President Obama signed H.R. 34: The 21st Century Cures Act on Dec. 13, 2016. The 21st Century Cures Act ("the Act") provides expansive reforms to the approval process for drug and medical devices and increases access to research funds for cancer, neuroscience and genetic research.
The Act requires enhanced compliance with existing laws for parity of insurance coverage and supports that objective with guidance and a new compliance program with illustrative examples from the Departments of Health and Human Services, Labor and Treasury. The Act also eliminates the Medicaid “same day” exclusion, which prohibits separate payments for mental health and primary care services provided to a Medicaid enrollee on the same day. This change will especially impact individuals and providers in rural areas.
Beyond changes and clarifications to insurance requirements for mental health coverage, the Act also calls on the Secretary of the Department of Health and Human Services (“HHS”) to clarify the permissible uses and disclosures of health information under the Health Information Portability and Accountability Act (“HIPAA”) Privacy Rule. The Privacy Rule addresses communications between health care providers and caregivers of adults with a serious mental illness to facilitate treatment, as well as the circumstances in which that information can be shared with family members, within one year after the enactment of the Act. HHS, in carrying out this directive, will make available to health care providers, professionals, patients, patients’ families and others involved in mental or substance abuse disorder treatments adequate, accessible and comprehensible resources relating to appropriate uses and disclosures of protected health information before the one-year period expires.
Title IV of the Act is dedicated to the delivery of electronic health information. The Act amends the Health Information Technology for Economic and Clinical Health Act (“HITECH”) to assist doctors and hospitals in improving quality of care for patients by reducing the burdens of maintaining electronic health information. Within one year of the Act’s enactment, the HHS will develop strategies and recommendations to help meet this goal, including prioritizing incentives for meaningful use of electronic health records and provisions allowing a physician to delegate electronic medical record documentation requirements.
Additionally, the Act amends Subtitle C of title XXX of the Public Health Service Act regarding “information blocking.” For a health care provider, “information blocking” is a practice that is likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information, and the provider knows that such practice is unreasonable and is likely to lead to those results. The Act authorizes the Inspector General of the HHS to investigate individuals and entities that have engaged in “information blocking” related to electronic health information. Any provider found to have engaged in “information blocking” may be penalized. The Inspector General will refer the matter to the appropriate agency for issuance of disincentives to combat information blocking.
Full text of the Act can be found here.