Categories

Category: Uncategorized

Will the Pharmaceutical Industry Learn From Past Mistakes?

Soeren MattkeAwash in negative headlines, public condemnation and government scrutiny, the pharmaceutical industry faces a public relations problem that, left untreated, could bring new regulations or sanctions either from governments or the courts. At the same time, though, the recent scandals over price gouging could offer an opportunity for responsible, research-based companies to distance themselves from the profiteers.

The industry has come under fire at a time of unprecedented innovation. As a physician who trained in the 1990s, I am in awe of the recent breakthroughs. Immuno-oncology drugs like Keytruda (pembrolizumab) and Opdivo (nivolumab) offer hope for patients with previously untreatable cancers. Entresto (sacubitril/valsartan) – the first novel treatment in over a decade for congestive heart failure, a condition deadlier than most cancers – was approved this year. There is a cure for many forms of Hepatitis C with Sovaldi (sofosbuvir) and vaccines for dengue fever and maybe even malaria may become available soon. More patients in developing countries than expected have access to antiretroviral drugs for HIV/AIDS and companies are devoting resources to achieving the same for the new scourge of noncommunicable diseases.

At the same time, some in the industry have been seeking to tackle the image problems. Overeager sales representatives are being reined in. Financial ties to physicians and clinical trial data are being disclosed. The main industry bodies in the United States, PhRMA and BIO, disowned Turing Pharmaceuticals, the company behind the notorious 5,000 percent price increase for Daraprim, a critical drug for certain infections in immunocompromised patients.

Continue reading…

The Unaffordable Care Act

Liberal public health advocates and left-of-center health policy wonks have long thought every American needs health insurance (they don’t, but that’s another discussion). Lefties assume health insurance is the only way Americans access medical care. After all, the purpose of the Affordable Care Act was to insulate Americans from the financial hardship of medical care they couldn’t afford to pay for out of pocket. Moreover, many pundits believe having to reach for one’s wallet during a medical encounter is unacceptable. So imagine my shock when I read a headline in  The New York Times claiming that Obamacare is no guarantee against crushing medical bills.

In a survey of non-seniors, the New York Times/Kaiser poll found about one-in-five people struggle with medical bills even though they have insurance. Among insured people who reported crushing medical debts, about three-quarters reported putting off vacations, major purchases and cutting back on household spending. Nearly two-thirds used up all or most of their savings. Far fewer had to resort to second jobs, take on more hours or ask family members for funds (42 percent to 37 percent).

Why are these insured Americans having to reduce their standard of living and, in fewer instances, having to resort to more drastic measures? Was it entirely because they’re sick? A common refrain among those struggling with medical bills was that money was tight prior to a family illness. This includes high-income households as well as low income households.

Continue reading…

FHIR: The Last, Best Chance to Achieve Interoperability?

Can an impassioned band of savvy, battle-tested techno-optimists save our healthcare system from its worst instincts, and deliver at least a soupcon of real interoperability?

That’s the question I found myself seriously contemplating after last week’s JP Morgan Healthcare Conference in San Francisco, and in particular after an inspiring data science roundtable discussion led by Aneesh Chopra (the first Chief Technology Officer of the United States, now at Hunch Analytics) and Claudia Williams, a senior advisor in the White House Office of Science and Technology Policy (OSTP).

The FHIR Engine

The (not so) secret sauce in question is the FHIR (pronounced “fire”) interoperability standard that has emerged from the non-profit HL7 organization, and functions as a universal adaptor, allowing some types of clinically-relevant data types to be shared easily and securely. Remarkably, most major electronic health record (EHR) vendors – including athenahealth ATHN +0.00%, Cerner CERN +0.00%, and yes, Epic — have signed onto this concept, and agreed to support an early effort at implementation, known as the Argonaut Project.

Continue reading…

Ann Marie O’Callaghan and Perjeta

Screen Shot 2016-01-20 at 5.10.39 PMA respected group of cancer specialists developed a chemotherapy program for a breast cancer patient. But then her insurance company denied the claim, so the cancer center stuck her with a bill three times as large as what they would have required from the insurance company.

In June of 2012 Ann Marie O’Callaghan got some of the most terrifying news a woman can get: she had breast cancer. Worse, Ann Marie was only 39 at the time and the oldest of her two children was about to go into kindergarten.

Cancers that strike young women can often be very aggressive, but fortunately there were proven treatments for her particular breast cancer. After six months of intensive chemotherapy her stage III tumor had shrunk to become a stage I tumor which could be removed by a simple lumpectomy. After she received local radiation treatment to her breast there was good reason to believe she might be cured.

Then, last summer, her cancer came back. It was only a small, locally recurring tumor, but any cancer that recurs is likely to be tougher to treat because it’s already learned to survive the original therapy. Ann Marie wanted to be able to raise her children, so she returned to the same specialists who had knocked her cancer back the first time.

Continue reading…

Should Companies Invest In a Chief Health Officer?

flying cadeuciiWhile employer-sponsored wellness, health promotion and disease prevention programs have been linked to “human capital,” talent recruitment and retention, improvements in employee morale, reductions in absenteeism, reductions in presenteeism and bending the curve of claims expense, should shareholders care?

After all, according to President Obama’s latest State of the Union Address, corporate America’s pursuit of profits have resulted in greater automation, less competition, loss of worker leverage and “less loyalty to their communities.” According to that narrative, employees are just another commodity on the road to total shareholder return.

Well, according to an expanding body of peer-reviewed scientific literature, shareholders should care.

The latest example of why is this publication by Ray Fabius and colleagues that appeared in the January issue of the Journal of Occupational and Environmental Medicine.

Continue reading…

EHR Incentive Programs: Where We Go From Here

Screen Shot 2016-01-19 at 8.34.45 AMAs we mentioned in a speech last week, the Administration is working on an important transition for the Electronic Health Record (EHR) Incentive Program. We have been working side by side with physician organizations and have listened to the needs and concerns of many about how we can make improvements that will allow technology to best support clinicians and their patients. While we will be putting out additional details in the next few months, we wanted to provide an update today.

In 2009, the country embarked on an effort to bring technology that benefits us in the rest of our lives into the health care system. The great promise of technology is to bring information to our fingertips, connect us to one another, improve our productivity, and create a platform for a next generation of innovations that we can’t imagine today.

Not long ago, emergency rooms, doctor’s offices, and other facilities were sparsely wired. Even investing in technology seemed daunting. There was no common infrastructure. Physician offices often didn’t have the capital to get started and it was hard for many to see the benefit of automating silos when patient care was so dispersed. We’ve come a long way since then with more than 97 percent of hospitals and three quarters of physician offices now wired.

Continue reading…

Is Health care Ripe for Disintermediation?

Ashton KutcherWhat do Ashton Kutcher, Donald Trump and Travis Kalanick have in common? They recognized an opportunity and used it to their advantage. That trend: disintermediation—the opportunity to deliver a product or service to a consumer with higher perceived value than an incumbent’s by changing the fundamental way it is delivered.

  • Kutcher made a major investment in Brian Chesky and Joe Gebbia’s start-up. The trio recognized that hoteliers who gouge patrons around peak events like the Super Bowl or conventions are vulnerable. They created Airbnb that provides overnight guests accommodations in private homes at half the price of a hotel’s rate. But Airbnb doesn’t own or operate a hotel room anywhere.1
  • Trump recognized that 70% of American voters say they’re independents or moderates and do not align with either party. Thus, he’s leading the GOP pack by appealing directly to voters while skirting traditional conventional campaigning and the traditional ground game in politics. And his style of straight talk and disdain for political correctness has tapped into a segment of public disdain for traditional politicians.2
  • Kalanick concluded that urbanites wanted convenient transportation service and millions who have cars wanted part-time income. With a $60 billion market cap after five years of operation, Uber is history’s most successful IPO. But Kalanick doesn’t own a fleet of taxis. 

Continue reading…

Bernie May Have a Point …

Screen Shot 2016-01-16 at 7.05.20 PM

It doesn’t seem likely that Senator Bernie Sanders will be our next president, but the current primary election campaign is throwing some pretty startling curveballs. With substantial popular support for one candidate with a fondness for the bankruptcy courts, and another who believes the pyramids were grain silos, a “democratic socialist” can’t be counted out.

In this world of the politically unexpected, Senator Sanders’ “Medicare for All” proposal for restructuring our healthcare system seems like something we should take seriously.

It’s a great slogan – a lot zippier than “Patient Protection and Affordable Care Act” — although the specifics are a little hazy. Senator Sanders has been promising since July to provide more details, but so far has provided only some tantalizing sound bites, like this one from his spokesman a week ago: “At a time when we are the only major country on earth that does not guarantee health care for all and when we spend far more per person that any other country, the time is long overdue for us to pass a Medicare for All, single-payer program. Medicare for All would save the average family thousands of dollars a year in health care costs…”

Most liberals would agree that one of the disappointments of the Affordable Care Act is its failure to assure universal coverage. We still have millions of uninsured and, with coverage increasingly expensive and deductibles skyrocketing, the number seems more likely to grow than decrease. In comparison, a totally tax-supported (as Senator Sanders has proposed in the past) Medicare for All model would bring the United States into line with other nations and protect millions from healthcare financial crises.

However, the claim that “single-payer… Medicare for All would save the average family thousands of dollars a year” is a lot more questionable.

Continue reading…

Risk Scoring and Value-based Payments Haven’t Worked: The Medicare Advantage Story

Mrs. Cassidy slowly walks into my office one busy afternoon.  I see her out of the corner of my eye because she is hard to miss.  Mrs. Cassidy has some serious style.  She has a deep orange dress with a bright blue blazer on.  There aren’t too many folks that can pull that outfit off, but she can.  She has a wide slow smile, and she speaks with a slow southern drawl that belies her southern roots.  This was supposed to be a routine follow up visit for a 67 year old woman with a history of a mechanical mitral valve replacement and coronary disease.

Unfortunately, she tells me a story that is concerning for angina.  I think she needs a stress test. I slide over to the insurance tab on the EMR and I let out a somewhat audible groan.  She has a Medicare Advantage (MA) plan.  I explain to Mrs. Cassidy that we will need to go through an extra step to pre-certify her stress test.  She expresses surprise and asks me what she should do.  I will tell you what I told her, but first, let me tell you why.Continue reading…

Toyota-ism vs Taylor-ism

flying cadeuciiIf you’re new to the idea of “Lean,” I invite you to download and read chapter 1 of my book Lean Hospitals.

Hat tip to Suresh for pointing me toward this article that was just published January 14th in the New England Journal of Medicine: “Medical Taylorism

NEJM is the same journal that published Dr. Don Berwick’s article about Kaizen and Dr. Deming in 1989, how those concepts would be helpful in healthcare. Dr. Berwick realizes, as he talks about in that article, that not all factories are the same. Some are managed better than others. Employees are treated better in the “Lean” factories. Berwick was right to point out that medicine can learn from other industries… but that doesn’t turn the hospital into an assembly line.

In the article posted this week, Pamela Hartzband, M.D., and Jerome Groopman, M.D. (the later the author of the popular book How Doctors Think), rant about all sorts of things… some of which have nothing to do with Lean.

“Advocates lecture clinicians about Toyota’s “Lean” practices, arguing that patient care should follow standardized systems like those deployed in manufacturing automobiles. Colleagues have told us, for example, that managers with stopwatches have been placed in their clinics and emergency departments to measure the duration of patient visits. Their aim is to determine the optimal time for patient-doctor interactions so that they can be standardized.”

This is wrong headed and insulting toward Toyota. I’m pretty sure Toyota would not alienate physicians or other healthcare professionals this way.

Continue reading…

assetto corsa mods