Ala. Admin. Code r. 410-2-3-.08

Current through Register Vol. 42, No. 12, September 30, 2024

Section 410-2-3-.08 - New Technology

(1) Definition

(a) New technology is emerging equipment (1) intended for use in the diagnosis and/or treatment of medical conditions; (2) for which adequate data is not yet available to fully develop State Health Plan criteria and standards on a technology-specific basis; and (3) whose cost exceeds the thresholds established in § 22-21-263, Code of Ala. 1975. New technologies often involve costly capital expenditures and significant increases in operational costs. Therefore, adequate standards and criteria shall be established to determine need, efficiency and appropriateness as required by § 22-21-266, Code of Ala. 1975.

(b) Emerging equipment shall be considered new technology prior to and for eighteen (18) months following its approval by the Food and Drug Administration (FDA). After eighteen (18) months, equipment initially classified as new technology shall be treated as any other major medical equipment (§ 22-21-263, Code of Ala. 1975) acquisition; if technology-specific criteria are made a part of the State Health Plan, they shall apply, and where no technology-specific section exists, other pertinent statutory, regulatory and State Health Plan provisions shall govern.

(c) New technology provisions do not apply to the acquisition of equipment to be used solely for research.

(2) Process

(a) Prior to approval of a new technology by the FDA, applications for Certificate of Need for the subject technology shall not be approved by the CON Review Board unless technology-specific criteria have been adopted by the Statewide Health Coordinating Council (SHCC) and approved by the Governor for inclusion in the State Health Plan.

(b) To facilitate this process (and thereby avoid unwarranted delays in equipment acquisition), providers considering acquisition of new technology shall notify the State Health Planning and Development Agency in writing of their interest at the earliest possible date. Within ten (10) days of such notification, the Chairman of the SHCC shall appoint the leader of a technology-specific task force to complete development of criteria and standards for review of the identified new technology within sixty (60) days. At a minimum, such standards shall incorporate the Planning Policy requirements section.

(c) The earliest point at which CON approval for new technology shall be granted is the point at which technology-specific criteria and standards have been adopted. However, should such criteria and standards not be in place before FDA approval is granted, then beginning with FDA approval and extending for eighteen (18) months, or until technology-specific criteria and standards are adopted and approved by the Governor, whichever comes first, the requested new technology shall be reviewable using the Planning Policy criteria incorporated as a portion of this section. Under these circumstances, a CON may be granted if the project meets the threshold requirements and discretionary provisions stated in the Planning Policy and is consistent with other pertinent statutory, regulatory, and State Health Plan provisions for determining need, efficiency, and appropriateness of proposed equipment acquisitions.

(d) Following adoption of a technology-specific section of the State Health Plan, the Statewide Health Coordinating Council shall review the new section eighteen (18) months after approval of the specific technology by the FDA. The basis for such review may include utilization, financial, and demographic data obtained from clinical use of the equipment in Alabama, nationally, and internationally. SHCC's 18-month review may result in (1) continuation of the State Health Plan standards; (2) removal of the technology-specific section from the State Health Plan; or (3) modification of the standards for continued inclusion in the State Health Plan.

(3) Planning Policy. In addition to all other statutory, regulatory, and State Health Plan requirements, all applicants for new technology shall meet the following:

(a) Threshold Requirements

1. Applicants for new technology shall demonstrate that they will have the ability to employ staff who are adequately trained and qualified. Demonstration of operators' competence may include appropriate residency training, formal continuing medical education courses, and on-the-job training. The applicant must also demonstrate the ability to employ adequate numbers of trained technical staff and support personnel to work in conjunction with the operators.

2. Applicants requesting new technology shall demonstrate that the new technology is needed by the population of a defined geographic area. Estimates of need shall be based upon the number of patients who will use the service, classified by diagnosis and by county of residence. Institution-based data alone shall not be sufficient to meet this requirement. The effect the new technology may have on utilization of existing technology or procedure shall be considered.

3. Before acquiring new technology, the applicant shall have complementary services available for support and evaluation purposes and must show the capability for providing adequate quality assurance.

4. Applicants shall guarantee uninsured (those not covered by Medicare, Medicaid, Blue Cross/Blue Shield or commercial insurance coverage) patients equal access to the new technology.

5. A new technology must be offered in the most cost effective manner at reasonable charges (professional and facility), especially where only one or a few applicants will have an opportunity to acquire the new technology early in its development.

6. Applicants requesting the new technology must agree to report basic utilization, insurance, financial, and demographic data (including patient origin data by diagnosis and patient insurance status) in the frequency and format prescribed by the SHPDA, with the advice and consent of the Health Care Information and Data Advisory Council, to permit an evaluation of the technology, to facilitate regional and statewide planning for diffusion, and to monitor compliance with the provisions above.

(b) Discretionary Provisions

1. All potential patients shall have access to new technology. To the extent that is medically-indicated, a new technology shall be available 24 hours a day, seven days a week on an emergency (on-call) basis.

2. Provision shall be made for participation in research, resident training, and continuing medical education for physicians, nurses, and technicians, as appropriate.

3. Whenever possible, the applicant shall acquire new equipment in conjunction with other providers. If such sharing in acquisition is not possible, the applicant shall demonstrate efforts to establish a multi-provider referral system.

Ala. Admin. Code r. 410-2-3-.08

Amended by Alabama Administrative Monthly Volume XXXIII, Issue No. 03, December 31, 2014, eff. 1/6/2015.

Amended by Alabama Administrative Monthly Volume XXXVIII, Issue No. 06, March 31, 2020, eff. 5/15/2020.

Adopted by Alabama Administrative Monthly Volume XLII, Issue No. 07, April 30, 2024, eff. 6/14/2024.

Author: Statewide Health Coordinating Council (SHCC)

Statutory Authority:Code of Ala. 1975, § 22-21-260(4).