Congress Approves $6.3 Billion Medical Innovation Legislation

December 12, 2016
congress

California Medical Association

After several years of hearings and negotiations, Congress has passed a $6.3 billion medical innovation package intended to accelerate the discovery, development and delivery of new therapies, including $1 billion to help states address the opioid epidemic. It also provides important electronic health record (EHR) reforms for physicians and for the first time will penalize vendors for failing to have interoperable systems. The bill (HR 6), known as the "21st Century Cures Act," is intended to bridge the gap between medical science and legislative action and regulations that slow progress. It passed with strong bipartisan support.

While the California Medical Association (CMA) and the American Medical Association (AMA) had concerns with some aspects of the legislation, CMA was pleased that it met two of our top federal legislative priorities – actual funding to address the opioid crisis and vendor accountability for EHR problems.

Among other things, the legislation would speed up drug approvals, increase funding for disease research, address weaknesses in the nation’s mental health systems and alter the regulatory system for drugs and medical devices. It now heads to President Obama for his signature.

Of the bill’s $6.3 billion in biomedical research funding, $4.8 billion will go to the National Institutes of Health, including $1.8 billion for Vice President Joe Biden’s Cancer Moonshot Task Force and $1.4 billion for President Obama’s Precision Medicine Initiative and brain research activities.

The bill marks the first time Congress has approved funding to address the nation’s growing opioid epidemic. It provides $1 billion in funding to states over two years to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs, implementing prevention activities, providing training for health care providers and expanding access to opioid treatment programs. The bill also reinforces current laws that require insurers to treat mental illness as they do any other illness in terms of benefits. And, it creates a new position in the U.S. Department of Health and Human Services (HHS) called the Assistant Secretary for Mental Health and Substance Use as a focal point for coordinating mental health programs across the federal government.

An entire section of the bill that CMA fought particularly hard to keep was related to the use of electronic health records. The bill includes provisions that will ease physicians' reporting burdens, including one that excludes providers who furnish most of their Medicare services at ambulatory surgical centers from penalties under the EHR meaningful use program and the new Medicare MACRA Quality Payment Program. Additionally, the bill allows physicians to delegate certain EHR documentation requirements to non-physician staff.

Another key element of the EHR section is a focus on EHR interoperability. HHS will receive $15 million in funding to help push interoperability and fight information blocking by EHR vendors. For the first time, the Office of the Inspector General (OIG) can penalize vendors for not having interoperable systems. CMA aggressively advocated for more EHR vendor accountability and enforcement. In the past, physicians were penalized by the meaningful use program for problems caused by vendors. Now, EHR vendors will have to be more responsible and accountable to ensure that systems are working and interoperable. The bill also calls for the establishment of a national directory of health professionals so that physicians can easily contact each other.

Finally, the bill provides $500 million to the Food and Drug Administration (FDA) to speed up the development and approval of new drugs and medical devices by putting less emphasis on randomized clinical trials in FDA reviews of new indications for a drug already on the market. Instead, the bill encourages the FDA to use "real-world evidence," such as data from observational trials and insurance claims.

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