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REGULATORY REVIEW


ONC Releases New Electronic Health Information Regulations What the rules could mean for ASCs BY ALEX TAIRA


On March 9, 2020, the Office of the National Coordinator (ONC), the federal agency in charge of coordinating nationwide


healthcare information technology, or health IT, published a long-awaited final rule: 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program or the Information Blocking Rule. Two of eight exceptions in the rule that would absolve a party from charges of information blocking might apply to ASCs.


The final rule arrived over one year after the initial proposed rule was released, and more than three years after the initiating legislation was passed. The regulation contains several new provisions and gives definition to the term “information blocking.” Under the statutory authority of the 21st Century Cures Act of 2016, the US Department of Health and Human Services (HHS) Office of the Inspec- tor General (OIG) may assess civil monetary penalties against a health- care stakeholder found to be “informa- tion blocking” according to definitions finalized in this rule.


Background: 21st Century Cures Act and Proposed Rule


President Obama signed the 21st Century Cures Act into law on December 13, 2016. The $6.3 billion law is best-known for its funding of medical research—such as the “Can- cer Moonshot” program—as well as for allocating additional funding to the US Food and Drug Administra- tion (FDA) to create streamlined pro- cesses for approving new drugs and medical devices.


Section 4004 of the law, however, is titled “Information Blocking” and defines “information blocking” as a practice that is “likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” The law further directs the HHS secretary to develop through rulemaking exceptions “rea- sonable and necessary activities that do not constitute information blocking.” It empowers the HHS OIG to investigate any conduct suspected of being infor- mation blocking and apply penalties of up to $1 million per violation to health IT developers, exchanges or networks found to be engaging in information blocking. The law does not specify limits for penalties against healthcare providers, but rather directs OIG to assess “appropriate disincentives.” The law left many basic defini-


tions involved in information block- ing enforcement unresolved, most notably what health information


30 ASC FOCUS JUNE/JULY 2020 | ascfocus.org


would be covered, what stakehold- ers would be subject to oversight, and what practices would be consid- ered acceptable and not information blocking. Despite much impatience from the healthcare community, it would take more than two years for ONC to


deliver answers to these


questions in the form of a proposed rule. More than 2,000 comments were submitted to that proposed rule, and the final rule was released almost exactly one year later.


Important Definitions


A primary goal of the rulemaking is definitional. ONC is best known for administering the Health IT Certification Program by which health IT develop- ers can “certify” their products against established


technical standards. ONC


established this program in 2010 so that providers and facilities could meet tech- nology use standards required by the Meaningful Use Program, now known as


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