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Three, Five, Ten, Fifteen and Twenty Year Regulation Review

Pursuant to the State Administrative Procedure Act Section 207 and 202-d, the Department of Health invites public comment on the continuation or modification of the following rules. Public comments will be accepted for 45 days from the date of publication in the State Register and should be submitted to Katherine Ceroalo, Bureau of Program Counsel, Regulatory Affairs Unit, Corning Tower, Room 2438, Empire State Plaza, Albany, NY 12237 by email at REGSQNA@health.ny.gov.

To view the full version of the document, please click on this PDF link: 2018 Three, Five, Ten, Fifteen & Twenty Year Regulation Review.pdf

Title 18 NYCRR - Ten 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 conform to current standards.

 

Addition of paragraph 505.8(g)(6) to Title 18 NYCRR - Payment for Nursing Services Provided to Medically Fragile Children

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 - Fifteen 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:   

Section 2.1 lists diseases that physicians are required report, and section 2.5 lists diseases for which physicians need to submit specimens for laboratory examination. 

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 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 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

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.  Amendments may be required in the future to address updated technologies and revise testing algorithms for the management of HIV. 

 

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 should be updated to conform to updated standards and to establish vaccination schedules.

 

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.   New York State Public Health Law Section 2500-a authorizes the Commissioner of Health to designate additional diseases or conditions for inclusion in the Newborn Screening Program test panel by regulation. The most recent amendment, effective October 19, 2016, modified the newborn screening panel by adding adrenoleukodystrophy (ALD) and Pompe disease.

Amendments will be proposed that will reflect recent recommendations by the Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children related to improving timeliness in newborn screening programs.  Addition of other diseases or conditions may also be required in the future.

 

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.  The regulation should be amended to update definitions and clarify and update requirements. 

Title 10 NYCRR - Twenty 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:

Public Health Law Section 3121(5)

Description of the regulation: 

Subpart 58-2 describe requirements for blood banks and laboratories performing immunohematology testing.  The regulation establishes standards for the proper collection, processing, fractionation, storage, distribution and supply of human blood or blood products for use in transfusion.  The most recent amendment, effective September 27, 2015, were necessitated by advances in medical technology and the need to codify practice standards and eliminate obsolete requirements, afford regulated parties with greater flexibility in complying with department regulations, clarify regulatory intent, and provide for safe transfusion of blood components during interfacility transport of patients.

Future amendments will likely be required to align the Department’s rules with new federal requirements that may be established and to define requirements when new therapies and procedures that are established in the field.

 

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:

Public Health Law Section 206(1)(r) requires and authorizes DOH to promulgate regulations to implement Section 322-c(a)(ii) of the General Business Law. The stated purpose of this rule is to protect public health, safety and welfare by specifying requirements for vent-free gas space heating appliances offered for sale or sold in New York State. The requirements are intended: to caution customers about the proper installation, sizing, maintenance and use of vent-free gas space heaters through mandatory shipping carton labels; to provide consumers with information on the carbon monoxide and nitrogen dioxide emissions from these units; and to assist consumers with selecting appropriately sized units based on heat output.

The regulation should be amended to update requirements for appliance shipping carton labels, based on data and literature since the last regulation review.

 

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.  Additionally, subparagraph (h) places specific limits on the residents regarding their interaction with client families and the public to ensure protection for the customer and eliminate the possibility of consumer confusion.  Because the benefits of the regulatory amendment continue to be realized, continuance of the regulation is warranted with modification. 

 

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.  This regulation should continue without modification.

 

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 regulation govern those activities in the New York City watershed that threaten the quality of the water supply of the numerous upstate communities and the City of New York.

They help insure compliance with the Federal and State drinking water standards by providing a comprehensive watershed protection program.  The goal and intent of these rules and regulations to protect the public health by averting future contamination to and degradation of the water supply and by remediating existing sources of pollution or degradation of the New York City water supply.

This regulation is under review for potential amendment.

 

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.

These regulations were amended on May 17, 2017 to comply with CMS regulatory changes which permit more flexibility in the authentication of verbal orders. The recent amendment removed the requirement for co-signature of verbal orders within 48 hours, allowing the hospital, in their policy and procedures, to create a policy on authentication of such orders which defies the acceptable time frame. This is consistent with CMS regulatory changes.

This regulation should continue without modification.

 

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 Department is considering amendments to these regulations to establish requirements for hospitals to report select hospital acquired infections. 

           

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 should continue without modification.

 

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 continue without modification.

 

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 continue without modification.

 

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.  These regulations should continue without modification.

 

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 and 2017 to further raise the project cost thresholds for administrative and full review.  This regulation should continue without modification.

 

Amendment of Section 710.1 (Conversion of Article 28 Beds)

Statutory Authority:

Public Health Law Section 2803

Description of the regulation:

This regulation sought to 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.  This regulation should continue without modification.

 

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:

This regulation permits CON administrative review for extension clinics regardless of location relative to the main facility.  The previous modification to the regulation removed a non-essential regulatory requirement applicable to extension clinics of hospitals and diagnostic and treatment centers.  The regulation promotes efficiency in the operation of such clinics services without compromising service quality.  This regulation should continue without modification.

 

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.   These regulations should be amended to reflect updated standards.

 

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.  This regulation should be continued without modification.

 

Title 18 NYCRR - Twenty 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. 

This regulation should continue 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 regulation 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 regulation clarified the Department's ability to establish reimbursement amounts for transportation services. The regulation listed the documentation needed in order for ambulette services to receive payment. These clarified Department policy, enabling providers and orderers to adhere to Medicaid rules. 

This regulation should be updated to conform to amendments to Section 365-h of the Social Services Law (SSL). Additionally, the update should 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:           

The Department is developing amendments to this regulation. 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.