Controlled Substances 101: Introduction to the Fundamentals

May 28, 2019 9:00am - 12:30pm

Speakers

Ronald Friedman
Counsel
Karr Tuttle Campbell (Seattle, WA)

Daniel Kracov
Partner
Arnold & Porter Kaye Scholer (Washington, DC)

Building And Enhancing Your Controlled Substances Compliance Program

May 28, 2019 1:30pm - 5:00pm

Speakers

Ronald Chapman
Shareholder
Chapman Law Group (Troy, MI)

Jodi Switalski
Founder and Chief Consultant
Switalski Law and Consulting (Huntington Woods, MI)

Day 1 - Wednesday, May 29, 2019

7:30
REGISTRATION AND CONTINENTAL BREAKFAST
8:30
Co-Chairs’ Opening Remarks
9:00
Understanding the Implications of the National Policy Response to the Opioid Overdose Crisis
10:00
MORNING COFFEE BREAK
10:30
Untangling the Intricacies of Suspicious Order Monitoring Requirements
11:45
Analyzing the Verified Accredited Wholesale Distributor (VAWD) Certification and its Effects on Pricing and the Supply Chain
12:45
NETWORKING LUNCHEON
2:00
How the Uptick in Opioid Litigation is Affecting the Industry: Key Takeaways from the MDLs
3:00
AFTERNOON REFRESHMENTS BREAK
3:15
Deciphering Controlled Substance Disposal Requirements and Takeback Programs
4:30
CONFERENCE ADJOURNS TO DAY 2

Day 2 - Thursday, May 30, 2019

7:45
CONTINENTAL BREAKFAST
8:15
Co-Chairs’ Welcome and Recap of Day 1
8:30
When DEA Comes Knocking: Ensuring your Facility Successfully Passes Inspection
10:00
MORNING COFFEE BREAK
10:30
Dissecting DEA’s Quota Reduction Regulation
11:30
Drug Scheduling and Shipments: A Practical Review of State Rules and Regulations
12:15
NETWORKING LUNCHEON
1:15
Spotlight on New Jersey’s Opioid Abuse Prevention and Enforcement Unit
1:45
Keeping up and Complying with Evolving State Prescription Drug Monitoring Programs
2:45
AFTERNOON REFRESHMENT BREAK
3:00
Inside Perspectives on Federal and State Government Trends in Opioid Enforcement
4:30
CONFERENCE ENDS

Day 1 - Wednesday, May 29, 2019

7:30
REGISTRATION AND CONTINENTAL BREAKFAST
8:30
Co-Chairs’ Opening Remarks

Richard Hartunian
Partner
Manatt, Phelps & Phillips, LLP (New York, NY)
Former U.S. Attorney – Northern District of New York U.S. Department of Justice

Lynn Mehler
Partner
Hogan Lovells LLP (Washington, D.C.)

9:00
Understanding the Implications of the National Policy Response to the Opioid Overdose Crisis

Shruti Kulkarni
Associate
DCBA Law & Policy (Washington, D.C.)

Seth Mailhot
Partner
Husch Blackwell LLP (Washington, D.C.)

Over the past year, President Trump has initiated various actions in the fight against the opioid overdose crisis. Recently, the President called on Attorney General Sessions to initiate a federal law suit against the drug companies, paralleling the current multidistrict and standalone state-level litigations. Our panel of policy experts will address these actions and other relevant developments on the Hill and their insights into closing the door on this crisis.

Topics of discussion include:

  • Establishment and status of opioid task forces,
  • Analysis of proposed and pending legislation,
  • Up-to-date status of DEA notices, FDA Guidances, and related industry commentary

10:00
MORNING COFFEE BREAK
10:30
Untangling the Intricacies of Suspicious Order Monitoring Requirements

Cathy Gallagher
Senior Consultant, U.S. Compliance Solutions
IQVIA (Richmond, VA)

  • Aligning manufacturer and distributor obligations with DEA’s current stance
    • Masters and the aftermath: deciphering responsibilities related to chargeback data
    • Determining when to fill flagged potentially-suspicious orders
  • Enhancing your “Know Your Customer” and “Know Your Customer’s Customer” programs
    • Making proper adjustments to statistical analysis and algorithms to capture customer and expected downstream data
    • Bolstering internal pharmacy investigations
  • Update on DEA’s Suspicious Order Monitoring Guidance
    • Evaluating the interpretation of SOM requirements through final order without notice and comment rulemaking
    • Diving into recent DEA settlements related to failure to report suspicious orders

11:45
Analyzing the Verified Accredited Wholesale Distributor (VAWD) Certification and its Effects on Pricing and the Supply Chain

Sumeet Singh
President
Five Rivers RX (Penn Valley, PA)

  • Understanding the role and attributes of a VAWD-certified distributor
  • Developing strategies for successfully and timely obtaining VAWD certification
  • Update on state by state VAWD recognition and requirements
  • Examining the intersection of VAWD certification, PBMs, public policy, and the resulting market effects
    • Analyzing the facts and arguments in Association of Independent Pharmaceutical Wholesalers v. OptumRx and insights into the outcome

12:45
NETWORKING LUNCHEON
2:00
How the Uptick in Opioid Litigation is Affecting the Industry: Key Takeaways from the MDLs

Jason Parish
Shareholder
Buchanan Ingersoll & Rooney PC (Washington, D.C.)

Edward Rickert
Partner
Quarles & Brady LLP (Chicago, IL)

In the year that has passed since our inaugural event, the Judicial Panel on Multidistrict Litigation has centralized more than 1100 opioid-related lawsuits in the Northern District of Ohio- National Prescription Opiate Litigation, MDL #2804. The DOJ has joined the case as a “friend of the court” to assist with settlement negotiations. Presently, the MDL trial is set for September 2019, with ongoing potential settlement discussions.

In this session, our panelists will take a deep dive into the MDL as well as similar proceedings such as the Native American Tribe suits and the Texas counties MDL. Our speakers will provide a thorough analysis of how the outcomes of these cases will affect your business and manufacturing practices. Topics of discussion include:

  • Dissecting the strength of proposed arguments and defenses
  • Understanding the unique challenges of each of these proceedings
  • Evaluating strategies and potential outcomes

3:00
AFTERNOON REFRESHMENTS BREAK
3:15
Deciphering Controlled Substance Disposal Requirements and Takeback Programs

Hilary Bowman
Attorney
K&L Gates (Morrisville, NC)

  • Identifying industry initiatives for drug disposal including push for in-house disposal
  • Fine-tuning federal regulations on establishing and maintaining takeback programs
  • Understanding varying state and local regulations related to disposal
  • Balancing the risks, liabilities, and costs of takeback programs with the overall benefits
  • Ensuring your program is compliant, safe, and environmentally sound

4:30
CONFERENCE ADJOURNS TO DAY 2

Day 2 - Thursday, May 30, 2019

7:45
CONTINENTAL BREAKFAST
8:15
Co-Chairs’ Welcome and Recap of Day 1
8:30
When DEA Comes Knocking: Ensuring your Facility Successfully Passes Inspection

Antonio Pozos
Partner
Drinker Biddle & Reath LLP (Philadelphia, PA)

Brian Rucker
President
DEA Audit Group, LLC (Phoenix, AZ)
Former Supervisory Diversion Investigator, Atlanta Field Division Drug Enforcement Administration

Join our team of veteran investigators for this interactive mock DEA facility walkthrough. Our speakers will take you on an interactive journey through several real-life situations and will provide you with tools you can immediately incorporate into your facility programs. Topics of discussion will include:

  • Understanding required controls and oversight measures to ensure consistency with Code of Federal Regulations (CFR)
  • Enhancing your internal procedures and policies including: due diligence/know your customer programs
  • Standard operating procedures (SOPs), security and theft procedures
  • Examining risk-management, inventory control issues, record-keeping and security issues, to maintain compliance and avoid unforeseen fines and/or federal charges.
  • Crafting and compiling a DEA readily retrievable file

10:00
MORNING COFFEE BREAK
10:30
Dissecting DEA’s Quota Reduction Regulation

Karen Owen Gibbs
Partner
McDermott Will & Emery LLP (Chicago, IL)

Lynn Mehler
Partner
Hogan Lovells LLP (Washington, D.C.)

DEA’s final Controlled Substances Quota Regulation is in effect as of August 15th, 2018. Take a seat as Ms.Harper-Avilla discusses the ins and outs of the regulation. Learn how to assess your internal policies and make the proper adjustments to your business practices to minimize the impact to your company.

11:30
Drug Scheduling and Shipments: A Practical Review of State Rules and Regulations

Christina Markus
Partner and Deputy Practice Leader, FDA & Life Sciences
King & Spalding LLP (Washington, DC)

  • Developing strategies for adhering to state-specific scheduling requirements
  • Untangling reporting requirements for shipments of controlled substances
  • Setting the bar: focusing on unique state prescribing/dispensing guidelines and task forces
    • Understanding the impact of state policies on prescribing rates

12:15
NETWORKING LUNCHEON
1:15
Spotlight on New Jersey’s Opioid Abuse Prevention and Enforcement Unit

Erica Liu
Chief, Opioid Abuse Prevention and Enforcement Unit Assistant U.S. Attorney
U.S. Attorney's Office District of NJ (Newark, NJ)

1:45
Keeping up and Complying with Evolving State Prescription Drug Monitoring Programs

Ronald Chapman
Shareholder
Chapman Law Group (Troy, MI)

Amanda Glover, Pharm.D.
VP, Regulatory Affairs DMEPOS Compliance Officer
Rite Aid Corp. (Camp Hill, PA)

  • Understanding corresponding responsibility for pharmacists
  • Complying with differing state reporting requirements
  • Comparing and contrasting applications of prescription data to further enhance the program
  • Exploring the status of interstate data sharing among PDMPs
  • Evaluating prescriber mandates across states
  • Understanding the use of PDMP data as a basis for disciplinary actions against physicians and pharmacies

2:45
AFTERNOON REFRESHMENT BREAK
3:00
Inside Perspectives on Federal and State Government Trends in Opioid Enforcement

Richard Hartunian
Partner
Manatt, Phelps & Phillips, LLP (New York, NY)
Former U.S. Attorney – Northern District of New York U.S. Department of Justice

John Kelly
Member
Bass, Berry & Sims PLC (Washington, D.C.)
(Former Asst. Chief for Health Care Fraud, U.S. Department of Justice)

Erica Liu
Chief, Opioid Abuse Prevention and Enforcement Unit Assistant U.S. Attorney
U.S. Attorney's Office District of NJ (Newark, NJ)

Elliot M. Schachner
Assistant U.S. Attorney
U.S. Attorney’s Office – Eastern District of New York (Brooklyn, NY)

Join our stellar group of current and former government enforcement leaders as they dive into the most recent opioid enforcement actions and initiatives. This unique panel will provide their unique insights on:

  • Addressing hot-button orders to show cause and immediate suspension orders
  • Exploring the evolving corresponding responsibility standard for pharmacists and related red flags
  • Examining the appropriateness of criminal charges
  • Tackling Medicare/Medicaid fraud through the Medicare Fraud Strike Force
  • Establishing and deploying of task forces

4:30
CONFERENCE ENDS

Controlled Substances 101: Introduction to the Fundamentals

May 28, 2019 9:00am - 12:30pm

$600

Speakers

Ronald Friedman
Counsel
Karr Tuttle Campbell (Seattle, WA)

Daniel Kracov
Partner
Arnold & Porter Kaye Scholer (Washington, DC)

What is it about?

This workshop provides a basic overview of controlled substance regulations and will set the stage for the main conference by helping attendees thoroughly comprehend the structure and authority of the DEA and FDA in this area while walking through the evergreen and recent challenges that arise when working with controlled substances. Get the background information you need to flow seamlessly into the more in-depth discussions that will take place during the main conference.

Topics include:

  • Introduction to the DEA and FDA: agency missions, authority and organizational structures
  • History of controlled substances regulations
  • Intersection between FDA and the DEA: how to work effectively with both agencies
  • Reviewing the drug scheduling process and effects on approval
    • How to de-schedule a drug or move to a different schedule
    • Applying for a schedule I license, including for research purposes
  • Registration requirements for a DEA number and DEA X number
  • Understanding abuse-deterrence, its current status, and its effect on the approval process
  • Responding to DEA audits, investigations, and enforcement actions
  • State licensing and the interplay with federal regulations
  • Advertising and promotion of controlled substances

Building And Enhancing Your Controlled Substances Compliance Program

May 28, 2019 1:30pm - 5:00pm

$600

Speakers

Ronald Chapman
Shareholder
Chapman Law Group (Troy, MI)

Jodi Switalski
Founder and Chief Consultant
Switalski Law and Consulting (Huntington Woods, MI)

What is it about?

(Registration begins at 1:00 pm)

 

In this targeted session, our compliance experts will provide you with an extensive analysis of tried and true methods for strengthening your internal controlled substance compliance programs. Attend this one-of-a-kind workshop and walk away with tools you can immediately incorporate into your workplace. The indepth discussion will provide ways to address the biggest compliance-related challenges including:

  • Conducting internal audits of your facility and controlled substance inventory
    • Understanding your data and expected trends
    • Knowing what to do when you discover noticeable volume changes
  • Utilizing your data to prophylactically identify highest risks
  • Monitoring and internal controls
  • Completing an appropriate biennial inventory of all Schedule II-IV controlled substances
  • Ensuring proper whistleblower policies for your program
  • Improving theft and loss reporting requirements