Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 500 - RULES GOVERNING THE MAINE CERTIFICATION OF HEALTHCARE COOPERATIVE AGREEMENTS
Section 144-500-3 - COPA APPLICATION PROCESS
Universal Citation: 10 ME Code Rules ยง 144-500-3
Current through 2024-38, September 18, 2024
3.1 Forms and Format
3.1.1
Department-approved Forms. COPA applicants must use the
department-approved forms for a COPA letter of intent and COPA
application.
3.1.2
Documentation. Documentation submitted with the letter of intent or the
application must be unbound, on 8 1/12 x 11 paper, one sided only, and three
hole punched on the left side, unless impracticable.
3.2 Letter of Intent: Mergers Only. At least 45 days prior to filing a COPA application for a merger, the parties to the merger agreement must file a department-approved letter of intent form and all required documentation describing the proposed merger with the department's Division of Licensing and Regulatory Services.
3.2.1
Copies of Letter of Intent.
The applicant must submit one copy of the letter of intent and all
accompanying materials to the Office of the Attorney General and to the
Governor's Office of Health Policy and Finance or its successor at the time the
letter of intent is filed with the department's Division of Licensing and
Regulatory Services. See
22 M.R.S.A.
§1844(2)(A).
3.2.2
Content of Letter of Intent.
The letter of intent must include at least the following information:
3.2.2.1 A brief description, including the
location of the covered entities and the parties to the cooperative
agreement;
3.2.2.2 The name,
address and contact information of all parties to the cooperative
agreement;
3.2.2.3 The anticipated
date of submission of a COPA application; and
3.2.2.4 The anticipated date of the
initiation of the proposed merger.
3.2.3
Expiration of Letter of Intent.
A letter of intent expires 12 months after the date of receipt by the
department, if no COPA application was timely filed with the
department.
3.2.4
Resubmission of Letter of Intent.The parties may resubmit the same
letter of intent after its expiration.
3.2.5
Public Record. Letters of
intent filed with the department shall be made available to the public,
including a timely posting on the department's Division of Licensing and
Regulatory Services website.
3.3 COPA Application. The parties to a cooperative agreement may apply for a certificate by filing with the department's Division of Licensing and Regulatory Services, an original and one copy of the department-approved COPA application form with all required documentation, and payment of the application fee (Section 2.11.1). See 22 M.R.S.A. §1844(2)(B).
3.3.1
Cooperative Agreement.
The application must include a signed copy of the original cooperative
agreement and must state all consideration passing to any party under the
agreement. See
22 M.R.S.A.
§1844(2)(C).
3.3.2
Copies of COPA Application.
The applicant must submit one copy of the application and all
accompanying materials to the Office of the Attorney General and to the
Governor's Office of Health Policy and Finance or its successor at the time the
application is filed with the department's Division of Licensing and Regulatory
Services.See
22 M.R.S.A.
§1844(2)(D).
3.3.3
Content of Application. A
COPA application must describe with specificity how the cooperative agreement
meets each of the requirements set out in Section
4 of these rules. A statement that the
cooperative agreement meets the requirements without supporting facts backed by
relevant documentation and analysis constitutes sufficient cause to deny the
COPA application. An application must contain at least the following
information.
3.3.3.1 A detailed description
from the parties' perspective of the cooperative agreement including
identification of all the parties and each party's responsibilities and
obligations.
3.3.3.2 A description
of the nature and scope of the cooperation that is required by each party to
the agreement.
3.3.3.3 A detailed
description of any merger, lease, change of ownership or other acquisition or
change in control of the assets of any party to the cooperative
agreement.
3.3.3.4 A detailed
description of potential benefits of the cooperative agreement in accordance
with Section 4.3 of these rules.
3.3.3.5 A detailed description of potential
disadvantages of the cooperative agreement in accordance with Section 4.4 of
these rules.
3.3.3.6 A detailed
description of any monetary or other consideration passing to any party under
the cooperative agreement.
3.3.3.7
A detailed statement describing whether and to what extent the cooperative
agreement may change the existing services of a hospital or healthcare
provider.
3.3.3.8 A detailed
description of any shared services.
3.3.3.9 A detailed description of any
obligation for future negotiations.
3.3.3.10 A detailed description of the total
cost resulting from the cooperative agreement and the costs to be incurred by
categories, including but not limited to consultants, capital costs, and
management costs, including identification of any costs associated with the
implementation of the cooperative agreement including documentation of the
availability of the necessary funds. Describe what part of the cost is borne by
each party.
3.3.3.11 A detailed
description of the following ownership information for each party to the
cooperative agreement:
3.3.3.11.1 The name of
each party;
3.3.3.11.2 The address
and other contact information of each party;
3.3.3.11.3 The complete title of the
governing body of each party (if any);
3.3.3.11.4 The name, title, address and other
contact information of the presiding officers of the governing body of each
party;
3.3.3.11.5 The name, mailing
address and other contact information of any person that has an
ownership interest
in any of the parties
filing a COPA application, when the ownership interest is 5% or more;
3.3.3.11.6 The name, mailing address and
other contact information of any person that is owned by any of the
parties filing a COPA application when the ownership interest is 5% or
more;
3.3.3.11.7 The name, mailing
address and other contact information of any person that does not have an
ownership interest in any of the parties filing a COPA application, and is not
owned by any of the parties filing a COPA application, that may have an
agreement, contract, option, understanding, intent or other arrangement
with any party to a COPA application that may have a financial or
operational impact on the cooperative agreement.
3.3.3.11.8 Submit the following information
for each person identified in Sections 3.3.3.11.5, 3.3.3.11.6 and 3.3.3.11.7 of
these rules:
3.3.3.11.8.1 A schedule of
percent and type of ownership of each person identified in Sections 3.3.3.11.5
and 3.3.3.11.6 of these rules;
3.3.3.11.8.2 A copy of any agreement,
contract, option, understanding, intent, or other arrangement identified in
Section 3.3.3.11.7 of these rules.
3.3.3.11.8.3 The name, mailing address and
other contact information of any related party (Section 1.14) of those
identified in Sections 3.3.3.11.5, 3.3.3.11.6 and 3.3.3.11.7 of these
rules:
3.3.3.11.8.4 The name,
title, address and other contact information of the presiding officers of the
governing body of each entity identified in Sections 3.3.3.11.5, 3.3.3.11.6 and
3.3.3.11.7 of these rules;
3.3.3.11.8.5 A detailed description of any
shared services between any of the parties to the COPA application and any
person identified in Sections 3.3.3.11.5, 3.3.3.11.6 and 3.3.3.11.7 of these
rules that may impact the cooperative agreement;
3.3.3.11.8.6 A detailed description of any
obligation for future negotiations between any of the parties to the
cooperative agreement and any person identified in Sections 3.3.3.11.5,
3.3.3.11.6 and 3.3.3.11.7 of these rules that may have a financial or
operational impact on the cooperative agreement;
3.3.3.11.8.7 A detailed description of any
merger, lease, acquisition or change of ownership or other change in control of
the assets of any person identified in Sections 3.3.3.11.5, 3.3.3.11.6 and
3.3.3.11.7 of these rules that may have a financial or operational impact on
the cooperative agreement; and
3.3.3.11.8.8 A detailed description of any
monetary or other consideration passing between any party to the cooperative
agreement and any person identified in Sections 3.3.3.11.5, 3.3.3.11.6 and
3.3.3.11.7 of these rules that may have a financial or operational impact on
the cooperative agreement.
3.3.3.12 A detailed description documenting
and demonstrating that the likely benefits accruing from the cooperative
agreement outweigh the likely disadvantages attributable to a reduction in
competition likely to result from the cooperative agreement. A Health Economic
Study conducted by an economist experienced in the field of health economics
shall be provided and shall include a quantitative analysis of the evidence
presented including references to the methodology employed, experience of the
economist and the statistical significance of the assertions. The Study is the
responsibility of the applicant to present and includes but is not limited to
the economic, administrative, and patient impact of the agreement as it applies
to the following:
3.3.3.12.1 The effectiveness
of the proposed action including documentation of:
3.3.3.12.1.1 Resource allocation implications
and the cost benefit of the proposed action (Cost Benefit Analysis);
and
3.3.3.12.1.2 Cost effectiveness
of the proposed action.
3.3.3.12.2 The efficiency of the proposed
action:
3.3.3.12.2.1 a description of how the
cooperative agreement will foster cost containment, eliminate duplicate
services or otherwise positively impact the health care system.
3.3.3.12.3 The equity of the
proposed action including:
3.3.3.12.3.1 a
description of how the cooperative agreement will reduce competition, reduce
patient choice, or otherwise negatively impact the health care system;
and
3.3.3.12.3.2 Consumer views of
the proposed action.
3.3.3.12.4 The Study should draw from the
following types of statistical data:
3.3.3.12.4.1 Healthcare finance
data
3.3.3.12.4.2 Epidemiological
data
3.3.3.12.4.3 Cost of care
data
3.3.3.12.4.4 Demographic
data
3.3.3.12.4.5 Socioeconomic
data
3.3.3.12.4.6 Comparative
data
3.3.3.13
A detailed description and discussion of alternatives that have been considered
and the advantages and disadvantages of each alternative. See
22 M.R.S.A.
§1844(5)(B)(5).
3.3.3.14 A detailed description and
discussion of any improvements in patient access and any problems patients may
experience, such as costs, availability, or accessibility, upon initiation of
the cooperative agreement.
3.3.3.15
A detailed description of the current health service area of each party to the
cooperative agreement and a description of the proposed health service area
upon initiation of the cooperative agreement. This shall include primary and
secondary service areas for both inpatients and outpatients
3.3.3.17 A detailed description of the
current market share of each party to the cooperative agreement and a
description of the proposed market share upon initiation of the cooperative
agreement.
3.3.3.18 A copy of the
current annual budget for each party to the cooperative agreement and a
three-year projected budget for all parties after the initiation of the
cooperative agreement. The budgets must be in sufficient detail so as to
determine the fiscal impact of this cooperative agreement on each party. The
budgets must be prepared in conformity with Generally Accepted Accounting
Principles (GAAP) and all assumptions used must be documented.
3.3.3.19 Detailed documentation that the
cooperative agreement is economically feasible both immediately and long term.
Describe the impact that the cooperative agreement will have on costs per unit
of service.
3.3.3.20 Detailed
comparison of current and projected utilization data and associated changes in
revenue, and documentation of the verifiable data source or methodology of this
comparison..
3.3.3.21 A detailed
description of how the cooperative agreement enhances or restricts health care
services to MaineCare patients, Medicare patients, patients eligible for free
care under
22 M.R.S.A.
§1716, or patients who are unable to pay
for health care services.
3.3.3.22
The name, address, telephone number and other contact information for the party
responsible for completing future reports who may be contacted by the
department to monitor the implementation of the cooperative
agreement.
3.3.3.23 A timetable for
implementing all components of the cooperative agreement.
3.3.3.24 The department reserves the right to
request additional information from the parties at any time prior to issuing a
final decision if the department determines that such information may assist
the department in its determination of whether a cooperative agreement meets
the requirements set out in Section
4 of these rules.
3.4 Public Notice of COPA Filing. Within 10 business days of the filing of a COPA application, the department shall give public notice of the filing in compliance with the following:
3.4.1 The department shall publish
a notice of the filing of a COPA application in a newspaper of general
circulation in Kennebec County and in a newspaper published within the health
service area in which the cooperative agreement would be effective. See
22 M.R.S.A.
§1844(3)(A).
3.4.2 The notice shall include at least the
following information:
3.4.2.1 A brief
description of the cooperative agreement.
3.4.2.2 A description of the department's
review schedule and process, and if a public hearing is scheduled, the
information required pursuant to Section 3.8.2 of these rules.
3.4.2.3 A statement that copies of the
application, and records pertaining to it, may be examined by the public
pursuant to Section 3.7 of these rules. See
22 M.R.S.A.
§1844(3)(C).
3.4.2.4 A statement that any person may
submit written comments pursuant to Section 3.6 of these rules.
3.4.3 The department shall mail
copies of the application and letter of intent, if any, to all persons on the
department's interested parties mailing list (Section 2.14) who request
notification on a department-approved form when a COPA application or letter of
intent is filed. See
22 M.R.S.A.
§1844(3)(B).
3.5 Initial Meeting. Within 20 business days of the date of publication of the notice of the filing of a COPA application, the parties filing the COPA application shall attend an initial meeting with the department staff in order to assist the department in understanding the parties' collaborative agreement, letter of intent and application.
3.5.1 The department
shall provide timely written or electronic notice of the initial meeting to all
approved intervenors (Section 2.10.1), who shall be invited to attend and
participate in this meeting.
3.5.2
The department may limit by time or subject matter the participation of
intervenors at the initial meeting for the sake of efficiency and instead defer
such participation until the public hearing set out in Section 3.8 of these
rules.
3.5.3 The initial meeting
shall be electronically recorded and included in the records of the department
maintained with regard to the application.
3.6 Public Comments. Any person may submit written comments to the department concerning the COPA application within 30 calendar days after the date of publication of the public notice of the COPA filing. See 22 M.R.S.A. §1844(4)(B).
3.6.1 The department shall provide copies of
all comments to the Office of the Attorney General and the Governor's Office of
Health Policy and Finance or its successor. See
22 M.R.S.A.
§1844(4)(C).
3.7 Access to COPA Records. Copies of the application and all accompanying materials filed by the applicant, public comments, department records maintained with regard to the COPA application, and copies of the letter of intent filed for a merger may be examined by any person during business hours at the Augusta office of the Division ofLicensing and Regulatory Services. See 22 M.R.S.A. §1844(2).
3.7.1 The materials specified in Section 3.7
of these rules will be treated as public records to the extent provided by the
Maine Freedom of Access Act.
3.7.2
If a person submitting material specified in Section 3.7 of these rules claims
a trade secret, the submitter must label the material as a trade secret and
identify any harm to the submitter by the disclosure of the material as a
public record.
3.7.3 Should the
department receive a request to inspect and/or copy materials claimed as trade
secret, the department will notify the submitter prior to disclosing such
materials.
3.8 Public Hearing. The department may hold a public hearing when it determines a public hearing is appropriate. See 22 M.R.S.A. §1844(4)(D)(1).
3.8.1 The department shall hold a public
hearing if five (5) or more persons who are residents of the State and who are
from the health service area to be served by the COPA application submit a
written request that a hearing be held.
3.8.1.1 The written request must be received
by the department no later than 30 calendar days after the date of publication
of the public notice of the COPA filing (Section 3.4). See
22 M.R.S.A.
§1844(4)(D)(2).
3.8.2 If a public hearing is held,
a notice shall be published by the department in a newspaper of general
circulation in Kennebec County and in a newspaper published within the service
area in which the cooperative agreement would be effective. See
22 M.R.S.A.
§1844(3)(A). The notice
shall include at least the following information:
3.8.2.1 The date, time and location of the
public hearing.
3.8.2.2 A brief
description of the proposed COPA project.
3.8.2.3 A statement that written comments
shall be accepted by the department for 10 business days following the public
hearing.
3.8.2.4 A statement that
copies of the application, and records pertaining to it, may be examined by the
public pursuant to Section 3.7 of these rules.
3.8.3 If a public hearing is held, it shall
be conducted by department personnel responsible for the administration of the
COPA laws and rules.
3.8.4 If a
public hearing is held, an electronic or stenographic record of the public
hearing must be kept by the department as part of the COPA application record.
See
22 M.R.S.A.
§1844(4)(D)(3).
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