The recent ruling from the U.S. Court of Appeals for the Fifth Circuit on the case of Alliance for Hippocratic Medicine v. Food & Drug Administration is engendering notable responses from various state attorneys general. The court’s decision, released on Wednesday, stipulates the cessation of mail-order access to the FDA-approved abortion pill, Mifepristone. The judgement,…
In a turn of events that brings some relief to healthcare consumers, approximately 43,000 former patients of Santa Clara Valley Healthcare in California could potentially receive bill corrections and refunds. This comes as the health system, which incorporates a network of primary and specialty clinics as well as three acute care hospitals including Santa Clara…
Attorneys often grapple with the line between professional conduct and personal relationships when dealing with clients. This has led to debates on whether friendship between lawyers and their clients is acceptable or not. According to an article on Above the Law, lawyers are generally free to develop friendships with their clients, as long as there…
Following the dismissal of Johnson & Johnson’s second talc bankruptcy, plaintiffs’ lawyers are showing a renewed commitment to their plans of pursuing trials nationwide. The leading attorneys in the talc multidistrict litigation, have suggested a bellwether trial plan in a letter to the judge on August 11. This proposed strategy includes the pursuit of consolidated…
In the realm of employment law, July 2023 has marked several important decisions by Californian courts. The following are summaries of key judgments, unpacking their implications for legal professionals working in multinational corporations and the foremost law firms. Kuciemba v. Victory Woodworks Inc., 14 Cal. 4th 993 (2023): The details of the case remain undisclosed,…
The No Surprises Act (NSA), a landmark piece of legislation affecting the healthcare industry, has been in effect since January 2022. Despite its intent to mitigate the financial strain of unexpected medical bills for patients, the act has continuously faced litigation initiated by healthcare providers since its implementation. Both state and federal agencies are scrutinizing…
Mary L. Smith has made history becoming the first Native American female president of the American Bar Association (ABA), the largest voluntary bar association across the globe. Smith, who is also vice chair of the VENG Group—a national consulting firm—and a remarkable figure in healthcare executive leadership, assumed her new role at the ABA on…
The issue of women’s reproductive health access has never been more pivotal, with the Medicaid Market presenting a growing investment opportunity both ethically and financially. A recent article by Manatt, Phelps & Phillips, LLP underlines the critical role Medicaid plays in providing healthcare coverage to women at their childbearing age. As it stands, the Medicaid…
From the moment an employee shares the thrilling news of their pregnancy, a myriad of legal considerations loom for employers. Yes, it’s time for celebration, but for corporate legal teams, it’s also a reminder of the vast array of pregnancy-related legal protections that need strict adherence. To breeze through this transition and ensure compliance, here’s…
As the global pandemic continues, we find ourselves in the midst of a medical device and equipment shortage. The shortage has compelled medical providers to invest heavily in alternative sterile medical products and, in some instances, to implement rationing. Amidst these already tense dynamics, the FDA has requested that the EPA pump the brakes on…
In a recent development, the US Department of Health and Human Services Office of Inspector General (OIG) has shared Advisory Opinion No. 23-04 on per-click marketing arrangements involving online healthcare directories. This move is highly significant for legal professionals, both in the corporate world and in law firms, given its implications for online healthcare marketing…
In what can be considered a major victory for the federal government, the Association of Air Medical Services’ case against the No Surprises Act encountered a defeat at summary judgment. This occurrence marks the government’s first distinction in the fold of court challenges against the No Surprises Act. The case was decided in U.S. District…
The Centers for Medicare and Medicaid Services (CMS) continue to make their mark on hospital price transparency regulations as they recently issued three civil monetary penalty (CMP) notices. The CMP notifications were administered due to violations of the Hospital Price Transparency (HPT) Rule. For context, the HPT Rule calls for hospitals to publicly disclose their…
The Office for Civil Rights (OCR) under the U.S. Department of Health and Human Services (HHS) recently proposed amendments to the HIPAA guidelines, specifically the Standards for Privacy for Individually Identifiable Health Information (the “Privacy Rule”), as indicated by an April 17, 2023 release. This proposal pertains to the Health Insurance Portability and Accountability Act…
Repercussions of the patent application disclosure process for medical device companies intending to profit from their inventions has long been under-discussed. Industries across the board have the shared experience of navigating two agency approvals, one from the U.S. Food and Drug Administration (FDA), and another from the U.S. Patent and Trade Office. Recently, a fascinating…
In a recent turn of events, the Office of the Attorney General (OAG) in Texas has concluded a settlement of $42.7 million with six of Takeda Pharmaceutical Co.’s subsidiaries, effectively resolving the allegations that these companies perpetrated Medicaid fraud, disobeying the Texas Medicaid Fraud Prevention Act (TMFPA). This information was obtained from an article on…
Mark your calendars for the upcoming Regional Healthcare Compliance Conference, slated for September 8th in Waltham, Massachusetts. This event, orchestrated by the Health Care Compliance Association (HCCA), aims to provide local compliance education to practitioners in the region. The conference will span a wide variety of highly relevant topics designed to impact compliance programs in…
Connecticut Governor Ned Lamont signed into law Public Act 23-204 on June 27, 2023. This Act, dubbed “An Act Concerning the State Budget for the Biennium Ending June 30, 2025, and Making Appropriations Therefor, and Provisions Related to Revenue and Other Items Implementing the State Budget,” contains multiple components crucial to the healthcare sector, mainly…
In a recent development underscoring the focus on fraud in Part C by the U.S. Department of Justice (DOJ), it was announced last week that Martin’s Point Health Care, Inc. (Martin’s Point) has settled allegations of False Claims Act (FCA) violations to the tune of $22.4 million. The case against Martin’s Point emphasized its submission…
The global trend toward the application of artificial intelligence (AI) in a multitude of sectors seems inexorable. Health care providers are no exception to this, increasingly testing the waters of machine learning and generative AI, majorly in the patient care realm. While the potential benefits of this technological evolution are compelling, these explorations raise certain…
Study pre-screening and recruitment initiatives in the healthcare industry have increasingly moved towards the digital paradigm, presenting a range of critical considerations. This digital transformation carries a host of implications for sponsors, contract research organizations (CROs), research sites, regulators, and patient advocates involved in fostering successful and timely enrollment of study subjects. The following elaboration…
The Illinois Legislature has recently passed a bill, HB2222, that promises to implement greater oversight on healthcare transactions, a move that will undoubtedly be of keen interest to legal professionals within the healthcare sector. Should this new piece of antitrust legislation receive the governor’s signature, it will demand that “covered transactions” between healthcare facilities and…
In an effort to enhance transparency within the nursing home sector, the Centers for Medicare & Medicaid Services (CMS) have commenced publishing affiliations of nursing home on Nursing Home Care Compare. The undertaking by CMS aims to facilitate consumers in identifying related institutions in a more streamlined manner, in addition to enabling an understanding of…
Between November 13th and 16th, the Healthcare Basic Compliance Academy will take place in Denver, CO. The event is built to cater to professionals who are already equipped with some compliance knowledge and experience. Initiated by the Health Care Compliance Association (HCCA), the academy is a choice platform for practitioners who are on the threshold…
For legal professionals across the globe, it’s imperative to stay updated with recent developments in legal news. One such noteworthy announcement is the suspension of the arbitration process for “Surprise Billing” put in place by the “No Surprises Act”. This marks the second time the Centers for Medicare & Medicaid Services (CMS) has opted to…