Impact Insights

Week in Review 1/8/16 – New MU Hardship Exception; Next Generation of Wearables

RELIEF (AND ALSO MORE CONFUSION) WITH MEANINGFUL USE… Last week, President Obama signed a bill into law that essentially establishes a blanket hardship exception for hospitals and EPs unable to meet meaningful use requirements in 2015.  Although there is some “anxiety” over how CMS will actually implement the new exception, it is clear from lawmakers’ comments that Congress’ intention was to ensure EPs and hospitals won’t face reimbursement penalties for failing to meet requirements in 2015 that CMS essentially changed at the last minute.  There is a caveat though: hospitals must apply for the blanket exception by April 1, 2016, while EPs must apply by March 15, 2016 It is also important to note that it appears CMS will still accept applications for traditional hardship exceptions (including a hardship in the “extreme circumstances” category due to the late publication of the Final Rule) until July 1, 2016 – but those applications will be reviewed by CMS on a case-by-case basis.

Impact Advisors’ Thoughts:  Unfortunately, CMS has yet to update its website with details on how to actually apply for the blanket hardship exception established by the new law.  Either way, the fact that Congress had to pass a bill because CMS modified requirements with virtually no time left in the year underscores what a confusing, frustrating mess the meaningful use program has become for many provider organizations.

WHAT’S NEXT WITH WEARABLES IN HEALTHCARE?… An interesting article in Reuters looks at the “next wave” of wearables: medical-grade devices.  Unlike virtually all of the popular fitness trackers on the market today, “medical-grade” wearables are devices that have been clinically tested and approved by the FDA.  For example, one of the companies highlighted in the article is Empatica, which is seeking FDA approval to market a device designed to alert epilepsy patients and physicians when seizures occur.  However, as the article notes, earning FDA approval is no small task; in fact, the process was seen as “a rigorous regulatory hurdle that first-generation wearables sought to avoid.”  The market is quickly changing though, and according to Reuters, “the FDA is now seen as an important ally by companies eager to show that their devices can improve peoples’ health.”

Impact Advisors’ ThoughtsWe think the healthcare industry is at a critical turning point when it comes to wearables.  Products like Fitbit have successfully introduced the concept of wearable monitoring devices to a wide audience of patients.  That development, combined with recent advancements in sensor technology (and an increased interest in getting FDA approval) means it may soon be possible to engage high risk patients with sophisticated, clinically-tested wearable devices with proven benefits for certain conditions.  We believe the key to actually capitalizing on this turning point will be 1) getting payers – and possibly even health delivery organizations – to subsidize some of the costs of the devices for high risk patients, and 2) ensuring that the right processes and workflows are in place so providers can actually respond to alerts.

NEW TOOL LETS PATIENTS SEARCH FOR HIPAA VIOLATIONS… ProPublica has created a database called the “HIPAA Helper” that allows patients to look up privacy complaints, data breaches, and HIPAA violations by specific healthcare organization.  According to an article published by ProPublica, the online tool includes data obtained from the HHS’ Office of Civil Rights under the Freedom of Information Act, as well as information from the U.S. Department of Veterans Affairs and the California Department of Public Health.

Impact Advisors’ ThoughtsThe costs associated with a data breach or HIPAA violation have been covered in detailOne of the impacts that doesn’t always receive enough attention though is the public relations damage and fallout (perhaps because it is so hard to quantify).  The launch of tools like the one above serve as an important reminder that the visibility of privacy complaints, data breaches, and HIPAA violations is only going to increase as time goes on – and patients will have easier access to that information.