Cameron Miranda
The North Carolina Certificate of Need (CON) Law requires health care providers to obtain a CON from the Department of Health and Human Services before developing or offering a “new institutional health service”. The CON law prohibits healthcare providers from acquiring certain medical equipment or developing new health services, health service facilities, and health service facility beds without prior approval. North Carolina is one of 35 states with a CON program, which requires health providers to obtain permission from a state board before opening, expanding, or offering a new type of service. The CON application process involves two different forms, depending on the type of facility or service proposed. The Agency reviews each application within 90 to 150 days, considering written and public comments, and may approve, deny, or conditionally approve applications. The CON law has undergone major reforms in 2023, including doubling the cost threshold triggering CON review of diagnostic centers and exempting certain facilities from CON requirements.
| Characteristics | Values |
|---|---|
| What is a Certificate of Need (CON) | A law requiring health providers to obtain permission from a state board before opening, expanding, or offering a new type of service. |
| Which states have a CON program | North Carolina is one of 35 states with a CON program. |
| Who can sign a CON | The Department of Health and Human Services. |
| Who reviews a CON application | The Agency reviews each application against the review criteria in the CON Law and any applicable rules adopted by the Agency. |
| Time taken to review a CON application | The Agency has from 90 to 150 days to review a CON application. |
| What is the process for appealing a decision | Within 30 days of a decision, any affected person may file a petition for a contested case hearing with the Office of Administrative Hearings. |
| What is the process for monitoring project development | After the CON is issued, the Agency requires the certificate holder to submit periodic progress reports. |
| What is the process for enforcing the CON | The Agency may withdraw a CON if the certificate holder does not develop the project in a timely manner and cannot show a good-faith effort. |
| What are some recent reforms to the CON program in North Carolina | Session Law 2023-7 has resulted in major reforms, including doubling the cost threshold triggering CON review of a diagnostic center from $1,500,000 to $3,000,000, and exempting MRI scanners in "urban" counties with a population of more than 125,000 from CON requirements. |
Explore related products
What You'll Learn
The North Carolina Certificate of Need (CON) Law
The purpose of the CON law is to control rising healthcare costs by restricting the unnecessary duplication of health service facilities. The law is administered by the Department of Health and Human Services, with the Healthcare Planning and Certificate of Need (HPCON) Section responsible for its implementation. The HPCON Section evaluates applications based on specified "review criteria" and determines whether to approve, deny, or conditionally approve a project.
The State Medical Facilities Plan (SMFP) is prepared annually by the Department and the North Carolina State Health Coordinating Council (SHCC), an advisory body consisting of 25 members appointed by the Governor. The SMFP includes need methodologies for determining the necessity of various facilities and services, with the exception of some areas such as diagnostic centres, hospice residential facilities, and the acquisition of certain major medical equipment.
The CON application process involves two different forms, depending on the type of facility or service proposed. Applicants must submit the appropriate form and provide information that demonstrates compliance with the review criteria outlined in the CON Law. The Agency may approve, deny, or conditionally approve an application based on its adherence to the review criteria and applicable rules.
Appeals can be made within 30 days of a decision, with the possibility of a contested case hearing and subsequent appeals to the N.C. Court of Appeals if necessary. Once a certificate of need is issued, the Agency monitors the project's development and requires periodic progress reports from the certificate holder. Non-compliance or lack of timely development can result in the withdrawal of the certificate.
North Carolina has one of the strictest CON programs in the country, and there have been calls for its reform or repeal by organizations such as the Department of Justice, the Federal Trade Commission, and the American Medical Association. Critics argue that CON laws lead to higher costs, fewer hospitals and hospital beds, longer emergency room wait times, and reduced access to care. However, supporters of the CON law in North Carolina argue that it helps control rising healthcare costs and prevents unnecessary duplication of services.
Should You Confront Lawbreakers?
You may want to see also
Explore related products
Health providers must obtain permission from a state board
North Carolina is one of 35 states with a Certificate of Need (CON) program, which requires health providers to obtain permission from a state board before opening, expanding, or offering a new type of service. The CON law prohibits healthcare providers from acquiring certain medical equipment or developing new health services, health service facilities, and health service facility beds without prior approval. This law is designed to control rising healthcare costs by restricting unnecessary increases in healthcare costs and limiting unnecessary health services and facilities based on geographic, demographic, and economic considerations.
The CON law in North Carolina is the strictest in the Southeast and the third strictest in the country. Research has found that CON is associated with 30% fewer hospitals per capita, 13% fewer hospital beds, 14% longer emergency room wait times, and 3% higher spending. As a result, reforming or repealing CON laws is likely to bring more healthcare facilities, lower healthcare prices, and better access to care in North Carolina.
To obtain permission from a state board, health providers must meet various requirements, including education, exams, and background checks. State medical boards ensure that all practicing physicians have appropriate education and training and that they abide by recognized standards of professional conduct. The licensure process can be streamlined through multi-state licensure compacts, which allow health care providers to practice in participating states.
One example of a multi-state licensure compact is the Interstate Medical Licensure Compact, which offers an expedited pathway to licensure for qualified physicians who wish to practice in multiple states. As of 2020, 29 states, Guam, and the District of Columbia are participating members of the Compact, with several other states considering legislation to join. The Compact helps increase access to healthcare for patients in underserved or rural areas by making it easier for physicians to obtain licenses to practice in multiple states.
Gun Rights for Lawful Permanent Residents: What's Allowed?
You may want to see also
Explore related products
The Department of Health and Human Services
In North Carolina, the Certificate of Need (CON) law falls under the purview of the Department of Health and Human Services. The CON law requires healthcare providers to obtain prior approval from the HHS before acquiring certain medical equipment or expanding their services. This includes developing new health services, facilities, or facility beds. The fundamental goal of the CON law is to control healthcare costs by preventing unnecessary duplication of health services and facilities, considering geographic, demographic, and economic factors.
The HHS plays a crucial role in evaluating and approving these requests from healthcare providers. By assessing the need for new health services or facilities, the department ensures that healthcare costs are managed effectively and that there is no unnecessary overlap with existing services. This process aims to benefit the citizens of North Carolina by improving access to healthcare and ensuring that resources are allocated efficiently.
While the CON law is specific to North Carolina, similar laws exist in other states. Originally, the federal government passed the National Health Planning and Resources Development Act in 1974, encouraging states to adopt CON programs. By the early 1980s, almost every state had implemented some version of CON laws. However, over time, it became evident that these laws were not meeting their intended goals, and several states, including the federal government, repealed them.
Today, the impact of CON laws is still debated. While they were designed to improve access to healthcare, control costs, and enhance quality, critics argue that they have had the opposite effect. CON laws have been accused of reducing healthcare quality, limiting access, particularly in rural areas, and increasing healthcare costs for patients and taxpayers. As a result, several states have suspended or repealed these laws, allowing for more flexibility in meeting healthcare needs.
My Passion for Law: A Lifelong Interest
You may want to see also
Explore related products
Application review and approval process
The North Carolina Certificate of Need (CON) law requires health care providers to obtain approval from the Department of Health and Human Services before acquiring certain medical equipment or developing new health services, facilities, or beds. The Healthcare Planning and Certificate of Need (HPCON) Section within the department's Division of Health Service Regulation is responsible for implementing the CON law.
The application review and approval process for a CON in North Carolina is as follows:
Submission of Application
To obtain a CON, an applicant must submit an application to the HPCON Section. The application must include information demonstrating that the proposed project meets the specified "review criteria." The review criteria are based on geographic, demographic, and economic considerations to restrict unnecessary increases in healthcare costs and limit unnecessary health services and facilities.
Initial Review by HPCON Section
The HPCON Section reviews the application to determine if it meets the specified review criteria. The Section may approve or deny the application outright or approve it with conditions necessary to bring the project into compliance with the mandated criteria.
Competitive Nature of the Process
The CON application process in North Carolina is highly competitive, especially for projects involving ambulatory surgery facilities (ASFs) and magnetic resonance imaging (MRI) scanners. Multiple applicants often vie for a limited allotment of resources, such as operating rooms and MRI scanners.
Impact of Competitors and Public Comments
Competitors and other interested parties can intervene in the application process and provide evidence or arguments for denying an application. This aspect of the process can make it challenging to obtain a CON in North Carolina.
Recent Reforms and Exemptions
Recent reforms to the CON program in North Carolina, through Session Law 2023-7, have resulted in significant changes. The law has doubled the cost threshold triggering CON review of diagnostic centres from $1,500,000 to $3,000,000. It has also exempted certain types of facilities, such as qualified urban ASFs and endoscopy room-only ASFs in highly populated counties, from CON review.
Ongoing Dialogue and Adjustments
As the CON law continues to evolve, the NC Division of Health Service Regulation, Healthcare Planning, and Certificate of Need Section remain active in interpreting the impact of the law and its exemptions.
How Northwestern Law Grads Land Top Firm Jobs
You may want to see also
Explore related products
Appeals and enforcement
The North Carolina Certificate of Need (CON) Law requires health care providers to obtain a CON from the Department of Health and Human Services before developing or offering a “new institutional health service.” The CON law is administered by the Healthcare Planning and Certificate of Need (HPCON) Section within the Department's Division of Health Service Regulation. The HPCON Section is responsible for reviewing and approving or denying CON applications based on specified "review criteria."
The CON law restricts unnecessary increases in healthcare costs and limits unnecessary health services and facilities based on geographic, demographic, and economic considerations. It is intended to control rising healthcare costs by restricting the unnecessary duplication of existing or approved health service facilities.
The CON application process is as follows: Applicants must submit their applications to the HPCON Section by the specified deadline. The Agency then reviews the applications according to a batched review schedule and determines if the application meets the review criteria and any applicable rules. The Agency may approve or deny the application outright or approve it with certain conditions to ensure compliance with the mandated criteria.
Additionally, the enforcement of the CON law ensures that health care providers do not acquire certain medical equipment or develop new health services, facilities, or beds without prior approval. The State Medical Facilities Plan (SMFP), prepared annually for the Governor's approval, includes need methodologies for determining the necessity of various facilities and services. The SMFP addresses the relocation of specific types of health service facility beds and equipment, such as nursing facility beds and dialysis stations.
Law Enforcement and Jury Duty: Compatible or Conflicted?
You may want to see also
Frequently asked questions
The North Carolina Certificate of Need (CON) Law requires health care providers to obtain a CON from the Department of Health and Human Services before developing or offering a “new institutional health service”.
This includes developing new health service facilities, adding beds, operating rooms, gastrointestinal endoscopy rooms, or dialysis stations to existing health service facilities, and initiating new cardiac catheterization services, open-heart surgery services, burn intensive care services, neonatal intensive care services, or solid organ or bone marrow transplantation services.
Within 30 days after the date of a decision, any affected person may file a petition for a contested case hearing with the Office of Administrative Hearings.
