On May 16, 2016, President Obama signed into law the Defend Trade Secrets Act of 2016 (DTSA). The new law takes immediate effect and will provide important new federal protections against unauthorized disclosure of proprietary and confidential business information. However, one provision of DTSA immediately affects employers and other parties using confidential information and non-disclosure agreements with employees and independent contractors.Read More
The Equal Employment Opportunity Commission issued final regulations on Wednesday that place limits on financial incentives used in certain employer-sponsored wellness programs. The two rules issued under the ADA and GINA, essentially limit such incentives or penalties to 30 percent of the cost of employee-only group medical coverage. Wellness programs that require employee or spouse medical examinations, or disclosure of family medical history, cannot include financial terms that reward or punish employees beyond this level based on their participation decision.Read More
Section 1128 of the Social Security Act (42 U.S.C. 1320a–7) (available here) established mandatory and permissive authority for exclusion of health care providers from federal health care programs based on provider conduct. In April 2016, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an updated list of non-binding criteria for evaluation of provider exclusion under the permissive exclusion authority (the “Exclusion Guidance”). The new Exclusion Guidance is available here. The Exclusion Guidance (i) establishes a presumption of exclusion for any provider who defrauds a federal health care program, (ii) contemplates that the presumption may be rebutted, and (iii) sets forth a list of criteria to be used by the OIG in making a determination whether to seek exclusion.
In applying the Exclusion Guidance, the OIG assesses whether the entity presents a future risk to a federal health care program One of the considerations is an evaluation of the provider’s history of compliance. Lack of a preexisting compliance plan that incorporating the U.S. Sentencing Commission Guidelines Manual’s seven elements of an effective compliance program (available here) indicates that a provider presents a higher risk to the federal health care program supporting exclusion. On the other hand, if the provider has a history of “significant self-disclosures made appropriately and in good faith,” the provider presents a lower risk. The fact that the provider has a preexisting compliance plan alone (in the absence of a history of self-disclosures) does not impact the risk assessment.
Health care providers are subject to a broad range of laws and regulations requiring the development of internal policies and plans to ensure training, ongoing compliance and appropriate response to suspected violations. Parker Poe’s attorneys understand the complex requirements of these laws and regulations and work closely with our health care clients to conduct a risk assessment to identify the appropriate scope of compliance plans, to design and implement those plans, to design training for staff, and to develop procedures to monitor for compliance. When suspected violations of the compliance plan are identified, we work with clients to appropriately investigate and address any non-compliant activity.
The Affordable Care Act (sometimes referred to as Obamacare) included a requirement for providers to report and return all Medicare and Medicaid overpayments within 60 days of identification. Although this requirement has been in effect since 2010, the Centers for Medicare and Medicaid Services (“CMS”) has proposed but failed to promulgate rules serving to further clarify this requirement. On February 12, 2016, CMS published a final rule, which went into effect March 14, 2016. The final rule applies to Part A and Part B of Medicare.
On March 11, 2016, CMS proposed implementation of a new two-phase model for drugs reimbursed under Part B of the Medicare Program (“the Proposed Model”). Drugs reimbursed under Part B include drugs administered in hospital outpatient departments or in physician offices. The purpose of the Proposed Model is to test alternative drug payment designs with the goal of (i) reducing overall costs to the Medicare program, and (ii) enhancing quality of care.Read More