On October 24, 2018, the SUPPORT Act was signed into law, marking the single largest bill to combat the drug crisis in the history of the United States. This law combined 42 separate pieces of legislation, all aimed at making treatment for opioid addiction more available, while at the same time reducing the illicit use of controlled substances.

This blog article will focus on reviewing this law and explaining how it may affect controlled substance manufacturers, distributors, and (most importantly) our long-term care pharmacy customers.

DISCLAIMER: The information in this post is provided for informational purposes only, and should not be construed to be legal advice or sufficient to achieve compliance with any particular law, regulation, mandate, or guideline. All material is provided “as is” without warranty of any kind, express or implied In no event will SoftWriters, Inc. be liable for any damages on any claim or action arising from the use of this material.

Overview of the SUPPORT Act

The official title of the SUPPORT Act is the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act”.  Although it has many parts, much of the bill deals with providing access to substance use disorder treatment. It also contains provisions for reporting and publishing data on the manufacture and distribution of controlled substances. It also codifies existing guidance and gives additional recall authority to the DEA and FDA.

One of the hallmarks of this law is the mandate for DEA registrants to report suspicious orders of controlled substances. Registrants are required to identify suspicious orders and report them to the DEA. This is not about prescriptions, but orders. This means orders from a wholesaler or manufacturer. 

You may be wondering, what is a suspicious order? While no exact criteria are specified in the law, suspicious orders are defined as orders of unusual size, orders that deviate substantially from a normal pattern, or orders of unusual frequency. 

ARCOS Data

The SUPPORT Act establishes a database for collecting reports of suspicious orders. Today, orders for controlled substances are reported to ARCOS, an automated comprehensive reporting system that tracks controlled substances from manufacture to the point of distribution.

Manufacturers and distributors are now required to review the ARCOS data, which was previously unavailable. The ARCOS data is updated at least quarterly and contains information on the volume and type of controlled substances shipped to a pharmacy or practitioner.

The SUPPORT Act also imposes penalties on manufacturers and distributors for failing to review the ARCOS data, report a suspicious order, or maintain effective controls against diversion.

It is important to note that pharmacies are not considered distributors unless they are dispensing controlled substances to another registrant (i.e. not pursuant to a prescription). 

Pharmacies are generally not required to report to ARCOS or to review ARCOS reports. For the interpretation and applicability of provisions, please refer to the text of the actual law.

Recall Authority

Another feature of the SUPPORT Act is the additional authority given to the DEA and FDA regarding drug recalls. This law gives the DEA and HHS mandatory recall authority. 

This allows the DEA to require the FDA to stop the distribution of a controlled substance and order a recall if it is found to be a public hazard. If there is a possibility of a controlled substance causing adverse health consequences or death, the HHS Secretary may issue an order requiring manufacturers, distributors, and pharmacists to stop distribution and recall the product in question.

Electronic Prescribing of Controlled Substances

The biggest impact of this law on long-term care pharmacies is the mandatory electronic prescribing of controlled substances for Medicare Part D patients, effective January 1, 2021. This will significantly increase the number of electronic prescriptions received by LTC pharmacies.

As more and more facilities transition to e-prescribing, LTC pharmacy workflows will require efficient processing and management of e-prescriptions. 

The FrameworkLTC suite of products is uniquely positioned to offer the operating efficiencies and automated workflows necessary to interpret and process electronic prescriptions.

FrameworkLTC is one of the early adopters of the NCPDP 2017071 SCRIPT standard for electronic prescriptions and is certified for this capability by SureScripts. FrameworkLTC also allows integrations with many point-to-point vendors and partners, such as PointClickCare, that allow electronic prescription transfer and processing between E-HR/E-MAR systems and the FrameworkLTC suite of products.

ERx Processing in FrameworkLTC

If you haven’t used or tried the electronic prescription processing in the FrameworkLTC suite of products, please reach out to the Customer Success Team at SoftWriters. We will be happy to help you in your journey to be prepared for the SUPPORT law-mandated provision of electronic prescribing of controlled substances for Medicare Part D patients, which will be effective on January 1, 2021.