On Friday, December 27, 2013, the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) will publish final rules that extend through December 31, 2021 the existing Stark Law Exception (42 CFR 411.357(w)) and Anti-Kickback Statute Safe Harbor (42 CFR 1001.952(y)) applicable to the donation of electronic health records (EHR) items and services. December 31, 2021 is the last year of the Medicaid Meaningful Use incentive payments.
In the Final Rule, CMS and OIG also:
- Update the provisions under which EHR software is deemed interoperable;
- Remove the requirement relating to e-prescribing from the Exception and Safe Harbor;
- Limit the scope of protected donors to exclude laboratory companies; and
- Clarify the condition that prohibits a donor from limiting or restricting the use, compatibility or interoperability of donated EMR items and services.
The final rules require the donated EHR technology to be “interoperable” as of the date it is donated. Such technology will be deemed to be interoperable if it has been certified by a certification body authorized by the Office of the National Coordinator for Health Information Technology (ONC) to an edition of the EHR certification criteria identified in the then-applicable 45 CFR part 170 (i.e., the HITECH Act’s definition of “Certified EHR”). This will require donated software to be “as interoperable as feasible given the prevailing state of technology at the time they are provided to the recipient.” For example, in 2013, the HITECH Act’s definition of “Certified EHR” permits certification pursuant to either the 2011 or 2014 editions of the EHR certification requirements; in 2014, the HITECH Act requires certification pursuant to the 2014 edition only.
CMS and OIG have concluded that there are sufficient alternative policies driving the adoption of electronic prescribing such that it need not be included in the Exception and Safe Harbor. Thus, under the final rules, an EHR is no longer required to have electronic prescribing capability in order to be subsidized.
In the proposed rules, CMS and OIG identified concerns of potentially abusive practices stemming from the donation of EHR software that seemed to provide for the interoperable exchange of information, but instead led to data and referral “lock-in” between the donor and the referral source. OIG and CMS specifically referred to EHR items and services donated by ancillary service providers and suppliers, i.e., those do not have a direct primary patient care relationship, as subject to this concern. In the proposed rules, CMS and OIG sought comments on whether to limit the list of permissible donors of EHR items and services to hospitals, group practices, Prescription Drug Plan sponsors and Medicare Advantage organizations – or others with front-line patient care responsibilities. In light of the comments received, in the final rules, CMS and OIG specifically exclude laboratories from the list of permissible donors. Otherwise, the universe of protected donors remains the same.
In the proposed rules, CMS and OIG also requested comments on “new and modified conditions” that would prevent EHR donations from becoming a method for locking-in referrals (generally, to the donor), and instead encourage the free exchange of data. CMS and OIG do not adopt any such additional conditions in the final rules, but clarify that neither a donor “nor any person on the donor’s behalf may take any action to limit or restrict the use, compatibility or interoperability of the donated items or services with other electronic prescribing or other EHR systems, including but not limited to health information technology applications, products or services.” This expanded language is meant to clarify that neither donors nor recipients may limit interoperability and that donated EHRs must be interoperable both with other EHRs and with health information exchanges and other forms of technology.