Articles Posted in Healthcare Reform

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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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medical-doctor-1314902-mThe FDA has announced that it will begin requiring opioid manufacturers to provide more training for healthcare providers.  At present, manufacturers must provide training about long-acting, extended release opioids to prescribers.  In the future, the manufacturers of short-term and immediate release opioids will also be required to provide the same type of training.  The training will be available to physicians, nurses, and pharmacists.

This change was brought about by the continuing high rate of drug overdose incidents by prescription drug abusers, particularly those abusing opioid painkillers.  The training was previously only required by makers of long-acting opioids.  However, the FDA stated statistics show that today the vast majority, 90% to be exact, of opioid pain medication prescriptions are for the short-acting variety.  It has been found that abusers of opioids are misusing the short-acting, immediate release versions as well as the long-acting types.  After becoming addicted to the commonly prescribed short-acting versions of the medication, most abusers graduate to higher doses of the prescription drugs or move to illegal drugs, which present a lower cost alternative.

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doctorIn late 2016, the 21st Century Cures Act was passed to assist the FDA in keeping pace with the rapid changes in health care technology.  Our business and healthcare law firm, follows developments in the healthcare industry.

Among other things, this Act amended the definition of a “device” in the Food, Drug, and Cosmetic Act to remove some medical software functions.  The immediate result is that the FDA must draft new guidance for its oversight of software for medical devices.

Healthcare Technology Lawyers

Included in the concept of “Digital Health” are health information technology, wearable devices, personalized medicine, mobile health and telemedicine.  The FDA has recognized that these technologies are used to reduce cost and inefficiencies, improve care and access, and better tailor medicine to the individual patient.  Furthermore, patients can use the technology on their own to track and manage their own health activities.  The FDA acknowledged that new technology allows unprecedented opportunities for people to obtain and potentially share information that can result in significant improvements in health care.

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861958_hidoc-on-whiteGeorgia physicians seeking licensure in other states hope to benefit soon from a more streamlined process.  In fact, a bill was recently introduced in the Georgia House of Representatives to allow Georgia to join the growing number of states participating in the Interstate Medical Licensure Compact.  (House Bill 637). Such a bill, if passed by both houses of the legislature and signed into law by the Governor, would greatly simplify the process for Georgia physicians to obtain licenses in other member states, allowing a wider population of patients access to their services and expertise.  This type of bill would not change the existing methods of obtaining a license in Georgia but would provide an additional route.  Although the bill was not voted on, the effort indicates this type of change may be on the horizon.

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