Telehealth compliance programs avoid and mitigate risk

The dramatic expansion of telehealth across the United States in response to the COVID-19 pandemic has allowed providers to continue servicing their patients during this stay-at-home era while minimizing disruption to their business. Telehealth expansion also has spurred innovation by enabling companies to harness technology, identify new ways of delivering patient treatment, collect and aggregate patient data, and lower costs associated with brick-and-mortar provider facilities.

While telehealth represents tremendous opportunity for providers, it also poses substantial risk. The current proliferation of telehealth services has been prompted, in large part, by changes to federal and state regulations and requirements in response to the COVID-19 pandemic. The shifting landscape and complex web of federal and state regulations make legal compliance for telehealth providers extraordinarily difficult. Moreover, even prior to the COVID-19 pandemic, federal enforcement authorities prioritized rooting out fraud in the telehealth industry, as evidenced by the prosecution in the past year of several telemedicine providers accused of improper billing, kickbacks, bribes and prescribing medically unnecessary drugs or devices.

The federal government is now providing hundreds of millions of dollars in stimulus funds to support the delivery of telemedicine services. The flow of federal dollars to telehealth providers and the overall visibility of this industry mean that law enforcement actively will pursue bad actors in this space, particularly those who seek to profit unlawfully from the circumstances created by the pandemic.

Implement strong compliance programs

Compliance programs are designed to prevent misconduct from occurring. They ensure that applicable laws and regulations are followed, provide mechanisms for reporting suspected misconduct, and set clear expectations and obligations for employees of an organization. Law enforcement authorities look to the adequacy of companies’ compliance programs in assessing culpability and criminal and civil penalties.

Given the current environment and the importance of compliance programs, telehealth providers should take immediate steps, with input from legal counsel, to implement effective and comprehensive compliance programs. Among other measures, providers should consider the following:

Implement/review written policies: Ensure that written policies are in place that expressly require compliance with applicable federal and state laws, regulations and requirements. Considering recent changes, policies put into place prior to the COVID-19 outbreak should be reviewed and revised as necessary.

Designate a compliance officer: Identify an individual to serve as a compliance officer to oversee the implementation of the organization’s compliance program. Designating a compliance officer is an important step in ensuring the allocation of adequate resources to implement a compliance program.

Train and educate: Conduct regular trainings of business management, administrative staff, physicians and other affected employees regarding existing compliance policies. Provide refreshers and updates to employees through newsletters, memoranda and the like.

Establish reporting mechanisms for suspected misconduct: Implement reporting mechanisms, such as an anonymous tip line, so employees at all levels of the organization can report instances of suspected wrongdoing. Put in place processes to act upon reports and to assess and investigate allegations.

Regularly audit/monitor compliance program: Conduct annual audits of the compliance program to assess compliance activity and effectiveness. In addition, stay apprised of changing laws and requirements to ensure that existing compliance policies are effective and up-to-date.

Ariel Glasner is a partner based in Blank Rome LLP’s Washington, D.C. office, specializing in white collar defense and government investigations. Jane Thomas is an associate in Blank Rome LLP’s Washington, D.C., office, where she concentrates her practice on insurance recovery and a wide range of general litigation matters. Send your legal questions to medec@mjhlifesciences.com.