Category:Healthcare Compliance
Exploring the Ramifications of the Department of Justice’s Withdrawal from Health Care Antitrust Guidelines
On February 3, 2023, the Department of Justice (DOJ) formally withdrew its support for three policies that created longstanding safe harbors from antitrust enforcement, relied upon by the healthcare industry for nearly thirty years. Assistant Attorney General, Jonathan Kanter, of the DOJ’s Antitrust Division stated that these changes were “long overdue”, and that the, “[DOJ] will continue to work to ensure that its enforcement efforts reflect modern market realities.” In striking these guidelines, the DOJ notably left no new guidelines in its place, leaving many healthcare providers and purchasers uncertain of whether they will face litigation or even criminal prosecution under the Sherman Act.
The FTC’s Enforcement Action: GoodRx’s Failure to Protect Its Customers’ Personal Health Information
On February 1, 2023, the Federal Trade Commission (FTC) brought an enforcement action against GoodRx, a provider of telehealth and prescription drug services at discounted rates. In a first-of-its-kind action, the FTC alleged that GoodRx violated the Health Breach Notification Rule (HBNR) by sharing their consumers’ confidential health information with several advertising companies. While GoodRx is already facing a $1.5 million penalty for the violation, the FTC has also proposed an order that will require GoodRx to remedy the situation and make several changes to protect confidential health information in the future.
The Future of Telemedicine: Controlled Substance Proposed Rule
On January 31, 2020, the Secretary of the Department of Health and Human Services issued a public health emergency as a result of COVID-19. The emergency declaration requires public health professionals, first responders, and public officials to work together to minimize death while preventing illnesses. The declarations provided the government with the flexibility to waive or modify standard requirements as it relates to both public and private insurance, service providers, and authorizations including telehealth. Telehealth provided access to healthcare to those who face barriers as well as flexibility in being able to manage care while reducing the spread of COVID-19 along with other infectious diseases. There remained uncertainty regarding the freedom to prescribe controlled substances via telemedicine with the Biden administration set to end the public health emergency on May 11, 2023. However, on February 24, 2023, the Drug Enforcement Administration (DEA) released a proposed rule that aims to permanently extend controlled substance prescribing flexibilities.
AI-ming for Better Healthcare: Legal Issues in Healthcare AI Usage
Artificial intelligence (AI) is a simulation of human intelligence that is subsequently processed by machines. It has revolutionized the healthcare space by improving patient outcomes in a variety of ways. It has also begun to leave a positive impact in health systems and hospitals as healthcare worker burnout remains on the rise. However, there are significant legal challenges that accompany its groundbreaking nature. Hospitals and health systems have a duty to mitigate these legal challenges and understand that AI should be used as a supplement, not a replacement, to human intelligence.
AI Nancy Drew, Is That You?
The United States spends more money per person on health care than any other country, approximately $4.2 trillion in 2021. Unfortunately, our complex health care system and the large budget make fraud a significant concern for the U.S. Government, payers, and patients. The National Healthcare Anti-Fraud Association estimates that as much as 10% of annual healthcare spending is lost to scams, resulting in billions in losses yearly. To combat healthcare fraud, the Department of Health and Human Services Office of the Inspector General, in collaboration with state law enforcement and other governmental agencies has created special Strike Forces. These efforts have led to substantial recoveries of federal funds and criminal/civil prosecution of individuals or entities involved in Medicare and Medicaid fraud. Besides avoiding unnecessary or fraudulent claims, individual healthcare payers are motivated to prevent fraud due to severe penalties associated with the False Claims Act, Anti-Kickback Statute, Physician Self-Referral Law (Stark Law), and Civil Monetary Penalties Law. How can individual payers detect and try to prevent fraud? The answer is AI.
Biden Ties Medicare Reimbursement to Sepsis Treatment
The Centers for Medicare and Medicaid Services (CMS), under the Department of Health and Human Services (HHS), finalized CMS-1785-P in August, a rule that links Medicare reimbursement to the treatment of sepsis. Previously, hospitals were required to report on their sepsis treatment patients, but there was no penalty for not adhering to treatment guidelines. Beginning in Fall 2024, hospitals must meet the specific treatment benchmarks integrated into Medicare’s Hospital Value-Based Purchasing Program (MHVBPP) specifically the provisions outlined in the Severe Sepsis/Septic Shock Management Bundle (SEP-1). Failing to meet these benchmarks could result in significant financial losses for hospitals, ranging from thousands to millions of dollars for larger entities. While hospitals should presently be aware of these requirements and implement plans to meet them, there are concerns about whether the proposed rule is the optimal solution for improving outcomes for sepsis patients.
The Attack on Gender Affirming Care: How Should Providers in Sanctuary States React?
The political debate surrounding Gender Affirming Care (GAC) is gaining momentum nationwide as 22 states have already enacted laws that restrict medical professionals from offering hormonal and/or surgical treatments to transgender minors. Despite endorsement and approval of this treatment by various medical organizations, such as the AMA, efforts to limit access for minors continues to press forward. Aside from the ongoing battle between politicians and medical providers, the constitutional implications of such legislation remain uncertain.
From Chatbots to Diagnosis: The Power and Pitfalls of AI in Healthcare
The capabilities of generative artificial intelligence (AI) could completely transform our healthcare system as we know it. For better or for worse, the technology advancements in healthcare are rapidly growing. Given the accelerated rollout, experts have yet to predict all the risks associated with such high-functioning computations in the healthcare system. Even though the Food and Drug Administration (FDA) regulates software being used as medical devices (SaMD), there is an overall lack of urgency, agency oversight, and sufficient regulations to tame AI technology in the healthcare system.
Neuropsychological Exams for Physicians: Good Practice or Discrimination?
Recent instances of politicians experiencing medical episodes in the public eye have sparked discussions regarding age limits for politicians. However, a parallel conversation is emerging about the healthcare professionals responsible for our well-being. About four years ago, a small number of health care institutions began implementing various forms of neuropsychological testing policies for older physicians. Since then – over the past few years – this practice has continued to grow and become increasingly controversial. The ongoing debate centers around determining the appropriate age to commence testing for physicians, the specific parameters to test for, and the ethics of mandating such testing. These questions remain subjects of ongoing debate, yet considering the rising demographic of physicians over the age of 60, there is a growing argument for integrating some form of neuropsychological examination.
Healthcare’s Red and Blue Pill: AI
Artificial Intelligence (AI) has gained widespread attention, often perceived as a buzzword. Recently, concerns about its potential dangers and issues with plagiarism have surfaced. However, AI holds immense promise for transforming industries reliant on data analysis and predictive algorithms, especially in healthcare. AI can significantly improve healthcare by aiding in diagnosis, optimizing patient outcomes, reducing costs, and saving time.