Understanding Changes to the Controlled Substance Act and an Update on Pharmacy Related Controlled Substance Enforcement Actions: PSSNY
At the completion of the activity, the participant will be able to:
Understand the changes to federal law regarding the prescribing and dispensing of Buprenorphine and related controlled drugs which are prescribed for patients efforts to withdraw from addiction to controlled drugs .
Recognize the changes to DEA regulations with the recent elimination of DEA Data Waiver prescriber process, and the related elimination of the secondary DEA numbers previously used in ordering Buprenorphine for treatment of opioid addicted patients.
Understand the collateral consequences of civil and criminal charges brough by state or federal agencies even when the practitioner is able to salvage their professional license after the civil/criminal disposition resolution of their legal matter.
Define the new limitations on who is permitted to register with the DEA on behalf of the pharmacy as the pharmacy’s “Registrant”.
Describe recent examples of civil penalties for routine violations of the Controlled Substance Act found by DEA Diversion Investigators upon inspections of pharmacies
Paige Clark, RPh.
Paige Clark, RPh, is the Vice President, Policy & Programs at Prescryptive Health, a pharmacy technology company focused on providing pharmacies with groundbreaking technology such as an Artificial Intelligence Optimized Pricing Engine, and a clinical platform to transform pharmacy practice. A pharmacist for over 30 years, prior to Prescryptive, Paige spent 5 years working for the Oregon Board of Pharmacy followed by 11 years at Oregon State University College of Pharmacy as the Director of Professional Development and Alumni Relations. These positions required supporting the board's regulatory work and providing legislative and executive branch support--- and then building the college's Professional Development department which included coordinating the construction of Continuing Education programming to expand pharmacist's scope of practice in areas of patient assessment, pharmacist prescribing, and payment. Seven of these programs are nationally utilized in 22 states. She has co-authored and is published in multiple pharmacy papers and articles, and frequently provides insights to national pharmacy publications. She has been honored nationally and regionally including as Pharmacist of the Year, joined the honorees the Bowl of Hygiea in 2011 and received the American Colleges of Pharmacy’s Blockstein lifetime achievement award in 2021. Paige is a frequent speaker at national and regional pharmacy conventions on topics ranging from scope expansion to technology and data security for pharmacists.
Brad concentrates his national practice on providing legal services to clients in the pharmaceutical industry, including independent retail, chain, specialty, infusion and compounding pharmacies, as well as health care systems. Brad also represents wholesalers, manufacturers, technology companies, and others with legal, regulatory, and compliance issues in the pharmacy space. He represents other health care providers, including physicians, laboratories, and durable medical equipment (DME) providers, with issues relating to network participation and reimbursement issues. Brad counsels clients nationwide on issues with health plans, pharmacy benefit managers (PBMs), and government entities, such as credentialing and enrollment, audits and investigations, network terminations, and reimbursement disputes. Specifically, Brad has assisted providers in overturning enrollment denials and with the recovery of millions of dollars for providers following challenges to audit findings or improper reimbursements. Brad also counsels clients in matters pertaining to contract management, best practices, and other business-related issues, with a focus on those entities operating in the pharmaceutical industry. For example, Brad assists clients in understanding and evaluating risks with data privacy and security, marketing and payment models, and interplay with other agreements entered by the client. Brad represents entities in pharmacy- and other health carerelated transactions, including those involving private and chain sales or private equity. Brad also assists entities with corporate formation, due diligence, licensing, and credentialing.
ACPE UAN # 0042-9999-23-017-L03-P
- 1.50 ACPEThe Arnold & Marie Schwartz College of Pharmacy and Health Sciences is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.