Dan Haley – The Health Care Blog

Congratulations, Doctor, On Your Federally-Subsidized “Hardship”

Mar 13, 2014• 32

By Dan Haley

At HIMSS 2014, the health information technology’s (HIT) largest annual confab, the bestest-best news we heard from a policy perspective, and maybe even an industry perspective, was the Centers for Medicare & Medicaid Services’ (CMS) dual announcement that there will be no further delays for either Meaningful Use Stage 2 (MU-2) or ICD-10.

Perhaps we should have immediately directed our gaze skyward in search of the second shoe preparing to drop.

As it turns out, CMS de facto back-doored an MU-2 delay by issuing broad “hardship” exemptions from scheduled MU-2 penalties. To wit: any provider whose health IT vendor is unprepared to meet MU-2 deadlines, established lo these many months ago, is eligible for a “hardship” exemption.

Few would disagree with the notion that it’s unproductive to criticize policy without offering constructive ideas to fix the underlying problems.

Here, the underlying problem is easy to define: it is in point of irrefutable fact fundamentally unfair to penalize care providers for their vendors’ failings—especially when the very government proposing to penalize them put its seal of approval on the vendors’ foreheads to begin with.

CMS’s move to exempt providers from those penalties is correctly motivated, but it seeks to ease the provider pain without addressing its cause.

Instead of issuing a blanket exemption for use of unprepared vendors, CMS should:

Waive penalties only for those providers who take steps to replace their inferior technologies with systems that can meet the demands of the 21^st century’s information economy;
Publish lists of health IT vendors whose systems are the basis for a hardship exemption, along with an accounting of how many of those 21 billion dollars have been paid to subsidize those vendors’ products; and
Immediately initiate a reevaluation of the MU certification of any vendor whose products form the basis for a hardship exemption.

This proposal might seem bold, but if we’re truly looking to advance health care through the application and use of EHR, then what I’ve outlined above simply represents necessary and sound public policy. Current practice rewards vendors whose products are falling short by perpetuating subsidies for those products.

The federal government should stop paying doctors to implement health IT that cannot meet the standards of the program under which the payments are issued. That’s just a no-brainer.

An EHR should not be a federally-subsidized “hardship.”

Regulating Health IT: When, Who, and How?

Sep 10, 2013• 7

By Rebecca L. Jewell, Esq. & Dan Haley

Health care providers and consumers are increasingly using mobile technology to exchange information. Many health IT providers readily acknowledge that some level of oversight is required to ensure patient safety and privacy protections, but many providers question whether the FDA is the right agency for the job and want to see the FDASIA recommendations.

Can the FDA, with its already limited resources and lengthy review cycles, regulate the fast-moving health IT industry? Should it? Health IT is fundamentally different from a medical device in many ways. For oversight purposes, the key differentiator between the two is the opportunity for clinical intervention in the use of health IT. Many medical devices interact directly with the patient (such as an infusion pump or pacemaker). Most health IT, on the other hand, merely provides information to clinicians, who ultimately make independent, experienced care decisions. Physicians are informed, but not controlled, by the information. This leads to a vast difference in the patient risk proposition and rigid regulatory oversight is not appropriate.

Advocates of a broad health IT oversight framework – which encompasses mobile health IT – are urging the FDA to delay release of its final guidance, particularly in light of a July 2012 Congressional mandate for the creation of a comprehensive oversight framework that avoids regulatory duplication.

But some mobile medical application developers are pressing the FDA to move forward immediately, believing its guidance will reduce the regulatory uncertainty that they believe is stifling innovation and investment in some aspects of mHealth.