CMS issues rule on Stark exceptions
The Centers for Medicare & Medicaid Services (CMS) has released a final rule that revises the exception to the federal physician self-referral prohibition (known as the Stark Law) for certain arrangements involving the donation of electronic health record (EHR) items and services.
The rule addresses what is known as the Stark Exception. The Office of Inspector General (OIG) of the Department of Health and Human Services simultaneously released a companion rule revising the safe harbor regulation concerning EHR items and services under the Federal Anti-Kickback Statute, known as the Safe Harbor.
CMS and OIG amended the final rules from 2006 as part of an ongoing effort to encourage the adoption of EHR systems. The systems can be too expensive for some physician practices, and hospitals have been interested in assuming some of the costs.
These were the five key changes in the amendment:
- The Stark Law exception and the Safe Harbor are extended until Dec. 31, 2021.
- After March 27, 2014, laboratory companies will no longer be protected donors.
- The EHR software is deemed interoperable if, on the date the software is provided to a physician, a certifying body authorized by the National Coordinator for Health Information Technology certifies that the software meets the then-applicable EHR certification criteria.
- The rule clarifies the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services.
- The electronic prescribing capability requirement is removed.