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Washington Debrief: What CIOs Need to Know About Proposed Rules to Stark, Anti-kickback Exceptions

April 16, 2013
by Jeff Smith, Director of Public Policy at CHIME
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Jeff Smith, Director of Public Policy at CHIME

What CIOs Need to Know about Proposed Rules to Stark, Anti-kickback Exceptions The HHS Inspector General Office and the Centers for Medicare & Medicaid Services recently unveiled proposals to amend the safe harbor regulation concerning electronic health records (EHRs) items and services.  The proposed amendments include an update to the provision under which EHR software is deemed interoperable; removal of the electronic prescribing capability requirement; and extension of the sunset provision to Dec. 31, 2016. 

Generally, the proposed regulations take some “common sense” steps.  To be deemed interoperable, for example, the donated software has to be certified to applicable definitions of Certified EHR Technology, as defined by the EHR Incentive Payments program.  This means that in 2013, both 2011 Edition CEHRT and 2014 Edition CEHRT is permissible; but in 2014 only 2014 Edition CEHRT is allowed.  As mentioned previously, the eRx conditions would be deleted under the proposed rule and the sunset provision would be extended to Dec. 31, 2016.  But CMS and the IG ask if the sunset should be extended to Dec. 31, 2021 to correspond to Medicaid EHR incentive payments – or if there is another date that would be more appropriate (tied to a program other than EHR Incentive Payments program).

Two other parts of the regulation that will likely spark interest, include questions about (1) how to prevent data / referral lock-in, while encouraging free exchange of data and (2) the clarity of “covered technology” definitions under the current regulation.  CMS and the IG seek comments on what new or modified conditions could be added to the exception for EHRs to avoid lock-in and promote data exchange and whether those conditions should be in addition to, or in lieu of, our proposal to limit the scope of permissible donors (the proposed regulation seeks comment on plans to limit protected donors to only hospitals, group practices, PDP sponsors, and MA organizations).

Finally the proposed regulations seek input on whether current regulatory text regarding the scope of covered technology needs further examination.  Types of technology, services / training covered include:

  • Interface and translation software
  • Rights, licenses, and intellectual property related to electronic health records software
  • Connectivity services, including broadband and wireless internet services
  • Clinical support and information services related to patient care (but not separate research or marketing support services)
  • Maintenance services; secure messaging (for example, permitting physicians to communicate with patients through electronic messaging)
  • Training and support services (such as access to help desk services)

CHIME will look at these and other questions found in the two NPRMs.  If you are interested in learning more about the proposed regulations or CHIME’s response, please contact Director of Public Policy, Jeff Smith.

Confirmation within View for Acting Administration Whether it was a ‘lovefest’ or just ‘remarkably friendly,’ CMS Acting Administrator Marilyn Tavenner breezed through a confirmation hearing this week in front of Senators from the Finance Committee.  While the bulk of Tuesday’s hearing focused on implementation of high-profile aspects of the Affordable Care Act (ACA), Tavenner focused heavily on delivery reform aspects of the ACA in her testimony.  “These past three years managing CMS have been a busy time, and I am proud of these examples and everything else we have been able to accomplish,” she said in her testimony.  “Hospital readmissions in Medicare have fallen dramatically in the past year, resulting in an estimated 70,000 fewer patients returning to the hospital with dangerous and costly complications,” she said.  She also focused on how CMS is streamlining regulations and improving data access.  “Under my leadership CMS is improving data access and sharing with strong privacy protections to develop new tools for policy and decision makers both within and outside CMS.”  Senate Finance Chairman, Max Baucus (D-Mont.) said he was hopeful that a vote could be held next week.

Budget Week in Washington; President’s Plan Would Increase Funding for Health IT Agencies Thousands of Washington eyes were wading through a $3.77 trillion budget released by President Obama this week.  Of interest to the healthcare sector were proposed cuts of nearly $400 billion, the bulk of which would come from reduced payments to hospitals and health care providers.  Funding for agencies involved with health IT, however, would see modest gains, according to the proposed budget.  For example, ONC would have $78 million for FY 2014 – roughly $17 million than was allocated under the previous budget.  Specifically, that total includes:

  •  $56.3 million in public health service evaluation funding;
  •  $20.6 million in budget authority; and
  •  $1 million in certified electronic health record technology fees to support program activities, such as maintenance of the Certified Health IT Products List.

Other queues gleaned from the budget include $1 million increase to the Office for Civil Rights to help fund seven new full-time employees.  OCR's privacy and security enforcement team received and resolved more than 9,500 complaints of HIPAA violations in FY 2012.  The unit will be ramping up its oversight and investigation activities following recent updates to HIPAA.  Additionally, funding for the Agency for Healthcare Research and Quality (AHRQ) would increase to $434 million, a $29 million increase over AHRQ's budget for FY 2012.

Edited by Gabriel Perna

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