21st CCA Signed into Law

http://thehill.com/policy/healthcare/310223-obama-signs-medical-cures-bill-into-law

BY PETER SULLIVAN – 12/13/16 03:27 PM EST

President Obama on Tuesday signed a sweeping medical cures bill into law, capping more than a year of bipartisan negotiations.

The 21st Century Cures Act seeks to speed up the approval of new drugs and invests new money in medical research.

The measure grew to include a slew of bipartisan priorities, including $1 billion over two years to fight the epidemic of opioid addiction and $1.8 billion for Vice President Biden’s cancer “moonshot” initiative. A long-awaited mental health bill was also included in the package.

The bill passed both houses of Congress on overwhelming bipartisan votes, an unusual development on healthcare as lawmakers gear up for a partisan fight over ObamaCare in the new year.

“It is wonderful to see how well Democrats and Republicans in the closing days of this Congress came together around a common cause,” Obama said at the signing ceremony, surrounded by members of Congress of both parties. “I think it indicates the power of this issue and how deeply it touches every family across America.”
Liberal Sens. Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.) objected to the bill, arguing it was a giveaway to pharmaceutical companies because it lowered regulations on them while doing nothing to address the hot-button topic of high drug prices.

Many Democrats were brought on board because of the new money, $4.8 billion over 10 years, allocated for research at the National Institutes of Health. That sum includes funds for Biden’s effort against cancer, as well as other innovative medical projects, such as on brain research.

The sections speeding up the Food and Drug Administration’s approval of new drugs were somewhat more controversial. Some consumer groups have expressed concerns that the changes will lower safety standards, but sponsors in both parties have argued that despite the changes, safety will be maintained.

The measure allows for ideas like sometimes using “real world evidence,” rather than more rigorous and time-consuming clinical trials, in drug approvals.

The mental health portion, which draws on the years of work of Rep. Tim Murphy (R-Pa.), has been billed by Republicans as their response to mass shootings, though that messaging has been emphasized less now that the provisions are part of a larger package.

Democrats have long argued that gun control is needed to address shootings.

The parties put aside those differences, though, to pass the mental health sections, which establish a new assistant secretary for mental health in the Department of Health and Human Services as well as a chief medical officer.

Murphy argues that these positions will bring more accountability and medical knowledge to the Substance Abuse and Mental Health Services Administration, an agency he has criticized as ineffective.

The bill also authorizes grants for areas like suicide prevention and seeks to improve enforcement of “parity” rules that require insurance companies to cover mental health services to the same degree that they cover physical health services. Sens. Chris Murphy (D-Conn.) and Bill Cassidy (R-La.) worked on those sections and others in the mental health portion.

The mental health measure is significantly scaled down from the more sweeping version originally proposed by Murphy. It does not lift restrictions on Medicaid paying for care at mental health facilities, which would have cost billions of dollars.

***What isn’t mentioned in this article is the language about Lyme Disease/MSIDS.  For that specific language in the bill, please read: https://madisonarealymesupportgroup.com/2016/11/30/latest-on-21st-cca/