Articles Posted in Healthcare Reform

medical-doctor-1314902-mAs technology improves the ability for providers to communicate, existing healthcare laws will continue to be put to the test. Now, a new call for care coordination is driving quality improvement initiatives for physicians and hospitals. In 2018, U.S. Department of Health and Human Services (HHS) launched its initiative “Regulatory Sprint to Coordinated Care,” to facilitate value-based healthcare and promote effective communication strategies between physicians. The Regulatory Sprint seeks to increase a patient’s ability to understand their treatment plan, promote coordination between providers, establish incentives for providers to coordinate efficient care, and encourage information-sharing between providers and facilities.

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The initiative highlights the importance of removing the barriers created by four federal healthcare laws: the Physician Self-Referral Law; the Federal Anti-Kickback Statute; the Health Insurance Portability and Accountability Act (HIPAA); and substance-disorder treatment rules stemming from 42 CFR Part 2. Previously, critics have claimed that the monetary penalty provisions within the statutes prevent providers from being able to adequately coordinate care. In response, HHS has proposed Stark Law and Anti-Kickback reforms.

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pills-2-300x225More than 2,000 opioid lawsuits are pending nationwide. A large portion of these lawsuits target drug manufacturing companies for their contributions to the opioid epidemic that is plaguing the country.

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For example, in one case earlier this summer in Oklahoma, a judge ordered Johnson & Johnson to pay $572 million for the company’s contribution to the opioid crisis. Furthermore, over the next few months, other courts will continue to handle cases as state governments work diligently to mitigate the impacts that the opioid epidemic has had within their jurisdictions. Although Big-Pharma companies are being targeted in litigation, however, retail pharmacies, large and small, are gatekeepers for opioid prescriptions. Given the role of pharmacies, they might be used effectively to combat the opioid epidemic. The role of retail pharmacies in the battle against opioid addiction is crucial, but not necessarily recognized by city governments. A new databank from the DEA tracks opioids at a local level, and makes it possible for pharmacies to band together in understanding unique trends within their own communities.

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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.

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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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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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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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dna-1-1444488-300x300Genetic 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 ›

1238683_untitledBy press release on September 19, 2017, Massachusetts Attorney General Maura Healey announced the expansion of a pending review of an opioid related scheme to include additional manufacturers and distributors of opioids.  The investigation has been undertaken by a 39-member bipartisan group of state attorneys general, which was first announced earlier this past summer.  Our business and health care law firm follows developments in the pharmaceutical industry and our Country’s opioid addiction and overdose crisis that has led to many thousands of deaths and, in particular, related issues in Georgia and South Carolina.

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