Five, Ten and Fifteen 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 House Counsel, Regulatory Affairs Unit, Corning Tower, Room 2438, Empire State Plaza, Albany, NY 12237 by email at REGSQNA@health.state.ny.us.

Title 10 NYCRR - Five Year Review

Amendment of Subpart 7-1 and Addition of New Subpart 7-4 of Part 7 of Title 10 - Temporary Residences and Mass Gatherings

Statutory Authority:

Public Health Law Section 225(5)

Description of the regulation:

Amended Subpart 7-1 of Title 10 NYCRR to: relocate sections pertaining to mass gatherings to a newly created Subpart 7-4; repeal sections pertaining to campgrounds (text previously moved to Subpart 7-3); repeal sections applicable to special provisions of hotels and motels and other requirements for employers; delete section reserved for mobile home parks; repeal text applicable to temporary residences and replace with newly drafted text. The regulation should continue without modification.

Addition of New Section 16.112 to Part 16 of Title 10 - Fingerprinting and Criminal Background Check Requirements for Unescorted Access to Radioactive Materials)

Statutory Authority:

Public Health Law Sections 225(5)(p) & (q)

Description of the regulation:

The amendments that incorporated a new Section 16.112 of Part 16 required fingerprinting of individuals who are allowed unescorted access to large quantities of radioactive material. This provision is necessary to be compliant with the requirements of the United States Nuclear Regulatory Commission. The regulation should continue without modification.

Amendment of Part 53 of Title 10 - Drinking Water State Revolving Fund

Statutory Authority:

Public Health Law Sections 1161 and 1162

Description of the regulation:

This regulation outlined rules and procedures for the New York State Department of Health to provide financial assistance to public water systems through the New York State Drinking Water State Revolving Fund (DWSRF). The DWSRF was created by Chapter 413 of the Laws of 1996 of the State of New York. Amendments were enacted in 2009 facilitate the use of additional Federal Capitalization Grant funds provided to the program through the American Recovery and Reinvestment Act. The regulation should continue without modification.

Amendment of subdivisions 59.1(c) & 59.4(b) of Title 10 - Chemical Analyses of Blood, Urine, Breath or Saliva for Alcohol Content

Statutory Authority:

NYS Vehicle and Traffic Law, Section 1194(4)(c) and Dept. of Environmental Conservation Law, Section 11-1205(6)

Description of the regulation:

This regulation established standards for the chemical analyses of blood, urine, breath and saliva for alcoholic content, instrument approval, and operator permits, to ensure law enforcement agencies have the appropriate tools and proficiency in their use for effective enforcement of DWI prosecution laws. Subdivision 59.1(c) clarified that chemical tests/analyses includes breath tests conducted on breath analysis instruments approved by the commissioner and 59.4(b) lists approved instruments found on the Conforming Products List of Evidential Breath Alcohol Measurement Devices as established by the U.S. Department of Transportation/National Highway Traffic Safety Administration (NHTSA). The regulation should continue without modification.

Amendment of Subparts 67-1 and 67-3 of Part 67 of Title 10 - Childhood Lead Poisoning Screening and Follow-up

Statutory Authority:

Public Health Law Section 206

Description of the regulation:

Subpart 67-1 was amended to lower the blood lead level threshold for requiring comprehensive case management services and environmental interventions from 20 micrograms per deciliter (mcg/dL) to 15 mcg/dL. Subpart 67-3 was amended to authorize the use of waived blood testing equipment by physician office laboratories and limited service laboratories, with reporting requirements to the Department. The regulations should continue without modification.

Addition of New Subpart 72-1 to Title 10 - Tanning Facilities

Statutory Authority:

Public Health Law Section 3551 and 3554

Description of the regulation:

The regulations established permit requirements, fees and standards for the safe and sanitary operation of ultraviolet (UV) tanning facilities. The regulation should continue without modification.

Amendment of Sections 80.2, 80.23, 80.67, 80.68, 80.69, 80.71, 80.73, 80.74, 80.132 and 80.134 of Part 80 of Title 10 - Controlled Substances Data Submissions

Statutory Authority:

Public Health Law Section 3308(2), 3333, 3343-a, 3371

Description of the regulation:

These regulations govern and control possession, prescribing, manufacturing, dispensing, distribution and reporting of controlled substances and needles and syringes within New York State. They should continue without modification.

Amendment of Section 86-1.62 of Title 10 - Service Intensity Weights (SIWs) and Average Lengths of Stay

Statutory Authority:

Public Health Law Section 2807-c(3)

Description of the regulation:

Section 86-1.62 has been re-codified as 86-1.18. Service intensity weights (SIW) and average lengths of stay (LOS) are integral components of the current DRG based inpatient Medicaid rate-setting methodology. This regulation should therefore be retained.

Amendment of Section 86-4.9 of Subpart 86-4 of Title 10 - Payment for FQHC Psychotherapy and Off-site Services (previously known as Payment for Psychiatric Social Work Services in Article 28 FQHCs)

Statutory Authority:

Public Health Law Section 201.1(v)

Description of the regulation:

Medicaid reimbursement for psychotherapy and off-site services provided by federally qualified health centers (FQHCs) continues to be required under federal Medicaid statutes. Accordingly, this regulation should be retained.

Amendment of Part 89 of Title 10 - Practice of Radiologic Technology

Statutory Authority:

Public Health Law Section 3504

Description of the regulation:

The amendments updated educational, licensing and certification requirements for persons engaged in the practice of radiologic technology as well as standards for educational programs in radiologic technology. The regulation should continue without modification.

Amendment of Section 400.12 of Title 10 - PASRR SCREEN Requirements

Statutory Authority:

Public Health Law Section 2803(2)

Description of the regulation:

This measure updated Pre-Admission Screen and Resident Review (PASRR) provisions. The SCREEN is used to determine a person's potential to be appropriately cared for in a setting other than a Residential Health Care Facility (RHCF). It is also used to assess persons being recommended for RHCF placement for possible mental illness and/or mental retardation or developmental disabilities. The regulation should continue without modification.

Addition of new Part 402 to Title 10 - Criminal History Record Check

Statutory Authority:

Public Health Law Section 2899-a(4) and Executive Law Section 845-b(12)

Description of the regulation:

These regulations are required by Chapter 769 of the Laws of 2005, as amended by Chapters 331 and 673 of the Laws of 2006. The regulations required prospective unlicensed employees of nursing homes, certified home health agencies, licensed home care services agencies and long term home health care programs that will provide direct care or supervision to patients, residents or clients of such providers to undergo a criminal history record check. The regulations established standards and procedures for the criminal history record checks required by statute. The regulation should continue without modification.

Amendment of Sections 405.19, 405.22 and Addition of new Section 405.29 of Title 10 - Emergency and Cardiac Services

Statutory Authority:

Public Health Law Sections 2800 and 2803

Description of the regulation:

These provisions created a new Section 405.29 specific to cardiac services and set forth requirements for the direction, staffing, structure and services, patient selection and minimum workload standards for cardiac surgery, diagnostic cardiac catheterization, percutaneous coronary intervention (PCI), and for cardiac electrophysiology (EP) programs. The regulation should continue without modification.

Amendment of Section 709.14 of Title 10 - Cardiac Services Need Methodology

Statutory Authority:

Public Health Law Sections 2800 and 2803

Description of the regulation:

These standards are used to evaluate certificate of need (CON) applications for cardiac catheterization laboratory center services and cardiac surgery center services. The regulation should continue without modification.

Amendment of Section 710.1 of Part 710 of Title 10 - Certificate of Need Process for Cardiac Services

Statutory Authority:

Public Health Law Section 2803(2)

Description of the regulation:

This regulation streamlined approvals of applications by approved cardiac surgery programs and cardiac catheterization laboratory centers to expand capacity and/or add electrophysiology (EP). It also addressed in regulation for the first time the Certificate of Need (CON) reviews of cardiac EP services. The regulation should continue without modification.

Amendment of Section 710.1 of Part 710 of Title 10 - Initial Purchase of Magnetic Resonance Imagers (MRIs)

Statutory Authority:

Public Health Law Section 2802

Description of the regulation:

Proposals for acquisition of MRIs were eligible for administrative review provided that acquisitions of MRIs by a general hospital may be reviewed under the provisions for proposals requiring a limited review. The regulation should continue without modification.

Amendment of Section 710.1 of Part 710 of Title 10 - Non-clinical Projects

Statutory Authority:

Public Health Law Section 2802

Description of the regulation:

These provisions exempted those non-clinical projects from requiring a Certificate of Need that are subject to the provisions for proposals requiring a limited review. The regulation should continue without modification.

Amendment of Section 710.1 of Part 710 of Title 10 - Relocation of Extension Clinics

Statutory Authority:

Public Health Law Section 2802

Description of the regulation:

This regulation authorized administrative review for the operation or relocation of an extension clinic when such relocation is to a site outside the current services area of the extension clinic and did not entail an increase in scope of services or clinical capacity.

It also authorized for limited review the relocation of an extension clinic within the same service area, defined and (1) one or more postal zip code areas in each of which twenty-five (25) percent or more of the extension clinic's patients reside, or (2) the area within one mile of the current location of such extension clinic, which does not entail an increase in services or clinical capacity. The regulation should continue without modification.

Amendment to Section 901.9 of Title 10 - Notification & Submission Requirements for Continuing Care Retirement Communities

Statutory Authority:

Public Health Law Section 4602(2)(g)

Description of the regulation:

The amendment provided that requests made by Continuing Care Retirement Communities (CCRCs) for certain extensions of construction completion dates can be approved by the Commissioner of Health, in consultation with the Superintendent of the Division of Financial Services, and eliminated the requirement to obtain CCRC Council approval. This provision streamlined the process for such requests and assists CCRCs working within strict financing deadlines. The regulation should continue without modification.

Amendment of Section 1000.1 of Title 10 - Physician Board Certification Entities

Statutory Authority:

Public Health Law Section 2995(1)(b)

Description of the regulation:

Part 1000 of 10 NYCRR set forth the Physician Profiles provisions. Section 1000.1 contained the definitions for Part 1000 including the definition for Board Certification. This definition specified that Board Certification means a specialty or subspecialty in which a physician is certified by the American Board of Medical Specialties (ABMS), American Osteopathic Association (AOA), or Royal College of Physicians and Surgeons of Canada (RCPSC). The regulation should continue without modification.

Title 18 NYCRR - Five Year Review

Amendment of Section 505.11 of Title 18 - Physical Therapist Assistants and Occupational Therapy Assistants

Statutory Authority:

Social Services Law Section 363-a and Public Health Law Section 201(1)(v)

Description of the regulation:

Section 505.11 pertained to rehabilitation services (physical, occupational and speech therapy).

Section 505.11 of Title 18 is on the current Regulatory Agenda. This regulation is being amended to align it with State Education law, federal guidelines, and current standards of practice for physical, occupational, and speech therapy.

Title 10 NYCRR - Ten Year Review

Amendment of Sections 2.1 and 2.5 of Title 10 (Communicable Disease Reporting-Severe Acute Respiratory Syndrome (SARS))

Statutory Authority:

Public Health Law (PHL) § 206(1)

Description of the regulation:

Severe Acute Respiratory Syndrome (SARS) is a viral respiratory illness that was recognized as a global threat in March 2003, after first appearing in Southern China in November 2002. In 10 percent to 20 percent of cases, patients require mechanical ventilation. Most patients develop pneumonia. The primary way that SARS appears to spread is by close person-to-person contact. In 2003, SARS was added to the communicable disease list in 10 NYCRR.

Although there have been no SARS cases reported since July 2003, it remains critical to keep SARS as a reportable condition to ensure the immediate identification, reporting, and investigation of any possible new cases. If cases go unidentified, spread in the population could have significant public health consequences. The regulation should be continued without modification.

Amendment of Sections 2.1 and 2.5 of Title 10 (Communicable Diseases - Monkeypox)

Statutory Authority:

PHL §§ 225(4), 225(5)(a), (g), (h) and (i), and 206(1)

Description of the regulation:

Monkeypox is a viral disease from Africa that resembles smallpox in humans and can be spread from animal to person or person to person through direct contact or respiratory droplets. Although human cases in the U.S. have not been seen since 2003 when this regulation was enacted, there is the possibility of cases occurring again in the future. Continuance of this regulation is warranted in order to improve reporting (Section 2.1) and laboratory testing (Section 2.5) of cases. The regulation should be continued without modification.

Amendments to Section 2.1(a) and addition of new Section 2.2(h) to Title 10 (Communicable Diseases - Arboviral Infection Reporting)

Statutory Authority:

PHL §§ 206(1) and 602.3

Description of the regulation:

This regulation simplified the requirements for reporting all arthropod-borne viral (arboviral) diseases rather than listing individual diseases with separate responses. This regulation grouped all of these, primarily mosquito-borne and potentially fatal diseases, into one inclusive term. As such, any potential confusion regarding responses to individual disease pathogens is minimized. The regulation should be continued without modification.

Amendment to various Sections in Part 5 of Title 10 (Public Notification, ByProducts and Interim Enhanced Surface Water Treatment Rule (SWTR) - Drinking Water)

Statutory Authority:

PHL § 225

Description of the regulation:

The amendment to various sections of Subpart 5-1 incorporated the requirements of the federal Interim Enhanced Surface Water Treatment Rule (IESWTR) and the Stage 1 Disinfectants and Disinfection Byproducts Rule (DBP Rule) and the Public Notification Rule (PNR) which were promulgated by the United States Environmental Protection Agency. All of these rules are requirements of 40 CFR Part 141. As a condition of the New York State Department of Health's primacy, there must be state rules or other authority that are at least as stringent as 40 CFR Part 141 to assure that public water systems comply with the requirements of the IESWTR, DBP Rule, and the PNR. The amendment should continue without modification.

Amendment of Subpart 6-2 of Title 10 (Bathing Beaches)

Statutory Authority:

PHL § 225

Description of the regulation:

The 6/23/04 amendments clarified the definition of "bathing" so that activities such as fishing, scuba diving and surf boarding were no longer prohibited at areas outside of regulated bathing beaches or at regulated bathing beaches when not open to bathing. The amendment also added enterococcus and E. coli as acceptable bacteriological indicator organisms to assess water quality at bathing beaches and clarified factors to be considered when determining if water quality creates a potential health hazard requiring closure of a beach. The regulation should continue without modification.

Amendment of Subpart 7-2 of Part 7 of Title 10 (Children's Camps)

Statutory Authority:

PHL §§ 225 and 1394

Description of the regulation:

The 9/29/04 amendments to Subpart 7-2 added standards for children's camp trips, swimming, incidental water immersion, on-site activities and bunk bed guardrails; clarified and added potable water standards; and updated and clarified obsolete wording and standards. Analysis of the rule identified the need for minor revisions to the 9/29/04 amendments pertaining to swimming, which are included in current amendments proposed for this Subpart. The other amendments to the rule should continue without modification. Regulatory Status: Analysis of the rule identified the need for minor revisions to the September 29, 2004 amendments pertaining to swimming, which were made on July 6, 2011. The other 2004 amendments should continue without modification.

Amendments to Section 16.58 of Part 16 of Title 10 (Fluoroscopic X-ray Equipment)

Statutory Authority:

PHL § 225

Description of the regulation:

The amendment to Section 16.58 of Part 16 updated the quality control testing for fluoroscopic x-ray equipment. The requirements assured uniformity in testing and compliance with standards for image quality and patient doses. The amendment should continue without modification.

Amendment of Sections 55-2.1 through 55-1.12 of Subpart 55-2 of Title 10 (Environmental Laboratories)

Statutory Authority:

PHL § 502

Description of the regulation:

The rule established minimum standards for the certification and operation of environmental laboratories analyzing New York State samples, including personnel qualifications and quality systems standards for analytical processes and record keeping.

A revision is under consideration to update technical standards.

Addition of new Sections 55-2.12 and 55-2.13 to Subpart 55-2 of Title 10 (Environmental Laboratory Standards)

Statutory Authority:

PHL § 502

Description of the regulation:

This regulation established requirements for the certification and operation of environmental laboratories. The two sections established requirements for laboratories engaged in testing for critical agents in environmental samples and qualifications for contract laboratory protocol personnel. Modifications to section 55-2.12 are proposed to establish consistency with Department of Environmental Conservation requirements. Section 55-2.13 should be continued without modification.

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

Statutory Authority:

PHL § 3121(5)

Description of the regulation:

Subpart 58-2 promoted the public health, safety and welfare by establishing minimum standards for the proper collection, processing, fractionation, storage, distribution and supply of human blood or blood products for use in transfusion. In order to keep pace with current technology, periodic amendments are necessary. The rule was most recently amended in 2007 to update practice standards, lower donor age, and recognize advances in technology. Continuance of these regulations is warranted. A proposed amendment of Subpart 58-2 is currently under consideration. This amendment would update technical requirements for the collection, testing, and storage of blood and blood components, allow increased flexibility in compliance, and allow advanced life support emergency medical technicians to administer blood components during transport of patients from one hospital to another. This proposed rule was included in the June 1, 2013 Regulatory Agenda. No comments have been received.

Amendment of Subpart 58-5 of Title 10 (Hematopoietic Progenitor Cell Banks)

Statutory Authority:

PHL §§ 3121(5) and 4365(7)

Description of the regulation:

Subpart 58-5 promoted the public health, safety and welfare by establishing minimum standards for the banking of hematopoietic progenitor cells (HPCs), which are immature blood cells. These requirements have helped ensure that HPCs collected, processed, and used in New York State are obtained from fully screened and tested donors with documented informed consent. HPC banks operating in New York are subject to tissue bank licensure under Part 52 pursuant to PHL 4364. The regulations must be amended from time to time, in order to keep pace with advances in technology and practice standards; such amendment is under consideration. Continuance of these regulations is warranted.

Amendment of Section 69-1.3(1)(2) of Part 69 of Title 10 (Expedited HIV Testing of Women and Newborns)

Statutory Authority:

PHL §§ 576, 2500-a, and 2522

Description of the regulation:

Subpart 96-1.3(1)(2) promoted the public health and welfare by ensuring that the HIV exposure status is available for all newborns for mothers who have not been tested for HIV during the current pregnancy or for whom HIV test results are not available at delivery. This allows providers and patients information that is critical for the timely and efficacious administration of antiretroviral medications to prevent mother-to-child HIV transmission should the mother be HIV-infected. This amendment should be continued without modification.

Amendment of Section 80.86 and addition of a new Section 80.84 of Title 10 (Treatment of Opiate Dependence in the Outpatient Setting)

Statutory Authority:

PHL § 3308(2), 3351and 3352

Description of the regulation:

This regulation allowed the treatment of narcotic addiction in the outpatient setting, pursuant to the provisions of the federal Drug Addiction Treatment Act of 2000. Under the regulation, a qualified physician may treat narcotic addiction by issuing a prescription for buprenorphine, a controlled substance approved by the U.S. Food and Drug Administration and the New York State Department of Health for such treatment. The prescription may be dispensed to the patient by a pharmacist. Prior to the regulation, narcotic addiction could only be treated by enrollment in a Methadone Maintenance Treatment Program (MMTP). The regulation ensures effective addiction treatment in the confidentiality of an office setting for persons who may be unable or unwilling to seek treatment in a MMTP venue. The regulation protects the public health by resulting in more persons entering treatment. Continuance of this regulation is warranted with modification of the total number of patients an authorized physician may treat, which will mirror current federal regulations, and modification to records and reports of treatment programs pursuant to statutory changes in Chapter 178 of the Laws of 2010.

Amendment to Section 85.21 of Title 10 and Section 505.3 of Title 18 (Smoking Cessation Products):

Statutory Authority:

Social Services Law (SSL) § 365-a(4)

Description of the regulation:

This regulation provided for inclusion of non-prescription smoking cessation drugs on the list of reimbursable drugs under the NYS medical assistance program. This regulation supports the DOH's commitment to curtail tobacco use and to encourage smoking cessation. There have been no changes that would necessitate further amendment or repeal of this section. Continuance of the regulation is warranted.

Amendments to Sections 86-1.62 and 86-1.63 of Title 10 (DRGs, SIWs, Trimpoints and Arithmetic Mean LOS)

Statutory Authority:

PHL §§ 2803(2), 2807(3), and 2807-c(3) and (4)

Description of the regulation:

Section 86-1.62 has been re-codified as 86-1.18. Service intensity weights (SIW) and average lengths of stay (LOS) are integral components of the current DRG based inpatient Medicaid rate-setting methodology. This regulation should therefore be retained.

Amendment of Sections 88-2.1 and 88-2.2 of Part 88 of Title 10 (New York State Veterans' Home)

Statutory Authority:

PHL Article 4, Title 1 and PHL Article 26-A.

Description of the regulation:

The amendments to these sections were technical in nature by incorporating all the veterans' homes owned and operated by the NYS Department of Health. The Department currently owns and operates the Veterans' Homes at Batavia (Genesee County), Montrose (Westchester County), Oxford (Chenango County) and St. Albans (Queens County).

There have been no other technical or procedural changes that would necessitate further amendments or repeal of these sections. The benefits of this technical change to include all four veterans' homes as covered by this regulation continue to be realized. Continuance of the regulation is warranted.

Repeal of Section 131.1 of Part 131 and addition of new Section 131.1 of Title 10 (City of Syracuse Watershed Rules and Regulations)

Statutory Authority:

PHL § 1100

Description of the regulation:

The rule provided extensive regulations intended to protect Syracuse's Skaneateles Lake Watershed by providing various limitations on activities and construction. The continuation of the rule is necessary to maintain protection of Syracuse's Skaneateles Lake Watershed and for Syracuse to maintain filtration avoidance for this surface water source. The regulation should continue without modification.

Amendment of Section 405.22 of Title 10 (Live Adult Liver Donation and Transplantation)

Statutory Authority:

PHL § 2803(2)

Description of the regulation:

This regulation set forth provisions to ensure that potential donors are competent, willing to donate, free from coercion, medically and psychosocially suitable, fully informed of the risks and benefits as a donor and understand the alternative treatments that may be available to the recipient.

This measure is currently being modified. The provisions in 405.22 will be repealed and incorporated into two new Sections in 10 NYCRR. Section 405.30 will contain the Organ and Vascularized Composite Allograph Transplant Services/Programs provisions. Section 405.31 outlines the Living Donor Transplantation Services provisions.

Amendment of Sections 405.24(h) and 415.29(l) of Title 10 (Standards for Animals in Health Care Facilities)

Statutory Authority:

PHL §§ 2803(2) and 2803-h

Description of the regulation:

This regulation was amended to be consistent with the federal Americans with Disabilities Act (ADA) and PHL § 2803-h which gives hospitals and nursing homes the option to board animals. Service animals, not limited to guide dogs, for a disabled person are allowed, as long as they do not pose a significant risk to the health or safety of others that cannot be eliminated by reasonable accommodation and are not medically contraindicated. This regulation should be retained.

Repeal Parts 425-427 and addition of new Part 425 and amendment to Parts 711 and 713 of Title 10 (Adult Day Health Care)

Statutory Authority:

PHL § 2803(2)

Description of the regulation:

Effective 3/17/2004, PHL § 2803(2) defined "adult day health care" as the health care services and activities provided to a group of registrants with functional impairments to maintain their health status and enable them to remain in the community. This program serves registrants, defined as a person (1) who is not a resident of a residential health care facility, is functionally impaired and not homebound, and requires supervision, monitoring, preventive, diagnostic, therapeutic, rehabilitative or palliative care or services but does not require continuous 24-hour-a-day inpatient care and services, except that where reference is made to the requirements of Part 415 of this Subchapter, the term resident as used in Part 415 shall mean registrant; (2) whose assessed social and health care needs can satisfactorily be met in whole or in part by the delivery of appropriate services in the community setting; and (3) who has been admitted to an adult day health care program based on an authorized practitioner's order and the adult day health care program's interdisciplinary comprehensive assessment. The program is defined as an approved adult day health care program located at a licensed residential health care facility or an approved extension site.

Amendments to these regulations are proposed that would enable adult day health care programs in nursing homes to contract and work effectively with managed long term care

Plans (MLTC) and coordinated care models (CCM) as more Medicaid recipients are required to enroll in MLTC and CCM.

Amendment of Section 700.2(b)(32) and (44) of Part 700 of Title 10 (Certification Requirements for Physical Therapist Assistants and Limited Permits for Physical Therapists)

Statutory Authority:

PHL § 2803(2) and Chapter 404 of the Laws of 2002

Description of the regulation:

This regulation amended the definitions in the State Hospital Code for "physical therapy assistants" and "physical therapists" to conform to definitions consistent with Chapter 404 of the Laws of 2002.

The law shortened the duration of a limited permit to practice physical therapy from 1 year to 6 months. The previous regulation was silent on the issue of limited permits. New language was also added to the definition for those individuals who are not yet licensed and registered with the Education Department that specifies that they be issued a valid limited permit by the Education Department. The law also added an examination for certification as a physical therapy assistant and provides for limited permits for physical therapy assistants prior to certification. The physical therapy assistant definition added language specifying that they are licensed and currently registered with the New York State Education Department, or have been issued a valid limited permit by that Department. This regulation should be retained.

Amendment of Section 709.3 of Title 10 (Need Methodology for Residential Health Care Facility (RHCF) Beds)

Statutory Authority:

PHL § 2802

Description of the regulation:

This regulation was updated in 2010 to reflect changes in demographics and in

long-term care services that affect the public need for RHCF (nursing home) beds. The regulation projected RHCF bed need through 2016 and should be retained.

Amendment of Section 800.26 of Part 800 of Title 10 (Emergency Ambulance Service Vehicle Equipment Requirements)

Statutory Authority:

PHL §§ 3011(4) and 3016

Description of the regulation:

This regulation described an emergency ambulance service vehicle (EASV). These vehicles are either owned or operated by an ambulance service and designated for the purposes of responding to medical emergencies with personnel and/or equipment and supplies. The EASV is not to be used to transport patients. This amendment was intended to give ambulance agencies greater flexibility in deploying their equipment and personnel to the scene of a medical or traumatic emergency. Continuance of this regulation amendment is warranted.

Addition of a new Part 801 to Title 10 (Resuscitation Equipment in Public Places)

Statutory Authority:

PHL § 3000-D

Description of the regulation:

This regulation required the owner or operator of a public place, as described in law and the regulation, to make available certain items of resuscitation equipment and make them readily accessible for use by either trained staff or the public during a medical emergency. It required that the equipment be located in such place that it may be brought to a patron's side within three minutes of the onset of an event. Further, the regulations included requirements for appropriate signage indicating the availability of resuscitation equipment for emergency use and providing information on how to obtain cardiopulmonary resuscitation training. Continuance of these regulations is warranted.

Title 10 NYCRR - Fifteen Year Review

Amendment of Section 16.58 of Title 10 (Fluoroscopic X-ray Systems)

Statutory Authority:

PHL § 225

Description of the regulation:

The amendment to Section 16.58 of Part 16 limited the radiation output of fluoroscopic x-ray tubes when the fluoroscopic unit was operating in the high-level control mode. There have been no technological or procedural changes that would necessitate further amendment or repeal of this section. The amendment should continue without modification.

Addition of Subparts 47-3, 47-4, 47-5 and 47-6 to Part 47 of Title 10 (Primary Care Education and Training)

Statutory Authority:

PHL §§ 901, 903 and 904

Description of the regulation:

These regulations effectively served NYS DOH scholarship and loan repayment recipients who fulfilled their service obligations under these programs in the past. However, because the benefits of the amendment no longer continue to be realized, continuance of the regulation is not currently warranted.

Amendment to Subpart 58-5 of Title 10 (Hematopoietic Progenitor Cell Banks)

Statutory Authority:

PHL §§ 3121(5) and 4365(7)

Description of the regulation:

Subpart 58-5 established minimum standards for the banking of hematopoietic progenitor cells (HPCs), which are immature blood cells. These requirements have helped ensure that HPCs collected, processed, and used in New York State are obtained from fully screened and tested donors with documented informed consent. HPC banks operating in New York are subject to tissue bank licensure under Part 52 pursuant to PHL 4364. Most recently amended in 2004, these regulations must be amended from time to time, in order to keep pace with advances in technology and practice standards; such amendment is under consideration. Continuation of these regulations is warranted.

Amendment of Subpart 58-8 of Title 10 (HIV Testing of Newborns)

Statutory Authority:

PHL §§ 576(4) and 2786

Description of the regulation:

Subpart 58-8 promoted the public health, safety and welfare by establishing minimum standards for clinical laboratory testing and reporting of test results to detect human immunodeficiency virus (HIV) and to monitor infected individuals. Future amendments may be required to create consistency with the HIV testing law implemented September 1, 2010 and supporting regulations of Part 63. The amendments will also address updated technologies and revise the testing algorithms for the management of HIV. Continuance of these regulations is warranted.

Amendment of Sections 80.67, 80.69, 80.73 and 80.74 (Addition of Prescription Information)

Statutory Authority:

PHL §§ 3308(2) and 3338(3)

Description of the regulation:

This regulation allowed pharmacists to complete certain missing or incorrect information on an official New York State prescription, upon receiving oral authorization to do so from the prescribing practitioner. Allowing the pharmacist to add or change such information saved the patient the inconvenience of having to return to the practitioner who issued the prescription. The regulation ensured access to controlled substances for legitimate medical use and saved practice time for the prescriber and the pharmacist resulting from return visits to each. Continuance of this regulation is warranted.

Amendment of Sections 80.67, 80.69, 80.71 and 80.72 (Three-Month Controlled Substance Medication)

Statutory Authority:

PHL § 3308(2)

Description of the regulation:

The regulations provided consistent access to medication for all patients being treated with controlled substances for attention deficit disorder (ADHD). This regulation allowed patients of any age to obtain up to a 3-month supply of a controlled substance for treatment when prescribed by their practitioner since ADHD has been proven to extend into adulthood. Some prescription plans allowed for a single co-pay for a 3-month supply. The amendment has resulted in significant cost savings to the patient. Continuance of this regulation is warranted.

Amendment of Section 86-6.6 (Hospice Supplemental Financial Assistance)

Statutory Authority:

PHL § 4012-a

Description of the regulation:

The regulation permanently extended the Hospice Supplemental Financial Assistance Program until the supporting program legislation expires. The rule shouldcontinue without modification.

Amendment of Paragraph 415.14(a)(1) (Qualifications of Nursing Home Director of Food Services)

Statutory Authority:

PHL § 2803(2)

Description of the regulation:

The amendment modified a restrictive personnel qualification standard for the food service director which exceeded the federal requirements set forth at 42 CFR Section 483.35, and did not necessarily contribute to nursing home resident well-being. It also provided nursing home operators greater flexibility in the recruitment of a staff position. Based upon outcomes identified during nursing home surveillance activities, the amended regulation has not had a negative impact on resident health and safety. The regulation should continue without modification.

Title 18 NYCRR - Ten Year Review

Amendment of Section 486.5 of Part 486 of Title 18 (Non-Rectifiable Offenses in Adult Care Facilities)

Statutory Authority:

SSL §§ 460-d and 461

Description of the regulation:

The regulation allowed for the imposition of civil penalties against adult care facilities (except those operated by a social services district) for violation of regulations related to adult care facilities or any order of the Department issued pursuant to Social Services Law § 460-d. Most penalties may be abated if rectified by the facility within 30 days. Subdivision (a)(4) of the regulation provided that penalties imposed because a violation endangered or resulted in harm to a resident may not be rectified so as to abate the penalty, if the endangerment or harm is the result of one of the following actions or failures to act by the facility:

(i) Total or substantial failure of the facility's fire protection or prevention systems or emergency evacuation procedures;

(ii) Retention of a resident medically requiring placement in a nursing home when the operator has not made and cannot document efforts to secure an appropriate placement;

(iii) Failure of the operator to take appropriate action in the event of a resident's illness, accident, death or attempted suicide;

(iv) Failure of the facility to provide supervision in accordance with the staffing requirements of the regulations;

(v) Failure of systemic practices and procedures;

(vi) Threats of retaliation or taking reprisals against a resident who participates in the investigation of a complaint or who is the subject of an action identified in a complaint.

This regulation enabled the Department's collection of civil penalties from facilities who fail to meet acceptable standards of resident care and supervision in these critical areas and also facilitated enforcement of basic resident protections and the prevention of endangerment and resident harm. Continuance of this regulation is warranted.

Repeal clause (a) of 505.14(h)(7)(iii) and add new clause (a); amendment of 505.14(h)(7)(iii)(b)(1); repeal of subclause (6) of 505.14(h)(7)(i)(a) and add new subclause (6),(i) and (ii) to Title 18 (Personal Care Services Reimbursement (BLTCR))

Statutory Authority:

SSL §§ 363-(a)(2) and 365a(2)(e)

Description of the regulation:

The rule revised Medicaid reimbursement regulations to include a two percent penalty when cost reports are submitted late, and instituted advance notification of January personal care rates.The rule should continue without modification.

Title 18 NYCRR - Fifteen Year Review

Amendment of Sections 347.5, 369.1, 369.7, 370.2, 370.7 and 360-3.2 of Title 18 (Child Support-MA)

Statutory Authority:

Chapter 398 of the Laws of 1997

Description of the regulation:

The regulation revision enhanced child support enforcement efforts by requiring Medicaid applicants and recipients to assist in establishing, modifying and enforcing child support orders. Section 360-3.2 was part of a regulatory package submitted by the Office of Temporary and Disability Assistance (OTDA). The revision remains valid in order to implement Chapter 398 of the Laws of 1997. Continuance of this regulation is warranted.

Amendment of Paragraph 505.5(d)(2) of Title 18 (Medicaid DME Pricing Methodology)

Statutory Authority:

Chapter 474 of the Laws of 1996.

Description of the regulation:

The regulation established maximum reimbursable prices for standard items of durable medical equipment. This regulatory change was developed with the support and assistance of the State's durable medical equipment providers as a means to simplify billing procedures, to limit cost increases to Medicaid of durable medical equipment, and to minimize audit issues related to the determination of actual invoice cost for pricing. The methodology remains appropriate and consistent with the payment policy of other medical care insurers. This regulation should be retained without modification.