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

Title 10 NYCRR - Fifteen Year Review

Amendment of Section 2.1(a) of Title 10 (Communicable Diseases-Addition of Laboratory Confirmed Influenza)

Statutory Authority: 

             Public Health Law (PHL) §§ 225(4) and (5)(a), (g) and (h)

Description of the regulation: 

            This amendment to the regulation added laboratory confirmed influenza to the NYS list of reportable communicable diseases.  This initiative protected the public health by permitting closer monitoring of communicable diseases.  This addition was the basis for the Department's enhanced monitoring of influenza and has been instrumental in the prompt identification and surveillance of unusual strains of influenza circulating in NYS such as the novel A influenza H1N1virus.  Requiring laboratories to electronically submit confirmed influenza laboratory data via the NYSDOH electronic clinical laboratory reporting system (ECLRS) permitted adequate disease monitoring without unnecessarily burdening the disease reporting system.  During the 2008-2009 influenza season there were 30,144 laboratory reports of confirmed influenza received via ECLRS which has more than doubled the number of cases previously reported. This data allowed the department to characterize the outbreak, watch for changes in transmission, monitor for antiviral resistance, determine geographic and temporal changes and mount an appropriate public health response.  For these reasons, amending the list of reportable communicable diseases to add laboratory confirmed influenza, should be retained. The Department intends to further amend the list of reportable diseases set forth in the regulation in the future.

Revisions to Subparts 5-1, 5-2, Repeal existing Appendix 5-B and add a new Appendix 5-B, and addition of a new Appendix 5-D to Part 5 of Title 10 (Water Well Construction)

Statutory Authority: 

               PHL §§ 201, 206(18), 225 and 1120

Description of the regulation:

              Section 206 of Public Health Law was amended in 1999 to require the Department to promulgate standards for water wells, including drilling, construction, abandonment, repair, maintenance, water flow and pumps. Extensive outreach to water well drillers, other interested parties and also to other states with long-standing water well programs was conducted to assure that all directives of the law were implemented.  Appendix 5-B was promulgated, containing standards for all water supply wells, including both residential and public water supply wells.  Appendix 5-D was promulgated to include supplementary and complementary requirements for public water supply wells.  Subparts 5-1 and 5-2 were revised to accommodate 5-B and 5-D as reference standards.  These regulations should continue without modification.      

Amendment of Section 5-1.52 and 5-1.91 of Subpart 5-1 of Title 10 (Treatment, Monitoring and Reporting for Radionuclides)

Statutory Authority: 

               PHL § 225

Description of the regulation:

               Sections 5-1.52 and 5-1.91 of Subpart 5-1 were amended to incorporate and reflect federal regulations promulgated by the U.S. Environmental Protection Agency.  New maximum containment levels, monitoring frequencies, notification and compliance requirements for various radionuclide contaminants were established, as were provisions for variances from specified treatment techniques.  The U.S. Environmental Protection Agency has further revised federal regulations. For the Department to obtain primacy for the implementation and enforcement of federal drinking water regulations, these regulations should be amended.

Amendment of Sections 69-1.1, 69-1.2 and 69-1.3 of Subpart 69-1 of Title 10 (Newborn Screening Panel)

Statutory Authority: 

               PHL § 2500-a

Description of the regulation: 

              Subpart 69-1 designates diseases or conditions which must be included in the state's newborn screening panel and enumerates the responsibilities of the hospital CEO with regard to such screening, in accordance with the Department’s mandate to prevent infant and child mortality, morbidity and diseases and disorders of childhood. The rule implemented the public health aims of early identification and timely medical intervention for all the State’s youngest citizens.  The Department’s Newborn Screening Program continues to perform testing on newborns and continually updates the panel of tests that are performed.  The regulation should continue with modification.  Subpart 69-1 was recently amended, effective on 2/13/19, that 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.  Section 69-1.2 was amended such that the diseases to be screened will no longer be listed and will instead be listed on the Department’s web page.

Addition of new Subpart 69-9 to Title 10 (Standardized Autopsy Protocols for Unanticipated Infant Deaths)

Statutory Authority: 

         PHL § 4210, as amended by Chapter 58 of the Laws of 2002

Description of the regulation: 

        The regulation was established to provide standardized autopsy protocols.  The Infant Autopsy Protocol is intended to:

•  Ensure comprehensive postmortem examinations of infants who die suddenly and unexpectedly.
• Provide findings to correlate with the decedent’s medical history.
• Provide findings to correlate with the death scene investigation.
• Develop documentation that justifies the autopsy diagnoses.
• Establish accurate causes of death.
• Develop accurate vital statistics, information and records.
• Assist in prioritizing the allocation of health care resources.
• Fulfill criteria to make a diagnosis of Sudden Infant Death Syndrome (SIDS)
• Allow comparison of SIDS and sudden, unexpected death cases in different locales.

        The regulation should continue without modification.

Amendment of 86-1.89 of Part 86 of Title 10 (Supplemental Distributions of Regional Professional Education Pools)

Statutory Authority: 

               PHL § 2807-m(5)

Description of the regulation:

              This regulation defined “reform goals” for the Supplemental Distribution of Regional Education Pools and specified the method of distributing funds to the pools.  This rule was repealed in 2011 as part of the 2009/2010 Executive Budget implementation.

Addition of Subpart 86-8 of Part 86 of Title 10 (Rates of Payment for Limited Home Care Agencies)

Statutory Authority: 

             Laws of 1995, Chapter 81, section 105-d as amended by Laws of 1997, Chapter 433, section 69

Description of the regulation: 

            The regulation establishes a rate of payment for limited home care services agencies to reduce Medicaid expenditures for certain personal care services furnished to eligible residents of an adult home or enriched housing program.  It provides reimbursement directly to the limited home care services agency rather than an outside personal care provider or certified home health agency.  The regulation should continue without modification.

Amendment of Subpart 98-1 of Title 10 (Managed Care Organizations)

Statutory Authority:

               PHL Article 44

Description of the regulation:

              Article 44 was amended by Chapter 649 and 705 of the Laws of 1996, Chapter 433 of the Laws of 1997 and Chapter 659 of the Laws of 1997 in relation to Medicaid managed care, managed care consumer rights and managed long term care programs.  The amendments changed the title and clarified the department’s authority over specified forms of managed care organizations, including primary care partial capitation providers, HIV special needs plans and managed long term care plans.  The regulations removed obsolete provisions and provided clearer guidance to the health care industry concerning certification and operational requirements for managed care organizations.  This regulation should continue without modification because it is necessary for the operation of managed care programs in NYS.

Amendment of Sections 128-1.6 and 128-3.8 of Title 10 (New York City Watershed Rules and Regulations)

Statutory Authority: 

               PHL §§ 1100-1103

Description of the regulation:

                The Department adopted amendments to NYC's Watershed Rules and Regulations at New York City's request for the purpose of protecting the water quality of NYC reservoir sources.  These amendments were also necessary for NYC to maintain the “filtration avoidance” issued by U.S. Environmental Protection Administration and NYSDOH for the City's Catskill/Delaware sources. Due to recent federal and state regulatory changes and in order to implement new “filtration avoidance” mandates, these regulations should be amended. The Department plans to propose amendments to this regulation that will continue to protect NYC’s watersheds and preserve NYC’s Filtration Avoidance Determination (FAD).  This regulation should continue until the proposed amendments are adopted.

Amendment of Section 131.1 of Title 10 (City of Syracuse-Watershed Rules and Regulations)

Statutory Authority: 

               PHL § 1100   

Description of the regulation:

               The Department adopted amendments to the City of Syracuse's Watershed Rules and Regulations at Syracuse's request for the purpose of protecting the water quality of Syracuse's Skaneateles Lake source.  These amendments were also necessary for the City of Syracuse to maintain “filtration avoidance,” previously issued by the Department for this source.  These regulations should continue without modification.

Addition of new Section 400.10 to Part 400; Addition of new subdivision (f) to 763.11, new subdivision (o) to 766.9 and new subdivision (n) to 793.1 of Title 10 (Health Provider Network (HPN) Access and Reporting Requirements)

Statutory Authority:

            PHL §§ 2800, 2803, 3612 and 4010

Description of the regulation:

            This regulation required Article 28 facilities, home care facilities and hospices to establish and maintain health commerce system (HCS) accounts with the Department of Health for the purpose of exchanging information with the Department in a rapid and efficient manner in times of emergency or urgent matters.  The HCS is a secure web-based application that can be utilized by facilities to receive current and up-to-date information as well as submit data to specialized programs for reporting or surveillance purposes.  In times of emergencies or urgent matters, such as disease outbreaks, it is imperative that facilities receive from and submit to the Department information in a rapid, efficient manner.  The HCS, a free service, is the best means to ensure this exchange of information.   This regulation should continue with the above noted technical modification to the System’s correct name.

Amendment of Section 400.18, Appendix C-4 & C-5 of 400.18 and Section 405.27 (Emergency Department Data Collection by SPARCS)

Statutory Authority:

               PHL § 2816

Description of the regulation:

               Section 400.18 regulates the operation of the Statewide Planning and Research Cooperative System (SPARCS). The Department intends to repeal the current Section 400.18 and a new Section 400.18 will be promulgated. The reasons for the complete revision are to delete obsolete language and to update the regulation. The new Section 400.18 will authorize SPARCS to collect additional outpatient data not currently being collected by SPARCS from general hospitals and diagnostic and treatment centers licensed under Article 28 of the Public Health Law.  This regulation should continue until it is amended. 

Amendment of Sections 405.21, 407.14, 708.2, 708.5, 711.4 and Addition of new Part 721 of Title 10 (Perinatal Regionalization)

Statutory Authority:

               PHL §§ 2500, 2800, 2803(2) and 2803-j

Description of the regulation:

               These regulatory changes updated previous requirements for maternal and newborn care, and formalized perinatal regionalization and designation requirements.  The new Part 721 was added to collect in one section all the regulations governing the perinatal regionalization system, which had been divided among several sections of the New York State Hospital Code. The regulatory changes also described the kinds of resources that should be available for different levels of hospitals, and deleted outdated appropriateness-review standards used in the 1985 designation of hospitals at different levels of high-risk neonatal care.

               These regulations govern the perinatal regionalization system, in which Regional Perinatal Centers (RPCs) coordinate the perinatal delivery system within their region; provide critical care and transport of pregnant women and infants; provide specialty care, including pediatric open heart surgery; and oversight of quality improvement activities within affiliate hospitals. Perinatal regionalization plays a critical role in reducing maternal and newborn morbidity and mortality. 

                Section 405.21 for hospital-based perinatal services was amended to support perinatal regionalization efforts, and to clarify and simplify some other existing regulatory requirements.

                Sections 407.14, 711.4(d)(21) and (e)(10) were amended to reflect the change in terminology in section 405.21 in which hospital-based "maternity and newborn" services began to be referred to as "perinatal" services.

                Section 708.2(b)(6) and Section 708.5(f) were repealed since new Part 721 integrated the requirements for perinatal re-designation and regionalization in one section.

                Part 721 defines the perinatal regionalization system including requirements for affiliation agreements between Levels I, II and III hospitals and regional perinatal centers (RPCs), staffing requirements and quality improvement activities. The regulations formalize the designation process, update the Department of Health expectations for resources to be available at each level of care, and clarify the relationship between Levels I, II, and III programs and RPCs.

               Amendments to these regulations have been proposed. In particular:

              405.21 Perinatal Services - Perinatal hospital standards to be reviewed and updated to be consistent with national authorities based on a literature review and input from an expert workgroup of clinicians and key stakeholders. The regulations will address the professional qualifications of the obstetric and pediatric staff, the requirements for consultation with a qualified specialist when required by specific medical conditions, protocols and resources available to stabilize and assess newborns for their need of neonatal intensive care, and the daily care of maternity patients and infants in the perinatal service.

              721.4 Statewide Perinatal Regionalization System - Perinatal hospital standards to be reviewed and updated to be consistent with national authorities based on a literature review and input from an expert workgroup of clinicians and key stakeholders.  The regulations will provide definitions and requirements for level of care designations as well as patient care and patient transfers, qualifications and responsibilities of staff and ancillary personnel, quality improvement activities, and affiliation and transfer agreements.

Amendment of Sections 703.6 and 710.1 of Title 10 (Part-Time Clinics)

Statutory Authority:

             PHL § 2803(2)

Description of the regulation:

            Since its issuance in 2005, the current regulation has proven adequate to help ensure that services provided in part-time clinics are appropriate to those settings, and that the existing number of part-time clinics is sufficient to promote access to needed care.  The regulation has also guarded against the operation of an excess number of part-time clinics, which occurred in some parts of the State prior to the amendment of the rule.  The regulations should continue without modification.

Amendment of Sections 708.2, 708.5 and 709.16 of Title 10 (Review Criteria for Therapeutic Radiology)

Statutory Authority:

               PHL § 2803(2)

Description of the regulation:

              The regulations establish a methodology to be used to evaluate public need for therapeutic radiology devices as affected by prevailing medical practice in the use of these devices for curative and palliative care. 

              The Department intends to repeal this regulation as technological advances in the last 15 years have made it no longer necessary.

Amendment of Sections 709.16 and 709.17 of Title 10 (Need Methodology for Long-Term Ventilator Beds in Nursing Homes)

Statutory Authority:

              PHL § 2803(2)

Description of the regulation:

            The current regulation provides a methodology to be used in the evaluation of certificate of need applications for certification of long term ventilator beds.  Since its issuance in 2005, the regulation has ensured that long-term ventilator beds are distributed throughout the State in a manner that both provided sufficient access to care and guarded against the costs associated with the operation and maintenance of beds in excess of those needed. 

            The regulation should continue with modification.  The Department intends to amend this regulation in keeping with medical and technological advances that have occurred over the last 15 years.

Amendment of Section 763.13, Section 766.11 and addition of new Section 400.32 to Title 10 and amendment of Section 505.14 of Title 18 (Criminal History Record Check)

Statutory Authority:

               PHL §§ 201, 2803 and 3612 and Social Services Law (SSL) § 363-a

Description of the regulation:

               Section 400.23 related to the criminal history record check program and was repealed on December 19, 2007.  It was replaced by Section 402 which implemented the statutory criminal history record check program defined in PHL Article 28-E. Sections 763.13, 766.11 of Title 10, and the amendment of Section 505.14 of Title 18 added a criminal background check requirement under Section 402.  Although the CHRC program had been covered by emergency regulations since August 2006, permanent regulations became effective on December 2, 2009.   The regulation should continue without modification.