Key Health Care Issues to Track in 2024 in the Carolinas


1. Significant Regulatory Reform Across the Carolinas

Changes to State Certificate of Need (“CON”) Laws: Last year, we suggested changes to CON laws could make a big impact in the Carolinas in 2023: they did. The South Carolina legislature all but repealed the state’s CON program with the State Health Facility Licensure Act. Meanwhile, in North Carolina, legislative efforts to expand Medicaid culminated in Session Law 2023-7 (“Access to Healthcare Options”), which will result in significant changes to the state’s CON program. 

CON Reform in North Carolina – “Access to Healthcare Options”: Session Law 2023-7, known as “Access to Healthcare Options,” was signed into law on March 27, 2023, in order to expand North Carolina’s Medicaid program.[1] Simultaneously, however, the law affects several major reforms to the state’s CON program. Some changes will occur immediately, while others will kick in later in the Medicaid expansion process, specifically after Health Access Stabilization Program (“HASP”) payments are issued to hospitals.

  • In the Short Term: Already in effect are several reforms to N.C. Gen. Stat. § 131E-176:
    • Psychiatric Facilities and Chemical Dependency Treatment Facilities are no longer subject to CON.
    • The aggregated threshold before triggering CON review of equipment used in diagnostic centers is raised from $1.5 million to $3 million—effectively doubling the amount of inventory an entity can hold before it requires CON approval. Diagnostic centers are defined as freestanding programs or providers, including physician offices, clinical laboratories, radiology centers, and mobile diagnostic programs.
    • The monetary thresholds for some other activities are also increased. For purchasing replacement equipment, the threshold cost is increased from $2 million to $3 million. For Nursing Homes, Adult Care Homes, Intermediate Care Facilities, and certain similar facilities, the proposed capital expenditure for renovations or improvements to an existing site is increased from $2 million to $4 million.
  • Two Years after HASP Payments are received: Ambulatory Surgical Facilities (“ASFs”) that: (a) are licensed by DHHS; (b) have a single-specialty or multi-specialty ambulatory surgical program; and (c) are located in a county with a population over 125,000 will be deemed “Qualified Urban Ambulatory Surgical Facilities” and no longer subject to CON review.
  • Three Years after HASP Payments are received: Magnetic Resonance Imaging (“MRI”) scanners will no longer be subject to CON review in counties with populations exceeding 125,000.[2]

CON Repeal in South Carolina – The State Health Facility Licensure Act: On May 16, 2023, Governor McMaster signed into law S. 164, which renamed the State Certificate of Need and Health Facility Licensure Act to the State Health Facility Licensure Act (the “Act”) and drastically reduced its scope.[3] The Act represents a complete overhaul of South Carolina’s previous CON program, eliminating CON requirements for the vast majority of the 18 services and technologies previously within its purview. Hospitals and Nursing Homes are two exceptions:

  • Hospitals: With respect to the CON requirements applicable to hospitals, the Act provides for a three-year sunset period ending on January 1, 2027. Until then, the construction of new hospitals or addition of beds in existing hospitals will continue to be subject to existing CON requirements. However, certain exemptions will allow for the construction of new hospitals in counties without one or for intracounty relocation, provided the hospital does not increase the number of beds.
  • Nursing Homes and Home Health: Nursing homes and home health will continue to be subject to CON approval under the Act.[4]

For industries still subject to the CON process, appeals also look a bit different. Contested case hearings before the Administrative Law Court are now appealed directly to the South Carolina Supreme Court. There is also a question about the application of CON to home health. The South Carolina Department of Health and Environmental Control (“DHEC”) is taking the position that CON still applies to home health services despite the passage of CON reform. This could be addressed with additional legislation or court challenges. For the first time in 53 years since the CON program was imposed, laboratories, cath labs, ASCs, and imaging centers will see a tremendous opportunity for growth in 2024. Hospitals, on the other hand, must wait three years to take advantage of this growth opportunity, as sunset provisions in the Act keep the CON program alive for hospitals until 2027.

Restructuring of the Health Care Regulatory System in South Carolina: This time last year, we predicted that for South Carolina, regulatory changes in 2023 could result in a complete restructuring of the state’s administrative body tasked with regulating health care services, the food service industry, and natural disaster response, just to name a few. On May 19, 2023, Governor McMaster signed S. 399 into law as Act 60. Act 60 abolishes DHEC and divides the bulk of its former responsibilities among two newly created state agencies: the Department of Public Health (“DPH”) and the Department of Environmental Services (“DES”). DPH will assume responsibility for most of the public health-related services previously administered by DHEC, while DES will assume nearly all environmental-related services. In January 2024, new legislation, like S. 915, was filed that will create further reform for the new regulatory framework for healthcare that could change the structure and open discussions for Medicaid expansion. We will be monitoring this issue closely as there will be significant changes in how health care is regulated in South Carolina.

2. Further Consolidation Across the Carolinas: As expected, 2023 saw the consolidation of healthcare providers through mergers and acquisition activity rebound to pre-pandemic levels.[5] The Carolinas were not left out of the action. North Carolina, in particular, was a hotbed for merger and acquisition:

  • In 2023, MUSC took over the operations of Regional Medical Center in Orangeburg, which has created a health care delivery corridor from MUSC’s flagship hospital in Charleston up through Orangeburg, Columbia, Chester, and ending in Lancaster, South Carolina.
  • On January 17, Blue Cross Blue Shield of North Carolina announced the acquisition of all in-state locations of FastMed, an urgent care provider striving to improve access to care in rural areas of the state.[6]

  • Eastern Carolina Emergency Physicians (“ECEP”), a North Carolina-based provider of outsourced emergency department management services, is merging with Emergency Care Partners (“ECP”), a national provider of emergency medicine and emergency department management services for hospitals. The companies’ combined platform “will service departmental operations at 49 locations, supported by a combined clinical workforce of approximately 900 physicians and mid-level providers.”[7]
  • In South Carolina, Self Regional Healthcare and Abbeville Area Medical Center recently finalized a partnership agreement that will seek to integrate and improve healthcare for the citizens of Abbeville County in 2024.[8]
  • In a similar announcement, Conway Medical Center and Novant Health finalized a strategic relationship in 2023 that will begin expanding access to quality care on the coast of South Carolina in 2024.[9]
  • Expected to close this quarter, North Carolina-based Novant Health announced the acquisition of three South Carolina hospitals located near the coast from Dallas-based Tenet Healthcare.[10]

 3. Continued Expansion of Private Equity: In 2023, private equity (“PE”) firms continued to expand their presence in healthcare across the nation. The Carolinas were no exception. One 2023 report, released at the start of the new year, suggests that North American healthcare PE “announced deal values came in around $29 billion, with biopharma accounting for 25% of deal activity and 54% of deal value.” The same report notes that while activity in healthcare provider business slowed due to inflation and labor market pressures, PE firms nonetheless closed a number of substantial healthcare provider deals last year.[11] This trend towards increased PE activity will continue in 2024. In the Carolinas:

  • Last October, Dallas-based PE firm Havencrest Capital Management announced the acquisition of Well Care Home Care (“WCHC”), the home care division of North Carolina-based Well Care Health. WCHC represents Havencrest’s second acquisition under its Avid Health at Home (“Avid”) platform.[12]
  • Raleigh-based QHP Capital, a PE firm “purposely built around life sciences,” has garnered attention for its continued acquisition of majority stakes in specialty healthcare companies. Rather than downsizing, as is typical among PE firms, QHP aims to grow these companies by financing innovation in drug discovery and other healthcare services.[13]

In 2024, we are already involved in representing PE firms and various providers related to projected merger and acquisition activity in the Carolinas.

4. Federal Government Clawbacks of Covid-19 Provider Relief Fund Payments: On September 21, 2023, the U.S. Government Accountability Office (“GAO”) released a report suggesting that the Health Resources and Services Administration (“HRSA”) was still attempting to clawback $1.36 billion of the $2.62 billion in Provider Relief Payments that were previously identified for recovery.[14] According to the GAO’s report, recoverable funds include overpayments, unused payments, and payments received during the distribution period by providers who failed to comply with the reporting requirement.[15] In August 2023, HRSA established a timeframe to distribute final repayment notices to providers, announcing that all identified providers should receive a notice by April 2024.[16] Once HRSA issues a final repayment notice to a provider, the provider has 60 days to return payment to HRSA or request a decision review to appeal HRSA’s request.[17] In the first few months of 2024, providers in the Carolinas should be on the lookout for these final repayment notices and act quickly to provide a response to the HRSA. Providers who do not take action within 60 days are referred to debt collection services within the Department of Health and Human Services (HHS), which may result in a lengthy resolution process or higher payments in the form of penalties and fees.

In addition to HRSA clawbacks from providers who received Provider Relief Fund payments, the DOJ is also continuing to audit and investigate recipients of PPP loans and other CARES Act funding, bringing fraud allegations on those who have abused those programs.

5. Rapid Development in Artificial Intelligence (AI): Over the past couple of years, generative AI has revealed a promising transformative potential that transcends nearly every industry. As lawmakers scramble to develop an adequate regulatory and policy framework, perhaps all that can be said for certain about the future of AI in healthcare is that it’s here to stay:

  • Last year, the National Science Foundation announced a $20 million investment in a five-year research project to be spearheaded by Clemson University. Referred to as “ADAPT-SC” (Artificial Intelligence-Enabled Devices for the Advancement of Personalized and Transformative Healthcare in South Carolina), the project seeks “to advance AI-enabled medical devices and to train an AI-ready workforce.”[18]
  • North Carolina-based medical technology company Gradient Health raised $2.5 million in a 2022 seed round seeking investments in its AI-enabled medical imaging technology. Gradient will use machine learning to develop AI technologies that can more accurately diagnose pathologies based on medical images.[19]
  • Ten physicians at University of North Carolina (UNC) Health are slated to adopt the first rollout of Epic’s generative AI tools designed to assist clinicians in their communication with patients. “The program will use generative AI to auto-draft responses to some of the most common and time-intensive patient messages.”[20]

Legislators have yet to promulgate a comprehensive legislative or regulatory scheme governing the use and creation of AI, but that is not to say there are no laws currently restricting its use.  However, even in the absence of a comprehensive regulatory scheme governing the use and creation of AI there are some existing regulations that should be considered when using or creating AI.

With respect to the use of AI technology in the delivery of care, the FDA oversees the use of AI technology in medical devices and, in fact, in January, accepted the first AI-powered clinical outcome assessment tool into their Innovative and Technology Approaches for New Drugs (Istand) pilot program.[21]

HIPAA’s existing privacy and security protections should be considered when reviewing the use of patient data in conjunction with the development of AI software, and many questions surrounding the need for patient authorization, the permitted uses of de-identified information, and what constitutes a limited data set are triggered. Data uses and the joint development of AI software and/or services may implicate questions regarding intellectual property rights. The public is cautious, if not skeptical, about the use of AI in healthcare settings, with 60% of Americans reporting they would be “uncomfortable” if their provider relied on AI for their medical care.[22] Given the public’s general apprehension and the probability of a legislative and regulatory response, it is critical that providers tread with appropriate caution in navigating the AI frontier.

In Georgia, we are monitoring legislation introduced on January 9 that addresses the use of AI in the healthcare industry. Georgia House Bill 887 precludes physicians from relying solely upon clinical decisions generated by AI software and requires review of the software’s decision by a healthcare practitioner with the ability to override the software’s determination with their own.[23] We anticipate that the prevalence of AI and its use within the healthcare industry to prompt a response from legislators in more states, including the Carolinas.

6. Medicare & Medicaid in the Carolinas

Medicaid expansion is intended to extend health care coverage to more low-income Americans. Under Medicaid expansion guidelines within the Affordable Care Act (“ACA”), eligibility is extended to “adults under the age of 65 with incomes up to 138% of the federal poverty level/FPL (133% plus a 5% income disregard).”[24]

North Carolina Medicaid Expansion: It is hard to imagine that South Carolina’s near-total repeal of its CON program wouldn’t be the biggest healthcare news in the Carolinas coming into 2024[25]—but it wasn’t: North Carolina became the 40tht state to adopt the ACA Medicaid expansion. Here is a rundown of what that means for the state:

  • As a result of the expansion, an estimated 600,000 received eligibility for coverage under Medicaid.[26]
  • On December 1, 2023, 300,000 individuals who were previously enrolled in family planning coverage were automatically enrolled in full Medicaid Coverage.[27]
  • State departments are now partnering with communities to assist in enrollment and providing detailed instructions to eligible people who will seek to enroll on their own.

Continued Growth of Medicare Advantage: A 2023 report concluded that more than half of all eligible Medicare beneficiaries are enrolled in Medicare Advantage (MA) and that MA accounts for over half of federal Medicare spending. Notably, despite its massive scope, enrollment in MA is highly concentrated among a handful of companies, with UnitedHealthcare and Humana accounting for nearly half of all MA enrollees in the nation. Unsurprisingly, in the Carolinas, especially in North Carolina, MA enrollment rates will likely continue to climb in 2024 as MA solidifies its dominant status in the Medicare sphere. Last October, for example, Cigna Healthcare announced an expansion of its MA presence to four new North Carolina counties. As of December 2023, CMS reported that MA enrolled comprised approximately 53.1% of North Carolina Medicare enrollees (up from 49.2% in January 2023) and 42.8% of South Carolina enrollees (up from 41.3% in January 2023).

 7. Rise of Nontraditional and Specialty Services and the Potential for New Regulation: The market for various nontraditional or medical-adjacent services continues to grow, and regulators are likely to be hot on its heels. In 2024, we expect that the rising popularity of services like recreational Botox injections, “IV Therapy,” and the expansion of Direct Primary Care (DPC) will continue to demand the attention of lawmakers across the nation.

  • In South Carolina, the state boards of Pharmacy, Nursing, and Medical Examiners recently issued a combined Advisory Opinion stating, “[t]here is no question that the services being provided by IV retail clinics constitutes the practice of medicine. . .” and cautioning that “failures by licensees to follow the laws governing their practice(s) could result in disciplinary proceedings and sanctions.”[28]
  • In North Carolina, the state Board of Nursing issued a Position Statement explaining that “[i]t is within the scope of practice for the RN and LPN to administer intravenous fluids (IV hydration), nutrient therapies, and medications. . .,” as long as they are supervised by a healthcare practitioner with prescriptive authority. The Statement did not take an explicit position as to whether IV therapy constitutes the practice of medicine.[29]
  • In the Carolinas, state lawmakers and regulators have yet to weigh in on the proliferation of nontraditional Botox delivery. In 2024, we suspect that the growth of this industry in the Carolinas will force lawmakers and regulators to pick a side.
  • Direct Primary Care (DPC) and Concierge Medicine are both employing a membership fee structure to revolutionize ready access to physicians. DPC emerged from earlier concierge models in the mid-2000s, and an estimated 2,060 DPC practices operate throughout the United States, including in the Carolinas.[30]
  • Pending legislation in South Carolina would make it one of 30+ states to declare that DPC agreements are not contracts of insurance. If passed, H. 4157 would allow DPCs to operate in South Carolina without fearing expansive oversight from the Department of Insurance. Accordingly, we should expect to see an increase in the prevalence of DPC practices across the state. North Carolina passed a similar statute in 2020 and is now home to a high number of DPC practices relative to other states.

8. Life Sciences Continue to Grow Rapidly in the Carolinas: It appears that the life sciences industry in the Carolinas will continue to expand in 2024. North Carolina has announced a number of key investments that will impact the industry throughout 2024 and beyond:

  • FUJIFILM Diosynth has announced a $2 billion expansion to its bio-manufacturing site in Holly Springs, NC, investing at least $1.5 billion by the end of 2024.[31]
  • Virginia-based pharmaceutical company INDIVIOR will expand its facilities into North Carolina with a $60 million manufacturing plant to be constructed over the next five years.[32]
  • Clinical-stage biotechnology company ProKidney has announced plans to invest up to $485 million to establish a new manufacturing facility in Greensboro by 2027.[33]

At a recent SCBio Annual Conference, President and CEO James Chappell provided a strong outlook for the future of life science growth in South Carolina, sharing that the state is now home to nearly 1,000 life sciences companies with an annual impact to the state’s economy of more than $25 billion.[34] Continuing the trend of growth and expansion, action in South Carolina’s life sciences industry is set to start off strong in the first quarter of 2024, as Orangeburg medical device manufacturer, Zeus, has agreed to a $3.4 billion acquisition of their company by a Swedish private equity firm.[35]

9. The Future of Non-Compete Agreements With Physicians is in Question: South Carolina legislators introduced a bill in 2023 that could have a substantial impact on the relationship between the state’s hospital systems and their physicians. This bill signals to providers and physicians in the state that conversations of serious reform have begun with bipartisan support.

House Bill No. 4488 proposes to amend the S.C. Code of Laws by adding Section 44-7-267, which seeks to prohibit the contractual agreements used by health care facilities to limit a physician’s ability to practice after the termination of the contractual relationship. The bill would make a health care facility’s use of contractual provisions that limit a physician’s right to practice a bar to obtaining required licenses from DHEC. In an apparent attempt to limit physician movement and turnover, the bill stipulates that a health care facility may require a physician to repay things like relocation expenses, signing bonuses, and education and training expenses if the physician terminates the contractual relationship in less than three years from the date of signing. As it stands, the bill has no retroactive effect and applies only to new contracts or renewals of contracts that are entered into on or after the bill’s potential effective date.

This legislation appears to mimic the FTC’s proposed rule that was released on January 5, 2023. The FTC’s proposed rule seeks to ban non-competes, citing harm to workers and competition. We expect to know more about the proposed FTC rule in 2024, but if it is adopted, it will likely be challenged by multiple states and held up within the court system.

We will be monitoring the proposed legislation in 2024 and suspect that providers and physicians across the state will be tracking the support and conversations around this bill due to the magnitude of its potential impact.

10. Anticipated Growth of ASCs in the Carolinas as Care Continues to Shift Towards Outpatient Settings: In 2024, we can expect the continued shift in surgery-related care from inpatient to outpatient services in the Carolinas to draw significant investments into Ambulatory Surgery Centers (ASCs) from the region’s largest providers. The repeal of CON in South Carolina and reform in North Carolina will undoubtedly accelerate the proliferation of ACSs in the Carolinas. Many providers in the Carolinas and their physicians are recognizing the benefits of transferring their patients to ASCs for their procedures and now have the opportunity to do so without CON requirements in South Carolina and less in North Carolina. Outsourcing procedures to ACSs allows hospital systems to direct their focus toward providing high-quality care at those sites, which, in turn, has resulted in lower costs to patients.

  • Bon Secours Mercy Health, a 48-hospital system with campuses in South Carolina, recently partnered with Compass Surgical Partners to construct 30 ASCs across its system, signaling its intent to continue strategic investment and recognizing the long-term benefit of utilizing ASCs as an integral part of its growth model.[36]
  • In North Carolina, Atrium Health Wake Forest Baptist (AHWFB) will spend 2024 constructing a new $78.4 million ASC in Winston-Salem. With eight new operating rooms and two procedure rooms, the new ASC is predicted to serve over 9,000 patients annually.[37]

As we look into 2024, we expect hospital systems in the Carolinas to continue exploring how they can best utilize ASCs to improve care to their patients.

Maynard Nexsen will be following these and other key health care and life sciences issues in the Carolinas throughout 2024.  

This article was published with the assistance of Mason Rajaee, Law Clerk.

[1] S.L. 2023-7 (H.B. 76),
[2] Id.; Lee M. Whitman & J. Blakely Kiefer, CON Reform Has Arrived, Wyrick Robbins (April 6, 2023)
[3] S. 164, Act no. 20,
[4] Phillip Mullinnix et al., South Carolina Sunsets Certificate of Need Law, The Nat’l L. Rev (May 19, 2023), 
[5] Jeff Lagasse, M&A Activity Returning to Pre-Pandemic Levels, Healthcare Finance (July 18, 2023),
[6] Blue Cross Blue Shield of North Carolina, Blue Cross NC Acquires FastMed’s NC Locations, (January 17, 2024),
[7] Amelia Ickes, Eastern Carolina Emergency Physicians Merges with Emergency Care Partners, Becker’s Physician Leadership (July 14, 2023),
[8] Self and Abbeville Hospitals Seal the Deal with Signing of Agreement, Index-Journal (Aug. 29, 2023),
[9] Conway Medical Center, Novant Health Announces Plans to Expand Access to Quality Care on the Coast, Novant Health (Aug. 1, 2023),
[10] Novant Health to Acquire Three Hospitals from Tenet Healthcare, Novant Health (Nov. 17, 2023),
[11] Nirad Jain, et al., Healthcare Private Equity Market 2023: Year in Review and Outlook, Bain & Co. (Jan. 3, 2024),
[12] Havencrest Homecare Platform, Avid Health at Home, Announces Acquisition in North Carolina, PR Newswire (Oct. 18, 2023),
[13] David Mildenberg, A Raleigh Private-Equity Group Eyes Opportunities in Financing Innovation in Drug Discovery and Healthcare Services, Bus. N.C. (June 1, 2023),
[14] U.S. Government Accountability Office, COVID-19 Provider Relief Fund: HRSA Continues to Recover Remaining Payments Due from Providers, GAO (September 21, 2023),
[15] Id.
[16] Id.
[17] Health Resources & Services Administration, Repayment and Debt Collection, HRSA (November 2023),
[18] David Raths, South Carolina Consortium Seeks to Advance AI-Enabled Medical Devices, Healthcare Innovation (May 31, 2023),
[19] Hayden Schmidt, Startups Cash In on Artificial Intelligence for Medical Imaging as Industry Shifts, Life Sci. Intel. (June 29, 2023),
[20] Heather Landi, Epic is Going All In on Generative AI in Healthcare. Here’s Why Health Systems are Eager to Test-Drive It, Fierce Healthcare (May 25, 2023),
[21] FDA Accepts 1st AI-Based Tool into Istand Pilot Program, (Jan. 26, 2024),
[22] Alec Tyson, et al., 60% of Americans Would Be Uncomfortable with Provider Relying on AI in Their Own Health Care, Pew Rsch. Ctr. (Feb. 22, 2023),
[23] Jared Augenstein, Annie Fox & Randi Seigel, Georgia Proposes a Bill to Regulate Physician and Insurer AI Use, JD Supra (January 30, 2024),
[24] Medicaid Expansion,, (last visited Feb. 1, 2024).
[25] The Carolinas saw an unprecedented wave of Medicaid disenrollment in 2023 as protective conditions placed on the receipt of federal COVID-19 Medicaid funds were lifted in April. The Department of Health and Human Services (HHS) initially forecasted that as many as 15 million people could be disenrolled during the “unwinding” process, with almost half of those people still likely to be eligible. In fact, across all states, it is currently estimated that around 71% of all disenrollments resulted from procedural reasons, meaning that despite continuing eligibility, people were disenrolled for “paperwork reasons” such as failure to complete the renewal process due to outdated contact information or misunderstandings about the applicable time frame. The latest available data suggests an overall disenrollment rate of 39% in South Carolina, and 19% in North Carolina.
[26] Jada Raphael & Robin Rudowitz, An Update on ACA Medicaid Expansion: What to Watch in North Carolina and Beyond, KFF (December 18, 2023),December%201%20in%20North%20Carolina.
[27] Id.
[28] S.C. Dep’t Lab., Licensing & Regul., Joint Advisory Opinion of the South Carolina State Boards of Medical Examiners, Pharmacy, and Nursing Regarding Retail IV Therapy Businesses (Aug. 11, 2023),
[29] N.C. Bd. Nursing, Administration of Intravenous Fluids (IV Hydration), Nutrient Therapies, and Medications for Hydration, Health, and Wellness (Sept. 2022),
[30] Jennifer Nelson, The Evolution of Direct Care and Concierge Medicine, Medscape (November 1, 2023),
[31] Transforming Life Sciences in North Carolina, N.C. Biotechnology Ctr.,
[32] Barry Teater, Virginia-Based Indivior to Invest $60M in Raleigh Manufacturing Plant, N.C. Biotechnology Ctr. (Nov. 8, 2023),
[33] Christopher Capot, ProKidney Announces Plans to Invest $485 Million and Create 330 Jobs in Greensboro, N.C. Biotechnology Ctr. (June 6, 2023),
[34] Alex Keown, South Carolina Life Sciences Industry Continues Exponential Growth, SC bio (Apr. 5, 2023),
[35] Orangeburg Medical Device Manufacturer Zeus Acquired in $3B Deal, SC bio (Dec. 20, 2023),
[36] Alan Condon, Health Systems Investing Heavily in ASCs, Becker’s Hosp. CFO Rep. (Sep. 15, 2023),
[37] Lillian Johnson, AHWFB Gets State Approval for $78 Million Ambulatory Surgery Center, Site Prep Begins, Triad Bus. J. (Nov. 14, 2023),

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