So what is interoperability anyway?

By John D. Halamka, MD

One of my most memorable experiences as an IT leader was working with with a dissatisfied customer.   I asked what requirements were unmet, what features were priorities, and what future state was desired.   The answer was “I’m not sure, but I know I’m not getting what I need”.

The use of the term interoperability is being tossed around in ways that makes it seem like the test for obscenity used by Supreme Court Justice Potter Stewart in 1964 when he wrote “I shall not today attempt further to define the kinds of material I understand to be embraced within that shorthand description [“hard-core pornography”], and perhaps I could never succeed in intelligibly doing so. But I know it when I see it…”

Congress is angry about the lack of interoperability.   What does that mean?

House and Senate stakeholders believe that vendors enjoyed a government funded windfall yet are building proprietary networks.   They have heard that vendors are blocking information sharing by charging significant interface fees and that HITECH distributed $30 billion with minimal requirements for information sharing. Many in the House feel after all this investment, the country is not prepared for new payment models.

Some in the House have stated that Americans can communicate because “we speak English” so interoperability is about picking a common language.

Senate HELP Committee Chairman Lamar Alexander plans to take up this issue, working closely with Ranking Member Senator Patty Murray through a bipartisan effort over the coming months.

So what is the real issue causing providers anxiety and resulting in Congress wanting to take action?

Providers are fed up with interface fees and at how hard it is to accomplish the workflow required by Accountable Care business models including care management and population health. They are unsatisfied with the kind of summaries we’re exchanging today which are often lengthy, missing clinical narrative and hard to incorporate/reconcile with existing records.

All these things are true.

So what is our next step to help providers do their job and improve satisfaction to the point that Congress no longer wants to legislate the solution to the problem?

I think we all have to step back, carefully define the requirements for care coordination and care management in an ACO world and admit that the Meaningful Use regulations did not address those requirements.   We should allow the private sector initiatives already in progress (Argonaut, Commonwell, eHealthExchange) to address these market needs in collaboration with vendors, entrepreneurs, and innovators.   The economic incentives of the Affordable Care Act and the Sustainable Growth Rate fix will result in hospitals and professionals demanding different kinds of technology than was prescribed in regulation.

The role for Congress should be to hold us accountable for the outcomes we want to achieve.

At a recent AMIA presentation in Boston, Zak Kohane, Ken Mandl and I were asked to be provocative – to go rogue.

I suggested that the Meaningful Use program should be eliminated.    Yes, there should be Merit-based incentives for achieving stretch goals, but those can be created in another CMS program. Meaningful Use is no longer necessary.

ONC should focus on the 5 enablers I’ve written about

1.  Facilitating the creation of a national provider directory for message routing

2.   Encouraging the adoption of a voluntary national identifier for healthcare

3.  Providing guidance to streamline the heterogeneous patchwork of state privacy laws that are impeding information exchange

4.  Serve as the coordinating body for aligning federal government health IT priorities.

5.  Supporting private sector initiatives such as Argonaut that are simplifying the tools for health information exchange.

It’s not a problem of “language”.  We have the terminologies we need, already included in certified EHRs. We have standards for content and transport, again written into certification requirements. So what’s the gap? We need to make the standards better, and build interoperability into EHR workflow. That doesn’t require top down regulation, it takes the kind of  goal-oriented interaction between providers, developers, and standards bodies that characterizes efforts like the Argonaut Project.

No more regulation, no more legislation.   Those will only crush innovation.

Instead of saying we need interoperability, the conversation needs to include a crisp set of requirements for care management and care coordination with defined metrics of success, supported by government enablers, and accelerated with the economic incentives provided by new reimbursement models.

To paraphrase Justice Potter, if patients and providers are happier, I’ll know it when I see it.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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EarLens wins FDA 510(k) for novel hearing aid

EarLens said Tuesday it won FDA 510(k) clearance for its laser diode-equipped direct vibration-based contact hearing device for use in adults with mild to severe sensorineural hearing impairment.

The device is designed to directly contact the patient’s eardrum and use it as a speaker and act as an amplifier for a wide range of frequencies, the Menlo Park, Calif.-based company said. It consists of a tympanic membrane transducer placed into the ear canal on the eardrum and a behind-the-ear audio processor.

“For the millions of Americans with hearing impairment, hearing aids can significantly improve regular daily communications, as well as overall quality of life. People with hearing impairment now have a new option that may help improve their hearing by amplifying sounds over a broad spectrum of frequencies,” FDA Center for Devices and Radiological Health chief scientist Dr. William Maisel said in a prepared statement.

The device is the 1st of its kind to use light, emitted from a diode attached to the behind-the-ear audio processor, to transmit sound to the receiver against the patient’s eardrum, the company said.

EarLens said the device was reviewed by the FDA through a de novo pathway, and expects to commercialize the device in 2016.

Last March, EarLens said it raised some $36 million in an equity round for its sound-to-light hearing aid. The company, which is led by a former Abbott Vascular honcho, said 22 unnamed investors participated in the round as of Feb. 24. EarLens hoped to raise a total of $38.8 million, according to a regulatory filing.

Medtronic (NYSE:MDT) has a stake in EarLens, according to its website, having participated in a Series A funding round. The 1st sale in the current round occurred Feb. 14, according to the filing.

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Medtronic wins expanded FDA PMA for Verify system

Medtronic (NYSE:MDT) said yesterday it won an expanded FDA premarket approval for its Verify system for testing patients for use with its Interstim bladder or bowel control sacral neuromodulation device during basic evaluations.

The Verify allows patients with overactive bladder, non-obstructive urinary retention or bowel incontinence to test Interstim system for 3-7 days before making a long-term commitment, the Fridley, Minn.-based company said.

“Many patients suffering from OAB have failed multiple treatments and the Verify system for basic evaluations uses new technology to make it easier and faster for patients to assess the potential for effective long-term bladder control. Trying sacral neuromodulation before committing to the therapy allows patients to make a long-term decision with confidence and with an excellent chance to get their lives back,” Dr. Steven Siegel of Minneapolis, Minn.’s Metro Urology Centers for Female Urology and Continence Care said in a press release.

The Verify device is a temporary, belt-worn external neurostimulator with a thin lead implanted during a minimally invasive procedure, Medtronic said. After an evaluation period, it helps physicians decide whether to implant the InterStim device, a pacemaker-like neurotransmitter placed under the skin.

“Medtronic developed the Verify system as part of our commitment to provide meaningful innovations that restore health and advance the treatment of overactive bladder, urinary retention and bowel incontinence. Our goal is to provide long-term benefits to patients and the verify system was designed to deliver clinical value by being easy for patients to use and helping physicians make informed treatment decisions with their patients along the continuum of care,” gastro/urology veep Linnea Burman said in prepared remarks.

Medtronic originally launched the device in the U.S. last October with a 2-week evaluation period indication.

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InspireMD pulls trigger on 10-for-1 reverse stock split

InspireMD (OTC:NSPR) said it pulled the trigger on a reverse 10-to-1 stock split with shareholders receiving 1 share of common stock for each 10 they own.

The reverse split went into effect today for the Boston-based stent maker, according to a press release. In response, Inspire shares are down 11.8% to $1.45 in mid-day trading.

The split reduced the amount of authorized shares from 125 million to 50 million, the company said.

Last November, InspireMD said it was seeking to raise roughly $8 million via a direct offering to help fund development of its MGuard and CGuard stent platforms.

The company said it agreed to sell approximately 6.2 million shares $1.30 each, plus warrants to purchase up to 3.1 million additional shares. Each purchased share included a warrant to buy 0.5 shares at a strike price of $1.75 apiece. The warrants are exercisable for a 42-month period starting 6 months after issuance.

Last October, InspireMD said it halted enrollment in a clinical trial of its flagship MGuard stent to focus on developing new drug-eluting stents with an unnamed strategic partner, abandoning plans to bring the MGuard device to the U.S. market.

InspireMD last June began re-introducing the MGuard Prime EPS in Europe after pulling it in 2013 and suspending the Master II trial due over the risk of the stent being dislodged during implantation.

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Hansen Medical inks distro deal with AB Medica Sagl

Hansen Medical (NSDQ:HNSN) said today it inked an agreement with AB Medica Sagl to operate as the exclusive distributor of its Magellan robotic system in Switzerland.

The Magellan system drives Magellan robotic catheters and guide wires in minimally-invasive endovascular procedures and can be controlled remotely to allow for the use of interventional fluoroscopy during the procedures without risking radiation exposure, the company said.

“We are pleased to expand our relationship with AB Medica to include exclusive distribution of the Magellan Robotic System in Switzerland. This is another important step in the development of a strong global market for intravascular robotic systems. AB Medica is the largest medical technology distributor in Italy and Switzerland, and this expanded partnership will enable more patients to access and benefit from robotic endovascular procedures with Magellan,” Hansen CEO Cary Vance said in a press release.

AB Medica Sagl also serves as the company’s exclusive distributor in Italy, California-based Hansen Medical said. Hansen Medical shipped one of its Magellan robotic systems to AB Medica as part of the agreement, the company said.

Last month, Hansen Medical pulled the trigger on a reverse 10-for-1 stock split in which HNSN shareholders received 1 share for every 10 they owned.

The reverse split went into effect Sept. 22, according to a regulatory filing, sending HNSN shares down -13% to $4.35 apiece.

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Medical Devices in a new world│#AdoptUDI

by Patrick Lupinetti

Here’s a thought experiment: imagine that everything is just as we know it now, except there are no NDCs for drugs. There are numbers, to be sure, but a dizzying array of them – UPC codes, GTIN-14s, one set of unique alphanumerics from manufacturers and entirely different sets from wholesalers.

It’s the same with drug names, and are all different in this world. You’d have “amoxicillin powder for suspension,” “amoxicillin for oral suspension,” “amoxicillin suspension,” and “amox, oral, powd., susp.”  Supply chain management would be trickier – sometimes you would be duplicating drug orders, and sometimes you would order something that wasn’t what you intended. Claims processing wouldn’t be a picnic either, since cross-walking all those numbers and descriptions to a reimbursement code would be a tedious process on both ends. And, what you recorded in an EHR would be just as accurate as clinicians were consistent in how they identified drugs, which is to say not very. Things would be very, very messy.

Now return from that vision, back to the world of NDCs, where there’s a single, universally-recognized identifier that lets two people talking about a drug know with certainty that they’re talking about the same thing. The nightmare is over. Or, it is for drugs. For medical devices, not so much.

In this world, devices still have multiple names, variable identifiers, inventory management challenges, limited identifiability, and only a rudimentary amenability to classification. You could fairly say that, until now, devices are where drugs were back in the 1960s. But that’s all changing and you’ll need to add “UDI” to your list of commonly-used acronyms because of the introduction of the Unique Device Identifier (UDI).

Required by federal legislation in 2007, the concept of distinctive UDIs assigned to medical devices first became a reality last September, with the inaugural filing of these new identifiers for high-risk Class III devices such as pacemakers and stents. The next milestone in UDI history arrives today, September 24, for Class II implantable/life sustaining/life supporting devices, to be followed next September by the other Class IIs; then by the Class I products in 2018.

You can read all about it – how you get a UDI, the structure of the number, the FDA’s GUDID database and more – on the FDA’s CDRH Learn website here.

Let’s go back to the thought experiment for a moment. If you had found yourself in that benighted, unenlightened, pre-NDC environment, and the FDA had just come out with a five-year timetable during which this new, unique drug identifier would be rolled out, what would you do?

Let me ask that again. Knowing what you know now about all the use cases to which an NDC can be productively applied what would you do? Wouldn’t you want to use it…everywhere? Wouldn’t you want them in EHRs for clinical documentation and outcomes research; in purchasing to control your inventory and conduct materials management more effectively; and in claims adjudication, to streamline the process and ensure that billers and payers had a common understanding? There would be effort in the transition, but again, with the benefit of your experience with NDCs, wouldn’t you see it as worth the effort?

That’s precisely where we are with the UDI. Yes, there are other reasons for widespread adoption—from MU3 and EHR certification requirements, to the scheduled phase out of NDCs and NHRICs for devices—but the foreseeable benefits make a compelling argument by themselves.

You don’t often get a chance to take advantage of hindsight before something happens, but maybe thinking about NDCs as UDI ancestors can enable us to do just that.

About Patrick Lupinetti, JD
Patrick Lupinetti is senior vice president and editorial director for FDB’s Knowledge Base Services Department, where he has responsibility for drug descriptive data acquisition, government pricing, data structure and clinical content for all of FDB’s product modules.

 

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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Wright and Tornier complete $3.3B merger

Wright Medical (NSDQ:WMGI) and Tornier N.V. (NSDQ:TRNX) said today they successfully completed their $3.3 billion merger, with Tornier acquiring Wright and taking up the name Wright Medical N.V.

Wright Medical’s shares will cease trading today under its old name and shares in the combined company will begin trading under Wright’s previous ticker of “WGMI” tomorrow, the company said.

“The culmination of this merger marks a significant milestone for our company, creating the premier, high-growth extremities-biologics company uniquely positioned with leading technologies and specialized sales forces in 3 of the fastest growing areas of orthopedics – upper extremities, lower extremities and biologics.  By bringing together the extensive and innovative capabilities of both Wright and Tornier, we can extend our leadership position and further accelerate our growth opportunities and path to profitability, all of which we believe will generate long-term value for our shareholders.  This is also an exciting day for our employees as we officially join forces to pursue our shared commitment to serving extremities specialists and building the leading global business in this market,” Wright CEO Robert Palmisano said in prepared remarks.

Each outstanding share of Wright common stock was exchanged for 1.0309 shares of Tornier, which will now be known as Wright Medical N.V., the company said.

In June, Wright and Tornier said both companies’ shareholders approved the $3.3 billion merger of the 2 orthopedic giants.

Wright is reincorporating in Holland, but will base its lower extremities and biologics business in its previous Memphis home base. The upper extremities business will be based at Tornier’s Bloomington, Minn., facility with its engineering in Warsaw, Ind.

Last month, Integra LifeSciences (NSDQ:IART) agreed to acquire some of Tornier’s ankle and toe assets in the U.S., as the Dutch orthopedics company looked to satisfy anti-trust regulators over the merger. With the deal, Integra will acquire the U.S. rights to Tornier’s Salto Talaris and Salto XT ankle replacement devices and its Futura silastic toe replacement, for an undisclosed amount in cash.

The agreement also includes an option on the rights to the Salto Talaris, Salto XT, Salto Mobile and Futura silastic toe replacement devices outside the U.S.

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