BY Bradley S. Byars, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   Consider, for a moment, how dramatically our healthcare landscape has transformed in the last five years. What began as an emergency response to a global pandemic has evolved into something far more permanent: a fundamental reimagining of how we deliver medical care. Most recently, on December 21, 2024, Congress took another step in this evolution, passing legislation that extends Medicare...

BY Blinn E Combs, Esq. and Michael Alexander, Esq., Brown & Fortunato, P.C.   As we reported here in August, the Federal Trade Commission (“FTC”) recently released a draft report broadly accusing Pharmacy Benefit Managers or “PBMs”—the middlemen who negotiate prescription drug prices—of engaging in an array of tactics to drive up prescription drug costs. The FTC’s long-expected suit was filed on September 20. The complaint accuses PBMs of “manipulation of drug price competition for...

BY Rossanna Madrigal, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   On August 1, 2024, the Criminal Division of the Department of Justice (“DOJ”) rolled out a new Corporate Whistleblower Awards Pilot Program (the “Pilot Program”). According to the DOJ, under the Pilot Program, individuals that provide truthful and complete information that leads to a successful forfeiture exceeding $1,000,000 in net proceeds may be eligible for an award from the proceeds. An...

BY Kianna Sitarski, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   As enforcement for civil and criminal healthcare fraud continues to be on the rise, it is more important than ever that healthcare companies implement and adhere to effective corporate compliance plans to prevent and detect any potential misconduct. To assist healthcare companies in understanding (i) their legal obligation to prevent, detect, and possibly report misconduct, and (ii) the potential consequences for...

BY Phuong D. Nguyen, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   In November of last year, the Office of Inspector General for the Department of Health and Human Services (“OIG”) published revised General Compliance Program Guidance “CPG.” While much of the content of the revised CPG will be familiar, the format has been significantly revised with a few updates along the way. The OIG intends to publish industry segment-specific CPGs later...

BY Blinn E. Combs, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   On July 9, the Federal Trade Commission (“FTC”) released an Interim Staff Report (“Report”) stating that Pharmacy Benefit Managers drive up drug costs. The Report, which details a two-year investigation into the market power of PBMs, has already prompted congressional action. The House Committee on Oversight and Accountability, which released its own contemporaneous PBM report, held a hearing on July...

BY Michael R. Alexander, Esq. and Kianna Sitarski, Esq., Brown & Fortunato, P.C.   As healthcare costs across the United States continue to rise, healthcare providers are feeling the financial squeeze associated with increasing costs of providing necessary products and services coupled with the trend of decreasing reimbursement rates paid out from patient healthcare plans. One method by which providers and healthcare systems may ease this financial burden is through participation in the 340B Drug...

BY Michael R. Alexander, Esq. and Jordan Vogel, Esq., Brown & Fortunato, P.C. Inaccurate coding and reporting of services can have devastating impacts on a medical business. You cannot bill insurance or insurance beneficiaries for services that are incorrectly coded, and advanced notices will not allow you to shift liability to a beneficiary under Medicare in that circumstance, either. To ensure payment for your services, you need to avoid common improper claims and understand the...

BY Jacque K. Steelman and Michael R. Alexander, Brown & Fortunato, P.C.   On April 29, 2024, Philips Respironics (“Philips”), a leading sleep apnea and respiratory therapy equipment manufacturer, announced that it reached a $1.1 billion settlement following allegations regarding faulty sleep machines. The settlement came from a class-action lawsuit against the company, claiming that certain devices were defective and potentially harmful to users. This legal action had wide-ranging implications for Philips and the millions...

BY Phuong Nguyen, Esq. and Michael Alexander, Esq., Brown and Fortunato, P.C.   On February 8, 2024, the Centers for Medicare and Medicaid Services (“CMS”) issued a memorandum entitled “Texting of Patient Information and Orders for Hospitals and CAHs,” allowing texting patient information and patient orders among members of the health care team under certain conditions. This new memorandum relaxes CMS’s previous prohibition on texting patient information and patient orders.   By way of background,...