Current through Register Vol. 54, No.43, October 26, 2024
Section 401.5 - Certificate of Need(a)Letter of intent.(1) As early as possible, any person desiring to obtain a certificate of need shall submit a letter of intent to the Division of Need Review of the Department and to the Health Systems Agency (HSA) responsible for reviewing applications in the health service area where the proposed project will be located. A letter of intent shall contain at least the following information: (i) The name and address of the applicant.(ii) The name and location of the project.(iii) The reason the project is needed.(iv) The type of capital expenditure, acquisition, health service, or change in bed capacity involved in the project.(v) The expected date of project commencement and completion.(vi) The estimated cost and anticipated source of project financing.(2) The Department, after consultation with the HSA, will determine whether the project is subject to review and notify the applicant within 30 days of receipt of the letter of intent. Only projects for which letters of nonreviewability are issued will be considered not subject to review. A determination by the Department that a project is subject to review may be appealed to the Hearing Board, under 37 Pa. Code Chapter 197 (relating to practice and procedure). An application may be submitted and reviewed during an appeal to the Hearing Board.(3) If the project has been inactive for more than 1 year the project proposed by the applicant shall be considered withdrawn.(b)Application.(1) An applicant for a certificate of need may obtain the necessary application forms from the local HSA. Applications to obtain or amend a certificate of need shall be submitted simultaneously to the Department and the HSA responsible for reviewing applications in the health service area where the proposed project will be located. The HSA shall advise the applicant as to the number of copies of the application the agency will require to conduct a review.(2) Applications for a certificate of need shall contain all data and information required by the Department and the HSA. The following information shall be submitted in a format published by the Department: (i) General. (A) Identifying information.(E) Anticipated proposal schedule.(ii) Synopsis of proposal.(iii) Proposal planning process.(A) Description of annual institutional planning process.(B) Results of planning with other organizations.(C) Description of institutional long range plan.(iv) Specific description of proposal.(A) Service, building, equipment and bed changes.(B) Personnel requirements.(C) Projected utilization by service.(E) Anticipated financing.(v) Need for proposal.(A) Compatibility with institutional long range plan.(B) Consistency of proposal objectives with the following:(I) Goals, objectives and recommended actions in the health systems plan and annual implementation plan.(II) Goals, objectives, and recommended actions in the State health plan.(C) Consistency of specific criteria used to calculate need with the following: (I) Criteria in the health systems plan.(II) Criteria in the State health plan.(III) Other relevant criteria developed by professional organizations, if available.(D) Documentation of alternatives studied and found not practicable.(I) More efficient use of existing services or facilities, or both.(II) Implementation of modernization or sharing arrangements to the maximum extent feasible.(vi) Economic feasibility of proposal.(A) Documentation of financial feasibility.(I) Past historical financial data.(II) Pro Forma statements: status quo; proposal; alternatives.(III) Financing arrangements and assumptions.(B) Evaluation of economic feasibility.(I) Adequate volume of care projected.(II) Availability of financing.(III) No inappropriate adverse impact on overall areawide cost of providing services.(IV) No appropriate, less costly or more effective alternative methods of providing the services available.(vii) When the HSA, with concurrence of the Department, has adopted additional information requirements, the information requirements shall be published by the HSA in a format approved by the Department, and incorporated into the application. The applicant shall submit this information within the format published by the HSA.(3) The application for a certificate of need shall specify the time the applicant will need to make the service or equipment available or to complete the project, and a timetable to substantially implement the approved project. The timetable to substantially implement the project must conform with the timetable established at subsection (m).(4) The appropriate HSA and the Department will review each certificate of need application for completeness. If it is determined that the application is incomplete, the reviewing agency shall send notice to the applicant within 20 business days of the receipt of the application and shall advise such persons in writing of the additional information required to complete the application. Upon receipt of the additional information, the reviewing agency shall determine if the application is complete and send notice within 15 business days of the receipt of same. The application and additional information must be sent to both the Department and the HSA. The time frames for review of the application or additional information will not begin until both the Department and HSA have received the information. If the Department and HSA receive information on different dates, the time frame begins on the later of the two dates. An applicant shall only be required to provide information under paragraph (2).(5) Any conflicts regarding the completeness of an application will be resolved by the Department. An applicant may notify the Department at any time while an application is under consideration for completeness by an HSA, and request in writing a determination by the Department as to whether the application is complete. The request must indicate the reasons why the HSA determined the application incomplete, and the reasons why the applicant believes the information is contained in the application or in the additional information provided. The Department will notify the applicant of its determination within 14 business days. If the Department determines the application is complete, the HSA shall review the application.(6) An applicant may, 60 days or more after filing an application, request in writing that the review begin. Requests shall be mailed to the HSA and the Department by certified mail, return receipt requested. Upon receipt of such a request the HSA shall notify the applicant and the Department in writing that the review process will begin on the date of notification in accordance with subsection (d)(1) and shall include at least the same information as required in subsection (c)(3). All subsequent requirements pertinent to a complete application shall apply.(c)HSA notification of review.(1) After the HSA determines that an application is complete in accordance with subsection (b)(3) or upon expiration of the time to determine that an application is complete, whichever comes first, the HSA shall send a written notice to the applicant stating that the application is deemed complete and that the review process will begin on the date of notification in accordance with subsection (d)(1).(3) The HSA shall notify all affected persons of a complete certificate of need application by publishing a notice in at least one newspaper of general circulation serving the locality in which the proposed service or facility will be developed. The notice shall contain the name and address of the applicant, a brief description and an estimate of the cost of the project, the schedule for review by the agency, the date by which a public hearing must be requested, and the manner in which notice will be given if a public hearing is to be held. If this notice states the date and location of the public hearing, it shall satisfy the requirement for public notice of the HSAs. The Department will publish a similar notice in the Pennsylvania Bulletin.(4) The HSA shall also provide written notice of a completed certificate of need application to HSAs serving contiguous health service areas, any health care facilities and health maintenance organizations located in the health service area which provide institutional health services, appropriate third party payors, and public agencies. The written notice shall contain the same information as required in paragraph (3) and may be satisfied if published as part of a newsletter.(d)HSA period for review.(1) The date of notification begins the time period in which the HSA must complete the review of an application for a certificate of need. The date of notification is the date the HSA publishes a notice in accordance with subsection (c)(3). The HSA shall send the applicant the required notice that the review process will begin and publish such notice within 30 days after either the application is deemed complete in accordance with subsection (b)(4) or after receipt of the applicant's request that review begin in accordance with subsection (b)(6), whichever date first occurs.(2) The HSA shall have 60 days from the date of notification to complete its review of the application.(3) The HSA with concurrence of the Department may extend the time for review beyond 60 days from the date of notification only if the applicant agrees in writing to a specific extension of time for the review by the HSA. Any agreed extension of time must indicate the date upon which the running of the 60 day period stops and begins, and the date upon which the 60 day period expires. Copies of agreed extensions must be submitted to the Department. If there are not agreed extensions in writing, the 60 day period shall not be considered extended, and will expire on the 60th day from the date of notification.(5) The HSA, with concurrence from the Department, may establish review cycles for the review of applications. There shall be at least six review cycles per year-one every other month. During a review cycle, all completed applications pertaining to similar types of services, facilities or equipment shall be considered in relation to each other.(e)Public hearing and objection procedures.(1) A public hearing shall be conducted by the appropriate HSA if any affected person or any appropriate third-party payor submits a written request for a hearing to the HSA within 15 days from the notice published under subsection (c)(3). Timely notification within the 15 day period shall be determined by the postmark. The HSA may require a public hearing during the course of its review of any application for a certificate of need.(2) Any person directly affected may file an objection to an application within 15 days from the publication of notice in accordance with subsection (c)(3). The date of filing will be determined by the postmark. Such an objection must be filed with the appropriate HSA and set forth specifically the reasons such objection is filed. Persons filing objections shall be parties to the proceeding unless and until such objections are withdrawn. Any person, other than the applicant, or the HSA, who appeals the decision of the Department subsection (j)(1) must have become a party to the proceedings by having filed an objection with the appropriate HSA.(3) Notice of a public hearing on a certificate of need application shall be published by the HSA in a newspaper of general circulation serving the locality in which the proposed service or facility would be developed. The HSA shall notify affected persons of the hearing at least 14 days prior to the hearing. This requirement may be satisfied as part of subsection (c)(3).(5) Each HSA shall adopt and publish specific procedures for conducting public hearings on certificate of need applications. The procedures must be approved by the Department and shall conform to the following:(i) The applicant and any person shall be afforded the opportunity to submit testimony, oral or written arguments, and relevant evidence at the hearing. Such persons should request the opportunity to testify by notifying the HSA prior to the hearing date or may register to testify at the hearing. Any person shall have the right to be represented by counsel. Any person directly affected may conduct reasonable questioning of persons who make relevant factual allegations. A record of the hearing shall be maintained. A transcript of this record shall be made upon request of a party to the proceedings and at the expense of the requesting party.(ii) The time allocated to persons wishing to present testimony may be limited under the hearing procedures adopted and published by the HSA governing body.(iii) The public shall be notified as soon as possible regarding any changes in the scheduled date of a public hearing or any changes in the applications to be heard therein.(f)HSA review and recommendations.(1) A HSA may, with the approval of the Department, give a nonsubstantive review to a proposed new institutional health service. See § 401.2 (relating to definitions) for definitions of nonsubstantive reviews.(2) HSAs, in formulating recommendations to the Department on a certificate of need application, shall make their findings regarding the criteria set forth in § 401.4 (relating to criteria for Certificate of Need review) under procedures established by the Department.(3) The HSA shall concurrently send the applicant notification of the findings and recommendations it submits to the Department. The findings shall be submitted to the Department in such form as the Department requires.(4) The HSA shall submit its findings and recommendations to the Department within the time period allotted in subsection (d)(2) and (3).(g)Department review and findings.(1) The Department will consider the timely filed findings and recommendations of the HSA, any information accompanying the application or presented on behalf of the application, any duly promulgated criteria and standards adopted by the Department, and the criteria listed in § 401.4.(2) If there has been no provision for a public hearing before the HSA, the Department will comply with the requirements of subsection (e).(3) The Department will approve or disapprove the application within 30 days from the date that the HSA's recommendation is received.(4) If the Department determines that an application cannot be adequately reviewed within the time periods stated in paragraph (3), it will notify the applicant indicating the reasons why, and request the applicant to agree to an extension of the review period.(5) If a decision is not made within the required time period, the applicant may bring an action in the Commonwealth Court to require the Department to approve or disapprove the application. If an order is issued by the Court, the Department will promptly, and in accordance with the order, issue its decision. If the decision is adverse to the applicant, the applicant may appeal to the Hearing Board.(6) Decisions of the Department will be based solely on the record. There shall be no ex parte contacts.(i) For purposes of this section, an ex parte contact is a contact between an applicant for a certificate of need, any person acting on behalf of the applicant, or any person opposed to the issuance of a certificate, and any person in the Department who exercises any responsibility respecting the application after the commencement of the public hearing on the applicant's application and before a decision is made with respect to it. A status report shall not be considered an ex parte contact. A contact which is recorded as part of the official application file in accordance with paragraphs (ii) and (iv) shall not be considered an ex parte contact.(A) For the purpose of this subsection, a person acting on behalf of the applicant for, or holder of, a certificate of need is any person, including an HSA, who favors the issuance of a certificate of need.(B) For the purpose of this subsection, a person in the Department who exercises any responsibility respecting the application includes any Departmental employe involved in a given review, from the initial reviewer up to and including the Secretary.(C) For the purpose of this section, status reports are any communications which do not go to the substance of a certificate of need review. They are routine statements of the progress of the review of an application for a certificate of need.(ii) When the Department receives a written communication from a person who supports or opposes the granting of a certificate of need, the communication shall be made a part of the official project file regarding the issuance of the certificate of need. Any person may review the official project file during the normal business hours of the Department. Any affected person may receive a copy of written communications which have been made part of the official project file by contacting the Division of Need Review. Requests will be considered to be requests for status reports as defined in clause (C).(iii) When the Department receives a communication either in person or by telephone from a person who supports or opposes the granting of a certificate of need, a summary of the communication will be made part of the file.(iv) When the Department holds a meeting with an applicant or a person opposing or supporting the issuance of a certificate of need, parties to the proceeding will be notified, in advance of the time and place of the meeting. A summary of the meeting will be made part of the project file.(7) When the Department approves an application, the certificate of need shall specify the maximum amount of capital expenditures which may be obligated under the certificate.(8) Certificates of need shall be granted or refused. They shall not be conditioned upon the applicant changing other aspects of its facilities or services or requiring the applicant to meet other specified requirements and no such obligation shall be imposed in granting or refusing approval.(9) The Department may grant a certificate of need which permits expenditures only for predevelopment of the new institutional health service with respect to which such predevelopment costs are incurred.(10) When the Department makes a decision regarding the proposed new institutional health service which is inconsistent with the recommendation made with respect thereto by a HSA, or with the applicable health systems plan, or annual implementation plan, the Department will submit to the HSA and all parties to the proceeding a written detailed statement which describes why it has made findings that are inconsistent with the findings of the HSA, the health systems plan or the annual implementation plan.(11) The Department will make written findings which state the basis for any final decision made by the Department. The findings shall be sent to the applicant, the HSA, and all parties to the proceedings as soon as reasonably possible following its decision, but no later than 10 business days after its decision, and it shall be made available to others upon request.(12) A person proposing a new institutional health service may withdraw a previously filed application without prejudice by filing written notice of the withdrawal with both the HSA and the Department at any time prior to final approval or disapproval of the required certificate of need.(13) An applicant may modify a proposal at any time during the review period. When an applicant desires to modify a proposal, the applicant shall submit in writing a detailed statement of the desired changes and an explanation to justify each change to the HSA and the Department. The HSA shall review the proposed changes to determine if a substantial modification to the original application would occur. If it is determined that a substantial modification would occur, the proposed change will be submitted to the HSA for review and a recommendation on the proposed change returned to the Department within 60 days. The Department will approve or disapprove the application within 30 days from the date the HSA recommendation is received. For the purposes of this paragraph, a substantial modification occurs when one of the following occurs: (i) The proposed bed complement is increased.(ii) The total costs are increased by more than 20% or $2 million, whichever is less.(iii) A proposed service is added or deleted.(iv) The Department and HSA determine there is a significant change in site.(h)Emergency certificates.(1) The application and review process may be suspended, with the concurrence of the HSA and the Department, for a project limited to a replacement of plant and equipment as a result of natural disaster, fire, unforeseen equipment failure or similar occurrence, which endangers the health and safety of patients. Within 5 days of the occurrence, written notification shall be given to the Department and the local HSA.(2) If the Department suspends the review process, an emergency certificate of need shall be issued subject to any restrictions imposed by the Department. Within 30 days of the issuance of the emergency certificate, the health care provider shall file an application for review of the plant and equipment replaced as a result of the emergency. This application shall be reviewed under the HSA's nonsubstantive review procedures.(i)Reconsideration of Department decision.(1) Any person may, for good cause shown, request, in writing, a public hearing for the purpose of reconsideration of a decision of the Department within 10 days of the decision of the Department. If such hearing is granted, the Department will set forth the cause for the hearing and the issues to be considered at such hearing. The hearing shall be held no sooner than 6 days and no later than 14 days after a request is made, and may be limited to the issues submitted for reconsideration. Notification of such a public hearing shall be sent at least 5 days prior to the date of the hearing, to the person requesting the hearing, the person proposing the new institutional health service, the HSA for the health service area in which the new institutional health service is proposed to be offered or developed, and shall be sent to others upon request. Within 14 days of the conclusion of the hearing, a summary of the oral testimony shall be made of the hearing, and copies thereof supplied at cost to the person proposing the new institutional health service, the appropriate HSA and any parties to the proceeding, and shall be made available by the Department to others upon request. The Department will affirm or reverse its decision and submit the same to the parties, the person requesting the hearing, and the HSA within 14 days of the conclusion of such hearing. Any change in the decision shall be supported by the reasons therefore.(2) Where reconsideration hearings are held on more than 2 days, consecutive days of hearings and intervening weekends and holidays shall be excluded in calculating the time permitted for the Department to conduct its review and if briefs are to be filed, 10 days subsequent to the adjournment of the hearing shall also be excluded.(3) Good cause shall be deemed to have been shown if one of the following occurs: (i) There is significant, relevant information not previously considered.(ii) There is significant change in factors or circumstances relied on in making the decision.(iii) There has been material failure to comply with the procedural requirements of this chapter.(iv) The Department determines that there is good cause shown for some other reason.(4) If good cause under paragraph (3)(i) and (ii) is found by the Department, a reconsideration hearing will be conducted under section 704(b) and (c) of the act (35 P. S. § 448.704(b) and (c)).(j)Appeals.(1) Decisions of the Department on an application for a certificate of need or amendment thereto may be appealed within 30 days by any party or HSA who is involved in the proceeding. The appeal to the Hearing Board shall be commenced within 30 days of receipt of the appeal request and shall be limited to issues raised by the appellant in the specification of objections to the decisions of the Department. Those issues shall be restricted to whether the findings and recommendations of the Department are supported by substantial evidence, and must have been raised or brought to the attention of the HSA or the Department during the course of the review.(2) The Board shall entertain no evidence that the Hearing Board is satisfied the appellant was able, by the exercise of reasonable diligence, to have submitted before the HSA and the Department.(k)Cost increases to certificates.(1) A certificate of need shall state the maximum amount of expenditures which may be obligated under it. Applicants proceeding with an approved project may not exceed this level of expenditures except under the following procedures:(i) When the applicant proposes an expenditure greater than that stated on the certificate, the applicant shall notify the Division of Need Review in writing. The applicant may not proceed with the proposed changes until the appropriate Departmental approvals have been granted. The written notice shall include at least all of the following:(A) The name and address of the applicant.(B) The name and location of the project.(C) The amount of the cost increase.(D) The primary reasons for the cost increase.(E) The anticipated source of financing for the cost increase.(ii) Within 20 days of receipt of the information set forth in subparagraph (i), the Department, after consultation with the HSA, will notify the applicant of the type of review which will be conducted.(A) A cost increase which exceeds 20% of the originally approved amount shall receive a full review as specified in subparagraph (iii).(B) A cost increase which is less than or equal to 20% of the originally approved amount may receive a nonsubstantive review.(iii) For purposes of this subsection, a full review shall be limited to the criteria specified in section 707(a)(4)-(6), and (8), (b)(1) and (2) and (c)(1) and (5) of the act (35 P. S. § 448.707(a)(4)-(6), and (8), (b)(1) and (2) and (c)(1) and (5)).(iv) Due to the relatively insignificant consequences of some of the changes that would require a nonsubstantive review, an administrative review can be substituted if the HSA and the Department agree that only an administrative review is necessary. The Department will render its decision on the project within 30 business days of receipt of the required information.(v) The procedures set forth in this section shall also apply to approvals under 42 U.S.C.A. § 1320a-1 and projects covered under section 901 of the act (35 P. S. § 448.901).(l)Changes to certificate of need.(1) When an applicant proposes a change to an approved certificate of need, the applicant shall notify the Division of Need Review in writing. The applicant may not proceed with the proposed changes until the appropriate Departmental approvals have been granted. The written notice shall include at least the following: (i) Name and address of the applicant.(ii) Name and location of the project.(iii) The change and reason for the change.(2) Within 20 days of receipt of the information in paragraph (1)(i), the Department, after consultation with the HSA, will notify the applicant of the type of certificate of need review which will be conducted.(3) Substantial changes which require a full review include, but are not limited to, the following:(i) A significant change in site as determined by the Department and the HSA.(ii) The addition or deletion of a health service.(iii) A change in an application line item by 20%. Line item is defined as single cost categories as listed in the financial section of the certificate of need application. If the overall cost increase does not meet the full review criteria under paragraph (1)(ii)(A) the Department after consultation with the HSA may elect to do a nonsubstantive review.(iv) A change of greater than 10 beds or 10%, whichever is less, of affected beds in the application.(v) A 20% change in renovation or construction square footage. Square footage is defined as allocations as listed in the space exhibit of the certificate of need application.(4) Changes which do not meet the thresholds set forth in this subsection may receive a nonsubstantive review. A change of less than 10 beds or 10%, whichever is less, is not reviewable if the project has been substantially implemented.(5) Due to the relatively insignificant consequences of some of the changes that would require a nonsubstantive review, an administrative review can be substituted if the HSA and the Department agree that only an administrative review is necessary. The Department will render its decision on the project within 30 business days of receipt of the required information.(6) This subsection shall also apply to approvals under 42 U.S.C.A. § 1320a-1 and projects covered under section 901 of the act (35 P. S. § 448.901).(m)Withdrawal of certificates.(1) A certificate of need shall remain in effect, providing the facilities and services authorized are in use. In the absence of substantial implementation of an approved project for which a certificate of need was issued, the certificate shall be withdrawn 1 year after issuance, unless the Department extends the time for a definite period, not to exceed 6 months. Notification of a request for an extension shall be made in writing to the Department and appropriate HSA and should be made at least 60 days prior to the expiration of the certificate. Only one such extension may be granted for a project. For projects which are approved to be carried out in phases estimated to require no more than 3 years, the certificate of need shall remain in effect after the first phase is implemented but no longer than 3 years unless the project is substantially implemented. All phased construction must commence within 5 years of approval. All phased construction time frames must be approved as part of the review process.(2) When it comes to the attention of the Department that the time period in which to substantially implement the project has passed without the project being substantially implemented, the Department will send a notice to the holder of the certificate advising that the certificate shall be withdrawn for failure to implement the project in a timely manner.(i) A notice of the withdrawal shall be sent to all affected persons, published in a newspaper of general circulation in the area to be served by the project, and published in the Pennsylvania Bulletin. The notice shall state the reasons for the withdrawal, and the date by which any affected person may request a hearing on the withdrawal. Objections or comments on the withdrawal may be filed by any persons directly affected.(ii) If a hearing is requested, the Department will forward the request to the appropriate HSA to hold a hearing in accordance with the procedures established by the HSA for public hearings. Notice of the hearing shall be given in writing to all affected persons, and through a newspaper of general circulation for all others.(iii) A record of the hearing shall be maintained and forwarded to the Department along with a recommendation by the HSA as to whether the certificate should be withdrawn.(iv) The Department will consider the recommendation of the HSA, the record of the hearing, and any other pertinent information and render a final decision on the withdrawal within 30 days of receipt of the HSA recommendation.(3) Substantial implementation of a project occurs when the following requirements are completed relative to, but not limited to, the following types of projects. All of the requirements listed in this paragraph must be completed within 1 year after issuance of the certificate or within 18 months after issuance of the certificate if an extension has been granted.(i) New construction or renovation projects shall include the following: (A) The title or long-term lease to the appropriate site has been acquired.(B) The appropriate State agency has approved the complete set of schematic drawings for the project.(C) A financial commitment has been obtained, for at least 60% of the total approved capital expenditure. The commitment may be any combination of funds such as the applicant's own funds, grants, gifts, or an enforceable offer and acceptance from a financial institution to provide adequate capital financing for the project.(D) An enforceable construction contract has been entered into causing the commencement of construction no later than 24 months after issuance of a certificate. Failure to commence construction within this time period shall be considered an abandonment of the project and the certificate issued shall be withdrawn. Erection of the foundation shall constitute commencement of construction.(ii) Acquisition of equipment. The equipment must either be purchased; the lease agreement must be entered into by the proponent; or if acquired by a comparable arrangement the health care facility or health maintenance organization must have possession of the equipment.(iii) Addition of new service. A written statement must be submitted to the Department verifying that the service is in operation.(iv) Donated property. In the case of donated property, the date on which title to the donated property is transferred in accordance with applicable State statutes.(n)Reporting requirements.(1) During the course of review, the HSA and the Department will, upon request of any person, set forth the status and any findings then made or any other appropriate information regarding an application before them. Other appropriate information includes information regarding the conducting of public hearings, the review cycle, or other information to which the public has access under this chapter.(2) Each HSA shall prepare and publish, at least annually, reports of certificate of need reviews, including a statement of findings and decisions made in the course of each review since the last report.(3) The Department will prepare and publish, at least annually, reports of the reviews being conducted, including a statement concerning the status of each review, and of the reviews completed by the agency since the publication of the last report and a general statement of the findings and decisions made in the course of review.(4) Persons subject to review under this chapter shall submit periodic progress reports to the HSA and the Department pertaining to the development of projects which have received certificate of need approval. The reports must detail the progress toward the substantial implementation of projects as defined in subsection (m). The time period for submission of the progress reports is the end of the 10th month following certificate of need approval, although in the case of an extension, an additional report is required by the end of the 18th month following project approval.(5) For information purposes only, at least 30 days prior to termination or substantial reduction of a service or a permanent decrease in the bed complement, a health care provider shall notify in writing the HSA and the Department of its intended action. However, if any such change should involve a capital expenditure in excess of the minimum threshold for review of capital expenditures, as established by Federal law or regulation, the health care provider shall be required to obtain a certificate of need in accordance with this section.(o)Penalties. Penalties shall be imposed in accordance with the act.The provisions of this §401.5 amended April 13, 1984, effective 4/14/1984, 14 Pa.B. 1294.The provisions of this §401.5 issued under section 2102 (a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)); and section 201(14) of the Health Care Facilities Act (35 P. S. § 448.201(14)).
This section cited in 28 Pa. Code § 401.7 (relating to simultaneous and comparative review); 55 Pa. Code §1163.453 (relating to allowable and nonallowable costs); 55 Pa. Code §1181.65 (relating to cost-finding); 55 Pa. Code §1181.259 (relating to depreciation allowance); and 55 Pa. Code §1181.260 (relating to interest allowance).