HLT-30-09-00022-P Certificate of Need Process for Cardiac Services

7/29/09 N.Y. St. Reg. HLT-30-09-00022-P

NEW YORK STATE REGISTER

VOLUME XXXI, ISSUE 30

July 29, 2009

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-30-09-00022-P

Certificate of Need Process for Cardiac Services

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:

Proposed Action:

Amendment of section 710.1 of Title 10 NYCRR.

Statutory authority:

Public Health Law, section 2803(2)

Subject:

Certificate of need process for cardiac services.

Purpose:

To align the certificate of need process in cardiac services.

Text of proposed rule:

A new paragraph (5) of subdivision (b) of Section 710.1 is added to read as follows:

(5) For purposes of this Part, Cardiac Catheterization Laboratory Center, PCI Capable Cardiac Catheterization Laboratory Center, Diagnostic Cardiac Catheterization Service, and Cardiac Electrophysiology (EP) Laboratory Program shall have the same meanings as in section 405.29(a)(4) of this Title.

Subparagraph (iii) of paragraph (1) of subdivision (c) of Section 710.1 is amended as follows:

(1) Proposals requiring a certificate of need application. Any proposal which involves any of the following shall be the subject of an application submitted for review pursuant to the requirements of this Part and Article 28 of the Public Health Law:

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(iii) the initial acquisition or addition of any equipment, regardless of cost, utilized in the provision of a service listed in paragraph (2) of this subdivision, other than the acquisition or addition of equipment subject to paragraph (7) of this subdivision. A proposal for the replacement of existing equipment, regardless of cost, which meets the criteria contained therein, shall not require an application but shall be processed pursuant to subparagraph (iii) of paragraph (4) of this subdivision;

Clause (b) of subparagraph (i) of paragraph (2) of subdivision (c) of Section 710.1 is amended as follows:

(b) any proposal for the addition, modification or change in the method of delivery of the following services, including the initial acquisition [or addition] of any equipment relating thereto, regardless of cost; [provided, however, that the addition of equipment utilized in the provision of the following services, except cardiac catheterization services, by a medical facility already approved to provide such service shall be eligible for administrative review pursuant to paragraph (3) of this subdivision;]

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(2) [open heart] adult or pediatric cardiac surgery;

(3) cardiac catheterization, including the relocation of any Cardiac Catheterization Laboratory Center service within a network or to another site in a multi-site facility, as defined in Section 401.1 of this Title, and the addition of a PCI Capable Cardiac Catheterization Laboratory Center at a facility that is not already approved to provide cardiac catheterization services; provided however that the addition of a PCI Capable Cardiac Catheterization Laboratory Center or Cardiac EP Laboratory Program at a facility approved to provide cardiac catheterization services shall be reviewed pursuant to paragraph (3) of this subdivision, and the addition of a Cardiac EP Laboratory Program services at a facility approved to provide cardiac surgery shall be reviewed pursuant to paragraph (7) of this subdivision;

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A new subparagraph (ii) of paragraph (2) of subdivision (c) of Section 710.1 is added and existing subparagraph (ii) is renumbered (iii) as follows:

(ii) The addition of equipment utilized in the provision of a service set forth in subparagraph (i) of this paragraph by a medical facility already approved to provide such service shall be reviewed as follows:

(a) The addition of equipment utilized in the provision of Cardiac Catheterization Laboratory Center services shall be eligible for limited review pursuant to paragraph (7) of this subdivision, to the extent that it does not otherwise require an administrative or a full review under this Part;

(b) The addition of equipment utilized in the provision of all other services set forth in subparagraph (i) shall be eligible for administrative review pursuant to paragraph (3) of this subdivision, to the extent that it does not otherwise require a full review under this Part;

[(ii)] (iii) For any application subject to full review for which the total basic cost of construction does not exceed $10,000,000, the commissioner may, in lieu of requiring some or all of the architectural information and documentation required by this Part, accept a written certification by an architect or engineer licensed by the State of New York that such project complies with Part 711 of this Title. The certification shall be attached to and made a part of the application. The costs of any subsequent corrections necessary to achieve compliance with the requirements of Part 711 of this Title, when the prior work was not completed properly and was not accurately certified, shall not be considered allowable costs for reimbursement under Part 86 of this Title. This subparagraph does not waive any of the requirements of section 5-1.22 of this Title.

Clauses (f) and (l) of subparagraph (i) of paragraph (3) of subdivision (c) of Section 710.1 are amended to read as follows:

(3) Proposals eligible for administrative review.

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(f) in addition, updating or modification of equipment utilized in the provision of a service listed in paragraph (2) of this subdivision, by a medical facility already approved to provide such service, except for the addition of equipment utilized in cardiac catheterization laboratory center services by a facility already approved to provide such service, which shall be subject to limited review pursuant to paragraph (7) of this subdivision;

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(l) [reserved] the conversion of a Diagnostic Cardiac Catheterization Service as described in section 405.29(a)(4)(ii) of this Title into a PCI Capable Cardiac Catheterization Laboratory Center as described in section 405.29(a)(4)(i) of this Title; and the addition of Cardiac EP Laboratory Program services at a facility approved to provide Cardiac Catheterization Laboratory Center services that is not also approved to provide cardiac surgery services;

A new paragraph (7) of subdivision (c) of Section 710.1 is added, and existing paragraphs (7) and (8) are renumbered as (8) and (9), to read as follows:

(7) Cardiac Catheterization Proposals Requiring a Limited Review.

(i) The following proposals related to the expansion or modification of Cardiac Catheterization Laboratory Center services and equipment shall be subject to review pursuant to this paragraph, provided that they do not involve a total project cost in excess of the amount set forth in paragraph (5) of this subdivision or otherwise require a certificate of need under this Part:

(a) Any proposal to add or modify cardiac catheterization laboratories, facility areas or equipment to be utilized in the provision of approved Cardiac Catheterization Laboratory Center services by a facility already approved to provide PCI Capable Cardiac Catheterization Laboratory Center services;

(b) Any proposal to add or modify equipment in approved space by a facility already approved to provide Diagnostic Cardiac Catheterization Services; and

(c) Any proposal to add Cardiac EP Laboratory Program services at a facility that is already approved to provide cardiac surgery services.

(ii) (a) Reviews under this paragraph shall include, but not be limited to, the proposal’s compliance with applicable statutes, codes and rules and regulations relating to the structural, architectural, engineering, environmental, safety and sanitary requirements of licensed medical facilities and with Part 405.29 of this Title.

(b) Requests for approval of proposals described in this subparagraph shall be made directly to the Director of the Division of Health Facility Planning. The applicant shall submit three (3) copies of such request, including information indicating the services to be provided, the facility areas to be utilized, and such other information as the Department may require. If construction is required, the request should include the cost of such construction and other information required by the Bureau of Architectural and Engineering Facility Planning under this Part. If the proposal involves the addition of Cardiac EP Laboratory Program Services, the applicant shall also submit a copy to the local health systems agency (HSA) having jurisdiction, if any. The HSA shall have 10 days to make a recommendation to the department.

(c) If the proposal is acceptable to the department, the applicant will be notified in writing and, if appropriate, an amended operating certificate will be issued. If the proposal is not acceptable, the applicant shall be notified in writing of such determination and the basis thereof. If the applicant has not submitted an acceptable proposal within 30 days of such determination, then the proposal shall be deemed an application subject to full or administrative review pursuant to section 2802 of the Public Health Law.

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Text of proposed rule and any required statements and analyses may be obtained from:

Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, telephone: [phone], e-mail: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 days after publication of this notice.

Regulatory Impact Statement

Statutory Authority:

The authority for the proposed revision to Title 10 NYCRR Parts 710 is section 2803(2)(a) of the Public Health Law (PHL), which authorizes the State Hospital Review and Planning Council (SHRPC) to adopt and amend rules and regulations, subject to the approval of the Commissioner of Health, to effectuate the provisions and purposes of Article 28 of the PHL with respect to hospitals, including but not limited to, requirements for construction projects subject to Certificate of Need (CON) review.

Legislative Objectives:

Article 28 of the PHL authorizes Certificate of Need (CON) reviews to govern the construction of health care facilities and the addition of certain health care facility services and equipment. The mission of the CON process is to promote an accessible, high-quality, cost-effective health care delivery system. CON reviews of construction applications (including applications to add services or equipment) include consideration of public need, financial feasibility, current compliance of the operator, architecture and engineering standards and legal matters. The cost, impact, and complexity of the proposed project determine the level of review.

Current Requirements:

Recently, the Department proposed amendments to 10 NYCRR § 709.14, the need methodology for cardiac services and section 405.22, hospital minimum standards for cardiac services. The Department is seeking changes to those regulations to reflect the most recent advances in the provision of cardiac care. Proposed changes in Parts 405 and 709 include:

• Provisions requiring appropriate inter-hospital transfer protocols for acute myocardial infarction patients;

• New standards for health care facilities that have cardiac catheterization laboratories, but do not have cardiac surgery on site, that seek to perform Percutaneous Coronary Interventions (PCI);

• Prohibiting approval of new diagnostic-only cardiac catheterization laboratory centers;

• Establishing appropriate provider volumes associated with high quality care; avoiding unnecessary duplication of resources;

• Addressing geographic distribution of services.

Proposed amendments would also establish standards, and a formal CON review mechanism, for the provision of a new subspecialty in cardiac services, intra-cardiac electrophysiology (EP).

Proposed amendments to 710.1 are needed to conform to these changes and to ensure that CON levels of review for cardiac services are appropriate to promote access to high-quality cardiac services throughout the state. These proposed amendments would streamline the review process for CON applications to expand cardiac catheterization services, and/or to add EP services, at a previously approved cardiac catheterization site.

Need and Benefits:

The CON process is an effective health care planning tool that can help improve the distribution of health care resources, improve health care quality, and control health care spending. The proposed changes in CON regulations governing cardiac catheterization laboratory centers recognize the evolving nature of these services and the facilities that provide them. When regulations governing cardiac services were last updated, cardiac catheterization laboratories were primarily engaged in diagnostic procedures. Over the past decade, advances in cardiac services have greatly expanded the scope of cardiac catheterization services, and cardiac catheterization has become a widely-used intervention in treating coronary artery disease, as well as in the diagnosis of disease. PCI provides an alternative to more invasive cardiac interventions, and as a result, more PCIs are being performed each year, while cardiac surgeries are declining. Today, PCI is considered a life-saving intervention when performed in the early phases of a heart attack and can safely be performed in hospitals that do not offer cardiac surgery.

Further, as cardiac catheterization procedures have become increasingly interventional, the facility areas in which these procedures are performed have also evolved. Initially, cardiac catheterization procedures were largely performed in specialized procedure suites dedicated to catheterizations. Today, PCIs can be performed in the same cardiac lab visit as the angiogram, or diagnostic catheterization, or in operating rooms, as well as in “laboratories.” In addition, hybrid procedures that combine catheterization and open surgery in operating rooms are growing. Accordingly, it no longer makes sense to closely scrutinize the number of “laboratories” operated by a hospital. Rather, CON regulations should focus on the need for additional centers and the ability of applicants to meet the requisite quality and volume standards.

Further, existing CON regulations do not address cardiac electrophysiology (EP) services. EP identifies and treats life threatening conditions in the electrical system of the heart. EP is a catheter-based procedure performed in a specially equipped cardiac laboratory. Regulations are needed to ensure that these services are delivered by qualified providers in approved settings and that the Department has the necessary information to monitor utilization and quality at these facilities.

Proposed changes to 710.1 will align levels of CON review with advances in the delivery of cardiac services and with other proposed regulations governing quality of care of, and public need for, cardiac services.

COSTS:

Costs to the Department of Health:

The proposed amendment would impose no new costs on the Department. The Department does not expect a significant change in the number of CON applications as a result of these amendments. Hospitals currently performing PCIs without cardiac surgery on-site will be allowed to continue doing so without a CON application. In addition, demand for cardiac surgery, and accordingly, for cardiac surgery CON approvals, has dropped in recent years. However, facilities engaged in cardiac catheterization procedures are increasingly seeking to add EP. These amendments will clarify the process for obtaining such approvals. They will also streamline the process for existing cardiac catheterization laboratory centers to secure approval to expand their capacity.

Costs to Other State Agencies:

There are no costs to other State agencies or offices of State government.

Costs to Local Government:

There are no costs to local government.

Costs to Private Regulated Parties:

Because the proposed amendment imposes no new burdensome requirements, duties or responsibilities on any entity subject to Article 28 of the PHL, there are no costs to private regulated parties.

Local Government Mandates:

The proposed amendment does not impose any new programs, services, duties or responsibilities upon any county, city, town, village, school district, fire district or other special district.

Paperwork:

The proposed amendment imposes no new reporting requirements, forms or other paperwork. The amendment will actually reduce paperwork by requiring a less intensive review for certain projects.

Duplication:

There are no relevant State or Federal rules which duplicate, overlap or conflict with the proposed amendment.

Alternatives:

The Department discussed several options for the level of review that should be required for various cardiac catheterization services. The proposed regulations strike an appropriate balance between oversight of quality and safety and simplicity for regulated parties.

Federal Standards:

The proposed amendments do not exceed any minimum standards of the Federal government. There are no Federal rules currently addressing the CON process or state approval procedures for cardiac services.

Compliance Schedule:

The proposed amendment will be effective upon publication of a Notice of Adoption in the New York State Register. It is anticipated that the proposed amendment will be announced within one month of the effective date through the posting of an announcement on the Department of Health’s Internet site. There is no schedule of compliance for regulated parties, since the proposed amendment does not require providers to change their day-to-day practices, but rather affects their submission of CON applications and the processing of those applications by the Department.

Regulatory Flexibility Analysis

No regulatory flexibility analysis is required pursuant to section 202-(b)(3)(a) of the State Administrative Procedure Act. The proposed amendments does not impose an adverse economic impact on small businesses or local governments, and it does not impose reporting, record keeping or other compliance requirements on small businesses or local governments.

Rural Area Flexibility Analysis

No rural area flexibility analysis is required pursuant to section 202-bb(4)(a) of the State Administrative Procedure Act. The proposed amendment does not impose an adverse impact on facilities in rural areas, and it does not impose reporting, record keeping or other compliance requirements on facilities in rural areas.

Job Impact Statement

No Job Impact Statement is required pursuant to section 201 a(2)(a) of the State Administrative Procedure Act. It is apparent, from the nature of the proposed amendment, that it will not have a substantial adverse impact on jobs and employment opportunities.