Life Science Compliance Update

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March 14, 2018

CARA 2.0 Introduced by Bipartisan Group of Senators


A bipartisan group of senators have introduced legislation framed as a follow-up bill to the Comprehensive Addiction and Recovery Act (CARA) of 2016. Dubbed CARA 2.0, the bill includes a combination of policy changes and increased funding authorizations that seek to restrict access to opioid-based painkillers and boost access to addiction treatment, including establishing a three-day initial prescribing limit on opioids for acute pain and aiming to increase the availability of treatment. The legislation was introduced by Sens. Rob Portman (R-OH), Sheldon Whitehouse (D-RI), Shelley Moore Capito (R-WV), Amy Klobuchar (D-MN), Dan Sullivan (R-AK), Maggie Hassan (D-NH), Bill Cassidy (R-LA) and Maria Cantwell (D-WA).

CARA 2.0 is the latest in a series of proposals that have come out of Congress to address the nation’s opioid epidemic. Last month, Congress agreed to allocate $6 billion over two years to combat the epidemic in a two-year budget proposal. Given that the bill would allocate new funding and Congress is currently working on a large budget measure, it’s possible that parts of the bill could be rolled into the larger budget package.

CARA 2.0 builds upon the original CARA by increasing the funding authorization levels to better coincide with the recent budget agreement.

Among the key policy changes included in the bill, the measure would: (1) establish a three-day initial prescribing limit on opioids for acute pain; (2) permanently allow physician assistants and nurse practitioners to prescribe buprenorphine with guidance from a qualified physician; (3) require doctors and pharmacists to use prescription drug monitoring programs (PDMPs) before prescribing or dispensing opioids; and (4) increase civil and criminal penalties for opioid manufacturers if they fail to report suspicious orders or fail to do enough to prevent diversion. Passage would also create a national standard for recovery residences to ensure quality housing for individuals battling long-term recovery.

Additionally, the bill allocates $1 billion toward various efforts aimed at combating the opioid epidemic, broken down into millions going to different campaigns and causes, including:

  • $300 million toward expanding responder training and access to naloxone.
  • $300 million toward an expansion of evidence-based medication-assisted treatment (MAT).
  • $200 million toward building an infrastructure that helps move patients into long-term recovery.
  • $100 million toward treatment for pregnant and postpartum women, including facilities that allow children to reside with their mothers.
  • $60 million toward helping states develop an “Infant Plan of Safe Care” to assist states, hospitals and social services to report, track and assist newborns exposed to substances and their families.
  • $20 million toward an expansion of Veterans Treatment Courts.
  • $10 million toward the development of a  “National Youth Recovery Initiative” designed to boost youth recovery support services
  • $10 million to fund a National Education Campaign on the dangers of prescription opioid misuse, heroin, and lethal fentanyl.

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