Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 100.000 - Determination of Need
Section 100.405 - Filing of Applications for Determination of Need

Universal Citation: 105 MA Code of Regs 105.100

Current through Register 1518, March 29, 2024

(A) All materials related to an Application for Determination of Need including, but not limited to, Application forms, computation sheets, notification requirements, Guidelines, and other pertinent documents shall be made publicly and readily available electronically at all times, such as on the Department's website. Applications for Determination of Need shall include, at a minimum: a statement of the Proposed Project, including the Total Value; information and supporting documentation consistent with 105 CMR 100.210; all applicable computation sheets; a filing fee; an affidavit of truthfulness, signed under the pains and penalties of perjury pursuant to 105 CMR 100.405(B); an attestation of compliance with all federal, state, and local laws, including compliance with M.G.L. c. 30, §§61 through 62H and the applicable regulations thereunder; a disclosure of the total proposed Construction costs specifically related to the Proposed Project, if any, which will be contracted out to local or minority-, women-, or veteran-owned businesses; and any additional requirements, attestations, or information that the Applicant wishes to place before the Department, or as the Commissioner requests or requires.

(B) All Persons seeking a Notice of Determination of Need shall file a completed Application, accompanied by an affidavit signed under the pains and penalties of perjury by the Applicant's chief executive officer and board chair and the filing fee to the Department, labeled "Attn: Determination of Need Program". Simultaneous filings of duplicate copies of the Application shall be required to the AGO, CHIA, HPC, and to all Government Agencies with relevant licensure, certification, or other regulatory oversight of the Applicant or the Proposed Project, or components therein. The filing fee shall be nonrefundable and shall be $500 or 0.2% of the Total Value of the Proposed Project, whichever is greater.

(C) All Persons seeking a Notice of Determination of Need, or an amendment to a previously issued Notice of Determination of Need, shall publish a notice of intent of its Application, and of any amendment thereto at least 14 days prior to the Submission Date of such Application or amendment with the Department. The notice of intent shall accurately describe the Proposed Project, and shall be published prominently on the website(s) for the Health Care Facility or Heath Care Facilities for which the Application for Notice of Determination of Need will be submitted, and in the daily newspaper(s) within the affected cities or towns of, or nearest to, the Location of the Proposed Project, or as directed by the Commissioner. Every notice of intent, at a minimum, and subject to amendment by the Commissioner, shall conform to the following standards

(1) Form. The notice of intent published in the daily newspaper(s) shall appear within the Legal Notice, as well as the appropriate local news or interest sections of the publication, and shall be captioned: "Public Announcement Concerning a Proposed Health Care Project". The notice of intent shall be published prominently on the website(s) for the Health Care Facility or Heath Care Facilities for which the Application for Notice of Determination of Need or request for amendment to a previously issued Determination of Need will be submitted and shall comport, at a minimum, with the most current web accessibility standards of the Commonwealth.

(2) Content. The notice of intent shall, at a minimum: identify the Applicant or Holder by name and address; the name and address of the Health Care Facility or Health Care Facilities involved or proposed; shall provide a brief and accurate description of the Proposed Project, including the type of Health Care Facility or Health Care Facilities involved, and the type of service(s) proposed or involved; shall state the Total Value of the Proposed Project; any anticipated price or service impacts on the Applicant's or Holder's Patient Panel; and, for all other applications other than requests to amend a previously issued Notice of Determination of Need, the notice shall contain the following statements: "Any ten Taxpayers of Massachusetts may register in connection with the intended Application by no later than (INSERT DATE) or 30 days from the Filing Date, whichever is later, by contacting the Department of Public Health Determination of Need Program (INSERT CONTACT INFORMATION AS SPECIFIED BY DEPARTMENT STAFF)." Said inserted date shall be 30 days from the proposed Filing Date.

The Applicant or Holder shall simultaneously provide a copy of said notice of intent to the Department, all Parties of Record, and all carriers or third-party administrators for the payment of health care services, including Medicare and Medicaid, with which the Applicant or Holder contracts. The Commissioner may waive 105 CMR 100.405(C) in the case of an emergency Application made pursuant to 105 CMR 100.740. Should the Commissioner determine errors existed within the Applicant's or Holder's published notice of intent pursuant to 105 CMR 100.405(C), the Applicant or Holder shall ensure a corrected notice of intent is published within a reasonable period of time, as specified by the Commissioner.

(D) Pursuant to M.G.L. c. Ill, § 25C(h), at its discretion, the Department may require an independent cost-analysis, conducted at the expense of the Applicant, to demonstrate that the Proposed Project is consistent with the Commonwealth's health care cost-containment goals. If the Department requires an independent cost-analysis, the Department shall make such request no later than 30 days following the Filing Date. The four-month period for review of the Application shall be stayed until a complete and final independent cost-analysis is received and accepted by the Department. For the purposes of a Department-required independent cost-analysis, the Department shall select a mutually agreeable party to conduct such analysis, and shall develop the scope and terms of such analysis. Upon the Department's acceptance of the independent cost-analysis, the Department shall provide the analysis to all Parties of Record. Parties of Record may submit written comments in response to the accepted independent cost-analysis. All written comments must be received by the Department within 30 days of Department acceptance. The accepted independent cost-analysis shall be attached to the staff report issued pursuant to 105 CMR 100.510.

(E) Applicants are responsible for ensuring proper notification and submissions to the Secretary of Environmental Affairs pursuant to 301 CMR 11.00: MEPA Regulations.

(F) If the Applicant is subject to a performance improvement plan pursuant to M.G.L. c. 6D, § 10(d), the Applicant shall provide notification of such in its Application.

(G) If the Applicant is subject to filing with HPC pursuant to M.G.L. c. 6D, § 13, the Applicant shall provide notification of such in its Application, and the Applicant shall file such notice of material change prior to, or on the same day as the Submission Date of an Application for Determination of Need with the Department.

(H) The Department shall notify the Applicant and all Parties of Record within two business days of determining an Application meets the definition of Filing Date. The Department may provide the Applicant reasonable accommodations for any necessary technical corrections. However, the existence of any defects, as determined by the Commissioner, may constitute grounds for dismissal pursuant to 105 CMR 100.615(E).

(I) The Applicant may request Part 1 Plan Review by the Department following the Filing Date of the Application for Determination of Need. Part 1 Plan Review may coincide, as is reasonably feasible, with Department consideration of the Proposed Project pursuant to 105 CMR 100.000.

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