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.”
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
By 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.
The 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.
In 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.
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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.
Georgia 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.
The United States only holds about 5% of the world’s population yet is consuming 99% of the word’s hydrocodone, 80% of the world’s oxycodone, and 65% of the world’s hydromorphone; all powerful narcotics. Those statistics show themselves in the most disheartening of ways with an opioid epidemic that has 1.3 million Americans needing hospital care for opioid related issues and over 30,000 dying from opioid overdoses in one year alone, with the number climbing every year. The nation’s opioid crisis also costs the U.S. over $70 billion a year when accounting for healthcare costs, productivity loss, addiction treatment and the costs of criminal justice actions and resources. The nation’s epidemic has garnered a federal response in the form of CDC guidelines that are discouraging primary care physicians from prescribing opioids as a first line of defense (or only line of defense) for patients with chronic pain and instead encouraging the use of non-opioid and even non-drug treatments for pain. A DEA response shortly thereafter indicated production quotas would be enforced for Schedule II pain medications, reducing the production of some medications by a quarter or even a third.
Prescribing opioids for pain can be a routine part of medical treatment, however, opioids are a national dilemma and though patients may need them for pain management, they are also highly addictive. Some patients being administered these prescriptions are recovering from opioid addictions and face a high-risk of relapse. And, because some more unscrupulous health care providers use “pill mills” to make money, there is a strong push in many states to protect patients. This push has brought about a new idea – patient directives that notify providers NOT to prescribe or administer opioids to them.