On Monday April 8, 2013, the Department of Health and Human Services Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS) released closely aligned proposed rules to extend their parallel anti-kickback safe harbor and physician self-referral exception for electronic health record (EHR) systems beyond the current end-of-year sunset dates. The agencies also proposed several other adjustments based on changes in the EHR landscape since the rules were promulgated in 2006.
First, the agencies propose to extend the sunset date to December 31, 2016, to coincide with the end of Medicare EHR incentive payments, or alternatively to December 31, 2021, when EHR incentives for Medicaid end. The agencies recognize that not all potential recipients of EHR donations are necessarily eligible to receive the incentive payments and so also seek comment on whether another alternative date would be appropriate, including a later timeframe.
Next, under the proposed rule, the e-prescribing capability requirement would be removed from the safe harbor and exception’s requirements. Here, the agencies highlighted the significant industry progress made, especially in light of the HITECH Act’s Meaningful Use initiative and e-prescribing incentives under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), along with the minimal risk of abuse in removing the condition. Organizations that develop or utilize specialized EHR software may find this proposal of particular interest for comment, as may those who prefer that EHR systems provide more comprehensive capabilities.
The proposed rule also calls for an update to the interoperability provisions. The current rules deem EHR software to be interoperable if it has been certified no more than 12 months prior to the time it is provided to a physician by a certifying body that is “recognized by the Secretary.” The agencies emphasized the continued necessity for interoperability as a condition of the safe harbor and exception to minimize referral lock-in. For example, the agencies note that interoperable software can communicate across the EHR ecosystem, perhaps even with a donor’s competitors. However, over the past few years, the approach to EHR certification and standards-setting has evolved. So to keep pace with those changes, the agencies propose to change the EHR certification requirements that address interoperability to better track with the Office of the National Coordinator for Health Information Technology’s (ONC) current authorization process. Specifically, the 12-month certification timeframe would change to a more flexible standard that deems software to be eligible if it has been certified “to any edition of the electronic health record certification criteria that is identified in the then applicable definition of Certified EHR Technology” maintained by ONC at the time the donation is made. This change also recognizes the ONC’s direction towards a two-year regulatory interval for certification standards.
The agencies also seek comment on a proposal to limit the scope of protected donors or to exclude certain software/services donors that may be perceived as higher risk, such as laboratories, durable medical equipment (DME) and independent home health agencies. As a potential alternative or to provide further protection against “data and referral lock-in,” the agencies also seek comment on adding or modifying conditions to the safe harbor and self-referral exception that would meet dual goals: (1) “to prevent the misuse of the exception in a way that results in data and referral lock-in,” and (2) “to encourage the free exchange of data (in accordance with protections for privacy).”
Finally, CMS and OIG seek input on whether the current regulation text regarding “covered technology” is sufficiently clear or calls for further explanation. Comments are due 60 days following publication in the Federal Register, which we expect to occur shortly. Both agencies note that each may consider comments submitted to the other in their final rules, given the close nexus of the rulemakings.
Patton Boggs regularly assists a variety of health care organizations in building their EHR strategies and navigating the anti-kickback and physician self-referral laws and regulations, including donor and recipient groups. We can also help organizations in formulating their policy strategies and submitting comments.