Proposed Legislation Aids Personalized Medicine Agenda

H.R. 6, the 21st Century Cures Act, has been presented to the House of Representatives by the Energy & Commerce Committee. “The nonpartisan legislation will help to modernize and personalize health care, encourage greater innovation, support research, and streamline the system to deliver better, faster cures to more patients,” according to the Committee’s announcement of its unanimous vote (51-0) approving the proposed legislation. The stated purpose for the bill is “[t]o accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.” One of the legislation’s authors, Committee Chairman Fred Upton, declared in the announcement: “Americans deserve a system second to none. We can and must do better. The time for 21st Century Cures is now.”

Sections of the bill promote a global pediatric clinical study network, sharing NIH-funded research data, use of patient experience data in the drug development process, antibiotic development, precision medicine, improved medical device regulation, and vaccines. The bill also addresses improvements to the Local Coverage Determination process.

Section 3081 requires MACs make local coverage determinations available on their websites and Medicare’s website 45 days before the effective date and include: the entire determination, when and where it was made public, links to the proposal and comments received regarding same, “summary of evidence that was considered” when developing the determination and sources for the evidence, and “an explanation of the rationale that supports such determination.” The College of American Pathologists criticized this provision of the proposed legislation for not going far enough and has proposed even further access—calling for “open, public, and on the record” advisory committee meetings and “upfront disclosure of evidence by MACs when drafting LCDs,” according to the May 19, 2015 issue of CAP’s Statline.

Another section of interest to laboratories (Section 2228) requires that HHS produce within 12 months of the bill’s enactment draft guidance revising section V “Demonstrating Insignificant Risk of an Erroneous Result—‘Accuracy’” in the January 30, 2008 Guidance titled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The draft guidance must also advise about the “appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.” The proposal requires that guidance be finalized by HHS no later than 12 months after the comment period ends for the guidance.

Not surprisingly given the proposal’s title, provisions promote development of precision medicine. Section 1141 establishes a Council for 21st Century Cures, charged with “accelerat[ing] the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients.” The bill calls for $10 million in funding for the council in each year from 2016 to 2023. Section 2041 adds a new Subchapter J—Precision Medicine to the Federal Food, Drug, and Cosmetic Act, which calls for “guidance to assist sponsors in the development of a precision drug or biological product.” The guidance would, among other things, address “development of companion diagnostics in the context of a drug development program.”

With regard to new devices, Section 2226 amends the Federal Food, Drug and Cosmetic Act to provide that panels determining device classification must have “adequate expertise” to evaluate the device technology and the disease or condition it treats or diagnoses. The applicants making a premarket submission can make recommendations about the expertise needed on the panel. The bill defines adequate expertise to require a panel have at least two voting members “with a specialty or other expertise clinically relevant to the device under review” and “at least one voting member who is knowledgeable about the technology of the device.”

The proposed legislation also provides significant attention to sharing of data and interoperability. One section requires NIH grant recipients to share their scientific data gained from NIH-funded research unless subject to confidentiality, privacy or intellectual property rights. Another amends the HITECH Act to “allow the use and disclosure of protected health information by a covered entity for research purposes, including studies whose purpose is to obtain generalizable knowledge, to be treated as the use and disclosure of such information for health care operations” as defined in Section 164.501 of the regulations. It will also allow researchers to remotely access health information if “appropriate security and privacy safeguards are maintained by the covered entity and the researcher” and the researcher doesn’t keep a copy of the information. Another section (Section 3001) sets criteria for interoperability: secure transfer, access to all of a patient’s available data that is authorized for use, and no information blocking. HHS’ National Coordinator of the Office of the National Coordinator for Health Information Technology is charged with issuing guidance with regard to these requirements. HHS will also contract with American National Standards Institute-accredited entities to devise recommendations for interoperability standards. HHS must report to Congress by July 1, 2017 about the initial standards adopted, strategies for achieving interoperability” and barriers to achieving same and a timeline for achieving “widespread interoperability and by December 31, 2019, must report whether the goal was achieved.

Takeaway: Proposed legislation addresses issues of interest to laboratories as it aims to advance personalized medicine.


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