as in don't smoke, don't drink too much and don't text while driving ― that doctors can talk about with patients.
Climate change is different, said Rice, because an individual patient can't prevent it. So Rice focuses on steps her patients can take to cope with the consequences of heat waves, such as more potent pollen and a longer allergy season.
That was Mary Heafy's main complaint. The 64-year-old has asthma that is worse during the allergy season. During her appointment with Rice, Heafy wanted to know why her eyes and nose were running and her chest feels tight for longer periods every year.
"It feels like once [the allergy season] starts in the springtime, it doesn't end until there's a killing frost," Heafy told Rice.
"Yes," Rice nodded, "because of global warming, the plants are flowering earlier in the spring. After hot summers, the trees are releasing more pollen the following season."
So Heafy may need stronger medicines and more air filters, her doctor said, and may spend more days wearing a mask — although the effort of breathing through a mask is hard on her lungs as well.
As she and the doctor finalized a prescription plan, Heafy observed that "physicians talk about things like smoking, but I don't know that every physician talks about the environmental impact."
Why do so few doctors talk about the impact of the environment on health? Besides a lack of guidelines, doctors say, they don't have time during a 15- to 20-minute visit to broach something as complicated as climate change.
And the topic can be controversial: While a recent Pew Research Center poll found that 59% of Americans think climate change affects their local community "a great deal or some," only 31% say it affects them personally, and views vary widely by political party.
We contacted energy-industry trade groups to ask what role — if any — medical providers should have in the climate change conversation, but neither the American Petroleum Institute nor the American Fuel & Petrochemical Manufacturers returned calls or email requests for comment.
Some doctors say they worry about challenging a patient's beliefs on the sometimes fraught topic, according to Dr. Nitin Damle, a past president of the American College of Physicians.
"It's a difficult conversation to have," said Damle, who practices internal medicine in Wakefield, R.I.
Damle said he "takes the temperature" of patients, with some general questions about the environment or the weather, before deciding if he'll suggest that climate change is affecting their health.
Dr. Gaurab Basu, a primary care physician at Cambridge Health Alliance, said he's ready if patients want to talk about climate change, but he doesn't bring it up. He first must make sure patients feel safe in the exam room, he said, and raising a controversial political issue might erode that feeling.
"I have to be honest about the science and the threat that is there, and it is quite alarming," Basu said.
One environmental group isn't waiting for doctors and nurses to figure out how to talk to patients about climate change.
Molly Rauch, the public health policy director with Moms Clean Air Force, a project of the Environmental Defense Fund, urges the group's more than 1 million members to ask doctors and nurses for guidance. For example: When should parents keep children indoors because the outdoor air is too dirty?
"This isn't too scary for us to hear about," Rauch said. "We are hungry for information about this. We want to know."
Mark Rubinstein, MD, a pediatrician and formerly a leading researcher with UC San Francisco's Center for Tobacco Control Research and Education, took up the post of executive medical officer at Juul last week.
Juul Labs, the nation's leading manufacturer of e-cigarettes, has hired as its medical director a prominent University of California researcher known for his work on the dangers nicotine poses for the adolescent brain.
The company said the hire will support its efforts to stem a teen vaping craze the Food and Drug Administration has labeled an epidemic. But critics see a cynical tactic taken straight from the Big Tobacco playbook.
Dr. Mark Rubinstein, a pediatrician and formerly a leading researcher with UC San Francisco's Center for Tobacco Control Research and Education, took up the post of executive medical officer at Juul last week, a move first reported by Politico. Rubinstein has done signature research on teen addiction and how nicotine, which is present in high levels in e-cigarettes, affects adolescents. He has spoken openly of the potential risks of vaping for children.
In a statement, Juul said Rubinstein would oversee research on underage use of vapor products, guide the company's youth prevention programs and policy positions, and help form links with the public health community. The company declined to make Rubinstein available for an interview. It says the move is part of its effort to reduce teen vaping while it continues to provide an alternative to smoking for adults.
Colleagues of Rubinstein, however, said they were disturbed by the move and skeptical of Juul's motivations. At the heart of their concerns is whether Juul is willing to lose the giant base of teen users who have helped fuel the company's meteoric rise and hefty market share.
Stanford University professor Bonnie Halpern-Felsher, who researches teen vaping and writes curriculum on teen prevention, helped train Rubinstein at UCSF. She said she was both incensed and disappointed when she heard about his move.
"Even if you believe in harm reduction," she said, "to go work for a tobacco company … to me goes against everything that anybody doing control should believe in." She said she is particularly concerned that a specialist on the effects of nicotine in adolescents has gone to work for the industry. Last year, Altria, one of the world's largest cigarette makers, bought 35% of Juul for $12.8 billion.
Stanton Glantz, director of the Center for Tobacco Control Research and Education, concurred, saying he was "shocked and depressed" by Rubinstein's decision to leave UCSF for Juul. He sees Juul's early social media campaigns as evidence the company has intentionally marketed to teens. Research supports this claim, though the company denies it and has shut down its Facebook and Instagram presence.
Not everyone shares their skepticism. Dr. Neal Benowitz, a UCSF professor who has studied addiction and smoking cessation for decades, frequently published with Rubinstein. He said he is hopeful that e-cigarettes can help people quit smoking and wants them to remain on the market while more research is done. He was shocked by the job change but said that if anyone can help figure out strategies to reduce youth vaping, it's Rubinstein.
Rubinstein's hire comes as Juul works to gather evidence to submit to the FDA that its devices offer more public benefit than risk. If it fails to convince the agency, Juul could be prohibited from selling most of its products.
Under the Trump administration, the FDA, which has oversight of all tobacco products, originally gave e-cigarette manufacturers until 2022 to file applications for approval for their devices, but a federal judge recently advanced the deadline to 2020. Juul has been wooing prominent researchers in the lead-up to the deadline, but with limited success amid concerns about the company's goals.
"Part of Juul's strategy is to create credibility and buy influence by hiring everybody who would take their money. We shouldn't be fooled: Juul created the youth e-cigarette epidemic and refuses to take responsibility for it," said Vince Willmore, spokesman for the Campaign for Tobacco-Free Kids
Some believe it will be a tall order for the companies to show that e-cigarettes are a net benefit, given what is known about the risks of teen vaping and how few studies there have been on their long-term efficacy to help people quit smoking. Others see the FDA's relatively lenient approach to the industry so far as a sign it may take a more favorable view of the products.
The FDA last year labeled teen vaping an "epidemic," noting federal survey data showed nearly 1 in 5 high school students had tried vaping in 2018. While not as harmful as older tobacco products, e-cigarettes contain high doses of nicotine and a variety of carcinogenic chemicals, according to Rubinstein's research. When it comes to vaping, Juul is by far the biggest seller in the U.S., capturing an estimated 70% of the e-cigarette market.
Anti-tobacco activists contend Juul increasingly is drawing on the tactics of tobacco companies to push back against regulation of its products. They point to a recent Juul campaign to overturn restrictions on e-cigarettes and flavored tobacco in San Francisco, where the company is based.
Last month, a Juul-backed ballot proposal gathered enough signatures to make the city's November ballot. The bill's supporters claim it would strengthen regulations around adolescent access to tobacco products, while ensuring the devices are available to those who want to quit smoking. Opponents,including the city's former attorney, say the measure would take away local control and peel back existing bans on flavored tobacco products and the sale of e-cigarettes until they are approved by the FDA.
"To us, Juul is Big Tobacco 2.0," said John Schachter of the Campaign for Tobacco-Free Kids, asserting the company is using deceptive legislation to maintain the sale of its products.
Benowitz of UCSF disagreed with the comparison, saying he sees a big difference between Juul, whose products show legitimate potential to help people addicted to cigarettes, and the tobacco companies that predate it.
One question at the core of the concerns over Rubinstein's move is whether research and prevention should come from within the industry. An internal research program is problematic, said David Michaels, a professor at George Washington University who has studied corporate attacks on the science underpinning environmental protection. "I understand why scientists are concerned about a program like this, and I think they should be," he said.
E-cigarette manufacturers, not taxpayers, should fund research of their products, Michaels said, but the research must be completely independent of the company. Tobacco companies have long used scientists to manufacture uncertainty and defend products that have harmed public health, he said, and the research they produce in-house will always be called into question.
By all accounts the woman, in her late 60s, appeared to have severe dementia. She was largely incoherent. Her short-term memory was terrible. She couldn't focus on questions that medical professionals asked her.
But Dr. Malaz Boustani, a professor of aging research at Indiana University School of Medicine, suspected something else might be going on. The patient was taking Benadryl for seasonal allergies, another antihistamine for itching, Seroquel (an antipsychotic medication) for mood fluctuations, as well as medications for urinary incontinence and gastrointestinal upset.
To various degrees, each of these drugs blocks an important chemical messenger in the brain, acetylcholine. Boustani thought the cumulative impact might be causing the woman's cognitive difficulties.
He was right. Over six months, Boustani and a pharmacist took the patient off those medications and substituted alternative treatments. Miraculously, she appeared to recover completely. Her initial score on the Mini-Mental State Exam had been 11 of 30 — signifying severe dementia — and it shot up to 28, in the normal range.
An estimated 1 in 4 older adults take anticholinergic drugs — a wide-ranging class of medications used to treat allergies, insomnia, leaky bladders, diarrhea, dizziness, motion sickness, asthma, Parkinson's disease, chronic obstructive pulmonary disease and various psychiatric disorders.
Older adults are highly susceptible to negative responses to these medications. Since 2012, anticholinergics have been featured prominently on the American Geriatrics Society Beers Criteria list of medications that are potentially inappropriate for seniors.
"The drugs that I'm most worried about in my clinic, when I need to think about what might be contributing to older patients' memory loss or cognitive changes, are the anticholinergics," said Dr. Rosemary Laird, a geriatrician and medical director of the Maturing Minds Clinic at AdventHealth in Winter Park, Fla.
The Basics
Anticholinergic medications target acetylcholine, an important chemical messenger in the parasympathetic nervous system that dilates blood vessels and regulates muscle contractions, bodily secretions and heart rate, among other functions. In the brain, acetylcholine plays a key role in attention, concentration, and memory formation and consolidation.
Some medications have strong anticholinergic properties, others less so. Among prescription medicines with strong effects are antidepressants such as imipramine (brand name Trofanil), antihistamines such as hydroxyzine (Vistaril and Atarax), antipsychotics such as clozapine (Clozaril and FazaClo), antispasmodics such as dicyclomine (Bentyl) and drugs for urinary incontinence such as tolterodine (Detrol).
In addition to prescription medications, many common over-the-counter drugs have anticholinergic properties, including antihistamines such as Benadryl and Chlor-Trimeton and sleep aids such as Tylenol PM, Aleve PM and Nytol.
Common side effects include dizziness, confusion, drowsiness, disorientation, agitation, blurry vision, dry mouth, constipation, difficulty urinating and delirium, a sudden and acute change in consciousness.
Unfortunately, "physicians often attribute anticholinergic symptoms in elderly people to aging or age-related illness rather than the effects of drugs," according to a research review by physicians at the Medical University of South Carolina and in Britain.
Seniors are more susceptible to adverse effects from these medications for several reasons: Their brains process acetylcholine less efficiently. The medications are more likely to cross the blood-brain barrier. And their bodies take longer to break down these drugs.
Long-Term Effects
In the late 1970s, researchers discovered that deficits in an enzyme that synthesizes acetylcholine were present in the brains of people with Alzheimer's disease. "That put geriatricians and neurologists on alert, and the word went out: Don't put older adults, especially those with cognitive dysfunction, on drugs with acetylcholine-blocking effects," said Dr. Steven DeKosky, deputy director of the McKnight Brain Institute at the University of Florida.
Still, experts thought that the effects of anticholinergics were short-term and that if older patients stopped taking them, "that's it — everything goes back to normal," Boustani said.
Concerns mounted in the mid-2000s when researchers picked up signals that anticholinergic drugs could have a long-term effect, possibly leading to the death of brain neurons and the accumulation of plaques and tangles associated with neurodegeneration.
Since then several studies have noted an association between anticholinergics and a heightened risk of dementia. In late June, this risk was highlighted in a new report in JAMA Internal Medicine that examined more than 284,000 adults age 55 and older in Britain between 2004 and 2016.
The study found that more than half of these subjects had been prescribed at least one of 56 anticholinergic drugs. (Multiple prescriptions of these drugs were common as well.) People who took a daily dose of a strong anticholinergic for three years had a 49% increased risk of dementia. Effects were most pronounced for people who took anticholinergic antidepressants, antipsychotics, antiepileptic drugs and bladder control medications.
These findings don't constitute proof that anticholinergic drugs cause dementia; they show only an association. But based on this study and earlier research, Boustani said, it now appears older adults who take strong anticholinergic medications for one to three years are vulnerable to long-term side effects.
Preventing Harm
Attention is now turning to how best to wean older adults off anticholinergics, and whether doing so might improve cognition or prevent dementia.
Researchers at Indiana University's School of Medicine hope to answer these questions in two new studies, starting this fall, supported by $6.8 million in funding from the National Institute on Aging.
One will enroll 344 older adults who are taking anticholinergics and whose cognition is mildly impaired. A pharmacist will work with these patients and their physicians to take them off the medications, and patients' cognition will be assessed every six months for two years.
The goal is to see whether patients' brains "get better," said Noll Campbell, a research scientist at Indiana University's Regenstrief Institute and an assistant professor at Purdue University's College of Pharmacy. If so, that would constitute evidence that anticholinergic drugs cause cognitive decline.
The second trial, involving 700 older adults, will examine whether an app that educates seniors about potential harms associated with anticholinergic medications and assigns a personalized risk score for dementia induces people to initiate conversations with physicians about getting off these drugs.
Moving patients off anticholinergic drugs requires "slow tapering down of medications" over three to six months, at a minimum, according to Nagham Ailabouni, a geriatric pharmacist at the University of Washington School of Pharmacy. In most cases, good treatment alternatives are available.
Advice For Older Adults
Seniors concerned about taking anticholinergic drugs "need to approach their primary care physician and talk about the risks versus the benefits of taking these medications," said Shellina Scheiner, an assistant professor and clinical geriatric pharmacist at the University of Minnesota.
Don't try stopping cold turkey or on your own. "People can become dependent on these drugs and experience withdrawal side effects such as agitation, dizziness, confusion and jitteriness," Ailabouni said. "This can be managed, but you need to work with a medical provider."
Also, "don't make the assumption that if [a] drug is available over the counter that it's automatically safe for your brain," Boustani said. In general, he advises older adults to ask physicians about how all the medications they're taking could affect their brain.
Finally, doctors should "not give anticholinergic medications to people with any type of dementia," DeKosky said. "This will not only interfere with their memory but is likely to make them confused and interfere with their functioning."
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