Legislation may have significant impact for orthopaedists
On July 10, 2015, the U.S. House of Representatives approved the 21st Century Cures Act (HR 6). This act aims to help advance health care for the country through modernization and innovation. Areas addressed in the bill include the following:

• accelerating innovation
• increasing funding for the National Institutes of Health (NIH)
• modernizing the U.S. Food and Drug Administration (FDA)
• enhancing interoperability (of electronic health records (EHRs) and health information technology systems) and telemedicine

A set of smaller bills was then considered by the Senate Health, Education, Labor and Pensions Committee (HELP). These measures, which complement HR 6, are focused on NIH funding and encouraging innovation through quicker approval of drugs and devices (particularly "breakthrough" products) by decreasing paperwork and streamlining the approval process.

The measures will also address the "Moonshot Agenda" proposed by the Obama administration to cure cancer and advance precision medicine. They will also help the NIH and FDA recruit top talent, improve research focused on women and minorities, and encourage young investigators.

The legislation also focuses on health information technology (HIT), specifically ways to improve and legislate more rapid advancement in interoperability. HIT provisions aim to reduce the documentation burden for physicians, improve access to information for patients, and improve physician access to patient medical records.

This article summarizes the following specific aspects of the legislation that are most likely to have a direct impact on orthopaedic surgeons:

• interoperability and HIT provisions
• expediting device approval, approval for combination products and the "least burdensome requirement"
• NIH funding and the Next Generation Researchers Act, as well as promotion of research involving women and minorities

Getting HIT to work better
The 2009 HITECH (Health Information Technology for Economic and Clinical Health) Act successfully funded broad adoption of EHRs through the "meaningful use" program. It also brought a range of HIT shortcomings to the fore.

Chief among these shortcomings has been the failure to achieve HIT interoperability that would enable the secure sharing of health information across different systems and products. Because the Office of the National Coordinator for Health Information Technology has made only limited progress in that direction, this legislation largely transfers responsibility to the Secretary of Health and Human Services (HHS). It also sets specific interoperability development mandates and timelines—ostensibly elevating the priority, if not productivity, of this effort.

The legislation also addresses "information blocking" by vendors and systems. The measure would create a standard process for public reporting of information blocking and nonconformance with interoperability requirements and would authorize the inspector general to investigate violations. Furthermore, violations would be subject to civil monetary penalties, as well as possible "consultation" with the Federal Trade Commission if adverse competitive or consumer welfare implications are found.

The bill uses health technology certification—and possible decertification—to effect desired changes. Technology vendors will be required to attest that they have implemented and complied with the interoperability standards and conducted "real world use" testing. They will also have to demonstrate data sharing between different systems, publish application program interfaces, and show unimpeded export of data for transitions from one EHR to another. To improve cost transparency, comparative product pricing and feature information will be posted on a public website.

The legislation also defines health software with low risk to patient safety. This would foster innovation in areas such as health apps and exempt them from more stringent FDA regulation. Instead, the HHS would, with stakeholder input, develop new regulations.

The legislation promotes patient engagement and empowerment with an enunciated right of patients to the "entirety" of their health information—including both structured and unstructured data. Certified HIT will have to facilitate personal health information sharing and bidirectional exchange.

Smaller bills for FDA
The Senate developed four smaller bills (S 2700, S 1622, S 1077, and S 1767) to address issues related to the FDA. S 2700—the FDA and NIH Workforce Authorities Modernization Act—is focused on attracting the best scientists to the agency (similar to a program in place at the NIH). Introduced by Sen. Lamar Alexander (R-Tenn.), the measure will enable FDA to better compete with the private sector for the best scientific minds.

S 2700 will also improve data sharing and communication between FDA and research centers, particularly for advancing treatments and cures for high-priority diseases. Most importantly, it will enable FDA to better partner and collaborate with the private sector to remain on the leading edge of rapid scientific advancement.

S 1622—the FDA Device Accountability Act—was introduced by Sen. Richard Burr (R-N.C.) to modernize the technology review process and shorten the time to market for medical devices. When requesting additional information to support a premarket approval application, FDA auditors will be required to allow sponsors to demonstrate safety and effectiveness in the least burdensome way. More emphasis will be placed on postmarket surveillance data to safeguard the process. Another portion of this bill will allow more centralized institutional review board efforts, eliminating the need for local facilities to have a review board.

Sen. Burr also proposed S 1077—the Advancing Breakthrough Medical Devices for Patients Act. This bill expands the priority review process for medical devices. Currently, only Class III (new or highest risk) devices are eligible for priority review. The bill will allow a sponsor for any class of device to apply for priority review, which institutes a 60-day limit on review and assignment of team or staff for each device. This will enable FDA and device sponsors to coordinate efforts, reach early agreement on data development, and work together to design efficient clinical trials. They will then make timely use of postmarket data. The bill's language also changes the Humanitarian Device Exemption definition to include disease states that affect up to 8,000 individuals, double the existing limit.

Finally, S 1767—the Combination Product Regulatory Fairness Act of 2015—would allow the product sponsor to propose a study to assign a product's classification for a combination product (products that may combine a drug, a device, or a biologic product). If it disagrees with the sponsor's recommendation, FDA must provide the scientific rationale for deciding on the primary mode of action.

Introduced by Sen. Johnny Isakson (R-Ga.), this bill aims to create an innovation-friendly process under which the primary mode of action and the safety and effectiveness issues raised would dictate the regulatory pathway. Such a step is important in orthopaedics, with increasing numbers of new products combining devices and biologics, such as implants coated with growth factors.

Support for the NIH
Another aspect of the Cures legislation of interest to orthopaedic surgeons is its impact on NIH funding. The original House version asked for $8.75 billion in funding for the NIH, through an Innovation Fund of $1.75 billion each year for 5 years. The FDA would receive an extra $110 million each year for 5 years. However, the anticipated funding offsets were lost during the budget process, and bipartisan efforts will be required to secure final funding.

The supporters of the legislation recognize that investing in younger scientists will be critical for continued medical advancement. The Next Generation Researchers Act (S 2014) supports programs that provide opportunities and earlier research independence, such as enhanced training for research-related careers, mentorship programs, renewal funding assistance, and expanding workforce diversity. As previously mentioned, S 2700 promotes a similar drive to enable the FDA to compete with the private sector for talent.

Addressing diversity in clinical research
The Advancing NIH Strategic Planning and Representation in Medical Research Act (S 2745) addresses research priorities for the NIH. By establishing a 6-year strategy, the intent is to match research goals with the country's needs.

The legislation directs NIH to consider the disease burden in the United States, rare diseases and conditions, and the biologic, social, and other determinants of health that contribute to health disparities. It specifically calls for the inclusion of women, minority groups, and relevant age categories, and gives the NIH director the option of including other demographic variables.

Conclusion
The ultimate goal of the 21st Century Cures Act is to remove obstacles to innovation and directly improve the health of the nation with innovative care brought to market through a more streamlined research approval process. The smaller Senate bills will now be consolidated into one package for introduction on the Senate floor.

Although the content of these measures has bipartisan support, the primary barrier is an agreement on funding. Due to the direct impact on the orthopaedic community that this legislation can have, the AAOS office of government relations will be actively engaged in this process.

Alexandra E. Page, MD, chairs the AAOS Health Care Systems Committee (HCSC). She can be reached at alexe.page@gmail.com

Leslie Kim, MD, is a member-at-large of the HCSC. He can be reached at lhkimmd@gmail.com

Joshua C. Patt, MD, MPH, is a Leadership Fellows Program member of the HCSC. He can be reached at joshua.patt@carolinashealthcare.org

Bottom Line

• If enacted, the 21st Century Cures Act (or a similar package of bills being considered in the Senate) could have a significant impact on orthopaedics through its focus on health information technology, innovation, and research.
• Increases in funding for the NIH and legislation designed to attract researchers and increase diversity are other steps that would affect orthopaedics.
• Despite bipartisan support for the content of these measures, finding ways to fund them is problematic.

Additional Information:

• House Passes 21st Century Cures Bill—AAOS Now
• Senate Health Innovation Bills Approved—AAOS Advocacy Now
• 21st Century Cures Act
• Advancing NIH Strategic Planning and Representation in Medical Research Act
• Generation Researchers Act
• Combination Product Regulatory Fairness Act of 2015
• Advancing Breakthrough Medical Devices for Patients Act
• FDA Device Accountability Act
• FDA and NIH Workforce Authorities Modernization Act