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REGULATORY REVIEW


multi-step process by which EHR plat- forms could be tested for compliance with a list of certification criteria (i.e., minimum EHR capabilities). The list of standard criteria has been updated through the years, with full criteria set “editions” released in 2011, 2014 and 2015. The 2015 Edition EHR Certifi- cation Criteria is the current standard. The Incentive and Certification pro- grams had their intended effect; ONC reports that more than 90 percent of eli- gible hospitals and clinicians are using certified EHR technology as of Novem- ber 2018, up from 17 percent of physi- cians and 9 percent of hospitals in 2008, according to the November 2016 HHS report to Congress on HIT progress. EHR penetration is significantly lower in ASCs, which received no financial assistance to implement these systems. Rough estimates place EHR penetra- tion in ASCs under 20 percent. However, incentivizing providers to implement a quality EHR was just the initial goal of HITECH. A more expansive goal was the free movement of EHI, both between providers—cre- ating more efficient, precise care coor- dination—as well as from providers to patients. These two goals, respectively referred to as interoperability and patient access, were the purview of a landmark December 2016 bill called the 21st Century Cures Act. This act set new governmental parameters and responsibilities in several HIT areas, including specialty EHR certifications, an EHR reporting system and, most notably, the need for further definition for the term interoperability and its inverse “information blocking.” At this time, there is no ASC-spe- cific EHR certification; while some ASCs use EHRs in their


facilities,


most products continue to be designed for use in either a hospital or physician office. This burdens clinicians who primarily operate in ASCs but treat enough Medicare patients to be eligi- ble for payment adjustments (± 4 per- cent in 2019 rising to ± 9 percent by


2022) under the Quality Payment Pro- gram (QPP). To combat this burden, Congress included Section 16003 in the 21st Century Cures Act. That sec- tion of the law states that no payment adjustment related to meaningful EHR use will be made for eligible profes- sionals who furnish “substantially all” of their services in an ASC. The defini- tion of “substantially all” was clarified in the CY 2018 Inpatient Prospective Payment System (IPPS) Final Rule: an ASC-based eligible professional is one who furnishes 75 percent or more of covered professional services in an ASC setting.


From 21st Century Cures to the Information Blocking Rule Section 4003 of the 21st Century Cures Act gives a definition to interop- erability: “such healthcare technology that enables the secure change of elec- tronic health information … without special effort on the part of the user.” However, the act also adds an impor- tant caveat, that technology is only considered interoperable if it “does not constitute information blocking.” Although Section 3022 of the act gives a broad definition of “information blocking”—practices “likely to inter- fere with, prevent, or materially dis- courage the access, exchange, or use of electronic health information”—


30 ASC FOCUS JUNE/JULY 2019 | ascfocus.org


and gives a few examples of such prac- tices the definition is vague at best. The 21st Century Cures Act did establish enforcement authority, giv- ing the US Health and Human Services (HHS) Office of the Inspector General (OIG) the power to levy civil penalties up to $1 million against entities found to be information blocking. First, how- ever, the HHS secretary was to refine OIG’s enforcement power by establish- ing a list of reasonable business prac- tices that would not constitute informa- tion blocking. This list of exceptions would be published in what stakehold- ers called the Information Blocking Rule. After several delays causing sig- nificant industry displeasure, the rule was released in February 2019. First, it is important to understand the actors who are subject to regula- tions in the rule: providers, develop- ers of certified HIT, health information exchanges (HIEs) and health infor- mation networks (HINs). ASCs are included in ONC’s definition of “pro- viders” (Section 3022 of the Public Health Service Act). ONC also pro- poses a new comprehensive definition for EHI: information that is 1) trans- mitted or maintained electronically, 2) identifies an individual, and 3) relates to the health condition of an individual, the provision of healthcare, or the pay- ment for the provision of healthcare. Note that the definition as proposed certainly encompasses traditional clinical, electronic protected health information (ePHI) but also includes a broader range of healthcare-related information. ONC also requests com- ment on whether to include price infor- mation in its EHI definition, thereby giving it the power to regulate price transparency issues under the informa- tion blocking mandate. How these broad definitions will


affect ASCs, and the healthcare land- scape in general, is unclear. Although ONC has traditionally kept its pur- view to monitoring certified EHRs and the data they encompass, this


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