The importance of an effective compliance program for healthcare organizations cannot be overstated. Under the Affordable Care Act, compliance programs are mandatory for healthcare providers that participate in the Medicare or Medicaid program. For decades, the Department of Health and Human Services Office of Inspector General (OIG) has instructed healthcare organizations to implement effective compliance programs. Moreover, a robust compliance program provides immense benefits to healthcare organizations by reducing the likelihood of unlawful or unethical behavior, providing a mechanism for employees to report problems allowing for internal inquiry and corrective action, and potentially minimizing financial losses to the organization through early detection of issues.
Healthcare fraud and abuse is a high priority issue for the federal government, and there has been a tremendous increase in the complexity of the healthcare regulatory landscape over the past two decades. Moreover, financial penalties for noncompliance can be enormous, and they continue to increase. Given the importance of a strong compliance program, it’s imperative that health care attorneys are up-to-date on recent developments in healthcare compliance.
Erin Atkins and Rachel Yount of Arent Fox will provide an overview of the seven elements of an effective compliance program, the OIG’s compliance program guidance for specific provider types, and recent Department of Justice and OIG guidance on implementing healthcare compliance programs. The course will also provide practical tips for both healthcare organizations in the early stages of developing a compliance program and healthcare organizations with compliance programs already in place.
Erin’s practice focuses on counseling pharmaceutical and device manufacturers and their customers on statutory and regulatory compliance, reimbursement, and transactional issues related to the Medicare, 340B, and Medicaid programs.
Erin also provides her clients with fraud and abuse counseling under the federal Anti-Kickback Statute. In addition, Erin’s practice extends to counseling on Medicare Part D matters, advising clients with respect to compliance program operations, and representing her clients in contract negotiations. Erin’s clients include health care providers (including long term care providers and pharmacies), brand and generic pharmaceutical manufacturers, medical device manufacturers, and independent patient assistance charities.
Rachel Yount is an associate in the Health Care group at Arent Fox where she regularly advises clients on compliance with health care fraud and abuse laws, with an emphasis on the Stark law and Anti-Kickback statute. She also advises clients on internal and external investigations, particularly investigations related to the False Claims Act, as well as on reimbursement issues, licensing requirements, and other compliance matters. She assists clients with drafting, implementing, and evaluating compliance programs.
Additionally, Rachel routinely represents health care providers in significant reimbursement and coverage disputes with government payers, managed care companies, health insurers, third-party administrators, Medicare Advantage plans, and employer-sponsored health plans. Her work frequently addresses issues that arise under ERISA, COBRA, the Affordable Care Act, and the Medicare Secondary Payer Act.
Rachel also monitors and advises pharmaceutical manufacturers on recently-enacted state laws affecting drug pricing transparency laws.
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