Proposed Regulations
NEW YORK STATE DEPARTMENT OF HEALTH
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Proposed Rule Making:
Amendment of Sections 405.6, 405.7, 405.19, 708.5 of Title 10 NYCRR
(Hospital Minimum Standards and Appropriateness Review)


Publication Date: 09/29/2010Comment Period Expiration: 11/15/2010
Proposed Text and Statements:

Pursuant to the authority vested in the State Hospital Review and Planning Council by section 2803(2)(a) of the Public Health Law, Part 405 of Subchapter C, of Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York is hereby amended as hereinafter indicated to be effective upon publication of the Notice of Adoption in the New York State Register.

Subparagraph (iii) and (iv) of paragraph (7) of subdivision (b) of Section 405.6 is amended to read as follows:
(iii) prior to granting or renewing privileges or association to any physician, dentist, or podiatrist, or hiring a physician, dentist or podiatrist, the hospital shall request from
:
(a) any hospital with or at which such physician, dentist or podiatrist, has or had privileges, was associated or was employed during at least the preceding [10 ] 5 years the following information concerning the physician, dentist or podiatrist: (b) the National Practitioner Data Bank or any successor database, any information available concerning:
(1) payments for the benefit of the physician, dentist or podiatrist in settlement of, or in satisfaction of, in whole or in part, a claim or a judgment against such physician, dentist or podiatrist for medical malpractice;

(2) licensure actions by any medical or professional board relating to the physician, dentist, or podiatrist;

(3) adverse actions affecting clinical privileges of the physician, dentist or podiatrist; and

(4) other actions or information relevant to the professional competence and conduct of the physician, dentist or podiatrist.

(iv) The provision by the hospital, within 45 days, in response to requests from any other hospital or facility performing credentials review for medical staff appointment or reappointment, of information related to the physician's, dentist's or podiatrist's professional practice within the facility for at least [ten] 5 years;

Paragraph (2) of subdivision (b) of Section 405.7 is amended to read as follows:
(2) treatment without discrimination as to race, color, religion, sex, national origin, disability, sexual orientation, age, or source of payment;
Paragraph (2) of subdivision (c) of section 405.7 is amended to read as follows:

(2) Receive treatment without discrimination as to race, color, religion, sex, national origin, disability, sexual orientation, age, or source of payment.

Subparagraph (ii) of paragraph (1) of subdivision (d) of section 405.19 is amended to read as follows:

(ii) There shall be at least one emergency service attending physician on duty 24 hours a day, seven days a week. For hospitals that exceed 15,000 unscheduled visits annually the attending physician shall be present and available to provide patient care and supervision in the emergency service. As necessitated by patient care needs, additional attending physicians shall be present and available to provide patient care and supervision. Appropriate subspecialty availability as demanded by the case mix shall be provided promptly in accordance with patient needs. For hospitals with less than 15,000 unscheduled emergency visits per year, the supervising or an attending physician need not be present but shall be available within [twenty] thirty minutes, provided that at least one physician, nurse practitioner, or registered physician assistant shall be on duty in the emergency service 24 hours a day, seven days a week.

Paragraph (4) of section 708.5 is amended to read as follows:

(4) The following standards shall apply to emergency services

(i) A person presenting to the emergency service for emergency care shall be promptly seen by a physician (or a nurse practitioner or a physician's assistant operating under the direction of the emergency services physician director), or evaluated by a registered nurse and seen by a physician, nurse practitioner, or physician's assistant prior to discharge.
* * *
(iii) At least one physician, nurse practitioner, or [a] registered physician assistant shall be on duty in the emergency service 24 hours a day, seven days a week. In addition, a licensed physician shall be available within [20] 30 minutes, when a registered physician assistant or nurse practitioner is on duty in the absence of a licensed physician.


Regulatory Impact Statement

Statutory Authority:
The authority for the proposed revision to Title 10 NYCRR Part 405 is section 2803 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 minimum standards for hospitals.

Legislative Objectives:
This package of amendments is part of an effort, in conjunction with Executive Order 25, to update hospital regulations that have become obsolete, that may have the unintended result of limiting access to services, or that impose substantial burdens without providing a material benefit in terms of patient safety, quality or integrity. Executive Order 25 charged agencies with identifying rules and regulations that impose unnecessary, burdensome or excessive costs, paperwork, reporting or other requirements. Hospital industry representatives recommended amendments to various regulations. As an initial response to those recommendations, three amendments are proposed: (1) decreasing the look-back period associated with credentialing and privileging health care providers; and (2) extending the physician coverage response time for rural emergency departments. In addition, the Department proposes to add ‘age’ to the types of prohibited discrimination under the New York Patient Bill of Rights, as required by recently enacted legislation.

Current Requirements:
The existing regulations governing credentialing, patients’ rights, and physician coverage in emergency departments are:

Credentialing and Privileging:
The Department’s regulations at section 405.6 require hospitals to request, with respect to each physician, dentist or podiatrist seeking privileges, from each hospital at which he or she was employed in the previous ten (10) years (known as the “look-back period”) any: (1) pending professional misconduct or malpractice proceedings; (2) judgments, settlements or findings related to malpractice or professional misconduct; and (3) reports to the Office of Professional Medical Conduct concerning impairment, misconduct, voluntary resignation or withdrawal of privileges to avoid disciplinary measures, or criminal convictions.

Patients’ Rights:
Current regulations prohibit hospitals from discriminating against patients on the basis of race, color, religion, sex, national origin, disability, sexual orientation, or source of payment. Discrimination based on age is not specifically prohibited.

Physician Coverage in Emergency Departments:
State regulations at 405.19 allow hospitals with less than 15,000 emergency department visits a year to staff their emergency departments with a supervising or attending physician who is not present, but is available within 20 minutes, provided that a nurse practitioner or physician assistant is on site.

Needs and Benefits:
State regulations governing hospitals should safeguard and promote patient safety, while also allowing hospitals to operate efficiently and maintain access to services. The health care environment is evolving, federal regulations are changing, and electronic information systems have made certain requirements outdated. The Department’s goal is to keep pace with the health care environment, while assuring patient safety and quality of care.

Credentialing and Privileging:
When the existing regulation was first promulgated, it was deemed necessary to verify a practitioner’s 10-year history through the hospitals with which the practitioner had been affiliated. Today, with the establishment of the National Practitioner Data Bank (NPDB), the requirement to seek a practitioner’s 10-year history via communications with other hospitals imposes a significant burden without providing a concomitant benefit.

The requirement to request information from each hospital with which a practitioner has been affiliated in the past 10 years is particularly onerous for hospitals in areas with physician shortages. Such hospitals rely on professional service vendors to provide physician coverage. Physicians retained through such venders typically work as contracted professionals at multiple facilities, making it necessary for hospitals to seek credentialing information from all such facilities. As a result, individual hospitals retaining contract physicians must employ staff to conduct the ten (10) year look-back reviews for both hospital staff and contractors with multiple hospital affiliations.

The NPDB provides hospitals seeking to verify the professional history of a practitioner with a great deal of information, thereby reducing the information needed from the hospitals at which a practitioner previously practiced. The NPDB started in 1990 and tracks adverse actions against physicians that involve licenses, clinical privileges, professional society memberships and exclusions from participation in Medicare and Medicaid. However, the NPDB does not include information regarding pending privilege, misconduct, or malpractice actions. Thus, certain inquiries of hospitals with which a practitioner has been affiliated continue to be needed.

The Department maintains that it is reasonable to expect hospitals to query the NPDB concerning practitioners seeking privileges. It is also reasonable to expect hospitals to seek information from hospitals with which a practitioner was affiliated in the previous five years. However, requiring the solicitation from other hospitals of information that is more than 5 years old is burdensome and no longer provides a significant added benefit, given the availability of information from the National Practitioner Data Bank. The Department proposes amending regulations to require a five (5) year look-back period to require hospitals to gather more current information not available through the NPDB, while reducing the administrative burden posed by a ten (10) year look-back period.

Patients’ Rights:
Chapter 515 of the Laws of 2008 expands the New York Patients’ Bill of Rights to prohibit discrimination based on age, in addition to existing prohibitions related to race, color, religion, sex, national origin, disability, sexual orientation and source of payment. This regulation would not supersede any existing statute or constitutional provision or (case law based on such statute or constitutional provision) that provides a basis for different treatment based on age (e.g. age of consent for certain services by minors). Nor would this regulation prohibit the use of pediatric wings or NICUs -- it should not interfere with clinical decisions about the appropriate setting for hospital services or the appropriate treatment based on age. The proposed amendment to the regulations is required to comply with the statute

Physician Coverage in the Emergency Department:
Providing health care in rural areas continues to be a challenge due to health professional shortages. The Department’s regulations governing emergency department staffing recognize this challenge by allowing, in hospitals with less than 15,000 emergency department visits annually, nurse practitioners and physician assistants to cover the emergency department, provided that a physician can respond within 20-minutes if necessary. The 20-minute time frame is difficult for rural hospitals to meet. Extending the physician coverage time for hospitals with less than 15,000 emergency department visits to thirty (30) minutes affords rural hospitals the flexibility they may need to keep their emergency departments accessible, when they cannot meet the current coverage requirements. It is also an opportunity to align state regulations with federal requirements governing Critical Access Hospitals (CAHs) which is thirty (30) minutes.

We propose amending the regulation to extend the response time to 30 minutes, provided that a nurse practitioner or physician assistant is present in the emergency department.

COSTS
Costs to the Department of Health:
The proposed amendment would impose no new costs on the Department.

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 requirements, duties or responsibilities on any entity subject to Article 28 of the PHL, they do not result in cost increases for 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 legislation amending the Patients’ Bill of Rights required hospitals to print new Patients’ Bill of Rights posters and paperwork because ‘age’ was not included in the previous version. The other proposed amendments impose no new reporting requirements, forms or other paperwork.

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

Alternatives:
The Healthcare Association of New York State (HANYS) is recommending that the state accept the credentialing review conducted by physician staffing organizations in lieu of credentialing by Article 28 facilities. Greater New York Hospital Association (GNYHA) is recommending that the state decrease to five years the look-back period for privilege inquiries solicited from hospitals and increase reliance on the NPDB. The Department solicited input from the New York State Association of Medical Staff Services (NYSAMSS), a non-profit member association of medical staff professionals. NYSAMSS also suggested that a five (5) year look-back period for privilege inquiries solicited from hospitals is more appropriate, given the availability of the NPDB.

The Department determined that a 5-year look-back period for contacting hospitals, together with queries of the NPDB, is appropriate to gain relevant information that contributes to the credentialing review.

HANYS also requested that hospitals meet the requirement for physician coverage in Emergency Departments through the use of telemedicine. The Department has granted one waiver to Margaretville Hospital to allow the use of telemedicine in lieu of on-site physician coverage. The Department will monitor Margaretville’s experience and determine at the end of the waiver period whether allowing broader use of telemedicine in lieu of on-site physician coverage would be appropriate.

Federal Standards:
The proposed amendment does not exceed any minimum standards of the federal government. One of the proposed amendments seeks to align state regulations with federal requirements

Compliance Schedule:
The proposed amendment will be effective immediately after publication of a Notice of Adoption in the New York State Register. A compliance schedule is not needed as the regulations do not impose any new requirements on regulated entities.

Contact Person: Katherine Ceroalo
New York State Department of Health
Bureau of House Counsel, Regulatory Affairs Unit
Corning Tower Building, Rm 2438
Empire State Plaza
Albany, New York 12237
(518) 473-7488
(518) 473-2019 (FAX)
REGSQNA@health.state.ny.us
REGULATORY FLEXIBILITY ANALYSIS

No regulatory flexibility analysis is required pursuant to section 202-(b)(3)(a) of the State Administrative Procedure Act. The proposed amendment 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.


STATEMENT IN LIEU OF
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. The proposed amendment to extend physician coverage time seeks to maintain access to health care in rural areas.


STATEMENT IN LIEU OF
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 an adverse impact on jobs and employment opportunities.