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. 

Employee Classification in the Healthcare Industry: W2 Employee or Independent Contractor and Why it Matters

By Cara N. Ludwig, Alyssa Riggins

On this episode of the NM Talks Healthcare Podcast, join healthcare attorney Cara Ludwig and employment attorney Alyssa Riggins as they dive into issues of employee misclassification and the legal differences between an independent contractor and an employee. With enforcement actions for employee misclassification in the healthcare industry on the rise, tune in to learn more about this important topic. Read more.

Physician Wellness Program Exception

By Bob Wade, Myatt McClure

On Dec. 29, 2022, the Consolidated Appropriations Act (the “CAA”) was signed into law. The CAA provides for a new exception to the Stark Law and Anti-Kickback Statute (the “AKS”). Section 4126 of the CAA introduces a new exception (the “Exception”) for physician wellness programs that allow healthcare entities to provide mental and behavioral health programs to physicians and other clinicians. Read more.

Monitor Mondays Podcast Featuring Knicole Emanuel; Suffocating Regulations, SNF Transfers, Federal Regulations, and Staffing Shortages 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: Split and Shared Billing, FCA, and AAPs Episodes

By Bob Wade

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

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

By Michael J. Halaiko, JD, CIPP/E, Cara N. Ludwig

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from June 6, 2023. Read more.

Clinical Leader: Considerations for Compliance with CTIS Submissions Under the EU-CTR

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

In an article published by Clinical Leader on May 31, 2023, partners Mike Halaiko and Alexandra Moylan provided guidance for clinical trial application submissions within the European Economic Area (EEA) which are required to be submitted through the Clinical Trial Information System (CTIS) portal as of Jan. 1, 2023. Read more.

South Carolina Sunsets Certificate of Need Law

By Phillip Mullinnix, Caroline Warner, Travis Dayhuff

On May 3, 2023, the South Carolina General Assembly passed Bill 164 which overhauled the state’s Certificate of Need (CON) law. The bill was signed by Governor McMaster on May 16, 2023 and is now in effect. Read more.

End of the Public Health Emergency Marks End of HIPAA Enforcement Discretion for Telehealth Practices

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

The COVID-19 public health emergency (PHE) in the United States came to an end on May 11, 2023. Simultaneously, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced that its enforcement discretion regarding violations of the Health Insurance Portability and Accountability Act (HIPAA), applicable during the PHE, also would be coming to an end.[i] Covered entities and business associates now have a 90-day transition period, ending on Aug. 9, 2023, in which to bring their telehealth practices into compliance with the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (HIPAA Rules). Read more.

Using Value-Based Enterprises as a Business Strategy

By Edward K. White, Mike Segal, Heather S. Miller

On this episode of NM Talks Healthcare, join of counsel Heather Miller as she interviews partners Ed White and Mike Segal about the topics of value-based care and value-based enterprises. Healthcare reimbursement is steadily moving towards reimbursement based upon providing a better quality of care at a lower cost, value-based care. Segal and White will also dive into changes in rules regarding the Stark and anti-kickback laws, the creation of the concept of value-based enterprise, and how healthcare providers and companies can use value-based enterprises as a business tool. Read more.

Monitor Mondays Podcast Featuring Knicole Emanuel; Managed Care Denials, Compliance Risk, Hospital Utilization and Billing, and The False Claims Act 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: Tuomey Case Part 1 and 2 and EKRA Compared to AKS Episodes

By Bob Wade, Bart Daniel

Check out the latest episodes 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.

Proposed Rule Season

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

The Centers for Medicare & Medicaid Services (CMS) have released the proposed updates to the Medicare payment policies and rates for skilled nursing facilities (SNFs) for 2024. While the ruling is not final, “CMS estimates that the aggregate impact of the payment policies in this proposed rule would result in a net increase of 3.7% or approximately $1.2 billion.” Read more.

CMS Continues Transparency Efforts for Home Health and Hospice

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

The Centers for Medicare & Medicaid Services (CMS) announced on April 27, 2023, that it will publicly release all ownership information of home health and hospice agencies. This move is aimed at increasing transparency and promoting accountability in the healthcare industry, and more specifically to enable reviewers to identify owners with negative performance histories. The information to be released will include the names of all individuals with an ownership interest in these agencies, their percentage of ownership, and their role in the company. Additional files include data on mergers, acquisitions, consolidations, and changes of ownership since 2016 for Medicare-enrolled hospices and home health agencies. Read more.

Price Transparency – CMS Updates Enforcement Process

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

As many are aware, compliance with price transparency requirements continues to lag. Under the final rule, effective Jan. 1, 2021, hospitals are required to provide clear, accessible pricing information online about the items and services they provide in two ways: as a comprehensive machine-readable file with all items and services and via a display of shoppable services in a consumer-friendly format. This information is intended to make it easier for consumers to shop and compare prices across hospitals and estimate the cost of care before going to the hospital. As of last fall, less than two-thirds of hospitals were meeting all transparency requirements. CMS has been auditing hospitals which has resulted in monetary penalties for some of them. Read more.

If Enacted, North Carolina House Bill 737 Will Transform the Legal Landscape for Hospital Transactions

By Denise M. Gunter, Carrie A. Hanger, Candace S. Friel, Chelsea K. Barnes

On April 18, 2023, Representative Caleb Rudow (D-Buncombe) introduced House Bill (HB) 737, entitled An Act Preserving Competition in Health Care by Regulating the Consolidation and Conveyance of Hospitals. If enacted, HB 737 will impose significant new requirements on mergers, acquisitions, joint operating agreements, and other transactions involving North Carolina hospitals. The legislation is proposed to be codified as new Article 11C of Chapter 131E of the General Statutes, §§ 131E-214.20 through 214.42. Read more.

Transitioning out of the COVID-19 PHE

By Hannah L. Cross, Courtney G. Tito

On this episode of NM Talks Healthcare, join partners Hannah Cross and Courtney Tito as they discuss some key considerations for providers when transitioning out of the COVID-19 Public Health Emergency (PHE). With less than a month before the PHE ends on May 11, 2023, providers should already be working on how to transition out of the waivers and flexibilities they relied on to keep going during the heart of the pandemic. Hannah and Courtney discuss the broader Stark Waivers and AKS flexibilities, some provider specific items and round out the discussion looking at enforcement. Read more.

Monitor Mondays Podcast Featuring Knicole Emanuel; Artificial Intelligence, CMS Inpatient-Only List, Three-Midnight Rule, Medicaid's Continuous Enrollment, and Reverse False Claims 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.

North Carolina Session Law 2023-7 Results in Major Reforms to Certificate of Need

By Denise M. Gunter, Candace S. Friel, Carrie A. Hanger, Chelsea K. Barnes

On March 27, 2023, North Carolina Governor Roy Cooper signed House Bill 76, now known as Session Law 2023-7, into law. Also called “Access to Healthcare Options,” Session Law 2023-7 primarily aims to expand Medicaid. However, the law will also result in major reforms to the State’s Certificate of Need (CON) program. These reforms are described below. While some reforms go into effect immediately, others will go into effect after Health Access Stabilization Program (HASP) payments are issued to hospitals as part of Medicaid expansion. Read more.

FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions

By Christopher Hanson

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance).[1] The Guidance outlines the implementation of new Section 524B of the Federal Food, Drug, and Cosmetic Act (FDCA), which requires that manufacturers submitting premarket submissions for cyber devices meet specific cybersecurity requirements.[2] In addition to issuing the Guidance, FDA also published FAQs related to cybersecurity in medical devices. Read more.

HHS Finalizes Payment Rates and Policies for the 2024 Medicare Advantage Program

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

On March 31, 2023, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced the finalized capitation rates and payment policies for the 2024 Medicare Advantage Program. Notably, CMS indicated it expects and average change in revenue of 3.32% (compared with 1.03% in the Advance Notice) and opted to phase in the finalized risk adjustment program over three years. The updated risk adjustment model uses ICD-10 codes and includes clinically based adjustments to support the inclusion of conditions that are stable predictors of costs to discourage discretionary coding, It removed 2,000 codes. Overall, the allocation of funds seeks to improve payment accuracy for current Medicare beneficiaries and for Medicare recipients in the future. Read more.

Stark Integrity Podcast: Logos and Slogans, Value-Based Reimbursement Arrangements, and Stark Law and Anti-Kickback Issues Episodes

By Bob Wade, Christine Burke Worthen

Check out the latest episodes 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 Christine Burke Worthen. Read more.

FDA Announces First-Ever AI/ML Medical Device Draft Guidance

By Christopher Hanson

On April 3, 2023, the U.S. Food and Drug Administration (FDA) published a groundbreaking draft guidance concerning the use of artificial intelligence/machine learning (AI/ML) in medical devices (Draft Guidance).[1] This notable move suggests FDA’s intent to provide a forward-thinking, least burdensome approach to support the development of safe and effective medical devices that use machine learning-enabled device software functions (ML-DSF). Read more.

The OIG Provides Stakeholders a Newly Expanded FAQ Process

By Hannah L. Cross, Shane M. Duer, JD, CIPP/US

The Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published a revamped frequently asked questions (“FAQs”) page and process on March 23, 2023, creating a new platform to foster engagement between the government and stakeholders. The OIG has historically provided guidance on a limited range of topics and issues through an advisory opinion process that contains specific requirements and limitations. This new initiative expands the previously available FAQ topics while also providing an avenue for stakeholders to submit questions and receive informal feedback from the OIG. This is a welcome development, as often providers are in need of reasonably tailored guidance regarding an arrangement that, for one reason or another, is not appropriate for a formal advisory opinion request. Read more.