This article is more than 5 years old. Information may no longer be current.
House passes 21st Century Cures Act
Click Here to Manage Email Alerts
By a vote of 344 to 77, the U.S. House of Representatives on July 10 passed the 21st Century Cures Act, a bipartisan bill that authorizes several changes to the approval process for drugs and medical devices.
The bill, H.R. 6, also authorizes an $8.7 billion spending increase for the NIH and a $550 million increase for the FDA over 5 years.
According to a summary of the bill posted on the Congress website, the bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process by allowing patient experience data to be considered in the risk-benefit assessment of new drugs; requiring the FDA to qualify drug development tools; allowing the FDA to rely on data previously submitted for a different purpose to expedite the development of certain drugs; and establishing a streamlined data review program for approval of drugs for additional indications.
The bill requires the FDA to establish a program for priority review of breakthrough medical devices, identify types of devices that do not require a report preceding introduction, and rely on a third party to determine the safety and effectiveness of changes to medical devices, according to the summary.
In addition, the bill requires manufacturers and distributors of investigational drugs for serious conditions to publish their policies on compassionate requests; revises and extends the priority review voucher program for rare pediatric diseases; and requires a pharmaceutical and technology ombudsman within the CMS to respond to complaints from manufacturers of medical products.
The bill allows Medicare prescription drug plan sponsors to limit certain beneficiaries’ access to frequently abused drugs and mandates interoperability and certification of electronic health records.
According to the American Academy of Ophthalmology, the House overturned a last-minute amendment that threatened the bill’s passage by proposing to make the new NIH and FDA spending discretionary.
According to the AAO, two provisions of the bill may affect ophthalmology. The first provision would facilitate price transparency on the cost of services between ASCs and hospital outpatient departments. The other provision would encourage the use of unique device identifiers at the point-of-care in EHR systems.
The Senate is expected to consider its own version of the bill in the fall. – by Matt Hasson
Perspective
Back to Top
William L. Rich III, MD, FACS
Ophthalmologists frustrated by the lack of interoperability between electronic health record systems may be pleased to know that the 21st Century Cures Act includes a provision which requires that EHRs be interoperable by 2018 or face Meaningful Use decertification the following year. In addition, EHR vendors who are found to be purposefully blocking information would be subject to monetary fines.
The Academy and other stakeholder groups lobbied for the provision to be included because interoperability issues have prevented easy patient record sharing between health care providers and caused significant workflow disruption. In addition, data blocking by certain vendors has precluded physicians from participating in national EHR-based quality improvement efforts such as the Academy’s IRIS Registry, the country’s only longitudinal, comprehensive eye disease and condition database, which enables users to gain a quantitative, evidence-based, real-time view of patient care, interventions and outcomes on the practice, regional and national levels.
The IRIS Registry is currently used by more than 8,000 U.S. ophthalmologists on 31 different EHR systems who share de-identified quality data on 10 million patients, but some ophthalmologists are unable to join the effort due to their EHR vendors refusing to integrate with the database. It’s very reassuring to see strong bipartisan support for prohibiting data blocking practices through the 21st Century Cures Act and legislative recognition that establishing EHR interoperability is vital to the country’s ability to speed innovation in medicine.
Click Here to Manage Email Alerts