reglab/statecodes huggingface dataset:
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XII - Innovative Delivery Models › Part 1003 - Accountable Care Organizations › Section 1003.12 - Termination

Current through Register Vol. 46, No. 28, July 10, 2024
The Commissioner may limit, suspend or terminate the
				  certificate of authority of an ACO after written notice and an opportunity for
				  review and/or hearing based on, but not limited to, the following:
(a) Unsatisfactory performance by the ACO,
				ACO participants, providers/suppliers or other individuals or entities
				performing functions or services related to ACO activities;
(b) Unsatisfactory performance may include
				but is not limited to:
(1) Imminent harm to
				patients;
(2) Financial fraud and
				abuse;
(3) Fiscal insolvency of the
				ACO;
(4) The imposition of
				sanctions or other actions taken against the ACO by the accrediting
				organization, state, federal or local government agency leading to inability of
				the ACO to comply with the requirements under this Part;
(5) Violations of the physician self-referral
				prohibition, civil monetary penalties (CMP) law, federal or state anti-kickback
				statute, antitrust laws, or any other applicable federal or state laws, rules,
				or regulations that are relevant to ACO operations; and
(6) Failure to adhere to established quality
				measures or comply with corrective action plans related to poor performance on
				established quality of care standards.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XII - Innovative Delivery Models › Part 1003 - Accountable Care Organizations › Section 1003.13 - Reporting

Current through Register Vol. 46, No. 28, July 10, 2024
An ACO shall submit data to the commissioner annually or at
				  such other times as requested and in such manner and form as prescribed by the
				  commissioner regarding ACO participants, patient characteristics, utilization
				  of services, quality metrics, shared savings or losses information, complaints
				  and grievances and other information deemed necessary to monitor the ACO's
				  operations, eligibility and compliance. Entities with certificates of authority
				  reflecting the provision of state action immunity pursuant to section
				  1003.14(a) of
				  this Part shall submit such materials or information as is requested by the
				  department for purposes of active state supervision.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.1 - Practitioner registration

Current through Register Vol. 46, No. 28, July 10, 2024
(a) No
				practitioner shall be authorized to issue a patient certification as set forth
				in section
				1004.2 unless the practitioner:
(1) is qualified to treat patients with one
				or more of the serious conditions set forth in subdivision
				1004.2(a)(8) of
				this Part;
(2) is licensed, in
				good standing as a physician and practicing medicine, as defined in article 131
				of the Education Law, in New York State, or is certified, in good standing as a
				nurse practitioner and practicing, as defined in article 139 of the Education
				Law, in New York State, or is licensed, in good standing as a physician
				assistant and practicing in New York State, as defined in article 131-B of the
				Education Law, under the supervision of a physician registered under this
				Part;
(3) has completed a two to
				four hour course approved by the commissioner as set forth in subdivision (b)
				of this section;
(4) has applied to
				the department for a registration or a renewal of registration to issue patient
				certifications in a manner and format determined by the commissioner;
				and
(5) has been granted such
				registration by the department.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.3 - Application for registration as a certified patient

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A person
				applying for issuance or renewal of a registration as a certified patient
				shall:
(1) be a resident of New York State,
				or be receiving care and treatment in New York State; and
(2) possess a certification issued by a
				registered practitioner.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.6 - Consideration of registered organization applications

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Applicants for approval to operate as
				registered organizations shall submit an application to the department,
				containing the information required in section
				1004.5 of this Part, in a manner
				and format determined by the department.
(1)
				Applications shall be accompanied by a non-refundable application fee in the
				amount of $10,000.
(2) The
				registration fee for the registration period shall be $200,000. Applicants
				shall submit the registration fee by certified check, or another method
				approved by the Department, at the time of submission of the application. The
				registration fee shall be returned to the applicant if the applicant is not
				granted a registration under this Part.
(3) Only applications completed in accordance
				with this part as determined by the department and for which the application
				and registration fees have been submitted shall be considered if submitted in a
				timely manner. The department shall return the fee for $200,000 to all
				applicants who are not granted a registration.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.7 - Applications for renewal of registration as registered organization

Current through Register Vol. 46, No. 28, July 10, 2024
(a) An application
				to renew any registration issued under this Part shall be filed with the
				department not more than six months nor less than four months prior to the
				expiration thereof. If a renewal application is not filed at least four months
				prior to the expiration thereof, the department may determine that the
				registration shall have expired and become void on such expiration
				date.
(b) Applications shall be
				accompanied by a non-refundable application fee in the amount of $10,000.
				Applications shall also be accompanied by a registration fee in the amount of
				$200,000 made by certified check. Only applications completed in accordance
				with this part as determined by the department and for which the application
				and registration fees have been submitted shall be considered if submitted in a
				timely manner. The registration fee shall be returned to the applicant if the
				applicant is not granted a renewal registration under this section.
(c) The application for renewal shall include
				such information prepared in the manner and detail as the commissioner may
				require, including but not limited to:
(1)
				any material change as determined by the department in the information,
				circumstances or factors listed in section
				1004.5 of this Part;
(2) every known complaint, charge or
				investigation, pending or concluded during the period of the registration, by
				any governmental or administrative agency with respect to:
(i) each incident or alleged incidence
				involving the theft, loss, or possible diversion of medical marihuana
				manufactured, distributed, or dispensed by the registered organization;
				and
(ii) compliance by the
				applicant with local or State laws, or regulations of the department, including
				but not limited to, with respect to any substance listed in section
				3306 of the
				Public Health Law;
(3)
				information concerning the applicant's ability to carry on the manufacturing
				and distributing activity for which it is registered, including but not limited
				to approved medical marihuana product shortages or wait lists occurring during
				the registration period; and
(4) a
				summary of quality assurance testing for all medical marihuana products
				produced in the prior year including but not limited to the percentage of lots
				of each brand and form passing all required testing, the percentage of lots
				failing contaminant testing, the percentage of lots failing brand requirements,
				all recalls of product lots and all adverse events reported.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.8 - Registrations non-transferable

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
				Registrations issued under this part shall be effective only for the registered
				organization and shall specify:
(1) the name
				and address of the registered organization;
(2) name of the contact person for the
				registered organization;
(3) the
				activities the registered organization is permitted to perform under the
				registration for each approved location; and
(4) the real property, buildings and
				facilities that may be used for the permitted activities of the registered
				organization.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.9 - Failure to operate

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
				registration shall be surrendered to the department upon written notice and
				demand if the registered organization fails to begin operations, to the
				satisfaction of the department, of a manufacturing and/or dispensing facility
				within six months of the date of issuance of the registration.
(b) A registered organization who is required
				to surrender its registration in accordance with this section shall not be
				entitled to any refund of fees paid to the department.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.10 - Registered organizations; general requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) In addition to the requirements in Public
				Health Law and as otherwise set forth in this Part, a registered organization
				shall:
(1) make its books, records and
				manufacturing and dispensing facilities available to the department or its
				authorized representatives for monitoring, on-site inspection, and audit
				purposes, including but not limited to periodic inspections and/or evaluations
				of facilities, methods, procedures, materials, staff and equipment to assess
				compliance with requirements set forth in article 33 of the Public Health Law
				and this Part;
(i) Any deficiencies
				documented in a statement of findings by the department shall require that the
				registered organization submit a written plan of correction in a format
				acceptable to the department within 15 calendar days of the issue date of the
				statement of findings. A plan of correction shall address all deficiencies or
				areas of noncompliance cited in the statement of findings and shall:
(a) contain an assessment and analysis of the
				events and/or circumstances that led to the noncompliance;
(b) contain a procedure addressing how the
				registered organization intends to correct each area of
				noncompliance;
(c) contain an
				explanation of how proposed corrective actions will be implemented and
				maintained to ensure noncompliance does not recur;
(d) contain the proposed date by which each
				area of noncompliance shall be corrected;
(e) address any inspection finding which the
				department determines jeopardizes the immediate health, safety, or well-being
				of certified patients, designated caregivers or the public. Such a finding
				shall be deemed a critical deficiency and shall require immediate corrective
				action to remove the immediate risk, followed by the submission of a corrective
				action plan within 24 hours of notification by the department of the critical
				deficiency. The department will acknowledge receipt within 24 hours and respond
				as soon as practicable to notify if the plan is accepted or needs modification.
				If the corrective action plan needs modification, the registered organization
				shall modify the plan until it is accepted by the
				department.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.11 - Manufacturing requirements for approved medical marihuana products

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
Definitions.
Wherever used in this Part, the following terms shall have
				  the following meanings:
(1)
Approved medical marihuana product
is the final manufactured
				product delivered to the patient that represents a specific brand with a
				defined cannabinoid content and active and inactive ingredients, prepared in a
				specific dosage and form, to be administered as recommended by the
				practitioner.
(2)
Brand
means a defined medical marihuana product that has a
				homogenous and uniform cannabinoid concentration (total THC and total CBD) and
				product quality, produced according to an approved and stable processing
				protocol and shall have the same inactive ingredients as that defined for that
				form of the brand.
(3)
Form
of medical marihuana shall be a type of a medical
				marihuana product approved by the commissioner and shall refer to the final
				preparation of an approved medical marihuana brand; for example, an extract in
				oil for sublingual administration, an extract for vaporization or an extract in
				a capsule for ingestion.
(4)
Lot
means a quantity of a medical marihuana extraction product
				that has a homogenous and uniform cannabinoid concentration and product
				quality, produced according to an approved and stable processing protocol
				specific to that brand and form of medical marihuana product, during the same
				cycle of manufacture.
(5)
Lot unique identifier (lot number or bar code)
means any
				distinctive combination of letters, numbers, or symbols, or any combination of
				them, from which the complete history of manufacturing, testing, holding,
				distribution or recall of a lot of medical marihuana product can be
				determined.
(6)
Manufacturing
shall include, but not be limited to
				cultivation, harvesting, extraction (or other processing), packaging and
				labeling.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.12 - Requirements for dispensing facilities

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Medical marihuana products shall not be
				dispensed or handled unless an individual with an active New York State
				pharmacist license, as defined in article 137 of the Education Law, who has
				completed a four-hour course pursuant to section
				1004.1 of this part, is on the
				premises and supervising the activity within the facility.
(b) Dispensing facilities shall only sell
				approved medical marihuana products, related products necessary for the
				approved forms of administration of medical marihuana, and items that promote
				health and well-being subject to disapproval of the department and only in such
				a manner as does not increase risks of diversion, theft or loss of approved
				medical marihuana products or risk physical, chemical or microbial
				contamination or deterioration of approved medical marihuana
				products.
(c) No approved medical
				marihuana products shall be vaporized or consumed on the premises of a
				dispensing facility.
(d) Dispensing
				facilities shall not dispense approved medical marihuana products to anyone
				other than a certified patient or designated caregiver.
(e) When dispensing approved medical
				marihuana products, the dispensing facility shall:
(1) not dispense an amount greater than a 30
				day supply to a certified patient, and not until the patient has exhausted all
				but a seven day supply provided pursuant to any previously dispensed medical
				marihuana product by any registered organization;
(2) ensure that medical marihuana product
				packaging shall not be opened by dispensing facility staff;
(3) provide a patient specific log of medical
				marihuana products (brand, administration form, and dosage, and dates dispensed
				and any return of product) to the patient, the patient's designated caregiver,
				if applicable, or the patient's practitioner upon request;
(4) ensure the prescription monitoring
				program registry is consulted pursuant to 3343-a and section
				3364 of the
				Public Health Law, prior to any sales transactions and dispensing of any
				approved medical marihuana products by the facility.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.15 - Pricing

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
Definitions.
For purposes of this section, the following terms have the
				  following meanings:
(1)
Cost
				analysis
shall mean the review and evaluation of the separate cost
				elements and profit of a proposed price and the application of judgment to
				determine how well the proposed costs represent what the price per unit for
				approved medical marihuana products should be, assuming reasonable economy and
				efficiency.
(2)
Price
shall mean the cost to manufacture, market and
				distribute approved medical marihuana products plus a reasonable
				profit.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.16 - Medical marihuana marketing and advertising by registered organizations

Current through Register Vol. 46, No. 28, July 10, 2024
(a) All physical
				structures owned, leased or otherwise utilized by a registered organization,
				including any dispensing facility, shall:
(1)
				not advertise medical marihuana brand names or utilize graphics related to
				marihuana or paraphernalia on the exterior of the physical structures;
				and
(2) not display medical
				marihuana products and paraphernalia so as to be clearly visible from the
				exterior of a physical structure.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.17 - Reporting dispensed medical marihuana products

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A record of all approved medical
				marihuana products that have been dispensed shall be filed electronically with
				the department, utilizing a transmission format acceptable to the department,
				not later than 24 hours after the marihuana was dispensed to the certified
				patient or designated caregiver.
(b) The information filed with the department
				for each approved medical marihuana product dispensed shall include but not be
				limited to:
(1) a serial number that will be
				generated by the dispensing facility for each approved medical marihuana
				product dispensed to the certified patient or designated caregiver;
(2) an identification number which shall be
				populated by a number provided by the department, to identify the registered
				organization's dispensing facility;
(3) the patient name, date of birth and
				sex;
(4) the patient address,
				including street, city, state, zip code;
(5) the patient's registry identification
				card number;
(6) if applicable,
				designated caregiver's name and registry identification card number;
(7) the date the approved medical marihuana
				product was filled by the dispensing facility;
(8) the metric quantity for the approved
				medical marihuana product;
(9) the
				medical marihuana product drug code number, which shall be populated by a
				number provided by the department, to represent the approved medical marihuana
				brand that was dispensed to the certified patient or designated caregiver, as
				applicable;
(10) the number of days
				supply dispensed;
(11) the
				registered practitioner's Drug Enforcement Administration number;
(12) the date the written certification was
				issued by the registered practitioner; and
(13) the payment method.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.20 - Proper disposal of medical marihuana products by certified patients or designated caregivers

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
				certified patient or designated caregiver shall dispose of all approved medical
				marihuana product in the certified patient's or designated caregiver's
				possession no later than 10 calendar days after the expiration of the patient's
				certification, if such certification is not renewed, or sooner should the
				patient no longer wish to possess medical marihuana.
(b) A certified patient or designated
				caregiver shall complete disposal of approved medical marihuana products by one
				of the following methods:
(1) rendering the
				approved medical marihuana product non-recoverable beyond reclamation in
				accordance with the Department of Environmental Conservation's guidance;
				or
(2) returning the approved
				medical marihuana product to the dispensing facility from which it was
				purchased or any dispensing facility associated with the registered
				organization which manufactured the approved medical marihuana product, to the
				extent that the registered organization accepts product
				returns.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.21 - General prohibitions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) No
				person, except for a certified patient or designated caregiver, or an approved
				laboratorian shall open or break the seal placed on an approved medical
				marihuana product packaged by a registered organization and provided to the
				certified patient.
(b) No person
				associated with a registered organization shall enter into any agreement with a
				registered practitioner or health care facility concerning the provision of
				services or equipment that may adversely affect any person's freedom to choose
				the dispensing facility at which the certified patient or designated caregiver
				will purchase approved medical marihuana products.
(c) No approved medical marihuana product
				shall be sold, dispensed or distributed via a delivery service without prior
				written approval to the registered organization by the department, except that
				a designated caregiver may deliver the approved medical marihuana product to
				the designated caregiver's certified patient.
(d) No employee of a registered organization
				shall counsel a certified patient or designated caregiver on the use,
				administration of, and the risks associated with approved medical marihuana
				products, unless the employee is a physician, nurse practitioner, physician
				assistant or pharmacist with an active New York State license who has completed
				a four hour course pursuant to section
				1004.1 of this Part, or the
				employee is under the direct supervision of, and in consultation with, such
				physician, nurse practitioner, physician assistant, or pharmacist on-site in
				the dispensing facility.
(e) No
				certified patient or designated caregiver shall be in possession of approved
				medical marihuana products without having in his or her possession his or her
				registry identification card. The certified patient or designated caregiver,
				upon request by the department or law enforcement, shall present such card to
				verify that the certified patient or designated caregiver is authorized to
				possess approved medical marihuana products.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.22 - Practitioner prohibitions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A practitioner
				that is registered with the department shall not:
(1) directly or indirectly accept, solicit,
				or receive any item of value from a registered organization;
(2) offer a discount or any other item of
				value to a certified patient based on the patient's agreement or decision to
				use a particular practitioner, registered organization, brand or specific form
				of approved medical marihuana product produced by a registered
				organization;
(3) examine a
				qualifying patient for purposes of diagnosing a debilitating medical condition
				at any location owned or operated by a registered organization, or where
				medical marihuana products or related products necessary for the approved forms
				of administration of medical marihuana are acquired, distributed, dispensed,
				manufactured, sold, or produced; or
(4) directly or indirectly benefit from a
				patient obtaining a written certification. Such prohibition shall not prohibit
				a practitioner from charging an appropriate fee for the patient
				visit.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.23 - Designated Caregiver Prohibitions and Protections

Current through Register Vol. 46, No. 28, July 10, 2024
(a) An individual
				shall not serve as a designated caregiver for more than five certified patients
				at any given time.
(b) A designated
				caregiver may only obtain payment from the certified patient to be used for the
				cost of the approved medical marihuana product purchased for the certified
				patient in the actual amount charged by the registered organization; provided,
				however, that a designated caregiver may charge the certified patient for
				reasonable costs incurred in the transportation, delivery, storage and
				administration of approved medical marihuana products.
(c) Designated caregivers, including
				employees of facilities registered as designated caregivers and acting within
				their scope of employment, shall not be subject to arrest, prosecution, or
				penalty in any manner, or denied any right or privilege, including but not
				limited to civil penalty or disciplinary action by a business or occupational
				or professional licensing board or bureau, solely for an action or conduct in
				accordance with this Part.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.24 - Registered organizations; disposal of medical marihuana

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The disposal of medical marihuana shall
				mean that the medical marihuana has been rendered unrecoverable and beyond
				reclamation.
(b) Registered
				organizations shall dispose of any medical marihuana that is outdated, damaged,
				deteriorated, contaminated or otherwise deemed not appropriate for
				manufacturing or dispensing, or any plant-based waste created as a by-product
				of the manufacturing processes. Registered organizations shall:
(1) obtain department approval of disposal
				methods; and
(2) dispose of liquid
				and chemical waste in accordance with applicable federal, state and local laws
				and regulations.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIV - Vapor Products › Part 1006 - Ingredient Disclosures for Vapor Products and E-Cigarettes › Section 1006.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
As used in this Part:
(a) "Vapor products'' shall mean any vapor
				product, as defined by Public Health Law § 1399-aa, intended or reasonably
				expected to be used with or for the consumption of nicotine.
(b) "Electronic cigarette'' or "e-cigarette''
				shall mean an electronic cigarette or e-cigarette as defined by Public Health
				Law § 1399-aa.
(c) "Ingredient''
				shall mean each of the following:
(i) any
				intentionally added ingredient present in any quantity in a vapor
				product;
(ii) a byproduct or
				contaminant, present in a vapor product in any quantity equal to or greater
				than one-half of one percent of the content of such product by
				weight;
(iii) a byproduct present
				in a vapor product in any quantity less than one-half of one percent of the
				content of such product by weight, provided such element or compound is a
				chemical of concern; and
(iv) a
				contaminant present in a vapor product in any quantity less than one-half of
				one percent of the content of such product by weight, provided such element or
				compound is a chemical of concern.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIV - Vapor Products › Part 1006 - Ingredient Disclosures for Vapor Products and E-Cigarettes › Section 1006.2 - Ingredient Disclosure

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
				Manufacturers of vapor products or e-cigarettes distributed, sold, or offered
				for sale in this state, whether at retail or wholesale, shall furnish to the
				Commissioner for public record and post on such manufacturer's website, in a
				machine-readable format, the information described in this Section.
(b)
(i) For
				each vapor product, the information posted pursuant to this section shall
				include, at a minimum:
(a) Manufacturer
				information including name and address of the business entity and contact
				information for a point-of-contact, including name, address, telephone number,
				and email address.
(b) A list
				naming each ingredient of such vapor product and all expected functions of each
				ingredient. The ingredients must be listed in descending order of predominance
				by weight in such product, except that ingredients present at a weight below
				one percent may be listed following other ingredients without respect to the
				order of predominance by weight.
(c) The nature and extent of investigations
				and research performed by or for the manufacturer concerning the effects on
				human health of such product or its ingredients. This includes but is not
				limited to health-related documents required by section 904(a)(4)of Title 21 of
				the United States Code (a copy of which is available for copying and inspection
				at the Regulatory Affairs Unit, New York State Department of Health, Corning
				Tower, Empire State Plaza, Albany, New York 12237). Any investigations and
				research that was developed after the required submission of health-related
				documents to the United States Food and Drug Administration must also be
				posted.
(d) Where applicable, a
				statement disclosing that an ingredient of such product is a chemical of
				concern.
(e) For each ingredient
				that is a chemical of concern, an evaluation of the availability of potential
				alternatives and potential hazards posed by such alternatives.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIV - Vapor Products › Part 1006 - Ingredient Disclosures for Vapor Products and E-Cigarettes › Section 1006.3 - Proprietary Information

Current through Register Vol. 46, No. 28, July 10, 2024
(a) For
				purposes of this Part only, proprietary information may consist of any
				information subject to disclosure pursuant to this Part the disclosure of which
				would compromise a manufacturer's competitive position. Any proprietary
				information submitted or divulged to the Department of Health pursuant to this
				Part shall not be available for, or subject to, public disclosure. Proprietary
				information shall include, but is not limited to, any:
(i) Commercially valuable plan, formula,
				process, or device that is used for the making, preparing, or processing of
				vapor products, e-cigarettes, or their components, and that can be said to be
				the end product of either innovation or substantial effort. There must be a
				direct relationship between the proprietary information and the productive
				process; or
(ii) Valuable data or
				information which is used in a manufacturer's business and is of a type
				customarily held in strict confidence or regarded as privileged and not
				disclosed to any member of the public by the person to whom it
				belongs.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIV - Vapor Products › Part 1006 - Ingredient Disclosures for Vapor Products and E-Cigarettes › Section 1006.4 - Schedule of Disclosure

Current through Register Vol. 46, No. 28, July 10, 2024
Manufacturers shall furnish the information required to be
				  posted pursuant to this section within thirty days of the effective date
				  hereof, and every two years thereafter. In addition, such manufacturers shall
				  furnish such information: prior to the sale of any new vapor product or
				  e-cigarette; when the formulation of a currently disclosed product is changed
				  such that the predominance of the ingredients in such product is changed, prior
				  to the product being sold at retail; or at such other times as may be required
				  by the Commissioner.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIV - Vapor Products › Part 1006 - Ingredient Disclosures for Vapor Products and E-Cigarettes › Section 1006.5 - Penalties

Current through Register Vol. 46, No. 28, July 10, 2024
Any manufacturer who violates any of the provisions of, or
				  who fails to perform any duty imposed by this Part shall be liable, in the case
				  of a first violation, for a civil penalty not to exceed five thousand dollars.
				  In the case of a second or any subsequent violation, the liability shall be for
				  a civil penalty not to exceed ten thousand dollars for each such
				  violation.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.1 - Applicability

Current through Register Vol. 46, No. 28, July 10, 2024
This Part shall be applicable to every person or entity
				  seeking state certification to establish and operate a medical respite program
				  pursuant to article 29-J of the Public Health Law.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.2 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
The following words or terms when used in this Part shall
				  have the following meanings:
(a)
				Commissioner means the Commissioner of the New York State Department of
				Health.
(b) Department means the
				New York State Department of Health.
(c) Facility means the physical plant
				location where the medical respite program provides medical respite services to
				recipients.
(d) Inspection means
				periodic scheduled, announced or unannounced onsite survey, inspection or
				investigation by the department or its contractor to determine compliance by
				the operator with the applicable statutes and regulations, and may include
				observation or review of a sample of the medical respite program records to
				determine the quality and adequacy of the medical respite services.
(e) Medical respite program means the
				not-for-profit corporation certified by the department to serve recipients
				whose health condition necessitates the receipt of:
(1) Temporary room and board; and
(2) The provision or arrangement of the
				provision of health care services and supports; provided, however, that the
				operation of a medical respite program shall be separate and distinct from any
				housing programs offered to individuals or their families who do not qualify as
				recipients.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.3 - Certification; Operating Certificate

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Certificate of Authority
(1) The department may issue a certificate of
				authority if the applicant has met the requirements of article 29-J of the
				Public Health Law and this Part. The department shall evaluate a medical
				respite program application based on the information contained in and submitted
				with the application and any other relevant information known to the
				department. The department will notify an applicant if the application is
				incomplete and provide the applicant an opportunity to submit any additional
				information to complete the application. Any application that remains
				incomplete 90 days after receiving a request from the department for additional
				information may be denied.
(i) The operator
				of a DOH certified medical respite program will be expected to recertify every
				5 years to remain compliant.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.4 - General Provisions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The
				operator of a medical respite program must provide, through its employees,
				contractors and agents, an organized program that:
(1) Meets the operating standards set forth
				in this Part;
(2) Ensures the
				protection of recipient rights; and
(3) Promotes the social, physical and mental
				well-being of recipients.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.5 - Required Services

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Medical
				respite programs shall provide, or arrange for the provision of, the following
				services in accordance with this Part:
(1)
				Temporary room and board, which must include, at a minimum:
(i) A dedicated bed, available to a recipient
				24 hours a day, seven days a week.
(ii) Meals in accordance with standards set
				forth by the Commissioner.
(iii)
				Compliance by the facility with the physical standards set forth by the
				department in section
				1007.12 of this Part.
(iv) The medical respite program shall
				provide the department with any information relating to its physical plant
				environment and equipment necessary to evaluate its application.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.6 - Personnel

Current through Register Vol. 46, No. 28, July 10, 2024
(a) General
				Requirements.
(1) The operator must provide
				staff sufficient in number and qualified by training, background and experience
				to render, at a minimum, medical respite services.
(2) The operator shall ensure a sufficient
				number of staff members are on-site 24 hours a day, seven days a week. On-site
				staff must be trained to provide first aid and basic life support services,
				which shall include but not be limited to training in opioid overdose
				prevention and naloxone administration. At least one manager must be available
				onsite or by telephone 24 hours a day, seven days a week.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.7 - Eligibility and Admission

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
				Recipient Eligibility. An individual is eligible for admission to a Medical
				Respite Program as a recipient if meets the definition of a recipient set forth
				in section
				1007.2(g) of this
				Part and:
(1) The individual is 18 years of
				age or older, unless otherwise authorized in the facility's operating
				certificate by the department;
(2)
				The individual has a qualifying medical condition for which they require
				temporary rest and recuperation and may require access to medical care or other
				supportive services to support recuperation;
(3) The individual is able to perform
				activities of daily living with no or minimal assistance, or receives
				assistance on an interim or part-time basis from a local social services
				department, an outside agency, or other formal organization and such assistance
				is able to be provided in the facility;
(4) The individual is self-directing (i.e.,
				is capable of making choices about the individual's activities of daily living,
				understanding the impact of the choice, and assuming responsibility for the
				results of the choice), or receives supervision or direction on an interim or
				part-time basis as part of a plan of care in which the responsibility for
				making choices about activities of daily living is assumed by a self-directing
				individual, including but not limited to a local social services department, an
				outside agency, or other formal organization;
(5) The individual is able, with direction,
				to take action sufficient to ensure self preservation in an
				emergency;
(6) The individual does
				not require hospital inpatient, observation unit or emergency room level of
				care, or a medically indicated emergency department or observation visit or
				skilled nursing home level of care; and
(7) The individual does not pose a risk of
				safety to themself, other recipients or staff, as determined in the reasonable
				discretion by the medical respite program operator.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.8 - Discharge Planning

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
				Discharge Planning.
(1) The medical respite
				program shall discharge recipients when they no longer qualify for medical
				respite services, as defined in section
				1007.7(a) of this
				Part.
(2) If housing has not been
				identified when the recipient is ready for discharge, all housing packets and
				applications should be transferred to the recipient's discharge location, which
				has agreed to continue to assist the recipient with securing permanent
				housing.
(3) The medical respite
				program shall begin discharge planning upon a recipient's admission and shall
				engage in discharge planning throughout a recipient's stay at the
				facility.
(4) In order to discharge
				a recipient, the medical respite program shall:
(i) Develop a discharge plan that identifies
				and provides referral to potential housing options, healthcare providers, and
				supportive services for the recipient;
(ii) Provide, at least 14 days advance
				written notice, of the discharge to the recipient, and as applicable and
				appropriate, the recipient's managed care organization, referring entity or
				person, discharge location, health home, and family and caregivers, provided,
				any required authorization as set forth in section
				1007.4(c) of this
				Part is obtained;
(iii) Coordinate
				the discharge with the recipient's managed care organization, discharge
				location (e.g. shelter or housing provider, family member or friend's home,
				etc.), the referring entity or person, as applicable, and if applicable, the
				health home, as described in section
				1007.5(a)(3)(v)
				of this Part, provided, any required authorization as set forth in section
				1007.4(c) of this
				Part is obtained;
(iv) Provide the
				recipient with the discharge summary, which shall comply with subdivision (b)
				of this section; and
(v) Comply
				with any other requirements established by the department.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.9 - Quality Improvement Activities; Policies and Procedures

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A medical
				respite program shall implement a quality improvement program that provides for
				an annual or more frequent review of the medical respite program. The quality
				improvement program must evaluate, at a minimum, a profile of the
				characteristics of recipients admitted to the program, the services and degree
				of services most utilized, the length of stay and use rate, recipient need for
				care and services, recipient feedback about services received, and disposition
				upon discharge.
(b) The quality
				improvement process must:
(1) Include an
				evaluation of all services in order to enhance the quality of care and to
				identify actual or potential problems concerning medical respite
				services;
(2) Review accident and
				incident reports, recipient complaints and grievances, recipient feedback, and
				the actions taken to address problems identified by the process;
(3) Develop and implement revised policies
				and practices to address problems found and the immediate and systematic causes
				of those problems; and
(4) Assess
				the impact of the revisions implemented to determine if they were successful in
				preventing recurrence of past problems.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.10 - Food Service

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The
				operator of a medical respite program shall provide or arrange for meals to be
				provided to recipients that are balanced, nutritious and adequate in amount and
				content to meet their dietary restrictions and needs, and accommodate any
				religious dietary restrictions.
(b)
				Meal service shall be provided at the facility. Meal service may be provided
				directly or through contractual arrangements.
(c) At a minimum, recipients shall be
				provided with the opportunity to obtain breakfast, lunch and evening meals at
				regularly scheduled times, and two snacks a day.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XV - Medical Respite Program › Part 1007 - Medical Respite Program › Section 1007.11 - Recipient Rules

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The operator
				of a medical respite program shall adopt rules governing a recipient's
				day-to-day life in the program and post these rules in a location accessible to
				recipients of the facility and visitors.
(b) Prior to admission, each recipient must
				be provided with a copy of the medical respite program's code of conduct,
				facility rules, and recipient's rights, which shall comply with all
				requirements set by the department. The recipient shall sign an acknowledgment
				of a receipt of the code of conduct, facility rules, and recipients rights; a
				hard or electronic copy of the signed acknowledgement and the code of conduct,
				facility rules, and recipients rights shall be provided to the recipient and a
				hard or electronic copy shall be maintained by the operator at the facility in
				the recipient's records.