DOJ announces critical changes to its Corporate Compliance Program guidance

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...

The seven elements of a compliance program

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...

Who benefits from PBMs? Federal regulators scrutinize drug middlemen

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...

Lifting the veil on the 340B drug pricing program: Overview and recent developments

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...

CMS National Correct Coding Initiative

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...

Billion-dollar settlement by Philips Respironics to settle faulty sleep machine allegation

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...

CMS allows texting of prescription orders

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,...

Litigation survey and update on the Telephone Consumer Protection Act

BY Jordan T. Vogel and Michael R. Alexander, Brown & Fortunato, P.C.   The use of modern technology to communicate with clients and to market products is increasingly common. On an almost weekly basis, I am on the receiving end of an autodialed or prerecorded text message or phone call encouraging me to purchase something. As these technologies become more common, so too does regulatory control and the risk of liability.   As an example,...

Continuity of care and prior authorizations streamlined by CMS final rule

BY Jacque K. Steelman and Michael R. Alexander, Brown & Fortunato, P.C.   The Centers for Medicare & Medicaid Services (“CMS”) recently finalized the CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) (the “Rule”). The Rule requires a number of federally funded payers (“Payers”) to implement and maintain application programming interfaces (“APIs”). These APIs are intended to improve the electronic exchange of healthcare data and streamline the authorization process required by payers for specific procedures...

Upcoming changes from HHS in the world of cybersecurity

BY Michael Alexander, Esq., Brown & Fortunato, P.C.   Periodically, and it seems with greater frequency, I open my work email to find an email that just stands out as being odd in one form or another. Due to my generally conservative approach to technological issues, I do not understand, my immediate response is to forward the message along to our firm’s IT expert. Occasionally he will respond that the email is legitimate, and I...

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