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May 8 2012   8:18AM GMT

Health Law 2.0: Data exchange spurs HIT compliance challenges



Posted by: Jenny Laurello
Health 2.0, Health law, HIPAA

Guest post by: David Harlow, principal of The Harlow Group LLC, and featured speaker at Health 2.0’s Spring Fling Matchpoint Boston conference’s special session: Health Law 2.0 on May 14, 2012.

Q. Though the health care industry is notorious for operating in silos, collaboration among key stakeholder groups, including providers, payers, technology vendors, and patients, is needed to make a marked difference in the health care technology and data exchange landscape. What would you say are the top three challenges in terms of creating collaborative partnerships, and how should the industry be moving forward?

  • A. The top challenges to creating collaborative partnerships are a combination of financial issues and questions about the evidence base associated with the new technologies. Payers are interested in reducing costs while promoting effective prevention and other forms of care. Providers already have too much on their plates, so they are less likely to adopt innovations that are disruptive to their workflow unless they are convinced of their effectiveness and/or are being compensated in a way that works for them. This means either being paid for the additional time and expense spent using these tools or being paid in a manner that breaks from the traditional fee-for-service model and pays instead for outcomes. When providers are paid for outcomes, they have more flexibility to innovate using proven new tools, because they are focused on the outputs — healthier patients who have internalized healthy behavior change — rather than the inputs — higher costs expended for a case that won’t be reimbursed at a higher rate under a fee-for-service model. Some forward-thinking payers recognize the value of new technology and other new tools and have modified their payment systems to change the incentive structure and break down the silos in health care. Commercial accountable care organizations are a prime example of this sort of development.

Q. The FDA rules with a heavy fist, though sometimes that fist is slow to come down with formal rules and guidelines related to the use and advancement of HIT in the industry. What are some of the top compliance guidelines, beyond meeting MU, with which the industry will have to grapple this year? Medical device implementation issues? HIPAA and PHI privacy and security mandates?

  • A. The final unified HIPAA rule is expected to be released in late spring or early summer. The steady stream of news about significant data breaches is somewhat surprising, because there are clear steps that may be taken to mitigate this sort of exposure, such as encryption. The positive uses to which HIPAA-protected data may be put will continue to strain the HIPAA privacy and security framework, as well. The FDA has signaled its thinking on mHealth and on the use of social media with respect to off-label uses of pharmaceuticals. The FDA has also been making noises about regulating electronic health records as “devices.” As EHRs have gotten smarter, moving from electronic notepads to real decision support tools, they have gotten closer to the FDA definition of “device.” The overlapping jurisdiction of the ONC and FDA in this arena is of great interest and concern to a plethora of people, and it remains to be seen how it will play out.

Q. In following the coverage from the American Telemedicine Association’s conference, it is clear that there are great strides being taken to deliver care remotely. However, when reimbursement comes into play, care delivery expectations and workflows must be reexamined. How is the industry addressed telehealth/telemedicine reimbursement, and how can organizations continue to move ahead in building out these capabilities in the interim (i.e., convince the CFO it’s worth the investment)?

  • A. A recent study concluded that telehealth visits yielded better results than in-person office visits. Now, there will always be a study supporting one side or another of this debate, but I think there is greater acceptance overall of the notion that telehealth has its place in our system on a regular basis. I see its use growing as a means to contain cost growth in health care, specifically by leveraging personnel expenses (home health monitoring can be done more on a remote basis than on an in-person basis, for example) and as another example, making a primary care visit simpler for both patient and clinician through the use of remote communication tools that may be no more exotic than an iPhone app. (Hey doc, what do you think about this rash? Can Johnny go to school?”)

Q. With the advancements in telemedicine, HIEs and other information exchange initiatives, will providers be able to navigate state licensing laws to ensure compliance while also maintaining efficient use of technologies? Are states making it easier for providers and if not, what might have to change in the legal landscape to accommodate technology?

  • A. The regulatory landscape presents a challenge to innovators of all types. A handful of states have adopted limited licensure rules for telemedicine, so physicians providing services to patients in those states remotely do not need to go through the full state licensure process. One big issue, still down the road a piece, will be cross-border licensure for surgery performed remotely. A specialist in one city could use robotic controls to treat a patient using a surgical robot in another city, perhaps halfway across the country or around the world. But we are already dealing with line-drawing around cross-border practice. If a specialist is consulting to a treating physician, that does not require licensure in the treating physician’s state. If consulting with a patient, then licensure IS required. Perhaps we should work on rationalizing these requirements. On the other hand, frictionless sharing of patient information from provider to provider is a good thing. Patients who need care when away from home — some day, not tomorrow, but relatively soon, as the interoperability of electronic health records continues to improve thanks to the incentive dollars under the HITECH Act — will be able to rely on the fact that their medical records will be available to treating clinicians wherever they are. So long as one isn’t brought in to an emergency room unconscious and with no ID, the system is being built that will allow any emergency room in the U.S. to call up that patient’s medication list, recent diagnostic images and more to improve patient care and outcomes.

David Harlow is a featured speaker during the Health 2.0 Spring Fling Matchpoint Boston conference’s special session: Health Law 2.0 on May 14, 2012. David is principal of The Harlow Group LLC, a health care law and consulting firm based in Boston.

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