Earlier this month, CMS and OIG proposed amendments to and extension of the temporary Stark exception and Anti-kickback safe harbor for electronic health record (EHR) donations to physicians. The Proposed EHR Rules would extend the deadlines for EHR donations which are set to expire December 31, 2013.
The Proposed EHR Rules come at a perfect time, when many organizations are adopting EHRs for purposes of participating in the Medicare and Medicaid EHR Incentive Programs ("Meaningful Use"). Although the OIG Proposed Rule would extend EHR donations until at least December of 2016, the CMS Proposed Rule contemplates extending EHR donations through December of 2021 to align with the end of Medicaid Meaningful Use.
The Anti-kickback Statute prohibits referrals for federal health care business. Certain "safe harbors" provide assurances that certain conduct will not violate the Anti-kickback Statute. One of these safe harbors, the EHR safe harbor, permitted certain EHR donations of interoperable EHRs and other technology and services.
The OIG Proposed Rule would:
- Amend how interoperable EHRs are treated, permitting also certified EHR technology adopted for purposes of Meaningful Use;
- Remove the e-prescribing capability requirement; and
- Extend the sunset date of the safe harbor to coincide with the end of Medicare Meaningful Use payments and the last year in which one can begin participating in Medicaid Meaningful Use.
OIG also requests public comment on additional amendments, such as limiting the scope of protected donors to only hospitals group practices, PDP sponsors and MA organizations. It also requests comment on modifying or adding conditions to prevent risk of misuse of the EHR safe harbor and limit the risks of data and referral lock-in.
The Stark Law prohibits physician self-referrals for designated health services payable by Medicare. The Stark Law allows for certain exceptions which an arrangement must fit into. Almost identical to the EHR safe harbor under the Anti-kickback Statute, the EHR exception also allowed for donations of interoperable EHRs.
Like the OIG Proposed Rule, the CMS Proposed Rule would likewise amend what interoperable EHRs are permitted to include those adopted for Meaningful Use, remove the e-prescribing capability requirement, and extend the sunset date of the safe harbor. Both CMS and OIG acknowledged that e-prescribing is adequately provided for by Meaningful Use and the Medicare E-Prescribing Incentive Program. However, while CMS proposes to extend the sunset date to December 2016, it acknowledges that it is contemplating extending EHR donations through December 2021.
Comments to the EHR Proposed Rules are due no later than 5pm EST on June 10, 2013.