December 07, 2016

The 21st Century Cures Act


Last week, the House passed the bipartisan "21st Century Cures Act" (as an amendment to an unrelated bill, H.R. 34) by a roll-call vote of 392-26. The bill would modify regulatory policies at the Food and Drug Administration (FDA) to accelerate the approval of some drugs and devices. In addition, it would promote and increase funding for medical research, including Vice-President Biden's "Cancer Moonshot." In fact, on Monday evening, Mr. Biden had the honor of presiding over the Senate during its vote to end debate on the bill. The measure advanced on a broad bipartisan vote of 85-13. Final passage in the Senate is expected this week.

Although the bill is bipartisan in both the House and Senate, and is supported by the administration, it is not without controversy. Some consumer advocates, along with Senators Elizabeth Warren (D-MA), Bernie Sanders (I-VT), Jeff Merkley (D-OR), and possibly others, oppose it because they believe it weakens FDA regulations too much, thus compromising patient safety (and giving a boon to pharmaceutical and medical device companies without addressing the high cost of prescription drugs). Rep. Diana DeGette (D-CO), one of the original cosponsors of the bill, said, however, that lawmakers worked with FDA to ensure the legislation didn't put patients at risk.

In addition, some Senate Democrats are unhappy that the new version of the bill would only authorize additional appropriations for the National Institutes of Health - of about $4.8 billion - rather than provide mandatory funding that does not have to go through the annual appropriations process. Generic drug manufacturers are disappointed that it does not include provisions to speed the development of generic drugs. The bill is paid for, in part, by taking $3.5 billion from the Prevention and Public Health Fund that was created by the Affordable Care Act. An article from Kaiser Health News characterizes the bill's "winners" and "losers."

The Energy and Commerce Committee has posted key information about the 2016 (and 2015) legislation (text, summaries), and some of its key features. Some of the bill's provisions are described below:

Mental health provisions. The 21st Century Cures Act also includes some of the proposals that were included in the controversial "Helping Families Mental Health Crisis Act," sponsored by Rep. (and psychologist) Tim Murphy, PhD. Among these are provisions to improve mental health and substance abuse treatment for women, children, and adolescents. The bill also includes provisions intended to clarify the parameters of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Secretary must ensure that health care providers, patients and families have clear information about when it is appropriate to share the health information of patients receiving mental health or substance use disorder treatment. The Secretary will also be required to issue guidance clarifying the circumstances under which a health care provider may disclose HIPAA-protected health information to family members or caretakers of a minor or adult patient, including situations in which the information would be shared in order to involve family members or caregivers in the patient's care plan, treatment, or medication adherence.

Medicaid provisions. The bill also includes some Medicaid provisions. Among others things, it allows children in inpatient psychiatric facilities (IMDs) to receive the full range of early and periodic screening, diagnostic, and treatment (EPSDT) services, effective in 2019; directs HHS to perform a study on Medicaid managed care and coverage of individuals in IMDs as allowed under the recent managed care final rule; requires states to publish a Medicaid fee-for-service provider directory on their website; and incorporates the Fairness in Medicaid Supplemental Needs Trusts, which allows non-elderly individuals with disabilities to establish a special needs trust on their own without having to file a petition with a court.

Pediatric research and treatment; foster children. In addition, the Cures Act includes provisions to promote pediatric medical research; reauthorize a program to encourage treatments for rare pediatric diseases; and reauthorize the National Child Traumatic Stress Initiative (NCTSI), which supports a national network of child trauma centers. It also includes provisions intended to improve services for foster children.