Michigan Compiled Laws
368-1978-17-222 - Part 222 Certificates of Need (333.22201...333.22260)
Section 333.22241 - “New Technology” Defined; New Technology Review Period; Conditions to Acquisition of New Technology Before End of Review Period; Appointment, Composition, and Purpose of Standing New Medical Technology Advisory Committee.

Sec. 22241.
(1) For purposes of this section and section 22243, "new technology" means medical equipment that requires, but has not yet been granted, the approval of the federal food and drug administration for commercial use.
(2) The period ending 12 months after the date of federal food and drug administration approval of new technology for commercial use shall be considered the new technology review period. A person shall not acquire new technology before the end of a new technology review period, unless 1 of the following occurs:
(a) The department, with the concurrence of the commission, issues a public notice that the new technology will not be added to the list of covered medical equipment during the new technology review period. The notice may apply to specific new technology or classes of new technology.
(b) The person complies with the requirements of section 22243.
(c) The commission approves the addition of the new technology to the list of covered medical equipment, and the person obtains a certificate of need for that covered medical equipment.
(3) To assist in the identification of new medical technology or new medical services that may be appropriate for inclusion as a covered clinical service in the earliest possible stage of its development, the commission shall appoint a standing new medical technology advisory committee. A majority of the new medical technology advisory committee shall be representatives of health care provider organizations concerned with licensed health facilities or licensed health professions and other persons knowledgeable in medical technology. The commission also shall appoint representatives of health care consumer, purchaser, and third party payer organizations to the committee. The commission shall also appoint faculty members from schools of medicine, osteopathy, and nursing in this state.
History: Add. 1988, Act 332, Eff. Oct. 1, 1988 ;-- Am. 1993, Act 88, Imd. Eff. July 9, 1993 ;-- Am. 2002, Act 619, Eff. Mar. 31, 2003 Popular Name: Act 368

Structure Michigan Compiled Laws

Michigan Compiled Laws

Chapter 333 - Health

Act 368 of 1978 - Public Health Code (333.1101 - 333.25211)

Article 17 - Facilities and Agencies (333.20101...333.22260)

368-1978-17-222 - Part 222 Certificates of Need (333.22201...333.22260)

Section 333.22201 - Meanings of Words and Phrases; Principles of Construction.

Section 333.22203 - Definitions; a to F.

Section 333.22205 - Definitions; H to M.

Section 333.22207 - Definitions; M to S.

Section 333.22208 - Definitions; T.

Section 333.22209 - Activities Requiring Certificate of Need; Exceptions; Requirements; Acquisition of Existing Health Facility; Relocation; “Sharing Agreement” Defined.

Section 333.22210 - Certificate of Need for Extended Care Services Program; Application; Criteria; Modification; Fee Prohibited; Compliance; Report; Discrimination Prohibited; Exercise of Rights; Written Acknowledgment; Forms; Additional Rights; Viol...

Section 333.22211 - Certificate of Need Commission; Creation; Appointment, Qualifications, and Terms of Members; Vacancy; Laws to Which Commission Members Subject.

Section 333.22213 - Commission; Bylaws; Removal of Member; Election of Chairperson and Vice-Chairperson; Meetings; Quorum; Final Action; Compensation and Expenses; Duties of Department; Professional Employees.

Section 333.22215 - Duties of Commission; Purpose; Public Hearing Before Final Action; Submission of Proposed Final Action to Joint Committee; Approval or Disapproval; Review Standards; Revision of Fees.

Section 333.22217 - Repealed. 2002, Act 619, Eff. Mar. 31, 2003.

Section 333.22219 - Joint Legislative Committee.

Section 333.22221 - Duties of Department Generally.

Section 333.22223 - Application for Certificate of Need; Statement Addressing Review Criteria.

Section 333.22224 - Certificate of Need Not Required.

Section 333.22224a - Magnetic Resonance Image Units.

Section 333.22224b - Positron Emission Tomography Scanner Services Pilot Project.

Section 333.22225 - Demonstration of Need for Proposed Project; Additional Requirements.

Section 333.22226 - Regional Certificate of Need Review Agency; Standards; Designation of Person for Specific Review Area; Requirements; Duration and Termination of Agency; Local Certificate of Need Review Agency; Application or Other Information; Re...

Section 333.22227 - Health Maintenance Organization; Purposes for Which Certificate of Need Required; Capital Expenditures; Considerations and Criteria.

Section 333.22229 - Projects and Services Subject to Comparative Review; Exceptions; Establishment of Comparative Review or Alternative Procedure; Proposed Site for Project; Utilization and Financing of Covered Clinical Services.

Section 333.22230 - Participation in Medicaid Program as Distinct Criterion.

Section 333.22231 - Decision to Grant or Deny Application for Certificate of Need; Conditions; Single Decision for All Applications; Proposed Decision; Final Decision; Notice of Reversal; Hearing; Judicial Review; Effect of Exceeding Time Frames.

Section 333.22232 - Hearing; Written Request; Appointment and Duties of Hearing Officer; Governing Law.

Section 333.22233 - Waiver of Criteria and Procedures.

Section 333.22235 - Waiver of Law and Procedural Requirements and Criteria for Review; Affidavit; Emergency Certificate of Need.

Section 333.22237 - Data and Statistics as Condition Precedent to Issuance of Certificate of Need.

Section 333.22239 - Stipulation.

Section 333.22241 - “New Technology” Defined; New Technology Review Period; Conditions to Acquisition of New Technology Before End of Review Period; Appointment, Composition, and Purpose of Standing New Medical Technology Advisory Committee.

Section 333.22243 - Acquisition of New Technology Before Approval of Federal Food and Drug Administration; Notice; Requirements; Deactivation and Removal of New Technology From Service; Conditions to Utilizing New Technology Beyond Specified Period.

Section 333.22247 - Monitoring Compliance With Certificates of Need; Investigating Allegations of Noncompliance; Violation; Sanctions; Refund of Charges.

Section 333.22249 - Agreement Authorizing Hospital to Lease Space and Operate Beds in Another Hospital; Conditions.

Section 333.22251 - Repealed. 1993, Act 88, Imd. Eff. July 9, 1993.

Section 333.22253 - Injunction or Other Process to Restrain or Prevent Violation.

Section 333.22255 - Procedural Rules.

Section 333.22257 - Certificate of Need Issued Under Former Part 221.

Section 333.22260 - Reports of Reviews; Preparation and Publication; Statements; Recommendations; Public Examination of Applications and Written Materials on File; Providing Copies.