In a proposed rule scheduled to appear on the Federal Register on April 10, the Centers for Medicare & Medicaid Services (CMS) intends to extend the safe harbor for EHR donations (i.e., the Federal Anti-kickback Provision) beyond its current expiration on Dec. 31, 2013. Likewise, the Office of the Inspector General (OIG) is slated to publish a nearly identical proposed rule as well.
As CMS has noted in the proposed rule, the motivation behind extending the safe harbor is to support the further adoption of EHR systems. “However, while the industry has made great progress, use of such technology has not yet,” states the proposed rule (CMS-1454-P; RIN 0938-AR70).
CMS is proposing a three-year extension of the safe harbor (i.e., Dec. 31, 2016) that aligns with the final year for eligible providers to participate in the EHR Incentive Program for Medicare:
We continue to believe that, as this goal is achieved, the need for an exception for donations of such technology should continue to diminish over time. Accordingly, we propose to extend the sunset date to December 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.
As part of its proposal and request for comment, CMS is also considering Dec. 31, 2021 as an alternative that syncs with the end of the EHR Incentive for Medicaid:
As an alternative to this proposed, extended sunset date of December 31, 2016, we are also considering establishing a later sunset date. For example, we are considering extending the sunset date to December 31, 2021, which corresponds to the end of the electronic health records Medicaid incentives. While these sunset dates are associated with specific Medicare and Medicaid electronic health record incentive programs, we recognize that not all health care providers to whom donations can be made are eligible for such incentives. These health care providers include, for example, many in the mental health and behavioral health communities as well as long-term and post-acute care facilities.
Although the proposed rule will not introduce new cost requirements, it does place a high value on the need for donated EHR systems to meet interoperability requirements as a means of avoiding provider lock-in and enabling health information exchange:
Although we have long been concerned that parties could use the donation of technology to capture referrals, we have viewed interoperability as a potential mitigating factor, or safeguard, to justify other exception conditions that are less stringent than might otherwise be appropriate in the absence of interoperability. This is because if the donated technology is interoperable, the recipient will be able to use it to transmit electronic health records not only to the donor, but to others, including competitors of the donor, and will not be “locked in” to communications with the donor only.
To ensure that EHR systems meet necessary interoperability, CMS will remove its 12-month certification timeframe in favor of following the certification timeline established by the Office of the National Coordinator for Health Information Technology (ONC).
One significant change with little anticipated effect on healthcare organizations and providers is the removal of the exception for electronic prescribing, for which CMS believes there to be “sufficient alternative policy drivers” that have emerged since the initial safe harbor went into effect in 2006.
Once the proposed rule is published on the Federal Register, the public will have 60 days to submit comments, and as CMS has stated, it will also take into consideration commentary on the OIG’s proposed rule.
Read the complete CMS proposed rule