The HRSA Proposed 340B Pricing Program Omnibus Guidance: Best Compliance Practices Your Firm Should Know
The Health Resources and Services Administration (HRSA) in August 2015 issued a notice proposing guidance under the 340B Drug Pricing Program. The proposal is an attempt to clear up confusion about program rules and eliminate ambiguity in the marketplace for all 340B Program stakeholders. Although the proposed guidance is intended to clarify HRSA’s existing policy interpretations, a significant practical effect is to change the standard for 340B patient eligibility. It would also restrict the number of physicians who could write 340B-eligible prescriptions.
The program allows certain participating covered entities and other health care providers to obtain discounted prices on outpatient prescription drugs. These entities are required to prove compliance with 340B program requirements overseen by the HRSA within the Department of Health and Human Services (HHS), and are subject to audit. The “mega” guidance could have significant impact on plans and operations, once the final guidance is published in September 2016.
In this two-hour LIVE Webcast, a panel of key thought leaders assembled by The Knowledge Group will provide healthcare practitioners and professionals with an in-depth review of HRSA’s 340B Drug Pricing Program Omnibus Guidance. The panel will also help analyze the possible effects and challenges of the Guidance and will offer a roadmap on how to prepare and what needs to be done in order to ensure compliance.
Key topics include:
- Proposed 340B Drug Program Guidance
- Covered Entity Eligibility and Registration
- Program Requirements
- Contract Pharmacy Requirements
- Manufacturer Responsibilities
- Patient Definition
- Scope of Eligible Drugs
- 340B Prime Vendor Program
- Medicaid Managed Care and Duplicate Discounts
- Auditable Records and Audits
- Who Will Be Impacted and How
- Best Compliance Practices
Neil W. Hoffman, Ph.D., Partner
Arnall Golden Gregory LLP
- Overview of 340B program
- How did we get here?
- Manufacturing responsibilities
Christine M. Morse, Principal
Ober | Kaler
- Patient definition – overview on what it would be
- Registration for covered entities
- Provider based rules on reimbursement
John A. Mills, Partner
Nelson Hardiman, LLP
- Contract pharmacy arrangements
- Medicaid aspects – duplicate discounts
- Record keeping requirements
Who Should Attend:
- Federal Healthcare Facility Managers
- Healthcare Law Attorneys
- Health Industry Advisors
- Health Policy Directors
- Contract Pharmacy Providers
- Biopharmaceutical Attorneys
- Health Compliance Officers
- State Health Executives & Professionals
- Food and Drug Industry Specialists
- Healthcare Facilities
- Pharmaceutical Manufacturers
- Other Interested Professionals
Neil W. Hoffman, Ph.D., is a partner in the Healthcare Practice. Dr. Hoffman offers niche knowledge of the healthcare and life-sciences industry derived from more than 15 years' experience in providing legal representation to clients operating within this heavily regulated sector of the economy.
Dr. Hoffman focuses his practice on providing transactional and regulatory representation to health and life-sciences clients, including hospitals and health systems, long-term care providers, home health providers, and hospice providers, both regional and national, as well as academic medical centers, medical groups, allied professionals, pharmaceutical and device companies, and clinical research organizations. His particular areas of focus include federal and state fraud-and-abuse laws (such as Stark law and the federal Anti-Kickback Statute), healthcare mergers and acquisitions, healthcare lending arrangements, health regulatory due diligence, Medicare/Medicaid reimbursement, privacy and security under the Health Insurance Portability and Accountability Act (HIPAA) and applicable state law, medical-device transactions, and clinical research and applicable regulations of the Food and Drug Administration (FDA). He is experienced in helping clients to structure transactions and service models for regulatory compliance while achieving business objectives.
Dr. Hoffman previously held research positions at the Neuropsychiatric Institute at the University of California, Los Angeles, and the Department of Psychobiology at the University of California, Irvine, where he studied neuronal signaling properties and pathways relevant to hormonal and reproductive activity and participated in multi-disciplinary epilepsy research. Dr. Hoffman has co-authored numerous publications of original research in peer-reviewed journals in these fields.
Neil W. Hoffman, Ph.D., is a partner in the Healthcare Practice. Dr. Hoffman offers niche knowledge of the healthcare and …
John A. Mills is a partner at Nelson Hardiman and has years of experience representing and advising health care providers in a wide range of regulatory compliance issues and litigation proceedings. John’s practice focuses on managed care and ERISA compliance and litigation, medical staff and peer review, civil False Claims Act and fraud lawsuits, commercial litigation, healthcare fraud investigations, and a wide range of regulatory compliance issues, including corporate internal investigations and voluntary disclosures of possible Medicare overpayments, analysis of business arrangements to ensure compliance with the anti-kickback and Stark laws, and providing transactional and regulatory guidance to covered entities and contract pharmacies in connection with the federal 340B program. John has jury trial experience and has handled numerous arbitrations and administrative hearings.
John A. Mills is a partner at Nelson Hardiman and has years of experience representing and advising health care providers …
Christine M. Morse, a principal in the Health Law Group at Ober|Kaler, focuses on general health care law and regulatory matters. She represents a wide range of providers, including pharmacies, labs, hospitals, hospital systems, DME providers, home health providers, physicians and other health care practitioners, device manufacturers, nursing homes and other long-term care providers. Chris assists both pharmacies and “covered entities” such as Disproportionate Share Hospitals (DSHs), Federally Qualified Health Centers (FQHCs), and Ryan White Centers, with issues related to their participation in the Health Resources and Services Administration’s (HRSA’s) 340B Drug Discount Program.
Christine M. Morse, a principal in the Health Law Group at Ober|Kaler, focuses on general health care law and regulatory …
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About Arnall Golden Gregory LLP
Arnall Golden Gregory, with more than 150 attorneys in Atlanta and Washington, DC, employs a “business sensibility” approach, developing a deep understanding of each client’s situation in order to find a customized, cost-sensitive solution. A past recipient of The National Law Journal’s prestigious Midsize Hot List honor, the firm advises on corporate, litigation and restructuring and regulatory matters for numerous industries, including business services, healthcare, life sciences, logistics and transportation, real estate, telecommunications, franchising, financial services, information services, energy, and manufacturing. Since 1949, AGG has been a solutions partner that subscribes to the belief “not if, but how.”
About Nelson Hardiman, LLP
Finding a healthcare lawyer that can navigate you through the labyrinth of rules, regulations and procedures that pervade modern health care is more essential than ever. For more than 25 years, our practice has focused on serving clients in diverse areas ranging from healthcare compliance, waste, fraud and abuse defense, general litigation, telemedicine, long-term care, hospital reimbursement, and various types of hospital and long-terms care facility purchases, sales and other transactions specific to the California healthcare industry. Whether you seek a HIPAA attorney, health insurance lawyer, mental health lawyer, DEA/FDA attorney; or are interested in physician contract negotiation or drafting a physician employment agreement, we are in your corner.
About Ober | Kaler
Ober|Kaler is a national law firm providing integrated regulatory, transactional and litigation services to health care, financial, construction and other business organizations.