Two regulations extending the sunset date for donation of items and services for electronic health record adoption to Dec. 31, 2021, have been released by the Centers for Medicare & Medicaid Services and the U.S. Department of Health & Human Services Office of Inspector General.
The extensions amending the Stark Law exception and the Anti-Kickback Statute safe harbor for donations and subsidies paid for adopting EHRs go into effect Dec. 31, when the old guidelines were due to expire.
In addition to extending the sunset date by eight years, the CMS final rule bans laboratory companies from donating EHR items and services under the Stark EHR exception, removes a requirement for electronic prescribing equipment, updates a provision relating to interoperability, and clarifies the prohibition against action restricting use, compatibility or interoperability of the donated items or services, health attorney Ralph Topinka of the law firm von Briesen & Roper explained in a blog post.
Although its focus is on preventing fraud and abuse through the anti-kickback statute safe harbor, the OIG final rule covers the same areas, Topinka wrote.
The "agencies believe that the sunset date is necessary to ensure adoption of interoperable EHR technology in the near-term and to guard against 'inappropriate donations' that 'lock in data and referrals between a donor and physician recipient, among other risks,' Karen S. Lovitch wrote in a post for the Mintz Levin law firm's Health Law and Policy Matters blog.
The final rules were published Dec. 27 in the Federal Register.
Stakeholders including the American Hospital Association had weighed in on the proposed rules earlier this year. In its May 13 comment letter, the AHA called temporary protections from the Stark and anti-kickback laws critical to developing a "robust national health IT infrastructure."
The temporary protections from the Stark and anti-kickback laws were created in 2006 to encourage more physicians to transition to EHRs. The subsidies, also called donation programs, can cover up to 85 percent of the cost of the EHR's software, training and upgrades.
For more information:
- here's the CMS final rule (.pdf)
- here's the OIG final rule (.pdf)
- read Topinka's take on the rules
- check out Lovitch's blog post