ASCA is continuing to work with officials at Medicare and in the ONC to determine what impact, if any, these regulations will have on ASCs. Until more information specific to ASCs becomes available, this overview of recent actions in this area can help ASCs anticipate how federal activity surrounding these priorities might affect their facilities, physicians and patients in the future.
The ONC proposed rule is called the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program or the Information Blocking Rule. As its title suggests, the rule seeks to define “information blocking,” a key term that has caused industry consternation since its introduction in Sec. 4004 of the 21st Century Cures Act. The rule also proposes a number of changes to elements of the ONC Health IT Certification Program and the 2015 Edition Certification Criteria.
The CMS proposed rule is called the Interoperability and Patient Access Rule. Whereas the Information Blocking Rule adds definition to existing rules and regulations, the Interoperability Rule builds on some of the current administration's policy priorities, namely, giving patients access and control over their personal health information (e.g. claims data) across public payers and providers.
As of the writing of this piece both rules are open for public comment until May 3, 2019. Additionally, there is strong industry pressure for CMS and ONC to extend the comment deadlines.
A Summary of Relevant HIT Regulation
The history of EHR regulation has been covered in the May 2018 issue of ASC Focus but is worth revisiting as the new rules directly build on previous laws and regulations.
The foundation for this year’s rules, and the governance of HIT overall, was laid in 2009’s Health Information Technology for Economic and Clinical Health (HITECH) Act, which carved out billions of federal dollars for the promotion and proliferation of HIT. Much of the HITECH dollars were for electronic health record (EHR) implementation stimulus via the Medicare and Medicaid EHR Incentive Programs; if a hospital or physician could prove that they were “meaningfully using” an EHR that adhered to certain federal standards they could receive thousands of dollars in incentive payments (beginning in 2014, there also were penalties for not using an EHR).
The federal standards delineating what qualifies as an acceptable EHR for physicians and hospitals to use are set by the ONC Health IT Certification Program. In 2010, ONC collaborated with the National Institute of Standards and Technology (NIST), to develop a multi-step process by which EHR platforms 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 Certification Criteria is the current standard.
The Incentive and Certification programs had their intended effect; ONC reports that more than 90 percent of eligible hospitals and clinicians are using certified EHR technology as of November 2018, up from 17 percent of physicians 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; rough estimates place EHR usage 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—creating more efficient, precise care coordination—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 a number of 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-specific 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 eligible for payment adjustments (± 4 percent in 2019 rising to ± 9 percent by 2022) under the Quality Payment Program (QPP). To combat this burden, Congress included Section 16003 in the 21st Century Cures Act, which states that no payment adjustment related to meaningful EHR use will be made for eligible professionals who furnish “substantially all” of their services in an ASC. The definition 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 interoperability: “such healthcare technology that enables the secure change of electronic health information … without special effort on the part of the user.” However, the act also adds an important 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 interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information”—and gives a few examples of such practices the definition is vague at best.
The 21st Century Cures Act did establish enforcement authority, giving the 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, however, the HHS secretary was to refine OIG’s enforcement power by establishing a list of reasonable business practices that would not constitute information blocking. This list of exceptions would be published in what stakeholders called the Information Blocking Rule. After several of delays causing significant industry displeasure, the rule was released in February 2019.
First, it is important to understand the actors who are subject to regulations in the rule: providers, developers of certified HIT, health information exchanges (HIEs), and health information networks (HINs). ASCs are included in ONC’s definition of “providers” (Section 3022 of the Public Health Service Act). ONC also proposes a new comprehensive definition for EHI: information that is 1) transmitted or maintained electronically, 2) identifies an individual, and 3) relates to the health condition of an individual, the provision of healthcare, or the payment 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 comment on whether to include price information in their EHI definition, thereby giving them the power to regulate price transparency issues under the information blocking mandate.