Tuesday, December 11, 2018

What Happens when Big Pharma "Exploits" the Opioid Epidemic for Financial Gain? Kaleo Is Doing It.

The opioid crisis has grown exponentially - ravaging communities and taking an estimated 64,000 lives each year – escalating into a public health epidemic. In response to the increased availability of synthetic opioids like oxycodone and fentanyl, the Surgeon General called for expanded access to the opioid overdose antidote, naloxone, by using the slogan:  Be Prepared. Get Naloxone. Save a life. 

Naloxone is a compound which can literally cheat death, however due to price increases of up to 600%, public agencies are unable to afford to supply their first responders despite a federal mandate to do so.  According to data collected by the FDA, the price of generic naloxone—made by Hospira -- jumped by 50% in January 2014.  Amphastar, the producer of a product that can be used intranasally, doubled their price recently.  And Kaleo, which developed an ingenious “talking” naloxone auto-injector, known as Evzio, increased their price from $575 at market entry to $4500 for a two-pack.

While the government could use existing legal authority to slash prices for the lifesaving naloxone, there is more to reducing drug costs than meets the eye.  Medicare is legally prohibited from negotiating prices with drug companies. By employing a sales force to encourage doctors to sign off on paperwork that Evzio was “medically necessary”, Kaleo forced insurers and the federal government to foot the bill–Medicare shelled out $142 million for Evzio over the last 4 years—due to exorbitant price increases.

Secretary Alex Azar is contemplating removing the “safe harbor” provision, which was added to the anti-kickback statute of the Social Security Act by Congress in 1987.  The provision was designed to support group purchasing organizations, or GPOs, which got their start at the turn of 20th century as hospital cooperatives. GPOs, it was thought, could score better deals by buying medications in bulk, bringing down health care costs by negotiating discounts with drug manufacturers. 

But that’s not what happened.

Instead, the safe harbor provision led to an institutionalized system of “pay-to-play” corruption that would be illegal in any other industry. With only four GPOs supplying virtually all U.S. hospitals, the competition to secure the exclusive right to supply each of those hospitals with any given drug is fierce – and, thanks to the safe harbor provision – dirty. Under the provision, pharmaceutical companies are forced to pay what amounts to kickbacks to GPOs to win coveted supply contracts.

Drug shortages result because there’s little incentive for drug companies to continue producing a particular drug after their competitor wins the lucrative GPO supply contract. Relying on the lone contracted manufacturer then increases the chance of experiencing a dangerous drug shortage.

In 2005, a bipartisan bill to repeal this obscure provision was drafted by Senators Herb Kohl (D-WI) and Mike DeWine (R-OH), but the legislation died in Subcommittee and has not been resurrected.   Congress is well aware of the risk the safe harbor provision poses to the American people, yet have proven loathe to act.  Why?

The answer lies in the power of the pharmaceutical lobby, which spent $171.5 million in 2017 and boasts two lobbyists for every member of Congress. Nine out of 10 members in the House and 97 of 100 U.S. senators accepted campaign contributions from pharmaceutical companies seeking to impact legislation, including both senators from Washington State. (As the ranking member on the Senate’s committee on Health, Education, Labor and Pensions, Sen. Patty Murray has yet to formally weigh in on the issue safe harbor repeal).

Return on investment for big pharma lobbying efforts has resulted in nothing short of a windfall.  By ramping up lobbying in 2008, Mylan –of Epi-Pen autoinjector fame—garnered legislation mandating the placement of epinephrine autoinjectors in every school in America.   By the time President Obama signed the “EpiPen Law” in 2013, known as the School Access to Emergency Epinephrine Act, Mylan secured themselves a market monopoly.

Initially, Kaleo created an Epi-Pen alternative to compete with Mylan, but soon set their sights on a more lucrative, not-yet-exploited niche: the opioid crisis.  Company documents demonstrate the Kaleo business model was restructured to “capitalize on the opportunity” of “opioid overdose at epidemic levels.”  Naloxone --the lone antidote -- costs less than ten cents to produce, yet has become cost-prohibitive to public agencies.

Using the Mylan roadmap, Kaleo successfully lobbied the FDA for approval of their device for consumer use,  then increased the price substantially.  By the time fifty states enacted laws mandating law enforcement and first responders to carry naloxone to treat opioid overdoses, Kaleo secured a market monopoly of their own.   The drug supply landscape is more of a coercive monopoly: the fees “kicked-back” to the GPOs are based on a percentage of the charges; higher prices are in the best interest of the pharmaceutical companies and the GPOs alike. 

The bottom line is opioids are costing too many American lives. Congress has the power to alter the course of the worst public health crisis facing Americans by reigning in the pharmaceutical industry through legislative intervention.  Removing “safe harbor” provision of the Social Security Act could save up to $30 billion annually and save 47 Americans from opioid overdose deaths per day.  We must push lawmakers to close the pharmaceutical industry loophole before it is too late. 

Tuesday, November 27, 2018

Will the CVS-Aetna Merger Give Aetna Freedom to Kill?

The United States has a worldwide reputation for litigiousness. And it seems like just about everyone the world over is familiar with that anecdote about the woman who won millions after suing McDonalds because their coffee was too hot. (Never mind that coffee is expected to be hot as molten lava.)

But there’s one thing we never see in our notoriously litigious country: Patients and their families suing their health insurance companies over their profit-driven decisions to deny potentially life-saving treatments.

That is, we never used to, until a recent case turned that notion on its’ head.

Recently, a jury in Oklahoma City ordered insurance giant Aetna to pay $25 million to the family of Orrana Cunningham, an Aetna customer who died of cancer after the company refused to cover radiation therapy. “The jury ruled that Aetna recklessly disregarded its duty to deal fairly and in good faith with Cunningham,” according to a Nov. 10 article by the Associated Press.

Cunningham was diagnosed with Stage 4 nasopharyngeal cancer, a rare type of head and neck cancer that starts in the upper reaches of the throat. Her physicians prescribed proton beam therapy, a form of radiation that would attack the tumor accurately enough to reduce her risk of serious complications, such as blindness. 

The treatment had been approved by the Food and Drug Administration and was covered by Medicare.  However, Aetna declined to cover it, after three separate medical directors alleged this treatment was “experimental.” To save the love of his life, Orrana’s husband of 28 years, Ron Cunningham, a retired Oklahoma City firefighter, mortgaged their home and set up a GoFundMe page to raise the $92,082.19 needed to pay for the treatment. But it was too late. Before the family raised that prodigious sum, Orrana Cunningham died of a viral brain infection on May 30, 2015.

But before passing away, Orrana filed suit against Aetna for “bad faith,” as part of her fruitless attempt to force the insurer’s hand. After her death, Ron decided to proceed with the suit, taking Aetna to court. 

At trial, all three medical directors acknowledged they’d spent more time preparing for the lawsuit than they had on the decision to deny Ms. Cunningham’s life-saving medical treatment. Still, Aetna’s attorney, John Shely, thanked the medical directors personally for denying Orrana’s coverage and in closing arguments, went so far as to say he was proud of their decision.

While Aetna has vowed to appeal the ruling, Ron Cunningham’s attorney, Doug Terry, said he hoped the case would prove a watershed. “We believe this case pulled the curtain back on what goes on at a health insurance company when claims are being denied,” he told reporters.

One can only hope, as, tragically, Orrana Cunningham’s case is anything but unusual.

Insurers in the U.S. deny coverage for life-saving treatments on a daily basis, and our legislation doesn’t hold the insurance companies or their medical directors -- those who make the ultimate decision after coverage denials are appealed--accountable. 

Take any run-of-the-mill practicing physician like me, for example. If an improper medical decision on my part results in the death of my patient, I could have my medical license suspended or even revoked – not to mention facing the possibility of a malpractice suit.

Ironically, medical directors at insurance companies ––almost invariably licensed medical doctors -- face no consequences when their poor medical decisions harm or even kill patients. It may seem like common sense that physicians employed by insurance companies should be charged with unprofessional conduct when the medical decisions they make fail to meet the standard of care, but the fact is they rarely, if ever, are.

That’s because, unfortunately, health insurers fall outside the jurisdiction of state Medical Boards and are overseen by the Office of Insurance Commissioner (OIC) in each state, an entity with more bark than bite. 

Last year, California's Office of the Insurance Commissioner launched an investigation on Aetna after learning their former medical director, Dr. Jay Iinuma, admitted under oath that he never reviewed patients’ medical records when deciding to approve or deny care for patients.  Despite the outrageous admission by the medical director, California signed off on the Aetna-CVS merger last week, meaning there will be little more than a slap on the wrist for Aetna or their employed physician.

Insurance companies and the paper-pushing physicians in their employ have a clear conflict of interest: They’re job is to watch out for the company’s bottom line by signing off on the denial of costly treatments, regardless of whether those treatments could save patients’ – their customers’ - lives.

Hopefully, the stunning Orrana Cunningham decision has put us on a path toward increased insurer accountability. With Aetna’s $69 billion megamerger with pharmacy giant CVS Health expected any day now, the stakes have never been higher.

Tuesday, November 13, 2018

Why Affordable Housing Matters in Health Care.

Whether we recognize it or not, we’re in a housing affordability crisis.  Over a third of households in the U.S., carry a shelter burden that is beyond the standard of affordability – that is, costs usurp more than 30% of monthly income.  Locally, rents have increased by 50% over the last 5 years and more startling, the number of evictions has grown by 90% in the last 3 years.   Wages aren’t keeping up with costs.  The tipping point of housing instability comes when there is a health crisis, loss of employment or reduction in hours, rent increase, expensive car repair, or any combination of these unanticipated or unwanted life events.

Why do I, a columnist usually sharing a perspective from my medical expertise, bring these statistics up? Because if we cannot provide an adequate supply of safe, affordable housing in this community, we are wasting time trying to reform health care.

Health care and other social services can improve life outcomes for individuals and families, but stable and affordable housing must be the platform where it begins.  Research supports a critical link between affordable housing and health outcomes.  In 2016, the Providence Center for Outcomes Research and Education found that health care costs were 12% lower after individuals moved into affordable housing; study subjects were 20% more likely to go see their primary care physician and 18% less likely to visit the emergency room. 

The Olympic Region -which includes Kitsap County- leads the state in number of Medicaid patients visiting the Emergency Department unnecessarily.  While the state average is 436.8 visits per 1000 patients, the average in the Olympic region is 617.6 per 1000, fully 41% higher.  

Is this a result of poor-quality health care?  No.  We believe it is a direct result of food insecurity combined with a dearth of affordable housing in our community.

Affordable housing frees up financial resources for nutritious food, adequate clothing for growing bodies, and ultimately results in a healthier mothers and children – saving money for both the family and society in the long-term.    

Critics say government-subsidized housing is detrimental to the economy and individual freedom. However, this column’s co-author, Kurt Wiest of Bremerton Housing Authority, and I have seen the lives of families literally transformed by obtaining a stable residence.  We have also witnessed the fear on a child’s face when they are told they must sleep in a car one more night.  We cannot impact the health of a child without placing it in the context of stable housing.

Affordable housing --where the cost of shelter is at or below 30% of household income-- reduces family stress and related adverse childhood experiences (ACEs).  Children who move frequently, are forced to double up in small living spaces, or face eviction can be traumatized by the experience. Studies demonstrate these children are more likely to suffer from mental health disorders, developmental delay, learning disabilities, and are hospitalized for illness more often.  Children experiencing housing instability are four times more likely to be sick than their same-aged counterparts. 

Well-constructed and maintained housing reduces the health problems by reducing the risk of overcrowding and in turn, decreasing the spread of infectious diseases.  In Kitsap County, there are many families living in homes overrun with mold, dust mites, or rodents. Those without the option of affordable housing often face substandard living situations with increased risks of accidental injury to children.  Affordable housing can improve health outcomes for those with chronic disease simply by providing a consistent environment in which to deliver health care.

Finally, affordable housing allows women and children to leave abusive situations.  Domestic violence is one of the leading causes of homelessness for women and their children.   The rate of women returning to their abusers is inversely correlated with the availability of affordable housing.  Adverse childhood experiences, such as physical or emotional abuse, have life-long impact on health and life expectancy. 

The gap between survival and self-sufficiency continues to widen.  The federal poverty line for a family of 4 is $24,600, however, “self-sufficiency” in Kitsap County during 2017 required $59,075.  The average monthly rent in Kitsap County is now $1,350.  To meet the 30% threshold, a householder must earn nearly $25 per hour, working 40 hours a week, 52 weeks a year. 

For those adults with children working minimum wage jobs, public supports, such as child care assistance and federally subsidized housing, can help families meet their basic needs.  If we are to make a difference in the health of individuals and families in Kitsap County, we must address the supply of safe, decent, and affordable housing.   Health outcomes and housing stability are inexorably connected. Without investing in affordable housing first, quality health care that’s available to all is just a pipe dream. 

Tuesday, October 30, 2018

2018 Midterm Election: The Year of the Female Physician

While women make up more than half of the U.S. population, an imbalance remains between who we are as a nation and who represents us in Congress. The gender disparity is no different for physicians; more than a third of doctors in the U.S. are women, yet 100 percent of physicians in Congress are men. To date, there have only been two female physicians elected to Congress.

But in the coming midterm election there are six races with a chance at making history. It's these battles which could make 2018 "The Year of the Female Physician."
I remember being a first-time voter in 1992, labeled at the time "The Year of the Woman." I was a sophomore at Michigan State University and turned 18 just three days before the election. Following the contentious Supreme Court hearings involving Clarence Thomas and Anita Hill, an unprecedented number of female candidates were vying for office that election year.

President George H.W. Bush was vilified for an appalling answer to the question of when his party might nominate a woman for President. “This is supposed to be the year of the women in the Senate," he quipped. "Let's see how they do. I hope a lot of them lose." Frustrated about the state of gender inequality in politics, a little known “mom in tennis shoes,” Patty Murray, decided to run for the U.S. Senate to represent Washington. She won, paving the way for an unprecedented number of women to enter national politics over the next 30 years. Yet very few of them have come with a background in medicine.

Since 1960, just 49 physicians have been elected to the U.S. House or Senate.  Currently there are 15 physicians serving in Congress, 13 of whom are Republican and all of whom are men. Technically, the first female physician to win a congressional election was a non-voting delegate from the Virgin Islands, Rep. Donna Christian-Christensen. The only two voting members were former Reps. Nan Hayworth of New York and Shelley Sekula-Gibbs of Texas, both Republicans.

In 2018, eight Democratic female physicians ran for Congress: Dawn Barlow (TN-6), Kyle Horton (NC-7), Danielle Mitchell (TN-3), Hiral Tipirnini (AZ-8), Jennifer Zimmerman (FL-1), Shannon Hader (WA-8), Kim Schrier (WA-8), and Nadia Hashimi (MD-6). After state primaries, six remain in contention for Congressional seats. Here's who they are, and what their election could portend.

Dr. Dawn Barlow is an internal medicine physician running in Tennessee’s 6th Congressional District. She is married to an Iraq War veteran and hopes to improve the health of veterans. She supports preserving the 10 essential benefits of the ACA, Medicaid expansion and a single-payer system.

Dr. Kyle Horton is an internal medicine physician running for the seat in North Carolina’s 7th District. She wants to lower the Medicare age to 50 and provide universal health coverage though public option coverage that can be purchased. Her focus is to reduce pharmaceutical costs, expand Medicaid and Medicare, and fund the Children's Health Insurance Plan (CHIP.)

Dr. Danielle Mitchell is a family physician running in Tennessee’s 3rd. Raised in poverty, she lost her 12-year-old brother to a life-threatening, though treatable, medical condition due to inability to afford health coverage. She supports universal health care, the preservation of Medicare and Medicaid, and making pharmaceuticals more affordable.

Hiral Tipirnini, MD a candidate in Arizona's 8th District, is an emergency physician who supports repairing the ACA, rather than repealing it. She wants those under 65 to “buy-in” to Medicare and feels free market competition the best way to reign in healthcare costs.

Jennifer Zimmerman, MD, is a pediatrician and Filipino immigrant who is running in Florida’s 1st District. Her campaign slogan is apropos: “This woman can.” Having faced adversity in her formative years, she believes in Medicare and Medicaid expansion and universal healthcare.  

One of this years’ most watched races is in Washington State’s 8th District, where Dr. Kim Schrier is vying for the open seat vacated by Rep. Dave Reichert. Dr. Schrier is a physician, wife, and mother, with a broad view of the world; but, she is also a patient who was diagnosed with Type I Diabetes as a teenager.

Her academic resume is impressive. Despite having chronic disease, she earned an Astrophysics degree from UC Berkeley, finished medical school at UC Davis, and did residency at Lucile Packard Children’s Hospital at Stanford, one of the top pediatric programs in the country. She lacks deep political ties, not unlike Sen. Murray did once upon a time. Practicing as a pediatrician in Issaquah for the past 16 years lends a unique perspective — one currently missing — when Congress debates issues of women’s healthcare, reproductive rights, and children’s health. Her steely resolve to strengthen our healthcare system so every person has access to affordable, high-quality care is one ideal the nation should endorse.

Physicians are experts on the implementation of policies which facilitate an effective healthcare system. These six female physicians have the knowledge, intelligence, and determination that Congress and the nation need. I, for one, plan to keep my fingers crossed that these female physicians make history on election night.     

Tuesday, October 16, 2018

The Reasons Childbirth is safer in Libya than the United States.

Maternal mortality can seem like a throwback to the Victorian era, a bygone relic of a time before modern medical technology turned childbirth from a dicey, high-stakes gamble into an anodyne rite of passage. I must admit that until recently, I, a practicing pediatrician, agreed with this view – despite the fact that my great-grandmother died in childbirth and my grandmother nearly suffered the same fate. But statistics on childbirth and the local case of a 2014 death at Naval Hospital Bremerton, back in the news just this week, remind us of the risks that still exist to a high degree in our developed world.

According to the World Health Organization, the global maternal mortality rate has fallen by 44 percent in since 1990, with 157 of 183 countries tracked by the organization experiencing a decrease between 2000 and 2015. The United States, however, was not among those 157 countries.

During the same period, the U.S. maternal mortality more than doubled, skyrocketing from 9.8 to 21.5 maternal deaths per 100,000 live births. That’s six times higher than most Scandinavian countries and three times higher than Canada and the United Kingdom. In the U.S., around 700-900 women die and another 65,000 experience life-threatening complications during or after childbirth. By any standard, the U.S. has the worst performance on this crucial measure of any country in the developed world. 

And while complications from pregnancy and childbirth can, of course, strike women of all backgrounds, maternal mortality in the U.S. afflicts certain demographics --African Americans, low-income women and those living in rural areas-- much more than others. According to the Centers for Disease Control, the maternal mortality rate is three times higher for African American women than white women. (40.0 vs. 12.4 deaths per 100,000 live births in 2011-2014.) 

To make matters worse, research done by the CDC Foundation determined up to 60% of these maternal deaths were preventable.

These stats got me thinking: Seeing that maternal mortality clearly remains a serious problem, why are we taking a head-buried-in-the-sand approach? (The most recent nationwide maternal mortality statistics date from 2007.) And how can childbirth in the U.S. become equally as safe as it is in Libya or Vietnam? 

Since 2006, the state of California has been working with Stanford University School of Medicine to buck the status quo, by starting the California Maternal Quality Care Collaborative (CMQCC), aimed at developing best practices to reduce maternal mortality.  The medical director at CMQCC, Elliott Main, formed a review board made up of concerned doctors, nurses, midwives, and hospital administrators to analyze root causes of mortality and propose solutions. Through their work, it quickly became apparent that hemorrhage and preeclampsia were the most common preventable causes of maternal death.

While hemorrhaging is associated with such risk factors as delivering twins or having multiple pregnancies, as many as one-third of mothers don’t fit into a risk profile. This means that a life-threatening hemorrhage – which can be lethal in under five minutes-- often comes on suddenly making time, of the essence. The maternal mortality review board found that obstetric teams were often unprepared to deal with unexpected hemorrhaging and wasted precious time searching for the drugs and supplies needed to staunch bleeding. 

Hopsitals have had “code carts” for decades - wheeled contraptions stocked with basic equipment necessary to resuscitate patients - so why, the mortality review team reasoned, don’t obstetric units have “hemorrhage carts” to keep all the emergency supplies in one easy-to-reach place?

The CMQCC team also took umbrage with the tried and true practice of eyeballing maternal blood loss. There are better, more objective ways of measuring real blood loss. They recommended that obstetric teams weigh the pads and sponges they use to collect blood before and after they are soaked to quantify the exact volume of blood loss and therefore replace losses when necessary.

Another top maternal killer, a condition called preeclampsia, is highly treatable, if caught early and treated aggressively. However, it’s been shown that in fatal cases, healthcare providers fail to do either. In 2014, CMQCC developed a “preeclampsia toolkit” calling for more careful monitoring of blood pressure and swift administration of magnesium sulfate and anti-hypertensive medications when vital signs indicate abnormal blood pressure readings.

While data evaluating effectiveness of CMQCC’s approach has yet to be published, among the 126 hospitals taking part in the group’s maternal hemorrhage and preeclampsia projects, maternal morbidity fell by 20.8 percent between 2014 – 2016. And overall, their efforts are credited with helping the state of California reduce its maternal mortality rate by 55 percent from 2006-2013. The state’s rate dropped from 16.9 to 7.3 per 100,000, even as the U.S. maternal mortality rose from 13.3 to 22.0 per 100,000 during the same period.

Though, in Washington State, our maternal mortality ratio has held steady at 9.0 per 100,000 births for years, we too stand to learn from California’s example.  Childbirth is no party.  It can be one of the riskiest endeavors women face in their lifetime.  We must mobilize our health providers, policy-makers, and communities to do better. With increased awareness of maternal mortality– and tangible, targeted actions to ensure pregnant women receive the highest quality care– many fatal and near-fatal outcomes can be avoided.

Tuesday, October 2, 2018

Can Physicians Push Back Against Big Pharma?

A few weeks ago, I saw a young patient who was suffering from an ear infection. It was his fourth visit in eight weeks, as the infection had proven resistant to an escalating series of antibiotics prescribed so far. It was time to bring out a heavier hitter. I prescribed Ciprofloxacin, an antibiotic rarely used in pediatrics, yet effective for some drug-resistant pediatric infections.

The patient was on the state Medicaid insurance and required a so-called prior authorization, or PA, for Ciprofloxacin. Consisting of additional paperwork that physicians are required to fill out before pharmacists can fill prescriptions for certain drugs, PAs boil down to yet another cost-cutting measure implemented by insurers to stand between patients and certain costly drugs.

The PA process usually takes from 48-72 hours, and it’s not infrequent for requests to be denied, even when the physician has demonstrated an undeniable medical need for the drug in question.

I saw my patient with the persistent ear infection on a Thursday afternoon. It would be Monday, at the very earliest, that his Ciprofloxacin prescription could be filled – provided the insurance company granted my PA request.  Because he needed the drug as soon as possible, the patient’s mother and I called the pharmacy to see how much a 100ml bottle of Ciprofloxacin would cost if she were to pay out of pocket. The answer was $135 – an almost unthinkable sum for a single mother of three who was working two jobs to make ends meet.

That’s when my frustration led to a breakthrough.

My grandfather was a general practitioner who prepared medications from the “virtual pharmacy” that lined his office walls in order to send patients home with medically-necessary medications.  Washington State allows physicians to dispense medications directly to patients, just as most general practitioners did well into the 1960s.

As my patient and his mother waited, I contacted Andameds, one of the country’s largest distributor of wholesale generic drugs.  I was told that the same 100 ml bottle of Ciprofloxacin that would have cost $135 at the pharmacy could be purchased directly by me for under $20. It arrived at my office the next day, and I sold it to my patient’s mom at cost, thus bypassing the insurer and the pharmacy benefit manager (PBM) entirely. 

Bypassing both the insurer and PBM entirely will soon take on a great deal of significance to physicians and their patients. 

The PBMs are essentially middlemen, who go between pharmaceutical companies and insurers, negotiating lower prices for drugs bought in bulk and passing much of those savings on to the insurance company. (They make their money on the margin between what the pharmaceutical companies charge for the drugs and the slightly up-charged price PBM’s charge the insurance companies.)  According to recent disclosures, CVS and Express Scripts—two of the largest PBM’s in the nation – are passing 95-98% of the rebates they receive from the drug manufacturers on to the insurers. 

While it is not clear exactly what insurers are doing with the revenue generated through drug rebates, it is obvious why a merger between CVS and insurance giant, Aetna, might be so lucrative.  If the Department of Justice approves this merger of titans, it will surely pave the way for another, between insurance behemoth Cigna and Express Scripts - which is, along with CVS and OptumRx, one of the Big Three in pharmacy benefit management entities.  After merging into one entity, it is conceivable that Aetna-CVS and Cigna-Express Scripts will control price, access, and distribution of drugs for the majority of the U.S. population. 

Purchasing generic medications through Andameds allows me to bypass the insurer and the PBM, and purchase Epi-Pens for $300, compared to the $600 retail price; Amoxicillin suspension for $2 per bottle, compared with $15; and just about any other generic medication for pennies on the dollar. 

Darwin said, “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change.”  At the rate we are going, a bottle of Amoxicillin suspension will soon cost more than $1000.  With the pharmaceutical industry poised to become increasingly vertically integrated, this sort of direct distribution of medications by independent physicians, like me, can be an efficient and effective way to get necessary drugs into the hands of patients who need them at prices they can afford.  

Tuesday, September 18, 2018

Prior Authorizations: Who is Responsible for the Death of a Patient when Insurers Practice Medicine?

In July, 2009, the family of Massachusetts teenager Yarushka Rivera went to their local Walgreens to pick up Topomax, an anti-seizure drug that had been keeping her epilepsy in check for years. Rivera had insurance coverage through MassHealth, the state’s Medicaid insurance program for low-income children, and never ran into obstacles obtaining this life-saving medication.
But in July of 2009, she turned 19, and when, shortly after her birthday, her family went to pick up the medicine the pharmacist told them they’d either have to shell out $399.99 to purchase Topomax out-of-pocket or obtain a so-called “prior authorization” in order to have the prescription filled.
Prior authorizations, or PAs as they are often referred to, are bureaucratic hoops that insurance companies require doctors to jump through before pharmacists can fulfill prescriptions for certain drugs. Basically, they boil down to yet another risky cost-cutting measure created by insurance companies, in keeping with their tried-and-true penny-pinching logic: The more hurdles the insurance companies places between patients and their care, the more people who will give up along the way, and the better the insurers’ bottom line.
PAs have been a fixture of our health care system for a while, but the number of drugs that require one seems to be escalating exponentially. Insurance companies claim that PAs are fast and easy. They say pharmacists can electronically forward physicians the necessary paperwork with the click of a mouse, and that doctors shouldn’t need more than 10 minutes to complete the approval process.
But in my experience, that’s rarely the case. In order to get my patients the drugs they need, I regularly spend more than half an hour on the phone with ill-trained customer service reps who don’t know the first thing about pharmaceuticals and whose job description consists of being as obstructionist as possible.
And I’m not alone. A video by an independent physician with a sense of humor documented his Kafka-esque bid to obtain a PA for a patient. The video lasts 21 agonizing minutes. And studies have shown that PAs gobble up at least 20 hours per week in the average physician’s office. Even in an age when many aspects of practicing medicine in the United State have become nightmarish, PAs hold a place of particular sinister distinction.
Now, back to the Rivera case in Massachusetts. After Walgreens declined to fill Yarushka’s Topomax prescription, her family returned to the pharmacy four more times –each time without success. (It’s unclear whether or not Walgreens ever actually sent an authorization request to the physician’s office.)
Without the drug she’d relied on for years, Yarushka had three seizures. The last one proved fatal.
Her grief-stricken family subsequently filed a wrongful death suit – not, as might be expected, against the insurance company that required the PA in the first place, but rather against Walgreens, Yarushka’s physician and his practice.
To my mind, this case gets it all wrong, and in so doing, potentially dangles Damocles’ sword over the heads of each and every physician and pharmacist practicing in the United States today. The fact is that both Yarushka’s doctor and the Walgreens pharmacist did their jobs: Her physician issued a prescription for the life-saving anti-seizure drug, and the pharmacist tried to dispense the medication. It was Yarushka’s insurance company — not the physician or the pharmacist — that was the monkey wrench, arbitrarily denying coverage for her medication without any reasonable justification. 
Medical malpractice is defined as negligence by act or omission in cases where the prescribed treatment fell below the accepted standard of practice and caused injury or death. In the Rivera case, MassHealth alone created the barrier between Ms. Yarushka and her life-sustaining medication.  The insurance company was, effectively, practicing medicine without a license. And it alone should be held accountable for the tragically predictable outcome after overriding the sound judgement of her physician and pharmacist. 
But because of a legal doctrine called sovereign immunity, which shields states from civil or criminal prosecution, it’s highly unlikely that MassHealth, a state-run insurer, will ever face legal consequences from the Yarushkas — or any other, for that matter. How many more patients have to die before we force insurers to prioritize patients over profit?
The Rivera case is still winding its way through the court system in Massachusetts, but a verdict against Walgreens will open a Pandora’s box for medical professionals across the country, effectively holding them legally liable for the decisions and practices of an all-powerful third party that’s under no obligation to follow their medical recommendations. If MassHealth is not held accountable for causing the wrongful death of Yarushka Rivera, then more insurers will be emboldened to practice medicine without a license, which will surely lead to the deaths of countless other patients nationwide.