Little Health Law Blog

FDA Addresses Digital Health Advances

August 25, 2017 | Little Health Law

doctor In late 2016, the 21^st 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.

Cybersecurity: Is your patient information susceptible to a cyberattack?

July 28, 2017 | Little Health Law

data-storage-1-1155466-m If you are like most of the healthcare industry, the answer is “yes” according to a recent study by the United States Department of Health and Human Services. The department’s Health Care Industry Cybersecurity Task Force report, a result of the work of 21 cybersecurity experts, was issued in late spring and found that this most private of information is at significant risk of being compromised by malware or cyber hacking. “HHS task force says healthcare cybersecurity in ‘critical condition’,” according to Jessica Davis from Healthcare IT News.

The task force reported that the health care industry was breached by cyberattacks more often than any other industry in 2015. Combined with the increase in ransomware attacks the following year, the report found that sensitive patient information is at high risk of attack. The report listed several contributing factors. These include the idea among smaller entities that they are relatively safe from these attacks, because attackers target larger health care providers. This has proven false. Because the health care industry is so interconnected and interdependent, the industry’s cyber safety is only as “secure as the weakest link.” Id. Basically, if the would-be attacker can gain access to anyone within the system, it can probably access all who do business within that system. Furthermore, the report found that due to staffing shortages, three-fourths of hospitals do not have anyone dedicated to these security issues.

July 26, 2017, Lee Little speaks to local artists at Arts Business Workshop sponsored by the Greater Augusta Arts Council regarding incorporating and setting up arts businesses

July 26, 2017 | Little Health Law

Lee Little speaks to local artists at Arts Business Workshop sponsored by the Greater Augusta Arts Council regarding incorporating and setting up arts businesses.

Interstate Medical Licensure Compact: Will Georgia physicians soon be able to share their expertise with more patients?

July 14, 2017 | Little Health Law

861958_hidoc-on-white 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.

July 11, 2017, Lee Little is a speaker/panelist, American Health Lawyers Association Considerations for Academic Medical Centers in Developing Clinically Integrated Networks and ACO’s

July 11, 2017 | Little Health Law

Lee Little is a speaker/panelist, American Health Lawyers Association Considerations for Academic Medical Centers in Developing Clinically Integrated Networks and ACO’s.

U.S. Opioid Crisis and the Effects on Pain Management Clinics

June 30, 2017 | Little Health Law

pills-2-300x225 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.

AMA Announces Physician Ownership of Medical Practices Drops Below 50%

June 13, 2017 | Little Health Law

medical-doctor-1314903-m1 Traditionally a hallmark of success for many physicians, physician ownership of medical practices continues to decline, for now, according to a recent study by the American Medical Association (AMA). The AMA recently issued the results of a survey, entitled Policy Research Perspectives, Updated Data on Physician Practice Arrangements: Physician Ownership Drops Below 50%.

Physician and Medical Practice Attorneys

The survey evaluated, among other things, whether physicians fall into one of four categories as to a physician’s “main” practice: (1) whether the physician is an owner, employee, or independent contractor of the medical practice; (2) the type of medical practice; (3) ownership structure of the practice; and (4) how many physicians are in the practice. The information and data reviewed spanned the period from 2012 to 2016. The survey results confirm a continued trend favoring employment and larger practices. 2016 was the first year with survey results demonstrating that less than half of practicing doctors (about 47%) own their own practice. Surveying over 30,000 physicians, the survey excluded physicians who work less than 20 hours/week providing patient care or are Federal employees.

June 5, 2017, Kevin Little speaks to American Osteopathic Association physicians on, Physician as W2 or 1099? Why Proper Legal Classification of a Physician as “Employee” or “Independent Contractor” is Essential

June 5, 2017 | Little Health Law

Kevin Little speaks to American Osteopathic Association physicians on, Physician as W2 or 1099? Why Proper Legal Classification of a Physician as “Employee” or “Independent Contractor” is Essential.

FQHC Suffers Monetary Consequences for HIPAA Violations

May 9, 2017 | Little Health Law

files A Denver area Federally Qualified Health Center (FQHC) must pay $400,000 in fines and implement a corrective action plan for HIPAA violations that resulted from a hacker’s breach into the health center’s employee emails. The breach led to theft of electronic protected health information (ePHI) of 3,200 individuals. Although the HIPAA violations were a result of a malicious breach, Metro Community Provider network (MCPN) was found at fault by OCR officials after OCR’s investigation showed MCPN did not conduct a risk analysis of its ePHI environment and waited another two months after discovery of the breach to conduct a risk analysis. MCPN had no system of risk management in place to determine what vulnerabilities the center was susceptible to.

Georgia Healthcare and HIPAA Compliance Lawyers

The HIPAA Privacy Rule was enacted to protect patient health information and secure for patients more control over the use of their private information. Under Federal law, healthcare businesses have a strict obligation to protect the information of patients. While there is no private cause of action for violations of HIPAA, complaints can be filed with the Office of Civil Rights (OCR) of the Department of Health and Human Services (HHS), states’ Departments of Health, federal third-party Payors (Medicare, TRICARE, VA, etc), state licensing boards, and, in some cases, state law may provide a cause of action for individuals under specific state privacy laws. Such complaints can lead to investigations, fines and other negative consequences for a healthcare professional or practice.

Convictions Will Stand for Mental Health Employees in $200 million Medicare Fraud Case

April 26, 2017 | Little Health Law

gavel-952313-m The Eleventh Circuit Court of Appeals denied an appeal and upheld the convictions of a physician assistant and a patient recruiter in Florida for their actions in allegedly defrauding the Medicare program of $200 million in false claims. Both the physician assistant, Roger Bergman, and the patient recruiter, Rodolfo Santaya, worked for American Therapeutic Corporation based out of Miami. ATC provides psychiatric care for patients with mental illness.

Medicare Fraud

Bergman was alleged to have submitted false claims to the Medicare program by falsifying patient documents to make it appear that the patients were eligible for the programs offered at ATC, but in fact they were not. In addition, Bergman submitted false patient documentation that stated Medicare-eligible care was given to patients when no such services were ever provided. Claims for payment from the Medicare program for false or ineligible services were billed by ATC and paid out to the company. Santaya’s alleged role in the fraud scheme was to go to low-income neighborhoods, apartment complexes, and retirement homes to recruit disabled or elderly patients to ATC, receiving up to a $45 kickback for each patient obtained. The patients brought in by Santaya would be ineligible for the outpatient psychiatric care provided by ATC or did not even have medical needs necessitating psychiatric care at all. Santaya was alleged to have focused only on Medicare beneficiaries in his recruitment efforts and instructed the patients to lie about their symptoms in order to administer billable services to them. The subject convictions and sentences affirmed by the Eleventh Circuit are 15 years for Bergman and 12 years for Santaya.