In this edition of our Healthcare Essentials blog, we've provided a refresher that includes the latest blog posts and podcast episodes by Nelson Mullins Riley & Scarborough LLP Healthcare professionals from across our firm's 33 offices that stretch from California to Massachusetts. 

Medicaid Expansion in North Carolina

By Cara N. Ludwig, Shane M. Duer, JD, CIPP/US

North Carolina Governor Roy Cooper announced on September 22, that the state’s $30 billion budget bill will become law and effective on October 1. The budget bill funds the North Carolina Medicaid expansion agreement that was signed in March, but was pending budgetary approval before Medicaid coverage could be implemented by the Department of Health and Human Services (“DHHS”).[1] The Medicaid expansion legislation does not include a specific date when eligibility rules will change, but Governor Cooper and DHHS Secretary Kody Kinsley announced in a press conference on September 25 that DHHS will launch expansion on December 1. Read more.

Monitor Mondays Podcast Featuring Knicole Emanuel; The Medicare Report Card, RAC Audits, and Financial Woes Facing Healthcare Providers Episodes

By Knicole Emanuel

The Monitor Mondays Podcast is hosted by MedLearn, with each episode being around 30 minutes long. Monitor Mondays dives into the latest regulatory audit news and information from CMS, OIG, and OMHA. Each Monday, listeners will gain a new perspective into healthcare from leading professionals in the industry, specifically related to information for providers, decision makers, third-party contract auditors, and governmental auditors. Read more.

Stark Integrity Podcast: FCA, CARES Act, and Call Arrangements Episodes

By Bob Wade

Check out the latest episode on the Stark Integrity podcast hosted by Nelson Mullins Riley & Scarborough LLP's Nashville partner Bob Wade, featuring professionals in the healthcare industry, including Nelson Mullins partner Bart Daniel and Ashley Graver, Vice President of Coker Group. Read more.

North Carolina Health Planning Update for 2024: Summer Petitions Have Been Filed

By Denise M. Gunter, Candace S. Friel, Carrie A. Hanger, Nathaniel J. Pencook

As we reported last month, the draft 2024 State Medical Facilities Plan (SMFP) was released on July 3, 2023. The SMFP is North Carolina’s key health planning document in which the State publishes need determinations for healthcare services and equipment such as acute care beds, operating rooms, and MRI scanners. If a need determination is included in the SMFP, providers may then file certificate of need (CON) applications proposing to meet the need. The draft SMFP applies various methodologies that generate need determinations, but these methodologies do not always address specific needs that a particular geographic area or population may have, and in some cases, the methodology may overstate the need for certain services or equipment. Read more.

The Other Shoe Drops: What the FTC’s Withdrawal of Long-Standing Antitrust Guidance in the Healthcare Industry and the Demise of its Information Sharing Safety Zone Really Means for Clients

By Denise M. Gunter, Karen Rigberg, Candace S. Friel, Carrie A. Hanger

With minimal fanfare on a quiet summer Friday afternoon, the Federal Trade Commission (FTC) did what many have been expecting it to do for several months: it officially withdrew from two healthcare antitrust enforcement policy statements (the Statements) it co-authored with the Department of Justice Antitrust Division (DOJ) in 1996 and 2011.[1] The DOJ had already withdrawn from these two Statements, plus one other Statement, on February 3, 2023.[2] One might ask what took the FTC so long. The better question, though, is now that these Statements have officially met their demise, what do we do? More specifically, are past arrangements that were permissible under the Statements now illegal? The agencies have offered nothing to replace the now-withdrawn Statements. While the law certainly has not changed, the absence of clear cut guidance in the form of the Statements makes traversing the antitrust landscape increasingly difficult for clients and counsel. In this article, we offer perspective on the Statements, what their withdrawal means in practical terms, and where we go from here. Read more.

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

By Michael J. Halaiko, JD, CIPP/E, Alexandra P. Moylan, JD, CIPP/US

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical Trials Information System (“CTIS”)” on July 10, 2023 (Guidance). The report closely adheres to the Draft of the Guidance that the EMA published on April 7, 2022. Read more.

Monitor Mondays Podcast Featuring Knicole Emanuel; Refund to 340B, 21st Century Cures Act, and Medicaid Disenrollment Episodes

By Knicole Emanuel

The Monitor Mondays Podcast is hosted by MedLearn, with each episode being around 30 minutes long. Monitor Mondays dives into the latest regulatory audit news and information from CMS, OIG, and OMHA. Each Monday, listeners will gain a new perspective into healthcare from leading professionals in the industry, specifically related to information for providers, decision makers, third-party contract auditors, and governmental auditors. Read more.

Hospital Price Transparency Changes in the Calendar Year 2024 Hospital Outpatient Prospective Payment System Proposed Rule

By Christine Burke Worthen, Lily Shannon

As part of the Calendar Year 2024 Outpatient Prospective Payment System and Ambulatory Surgical Center Proposed Rule issued on July 13, 2023, the Centers for Medicare and Medicaid Services (CMS) proposed changes to the hospital price transparency regulations. The proposals are part of CMS’ efforts to increase hospital compliance with the regulations as well as to streamline and clarify certain components of the regulations. CMS is seeking comment on the following proposals through Sept. 11, 2023 Read more.

European Commission’s Adequacy Decision Paves the Way for U.S. Companies to Begin Enrolling in the E.U.-U.S. Data Privacy Framework Program

By Michael J. Halaiko, JD, CIPP/E, Mallory Acheson, CIPM, CIPP/E

The U.S. Department of Commerce’s Data Privacy Framework (DPF) program website went live on July 17, and contains guidance documents for those companies wanting to know the costs and benefits of enrollment in the DPF program.

The DPF website is a result of the European Commission's Adequacy Decision issued on July 10 finding that the E.U.-U.S. Data Privacy Framework meets the equivalency requirements of the GDPR. The Adequacy Decision allows for the free flow of data from those countries within the European Economic Area (EEA) to those companies in the United States certifying under the Data Privacy Framework program. Read more.

FTC Proposes to Vastly Expand the Health Breach Notification Rule

By Patricia A. Markus, JD, CIPP/US, Shane M. Duer, JD, CIPP/US

The Federal Trade Commission (FTC) recently proposed changes to the Health Breach Notification Rule (Rule), enacted in 2009, to clarify that the Rule applies directly to an estimated 170,000 health and wellness mobile applications (apps), as well as similar technologies that have proliferated since the Rule’s enactment. Recognizing the increasing prevalence of health apps and direct-to-consumer health technologies like fitness trackers, the FTC now seeks to update the Rule in what appears to be an aggressive fashion to effectively respond to changes in the health technology marketplace. The Proposed Rule is specifically intended to cover developers and vendors of health and wellness apps and internet-connected health devices, such as wearable blood pressure monitors, that are not covered by the Health Insurance Portability and Accountability Act (HIPAA) because they are neither “covered entities” nor “business associates” under HIPAA. This article does not address all of the FTC’s proposals but instead focuses on updated and new definitions that vastly expand the scope of information and types of entities covered by the Rule. Read more.

Stark Integrity Podcast: False Claims Act: Supreme Court Holds Knowledge Is Subjective Not Objective Episode

By Bob Wade, Bart Daniel

Check out the latest episode on the Stark Integrity podcast hosted by Nelson Mullins Riley & Scarborough LLP's Nashville partner Bob Wade, featuring professionals in the healthcare industry, including partner Bart Daniel. Read more.

Payment Cuts and Program Changes: CMS Issues Calendar Year 2024 Home Health Prospective Payment System Proposed Rule

By Christine Burke Worthen, Wes Scott, Jason Brace, Lily Shannon

On June 30, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule for the Home Health Prospective Payment System for the 2024 calendar year. The proposed rule aims to permanently update the payment rate for home health based on the “impact of the implementation of the Patient-Driven Groupings Model (PDGM).” The PDGM demonstrates the difference between the assumed and actual behavior changes and their effects on the estimated aggregate expenditures. Read more.

The Proposed 2024 SMFP Has Arrived - Petitions to Adjust Need Determinations Are Due Soon!

By Denise M. Gunter, Candace S. Friel, Carrie A. Hanger, Nathaniel J. Pencook

The North Carolina Department of Health and Human Services Division of Health Service Regulation (DHSR) has published the draft 2024 State Medical Facilities Plan (SMFP), which was developed by the State Health Coordinating Council (SHCC). The SMFP sets forth need determinations for many healthcare services, such as acute care beds, operating rooms and MRI scanners. While significant changes to North Carolina’s Certificate of Need laws are on the horizon, the SMFP remains a critical step in this process because, unless there is a published need determination for certain services, such as acute care beds, a Certificate of Need (CON) application cannot be filed to add the service. Read more.