Department of Health

The following regulatory actions are under consideration for submission as a Notice of Proposed Rulemaking from January through June 2013:

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 regulation 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 be more inclusive, allowing more types of relevant research access to the Registry and expanding surveillance use of confidential data.

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 regulation to reflect changes to Public Health Law section 1125 pertaining to water supply emergency plans.

5-1 Public Water Systems - Amend the regulation 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 regulation 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 regulation to update provisions pertaining to backflow device tester certification requirements; revise the provisions applicable to variances and exemptions 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 reflect consistency 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 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 regulation by requiring reporting to the Congenital Malformations Registry of children up to 10 years of age with certain birth defects, as well as fetuses diagnosed with defects prior to birth. Both changes will support an improved ability to accurately document prevalence rates for certain birth defects. Fetal alcohol syndrome and Duchenne muscular dystrophy are often not diagnosed until a child is older than two years of age, the current maximum age for required reporting. Anencephaly, spina bifida, and trisomies 13, 18 and 21 are often diagnosed prenatally, and would not be reported if the pregnancy is not carried to term. Improved surveillance will help monitor the impact of environmental factors or any preventive measures.

22.7 Reportable Levels of Heavy Metals in Blood and Urine - Amend the regulation 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.

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.

Part 46 Physically Handicapped Children - Amend the existing regulation to update and clarify current policy regarding coverage of medical and orthodontic services to children under the age of 21 years under the Physically Handicapped Children's Program. The proposed amendments will allow the inclusion of specific orthodontic procedures and criteria in the Department's Medicaid Dental Provider Manual.

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 update technical requirements to reflect advances in technology and changes in industry standards and enhance monitoring and enforcement of restrictions on the sale of human tissue for transplant.

52-12 Therapeutic Cell Banks - Promulgate a new subpart to propose standards for the collection, processing, storage, and distribution of nucleated somatic 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.

55-2 Approval of Laboratories Performing Environmental Analysis - Amend the regulation to accommodate for a tiered level of certification pertaining to types of analysis performed, application requirements, requirements for on-site assessment and proficiency testing as well as requisite qualification of technical directors, and to clarify that regulated analytes exclude analytes considered process controls by the NYS Department of Environmental Conservation (DEC).

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.

58-8 Human Immunodeficiency Virus (HIV) Testing - Amend the regulation to create consistency with the HIV testing law implemented September 1, 2010 and supporting regulations of Part 63. Address updated technologies and revise testing algorithms for the management of HIV.

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 codify Advisory Committee on Immunization Practice recommendations and incorporate by reference the recommended vaccination schedule, as well as the catch-up schedule. Language will also be added to clarify medical exemptions, acceptable serology, what it means to be "in process", annual school immunization survey requirements, and change physician diagnosis standards for measles and mumps to reflect the rarity of these diseases. The regulations will also seek to 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.

69-4 Early Intervention Program - Amend the regulations, as needed, to comply with 34 CFR Parts 300 and 303 issued on September 28, 2011. Amendments are also needed to Early Intervention Program regulations to comply with statutory changes enacted with the SFY 2012-13 budget. Section 10 NYCRR Section 69-4.30 will be amended to clarify the commissioner's authority to establish a fixed payment methodology for service coordination services. Amendments may also be needed to address other areas of regulation to ensure quality and consistency of EI service delivery.

69-8 Newborn Hearing Screening - Amend the regulation 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.

72-1 Tanning Facilities - Amend the regulations to be consistent with recent Chapter 105 of the Laws of 2012 amendments to Public Health Law Article 35-A -Tanning Facilities. The regulations will be amended to reflect the recent changes to the Public Health Law Section 3555 which prohibit individuals under seventeen (17) years of age from utilizing indoor tanning facilities.

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 and body piercing studios and the permitting of body piercing specialists and tattooists.

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 regulation 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 preclude operation of tissue banks and nontransplant anatomic banks within such establishments and the requesting of consent for an anatomical donation by funeral directors and employees of a funeral firms.

80 Controlled Substances - Amend the regulations to reflect recent statutory changes pertaining to the implementation of an upgraded Prescription Monitoring Program (PMP) Registry for collecting, monitoring and reporting data concerning the prescribing and dispensing of controlled substances. The amended regulations will address the statutory requirements for prescribing practitioners to consult the Registry prior to prescribing controlled substances; provide pharmacists access to the Prescription Monitoring Program Registry; allow for the use of designees to assist in accessing the PMP; and provide for more timely reporting of prescription information. Amended regulations will reflect statutory changes mandating the implementation of electronic prescribing for all prescriptions with limited exceptions. Amend the regulations pertaining to the Official New York State Prescription Forms reflecting required changes to the prescription forms and electronic prescriptions to include a section where prescribers may indicate whether an individual is limited English proficient and a line where the prescriber may specify the preferred language indicated by the patient. Amend the regulations to allow for electronic transmission, documentation, record keeping and endorsement of 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 of 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 provided in State Education Law section 6810 (7) (b) for noncontrolled substances. Amend Part 80 to update reporting requirements for Methadone Maintenance Treatment Programs enacted by Public Health Law section 3352 statutory changes. Outline training and certification requirements applicable to 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 PMP 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 become permanent.

80.138 Opioid Overdose Prevention Programs - Public Health Law section 3309(1) authorizes the Commissioner "to establish standards for approval of any opioid overdose prevention programs which may include, but not be limited to, standards for program directors, appropriate clinical oversight, training, record keeping and reporting." Revision is needed with respect to language pertaining to the definitions of "person," "affiliated prescriber" and "registered provider" in 10 NYCRR 80.138(a); the responsibilities of the program director in 10 NYCRR 80.138(c)(1); and the supplies which must be maintained and provided by opioid overdose prevention programs in 10 NYCRR 80.138(c)(5).

85.45 Orthodontic services. Amend the existing regulation to clarify current policy regarding coverage of orthodontic services under the Physically Handicapped Children's Program (PHCP). The proposed amendments will allow the inclusion of specific procedures and criteria in the Department's Medicaid Dental Provider Manual.

86-1.16 Statewide Base Price - Amend the regulations to continue a statewide base price reduction. The amount of the reduction will be $19,200,000 for the period May 1, 2012, through March 31, 2013, and for state fiscal year periods on and after April 1, 2013.

86-1.31 Safety Net Vital Access Provider (VAP) Program - Amend the regulation, as a result of the MRT waiver submitted to CMS, as it relates to Safety Net/VAP temporary Medicaid rate adjustments for hospital inpatient services.

86-1.38 Redirect Inpatient Reform Transition II Funds to the Safety Net/Vital Access Provider (VAP) Pool - Amend the regulations relating to Transition II funds that were to be returned to the base rate for distribution to all hospitals. Such funds will now be dedicated toward establishing a $100M Safety Net/VAP Pool instead.

86-1.45 Language Assistance Medicaid Reimbursement for Hospital Inpatient Services - Add regulations and develop rates for the payment of Language Assistance services provided by hospitals to inpatients.

86-2 Safety Net Vital Access Provider (VAP) Program - Amend the regulation, as a result of the MRT waiver submitted to CMS, as it relates to Safety Net/VAP temporary Medicaid rate adjustments for nursing homes.

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

86-2.41 Nursing Home Sprinkler Systems - Add a regulation to assist financially distressed nursing homes with the capital costs related to installing automatic sprinkler systems that comply with applicable federal regulations.

86-4.20 FQHC Medicaid Capital - Amend the regulation to reflect the ability for FQHC's to receive Medicaid capital appeal increases due to projects now exempt from the CON process due to enacted legislation.

86-8 Physician Home Visits for Hospitals and Clinic - Amend the regulation to establish Medicaid rates and billing policies to allow hospitals and clinics to be reimbursed for physician home visits for chronically ill patients.

86-8 Safety Net Vital Access Provider (VAP) Program - Amend the regulation, as a result of the MRT waiver submitted to CMS, as it relates to Safety Net/VAP temporary Medicaid rate adjustments for free standing clinics.

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 (e) Operational and Financial Requirements for MCOs - Section 98-1.11(e) would be amended to extend the lower contingent reserve requirement applied to revenues from the Medicaid managed care, Family Health Plus and HIV SNP 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 Department of Financial Services 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.

400.15 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 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. In addition, the regulations will be updated to be consistent with the amendment to the PHL for the collection of claims data and covered person data from third party health care payers. 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.

405 Federal Conditions of Participation - Amend the regulation to include recent federal conditions of participation.

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

405 Sepsis - Amend the regulations to require hospitals to develop policies and procedures related to sepsis.

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.

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

405.21 Perinatal Services - Technical amendments are required in Section 405.21 Perinatal Services. A specialty hospital releasing a neonate back to the hospital of birth would be entitled to billing as a discharge, while transfer to another community hospital would be considered a transfer and therefore reimbursed at a lower rate. Transfer back to the hospital of birth or another lower level perinatal service hospital is strongly encouraged to ensure proximity to parents, and to ensure that neonates who no longer need the higher level of care do not use higher level resources. It is anticipated that 86-1.15 will be amended as well. Therefore, to ensure consistency, amend the perinatal services regulations to allow release to "the sending hospital or other hospital providing a lower level of perinatal services….." to conform with changes to Sections 86-1.15 and current language in Section721.4(c)(1).

405.21 Perinatal Services - Amend the regulations in Section 405.21 (c)(2)(ii) to cross reference 405.9(b)(12) of this Part, which is the correct regulatory reference instead of 405.9(b)(11).

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.

407 Federal Conditions of Participation - Amend the regulation to incorporate federal conditions of participation for Critical Access Hospitals (CAHs).

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 create a more flexible model appropriate to the clinical state of the HIV/AIDS epidemic and for inclusion into the Medicaid Managed Care benefit package.

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.

600.3 Certificate of Need (CON) Applications - Amend the regulation to simplify the process for review of amendments to Certificate of Need (CON) applications that have received approval for establishment by the Public Health and Health Planning Council (PHHPC) but which have not yet proceeded to actual establishment.

700 Accountable Care Organizations (ACOs) - It is anticipated that regulations will be added to 10 NYCRR Part 700 pursuant to amendments to PHL Article 29-E governing Accountable Care Organizations (ACOs).

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.

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 and further amend to allow greater flexibility in the relocation of extension clinics in rural areas.

710.5 Certificate of Need (CON) Applications - Amend the regulation to simplify the process for review of amendments to Certificate of Need (CON) applications that have received approval for construction by the Public Health and Health Planning Council (PHHPC) but which have not yet proceeded to actual construction.

721.4 Patient Care and Patient Transfers - Amend the regulations to allow release to "the sending hospital or other hospital providing a lower level of perinatal services….." to conform with proposed changes to Section 86-1.15, 405.21 and current language in Section 721.4(c)(1).

722 Sexual Assault Forensic Examiner (SAFE) Program - Amend existing regulations related to the review and approval of licensed Article 28 hospitals as Sexual Assault Forensic Examiner (SAFE) programs. This includes the standards for approving SAFE hospital programs, approving programs that train individual SAFE examiners, and certifying individual SAFE examiners and criteria for continuous quality improvement program activities. The SAFE program provides a specialized standard of medical care and evidence collection to victims of sexual assault.

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 create a more flexible model appropriate to the clinical state of the HIV/AIDS epidemic and for inclusion into the Medicaid Managed Care benefit package.

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. Modernize course sponsors provisions to address the current environment and technology as well as reflecting the current EMS education curricula. Strengthen the surveillance portions of these provisions to appropriately address issues of quality, student rights and safety. Establish a new section on the mobilization and/or sharing of resources in the event of a declared disaster. Amend to reflect current ambulance vehicle construction requirements, technology and safety for the patients and EMS providers.

910 Official New York State Prescription Forms - Amend the regulations pertaining to the Official New York State Prescription Forms reflecting required changes to the prescription forms and electronic prescriptions to include a section where prescribers may indicate whether an individual is limited English proficient and a line where the prescriber may specify the preferred language indicated by the patient.

Title 18 NYCRR (Social Services)

360-10 Medicaid Managed Care Program - Replace emergency regulations promulgated 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 and provide clearer guidance regarding fair hearing rights and requirements specific to Medicaid managed care and Family Health Plus.

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 existing regulations to incorporate changes in Social Service Law that authorize the Commissioner to establish payments and dispensing fees for prescription drugs. The definition of estimated acquisition cost for the Medicaid fee-for-service pharmacy program will be added to regulation and prescription drug dispensing fees will be identified.

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.

505.12 - Podiatry Services - Amend the regulation to expand podiatry coverage to Medicaid eligible adults with a diagnosis of Diabetes Mellitus. This will align regulation with 2012 changes made to state social service laws.

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.

505.18 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.

505.28 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) 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
New York State Department of Health
Bureau of House Counsel, Regulatory Affairs Unit
Empire State Plaza
Corning Tower Building, Room 2438
Albany, New York 12237
(518) 473-7488
(518) 473-2019 FAX

REGSQNA@health.state.ny.us