The 340B Drug Pricing Program: Practical Tips to Ensure Compliance
Implementing an efficient and effective 340B Drug Pricing Program is an unnerving task. One of the challenges encountered by numerous covered entities when complying with the requirements of the 340B Program is the lack of clarity around the rules and regulations. The vagueness and complexity of rules can result in lost savings and an increased risk of noncompliance. In order to avoid such risks, it is necessary to develop policies and procedures that are in line with the framework of the 340B Program, maintain auditable records, conduct rigorous internal and external monitoring, and respond promptly to issues in the 340B compliance process.
In this LIVE Webcast, a seasoned panel of thought leaders and professionals assembled by The Knowledge Group will provide the audience with an in-depth analysis of the contextual and hot button compliance issues surrounding 340B. Speakers will also offer practical tips in navigating the complexity and the lack of clarity around issues like patient definition and duplicate discounts.
Key topics include:
- Overview of the 340B Drug Pricing Program
- Legislative and Regulatory Updates
- Covered Entity Eligibility and Patient Definition
- Significance of HRSA
- Contextual and Compliance Issues
- Contract Pharmacies
- Self-Reporting Noncompliance
- What’s Next for the 340B Program?
Sarah Persinger, Attorney
- Registered Pharmacist & Attorney
- Used to work for a hospital system – compliance & audits
- Self-reporting of non-compliance
- Dealing with Medicaid compliance
Lisa Tofil, Partner
Holland & Knight LLP
- Lawyer & Lobbyist/policy work & compliance
- Legislative & regulatory guidance
- Context on hot button issues of compliance
- Political issues linked with this
Abbey Coffin, Attorney
Donoghue, Barrett & Singal
- Works with provider entities, 340B eligibility, regulatory guidance
- Medicare and CMS policy changes – how these rural changes may impact 340B
Who Should Attend:
- Healthcare Law Legal Counsel
- Health Policy Directors
- Bio/Pharma and Related Attorneys
- 340B Compliance Officers
- 340B Managers and Coordinators
- State Health Executives/Professionals
- General Counsel
- Pharmacists and Clinic Directors
- Pharmaceutical Companies
- Group Purchasing Organizations
- Pharmacy Service Companies
- Drug Assistance Program Managers
- Healthcare Facilities
- Pharmacy Benefit Management Companies
Ms. Tofil represents a number of health care organizations, with significant expertise in hospital and health system financing, trauma centers and systems, air medical transport, emergency medical services and the 340B Drug Discount Program. She is an experienced advocate on numerous other healthcare issues and programs, including graduate medical education, biomedical research, transplantation, health resources issues, as well as public records and open meetings laws. Ms. Tofil works with clients on policy development, devising legislative and regulatory strategies, and intervening as necessary to draft and secure legislative or regulatory changes that advance client interests. In previous roles, she served as in house counsel to two large health systems, building their government relations functions and executing strategic government relations plans.
Ms. Tofil represents a number of health care organizations, with significant expertise in hospital and health system financing, trauma centers …
Sarah is a member of our Health Care Practice Group. She holds a Doctor of Pharmacy degree and is a registered pharmacist with extensive pharmacy practice experience and a working knowledge of regulatory affairs. She has managed health system pharmacy compliance with Ohio State Board of Pharmacy, DEA, and CMS regulations, the federal 340B Drug Discount Program, USP 797 and FDA Sterile Compounding requirements, and Joint Commission and HFAP Accreditation standards.
Sarah has a strong working knowledge of specialty pharmacy, managed care and pharmacy benefits management, HIPAA and healthcare information security, and trade association industry relations, as well as work experience in the retail, hospital, and long term care pharmacy practice settings.
Prior to joining Dinsmore, Sarah managed regulatory compliance and industry and government relations for a healthcare technology company and before that she coordinated regulatory compliance operations for the pharmacy services department at a major Ohio health system. She has developed strong relationships with staff, members, and executive leaders of the Ohio State Board of Pharmacy and was a member of its 2015 Rules Review Committee. She has served as an adjunct professor at Ohio Northern University, teaching about the legal and regulatory environment of the pharmaceutical industry.
Sarah is a member of our Health Care Practice Group. She holds a Doctor of Pharmacy degree and is a …
Abbey Coffin is an associate in Donoghue, Barrett & Singal’s Health Law practice where she provides services and consultation to hospitals, clinics, physicians, and other health care providers and suppliers. Abbey advises clients on a broad range of issues, including patient care, data privacy and security, corporate and transactional issues, policy development, clinical research compliance, risk management, and general regulatory compliance. She also counsels her covered entity clients on how to achieve compliance with the 340B Drug Pricing Program rules and regulations.
Prior to joining Donoghue Barrett & Singal, Abbey worked in the technology transfer office at a large academic medical center in Boston, Massachusetts where she was responsible for drafting and negotiating a variety of basic science and clinical research agreements. Abbey is a graduate of Boston College and Suffolk University Law School.
Abbey Coffin is an associate in Donoghue, Barrett & Singal’s Health Law practice where she provides services and consultation to …
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About Holland & Knight LLP
Holland & Knight is a global law firm with more than 1,200 lawyers and other professionals in 27 offices throughout the world. Our lawyers provide representation in litigation, business, real estate and governmental law. Interdisciplinary practice groups and industry-based teams provide clients with access to attorneys throughout the firm, regardless of location.
With offices located coast-to-coast, Dinsmore now operates with over 650 attorneys in 21 cities nationwide. Dinsmore is recognized among the top firms in the nation, ranking on both the AmLaw 200 and NLJ 250 lists. One hundred eighty-nine (189) of our attorneys are named in The Best Lawyers in America® (2016) with Dinsmore “Top Listed” in more than 35 practice areas. Dinsmore was also selected as a "Go-To Law Firm" by Corporate Counsel Magazine based on surveys of Fortune 500 companies.
We have also received accolades from Chambers USA® Guide to America's Leading Business Lawyers, The Legal 500 United States, Martindale-Hubbell, Corporate Board Member Magazine and many other business and legal industry organizations.
About Donoghue, Barrett & Singal
Donoghue Barrett & Singal is a full-service law firm that provides integrated legal services from its offices in Boston, Massachusetts and Providence, Rhode Island. The firm’s primary areas of practice are health care, corporate, litigation (complex civil and white-collar criminal), and government relations. Founded in 1989, the firm serves a growing list of clients, ranging from individuals to Fortune 500 companies. The firm acts in a variety of roles as clients’ needs dictate, from general counsel, to advisor on important transactions, to litigator in complex civil matters, to counsel for the defense in criminal cases.
Donoghue Barrett & Singal combines deep industry knowledge, dynamic thinking, and a collaborative approach to help clients achieve their most important objectives.