As part of National Health IT Week, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) this week issued a policy reminder that information blocking could potentially violate the federal anti-kickback law and may not be subject to safe harbor.
The anti-kickback law prohibits individuals and organizations from knowingly and willingly offering, paying, soliciting or receiving remuneration to induce or reward referrals of business reimbursable under any federal health care program. There are exceptions to the federal anti-kickback statute, known as safe harbors.
With the aim of promoting the adoption of interoperable electronic health record (EHR) technology for the benefit of patient care, OIG created an EHR safe harbor that “protects certain arrangements involving the provision of interoperable EHR software or information technology and training services,” according to the three-page OIG memo.
The memo reminds providers that they may donate software or information technology to existing or potential referral sources, such as a physician practice, under the safe harbor provision.
However, the OIG alert also reminded providers that a condition of the safe harbor provision is that the donor does not take any action to limit or restrict the use, compatibility or interoperability of the EHR platform or services with other EHR or health IT systems.
“In connection with this requirement, OIG has stated that ‘donations of items or services that have limited or restricted interoperability due to action taken by the donor or by any person on the donor’s behalf (which could include the recipient acting on the donor’s behalf) would fail to meet the condition and is inconsistent with the intent of the safe harbor to promote the use of technology that is able to communicate with products from other vendors,’” the OIG memo stated.
According to the OIG, failure to meet this condition would mean that the safe harbor would not apply and the arrangement would be subject to case-by-case review under the federal anti-kickback statute.
OIG has stated that such “donations would be suspect under the law as they would appear to be motivated, at least in part, by a purpose of securing federal health care business.”
Situations where an EHR vendor agrees with providers or donors to charge high interface fees to non-recipient providers, suppliers or competitors may also fail to satisfy the safe harbor conditions, according to OIG.
And, laboratories are no longer potentially protected donors for purposes of the safe harbor, the OIG memo stated.