OIG to amend safe harbor, anti-kickback
Agency proposes three big changes, seeks public comment
The Office of Inspector General has proposed three significant changes to safe harbor regulations pertaining to electronic health record services, according to a notice in Wednesday's Federal Register. These amendments include updating the provision under which EHR software is considered interoperable, eliminating the electronic prescribing requirement from safe harbor and extending the sunset provision date.
"We expect these proposed changes to continue to facilitate the adoption of electronic health records technology," the notice reads.
"Congress intended the safe harbor regulations to be updated periodically to reflect changing business practices and technologies in the health care industry," Wednesday's notice read. Officials are also requesting public comment on other suggested changes.
Interoperable provision:
Currently, the OIG's safe harbor requires that donated software be interoperable when the software is provided. In efforts to further support the Office of the National Coordinator's EHR certification program, OIG officials have proposed that to become a certifying body, the entity will be required to "successfully complete an authorization process established by the ONC."
The second modification to this provision pertains to the certification time period for the software. The current provision requires software to be certified within 12 months before the donation, which officials say aligns poorly with the ONC's certification program. "We believe our proposed change is consistent with that understanding and our objective of ensuring that products are certified to the current standard of interoperability when they are donated." The agency is currently seeking further comment for a new time period.
Electronic prescribing provision:
The OIG amendments would alter the original safe harbor provision requiring that donated EHR software must have electronic prescribing abilities. According to the notice, "in light of developments since the 2006 Final Rule, we do not believe that it is necessary to retain a requirement related to electronic prescribing capability in the electronic health records safe harbor." Cited in the notice were the 2008 Medicare Improvements for Patients and Providers Act of 2008, which established an electronic prescribing incentive program, and the HITECH Act. "We believe that there are sufficient alternative policy drivers supporting the adoption of electronic prescribing capabilities," the notice continued.
The Sunset Provision:
Currently, the EHR safe harbor is slated for a sunset date of Dec. 31, 2013, which OIG officials have proposed changing to Dec. 31, 2016. "We selected this date because it corresponds to the last year in which one may receive a Medicare electronic health record incentive payment and the last year in which one may initiate participation in the Medicaid electronic health record incentive program."
Other minor changes proposed by OIG include limiting the scope of protected donors.
The anti-kickback statute issues criminal penalties for individuals or groups that "knowingly and willfully offer, pay, solicit, or receive renumeration (including bribes, kickbacks and/or rebates)" for the purpose of rewarding the referral all of business payable under specific federal healthcare programs. These offenses are considered felonies.
Officials say safe harbor was enacted in response to industry groups expressing concern that the anti-kickback statute applied to "relatively innocuous commercial arrangements," which would make these groups subject to criminal prosecution.
"Parties may voluntarily seek to comply with safe harbors so that they have assurance that their conduct will not subject them to any enforcement actions under the anti-kickback statute, but safe harbors do not impose new requirements on any party," the notice reads.
