Anjali Downs Quoted in "Evolution of Healthcare Industry Poses New and Ongoing Compliance Risks in 2019"

Legal experts focusing on healthcare compliance say there will be plenty to keep healthcare risk managers busy in the coming months, with more emphasis on telemedicine, electronic health records (EHRs), and opioids. The continuing move to value-based care also is creating new challenges for compliance with laws that were designed in a fee-for-service era.

The challenges in healthcare compliance continue to expand, says Anjali N.C. Downs, JD, an attorney with the Epstein Becker Green law firm in Washington, DC. Healthcare entities must focus on cybersecurity to ensure that they have robust systems in place to protect the privacy and security of patient and consumer data, she says.

“In addition, EHR compliance will remain front and center. Medicare providers must meet the interoperability requirements, and in light of recent settlements, ensure that their EHR technologies are compliant. Fraud and abuse enforcement with an emphasis on criminal enforcement will continue to expand, as will an emphasis on individual liability in civil corporate investigations,” Downs says. “The opioid crisis will continue to receive government attention, and fraud enforcement in the opioid context is likely to expand beyond just federal healthcare payers.”

Downs says she is hopeful that 2019 will bring new Stark Law and Anti-Kickback regulations focused on easing the regulatory burdens and promoting value-based payment methodologies. Until then, healthcare entities wanting to focus on care coordination and value-based systems must continue to navigate the rigidness of fraud and abuse laws that were designed for fee-for-service payment methodologies.

“Expect regulatory reforms that are focused on drug rebates. The Office of the Inspector General of HHS issued a proposed rule restricting Anti-Kickback safe harbor protection for pharmaceutical rebates from manufacturers to Part D plan sponsors, Medicaid managed care organizations, and contracted PBMs [pharmacy benefit managers], while expanding protection for point of sale rebates that meet specific elements of the safe harbor,” Downs notes.

“If adopted, the proposed rule would go into effect Jan. 1, 2020, so those impacted by the proposed rule must watch developments to ensure that they have made any necessary adjustments or restructuring.”

In addition to the Anti-Kickback Statute, which will continue to play a role in fraud enforcement in the opioid crisis, the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) contains specific criminal provisions to prevent fraud and kickbacks for referrals for substance abuse treatment payable by federal healthcare programs and commercial payers, Downs notes. EKRA appears to have a broad reach, potentially implicating all arrangements for laboratory services, she says.

“Likewise, as evidenced through the DOJ’s actions in seeking a permanent injunction against prescribing and practicing medicine of two physicians in Ohio, federal and state governments will continue to aggressively pursue fraudulent schemes in which providers write illegal prescriptions or submit claims to Medicare, Medicaid, TRICARE, and private insurance companies for treatments that were medically unnecessary,” Downs says.

Healthcare entities need to remain vigilant in staying on top of changing regulations and analyzing how those changes may impact operations and compliance activities, she says.

To address cybersecurity concerns, organizations should assess current practices and consider having a formal risk assessment and review of current cybersecurity infrastructure.

Regarding the opioid crisis, organizations should review and audit physician prescription practices, marketing activities, and relationships with vendors and substance abuse treatment facilities, she suggests.