26:2H-7.23 Application, issuance of license as cardiac surgery center.
2. a. An applicant hospital may apply to the commissioner for a license to provide full service adult diagnostic cardiac catheterization services. The commissioner shall issue a license pursuant to such application to any hospital that:
(1) is not licensed as a cardiac surgery center;
(2) demonstrates the ability to provide full service adult diagnostic catheterization services consistent with national standards of care and current best practices;
(3) commencing in the second year of licensure pursuant to this subsection, and in each year thereafter, performs at least 250 catheterizations per year, with each interventional cardiologist performing at least 50 catheterizations per year; and
(4) meets such other requirements as the commissioner may establish by regulation including, but not limited to, participation in the department's data collection programs and in national registries such as the National Cardiovascular Data Registry to monitor quality, outcomes, and compliance with State regulations.
b. An applicant hospital may apply to the commissioner for a license to provide primary angioplasty services. The commissioner shall issue a license pursuant to such application to any hospital that:
(1) is not licensed as a cardiac surgery center;
(2) has been licensed for at least six months pursuant to subsection a. of this section to provide full service adult diagnostic catheterization services;
(3) demonstrates the ability to consistently provide primary angioplasty services 24 hours per day and seven days per week, consistent with national standards of care and current best practices; and
(4) meets such other requirements as the commissioner may establish by regulation.
c. An applicant hospital may apply to the commissioner for a license to provide elective angioplasty services. The commissioner shall issue a license pursuant to such application to any hospital that:
(1) is not licensed as a cardiac surgery center;
(2) holds licensure to participate in the C-PORT-E study or the Elective Angioplasty Demonstration Project, or is an applicant hospital licensed by the department to provide primary angioplasty services pursuant to subsection b. of this section;
(3) demonstrates the ability to provide elective angioplasty services consistent with the provisions of N.J.A.C.8:33-3.11 or any successor regulation, as well as national standards of care and current best practices, including ensuring that all patients considered for elective angioplasty undergo careful selection, screening, and risk stratification pursuant to requirements promulgated by the department by regulation, and ensuring that patients who do not meet such screening criteria are transferred to an appropriate cardiac surgery facility for elective angioplasty;
(4) commencing in the second year of licensure pursuant to this subsection, and in each year thereafter, performs a minimum of 200 angioplasty procedures per year, with each interventional cardiologist performing at least 50 angioplasty procedures per year; and
(5) meets such other requirements as the commissioner may establish by regulation.
d. (1) A hospital issued a license pursuant to subsection a. or b. of this section that fails to meet the qualification requirements for that license shall be subject to corrective administrative action or other remedial action as the commissioner may establish by regulation, including, but not limited to, submitting a corrective action plan to the department for approval and meeting any benchmarks or deadlines for compliance as may be required by the department.
(2) A hospital issued a license pursuant to subsection c. of this section shall have two years to meet the volume requirements set forth in paragraph (4) of subsection c. of this section. A hospital that fails to meet or maintain the qualification requirements for that license, including the volume requirements set forth in paragraph (4) of subsection c. of this section, shall be subject to corrective administrative action or other remedial action as the commissioner may establish by regulation, including, but not limited to, submitting a corrective action plan to the department for approval and meeting any benchmarks or deadlines for compliance as may be required by the department. If a hospital that has entered into a corrective action plan pursuant to this subsection fails to meet and maintain the qualification requirements for a license issued pursuant to subsection c. of this section, including attaining the volume requirements set forth in paragraph (4) of subsection c. of this subsection, within two years after the hospital enters into a corrective action plan, the hospital's license issued pursuant to subsection c. of this section shall be revoked.
e. The department may impose fines, suspend or revoke a license, require corrective administrative action or other remedial action, including requiring submission of a corrective action plan, or impose other lawful remedies against any entity issued a license pursuant to this section that violates any of the requirements of this section. Subject to the provisions of subsection d. of this section, the department may revoke the license of a hospital authorized to provide any cardiac service, including elective angioplasty, which fails to comply with the licensing requirements set forth in this section related to that license, including facility volume requirements, within two years after the date of licensure.
f. (1) Diagnostic cardiac catheterization and angioplasty programs in all cardiac surgery facilities shall meet such other requirements as the commissioner may establish by regulation including, but not limited to, participation in the department's data collection programs and in national registries such as the National Cardiovascular Data Registry to monitor quality, outcomes, and compliance with State regulations.
(2) A licensed cardiac surgery facility may request a waiver based on documented and continued accreditation by the Accreditation for Cardiovascular Excellence or by a national organization or association that meets similar standards specific to cardiac catheterization and percutaneous coronary intervention. Licensed facilities that seek accreditation shall provide the department with access to reports, site visits, site visit reviews, any notice related to compliance standards, and notices related to change of accreditation status.
g. The commissioner shall establish by regulation the application and renewal fees for licenses issued pursuant to this section, including a nonrefundable fee for initial licensure in the amount of at least $5,000.
L.2021, c.18, s.2.