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 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.
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 specific criteria. Pharmacy Monitoring Systems are regulated by individual states, each imposing its own unique requirements for reporting.
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 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.”
Today, the United States Department of Justice announced by press release its formation of Operation Synthetic Opioid Surge (S.O.S.). An objective of SOS is the reduction of dangerous opioids in particular areas of focus, to identify wholesale distribution networks, and to locate suppliers.
The Opioid Crisis
Opioids are medications that affect the nervous system and/or specific receptors in the brain, for the purpose of reducing pain. In the late 1990s, based on assurances from the pharmaceutical industry that patients were not likely to become addicted to pain relievers, physicians began to prescribe opioids at a higher level than in prior years. Increased prescriptions led ultimately to widespread misuse of opioids. Later, it became clearer to the medical community that opioids can be highly addictive.
Genetic testing companies, such as 23andMe, have become a craze in the United States within the last 10 to 15 years. 23andMe was formed with the purpose of informing its customers of their genetic health risks, carrier status, and ancestry information. After collecting DNA from saliva, the DNA is sent off to research labs that perform qualitative genotyping–the process of discovering variants in DNA. The genetic tests that 23andMe runs analyze the donor’s DNA, RNA, chromosomes, proteins, and metabolites to determine mutations and changes in chromosome structure. This genotyping allows the labs to discover the customer’s genetic information and background.
Many citizens remain wary of using such resources due to a fear that employers and health insurance companies will use the genetic information for discriminatory purposes. In 2008, the Genetic Information Nondiscrimination Act (GINA) was passed to combat this potential discrimination and protect those employees or insured persons. Continue reading
As trial counsel in Soo Hyun Engineering USA, LLC v. KG USA, Inc., Case No. 16-CV-0644, Troup County Superior Court, wherein the plaintiff sought in commercial litigation a recovery of approximately $1 million, our firm recently obtained dismissal of the lawsuit following our filing of a motion for summary judgment. Kevin Little, a partner in Hamil Little, represented the defendant.
House Bill 1, Haleigh’s Hope Act, went into effect on April 16, 2015. HB 1 makes it lawful to possess up to 20 fluid ounces of low-THC oil, commonly known as “medical marijuana.” On May 8, 2018, Governor Deal signed House Bill 65, which expanded the conditions medical marijuana could be used to treat. As a consequence of HB 65’s expansion, it is likely that more employees will be allowed to possess and use medical marijuana.
Does this mean that you must permit your employees to possess and use medical marijuana while at work, and if you terminate their employment, you are committing disability discrimination?
Kevin Little speaks to audiologists and speech pathologists at the American Academy of Private Practice in Speech Pathology and Audiology’s Annual Business Conference in Atlanta, regarding building an ancillary healthcare practice with a vision to sell it.
Healthcare employees filed the fourth largest number of sexual harassment claims with the EEOC from 2005 to 2015, according to Jocelyn Frye, a senior fellow at the Center for American Progress. As a result of the #MeToo movement, many healthcare organizations in Georgia are rethinking their sexual harassment policies, and employees are educating themselves on their rights. This post examines Georgia employees’ rights and how Georgia employers can reduce sexual harassment in the workplace.
Georgia Discrimination Laws
Georgia’s employment discrimination laws protecting employees in the private sector are limited to age, wage, and disability discrimination. Although Georgia’s Fair Employment Practices Act covers a wider range of protected classes, it only applies to state agencies with fifteen or more employees.
The United States Department of Justice issued a press release on March 28, 2018 regarding the sentencing of Sandra Parkman, age 63, for Medicare fraud. Our business and health care law firm follows developments in the fraud and abuse legal arena. The DOJ, as well as numerous other Federal and state law enforcement agencies, are continuing with their push to crack down on offenses they determine to constitute “fraud and abuse” under applicable statutes and rules.
United States District Judge Kurt D. Engelhardt of the Eastern District of Louisiana sentenced Ms. Parkman to 32 months in prison. Additionally, she was ordered to pay $277,197 in restitution. Ms. Parkman elected to go to trial in her case. There was a three-day jury trial. At trial, the government presented evidence that Ms. Parkman engaged in a scheme to provide durable medical equipment (DME) that was not medically necessary to federal program beneficiaries in the New Orleans area. The owner of a DME supply company, Tracy Browns, a co-defendant in the case, allegedly paid kickbacks to Ms. Parkman to provide information of eligible Medicare beneficiaries and to obtain physician signatures on order forms for the DME in question. Brown was convicted in a separate trial and sentenced to 80 months in prison.