Department of Health

Title 10 NYCRR - Five Year Review

Pursuant to the State Administrative Procedure Act Sections 207 and 202-d, the Department of Health invites public comment on the continuation or modification of the following rules. Public comment should be submitted to Katherine Ceroalo, Bureau of House Counsel, Regulatory Affairs Unit, Corning Tower, Room 2438, Empire State Plaza, Albany, NY 12237.

Amendment of Part 11 of Title 10 NYCRR - Qualifications of Local Health Personnel

Statutory Authority:

Public Health Law Sections 225(4) and (5) and 206(1)(9)(a)

Description of the regulation:

Part 11 of the State Sanitary Code provides job descriptions and minimum qualifications for public health personnel working in county and city health departments. Changes made to the Part 11 in 2008 include:

• Revised job descriptions and/or minimum qualifications for the following titles:

- Commissioner of Health

- Public Health Director

- Local Health Officer

- Public Health Nurse 1

- Public Health Nurse 2

- Supervising Public Health Nurse

- Environmental Health Director

- Public Health Engineer

- Public Health Sanitarian

- Supervising Public Health Sanitarian

- Public Health Technician

- Public Health Nutritionist

- Supervising Public Health Nutritionist

- Public Health Educator

- Supervising Public Health Educator

- Public Health Social Worker

- Public Health Epidemiologist

- Supervising Public Health Epidemiologist

• New requirements for those newly hired in Public Health Nurse 2, Supervising Public Health Nurse and Local Public Health Educator titles to complete 15 hours of continuing education within their first year of employment.

• An extension from one year to two years after appointment, in which Public Health Sanitarians must complete a continuing education training program.

• For conditional appointments made to positions of Commissioner of Health and Public Health Director for up to four years contingent on a public health education or experience plan developed in conjunction with and approved by the New York State Commissioner of Health.

The regulation should continue without modification.

Amendment of Section 66-1.2 of Part 66 of Title 10 NYCRR - Immunization Registry

Statutory Authority:

Public Health Law Section 2168

Description of the regulation:

These regulations need to be updated to be consistent with changes enacted to the PHL. The regulations will codify Advisory Committee on Immunization Practice recommendations and incorporate by reference the recommended vaccination schedule, as well as the catch-up schedule. Language will also be added to clarify medical exemptions, acceptable serology, what it means to be "in process", annual school immunization survey requirements, and change physician diagnosis standards for measles and mumps to reflect the rarity of these diseases. The regulations will also seek to establish time limits for completion of needed immunizations.

Amendment of Sections 86-1.55, 86-1.62 and 86-1.63 of Title 10 NYCRR - DRGs, SIWs, Trimpoints and the Mean LOS

Statutory Authority:

Public Health Law Sections 2803(2), 2807(3), 2807-c(3) and (4)

Description of the regulation:

These represented the annual update of SIWs, DRGs and Length of Stays required under the statute. These regulations were repealed effective 12/1/2009 with the implementation of the new reform regulations.

Addition of new section 86-2.38 of Title 10 NYCRR - Rate Enhancement/Pay for Performance

Statutory Authority:

Public Health Law Section 2808(22)

Description of the regulation:

The nursing home incentive payments regulation provides for additional payments to nursing homes (in the form of a rate enhancement) that exceed defined quality standards. One set of awards was for (1) the best overall performers during the evaluation period (calendar year 2007) and (2) best improvement in performance in pressure ulcer care (comparison of performance from July 1, 2006-June 30, 2007 to performance from July 2007, June 2008). A nursing home could receive an award in both categories. Nursing homes that received a deficiency for substandard quality of care or were in the bottom quarter percentile of all eligible nursing homes during the periods under review were not eligible for these incentives. The regulation should continue without modification.

Addition of new Subpart 86-8 to Title 10 NYCRR - APGs Outpatient Reimbursement

Statutory Authority:

Public Health Law Section 2807(2)(a)

Description of the regulation:

Established regulations for the new APG reimbursement system effective 12/1/2008 forward. The regulation should continue without modification.

Addition of new Subpart 86-9 to Title 10 NYCRR - Limited Home Care Services Agencies

Statutory Authority:

Public Health Law Sections 2803, 2807, 2808

Description of the regulation:

The regulation enables licensed adult home and enriched housing program operators under contract to local departments of social services (LDSS) to be reimbursed by the New York State Medical Assistance (MA) program for providing specified home care services to eligible persons under Title XIX of the Social Security Act. The services that may be provided for which the operator may be reimbursed by MA are personal care services, the administration of medications, and the application of sterile dressings by a registered nurse. The regulation should continue without modification.

Amendments to Sections 98-2.2, 98-2.6 and 98-2.10 of Subpart 98-2 of Title 10 NYCRR -

External Appeals of Adverse Determinations

Statutory Authority:

Public Health Law Sections 4910 - 4916

Description of the regulation:

Subpart 98-2 codifies requirements and responsibilities for health plans and certified external appeal agents to afford enrollees and providers independent external review of health plan determinations that a requested service was not medical necessary. Section 98-2.2 provides definitions for certain words and terms used in this Subpart. Section 98-2.6 describes certified external appeal agents' prohibited material affiliations and conflicts of interest. Section 98-2.10 describes the responsibilities of certified external appeal agents to process external appeal requests.

The Subpart continues to be required to affect the external appeal process in conjunction with Department of Health responsibilities under Public Health Law and the Department of Financial Services responsibilities under Insurance Law Article 49. The entire Subpart requires revision in various paragraphs to reflect changes to Article 49 of the Public Health Law made by Chapter 237 of the Laws of 2009, Chapter 451 of the Laws of 2007, Chapter 219 of the Laws of 2011 and the Patient Protection and Affordable Care Act (PPACA). Section 98-2.10 currently contains provisions and timeframes that have been changed by Chapter 219 of the Laws of 2011. These revisions are to be promulgated in conjunction with revisions to Department of Financial Services regulations at 11 NYCRR 410.

Amendment of Section 415.13, addition of subdivision 415.2(u) and addition of subdivision 415.26(k) to Title 10 - Feeding Assistants in Nursing Homes

Statutory Authority:

Public Health Law Sections 2800 and 2803

Description of the regulation:

This regulation amends § 415.13 (c) (1) to exclude feeding assistants from the definition of nurse aide. The addition of subdivision (d) to § 415.13 (which is referenced in subdivision [u] of Section 415.2) defines the term "feeding assistant" and sets forth the circumstances under which a feeding assistant may be used, consistent with federal requirements. Subdivision (k) of § 415.26 describes the feeding assistant training course that feeding assistants are required to complete pursuant to paragraph (2) of subdivision (d) of § 415.13 and 42 CFR § 483.35 (h) (i). The training course requires a minimum of 15 hours (as opposed to the federally-required minimum of eight hours) of training for feeding assistants and includes all federally-required topics. This regulation should continue without modification.

Amendment of Sections 763.12, 766.10 and 766.12 of Title 10 NYCRR - Licensed Home Care Services Agency Reporting

Statutory Authority:

Public Health Law Sections 3612(3) and (6)

Description of the regulation:

This regulation implements the provisions of Public Health Law (PHL) § § 3612 (3) and (6). Under § 763.12 and § 766.12, certified home health care agencies (CHHAs) and licensed home care services agencies (LHCSAs) are required to submit annual reports that must include reports on the type, frequency and reimbursement for services provided, including reimbursement from federal and state agencies. Subdivision (c) of § 763.12 requires CHHAs to provide all information necessary to any LHCSA that subcontracts with the CHHA to allow the LHCSA to file its annual report. Subdivision (h) of § 766.10 establishes a cap on administrative and general costs for LHCSAs equal to the cap or administrative and general costs applied to CHHAs, in accordance with subdivision seven of PHL § 3614. The regulation should continue without modification.

Addition of a new Part 910, amendment of existing sections 85.21 & 85.22, repeal of existing sections 85.23 & 85.25, & amendment of Part 80 of Title 10 NYCRR, amendment of existing section 505.3 & repeal of existing sections 528.1 & 528.2 of Title 18 NYCRR - Enactment of a Serialized New York State Prescription Form

Statutory Authority:

Public Health Law Sections 206 and 3308(2)

Description of the regulation:

Public Health Law Section 21 defined the use of the Official New York State Prescription Form as it applies to all medications issued by New York State licensed practitioners authorized to issue such prescriptions and institutional dispensers. The corresponding new Part 910 established definitions, minimum standards for registration to utilize the forms, a system for ordering and tracking the serialized forms, safeguards and storage of the forms by registered practitioners and institutional dispensers, and dispensing upon prescription forms. Because this regulation provides parameters for combating fraud and diversion of controlled substances through the Official New York Prescription Program, continuance of this regulation is warranted. The Official Prescription Program is still in effect and operating efficiently under the support of these regulations and should be retained. The regulation should continue without modification.

Addition of new Part 1001 within Title 10 NYCRR - Assisted Living Residences

Statutory Authority:

Public Health Law Section 4662(1)

Description of the regulation:

This regulation implements Public Health Law Article 46-B, which creates new licensure and certification categories for assisted living residences (ALRs), entities that provide or arrange for housing, onsite monitoring and personal care services and/or home care services in a home-like setting. An operator of an ALR must be certified as an adult home or enriched housing program. In addition to its obligations to residents under that certificate, the ALR operator must have an individualized service plan for each resident and provide prospective residents, residents and their representatives with significant residency agreements and disclosure information. ALR operators will also have additional or different requirements with regard to case management and staff qualifications and training. The regulation should be modified to conform with the provisions of a stipulation and order resolving Empire State Association of Assisted Living v Daines venued in the Supreme Court, Albany County.

Title 18 NYCRR - Five Year Review

Amendment of paragraph 505.3(b)(1) of Title 18 NYCRR - Non-Prescription Emergency Contraceptive Drugs

Statutory Authority:

Public Health Law Sections 201(1)(v) and 206(1)(f); Social Services Law, Section 365-a(2)

Description of the regulation:

This rule allows for Federal Drug Administration (FDA) approved non-prescription emergency contraceptive drugs to be dispensed by a pharmacy without a fiscal order for women 18 years of age and older. This was enacted to allow women, 18 years of age and older, to have access to this time sensitive medication. It is critical for women to take emergency contraceptive drugs within 72 hours, although ideally within 12 hours, of unprotected intercourse.

The regulation should continue with modification to address the March 23, 2009 federal court order that requires the FDA to make non-prescription emergency contraceptive drugs available without a prescription to women 17 years of age and older.

Addition of paragraph 505.8(g)(6) to Title 18 NYCRR - Payment for Nursing Services Provided to Medically Fragile Children (RAU # 07-11) Effective: 4/16/08

Statutory Authority:

Social Service Law Section 367-r(1-a)

Description of the regulation:

This regulation provides that Medicaid reimbursement for private duty nursing services furnished to medically fragile children will be made at an enhanced rate. The regulation should continue without modification.

Title 10 NYCRR - Ten Year Review

Amendment to Section 2.1 (Effects of Smallpox Vaccination)

Statutory Authority:

Public Health Law Sections 225(4) and (5)(a), (g), and (h) authorize the Public Health and Health Planning Council to establish, and from time to time amend, the Sanitary Code with respect to preserving and improving public health in the State and to designate those communicable diseases deemed dangerous to public health. Further, the Public Health and Health Planning Council is authorized to establish the reporting standards associated with such reports, and those diseases for which specimens shall be submitted to approved laboratories.

Description of the regulation:

Cases of vaccinia infection due to contact transmission or other complications resulting from vaccination must be reported immediately to the local health department (which would then notify the Department).

In the event that a reimplementation of smallpox vaccination is necessary, it is critical that adverse events due to vaccination be reported, monitored and treated. This requirement must remain in place as an important piece of the response to a bioterrorism event in NYS. The regulation should continue without modification.

Amendment of Part 2.1(a), (b) and (c), 2.5, 2.10 (Reportable Communicable Disease List and Quarantine Authority)

Statutory Authority:

Public Health Law Sections 225(4) and (5)(a), (g), and (h) authorize the Public Health and Health Planning Council to establish, and from time to time amend, the Sanitary Code with respect to preserving and improving public health in the State and to designate those communicable diseases deemed dangerous to public health. Further, the Public Health and Health Planning Council is authorized to establish the reporting standards associated with such reports, and those diseases for which specimens shall be submitted to approved laboratories.

Description of the Regulation:

Part 2.1(a) is a list of diseases physicians are required report and 2.5 for which physicians need to submit specimens for laboratory examination. New diseases/infections of substantial public health importance need to be added to the list of communicable diseases that require reporting to public health authorities and/or specimen submission for laboratory testing. These changes will facilitate the diagnosis and treatment of disease and implementation of preventive measures to stop the spread of disease.

The regulation should be modified to require the reporting of new diseases of public health importance and the submission of needed laboratory specimens.

Amendment to Subpart 5-1 of Title 10 (Public Water Systems - Revised Maximum Contaminant Level (MCL) - Propylene Glycol)

Statutory Authority:

Public Health Law, Sections 201 and 225

Description of the regulation:

This amendment revised the Maximum Contaminant Level (MCL) for Propylene Glycol in water, which is delivered to any user of a public water system, to 1.0 mg/L. This amendment should continue without modification.

Amendment to Subpart 5-1 of Title 10 (Public Water Systems - Revised Maximum Contaminant Level (MCL) - MTBE)

Statutory Authority:

Public Health Law, Sections 201 and 225

Description of the regulation:

This amendment revised the Maximum Contaminant Level (MCL) for Methyl-tertiary-butyl-ether (MTBE) in water, which is delivered to any user of a public water system, to 0.010 mg/L. The amendment should continue without modification.

Amendments to Subpart 58-8 (HIV Testing)

Statutory Authority:

Public Health Law section 576 (4) authorizes the Department of Health to adopt, and amend rules and regulations to implement the provisions of Public Health Law Article 5, Title V, and ensure high quality clinical laboratory services, including testing related to HIV. Public Health Law section 2786 authorizes the Department to promulgate regulations concerning the implementation of article 27-F of the Public Health Law, which, among other things, protects the confidentiality of information concerning whether an individual has been the subject of an HIV related test.

Description of the regulation:

Subpart 58-8 promotes the public health, safety and welfare by establishing minimum standards for clinical laboratory testing and reporting of test results to detect human immunodeficiency virus (HIV) and to monitor infected individuals. Revisions of this regulation are required to create consistency with the HIV testing law implemented September 1, 2010 and supporting regulations of Part 63. The revisions will address updated technologies and revise testing algorithms for the management of HIV. This proposed rule was included in the October 2012 Regulatory Agenda. The regulation should continue.

Amendment to Sections 66-1.1 and 66-1.3 (Seventh Grade Hepatitis B School Entry)

Statutory Authority:

Public Health Law Section 2164

Description of the regulation:

The rule requires children entering the seventh grade to receive adequate doses of hepatitis B vaccine.

Hepatitis B is a serious, vaccine preventable disease that can lead to liver cancer. According to the Centers for Disease Control and Prevention approximately 70% of hepatitis B infections occur in late adolescence and early adulthood. It is very important that children attending NY schools who have not been vaccinated against hepatitis B in infancy receive this immunization before they reach the age when they are most likely to become infected. The rule should continue without modification.

Amendment to Sections 66-1.1 and 66-1.3 (Varicella Vaccine for School Entry)

Statutory Authority:

Public Health Law Section 2164

Description of the regulation:

The rule requires all children entering kindergarten to have received adequate doses of varicella (chickenpox) vaccine.

Varicella, or chickenpox, is a highly contagious and potentially serious vaccine preventable disease that was once a common illness in young children. Use of the vaccine to prevent varicella has significantly reduced the incidence of this disease in recent years. Children attending school in NY must be protected against this disease, as it is easily transmitted in a school setting. In addition, if an individual reaches adolescence or adulthood without having been vaccinated, the occurrence of natural disease could have even more serious consequences. These regulations need to be updated to be consistent with changes enacted to the PHL. The regulations should also codify Advisory Committee on Immunization Practice recommendations and incorporate by reference the recommended vaccination schedule, as well as the catch-up schedule.

Amendment of Section 69-1.2 (Newborn Screening-Testing for Phenylketonuria & Other Diseases and Conditions)

Statutory Authority:

Public Health Law Section 2500-a

Description of the regulation:

The regulation designates diseases or conditions for the state's newborn screening panel, in accordance to the Department's mandate to prevent infant and child mortality, morbidity, and diseases and disorders of childhood, in keeping with the Legislature's public health aims of early identification and timely medical intervention for all the State's youngest citizens. The regulation is updated as needed; the most recent amendment, effective December 11, 2012, modified the newborn screening panel by adding severe combined immunodeficiency (SCID), and by deleting hyperammonemia/ornithinemia/citrullinemia (HHH). The regulation should be continued.

Amendments to Part 1000

Statutory Authority:

Public Health Law Section 2995-a

Description of the regulation:

The rule sets forth the requirements for collecting and presenting information on New York's licensed and registered physicians for purposes of the New York State Physician Profile. Modifications are needed to this rule to define physician membership other than "board certification" and update definition of "board certification", clarify the circumstances under which a physician may be granted an extension to submit additional medical malpractice appeal information because of physical incapacitation, etc, and add the requirement that physicians must notify the department at least annually if there are no changes in profile information.

Title 10 NYCRR - Fifteen Year Review

Amendment to Subpart 5-1 of Title 10 (Public Water Systems)

Statutory Authority:

Public Health Law Sections 201 and 225

Description of the regulation:

This regulation incorporated the federal EPA Phase V drinking water standards for certain organic and inorganic chemicals into the state sanitary code. To ensure compliance with federally mandated regulations, amendments to Subpart 5-1 were made to incorporate specific Maximum Contaminant Levels for six inorganic and eight organic contaminants in water, which is delivered to any user of a public water system. This regulation should continue without modification.

Amendment to Subparts 6-1 and 6-2 (Swimming Pools and Bathing Beaches)

Statutory Authority:

Public Health Law Sections 225(5) and 1340-1342

Description of the regulation:

The revisions to the regulations (1) clarify lifesaving equipment requirements; (2) provide flexibility in determining the number of toilet and handwashing facilities at swimming pools and bathing beaches and guidelines for determining the location of such facilities at bathing beaches; (3) accept ozone as a supplement to chlorine or bromine disinfection systems; and (4) require installation of a minimum of two main drains at pools and spas, which provides additional protection for bathers against suction entrapment and hair entanglement. The amendments should continue without modification.

Amendment to Section 35.8 (Form and Content of Certificates)

Statutory Authority:

Public Health Law Sections 4100(1)(c), 4132(1) and 4141(1).

Description of the regulation:

This regulation establishes a basis for the electronic preparation and filing of birth and death certificates. It supports the efforts of the Department of Health to electronically file vital records certificates. No changes in this regulation are required at this time.

Amendment to Subpart 58-2 (Blood Banks)

Statutory Authority:

The Council on Human Blood and Transfusion Services is authorized by Section 3121(5) of the Public Health Law to enact, amend and repeal rules and regulations establishing minimum standards for the collection, processing, fractionation, storage, distribution and supply of blood, subject to the approval of the Commissioner of Health.

Description of the regulation:

Subpart 58-2 is necessary to promote the public health, safety and welfare by establishing minimum standards for the proper collection, processing, fractionation, storage, distribution and supply of human blood or blood products for use in transfusion. The regulation is updated as needed; the most recent amendment, effective November 7, 2007, updated practice standards, lowered donor age, and recognizes advances in technology. A proposed amendment of Subpart 58-2 is currently under consideration. This amendment would update technical requirements for the collection, testing, and storage of blood and blood components, allow increased flexibility in compliance, and allow advanced life support emergency medical technicians to administer blood components during transport of patients from one hospital to another.

Amendment to Part 71 (Requirements for Vent-Free Gas Space Heating Appliances)

Statutory Authority:

Public Health Law Section 206(1)(r).

Description of the regulation:

The three requirements of this regulation are intended to provide consumers with information that will help them to select a vent-free heater with appropriate heat output and use the heater in an appropriate manner. The first requirement describes a shipping carton and point-of-sale label with language intended to minimize the potential for adverse health effects from the use of these heaters. The second requirement describes an emissions rating label that informs consumers about the performance of each product relative to industry emission standards. The third requirement describes point-of-sale sizing guidelines that provide information on selecting a properly sized unit (in terms of heat output) and gives the general format of the information. The amendments should continue without modification and are necessary to minimize the potential for adverse health effects from the use of vent-free gas space heating appliances.

Amendment of Section 77.7 (Registered Residents - Funeral Directing)

Statutory Authority:

Section 3401(1) of the Public Health Law authorizes the Commissioner of Health to adopt rules and regulations not inconsistent with law as may be necessary in the performance of his/her duties and in the administration of Article 34 (Funeral Directing) of the Public Health Law and to govern and regulate the conduct and transaction of the business and practice of funeral directing, undertaking and embalming.

Section 3400(k) of the Public Health Law defines a "registered resident" in a manner consistent with the regulation.

Description of the regulation:

These amendments clarify the duties of registered residents in the practice of funeral directing and clarify the role of registered residents, funeral directors and undertakers regarding supervision of an interment or cremation. This clarification was necessary due to confusion among the funeral directing industry about what registered residents may do. By eliminating the confusion, the industry can better utilize this personnel resource and registered residents can find employment under appropriate supervision, for their mandated supervision period. Because the benefits of the regulatory amendment continue to be realized, continuance of the regulation is warranted. This regulation should be continued.

Amendment of Sections 80.1, 80.46, 80.64, 80.67, 80.69, 80.70, 80.73 and 80.75 (Physician's Assistants Controlled Substances)

Statutory Authority:

The authority for the promulgation of these regulations comes in Public Health Law, Sections 3701(1), (6) and 3308(2).

The definition of practitioner who is permitted to dispense, administer or conduct research with respect to a controlled substance in the course of a licensed professional practice or research license, including a physician assistant, is provided for in Section 3302(29) of the Public Health Law.

Description of the regulation:

The above regulation governs the prescribing, dispensing, and administration of controlled substances in a variety of circumstances by practitioners, including physician assistants. In 1998, the definitions of "authorized practitioner" and "practitioner" in 10 NYCRR Section 80.1(a) were amended to add physician assistants to the categories of licensed practitioners who can lawfully prescribe controlled substances in New York State. This regulation permits physician assistants to perform an activity for which they are well trained while providing the necessary regulatory safeguards for controlled substances required of all practitioners. In 2006, section 80.46 was further amended to bring into conformity with an amendment to Public Health Law, Section 3703 (1). In this law a physician's assistant's written medical order for the administration of a controlled substance in a hospital setting is required to be countersigned by his or her supervising physician only if deemed necessary by the supervising physician or the hospital. In 2007, Public Health Law, Section 3703 (3) was amended to authorize physician assistants to prescribe controlled substances, including Schedule II, when acting in good faith and in the physician assistant's lawful scope of practice. These regulations continue to appropriately govern the prescribing, dispensing and administration of controlled substances by physician assistants and reflect all the changes in this period of time. Therefore, continuance of this regulation is warranted. This regulation should be retained.

Amendment of 86-1.88 (Distribution of Regional Professional Education Pools)

Statutory Authority:

Public Health Law Section 2807-m

Description of the regulation:

Clarifies the definitions and data collection time frames for making distributions from the Regional Professional Education Pool to teaching general hospitals. This regulation was repealed as part of the inpatient reimbursement reform regulatory package.

Amendment to 86-1.89 (Supplemental Distribution of Regional Professional Education Pools)

Statutory Authority:

Public Health Law Section 2807-m(5)

Description of the regulation:

Describes the graduate medical education reform goals and methodology for receiving supplemental distributions from the Regional Professional Education Pool. This regulation was repealed as part of the inpatient reimbursement reform regulatory package.

Amendment to Part 128 (New York City Watershed)

Statutory Authority:

Public Health Law Section 1100

Description of the regulation:

These rules and regulations govern those activities in the watershed that threaten the quality of the water supply of numerous upstate communities and the City of New York to protect public health by averting future contamination to and degradation of the New York City water supply and by remediating existing sources of pollution or degradation of the New York City water supply.

Proposed amendments to these regulations are currently under review. The amendments propose to incorporate changes made by the Department of Environmental Conservation (DEC) to the State Pollution Discharge Elimination System (SPDES) General Permit for Stormwater Discharges from Construction Activity. Other proposed changes include clarifying authority with respect to new sewage holding tanks and alterations to existing holding tanks. Additionally, the proposed amendments include technical corrections to referenced materials, changes in certain text and technical terminology to improve clarity, and revisions to the definition of "phosphorus restricted basin." The proposed regulatory changes add a provision authorizing the granting of a variance for new or expanded surface wastewater treatment plant discharges within a 60-day travel time to a terminal water intake.

Amendment of Section 405.4, 405.5 and 405.10 (Hospital Medical Records)

Statutory Authority:

The authority for the promulgation of this regulation is contained in Section 2803(2) of the Public Health Law which authorizes the Public Health and Health Planning Council to adopt and amend rules and regulations, subject to the approval of the Commissioner, to implement the purposes and provisions of Article 28 of the Public Health Law, and to establish minimum standards governing the operation of health care facilities.

Description of the regulation:

These amendments are intended to establish criteria and safeguards for hospital usage of modern data communications technology and to update provisions for the acceptance of verbal orders. The amendments permit hospitals to use the most current electronic and computer technology for the transmission and storage of information. It includes safeguards for author identification/authentication and security and confidentiality of records. It also clarifies standards for the use of telephone orders. These are important advances in giving hospitals the flexibility to operate an effective and efficient medical records unit and continuance of these regulations is warranted. This regulation was updated to allow verbal orders to be authenticated by not only the ordering practitioner, but also by other practitioners responsible for the care of the patient within 48 hours rather than "as soon as possible" consistent with federal requirements that had a sunset date of January 26, 2012. The Centers for Medicare and Medicaid Services (CMS) permanently adopted their provisions. This regulation will be modified to remove the sunset date.

Amendment of Sections 405.8 and 405.11 (Infection Control Standards and Reporting)

Statutory Authority:

The authority for the promulgation of this regulation is contained in Sections 2803(2) and 2819 of the Public Health Law. PHL Section 2803 authorizes the Public Health and Health Planning Council to adopt and amend rules and regulations, subject to the approval of the Commissioner, to implement the purposes and provisions of Article 28 of the Public Health Law, and to establish minimum standards governing the operation of health care facilities. PHL Section 2819 sets forth the provision for hospital acquired infection reporting.

Description of the Regulation:

These amendments are intended to streamline reporting requirements for infection outbreaks and reorganize and update infection control standards focusing on outcome rather than processes. Unnecessary bureaucratic requirements have been eliminated so the regulations can focus on promotion of safe and effective infection control practices and appropriate reporting of untoward events.

These provisions are currently being modified to define requirements for hospitals to report select hospital acquired infections using methods, definitions and protocols defined by the Department, ensure patient privacy in collection and release of data and create standards for publication and release of the data reported.

Amendment of Sections 405.20, 670.4, 709.5, 711.4, 711.10, 715.16, 755.1 and 755.2 (Ambulatory Surgery)

Statutory Authority:

Public Health Law Sections 2801-a(10)(a) and 2803(2)(a).

Description of the regulation:

The regulation updated the need methodology for ambulatory surgery services and changes the definitions of hospital-based ambulatory surgery services and of extension clinics. These amendments promoted efficiency, accessibility and quality in the operation of Ambulatory Surgery Centers. The regulation continues to serve its original purposes, and continuance is warranted.

Amendment of Paragraph 405.24(h) (Pet Therapy in Hospitals)

Statutory Authority:

The authority for the promulgation of this regulation is contained in Section 2803(2) of the Public Health Law which authorizes the Public Health and Health Planning Council to adopt and amend rules and regulations, subject to the approval of the Commissioner, to implement the purposes and provisions of Article 28 of the Public Health Law, and to establish minimum standards governing the operation of health care facilities.

Description of the regulation:

This amendment establishes the parameters under which hospitals may establish and operate organized animal visitation or animal-assisted therapy programs. Such programs have proven to be of medical benefit to some patients; especially patients undergoing rehabilitation.

The regulations ensure that such programs are safe and consider the well-being of patients affected both directly and indirectly as well as the animals. Department of Health staff who review patient complaints and perform routine hospital surveys have not identified any problems associated with this regulation and the continuance of this regulation is warranted. This regulation should be retained.

Amendment of Paragraph 405.24(i) (Sterility Assurance)

Statutory Authority:

The authority for the promulgation of this regulation is contained in Section 2803(2) of the Public Health Law which authorizes the Public Health and Health Planning Council to adopt and amend rules and regulations, subject to the approval of the Commissioner, to implement the purposes and provisions of Article 28 of the Public Health Law, and to establish minimum standards governing the operation of health care facilities.

Description of the regulation:

Under these regulations, hospitals are given the right to implement an alternative process of assuring the sterility of supplies and equipment known as "event related sterility assurance". Such process has been endorsed by the Association for the Advancement of Medical Instrumentation and the Joint Commission on the Accreditation of Healthcare Organizations as an effective way to ensure sterility of supplies and equipment. Since adoption of this amendment, Department of Health staff have not identified any problems related to the implementation of this process. Continuance of this regulation is warranted. This regulation should be retained.

Amendment of Section 415.37 and Repeal of 422 (Services for Residents with AIDS)

Statutory Authority:

Public Health Law Section 2803(2)(a)

Description of the regulation:

These regulations reflect the additional experience required of the health professionals to adequately care for residents with HIV/AIDS and the corresponding staffing levels for rending such care. Continuance of these regulations is warranted.

Amendment of Section 710.1 (Project Cost Thresholds for CON Administrative Review and Full Review)

Statutory Authority:

Public Health Law Sections 2802(2) and 2803(2)(a)

Description of the regulation:

The rule helped streamline and focus the CON process on project proposals that have a significant impact on how and where Article 28 providers deliver care. This rule was amended in 2010 to further raise the project cost thresholds for administrative and full review. Continuance of these regulations as amended in 2010 is warranted.

Amendment of Section 710.1 (Conversion of Article 28 Beds)

Statutory Authority:

Public Health Law Section 2803

Description of the regulation:

Reduce costs for providers by removing the requirement for CON review of bed conversions within certain categories of services for which the hospital is an approved provider. Continuance of these regulations is warranted.

Amendment of Section 710.1 (CON Requirements for Article 28 Extension Clinics)

Statutory Authority:

Public Health Law Sections 2802(2) and 2803(2)(a)

Description of the regulation:

A review to permit CON administrative review for extension clinics regardless of location relative to the main facility. It removed a non-essential regulatory requirement applicable to extension clinics of hospitals and diagnostic and treatment centers. It promotes efficiency in the operation of such clinics services without compromising service quality. Continuance of this regulation is warranted.

Amendment of Parts 711, 712, 713, 714, 715 and 716 (Construction Regulations for Medical Facilities)

Statutory Authority:

Public Health Law Sections 2803(1) and (2803(2)

Description of the regulation:

The regulation updates referenced technical standards and allows providers greater flexibility in the design and construction of health care services. The regulations ensure that the initial construction of new medical facilities as well as their subsequent repair, maintenance, refurbishing and modernization conform to the latest architectural and engineering standards for the structure, dimensions and physical appointments of medical facility buildings. These several Parts were amended in 2010 to reflect updates of their referenced technical standards and changes in prevailing industry practices in health care facility design and construction. Continuance of these regulations as amended in 2010 is warranted.

Amendment of Subdivision 800.20(c) (EMS Curricula Approval/Course Standards)

Statutory Authority:

The authority for promulgation of this regulation is contained in Section 3002(2) of the Public Health Law which authorizes the New York State Emergency Medical Services Council (SEMSCO), subject to approval by the Commissioner, to enact, amend and repeal rules and regulations establishing minimum standards for the training, examination and certification of prehospital care personnel.

Description of the regulation:

The regulations contained in Subdivision 800.20 establish the criteria for approval by the Department of EMS Course Sponsors (training academies) and standards by which Course Sponsors must provide prehospital education in New York State. This section also establishes the minimum standards for prehospital curricula for each level of prehospital certification. The regulations also describe EMS Course Sponsor responsibilities and standard operating procedures.

Proposed amendments to these regulations are under consideration to address the current environment and technology as well as reflect the current EMS education curricula. The surveillance portions of these provisions need to be strengthened to appropriately address the issues of quality, student rights and safety.

Title 18 NYCRR - Fifteen Year Review

Amendment of Section 505.2 (Gender Reassignment)

Statutory Authority:

This is consistent with the Legislature's objective of providing high-quality medical assistance services to recipients under the Medicaid program. The Department has the responsibility of allocating available resources and assuring that services available are safe and effective. These treatments have not been proven to be safe and effective over the long term, and therefore have been eliminated from the list of covered services under the Medicaid program.

Description of the regulation:

The purpose of this regulation is to exclude payment for care, services, drugs or supplies rendered for the purpose of gender reassignment (also known as transsexual surgery) or any care, services drugs, or supplies intended to promote such treatment. It is recommended that this regulation be continued without modification.

Amendment of Section 505.10 (Medicaid Transportation)

Statutory Authority:

Social Services Law Section 363 and Chapter 474 of the Laws of 1996

Description of the regulation:

The cited regulatory change clarified the ordering of Medicaid transportation services. The list of qualified orderers was expanded, as well as offering guidelines for the appropriate ordering of various modes of transportation. The change stated that the ordering practitioner should keep a record of the justification for the order, and that ordering practitioners may be subjected to monetary claims and/or program sanctions. The cited regulatory change clarified the Department's ability to establish reimbursement amounts for transportation services.

The cited regulatory change listed the documentation needed in order for ambulette services to receive payment.

These changes to the regulation did not impose new requirements on providers and orderers of transportation services. Rather, these changes clarified department policy, enabling providers and orderers to adhere to Medicaid rules.

This regulation needs to be updated incorporating Chapter 109 of the Laws of 2010 which amended Section 365-h of the Social Services Law (SSL). This law allows the department to assume the administration of the Medicaid transportation program from the local county. Additionally, the update will include emergency medical services guidelines and new quality standards expected of Medicaid transportation providers.

Amendment of Section 505.18 (Medicaid Billing for Certified School Counselors)

Statutory Authority:

Social Services Law Section 368-d

Description of the regulation:

Section 505.18 is in the process of being changed. Certified School Counselors are no longer considered Medicaid qualified providers. The only Medicaid qualified providers for psychological counseling for disabled children with an Individualized Education Program (IEP) are psychiatrists, psychologists, and licensed clinical social workers (LCSWs). Licensed master social workers (LMSWs) may also provide psychological counseling services when services are provided under the supervision of one of either a psychiatrist, psychologist, or a LCSW.

This regulation is in the process of being repealed and rewritten.