The 19th Annual Pharmaceutical and Medical Device Compliance Forum (PCF) was held in Washington, DC, in November. The conference was attended by 450 people, including pharmaceutical and medical device manufacturers and representatives from government agencies, academic institutions, industry associations, and outside service providers. 

Jeffrey M. Kawalek, MBA, senior director, Ethics and Compliance, North America, for Ipsen Biopharmaceuticals, Inc., provided attendees with a look back to the first conference held in 2000 to see what’s changed and what hasn’t. While attendance has grown from 135 in 2000 to 450 in 2018, the topics, though increasing in complexity, remain similar. Today, the industry is still grappling with how to manage the risks associated with the complexity of engaging and interacting with healthcare professionals (HCPs).

PCF attendees heard from government leaders from the Department of Justice (DOJ), Office of the Inspector General (OIG), Federal Bureau of Investigation (FBI), and the Food and Drug Administration (FDA). These experts described the collaborative culture and coordinated efforts that have evolved over the past year as they gather and share data focusing on healthcare fraud. All agencies have had an increase in resources, hiring additional auditors and fraud examiners while creating new task forces. The government leaders shared the following as their areas of focus in the coming year:

• Data Analytics — Big data is getting bigger. Sales data exists and the DOJ expects it to be shared with compliance and used to identify potential risks. Sales and marketing do a lot of data analysis and this data should be used by compliance to identify trends, red flags, and outliers. The government is reviewing HCP data and linking money paid to the claims the HCP is submitting.
• Risk Assessments — The importance of the risk assessment and of designing the compliance program around those risks is a key part of an effective compliance program.
• Open Payments — With the open payments data available, the OIG is looking closely at the financial relationships between HCPs and manufacturers. They also discussed the potential of expanding the definition of HCP to include additional prescribers such as clinical nurse specialists, nurse practitioners, and physicians’ assistants in the coming years. Read Guidehouse’s white paper that highlights the importance of companies getting out in front of their Sunshine Act data.
• Patient Assistance Programs/Patient Support Programs — Are these programs being used to influence the use of branded products? Is this a bribe to the patient to fill a prescription? Are donations to independent charities a means of funneling funds to cover out-of-pocket expenses? Is the charity providing data back to the manufacturer that can be used to do a return-on-investment analysis?
• Opioid Crisis — The government considers the opioid crisis a major driver of kickbacks, with much attention on both HCPs and corporations.
• Drug Pricing and Specialty Pharmacies — The government is focusing on these “middlemen” and how they are increasing the prices of drugs.
• Nurse Educators — Is this “whitecoat marketing”? Make sure you have justification for using a nurse educator and thoroughly outline what the appropriate interactions with patients look like.
• Copay Foundations — These programs can be viewed as an enabler to mitigate the impact on price decisions and steer prescriptions through foundations.
• Patient Support Hub Services (HUBs) — What’s the value of the HUB with respect to helping the HCP? If it’s a benefit to the doctor, it’s a transfer of value and considered to be a kickback.
• Data Privacy and Cybersecurity — California Consumer Privacy Act (CCPA) is a key component in developing your compliance plan in 2020. How can you leverage what you did for the General Data Protection Regulation (GDPR) to get a leg up on CCPA? As new regulations are passed, companies will need to make a business decision to separate data or treat all data the same and take the highest level of control. As data analytics and machine learning continue to grow, how can companies justify the use of more data on the privacy side?

The DOJ panel included specific information that assistant U.S. attorneys consider when evaluating a compliance program. Topics included:

• The relationship between the compliance officer and heads of business functions.
• The budget of the compliance function and whether it’s commensurate with the size of the company relative to the commercial budgets.
• Staffing and background of compliance department personnel and their compensation levels relative to other parts of the company.
• The awareness level of employees of the compliance program and the compliance hotline.
• Does the company regularly evaluate and evolve the compliance program? Do they perform assessments? How has the function addressed any deficiencies noted?

Guidehouse offers compliance, regulatory, investigative, and disputes services for life sciences companies, providing clients with innovative solutions to address their most critical business challenges. Please contact us to discuss your needs in more detail.

Questions or comments? Reach out to one of our experts.

Saul B. Helman, MD
saul.helman@guidehouse.com

J. Mark Farrar
mark.farrar@guidehouse.com

Casey Horton
casey.horton@guidehouse.com

Ann E. Beasley
ann.beasley@guidehouse.com

Johna Carufel
johna.carufel@guidehouse.com

Stephanie M. Lewko
slewko@guidehouse.com