10 CCR 2505-1
I. STATEMENT OF BASIS AND PURPOSE A. Basis. The authority for these rules is based on 25.5-1-301 through 25.5-1-303 C.R.S. as amended by S.B. 94-133; 24-32-2704(3), 24-32-2705(1)(e), 24-32-2705(2), 24-32-2708(1), 24-32-2713(1).
B. Purpose. These rules establish a framework for the review, approval, and supervision of applications for approval by the Cooperative Health Care Agreements Board (“board”) that is intended to give such agreements “state action” immunity from anti-trust prosecution. The rules specify the content of applications and provide guidelines to the board for reviewing the applications by specifying what kinds of information can fulfill the standards for cooperative agreements specified in 24-32-2706(1). The legal and practical procedures of the board are stated clearly. More specifically, these rules serve the following purpose:
1. To ensure that the actions and processes of the board are fair and unbiased and to prevent conflicts of interest which would result in the approval of agreements that do not benefit the consumers of health care, but rather only the applicants to the board.
2. To ensure that the board's review of applications and supervision of cooperative agreements will be thorough enough to satisfy the “active supervision” requirement for state action immunity.
3. To establish clear procedures for both the confidentiality and the public availability of records of the board's proceedings and of certain information reviewed by the board.
4. To clearly articulate the types of information applicants must submit to the board, and the way in which the board will use that information to judge agreements under the standard of 24-32-2706(1).
5. To clarify the actions available to the board, independent of the executive director of the department.
6. To set reasonable fees to support the direct and indirect costs of operating the board.
II. DEFINITIONS As used in the following rules and policies, the term:
A. “anti-competitive behavior” means the reduction, restriction or impediment of competition in any manner.
B. “application” means the original application submitted by the parties for board approval under CRS 24- 32-2705 as well as all supporting documentation requested by the department.
C. “availability” means the financial and geographic access to health care services and/or goods.
D. “board” means the Cooperative Health Care Agreements Board created by section 24-32-2704.
E. “business” means any corporation, limited liability company, partnership, sole proprietorship, trust or foundation, or other individual or organization carrying on a business, whether or not operated for profit.
F. “competition” means the independent striving of businesses for the opportunity to provide goods and services to customers through beneficial means including, but not limited to, independently striving to reduce costs to the business of supplying goods and services, to lower prices to consumers, to supply new and higher quality goods and services, and to develop new methods of supplying goods and services.
G. “competitor” means a health care provider supplying services and/or goods similar to those provided by the applicants in any of the zip codes included in the applicants' primary or secondary service areas.
H. “conflict of interest” means an official act which may have a direct economic benefit on a business or other undertaking in which such person has a direct or substantial financial interest as described in 24-18-108.5.
I. “cooperative agreement” means any joint venture or other agreement to which one or more hospitals are a party for the purposes of sharing, allocating, consolidating, or referring:
1. patients, personnel, instructional programs, support services, and facilities;
2. medical, diagnostic, or therapeutic facilities, services, or procedures; or 3. other services traditionally offered by health care providers. Cooperative agreements do not include mergers, consolidations, share exchanges, or other agreements that result in two or more entities consolidating into a new entity, result in two or more entities merging into one entity, result in one or more entities ceding all or substantially all control to a new or existing entity, or result in a sale, exchange, lease, or other disposition of all or substantially all the property and assets of an entity.
J. “cost” of health care means the amount of direct and indirect expenses incurred by the providers of health care services and/or goods.
K. “department” means the Department of Health Care Policy and Financing.
L. “director” means the Executive Director of the Department of Health Care Policy and Financing.
M. “DRG” means diagnostic related grouping.
N. “ex parte contact” means any oral or written communication between any member of the board and an interested person, or a representative of an interested person, about a specific matter related to an anticipated or pending application or ongoing oversight of an agreement within the board's jurisdiction and which does not occur in a public hearing, board meeting, or other official proceeding, and on the official record of the proceeding on the matter.
O. “financial interest” means a financial interest as defined in CRS 24-18-102(4) of the person or a member of his or her immediate family.
P. “geographic service area” means the service areas that are defined using the following method:
1. Determine a relative frequency distribution by: (1) sorting by zip code the number of discharges (or, as used throughout this section, encounters if the service is not always performed inpatient) occurring in the last twelve months for which data are available for the services included in the application (2) Rank in descending order (using the sum of discharges for each zip code) the zip codes of such patients. If an application involves multiple services, a separate analysis should be completed for each service.
2. Using the relative frequency distribution defined in (a), include in the geographic service area the zip codes that account for the highest 80% of discharges.
3. Also include in the geographic service area communities, not included based on paragraph 2 above, that have a heavy reliance on the applicants for their health care services affected by the cooperative agreement. Applicants should describe their methodology for making determinations under this paragraph 3. If the department determines that applicants have not included some communities with a heavy reliance on the applicants, then the department may ask the applicants to include those communities.
Q. “immediate family” means the board member's spouse and any parent, brother, sister, or child of the board member, and the spouse of any such parent, brother, sister, or child.
R. “interested person” means anyone or the agent of anyone who takes a position on behalf of an organization, or who has financial interest with respect to the outcome of an anticipated or pending application, or ongoing oversight of an agreement within the board's jurisdiction.
S. “majority” means the majority of board members participating in the meeting.
T. “meeting” means any kind of gathering convened to discuss public business in person, by telephone, or by other means of communication as described in CRS 24-6-402.
U. “ownership interest” means the possession of stock, equity in capital, or any interest in the profits of the entity.
V. “price” of health care means the amount actually paid by buyers for health care services and/or goods.
W. “provider of substitutes” means a health care provider that supplies services and/or goods that are substitutable for the services and/or goods provided by the applicants in any of the zip codes included in the applicant's primary or secondary service areas.
III. RULES OF CONDUCT A. Ex Parte Contacts (C.R.S. 24-32-2704(3))
1. Ex Parte Contact Prohibited. Members of the board shall not initiate or maintain any ex parte contacts, either directly or through an agent or department staff.
2. Procedure Relevant to Ex Parte Contacts. A board member who receives an ex parte contact in violation of this section shall place on the record, prior to any further board discussions of the matter with which the communication is associated, all written communications, all written responses to the communications, and a memorandum stating the substance of all oral communications, all responses made, the identity of each person from whom the ex parte communication was received, and shall advise all parties to the ex parte communication that these matters will be placed on the record.
3. Rebuttal of Ex Parte Contact. Any person desiring to rebut the content of the ex parte contact shall be allowed to do so, upon requesting the opportunity within 10 days after notice that said communication has been placed on the record.
4. Exceptions. The following contacts are not prohibited:
a) Any communication between a staff member acting in his or her official capacity and any board member or interested person.
b) Any communication limited entirely to procedural issues, including, but not limited to, matters such as the schedule for board meetings, location, format, or date of such meetings.
c) Any communication between a member of the board and an organization with which he or she is affiliated, so long as that member has recused or intends to recuse himself or herself from all matters related to that organization. This exception does not extend to consulting or advisory arrangements initiated after a person becomes a member of the board.
5. Removal for Violation. Failure to comply with the requirements of this section may result in a board recommendation to the Governor that the violating member should be removed from the board. In addition, the board shall have authority to set aside any prior board decision involving the related matter.
B. Conflict of Interest and Breach of Fiduciary Duty (C.R.S. 24-32-2704(3)) 1. Breach of Fiduciary Duty. Members of the board shall be held to the standards of conduct of CRS 24-18-101 through 24-18-113.
2. Duty to Recuse. Any member of the board who, in the discharge of his or her official duties, may be required to take an action which would be a conflict of interest shall:
a) Prepare a written statement immediately upon the board member's discovery of the potential conflict of interest, listing the amount of financial interest, if any, the purpose and duration of his or her services rendered, if any, and the compensation received for his or her services rendered, or other such information as is necessary to describe his or her interest;
b) Recuse him or herself from voting in any proceeding associated with the conflict of interest;
c) Cause copies of the written statement described in subsection (a) above to be delivered to the Secretary of State, State of Colorado Attorney General's Office, the director, and to other members of the board.
d) The Chairperson of the board shall cause such statement to be printed in the record of the proceedings at the first meeting after the statement has been filed with the Secretary of State, and shall excuse the member from votes, deliberations, and other actions and decisions on the matter on which the potential conflict exists.
3. Affirmative Defense. Recorded recusals shall constitute an affirmative defense to any civil or criminal action or any other sanction arising out of an alleged conflict of interest of a board member.
4. Status of Recused Member. A board member who has been excused from participating in any board activity relating to a matter that would violate this section may be counted for purposes of establishing a quorum. All recorded votes on such matters shall note that the board member recused himself or herself.
C. Board Meeting Attendance (C.R.S. 24-32-2704(5))
1. Pre-Excused Absence. Each board member should make every effort to attend the scheduled board meetings, however, in the event that a board member becomes aware that he or she will be unable to attend a future board meeting, such board member shall submit in writing to the department a request for board approval of such absence. The board shall decide whether to approve the absence at its next meeting. The results of the board's decision shall be entered into the minutes.
2. Request for Approval of Past Absence. In the event that a board member fails to attend a meeting without prior approval of the board, said board member shall have thirty days from the date of the absence to submit a written request for approval of the prior absence to the department, who shall ask the board to approve or disapprove the absence at its next meeting and enter the same into the minutes.
3. Removal for Unapproved Absence. Failure by any board member to attend three regular board meetings during any twelve-month period, without approval of the absences by the board, shall result in a recommendation to the Governor that such member be removed from the board in accordance with C.R.S. 24-32-2704(5).
D. Open Records/Meetings 1. Record Keeping (C.R.S. 24-32-2710). The department shall maintain on file all cooperative agreements which the board has approved and which remain in effect. All agreements submitted to the board shall be open for public review and inspection, however, such inspection is limited to materials not prohibited from disclosure under paragraph 2 of this subsection D.
2. Requirement of Confidentiality. Pursuant to C.R.S. 24-72-204(3)(a)(IV), the department and board shall deny inspection of, and keep confidential, any information or documents which would consist of trade secrets, privileged information, or confidential commercial or financial data furnished or obtained from any person or party. 3.- Despite the exception of the open meeting requirement in CRS 24-6-402 for chance meetings or social gatherings, the board members shall avoid discussing matters related to an anticipated or pending application or ongoing supervision of an agreement within the board's jurisdiction under any circumstances other than at an official meeting on the record for which public notice has been given.
E. Donations and Grants (C.R.S. 24-32-2714)
1. Limitations on Acceptance. The department may accept donations and grants for any purpose connected with the work of the board, and the director has the power to direct the disposition of any such donations and grants for any purposes consistent with the terms and conditions under which given; except that no grant or donation shall be accepted if:
a) The conditions attached to such grant or donation require the expenditure thereof in a manner contrary to law; or b) Such grant comes from a person or entity whose prior, present, or anticipated relationship with the board is such that acceptance of the donation would create, or create the appearance of, a present or potential conflict of interest.
2. Record All Donations and Grants Offered. The department must keep a record and make it available to the public upon request of all donations and grants offered, why they were offered, and whether they were accepted or rejected.
IV. APPLICATION REQUIREMENTS FOR COOPERATIVE AGREEMENTS A. Application Procedure All organizations, persons, or parties who wish to submit an agreement for consideration by the board must include the following information in the following format, as specified in sections IV(B) to IV(E). Applicants must submit fifteen copies of their application to the board in care of the department, except that applicants only must submit one copy of the information required by section C 2 below. If the director determines that an application is incomplete, the department may request additional information it deems necessary to make a complete application. Any incomplete application, due to unwillingness or inability of the parties involved, may render the application ineligible for consideration, at the discretion of the board.
B. Administrative Information 1. A copy of the agreement together with the names and addresses of all parties to the agreement. Parties to an agreement are assumed to be seeking antitrust immunity by the filing of the application, unless otherwise specified.
2. Names and addresses of the principal business offices of each party, if different than above.
3. Name and address of a contact person authorized to receive notices and communications with respect to the application.
4. A written statement attesting to the accuracy of all information given in the application verified and signed by a responsible officer of each party to the application.
5. A written statement by each of the governing bodies of the parties involved expressing their approval of the agreement and the filing of the application.
6. Name and addresses of all individuals and organizations that have direct or indirect ownership interests amounting to an ownership interest of 5 percent or more in the applicants.
7. A description of the agreement, including a time table, expected completion date, and the consideration passing to any party under the agreement.
8. A succinct explanation of how the agreement meets the standard set forth in CRS 24-32- 2706(1).
9. A written description of community involvement, planning, oversight, control, or support for the agreement, if any, and any formal processes for such involvement, oversight, support, and control.
C. Cost Effectiveness Information 1. A statement of pricing history and anticipated pricing for services including: past, current, and projected case-mix adjusted charges, payments, and expenses for services affected by the agreement.
2. A statement of the applicants' financial condition consisting of:
a) financial statements audited by a Certified Public Accountant for the five most recent years;
b) budget “pro formas” for the next three years and a letter from a Certified Public Accountant reviewing the budget “pro formas”; and, c) current year's report to Dun and Bradstreet from parties to the application who participate in this service.
3. A detailed description of the basis of any efficiencies that will be achieved by the agreement.
4. All other information, descriptions, and analysis necessary to show how the agreement meets the cost effectiveness review criteria of section (VI)(C).
D. Availability Information 1. A description of the geographic service area for each service affected by the agreement (by DRG or other service measure) including the methodology for determining the areas and the following:
a) current and projected geographic service area by zip code;
b) current and projected population in each zip code in the geographic service area;
c) current and projected number of patients originating from each of the zip codes;
d) current and projected percentage of total patients each zip code represents;
e) current and projected average distances and travel times from these zip codes or reasonable groupings of these zip codes to the facilities provided by the applicants; and, f) a legible map which clearly identifies the zip codes in the current and projected geographic service area. The map should identify major highway systems, sites of applicants, and sites of other health care facilities that provide services and/or goods similar or substitutable to those provided by the applicants.
2. All other information, descriptions, and analysis necessary to show how the agreement meets the financial, physical, and geographic availability review criteria of section (VI)(D).
E. Quality and Delivery Information 1. A description of the specific qualitative and quantitative quality goals for the proposed agreement.
2. All other information, description, and analysis necessary to show how the agreement meets the quality and delivery review criteria of section (VI)(E).
V. APPLICATION REVIEW, TERMINATION, AND IMMUNITY PROCEDURES A. Procedures for Review of an Application 1. 90 Day Review Requirement (C.R.S. 24-32-2705(2)). Upon receipt of a complete application, as described in section IV, the board shall have 90 days to review such application and approve or disapprove the same, in whole or in part. The ninety day review requirement of CRS 24-32-2705(2) shall be tolled until such time as the department receives all information necessary for a complete application.
2. Actions Available to the Board a) Rejection of an application. The board may reject an application if:
b) Approval of an application. If the board determines that the agreement meets the standard in section 24-32-2706(1), C.R.S., the board shall approve the agreement in whole, or in part, and may place reasonable and related conditions and restrictions, specific to the agreement, on the parties. Such conditions and restrictions must be provided to the parties in writing.
3. Written Decision Requirement (C.R.S. 24-32-2705(2)). After making a determination the board shall render a written decision which shall include its specific findings and the basis therefore. Such decision shall be mailed to the applicants, the Attorney General, and any other admitted party.
B. Application and Processing Fees 1. Applicants shall submit with their application a fee of four thousand dollars ($4000).
2. In the course of reviewing an application, if the department determines that the application is of such a complex nature that the actual costs of reviewing such application will exceed the initial application fee set forth in paragraph 1 of this subsection B, then the department shall require the parties to the application to submit additional processing fees equaling the actual costs in excess of the initial application fee, up to an additional amount of fifteen thousand dollars ($15,000) for any single application. These actual costs will be itemized and provided to the applicant in writing. Failure of the applicants to submit the additional fees required by this paragraph shall cause the application to be incomplete and shall result in the application being denied.
3. After an agreement has been approved, the department shall require the parties to the agreement to submit an annual processing fee of five hundred dollars ($500) for each approved agreement.
a) If the department determines that the review of the annual report is of such a complex nature that the actual costs of review of the report will exceed the annual processing fees set forth in paragraph 3 of this subsection B, then the department shall require additional fees not to exceed the actual costs in excess of the processing fee, up to a maximum additional amount of $5000 per annual report. The actual costs will be itemized and provided to the parties to the agreement in writing.
b) Pursuant to 24-32-2707 (1) (b), failure of the applicants to submit the fees required by this paragraph 3 shall be grounds for termination of the board's approval of the agreement.
4. If the board rejects an application in accordance with section V(A)(2)(a)(i) of these regulations or if the parties choose to terminate the application process when advised of additional review expenses pursuant to paragraph 2 of this subsection B, then the department shall refund to the applicants the initial application fee, except that the amount refunded may be reduced by any actual costs, attributable to such application, which have already been incurred. The actual costs will be itemized and provided to the applicant in writing. If an application is rejected pursuant to (V)(A)(2)(a)(ii) because the parties refused to provide information necessary to constitute a completed application, then a refund shall be denied.
VI. APPLICATION REVIEW CRITERIA A. Basis for Approval 1. General. Approval of a proposed agreement, in its entirety or in part, shall be based upon the board's determination that such agreement is likely to improve, on balance, cost effectiveness, availability, quality, or delivery of health care, and is consistent with other state statutory health care policies and programs. In evaluating whether an agreement meets this standard, the board will consider the factors in CRS 24-32-2706(2). The board recognizes that deficient marks in any specific area of analysis should not disqualify an applicant per se, but should be balanced with marks in other areas analyzed in the review of the application. The following sections are a detailed exposition of the questions the board will ask in evaluating an application against the standard of approval. While not all questions may be appropriate for all applications, the answers to all applicable questions shall serve as the basis for the board's decision.
2. Modification. If answers to the questions in sections C through E raise concerns that the entire agreement or portions of the agreement do not meet the standard in CRS 24-32-2706(1), then the board may propose modifications to the agreement that will permit its approval in whole or in part.
B. Completeness of Information. Does the application provide sufficient factual information to allow the board to determine whether or not the agreement meets the standard of CRS 24-32-2706(1)? C. Cost Effectiveness 1. Will the agreement reduce health care prices? a) Have the pricing structures of the applicants typically been higher or lower than their competitors and/or providers of substitutes for the goods and/or services affected by the application? b) How will pricing structures change under the agreement? 2. Will the agreement produce efficiencies? a) What kinds of efficiencies will be produced by the agreement? b) How will efficiencies be measured? c) How will the applicants achieve such efficiencies? 3. Will consumers benefit from any efficiencies? a) How will the parties pass any efficiencies on to the consumer? b) Do the applicants' financial statuses permit them to pass on benefits to consumers? c) Do the applicants expect to gain financially from the implementation of the agreement (e.g. higher profits, salaries, retained earnings, or expenses)? 4. Are there alternative measures that would produce the same level of net benefits using competition, rather than regulation? a) If there are no such alternative measures, why not? b) If there are such alternative measures, what are their costs and benefits and why were they not pursued? 5. Is there now and will there be competition for the goods and/or services affected by this agreement? a) What are the applicants' business histories as they pertain to anticompetitive behavior and consumer law violation? Is this past behavior an indicator of similar behavior in the future? b) Has the agreement been submitted for business review or advisory opinion to the Department of Justice or the Federal Trade Commission? If so, what was the outcome of such review or advisory opinion? How has that review or opinion affected the applicants' decision to seek board approval for the agreement? How should the board interpret the outcome of that review or opinion? c) Do providers of substitutes and/or competitors exist in the primary and/or secondary service areas for the goods and/or services affected by the application? d) If providers of substitutes and/or competitors exist, what is their market share? Will these market shares change after the agreement? If so, how? e) What are the steps an entity would need to take (e.g. regulatory approvals, capital investments, participation by a significant number of providers) to enter the relevant geographic market and effectively compete if there were no cooperative agreement? f) Does the agreement significantly increase barriers to entry for a potential competitor or provider of a substitute? 6. What is the cost of regulating this agreement? a) What are the costs for the department of effective regulation including, but not limited to, the costs associated with monitoring the proposed agreement and enforcing the conditions and restrictions placed on the parties to the agreement? b) What are the costs to the applicants of observing regulation, enforcing and implementing the agreement, and submitting annual reports and reviews? 7. Will regulation be effective? a) Do methods and measures exist that, if appropriately applied, will allow the board to determine whether an agreement continues to meet the standard for approval? b) Is the information necessary to monitor the proposed agreement available and reliable? 8. Is there a potential for cost shifting? a) Do the applicants currently have significant market shares in areas not covered by the agreement? b) Could the applicants use market power to increase prices or decrease service in areas not covered by the agreement? D. Availability 1. Does the agreement increase the affordability of goods and/or services covered by the agreement? a) Will health care services become more affordable including, but not limited to, lower charges, or lower actual payments by third party payors and individual consumers? b) Will the agreement enable the applicants to provide more services and/or goods to low-income, uninsured, and high-need health care users? 2. Does the agreement increase geographic and physical availability? Will the agreement result in:
a) a decrease in distance consumers are required to travel after implementation of the agreement; or, b) a decrease in travel/access costs; or, c) an increase in the number and type of providers of substitutes and competitors within the relevant geographic service area? 3. Will the agreement increase the utilization of necessary and appropriate services? a) What is the expected change in patient utilization of services and/or goods covered by agreement? b) Is the increased or decreased utilization actually appropriate to patient needs? 4. Will the agreement preserve, reduce or expand the services and/or goods provided by the applicants? Which services and/or goods will be preserved, reduced, or expanded? 5. Will the agreement result in the applicants serving a larger geographic service area? E. Quality and Delivery 1. Are applicants currently licensed and/or certified from recognized state and national accreditation and licensing entities and will applicants obtain additional accreditation and licensure as a direct result of this agreement? a) Has accreditation or licensure ever been requested and denied? What was the reason for such denial? What is the relationship of any denial to the explicit goals for quality improvement under the proposed agreement? b) Are the applicants currently or planning to apply for additional accreditation or licensure? If so, is it related to the services and/or goods affected by this application? Does the cooperative agreement make this accreditation and licensure more likely? 2. Do the applicants have quality assurance and improvement programs and will these programs improve as a result of the agreement? a) What are the specific goals of the programs particularly for services and/or goods included in the agreement? b) What are the measurable quality variables used in the programs? c) What processes exist for identifying and solving quality problems? d) What is the representation of appropriate staff in the quality assurance and improvement process? 3. Do the applicants inform and educate health care consumers in the following areas: health behaviors, how the health care system works, and how patients can be more effective decision makers about personal health care needs and the use of health care resources? Will patient education efforts increase under the agreement? 4. Do applicants participate in any external clinical data collection and analysis projects (e.g. Colorado Health Data Commission, Colorado Hospital Association) and will these projects be integrated and expanded under the proposed agreement? 5. Do the applicants currently use patient satisfaction data to improve health care quality? Will the applicants use patient satisfaction data to measure satisfaction of patients with health care services and/or goods affected by the agreement? a) What are the methods for measuring and using patient satisfaction data? b) What are the measurable indicators of patient satisfaction, especially for targeted areas under the agreement, including factors such as convenience of services and relationships between providers, hospital and the patient? c) What is the process for addressing consumer complaints? d) What is the process for resolving problems between patient and hospital? 6. Do the applicants have quantitative quality goals for the agreement? a) Will the agreement reduce mortality and morbidity? b) Will the agreement improve the proficiency of health care delivery through increased service volume, better education and training, or other factors? c) Will the agreement improve the appropriateness of health care services given the needs of patients? d) Will the agreement increase patient satisfaction with the quality and delivery of health care? e) Will the agreement improve any other variables, proposed by the applicants, that are relevant to the quality and/or delivery of health care? 7. Will the agreement improve the work environment, conditions, professional opportunities, salaries, or benefits of employees of the applicants who are responsible for the delivery of health care? 8. Did the community plan, oversee, support, or influence the cooperative agreement? a) What was the involvement of the largest employers in the geographic service area? b) What was the involvement of health care providers in the geographic service area? c) What was the involvement of consumer, or neighborhood organizations in the geographic service area? d) What local, regional, and state government agencies regulate the activities of the applicants (e.g. zoning, land use, waste disposal, health care delivery) and did they plan, oversee, support, or influence the areas of the cooperative agreement related to their regulatory responsibilities? e) What formal processes did the applicants use and do they intend to use to submit their activities to community influence, input, or control, particularly for goods and/or services in portions of the geographic service area where they will have no competition? VII. ANNUAL REPORTING REQUIREMENTS FOR APPROVED COOPERATIVE AGREEMENTS A. General Reporting Requirement. The parties to each approved agreement must submit an annual report by the anniversary date of the board's approval of the agreement that includes at least the information specified in sections C through F below. The parties must submit fifteen copies of their annual report to the board in care of the department, except that the parties only must submit one copy of the information required by section D 3 below. With the exception of items B 1 through B 5 below, no annual report need be made for any items that are unchanged since the time of application or the prior annual report.
B. Ongoing Supervision. After the parties to an approved agreement submit their annual report, the board shall formally approve or disapprove of the agreement remaining in effect. This approval shall be based on a determination of whether the parties are in compliance with the terms of the agreement, the board's order approving the agreement, and any conditions or restrictions placed by the board on the parties to an approved agreement. If the board does not approve of the agreement remaining in effect, it shall begin termination or modification proceedings pursuant to C.R.S. 24-32-2707.
C. Administrative Information 1. Names and addresses of all parties to the approved agreement, as well as any changes in participation by or ownership of these parties.
2. Names and addresses of the principal business offices of each party, if different than above.
3. Name and address of a contact person authorized to receive notices and communications with respect to the approved agreement.
4. A written statement attesting to the accuracy of all information given in the annual report verified and signed by a responsible officer of each party to the approved agreement.
5. A statement confirming that all parties to the agreement have complied with any and all terms of the agreement, the board's order approving the agreement, and any and all conditions or restrictions placed by the board on the parties.
6. Name and addresses of all individuals and organizations that have direct or indirect ownership interests, separately or in combination, amounting to ownership interest of 5 percent or more in the parties to the approved agreement.
7. A written description of ongoing community influence, input, planning, oversight, support or control of the cooperative agreement and formal processes for such community involvement.
8. Additional administrative information requested by the department pursuant to the board's order approving the agreement and any conditions or restrictions placed on the parties by the board.
9. A summary description of the changes undertaken by the parties as a result of the agreement.
D. Cost Effectiveness Information 1. A statement of past, current, and projected case-mix adjusted charges, payments, and expenses for services and/or goods affected by the approved agreement.
2. A detailed description of the efficiencies realized by the agreement, how they have been measured, and how they have been passed on to health care buyers.
3. A statement of the applicants' financial condition including:
a) financial statements audited by a Certified Public Accountant for the most recent five years;
b) budget “pro formas” for the next three years and a letter from a Certified Public Accountant reviewing the budget “pro formas”;and, c) current year's report to Dun and Bradstreet from parties to the application who participate in this service.
4. A statement of the costs incurred by the parties to the agreement in the previous twelve months in complying with the order of the board approving the agreement and in completing this annual report. If this is the first annual report for an approved agreement, the statement shall include the costs incurred by the parties in making their original application to the board.
5. A statement of the market share of the competitors and providers of substitutes in the parties' geographic service area for the goods and/or services affected by the agreement.
6. Additional information related to cost effectiveness requested by the department pursuant to the board's order approving the agreement and any conditions or restrictions placed on the parties by the board.
7. A description of any differences between the actual cost effectiveness of the approved agreement and the projected cost effectiveness included in the applicants' original application to the board.
E. Availability Information 1. A description of how the agreement has met the goals stated in the original application for the provision of services and/or goods to lowincome, uninsured, and high-needs patients, for the improved affordability of health care goods and/or services, and for the improved geographic and physical availability of goods and/or services.
2. A description of the geographic service area for each service and/or good affected by the approved agreement including the following patient origin data:
a) current and projected geographic service area by zip code;
b) current and projected population in each zip code in the geographic service area;
c) current and projected number of patients originating from each of these zip codes;
d) current and projected percentage of total patients each zip code represents; and e) current and projected average distances and travel times from these zip codes or reasonable groupings of these zip codes to the facilities provided by the applicants; and a legible map which clearly identifies the zip codes of the current and projected geographic service area. The map should identify major highway systems, sites of applicants, and sites of other health care facilities that provide services and/or goods similar to those provided by the applicants.
3. A statement of whether the utilization goals stated in the application have been achieved.
4. A description of the effect of the agreement on the preservation, reduction, or expansion of services and/or goods provided by the applicants.
5. Additional information related to availability of health care requested by the department pursuant to the board's order approving the agreement, and any conditions or restrictions placed on the parties by the board.
6. A description of any differences between the actual availability of health care under the approved agreement and estimates made by the applicants in their original application to the board.
F. Quality and Delivery Information 1. A comparison of actual progress in accreditation and licensure under the approved agreement with projected accreditation and licensure included in the original application to the board.
2. A comparison of progress of actual quality assurance and improvement programs under the approved agreement with projected programs described in the original application.
3. A comparison of progress of actual patient education programs under the approved agreement with projected programs described in the original application.
4. A comparison of the progress of actual programs to collect, analyze, and use clinical data with projected programs described in the original application.
5. A comparison of progress of actual programs to use patient satisfaction data to improve health care quality with projected programs described in the original application.
6. A comparison of improvements in the circumstances of employees with those projected under the original application.
7. A description of progress toward the quantitative quality goals included in the applicants' original application.
8. Additional information requested related to quality of health care by the department pursuant to the board's order approving the agreement, and any conditions or restrictions placed on the parties by the board.