216-40-10 R.I. Code R. § 12.3

Current through June 12, 2024

Section 216-RICR-40-10-12.3 - Licensing Procedures

12.3.1General Requirements for Licensure

No person acting severally or jointly with any other person, shall establish, conduct or maintain a kidney disease treatment center in this state without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4.

12.3.2Application for License or for Changes in the Owner, Operator, or Lessee

A. Application for a license to conduct, maintain or operate a kidney disease treatment center shall be made to the licensing agency upon forms provided by it one month prior to the expiration date of the license and shall contain such information as the licensing agency reasonably requires which may include affirmative evidence of ability to comply with the provisions of R.I. Gen. Laws § 23-17-4 and the rules and regulations herein.

1. Each application shall be accompanied by an application fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.

B. A listing of names and addresses of direct and indirect owners whether individual, partnership or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of any mortgage, deed or trust note or other obligation secured (in whole or in part) by the facility or any of the property or assets of the facility. The list shall also include all officers, directors and other persons or any subsidiary corporation owning stock, if the facility is organized as a corporation, and all partners if the facility is organized as a partnership.

C. Application for initial licensure or changes in the owner, operator, or lessee of a kidney disease treatment center shall be made on forms provided by the licensing agency and shall contain but not be limited to information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the considerations enumerated in §12.3.3(E) of this Part. Twenty-five (25) copies of such applications are required to be provided.

1. Each application filed pursuant the provisions of this section shall be accompanied by a non-refundable, non-returnable application fee, as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.

12.3.3Issuance and Renewal of License

A. Upon receipt of an application for a license, the licensing agency shall issue a license or renewal thereof for a period of one (1) year if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17 and the rules and regulations herein. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year after inspection and approval by the licensing agency.

1. All renewal applications shall be accompanied by a license renewal fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.

B. A license shall be issued to a specific licensee for a specific location and shall not be transferable. The license shall be issued only for the premises and the individual owner, operator or lessee, or to the corporate entity responsible for its governance.

1. Any initial licensure or change in owner, operator, or lessee of a licensed kidney disease treatment center shall require prior review by the Health Services Council and approval of the licensing agency as provided in §§12.3.3(E) and (F) of this Part, or for expedited reviews conducted pursuant to §12.3.3(H) of this Part, as a condition precedent to the transfer, assignment or issuance of a new license.

C. A license issued hereunder shall be the property of the state and loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.

D. Except for expedited reviews conducted pursuant to §12.4.3(H) of this Part, reviews of applications for initial licensure or for changes in the owner, operator or lessee of licensed kidney disease treatment center shall be conducted according to the following procedures:

1. Within ten (10) working days of receipt, in acceptable form, of an application for initial licensure or a license in connection with a change in the owner, operator or lessee of an existing kidney disease treatment center, the licensing agency will notify and afford the public thirty (30) days to comment on such application.

2. The decision of the licensing agency will be rendered within ninety (90) days from acceptance of the application.

3. The decision of the licensing agency shall be based upon the findings and recommendations of the Health Services Council unless the licensing agency shall afford written justification for variance therefrom.

4. All applications reviewed by the licensing agency and all written materials pertinent to licensing agency review, including minutes of all Health Services Council meetings, shall be accessible to the public upon request.

E. Except as otherwise provided in R.I. Gen. Laws Chapter 23-17, a review by the Health Services Council of an application for initial licensure or for a license in the case of a proposed change in owner, operator, or lessee of a licensed kidney disease treatment center, may not be made subject to any criterion unless the criterion directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3. In conducting reviews of such applications the Health Services Council shall specifically consider, and it shall be the applicant's burden of proof to demonstrate:

1. The character, commitment, competence, and standing in the community of the proposed owners, operators, or directors of the kidney disease treatment center as evidenced by:

a. In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):

(1) In providing safe and adequate treatment to the individuals receiving the health care facility's services;

(2) In encouraging, promoting and effecting quality improvement in all aspects of health care facility services; and

(3) In providing appropriate access to health care facility services;

b. A complete disclosure of all individuals and entities comprising the applicant; and

c. The applicant's proposed and demonstrated financial commitment to the health care facility.

2. The extent to which the facility will provide or will continue, without material effect on its viability at the time of change of owner, operator or lessee, to provide safe and adequate treatment for individuals receiving the facility's services as evidenced by:

a. The immediate and long term financial feasibility of the proposed financing plan;

(1) The proposed amount and sources of owner's equity to be provided by the applicant;

(2) The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator or lessee of the health care facility;

(3) The relative availability of funds for capital and operating needs;

(4) The applicant's demonstrated financial capability;

(5) Such other financial indicators as may be requested by the state agency;

3. The extent to which the facility will provide or will continue to provide safe and adequate treatment for individuals receiving the facility's services and the extent to which the facility will encourage quality improvement in all aspects of the operation of the health care facility as evidenced by:

a. the credibility and demonstrated or potential effectiveness of the applicant's proposed quality assurance programs;

4. The extent to which the facility will provide or will continue to provide appropriate access with respect to traditionally underserved populations as evidenced by:

a. In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally underserved populations to its health care facilities; and

b. The proposed immediate and long term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the health care facility.

5. In consideration of the proposed continuation or termination of emergency, primary care and/or other core health care services by the facility.

a. The effect(s) of such continuation or termination on the provision of access to safe and adequate treatment of individuals, including but not limited to traditionally underserved populations.

6. And in cases where the application involves a merger, consolidation or otherwise legal affiliation of two or more health care facilities, the proposed immediate and long term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.

F. Subsequent to reviews conducted under §§12.4.3(D), (E), (G) and (H) of this Part, the issuance of a license by the licensing agency may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3, or to the review criteria set forth in §12.4.3(E) of this Part. This shall not limit the authority of the licensing agency to require correction of conditions or defects which existed prior to the proposed change of owner, operator or lessee and of which notice had been given to the facility by the licensing agency.

G. Applicants for initial licensure may, at the sole discretion of the licensing agency, be reviewed under expedited review procedures established in §12.4.3(H) of this Part if the licensing agency determines:

1. That the legal entity seeking licensure is the licensee for one or more health care facilities licensed in Rhode Island pursuant to the provisions of R.I. Gen. Laws Chapter 23-17 whose records of compliance with licensure standards and requirements are deemed by the licensing agency to demonstrate the legal entity's ability and commitment to provide quality health services; and

2. That the licensure application demonstrates complete and satisfactory compliance with the review criteria set forth in set forth in §12.4.3(E) of this Part.

H. Expedited reviews of applications for initial licensure of kidney disease treatment centers shall be conducted according to the following procedures:

1. Within ten (10) working days of receipt, in acceptable form, of an application for initial licensure the licensing agency will determine if such application will be granted expedited review and the licensing agency will notify the public of the licensing agency's initial assessment of the application materials with respect to the review criteria in §12.4.3(E) of this Part as well as the licensing agency's intent to afford the application expedited review. At the same time the licensing agency will afford the public a twenty (20) day period during which the public may review and comment on the application and the licensing agency's initial assessment of the application materials and the proposal to afford the application expedited review.

2. Written objections from affected parties directed to the processing under the expedited procedures and/or the satisfaction of the review criteria shall be accepted during the twenty (20) day comment period. Objections must provide clear, substantial and unequivocal rationale as to why the application does not satisfy the review criteria and/or why the application ought not to be processed under the expedited review mechanism. The licensing agency may propose a preliminary report on such application provided such proposed report incorporates findings relative to the review criteria set forth in §12.4.3(E) of this Part. The Health Services Council may consider such proposed report and may provide its advisory to the Director of Health by adopting such report in amended or unamended form. The Health Services Council, however, is not bound to recommend to the Director that the application be processed under the provisions for expedited review as delineated in §§12.4.3(G) and (H) of this Part. The Health Services Council shall take under advisement all objections both to the merits of the application and to the proposed expedited processing of the proposed application and shall make a recommendation to the Director regarding each. Should the Health Services Council not recommend to the Director that the application be processed under expedited review procedures as initially proposed, such application may continue to be processed consistent with the time frames and procedures for applications not recommended for expedited review. If expedited review is not granted, then the comment period may be forthwith extended consistent with the time frames in §12.4.3(D) of this Part for applications not proposed for expedited review. The Director, with the advice of the Health Services Council, shall make the final decision either to grant or to deny expedited review and shall make the final decision to grant or to deny the application on the merits within the expedited review mechanism and time frames.

12.3.4Capacity and Classification

Each license shall be issued for the licensed dialysis station capacity of the kidney disease treatment center. No kidney disease treatment center shall have more stations or operate more shifts than authorized by the licensing agency.

12.3.5Change of Ownership, Operation and/or Location

A. When a change of ownership or operation or location of a kidney disease treatment center or when discontinuation of a service is contemplated, the owner and/or operator shall notify the licensing agency in writing no later than six (6) weeks prior to the proposed action.

B. A license shall immediately become void and shall be returned to the licensing agency when operation of a kidney disease treatment center is discontinued or when any changes in ownership occur in accordance with the rules and regulations herein and R.I. Gen. Laws § 23-17-6.

1. When there is change in ownership or in the operation or control of an existing kidney disease treatment center the licensing agency reserves the right to extend the expiration date of such license, allowing the kidney disease treatment center to operate under the same conditions which applied to the prior licensee for such time as shall be required for the processing of a new application or for transfer of patients, not to exceed six (6) weeks.

12.3.6Inspections

A. The licensing agency shall make or cause to be made such inspections and investigations as deemed necessary in accordance with R.I. Gen. Laws § 23-17-10 or Chapter 23-17 and the rules and regulations herein.

B. Every kidney disease treatment center shall be given prompt notice by the licensing agency of all deficiencies reported as a result of an inspection or investigation.

C. Written reports and recommendations of inspections shall be maintained on file in each kidney disease treatment center for a period of no less than three (3) years.

12.3.7Denial, Suspension, Revocation of License or Curtailment of Activities

A. The licensing agency is authorized to deny, suspend or revoke the license or curtail activities of any kidney disease treatment center which: has failed to comply with the rules and regulations pertaining to licensing of kidney disease treatment centers; and has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.

1. Lists of deficiencies noted in inspections conducted in accordance with §12.4.6 of this Part shall be maintained on file in the licensing agency, and shall be considered by the licensing agency in rendering determinations to deny, suspend or revoke the license or curtail activities of a kidney disease treatment center.

B. Where the licensing agency deems that operation of a kidney disease treatment center results in undue hardship to patients as a result of deficiencies, the licensing agency is authorized to deny licensing to facilities not previously licensed, or to suspend for a stipulated period of time or revoke the license of a kidney disease treatment center already licensed or curtail activities of the kidney disease treatment center.

C. Whenever an action shall be proposed to deny, suspend or revoke a kidney disease treatment center license, or curtail its activities, the licensing agency shall notify the kidney disease treatment center by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9.

1. However, if the licensing agency finds that public health, safety, or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).

D. The appropriate state and federal placement and reimbursement agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension, or revocation of license or curtailment of activities.

216 R.I. Code R. § 216-RICR-40-10-12.3

Amended effective 9/28/2023
Amended effective 12/24/2023