Digital Pharmacies and Other Pharmacy Start-Ups: Legal Challenges and Pitfalls
Complying With Federal and State Regulations, Medicare and Medicaid Requirements, Patient Privacy
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Health
- event Date
Wednesday, October 7, 2020
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
Even before the current pandemic--which has prompted many to reduce in-person visits to healthcare providers and pharmacies--telemedicine and the digitization of healthcare have steadily increased. A new breed of digital pharmacies, such as Amazon’s PillPack, have emerged, providing convenient access to the medicine and 21st century user experiences. While these pharmacies challenge the model of traditional prescription dispensing, and have garnered the attention of private equity and venture capital investors, they have their own unique set of operational challenges, where laws, regulations, and payor policies oftentimes have not caught up with technological advances.
Mr. Dresser heads the firm’s Pharmacy Practice Group. In this role, his practice is dedicated to representing a broad cross-section of pharmacies and pharmacy providers, including community retail pharmacies, chain pharmacies, compounding pharmacies, specialty pharmacies, mail order pharmacies, home infusion providers, digital pharmacies, and dispensing physician practices. Mr. Dresser represents pharmacy providers nationally regarding issues with payors and Pharmacy Benefit Managers (PBMs), including PBM audit appeals, network terminations, network access and credentialing applications, and reimbursement issues.
Mr. Morrone is a partner in the healthcare department with a focus on transactional and regulatory law, working in the New York City office. He joined Frier Levitt in 2008 following over twenty years as a senior healthcare executive, holding positions with academic medical centers, and private and publicly-traded physician practice management companies, and healthcare consulting groups. Mr. Morrone received his Juris Doctorate from Seton Hall Law School and graduated cum laude. He also holds an MBA from Baruch College/Mount Sinai Medical School in Hospital and Healthcare Administration.
Digital pharmacies must meet all applicable federal and state statutes and regulations governing the practice of pharmacy where licensed or registered. Digital pharmacies must maintain and enforce policies addressing conflicts that may arise between individual states or between state and federal laws and regulations. They must also address challenges associated with identification of patients, patient privacy and security, and the prescribing of medications based upon telephonic, electronic, or online medical consultation.
In addition, the ongoing pandemic has greatly impacted the practice of pharmacy. Since COVID-19, pharmacies, as well as some regulators and payors, have relaxed their requirements for filling prescriptions and delivery. In March 2020, CMS permitted a relaxing of its refill and extended supply requirements. Further, Part D sponsors can waive prior authorization requirements to Part D drugs used to treat or prevent COVID-19. State boards of pharmacy and state Medicaid programs have also put in place relief measures in response to the pandemic and associated challenges.
Listen as our authoritative panel of healthcare attorneys examines the regulatory challenges and legal pitfalls of digital pharmacies and other pharmacy start-ups. The panel will also discuss legal issues brought on by the current pandemic and public health challenges and offer best practices for compliance.
- Federal regulations and Medicare requirements
- State regulations and state Medicaid requirements
- HIPAA and patient privacy
- Challenges and pitfalls for digital pharmacies
- Best practices for compliance
The panel will review these and other key issues:
- How has the regulation of digital pharmacies changed because of COVID-19?
- What unique legal challenges must digital pharmacies overcome?
- What are best practices to ensure compliance with federal and state regulation as well as Medicare and Medicaid requirements?
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