216 R.I. Code R. 216-RICR-40-10-22.10 - Review Procedures

A. Proposals for new institutional health services and new health care equipment shall be subdivided into three (3) categories for purposes of review:

1. Expeditious review;

2. Accelerated review; and

3. Regular review.

B. Applicants shall file a detailed letter of intent on a form provided by the state agency at least forty-five (45) days prior to the submission of a certificate of need application.

C. Applicants must file three (3) paper copies and one (1) electronic copy of the completed application at the time of initial submission. Any application filed with the state agency must include an application fee. The application fee shall be considered to be a necessary part of the initial submission and failure to abide by this application fee requirement shall preclude any further consideration of the application and review will be initiated. Once the state agency has determined that the original filing is acceptable in form (or that an amended filing is acceptable in form) a total of three (3) paper copies and one (1) electronic copy of the acceptable application materials shall be provided at least seven (7) days prior to the initiation date of the review.

1. Expeditious review requests may be submitted at any time. If an expeditious review is not granted, applicants may apply during the next review cycle.

2. Accelerated review requests shall be submitted on or before the date of the appropriate regular review cycle of January 10th or June 10th.

3. Regular reviews must be received at the Office of Health Systems Development by 4:30 P.M. on January 10th or June 10th.

D. For purposes of each review cycle category, each application received shall be batched with all other applications simultaneously under review. Further, each application may be grouped with similar applications based upon the type of health care facility involved, identity of the geographical area, service population, or the nature of the proposal to insure the full benefits of comparison for competing applications and to evaluate the impact on affordability of those proposals.

E. Except in the cases of expeditious reviews or accelerated reviews, the procedures outlined in §§ 22.10(F) through 22.10(L) of this Part shall be employed for the conduct of reviews of new institutional health services and new health care equipment.

F. The state agency, on July 20th and February 20th, shall give written notification to affected persons of the beginning of the review cycle. Such notice shall include the following specific facts:

1. A description of the subject matter of the applications filed and of the principal issues involved;

2. The proposed schedule for the review;

3. The period within which a public meeting may be held, if requested by an affected person;

4. The manner by which notification will be provided, of the time and place of the public meeting, should one be conducted;

5. The manner by which written comment may be provided to the state agency; and

6. If deemed appropriate by the state agency, whether accelerated review will be provided.

a. Failure of an affected person to receive written notification in accordance with this section shall not be grounds for reversal of a decision of the state agency or defeat the jurisdiction thereof or affect adversely the regularity of any proceedings before same.

b. "Notification" is the date on which the notice is sent to applicants and to affected persons.

G. If an application is deemed not acceptable in form after initial staff review, the applicant shall be informed of the reasons for its rejection within fifteen (15) working days of its receipt. The applicant may then submit the materials required by the state agency to correct the deficiencies cited as forming the basis for rejection, provided such submission can be made at least seven (7) days prior to the date for initiation of the review cycle. Such submissions shall be considered to form part of the original application filed by the applicant. Any submissions filed after the stipulated date shall be ineligible for review until the applicable subsequent cycle.

H. Acceptance of an application in form shall not be construed as affecting the sufficiency of the information provided in substance. The burden of proof is upon the applicant to prove the public need and affordability for the specific new institutional health service or new health care equipment proposed to be offered or developed, and the scope thereof, and to demonstrate compliance with all matters required by law and this Part, through the information provided in the application.

I. If, during the conduct of a review, new information provided by the applicant subsequent to the filing of its formal application is contradictory to the information provided in the formal application or if such new information suggests the proposal contemplated by the applicant to be materially different from that presented in the original application, the Director of Health may terminate the review. The applicant may resubmit the proposal in an applicable subsequent review cycle.

J. Affected persons, including those parties defined in § 22.2(A)(4) of this Part and the state Department of Business Regulation, the Department of Behavioral Healthcare, Developmental Disabilities and Hospitals, the Department of Human Services, the state peer review organization, affected cities and towns, and such other agencies and/or persons as may be deemed appropriate in the context of an individual application, shall be afforded an opportunity to provide written comment with respect to each application submitted. Any comment so initiated must be received by the state agency within thirty (30) days, when practicable, from the date of notification of affected persons except in the case of:

1. Expeditious reviews or accelerated reviews when comments must be received within ten (10) days, when practicable, of the date of notification of affected persons, or

2. Public meetings shall be held in accordance with § 22.11 of this Part.

K. The time frame for review shall be as follows:

1. The decision of the state agency may be rendered within one hundred twenty (120) days of the date of notification of affected persons. The maximum period of review by the Health Services Council shall not exceed one hundred fifteen (115) days and that the state agency decision shall be rendered within five (5) days of the Health Services Council's determination of its recommendation.

2. If the state agency fails to act upon an application within one hundred twenty (120) days, the applicant may apply to the superior court of Providence County to require the state agency to act upon the application.

L. The Health Services Council shall consider, as deemed appropriate, no less than the following considerations in conducting reviews:

1. The relationship of the proposal to such state health plans as may be formulated by the state agency;

2. The impact of approval or denial of the proposal on the future viability of the applicant and of the providers of health services to a significant proportion of the population served or proposed to be served by the applicant;

3. The need that the population to be served by the proposed equipment or services has for the specific new institutional health service or new health care equipment and the scope thereof; and the extent to which such proposed services or equipment will be accessible to residents of the state, particularly those traditionally underserved;

4. The availability of alternative, less costly, or more effective methods of providing such services or equipment, including economies or improvements in service that could be derived from feasible cooperative or shared services;

5. The availability of funds for capital and operating needs for the provision of the services or equipment proposed to be offered;

6. The effect of the means proposed for the delivery of such services on the clinical needs of health professional training programs in the state;

7. If such services are to be available in a limited number of facilities, the extent to which the health profession schools in the area will have access to the services for training purposes;

8. The immediate and long term financial feasibility of the proposal including:

a. The reasonableness of utilization projections,

b. The probable impact of the proposal on the reimbursement system, on the cost of and charges for health services of the applicant and on the cost of health care in the state,

c. The relative availability of funds for capital and operating needs for the provision of the services or equipment proposed to be offered,

d. The cost of financing the proposal including the reasonableness of the interest rate, the period of borrowing and the equity position of the applicant.

9. The impact of the proposal on the quality of health care in the state and in the population area to be served by the applicant;

10. In the case of existing services or facilities, the quality of care provided by those facilities in the past;

11. The efficacy of the proposed new institutional health service or new health care equipment;

12. The relationship, including the organizational relationship of the services or equipment proposed, to ancillary or support services and to the existing health care system of the state;

13. Special needs and circumstances of those entities which provide a substantial portion of their services or resources, or both, to individuals not residing within the state;

14. Special needs of such entities as medical and other health professional schools, multidisciplinary clinics and specialty centers;

15. The special needs for and availability of osteopathic facilities and services within the state, including the impact on existing and proposed institutional training programs for doctors of osteopathy and medicine at the student, internship and residency levels;

16. In the case of a construction project:

a. The costs and methods of the proposed construction, and projected life cycle operating costs;

b. The probable impact of the construction project reviewed on the costs of providing health services by the person proposing such construction project and on the costs and charges to the public of providing health services by other persons;

c. The proposed availability and use of safe patient handling equipment in the new or renovated space to be constructed.

17. The factors which affect the effect of competition on the supply of the health services being reviewed with particular emphasis on the prevailing method of paying for inpatient health services by public and private health insurers;

18. Improvements or innovations in the financing and delivery of health services which foster competition and serve to promote quality assurance and cost effectiveness, particularly as such relate to the prevailing method of paying for inpatient health services and other institutional health services by public and private health insurers;

19. The efficiency and appropriateness of the use of existing services and facilities similar to those proposed, including the extent to which the proposed new service or equipment, if implemented, will not result in any unnecessary duplication of existing services and equipment.

20. In the case of review of proposals by health care facilities who by contractual agreement, R.I. Gen. Laws Chapter 27-19 or other statute are required to adhere to an annual schedule of budget or reimbursement determination to which the state is a party, the State Budget Office, the Office of the Health Insurance Commissioner, and Hospital Service Corporations organized under R.I. Gen. Laws Chapter 27-19 shall forward to the Health Services Council within forty-five (45) days of the initiation of the review of the proposals by the Health Services Council under R.I. Gen. Laws § 23-15-4(f)(1) of the Act:

a. A cost impact analysis of each proposal which analysis shall include but not be limited to consideration of increases in operating expenses, per diem rates, health care insurance premiums and public expenditures; and

b. Comments on acceptable interest rates and minimum equity contributions and/or maximum debt to be incurred in financing needed proposals.

21. The ability of the people of the state to afford the proposal as defined in § 22.2(A)(5) of this Part including consideration of the condition of the state's economy, the statements of authorities and/or parties affected by such proposals, and economic, financial, and/or budgetary constraints affected by such proposals including such written cost impact analysis as may be provided by the State Medicaid Agency, State Budget Officer or other affected parties.

22. The potential of the proposal to demonstrate or provide one (1) or more innovative approaches or methods for attaining a more cost effective and/or efficient health care system;

23. The relationship of the proposal to the potential need indicated in any requests for proposals issued by the state agency in accordance with the requirements of § 22.5(E) of this Part;

24. Cost impact statements forwarded pursuant to R.I. Gen. Laws § 23-15-6(e) of the Act;

25. The input of the community to be served by the proposed equipment and services and the people of the neighborhoods close to the health care facility who are impacted by the proposal;

26. The relationship of the proposal to any long-range capital improvement plan of the health care facility applicant; and

27. Any other factors deemed relevant by the Health Services Council or the Director.

Notes

216 R.I. Code R. 216-RICR-40-10-22.10