balance-1172800-1-300x204This month, the abrupt closing of four Tennessee pain management clinics under investigation for state and federal health insurance fraud made headlines.  Those clinics, formerly affiliated with PainMD and rebranded as Rinova, closed last week.  Federal authorities alleged that PainMD and its parent company inflated profits by providing patients with unnecessary injections to be paid by federal health insurance programs.  Authorities of the state of Tennessee initiated their own investigation, with concerns that the conduct of clinic personnel may violate state law.

Georgia Pain Management and DEA Defense Law Firm

In the PainMD pain clinic investigations, not only were the companies and clinic administrators at risk for financial penalties and reputational harm in connection with potential fraud, but so were the health providers who worked at those clinics.  Three PainMD nurses were indicted on federal charges in connection with procedures provided at the Tennessee clinics under investigation.

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gavel-952313-mThe Trend: Mandatory Arbitration

As a physician employee, you might be aware of the “arbitration agreement” that you signed with your employer upon your hiring. In the employment context, an arbitration agreement may in the view of your employer be a more efficient way to privately resolve legal disputes associated with your employment than litigation is. Therefore, many physician employers will include in their proposed employment agreement a mandatory arbitration provision. Arbitration agreements are facing backlash however, as critics claim that employers insisting on mandatory arbitration do not have incentives to obey labor laws.

Georgia Physician Employment Lawyers

Critics of arbitration agreements state that these provisions are a way for employers to compel an employee into waiving valuable legal rights, including the right to a jury trial. Mandatory arbitration provisions are often discussed and scrutinized by courts and legislators.  Some arbitration clauses have been held unenforceable by courts. In Epic Systems Corp. v. Lewis, for example, the arbitration clause at issue barred employees from suing their employers. In that case, the Court enforced the company’s mandatory arbitration clause, favoring corporations and employers, after employees banded together to sue their employers for damages because they were underpaid. Since the ruling, more questions have arisen regarding the enforceability of mandatory arbitration agreements. More cases have come forth of employees having disputes that fall under the Fair Labor Standards Act (FLSA), The Americans With Disabilities Act (ADA), The Family and Medical Leave Act (FMLA) and Title VII of the Civil Rights Act. Now, since the Epic Systems ruling, it is more difficult for employees to contest mandatory arbitration provisions that (in the view of some legal experts) might make it harder to bring certain types of legal claims against an employer.

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pill-shadows-1200049The 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.

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pills-2-300x225In 2017, the Georgia General Assembly passed House Bill 249, implementing several changes to the Prescription Drug Monitoring Program (“PDMP”). Bill 249 held that:

  1. Beginning July 1, 2017, dispensers are required to enter prescription information for schedule II, III, IV, V controlled substances within 24 hours. This will give prescribers efficient access to information faster and allow the prescriber to make the best decision possible for patients.
  2. All prescribers will be required to register in the PDMP by January 1, 2018.
  3. Beginning July 1, 2018, prescribers are required to check PDMP before prescribing opiates or cocaine derivatives in Schedule II drugs or benzodiazepines.

The goal of the new PDMP was for physicians to be able to detect which patients were obtaining multiple prescriptions for highly addictive drugs and identify which practitioners were prescribing unlawful dosages.

Our Georgia-based business and healthcare law firm follows developments in healthcare law.  Shelia Pierce, the opioid program coordinator and director of the PDMP for the Georgia Department of Health, contends that enrollment into the program has been very difficult. While 24,000 physicians have enrolled, 1,100 Georgia physicians have ignored the new law and have not enrolled in the drug monitoring program. The Georgia Composite Medical Board has not determined how to impose punishment on those physicians. Each physician would need to have a case built on them, have documents assembled, call people in to testify, and hold individual hearings. The Attorney General’s office is currently trying to determine how to proceed against the violators.

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US-SUP-CTThe 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.

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dark-dollar-2-1193021-mOf 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.

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1066058_patrol_hat_too1In 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 2018 National Health Care Fraud Takedown providing the following statistics, which reflect law enforcement efforts to combat healthcare fraud and abuse:

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device-digital-pen-6336-e1540845862509On 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 FDA and HHS memorandum of agreement renews the agencies commitment to coordinate, identify, and address cybersecurity risks that pertain to patient safety by agreeing to communicate and share information about data being stored on medical devices.

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1238683_untitledIn 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 specific criteria. Pharmacy Monitoring Systems are regulated by individual states, each imposing its own unique requirements for reporting.

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law-education-series-3-68918-mIn 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 announced that the change in guidelines will “help improve access to hospital price information” and “give patients greater access to their health information.” However, hospitals are contending that the new guidelines may be problematic as they do not show prices after negotiating with insurance companies.  Jeffrey Bomme, the chief legal officer at Adventist Health System, commented on the new guidelines stating the charges will not be relevant to patients because the bill may be reduced or some services may have no charge due to a hospital’s charity policy. These reported prices may also mean that patients neglect needed care because of the listed price and not the price that they may have to pay out of pocket, says Tom Nickels, executive vice president for government affairs and public policy at the American Hospital Association. Yet, the CMS feels as though the new rule will “incentivize value-based, quality care at these facilities.”

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