Pre-Conference Workshop

COMPLIANCE THINK TANK — Building an Effective Controlled Substances Compliance Program

Jul 11, 2022 1:30pm – 5:00pm

Speakers

Karla L. Palmer
Director
Hyman, Phelps & McNamara PC

Delia A. Deschaine
Member of the Firm
Epstein Becker & Green P.C.

Day 1 - Tuesday, July 12, 2022

8:00
Breakfast and Registration
9:00
Co-Chairs’ Opening Remarks
9:05
DOJ KEYNOTE ADDRESS
9:35
Morning Coffee Break
10:00

TOWN HALL: THE CURRENT STATE OF THE U.S. DRUG OVERDOSE CRISIS

Analyzing the Implications of Recent State and Federal Controlled Substances Initiatives on the U.S. Drug Overdose Epidemic
11:00

OPIOID MDL SETTLEMENTS TRACKER

Navigating the Shifting Landscape of Opioid-Related Litigation and MDLs
12:00
Networking Luncheon
1:15

SCOTUS WATCH

Critical Takeaways from Ruan v. United and the Potential Implications for the Prescribing of Controlled Substances
1:45
Exploring the Regulation, Litigation and Enforcement of Marijuana
2:45
Afternoon Break
3:15
Considering Psychedelics as a Viable Therapeutic
4:15

FENTANYL & FAKE PILLS

Fighting Fentanyl and Fake Pills in the U.S.
5:00
Conference Adjourns to Day Two

Day 2 - Wednesday, July 13, 2022

8:00
Breakfast and Registration
8:55
Co-Chairs’ Opening Remarks and Recap of Day One
9:00
DEA KEYNOTE ADDRESS
9:30

SOM COMPLIANCE

Adjusting Your Compliance Program in View of New DEA Regulations
10:30
Morning Coffee Break
11:00

TECHNOLOGIES TRANSFORMING AND PREVENTING CONTROLLED SUBSTANCES DIVERSION

Harnessing the Power of Data Analytics, AI, and Prescription Drug Monitoring Programs (PDMPs) to Measure Patient Risk
12:00
Networking Luncheon
1:15
FDA KEYNOTE ADDRESS
1:45

TELEHEALTH AND TELEMEDICINE

Opportunities and Barriers: Examining the Embrace of Telehealth and Telemedicine and Resulting Impacts on the Prescription of Controlled Substances
2:45
Networking Break
3:15

THE FCA AND CONTROLLED SUBSTANCES

Controlled Substances and the False Claims Act: Reducing Legal Risk Amid the Expanding Reach of the FCA
4:15
Conference Concludes

Day 1 - Tuesday, July 12, 2022

8:00
Breakfast and Registration
9:00
Co-Chairs’ Opening Remarks

Uttam Dhillon
Chair, Regulatory Defense, Compliance & White-Collar Practice Group
Michael Best & Friedrich LLP
(Former Acting Administrator, U.S. Drug Enforcement Administration)

Dayle Elieson
Principal
Dayle Elieson PLLC
(Former Chief Counsel, U.S. Drug Enforcement Administration)

9:05
DOJ KEYNOTE ADDRESS

Amanda Liskamm
Principal Deputy Director, Consumer Protection Branch
U.S. Department of Justice

9:35
Morning Coffee Break
10:00

TOWN HALL: THE CURRENT STATE OF THE U.S. DRUG OVERDOSE CRISIS

Analyzing the Implications of Recent State and Federal Controlled Substances Initiatives on the U.S. Drug Overdose Epidemic

Scott B. Dahlquist
Trial Attorney | Opioid Coordinator
Consumer Protection Branch (CPB)

U.S. Department of Justice

Joshua Vinciguerra, JD
Director, Bureau of Narcotic Enforcement
New York State Department of Health

Moderator:

Uttam Dhillon
Chair, Regulatory Defense, Compliance & White-Collar Practice Group
Michael Best & Friedrich LLP
(Former Acting Administrator, U.S. Drug Enforcement Administration)

When the Controlled Substances Act (CSA) was enacted in 1971, approximately 7,000 people had died from overdose deaths. In 2021 alone, the CDC estimated that more than 100,000 people have died in the U.S. from drug overdose deaths, a marked increase likely driven by the global pandemic. In response, the DOJ and DEA have broadened the scope for establishing liability by bad actors under the CSA. In this opening Town Hall, key controlled substances stakeholders will provide you with insights into the current political and legislative landscape. Topics of discussion will include:

  • Addressing the alarming spike in U.S. drug overdose deaths
    • The path to today’s massive overdose crisis
    • Analyzing the correlation between the increase in overdose deaths and the COVID-19 pandemic
  • Addressing the strengthening of current legislation and state sentencing laws
    • Understanding pending legislation focused on the overdose crisis
  • Identifying barriers to evidence-based care for substance-use disorders
    • Developing collaborative, evidence-based solutions to improve outcomes
    • Identifying Best Practices for stakeholders looking to collaborate with policymakers to help end the U.S. overdose epidemic
  • Reviewing the CDC’s February 2022 draft revision to its 2016 Opioid prescribing guideline
  • Taking stock of the state of harm-reduction services and community prevention programs
    • Community-based prevention programs, including Syringe Service Programs (SSPs)
    • The impact of harm-reduction initiatives in various states
      • The rollout and impact of programs in New York, Rhode Island, and Philadelphia
    • How the National Harm Reduction Coalition is aiding in the fight against the U.S. Drug Overdose crisis

11:00

OPIOID MDL SETTLEMENTS TRACKER

Navigating the Shifting Landscape of Opioid-Related Litigation and MDLs

Derrelle M. Janey
Managing Partner
The Janey Law Firm
Of Counsel
Robert C. Gottlieb & Associates PLLC

Jay Baez
Legislative Director
New York State Senate

During this comprehensive assessment of the opioid MDLs, sessions leaders will review the status of sweeping settlements of the more than 3,000 lawsuits filed by cities and counties across the country, and forecast the outcomes of the pending cases. Points of discussion will include:

  • Addressing the impact of the MDLs and its impact on the controlled substances supply chain and communities across the country
    • How the Opioid Settlement Board will assist in funds distribution and its recommendations on how states should receive the funds
    • How funds are being distributed to communities across the country
    • How MDLs will impact the controlled substances industry

12:00
Networking Luncheon
1:15

SCOTUS WATCH

Critical Takeaways from Ruan v. United and the Potential Implications for the Prescribing of Controlled Substances

Ronald W. Chapman II
Shareholder
Chapman Law Group

This panel discussion highlights the Supreme Court case Xiulu Ruan v. United States of America. At issue before the Court is whether physicians can be convicted for unlawful distribution of controlled substances if they believe prescribing such drugs are under professional norms.

During this panel, we will explore the various facets of this case, including:

  • Analyzing the government’s brief in Ruan v. United States
  • Addressing what constitutes the “standard of care” and “usual course of professional practice” under the Controlled Substances Act (CSA)
  • Assessing when acting in “good faith” can be used as a defense for practitioners charged with unlawfully distributing narcotics under the CSA
  • Exploring the consolidated case, Kahn v. United States

1:45
Exploring the Regulation, Litigation and Enforcement of Marijuana

Corey Cox
Senior Counsel
Columbia Care

Tom Firestone
Partner & Co-Chair, White Collar & Internal Investigations
Stroock & Stroock & Lavan LLP

Jonathan A. Havens
Partner & Co-Chair, Cannabis Law; Co-Chair, Food, Beverage & Agribusiness
Saul Ewing Arnstein & Lehr LLP

Will Woodlee
Partner
Kleinfeld, Kaplan & Becker LLP

During this panel, we will review current marijuana and medical marijuana legislation in the U.S. Panel leaders will focus on navigating security and compliance measures in an industry filled with new possibilities, but rife with stringent regulatory restrictions. Topics will include:

  • Assessing landscape of marijuana as a schedule I controlled substance in 2022
  • Reviewing current marijuana laws, including legislation focused on adult-use marijuana and the current landscape of legalization
  • Addressing the latest regulatory updates from the federal government
  • Considering DEA’s authorization of increased legal production
  • Navigating DEA compliance of marijuana

2:45
Afternoon Break
3:15
Considering Psychedelics as a Viable Therapeutic

Todd A. Harrison
Partner
Venable LLP

Michael Labson
Partner
Covington & Burling LLP

Seth A. Mailhot
Partner
Husch Blackwell LLP

Kimberly Chew
Senior Counsel, Co-leader of Psychedelics and Emerging Therapies Practice Group
Husch Blackwell LLP

Jackie von Salm, PhD
Co-Founder & Chief Scientific Officer
Psilera

Recent studies are pointing to the promise for psychedelic drugs like LSD and psilocybin to help alleviate depression, anxiety and addiction. This panel will explore the legal status of psychedelic drugs under federal law, as we explore the DEA’s 2022 production goals for psychedelics, and the status of psychedelics as a Schedule I controlled substance. Topics include:

  • Reviewing the legal status of Psilocybin, MDMA, ibogaine and DMT
  • Understanding the basics of psychedelic therapy and navigating risks
  • Exploring Psilocybin designation as a breakthrough therapy

4:15

FENTANYL & FAKE PILLS

Fighting Fentanyl and Fake Pills in the U.S.

Dwayne Jeffcoat
DEA Diversion Investigator
U.S. Drug Enforcement Administration

Moderator:

Dayle Elieson
Principal
Dayle Elieson PLLC
(Former Chief Counsel, U.S. Drug Enforcement Administration)

The record number of counterfeit pills containing fentanyl seized by DEA is chilling. During this panel, we will explore the DEA-led “One Pill Can Kill” campaign designed to educate the public of the deadly dangers of fake prescription pills. During this panel, we will discuss:

  • Exploring Fentanyl and its impact as the “Counterfeit Killer”
    • Analyzing the impact of substance use disorders on compliance
  • Identifying community access to resources like Narcan nasal spray and Fentanyl test strips
  • How drug cartels and dealers are targeting youth on Snapchat
    • Identifying ways that dealers are advertising fentanyl-laced pills using emojis
    • Snapchat’s enforcement strategies and the path forward for social media
  • Exploring legislation that is tougher on street dealers
  • Identifying best practices for urgent and critical community education and exploring:
    • How are kids in school being educated about deadly fake pills?
    • How are community leaders responding to the crisis?

5:00
Conference Adjourns to Day Two

Day 2 - Wednesday, July 13, 2022

8:00
Breakfast and Registration
8:55
Co-Chairs’ Opening Remarks and Recap of Day One

Uttam Dhillon
Chair, Regulatory Defense, Compliance & White-Collar Practice Group
Michael Best & Friedrich LLP
(Former Acting Administrator, U.S. Drug Enforcement Administration)

Dayle Elieson
Principal
Dayle Elieson PLLC
(Former Chief Counsel, U.S. Drug Enforcement Administration)

9:00
DEA KEYNOTE ADDRESS

Eric Triana
Deputy Assistant Administrator
Office of Diversion Operations, Diversion Control Division
U.S. Drug Enforcement Administration

9:30

SOM COMPLIANCE

Adjusting Your Compliance Program in View of New DEA Regulations

Michele Buenafe
Partner
Morgan, Lewis & Bockius LLP

Hunter G. DeKoninck
Practice Group Attorney
Quarles & Brady LLP

Joseph Shepherd
Global Senior Director, Controlled Substances Leader
The Janssen Pharmaceutical Companies of Johnson & Johnson

Federal and state agencies are increasing investigation into the players of the pharmaceutical supply chain, paying close attention to the validity and fluctuation of ordering practices to combat the diversion of controlled substances. In order to avoid entanglements with the government for failing to report suspicious orders, session leaders will provide a forwardthinking analysis of the existing regulations, proposed reformations, and real-world guidance that can be proximately executed. Topics will include:

  • Adapting your Suspicious Monitoring program to respond to state and federal authorities
  • Identifying suitable due diligence and “know your customer” actions
  • Understanding the strategy and operation of a suspicious order monitoring and reporting system
  • Executing support for ongoing employee training

10:30
Morning Coffee Break
11:00

TECHNOLOGIES TRANSFORMING AND PREVENTING CONTROLLED SUBSTANCES DIVERSION

Harnessing the Power of Data Analytics, AI, and Prescription Drug Monitoring Programs (PDMPs) to Measure Patient Risk

Shannon Cox
Counsel
King & Spalding LLP

Charrai Byrd, PharmD, MBA, RPh
Pharmacy Operations Manager - Controlled Substances
New York-Presbyterian Hospital

Elliot M. Schachner
Assistant U.S. Attorney
U.S. Attorney’s Office Eastern District of New York

Jack Teitelman
Founder & CEO
TITAN Group

While drug diversion investigations historically focused on the role of individuals, future enforcement will focus on an organization’s role in preventing drug diversion and related liability. During this panel, we will explore the power of data analytics and other novel technologies to better understand patient risk with controlled substances. Topics we will explore include:

  • Exploring the data provided by Prescription Drug Monitoring Programs (PDMPs)
    • Using Data Analytics to identify heavy over prescribers
  • Addressing the need for data sharing and interoperability between states
  • Ensuring compliance with your state’s current requirements
  • Examining ways that PDMPs can impact the future of healthcare overall
  • Identifying the most successful, creative diversion techniques that can save money and bolster compliance

12:00
Networking Luncheon
1:15
FDA KEYNOTE ADDRESS

Dominic Chiapperino, Ph.D.
Director, Controlled Substances Staff
U.S. Food and Drug Administration

1:45

TELEHEALTH AND TELEMEDICINE

Opportunities and Barriers: Examining the Embrace of Telehealth and Telemedicine and Resulting Impacts on the Prescription of Controlled Substances

Nathan Beaver
Partner
Foley and Lardner LLP

Roger Cohen
Life Sciences Partner
Goodwin Procter LLP

Quinn Shean
Strategic Advisor
Tusk Venture Partners
State Policy Advisor
American Telemedicine Association

In a post-pandemic world, and with the growing demand for telemedicine, several changes have been made to telehealth policies to make telemedicine more accessible. During this panel, we will address ways that telehealth and telemedicine are impacting the controlled substances industry. Topics of discussion will include:

  • How e-Prescribing has impacted the opioid epidemic
    • How telemedicine is being used to treat opioid-use disorders
  • Reviewing the state and federal regulatory landscape of telehealth policy
  • Appreciating how the federal government is loosening restrictions on telehealth
  • Understanding electronic prescribing of controlled substances (EPCS) mandates
  • Discerning remote patient monitoring (RPM) and RPM tools can shape healthcare at large
  • Exploring the SUPPORT Act, enacted Jan. 1, 2022, which requires every controlled substance prescription to be transmitted electronically

2:45
Networking Break
3:15

THE FCA AND CONTROLLED SUBSTANCES

Controlled Substances and the False Claims Act: Reducing Legal Risk Amid the Expanding Reach of the FCA

Andrew O’Connor
Partner | Co-Iead, Health Care & Life Sciences Industry Group
Ropes & Gray LLP

Jason Parish
Shareholder
Buchanan Ingersoll & Rooney PC

Lindsay Saxe Griffin
Assistant United States Attorney Affirmative Civil Enforcement Coordinator
United States Attorney’s Office Middle District of Florida

In 2021, the DOJ targeted the opioid epidemic, Medicare Advantage program (Medicare Part C) fraud and abuse, kickbacks, including a $2.8 billion resolution with one opioid manufacturer. Even amidst the challenges associated with the pandemic, DOJ demonstrated that enforcement activity has not faltered, rather persisted. This panel discussion will explore the record-shattering year for FCA recoveries in the controlled substances arena. Topics include:

  • Evaluating the reason for the spike in False Claims Acts (FCA) recoveries
  • Implementing effective and comprehensive FCA compliance measures
  • Identifying compliance strategies to avoid FCA litigation
  • Outlining best practices to maintain FCA compliance

4:15
Conference Concludes

COMPLIANCE THINK TANK — Building an Effective Controlled Substances Compliance Program

Jul 11, 2022 1:30pm – 5:00pm

Karla L. Palmer
Director
Hyman, Phelps & McNamara PC

Delia A. Deschaine
Member of the Firm
Epstein Becker & Green P.C.

What is it about?

Workshops are offered in-person only

At this practical, industry-driven working group, our speakers will discuss how companies along the supply chain are using a tiered approach based on the appropriate risk level. This compliance think tank will provide you with the opportunity to upgrade your Best Practices, discover how your approach compares with your peers, and reevaluate your risk ranking approach while managing the costs of a robust controlled substances compliance program. Topics include:

  • Designing a comprehensive compliance handbook
    • Detailing the latest regulatory developments influencing risk management to maintain compliance and avoid unforeseen fines and/or federal charges
  • Examining your existing controlled substances compliance program and identifying gaps
  • Best Practices for conducting internal audits of your facility and controlled substance inventory to ensure preparedness
  • Understanding your data and mapping your trends
  • Responding to noticeable volume changes
  • Developing monitoring protocols and strengthening internal controls
  • Completing an appropriate biennial inventory of all Schedule II-IV controlled substances
  • Improving theft and loss reporting requirements
  • Ensuring proper whistleblower policies for your program
  • Exploring DEA compliance in a post-COVID world