Description

This advanced webinar first details an overview of the federal regulatory process of notice and comment rulemaking then delves into the history of the 340B Drug Pricing Program as amended from time to time. The specifics of the 340B Drug Pricing Program are implemented to the public and to health care providers and institutions, including drug companies where millions of dollars in drug purchases are at stake, through federal regulation. As with any bureaucratic program, not all will go smoothly from both sides – the pharmaceutical manufacturers and the purchasers of those products. While current updates are now pending in the federal rules with a Notice of Proposed Rule Making, the basics of the 340B Drug Pricing Program have not significantly changed.

With the government promulgating updates to the 340B Drug Pricing Program that are still pending, an administrative mechanism is created and tweaked to handle disputes from both sides. That is called the ADR, not to be confused with “alternative dispute resolutions” in the law such as mediation and binding arbitration. This is an Administrative Dispute Resolution that establishes, defines, and carries out that dispute process.

The proposed federal administrative regulation notes that under the 340B federal statute, the purpose of the ADR process is to resolve these things from both sides:

(1) covered entities’ claims they have been overcharged for covered outpatient drugs by pharmaceutical manufacturers, and;

(2) pharmaceutical manufacturers’ claims that a covered entity has violated the prohibition on diversion or duplicate discounts.

The proposed federal rule provides for the ADR process to be an administrative process implemented to assist covered entities and manufacturers in resolving these inevitable disputes. From this focus on the ADR process, the remainder of the webinar will detail the administrative procedures that you need to know to stay out of trouble and to comply with the ADR mandates to succeed in any dispute about the 340B Drug Pricing.

Areas Covered:-

• Introduction to federal regulatory Process -notice and comment rulemaking
• Overview of 340B Drug Pricing Program
• Establishing a more accessible ADR process
• Revising the structure of the ADR for subject matter experts
• Ensuring the parties have first worked in good faith before initiating and proceeding through the ADR process
• Aligning the ADR process with the diversion and duplication statute, discounts, and overcharges
• Including a reconsideration process for dissatisfied parties
• Conclusion:  avoiding risk and liability with best practices to succeed in the ADR process

Why should you Attend?

• This advanced webinar provides an overview of the federal regulatory process of notice and comment rulemaking that leads to federal administrative regulations to implement the current 340B Drug Pricing Program. 
• We next focus on the history of the federal government’s drug pricing program and its imprint on health care.
• Healthcare practitioners and healthcare financial employees need to know the top issues currently in the 340B Drug Pricing Program. 
• With the federal regulations implementing this federal health care program, this webinar will skim over the intent of this federal law and its implementation.
• From there, the advanced webinar will focus on the ADR process and how that works in actual practice.
• Erase the fear, uncertainty, and doubt about what the 340B Drug Pricing Program does specifically and what you need to know about the mechanics of the ADR process for full compliance in today’s healthcare practitioners world.

Who will Benefit?

• Healthcare Law Attorneys
• Licensed Health Care Practitioners in private practice in Mental Health and in Physical Medicine Medical Directors of Health Facilities
• Office Managers and Medical Directors of Private Medical Offices
• Health Care Managers and Executives
• Corporate Counsel in Health Care
• Health care Administrators
• University Faculty in Health Care and Medical Records
• Allied Health Professionals in Graduate-Level Medical Education across the many Healthcare Professions
• Corporate Compliance Officers
• Human Resource Directors and Departments