CMS and OIG Release Physician Referral, EHR Exception, and Safe Harbor/Anti-Kickback NPRMs

April 12, 2013

On Wednesday, April 10, the Centers for Medicare and Medicaid Services (CMS) and the HHS Office of the Inspector General (OIG) released two Notices of Proposed Rulemaking (NPRM). There is a 60-day public comment period, with responses due byJune 10, 2013.

The CMS NPRM, outlines the following proposals, among others:

  • Revising the exception to the physician self-referral prohibition for certain arrangements involving the donation of electronic health records (EHR) items and services.
  • Extending the sunset date of the exception to December 31, 2016, remove the electronic prescribing capability requirement, and update the provision under which EHR technology is deemed interoperable.

The OIG NPRM outlines the following proposals, among others:

  • Proposing to amend the safe harbor regulation concerning EHR items and services, which defines certain conduct that is protected from liability under the Federal anti-kickback statute in the Social Security Act (the Act).
  • Updating the provision under which EHR software is deemed interoperable.
  • Removing the electronic prescribing capability requirement.
  • Extending the Sunset provision to December 31, 2016.

Mentioned in both NPRMs are the following items under consideration:

  • Proposal to limit the scope of protected donors under the EHR exception, with the continued goal of promoting adoption of interoperability.
  • Considering whether other individuals or entities with front-line patient care responsibilities across health care settings, such as safety net providers, should be included, and, if so, which ones.
  • Considering retaining the current definition of protected donors, but excluding specific types of donors. We are considering excluding suppliers of ancillary services associated with a high risk of fraud and abuse.

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