Should the terminally ill have the RIGHT-TO-TRY non-FDA approved therapies?

“Five years ago, the phrase “right to try” wasn’t yet an inkling in the minds of its staunchest advocates. Today, the pithy shorthand for the campaign to get dying patients access to experimental treatments has been slapped on bumper stickers, emblazoned on T-shirts, and uttered by some of the most powerful figures in Washington…
But the story of the five-year fight over “right to try” actually starts at a small lunch meeting of Republican health care experts in Phoenix. It then winds through more than three dozen state legislatures and into the stately meeting rooms of Capitol Hill, where pharmaceutical company lobbyists, Food and Drug Administration officials, and libertarian leaders are still pushing to shape or even upend the ultimate package.
In September 2012, a group of executives from the Cancer Treatment Centers of America reached out to the Goldwater Institute, a small, libertarian think tank named for the former senator and presidential candidate.
Goldwater — which has in past years accepted support from major conservative organizations like the Charles Koch Foundation and Donors Capital Fund — had taken on a wide-ranging libertarian agenda that included activism on campus free speech and school choice. The for-profit hospital chain CTCA also has its own ties to the Koch family.
CTCA and, ultimately, the Goldwater experts believed the FDA’s existing expanded access program — through which the agency approves some 99 percent of requests from dying patients who can’t get into clinical trials but want to try experimental treatments — was too cumbersome.
It was time to do something about it, and a consultant with CTCA, Chuck Warren, coined the term “right to try,” recalled Starlee Coleman, a Goldwater senior adviser.
A little over a year after their meeting with CTCA, Goldwater’s model legislation was signed into law in Colorado, a largely Democratic state with a Democratic governor. Thirty-nine other state legislatures eventually followed, many without a single dissenting vote. (A)

“House lawmakers have unveiled their version of a bill that lets terminally ill patients try experimental treatments.
The bill was released early Saturday morning and is the House companion of a Senate version that passed last year. The White House has also made pushing legislation for right-to-try a major priority, with President Trump even mentioning it during his State of the Union address in January….
The bill would let patients gain access to a drug that has gone through the first of three phases of clinical trials. The patient must be terminally ill and have no other options to qualify to get the drug.
Manufacturers wouldn’t be required to supply the drug to terminally ill patients, but the bill hopes to entice drugmakers to participate in the program.
Drugmakers are sometimes hesitant to provide a drug outside of a clinical trial to a terminally ill patient because if the patient dies, then it could affect the approval of the product by the Food and Drug Administration. Experts have said that patients who would use right-to-try would likely be sicker than patients in a clinical trial.
The bill seeks to provide certainty to manufacturers on how the FDA will use patient outcomes when evaluating whether to approve the product. (B)

“In a major blow to the effort to pass a federal “right-to-try” law, House Republicans failed to muster the votes to pass a key compromise measure Tuesday.
The legislation was rejected by a vote of 259-140. The bill needed two-thirds majority to pass under suspension of rules.
The vote was an embarrassing defeat not only for House Republicans but for President Trump, who had called on Congress to quickly pass right-to-try legislation, and Vice President Mike Pence, a longtime supporter of the effort. It was also a rare misstep from Speaker Paul Ryan, who like most congressional leaders almost never schedules votes on legislation without some certainty that the given measure has the support to pass.
The controversial “right-to-try” bill would offer a pathway for patients with a terminal disease to get around Food and Drug Administration rules to request an experimental treatment from a drug maker before the agency has approved it. Supporters of the legislation, including the libertarian Goldwater Institute that first conceived of the pathway, say it would offer a necessary respite from what they say are overly cumbersome FDA rules.
Critics, however, including Minority Leader Nancy Pelosi of California, pointed out that the FDA already has a program in place to offer access to terminal patients, and the agency grants some 99 percent of all the requests it receives, often within a short time frame. They also argued that without more FDA oversight of the use of experimental therapies, desperate patients could be vulnerable to bad actors or unsafe treatments.” (C)

“Supporters of this legislation talk as if effective treatments are being withheld from patients,” said Dr. Robert M. Califf, who was the commissioner of the Food and Drug Administration under President Barack Obama. “The vast majority of experimental therapies are toxic or ineffective. The only way we find out is through controlled studies where we measure the effects.”
In a letter to House leaders, more than 75 patient advocacy groups, including the lobbying arm of the American Cancer Society, opposed the bill.
The American Medical Association said it “does not believe that the bill will substantially improve patient access to investigational therapies.” And the American Society of Clinical Oncology, representing cancer doctors, said the bill “could do more harm than good for patients with life-threatening illnesses” because it would remove the Food and Drug Administration from the evaluation of the risks and potential benefits of some treatments.
Drug companies can already provide experimental medicines to patients outside clinical trials under a program known as expanded access or compassionate use. The F.D.A. says it approves about 99 percent of compassionate use requests. In emergencies or other urgent cases, the agency says, it approves requests for the use of experimental medicines within hours or days of being contacted by a doctor.
Representative Jan Schakowsky, Democrat of Illinois, said the bill would have created “a dangerous back door around the F.D.A. approval process.”..
The drug industry was uncharacteristically quiet. The main lobbies for the industry — the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization — said they had not taken a formal position on the legislation.
The drive for right-to-try legislation was spearheaded by the Goldwater Institute, a public policy organization that advocates free markets and limited government.
Starlee Coleman, a policy adviser at the institute, said 38 states had adopted right-to-try laws, often with broad bipartisan support.” (D)

“The House will have to try again, before the bill can go back to the Senate (where it previously passed in August by unanimous consent) for further consideration. Before the new draft is revealed, here are several things about the Right To Try movement that need to be cleared up.
The “Right To Try” Is Not A New “Right”
A qualifying individual may petition to access an experimental therapy, but that does not mean they will receive it. Drug companies still have the authority to refuse any request. Thus, the right to try is really just federal-level permission to ask for an experimental therapy. The bill does, however, attempt to incentivize manufacturers by acknowledging that Right To Try patients will be sicker, and thus any negative outcomes from allowing terminally ill patients to try therapies will not be included in the FDA’s decision-making for future approvals.
Treatments Must Still Have Some Rigor. According to the new legislation, even an eligible investigational treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the FDA; and (3) not be approved, licensed, or cleared for sale under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act. This is good news for those concerned about safety, but some argue the barriers are not enough.
Clinical Trial Efforts Have Failed Patients. The truth is that many individuals pursue the right to try because they have been unsuccessful in clinical trials. Further, traditional trials add not only years to the review process for therapies, but inevitably increase drug costs. Ongoing arguments suggest that if the clinical trial process in the U.S. were improved, the need for the Right To Try Act wouldn’t exist. However, others contend that the FDA trial process is necessarily rigorous and that any patient rights to skip clinical trials will undermine future trial enrollment. (E)

“Every day, every hour, counts for them. But the process by which the federal Food and Drug Administration approves medicines and treatments takes an average of 14 years, and during that time, patients are, with a tiny number of exceptions, legally barred from using medicines that could save their lives — medicines the FDA has deemed safe and that it is giving people in clinical trials…
“The Right to Try movement was born to change this cruel reality. Alongside patients, doctors and policymakers nationwide, the Goldwater Institute crafted a new approach, a state-law reform that allows ill Americans to seek investigational treatments when they’re out of other options.
Right to Try’s success has been spectacular. In just five years, Right to Try bills have been introduced in every state, and 38 have adopted it, including Arizona, where voters passed it overwhemingly in 2014. The Wisconsin Legislature just sent a bill to the governor for his signature…
The wealthy and privileged have always been able to get the medicines they need, even without FDA approval. They can travel to other countries where they can get the medicines the FDA keeps locked up here.
A fortunate few get FDA permission to enter clinical trials or receive the so-called “Expanded Access” exception. It allows some people, on a case-by-case basis and through a cumbersome process, to request permission from the FDA to access medications outside of a clinical trial.
But these options provide false hope for most people, because only a fraction of those who need these exemptions are even allowed to request them, and most people can’t afford to travel the world to get treatment.” (F)

“Four former commissioners of the Food and Drug Administration are expressing opposition to congressional “right to try” legislation, just as Republican House leaders prepare to bring a bill up for another vote a week after it failed to pass….
“There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients,” they say…
The statement by the former FDA heads was signed by Robert Califf and Margaret Hamburg, who were commissioners during the Obama administration, and Mark McClellan and Andrew von Eschenbach, who served under George W. Bush. Some have previously expressed reservations individually about the bills. The joint statement is a show of bipartisan unity to try to slow the legislation’s progress on Capitol Hill.” (G)

“Thirty eight States have enacted right-to-try (RTT) laws, the intent is to increase the availability of experimental medicines to individuals battling life-threatening conditions A federal version has support at the highest levels of the Trump administration including the president himself. Yet the Goldwater Institute, which created and has strongly championed these laws, cannot provide clear examples of patients who have gained access to potentially life-saving treatments through state RTT laws that they otherwise wouldn’t have received under the FDA’s current Expanded Access Program (EAP). Furthermore, federal RTT law will not increase access either…
All this being said, one cannot ignore the desire to increase the access of critically and terminally ill individuals to experimental medicines. The question then becomes how to accomplish this in a way that meets the needs and requirements of regulators, companies and the current and future individuals in need?
One way to meld the intent of RTT laws with the existing EA process would be to create a more explicit regulatory pathway. This allows EA safety and efficacy data to be incorporated into the label of a new medicine once it is formally approved for its primary indication via “traditional,” highly controlled clinical trials.
In this way, companies could more fully balance the risks and benefits of an EAP to the overall development process of the experimental medicine. Companies would be incented to undertake these broader EA programs because they could determine how the EA program would potentially lead to the ability to treat a larger future patient population.
This would require legislative and regulatory changes to existing guidelines for intermediate- or large-scale EAPs, but would still be within the framework and intent of the 21st Century Cures Act.
Rather than circumventing the FDA oversight process, companies would have to reach agreement with the FDA as to the parameters under which “real-world evidence” (evidence regarding the potential benefits and risks of a product) collected from patients enrolled in expanded access trials could be used to support additional label claims for a new medicine. These programs would be overseen as if they were formal clinical trials designed to provide full input into the drug development process.” (H)

“Right-to-try legislation would create a pathway to remove FDA oversight of experimental, unproven therapies. These are the treatments that most need rigorous regulatory oversight tempered by willingness to allow pre-approval access for patients who need them most: those who have run out of treatment options. Excluding the FDA from the development and delivery of these therapies will make it harder to gauge their safety and effectiveness.
Advocates like us have spent decades fighting to accelerate the pace of scientific discovery and the development of new treatments, with patient safety and effectiveness as the North Star. We have each seen firsthand the perils of disease and the anguish of loved ones who have run out of options to fight deadly diseases like cancer or AIDS. But we cannot allow this pain, and our unwavering commitment to end suffering, blind our judgment about legislation that would create a climate where the most vulnerable patients are taken advantage of, their safety endangered, and drug development driven off track.
During the peak of the AIDS crisis, with 50,000 Americans dying from the disease each year, brave and determined activists pushed the FDA to increase regulatory flexibility — creating a variety of mechanisms that brought patients faster access to lifesaving therapies, therapies that are now saving millions of lives around the world and preventing new HIV infections. Cancer advocates have also long worked side-by-side with the FDA and Congress and continue to successfully enact innovative policy changes and expedited approval mechanisms such as Accelerated Approval and the Breakthrough Therapy designation. These changes have made a significant and lasting difference for patients.
If the right-to-try legislation can’t speed expanded access by circumventing FDA review, then what would it do? One result is certain: It would create uncertainty. In the 38 states that have passed similar bills, there is no evidence so far showing if these policies have increased patient access to experimental therapies. The absence of data here is both alarming and telling.” (I)

“The right-to-try bill, which suffered a surprise 259-140 defeat in the House of Representatives last week, is scheduled for another vote this week. The House Committee on Rules was scheduled to meet late in the day Monday to change the procedure so that it could be passed with just a simple majority, rather than a two-thirds majority, and this time approval seems likely.” (J)

(A) How the ‘right-to-try’ movement muscled its way into Washington, by ERIN MERSHON,
(B) House panel unveils right-to-try bill, by Robert King,
(C) ‘Right-to-try’ bill rejected by House, in major blow to GOP efforts, by ERIN MERSHON,
(D) House Rejects Bill to Give Patients a ‘Right to Try’ Experimental Drugs by By ROBERT PEAR,
(E) 7 Things To Know About Experimental Drugs And The ‘Right To Try’ Act, by Nicole Fisher,
(F) Your Turn: How Right to Try laws could one day help save your life, Christina Sandefur,
(G) Former FDA commissioners say right-to-try bills could endanger ‘vulnerable patients’, by Laurie McGinley,
(H) Here’s how to structure successful right-to-try laws, by BY KENNETH I. MOCH, ANDREW MCFADYEN AND ARTHUR CAPLAN,
(I) ‘Right-to-try’ law threatens patient safety and rational drug development, By MARK HARRINGTON and ELLEN V. SIGAL,
(J) Republicans Get Ready to Vote on “Right-to-Try” Bill Again, by Allison Inserro,

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Case Study on Disruption/Disintermediation in health care (10 posts)

Please feel free to use this case study, with attribution, and pass it onto others as well
and…your feedback would be appreciated

1. August 23, 2017 | UBER HEALTH Inc., WALMART HOSPITALS NFP, AMAZONrx (Ireland), MicrosoftCare LLC.

2. November 3, 2017 | Is “Silicon Valley” – artificial intelligence – disrupting and taking over the health care system?

3. December 25, 2017 | In 2018 the CVS-Aetna “Unicorn” will buy a mega-hospital system and become a very disruptive patient “ownership” trajectory

4. January 3, 2018 | Health care disruption….”executives are paying close attention to who/what poses the greatest threat to their business models.”

5. January 24, 2018 | Health care “disruption” doesn’t have any rules!

6. February 12, 2018 | Amazon is openly DISRUPTING health care as well as quietly under-the-radar

7. February 20, 2018 |health care DISRUPTERS like Amazon “have a strong self-interest in keeping hospital leadership on edge…”

8. February 26, 2018 | AMAZON: Health Care DISRUPTION by DISINTERMEDIATION. (what the heck is that?)

9. March 7, 2018 | The power of artificial intelligence in disrupting health care

10. March 15, 2018 | The HEALTH SECTOR is ripe for DISRUPTION… organizations need to rethink how & where care is delivered to consumers

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The HEALTH SECTOR is ripe for DISRUPTION… organizations need to rethink how & where care is delivered to consumers (F)

“Some of the biggest and most famous brands in America are making big bets on health care. The blue chips of Silicon Valley — Amazon, Apple, Google, Uber — have announced in the past few weeks they’re interested in disrupting an industry that has bedeviled us with rising costs and inefficiencies for decades.
Amazon is setting up a mysterious new partnership with JPMorgan Chase and Warren Buffett. Apple is planning a line of (surely sleek and minimalist) medical clinics. Google’s sibling under the umbrella company Alphabet, Verily, is looking at the Medicaid market. Uber wants to disrupt ambulances.
It is way, way, way too early to start imagining a world where health care is truly owned by Big Tech — you order prescription drugs with your Amazon Prime account, see a nurse at the Apple Clinic, get your benefits statements from Google, and call an Uber instead of an ambulance when you need to go to the hospital.
But something is happening here. The most proven, forward-thinking, and, dare I say, disruptive companies in our country have decided health care should be their next big move. They see a system rife with administrative inefficiencies, opaque prices, and customer dissatisfaction. In other words, a huge opportunity.” (A)

“Out of the gate, the new health care venture from Amazon, Berkshire Hathaway and JPMorgan Chase seems to be headed in the right direction — using new technology to provide their employees better value and health outcomes. That’s where things will start, but this could be a laboratory for a more sweeping transformation.
The big picture: To bring lower costs and better care to their employees and others, these companies will need to do more than deploy a modern technology overlay. They will have to better align payments and outcomes in health care across the board. If they accelerate this process, we will all benefit.
The problems: Our health care system is afraid of new technology, partially because of outdated ideas about how to pay for care that are layered into government programs. Consider the example of Type 1 diabetes — a chronic condition that affects more than 1.2 million Americans.
New technology called continuous glucose monitoring, or CGM, uses a digital sensor to monitor patients’ blood-sugar levels throughout the day, without requiring them to draw blood.
CGM is even more effective when it pairs with analytic algorithms and a smartphone. Patients can share readings with a doctor in real time, or automatically alert loved ones in the case of an emergency. These are precisely the kind of technologies a company like Amazon should know how to leverage.
Because of old and often inflexible rules, Medicare won’t have anything to do with CGM if a smartphone is involved. The government doesn’t want to be in the business of paying for smartphones.” (B)

“All journeys begin with a single step. The journey to value-based care is no different. One foot in front of the other. The steady accumulation of those steps and one finds oneself a thousand miles from the starting point. The same will be the story of artificial intelligence in healthcare.
For AI in healthcare, there is more focus on the high-profile failures than the small successes — the incremental steps. Yet those small wins offer a vibrant story of transformation, re-invention, and improved patient experience.
It is these small wins, in concert with each other that will alter the trajectory of healthcare in the U.S. and beyond. Let’s take a look at the range of some of these wins and consider the collective implications if adopted broadly across a major U.S. system.” (C)

“Alphabet, Microsoft and Apple have filed more than 300 healthcare patents between 2013 and 2017 — revealing the tech giants’ increasing desire to disrupt the healthcare space, according to a new report by Ernst & Young.
Between 2013 and 2017, Google’s parent company Alphabet filed 186 patents, Microsoft filed 73 and Apple filed 54.” (D)

“EY’s analysis of the US health patents filed by major technology players, including Alphabet, Apple and Microsoft, shows the investment technology giants are making in health care (see Figure 1). Alphabet, for instance, has a range of initiatives that span DeepMind and Verily Life Sciences, including joint ventures in diabetes (Onduo), bioelectronics (Galvani Bioelectronics) and smart operating rooms (Verb Surgical). Apple, meanwhile, has filed patents to turn its phones into medical devices capturing biometric data such as blood pressure and body fat levels; it has also partnered with Stanford University to develop algorithms to predict abnormal heart rhythms. Based on its filed patents, Microsoft has focused on expanding its AI capabilities and developing monitoring devices for chronic conditions.” (E)

“Patients and physicians both are ready to engage with one another using digital tools, according to a new Ernst & Young national survey released at HIMSS18 this week.
The survey found 54 percent of consumers said they are comfortable contacting their physician digitally and further expressed interest in using technology such as at-home diagnostic testing (36 percent), using a smartphone or connected device for information sharing (33 percent) and video consultations (21 percent).
There is widespread agreement among physicians that digital technologies and data sharing will contribute effectively to the overall well-being of the population, the survey found. And 83 percent of physicians believe that increased patient-generated data from connected devices would benefit the overall quality of care and enable more personalized care plans.
Further, 66 percent of physicians said that increased use of digital technologies would reduce the burden on the healthcare system and its associated costs, and 64 percent think it would help reduce the burden on doctors and nurses and have a positive impact on the critical issue of burnout, the survey said.
“The health sector today is ripe for disruption, and these findings reinforce the need for organizations to rethink how and where care is delivered to consumers,” said Jacques Mulder, U.S. health leader at Ernst & Young. “Both consumers and physicians are empowered by emerging technology and are hungry for better, more connected experiences. This demand paves the way for nontraditional players to make an impact on the industry, and is another indicator that health in entering an era of convergence.” (F)

“For the better part of a decade, the drive to adopt health information technology was focused on just that, adopting technology. Now, the push seems to be twofold: actually finding value in the billions spent on health IT and, equally as significant, trying to keep pace with consumer demand.
That means an increased focus on telehealth and virtual care; deploying consumer-friendly apps; experimenting with artificial intelligence; and collecting, analyzing and pushing out actionable data. Hospital executives, vendors and others gathered here last week at the Healthcare Information and Management Systems Society’s annual meeting were adamant in their belief that healthcare organizations need to stop nibbling at the edges and pick up the pace of embracing consumerism.
That push, however, has to be balanced with the reality that provider revenue streams are tightening, as well as the fact that payers, employers, consumers and the government are clamoring for more preventive and population health-based care.” (G)

“Interoperability” isn’t a word most people hear every day. But when it comes to the future of patient-centered healthcare in the United States, few technological developments may prove to be more important.
Interoperability is essentially the ability of different computer systems to communicate with each other quickly and effectively. For healthcare specifically, that means being able to share patient data in an instant regardless of what hospital, pharmacy, laboratory, or clinic houses the information—and being able to do so with complete reliability and privacy protection.
The Trump Administration views interoperability as a top priority for the Federal government. This week, White House Senior Adviser Jared Kushner laid out President Donald J. Trump’s plan at HIMSS18, a leading conference focusing on health information and technology transformation.
“Interoperability is about our shared bottom line: saving lives,” Kushner said. “There is overwhelming consensus: America needs better access to patient data and interoperability now.” (H)

“ Inc said on Wednesday it was expanding its discounted Prime membership offer to Medicaid members, the U.S. government’s health insurance program for the poor.
The move from the e-commerce giant comes nine months after it said it would offer a discount on its popular Prime subscription service for shoppers who receive U.S. government aid.
To qualify for the discounted $5.99 monthly Prime membership, customers must have a valid Electronic Benefits Transfer or Medicaid card and can renew it annually for up to four years, the company said.
The $12.99-per month or $99-per-year prime service offers users added perks like low prices and faster delivery for certain purchases and shipped over 5 billion items worldwide last year.
Any push by Amazon into poorer demographics comes at a time when traditional brick-and-mortar suppliers like Walmart Inc have been fighting the online shopping giant’s arrival by seeking to attract more high-spending shoppers.
The Medicaid connection may also stir more nerves among healthcare companies worried about tentative moves by Amazon to sell and distribute some medical supplies and drugs. (I)

“The program has earned Amazon praise for “doing well by doing good” but also draws attention to product offerings that will likely come in handy specifically for customers on Medicaid, such as over-the-counter medications and eyewear. Healthcare consultant Lyndean Brick of the Advis Group noted to the Indianapolis Star that the move is also aligned with the company’s larger strategy to expand into the healthcare marketplace. Amazon recently announced a plan to partner with Berkshire Hathaway and JPMorgan Chase to launch their own employee healthcare company.
“They have a strategy to enter into the healthcare market and it’s clearly well thought out, and they are going to enter the industry from all sides simultaneously,” Brick said.” (J)

“If you’re in the pharmacy business, Amazon’s roster of employees is starting to look ominous. In the past 18 months, the e-commerce giant has poached more than 20 employees from industry heavyweights such as CVS Health, Express Scripts, and UnitedHealth Group, according to a STAT review of available LinkedIn data. The new hires include software engineers, data analysts, business strategists, and others with years of experience in the prescription drug and health care” (K)

“Walmart Inc., the largest private employer in the U.S., has been buying health care for its workers directly from providers in six different regions — bypassing insurers who usually negotiate with doctors and hospitals. The retailer is trying to find out if its formidable purchasing power can squeeze out middlemen and drive down costs in the same way that its tough bargaining has brought down prices for shoppers.
“We wanted to see what was more effective — what works, and what doesn’t work,” said Lisa Woods, the company’s senior director of U.S. health care. “If we can’t impact and influence cost or how cost trends are increasing, then we need to change or do something different.”
Companies are the largest providers of health insurance in the U.S., giving more than 150 million people access to coverage. While premiums have soared 55 percent over the past decade, according to the Kaiser Family Foundation, most firms have done little tinkering with their health plans beyond asking employees to pay higher contributions and out-of-pocket costs.” (L)

“Uber launched Uber Health on March 1, a new form of non-emergency medical transportation. The new service allows patients to schedule rides to and from medical appointments hours before or up to 30 days in advance. Providers who order the rides do so through an online dashboard, and patients receive a text message or phone call for information about their trip, making rides accessible to those without smartphones.
Lyft Concierge, which launched in 2016, allows businesses to schedule rides on behalf of individuals, and Lyft has already partnered with health-care providers such as Blue Cross Blue Shield with this platform. On March 5, Lyft announced it is expanding its medical transportation service after partnering with Allscripts, one of the largest electronic health-care service companies.
Uber and Lyft have touted their services as solutions for the 3.6 million people who miss appointments due to a lack of accessible medical transportation. Although their services should be great ways to modernize medical transportation, Uber Health and Lyft Concierge come with concerns.
Unlike Medicaid’s non-emergency transportation program, for which a transportation provider’s staff must receive patient privacy and safety training, neither ridesharing company requires drivers to have any special training for escorting patients to and from their appointments. This poses a serious health risk for passengers who may be dealing with severe, chronic illnesses and, in the event of an emergency, will not have proper assistance.” (M)

“So, then why such a big buzz?…
In other words, whether or not these three companies will deliver true transformation in the future is still TBD, but they are absolutely providing motivation right now. And this is huge.
Why is this outside influence so critical in this industry? The simple truth is that healthcare delivery systems are incredibly complex multibillion dollar operations with tens of thousands of employees. All businesses of this size and scale, both inside and outside of healthcare, have an extremely hard time being nimble and are always at risk for innovation happening on the edge of their business model. So, while group purchasing, employer clinics and transportation are not burning platforms for any executive team in a hospital today, when they see the names Amazon, Apple and Uber playing in those spaces, these areas immediately become board level agenda items and initiatives…
There is a great line from a Tracy Chapman song All That You Have is Your Soul that goes “don’t get tempted by the shiny apple.” While it is easy to be attracted to simple ideas, healthcare is an incredibly complex industry with an overwhelming number of problems that need to be solved. And truly solving these problems is incredibly challenging work.
With that said, for too long it is has been too easy to accept healthcare’s shortcomings. And that is exactly why Amazon, Apple and Uber can be incredibly helpful — not just in producing ideas, but in providing the inspiration for us to truly take action to help heal healthcare, not in the future but right now.
And if they can do that it would truly be an, “OH MY!” (N)

“Health 2.0 looked at five drivers that could advance healthcare; the new interoperability and the increased use in FHIR and SMART system; novel modalities, such as voice assistants and virtual reality; new market entrances like Amazon and JP Morgan; business model disruptions, and new environments for health systems like schools.
But Subaiya said that no one system can solve healthcare a crisis alone. Partnering is key to solving some of the most pressing issues in healthcare, Subaiya said. However, some healthcare providers are still reluctant to embrace the change, citing little resources, difficulty in integration and a lack of domain experience.
Subaiya urged providers to go beyond their walls. She gave the example of the opioid epidemic. The condition isn’t limited to one type of doctor or care. Treating addiction includes mental health services, physician referrals, Pharma regulations, and emergency care.
“These problems are complex, the solution sets are starting to aggregate into small clusters that make sense for a large problem. Now they need the mechanism and the infrastructure with the care delivery system to have true impact,” she said.
For example, in solving the opioid epidemic innovation around the opioid epidemic is clustering into care coordination, digital therapeutics, identifying and monitoring, social determinant side.
“I think you’ll see incredibly powerful platforms that are consolidating units of innovations. We are going to be seeing people putting pieces of innovation together,” said Subaiya.” (O)

“Given that government intervention a la the “Affordable Care Act” failed to drive efficiencies or bend the cost curve in health care, now Amazon, Berkshire Hathaway and JPMorgan will have the opportunity to try their hand at modernizing the health care system.
While time will tell whether (and how) Amazon, et al. can make an impact on the market, their potential entrance thereto is already driving change in the industry as existing market players are having to re-think their strategies related to innovation, efficiency, and transparency in preparation for new competitive entrants.
And, as anyone with experience dealing with the health care system will quickly acknowledge, change to the status quo is sorely needed given that the current byzantine nature of the American health care system has over the course of several decades created barriers to entry for new competitors while also reinforcing perverse incentives among and between various players in the space.
In addition to stock price movements, 2017’s health care merger activity is an indication that change may be apace.
From horizontal mergers of hospitals and insurers to vertical mergers involving players in historically isolated segments of the industry, such as the proposed merger of pharmacy giant CVS Health and insurer Aetna, it appears that the market is positioning to improve integration and efficiency.” (P)

“Eric Schmidt delivered a hearty dose of optimism Monday evening in the HIMSS18 opening keynote.
“A revolution has been happening in my industry. Scale changes the rules, scale changes everything,” said Schmidt, who is the former Executive Chairman of Alphabet and today serves as a Technical Advisor to Google’s parent company. “The combination of cloud, deep neural networks, the explosion of data will give you a model.”..
Schmidt pointed as example to a theoretical technology product he called Dr. Liz — named in honor of the first woman to earn a medical degree, Elizabeth Blackwell — a scenario wherein a voice assistant in patient rooms interacts with consumers, makes evidence-based recommendations to doctors and handles all the administrative burden of working in an EHR.
“Everything I just described is buildable today or in the next few years,” Schmidt added. “All it takes is for all of us to figure out how.”
That’s not to say it will be here tomorrow, but Schmidt laid down a clear path toward just such an innovation akin to email, the Internet or smartphones that will be the proverbial killer app that causes all sorts of interactions and connections.
Here’s what Schmidt said that will take: A clinical data warehouse packed with diverse data sets that are curated and normalized such that sophisticated analytics can be run against the data and accessed with a rich API. Hospitals then need a second tier of data to supplement EHRs…
Reinforcement learning requires those powerful networks. Schmidt described the concept of consisting of a simulator, training data, real-time experience to that looks at forwarding outcomes.
“We believe we can build reinforcement solutions to significantly improve pathways of care,” Schmidt said.” (Q)

“Artificial intelligence is all the rage in Silicon Valley, but it has so far not made much of a dent in health care. That’s largely because the technology just isn’t good enough yet, according to a report in VentureBeat.
The most interesting applications so far have focused on diagnostics — using algorithms to process and distill published medical research at a volume humans simply couldn’t handle, or having them read patient data and look for abnormalities, the report says.
Key quote: “I have no doubt that sophisticated learning and AI algorithms will find a place in health care over the coming years,” data scientist Andy Schuetz tells VentureBeat. “I don’t know if it’s two years or 10 — but it’s coming.”” (R)

“Dan Patterson: Can you forecast the future for us? Some advice and insight on what technologies may be most disruptive, and what technologies may be most helpful in the next 18-36 months?
Ted Smith: I’ll leave you with something controversial that will be memorable. But my money is on the toilet, just to be clear, based on biometrics, considering all that can be done by sampling by what’s going on with someone, believe it or not, we can learn a lot about your health with a smart toilet.
It’s kind of a gross thought, but it’s something we all use multiple times a day. It’s probably the gateway to always knowing about your health.” (S)

““What if we told you we could back up your mind?”
So yeah. Nectome is a preserve-your-brain-and-upload-it company. Its chemical solution can keep a body intact for hundreds of years, maybe thousands, as a statue of frozen glass. The idea is that someday in the future scientists will scan your bricked brain and turn it into a computer simulation. That way, someone a lot like you, though not exactly you, will smell the flowers again in a data server somewhere.
This story has a grisly twist, though. For Nectome’s procedure to work, it’s essential that the brain be fresh. The company says its plan is to connect people with terminal illnesses to a heart-lung machine in order to pump its mix of scientific embalming chemicals into the big carotid arteries in their necks while they are still alive (though under general anesthesia).” (T)

(A) Why Apple, Amazon, and Google are making big health care moves, by Dylan Scott,
(B) How Amazon & Co. can revolutionize the health care system, by Dan Mendelson,
(C) Small wins vs. big losses: AI in healthcare, by JONATHAN MUISE,
(D) Google’s parent Alphabet, Microsoft and Apple have filed 300+ healthcare patents: 5 things to know, by Alia Paavola,
(E) When the human body is the biggest data platform, who will capture value,$FILE/ey-when-the-human-body-is-the-biggest-data-platform-who-will-capture-value.pdf
(F) Survey: Patients are comfortable engaging doctors digitally, but not with sharing data, by Bill Siwicki,
(G) Drive to embrace consumerism forcing change in health IT strategies, by Matthew Weinstock and Rachel Z. Arndt,
(H) The Trump Administration’s Plan to Put You in Charge of Your Health Information,
(I) Amazon offers discount Prime membership to Medicaid recipients, by Tamara Mathias, by Sarah Young,
(K) Amazon’s pharmacy hires hint of ambitions to upend a $360 billion market, by By CASEY ROSS,
(L) Amazon Isn’t the Only Retail Giant Trying to Remake Health Care, by Zachary Tracer,
(M) Corporations struggle to do what health-care system won’t,
(N) The No. 1 takeaway from HIMSS 2018: ‘Amazon and Apple and Uber, oh my!’ by Dan Michelson,
(O) Health 2.0 sees the future of healthcare innovation in collaboration, by Laura Lovett,
(P) Amazon’s early impact on health care, by David Bottoms,
(Q) Eric Schmidt lays out formula for healthcare innovation, by Tom Sullivan,
(R) When AI will start to disrupt health care, by Sam Baker,
(S) A smart toilet may be the future of IoT healthcare, by Dan Patterson,
(T) A startup is pitching a mind-uploading service that is “100 percent fatal”, by Antonio Regalado,

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New health care case study methodology starting with DISRUPTION/ DISINTERMEDIATION Doctor, Did You Wash Your Hands?™

My name is Jonathan Metsch and I would like to share my Career Capstone Project with you.

I taught full time in the Baruch MBA in Health Care Administration program from 1972 to 1975, then was a health care administrator for over thirty years, finishing for seventeen years as President & CEO of LibertyHealth/ Jersey City Medical Center, where we built a replacement safety-net hospital (it took 15 years), played a key role on September 11th, 2001, and while we had many successes, we learned much more from our failures.

After retiring from LibertyHealth, I returned to my academic roots in the Baruch program for four years as Adjunct Professor. And started writing case studies. Health care disruption is so complex that there are few, if any, up-to-date case studies. So I developed a method of contemporaneous cases studies each developed by curating news articles into a coherent thread.

Here’s how to take a test ride:
Go to my web site Doctor, Did You Wash Your Hands?™
Then on the top of the home page click on the category TRANSFORMATION
And you will find six posts on Health Care Disruption which together comprise a yet ongoing case study.

Similarly if you click on ObamaCare/ TrumpCare you will find fifty plus posts together tracking the legislative history of Repeal and Place.

And then you can click on Opioid Crisis and see that case study.

Finally you can scroll through the 150+ posts and see mini case studies on a variety of topics.

Coming soon will be cases on “Right to Try” and the cost of prescription drug/ generic drugs.
You are welcome to use any of the content on the web site, using hyperlinks (with attribution please)!

And I would appreciate your comments

If you would like to share your case studies I will be happy to post them on my web site.



Jonathan M. Metsch, Dr.P.H.
Clinical Professor, Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai
Adjunct Professor, Rutgers School of Public Affairs and Administration & Rutgers School of Public Health
Faculty Affiliate (formerly Adjunct Professor), Zicklin School of Business, Baruch College, C.U.N.Y.

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Thanx! for clicking on to

    Doctor, Did You Wash Your Hands?™

Here’s how to take a test ride:

On the top of this home page click on the category TRANSFORMATION
And you will find six posts on Health Care Disruption which together comprise an ongoing case study.

Similarly if you click on ObamaCare/ TrumpCare you will find fifty plus posts together tracking the legislative history of Repeal and Place.
And then you can click on Opioid Crisis and see that case study.
Finally you can scroll through the 150+ posts and see mini case studies on a variety of topics.

You are welcome to use any of the content on the web site using hyperlinks (with attribution please)!
And I would appreciate your comments

If you would like to share your case studies I will be happy to post them on my web site.



Jonathan M. Metsch, Dr.P.H.
Faculty Affiliate (formerly Adjunct Professor), Zicklin School of Business, Baruch College, C.U.N.Y.
Clinical Professor, Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai
Adjunct Professor, Rutgers School of Public Affairs and Administration & Rutgers School of Public Health

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The power of artificial intelligence in disrupting health care

“Speaking at the Federation of American Hospitals convention in D.C., Health and Human Services (HHS) Secretary Alex Azar laid out a series of actions the administration will take that are aimed at lowering health care costs, and warned that it wouldn’t be deterred by powerful special interests.
“Today is an opportunity to let everyone know that we take these shifts seriously, and they’re going to happen — one way or another,” Azar said. “The administration and this president are not interested in incremental steps. We are unafraid of disrupting existing arrangements simply because they’re backed by powerful special interests.”
The administration will make it easier for patients to access their health records, encourage health providers to be more transparent about costs of procedures and services and remove regulations that “impede” innovation. HHS will also “experiment” with payment models in Medicare and Medicaid to “drive value and quality,” he said…
“But there is no turning back to an unsustainable system that pays for procedures rather than value,” Azar said. “In fact, the only option is to charge forward — for HHS to take bolder action and for providers and payers to join with us.” (A)

“In his keynote, Webb first noted the importance of taking disparate data sets in healthcare and turning them into actionable insights that can be used to improve patient care or the patient experience. Webb, who also is the author of The Innovation Playbook, The Digital Innovation Playbook and the best-seller What Customers Crave, contended that there are four pillars of disruption in healthcare: consumerization; disruptive innovation; connection architecture; and economic models. “These pillars will impact everything about your business in the next six years. We used to believe that change was a linear curve, and we are [misled] in believing that change is linear. But it’s not; change is explosive,” said Webb, adding that the depth and speed of change could “sink” some healthcare organizations.
To this end, Webb said that his firm recently interviewed some 130 healthcare executives, asking them on a scale of 1 to 10, how important disruption is to their organization. Amazingly, Webb reported, every single person who was interviewed responded that disruption ranked a “10 out of 10” in importance.
But perhaps just as noteworthy, the executives were then asked to explain what disruption meant—and not a single person was able to do so clearly, Webb said. “Disruption is like a unicorn in [the sense] that nothing too weird has happened yet,” he said. Explaining further, Webb attested that breakthrough innovations are certainly occurring right now in healthcare, but he feels that isn’t the same as disruption. “Disruption means destruction. We are destroying clinical models and patient relationships and replacing it with betterness ran by three things: connection architecture, consumerization and disruption,” he said.” (B)

“Some of the biggest and most famous brands in America are making big bets on health care. The blue chips of Silicon Valley — Amazon, Apple, Google, Uber — have announced in the past few weeks they’re interested in disrupting an industry that has bedeviled us with rising costs and inefficiencies for decades.
Amazon is setting up a mysterious new partnership with JPMorgan Chase and Warren Buffett. Apple is planning a line of (surely sleek and minimalist) medical clinics. Google’s sibling under the umbrella company Alphabet, Verily, is looking at the Medicaid market. Uber wants to disrupt ambulances.
It is way, way, way too early to start imagining a world where health care is truly owned by Big Tech — you order prescription drugs with your Amazon Prime account, see a nurse at the Apple Clinic, get your benefits statements from Google, and call an Uber instead of an ambulance when you need to go to the hospital.
But something is happening here. The most proven, forward-thinking, and, dare I say, disruptive companies in our country have decided health care should be their next big move. They see a system rife with administrative inefficiencies, opaque prices, and customer dissatisfaction. In other words, a huge opportunity.” (C)

“The challenge inherent in building a system that involves healthcare stakeholders—care providers, payers and healthcare consumers—is deciding which areas should be influenced. A unified healthcare ecosystem, however, has but one purpose—to deliver the best, most effective and appropriate care in a cost-effective way to the patient.
Even with today’s many technologies, getting there won’t happen in a day, a month or even a year. It won’t occur by using a single methodology or solitary technology. Interoperability is needed across all healthcare stakeholders to effectively plan, execute and pay for services. The ability to view clinical data internally is deemed extremely important by 70 percent of healthcare executives, and 50 percent of those executives say it’s extremely important to view clinical data externally, according to a new HFMA report. Today, unfortunately, most systems don’t have the ability to talk to one another, which is why it’s so important to support the digital transformation of healthcare.
An effective way to accomplish this imposing task is by converting medical practices to fully digital organizations with the ability to accept and manage financial risk, integrate disparate software systems to improve efficiencies, build value-based care programs and optimize the entire revenue cycle.”…
Making the digital transformation won’t be easy, and most providers will benefit from outside assistance. Organizations that make the successful transitions will be well-positioned after they achieve digital transformation.” (D)

“Organizations need to understand what the umbrella term of AI includes and what to look for in different infrastructure tools that include AI technology. Some tools may contain different AI methods to achieve a certain goal…
IA was created to emulate the human mind and working processes, and can independently solve problems without needing to be programmed to do so. AI can accept new information and learn from it without human intervention.
The computing power behind AI allows it to process information exponentially faster than a human could, fixing problems or drawing conclusions that the human mind would never be able to achieve.
Gartner described AI as applications including autonomous vehicles, automatic speech recognition and generation, and detecting novel concepts and abstractions. Detecting concepts and abstractions is useful for detecting potential new risks and aiding humans to quickly understand very large bodies of ever-changing information.
The potential for AI in healthcare is vast and the technology can be applied from the infrastructure level all the way through treating patients.
“This radical transformation is already underway and is occurring as a response to the increasingly menacing nature of unknown threats and multiplicity of threat agents,”
“Analytics is another example of a patient facing use of AI in healthcare, especially when it comes to using images for diagnostics.
A computer with AI can look at an image of a healthy brain scan and an image of a brain scan with tumors. The device could then recognize the difference between the two images by breaking them down into machine-readable patterns.
The machine can remember and reference these patterns then apply them to future images to determine which patterns indicate that a brain tumor is present.” (E)

“In an environment where consumers are constantly expanding the use of technology in all areas of their lives, healthcare providers are also shifting their services to meet these customer needs. One such way has been virtual care, which has proven effective as a means to expand access and bring greater convenience, while providing quality care and reducing costs.
Virtual care helps increase the efficacy of both in-home and facility-provided management of acute and chronic diseases, promoting efficiency in clinical decision making and treatment recommendations. Technology is not a substitute for excellent clinical care; rather it is a tool which serves to enhance communication and collaboration, ultimately benefiting patients, particularly those in rural and underserved areas.
Virtual care services range from a patient at home interacting with a distant provider for a medical consultation, to the remote monitoring of a patient at home with chronic disease in order to prevent exacerbations, to patients in a hospital or at other facility, who require a specialty clinical consult. Patients can connect via their devices – smartphones, laptops, desktops, etc. – for “on-demand” medical consultation services in areas including urgent care, behavioral and mental health, and other cases with real-time clinical video interaction, often decreasing time and travel for patients.” (F)

“The term innovation loses so much meaning, and one of the meanings that it gets is ‘It’s innovation if it uses products designed by Apple,’” David Asch, MD, executive director at the Penn Medicine Center for Health Care Innovation, said in his keynote address. “Many of us love Apple products because of the design, but I’ve heard too many people say ‘We’re doing innovation because we’re using iPads.’”
Even outside of Apple, the assumption that all innovation needs to be technological is a problematic one.
“I think technology for technology’s sake is a mistake,” Luis Castillo, president and CEO of Ensocare, said on a leadership panel. “If you’re automating a bad process it’s still a bad process.”
Instead, Asch said, innovation needs to be undertaken the way hospitals take on research.
“Innovation is like research,” he said. “It’s hypothesis-driven, it’s falsifiable and it’s highly disciplined.”
One problem that many organizations have innovating is they don’t recognize that step one is to identify the problem.
“Often we are solving for the wrong problem, and if we solved for the right problem we might be in a better position to address our customers’ needs,” Asch said. “Until you identify the problem you fundamentally want to solve, you can innovate in the wrong direction.” (G)

“Regarding recent reports on plans for Amazon, JPMorgan Chase, and Berkshire Hathaway to create a new health care company: Kudos to Jeff Bezos, Jamie Dimon, and Warren Buffett for stepping forward to take on the bloated US health care system.
The challenges are clear: administrative waste, unnecessary treatment, monopoly pricing, inequitable access, and often lousy quality. Less obvious is how to address them.
A good start would be to question widely held assumptions: that current treatments — including drugs — all have been proven safe and effective (safe, maybe; effective, no); that physicians can tell you what’s best for you (they can, but only if they know what is important to you); or that more medical care is always better (it’s not).”
The system is ripe for disruption and new thinking. But it will take a fearless commitment to keeping patients at the center and the profiteers at bay.” (H)

“Organizations with existing innovation centers, and those considering developing them, should consider the following actions which can head off or, at least, reduce the drag on innovation these challenges pose:
– Identify a specific purpose that unifies efforts and engage only in activities which forward it.
– Create forums for project contributors to learn about varying approaches to problem-solving.
– Develop stakeholder co-creation methods and tools which ensure maximum engagement amidst resource constraints.
– Enlist project managers and ensure clear roles and responsibilities for all center employees.
– Set project budgets and scope design projects at the outset to align with funding size and horizons.
– Establish clear initial operational and performance metrics such as percent of innovation concepts expected to be implemented, number of clinicians and patients involved in co-creation processes, types of IP generated, and stage-gated timelines.
– Be prepared to revise metrics as the center evolves and celebrate small wins.” (I)

BIG TECH HAS a lot of problems: fake news, sexual harassment, Russian interference, privacy concerns, and growing fears that too much screen time rots your brain. But even as they struggle to solve these day-to-day problems, the industry’s biggest players are putting more resources into another notoriously hard problem: health care….
Tech companies like Apple are known for creating products that people love. It’s easy to picture the industry creating a better health care experience for patients, and Apple is already hard at work designing new health products and finding new applications for its existing products. It’s researching ways to monitor blood sugar non-invasively and is working with Stanford University to test whether the Apple Watch could screen for irregular heart rhythms. This week, CNBC reported that the company will use new on-campus clinics for employees to test new health products…
The problem is that it’s not enough to just make products that patients love. The products also need to be used by doctors, nurses, and administrators. For example, a company could create a great app for letting patients share their medical data with their doctors. But if the doctor can’t access the data through software approved by her clinic, it won’t help patients. Another problem: if doctors can’t easily track or bill for their time, they may not want to use an innovative app.” (J)

“The odds: Bezos, Buffett and Dimon are big names — big as they come — but the history of health care is littered with business titans who have declared war on health care costs. Amazon, Berkshire Hathaway and JPMorgan Chase may be able to get their own costs down, but that doesn’t mean they can do it for anyone else…
The big picture: Health care costs are not one problem but many: national health care spending, federal health care spending, employer premiums, out-of-pocket costs, and the value of the dollars spent. Each has different constituencies who care about them, requiring different solutions presenting different challenges…
Reducing national health spending is a different goal. What distinguishes the level of GDP we spend on health from other countries is primarily the prices we pay for everything in health care, not the volume or intensity of services we provide. These companies might make a small dent in the prices they pay, but as big as they are, they will not have the leverage to do much beyond that…
What to watch: Perhaps other employers will try to emulate them or buy into whatever they do, but they could be successful and still have almost no impact on national health spending, federal spending, or consumer out of pocket costs.
Nor will they be immune from the forces that have hampered previous efforts. Health coverage is a popular benefit and an important part of any employer’s wage structure; they will go only so far to “disrupt” it…
As intriguing as the recent announcement is, experience suggests keeping it in perspective. (K)

“According to a recent report from Moody’s Investors Services, both for-profit and nonprofit hospitals will face a new threat in the form of greater competition, volume losses and weakened margins as commercial health insurers aggressively continue pursuing growth strategies to reduce cost and increase efficiency.
The ratings agency cites a rise in the acquisition and expansion of outpatient and post-acute services by insurance companies as examples of the increased competition. The result of this trend will be a shifting of patients away from hospital settings and toward lower-cost outpatient settings, reducing hospital volumes and placing future margins at risk.
Moody’s discussed several of the large insurance industry deals announced in recent months, including the plan to merge Aetna (the nation’s third-largest health insurer) and CVS (the biggest drugstore chain). If successful, the new entity will be able to direct members to its own provider sites and shift more care away from hospitals. Further, the new entity would expand on its services. CVS already operates clinics within its retail pharmacies that provide blood drawing and diabetes care.
The report also referenced transactions such as plans by UnitedHealth Group’s Optum to acquire DaVita Medical Group, one of the nation’s largest independent physician groups. Optum has a legitimate presence in six states and owns physician groups in six other states, including New Jersey.
“As Optum and health insurers attempt to move to value-based payment models that emphasize quality over quantity of care, hospitals will see even less volume,” a Moody’s executive stated.
The agency believes that Optum is in a good position to adopt full-risk, value-based contracts since it has many contracts with managed care clients. A physician-centric, full-risk model would give physicians control of the full premium dollar and expenses, instead of hospitals.
“Beyond being vulnerable to losing market share because of potentially being carved out of contract provider networks, hospitals face the risk that insurers will move more quickly to population-based, full-risk contracts.” (L)

“Regarding “The Future of Hospitals” (Journal Report, Feb. 26), hospitals of the future must move health care from the expensive, inefficient and inequitable model we have now to one that truly empowers consumers to manage their own health, wherever they are. We also need to reimagine the roles clinicians will play in the future. While health systems focus on bringing care to patients, instead of patients to care, we must also select and foster doctors to embrace technology, collaborate across disciplines and deliver care with empathy rather than automaticity. Artificial intelligence will provide an opportunity to let the robots be robots. Meanwhile, doctors must be the humans in the room, regardless of where that room is located, or even if it’s virtual.” (M)

“A dentist office for employees in 1919 at the Lord & Taylor store on Fifth Avenue in Manhattan. In the 19th century, many department stores started providing worker benefits that included health clinics, exercise rooms and libraries.
Who knew? But yes, The New York Times reported in 1904 that “small hospital wards are the latest features among the comforts and conveniences of the shops in a big city.”
Long before the announcement in January of a new employee health care partnership among Amazon, Berkshire Hathaway and JPMorgan Chase & Company, America’s department stores, led by John Wanamaker, were introducing an array of free worker welfare benefits — innovations that were sometimes called Industrial Paternalism. Ill or injured patrons were also accommodated.
The initiatives quickly spread to Lord & Taylor, Macy’s, Saks & Company, Bloomingdale’s, B. Altman & Co., Jordan Marsh and other shopping emporiums whose names have passed into mercantile heaven.
The long-forgotten history emerges from articles in newspapers, journals and trade publications and photo archives at the Museum of the City of New York.
Common store services for employees, according to The Times, included pharmacies and emergency rooms to set broken limbs, perform surgery and deliver babies, employee-only lunchrooms, academic and vocational classrooms, sun lounges, vacation camps, libraries, parlors stocked with fine stationery and maid-attended bathrooms with combs and brushes, curling irons, weighing machines and “shoe-blacking damsels.
So Jeff Bezos, Warren Buffett and Jamie Dimon may be onto something with plans for an independent health care company for the U.S. employees of Amazon, Berkshire Hathaway and JPMorgan Chase. Welcome, gentlemen, to the 19th century.” (N)

“Health care is incredibly backward in its use of information and consumer technologies, so it seems ripe for disruption. And, there’s just a lot of damn money in health care,” Levitt said. “There is a potential convergence going on now. Electronic medical records, mobile phones, and wearables have achieved widespread adoption, creating new opportunities.”
It’s way too soon to know where any of this is going. It could be nowhere: Google and Microsoft have talked for years about breaking into health care, with little to show for it so far. Some of these ventures are more theories than concrete plans at this point.
But it’s still worth watching. Because if any industry is in dire need of disruption, it’s American health care.” (C)

(A) Trump’s health chief warns hospital execs about health care costs: ‘Change is coming’, by JESSIE HELLMANN,
(B) Healthcare Innovators Dig Deep on Disruption, Digital Medicine at HIMSS18, by Rajiv Leventhal,
(C) Why Apple, Amazon, and Google are making big health care moves, by Dylan Scott,
(D) HIT Think Why digital transformation is crucial for healthcare providers, by Joel Gleason,
(E) How Artificial Intelligence Can Shape Health IT Infrastructure, by Elizabeth O’Dowd,
(F) Virtual care is transforming our healthcare system one visit at a time, by Anthony R. Tersigni,
(G) Innovation is much more than just using new tech, by Jonah Comstock,
(H) Disrupting health care? Check your assumptions at the door, by Michael A. Cohen,
(I) Putting Humans at the Center of Health Care Innovation, by Yasser Bhatti,Jacqueline del Castillo, Kristian, and OlsonAra Darzi,
(K) Don’t overhype the new health care venture, by Drew Altman,
(L) Moody’s: Insurers’ Disruptive Growth Strategies Pose Threat to Hospitals, NJHA Newslink, March 5, 2018
(M) Prescriptions for the Hospitals of the Future, Stephen K. Klasko,
(N) Attention 1916 Shoppers: The Doctor Is In, by RALPH BLUMENTHAL and SANDRA ROFF,

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AMAZON: Health Care DISRUPTION by DISINTERMEDIATION. (what the heck is that?)

“Hospitals are disappearing. While they may never completely go away, they will continue to shrink in number and importance….” (A)

“What do Ashton Kutcher(Airbnb), Donald Trump and Travis Kalanick (Uber) 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…
Disintermediation is impacting every industry in our economy. Netflix put an end to Blockbuster’s fortune. Amazon and eBay disintermediated traditional retailing. And Instacart, Zirx, PostMates, Caviar, Taskrabbit and others hope to become established names in the fast-growing peer-to-peer economy that served 90 million Americans (44% of U.S. adults) last year.
What do successful disintermediators have in common? There appear to be four shared attributes:
They see unnecessary costs or unnecessary wrinkles in the traditional ways companies do business. They get rid of unnecesssary layers that incumbents view as “essential” and do business a new way.
They leverage online technologies to enhance access and use by their customers.
They are not afraid of retaliation by traditional incumbents. They play long-ball with the support of their investors and boards who see a new marketplace others don’t.
They relentlessly measure and monitor their own performance to maintain a strong value proposition for their customers. They do not believe their own publicity knowing they’re being chased by look-alikes wishing to ride the coattails of their success.
More than consolidation and the Affordable Care Act, disintermediation is the single greatest catalyst for change in the health system….” (B)

“The economic term for what’s happening in retailing is disintermediation—the removal of middlemen from a supply chain or a series of transactions.
Healthcare providers are experiencing their own disintermediation moment. Advancing technology and the growing ability of payers and patients to instantly access information electronically is transforming nearly every corner of healthcare.
The practice of radiology is probably farthest along the disintermediation road. Highly trained radiologists traditionally supervised imaging, interpreted the results and offered advice to the physician who ordered the image.
Today, physicians are using handheld ultrasound devices and loading images into picture archiving and communications systems that can be read anywhere by anyone at any time. Their consulting radiologist may be laboring over a computer screen in Bangalore…
But for providers, it means disintermediation may soon reach a tipping point where once reliable revenue streams have been mostly siphoned away. As in retailing, not all will survive.” (C)

“Triumphant in online retail, cloud computing, organic groceries, and streaming television, Amazon founder and chief disruptor Jeff Bezos is turning his seemingly limitless ambition to health care.
Amazon, launched as an Internet bookseller nearly 24 years ago, has branched into offerings including voice-commanded speakers infused with Alexa artificial intelligence and original TV shows streamed online at its Prime subscription service.
Health care now appears ripe for Bezos, who has earned a reputation for attacking high costs and inefficiencies…
“He has identified a market that is ready for disruption. The healthcare system in the US is ripe for reform.”
Bezos faces the challenge of taming skyrocketing costs throughout US health care from insurance and medicine to supplies and therapy.
“Just as with every other industry Amazon has entered, Bezos is envisioning lower-priced alternatives with frictionless services that could, over time, make a lot of money for Amazon,” Orsini said.
Barclays analysts said in a recent research note on Amazon’s potential in health care, “We are never dismissive of anything disruptive that Amazon is involved in. Amazon arguable has the best technical abilities of any company we cover.”..
Amazon’s pattern of success has caused fear to ripple through sectors it eyes.
When Amazon last year made the surprise buy of Whole Foods, shares sank of major retail chains Wal-Mart and Target.
S&P Global Ratings said in a research note that Amazon “has brought price transparency and convenience to many retail segments,” while shifting consumer expectations, thus creating problems for rivals.” (D)

“Amazon has made a science of cutting out the middleman, eliminating many of the brick and mortar stores that offered similar goods to the internet giant. While there may be good reason to mourn the loss of mom-and-pop bookstores, stores that suffered in the Amazon era, I can find no cause for sympathy for Walgreens and CVS. Pharmaceutical dispensaries such as these are likely to be cut out of a new health care model, with lower costs passed on to the patients themselves. But should you find yourself feeling a twinge of remorse for CEO Larry Merlo of CVS, who took home a cool 18 million dollars in salary last year, no doubt a charity can be established in his name to benefit struggling CEOs.” (E)

“Amazon, Berkshire and JPMorgan can perhaps rope themselves off from this for-profit ecosystem and deliver better, faster and cheaper healthcare for their employees, especially with appropriate subsidies. In other words, if Amazon, Berkshire and JPMorgan behave like the US Federal Government performs in the Obamacare marketplace, it could work. If they stay inside their own ropes, it could stop there. But if the number of covered lives increases to twenty or thirty million, all bets are off. Can it work? Yes. They need to (1) swerve past the huge cash cow in the road (and free up most of that cash for reinvestment back into the network), (2) focus initially on themselves and then (3) enlist other companies and providers into their network. As the network adds other companies (and covered lives) – they will build bargaining power they can leverage. But unless they acquire some meaningful scale, they will never defeat the (profit) force that defines and dominates the US healthcare market. At the end of the day, their joint effort is about a rapid technology-driven demonstrations followed by immediate, incentivized expansion. ..With scale, the Consortium can bargain and reward; without it, the Consortium becomes a self-funded boutique with three customers.” (F)

“Amazon is attempting to transform its medical products business into a major supplier to U.S. hospitals and outpatient clinics that could compete with large distributors. Amazon has reportedly met with hospital executives on several occasions, most recently in late January, to discuss an expansion of its business-to-business marketplace, Amazon Business, into one where hospitals could shop to stock outpatient locations, operating suites, and emergency rooms. Amazon Business already sells a limited selection of medical supplies. The company recently sent employees to a large Midwestern hospital system, where officials are testing whether they can use Amazon Business to order health supplies for the system’s approximately 150 outpatient facilities. The pilot is customized for the hospital system’s catalog of supplies, according to a hospital official overseeing the efforts, allowing employees to compare prices the system negotiates with its distributors against those in the Amazon Business marketplace. Amazon said it is building technology to serve health care customers, and seeking to sell hospitals on a “marketplace concept” that differs from typical hospital purchasing, which is conducted through contracts with distributors and manufacturers. So far, some hospitals have been reluctant to buy supplies from Amazon Business, for reasons including lack of options and lack of control over purchases and shipping, which hospitals closely safeguard to ensure prompt arrival of goods.” (G)

“Deepening its move into healthcare, Amazon is pushing to turn its developing medical supplies business into a major supplier to U.S. hospitals and outpatient clinics, reports The Wall Street Journal…
“1. Amazon Business, the company’s separate business-to-business marketplace, already sells a limited selection of medical supplies — ranging from sutures to hip implants — as well as industrial supplies and office supplies. However, Amazon is hoping to expand this marketplace into one where hospitals could shop to stock emergency rooms, operating suites and outpatient facilities…
3. Recently, Amazon Business sent employees to a large hospital system in the Midwest with roughly 150 outpatient facilities to test Amazon Business as a medical supplier. Essentially, the pilot is testing if the system can effectively order healthcare supplies for all of its facilities. The pilot is customized for the healthcare system’s catalog of supplies and allows employees to compare prices the hospital negotiates with its distributors and the supplies in Amazon Business’ marketplace…
5. Over the past year, Amazon slowly acquired more than 10 wholesale pharmacy licenses from state pharmaceutical boards. The licenses are held in Alabama, Arizona, Connecticut, Idaho, Louisiana, Michigan, Nevada, New Hampshire, New Jersey, North Dakota, Oregon and Tennessee. These licenses are necessary for selling medical equipment to licensed professionals…” (H)

“The online retailer’s plan to enter the hospital supply chain could bring major cost savings for hospitals.
Hospital CFOs are likely to welcome the most recent foray from Amazon into the healthcare market, as it should lead to lower supply costs, second only to labor as a major cost center, an investment banking analyst says.
Distributing medical supplies is so closely aligned with what Amazon already does on a huge scale that this new project is almost certain to threaten existing medical suppliers and distributors, with hospitals and health systems reaping the rewards…
On the heels of announcing a new health plan, Amazon is now looking to become a major supplier of medical products to U.S. hospitals and outpatient clinics, competing directly with suppliers such as McKesson, Cardinal Health, and Owens & Minor, according to a report in The Wall Street Journal.
The move on healthcare’s supply chain seems to bear out analysts’ predictions that Amazon’s threat to shake up the health insurance industry might be only the first step in tearing down other healthcare silos as well.
The company’s entrance into the medical supply chain could bring “massive change,” says W. Robert Friedman Jr., managing director in the healthcare practice of Dresner Partners Investment Banking.
“Hospitals are under tremendous financial pressure due to the reduction in Medicare rates and Medicaid. The major expense for hospitals is the cost of labor but supply is right behind it as a big percentage of their core operations,” Friedman says. “If hospitals can order directly from Amazon, which then ships directly to their distribution outlets, this would be a major transformation in the distribution component of the healthcare industry.” (I)

“Is Amazon about to do to orthopedic device makers and distributors what it did to retail goods?
The report that Amazon has been holding meetings with hospital execs to learn about their needs caused the stocks for companies like Cardinal Health, Inc. and Owens & Minor, Inc. that distribute medical supplies to tumble.
Who Is Threatened?
The threat of Amazon becoming a supplier shouldn’t be a cause for alarm for medical device manufacturers, according to Needham & Company, LLC analyst Mike Matson.
Amazon, in effect, wants to be the new middle man between manufacturers and hospital in a period of disintermediation in healthcare….
Matson writes that Amazon has typically disrupted middlemen much more than manufacturers. In his view, Amazon’s model “may work for ‘lower tech’ products but is unlikely to work with ‘higher tech’ products.” He believes that Amazon, “would simply represent another distribution channel for lower tech products. And with med tech pricing already under pressure, we don’t expect this to intensify with Amazon’s entry.” (J)

“Amazon sells branded over-the-counter medications such as Advil, Mucinex and Nicorette as well as options from Perrigo’s generic GoodSense brand.
Basic Care, Amazon’s recently launched exclusive line of Perrigo OTC health products, is a possible challenge to pharmacy retail chains.
CVS Health, Walgreens Boots Alliance and Rite Aid are losing traffic as people shop for OTC products online, including on Amazon.
Amazon has quietly launched an exclusive line of over-the-counter health products in a possible challenge to pharmacy retail chains that could spark a price war and put pressure on store-brand profit margins.
Technically, the company doesn’t own these products, which are produced by private-label manufacturer Perrigo, but it does put Amazon in a position to squeeze other retailers. The e-commerce giant launched the Basic Care line in August, including 60 products ranging from ibuprofen to hair regrowth treatment.
Pharmacies make money when people walk in looking to grab medicine and end up buying cosmetics and other goods. They’re already losing traffic as people shop for those products online, including on Amazon. Giving them another possible reason to skip the store could hurt even more.
“It’s a very different world, and having Amazon jump in is not a good sign for existing brands, either branded or private label, because the way Amazon works is its ability to take on unprofitable ventures for a time to see how things go,” said Matthew Oster, head of consumer health research at global market research firm Euromonitor International.
“And the fact they have a near monopoly in e-commerce gives them a lot of scale that can allow them to undercut price. So that aspect should be concerning for whoever their competitors are in that space,” he said.” (K)

“…Don’t get too excited. Not even a company as crafty as Amazon, or a bot as all-knowing as Alexa, can fix our nonsensical health care system.
The problem with America’s largely employer-based health insurance system for workers is not something these companies can necessarily fix. The problem is that its basic architecture is upside-down.
The health care system has neither market economics nor budgets to contain costs, so prices go up willy-nilly. To make matters worse, as most working Americans get their coverage through employers, they are forced to re-enroll each time they switch jobs — something people do at least 10 times by the time they are 50, according to the Labor Department, or their employers switch health plans. All of this hurts patients by disrupting the continuity of care and promoting unnecessary doctor-switching.
At the heart of America’s system is the central feature of patient and provider conspiring to spend what is mostly other people’s money. Though that is not unique to America, what is unique is that those other people have virtually no power to set limits.
While providers, such as hospitals and drug companies, often have monopoly or near-monopoly powers, the people who foot the bill are fragmented into thousands of insurance pools run by dozens of insurance companies, all but one of which — UnitedHealth Group — has a national market share in the single digits.
That’s why prices keep going up at rates well above inflation. It’s not a fair fight.
The three companies — particularly Amazon — are known for their ability to disrupt industries. But in health care, they aren’t up against an old-school industry fallen behind the times; they’re facing powerful monopolies or near-monopolies brimming with technology of their own.” (L)

“Blueshift Research thinks Amazon (NASDAQ: AMZN) has the potential to disrupt traditional Rx and medical and dental supply sales and distribution channels in as little as six months if it was to acquire a supply distributor, a mail order pharmacy, or a PBM.
They said a full disruption from Amazon would take two years, however, disruption of the medical and dental supply channels will be much faster due to their higher profit margins and fewer regulatory requirements.” (M)

“The prospect for escalating disintermediation in our industry seems certain. Conditions are ripe. Business schools use case studies to show how incumbent organizations facing disintermediation transformed themselves. In each, the organization was guided by data and facts about their market, reputation, performance, and positioning. They are led by visionary CEOs that see the future and a small team of competent managers focused on execution. They make bold changes with the support of their boards and take friendly fire from insiders threatened by loss of control or change. And they make some mistakes along the way.
Is healthcare ripe for disintermediation? Clearly yes. But are our leaders and boards ready? That’s to be determined. And lest we forget, it’s the consumer, our patients, who will be the ultimate judge of their success and our responses.”(B)

“The burgeoning collaboration between Amazon, JPMorgan Chase and Berkshire Hathaway seeking to transform the American health care system is long on ambition and short on details.
By their own admission, the companies are stepping up to the plate without much experience playing the game, which could easily translate into a swift strikeout.
Any prediction about the alliance’s plans must glean insight from Amazon’s success, which has been based on removing entire layers of product sales and distribution and adopting new ways of thinking. That’s caused massive disruption in the retail and tech industries.
With retail, Bezos refused to travel the well-worn path established by leaders in the business. Victims that failed to adapt, such as bookstore chain Borders, are gone. Others, such as Sears, are teetering.
The lesson for health care? The system you know today won’t necessarily exist in its current form for much longer if Bezos, Buffett and Dimon get their way.
To shake up health care, “it takes bold thinking on the part of thought leaders who are willing to go out there and stake a claim that they will be able to do something grand,” said Jean Abraham, a health care administration professor at the University of Minnesota and former senior economist on health issues for the White House Council of Economic Advisers.” (N))

“Hospitals will also continue consolidating into huge, multihospital systems. They say that this will generate cost savings that can be passed along to patients, but in fact, the opposite happens. The mergers create local monopolies that raise prices to counter the decreased revenue from fewer occupied beds. Federal antitrust regulators must be more vigorous in opposing such mergers…
As these trends accelerate, many of today’s hospitals will downsize, merge or close. Others will convert to doctors’ offices or outpatient clinics. Those that remain will be devoted to emergency rooms, high-tech services for premature babies, patients requiring brain surgery and organ transplants, and the like. Meanwhile, the nearly one billion annual visits to physicians’ offices, imaging facilities, surgical centers, urgent-care centers and “doc in the box” clinics will grow.
Special interests in the hospital business aren’t going to like this. They will lobby for higher hospital payments from the government and insurers and for other preferential treatment, often arguing that we need to retain the “good” jobs hospitals offer. But this is disingenuous; the shift of medical services out of hospitals will create other good jobs — for home nurses, community health care workers and staff at outpatient centers.” (A)

(A) Are Hospitals Becoming Obsolete?, b EZEKIEL J. EMANUEL,
(B) Is Health care Ripe for Disintermediation?, by PAUL KECKLY,
(C) Editorial: Healthcare disintermediation heads for a tipping point, by Merrill Goozner,
(D) After stunning growth streak, Amazon ambitions seem boundless,
(E) How Amazon Could Succeed in Overturning the Old Healthcare Model, by Aaron Krumins,
(F) Amazon, Berkshire & JPMorgan Can Fix Healthcare With Technology – And By Studying Winners, by Steve Andriole,
(G) Amazon’s latest ambition: To be a major hospital supplier,
(H) Amazon pushes to become a major hospital supplier: 7 things to know, by Alia Paavola,
(I) Supply Chain Is Natural Step for Amazon, Potential Boon for CFOs, by Gregory A. Freeman,
(K) Amazon has quietly launched an exclusive line of over-the-counter health products, by Angelica LaVito,
(L) Alexa, could health care be fixed?,
(M) Amazon (AMZN) Could Disrupt U.S. Healthcare System in as Little as Six,
(N) How Amazon, JPMorgan, Berkshire could transform American health care, by Nathan Bomey,

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