21st Century Cures Act Passes House

Tue, Jul 14, 2015 --

EMR/EHR, Skill Sharpener

digital health, technology, 21st century cures

A bill that would increase National Institutes of Health medical research funding by $8.75 billion over a five-year period passed the House of Representatives with a bipartisan 344-77 vote on Friday. Intended to fund breakthroughs in biomedical research, The 21st Century Cures Act (H.R.6), would also provide an additional $550 million to the Food and Drug Administration over the same five year period.

In a statement, the Obama administration expressed qualified support for the legislation’s bipartisan support for medical research, while voicing concerns regarding other issues in the bill, especially its proposed funding sources. The bill’s research funding would be paid for by selling off 80 million barrels of crude oil from the federal Strategic Petroleum Reserve over an eight-year period.

A vote on a similar bill in the Senate is expected before the end of the year. News service Reuters reported that Ross Muken, an investment analyst at Evercore ISI, said, “the strong bipartisan support for the Cures Act in the House, together with broad support from the Obama Administration, are strong indications that the Senate will approve the Cures Act with small changes.”

Bill Lessens Need for Clinical Trials for New Drug Indications

The bill’s most controversial measure is its overhaul of the FDA’s regulatory framework for approving new drugs and medical device technology, lessening reliance on randomized clinical trials. To approve a new indication for a drug already on the market, the FDA would be required to also evaluate evidence from “clinical experience,” such as observational trials, clinical registries, insurance claims, and FDA safety surveillance.

“The bill greatly benefits the pharmaceutical industry [and] medical device manufacturers,” said Diana Zuckerman, PhD, president of the National Center for Health Research, a think-tank focused on women, children, and families. “But by lowering standards for drugs and devices, it is likely to add billions to the cost of Medicare and all health programs without benefitting most patients,” she said, without giving patients and clinicians assurance that new treatments are safe and effective.

The bill has the support of more than 700 groups, including medical societies such as the American College of Surgeons, disease advocacy groups such as the American Heart Association, and medical schools. In a news release, Julie Vose, MD, president of the American Society of Clinical Oncology (ASCO), called the 21st Century Cures Act “monumental legislation that will accelerate the discovery, development, and delivery of promising new treatments to people living with cancer.” She lauded its support for big data, which pulls from large data sets like patient registries, as well as precision medicine, which targets treatment to a patient’s genetic profile. Vose said that ASCO has two major oncology research projects underway using both big data and clinical trials, and provisions in the Act will support these efforts.

Digital Health, HIT Interoperability Also Addressed

The bill also addresses health information technology interoperability, which was a hot topic in Senate committee meetings earlier this year. The bill requires interoperable technology to allow secure transfer of all of a patient’s data, with access to the data for authorized use without special effort. It also expressly forbids information blocking by institutions or electronic health record corporations. Information blocking is a phenomenon where EHRs block information exchange, allowing vendors to charge high fees to build interfaces to permit record sharing among other EHRs. Other types of information blocking have occurred when hospital systems make it hard to send patient records to their competitor systems, or when practices are blocked from moving to a different EHR because data migration is too expensive.

In a letter to the House Committee on Energy and Commerce on Friday, the American Hospital Association (AHA) supported the Act’s NIH funding but called the information blocking definition overly broad. The AHA said that Section 3001 of the Act gave the HHS Office of the Inspector General (OIG) the authority to set the amount of civil monetary penalties, allowing it to keep all amounts recovered, creating a financial incentive similar to the current Recovery Audit Contractor (RAC) program.

About 

Susan taught health information and healthcare documentation at the community college level for more than 20 years. She has a special love for medical language and terminology. She is passionate about ensuring accurate patient healthcare documentation through education. She has a master's degree in healthcare administration, is a certified healthcare documentation specialist, and serves as immediate past president for the Association for Healthcare Documentation Integrity (AHDI).

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