Alabama Administrative Code
Title 410 - STATE HEALTH PLANNING AND DEVELOPMENT AGENCY
Chapter 410-2-3 - SPECIALTY SERVICES
Section 410-2-3-.08 - New Technology
Universal Citation: AL Admin Code R 410-2-3-.08
Current through Register Vol. 42, No. 11, August 30, 2024
(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.
Author: Statewide Health Coordinating Council (SHCC)
Statutory Authority: Code of Ala. 1975, § 22-21-260(4).
Disclaimer: These regulations may not be the most recent version. Alabama may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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