Health Law Daily Wrap Up, ELECTRONIC HEALTH RECORDS—PROPOSED RULES: OIG proposes changes to the “safe harbor” rules concerning EHRs technology, (Apr 10, 2013)

By Harold M. Bishop, JD

The HHS Office of Inspector General (OIG) is proposing to amend the current safe harbor regulations concerning the donation of electronic health records (EHRs) items and services to (1) update the provision under which EHRs software is deemed interoperable; (2) remove the requirement related to electronic prescribing capability; and (3) extend the sunset date (Proposed rule, 78 FR 21314, April 10, 2013). The proposed rule would modify the existing safe harbor to the anti-kickback statute, which permits health care providers and other entities to provide technology-related items and services to certain parties to be used to create, maintain, transmit, or receive EHRs. The OIG is also soliciting public comment on limiting the scope of protected donors and adding or modifying conditions to limit the risk of data and referral lock-in. CMS is simultaneously proposing almost identical changes to the physician self-referral law EHRs exception (78 FR 21308).

“Safe harbor” history. Because of the broad reach of the anti-kickback statute (Soc. Sec. Act, sec. 1128B(b), 42 U.S.C. 1320a-7b(b)), and concern that some relatively innocent commercial arrangements would potentially be subject to criminal prosecution, Congress enacted section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987 (P.L. 100-93) (Soc. Sec. Act, sec. 1128B(b)(3)(E); 42 U.S.C. 1320a-7b(B)(3)(E)), to require the promulgation of so-called “safe harbor” provisions, that would specify various payment and business practices that would not be subject to sanctions under the anti-kickback statute, even though they might potentially be capable of inducing referrals of business under the federal health care programs.

Current EHR “safe harbor” regulations. On August 8, 2006 (71 FR 45110), OIG published a final rule that, among other things, finalized a safe harbor at 42 CFR 1001.952(y) for protecting certain arrangements involving interoperable EHRs software or information technology and training services. On the same day (71 FR 45140), CMS simultaneously published similar final regulations at 42 CFR 411.357(w). The EHRs safe harbor is scheduled to end (or sunset) on December 31, 2013 (42 CFR 1001.952(y)(13)).

The deeming provision. OIG’s current EHRs safe harbor specifies at 42 CFR 1001.952(y)(2) that the donated software must be “interoperable at the time it is provided to the recipient.” This provision states that “software is deemed to be interoperable if a certifying body recognized by the Secretary has certified the software within no more than 12 months prior to the date it is provided to the recipient.” OIG’s proposal would update this deeming provision to reflect that to become a certifying body “recognized” by the Secretary of HHS, an entity must now successfully complete an authorization process established by the Office of the National Coordinator for Health Information Technology (ONC-HIT).

Second, OIG proposes to modify the portion of the deeming provision concerning the time period within which the software must have been certified. Currently, the deeming provision requires that software must have been certified within no more than 12 months prior to the date of donation in order to ensure that products have an up-to-date certification. However, subsequent to the 2006 EHRs safe harbor rule, ONC developed a regulatory process for adopting certification criteria and standards that is anticipated to occur on a 2-year regulatory interval. As a result, OIG proposes that software would be eligible for deeming if, on the date it is provided to the recipient, it has been certified to any edition of the EHR certification criteria that is identified in the then-applicable definition of Certified EHR Technology in 45 CFR part 170.

Electronic prescribing provision. In light of developments since the 2006 final rule, OIG does not believe that it is necessary to retain a requirement related to electronic prescribing capability in the EHRs safe harbor. First, in 2006, the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (P.L. 110-275) was enacted authorizing an electronic prescribing incentive program for certain types of eligible professionals. Second, in 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of the American Recovery and Reinvestment Act of 2009 (ARRA) (P.L. 111-5) authorized eligible professionals under the Medicare and Medicaid EHR incentive programs to demonstrate meaningful use of certified EHR technology, including the use of electronic prescribing.

Third, the industry has made great progress related to electronic prescribing. Recent analysis by ONC notes an increase in the percentage of physicians electronically prescribing via EHR technology from 7 percent in 2008 to 48 percent in 2012. Furthermore, the regulations published in September 2012 to implement Stage 2 of the EHR Incentive Programs continue to encourage physicians’ use of electronic prescribing technology. In light of these developments, OIG proposes to delete the electronic prescribing condition at 42 CFR 1001.952(y)(10). OIG believes that there are sufficient alternative policy drivers supporting the adoption of electronic prescribing capabilities.

The sunset provision. The EHRs safe harbor is scheduled to sunset on December 31, 2013. OIG proposes to extend the sunset date to December 31, 2016, which corresponds to the last year in which one may receive a Medicare EHR incentive payment and the last year in which one may initiate participation in the Medicaid EHR incentive program. As an alternative, OIG would also consider extending the sunset date to December 31, 2021, which corresponds to the end of the EHR Medicaid incentives.

Comments on the proposed rule may be submitted through June 10, 2013.

FederalRegisterIssuances: ProposedRules AntikickbackNews EHRNews FraudNews HITNews MedicaidNews PartDNews PrescriptionDrugNews