BY Blinn E. Combs, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   On June 17, 2025, a little over two months after initiating large-scale layoffs at the agency, the federal Food and Drug Administration (“FDA”) announced a new Commissioner’s National Priority Voucher (“CNPV”) program. The CNPV aimed to give voucher recipients the opportunity to shorten new drug approval timelines from 10-12 months down to 1-2 months. The program aims to address four...

BY Phuong D. Nguyen, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   Earlier this year, the Centers for Medicare and Medicaid Services (“CMS”) published a Final Rule amending the standards for an “identified overpayment.” As a recap, the Patient Protection and Affordable Care Act of 2010 (the “Affordable Care Act”) requires that an overpayment be reported and returned by the later of 60 days after the date the overpayment was identified or...

BY Kianna L. Sitarski, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   Many recent additions to the healthcare regulatory framework have largely been aimed at adding much needed transparency for patients. One such addition with this objective is the Physician Payments Sunshine Act, colloquially known as the “Sunshine Act” or “Open Payments Act”, which seeks to require certain industry players to disclose certain financial interactions and relationships with physicians and other Covered...

BY Matthew D. Earl, Esq. and Michael Alexander, Esq., Brown & Fortunato, P.C.   On July 1, 2025, CMS announced updates to the procedures to initiate the Independent Dispute Resolution (“IDR”) process available under the No Surprises Act (“NSA”). The IDR process provides an independent and binding arbitration to decide reimbursement disputes between providers and health plans for specified services. The updates are part of an ongoing effort to refine and improve the IDR process...

BY Phuong Nguyen, Esq. and Michael Alexander, Esq., Brown & Fortunato, P.C.   Earlier this year, we wrote about the information blocking provisions of the 21st Century Cures Act (the “Cures Act”) and concerns related to the requirement to disclose medical information, particularly lab results. A new Texas law was passed that appears to largely address those concerns by requiring a 3-day delay for sensitive lab results. To recap, the Cures Act was passed in...

BY Kianna L. Sitarski, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   The healthcare industry is indisputably rife with economic, administrative, and regulatory hurdles that often have the unintended consequence of limiting healthcare access to patients, especially those in rural communities. Effective September 1, 2019, in recognition of one regulatory hurdle faced by hospitals, namely federal and state antitrust laws, Texas lawmakers passed House Bill (H.B. 3301) implementing a limited grant of...

BY Bradley Byars, J.D., M.H.A., LL.M. and Michael R. Alexander, J.D., Brown & Fortunato, P.C.   A patient checks her phone on a chilly January morning for lab results. She notices a note labeled: “This communication was generated by an artificial intelligence tool. She wonders: “Who, or what, is advising me?” This reaction captures a microcosm of the modern healthcare experience—where advanced algorithms increasingly shape patient interactions, while policymakers race to ensure these tools serve...

BY Blinn E. Combs, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.   On April 1, Robert F. Kennedy, Jr., newly installed Secretary of the federal Health and Human Services Department (“HHS”) began implementing changes announced on March 27 as part of the Trump Administration’s Make America Healthy Again initiative. The press release and related fact sheet promised large-scale restructuring of the HHS and the many departments operating under it. Released plans included...

BY Phuong Nguyen, Esq. and Michael Alexander, Esq., Brown & Fortunato, P.C.   As patients in this day and age, we take for granted that medical providers and facilities use some form of electronic medical record and offer an internet portal from which we, as patients, may access our health information, communicate with our health care providers, schedule appointments, and pay bills. With the prevalent use of electronic medical records and medical information flowing into...

BY Amanda F. Hobbs, Esq. and Michael Alexander, Esq., Brown & Fortunato, P.C.   On August 8, 2024, Governor Greg Abbott signed an executive order dictating that most Texas hospitals must collect data regarding the immigration status of patients and report it to the Texas Health and Human Services Commission (HHSC). This action follows the imposition of a similar requirement in Florida. In light of this recent change, it is important to know what obligations...