10- 144 C.M.R. ch. 505, § 4

Current through 2024-51, December 18, 2024

Section 144-505-4 - PROCEDURES

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.

10- 144 C.M.R. ch. 505, § 4