Archives for June, 2011
Up until the passage of the HITECH Act in 2009, electronic health records (EHR) were largely unregulated, with adoption rates among providers not significant enough to warrant government oversight. CMS’ final rule defining the Stage 1 ‘Meaningful Use’ criteria was the first widespread federal effort to control the implementation and use of EHRs. Given the financial commitment the federal government is making to wire the U.S. health care system, and the critical role EHRs will play in streamlining care and assisting in clinical decision-making, future regulatory oversight of health information technology (HIT) promises to be both rigorous and widespread.
While exact roles still need to be defined, there will be at least three federal agencies exercising some level of regulatory jurisdiction over EHRs.
Through the EHR Incentive program and the Meaningful Use criteria, the Center for Medicare and Medicaid Services (CMS) will play a hands-on role in the use of EHR systems through this decade. Though the final stage of the EHR Incentive program will occur in 2015, Medicaid providers have a much longer glide path to adoption and could conceivably receive incentive payments up until 2021. Even after incentive dollars cease to flow, CMS can still control behavior by levying penalties on providers and hospitals (in the form of lower reimbursements) who have not become meaningful users.
CMS is also beginning to build a foundation for oversight by including EHR-related requirements and mandates in other programs. For example, the recently released Notice of Proposed Rulemaking (NPRM) on the Medicare Shared Savings Program requires that at least 50% of an Accountable Care Organization’s (ACO) providers be meaningful users of HIT. The NPRM also requires an ACO’s infrastructure to include shared clinical decision support capabilities, and to report the percentage of their providers who use CDS.
The prospect of regulatory oversight by the Food and Drug Administration (FDA) has caused many a sleepless night for HIT vendors, who fear their product development efforts will suffer from the same filings, trials and delays the pharmaceutical and medical device industries have experienced. The FDA has already stated publicly that health information technology falls within its jurisdiction. The only question remaining is whether select HIT products will be labeled as Class III devices, subject to pre-market approval before being rolled out to doctors and hospitals. The HIT Industry received positive news (relatively speaking) in February when the FDA released a rule on Medical Device Data Systems, determining that these would be treated as Class I devices only, requiring registration, quality manufacturing practices and reporting of adverse events, but stopping short of pre-market approval. The FDA has recently indicated that it will regulate mobile medical applications that will run on smart phones, tablets and other hand-held devices, with specific guidance to be released later this year. Further definition of the FDA’s role may also be forthcoming this fall when the Institute of Medicine releases a report on HIT and patient safety.
A relative newcomer to the federal regulation scene, the Office of the National Coordinator for Health Information Technology (ONC) is already overseeing the EHR certification and standards setting processes that support the EHR Incentive program. As health information technology becomes more ingrained in other programs (i.e. ACOs, Medical Homes) as well as the default method for CMS quality reporting, look for ONC to continue providing certification for HIT functionality so doctors and hospitals can rest assured the new systems and modules they purchase meet government guidelines. Similarly the emphasis on health information exchange to foster care coordination will require ONC to continually update and articulate new data exchange standards. ONC’s future regulatory role will be further defined (and likely expanded) in the upcoming NPRM on Governance of the National Health Information Network.
Other federal agencies and offices will also play roles in overseeing or influencing HIT policy, including the National Institute for Standards and Technology (NIST) and HHS’ Office of Civil Rights (OCR). NIST will continue to work with ONC on testing procedures and scripts used in the certification process. OCR will focus on safeguarding personal health information that is more widely accessible through the use of HIT. OCR’s recent NPRM updating the Health Insurance Portability and Accountability Act (HIPAA) with new accounting of disclosures rules is just one example of their work in HIT.
And this is just the feds. In a future post, I’ll explore the possible role states will play in regulating health information technology.
Conventional wisdom suggests that getting one’s message out is easier than ever. Anyone can create a Twitter account, for example. But sending a message and actually getting through to the target audience are two different things. When it comes to effective message distribution, companies face several hurdles— including lack of interest, distrust of subjective information sources, competition from other messages, and numerous distractions (Internet browsing, smart phone games, text messaging, etc.). The compacting of message length is a profound issue for practitioners of PR and their clients. A study by Erik Bucy and Maria Elizabeth Grabe, published by the Journal of Communication, showed that the average sound bite for a presidential candidate on the nightly network news is about 7.8 seconds.
If you’re a corporate spokesperson trying to explain a nuanced rationale for a company action that’s under fire, your time slot isn’t much bigger. Moreover, we live in a world where the most common type of message – the text message – is 160 characters. (For why this is so, see here). And while a corporate message isn’t likely to be sent primarily via SMS, the point is that attention spans are getting shorter, not longer, and messagers need to act accordingly. By the way, Twitter also uses the 160 character format, but automatically reserves 20 for the messenger address, so one is left with 140 characters for this potent form of social media.
I realize I’ve already exceeded my allotted 160 characters, but I hope I’m making the case that message quality has never been more critical. So, let’s consider what goes into a good message:
Your message should speak to your audience. It needs to address the issues or values they care about. Too many messages are “inside-out” – they communicate the worldview of the organization looking out at the world instead of reflecting the audience’s perspective. When BP’s former chief executive said, in light of a catastrophic oil spill, that he’d like to get his life back, it made sense from his point of view, but obviously not to the audience he was hoping to address.
Your message should offer a distinct solution or perspective. Too many messages emphasize points that are not special. The law firm that knows business. The printing company that cares about quality. The auto dealer that offers the best deal. These points are really a requirement of doing business. They’re the ticket to the dance, so to speak. Snow Communications developed a campaign for Hormel Foods Specialty Products Division to speak to the many corporate customers that sell Hormel’s food products under their own private labels. Our message, “Brand Spoken Here” speaks to Hormel’s customers’ needs and offers a capability that Hormel can uniquely offer in this space. (See http://www.snowcommunications.com/services/advertising/.)
Your message should be simple and clear. “Death tax” is a powerful way to characterize an estate tax that primarily taxes people with substantial assets. “Vouchercare” is an equally effective way to characterize the Republican approach to limiting future Medicare costs. Subway’s “Eat Fresh” redefined the fast food market along lines that heavily favor Subway.
In summary, keep your messages short, clear and considerate of the audience’s perspective if you want to make an impact.