The Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services’ (OIG) have issued a pair of proposed rules (see CMS rule, OIG rule) that seek to revise the current Electronic Health Records exceptions to the Physician Self-Referral (Stark) and Anti-Kickback laws.
The proposed rules would amend the current exceptions in at least three ways. First, the rules would update the provision under which electronic health records software is deemed interoperable. Second, the current requirement for electronic prescribing capability would be removed. Third, the exception’s sunset date would be extended from December 31, 2013, to either December 31, 2016, or December 31, 2021.
In addition to the above, CMS is soliciting public comment on other possible amendments, such as limiting the scope of protected donors, and/or modifying conditions to limit the risk of data and referral lock-in.
II. Revision 1: Redefining Interoperability
Under the current electronic health record safe harbors, hospitals may provide physicians with “nonmonetary remuneration (consisting of items and services in the form of software or information technology and training services) necessary and used predominantly to create, maintain, transmit, or receive electronic health records items” so long as thirteen conditions are met.
Within the thirteen requirements, section 411.357(w)(2) specifically requires that donated software be “interoperable” at the time it is provided to the physician. Currently, software is deemed interoperable if a “certifying body” recognized by the Secretary has certified the software “no more than 12 months” prior to the date it is provided to the physician.
CMS proposes to modify the definition of interoperability in two respects. First, section 411.357(w)(2) will be modified to reflect that the Office of the National Coordinator for Health Information Technology, not the Secretary, shall be responsible for “recognizing” organizations that qualify as certifying bodies. Second, the twelve-month certification requirement will be eliminated.
II. Revision 2: Eliminating the Electronic Prescribing Requirement
Under the current Stark safe harbor, section 411.357(w)(11) requires that donated software:
contain […] electronic prescribing capability, either through an electronic prescribing component or the ability to interface with the physician’s existing electronic prescribing system that meets the applicable standards under Medicare Part D at the time the items and services are provided.
Based on the view that complimentary Acts including MIPPA, Pub. L. 110-275 and HITECH, Pub. L. 111-5 adequately address the need and requirement for electronic prescribing, CMS proposes deleting the electronic prescription requirement. Note however, e-prescribing technology remains eligible for donation under the electronic health records exception at 42 CFR § 411.357(v).
III. Revision 3: Extending the Sunset Provision
Finally, CMS proposes extending the current safe harbor sunset date from December 31, 2013, to either December 31, 2016 (the last year of Medicare incentive payments), or December 31, 2021 (the last year of Medicaid incentive payments). Either way, CMS believes that the sunset provision should be extended.
IV. Additional Considerations
In addition to the above three revisions, CMS seeks commentary on: (1) amending the scope of Protected Donors; (2) Data Lock-In and Exchange; and (3) Covered Technology. All three areas could drastically expand/limit the current safe harbor.
In August 2006, the definition of a Protected Donor (an entity that subsidizes up to 85% of the donee’s software cost) expanded from hospitals, group practices, prescription drug plan sponsors, and Medicare Advantage Organizations to any Designated Health Services (DHS) entity. In fear of possible ancillary service provider abuses, CMS proposes a revision back to the pre-2006 definition. This change will negatively affect multiple DHS entity donor programs.
Concerning Data Lock-In and Exchange, CMS is concerned that data systems which technically meet the interoperability definition under the rule may be restricted by donor policies and procedures that limit physician connectivity with non-donor entities. Under proposed revisions, CMS wishes to prevent donors from “locking-in” e-health technology recipients by restricting that donee’s ability to exchange data with other non-donor entities. How CMS will achieve its Data Lock-In goal remains to be seen.
Lastly, CMS proposes to define the term Covered Services to include:
interface and translation software; rights, licenses, and intellectual property related to electronic health records software connectivity services, including broadband and wireless internet services clinical support and information service related to patient care (but not separate research or marketing support services; maintenance service); secure messaging (for example, permitting physicians to communicate with patients through electronic messaging); and training and support services (such as access to help desk services).
While the proposed definition is viewed by many as the current industry standard, CMS believes that memorializing the definition will assist the providers.
Comments will be accepted for the next (60) days and may be submitted to http://www.regulations.gov via the “Submit a comment” link.