Key Takeaways from Newly Signed Bill Aimed to Combat Opioid Crisis

On October 24, 2018, President Donald Trump signed into law a massive bill intended to combat the opioid crisis. The bill's passage comes a year after President Trump declared the opioid crisis a national emergency. According to the Congressional Budget Office, the legislation will authorize appropriations for an estimated $7.9 billion for the Center for Disease Control, the Department of Health and Human Services, and other agencies with programs aimed at addressing the opioid epidemic. [1]

The 600-page bill unites more than 50 smaller proposals sponsored by hundreds of lawmakers. It addresses items such as illegal importation of drugs, researching non-addictive painkillers, changing opioid packaging, and increasing support for people with substance abuse disorders.  Additionally, it creates, expands, and reauthorizes programs and policies across almost every federal agency in an effort to address different aspects of the opioid epidemic. It is one of Congress' most significant legislative achievements this year and marks a rare moment of bipartisan accomplishment.

Here are several key takeaways from the bill:

1. Reduce Drug Trafficking: The Synthetic Trafficking and Overdose Prevention Act ("STOP Act") requires the U.S. Postal Service to screen packages for fentanyl shipped from overseas, mainly China. It requires foreign shippers to provide data in advance about what is in the package, where it is from and who it is going to. That means the U.S. will close the loophole in the international mail system that drug traffickers have exploited to ship fentanyl into the country. Commercial mail carriers already are required to collect such electronic information; however, the Postal Service did not require such information due to the high volume of mail flowing through the Customs and Border Protection.

1. Manage Day-Supply of Prescription Drugs: The bill authorizes the Food and Drug Administration to require special safety packaging for opioids, such as sealing them in plastic blister packs and limiting doses to three to seven days. Roughly two dozen states have already limited the number of pills that can be prescribed at one time. This authorization would allow the FDA to make it easier for health care providers to write prescriptions. Additionally, it requires manufacturers to provide patients a simple and safe way to dispose of leftover drugs as part of the packaging.

1. Increase and Improve Monitoring: The Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies (CONNECTIONS) Act gives the Centers for Disease Control (CDC) legal authority and funding to provide technical training and support to state PDMPs to improve their existing systems, increase data sharing, and facilitate the transmittal of PDMP information across state lines. As a condition of receiving this funding, states must demonstrate they have enacted laws or regulations related to the implementation of PDMP and implemented penalties for misuse of PDMP information. Providers should monitor state PDMP changes that may follow the implementation of a more robust interstate PDMP program.

1. Improve Training and Awareness: The Empowering Pharmacists in the Fight Against Opioid Abuse Act provides pharmacists with more resources to understand common fraudulent prescription practices. The bill requires agencies to develop reference materials for pharmacists to educate them regarding their authority to decline to dispense controlled substances, and resources for prescribers and the general public to raise awareness on fraudulent prescriptions. Many pharmacies already have such practices in place but this bill's effort would apply uniformly across the board. The bill also promotes continuing education on evidence-based prescribing guidelines across health care setting.

1. Expand Treatment Options:
   1. The bill expands the treatment options for opioid use disorder among Medicaid recipients. This provision would change the decades-old rule that prohibited Medicaid from covering Medicaid patients between the ages of 21 and 64 who were receiving treatment for substance abuse disorders in a mental health facility with more than 16 beds. Ultimately, the provision would lift the restriction and authorize matching federal funds for these facilities to provide for 30 days of residential treatment coverage.
   2. The bill also authorizes a grant program through the Substance Abuse and Mental Health Services Administration (SAMHSA) for entities to establish or operate comprehensive opioid recovery centers that serve as a resource for the community. These entities can utilize the ECHO model, which supports providers involved in addiction treatment through the coordination and services delivery via technology.
   3. Updates will be made to pain care programs to include alternatives to opioid pain treatment by promoting non-addictive and non-opioid pain treatments, and non-pharmacologic treatments.

1. Disposal of Controlled Substances by Hospice Programs: To help reduce the risk of diversion or misuse, the bill provides certain health professionals in qualified hospice programs the legal authority to dispose of controlled substances in the hospice setting. This provision addresses concerns related to unused controlled substances, which tend to have a high risk of diversion. The Attorney General must promulgate regulations authorizing hospice programs to dispose controlled substances on behalf of deceased patients.

1. Prevention:
   1. The bill requires Health and Human Services to submit to Congress a report on the impact of federal and state laws and regulations that limit the length, quantity, or dosage of opioid prescriptions.
   2. DEA registrants will be required to design systems to identify and report suspicious orders. (This is new to the extent that the current requirement was never based on the statute, and instead was created via DEA regulations.) The new system designs will give manufacturers and distributors information on pharmacies' ordering behavior with the intention of holding manufacturers and distributors accountable when they fail to identify, stop, and report suspicious orders of opioids. Additionally, the DEA is required to establish a database for the collection of all suspicious orders reported by all registrants, and to share suspicious order information with states.
   3. Mandatory factors for the DEA to consider when setting annual opioid quotas will also be put into place under the Quota Reform Act. Such factors include diversion, abuse, overdose deaths, and public health impacts. It will also require the DEA to adequately explain health benefits if the DEA approves any increase in annual opioid quotas.

• Edward D. Rickert: (312) 715-5139 / edward.rickert@quarles.com