The team at ALN Consulting makes it a priority to ensure we have access to cutting-edge information related to the latest changes in legislation and compliance strategies in healthcare. This year, we attended the Health Care Compliance Association’s 4th Annual Healthcare Enforcement Compliance Conference in Washington, DC.

Here are a few of our top takeaways from this year’s conference:

Anatomy of a False Claims Act Case with Katherine Lauer, Amy Easton, Laura Ellis, and Amy Kossak.

This session offered an in-depth perspective regarding both the US Department of Justice (DOJ) and defense counsel views on the investigation, negotiation and resolution of the False Claims Act (FCA) case. Ms. Lauer, a civil litigator for 10 years, advised simple but essential steps in responding to the subpoena/CID, as well as missteps to avoid. She emphasized the importance of the defense team performing their own internal investigation into the claim alongside the DOJ so any issues can be anticipated and pro-actively planned for. She shared, that in her experience, an open exchange of investigation findings early on saved resources and increased trust between both parties if done in the right way. Such collaboration, for example, can sometimes yield a partial seal release for early sharing of Complaint details to help the defense team narrow the focus of their review.

As a take away point, Ms. Kossak, trial attorney for the Fraud Section of the Civil Division of the U.S. DOJ, offered sound practical advice for the compliance team to help avoid future issues – develop a compliance program – audit that program – actually review the results – and act on them!

It’s extremely helpful for our team to hear perspectives such as this from leaders in the industry like Katherine and Amy. It reinforces our belief that a critical analysis of pertinent records by qualified personnel, in the light of the suspected/alleged issues, is essential in the investigation of FCA cases.

Views from the Trenches: The Government’s Opioid Fraud & Abuse Initiatives with Scott Grubman, Neeli Ben-David, and Tamala Miles

During this session, the presenters offered various viewpoints from both a current AUSA and defense attorney related to opioid investigations, and recapped the government’s current initiatives addressing opioid fraud and abuse. Ms. Ben-David discussed recent focus areas in FCA enforcement, including the overprescribing of opioids; medically unnecessary lab and ancillary testing; provider relationships with pharma and outside laboratories; and overutilization of ancillary services. Specifically, she indicated that now more than ever, through the use of data analytics, healthcare provider practices were being scrutinized via peer to peer prescribing comparisons; analysis of average morphine mg equivalents (MME) per patient per day; determination of incidence of patient overdose/death within 60 days of receiving an opioid prescription; and examination of the number of patients “doctor shopping” within the practice.

Significant federal responses to the opioid crisis were discussed and include:

• 6/2017: FDA asks Endo International to withdraw Opana ER from the market
• 8/2017: Opioid Fraud & Abuse Detection Units launched
• 9/2017: FDA shuts down 500+ websites illegally selling unapproved versions of opioids
• 10/2017: Last shipment of Opana ER into the market. Trump declaration re national public health emergency – emergency funding unlocked
• 11/2017: Commission on Opioids – 56 recommendations
• 2/2018: Prescription Interdiction & Litigation (PIL) Task Force
• 6/2018: Largest HCF enforcement takedown in DOJ history
• 10/2018: Appalachian Regional Prescription Opioid (APRO) Strike Force announced

Examples of recent noteworthy Federal & State opioid initiatives:

• FL: Prescriber must consult PDMP prior to prescribing controlled substances
• AR: Require physicians to explore alternative treatments when prescribing 50 MME/day
• AR: Require physicians to avoid raising a patient’s dosage over 90 MME/day and carefully justify a decision for such a high dosage when prescribed
• AZ: 5-day limit on new Rx of opioids for patients that have not had Rx in 60 days; dosage limit of 90 MME/day.
• AZ: Prescribers can no longer dispense opioids directly to patient

Clearly, opioid fraud and abuse detection and enforcement efforts are full steam ahead. It is imperative that healthcare teams ensure compliance by creating policies, using models such as the CDC guidelines, that are in line with federal and state regulations, as well as DEA and state medical board mandates. The opioid regulatory environment is ever-changing and providers must be educated on these changes and kept up-to-date on current prescribing requirements for opioid therapy.

Managing Your Organization’s Response to a Federal Government Investigation with Josephine Harriott and Precious Gittens.

In this highly informative session, the panelists walked participants through common indicators of a government investigation, suggested due diligence efforts to detect fraud and recommended appropriate company responses after fraud is detected. Ms. Harriott advised healthcare providers/systems must be proactive and ensure compliance by way of proper monitoring (both automated and non-automated), auditing and taking reasonable steps to have a system whereby employees and agents may report potential or actual criminal conduct without fear of retaliation.

Ms. Gittens recommended the following when performing a company internal investigation:

• Properly scope the project
• Plan for an independent, objective review conducted by qualified personnel
• Targeted – determine what is necessary to answer the questions posed
• Use historical AND real-time data to determine if the issue is ongoing
• Appropriately document audit findings and a plan for how the company will use the findings (remediation)

ALN Consulting appreciates the crystal-clear message imparted by all presenters at the Healthcare Enforcement Compliance Conference – healthcare providers must have a robust compliance plan in place for the prevention of fraud and abuse, proactively audit that plan, take prompt action to halt any issues, perform root cause analysis to determine failure points and fix what went wrong. We are proud to be a part of the HCCA community and appreciate our new and ongoing partnerships with colleagues in the compliance industry. The ALN Consulting team is a leading provider of medical-legal consulting services nationwide. Contact us today to add our expertise to your next compliance matter.