21st Century Cures Act
The 21st Century Cures Act was signed into law by President Barack Obama in December 2016 to increase investment in medical research at the National Institutes of Health (NIH) and to change how the Food and Drug Administration (FDA) regulates and oversees the review and approval of new drugs, biologics, and medical devices. A number of additional provisions addressing mental health, opioid addiction, Medicare, and a number of bills that separately passed the Senate Health, Education, Labor, and Pensions (HELP) Committee were attached to the original legislation, which was introduced in the U.S. House of Representatives by Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.).
Several provisions in the Cures Act are of interest to the brain injury community:
Section 2040 – Improving Medical Rehabilitation Research at the NIH
This section is almost verbatim the Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act, introduced by Sen. Mark Kirk (D-Ill.) in December 2015 as S. 800. The language revises the purpose of the National Center for Medical Rehabilitation Research (NCMRR) to include coordination of research and research training. It requires NCMRR to develop and periodically update a comprehensive research plan for medical rehabilitation research. Prior to updating the research plan, the NCMRR must report on progress in achieving the goals and objectives described in the plan. The Medical Rehabilitation Coordinating Committee must periodically host a scientific conference or workshop on medical rehabilitation research.
Section 2061 – National Neurological Conditions Surveillance System
Through the Centers for Disease Control and Prevention (CDC), the Secretary of the U.S. Department of Health and Human Services (HHS) will improve the collection of information on the incidence and prevalence of neurological diseases and conditions, which may be through the establishment of a disease registry.
Section 3303 – Accelerated Approval for Regenerative Advanced Therapies
This section creates a separate, accelerated approval pathway for regenerative therapies that include the use of adult stem cells. This is the first time the FDA will be creating a separate avenue for accelerated approval granted based on data from a small number of trial sites, versus the traditional method of using a surrogate or intermediate endpoint.
Section 5002 – Medicaid Reimbursement to States for Durable Medical Equipment
This provision accelerates the implementation date of a limitation on Medicaid reimbursement to states for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), which, under existing law, would cap rates at Medicare reimbursement levels starting in 2019. This provision is intended to accelerate the application of competitive bidding rates for DME provided by Medicaid. The new date is moved up one year from January 1, 2019 to January 1, 2018. This reimbursement cap stems from a September 2015 HHS Office of the Inspector General report that recommended action to reduce costs for DME by obtaining pricing similar to Medicare.
Section 15004 – Regulatory Relief for LTCHs under Medicare Part A
This section allows Long-Term Care Hospitals (LTCHs) to qualify for a “mid-build” exception to current law, which has placed a moratorium on expansion of facilities, specifically by allowing LTCHs to increase the number of beds in existing or satellite facilities. The provision also modifies Medicare LTCH high cost outlier payments, reducing federal payment rates, and requiring a higher threshold for LTCHs discharges to qualify for LTCH outlier payments. The latter provision is viewed as an offset for the mid-build exception components.
Section 16005 – Delay Implementation of Medicare Fee Schedule Adjustments
This provision delays the implementation of the adjustments for wheelchair accessories and seating systems used in conjunction with power complex rehabilitation technology (CRT) wheelchairs through July 1, 2017. The delay falls short of the permanent exemption of power and manual CRT wheelchairs and related accessories from Medicare’s Competitive Bidding pricing that had been sought. However, the delay does provide temporary relief from application of competitive bidding pricing, which will assist beneficiaries with severe disabilities to obtain the specialized mobility devices they need, at least through June of 2017.
Section 16007 – Extension of the Transition to New Payment Rates for DME
This provision provides an interim period of relief that may help durable medical equipment (DME) providers in rural areas continue to serve their communities while a more comprehensive and long-term solution to address the appropriate reimbursement for such equipment is sought. Section 16007 also requires a study to quantify the impact of DME policies on providers.