On December 13, 2016, President Obama signed the 21st Century Cures Act (“Act”) into law with large bipartisan support. While the majority of the Act focuses on regulatory changes to the way the NIH and research instructions discover, develop, and deliver modern healthcare, parts of the Act are likely to have a direct effect on both hospitals and patients.
A. Changes to Clinical Trials
Hospitals conducting clinical trials should be aware that the requirements for use of “local” institutional review committees (“IRB”) have been removed from 21 U.S.C. 360(j). Presumably, this will permit clinical trials to be overseen by a broader category of IRBs. Hopefully, this will help to decrease the burden associated with IRB oversight.
Section 2262(b) of the Act requires the Secretary of Health and Human Services to issue new regulations and/or guidance by the end of 2017. Healthcare institutions conducting clinical trials should be on the lookout for these revisions as guidance for IRB requirements going forward.
B. New Requirements for Health Information Technology
The vast majority of healthcare institutions have now adopted some form of Electronic Health Record (“EHR”) system. Acknowledging the issues with interoperability between EHR systems, Section 3001 of the Act creates a three-part definition of “interoperability” which will be the new standard for reviewing health information technology. Going forward, interoperable technology must (1) permit the secure transfer of information, (2) allow complete access to health information for all permitted uses, and (3) not include any configurations that block access to information.
On December 20, 2016, the Department of Health and Human Services issued the “2017 Interoperability Standards Advisory”. The updated standards include topic-by-topic guidance with information on what areas are federally required.
C. Steps Forward for Telehealth
In Section 3021 of the Act, Congress has also acknowledged the growing use of telemedicine/telehealth services and has requested additional information to be provided within the next year by both the Centers for Medicare & Medicaid Services and the Medicare Payment Advisory Commission. While this section provides only an initial step toward regulation of telemedicine, Congress did define telemedicine as “the delivery of safe, effective, quality health care services, by a health care provider, using technology as the mode of care delivery” and required such delivery to “meet or exceed conditions of coverage and payment with respect to the Medicare Program….” Subsection (C) also specifically notes that telemedicine should “involve clinically appropriate means to furnish such services.” Such follow through has been a continuing problem with the provision of telemedicine and the new definition should be used as a baseline for the level of care expected in telemedicine going forward. Additional guidance or regulation may be expected in the coming years.
D. Changes to Laws Regarding Special Needs Trusts
Many of us are familiar with Special Needs Trusts which have been used to allow incompetent, disabled individuals to retain all public benefits notwithstanding receipt of substantial settlement funds. These Trusts have been helpful in resolving cases with large future medical and care expense calculations.
As an addition to the Act, Congress amended 42 U.S.C. 1396 to allow for disabled individuals less than 65 years old to utilize the benefits of a Special Needs Trust without a requirement of incompetency. This legislation allows competent disabled individuals less than 65 years old to protect their assets from Medicaid and SSI consideration without the need for a legal guardian, parent or court to establish the trust on their behalf. This streamlined approach will allow eligible disabled individuals to access the benefits of a Special Needs Trust more expeditiously and with less administrative burden.
From a litigation perspective, the ability of competent, disabled individuals to retain eligibility for government benefits in a cost effective manner will be a helpful tool in resolving claims and suits with significant future medical or care needs.
If you have questions about this client alert or related topics, please feel free to contact either of the attorneys below: