On July 10, 2015, the U.S. House of Representatives passed the 21st Century Cures Act, by an overwhelming vote of 344 – 77. The bill seeks to encourage innovation in medicine by increasing funding for research and expediting the approval of new devices and drugs. The Senate is expected to act on a similar measure later this year.

The bill also provides additional funding to the National Institutes for Health (NIH) and the Food and Drug Administration (FDA), while including reforms aimed at removing administrative barriers and streamlining clinical trials.

“On behalf of over 18,000 board-certified orthopaedic surgeons and members of AAOS, I commend the House of Representatives for passing this bipartisan and forward-looking legislation,” stated AAOS President David D. Teuscher, MD. “The 21st Century Cures Act makes a number of significant improvements—from streamlining the device-approval process at the FDA to increasing funding for the NIH—that will accelerate innovation, boost research, and modernize physician practices, all of which will advance patient care exponentially.”

Specifically, the bill directs that $1.75 billion be appropriated to the NIH for expanded research, and $110 million to the FDA, each year for 5 years.The bill also invests more resources in the “next generation of scientists” and includes provisions that would break down existing barriers to sharing and analyzing the growing amount of health data generated in research and clinical settings. It also establishes a new priority review program for breakthrough medical devices and incorporates the patient perspective into product reviews.

HIT interoperability
One area of the bill that has received considerable attention focuses on interoperability of health information technology (HIT). Rep. Mike Burgess, MD (R-Texas), who authored the section, explained that the bill will hold “bad actors” accountable for anticompetitive practices and protect doctors’ investments in HIT. AAOS supports efforts to work toward a national interoperable health information infrastructure.

“Physicians, through electronic health information exchange, must be able to modernize their practices to support coordinated care and enable participation in new payment and delivery models,” stated Dr. Teuscher. “Interoperability and telemedicine policies will help address barriers in this area and will effectively improve the quality, safety, and efficiency of healthcare delivery.”

Dr. Teuscher also noted that he hoped the Senate would strengthen these provisions and enact the legislation as soon as possible.

The Senate is working on a parallel track, and is also focusing on HIT interoperability. Companion legislation to the House bill could be introduced this month.

Sen. Lamar Alexander (R-Tenn.), who chairs the Committee on Health, Education, Labor, and Pensions, held a series of hearings during the summer focused on electronic health records (EHRs) and the practice of “information blocking.” According to a report by the Office of National Coordinator (ONC) for HIT, information blocking occurs “when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information.”

Although the ONC noted that lack of coordination presents a barrier to effective information sharing, it did not define that specifically as information blocking. The ONC did recognize that restrictive contracts or policies, excessive costs, and HIT programs that are likely to “lock in” users could qualify as information blocking.

Sen. Alexander wondered whether the federal government, through its program to encourage adoption of EHRs, played a role in encouraging the practice. He even suggested that the committee might push to delay implementation of the meaningful use program’s Stage 3 rules for use of EHRs.

“Since 2009, the American taxpayer has spent $30 billion to spur doctors and hospitals to install EHR systems—through incentive payments to Medicare and Medicaid providers,” he stated. “But interoperability—this communication between systems that is so critical to the success of EHRs—has been difficult to achieve.”

Rep. Fred Upton (R-Mich.), who chairs the House Energy and Commerce Committee, has been meeting with Sen. Alexander and Sen. Patty Murray (D-Wash.) to ensure Senate action on the companion bill to 21st Century Cures Act.

“With the kind of support it has now, and I expect it to have at the end of the year, I fully expect it to be the kind of legislation that even could be considered by the Congress in an election year, something a lot of people can take pride in,” said Sen. Alexander.

Elizabeth Fassbender is the communications manager and Julie Williams is the senior manager, government relations, in the AAOS office of government relations.

Additional Information:

• 21st Century Cures: What You Need to Know
• Statement by Dr. Teuscher