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Remembering the Real Stakeholders: Patient Privacy Rights Comments on the Proposed CMS Regulation Pursuant to the Cures Act

Deborah C. Peele
Adrian Gropper

By ADRIAN GROPPER, MD and DEBORAH C. PEEL, MD

Electronic health records (EHRs) are a polarizing issue in health reform. In their current form, they are frustrating to many physicians and have failed to support cost improvements. The current round of federal intervention is proposed rulemaking pursuant to the 21st Century Cures Act calls for penalties for “information blocking” and for technology that physicians and patients could use “without special effort.”

The proposed rules are over one thousand pages of technical jargon that aims to govern how one machine communicates with another when the content of the communication is personal and very valuable information about an individual. Healthcare is a challenging and unique industry when it comes to interoperability. Hospitals spend lavishly on EHRs and pursue information blocking as a means to manipulate the physicians and patients who might otherwise bypass the hospital on the way to health reform. The result is a broken market where physicians and patients directly control trillions of dollars in spending but have virtually zero market power over the technology that hospitals and payers operate as information brokers.

What follows below are comments by Patient Privacy Rights on the proposed rule. The common thread of our comments is the need to treat patients and physicians, not the data brokers, as the real stakeholders.

Comments to the ONC Rule

Overview: 21st Century health care innovation, policy, and practice is increasingly dependent on personal information. This is obvious with respect to machine learning and risk adjustment, but personal information is now central to the competitive strategy for most of the health care economy, clinical as well as research. ONC’s drafting of this rule reflects the importance of competition to innovation and cost containment.

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Health in 2 Point 00, Episode 84 | Health 2.0 HIMSS Europe, Part 2

Slide into Health in 2 Point 00 (or rather, Health 2.0 HIMSS Europe) with Jess and I today! On Episode 84, Jess asks me about the big news that CVS has now made it possible for employees to get reimbursed for Big Health’s Sleepio, an insomnia digital therapeutic, and about Atrium Health’s $10 million investment in an affordable housing plan, addressing the social determinants of health. Hear some of my key takeaways from the conference so far, too. –Matthew Holt

Medicare for All and Industry Consolidation

By KEN TERRY

Far more attention has been devoted to the ways in which industry consolidation has driven up health costs than to proposals on how to remedy the situation. But the introduction of Medicare for All and Medicare for More bills—however dim their short-term prospects are—has changed the terms of the debate. It is time to think about how we can eliminate the market power of health systems without causing harmful dislocations in health care and the economy.

Before we get to that, here are the main facts about consolidation: As a handful of health insurers have become dominant in many markets, health systems have done likewise in order to maintain or improve their negotiating positions. That has proved to be an effective strategy in many cases. Even dominant health plans cannot do without the largest hospital systems in their areas, especially when they employ many of the local physicians.

According to a Kaufman Hall report, 90 hospital and health system deals were publicly announced in 2018. This was a decline from the 115 deals unveiled in 2017, but the average size in the revenue of sellers hit a high of $409 million.

The biggest provider mergers are staggering in scale. In February 2019, for example, Catholic Health Initiatives and Dignity Health formed a new organization called CommonSpirit Health, which has 142 hospitals, 150,000 employees and nearly $30 billion in revenues. The union of Chicago-based Advocate Health Care and Wisconsin’s Aurora Health Care in April 2018 created a giant with 27 hospitals and $11 billion in revenues. A month later, Atrium Health (formerly Carolinas Healthcare System) joined with Wake Forest Baptist Health to form a system with 49 hospitals and combined revenues of $7.5 billion.

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Why A Diverse and Inclusive Healthcare Innovation Workforce Matters

By ANDRÉ BLACKMAN

There I was, my 10th-grade science fair. My mother made sure I had a tie that fit properly and a shirt that was perfectly pressed. I stood among my peers with our cardboard presentation displays highlighting what we did to make it to this point. I was a little nervous but also extremely proud of myself and excited to see the looks on the judge’s faces when they saw what my project was about:

“The Effects of Enzymes on DNA”

Boom. Oh, I wasn’t doing something that many people had seen already — I was working inside an NIH facility with a brilliant scientist mentor/coach, to get this done. The memories of taking multiple modes of transportation after school throughout the week for what seemed like forever wore me down enough to make sure that I knew this was going to be worth it. And then after the judges were introduced to all of our concepts and families poured throughout the gymnasium to see what we all came up with — now was the moment of truth.

Sweaty palms and teenage anxiety wouldn’t deter me. First place goes to….oh ok, yeah of course, they deserved that. They worked really hard I’m sure. Second place goes to….oh wow, I didn’t make second place? At least, I’ll get something. After a third place winner was announced and the applause faded. I looked, stunned, over at my mother in the audience whose face was covered in tears. I was ready for the night to be over. Did I not wear the right tie? Did I seem too confident? Not confident enough? The questions would consume me until later that evening when my science teacher told me that the judges thought I cheated or didn’t actually do any of the work.

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Health in 2 Point 00, Episode 83 | Health 2.0 HIMSS Europe

Today on Health in 2 Point 00, Jess and I are in Helsinki for Health 2.0 HIMSS Europe. In Episode 83, Jess asks me about Roche cheating on mySugr—Roche announced a new partnership with digital diabetes provider GlucoMe, about the new $100 million hospital venture fund in Iowa coming from UnityPoint Health, and about Infermedica’s recent $3.65 million raise for their cool symptom checker complete with an AI chatbot. Stay tuned for more updates from the conference. —Matthew Holt

The best medical AI research (that you probably haven’t heard of)

By LUKE OAKDEN-RAYNER

I’ve been talking in recent posts about how our typical methods of testing AI systems are inadequate and potentially unsafe. In particular, I’ve complainedthat all of the headline-grabbing papers so far only do controlled experiments, so we don’t how the AI systems will perform on real patients.

Today I am going to highlight a piece of work that has not received much attention, but actually went “all the way” and tested an AI system in clinical practice, assessing clinical outcomes. They did an actual clinical trial!

Big news … so why haven’t you heard about it?


The Great Wall of the West

Tragically, this paper has been mostly ignored. 89 tweets*, which when you compare it to many other papers with hundreds or thousands of tweets and news articles is pretty sad. There is an obvious reason why though; the article I will be talking about today comes from China (there are a few US co-authors too, not sure what the relative contributions were, but the study was performed in China).

China is interesting. They appear to be rapidly becoming the world leader in applied AI, including in medicine, but we rarely hear anything about what is happening there in the media. When I go to conferences and talk to people working in China, they always tell me about numerous companies applying mature AI products to patients, but in the media we mostly see headline grabbing news stories about Western research projects that are still years away from clinical practice.

This shouldn’t be unexpected. Western journalists have very little access to China**, and Chinese medical AI companies have no need to solicit Western media coverage. They already have access to a large market, expertise, data, funding, and strong support both from medical governance and from the government more broadly. They don’t need us. But for us in the West, this means that our view of medical AI is narrow, like a frog looking at the sky from the bottom of a well^.

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THCB Spotlight | Chris Gervais, CTO of Kyruus

Today on THCB Spotlight, Chris Gervais, Chief Technology Officer of Kyruus, tells us about what Kyruus is doing to improve patient access and help health systems match patients to the right providers. Health systems often don’t know enough about their providers, and Kyruus is working to empower health systems to use that data in a computable way in order to coordinate patient demand with physician supply.

ONC & CMS Proposed Rules – Part 6: Payer Data Requirements

Nikki Kent
Dave Levin

By DAVE LEVIN, MD and NIKKI KENT

The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking, and other activities as part of implementing the 21st Century Cures Act. In this series, we will explore ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics are open to interpretation, we invite readers to respond with their own ideas, corrections and opinions.

Interventions to Address Market Failures

Many of the rules proposed by CMS and ONC are evidence-based interventions aimed at critical problems that market forces have failed to address. One example of market failure  is the long-standing inability for health care providers and insurance companies to find a way to exchange patient data. Each has critical data the other needs and would benefit from sharing. And, as CMS noted, health plans are in a “unique position to provide enrollees a complete picture of their clams and encounter data.” Despite that, technical and financial issues, as well as a general air of distrust from decades of haggling over reimbursement, have prevented robust data exchange. Remarkably, this happens in integrated delivery systems which, in theory, provide tight alignment between payers and providers in a unified organization.

With so much attention focused on requirements for health IT companies like EHR vendors and providers, it is easy to miss the huge impact that the new rules is likely to have for payers. But make no mistake, if implemented as proposed, these rules will have a profound impact on the patient’s ability to gather and direct the use of their personal health information (PHI). They will also lead to reduced fragmentation and more complete data sets for payers and providers alike.

Overview of Proposed CMS Rules on Information Sharing and Interoperability

The proposed CMS rules affect payers, providers, and patients stating that they:

  • Require payers to make patient health information available electronically through a standardized, open application programming interface (API)
  • Promote data exchange between payers and participation in health information exchange networks
  • Require payers to provide additional resources on EHR, privacy, and security
  • Require providers to comply with new electronic notification requirements
  • Require states to better coordinate care for Medicare-Medicaid dually eligible beneficiaries by submitting buy-in data to CMS daily
  • Publicly disclose when providers inappropriately restrict the flow of information to other health care providers and payers

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The ABCs of Beginning a Clinical Encounter

By HANS DUVEFELT, MD

You’re running late and many things didn’t go right today. You knock on the door and enter the exam room with an apology. If you’re like me, you have a few papers and an iPad or a laptop in your hand. You sit down and open the patient’s chart in your device or perhaps on the big desktop, eyes not exactly locked on the patient.

Only after getting to where you need to be in the computer do you really look the patient in the eyes. Your body language has been one of hurry and distraction. Now you try to repair the damage of that, so you try to show you’re settling down now, at least for a few moments. You might sigh, move your arms in a gesture of relaxation and say something to get the history taking underway.

So far, you’re failing. I do that often, too.

Here’s what we all know we need to do, but often don’t; we should follow these ABCs:

A – Attention:

Clear your mind. It doesn’t matter what happened in the other room with the other patient, or on the phone with the insurance company or the smug specialist or ER doc who pointed out the diagnosis you missed. Open the door (I always knock first) and immediately look at the patient. Make eye contact and observe them. Pay attention to how they look, what they are signaling. The computer can wait; a few moments of focused attention will usually save you time in the end. After all, red or teary eyes, a leg cast, a big bruise or change in grooming can make the visit go in a direction you wouldn’t have expected from he listed chief complaint. How many times have we heard a patient comment about another doctor: He didn’t pay attention to me. Do we always do that ourselves if we’re rushed or preoccupied?

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Health in 2 Point 00, Episode 82 | Talkspace, Heal & Apple

Today on Health in 2 Point 00, I’m back (despite Jess’s attempt to replace me). In Episode 82, Jess asks me about Talkspace’s $50 million raise, Heal getting flack for adding telehealth to their house call service, and Apple acquiring Tueo Health last year—and we’re just now hearing about it. Jess also gets riled up by Pokemon Sleep and Pillo’s $11 million raise. —Matthew Holt

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