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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: 2020 Three, Five, Ten, Fifteen & Twenty Year Regulation Review.pdf


Title 10 NYCRR - Three Year Review

Amendment of Sections 23.1 and 23.2 of Title 10 (Expansion of Minor Consent for HIV Treatment Access and Prevention)                         

Statutory Authority:

              Public Health Law Sections 225(4), 2304, 2305 and 2311

Description of the regulation:

            This amendment supports the Governor’s plan to end the AIDS epidemic in New York State by 2020, by connecting persons diagnosed with HIV with treatment, including prevention services. After being diagnosed, young people currently face barriers that can prevent or delay access to care, including denial and fear of their HIV infection, misinformation, HIV-related stigma, low self-esteem, lack of insurance, homelessness, substance use, mental health issues, and lack of adequate support systems. Because of these factors, many young people need the ability to consent to HIV treatment, including prevention services. These regulations are necessary to provide appropriate health care rights and protections to minors and remove the barriers that can prevent or delay access to care.  The regulation should continue without modification. 

 

Amendment of Section 86-1.47 of Title 10 (Hospital Indigent Care Pool Payment Methodology)                           

Statutory Authority:

            Public Health Law Section 2807-k (5-d)   

Description of the regulation:

            Part 86-1.47 of Title 10 NYCRR extends for another two calendar years, 2019 and 2020, the current indigent care distribution methodology which replaced a complex distribution approach that expired December 31, 2012.  Public Health Law Section 2807-k (5-d) requires the Department to have such a methodology in place through 2020.  This regulation will be extended to accommodate a not greater than seventeen and a half percent for 2019 and a twenty percent for 2020 reduction in payments.

 

Addition of Part 350 to Title 10 (All Payer Database)                              

Statutory Authority:

              Public Health Law Sections 2816 and 206(18-a)(d)

Description of the regulation:

             These regulations establish New York State’s All Payer Database (APD). The APD provides a robust dataset that supports a variety of comparative analyses. The APD enables evaluation of care delivery and payment models and identifies opportunities to avoid waste, over/under utilization, misuse of treatments, and conflicting plans of care. The regulations should continue without modification.

 

Amendment of Part 405 of Title 10 (Federal Conditions of Participation)                                                           

Statutory Authority:

              Public Health Law Section 2803

Description of the regulation:

            The Centers for Medicare and Medicaid Services (CMS) requires hospitals to meet specified Conditions of Participation (CoPs) in order to participate in the federal Medicare and Medicaid programs. The CoPs outline the basic requirements related to a hospital’s structure, operations and delivery of patient care. CMS made numerous changes to the CoPs effective on July 16, 2012. As a result, New York State general hospital regulations were revised to reflect the federal changes.  The regulation should continue without modification. 

 

Amendment of Section 405.21 of Title 10 (Perinatal Services)                                                  

Statutory Authority:

              Public Health Law Section 2505-a

Description of the regulation:

            Describes hospital requirements for perinatal care.  This amendment expanded rights of breastfeeding mothers.  Marketing of breast milk substitutes was restricted.  Hospitals were required to annually disseminate hospital breastfeeding policies and procedures to staff providing maternity and newborn care, inform the mother of community services, including the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), and to make referrals to such community services as appropriate.  The regulation should continue without modification. 

 

Amendment of Part 1004 and Subpart 55-2 of Title 10 (Medical Use of Marihuana)                                      

Statutory Authority:

              Public Health Law Sections 3369-a and 502

Description of the regulation:

            These regulations comprehensively govern the medical marijuana program pursuant to Public Health Law §§3360-3369 and set the rules for patients to participate in the program, as well as for practitioners to certify them and for Registered Organizations to manufacture and distribute medical marijuana products in New York State. 

            Subpart 55-2 describes certification requirements for environmental laboratories that test samples that originate from New York State.  Section 55-2.15, which describes requirements for testing for medical marihuana, was updated to correct the name of the Drug Enforcement Administration and to include disposal requirements for medical marihuana.

            The regulations should be amended to improve patient access to the medical marijuana program, reduce the costs of medical marijuana products, clarify requirements for research on medical marijuana products, and promote social equity within the medical marijuana industry. Section 55-2.15 was recently amended, effective 08/21/2019, and future amendments may be required with changes in industry standards.

 

Title 10 NYCRR - Five Year Review

Amendment of Section 9.1 of Title 10 (Prohibit Additional Synthetic Cannabinoids)                                           

Statutory Authority:

              Public Health Law Section 225

Description of the regulation:

            The regulation prohibits the manufacture and sale of certain synthetic cannabinoids.

            The regulation should be amended to conform to and supplement subsequent amendments to Public Health Law §3306, which added several synthetic cannabinoids to New York State’s schedule of controlled substances.

 

Amendment of Subpart 50-3 of Title 10 (Medical Records Access Review Committees)                

Statutory Authority:

            Public Health Law Section 18(4)

Description of the regulation:

            Effective January 1, 1987, patients and other qualified persons were granted access to health care records by Section 18 of the New York State Public Health Law (PHL), which was enacted in Chapter 497 of the Laws of 1986.  The law contains the procedures for making records available, the conditions under which a provider can deny access to records, and a process to resolve situations in which patients or other qualified persons dispute a provider’s denial of access to records. 

            If a patient is denied access to their health care records, the patient or other qualified persons are afforded the right of appeal to Medical Records Access Review Committees (MRARC) designated by the Commissioner of Health pursuant to PHL Section 18 to hear and make determinations on appeals.  Subpart 50-3 of Title 10 of the New York State Codes, Rules and Regulations (NYCRR) governs the operations of the MRARCs, comprised of Department of Health professionals. 

           Subpart 50-3 describes the steps that physicians and non-physician professionals must take in the event of an appeal to the denial of access to patient information and the process to be followed by MRARCs in hearing and issuing determinations on appeals.  The regulation should continue without modification. 

 

Amendment of Parts 58 and 34 of Title 10 (Patient Access of Laboratory Test Results)                        

Statutory Authority:

              Public Health Law Sections 576 & 587

Description of the regulation:

            Subparts 58-1 (Clinical Laboratories), 58-8 (HIV Testing) and 34-2 (Laboratory Business Practices) had previously included language that prohibited a patient from obtaining their test results directly from a laboratory.  These regulations were amended to allow patients to access their test results directly from a laboratory.  The regulation should continue without modification. 

 

Amendment of Subpart 58-2 of Part 58 of Title 10 (Blood Banks)                                                         

Statutory Authority:

              Public Health Law Section 3121(5)

Description of the regulation:

            This regulation describes requirements for blood banks and requirements for laboratories performing immunohematology testing.  Numerous amendments were made to update practice standards, to address changes in nomenclature and technologies used in the field of blood banking and immunohematology testing and added requirements for ambulance services that administers blood components during transport from one hospital to another hospital.

            Amendments will be proposed to clarify requirements for reinfusion procedures; modify the requirements for the collection and handling of blood for subsequent transfusion; establish requirements for the issuance of blood, blood components and derivatives during routine and emergency situations; revise donor qualifications, collection and testing requirements for whole blood, apheresis and serial plasmapheresis; update record retention requirements to be consistent with the FDA and industry standards; amend requirements for standard operating procedures; amend the standards for transfusion and immunohematology testing requirements; clarify personnel and supervisory requirements for serial plasmapheresis and apheresis collection of blood components.; clarify requirements for transfusions that occur outside of a hospital setting and during interfacility transport; and revise criteria for exceptions to reflect industry standards.

 

Amendment of Subpart 66-1 of Title 10 (School Immunization Requirements)               

Statutory Authority:

              Public Health Law Sections 2164 and 2168

Description of the regulation:

              On June 13, 2019, Governor Andrew Cuomo signed legislation removing non-medical exemptions from school vaccinations for children.  Therefore, in August 2019, Section 2164(10) of the Public Health Law (PHL), sections 66-1.1, 66-1.2, 66-1.3, 66-1.6, and 66-1.10 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York were amended via emergency regulation changes, to be compatible with the new legislation.  At the same time, a notice of proposed rulemaking was submitted for public comment.

 

Amendment of Section 80.138 of Title 10 (Opioid Overdose Programs)

Statutory Authority:

              Public Health Law Section 3309

Description of the regulation:

            The Commissioner is authorized to establish standards for approval of any opioid overdose prevention program, and opioid antagonist prescribing, dispensing, distribution, possession and administration pursuant to this section which may include, but not be limited to, standards for program directors, appropriate clinical oversight, training, record keeping and reporting. 

            The standards, since the inception of New York State’s opioid overdose prevention initiative in 2006, have been codified in 10 NYCRR 80.138.  These standards, with minor proposed amendments to the regulation, must remain to ensure the orderly continuance of the state’s opioid overdose prevention initiative. Modifications will be proposed to conform to updated program standards.

 

Addition of Section 86-1.45 to Title 10 (Inpatient Rate for Language Assistance Services)                                                                  

Statutory Authority:

            Public Health Law Section 2807-c(35)

Description of the regulation:

            Reimbursement for language assistance services in the hospital inpatient setting.  The regulation should continue without modification. 

 

Amendment of Subpart 86-10 of Title 10 (Rate Rationalization for Community Residences (CRs) / Individualized Residential Alternatives (IRAs) Habilitation and Day Habilitation)                   

Statutory Authority:

            Public Health Law Section 201

Description of the regulation:

            Rate rationalization reformed the operating component of the rate by introducing methodological rigor into what was previously a negotiated rate.  Further, these regulations consolidate the rate-setting functions of Medicaid services previously exercised by the Office for People with Developmental Disabilities (OPWDD) within the Department of Health. 

            OPWDD was responsible for the reimbursement of the capitol cost component of Residential and Day Habilitation providers and the Department of Health is responsible for reimbursement of the operating cost component.  This arrangement has been ratified by the Centers for Medicare and Medicaid Services (CMS), along with the changes to reimbursement for Residential and Day Habilitation services reflected by this regulation.

            The regulation should not continue without modification.

            Amend regulation to add the following: 

  • Direct Care Support Professional and Clinical 2% compensation increases
  • Cap reimbursement of Agency Administration at 15 percent
  • Offset other income surpluses against allowable Medicaid costs.

 

Amendment of Subpart 86-11 of Title 10 (Rate Rationalization for Intermediate Care Facilities for Persons with Developmental Disabilities (ICF/DDs))

Statutory Authority:

            Social Services Law Section 201

Description of the regulation:

            Rate rationalization reformed the operating component of the rate by introducing methodological rigor into what was previously a negotiated rate.  Further, these regulations consolidate the rate-setting functions of Medicaid services previously exercised by the Office for People with Developmental Disabilities (OPWDD) within the Department of Health. 

           OPWDD was responsible for the reimbursement of the capitol cost component of ICF/DD services and the Department of Health is responsible for reimbursement of the operating cost component.  This arrangement has been ratified by the Centers for Medicare and Medicaid Services (CMS), along with the changes to reimbursement for ICF/DD services reflected by this regulation.

           The regulation should not continue without modification.

            Amend regulation to add the following: 

  • Direct Care Support Professional and Clinical 2% compensation increases
  • Cap reimbursement of Agency Administration at 15 percent

 

Addition of Subpart 86-12 to Title 10 (Outpatient Services Licensed Under the Mental Hygiene Law)                                                                   

Statutory Authority:

            Sections 26 and 111(a) of part H of chapter 59 of the laws of 2011

Description of the regulation:

            Utilization limits applied to Office for People with Developmental Disabilities licensed clinics.  The regulation should continue without modification. 

 

Amendment of Part 94 of Title 10 (Physician Assistants and Specialist Assistants)                                                             

Statutory Authority:

            Public Health Law Sections 3308, 3701 and 3703

Description of the regulation:

            Part 94 of Title 10 sets forth the supervision and scope of duties of a licensed physician assistant or a registered specialist assistant performing medical services only under the supervision of a physician. This includes the number of assistants that can be supervised by a physician, the prescribing authority of an assistant, and the types of specialist assistants.  The regulation should continue without modification. 

 

Amendment of Sections 98-1.2 & 98-1.11 of Title 10 (Managed Care Organizations)

Statutory Authority:

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

Description of the regulation:

            Section 98-1.2 includes a definition for the HARP line of business.  Section 98.11(e) (1) ii maintains the contingent reserve percentage at 7.25% for the Medicaid Managed Care, HARP and HIV SNP Programs.  The regulation should continue without modification. 

 

Amendment of Section 98-1.16(c) and Addition of Subpart 98-3 to Title 10 (Audited Financial Statements for Managed Care Organizations)     

Statutory Authority:

            Public Health Law Sections 4403(2) and 4403(f)(7)

Description of the regulation:

            The regulation extends audit and reporting standards to all managed care organizations (MCOs) certified under Article 44 of the Public Health Law.  The regulation applies to MCOs (Prepaid Health Services Plans, HIV Special Needs Plans and Managed Long Term Care Plans) (PHSPs, HIV SNPs and MLTCPs) that were not included under the Department of Financial Services Regulation 118.  This ensures that all MCOs authorized to operate under Article 44 must adhere to the same financial reporting requirements and standards in the filing of audited financial statements. The regulation is closely patterned upon 11 NYCRR 89 (Regulation 118)  adopted by the Department of Financial Services  and the  National Association of Insurance Commissioners model audit rule ("NAIC model") that reflects a consensus of the insurance regulators of all states and territories of the United States as to scope, detail, needs and benefits.  The regulation should continue without modification. 

 

Addition of Section 400.25 to Title 10 (Disclosure of Quality and Surveillance Related Information)                                                        

Statutory Authority:

            Public Health Law Sections 2803 and 2805-t

Description of the regulation:

            The Nursing Care Quality Protection Act (Chapter 422 of the Laws of 2009), added PHL Section 2805-t which requires Article 28 facilities to disclose identified nursing quality indicator information upon request to any member of the public, and to the Commissioner of any State agency responsible for licensing the facility or responsible for overseeing the delivery of services by the facility, or any organization accrediting the facility. PHL Section 2805-t authorizes the Commissioner to promulgate regulations regarding disclosure of nursing quality indicators to such requesters. This regulation establishes standards for the collection and disclosure of data regarding nursing staffing levels and nursing-sensitive patient outcome indicators.  The regulation should continue without modification. 

 

Addition of Part 404 to Title 10 (Integrated Outpatient Services)                                                                 

Statutory Authority:

            Public Health Law Section 2803

Description of the regulation:

            The regulation relates to standards applicable to programs licensed or certified by the Department of Health, Office of Mental Health or Office of Alcoholism and Substance Abuse Services which desire to add to services provided under the licensure or certification of one or both agencies.  The regulation should not continue without modification.  In response to the Regulatory Modernization Initiative and to and to make permanent the DSRIP Project 3.a.i. Licensure Threshold, these regulations will be amended by DOH, OMH, and OASAS to facilitate the integration of health care services by any provider licensed by one of those agencies.

 

Amendment of Part 405 of Title 10 (Hospital Observation Services)

Statutory Authority:

            Public Health Law Sections 2803, 2805-v & 2805-w

Description of the regulation:

            Legislation passed in 2013 added new Sections 2805-v and 2805-w of the Public Health Law. This legislation established new requirements for hospital observation services.  Since these requirements differed from those in the existing regulations, amendments were made to bring the regulations into conformance with the provisions of PHL.  The regulation should continue without modification. 

 

Amendments of Section 415.3(h) of Title 10 (Nursing Home Transfer and Discharge Rights)                     

Statutory Authority:

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

Description of the regulation:

            Resident rights as it relates to transfer and discharge from nursing home facility.  The regulation should continue without modification. 

            The Division is currently reviewing all of Part 415 of Title 10 and intends to make appropriate updates.

 

Amendment of Sections 600.3 and 710.5 of Title 10 (Amendment of Certificate of Need (CON) Applications)                                             

Statutory Authority:

            Public Health Law Sections 2801-a(1) and 2802(1)

Description of the regulation:

            The regulation clarified language relating to changes to Certificate of Need applications prior to and after Public Health and Health Planning Council (PHHPC) approval and set forth conditions under which such changes would be referred back to PHHPC for reevaluation and recommendations.  The regulation should continue without modification. 

 

Amendment of Section 710.1 of Title 10 (Certificate of Need Requirements)                           

Statutory Authority:

            Public Health Law Section 2802

Description of the regulation:

            The regulation removed CON review requirements for repair and maintenance projects and equipment replacement projects costing more than $6 million.  The regulation also removed the requirement that non-clinical infrastructure projects exceeding $15 million be subject to administrative review. In lieu of the submission of administrative or full review CON applications, the amended rule required the submission of only a written notice and, where applicable, specified certifications and a plan for patient safety during project construction.

            The regulation was amended again effective 9/6/17 to eliminate the requirement that notice be provided for non-clinical infrastructure projects that do not exceed $6 million and to apply the notice requirement to non-clinical infrastructure projects costing over $6 million.  The regulation should continue without modification. 

 

Amendment of Part 757 of Title 10 (Chronic Renal Dialysis Services)                                   

Statutory Authority:

            Public Health Law Section 2803

Description of the regulation:

            Part 757 of Title 10 of the New York Codes Rules and Regulations (NYCRR) outlines the requirements for services provided in New York State chronic renal dialysis centers. These centers must comply with the regulations contained in Title 42 of the Code for Federal Regulations (CFR), Amendments to 42 CFR established new conditions for coverage that chronic renal dialysis centers must meet to be approved by the Centers for Medicare and Medicaid Services. It establishes performance expectations for centers and encourages patients to participate in their plan of care and treatment. It also reflects advances in dialysis technology and standard care practices. This regulation was updated in 2015 to be in compliance with the revised federal requirements.  The regulation should continue without modification. 

 

Amendment of Part 800 of Title 10 (Emergency Medical Services)

Statutory Authority:

              Public Health Law Section 3002

Description of the regulation:

            This regulation provides descriptions of all terms used in regulations, outlines the requirements and process in order to become a certified EMS provider in New York State.  Further, this regulation outlines the requirements to participant in the NYS Continuing Medical Education recertification program, provides the guidelines that regulate the conduct of EMS providers related to pre-hospital care and provides the guidelines on disciplinary action of EMS providers and agencies.

            The regulations will be amended to match current medical practice, educational standards and EMS operations. 

 

Addition of Part 1004 and Amendment of Subpart 55-2 of Title 10 (Medical Use of Marihuana)                                          

Statutory Authority:

              Public Health Law Section 3369-a

Description of the regulation:

            These regulations comprehensively govern the medical marijuana program pursuant to Public Health Law §§3360-3369 and set the rules for patients to participate in the program, as well as for practitioners to certify them and for Registered Organizations to manufacture and distribute medical marijuana products in New York State.

            Subpart 55-2 describes certification requirements for environmental laboratories that test samples that originate from New York State.  A new section, Section 55-2.15, was added which describes requirements for testing for medical marihuana.

            The regulations should be amended to improve patient access to the medical marijuana program, reduce the costs of medical marijuana products, clarify requirements for research on medical marijuana products, and promote social equity within the medical marijuana industry.  

            Section 55-2.15 was recently amended, effective 08/21/2019, and future amendments may be required with changes in industry standards.

 

Title 18 NYCRR - Five Year Review

Amendment of Section 505.2(l) of Title 18 (Transgender Related Care and Services)                                                           

Statutory Authority:

            Public Health Law Sections 201 and 206 & Social Services Law Sections 363-a and 365-a(2)

Description of the regulation:

            Authorizes the provision of transition-related care and services for Medicaid eligible persons diagnosed with gender dysphoria.  The regulation should continue without modification. 

 

Amendment of Sections 505.14 and 505.28 of Title 18 Personal Care Services Program (PCSP) and Consumer Directed Personal Assistance Program (CDPAP)                                         

Statutory Authority:

            Social Services Law Sections 363-a(2), 365-a(2)(e) & 365-f and Public Health Law Section 201(1)(v)

Description of the regulation:

            Sets forth the requirements for Medicaid payment for home health services provided by personal care agencies.

            This regulation is under review for amendment.

 

Title 10 NYCRR - Ten Year Review

Amendment of Subpart 6-2 of Title 10 (Ocean Surf Bathing Beaches and Automated External Defibrillators (AEDs))                

Statutory Authority:

            Public Health Law Section 225

Description of the regulation:

          The regulation requires automated external defibrillation (AED) equipment and at least one lifeguard trained in the use of an AED at regulated surf beaches during all hours of operation.  The regulation further requires all ocean surf beaches operated by a homeowners association to have qualified surf lifeguards on duty, and to comply with Subpart 6-2 of the State Sanitary Code.  The regulation should continue without modification. 

 

Addition of Section 23.5 to Part 23 of Title 10 (Expedited Partner Therapy to Treat Chlamydia Trachomatis)

Statutory Authority:

            Public Health Law Section 2312

Description of the regulation:

            The regulation permits health care providers to provide Chlamydia trachomatis patients with antibiotics or a written prescription for antibiotics to deliver to his or her sexual partner(s) without prior clinical assessment of those partners.  The regulation furthers an important goal to reduce the incidence of Chlamydia re-infection and augments provider options for managing the care of Chlamydia patients.  The regulation is under review for amendment to conform to chapter 298 of the Laws of 2019.

           

Amendment of Part 40 of Title 10 (State Aid for Public Health Services:  Counties and Cities) 

Statutory Authority:

            Public Health Law Section 602(3)(a)

Description of the regulation:

            10 NYCRR Part 40 establishes regulations regarding State Aid to local health departments for general public health work. Subpart 40-1 establishes the administrative aspects of the State Aid program.  

            In 2010, certain Subpart 40-1 regulations relating to State Aid eligibility were amended. Effective December 31, 2014, Subpart 40-1 was repealed and a new Subpart 40-1 was issued. The new Subpart 40-1 clarifies, simplifies and modernizes certain regulations related to the administrative aspects of the State Aid program.

            Part 42 establishes regulations for State Aid for public health laboratories. Part 42 was also amended in 2010 to eliminate State Aid for laboratory services that do not support public health programs. The Part 42 regulations should continue without modification.

 

Amendment of Sections 40-1 & 40-3 of Title 10 (State Aid for Public Health Services:  Counties and Cities - Reimbursement to Municipalities per PHL Article 6 for Home Health Services) 

Statutory Authority:

            Public Health Law Section 602(3)(a)

Description of the regulation:

           10 NYCRR Part 40 establishes regulations regarding State Aid to local health departments for general public health work. Subpart 40-1 establishes the administrative aspects of the State Aid program.  In 2010, certain regulations relating to State Aid for home health services provided by the local health department were amended.

            Effective December 31, 2014, Subpart 40-1 was repealed and a new Subpart 40-1 was issued. The new Subpart 40-1 clarifies, simplifies and modernizes the regulations related to the administrative aspects of the State Aid program, including those for home health services provided by the local health departments.

            Subpart 40-3, related to optional programs reimbursable for State Aid, was also repealed effective December 31, 2014.  This regulation should continue without modification.

 

Amendment of Subpart 43-2 of Title 10 (HIV Uninsured Care Programs)          

Statutory Authority:

            Public Health Law Sections 2776(1)(e), 201(1)(h) & (p) & 206(3)

Description of the regulation:

            The regulation supports access to medications, primary care and insurance premium assistance for uninsured and underinsured New Yorkers.  Additional amendments to the regulation were promulgated in April 24, 2019.  The regulation should continue without modification.

 

Addition of New Part 48 to Title 10 (Palliative Care Certified Medical Schools and Residency Programs)                                   

Statutory Authority:

            Public Health Law Sections 2807-n

Description of the regulation:

           Section 48.10 establishes the criteria for New York Medical Schools and Residency programs to become certified. The regulation provides that in order to become NYS certified the school must be accredited by the Liaison Committee on Medical Education or the American Osteopathic Association.

          Section 48.20 provides for the Commissioner or his/her designee to award designation upon receipt of an application from a NYS Medical School or residency program which meets the criteria in 48.10

          The regulations should continue without modification. 

 

Amendment of Subpart 55-2 of Title 10 (Environmental Testing for Critical Agents Using Autonomous Detection Systems (ADS))

Statutory Authority:

            Public Health Law Section 502

Description of the regulation:

            Subpart 55-2 describes certification requirements for environmental laboratories that test samples that originate in New York State.   The amendment revised Sections 55-2.10 and 55-2.13, as well as added a new Section 55-2.14, established standards for the certification and operation of environmental laboratories that seek approval to engage in critical agent testing by means of new technologies, including polymerase chain reaction (PCR)-based methods and immune-based bioassays employed at a fixed-base facility, or by use of an autonomous detection system (ADS) deployed in the field.  An ADS is, generally speaking, an automated, real-time, self-contained sampling and analytical system for detection of critical agents situated outside a fixed-base laboratory.  This regulation should continue without modification. 

 

Amendment of Section 60-1.13 of Title 10 (WIC Vendor Minimum Stocking Requirements)                        

Statutory Authority:

            Public Health Law Section 2500

Description of the regulation:

           10 NYCRR 60.1.13 sets forth the criteria that a retail vendor must meet in order to become an approved vendor for the New York State Women, Infant and Children’s (WIC) supplemental food program.

           The regulations, as they pertain to minimum stocking requirements, should continue without modification.  However, the Department intends to propose amendments to other provisions of the existing regulation to conform to U.S. Department of Agriculture (USDA) program requirements regarding vendor authorization and management including vendor participant ratio, geographic proximity and transaction volume of nearby vendors. 

 

Amendment of Subpart 69-4 of Title 10 (Early Intervention Program)                            

Statutory Authority:

            Public Health Law Sections 2540 - 2559-b

Description of the regulation:

            These regulations set forth State requirements, in conformance with federal requirements, for New York’s Early Intervention Program for infants and toddlers ages birth to three years and their families.  The regulations include definitions, child find to identify potentially eligible children, provider qualifications and standards, multidisciplinary evaluations, initial and ongoing eligibility criteria, individualized family service plans, service delivery options and standards, monitoring of providers, procedural safeguards, transition, content and retention of records, and computation of reimbursement rates for program services.  These regulations must be revised to conform to revised federal regulations and amendments to state statute. 

 

Amendment of Appendix 75-A of Part 75 of Title 10 (Wastewater Standard-Residential Onsite Systems)

Statutory Authority:

            Public Health Law Section 201(1)(l)

Description of the regulation:

           The regulation sets forth design standards to be met in the construction of residential onsite wastewater treatment systems. These design standards provide for the safe, sanitary means of treating and dispersing wastewater.  The Department intends to propose amendments to the regulations to delete reference to obsolete standards.  This regulation should continue until the proposed amendments are adopted.

 

Amendment of Subpart 86-8 of Title 10 (Ambulatory Patient Groups (APGs) Methodology)                            
 
Statutory Authority:

            Public Health Law Section 2807(2-a)

Description of the regulation:

            Modifies existing APG transition provisions for new providers and the listing of APG reimbursable and non-reimbursable services.  The regulation is under review for amendment.

 

Amendment of Subpart 86-8 of Title 10 (Ambulatory Patient Groups (APGs) Outpatient Rate Setting Methodology)
 
Statutory Authority:

            Public Health Law Section 2807(2-a)(e)

Description of the regulation:

            To refine APG payment methodology regarding new APG weights, new procedure-based weights & minor changes in APG payment rules.  The regulation is under review for amendment.

 

Amendment of Parts 405, 410, 420, 600, 703, 705, 709 and 710 of Title 10 (Revisions to Certificate of Need (CON) Process for Threshold Levels)
 

Statutory Authority:

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

Description of the regulation:

            The regulations set forth the dollar cost thresholds that determine the various levels of CON review—limited, administrative or full review—for construction projects by health care facilities subject to Article 28 of the Public Health Law.  The regulations should continue as modified in 2017 to raise dollar cost thresholds for general hospital projects. 

 

Amendment of Sections 405.3, 405.9, 405.10, 415.26, 751.6, 763.13, 766.11, and 793.5 of Title 10 (Personnel Health Amendments and Medicare Conditions of Participation)

Statutory Authority:

            Public Health Law Sections 2800, 2803, 3612 and 4010

Description of the regulation:

            The regulations were amended to permit the use of the FDA-approved blood assays for the detection of latent TB infection, as an alternative to the skin test as a condition of employment or affiliation in general hospitals, diagnostic and treatment centers, nursing homes, certified home health agencies, long term home health care programs or AIDS home care programs, licensed home care service agencies, and hospices.  In addition, the amendments were made to update the regulations to be consistent with federal requirements (Medicare Conditions of Participation) regarding the timeframe for completion of the hospital admission history and physical examinations, and for authentication of verbal orders and persons who may authenticate verbal orders in hospitals.  The regulations should continue without modification. 

 

Amendment of Sections 405.6, 405.7, 405.19, 708.5 of Title 10 (Hospital Minimum Standards and Appropriateness Review)

Statutory Authority:

            Public Health Law Section 2803

Description of the regulation:

            The regulations were amended to allow hospitals a five year “look back” period of a person’s employment instead of ten years when granting privileges to physicians, podiatrists and dentists.  The existing regulation concerning patient’s rights prohibited hospitals from discriminating against patients on the basis of race, color, religion, sex, national origin, disability, sexual orientation, or source of payment.  This amendment added a prohibition against discrimination based on age.  In addition, hospital emergency department requirements were amended to allow hospitals with less than 15,000 emergency department visits a year to staff their emergency departments with a supervising or attending physician who is not present, but is available within 30 minutes, instead of the previous requirement of 20 minutes, provided that a nurse practitioner or physician assistant is on site.  The regulations should continue without modification. 

 

Amendment of Section 405.12 of Title 10 (Circulating Nursing Required)                                                  

Statutory Authority:

            Public Health Law Sections 2800, 2803(2) and 2805-s

Description of the regulation:

            The regulation was amended to implement Chapter 158 of the Laws of 2008.  This chapter law requires general hospitals to employ a registered nurse, qualified by training and experience, to be present as a circulating nurse, in any and each separate operating room where surgery is performed for the duration of the operative procedure.  The regulation should continue without modification. 

 

Amendment of Section 709.3 of Part 709 of Title 10 (Residential Health Care Facility (RHCF) Bed Need Methodology)                                           

Statutory Authority:

            Public Health Law Section 2803(2)

Description of the regulation:

            The regulation lists the factors and formulas used in the calculation of the public need for residential health care facility beds as reviewed in the Certificate of Need (CON) process under Article 28 of the Public Health Law.  The regulation should be amended to project bed need out to 2025. 

 

Amendment of Parts 711, 712, 713, 714, 715 & 716 of Title 10 (Standards of Construction for Health Care Facilities)

Statutory Authority:

            Public Health Law Section 2803(2)

Description of the regulation:

            These regulations establish architectural, engineering and construction standards for hospitals, nursing homes, diagnostic and treatment centers and other facilities subject to Article 28 of the Public Health Law.  The regulation should be amended to require that future health care facility construction projects conform to the 2014 edition of Guidelines for Design and Construction of Health Care Facilities.

 

Amendment of Section 755.6 of Part 755 of Title 10 (Post Anesthesia Evaluations at Freestanding and Hospital Off-Site Ambulatory Surgery Centers (ASCs))

Statutory Authority:

            Public Health Law Section 2803

Description of the regulation:

            This amendment was made to conform the regulation with a federal regulatory change (42 CFR 416.42), which specifies that in the ambulatory surgery center (ASC) setting the post anesthesia assessment must be completed and documented by a physician, anesthetist, or certified registered nurse anesthetist (CRNA).  Previously, the regulation only authorized a physician to evaluate each patient for proper anesthesia recovery in ASCs.  The regulation now permits CRNAs and dentists (the federal definition of physicians includes dentists) to conduct the post-anesthesia evaluation.  The regulation should continue without modification. 

 

 

Title 18 NYCRR - Ten Year Review

Amendment of Section 505.23 of Title 18 (Certified Home Health Agency Program)       

Statutory Authority:

            Social Services Law Sections 363-a(2), SSL 365-a(2)(d)

Description of the regulation:

            Sets forth the requirements for Medicaid payment for home health services provided by a certified home health agency.  The regulation should continue without modification.