Press Release

January 8, 2003

DHS Staff Issues Final Recommendation on Cancer Care Proposals for York County

Augusta: The Bureau of Medical Services, the division of the Department of Human Services that administers the Certificate of Need program, has issued its final recommendation on the competing proposals to construct a comprehensive cancer care treatment center in York County. The CON Unit has recommended that the proposal entitled “York County Cancer Care Center,” submitted by the Southern Maine Medical Center and Maine Medical Center and to be located in the town of Wells, be approved.

In accordance with the state statute governing this process, Kevin W. Concannon, Commissioner of the Maine Department of Human Services, was presented today with the entire public record, including the applications of both parties, the comments offered during the public hearing in Wells on December 4, 2002, all other comments received by December 13, 2002, the recommendation of the CON Advisory Committee, as well as the recommendation of the CON Unit. The Commissioner will be reviewing this public record and a final decision on the matter is expected in several weeks.

TO: Kevin W. Concannon, Commissioner

THROUGH: Eugene I. Gessow, Director, Bureau of Medical Services

FROM: Bill Perfetto, Manager, Certificate of Need Unit

SUBJECT: Competing Certificate of Need Application s by Cancer Care Center of York County (MMC/SMMC)[1] to Develop a Cancer Care Center in Wells and York County Radiation Therapy Collaborative (York/Goodall/W-D)[2] to Develop a Radiation Therapy Center in Wells.[3]

DATE: January 8, 2003

ISSUE ACTIVATED BY: The referenced proposal requires Certificate of Need approval as defined in "The Maine Certificate of Need Act of 1978," 22 MRSA Section 301 et seq., as amended.

BACKGROUND:

· The Maine Department of Human Services Licensing and Certification Unit stated the Cancer Care Center hospitals Maine Medical Center and Southern Maine Medical Center are both Medicare and MaineCare certified/licensed. No deficiencies have been noted that would affect quality of care.

· The Maine Department of Human Services Division of Licensing and Certification states the following for those hospitals associated with the York County Collaborative:

· H.D. Goodall is under a conditional license issued 8/31/02 due to deficiencies that affect quality of care. (These deficiencies relate largely to the record keeping system in the hospital’s quality assurance program.)

· York Hospital is both Medicare and MaineCare certified/licensed. No deficiencies have been documented that would affect quality of care.

· Wentworth-Douglas of New Hampshire -The Maine Department of Human Services Division of Licensing and Certification has no oversight over protocols, licensure or certification requirements.

· The American College of Surgeons’ Commission on Cancer has accredited both hospitals associated with the Cancer Care Center, Maine Medical Center and Southern Maine Medical Center, as accredited multidisciplinary cancer programs. Additionally, Maine Medical Center is approved as a “Teaching Hospital Cancer Program”.

· Of the three hospitals within the York County Collaborative, only Wentworth-Douglas of New Hampshire is accredited by the American College of Surgeon’s Commission on Cancer.

· The Cancer Care Center will provide comprehensive cancer treatment services. The proposal is not limited to radiation therapy. The Cancer Care Center will provide simulator and 3-D dimensional and intensity modulated radiation therapy services allowing patient access to all services in York County.

· The York County Collaborative will require that simulation services for all patients be provided in Dover, New Hampshire for an unknown period of time.

· The Cancer Care Center of York County is a joint effort by Maine Medical Center and Southern Maine Medical Center. Maine Medical Center and Southern Maine Medical Center currently provide the majority of inpatient cancer care and radiation therapy to citizens of York County.

· The Cancer Care Center (MMC/SMMC) and York County Collaborative (York/Goodall/W-D) proposals provide charges and costs that indicate each proposal is financially and economically feasible, although the York/Goodall/W-D proposal is slightly more expensive. The majority of the costs in both proposals are construction and equipment. Both facilities will not affect current charge structures beyond the normal inflation of expenses that would occur independently of the proposal.

· The Department of Human Services’ Bureau of Health will license the radiation therapy equipment. Bureau of Health Radiation Control program notes no deficiencies cited on the equipment owned and operated by Maine Medical Center.

· The Bureau of Health Radiation Control program is investigating the regulatory process to determine what, if any, licensure review can be performed on an out-of-state hospital such as Wentworth-Douglas of New Hampshire.[4]

· The current financial exposure to health care costs to the state is illustrated in the following statement: “ The Maine Consortium for Comprehensive Cancer Control notes in 1997, 6,636 hospitalizations occurred in Maine as a result of cancer with direct and indirect costs of cancer in Maine totaling $440M”. A high-quality screening and treatment program available and accessible to all citizens has the possibility of reducing individual and/or community health care expenditures through activities such as prevention, reduction in private/state transportation etc.

· American Cancer Society-Cancer Facts and Figures 2000 notes each year approximately 6,800 Maine residents are diagnosed with cancer and 3,100 die from the disease. Cancer is the second leading cause of death in Maine.

· American Cancer Society-Cancer Facts and Figures 2001 estimates over 800 new cancer cases in York County. This figure is very near actual data collected by the Maine cancer registry.

· The applicant groups’ service volume projections are contained in the following tables:

· The projections by both proposals are in line with American Cancer Society and Maine Cancer Registry data recognizing that all identified cancers do not require radiation therapy. Both proposals meet the current DHS Space and Needs Guidelines as follows:

1. At least 300 new cancer cases annually within three years after initiation.

2. At least 6,000 treatments per year within three years after initiation.

· York County residents are currently served by therapy programs in Scarborough and Portland, Maine or Dover, New Hampshire. The amount of radiation therapy equipment located in Scarborough and Portland has increased over the last two years and remains near or at capacity. The York County population of 180,000+ and annual increases in patients and population growth demonstrate a need to place a comprehensive cancer treatment center in York County.

· CONU has determined per the DHS Space and Needs Guidelines that only one radiation therapy center is needed in the proposed service area. (See the attached Preliminary Assessment.)

· In lieu of a state health plan the Certificate of Need staff has determined the Maine Comprehensive Cancer Control Plan is the proper plan to evaluate the two proposals.

· The Maine Comprehensive Cancer Control Plan assimilates many planning efforts of other program and organizations such as the American Cancer Society, the Maine Breast and Cervical Health Program, Healthy Maine 2000 and others. The vision is to improve the well being of Maine’s citizens; to reduce the suffering and economic burden caused by cancer in Maine; and eliminate, to the extent possible, the differences in how cancer affects Maine’s population group.

· The goals of the Maine Consortium for Comprehensive Cancer Control are to build a comprehensive cancer prevention, control and care infrastructure which includes but is not limited to:

Ø increased statewide integration/coordination,

Ø increase access to high-quality cancer prevention/detection/treatment and

Ø improve the quality and coordination of cancer surveillance/data systems.

· The Certificate of Need Unit, having reviewed the proposals and the record, has determined that the Cancer Care Center of York County (MMC/SMMC) is more able under Maine law to provide the full services that are the subject of this competitive review.

· CONU’s detailed analysis of the competing applications is contained in the attached Preliminary Assessment.

HIGHLIGHTS:

· In the Preliminary Assessment of Competing Proposals, the Certificate of Need Unit recommended, as follows:

· Copies of the "Preliminary Assessment" were sent to the applicants.

· The CON Advisory Committee held a public hearing in Wells on December 4, 2002.

· Both applicant groups, as well as members of the public, submitted post-hearing comments. (See attached.)

· The CON Advisory Committee held its deliberative meeting at the Bureau of Medical Services office in Augusta on December 23, 2002. At its deliberative meeting the Advisory Committee recommended on a 5-1 vote:

1. Approval of the York County Radiation Therapy Collaborative (York/Goodall/W-D), proposal and

2. Disapproval of the Cancer Care Center of York County (MMC/SMMC) proposal.

· On January 2, 2003 pursuant to 22 MRSA, 3307 (2-B) (G), CONU sent a letter to MMC/SMMC requesting clarification of two items contained in its December 13 Comments. CONU asked both SMMC/MMC and the Collaborative to respond to the following questions:

1. “What does ‘Alternate Site’ mean? Does SMMC/MMC’s identification of an ‘Alternate Site’ in its Comments mean that the ‘Alternate Site’ is, in fact, the new site?

2. “If this is a new site, how does the new site affect the application currently under consideration, for example, the impact to the Proposed Total Capital Expenditure etc.?”

· SMMC/MMC and the Collaborative’s responses to the questions are attached.

· CONU considers this identification of an alternate site to have no material effect upon the application under review and is not a new application. CONU believes the new site meets the requirements of Maine law for the reasons set forth in the Preliminary Assessment and because SMMC/MMC has indicated the following:

“The site is located in the Business Zone under the Wells Zoning ordinance; that zone permits medical care facilities and offices. (SMMC/MMC’s post-hearing comments.)

“SMMC/MMC is committed to constructing the proposed facility on the new site within the Proposed Total Capital Expenditure originally submitted. The design of the facility is unaffected by the change in site except for the absence of certain utility infrastructure costs described above and detailed in Tab 9 of our December 13 filing. The new site also will not affect operating costs, character and quality of services, or any other material component of the application.” (SMMC/MMC’s response to CONU questions concerning alternate site.)

In response to SMMC/MMC’s application, CONU presents the following analysis, in addition to its Preliminary Assessment analysis:

· Chapter 8: Principles Governing Reviews requires the following:

“Determinations Required. A certificate of need shall be issued whenever the Department determines:

“A. That the applicant is fit, willing and able to provide the proposed services at the proper standard of care;

· CONU has determined that SMMC/MMC remains the applicant most able to develop the proposed cancer center.

“B. That economic feasibility of the proposed services is demonstrated in terms of: Effect on the existing and projected operating budget of the applicant; the applicant's ability to establish and operate the facility or services in accordance with licensure rules adopted under pertinent state laws; the projected impact on the facility's costs and rates; the total health care expenditures in the community and the State; and the availability of State funds;

· CONU has determined that SMMC/MMC’s alternate site is consistent with the above requirement.

C. That there is a public need for the proposed services; and

York/Goodall/W-D submitted written comments regarding SMMC/MMC’s alternate site. Those comments failed to raise any substantive arguments against the alternate site.

· CONU has determined that there is a need for one cancer center within the proposed service area.

D. That the proposed services are consistent with the orderly and economic development of health facilities and health resources for the State, that the citizens of the State have the ability to underwrite the additional costs of the proposed services and that the proposed services are in accordance with standards, criteria or plans adopted and approved pursuant to the state health plan developed by the Department. 22 MRSA Sec. 309 (1).

· CONU has determined that SMMC/MMC’s application is more consistent with the above requirement.

(NOTE: CONU considered timely and properly submitted comments in reaching its recommendation.)

RECOMMENDATION: The Bureau of Medical Services recommends APPROVAL of Cancer Care Center of York County (MMC/SMMC) proposal.

The Bureau of Medical Services recommends DISAPPROVAL of the York County Radiation Therapy Collaborative proposal.

ATTACHMENTS: 1) CON Unit’s Preliminary Assessment of the proposals, dated November 1, 2002.

2) Public Hearing transcript and submissions.

3) Post Public Hearing comments submitted by the applicant groups and members of the public prior to the close of the public comments (December 13, 2002.)

4) CONU questions concerning SMMC/MMC’s alternate site, dated January 2, 2003.

5) SMMC/MMC responses to CONU questions, dated January 2, 2003.

6) Collaborative responses regarding CONU questions, dated January 3, 2003.

[1] Southern Maine Medical Center and Maine Medical Center.

[2] The York County Radiation Therapy Collaborative is a joint venture whose members include the Goodall Hospital in Sanford, ME, the Wentworth-Douglass Hospital in Dover, NH, and the York Hospital in York, ME.

[3] (NOTE: The applications at issue were received and entered into review prior to the effective date of the CON Act of 2002.)

[4] (BHRC has not made any determination as of the date of this report.)

[5] For 9 months.

[6] For 9 months.