November 12, 2018

As part of a new law aimed at curbing the opioid epidemic, lawmakers recently have made changes which expand the compliance requirements for pharmaceutical and medical device manufacturers under the Physician Payment Sunshine Act (aka. The Sunshine Act).

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act was passed with nearly unanimous support by Congress last month. The SUPPORT Act mandates that, beginning January 1, 2022, Life Sciences companies must track and report to the Centers for Medicare & Medicaid Services payments and other transfers of value not only to physicians and teaching hospitals, but also to nurse practitioners, physician assistants, clinical nurse specialists, registered nurse anesthetists, and certified nurse midwives, since these medical professionals are also prescribers of medication, including opioid medication.

According to lawmakers in support of this legislation, the SUPPORT Act will improve transparency around prescribing practices and promote accountability surrounding the prescribing of controlled substances. In a statement, Democratic Senator Richard Blumenthal, Democrat of Connecticut, said, “It is absolutely essential that pharmaceutical companies disclose gifts and payments made to additional healthcare providers who prescribe opioids and other drugs — not just doctors.”

The SUPPORT Act was modeled on legislation passed by Massachusetts in 2012. Although the results from that law indicate that only a tiny percentage of the reported payments were to this expanded pool of healthcare providers, the task of tracking and reporting these exchanges is a significant task for Life Sciences companies to undertake.

Manufacturers — not just of opioids, but of all kinds of therapeutic treatments and device — will need to substantially and quickly expand their platforms for tracking and reporting engagement with a much wider array of healthcare professionals. Companies in the industry that do not already have in place a robust, cross-platform system for accomplishing this have a fleeting window in which to meet the regulatory requirements for this much larger scope of engagement. The planning and execution of promotional speaker programs and other kinds of educational engagement will increase in complexity.

As lawmakers seek tools to rein in the opioid crisis, it should be clear that this legislative change is unlikely to be the last enhancement of regulatory authority. Life Sciences companies would do well to keep this in mind when entering into agreements with vendor partners, since a solution that seems comprehensive today might turn out to be woefully inadequate tomorrow.

Manufacturers using tools without the flexibility to include a wider array of healthcare professionals and reporting protocols will be faced with imperfect solutions: They could overlay another system on top of their existing platform, although such redundancy can increase costs and increase the possibility of error. They could build out from the tools they use now, but integration of legacy enterprise software with “bolt-on” upgrades has not, historically, had a great track record in terms of user experience and efficiency.

The best, most logical and — ultimately — most cost-effective and compliance-centric conclusion is to take this three-year window of opportunity to implement a single, end-to-end solution that will track and record in a comprehensive and scalable manner.

Contributed by:

Matthew Gallo, Director, Global Sales Excellence, IQVIA

With nearly 20 years’ experience in the Life Sciences industry, Matt joined IQVIA with the AHM merger. Matt currently leads the Development and Solution Engineering team with a focus on expanding compliance offerings, tailored to emerging market needs. Prior to his solutions engineering role, Matt led AHM’s Technology Support organization, where he built a product-driven support team, meeting a broad scope of client needs—including mobile app support, Salesforce platform support, aggregate spend reporting, and more. Matt’s expertise in the Life Sciences industry spans analytics to account management, giving him a broad range of insight into solutions and support needs across organizations. Matt previously served as a Technical Sergeant in the United States Air Force for seven years.

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