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 10 NYCRR - Three Year Review

Amendment of Section 9.1 of Title 10 NYCRR - Prohibit Additional Synthetic Cannabinoids                                                         

Statutory Authority:

Public Health Law Section 225 

Description of the regulation:

In 2012, the Department issued 10 NYCRR Part 9, which addressed the emergent threat to public health by prohibiting the possession, manufacture, distribution, sale or offer of dangerous synthetic cannabinoids and other substances.

Identification and addition of new synthetic cannabinoids to the regulation simplified and enhanced the efforts of local governments to control these dangerous chemicals.  The regulation should continue without modification. 

 

Amendment of Parts 58 and 34 of Title 10 NYCRR - Patient Access of Laboratory Test Results                          

Statutory Authority:

Public Health Law Sections 576 and 587  

Description of the regulation:

Part 58 contains the clinical laboratory and blood bank regulations and Part 34 establishes business practices that clinical laboratories must follow.  10 NYCRR § 58-1 (Clinical Laboratories), 58-8 (HIV Testing) and 34-2 (Laboratory Business Practices) had stated that laboratory test results cannot be reported directly to the patient unless written authorization is first provided by the physician or authorized person.  10 NYCRR § 58-8.4 and 10 NYCRR § 34-2.11 were amended to be consistent with new federal rules that provide individuals direct access to their laboratory test reports.  The regulation should continue without modification. 

 

Amendment of Subpart 58-2 of Part 58 of Title 10 NYCRR - Blood Banks                                                            

Statutory Authority:

Public Health Law Section 3121(5) 

Description of the regulation:

Subpart 58-2 describes requirements for blood banks and laboratories performing immunohematology testing.  The amendments 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 to define requirements when new therapies and procedures are established in the field. 

 

Amendment of Subpart 66-1 of Title 10 NYCRR - School Immunization Requirements                                                     

Statutory Authority:

Public Health Law Sections 2164 and 2168 

Description of the regulation:

Subpart 66-1 of Title 10 effectuate the provisions and purposes of Public Health Law Sections 2164, regarding school immunization requirements, and 2168, regarding the statewide immunization information system. Subpart 66-1 was updated in 2015 to make the regulations consistent with current immunization recommendations.  The regulation should continue without modification; however, revisions may be necessary in the future if pending Departmental proposals are approved.

 

Amendment of Section 80.138 of Title 10 NYCRR - Opioid Overdose Programs                                        

Statutory Authority:

Public Health Law Section 3309 

Description of the regulation:

The Commissioner of Health is authorized under Section 3309 of the Public Health Law to establish standards for approval of an opioid overdose prevention program. Section 80.138 of Title 10 sets forth the structure of the New York State Department of Health’s Opioid Overdose Program which outlines the responsibilities of a registered provider trained to administer a drug that negates or neutralizes in whole or in part the pharmacological effects of an opioid in the body. This regulation sets forth the requirements of a registered provider and the responsibilities required under the program.  The regulation should continue without modification. 

 

Amendment of Subpart 86-10 of Title 10 NYCRR - 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:

Provides for updating the cost base of the rate calculation.  The regulation should continue without modification. 

 

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

 Statutory Authority:

Public Health Law Section 201

Description of the regulation:

Provides for updating the cost base of the rate calculation.  The regulation should continue without modification. 

 

Addition of Subpart 86-12 to Title 10 NYCRR - 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 threshold limits established by OASAS, OMH, and OPWDD in conjunction with DOH to help control service utilization.  The regulation should continue without modification. 

 

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

Statutory Authority:

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

Description of the regulation:

The purpose of this regulation is to extend 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 adhere to the same financial reporting requirements and standards in the filing of audited financial statements.  The regulation should continue without modification. 

 

Addition of Section 400.25 to Title 10 NYCRR - Disclosure of Quality and Surveillance Related Information                                                          

Statutory Authority:

Public Health Law Sections 2803 and 2805-t

Description of the regulation:

The regulation provides that every facility with an operating certificate shall make available to the public nursing quality indicators including staffing, patient outcomes and data regarding complaints filed with any state or federal agency.  The regulation should continue without modification. 

 

Addition of Part 404 to Title 10 NYCRR - Integrated Outpatient Services                                                                    

Statutory Authority:

Public Health Law Section 2803

Description of the regulation:

The Integrated Outpatient Services regulations were issued jointly by DOH (10 NYCRR Part 404), the Office of Mental Health (14 NYCRR Parts 598), and the Office of Alcoholism and Substance Abuse Services (14 NYCRR Part 825), effective January 1, 2015, to permit a provider licensed or certified by one agency to provide services under the jurisdiction of a second agency at one of its sites without an additional license or certification.  The regulation should continue without modification. 

 

Amendment of Part 757 of Title 10 NYCRR - Chronic Renal Dialysis Services                                      

Statutory Authority:

Public Health Law Section 2803

Description of the regulation:

These regulations mirror the CMS Conditions for Coverage for End Stage Renal Disease Services (ESRD).  The Chronic Renal Dialysis Services regulations which were in effect in NYS prior to 2015 were out of date as they were an adaptation of the 1988 CMS ESRD regulations.  These amendments incorporated the most recent Federal dialysis regulations.  Part 757 also incorporated (by reference), important infection control recommendation from the CDC, established standards for pediatric dialysis, established more stringent regulations for testing of dialysis water, emergency preparedness, and established facility staffing responsibilities that are consistent with SED practice acts.    

The regulation should continue but will need to be modified in the future.  A new modality, Nursing Home Dialysis, has been approved by CMS.  The Federal regulations have not been amended yet.  CMS has developed draft guidance describing the requirements and we await final guidance from CMS for surveillance of this type of dialysis.

 

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

Statutory Authority:

Public Health Law Section 3369-a 

Description of the regulation:

This regulation establishes rules of the Medical Marijuana Program pursuant to the Compassionate Care Act.  Part 1004 regulates the participation and registration of practitioners; the issuance of certifications; application for registration as a certified patient or designated caregiver; applications, general requirements, manufacturing and dispensing requirements, security requirements, and operations of registered organizations; laboratory testing requirements for medical marihuana; pricing, medical marihuana marketing and advertising by registered organizations; reporting dispensed medical marihuana products; prohibitions of the use of approved medical marihuana products in certain places; reporting requirements for registered practitioners, certified patients and designated caregivers; proper disposal of medical marihuana products by certified patients or designated caregivers; general prohibitions, practitioner prohibitions, and designated caregiver prohibitions and protections. 

The enactment of the Compassionate Care Act required the establishment of Part 1004 which describes requirements for the medical use of marihuana.  These regulations cover a variety of areas for the use of medical marihuana including, but not limited to, requirements for practitioners, certified patients, registered organizations, and dispensing facilities.  Section 1004.14 establishes laboratory testing requirements of medical marihuana products and require the analysis of medical marihuana in accordance with subpart 55-2.  Subpart 55-2 describes requirements for environmental laboratories performing testing on environmental samples originating from New York.  Subpart 55-2 was amended to add a new section, 55-2.15, that describes the requirements for environmental laboratories performing testing of medical marijuana.  The regulation should continue without modification. 

 

Title 18 NYCRR - Three Year Review

Amendment of Sections 505.14 and 505.28 of Title 18 NYCRR - 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:

Provides guidance for program and personal care rates.  The regulation should continue without modification. 

 

Title 10 NYCRR - Five Year Review

Amendment of Sections 2.59, 405.3, 415.19, 751.6, 763.13, 766.11 and 793.5 of Title 10 NYCRR - Prevention of Influenza Transmission by Healthcare and Residential Facility and Agency Personnel

Statutory Authority:

Public Health Law Sections 225, 2803, 3612 and 4010

Description of the regulation:

This regulation requires certain healthcare workers who are unvaccinated for influenza during the time when the Commissioner declares influenza to be prevalent to wear surgical or procedure masks.  It also requires covered healthcare facilities and entities to report their personnel influenza vaccination rates.  The regulation should continue without modification. 

 

Amendment of Part 16 of Title 10 NYCRR - Quality Assurance Requirements for Medical Use of Radioactive Material and Radiation Therapy                                                 

Statutory Authority:

Public Health Law Section 225(5)

Description of the regulation:

Requires facilities that provide radiation therapy services become accredited by the American College of Radiology (ACR) or the American College of Radiation Oncology (ACRO).  In addition, updates to the quality assurance requirements for radiation therapy were implemented.  The regulation should continue without modification. 

 

Amendment of Section 35.4 of Title 10 NYCRR - Death Certificates                                         

Statutory Authority:

Public Health Law Section 4100(2)

Description of the regulation:

The regulation governs when a death record may be disclosed and provides that, after January 1, 1988, all death certificate forms shall contain a confidential section which shall list the cause and circumstances of death.  A certified copy or certified transcript of a death certificate, upon specific request by the spouse, sibling, children, or parents of the deceased or the lawful representative of such person(s) shall be entitled to a certified copy of certified transcript of a death certificate.   The regulation also authorizes the release of a death certificate upon request by municipal, State or Federal agencies for statistical or official purposes, when needed for medical, epidemiological or scientific research approved by the State Health Commissioner, or pursuant to a court order, a demonstrated legal right, or a claim of a demonstrated medical need by an applicant.  The regulation should continue without modification.

 

Amendment of Subpart 72-1 of Title 10 NYCRR - Tanning Facilities                                       

Statutory Authority:

Public Health Law Sections 3551 and 3554

Description of the regulation:

The regulation defines the term ‘tanning facility’ and requires facility operators to obtain a biennial permit to operate from the permit issuing official (PIO) having jurisdiction in the county where the tanning facility is located. Facility inspection and enforcement standards are established, as well as, operation standards for tanning facilities including age restrictions for use of ultraviolet radiation devices, requirements for patron identification, warning and consent requirements, operation and maintenance of physical facilities and equipment, use of protective eyewear during tanning and general operator responsibilities.  The regulation should continue without modification. 

 

Amendment of Part 80 of Title 10 NYCRR - Electronic Prescribing, Dispensing and Recordkeeping of Controlled Substances                                                  

Statutory Authority:

Public Health Law Section 3308(2)

Description of the regulation:

The regulations allow practitioners to electronically write and transmit prescriptions for controlled substances; permit pharmacies to receive, dispense, maintain and archive records of these electronic prescriptions; allow pharmacists to endorse a pharmacy’s electronic record with an electronic signature and other required information for refills of controlled substances; and authorize a pharmacist to document an oral prescription for controlled substances to an electronic record.  The regulation should continue without modification. 

 

Amendment of Part 80 of Title 10 NYCRR - Prescription Monitoring Program                                                   

Statutory Authority:

Public Health Law Article 33, Sections 3333, 3343-a and 3371

Description of the regulation:

The regulations require electronic reporting of prescription information from pharmacies and dispensing practitioners for controlled substances, to the New York State Department of Health, within 24 hours of delivery of the prescription.

Practitioners are required to consult the Prescription Monitoring Program (PMP) Registry prior to prescribing for or dispensing to a patient any controlled substance listed on schedule II, III, or IV, for the purpose of reviewing that patient’s controlled substance history.  A practitioner may authorize a designee to consult the prescription PMP Registry on his or her behalf, provided that the ultimate decision as to whether or not to prescribe or dispense a controlled substance remains with the practitioner.

The regulation ensures that practitioners are aware of other controlled substance prescriptions that their patients have recently received and avoid over-prescribing, misuse or abuse of controlled substances.

The legislation also authorizes the sharing of confidential data with statutorily identified entities.  The regulation should continue without modification.

 

Amendment of Sections 80.131 and 80.133 of Title 10 NYCRR - Electronic Prescriptions and Records for Hypodermic Needles and Hypodermic Syringes                 

Statutory Authority:

Public Health Law Section 3381

Description of the regulation:

Hypodermic needle and syringe regulations removed the barriers to prescribing and dispensing of needles and syringes. The regulations provide greater access to needles and syringes by the patient by allowing pharmacists to receive oral prescriptions from the agent of the practitioner; allowing practitioners to authorize necessary refills with no limits; allowing prescriptions to be valid for longer than a 6-month period; and allowing a refill to be transferred to another pharmacy for dispensing, based on the patient’s request.  The regulation should continue without modification.

 

Repeal of Section 85.45 of Title 10 NYCRR and Section 506.4 of Title 18 NYCRR - Orthodontic Screening 

Statutory Authority:

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

Description of the regulation:

            Section 506.4 describes the location of the review criteria, the age limitations, and the practitioner qualifications for the orthodontic benefit.  The regulation should continue without modification.

 

Amendment of Sections 86-1.2 and 86-1.4 of Title 10 NYCRR - Audits of Institutional Cost Reports 

Statutory Authority:

Public Health Law Section 2807-c (35)

Description of the regulation:

Section 86-1.2 describes the financial and statistical data filing requirements for hospitals.  Section 86-1.4 describes the audit requirements/process for the financial and statistical data filed by hospitals.  The regulation should continue without modification. 

 

Amendment of Part 405 of Title 10 NYCRR - Hospital Pediatric Care                                                            

Statutory Authority:

Public Health Law Section 2803(2)

Description of the regulation:

These regulations established minimum general hospital standards for administration, radiology/nuclear medicine, respiratory, emergency, surgical and anesthesia services, including new requirements for pediatric intensive and emergency care (Parts 405.3, 405.6, 405.7, 405.9, 405.15. 405.12, 405.17,405.19, 405.20, 405.22).  The regulation should continue without modification. 

 

Amendment of Parts 405 and 751 of Title 10 NYCRR - Adverse Event Reporting Via NYPORTS System                                             

Statutory Authority:

Public Health Law Sections 2803(2), 2805-1 and 2805(m)

Description of the regulation:

Part 405.8   Adverse event reporting

Part 405.8 requires general hospitals to report certain adverse events to the Department within a specified timeframe.  Part 405.8 provides the definitions of the adverse events.  The definitions are consistent with National Quality Forum (NQF) definitions, which the Department partially adopted in July 2011.  Part 405.8 requires the Hospital to conduct an investigation of certain adverse events, and to submit an electronic version of the investigation to the Department within a specified timeframe.   Part 405.8 states the investigation must identify and analyze the circumstances surrounding the event, and must develop and implement measures to prevent recurrence and to improve the overall quality of patient care.

Part 751.10 Adverse event reporting

Part 751.10 requires Diagnostic and Treatment Centers (D&TCs) to report certain adverse events to the Department within a specified timeframe.  Part 751.10 provides the definitions of the adverse events.  The definitions are consistent with National Quality Forum (NQF) definitions, which the Department partially adopted in July 2011.  Part 751.10 requires the D&TC to conduct an investigation of certain adverse events, and to submit an electronic version of the investigation to the Department within a specified timeframe.   Part 751.10 states the investigation must identify and analyze the circumstances surrounding the event, and must develop and implement measures to prevent recurrence and to improve the overall quality of patient care.

The language in the current versions of the regulations are consistent with national standards (National Quality Forum Never Events, and Joint Commission Sentinel Events).  The regulations hold Article 28 Hospitals and D&TCS accountable for correcting systematic problems that contribute to an adverse event.  The regulation should continue without modification.

 

Amendment of Sections 405.2 and 405.4 of Title 10 NYCRR - Hospital Sepsis Protocols  

Statutory Authority:

Public Health Law Sections 2800 and 2803

Description of the regulation:

Parts 405.2 and 405.4 were amended and enacted on May 1, 2013 to require all hospitals licensed to operate in New York State to have in place and implement evidence-based protocols for the early identification and treatment of severe sepsis and septic shock.  These amendments were made in response to the high prevalence and mortality rate of sepsis.

The sepsis regulations at part 405.4 as initially drafted include guidelines and a definition of sepsis that are no longer consistent with current international guidelines. The Office of Quality and Patient Safety, Office of the Medical Director has proposed an amendment that will refine the definition of sepsis and the guidelines for treatment to assure consistency with current evidence.  In addition, a revision is proposed to ensure the Department’s ability to receive data through different intake options in the future should the need arise due to bandwidth issues, i.e. poor network speeds, or due to contractual or funding constraints related to the current process of data intake through IPRO’s secure web portal.  The regulation at part 405.2 is not affected by the changes proposed to part 405.4 and therefore should continue without modification.

 

Amendment of Parts 763 and 766 of Title 10 NYCRR - Certified Home Health Agency (CHHA) and Licensed Home Care Services Agency (LHCSA) Requirements  

 

Statutory Authority:

 

Public Health Law Section 3612

Description of the regulation:

These regulations will be amended to reflect the enactment of legislation authorizing the performance of advanced tasks by Advanced Home Aides supervised by nurses employed by CHHAS, LHCSAS, hospice programs, or enhanced assisted living residences (Chapter 471 of the Laws of 2016).

 

Amendment of Section 910.2 of Title 10 NYCRR - Language Assistance and Official New York State Prescription Form Requirements                                       

Statutory Authority:

 Public Health Law Section 281(2)

Description of the regulation:                              

Language barriers and the inability to read or understand prescription information can pose health risks to patients with limited English proficiency (LEP).  Amendments to Section 281 of the Public Health Law require Official New York State Prescription (ONYSRx) forms and electronic prescriptions to include a section that allows prescribers to indicate whether an individual is limited English proficient and, if so, the preferred language of the patient.

Contents related to the ONYSRx form or electronic prescription, to meet the legislative mandate for LEP, was described and defined in detail.  The regulation should continue without modification.

 

Addition of Part 1002 to Title 10 NYCRR - Limits on Executive Compensation and Administrative Expenses in Agency Procurements                                                    

Statutory Authority:

Social Services Law Sections 363-a(2) and Public Health Law Sections 201 & 206(3)

Description of the regulation:

Limits administrative expenses and executive compensation.  The regulation should continue without modification. 

Title 18 NYCRR - Five Year Review

Amendment of Section 360-2.4 of Title 18 NYCRR - Medicaid Eligibility

Statutory Authority:

Public Health Law Sections 201 and 206 & Social Services Law Section 363-a

Description of the regulation:

Description of the regulation: Establishes times frames under which the social services district must determine an applicant’s Medicaid eligibility.  In general, it is within 45 days from the date of the application, subject to certain exceptions. The regulation also establishes the periods of time when coverage is available.

The regulation should continue without modification. 

 

Amendment of Parts 486 and Part 487 of Title 18 NYCRR - Adult Homes

Statutory Authority:

Social Services Law Sections 460-d, 461, and 461-e

Description of the regulation:

Effective January 16, 2013, regulations Section 486.7 of Part 486 and Part 487 of Title 18 of the Official Compilation of Codes, Rules and Regulations of the State of New York, were amended and adopted. The regulations affect New York State's adult homes. Specifically, the amended regulations provide definitions for the following: persons with serious mental illness; transitional adult homes; alternative community settings; community services; mental health census; housing contractors; and community transition coordinator.

In addition, the amended regulations, among other things:

  • Modify admission and retention requirements for all adult homes regarding individuals with serious mental illness;
  • Define adult homes with a certified capacity of 80 beds or more, in which 25% or more of the resident population are persons with serious mental illness, as "transitional adult homes;"
  • Require every operator of a transitional adult home to submit a compliance plan designed to bring the facility's mental health census to a level that is under 25 percent of the resident population over a reasonable period of time, through the lawful discharge of residents with appropriate community services to alternative community settings;
  • Expand the requirements for the completion of mental health evaluations, and make authority to complete a mental health evaluation subject to DOH approval;
  • Set forth requirements for quarterly statistical reporting by transitional adult homes;
  • Provide for additional record keeping requirements for all adult homes; and
  • Set forth penalties for provider non-compliance.

The regulation should continue without modification.

 

Amendment of Section 505.3 of Title 18 NYCRR - Authority to Collect Pharmacy Acquisition Cost                                     

Statutory Authority:

Social Services Law Sections 363-a(2) and 367-a(9)(b) & Public Health Law Sections 201(1)(v) and 206

Description of the regulation:

Per 505.3(f)(4), each pharmacy enrolled in the Medicaid program shall provide the department, in such manner, for such periods, and at such times as the department may require, with the drug acquisition cost, as defined in paragraph 505.3(a)(3), of prescription drugs.  The regulation should continue without modification. 

Title 10 NYCRR - Ten Year Review

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

Statutory Authority:

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

Description of the regulation:

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

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

 

GENERAL PROVISIONS

LOCAL HEALTH OFFICER

COMMISSIONER OF HEALTH

MEDICAL DIRECTOR OF COUNTY PHYSICALLY HANDICAPPED CHILDREN'S PROGRAMS

PUBLIC HEALTH NURSE 1

PUBLIC HEALTH NURSE 2

ENVIRONMENTAL HEALTH DIRECTOR

PUBLIC HEALTH ENGINEER

PUBLIC HEALTH SANITARIAN

PUBLIC HEALTH TECHNICIAN

PUBLIC HEALTH NUTRITIONIST

PUBLIC HEALTH EDUCATOR

PUBLIC HEALTH SOCIAL WORKER

PUBLIC HEALTH DIRECTOR

PUBLIC HEALTH EPIDEMIOLOGIST

 

The regulation should continue without modification.

 

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

Statutory Authority:

Public Health Law Section 2168

Description of the regulation:

Section 66-1.2 of Title 10 define authorized users of the New York State Immunization Information System (NYSIIS) and the Citywide Immunization Registry (CIR), mandated NYSIIS and CIR reporters, reporting requirements including information to be reported, methods of reporting, exceptions to reporting requirements, and timeliness of reporting, methods of accessing immunization data, maintenance of security and confidentiality, and the provision of NYSIIS information to registrants’ families or guardians.  The regulation should continue without modification.

 

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

Statutory Authority:   

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

Description of the regulation: 

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

 

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

Statutory Authority:

Public Health Law Section 2808(22)

Description of the regulation:

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

 

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

Statutory Authority:  

Public Health Law Section 2807(2)(a)

Description of the regulation: 

Established regulations for the new APG reimbursement system effective 12/1/2008 forward.   The Department is considering amendments to the regulation.

 

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

Statutory Authority:   

Public Health Law Sections 2803, 2807, 2808

Description of the regulation: 

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

 

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

Statutory Authority:

Public Health Law Sections 4910 – 4916

Description of the regulation: 

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

The Subpart should be revised to reflect changes to Article 49 of the Public Health Law.  These revisions will be promulgated in conjunction with revisions to Department of Financial Services regulations at 11 NYCRR 410.

 

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

Statutory Authority:

Public Health Law Sections 2800 and 2803

Description of the regulation:

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

 

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

Statutory Authority:

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

Description of the regulation:

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

 

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

Statutory Authority:

Public Health Law Sections 206 and 3308(2)

Description of the regulation:

Public Health Law Section 21 defined the use of the Official New York State Prescription Form as it applies to all medications issued by New York State licensed practitioners.  The corresponding Part 910 regulations established definitions, minimum standards for registration to utilize the prescription forms, a system for ordering and tracking the serialized forms, safeguards and storage of the forms by registered practitioners and institutional dispensers, and dispensing upon prescription forms.  Official New York State Prescription Program forms are still in use.  The regulation should continue without modification. 

 

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

Statutory Authority:

Public Health Law Section 4662(1)

Description of the regulation:

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