Section 33-03-31-03 - Application, filing fee, and prefiling procedure1.Form and content of application. The applicants may submit an application in whatever form or content they deem appropriate, subject only to the requirements of this section. The application must be supported by sufficient information and documentation to meet the applicants' burden of proof with respect to the standards for certification set forth in North Dakota Century Code section 23-17.5-03. 2.Minimum application requirements. An application for a certificate must include: a. The exact name of each applicant, type of business organization, and the address of each applicant's principal business office. b. For each applicant, the name, address, and telephone number of the person authorized to receive notices and communications with respect to the application. c. A description of the nature and scope of the cooperation in the agreement. d. A description of any consideration passing to any party under the agreement. e. A proposed plan for postcertificate monitoring and active supervision by the department. This proposed plan must include: (1) A description of the standards and criteria by which the benefits and disadvantages of the agreement may be measured. These may include the standards and criteria used by the applicable professional accreditation or certification agencies or bodies. It is preferred that any standards and criteria measuring quality focus on patient or client outcomes. (2) A description of the information and the format for reports to be submitted periodically to the department sufficient to permit the department to evaluate whether performance by the applicants under the cooperative agreement is consistent with state policy as expressed in North Dakota Century Code chapter 23-17.5. (3) A schedule setting forth the dates on which the compliance information will be periodically submitted to the department. f. A copy of the cooperative agreement. g. A verified statement by an authorized officer of each applicant attesting to the accuracy of the information contained in the application. 3.Optional information and documentation to meet burden of proof. The information and documentation in support of the application will vary with the subject matter of the cooperative agreement and the nature of the activities of the applicants. The applicants may consult with department and attorney general staff prior to filing the application for assistance in determining what supporting information and documentation may be useful in evaluating the application. a. Reduction in competition. The following items are examples of information and documentation that may assist the department and attorney general in evaluating the reduction in competition resulting from a cooperative agreement: (1) A list of the services or products that are the subject of the proposed cooperative agreement. (2) A list of the services or products that are necessarily connected or offered with the services or products that are the subject of the proposed cooperative agreement. (3) A description of the geographic territory that will be served under the cooperative agreement. (4) If the geographic territory described in paragraph 3 is different from the territory in which the applicants have offered these services or products over the last five years, a description of how and why it differs. (5) A list of all products or services that a substantial share of the users of the products or services to be provided under the cooperative agreement would consider substitutes for those products or services. (6) Identification of whether the services or products of the cooperative agreement are currently being offered or are reasonably capable of being offered by other providers in the geographic territory described in paragraph 3 and, if so, a list of those providers. (7) A list of the steps necessary, under current market and regulatory conditions, for a third party to enter the geographic territory described in paragraph 3 and compete by offering the same or similar services or products. (8) A description of how the cooperative agreement will affect competition in the geographical territory over the life of the cooperative agreement. (9) Copies of all business proposals, consultant reports, and feasibility studies used in the development of the proposed cooperative agreement. (10) A description of the previous history of dealings between the parties. (11) A pro forma statement of projected financial performance under the cooperative agreement. (12) An explanation of how the cooperative agreement will affect the product and geographical markets to be serviced. (13) An explanation of the projected effects of the cooperative agreement on each applicant's current business. (14) An estimate of the market share of the applicants before and after the cooperative agreement regarding the services or products that are the subject of the cooperative agreement. (15) A statement of why the services or products would not be provided at anticipated levels of price, availability, or quality in a competitive market. (16) A description of other anticipated effects of the cooperative agreement. In this description, the applicant may include information possessed by the applicants or otherwise available to them regarding: (a) Current and anticipated demand for the affected products or services. (b) Current and anticipated capacity within the market to supply the services orproduct. b. Likely benefits to health care consumers. The following items are examples of information and documentation that may assist the department and the attorney general in evaluating the likely benefits to health care consumers from a cooperative agreement: (1) An explanation of the anticipated effect of the cooperative agreement on costs, including: (a) Pro forma financial statements showing the effect of the cooperative agreement on the cost of services or products that are the subject of the application. (b) The intentions of the parties regarding the extent to which the projected cost savings will be passed on to the public. This explanation may include any undertaking by the applicants regarding their pricing for the services or products that are the subject of theapplication. (c) The intentions of the applicants regarding the pricing of other services or products as a result of the cooperative agreement that is the subject of the application. (2) An explanation of how the cooperative agreement will affect availability of health care services or products, including: (a) Information showing the relationship between the price of products or services and the demand for the products or services. (b) New sales or service outlets to be established. (c) Identity of target populations to be served by the cooperative agreement. (d) Identity of populations currently being served by the applicants. (e) Expected reductions, if any, in the availability of health care services and products to some populations, and how, in the view of the applicants, those reductions are compensated for by increases in the availability of health care services and products to other populations. (3) An explanation of how the cooperative agreement will increase the quality of health care. It is preferred that the application address quality issues in terms of patient or client outcomes and the standards and criteria used by the applicable professional accreditation or certification agencies or bodies or any other generally accepted quality measures. For example, a hospital may include: (a) Patient morbidity and mortality. (b) Periods required for convalescence. (c) Number of patient days in the hospital. (d) The ability of medical staff to attain needed experience and the frequency of treatment necessary to better outcomes. (e) Patient and family satisfaction. (f) Number of readmissions for the same condition. (g) Any other features which are likely to increase the quality of health care. 4.Limited waiver of time limit. If the department determines that the information submitted by an applicant is unclear, incomplete, or insufficient on which to base a decision, the department may request the applicant to augment or supplement the original filing. In the event the department requests that the applicants augment or supplement the original filing, the applicants may, by written notice to the department, waive the benefit of the ninety-day review time limit and extend the review period for an additional period not to exceed ninety days unless a longer extension of the review period is agreed to by the applicants and the department. 5.Filing fee. Except as provided in subsection 6, the application must be accompanied by a fee equal to the maximum assessment permitted by North Dakota Century Code chapter 23-17.5. 6.Prefiling procedure.a. Prior to filing an application, potential applicants may submit to the department a request for determination of filing fee. This request must be accompanied by a detailed summary of the proposed application and a fee of two thousand dollars. This fee must be credited against the filing fee if the application is timely filed. In the event the potential applicants choose not to file the application, this fee is not refundable. b. The department shall review the detailed summary of the proposed application and determine the amount of filing fee based upon the anticipated costs of review of the application and active supervision of the certified agreement. No later than twenty days following receipt of a request for determination of filing fee, the department shall notify the applicants of the amount of the filing fee. In no event may this amount exceed the maximum assessment permitted by North Dakota Century Code chapter 23-17.5. The notice must allocate the amount of the filing fee between the anticipated costs of review of the application and the costs of active supervision of the certified agreement. c. The filing fee determined under this subsection is effective if the application is filed within one hundred eighty days after notice of the amount of the filing fee. Upon filing the application, the applicants shall pay that portion of the filing fee allocated to the costs of review of the application, less the two thousand dollars previously paid. Upon approval of the application, the applicants shall pay that portion of the fee allocated to the costs of active supervision of the certified agreement. Failure to pay the balance of the fee within thirty days of approval of the application renders the certificate void. In the event the application is denied, the applicants shall not be obligated to pay the balance of the fee allocated to the costs of active supervision. In the event the department determines that the application filed is not substantially the same as that described in the summary, the department may assess an additional filing fee by notice to the applicants. The additional filing fee must be paid within thirty days of the notice. N.D. Admin Code 33-03-31-03
General Authority: NDCC 23-01-03, 28-32-02
Law Implemented: NDCC 23-17.4-03, 23-17.5-02, 23-17.5-11