After many months of debate and years of more broadly discussing some of the related concepts, the 21stCentury Cures Act (H.R. 34) passed the House and Senate last week, and was signed by the President today. It is a massive piece of legislation, 996 pages in length, and it will have a tremendous impact on medical innovation across the health sector.
The law’s primary objectives are to speed new medicines to market through a wide-ranging number of adjustments to the FDA’s work, the clinical trial process and the work of the National Institutes of Health (NIH). But the legislation also includes several important sections that address health IT, including the bulk of the Title IV – Delivery section, which recognizes that delivery reforms are reliant on health IT to move forward.
While there are elements of the new law that I believe could have been adjusted for greater efficacy and clarity, it is significantly improved from prior versions released in draft form over the last year. Some of the notable health IT provisions within the final legislation include:
Title I – Innovation
Fully funds the NIH Precision Medicine Initiative and Cancer Moonshot, which are key programs to improve patient diagnosis and advance medical research. The legislation defers to the NIH and the National Cancer Institute, an Allscripts client, for leadership of those programs.
Sec. 3060 – Certified Electronic Health Records (EHRs) carved out from FDA oversight. This clarification identifies EHRs (termed Electronic Patient Records) as a part of five specific categories of medical software that, given certain conditions, will not be regulated as a medical device by the FDA based on their low level of risk to patients.
Sec. 4001. Directs the Department of Health and Human Services (HHS) to evaluate ways to reduce the documentation burden on healthcare providers. Also establishes the opportunity for a voluntary certification process to address specific needs of medical specialties.
Sec. 4002. Creates a new EHR Reporting Program, authorizes $15 million to pay private sector ratings entities to prepare reports on EHR interoperability, usability and security. Reports will be public and posted on the ONC website at no cost. Replaces what would have been an onerous “star rating” program that could have led to decertification of EHRs or significant financial impacts on the industry. Instead encourages the development and support of a voluntary model framework and common agreement for the secure exchange of health information. Also directs ONC to defer to health IT standards developed in the private sector.
Sec. 4003. Codifies a definition of interoperability to be used by the government when crafting associated regulations or policies. This section will entail rule-making on the requirement that certified developers attest that their software is interoperable and does not block data. It creates a hardship exemption for eligible professionals (EP) related to EHRs that have been decertified. And it combines and reforms existing Health IT Policy and Standards Advisory FACA committees to create a more streamlined Health IT Advisory Committee with a direction to specifically address issues related to interoperability, privacy and security.
Standards: The new Health IT Advisory Committee will engage stakeholders to identify priorities for standards adoption. Within six months of the committee’s first meeting, the group will identify 1) priority uses of health IT, and 2) already existing standards and specifications that support the use and exchange of electronic health information needed to meet the priorities.
Sec. 4004. Defines Information Blocking. Establishes authority for the HHS Office of the Inspector General to investigate claims of information blocking and assign penalties of up to $1 million per instance. Investigations can be of health IT developers or provider organizations.
Sec. 4005. Leveraging EHRs to improve patient care. Encourages the exchange of health information between registries and EHRs. Adds developers of health IT to the protections afforded by Patient Safety Organizations to help improve reporting on patient safety and adverse events.
Sec. 4006. Empowering patients. Supports the certification and development of patient-centered EHRs to give patients better access to their secure and up-to-date health information. Requires HHS to educate healthcare providers on sharing of patient information, to clarify misunderstandings (particularly related to HIPAA) which may be currently impeding lawful sharing.
Sec. 4007. Patient matching. Requires the Government Accountability Office (GAO) to conduct a study on methods for securely matching patient records to the correct patient.
Sec. 4008. Patient access to health information. Requires the GAO to carry out a review of patient access to health information, including barriers to access, complications healthcare organizations experience when providing access and methods patients may use for requesting personal health information.
Sec. 4013. Telehealth services in Medicare. Requires specific actions of government bodies identified as critical to developing a long-term solution to telehealth services under the Medicare program.
Title XV – Provisions relating to Medicare Part A:
Subtitle B Provisions to Medicare Part B
Sec.16003. Treatment of eligible professionals in ambulatory surgical centers. Excludes physicians who furnish their Medicare services at ambulatory surgical centers (ASC) from the penalties under the EHR Incentives Program and subsequent program under the Merit-Based Incentive Payment System (MIPS). This exclusion ends three years after the Secretary of HHS, in consultation with stakeholders, determines that EHRs are available at the ASC setting.
More to come…
A large number of “Secretary shall” clauses within the legislative language provides a great deal of latitude to likely Secretary of HHS, Dr. Tom Price. Regulatory follow-ons from the legislation will be rolled out between 12-24 months, as required, and Allscripts will continue to be part of the conversation and advocate for our clients.
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