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Monday, May 2, 2016

"Better, Smarter, and Healthier" Really?

Been plowing through the new NPRM (Notice of Proposed Rulemaking, pdf) for MACRA ("Medicare Access and CHIP Reauthorization Act of 2015" pdf). 1,000+ pages of MEGO (962 pages in the NPRM alone).

Not a lotta love out there for MACRA et al these days in some quarters. See, e.g., "The Angry Physician" at THCB.
...It took me two years to realize the meaninglessness of meaningful use. I still can’t believe how long it took me to realize that creating a workflow in my office to print out and deliver clinical summaries to patients didn’t do anything other than fill the trash bin. I still held out hope.  I thought – this was a first draft, improvements would come. What came instead were positively giddy announcements of the success of the meaningful use roll out. The administration was actually doubling down. There was no acknowledgment for the mess that had been created – onward and forward on the same road we must continue to march. Except the road would no longer be paved and we would be walking uphill.

I watched as reimbursements were cut to physician practices, while hospital reimbursements were left alone. Independent practices collapsed only to reemerge in a hospital employed model. The landscape was changing seismically – and yet I saw no evidence that patients were safer, or that this new model was more cost efficient.

It is in this setting that MACRA arrives.  MACRA is the newest iteration of tying reimbursement to value instead of volume. An admirable goal that is spelled out in a 962 page document...
BTW: Peruse the comments in particular. Will MACRA largely be the Zombie Son of MU? Will "better, smarter, healthier" come in significant measure from HHS policy promulgations? Or in spite of them?

UPDATE: "A Deep Dive on the MACRA NPRM" by Dr. John Halamka
As promised last week, I’ve read and taken detailed notes on the entire 962 page MACRA NPRM so that you will not have to.

Although this post is long, it is better than the 20 hours of reading I had to do!Here is everything you need to know from an IT perspective about the MACRA NPRM...
Good stuff.
"After spending 20 hours reading the MACRA NPRM, I had one overwhelming thought.    Sometimes when you remodel a house, there is a point when additional improvements are impossible and you need to start again with a new structure. The 962 pages of MACRA are so overwhelmingly complex, that no mere human will be able to understand them."
Yeah. And these are just the draft regulations.

Federal regulation aside/notwithstanding, will health care become "essentially free, once delivered by the flawless AI-enabled robots in a decade or so" as the exuberant peeps at Singularity University would have us believe? Beyond tech per se, what will be the overlapping (and often confounding) impacts of policy and economics? (apropos, see Steve Findlay's "Measuring Hillary.")

Following on my recent reads concerning the myriad facets of "disruption," I've started a new one:

Dilemmas: Old and New
Britannica and Matson were both successful firms that faced disruption in the form of a new technology. In both cases, the industry was completely transformed by that new technology. However, while Britannica became a disrupted firm, Matson sailed on. Unpacking why their fates were so different is the purpose of this book.

While it is hard to compare encyclopedias and ocean shipping, there are similarities in the Britannica and Matson cases. As already noted, each faced a new technology that transformed their respective industries. Importantly, the senior management in both firms realized the potential of the new technology and sought early on, well ahead of most in the market, to enact strategies to respond to it. However, Britannica and Matson took distinct approaches in implementing that response. Understanding those different choices and their implications is the key to seeing how to deal with disruption.

Britannica and Matson faced variants of what has become known as “the innovator’s dilemma.” While the term was coined and explored by Clayton Christensen in his famous 1997 book of that title, the dilemmas have been posed in various forms through the academic literature on management both prior to Christensen and also contemporaneously with him. The dilemma an established firm faces when dealing with disruption—usually in the form of a new technology or innovation—is that seemingly good management practices not only can fail to deal with disruption but can, in fact, be a hindrance in finding a way of dealing with it. When Britannica explored digital technologies in the mid to late 1980s, its main encyclopedia business was thriving, and accommodating a digital product would require reengineering the entire organization. As a consequence, its approach was to wall off its digital endeavors, allowing them to be pursued freely in an autonomous unit. Matson faced the same organizational issues in adopting containerization for its shipping fleet, but rather than creating a separate unit to pursue this, from the start it adopted a new organizational structure that tightly integrated research and commercial divisions. Thus, it exposed the entire organization to change and in the process faced a slower path to adopting containerization.

The difference between dealing with disruption via a walled-off, independent unit and doing so with a more tightly integrated organizational structure is at the center of this book. To be sure, the independence path has received the most attention in recent times, due to its advocacy by Clayton Christensen under the mandate of disrupting one’s own company before a competitor does. However, the integration path stemmed from a distinct approach to analyzing disruption that emerged at the same time as Christensen’s. This approach was put forward mainly by Rebecca Henderson. Both Christensen and Henderson were Harvard PhD students around 1990, both looked at what we now call disruption as part of their seminal thesis work, and today both are professors at Harvard Business School. How they came to such distinct viewpoints will be covered later in this book.

To anticipate where this journey will take us, we will see that independence as a means of dealing with disruption has some inherent flaws that undermine its effectiveness. This is both theoretically the case—as every independent unit eventually needs to be integrated into the mainline organization, creating the very conflicts it was set up to avoid—but is also true as part of the historical record—very few firms have used independent units to successfully avoid disruption.

The track record on dealing with disruption via an integrated organizational structure is, in my opinion, stronger but itself leads to a new dilemma. To stave off disruption, integration comes with a price. Organizations that have integrated ways of dealing with radical technological change tend to be slower-moving and also tend, at any given point in time, not to operate at their most efficient. Consequently, while they tend to be long-lived and shielded when there are multiple disruptive waves, they tend not to lead or dominate their markets. Thus, a core dilemma firms must grapple with is whether to integrate for sustainability or adopt alternative structures to gain more transient but profitable market positions...

Gans, Joshua (2016-03-18). The Disruption Dilemma (MIT Press) (Kindle Locations 244-263). The MIT Press. Kindle Edition.
Also just downloaded this one.

"Had I, or my physicians, known what disruptive technologies would be impacting medicine in just the next few years, I may not have had three organs removed." [pg. 21]
Recall that Robin was one of the speakers at last week's 5th Annual AARP Health Innovation@50+ LivePitch™ event.
A convergence of technologies is happening in medicine. We’re entering a perfect storm of technological advancements that are enabling the era of the patient. We’re now in an era of not only patient-focused care but also patient-directed medicine [pg 19].

This book gives you a whiplash Six Flags roller coaster tour through a broad swath of cutting-edge health tech innovation.
I’ve sat down and spoken with almost all of the people mentioned in this book. We talk tech, trends, science, entrepreneurship, and healthcare. I attended the majority of presentations at Singularity University for over three years. I took dives into major areas of accelerating technology, including robotics, computing systems, biology, nanotechnology, artificial intelligence, future studies, space, global challenges, incentivized prizes, and entrepreneurship. I took very deep dives into medicine. I’ve spoken at, organized, or attended many other educational channels in medicine, biology, and technology, including Arc Fusion Programs, Health 2.0, TEDMED, TED, Connected Health Symposium, Differential Medicine, and workshops on tissue engineering and organ banking for the White House and DARPA with the Organ Preservation Alliance, among many others. I’ve listened to literally thousands of hours of content on technology, medicine, and science outside of my formal education. I’ve taken that knowledge and broken it down for you, as told through the eyes of a patient, to show just how rapidly medicine is changing, empowering, and enabling the patient to be a key decision maker [pp 22-23].
The Future of the Hospital
A lot of what happens in a hospital today is going to happen in the future in the patient’s home or at a nearby pharmacy or storefront clinic. All the point of care diagnostics, the sensors, the wearable technology, the cloud-based computing, the telepresent robots, and technology we haven’t even thought of yet will converge to make hospitals places where you will go a lot less often. Even people with chronic diseases and severe handicaps will be able to get excellent medical care without leaving home. And people who live far from advanced medicine will still be able to access it. 

When I was growing up in New Hampshire, our small town didn’t have a hospital. The closest hospital was several towns over. Specialists and more advanced hospital care were a long drive away. I sometimes forget how lucky I am now to live in California and be surrounded by high-end hospital systems like Stanford and UCSF and PAMF. I didn’t have that access when I was younger. Many people still don’t. If you’re in rural Wyoming, you might need to drive for hours to see a doctor. And if you live in rural parts of Africa or India or anyplace where the nearest doctor could be a two- or three-day walk away, your access to high-level medical care is basically nonexistent. The medicine of the future will give the world access to healthcare [pp 149-150].
Let's hope that all of this beneficent whiz-bang will indeed be universally affordable. The question remains: how will all of this get paid for?

Both of the foregoing books are more fun (and more usefully informative) than the MACRA NPRM. to wit,
[NPRM pg 36] … On October 16, 2015, ONC published the 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications final rule ("2015 Edition final rule"). The final rule made changes to the ONC Health IT Certification Program that strengthen the testing, certification, and surveillance of health IT. In addition, the final rule clarified and expanded the responsibilities of ONC-Authorized Certification Bodies (ONC-ACBs) with respect to the surveillance of certified EHR technology and other health IT certified under the ONC Health IT Certification Program, including requirements for ONC-ACBs to conduct more frequent and more rigorous surveillance of certified technology and capabilities “in the field” (80 FR 62707). The purpose of in-the-field surveillance is to provide greater assurance that health IT meets certification requirements not only in a controlled testing environment but also when used by health care providers in actual production environments (80 FR 62707).

In addition to these changes, on March 2, 2016, ONC published the ONC Health IT Certification Program: Enhanced Oversight and Accountability proposed rule, which would expand ONC’s role to strengthen oversight under the ONC Health IT Certification Program by providing a means for ONC to directly review and evaluate the performance of certified health IT in certain circumstances, such as in response to potential systemic or widespread issues, or in response to problems or issues that could pose a risk to public health or safety, compromise the security or privacy of patients’ health information, or give rise to other exigencies (81 FR 11055).

These efforts to strengthen surveillance and other oversight of certified health IT, including through expanded in-the-field surveillance and ONC direct review of technology and capabilities, are critical to the success of HHS programs and initiatives that require the use of certified health IT to improve health care quality and the efficient delivery of care. With respect to the use of certified EHR technology under the Medicare and Medicaid EHR Incentive Programs and the MIPS Program, effective surveillance and oversight is fundamental to providing basic confidence that such technology consistently meets applicable standards, implementation specifications, and certification criteria adopted by the Secretary when it is used by eligible clinicians, EPs, eligible hospitals, and CAHs, as well as by other persons with whom eligible clinicians, EPs, eligible hospitals, and CAHs need to exchange electronic health information to comply with program requirements. The need to ensure that technology consistently meets applicable standards, implementation specifications, and certification criteria is important both at the time it is certified and on an ongoing basis when it is implemented and used in the field by eligible clinicians, EPs, eligible hospitals, and CAHs in order to meet objectives and measures under the Medicare and Medicaid EHR Incentive Program or MIPS. Efforts to strengthen surveillance and oversight of certified EHR technology in the field will become even more important as the types and capabilities of certified EHR technology continue to evolve and with the onset of Stage 3 of the Medicare and Medicaid EHR Incentive Programs and MIPS, which include heightened requirements for sharing electronic health information with other providers and with patients using a broad range of certified EHR technology and other health IT. Finally, we note that effective surveillance and oversight of certified EHR technology is necessary if eligible clinicians, EPs, eligible hospitals, and CAHs are to be able to rely on certifications issued under the ONC Health IT Certification Program as the basis for selecting appropriate technologies and capabilities that support the use of certified EHR technology while avoiding potential implementation and performance issues.

For all of these reasons, the effective surveillance and oversight of certified health IT, and certified EHR technology in particular, is necessary to enable eligible clinicians, EPs, eligible hospitals, and CAHs to demonstrate that they are using certified EHR technology in a meaningful manner as required by sections 1848(o)(2)(A)(i) and 1886(n)(3)(A)(i) of the Act. Yet as ONC observed in the 2015 Edition final rule, such surveillance and oversight will not be effective unless EPs, eligible hospitals, and CAHs are actively engaged and cooperate with the authorized surveillance and oversight of their technology, including by granting access to and assisting ONC and ONC-ACBs to observe the performance of production systems (80 FR 62716).

Accordingly, we are proposing that as part of demonstrating that it is using certified EHR technology in a meaningful manner, an eligible clinician, EP, eligible hospital, or CAH must demonstrate its cooperation with these authorized surveillance and oversight activities. We are proposing to revise the definition of a meaningful EHR user at §495.4, as well as the attestation requirements at §495.40(a)(2)(i)(H) and §495.40(b)(2)(i)(H) to require EPs, eligible hospitals, and CAHs to attest their cooperation with certain authorized health IT surveillance and direct review activities, described in more detail in this section of the rule, as part of demonstrating meaningful use under the Medicare and Medicaid EHR Incentive Programs. Similarly, we are proposing to include an identical attestation requirement in the submission requirements for eligible clinicians under the advancing care information performance category proposed at §414.1375.

We propose that eligible clinicians, EPs, eligible hospitals, and CAHs would be required to attest that they have cooperated in good faith with the surveillance and ONC direct review of their health IT certified under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT. Under the terms of the attestation, such cooperation would include responding in a timely manner and in good faith to requests for information (for example, telephone inquiries, written surveys) about the performance of the certified EHR technology capabilities in use by the provider in the field. The provider’s cooperation would also include accommodating requests (from ONC-Authorized Certification Bodies or from ONC) for access to the provider’s certified EHR technology (and data stored in such certified EHR technology) as deployed by the provider in its production environment, for the purpose of carrying out authorized surveillance or direct review, and to demonstrate capabilities and other aspects of the technology that are the focus of such efforts, to the extent that doing so would not compromise patient care or be unduly burdensome for the eligible clinician, EP, eligible hospital, or CAH.

We understand that cooperating with in-the-field surveillance may require prioritizing limited time and other resources...
Lordy. A quick NPRM priority keyword/phrase-of-interest tally:
  • EHR(s) --  659
  • CEHRT --  135
  • "quality measures" -- 338
  • "Meaningful Use" -- 56
  • "quality improvement" -- 42
UPDATE: Healthcare Dive has a nice analytic summary of the MACRA NPRM here, "Breakdown of the MACRA Proposed Final Rule."

Primary Care—Leading the HIT Revolution, Part I: Supporting Clinical Processes
by JEROME CARTER on MAY 2, 2016 

No, the title is not a mistake. It simply reflects what I have come to realize over the last month or so. Innovation is about solving problems and, as the saying goes, “Necessity is the mother of invention.” Misery is a source of innovation, and the loudest cries about EHR systems with poor usability have come from primary care providers and their professional organizations. Having practiced primary care internal medicine, I understand the misery well. Primary care clinicians have been cast in the role of gatekeepers and monitors of their patients’ health, but have been given tools that mostly provide them data. The fact is clinicians are drowning in data because they do not have the tools required to make proper use of it...
Yeah. And, regarding policy, how about some contrarian Margalit Gur-Arie?
Comprehensive Primary Charade +

The most powerful persuasion tool in enlightened human society is language. The most powerful manipulation tool in any human society is language. Whereas in ancient times the pen was considered mightier than the sword, now the keyboard can be said to be mightier than any weapon of mass destruction, and nobody is mightier than the government of these United States. When our government wanted to strip citizens of privacy, it passed the Patriot act, because no one could oppose patriotism after 9/11. When it set out to facilitate corporate procurement of foreign slave labor, it enacted a set of XYZ Free Trade agreements, because this is the land of the Free. When it decided to ration health care services for the middle class, it put in place the Affordable care act, because we are all broke. Now that the U.S. government has decided to do away with the medical profession, it is feverishly rolling out Comprehensive primary care initiatives.

Comprehensive primary care is not a fuzzy, in the eye of the beholder, type of concept. Perhaps the most celebrated primary care advocate in recent times, Dr. Barbara Starfield, defined comprehensive primary care as “dealing with all health-related problems or interventions except those too uncommon to maintain competence,” where “common” means “encountered in at least one per thousand patients in a year.” The term comprehensive is an adjective intended to describe the spectrum of problems addressed in primary care without referrals to outside specialists. Comprehensive primary care is what country doctors used to provide to their patients from cradle to grave, and some still do. Comprehensive primary care is what family medicine was supposed to be all about, but it rarely is...


Just ran across a review of this book during my early morning requisite site-surfing -- in this case the always excellent, "Sharks Get Cancer, Mole Rats Don’t: Clues to Understanding Cancer"

We think of cancer as caused by mutations. Mutations are necessary, but not sufficient, to cause cancer. New research indicates that it’s the body’s response to mutant cells that determines whether cancer will develop. James S. Welsh, MD, a radiation oncologist and researcher, has written a book on the immunology of cancer, Sharks Get Cancer, Mole Rats Don’t: How Animals Could Hold the Key to Unlocking Cancer Immunity in Humans. In it, he pieces together clues from animals, pregnancy, Ebola virus, infections, organ transplantation, parasites, and human cancer patients, weaving a web of insights that point to a better understanding of cancer biology and treatment.

Sharks do get cancer

The first book claiming that sharks don’t get cancer came out in 1992. It persuaded so many people to take shark cartilage that the world market exceeded $30 million and shark populations decreased by as much as 80%. Sharks do get cancer, as you can see in this picture.

Ironically, sharks can even get cancer of the cartilage! And of course shark cartilage supplements don’t prevent cancer in humans. Welsh explains how that myth got started. It was magical thinking based on extrapolation from a legitimate scientific study on angiogenesis where tumor growth in lab animals was suppressed by placing rabbit cartilage next to the tumors...
Yeah, shark cartilage, that was in the endless mix of dubious to outright bozo stuff we had to examine in the late 90's back when Sissy was ill.
...The foregoing comprise a more or less representative sampling of our experience thus far with the quackery end of the alternative therapy spectrum, a distribution of propositions whose opposite terminus abuts the breadth of mainstream clinical research and practice, where methods as yet"unproven" but more logically reasonable and promising vie for acceptance by the medical establishment. In the middle lie tougher calls: does shark cartilage really shrink tumors, functioning as an angiogenesis inhibitor? (one skeptical journal article called it "the laetrile of the 90's") Hydrazine sulfate? (also reported on extensively in the mainstream clinical literature and generally-- though not uniformly-- dismissed as 'ineffective.') Nucleotide Reductase? Plant oils? Blue-green algae?

All of these unconventional therapeutic assertions-- many of which would prove to be merely unproductive, outlandish, maddening distractions-- would have to be checked out while also slogging through the vast archives of mainstream clinical literature, a quest that would take me through the most recent three years of month-by-month National Cancer Institute (NCI) hepatoma citations. Also, I began-- and continue to this day-- keyword-searching the Medline indices for anything related to Sissy's condition that might prove useful...
More from the SBM review:
Conclusion: A great book about a terrible scourge

This is an outstanding book. It combines a fun trip to the zoo with an introductory course in cancer immunology. It’s full of weird facts that you can repeat as trivia to impress your friends. I could only sample its riches here. There is much more in the book, with details and copious references. The subject is endlessly fascinating, and the writing style is clear, appealing, and accessible, broken into 36 short, easily-digested chapters. This is cutting edge hypothesis-generating science pointing to exciting discoveries sure to come in the near future...
These people are never prone to hyperbole or taking things at face value. Once I finish the two books currently underway (scroll up), I'll have to get it and read it.

I recall the last time a book review came to my attention, regarding Gideon Burrows' wonderful "This Book Won't Cure Your Cancer."

More to come...

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