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Proposed rules would extend EHR safe harbor


By Joseph Conn
Posted: April 9, 2013 - 12:30 pm ET
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(Story updated at 1 p.m. ET.)

The CMS and HHS' inspector general's office have issued a pair of complementary proposed rules to extend 2006 waivers that relaxed federal Stark and anti-kickback laws to promote the use of electronic health-record systems.

The proposed rules would extend the Dec. 31, 2013 sunset provisions in the original rules to Dec. 31, 2016. They also would drop an e-prescribing requirement in the original rules and amend language on what types of EHRs qualify for the waivers.

“We appreciate all that CMS and OIG have done here to extend the sunset date,” said Jeff Micklos, executive vice president of management and compliance and general counsel for the Federation of American Hospitals. “It's something we've asked for.”

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In 2004, then-President George W. Bush, in an executive order, set a national goal that most American should have access to an electronic medical record by 2014 and created the Office of the National Coordinator for Health Information Technology at HHS. The order provided little to no money to achieve that goal, but waiving Stark and anti-kickback laws was deemed as one way to try and induce hospitals to provide financial and technical assistance to office-based physicians to adopt EHRs without triggering federal laws policing financial conflicts of interest in referrals.

In the 2006 rules, to qualify for the waivers, the EHR systems being offered had to be interoperable, determined by whether the system had been certified within the previous 12 months by a certification body “recognized” by the HHS secretary.

In the updates, rulemakers propose revisions in the deeming language for interoperability, substituting that a certification body must be “authorized by” the ONC instead. They also added a two-year regulatory interval instead of 12 months.

The provisions more closely track the current ONC certification program established by the federal EHR incentive payment program created under the American Recovery and Reinvestment Act of 2009, according to Micklos.

“I think they're both helpful and logical,” Micklos said.

A 60-day public comment period on the proposed rules will begin once the rules are officially published in the Federal Register.

The rulemakers also propose limiting the waivers to cover only hospitals, group practices, prescription drug plan sponsors and Medicare Advantage plans, citing previously received comments that abusive donations have been made under the current, broader safe harbor that now protects “any donor” that provides healthcare goods or services under Medicare or Medicaid, including labs and durable medical equipment suppliers.


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