HLT-30-09-00021-P Cardiac Services Need Methodology

7/29/09 N.Y. St. Reg. HLT-30-09-00021-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-30-09-00021-P

Cardiac Services Need Methodology

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

Proposed Action:

Amendment of section 709.14 of Title 10 NYCRR.

Statutory authority:

Public Health Law, sections 2800 and 2803

Subject:

Cardiac services need methodology.

Purpose:

To update the need methodology to reflect current practice.

Summary of proposed rule (Full text is posted at the following State website: www.health.state.ny.us):

This amendment to Title 10 of the Official Code of Rules and Regulations of the State of New York Section 709.14, which amends subdivisions (a) and (b), repeals Subdivisions (c) and (d) and replaces Subdivisions (c) and (d) with new subdivisions (c) and (d), updates the planning and need methodology for cardiac surgery and provides methodologies for determining need for PCI Capable Cardiac Catheterization Laboratory Centers, Cardiac Electrophysiology (EP) Laboratory Programs and Pediatric Cardiac Catheterization Laboratory Centers.

Section 709.14(a) is amended by updating terminology and adding a reference to percutaneous coronary interventions (PCI) in the statement of intent.

Section 709.14(b) - relating to Cardiac Surgery Centers is amended as follows:

• Section 709.14(b)(3) retains the existing need methodology and adds a requirement that annual volume projections include a projected annual volume of at least 300 PCI cases within two years of approval for facilities proposing to initiate an Adult Cardiac Surgery Center. (Cardiac Surgery Centers will be approved to provide Cardiac Surgery Center and PCI Capable Cardiac Catheterization Laboratory Center services as per 709.14(b)(9)).

• Section 709.14(b)(4) changes the Pediatric Cardiac Surgery Center services projected annual volume requirement from 100 to 200 pediatric cardiac surgical procedures per year. A provision is also added allowing for a facility demonstrating the ability to perform 50 cases a year and operate as part of a coordinated program with another pediatric Cardiac Surgery Center to be considered for approval.

• Section 709.14(b)(5)(ii) updates standards for Hospital Based Prevention Programs to reflect more recent thinking in Public Health, focuses efforts on inpatients with a principal diagnosis of ischemic heart disease, reduces tracking and follow up requirements, and retains the philosophy that hospitals approved to provide cardiac services carry a responsibility for stewardship in the area of prevention. Requirements include: treatment plans that include risk factor assessment and education for cardiac patients, professional education, heart health promotion and an administrative team.

• Section 709.14(b)(9) specifies that all hospitals approved as adult Cardiac Surgery Centers shall be approved as PCI Capable Cardiac Laboratory Centers and must meet the standards at 405.29(c), 405.29(e)(1) and 405.29(e)(2) of this Title and specifies that all hospitals approved as Pediatric Cardiac Surgery Centers shall be approved as Pediatric Cardiac Catheterization Laboratory Centers and must meet the standards at 405.29(c), 405.29(e)(1) and 405.29(e)(4) of this Title.

Subdivision (c) of Section 709.14 is repealed and a new 709.14(c) is added to provide a definition for Cardiac Catheterization Laboratory Centers and the categories of Cardiac Catheterization Laboratory Centers, including PCI Capable Cardiac Catheterization Laboratory Centers, Cardiac EP Laboratory Programs and Pediatric Cardiac Catheterization Laboratory Centers by referencing definitions in 405.29(a).

Subdivision (d) of Section 709.14 is repealed and a new 709.14(d) is added to provide a need methodology for Cardiac Catheterization Laboratory Centers.

• Section 709.14(d)(1)(i) specifies that applicants approved as Cardiac Surgery Centers are approved PCI Capable Cardiac Catheterization Laboratory Centers.

• Section 709.14(d)(1)(ii) provides the methodology to be used in determining need for PCI Capable Cardiac Catheterization Laboratory Centers at hospitals with no cardiac surgery on-site. Factors for determining need include:

o Evidence that existing centers cannot meet the needs of patients in need of emergency PCI due to conditions such as capacity, geography and or EMS limitations.

o Defines the planning area as the area within 1 hour average surface travel time of the applicant institution.

o Applicants must demonstrate the ability to provide high quality appropriate care with a minimum of 36 emergency PCI cases within the first year of operation and 200 cases within two years of start up and must demonstrate the ability to comply with standards at Section 405.29. Documentation in support of volume projections must include: discharge data indicating the number of patients with a diagnosis of acute MI and or other diagnoses associated with PCI, the number of doses of thrombolytic therapy ordered for acute MI patient in the applicant hospital’s emergency department, and documentation of transfers to existing PCI Capable Cardiac Catheterization Laboratory Centers for PCI. Additional factors that may be considered are enumerated and include a provision specifying volume considerations for a Cardiac Catheterization Laboratory Center that is co-operated with an approved Cardiac Surgery Center.

o Applicants must demonstrate that the addition of the proposed program will not jeopardize the ability of existing centers to continue to meet minimum volume and quality expectations and that one of the following conditions exists: the applicant is greater than on hour from existing PCI sites or all existing PCI centers within an hour of the applicant perform at least 300 cases a year and are expected to continue to perform at that level after the addition of the proposed program.

o The applicant must submit a plan regarding initiatives in the area of access, outreach and continuity of care.

o A written, signed affiliation agreement with a New York State Cardiac Surgery Center is required in accordance with Section 405.29.

• Section 709.14(d)(2) provides the methodology to be used in determining need for Cardiac EP Laboratory Programs. Factors include:

o Applicant must be an approved PCI Capable Cardiac Catheterization Laboratory Center, an approved Diagnostic Cardiac Catheterization Laboratory Center, or be applying for EP in conjunction with an application to become a PCI center.

o Applicant must demonstrate ability to comply with standards at Section 405.29(e)(5) of this Title.

o Documentation of exiting referrals for cardiac electrophysiology patients treated by cardiologists on staff at the hospital must be submitted.

o Applicants from hospitals with no cardiac surgery on-site must submit a copy of the patient selection criteria.

o Hospitals approved as Cardiac Surgery Centers shall be deemed to have demonstrated public need for a Cardiac EP Laboratory Program.

• Section 709.14(d)(3) specifies that need for a Pediatric Cardiac Catheterization Laboratory Center shall be determined only in conjunction with an application for a Pediatric Cardiac Surgery Center.

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, [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 promulgation of these regulations is contained in Sections 2800 and 2803 (2). PHL Article 28 (Hospitals), Section 2800 specifies that “Hospital and related services including health-related service of the highest quality, efficiently provided and properly utilized at a reasonable cost, are of vital concern to the public health. In order to provide for the protection and promotion of the health of the inhabitants of the state, pursuant to section three of article seventeen of the constitution, the Department of Health shall have the central, comprehensive responsibility for the development and administration of the state’s policy with respect to hospital and related services, and all public and private institutions, whether state, county, municipal, incorporated or not incorporated, serving principally as facilities for the prevention, diagnosis or treatment of human disease, pain, injury, deformity or physical condition or for the rendering of health-related service shall be subject to the provisions of this article.”

PHL Section 2803 (2) authorizes the State Hospital Review and Planning Council (SHRPC) to adopt and amend rules and regulations, subject to the approval of the Commissioner, to implement the purposes and provisions of PHL Article 28, and to establish minimum standards governing the operation of health care facilities.

Legislative Objectives:

The legislative objective of PHL Article 28 includes the protection and promotion of the health of the residents of the State by requiring the efficient provision and proper utilization of health services, of the highest quality at a reasonable cost.

Needs and Benefits:

Title 10 Health Codes Rules and Regulations (10 NYCRR) Section 709.14 provides standards to be used in evaluating certificate of need (CON) applications for cardiac catheterization laboratory and cardiac surgery services in NYS hospitals. When used in conjunction with 10 NYCRR Section 709.1 they are intended as a set of planning principles and decision making tools for directing the distribution of these services, with a goal of ensuring appropriate access to high quality services while avoiding the unnecessary duplication of resources.

Section 709.14 was last updated in January 1994. The many changes and advancements in the provision of cardiac care that have taken place since adoption and last amendment of these regulations have rendered them outdated and incomplete.

Currently, the most widely used procedural intervention for the treatment of coronary artery disease is Percutaneous Coronary Interventions (PCI); also commonly referred to as angioplasty or stenting. When the existing need regulations were developed, PCI was still a relatively new procedure, provided ONLY in the setting of a Cardiac Surgery Center. As such, approval to perform the procedure was considered part-and-parcel of the cardiac surgery need methodology, and no PCI specific standards were set forth in regulation.

Changes in cardiac care over the years also include recognition of the life saving capability of rapid PCI for patients in the early phases of a heart attack, and recognition that under carefully controlled circumstances, the procedure can be performed in facilities with no cardiac surgery on site (SOS). In addition, performing PCI in conjunction with a diagnostic catheterization (thereby saving a second catheterization lab procedure for patients identified with significant pathologies) is now relatively routine in PCI capable hospitals.

Similarly, intra-cardiac electrophysiology (EP) is a growing subspecialty in cardiology. EP procedures are now used to effectively identify and treat life threatening conditions in the electrical system of the heart such as rapid heart beat. They require a highly specialized team of clinicians. In 2006, approximately 14,200 diagnostic EPs, 9,000 Implantable Cardiac Defibrillator (ICD) procedures and 6,800 ablations were reported in EP labs across the state. While we have developed some guidelines over the years regarding minimum criteria for the provision of EP, there are currently no regulations governing the EP procedures.

These regulations, when enacted, will allow non-SOS cardiac laboratory hospitals that meet specific criteria to perform PCI. The number of hospitals initially involved in this change would be relatively small. As of June, 2007, there were 40 hospitals approved through the Certificate of Need (CON) process to perform diagnostic only cardiac catheterization. Twelve of those hospitals have waivers to perform PCI with no SOS.

The proposed regulatory changes will supersede existing guidelines and, once enacted, will provide a formal CON review mechanism.

Costs for the Implementation of and Continuing Compliance with these Regulations to the Regulated Entity:

It is a voluntary choice for hospitals to provide these cardiac services and not a mandate. There are approximately 55 hospitals that are currently PCI Capable Cardiac Catheterization Laboratory Centers out of 228 hospitals.

The cost of implementation and compliance of these regulations is expected to be minimal for the affected entities already caring for these patients. Other companion regulations are being updated to reflect medical standards of care. Hospitals that choose to provide such services will need to adhere to the standards in the companion regulations (the medical standard of care), and may incur costs to upgrade their services. Hospitals approved as PCI Capable Cardiac Catheterization Laboratory Centers will be required to provide emergency PCI on a 24-hour, 7 day a week, 365 days a year basis. Hospitals approved as PCI Capable Cardiac Catheterization Laboratory Centers and hospitals approved as Cardiac Surgery Centers will be required to provide data to the Cardiac Reporting System as those who already provide this care do now.

Cost to State and Local Government:

Any hospital in New York State that is part of State or local government that chooses to provide cardiac services will need to comply with these provisions. Costs for these hospitals will be the same as for any hospital providing these services in New York State.

Cost to the Department of Health:

The Department of Health will need to monitor and provide surveillance and oversight for the system of care provided to these patients. It is not expected to incur any additional costs, as existing staff will be utilized to conduct such surveillance and oversight.

Local Government Mandates:

None.

Paperwork:

Hospitals seeking to provide Cardiac Catheterization Laboratory Center Services with no Cardiac surgery onsite will be required to maintain an affiliation agreement with an existing Cardiac Surgery Center. Cardiac Surgery and Cardiac Catheterization Laboratory Centers will continue to be required to report data to the Department. Amendments to Section 709.14(b)(5)(ii) would reduce the work required for hospital based heart disease prevention programs by deleting portions of regulations that require follow-up and tracking of prevention services, particularly for outpatients.

Duplication:

This regulation does not duplicate any other state or federal law or regulation.

Alternative Approaches:

The Department considered maintaining the current policy that limits PCI to approved Cardiac Surgery Centers. In order to facilitate access to timely PCI procedures, requirements will be implemented that allow PCI at non-surgery centers where the volume and standards associated with high quality care can be maintained.

Federal Requirements:

This regulatory amendment does not exceed any minimum standards of the federal government for the same or similar subject areas.

Compliance Schedule:

This proposal will go into effect upon a Notice of Adoption in the New York State Register.

Regulatory Flexibility Analysis

Effect of Rule:

Any facility defined as a general hospital pursuant to PHL Section 2801 (10) will be required to comply. Small businesses (defined as 100 employees or less), independently owned and operated, affected by this rule will include 3 hospitals.

Compliance Requirements:

The hospitals that are considered a small business will be required to have written transfer agreements in place with hospitals that will be receiving cardiac patients and also with emergency medical services to transport these patients to the appropriate facility for definitive care in a timely and appropriate manner.

Professional Services:

None.

Compliance Costs:

None.

Economic and Technological Feasibility:

This proposal is economically and technically feasible.

Minimizing Adverse Impact:

There is no adverse impact.

Small Business and Local Government Participation:

Outreach to the affected parties is being conducted. Organizations who represent the affected parties and the public can obtain the agenda of the Codes and Regulations Committee of the State Hospital Review and Planning Council (SHRPC) and a copy of the proposed regulation on the Department’s website. The public, including any affected party, is invited to comment during the Codes and Regulations Committee meeting.

Rural Area Flexibility Analysis

Types and Estimated Numbers of Rural Areas:

Rural areas are defined as counties with a population of less than 200,000 and, for counties with a population greater than 200,000, includes towns with population densities of 150 persons or less per square mile. All rural areas will be affected by this rule.

The following 43 counties have a population less than 200,000.

Allegany	Hamilton	Schenectady
Cattaraugus	Herkimer	Schoharie
Cayuga	Jefferson	Schuyler
Chautauqua	Lewis	Seneca
Chemung	Livingston	Steuben
Chenango	Madison	Sullivan
Clinton	Montgomery	Tioga
Columbia	Ontario	Tompkins
Cortland	Orleans	Ulster
Delaware	Oswego	Warren
Essex	Otsego	Washington
Franklin	Putnam	Wayne
Fulton	Rensselaer	Wyoming
Genesee	St. Lawrence	Yates
Greene

The following 10 counties have certain townships with population densities of 150 persons or less per square mile:

Albany	Erie	Oneida
Broome	Monroe	Onondaga
Dutchess	Niagara	Orange
		Saratoga

Reporting, Recordkeeping and Other Compliance Requirements; and Professional Services:

None.

Costs:

None.

Minimizing Adverse Impact:

This regulation is designed to minimize adverse impact on patients living in rural areas by improving timely access to appropriate care.

Rural Area Participation:

Outreach to the affected parities is being conducted. They include general hospitals, county health departments and emergency medical services. Organizations who represent the affected parties and the public can obtain the agenda of the Codes and Regulations Committee of the State Hospital Review and Planning Council (SHRPC) and a copy of the proposed regulation on the Department’s website. The public, including any affected party, is invited to comment during the Codes and Regulations Committee meeting.

Job Impact Statement

Nature of Impact:

This rule is not expected to have a significant impact on jobs and employment opportunities. The intent is to promote effective and appropriate care for acute myocardial infarction patients. It is also intended to clarify standards for appropriately credentialed staff who provide services to cardiac patients. This proposal is necessary to update the current provisions to address medical standards of care. Most facilities already have appropriate staff to meet these requirements.

The 24-hour cardiac team availability requirements may require some hospitals to increase staff if they are seeking approval to perform PCI. It is not mandatory that all hospitals perform PCI.

Categories and Numbers of Jobs and Employment Opportunities Affected:

This proposal is not expected to have any significant impact on jobs and employment activities.

Regions of Adverse Impact:

This rule will not impose a disproportionate or adverse impact on jobs and employment opportunities in any region in the State.

Minimizing Adverse Impact:

There is no adverse impact.