A. Written Notification of the Beginning of a
Review.
1. The Department shall provide
notice of the beginning of its review of each existing institutional health
service. Such notice shall be provided not later than the date on which it is
scheduled to commence its review of such existing institutional health service
and will contain the following information:
a. an identification of the specific service
to be reviewed;
b. an
identification of the schedule for the initiation and completion of the
Department's review of that service;
c. an indication of the manner in which
interested and affected persons may participate in the Department's review
activities.
2. Such
notice shall be provided in the following manner:
a. to the general public, by means of a legal
notice in a daily newspaper of general circulation in the area, and
b. by sending a notice by mail to the
following affected parties;
i The Maine
Health Systems Agency, Inc.;
ii All
health care facilities located within the state which provide, or have shown
interest or intent in providing, institutional health services, provided that
intermediate care facilities, skilled nursing facilities, and home health
agencies will not be notified by mail of the review of the following services.
AA open heart surgery;
BB cardiac catheterization;
CC megavoltage radiation therapy;
DD CT scanners;
EE end-stage renal dialysis;
FF neonatal special care nurseries;
GG pediatrics;
HH psychiatric care;
II chemical dependency units;
JJ obstetrics, and
KK CCU/ICU units.
iii Health care associations;
iv Health maintenance organizations located
in the health service area;
v The
appropriate Regional Planning Commission(s);
vi Other appropriate general or special
purpose regional planning or administrative agencies (including area agencies
or aging and local and/or regional alcohol abuse, drug abuse and mental health
planning agencies);
vii The Pine
Tree organization for Professional standards Review, Inc.;
viii The Maine Health Facilities Cost Review
Board;
ix The Voluntary Budget
Review organization of Maine;
x
Blue Cross/Blue Shield of Maine;
xi
The United Health Systems Agency of New Hampshire, and
xii Any other interested party who requests
such notification in writing to the Maine Health Systems Agency, Inc.
B. Review Schedules
To the extent practicable, the Department's review of the
appropriateness of each scheduled existing institutional health service will be
completed and written findings developed within 180 days of the Department's
notification to affected persons of the beginning of such review.
C. Submission of Information by
Health Care Institutions
To the fullest extent practicable, the Department will
attempt to limit the information it needs to conduct its review and develop its
findings of the appropriateness of each existing institutional health service
to that which was secured by the Maine Health Systems Agency, Inc. in the
course of its review of the service. This will be facilitated by the Bureau's
representation on any Maine Health Systems Agency, Inc. task force. As soon as
practicable, but in no event any later than the date on which the Department is
scheduled to commence its review of an existing institutional health service,
the Director of the Division of Planning and Administration of the Bureau of
Health Planning and Development shall inform the Maine Health Systems Agency,
Inc. of the information, if any, the Department will need to conduct its review
and develop its findings which the Agency did not forward to the Bureau with
its findings and recommendations. The Agency will comply with all reasonable
requests of the Bureau, forwarding such information to the Bureau as soon as
practicable or providing the Bureau with an opportunity to reproduce such
information at the Bureau's offices. In making any such request for information
from the Agency, the Director of the Division of Planning and Administration
shall specify the date by which the Agency is requested to forward the required
information or provide the Bureau with an explanation as to why it is unable to
do so.
As soon as practicable, but not later than ten days from the
day on which the written notices announcing the formal beginning of the
Department's review of a specific service are mailed, the Director of the
Division of Planning and Administration of the Bureau of Health Planning and
Development shall mail a written request for the information the Department
will need to conduct its review and develop its findings with respect to the
appropriateness of an existing institutional health service and which it has
not been able to secure through other means to each institution which offers
the service under review. Such requests shall be consistent with the
information requirements described in Appendix A. - Information Guidelines With
Respect to Appropriateness Reviews. The request for information may, as
considered necessary by the Director of Plan Development, contain additional
instructions and interpretations of the information requirements to best suit
the needs of the Department with respect to the institutional health service
subject to review. Such instructions and interpretations may vary according to
the purpose for which a particular review is being conducted and the type of
institutional health service being reviewed. In all such requests the
confidentiality of the patient/physician relationship shall be observed.
Information requests will give due consideration to the costs of securing such
information.
During the course of its review, the Department of Human
Services may not require additional information of a person subject to review
which is not described in Appendix A.-Information Guidelines With Respect to
Appropriateness Reviews as clarified by any instructions and interpretations
provided by the Director of the, Division of Plan Development. However, nothing
in this Manual shall prohibit a person subject to review from providing such
additional information if requested by the Department of Human Services.
The notice provided by the Director of the Division of Plan
Development shall specify the date by which persons subject to review must
submit the information the Department will need to conduct its review and
develop its findings regarding the appropriateness of the service to the
Department.
D. Access to
Pertinent Written Materials
The Bureau shall make all pertinent written materials
received or developed during the course of its review of a specific
institutional health service available to the public. Pertinent written
materials include, but are not limited to, the information submitted by
institutions which offer the service under consideration other communications
between the Bureau and the Maine Health Systems Agency, Inc. and reports
prepared by the Bureau's staff.
Members of the public may inspect such written material
during the Bureau's scheduled business hours or may request that such material
be copied and mailed to them. Such requests shall be made in writing to the
Director of the Bureau of Health Planning and Development who shall attempt to
honor them within three working days. Institutions will be notified by the
Director of any release of institution-specific data. In responding to any such
requests, the confidentiality of the patient/ physician relationship shall be
observed. A fee may be charged by the Bureau to recover the actual cost of
copying and mailing requested materials. The Director of the Division of
Planning and Administration shall maintain a record of all requests received
and shall make that record available for inspection by interested and affected
parties.
E. Public Hearings
Any person who may be directly affected by the Department's
review of a specific service may request the Bureau of Health Planning and
Development to hold a public hearing during the course of its review of that
service. To be effective such a request must be received by the Bureau of
Health Planning and Development within thirty days of the date on which the
Department announces the commencement of its review of the existing
institutional health service. Such a hearing will be held on the preliminary
analysis and findings of the Bureau of Health Planning and Development, a copy
of which shall be made available to interested and affected parties a
reasonable time prior to the scheduled hearing. The Bureau of Health Planning
and Development will be charged with conducting such a hearing. Persons who may
be directly affected by the Department's review include institutions which
offer services which are similar to the services under consideration, members
of the public who have used or may need to use the service under consideration
and all those who received a written notice of the beginning of the
Department's review of the service under consideration. The Director of the
Bureau of Health Planning and Development or his/her designee shall preside at
hearings held pursuant to such a request. The person who made the request and
other interested and affected persons may offer testimony at such public
hearings. The Bureau's staff shall:
1
Make the necessary arrangements for each hearing requested by persons affected
by the review;
2 Mail a written
notice containing the following information to the person or persons who
requested the hearing and all those who received a written notice of the
beginning of the Department's review of the service under consideration at
least one week prior to the scheduled hearing:
a the date, time, and location of the
hearing;
b the manner in which they
may inspect or receive copies of pertinent written material, and
c the manner in which they may participate in
the Department's review of the service under consideration.
3 Place a legal notice containing
the same information contained in the written notices described above in a
major daily newspaper serving each area in which an institution that offers the
service under consideration is located.
F. Written Findings
1 At the conclusion of its review of a
specific service, and after taking into consideration the recommendations of
the Maine Health Systems Agency, Inc., the Department shall develop written
findings regarding the appropriateness of the existing institutional health
service under review. The Department of Human Services may not make a finding
that an existing institutional health service is inappropriate unless it has
stated in writing that the service has not met one or more of the established
general or specific criteria and the ways in which the service failed to meet
the criteria, including any that are beyond the control of the person(s)
providing the service.
The Department of Human Services, in conducting an aerated
review resulting in institution-specific findings, may not make a finding that
an existing institutional health service provided by or through an HMO is
inappropriate solely because there is an HMO of the same type, as specified in
Section 1310(b) of the Public Health Service Act, in the same health service
area, or solely because the services being reviewed are not discussed in the
applicable health systems plan, annual implementation plan, or State health
plan.
To the extent practicable, the Department shall also develop
suggestions for remedial action with respect to any service it has found to be
inappropriate.
2 The
Department shall mail a copy of its findings regarding the appropriateness of
existing institutional health services as well as any suggestions for remedial
action with respect to any service it has found to be in appropriate to each
health care institution which offers such service, those who received a written
notice of the beginning of the Department's review of such service and those
persons who offered testimony at any public hearing held by the Bureau with
respect to the Department's review of the service. To the extent considered
practicable, the Department will attempt to notify affected institutions of the
release of any findings prior to any publication of such findings. The
Department may also publish its finding and recommendations for remedial
action, if any, in a major daily newspaper serving each area in which an
institution that offers the service is located thirty days after the date on
which the Commissioner of the Department readers the Department's findings with
respect to the service. If a request for reconsideration is received during the
thirty day period, the Department will delay any intended publication of its
findings until after it has decided whether to grant the request for
reconsideration and, if so, after the Department's reconsidered findings are
rendered by the Commissioner.
3 If
the Department makes a finding regarding an existing institutional health
service which is not consistent with the goals of the applicable Health Systems
Plan or the priorities of the applicable Annual Implementation Plan adopted by
the Maine Health Systems Agency, Inc., the Department will submit to the Maine
Health Systems Agency, Inc., a detailed statement of the reason(s) for the
inconsistency.
G.
Reconsideration of the Department's Findings
1 Any affected person may request the
Department to hold a public hearing to reconsider its findings regarding the
appropriateness of an institutional health service. The Department will grant
such a request if it is (a) made in writing, (b) received by the Bureau of
Health Planning and Development Within thirty days of the date on which the
Commissioner of the Department rendered the Department's findings with respect
to the service, and (c) demonstrates there is good cause to reconsider the
Department's findings. A request will be considered to have demonstrated good
cause to reconsider the Department's findings if, in the opinion of the
Commissioner of the Department it (a) presents significant relevant information
not previously considered by the Department, (b) demonstrates that there have
been significant changes in factors or circumstances relied on by the
Department in developing its findings, (c) demonstrates that the Department
materially failed to follow the procedures it adopted and published in
developing its findings, or (d) provides such other bases to reconsider the
Department's findings as the Commissioner determines constitutes good
cause.
2 In any case in which the
Commissioner determines that the Department has received a timely written
request which demonstrates good cause to reconsider the Department's findings
regarding the appropriateness of a specific institutional health service, the
Commissioner or such other individual as he or she might designate shall hold a
public hearing to reconsider the Department's findings. Such public hearing
shall, to the extent practicable, be held within thirty days of the date on
which the Commissioner agreed to reconsider the Department's findings. The
hearing will be conducted pursuant to Sub-chapter IV, Title 5, MRSA.
3 The Director of the Division of Planning
and Administration shall mail a written statement of the Department's
reconsidered findings to the person who made the request and all other
interested and affected persons (including those persons who provided testimony
at the public hearing(s) held by the Department) within forty-five days of the
day on which the Department held the public hearing. pursuant to the request to
reconsider the Department's findings.
H. Published Reports
At intervals of three months the Bureau of Health Planning
and Development will prepare and make available to affected and interested
persons reports concerning the status of each review and any related findings
developed since publication of the previous such report.
I. Appeal of the Department's Findings
1 If the Department makes a finding regarding
the appropriateness of an existing institutional health service which is
inconsistent with the recommendation made with respect thereto by the Maine
Health Systems Agency, Inc., such finding (and the record upon which it is
based) shall be reviewed upon the request of the Maine Health Systems Agency,
Inc.
To be effective, the Maine Health Systems Agency, Inc.'s
request for a review of the Department's decision must be received by the
Bureau of Health Planning and Development within thirty days of the date on
which the Commissioner of the Department rendered the Department's findings
with respect to the service. Any such review shall be conducted by an agency of
the State (other than the Department of Human Services) designated by the
Governor. The finding of the reviewing body shall be considered the final
finding of the Department of Human Services. If the reviewing body makes a
finding which is not consistent with the goals of the applicable Health Systems
Plan or the priorities of the applicable Annual Implementation Plan adopted by
the Maine Health Systems Agency, Inc., it will submit to the Maine Health
Systems Agency, Inc. a detailed statement of the reason(s) for the
inconsistency.
2 If the
Department makes an institution-specific finding that an existing
institutional. health service is inappropriate, such finding (and the record
upon which it is based) shall be reviewed upon the request of the institution
providing that service. To be effective, the affected institution's request for
a review of the Department's decision must be received by the Bureau of Health
Planning and Development within thirty days of the date on which the
commissioner of the Department rendered the Department's findings with respect
to the service. Any such review shall be conducted by an agency of the State
(other than the Department of Human Services) designated by the Governor. The
finding of the reviewing agency shall be considered the final finding of the
Department of Human Services.
