Prescription Audits: When the DEA or AG Come Knocking

Anticipating and Responding to Heightened Investigations of Prescribing and Dispensing Practices

Recording of a 90-minute CLE webinar with Q&A


Conducted on Wednesday, August 16, 2017
Recorded event now available


This CLE webinar will discuss the increased scrutiny of healthcare providers’ prescribing and dispensing practices by the Drug Enforcement Administration (DEA) and state attorneys general (AG) through their medical boards and other actions, and will guide counsel in preparing for and responding to prescription audits and ensuring ongoing regulatory compliance.

Description

This webinar will address the increased scrutiny being applied to medical providers at all levels who are involved in prescribing, administering and/or dispensing controlled substances, especially opiates and other abused drugs. Providers and counsel should be prepared for DEA or state AG audits and investigations of their practices and for meeting the varying record-keeping requirements, including those involved in prescribing and/or dispensing buprenorphine.

Providers should be aware of the extent to which their prescribing patterns are being "mined" by regulators through review of the various state prescription drug monitoring programs and used as a basis for further investigation. Investigations also stem from wholesaler reports of suspicious transactions.

Providers with prescription authority must comply with both federal and state drug regulations. Failure to comply—whether negligent or intentional—could result in penalties, including fines, being stripped of the ability to lawfully prescribe, and potential criminal prosecution.

Counsel and providers should understand their potential liability exposure, develop effective policies and procedures, and be prepared to encounter and respond to an audit and to take corrective steps to ensure federal and state law compliance and mitigate damages.

Listen as our authoritative panel of healthcare attorneys discusses current trends in DEA and state AG enforcement of prescribing practices and the audit process. The panel will examine the steps necessary to prepare for an audit and offer best practices to respond when the government comes knocking.

Outline

  1. Current trends in prescribing and dispensing enforcement
  2. Audit process
    1. DEA
    2. State AG
  3. Audit preparedness
    1. Maintaining records
    2. Policies and procedures
    3. Risk issues
  4. Responding to an audit

Benefits

The panel will review these and other key issues:

  • What should providers and counsel expect when the DEA or state AG conducts a prescription audit?
  • What policies and procedures should be in place to ensure compliance with federal regulations?
  • What best practices should counsel and providers employ when facing a DEA or state AG audit?

Faculty

Ronald J. Friedman, Shareholder
Karr Tuttle Campbell, Seattle

Mr. Friedman’s practice focuses on regulatory compliance, white collar criminal defense, pharmacy law, complex litigation, and professional license defense. He entered private practice after serving 22 years as a federal prosecutor with the U.S. Department of Justice. Mr. Friedman has extensive experience in pharmaceutical compliance and licensing, DEA and FDA regulatory compliance, FCPA compliance, and providing a defense and guidance in all matters which may arise under the federal criminal laws. He is a frequent author and lecturer on prescription regulations and compliance, among other topics.

Lee H. Rosebush, Partner
BakerHostetler, Washington, D.C.

A registered patent attorney and registered pharmacist, Mr. Rosebush focuses his practice on FDA, regulatory, compliance and enforcement issues pertaining to pharmaceuticals, biologics and medical devices. He assists clients with healthcare-related issues stemming from Medicare, Medicaid and state regulatory requirements. He advises clients in matters relating to FDA regulatory compliance, including governance in the drug naming process, clinical trial, marketing, promotion and advertisement and approval process.


Recordings

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CLE On-Demand Video $297.00

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Program Materials

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Program Materials

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Customer Reviews

Very current topic and I appreciated the real life examples.

Lisa Thompson

Adelman Sheff & Smith

I liked the topic and the tools provided in the handouts.

Mildred Johnson

Texas Tech University Health Sciences Center

The content covered was relevant and timely.

Francis LaMorte, MD

Alvarez and Marsal

The speakers were well prepared and knowledgeable.

Kathleem Murphy

San Francisco General Hospital

The program included very informative information on an important subject.

Jamie L. Webb

Baker Manock & Jensen

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Health Law Advisory Board

Lowell C. Brown

Partner

Arent Fox

Jennifer L. Evans

Shareholder

Polsinelli

Ryan S. Johnson

Shareholder

Fredrikson & Byron

Gina M. Kastel

Partner

Faegre Baker Daniels

Karen S. Lovitch

Member

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo

David A. Manko

Partner

Proskauer Rose

John J. Miles

Senior Counsel

Baker Donelson

C. Elizabeth O'Keeffe

Counsel

Wyatt, Tarrant & Combs

J. Peter Rich

Partner

McDermott Will & Emery

Donald H. Romano

Of Counsel

Foley & Lardner

Judith A. Waltz

Partner

Foley & Lardner

John R. Washlick

Shareholder

Buchanan Ingersoll & Rooney

Jesse A. Witten

Partner

Drinker Biddle & Reath

or call 1-800-926-7926

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