hen President Barack Obama signed the landmark 21st Century Cures Act into law in December 2016, he was surrounded by elated Republican and Democratic lawmakers. At the time, Obama said the measure would bring “to reality the possibility of new breakthroughs to some of the greatest health challenges of our time.”
Republican Sen. Lamar Alexander, who chairs the Senate’s Committee on Health, Education Labor, and Pensions, hailed the act as “a Christmas miracle … that will help virtually every American family.”
Their statements weren’t hyperbole. The bipartisan $6.3 billion medical innovation package was chock-full of policies to modernize the National Institutes of Health and the Food and Drug Administration, combat the nationwide opioid epidemic, advance Obama’s Precision Medicine Initiative, and speed approval of new, lifesaving therapies for the most devastating of diseases.
But laws passed by Congress must be implemented through regulations. The Cures Act gave broad authority to the executive branch to execute and enforce both the spirit and the letter of the law. Nineteen months after the act became law, that task mainly remains undone.
I should know. As executive director of Health IT Now — a broad-based coalition of patient groups, provider organizations, employers, and payers supporting the use of data and health information technology to lower costs and improve patient outcomes — my colleagues and I worked doggedly behind the scenes with lawmakers to add needed provisions to the law that would optimize the use of technology in our health care system.
One of the longtime goals of Health IT Now is the realization of true, nationwide interoperability. That means ensuring that an individual’s health information can flow seamlessly from one health care provider to another as well as to patients, offering an accurate picture of an individual’s health history at all times and keeping patients in control of their own health data.
To that end, we secured the inclusion of tough language in the Cures Act to crack down on the harmful practice of information blocking. This occurs when vendors or providers willfully take actions that impede the flow of health information. It happens in many ways, most commonly when electronic health record software companies purposefully deploy nonstandard technology that cuts off communication with other health systems or charge exorbitant fees for exchanging information.
Information blocking impedes health care providers from accessing the most current, accurate, or complete information on their patients. Just imagine your doctor not knowing of a serious allergy or prescribing a new medication without knowledge of all the others you are taking and possible drug interactions. When providers can’t make informed clinical decisions based on clear pictures of their patients’ health histories, patients’ lives are put in jeopardy.
To that end, Section 4004 of the Cures Act gave the secretary of health and human services the tasks of issuing regulations to prevent information blocking and identifying “reasonable and necessary activities that do not constitute information blocking.”
How’s that going?
More than 600 days after the enactment of the Cures Act, not a single regulation has been issued on information blocking. In a Health Affairs column in June of this year, Dr. Don Rucker, who leads the Office of the National Coordinator for Health Information Technology (ONC), suggested that implementation of the law’s information blocking provisions would occur “over the next few years” — a vague timeline that shows little urgency for combating this pressing threat to consumer safety and stumbling block to interoperability.
To be clear, Health IT Now has met with countless officials in the Trump administration who share our commitment to combat information blocking. But those sentiments must be met with meaningful action.
My organization recently led more than a dozen leading health care organizations and companies — the American Academy of Family Physicians, McKesson, the National MS Society, Oracle, and others — in sending a letter to administration officials urging them to start implementing provisions against information blocking in the Cures Act.
“Every day that the administration delays implementation of these critical provisions places patients at risk of harm,” we wrote. “We understand the nuance required but feel that it is past time for a proposal to be made.”
In August, a bipartisan group of lawmakers led by Sens. Bill Cassidy (R-La.) and Sheldon Whitehouse (D-R.I.) crafted an important amendment to the “minibus” government funding bill that would require the administration to give Congress a progress report on their work establishing regulations against information blocking by Sept. 30.
The Trump administration seems to understand the seriousness of the matter. It has reiterated that the proposed rule will be released in September while Rucker has said the regulation is “deep in the federal clearance process.”
For the sake of patients everywhere, it’s time to bring it to the surface.
Congress has done its part by getting the Cures Act signed into law — no small feat in the polarizing political climate during which it was forged. The administration must now uphold its end of the bargain.
Joel C. White is the executive director of Health IT Now.