Senate Approves 21st Century Cures Act

from National Family Voices:

The 21st Century Cures Act

As expected, the Senate last week approved, by an overwhelming margin, the House-passed "21st Century Cures Act" (as an amendment to an unrelated bill, H.R. 34). The legislation will modify regulatory policies at the Food and Drug Administration (FDA) to accelerate the approval of some drugs and devices. In addition, it will promote and increase funding for medical research, including Vice President Biden's "Cancer Moonshot." In fact, Mr. Biden's involvement in negotiations and his energetic lobbying of his colleagues could be the reason that this often-divided Congress was able to pass this bipartisan legislation. On Monday evening, December 5, Mr. Biden had the honor of presiding over the Senate during its vote to end debate on the bill. (A vice president also serves as president of the Senate.) In a surprise move that evening, Senate Majority Leader Mitch McConnell (R-KY) honored Mr. Biden by naming the cancer-related sections of the bill after the Vice President's son, Beau Biden, who died of brain cancer in 2015.

The Cures Act also incorporates mental health legislation, including some of the provisions from the controversial "Helping Families Mental Health Crisis Act," sponsored by Rep. (and psychologist) Tim Murphy, PhD. (See below.)

Although the Cures Act was bipartisan in both the House and Senate, and was supported by the administration, it has not been without controversy. Some consumer advocates opposed it due to concerns that it weakens the current standards for drug approvals so much that FDA-approval will no longer ensure the safety and efficacy of drugs available to consumers. Democratic Senators Elizabeth Warren (D-MA), Bernie Sanders (I-VT), and Jeff Merkley (D-OR) voted against the bill because they believe that it is a boon to pharmaceutical companies without addressing the high cost of prescription drugs.

In addition, some Democrats were concerned that the final bill did not provide mandatory funding for the National Institutes of Health, as earlier versions of the bill did; instead Congress will have to appropriate funds each year. But eventually, a special funding arrangement was reached and House Speaker Paul Ryan provided assurances that the year-end spending bill would include the initial year's appropriations. In fact, that bill (the CR described above) does provide $872 million in funding for the Cures Act, including $20 million for the Food and Drug Administration Innovation account, $352 million for the National Institutes of Health Innovation account, and $500 million for states to respond to the opioid abuse crisis (another provision that helped gain support for the bill). On the downside, 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 Cure Act'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 of special interest to families of children and youth with special health care needs 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.

[NEW: A blog post from the Georgetown Center for Children and Families, and an article from Politico note that any improvements to our nation's mental health services made by the Cures Act will be undermined if the Affordable Care Act is repealed and/or Medicaid is restructured. Medicaid is the largest payer for behavioral health care in the U.S.]

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.