The exposure and concern surrounding the opioid epidemic is at an all time high. Notwithstanding the urgency of the issue itself, this publicity places increased pressure on the intervening parties—sub-agencies of the Department of Health and Human Services, Department of Justice (DOJ) and state Attorney’s General—to implement regimens that make a difference. Our Georgia-based business and healthcare law firm follows developments that impact pain management physicians and medical practices.
At the Federal level, the DOJ is focused on taking steps to strategically intervene into physicians and pharmacies. Accordingly, the DOJ has expanded its enforcement to release a new tactic in the form of temporary restraining orders (TRO) against pharmacies that have violated the False Claims Act and the Controlled Substances Act. This tactic proved successful in a Tennessee District Court on January 13, 2019.
In 2017, the Georgia General Assembly passed House Bill 249, implementing several changes to the Prescription Drug Monitoring Program (“PDMP”). 
The highly anticipated “AseraCare” decision (United States v. GGSNC Admin. Serv. LLC) is still pending before the Eleventh Circuit Court of Appeals. The court is considering “whether a mere difference of opinion between physicians, without more, is enough to establish falsity under the False Claims Act.” To provide some context, the U.S. District Court evaluated the “falsity” element of the False Claims Act in the context of a hospice provider’s “clinical judgment” that a person meets the standard to be eligible for the Medicare Hospice Benefit. The requirement is that a patient be eligible for Medicare Part A and be “Terminally Ill” as defined by the regulation. “Terminally Ill” requires that the hospice Medical Director make a determination that the prognosis of the patient indicates a life expectancy of 6 months or less. So the issue is whether or not the “battle of expert opinion,” without some additional element, is enough to establish that a patient is not terminally ill rendering the subsequent Medicare reimbursement submissions false or fraudulent.
Of the “fraud and abuse” laws, the three decades old Ethics in Patient Referrals Act, 42 U.S.C. § 1395nn, dubbed “Stark Law” after Congressmen Pete Stark who sponsored it, can often be the most challenging to properly interpret and apply, easily leading to head scratching. The law as originally enacted was simple in concept: to remove any financial motivation for doctors to send their patients for unnecessary testing that could raise health care costs and/or result in bad health care. Now often subject to much criticism and even calls for repeal, Stark Law’s is often viewed as confusing, which is ironic because Congressman Stark intended for the law to create “bright line” tests that would provide clear guidance to physicians about what self-referral arrangements are unlawful. Instead, the evolution of the law over the years, including implementing regulations, advisory opinions and court cases have rendered proper interpretation and application of the law debatable and unpredictable in some circumstances.
In our Georgia business and healthcare law firm, we have noticed that cases involving Medicare fraud and billing compliance issues are published on virtually a daily basis, underscoring the critical need that physicians, nurses and other care providers and billing professionals exercise caution and vigilance in billing Medicare or other third party payers. For example, last week in Dallas, Texas, two physicians and three nurses were sentenced to prison for submitting fraudulent claims to Medicare through a home healthcare agency. The financial harm and potential billing fraud and serious “zero tolerance policy” of the Office of the Inspector and Federal Government for Medicare fraud has enhanced the financial and legal risks to healthcare providers and billing companies for all billing discrepancies. The OIG published its 
On October 16, the FDA’s Center for Devices and Radiological Health and Homeland Security’s Office of Cybersecurity and Communications announced a partnership to address cybersecurity issues related to the utilization of medical devices. As healthcare professionals continue to rely on computer-based systems to monitor and treat patients effectively, cybersecurity threatens providers and hospital systems. Confusion regarding the role of the FDA in medical device security, and questioning the accountability of manufacturers in terms of security issues, are two of the key factors concerning health IT professionals. The possibility of potential threats continues to grow alongside the need for data management for network security. The 
In July 2017, Georgia passed House Bill 249, transitioning the state’s Prescription Drug Monitoring Program (PDMP) from the Drug and Narcotic Agency to the Department of Public Health. “The goal of the Georgia PDMP is to reduce the misuse of controlled substances and to promote proper use of medications used to treat pain, as well as to help diminish duplicative prescribing and overprescribing of controlled substances,” said Georgia Department of Public Health Commissioner Patrick O’Neal, MD. The new mandates call for providers to utilize the PDMP system for prescriptions of opioid and benzodiazepine medications. Now, prescribers of CII medications are required to review a patient’s PDMP information every 90 days, unless the patient meets 
In early August, the Centers for Medicare & Medicaid Services (CMS) published an updated set of guidelines stating that hospitals will now be required to annually publish a list of charges online. CMS 
Genetic testing companies, such as