There's been a lot of media attention on interoperability and of information blocking by providers and vendors, from calls to increase decertification of electronic health record products that don't share data, to allegations that the activity is anticompetitive.
So it was only a matter of time before someone pointed out that information blocking can violate the healthcare trifecta legal heavy hitters: the Anti-Kickback statute, the Stark Law and the False Claims Act.
As you may recall, in 2006, the Health and Human Services Department Office of Inspector General issued regulations that created a "safe harbor" from anti-kickback enforcement (and the Centers for Medicare & Medicaid Services created a corresponding "exception" from the Stark law self-referral prohibition) for EHR donations programs that met certain criteria, including interoperability. The temporary safe harbor/exceptions were created to encourage more physicians to use EHRs by allowing hospitals and others to pay up to 85 percent of the cost of software, training and upgrades. The regulations were supposed to sunset in 2013, but were extended until 2021 to coincide with the expiration of the Meaningful Use program.
Now, OIG has issued an alert reminding everyone that you can't take advantage of the safe harbor/exception if you engage in information blocking. As Inspector General Daniel Levinson explained in an accompanying blog post:
"[A] donor, or someone on the donor's behalf, takes any action to limit or restrict the use, compatibility, or interoperability of the donated items or services with other electronic prescribing or EHR systems, the donation arrangement would not receive safe harbor protection and would be suspect under the Federal anti-kickback statute. ... We continue to support the goal of promoting adoption of EHR technology and recognize the potential benefits offered by health IT. At the same time, we remain committed to investigating potentially abusive donation arrangements that purport to meet the safe harbor conditions, but, in fact, do not. Such arrangements can undermine the benefits of health IT and present risks for the Department's programs and beneficiaries."
While the media has reported the issuance of the alert, its significance has been garnering little attention, and that's a mistake. This development is a big deal, for several reasons.
For one, the OIG issues relatively few alerts. This is a signal that practically screams "clean up your acts now; you've been warned." The agency means business. The alert even includes the phone number of its hotline and URL so people can report violations.
What's more, despite calls to decertify EHRs that don't share data to punish vendor information blockers, decertification is a Draconian action that has long-term consequences for users that have not engaged in information blocking. ONC has already gone on record as saying this is not a step it wants to take lightly. In the four years of the Meaningful Use program, only four EHR products have been decertified, and none of them for information blocking.
Enforcing the existing law is faster and easier.
And the government is very good at it. It's experienced at investigating and enforcing these three laws. The False Claims Act, in particular, is a powerful weapon, because many of those cases initially are reported by private whistleblowing citizens who bring the violations to the government's attention.
Moreover, the Department of Justice just updated its policies about holding individuals accountable for corporate misbehavior. In other words, the stakes just got higher. Much higher.
In addition, once the OIG is looking at safe harbor compliance, you can bet that it will check to see if the providers meet the other components of the donation safe harbor. You better make sure that the subsidy isn't over the 85 percent threshold and that it doesn't include hardware.
And once a provider is in the government's enforcement crosshairs, everything and anything can be exposed. Are medical office leases up to date and signed? Are you coding accurately? Is that fair market value for those medical director duties?
Of course, it's important to uphold the law and go after violators. And no doubt, information blocking is a major barrier to interoperability, which is the cornerstone not just of the Meaningful Use program, but also of health reform and care coordination.
But once again, it's the providers, not the vendors, who will bear the brunt of information blocking enforcement and be disproportionately at risk. The 21st Century Cures Act, which would extend info blocking enforcement to vendors, hasn't been passed.