BY THCBist
— Should We Fear an Amazon Monopoly on Healthy Food?
— On the Ethics of Accountable Care Research
— Confessions of a Healthcare Super User
— How Can I Tell If Medical News is Fake or Not?
— A Mystery Mission in LA: Aetna, Apple and a Vision of Digital Health’s Future Part I
— Dear Humans, Diverse Social Networks are the Answer
— Our Guide to Pre-Approval Access to Drugs for Both Patients and Doctors
We do things differently at the 11th Annual Health 2.0 Fall Conference. We’ve deliberately curated a wide-ranging, hands-on, attendee-driven experience that focuses on achieving the possible. Check it out:
Check out the latest from such companies as Headspace, Google Play, Welltok, and Microsoft. Want to see what’s really brand new? Check out Launch!
Register today before rates increase by $200 after tomorrow!
By ALISON-BATEMAN HOUSE
In April 2016, I published guidance, in the form of a mock case study, on how to access a drug before it has been approved by the FDA—what’s known as pre-approval (or expanded or compassionate) access. This is an updated version of that guidance, reflecting multiple important changes in the pre-approval landscape over the past year. In particular, the FDA rolled out a new, streamlined form for single-patient requests, and Congress passed the 21st Century Cures Act, which, among many other things, mandated that certain pharmaceutical companies provide public information about their pre-approval access policies.
Patients (and physicians) trying to access an unapproved drug outside of a clinical trial can feel as though they’re navigating uncharted waters. Many physicians don’t know that the FDA permits the use of unapproved drugs outside of clinical trials; those who do know often have no idea how to access such drugs for their patients. Those physicians who know about pre-approval access are largely specialists in certain areas—often, oncology or rare diseases—and they are generally self-taught: they didn’t learn about pre-approval access in medical school or in their residencies. Thus, while some physicians have become very accustomed to requesting pre-approval access to drugs, the majority lacks this knowledge. In this essay, I use a fictional case to trace the process for requesting access to an unapproved drug. I hope to explode several myths about the process, especially the beliefs that the FDA is the primary decision-maker in granting access to unapproved drugs and that physicians must spend 100 hours or more completing pre-approval access paperwork.
Imagine you are a physician, and you have a pregnant patient who has tested positive for the Zika virus. She is only mildly ill, but she’s terrified that the virus, which has been linked with microcephaly and other abnormalities, will harm her unborn child. She’s so concerned that she is contemplating an abortion, even though she and her husband have been trying to have a child and were overjoyed to learn she was pregnant.
Bright ideas are nothing without those who enable action. For every bright idea in the digital health space, developers are needed to turn that idea into a reality. We’ll be kicking of this year’s Annual Health 2.0 Fall Conference on October 1st (1-5pm) with Dev Day, a day dedicated to the developers, data scientists, and coders in the health tech space.
Expect your day to be filled with strong technical sessions in relation to interoperability and user testing, as well as opportunities to meet and learn from others in the industry. We’ll be showcasing the latest developer product and platform updates and chatting about exciting plans on the horizon for innovators working on blockchain, artificial intelligence, and FHIR.
Continue reading…
There is a grassroots movement, 4300 strong, known as “Save Our Hospital” gaining notoriety in Albert Lea, Minnesota. This story is symptomatic of the fact that hospital consolidation has slowly become a national pastime. With declining revenue under the Affordable Care Act, mergers increased by 70%, leaving small communities scrambling for healthcare access. The latest casualty in the ‘hospital-consolidation-for-sport’ trend is Albert Lea, a small city located in Freeborn County, Minnesota.
Known affectionately as the ‘Land between the Lakes,’ it has a population of 18,000 spread over 14 square miles. Not surprisingly, Mayo is their largest employer; the 70-bed hospital serves almost 60,000 in a region including patients who live in Iowa. In Rochester, MN, the Mayo Clinic is regarded by many as one of the premier medical facilities in the country. Originally of humble origins, founder William Mayo opened a practice during the Civil War and later, passed it down to his sons; today, the Mayo Clinic flagship is located in Rochester, Minnesota and plans to become a renowned premier medical destination for the world.
Corporations with such lofty ambitions tend to make “small” sacrifices along the way; often, on the back of a beloved rural town. On June 12, Mayo clinic administrators announced they would transition all inpatient services to Austin, more than 20 miles away. Mayo cited ongoing staff shortages, reduced inpatient censuses, and ongoing financial difficulties as their reasons for hospital closure. Rural care was mentioned to be at a crisis point, which is an altogether callous assessment of the troubling situation facing communities across this country.
By RICHARD DUSZAK, MD
The online membership forum of the Society of Interventional Radiology (SIR) blew up this week in response to an email announcement by the American Board of Radiology (ABR) that it will effectively be doing away with lifetime diagnostic radiology certificates for interventionalists whose original certificates pre-dated the introduction of time-limited certificates. Interventionalists were given two choices:
1. You can keep your lifetime diagnostic certificate if you give up your (earned) interventional subspecialty certification, or
2. You can keep your interventional certification, if you give up your lifetime diagnostic certification.
Talk about choice.
Kip Sullivan posted an op-ed in “The Health Care Blog,” “On the Ethics of Accountable Care Research,” on August 25, 2017.
Mr. Sullivan’s questioning the ethicality of health system generated research papers touting statistically insignificant results as triumphs, while perfectly valid and well-reasoned, is like questioning the validity of a teacher’s grading curve while missing that the class is gaming the system.
A system ginned up in the only policy factory in the country with policy-makers naïve enough to actually believe that hospital systems would actually cannibalize their core business to split the results with CMS, then split a legally mandated two thirds with the doctors, then pay its costs out of the rest, would ever work. Commercial payers do it, too, but for far more practical reasons.
The Accountable Care initiative, far more vulnerable than Obamacare, is being circled as easy prey for elimination by D.C. policy lions and pundits. It is undeserving of this fate for one, single, compelling reason. The program theory is valid and, with the right partners, is thriving as a win-win.
Its advantaged design partnership to exactly the wrong partners is the ill-conceived – and failing – part.
Who are the right partners? Independent physicians, for example. The ones that are focused on providing better value for their patients and are incentivized because the new money in healthcare is in delivering value. The broad delta between a bloated, wasteful, ineffective system and the improved one you create can restore fiscal stability to primary care physicians, who are on the verge of being price-cut out of business. Primary care physicians are the key because they can be very effective, and less costly, clinical managers for a patient’s overall care.
Two months ago, I wrote about the potential impact of the Amazon purchase of Whole Foods on grocery prices. Both here and in the Boston Globe, I hoped and predicted that Amazon would use its famed distribution network to drive down prices on the healthy and organic foodstuffs that made Whole Foods famous.
I’m happy to say that I was right. Today, on Day 1 of Amazon’s official ownership of Whole Foods, Americans got to see the first tangible impacts of Amazon ownership and, as predicted, it was lower prices. As noted by journalists, the chain once derided as Whole Paycheck should now be referred to as “3/4 Paycheck” given deep discounts averaging 25% on a wide range of products ranging from bananas to butter.
Though terrifying for Amazon’s competitors such as Kroger, Walmart and Costco, Amazon’s major foray into brick-and-mortar groceries may end up being a boon for consumers – at least in the short term. It’s no secret that Amazon retains its web startup mentality in aggressively promoting loss leaders to drive out competition. And increased competition will better serve consumers who have been squeezed by recovering inflation on food prices.
Soon, Amazon intends to install more of its Amazon lockers into Whole Foods locations, thereby facilitating deliveries for goods bought on the Amazon website while also increasing foot traffic to its stores. Analysts also speculate that Amazon’s grocery delivery service, Amazon Fresh, may get a much-needed shot in the arm with goods from Whole Foods. The corporate synergy of this deal is palpable – and just beginning.
This makes people nervous. Already, journalists and think tanks have sounded alarms about how Amazon’s growing power may make it a monopoly. They argue that Amazon is an antitrust problem given that it already captures nearly half of U.S. online sales, is the leader in providing cloud computing through Amazon Web Services and has a robust marketing and logistics division.
To bolster their point, it is true that Americans can now spend a large part of their day using Amazon services without even knowing it. You could wake up on a Saturday, go to Whole Foods for groceries, order supplies off Amazon, read a book with your Kindle, watch TV on Netflix (powered by Amazon Web Services) or catch a movie on Amazon Prime Video. All of your needs met by Jeff Bezos and company.
As if 100+ deaths on U.S. highways every day isn’t horrific enough, we are all too often reading and hearing about cars being intentionally used as weapons and seeing unbelievable images of victims on sidewalks that have been turned into killing fields.
Unfortunately, the list of these instances is growing. The attack Aug. 17 in Barcelona that saw 13 killed was just the most recent; Charlottesville, NC, and Columbus, OH, have been the scene of attacks as well. Since July of last year, vehicle-related assaults have claimed more than 100 lives in Nice, Berlin, Stockholm and London.
It may come as small comfort to know that advanced automotive safety technology, while not eliminating these instances, might be able to reduce the bloodshed. Automatic emergency braking systems monitor what is in front of a vehicle and apply the brakes when collisions appear imminent. This feature already may have saved lives.
A challenge for health care purchasers is choosing vendors whose performance matches their cost and outcomes claims. A 2015 Mercer survey found that only 41 percent of worksite clinic sponsors think that they’re saving money. As Al Lewis and Tom Emerick have detailed, many wellness and disease management companies simply overstate their results. In many cases employers may not realize that they, not the vendor, take the risk for results.
One important answer is the Care Innovations Validation Institute, founded by Intel, that offers health care vendors and purchasers objective validation of vendors’ claims. The Institute stands behind its work with a money-back guarantee. In the Wild West of the health care marketplace, the Validation Institute is an invaluable resource for purchasers, allowing them to confidently proceed with vendors, knowing that their promises have been vetted by scientists.
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