President Obama Signs 21st Century Cures Legislation
- FLASCO
- December 15, 2016
- News
President Obama Signs 21st Century Cures Legislation
In addition to the original intent of the legislation to speed the discovery, development, and delivery of cures, the bill became a vehicle for many other health care priorities including funding to address the opioid crisis, reforms to the mental health system and changes to hospital payments.President Barack Obama signed the 21st Century Cures legislation into law this week. On December 7, the Senate voted 94-5 to pass the bipartisan bill. The House previously passed the bill by a vote of 392-26. The $6.3 billion legislation authorizes funding for the National Institutes of Health to accelerate research into major diseases, including the Cancer Moonshot, and funding for the Food and Drug Administration (FDA) to streamline its approval process.
Key provisions in the Cures bill include:
Site Neutral Payments
The 21st Century Cures package included the Helping Hospitals Improve Patient Care Act (H.R. 5273), a priority for the House Ways and Means Committee. The bill provides an exception for “mid-build” hospital outpatient departments and NCI designated cancer hospitals to Medicare’s site neutral payment policy passed in last year’s Bipartisan Budget Act (BBA). The Network along with the Alliance for Site Neutral Payment Reform strongly opposed the inclusion of this provision in the 21st Century Cures legislation as it works counter to the bill’s goal of improving our nation’s healthcare system and protecting patients.
On January 1, 2017, CMS will begin implementing the BBA’s site neutral payment policy that will align payments for all eligible off-campus hospital outpatient departments with payments under the Physician Fee Schedule. The Network and our coalition partners will continue to strongly advocate for the advancement of site neutral payment policies in the next Congress.
Medicare Site of Service Transparency
The bill directs the Centers for Medicaid and Medicare Services (CMS) to create a searchable website for patients to compare the cost of services provided in a hospital outpatient department with the cost of services provided in an ambulatory surgical center.
Funding for NIH, Cancer Moonshot and Precision Medicine Initiative
The bill authorizes $4.8 billion in discretionary funding over 10 years, including $1.8 billion for the Cancer Moonshot and $1.4 billion for the Precision Medicine Initiative.
Improvements to Medicare Local Coverage Determinations
The bill requires Medicare Administrative Contractors (MAC) to publicly post local coverage determinations (LDC) in its entirety at least 45 days before the effective date. MACs will also be required to include:
- where and when the proposed determination was first made public,
- links to the proposed determination and a response to comments submitted,
- a list of sources and a summary of evidence that was considered by the contractor during the development of the LCD.
Clinical Trials
The bill requires the FDA to issue guidance to assist sponsors in incorporating adaptive designs and novel statistical modeling into new drug applications. The legislation also allows the National Center for Advancing Translational Sciences (NCATS) to support clinical trials through the end of phase IIB; encourages NIH to increase representation of underrepresented populations in clinical trials; updates the clinical trials database to clarify whether combination products are considered drug clinical trials or device clinical trials and to allow information from device clinical trials to be posted prior to clearance or approval; and requires the Secretary of HHS to consult with agencies and other stakeholders to receive recommendations on enhancements to the clinical trial registry.
To view the section-by-section, CLICK HERE.
To view the full legislative text, CLICK HERE.
