Department of Health

The following regulatory actions are under consideration for submission as a Notice of Proposed Rulemaking from January through June 2012:

DESCRIPTION OF THE RULE SUBJECT MATTER

Title 10 NYCRR (Health)

Family Health Care Decisions Act - Promulgate regulations as required under Public Health Law section 2994-t (L. 2010, Ch. 8).

Statewide Health Information Network for New York (SHIN-NY) - Promulgate regulations as required under Public Health Law section 206(18-a)(b) (L. 2010, Ch. 58, Part A, § 11).

1.31 Disclosure of Confidential Cancer Information for Research Purposes - Amend the existing regulations which specifies that confidential cancer data can only be disclosed for governmental or government-sponsored research projects to be more consistent with current cancer research needs and sponsorship practices. The regulations will provide clearer definitions of the circumstances under which confidential cancer information can be released for research and non-research purposes.

2.1 and 2.5 Communicable Diseases - Revise the list of reportable diseases in 10 NYCRR, section 2.1 to be consistent with those listed in section 2.5 (list of diseases for which physicians have a duty to submit specimens).

2.14 Communicable Diseases - Update the rabies regulations to be consistent with changes enacted to the Public Health Law (PHL). The regulations will provide definitions and requirements for reporting human exposures, confinement of animals exposing people to rabies, quarantine of animals exposed to rabies, and county responsibility for establishing provisions for animal control related to rabies.

5-1 Public Water Systems - Amend the regulations to incorporate mandatory federal regulations to improve control of microbial pathogens (federal LT2SWTR) while limiting risks associated with the formation of and exposure to disinfection byproducts (federal Stage 2 D/DBPR).

5-1 Public Water Systems - Amend the regulations to incorporate mandatory federal regulations to improve the control of lead and copper in public water supply systems. This will include the federal minor revisions and short-term revisions to the Lead and Copper Rule (LCR). To be included will be a restructuring of 5-1 Appendix C to update and simplify listings of analytical methods approved for drinking water, including lead and copper analyses.

5-1 Public Water Systems - Amend the regulations to update provisions pertaining to backflow device tester certification requirements; revise the provisions applicable to variances and exceptions and update and clarify specific code references.

14-1, 14-2, 14-4, 14-5 Food Protection - Modify the requirements to meet changing food service issues; exempt certain operators and rescind certain provisions, address the legislative mandate regarding food worker training courses.

16 Ionizing Radiation - Amend the regulations to be consistent with federal regulations and mandates applicable to medical and industrial use of radioactive material, radiation protection standards and license termination/decommissioning standards. Update and revise the quality assurance requirements for radiation therapy to align with current treatment delivery system technology to ensure patient safety and add a requirement for facility certification. Update the quality assurance requirements for diagnostic x-ray equipment, including computed tomography, to align with current equipment and imaging modalities to ensure patient safety. Consolidate current requirements in 12 NYCRR Part 38 (NYS DOL Ionizing Radiation) into 10 NYCRR Part 16, consistent with the merger of the NYS DOL Radiological Health unit into the DOH/CEH/BERP program in 2006.

19 Clinical Laboratory Directors - Revise qualifications for directors of clinical laboratories to recognize professional boards accepted as qualifying under the federal Clinical Laboratory Improvement Amendments (CLIA); and codify the definition of assistant director; and establish qualifications for directors of forensic identity and other categories not currently specified in the regulation.

22.3 Supplementary Reports of Certain Congenital Anomalies for Epidemiological Surveillance; Filing - Amend the regulations by requiring the reporting of children up to 10 years of age with certain birth defects to the Congenital Malformations Registry. This change will support an improved ability to accurately document prevalence rates for certain birth defects, such as fetal alcohol syndrome and Duchenne muscular dystrophy, which are often not diagnosed until a child is older. Improved surveillance will also help monitor the impact of any preventive measures.

22.7 Reportable Levels of Heavy Metals in Blood and Urine - Amend the regulations to remove the threshold levels for reporting cadmium, mercury and arsenic. All laboratory tests for cadmium, mercury and arsenic will be submitted to enable case monitoring to assist in assessing interventions and education to reduce elevated exposures.

23.1 Sexually Transmitted Diseases - Amend the regulations to update the list of sexually transmitted diseases to change archaic terminology, to add Human Papilloma Virus to the list; and to remove Genital Herpes Simplex from the list of conditions which require free treatment.

23.2(d) Sexually Transmitted Diseases - Amend the regulations to modify the treatment requirements for Pelvic Inflammatory Disease to include permission for out-patient management through immediate referral.

23.2(e) Sexually Transmitted Diseases - Amend the regulatory list of conditions which may be treated with a written prescription to include Yeast (Candida) Vaginitis, Bacterial Vaginosis, Pediculosis Pubis, and Scabies.

23.2(f) Sexually Transmitted Diseases - Add a new subsection providing for management and treatment of Genital Herpes Simplex and Human Papilloma Virus infection by either prescription or referral.

23.3 Sexually Transmitted Diseases - Amend the regulations to eliminate the section to be consistent with the reporting requirements of communicable diseases as written in Section 2.10, which requires cases of syphilis, gonorrhea, chlamydia, lymphogranuloma venereum, and chancroid to be reported individually and by name.

40-2 State Aid for Public Health Services: Counties and Cities - Amend the regulations to amend Subpart 40-2 to clarify eligible technical assistance activities pertaining to delivery of the Realty Subdivision program and Individual Water and Sewer programs.

40-2 and 40-3 State Aid for Public Health Services: Counties and Cities - Amend the regulations to repeal Subpart 40-3 and amend Subpart 40-2 to add new Subparts 40-2.240, 40-2.241, 40-2.250 and 40-2.251 to allow certified counties and New York City, when authorized by the Department to receive aid to implement Part 16 of the State Sanitary Code to inspect x-ray installations; and also to authorize New York City to license and inspect radioactive materials facilities.

44 State Aid for Approved Vector Surveillance and Control Programs - Amend the regulations to update State aid provisions to be consistent with changes enacted to PHL in January 2007. The regulations will provide new and updated definitions, add new vector borne diseases, and clarify eligible local health department activities for arthropod-borne disease surveillance, control and prevention.

52 Tissue Banks and Nontransplant Anatomic Banks - Revise requirements for procurement of tissue from deceased donors, including setting restrictions on banks' ownership and business relationships with funeral directors and funeral firms, and limiting recovery of tissue to hospitals and appropriately licensed banks, and enhancing monitoring and enforcement of restrictions on the sale of human tissue for transplant. In addition, update technical requirements to reflect advances in technology and changes in industry standards.

52-12 Therapeutic Cell Banks - Promulgate a new subpart addressing technical standards for the collection, processing, storage, and distribution of nucleated cells, including, but not limited to, mesenchymal cells, embryonic stem cells, dendritic cells, and stromal cells, intended for a therapeutic purpose other than hematopoietic reconstitution or reproduction.

57 Rabies - Dogs at Large in Rabies Areas - Delete this provision. It is outdated since rabies is endemic in wildlife in New York. Important provisions are being included in Section 2.14. This Part is no longer needed, and is proposed for deletion.

58-1 Clinical Laboratories - Revise laboratory personnel requirements to reflect industry standards; consolidate existing requirements for clarity; codify quality systems, performance testing and other requirements as necessary to align with federal CLIA standards; clarify assistant director responsibilities; establish standards for tracking and referral of critical agent and communicable disease specimens; and establish standards for demonstrating the technical and clinical validity of test methods.

58-2 Blood Banks - Amend the regulations to permit emergency medical technicians, with additional training, to administer transfusions during inter-facility transport; enhance donor and patient safeguards; update technical requirements; eliminate obsolete requirements; clarify regulatory intent; meet federal requirements as directed by the Centers for Medicare and Medicaid Services; provide regulated parties with greater flexibility in complying with regulations regarding emergency transfusions, qualifying donors over 75 and apheresis donors, and provide options for equivalent electronic records.

58-5 Hematopoietic Progenitor Cell Banks - Update requirements for donor suitability determination, infectious disease testing, and record keeping related to hematopoeitic progenitor cell (HPC) donation and transplantation. Amend the regulations to require the HPC bank medical director to establish a policy regarding testing allogeneic donors for West Nile virus, Trypanasoma cruzi, and hemoglobinopathies.

63 HIV/AIDS Testing, Reporting and Confidentiality of HIV-Related Information - Amend relevant sections of Part 63 to be consistent with Chapter 308 of the Laws of 2010, the HIV Testing Law.

66-1.1 thru 66-1.10 and 66-2.1 through 66-2.9 Immunization - Update the regulations to be consistent with changes enacted to the PHL. The regulations will add pertussis, tetanus and pneumococcal disease to the list of required pre-school immunizations and also address the requirement that children receive a booster for varicella and tetanus, diphtheria and pertussis, by the time they enter sixth grade. Various regulatory changes are also proposed to update immunization recommendations to reflect current recommendations, including the requirement of a second dose of varicella and mumps vaccine. Language will also be added to clarify medical exemptions and annual school immunization survey requirements, and change physician diagnosis standards for measles and mumps to reflect the rarity of these diseases. Redefine "in process" for students receiving mandated vaccinations and establish time limits for completion of needed immunizations.

66-3 Immunization - Amend the regulations to add Subpart 66-3 to Title 10 to require all health care personnel employed or affiliated with a health care facility, document as a precondition of employment and annually, immunizations for influenza virus. The requirement is subject to the availability of an adequate supply of the necessary vaccine and exemptions for medical contraindications. In addition, parallel regulatory changes are proposed to Sections 405.3 (hospitals), 751.6 (diagnostic and treatment facilities), 763.13 and 766.11 (home health agencies and programs), and 793.5 (hospices) of Title 10. Any facility defined as a hospital or diagnostic and treatment centers pursuant to PHL Article 28, home care agency within PHL Article 36, or hospice within PHL Article 40 will be required to comply with the referenced requirements detailed in Subpart 66-3.

68.6 Distributions from the Health Care Initiatives Pool for Poison Control Center Operations - Repeal previous regulations and add new regulations that revise the methodology for distributing Health Care Reform Act (HCRA) grant funding to Regional Poison Control Centers (RPCCs).

69-4 Early Intervention Program - Amendments may be needed to conform current state regulations to final federal regulations recently promulgated under Part C of the Individuals with Disabilities Education Act, as amended by the Individuals with Disabilities Education Improvement Act of 2004. The final federal regulations became effective on October 28, 2011. Several areas of regulations may include Section 69-41.1, Definitions; Section 69-4.8, Evaluators/Screening, Evaluation, and Assessment Responsibilities; Section 69-4.11, Individualized Family Service Plan; Section 69-4.17, Procedural Safeguards; Section 69-4.20, Transition Planning; and, Section 69-4.23, Initial and Ongoing Eligibility Criteria. State compliance must be achieved by July 1, 2012, to ensure continued receipt of federal funds. Amendments may be proposed to ensure quality, consistency, and equity in access to early intervention services, including Section 69-4.4, Qualifications of Service Coordinators; Section 69-4.9, Standards for Provision of Services; and Section 69-4.12, Monitoring of Approved Providers. Amendments related to Section 69-4.30, Computation of Rates for Early Intervention Services, resulting from Department's continuing review of the program's reimbursement methodology may also be proposed. Additional amendments may be proposed if Title II A of Article 25 of Public Health Law on the Early Intervention Program, is revised in 2011.

69-8 Newborn Hearing Screening - Amend the regulations to specify follow-up where conditions of the screening are considered to contribute to invalid results; require reporting of individualized, identifiable data to the department; require staff involved in newborn hearing screenings to complete training; require that infants who fail an initial screening receive at least one additional screening prior to discharge; require that a re-screening post discharge from a facility occur within 8 weeks of discharge; require that an infant be referred to the early intervention program as an at-risk child, unless the parent objects, if the results of a follow-up outpatient screening are not returned to the facility within 45 days post discharge; require reporting to an electronic data system.

72-2 Body Piercing and Tattooing - Amend the regulations to be consistent with Public Health Law Article 4-A - Regulation of Body Piercing and Tattooing. The regulations will provide definitions and requirements for permit, inspection, and operation of tattooing facilities and the licensing of tattoo artists.

73 Asbestos Safety Training Program Requirements - Amend the regulations to incorporate changes made by the New York State Department of Labor to Code Rule 56 as well as changes that have occurred in the industry that should be reflected in the training programs.

74 Approval of Realty Subdivisions - Amend the regulations to update and clarify requirements for plan submittals and approvals of realty subdivisions.

75 Standards for Individual Water Supplies and Individual Sewage Treatment Systems and Appendix 75C - Individual Water Well Quality Standards - Amend the individual water supplies and sewage treatment system regulations to clarify design submittal and approval procedures; add new regulations for individual water wells in order to establish water quality reference standards for individual household wells.

77 Funeral Establishments, Registrations, Funeral Directing, and Misconduct-Amend the regulations to prohibit the recovery of tissue within a funeral establishment and not allow non-transplant anatomical banks to operate within such establishments or the requesting of consent for an anatomical donation by a funeral director or employees of a funeral firm.

80 Controlled Substances - Amend the regulations to allow for electronic transmission, documentation, record keeping and endorsement of controlled substance and hypodermic needle and syringe prescriptions to allow for transfer of needle and hypodermic syringe prescriptions and eliminate the requirement for a written follow-up prescription for oral prescriptions (authorizations) for needles and syringes. Amend the regulations to permit prescribing of needles and syringes pursuant to a patient specific order form, as defined in State Education Law Section 6810 (7)(b). Amend Part 80 to update reporting requirements for Methadone Maintenance Treatment Programs enacted by Public Health Law Section 3352 statutory changes. Outline the training requirements associated with certification of Euthanasia Technicians (for animals) as required by Section 374 (3)(b) of the Agriculture and Markets Law. Amend the regulations to allow for interstate sharing of prescription monitoring program information.

80.131 and 80.137 Expanded Syringe Access Demonstration Program - Sale and possession of hypodermic syringes and hypodermic needles without a prescription under the Expanded Syringe Access Demonstration Project (ESAP) - Amend Section 3381 by removing "Demonstration" from the title of the program and formally adopt "Expanded Syringe Access Program" as the name of the program since the program has now been made permanent pursuant to Chapter 58 of the Laws of 2009.

81.5 Investigation and Determination - Amend the regulations to allow the NYS Department of Health to initiate an investigation within 2 working days to coincide with federal requirements for investigating a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.

85.13 Physically Handicapped Children - Rescind the regulation thus eliminating the designation of the Physically Handicapped Children's Program speech and hearing centers as the only providers of hearing assessments to Medicaid eligible children.

86-1 Inpatient Hospital Reform - Amend the regulations to: establish a new methodology to address potentially preventable readmissions and complications; establish a methodology to deny Medicaid reimbursement for hospital acquired conditions, based on quality-related measures; establish a new payment methodology for hospital inpatient psychiatric services; implement revised APR-DRGs, Service Intensity Weights, cost outlier thresholds and average length of stay effective January 1, 2012; implement a statewide base price reduction in order to achieve targeted savings on an interim basis while the State consults with stakeholders to develop and implement a clinically sound approach to reducing inappropriate cesarean deliveries; grant approval of temporary adjustment to rates for hospitals subject to mergers, acquisitions or consolidations; change the Hospital Quality Contribution rate; and establish a methodology for episodic payments for Certified Home Health Agency services.

86-1.2 Accountant's Certification - Amend the regulations to require an accountant's certification of institutional cost reports only for years prior to 2010.

86-1.4 Institutional Cost Reports/Audits - Amend the regulations to establish a fee for filing institutional cost reports and to fund Department audits of medical facilities.

86-1.13-b Episodic Pricing System for Certified Home Health Agencies - Amend the regulations by adding a new section to make Medicaid payments for certified home health agencies based on 60-day episodes of care, with adjustments for patient acuity and regional wage differences.

86-1.31 Merged Rates - Amend the regulations to eliminate the requirement that a merger, acquisition or consolidation needs to occur on or after the year the rate is based upon in the case of a hospital receiving a temporary rate adjustment as a result of such merger, acquisition or consolidation. Amend the regulations to expand the temporary rate adjustment to hospital closures or hospitals affected by the closure, merger, acquisition or consolidation of another hospital.

86-2 Nursing Home Reform - Amend the regulations to establish a regional pricing model for nursing homes.

86-4.39 Computation of Rates for Methadone Maintenance Treatment Services In Freestanding Ambulatory Care Facilities and Hospital Outpatient Clinics - Amend the regulations to conform with changes made to OASAS regulations at Parts 822, 828 and 841 of 14 NYCRR to implement Ambulatory Patient Group (APG) billing methodology.

86-8.15 Outpatient Reform - Amend the regulations to establish a regional pricing model for outpatient services; grant approval of temporary adjustment to rates for hospital outpatient facilities, diagnostic and treatments centers and ambulatory surgery centers subject to mergers, acquisitions or consolidations.

86-8.7 APGs and Relative Rates - Amend the regulations to revise the October 2011 weights and add new hospital peer groups.

94.2 Physician Assistants - Amend the regulations to allow a Registered Physician Assistant to prescribe controlled substances, including Schedule II substances, for patient's under the care of the supervising physician in conformance with Public Health Law Section 3703(3).

98-1 Various Technical Amendments - Revise the regulations, making technical corrections: 1) 98-1.9(b)(3), requiring managed care organizations (MCOs) to provide assurances of continuing compliance with Article 49 of the Public Health Law, in addition to Article 44 and Part 98; 2) 98-1.11(h), restoring language that prohibits health maintenance organizations (HMOs) from discriminating in enrollments and services provisions; 3) 98-1.11(k)(4), clarifying that the MCO is responsible for monitoring contractors' fiscal stability; 4) 98-1.11(q), clarifying that MCOs must comply with Article 49 of the Public Health Law, in addition to Article 44 and Part 98; 5) 98-1.13(c)(iii), correcting a 2005 change which inadvertently limited provider contract assignments to within one year of promulgation of the rule to reflect that the rule applies prospectively; and 6) amending 98-1.5(6)(e)(2) the MCO management functions to reflect that if an independent practice association (IPA) is delegated MCO management functions, then a separate management contract is required and it must be separate from the delivery of service contract.

98-1.5 Application for a Certificate of Authority - Amend the regulations to require electronic submission of the managed care organization's provider network, consistent with the filing requirements in 98-1.16(j). Modify Section (b)(6)(vii)(e)(2) to specify that an independent provider association (IPA) performing management functions should have requirements detailed in a contract separate and apart from the IPA provider agreement.

98-1.6 Issuance of the Certificate of Authority - Amend the regulations to add a provision requiring managed care organizations (MCOs) to maintain a complete file on each request for health care services or benefits and associated appeals pursuant to Article 49 of the Public Health Law and federal law and regulations.

98-1.8 Continuance of a Certificate of Authority - Amend the regulations to clarify that managed care organizations must maintain compliance with the requirements of PHL Articles 44 and 49 and 10 NYCRR Part 98, including provisions related to initial application and certification standards, in order to maintain their certificate of authority.

98-1.11(b) & (e) Operational and Financial Requirements for MCOs - Amend the regulations to specify criteria that would be used to evaluate requests for approval of asset transfers or loans. Section 98-1.11(e) would be amended to temporarily lower the contingent reserve requirement applied to revenues from the Medicaid managed care and Family Health Plus programs.

98-1.13 Assurance of Access to Care - Amend the regulations to: 1) require that managed care organizations (MCOs) ensure each member has selected a primary care provider from which the member receives all primary care services; 2) address requirements related to subdivision 5-d to Section 4406-c which imposes a "cooling off" period after termination or non renewal of a contract between an MCO and a hospital; 3) amend regulations to clarify that certain out-of-network service denial notices must include internal MCO and external appeal rights afforded by Section 4904(1-a); and 4) promote consistency of initial adverse determination notices issued in accordance with Section 4903(5) by clarifying notice content requirements.

98-1.16(c) Preparation and Filing of Audited Financial Statements - Amend this part and new section 98-3 to establish standards for the preparation and filing of audited financial statements by PHSPs, HIV SNPs, and managed long term care plans that are consistent with the National Association of Insurance Commissioners (NAIC) model audit rules already adopted by the New York State Insurance Department for other insurers.

98-1.18(a) MCO Agreements - Amend the regulations to add this section as it applies to MCO agreements with licensed pharmacies and laboratories acting as benefit managers arranging for services, equipment and supplies.

98-2 External Appeals of Adverse Determinations - Amend the regulations to reflect changes to Article 49 of the Public Health Law made by Chapter 237 of the Laws of 2009, Chapter 451 of the Laws of 2007, Chapter 219 of the Laws of 2011 and the Patient Protection and Affordable Care Act (PPACA).

128 New York City Watershed Rules and Regulations - Amend the regulations to incorporate requirements intended to protect NYC's Watersheds and preserve NYC's Filtration Avoidance Determination by providing various limitations on watershed activities and construction.

400 All Facilities - General Requirements - Amend the regulations to require that Article 28 facilities make available to the public and others information regarding nurse staffing and patient outcomes.

400.15 and 700.4 The Role of the Licensed Practical Nurse (LPN) in Intravenous Therapy Procedures - Amend the regulations to be consistent with the LPN scope of practice.

400.18 Ambulatory Care Data Collection (SPARCS) - Amend the regulations to authorize collection of medical record information for all patients in an ambulatory care setting.

400.18 Statewide Planning and Research Cooperative System (SPARCS) - Repeal Section 400.18 and add a new Section 400.18 to reflect current practices of SPARCS. New Section 400.18 will permit SPARCS to collect all other outpatient clinic data not presently being collected by SPARCS from general hospitals and diagnostic and treatment centers licensed under Article 28 of the Public Health Law. As a result of the changes to Section 400.18, the following will be repealed: Appendix C-2, Appendix C-3, Appendix C-5, Section 755.10, and Section 405.27. Section 407.5 and Section 400.14 will be amended to coordinate to the revised Section 400.18.

400.21 Advance Directives - Amend the regulations as required under Public Health Law Section 2994-t within Article 29-CC - Family Health Care Decisions Act. REPEAL identical provisions in 700.5.

400.25 Disclosure of Nursing Quality Indicators - Amend the regulations to create a new section 400.25 in response to Chapter 422 of the Laws of 2009, the Nursing Care Quality Protection Act. The law requires Article 28 facilities to disclose identified nursing quality indicator information upon request to any member of the public, any state agency licensing the facility or responsible for overseeing the delivery of services by the facility, or any organization accrediting the facility. The law requires promulgation of regulations to enable disclosure of this information to requestors.

402 Criminal History Record Check - Amend the regulations to provide specific timeframe requirements for scanning the fingerprints of covered employees.

403 Home Care Worker Registry - Amend the regulations to add a new section to develop and maintain a home care services worker registry of home care services workers.

405 Pediatric Amendments - Amend the regulations to incorporate various pediatric amendments into the Hospital Minimum Standards provisions.

405.7 Patients' Rights - Amend the requirements limiting the use of physical restraints to be consistent with federal guidelines.

405.8 Incident Reporting - Amend the regulations to update the Department's New York Patient Occurrence Reporting and Tracking System (NYPORTS) provisions for hospitals to reflect current practice.

405.9 Admission/Discharge - Revise regulations to clarify that all donor and procurement responsibilities must be carried out before a dead body is removed from a hospital.

405.11 Infection Control - Amend the regulations to conform to PHL Section 2819(2). The proposed regulation would define requirements for hospitals to report select hospital acquired infections using methods, definitions and protocols defined by the Department, ensures patient privacy in collection and release of data and creates standards for publication and release of the data reported.

405.19 Emergency Services - Amend the regulations to authorize and provide operating standards for observation units.

405.20 Outpatient Services - Amend the regulations to cross reference 752.2 for hospital based free standing emergency facilities.

405.22 Critical Care and Special Care Services - Update the regulations regarding the organ transplant center provisions; and provide specific minimum standards for pediatric intensive care units (ICUs) similar to adult ICUs, recognizing differences between adult and pediatric ICUs beyond just the size and weight of the patients.

405.27 Information, Policy and Other Reporting Requirements - Amend the regulations to repeal this section because the authority for the reporting requirements are detailed in either Section 400.18 (SPARCS data) or section 86-1.2 and 86-1.3 (Uniform financial report and uniform statistical reports).

405.43 Orders Not to Resuscitate - Amend the regulations to repeal provisions which are no longer current as a result of the adoption of PHL Article 29-CC - Family Health Care Decisions Act. Section 400.21 Advance Directives provisions will be updated consistent with PHL Article 29-CC.

413.1 Consumer Information - Amend the regulations to provide flexibility in meeting the requirement that the Department issue to each nursing home consumer, information based on the findings from any onsite regulatory visit.

415.3(h) Resident Rights - Amend the regulations to require nursing home providers to issue a valid written transfer/discharge notice to the resident and his or her designated representative. Such notice shall include date of notice, resident's identity, effective date of proposed transfer/discharge, reason for proposed discharge or transfer, notice of the resident's right to an evidentiary hearing to appeal the proposed discharge, contact information for the NYS Long Term Care Ombudsman, contact information for the agency responsible for the protection and advocacy of individuals with mental illness or development disabilities, and notice of the resident's right to remain in the facility (except in cases of imminent danger), pending the appeal hearing decision. The proposed amendment outlines the Department's interim policy in effect since December 1, 2004.

425.18 Adult Day Health Care (Services for Registrants with Acquired Immune Deficiency Syndrome) - Amend the regulations to establish a step-down aftercare program for Adult Day Care Program enrollees achieving a level of physical and mental health stability to transition to a less intensive model.

600.1 - 600.7; 610.1 - 610.2; 620.1 - 620.3; 630.1; 640.2 - 640.3; 650.1 - 650.2; 670.1 - 670.6; 680.2; 680.4 - 680.6; 680.8 - 680.10, 705.9 - Amend the regulations to change references to the Public Health Council to the Public Health and Health Planning Council; and to delete references to the State Hospital Review and Planning Council.

700.5 Advance Directives - Amend the regulations to repeal this section because it is identical to the Advance Directives section in Section 400.21. As a result of the adoption of PHL Article 29-CC - Family Health Care Decisions Act, Section 400.21 Advance Directive provisions will be updated consistent with PHL Article 29-CC.

705.7, 708.1, 710.1, 710.2, 710.5 - Amend the regulations to change references to the State Hospital Review and Planning Council to the Public Health and Health Planning Council.

708 Appropriateness Review - Amend the regulations regarding the Trauma Center Designation Standards for consistency with the current practice of trauma care in New York State. Repeal references to burn care.

709 Determination of Public Need for Medical Facility Construction - Amend the regulations related to the liver and human heart transplantation services provisions.

709.17 Long-term Ventilator Beds - Amend the regulations concerning the need methodology for ventilator beds in residential health care facilities (nursing homes).

710.1 Medical Facility Construction - Amend the regulations to reflect amendments to PHL 2802 that substitute written notice for limited review, CON administrative review and CON full review for projects confined to non-clinical infrastructure, repair and maintenance, and one-for-one equipment replacement.

750-759 Treatment Center and Diagnostic Center Operation - Update the regulations addressing the Department's New York Patient Occurrence Reporting and Tracking System (NYPORTS) provisions for Diagnostic and Treatment Centers to reflect current practice.

752-2 Up-Graded Diagnostic and Treatment Center Services - Amend the regulations, if necessary, which address freestanding emergency department classification.

757 Chronic Renal Dialysis Services - Amend the regulations to be consistent with federal changes to 42 CFR regarding Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities.

759 Adult Day Health Care (Services for Registrants with AIDS) - Amend the regulations to establish a step-down aftercare program for Adult Day Care Program enrollees achieving a level of physical and mental health stability to transition to a less intensive model.

760 and 761 Home Health Services - Amend the regulations to update the current need methodology for establishment of certified home health agencies and to reflect statutory modification of Certified Home Health Agency Charity Care program requirements.

763 Certified Home Health Agencies and 766 Licensed Home Health Services Agencies - Amend the regulations to require the plans of care and medical orders for patients of CHHAs or LHCSAs address the patient's need for palliative care.

766 Licensed Home Care Services Agencies - Amend the regulations to update and modernize provisions to improve service delivery, training and surveillance activities and to eliminate the requirement for a physician to serve on the quality improvement committee of LHCSAs.

790 Hospices - Add regulations implementing changes in the federal Conditions of Participation; expand the definition of terminal illness as a result of Chapter 441 of the Laws of 2011.

800 Emergency Medical Services (EMS) - General - Amend the regulations to conform with federal requirements/recommendations, current medical practice standards, and national safety standards. Add regulations related to the use and application by members of the public of automatic external defibrillators; codify regulatory requirements for Advance Life support First Response Agencies; codify regulatory requirements for Basic Life Support Providers; make updates to EMS certification and training regulations; and establish a new section on the mobilization and/or sharing of resources in the event of a declared disaster.

1001 Assisted Living Residences - Amend the regulations to address recent litigation settlements.

Title 18 NYCRR (Social Services)

360-6.7 Managed Care - Repeal the regulations to modify and consolidate with a new Part 360. The provisions describe the standards and processes by which managed care enrollees may disenroll from a managed care organization and will be revised to reflect Chapter 649 of the Laws of 1996 and Chapter 433 of the Laws of 1997.

360-7.7 Payments of Deductibles and Coinsurance Under Title XVIII of the Social Security Act (Medicare) - Amend the regulations to align with recent changes to New York State social services law. This modification will align payment of Medicare Part B coinsurance with Medicaid coverage and Medicaid rates.

360-10 Medicaid Managed Care Program - Replace the existing regulations to conform to changes authorized by Chapter 649 of the Laws of 1996 and Chapters 433 and 436 of the Laws of 1997. The proposed regulations will clarify provisions of law, provide clearer guidance regarding marketing and enrollment in the Medicaid managed care/Family Health Plus programs, add fair hearing rights and requirements specific to Medicaid managed care/Family Health Plus, and add provider prohibitions specific to the Medicaid managed care/Family Health Plus programs.

360-11 Medicaid Managed Care - Repeal the regulations describing the standards and processes by which special needs populations may obtain specialty care services with the Medicaid managed care program. It will be repealed because it was made obsolete by passage of Chapter 649 of the Laws of 1996 which authorized the development of Special Needs Plans for these populations.

460 and 461 Adult Homes, Enriched Housing Programs and Residences for Adults - Amend the regulations to improve the health and safety of New York residents living in adult care facilities by expanding current DOH authority regarding penalties and suspensions of operating licenses, timeframes for inspections of facilities and written plan of corrections and requiring plans for quality assurance activities; amend the regulations regarding reporting to appropriate law enforcement authorities felony crimes committed against a resident; amend the regulations by providing for additional rights of residents of ACFs choosing their own health care providers and to be fully informed by the physicians; amend the regulations relating to the actions and reports of state representatives when acting in good faith; adding a section providing that an individual or entity which is not the duly approved operator of an ACF shall not participate in the total gross income or net revenue of such facility or residence; and clarifying rules regarding rental fees based on fair market value and charitable contribution of state monies, medical assistance payments or social security or supplemental security income.

485, 486, 487, 488 and 490 Adult Homes, Enriched Housing Programs and Residences for Adults - Amend the regulations to consolidate and streamline provisions relating to adult homes, enriched housing programs and residences for adults, to reflect recent legislative changes and the changing environments of these types of facilities. Amendments will provide clarification and consistency to residents, operators and the public with regards to adult care facilities, including role of nurse practitioners and physician assistants.

505.3 Drugs - Amend the regulations to provide that women 17 years of age or older have access to emergency contraceptive without a prescription. This change will align the regulation with current standards of practice and federal FDA guidelines.

505.3(i) Drugs - Amend the regulations to allow the Department to require each enrolled pharmacy to report actual acquisition cost of a prescription drug to the Department in a manner specified by the Department. This will enable the Department to include Average Acquisition Cost (AAC), when available, in the Medicaid drug payment methodology, as required by SSL section 367-a 9(g)(b)(i).

505.11 Rehabilitation Services - Amend the regulations to align with State Education law, federal guidelines, and current standards of practice; clarify who can order rehabilitation services, particularly speech-language pathology services provided to Medicaid recipients; clarify supervision requirements for services provided "under the direction of" speech-language pathologists, occupational therapists, and physical therapists.

505.14 Personal Care Services Program - Amend the regulations to reflect statutory changes regarding limitations and definitions of services and recent federal audit findings.

505.15 Psychiatric Care - Amend Medicaid regulations to align with federal requirements regarding who may provide school supportive health services.

505.16 Case Management - Amend the regulations to reflect changes in program requirements.

505.18 Clinical Psychological Services - Amend the regulations to align with federal guidelines and current standards of practice and clarify which practitioners are qualified to provide services in the Preschool/School Supportive Health Services Program to Medicaid recipients.

505.23 Personal Emergency Response Services (PERS) - Amend the regulations to allow for annual authorizations and to delete the requirement that authorization of PERS be contingent upon a reduction/elimination of personal care aide/home health aide hours.

505.27 Chemical Dependence Services - Amend the regulations to conform with changes made to OASAS regulations at Parts 822, 828 and 841 of 14 NYCRR to implement Ambulatory Patient Group (APG) billing methodology and incorporate clinical and Medicaid billing standards.

505.28 Consumer Directed Personal Assistance Program (CDPAP) - Amend the regulations to reflect the statutory change regarding the limitation of housekeeping services to 8 hours weekly.

505.31(d)(e)(1) of Title 18 NYCRR Audiology, Hearing Aid Services and Products - Amend the regulations to align Medicaid regulations with federal guidelines, State Education Law and current standards of practice and clarify who can order audiology services.

Contact person: Katherine Ceroalo, Department of Health, Bureau of House Counsel, Regulatory Affairs Unit, Empire State Plaza, Corning Tower Bldg., Rm. 2438, Albany, NY 12237, (518) 473-7488, (518) 473-2019, FAX, e-mail: REGSQNA@health.state.ny.us