Bloomberg: The Opioid Epidemic’s First Corporate Casualty May Be a Drugmaker That Helped Fuel the Crisis

Sitting in a Boston courtroom in a dark, pinstriped suit, the former top sales executive at Insys Therapeutics Inc., Alex Burlakoff, listened as federal prosecutors read out crimes he and the company had allegedly committed.

Insys had bribed doctors and their employees with payments for sham medical events that often turned out to be parties. Physicians who didn’t write prescriptions for the company’s powerful opioid were cut off from the company’s money. There were lavish dinners, strip-club visits and gun-range outings, all of which led to booming sales of one of the world’s most powerful — and dangerous — pain drugs.

Burlakoff was prepared to plead guilty, his lawyers told the judge on Nov. 28 — there was even more evidence that prosecutors hadn’t listed, they said. He’s one of the first drug-company executives charged in the mounting legal backlash to the U.S. opioid crisis, which was tied to about 50,000 deaths last year. Burlakoff faces as many as 20 years in prison, though he has a cooperation agreement with the government as other former Insys executives go to trial in January.

The company, meanwhile, could become the first corporate casualty of the opioid epidemic. Its sales have plunged as it spends millions of dollars on legal defenses of its former executives, including billionaire founder and ex-chief executive John Kapoor.

In a desperate bid to save itself, Insys’s new managers are trying to sell off its main pain drug to a corporate buyer to raise money. They hope to use the proceeds to pivot out of the opioid business into something slightly less controversial – cannabis-derived drugs.

Insys’s main product is Subsys, a spray version of the ultrapowerful opioid fentanyl. When it was introduced in the U.S. in 2012 with a price tag ranging between $3,000 and $16,000 a month, depending on the dose, it was subject to a tightly controlled distribution system. The Food and Drug Administration allowed the company to market it to cancer patients, to help relieve their pain.

It didn’t sell well, at least at first. That changed, federal prosecutors have alleged, when Kapoor and other executives essentially bribed doctors to prescribe it for everything from chronic pain to back aches, and defrauded insurance providers who were reluctant to approve prescriptions for off-label use. In some cases, doctors were paid more than $200,000, prosecutors said at the Nov. 28 hearing where Burlakoff pleaded guilty.

Attorneys for Burlakoff and Kapoor didn’t respond to separate requests for comment.

Business boomed. Subsys sales grew from $8.6 million when it launched in March 2012 to $329.5 million in 2015 — making up all but a sliver of the company’s revenue. At the drug’s peak in 2015, Insys had a market valuation of more than $2 billion.

Then in June 2015, a Connecticut nurse pleaded guilty to federal charges of accepting more than $83,000 in kickbacks from the company. There were indictments of doctors, nurses, sales representatives and, eventually, Insys executives. In August, the company agreed to a $150 million settlement with the Department of Justice to resolve a civil and criminal probe, with the potential for as much as $75 million more due.

Sales plunged, as well, falling 80 percent from their 2015 peak. Subsys accounts for more than 95 percent of the company’s revenue. The company is short on cash, with $113 million in the bank, and has said it needs “substantial funds” to stay afloat.

“There’s no guarantee the process will yield any results,” Insys spokesperson Joe McGrath said in an phone interview. “We haven’t found a buyer — and we might not.” He called the decline in Subsys sales “an over-correction.”

Symphony Health data/Bloomberg

Now Insys is trying to find a new line of business by becoming a “cannabinoid pioneer,” said McGrath. It’s one of the hottest areas in medicine, and investors have flocked to tiny companies promising to win the race for a new class of marijuana-derived therapies.

Insys already produces one of a few drugs approved by the Food and Drug Administration made from synthetic cannabinoids, marijuana-inspired compounds that have become promising treatments for an array of medical conditions. Insys’s drug, Syndros, treats loss of appetite in people with AIDS and nausea caused by chemotherapy.

It’s a meager commercial product, bringing in only$976,000 in the third quarter, according to a company filing.  The company is developing more cannabidiol, or CBD, drugs for infantile spasms, childhood absence epilepsy and a rare genetic disorder called Prader-Willi syndrome. It’s also developing an overdose-reversal product that uses naloxone, a powerful anti-opioid medicine.

“This pivot may be forced, but CBD and opioid dependence are hot spaces with a lot of interest from investors,” said Curt Wanek, a pharmaceutical equity analyst for Bloomberg Intelligence. “It’ll cost money to bring these drugs to market, but all it takes is positive data” to raise more funding, Wanek said. The company has said it anticipates spending heavily to bring the products to market.

Time Running Out 

Insys is also paying for the legal-defense costs of its executives under an agreement, common at many large companies, that forces it to cover any investigation, defense, settlement or appeal-related expenses. Kapoor is scheduled to face criminal trial in Boston federal court along with other executives in January, where Burlakoff is expected to be a star witness. Kapoor’s defense has cost the company more than $28 million in indemnification fees through the 12 months through Sept. 30.

A third-quarter filing with the Securities and Exchange Commission said that Insys’s existing and future legal insurance coverage may be inadequate. In some cases, it “may not have any insurance coverage at all and which may entail settlement payments or litigation judgments that could individually, or in the aggregate, have a materially adverse effect on our financial condition and results of operations.”

“New management is figuring out a way to rationalize and minimalize the legal costs,” said McGrath, who said the company is disputing the indemnification fees. “It’s an unsustainable trajectory.”

Insys isn’t alone in facing opioid-related legal issues. Hundreds of cases have been filed against pharmaceutical companies and distributors. But no company’s troubles may be more acute than Insys’s.

“They’re fighting a losing battle,” said Robert Valuck, a professor of pharmacy at the University of Colorado Anschutz Medical Campus and director of the Colorado Consortium for Prescription Drug Abuse Prevention, which works with lawmakers to address the opioid crisis. “Whether they keep trying to defend or sell Subsys, there’s going to be some amount of perception that this is the product that got them sued.”

https://www.bloomberg.com/news/articles/2018-12-04/the-opioid-epidemic-s-first-corporate-casualty-may-be-a-drugmaker-that-helped-fuel-the-crisis

The Washington Post: After a record number of U.S. deaths in 2017, the opioid epidemic may be receding

The CDC released the official 2017 mortality and drug overdose data this week, and any way you slice it, it’s bad. The numbers show the United States in the midst of the longest sustained decline in life expectancy since World War I. The drop is driven in large part by the drug overdose epidemic, which claimed 70,237 lives, an increase of nearly 7,000 over the previous year.

Joshua M. Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, summed it up in an interview with The Washington Post: “I think this is a very dismal picture of health in the United States.”

Separately, however, public health researchers are pointing toward evidence of light at the end of the overdose tunnel. The CDC’s provisional monthly estimates of overdose deaths show more detail and are more recent than the year-end figures. Those numbers show that nationwide, drug overdose deaths peaked in September 2017 and have been steadily declining in the months since.

The data go through April of this year. They show that nationwide, the estimated number of overdose deaths for the 12-month period ending April 2018 was 70,859, a decline of more than 2,000 deaths vs. the 12-month period ending in September 2017.

These figures are provisional and subject to change as states finalize their death certificate data. However, they’ve proved to be fairly accurate in the past. The provisional data for the year ending in December 2017 showed 72,287 overdose deaths, off by less than 3 percent vs. the final number released Friday.

Experts have begun to take notice of this decline and have been weighing in on it with cautious optimism. “Three months ago I wasn’t sure the provisional deaths curve was really going down,” Daniel Ciccarone of the University of California at San Francisco told STAT News in October. “But the trend seems robust.”

ONE TIME USE ONLY WONKBLOG OPIOID DEATHS 11 30 18
Drilling down, the numbers show declining mortality from heroin and opioid prescription painkillers, in particular. The synthetic opioid category, which includes fentanyl, continues to be a chief area of concern, although there’s evidence the rate of increase in fentanyl mortality slowed in 2017 and 2018. Deaths from cocaine, which is not an opioid, have plateaued, while deaths from methamphetamine and other non-opioid stimulants are continuing a modest increase.

One particularly encouraging bit of news is that at the state level, overdose declines are particularly steep in the states with the highest rates of mortality. Ohio and Pennsylvania, for instance, have so far seen decreases in the neighborhood of 20 percent since mortality peaked in late 2017. West Virginia, the state with the nation’s highest rate of drug overdoses, has seen a decline of nearly 12 percent.

Overall, the CDC data show that 12-month drug overdoses declined in 20 states between April 2017 and April 2018.

Again, the CDC stresses that these numbers are provisional and should be treated with caution. But, so far, each of the past seven months has shown a decrease in overdose deaths, the first time that’s happened since the CDC began releasing this monthly data in 2015.

https://www.washingtonpost.com/business/2018/11/30/after-record-number-us-deaths-opioid-epidemic-may-be-receding/

Reason: Opioid-Related Deaths Keep Rising As Pain Pill Prescriptions Fall – Hit & Run : Reason.com

The official numbers for opioid-related deaths in 2017, released by the U.S. Centers for Disease Control and Prevention today, demonstrate once again the folly of trying to tackle this problem by reducing access to prescription pain pills. The volume of opioids prescribed for American patients has been falling since 2010, while the upward trend in deaths involving opioids has accelerated, reaching a record number last year.

Of the 47,600 opioid-related deaths the CDC counted in 2017 (the black line on the chart below), 60 percent involved the drug category that consists mainly of illicitly manufactured fentanyl and its analogs (the red line). Just 30 percent involved the category that includes the most commonly prescribed pain medications (the blue line), and some of those deaths also involved fentanyl or heroin (the yellow line), which was implicated in one-third of the opioid fatalities. Last year’s 13 percent increase in opioid deaths was due almost entirely to a 47 percent increase in deaths involving fentanyl and its analogs, since deaths involving heroin and pain pills stayed about the same, while deaths involving methadone fell.

Allowing for deaths involving multiple opioids, the CDC’s numbers indicate that pain pills account for less than 30 percent of these deaths, and the actual number is probably considerably lower. A 2017 analysis of opioid-related fatalities in Massachusetts found that heroin or fentanyl was the deadliest drug in 85 percent of the cases.

The Trump administration nevertheless wants to reduce opioid prescriptions by a third during the next three years. But opioid prescriptions, measured by total morphine milligram equivalents (MME) sold, have already fallen by a third since 2010, as indicated by the green area in the chart (with units, in billions of MME, on the right axis). During that period, opioid-related deaths more than doubled. Does this seem like a winning strategy?CDC & FDACDC & FDAFar from reducing deaths involving opioids, the crackdown on pain pills has pushed nonmedical users into the black market, where the drugs are much more dangerous because their potency is highly variable and unpredictable. “Synthetic drugs tend to be more deadly than prescription pills and heroin for two main reasons,” The New York Timesnotes. “They are usually more potent, meaning small errors in measurement can lead to an overdose. The blends of synthetic drugs also tend to change frequently, making it easy for drug users to underestimate the strength of the drug they are injecting. In some parts of the country, drugs sold as heroin are exclusively fentanyls now.”

Meanwhile, patients suffering from severe pain are finding it increasingly difficult to obtain the medication they need to make their lives bearable. Many people with severe chronic pain who have functioned well on opioids for years have seen their doses dramatically and arbitrarily cut as a result of government pressure, including the CDC’s own supposedly voluntary but increasingly mandatory prescribing guidelines.

Even people with agonizing terminal illnesses are not immune from the imperative to reduce opioid prescriptions. Barbara McAneny, the president of the American Medical Association, recently described a patient with metastatic prostate cancer who tried to kill himself after he could not get the medication he was prescribed for his bone pain because a suspicious pharmacist called his insurer, which denied coverage. While “I share the nation’s concern that more than 100 people a day die of an overdose,” she said, “my patient nearly died of an underdose.”

https://reason.com/blog/2018/11/29/opioid-related-deaths-keep-rising-as-pai

North Texas Hospital Sees Drastic Spike In RSV – CBS Dallas / Fort Worth

Dr. Ramon Kinloch, a pediatrician at Cook Children’s said, “RSV is something to be taken very seriously.”

Officials at Cook Children’s said last week they treated 178 confirmed cases of RSV in young children. Ninety percent of those kids ended up in the emergency room.

Doctors say they are seeing a peak in the spread of RSV much earlier than usual.

Dr. Kinloch said the symptoms present themselves similar to a common cold and usually the body can fight it off, but if the body can’t do that and it goes untreated it can become much more dangerous in younger patients.

“They can develop worsening respiratory symptoms that can lead to pneumonia or respiratory failure and those are the ones that will need hospital visits,” he said.

Dr. Kinloch said the best way to combat the spread of RSV in children is a easy.

“Hand washing is going to be the number 1 way to minimize spread and prevent that spread of that.”

Should your child come down with RSV or symptoms that worry you as a parent, doctors say don’t hesitate to see a physician.

“If you’re worried about those symptoms worsening and there is more that you need to do certainly check with your doctor,” Dr. Kinloch said.

https://dfw.cbslocal.com/2018/11/26/north-texas-hospital-rsv/

How Paramedics Choose a Hospital

One of the most common questions I get is how paramedics choose which hospital emergency department to take a patient. Like most questions about emergency medical services, the answer is a little complicated.

Most importantly, how an ambulance crew chooses where to take a patient depends on the system. In other words, where you are in the country when you call 911 has the biggest effect on how the paramedics will decide where to take you.

In some areas of the country, there is only one hospital in the response zone. In that case, the decision is simple.

Most parts of the country have protocols to help paramedics decide where to go. Some patients require special care while others might have insurance requirements. Sometimes the determination is based on the needs of the system, which uses a centralized coordinator to disperse patients equally to area hospitals. In the parts of California where I have practiced, patients are traditionally offered a choice of destination hospitals to choose from, unless their condition warrants a specialty hospital.

There’s just no way to say for sure how the paramedics will choose a hospital. Here are a few of the most common determinants.

Specialty Centers

There’s something to be said for specializing. When seconds count or knowing the tiniest details will make a difference, you want to go to a specialty center for your care. Some specialties don’t currently have a place in emergencies (cancer centers for instance) but there are a few that trump patient preference when it comes to figuring out which hospital to point the ambulance at.

  • Trauma centers are the most common type of specialty hospitals. There are 4 levels of trauma centers designated by Roman numerals. Level I trauma centers can handle the most patients and the most severe cases. In many EMS systems around the country, serious trauma patients must be taken to a trauma center for treatment, regardless of closest hospital or patient preference. In some EMS systems, patients have to be flown by helicopter to reach specialty centers.
  • Burn centers handle severely burned patients with treatments and equipment that other hospitals don’t have access to.
  • Cardiac care centers are sometimes referred to as “STEMI centers” because of the type of heart attack they most commonly treat in an emergency. These are the places you want to be if you are having an S-T elevated myocardial infarction (STEMI), which responds very well to certain types of treatment if that treatment is done quickly.
  • Stroke centers are to the brain what a STEMI center is to the heart. These teams also go for the NASCAR pit crew style, but they’re aiming a little farther north than their cardiac counterparts. Strokes happen in the brain.
  • Children’s hospitals know how to treat kids better than anyone else. When kids are involved and there’s a children’s hospital in the area, paramedics often have to transport patients there. Additionally, some children’s hospitals are also pediatric trauma centers.

Disasters and Muli-Casualty Incidents

When EMS systems get overwhelmed with too many patients—usually in a multi-casualty incident or a disaster—the patients will be divided up among the available hospitals. Transportation will be coordinated through a Disaster Control Facility. Neither the patients nor the paramedics will have a say in where an individual patient will be taken. In many cases, specialty centers are still utilized if possible.

In severe disasters such as hurricanes or floods, emergency patients can be transported to destinations as far away as other states. This is especially true if the infrastructure (hospitals, ambulance services, etc.) are damaged.

Insurance and Patient Choice

I’d say the most common determinant of hospital destination comes from the patients. In most parts of the country, patients get to choose their hospital. Most of the time, your insurance contracts with a particular hospital. It is illegal for an ambulance crew to ask about insurance before transporting a patient (theoretically, the patient could get funneled to a substandard hospital if he or she doesn’t have insurance or has a poor insurance). Therefore, it’s very important for each of us to know which emergency department our insurance wants us to use. If we are given a choice, the insurance will expect us to choose the correct one.

Closest Facility

The final and simplest choice for hospital destination is to just take the patient to the closest one. This might not be the case, however, for all the other options listed above. You shouldn’t be surprised if a loved one is transported to a hospital but doesn’t end up at the one nearest you. There are a lot of reasons why that may not be the best choice.

Source: How Paramedics Choose a Hospital

Washington Post: Dispelling deadly myths about the flu vaccine

Every year as flu season emerges, so too do myths and misconceptions about the flu shot.

Some people avoid getting the vaccine because they don’t think it works well enough to be worth it. Some think they are too healthy to need it. And some worry it will make them sick, possibly remembering a time when they got the shot and fell ill soon after.

“That’s the one I always hear from the taxi driver and the person at the grocery store: ‘The flu vaccine is going to give me the flu,’ ” says Mark Thompson, an epidemiologist at the Centers for Disease Control and Prevention in Atlanta. “That is a persistent myth.”

Despite years of consistent messages from health-care providers about the dangers of the flu and the protective power (and safety) of the flu shot, many people still hold false beliefs about both. One reason is that the flu, technically called influenza, encompasses a complicated and ever-changing group of viruses, says William Schaffner, an infectious disease specialist at Vanderbilt University School of Medicine in Nashville.

Some strains cause relatively mild coldlike illnesses. Others induce worldwide pandemics. (And plenty of respiratory viruses — even bad ones and others that strike soon after people get a flu shot — aren’t influenza at all.)

Influenza viruses also mutate constantly and without warning, which means that people’s experiences don’t apply from one year to the next. “As we say in flu, ‘If you’ve seen one flu season, you’ve seen one flu season,’ ” Schaffner says. “It’s like fighting a new fight every year.”

Some years are less successful than others, despite constant vigilance by a worldwide surveillance network that works year-round to isolate and analyze which influenza strains are circulating. During the months after experts decide which strains to include in the annual flu shot, viruses can mutate and new strains can show up, making the vaccine less effective than originally planned.

That happened last year, when the flu shot was about 40 percent effective overall, but only 25 percent effective against H3N2, a particularly virulent strain. The result was a record-breaking number of hospitalizations and deaths among children.

Some experts worry that these effectiveness numbers cause confusion and unnecessary distrust of the vaccine. In years with a good match, people who get the flu shot are 40 to 60 percent less likely to have to go to the doctor for an influenza infection, according to the CDC. It may not sound like much if people expect the flu vaccine to rival vaccines for measles or polio.

But a vaccine that is 40 percent effective has a 40 percent chance of completely preventing infection, Schaffner says, adding up to millions of people protected from a severe illness and hundreds of thousands kept out of hospitals. And complete protection isn’t the only useful measure.

Even when people get the flu, new research shows they are better off if they got the flu shot. In one 2018 study, Thompson and colleagues analyzed data on more than 3,000 patients admitted to two hospitals in New Zealand between 2012 and 2015. Among patients with influenza, those who had been vaccinated were 59 percent less likely to be admitted to the intensive care unit. And even if they did end up in the ICU, vaccinated patients spent an average of four fewer days in the hospital.

“As you get further and further along on the continuum of severity, this study suggests that the vaccine continues to provide protection,” Thompson says. “This gives us some extra ammunition to talk about people’s worries.”

Other recent studies have shown that:

●Adults are as much as five times more likely to die of influenza if they’re unvaccinated.

●Children are half as likely to die of influenza if they’re vaccinated.

●Pregnant women are less likely to be hospitalized if they get a flu shot, which also offers protection to their newborns.

The flu vaccine appears to also protect people from long-lasting influenza complications, such as heart attacks and strokes, which become more likely during a period of inflammation that can follow an initial infection, Schaffner says. And the vaccine remains especially important for older people who are frail or on the edge of frailty. For them, the flu can be like the first domino in a series of bad health consequences.

So far, this year’s flu season is starting off slowly and looking fairly conventional, with sporadic cases and small outbreaks starting to occur around the country. The H1N1 strain is circulating, and for now, the vaccine appears to be a good match, says Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group in Rochester, Minn.

But cases tend to peak in February, and there is still plenty of time for things to go haywire. That’s a lesson Poland learned in winter 2000, when he was on the committee that decided which strains to put in the vaccine. That year, the flu season started out looking tame. Then, in early November, a new variant showed up in the United States and spread rapidly, leading to a particularly bad flu season.

Hundreds of millions of new influenza mutants form every few minutes, Poland says. “People tend to think of the flu as a static virus, but it is an incestuous cesspool of viruses,” he says. “Prediction is impossible.”

Studies consistently show that the most effective motivator is an insistent recommendation from a health-care provider. But fewer than half of Americans got the flu shot last year.

To avoid the annual battle, some scientists are working on a universal vaccine that would cover all strains. Others are trying to make the flu vaccine easier to deliver with patches or other methods that don’t require needles.

For now, there are nine options, Poland says, including a version for older people, a newly re-approved nasal mist, a vaccine made in cells instead of eggs, and one that can be delivered by jet injector, a high-pressure stream of liquid. Poland recommends that people talk with their health-care providers about which is best for them.

As for the worry that the flu shot might give you the flu, Thompson offers reassurance.

“This is a vaccine made with a killed virus,” he says. “It is literally impossible for it to give you the flu.”

https://www.washingtonpost.com/national/health-science/dispelling-deadly-myths-about-the-flu-vaccine/2018/11/23/28dd3d68-ec0a-11e8-96d4-0d23f2aaad09_story.html

Why the Doctor Is Crying in Bohemian Rhapsody

Louis M. Profeta MD

I spoke recently at Marian University School of Medicine, one of those “older doc speaks to younger doc” career path kinda talks. I explained how I really didn’t know shit about medicine when I started medical school in the ‘80s, and how it seemed that one minute I was doing shots at a football tailgate in college and the next I was plopped right down in the middle of the AIDS epidemic, perhaps the first time in my career when I really started to understand what it meant to be a doctor. For the last week, however, I couldn’t shake the look on those students’ faces. There was this kind of wanting-to-understand blankness. It wasn’t their fault. It was their blessing in a way since most will never truly know this disease outside of books, and it hit me that in about 10–20 years or so there won’t be many of us left who practiced medicine during these days of AIDS. So why bring it up now?

Because I just got done sitting through the matinee showing of Bohemian Rhapsodysqueezing my wife’s hand and silently sobbing into my sweatshirt.

Without giving too much of it away, Freddie Mercury goes to a doctor’s office and passes by the dying shell of a young man who is covered in Kaposi’s lesions. He looks up and gives a tired smile and hums a few bars at a slightly disguised Freddy as he passes, a kind of compassionate lyrical wink that says, “I know who you are and I know you’re sick too.” Freddy responds with a few bars in kind.

And I sat there in the dark of the theater, tears pooled under my eyes and I stealthily wiped them away. I thought back to all those patients during my early days in medicine and how I still remember their names. How they often died alone, disenfranchised, cast off by families who grew up perhaps with a different interpretation of “family values” or just simply could not wrap their heads around the times or what was happening to their sons and daughters. But I also remember the fathers and mothers and sisters and brothers and lovers that cradled others in their arms, wiped bloody sputum from their lips, and fed them ice chips with small plastic spoons and filled their ears with “I love you, my son, my child, my love, no matter what, I love you. I’ll always love you.”

Yeah, I remember those sights and smells, the deep coughing and raspy sounds of ends-of-days and how like a light switch it all just seemed to stop when the drugs were discovered that actually worked. Isn’t that crazy? It all just kind of stopped. So I admit it. I cried in the movie, perhaps the first time since Field of Dreams.

I guess if I had one wish for today’s medical student it might be this:

May you never cry in Bohemian Rhapsody.

Dr. Louis M. Profeta is an emergency physician practicing in Indianapolis. He is a national award-winning writer and one of LinkedIn’s Top Voices and the author of the critically acclaimed book, The Patient in Room Nine Says He’s God. Feedback at louermd@att.net is welcomed. For other publications and for speaking dates or inquiries visit louisprofeta.com.

https://www.linkedin.com/pulse/why-doctor-crying-bohemian-rhapsody-louis-m-profeta-md

Anthem’s effort to punish patients for ‘unnecessary’ ER visits has been a bust — but still burdens patients 

In the last few years, Anthem Blue Cross has made a strong bid for the award for the most heartless and senseless coverage policy in the health insurance business.

Its competition entry is a policy that penalizes patients for seeking “unnecessary” treatment at an emergency room. If Anthem concludes that the reason for the visit wasn’t an emergency after all, it can deny the claim — saddling members with bills that could exceed $10,000.

Anthem’s rationale is that the ER is the costliest venue for medical treatment; therefore, weeding out patients whose medical complaints could more appropriately be managed through a doctor’s appointment or a visit to an urgent-care clinic will save money for Anthem and for its customers base. Anthem launched this program in Kentucky in 2015 and expanded it in 2017 and this year to Indiana, Georgia, Missouri and Ohio. (The company dropped plans to expand it this year into New Hampshire.)

Now, after several years’ experience in some of those states, a few conclusions can be drawn about it. First, the program as a whole appears to be a bust. According to statistics the company provided to Sen. Claire McCaskill, D-Mo., the vast majority of claims denials under the program have been reversed on appeal. The number of initial denials has fallen this year, too, after Anthem changed the rules to broaden the exemptions — that is, cases in which the ER claim would always be approved, no questions asked.

Perhaps most important, expecting consumers to diagnose their conditions as emergent or non-emergent before going to the ER is stupid and possibly illegal, insofar as it requires them to make judgments that ER doctors often can’t make without a professional examination. Using the ultimate diagnosis as a proxy for the urgency of the original visit to the ER is an imperfect standard to the point of being nonsensical, in medical terms.

“I’m a board-certified trained doctor of emergency medicine,” Jonathan Heidt, president of the Missouri chapter of the American College of Emergency Physicians, told me in January, “and I have trouble looking at the ER note and knowing what the patient was thinking at 3 o’clock in the morning.”

But the likelihood is that Anthem doesn’t actually want to deny members’ ER claims — what it really wants is for them not to go to the ER at all. Anthem’s policy is really just another hoop for consumers to jump through, which always translates into less usage. The drawback is that these obstacles result in less unnecessary medical care, but less necessary care too. More on that in a bit.

The statistics on claims denials and reversals come from a report McCaskill issued this summer, using Anthem data (even though the company stiff-armed her on some of her data requests). The conclusions about the wisdom of the policy come from an analysis by researchers at Yale and Harvard medical schools recently published by the Journal of the American Medical Assn. The researchers concluded that anthem’s system is so flawed it “could place many patients who reasonably seek ED (emergency department) care at risk of coverage denial.”

Anthem, the nation’s second biggest health insurer, says it’s standing by its policy, though it has no current plans to expand it to more states. The company told me by email that its “Emergency Department Review” was designed to “reduce the trend in recent years of inappropriate use of EDs for non-emergencies.” It said it found that about 5 percent of all claims it received for ER care were for non-emergencies, “which is in line with findings from the Centers for Disease Control and Prevention.”

The important questions, however, are what counts as a “non-emergency,” who makes the call, and when?

Anthem’s system is based on the diagnostic codes submitted by the ER with its claim — in other words, what the ER doctors ultimately judged the patient’s problem to be. In Indiana Anthem used a roster of 120 codes ranging from “abrasion” to “viral wart” and including various contusions and pain complaints; in Missouri, according to ER doctors, the list ran to more than 1,900 conditions. If the conditions appeared on the ER claim, Anthem would subject the claim to further review, with an eye to rejecting it.

Under Anthem’s original rules, the denial policy wouldn’t apply when the patient is 14 or younger, an urgent care clinic isn’t located within 15 miles, or the visit occurs on a Sunday or holiday. This year the company added several exclusions. Claims will always be paid if the patient was directed to visit the ER by a doctor; is traveling out of state; received any surgery, IV medications, or an MRI or CT scan at the ER.

The basic problem remains, however: A final diagnosis by an ER doctor isn’t very useful in judging what motivated a patient to report to the ER in the first place. That’s what the Harvard/Yale study found.

Patients aren’t diagnosticians. They don’t make decisions on whether to go to the ER based on a diagnosis, but based on their symptoms. And 90 percent of the symptoms that typically send a patient to the ER are common to both nonemergency conditions and potentially life-threatening emergencies.

Back or abdominal pain could be a muscle spasm — or herald a kidney stone or appendicitis; the researchers found that in their study sample of emergency cases from 2011 to 2015, abdominal pain resulted in hospital admission 16 percent of the time — but could result in Anthem denials in 4.3 percent of cases. Chest pain could be indigestion or a heart attack. Headache, vomiting, dizziness, cough and shortness of breath also could go either way.

In Anthem’s system, the researchers warned, “patients with acute illnesses are put in a difficult position of weighing the risk of delayed treatment for severe disease vs an uncovered medical bill.”

Anthem told me that “if a consumer reasonably believes that he or she is experiencing an emergency medical condition, then they should always call 911 or go to the ED.” But that’s just empty persiflage, if the consequence of guessing wrong is a bill for several thousand bucks.

The stakes are considerable. The Harvard/Yale study calculated that if Anthem’s policy were widely copied, nearly 1 in 6 ER visits by insured adults would result in a non-emergency diagnosis and be subject to denial.

McCaskill’s report traced the life cycle of Anthem ER claims denials and appeals in Kentucky, Georgia and her home state of Missouri. Her findings are eye-opening.

In July through December of last year, 5 percent of ER claims — 3,700 — were denied in Missouri, 4 percent (5,000) in Kentucky and 7 percent (3,500) in Georgia. Another 5 percent were initially denied but paid after appeals in Missouri, 7 percent in Kentucky and 13 percent in Georgia.

In fact, most denials were eventually overturned — and the rate of reversals rose almost every month into this year. In Missouri, the rate of reversals increased from 58 percent in July 2017 to 73 percent in November, a trend largely matched in the other two states.

Since January, when Anthem changed its standards, ER denials have plummeted — to zero in all three states by March 2018, McCaskill reports.

That points to the question of why Anthem’s program still exists at all. To begin with, it may well violate federal law, which requires insurers to cover ER services if a patient arrives with symptoms that a “prudent layperson” — one with an average knowledge of health and medicine — could reasonably expect to result in “serious impairment to his or her health.” Anthem says its physician reviews are aimed at matching ER diagnoses with the prudent layperson standard, which may explain why denials have plunged.

Even in 2017, when the company was still denying a sizable percentage of ER claims, the results appear to have fallen short of its expectations. McCaskill says Anthem had projected that its program would save $2.9 million a year via denials of unnecessary ER visits in Missouri alone; but in the last six months of 2017, the denials yielded only $1 million in savings through unpaid claims — not counting the reversals after appeal.

The statistics suggest that Anthem’s initiative might even have cost the company more than it saved. Thousands of ER claims had to be scrutinized by professionals before denials, examined again if they were appealed, and ultimately paid if the denials were reversed.

Some of these costs land on the shoulders of patients. Anthem customers face the tension of how to pay five-figure bills for ER visits they thought would be covered for a nominal co-pay, and weeks or months of lost work time or other inconveniences trying to challenge the decision. Emergency Departments face the uncertainty of getting reimbursed for their services.

Still, the gains Anthem may have garnered from its policy may not be obvious. If it succeeded in discouraging patients from presenting at the ER in the first place out of fear of a big bill, that wouldn’t show up in denial and appeal statistics. Anthem couldn’t be tagged for infringing the prudent layperson rule, because the decision to skip the ER would be made by its imprudent customers on their own, for their own reasons.

Perhaps it’s a bit unfair to criticize Anthem for trying to shift the costs of ER coverage to patients. After all, trying to avoid paying out on claims is what comes naturally to insurance companies. That’s what allowed Anthem to record a profit of $3.8 billion last year on revenue of $90 billion, and to pay its recently-retired chairman and CEO, Joe Swedish, nearly $50 million in 2015-2017.

Indulgent state regulators in five states have allowed Anthem to get away with this flagrantly anti-consumer practice. The blame belongs to them.

Source: Anthem’s effort to punish patients for ‘unnecessary’ ER visits has been a bust — but still burdens patients | Consumer & Retail | pilotonline.com

Antibodies in Llama Blood Might Eliminate the Need for Yearly Flu Shots | Mental Floss

Getting your yearly flu shot is an important way to protect yourself against the latest strains of the virus. But the annual practice can also be annoying, as evidenced by the more than half of all Americans who skip it. Now, BBC reports that scientists may have discovered the key to a perennial preventative flu treatment hiding in an unlikely source: llama blood.

According to a new paper published in the journal Science, the tiny antibodies produced by llamas are better equipped to fight the influenza virus than the larger ones found in humans. When the flu virus enters your body, specialized white blood cells called B lymphocytes make antibodies to attack it; they glob onto proteins on the outside of the virus, marking it so the immune system knows what to eradicate. But this only works if the shape of the antibody fits the proteins on the outside of the virus. If the exterior of the flu virus has mutated since your last flu shot, your body may not be able to recognize and stop it.

Llama antibodies work a bit differently. They’re much smaller than humans’, which means they can reach the core of an influenza virus—a.k.a. the part that looks the same from strain to strain. If scientists can make a human antibody that functions the same way, they will essentially develop a one-size-fits-all treatment that could continue to be effective as years progress.

For their study, researchers from the Scripps Institute in California made a synthetic antibody that borrowed elements from some of the strongest flu antibodies produced in llama blood. After wrapping the antibodies’ genetic information in a harmless virus and infecting flu-sickened mice with it, the flu virus was stopped in almost every case. Only one of the 60 flu strains that were tested persisted, and it was one that doesn’t infect humans.

This flu “vaccine” isn’t really a vaccine at all—it’s more like gene therapy. Unlike current flu shots, it doesn’t have to train the body’s immune system to be effective, which would make it an especially appealing option for people with weakened immune systems like elderly patients. But human trials still need to be completed before the promise of a stronger, longer-lasting flu treatment becomes a possibility.

Source: Antibodies in Llama Blood Might Eliminate the Need for Yearly Flu Shots | Mental Floss

Medicine: My Sacrifice (A Letter to my Family) — Jessica K. Willett, MD

https://jessicakwillettmd.com/rabble-rabble/2017/3/26/7mkf3gvhl665ni3k294kako7g1742t

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