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ONC & CMS Proposed Rules – Part 5: Business Models

Grant Barrick
Dave Levin

By DAVE LEVIN, MD and GRANT BARRICK

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 the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions. In part five of this series, we look at how competition unlocks innovation, and how the proposed rules may disrupt the balance between innovation, intellectual property (IP), and supporting business models.  

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The recent publication of proposed rules by ONC and CMS set off a flurry of activity. In anticipation of their implementation, the health care industry is wrestling with many questions around business models. What practices inhibit competition and innovation? How do we balance the need for competition while protecting legitimate intellectual property rights? How can vendors ensure profit growth when pricing is heavily regulated? In this article, we will examine how competition unlocks innovation and the possible disruptions the proposed rules may bring for innovation, intellectual property (IP) and supporting business models.

Unlocking Innovation via Competition

In most markets, innovation is driven forward by competition. Businesses compete on equal footing, and their investment in R&D drives innovation forward. Innovation in health care has been dramatically outpaced by other markets, leading to an urgent need for both disruptive and evolutionary innovation.

What is inhibiting health care innovation? The rules identify a combination of tactics employed in health care that restrict the free flow of clinical data, such as:

  • NDAs
  • Confidentiality Clauses
  • Hold-harmless Agreements
  • Licensing Language

These tactics slow innovation by contributing to an environment where stakeholders resist pushing the boundaries — often because they are contractually obligated not to. The legislation and proposed rules are designed to address the ongoing failure of the market to resolve these conflicts.

As the rules are finalized, we will continue to monitor whether the ONC defines these practices as innovation stifling and how they will implement regulations — both carrot and stick — to move the industry forward.

Continue reading…

What If You Give a Party and No One Comes?

Here is a short update on a post I put up about a month ago about CMS’ proposed regulations for setting up Accountable Care Organizations. The ACO proposal calls for shared savings and other incentives for providers, with a transition after a few years to a real risk contract. But Congress put a “poison pill” into the concept because it was afraid to limit customer choice. At the heart of my argument was this point: “How can you be held accountable, as a provider group, if you cannot control the management of care of your patients?”

The latest news, according to my sources, is that even the most advanced ACO-like organizations like Geisinger and Mayo are not interested in signing on to this proposition. The financial risks can come crashing down quickly and are just too great.

In a recent Boston Globe interview, consultant Marc Bard explains how it would have to work for providers to agree to share risk in an ACO network:

Q. Some consumers fear they won’t be able to go to the doctors or specialists they want in the new system. Is that a legitimate fear?

A. The answer is of course. We can’t be spending 17.5 percent of our gross national product on health care and allow everybody to broker his or her own health care. So ultimately there are going to have to be trade-offs made. The public’s going to have to make them. The delivery systems are going to have to make them. Absolutely there are going to be limitations.

Paul Levy is the former President and CEO of Beth Israel Deconess Medical Center in Boston. For the past five years he blogged about his experiences in an online journal, Running a Hospital. He now writes as an advocate for patient-centered care, eliminating preventable harm, transparency of clinical outcomes, and
front-line driven process improvement at Not Running a Hospital.

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