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.