reglab/statecodes huggingface dataset:
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-10 - NYS Medical Indemnity Fund › Section 69-10.16 - Claim and prior authorization denial review process

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A request for review of a denial of a
					 claim or of a prior approval request shall be made by completing and submitting
					 a review request form provided by the fund administrator for denial of a claim
					 or a prior approval request no later than 30 days from receipt of the denial.
					 The form shall be provided to all enrollees and/or their parent(s), guardian(s)
					 or legal representative(s) and shall be available on the fund administrator's
					 website; and when completed, shall be submitted electronically, mailed or faxed
					 to the fund administrator's office.
(b) A request for review of a denial of a
					 claim or a prior approval request shall specify the denial that the enrollee is
					 seeking to appeal and include the reason(s) the enrollee believes that the
					 decision was incorrect and whether the requestor wants:
(1) a review based on documents submitted by
					 both parties;
(2) a review in the
					 form of a hearing conducted by telephone; or
(3) a review in the form of a hearing
					 conducted in person.
The review option chosen by the enrollee shall be the
						only form of review conducted by the commissioner or his or her designee. A
						hearing officer, assigned by the commissioner or his or her designee, will
						conduct the review regardless of whether the review is to be a document review
						or a review in the form of a hearing.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-10 - NYS Medical Indemnity Fund › Section 69-10.17 - Right to expedited review of denials of requests for prior approval

Current through Register Vol. 46, No. 28, July 10, 2024
(a) An expedited
					 review will be provided upon an enrollee showing that:
(1) he or she submitted a written statement
					 from a physician, physician assistant, or nurse practitioner on the
					 practitioner's letterhead or on the letterhead of the supervising or
					 collaborating physician, if applicable, that the enrollee had an emergency need
					 for the medical service(s) or item(s) in issue and the reason the service or
					 item was needed on an expedited basis; and
(2) the fund administrator denied the request
					 for expedited prior approval.
Such reviews must be conducted within 10 business days
						from receipt of the request for expedited review and all documentation
						supporting the request.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-10 - NYS Medical Indemnity Fund › Section 69-10.18 - Withdrawal or abandonment of review request

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A request for review of a claim or prior
					 approval request denial will be considered to have been withdrawn under the
					 following circumstances:
(1) the fund
					 administrator has received a written statement from the enrollee or the
					 enrollee's authorized representative stating that the request for review is
					 withdrawn; or
(2) the enrollee or
					 the enrollee's authorized representative has made a statement withdrawing the
					 request to the hearing officer on the record at the
					 hearing.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-10 - NYS Medical Indemnity Fund › Section 69-10.19 - Actuarial calculations for the fund

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Following the annual deposit set forth in
					 section 2999-i (5)  of the Public
					 Health Law, and quarterly thereafter, the superintendent shall conduct an
					 actuarial calculation of the estimated liabilities of the fund for the year
					 following such annual deposit, resulting from qualified plaintiffs enrolled in
					 the fund.
(b) The analysis pursuant
					 to subdivision (a) of this section shall include a review of the various
					 elements contributing to the amount of benefits paid by the fund and to the
					 expenses of administration of the fund, including:
(1) the number of qualified plaintiffs
					 admitted in the fund, and estimates of the number of qualified plaintiffs not
					 yet admitted;
(2) the mortality
					 experience of the qualified plaintiffs admitted to the fund;
(3) the amounts of benefits paid by the fund
					 by types of services provided;
(4)
					 the patterns of utilization by types of services provided;
(5) the inflationary patterns by types of
					 services provided;
(6) the expenses
					 of administration of the fund;
(7)
					 the impact available health insurance has on the benefits paid by the fund;
					 and
(8) the investment earnings on
					 the assets held by the fund.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-10 - NYS Medical Indemnity Fund › Section 69-10.20 - Suspension of the fund

Current through Register Vol. 46, No. 28, July 10, 2024
(a) When
					 the fund's current liabilities equal or exceed 80 percent of the fund's assets,
					 as determined by the actuarial calculation performed under section
					 69-10.19 
					 of this Subpart, the fund administrator shall suspend enrollment in the fund
					 and new enrollments will no longer be accepted.
(b) When the fund's current liabilities no
					 longer equal or exceed 80 percent of the fund's assets, as determined by the
					 actuarial calculation performed under section
					 69-10.19 
					 of this Subpart, the fund administrator shall resume enrollment in the fund and
					 new enrollments will be accepted if otherwise eligible.
(c) The fund administrator will provide
					 prompt notice on the fund administrator's website of any suspension or
					 reinstatement of enrollment.
(d)
					 Once enrolled, a qualified plaintiff will remain in the fund for his or her
					 lifetime, and will not be impacted by a suspension in enrollment.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-10 - NYS Medical Indemnity Fund › Section 69-10.21 - Rates of payment

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Physicians shall be paid at the 80th percentile of the usual and customary
					 charges for services provided in private physician practices, as reported by
					 FAIR Health, Inc. in its Usual, Customary and Reasonable (URC) database at the
					 time of billing. Payment of these charges shall constitute payment in full for
					 any such services provided to an enrollee of the fund.
(b) Emods, vehicle modifications and
					 assistive technology will be paid at an amount established by the prior
					 approval process pursuant to sections
					 69-10.7,
					 69-10.8,
					 69-10.9
					 and
					 69-10.10 
					 of this Subpart.
(c) Services,
					 supplies, and equipment for which there is a Medicaid fee or rate available
					 will be paid at that fee or rate.
(d) Medications will be paid at the Medicaid
					 rate, provided however, if the Department of Health determines that Medicaid
					 rates are not available due to technological issues and related administrative
					 costs, a pharmacy benefits manager designated by the fund administrator and
					 approved by the Department of Health may be used to price
					 medications.
(e) Any other service
					 will be paid at a reasonable rate for that type of service in that geographic
					 area as determined by the fund administrator. Rates shall be deemed reasonable
					 if they are sufficient to provide the enrollee with access to services and are
					 not in excess of the prevailing rates paid by other payers in the region. When
					 Fair Health, Inc.'s UCR database specifies a rate for a particular service, the
					 fund administrator shall pay at the 80th percentile of such rate.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-10 - NYS Medical Indemnity Fund › Section 69-10.22 - Residence of qualified plaintiffs and enrollees

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Eligibility for or continued enrollment
					 in the fund is not dependent on the current or past residency of a qualified
					 plaintiff or enrollee.
(b) The fund
					 administrator shall advise enrollees to notify the fund administrator of any
					 changes in address within 10 business days from the date of the move in order
					 to prevent delays.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
As used in this Part:
(a) "Assisted reproductive technology
					 service" or "ART service" means a medical procedure intended to result in a
					 pregnancy, including, but not limited to, in vitro fertilization (including
					 intracytoplasmic sperm injection), embryo transfer and gamete intrafallopian
					 transfer. This definition, for purposes of this Part, does not include
					 artificial insemination, the process by which fresh or frozen sperm sample is
					 introduced into a vagina other than by sexual intercourse.
(b) "Assisted reproduction service provider"
					 means a medical provider, fertility clinic, or reproductive tissue bank (which
					 shall include a gamete bank), or any other entity which either provides ART
					 services in New York State or for which any component of the ART services
					 arranged by the entity is performed in New York State.
(c) "Child" means a born individual of any
					 age whose parentage may be determined under Article 5-C of the Family Court Act
					 or any other law.
(d) "Donor" means
					 an individual who does not intend to be a parent and provides reproductive
					 tissue used for ART procedures performed on recipients other than that person
					 or that person's spouse, whether or not for consideration.
(e) "Health commerce system" or "HCS" shall
					 mean the Department's secure internet portal used for communications and
					 information exchange with organizations licensed and certified by the
					 Department and health care providers, or any successor system used for such
					 information exchange as required by the Department.
(f) "Intended parent" means an individual,
					 married or unmarried, who manifests the intent to be legally bound as the
					 parent of a Child resulting from ART or a surrogacy agreement.
(g) "Surrogate" means an adult who is not an
					 intended parent, who enters into a surrogacy agreement to bear a Child
					 resulting from an embryo formed using an egg other than their own.
(h) "Surrogacy program" means any person or
					 entity licensed under this Subpart as a surrogacy program.
(1) Persons or entities who arrange or
					 facilitate transactions contemplated in a surrogacy agreement under Article 5-C
					 of the Family Court Act, regardless of whether such agreement ultimately
					 comports with the requirements of Article 5-C of the Family Court Act, are
					 required to be licensed as a surrogacy program. under this Subpart if:
(i) such person or entity is doing business
					 in New York;
(ii) the surrogate
					 resides in New York State during the term of the surrogacy agreement;
					 or
(iii) any medical procedures
					 under the surrogacy agreement are performed within New York State.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.2 - Surrogacy program licensure

Current through Register Vol. 46, No. 28, July 10, 2024
(a) In
					 order to operate a surrogacy program in New York State, a person or entity must
					 be duly and currently licensed by the Department. As a condition for licensure,
					 each owner shall submit to the Department, on a form and in a manner prescribed
					 by the Department:
(1) proof of the program's
					 professional liability insurance or other appropriate insurance
					 coverage;
(2) the program's
					 administrative policies and procedures, including:
(i) a conflict of interest policy
					 satisfactory to the Department;
(ii) policies and procedures to ensure that
					 surrogacy agreements meet the requirements of Article 5-C of the Family Court
					 Act;
(iii) policies and procedures
					 to ensure that the surrogate has given informed consent for the surrogacy and
					 is afforded all of the rights set forth in and that all parties were provided
					 with a copy of the Surrogate's Bill of Rights in Article 5-C of the Family
					 Court Act at the time of the initial consultation;
(iv) policies and procedures to monitor
					 parties' compliance with the terms of the surrogacy agreement, and ensure that
					 such surrogacy agreement is in compliance with Article 5-C of the Family Court
					 Act; and
(v) training materials for
					 all surrogacy program staff.
(3) a background investigation report from an
					 independent licensed private investigation company:
(i) demonstrating that the owners of the
					 program, the individual functioning as the chief executive officer, and the
					 individual functioning as the chief operating officer, regardless of
					 adjudication, have never previously been convicted or found guilty of, or
					 entered a plea of guilty or a plea of nolo contendere to any offense involving
					 racketeering, fraud, theft, embezzlement, fraudulent conversion, or
					 misappropriation of property; and
(ii) specifying any judgments and liens filed
					 with the county clerk in counties where the individuals identified in
					 subparagraph (i) of this paragraph worked and resided and all counties
					 contiguous to those counties (within the past 10 years); and
(4) a comprehensive credit report
					 for each owner of the program.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.3 - Surrogacy program owner information

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The surrogacy program shall provide, as a
					 condition of licensure, business and owner information to the Department such
					 as:
(1) The business name, each business
					 address, tax ID number, and date of incorporation if applicable;
(2) The true full legal name, date of birth,
					 driver license number, social security or tax identification number, and home
					 address of all owners;
(3) Degrees,
					 certifications and licenses or other professional designation of the primary
					 owner for the business and for all owners; and
(4) Each business or occupation engaged in by
					 all owners during the five years immediately preceding the date of the
					 application, including place of employment and the location thereof.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.4 - Surrogacy program conflicts of interest

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Surrogacy programs shall, as a condition
					 of licensure, develop and maintain policies to avoid conflicts of interest
					 while facilitating, arranging, and engaging in the services contemplated in a
					 surrogacy agreement.
(b) The
					 surrogacy program's conflict of interest policy shall apply to all personnel of
					 the surrogacy program, including but not limited to owners, employees, and
					 contractors, who help to facilitate, arrange, or engage in any service
					 contemplated in a surrogacy agreement.
(c) Such conflict of interest policies shall
					 prohibit, at a minimum, the following conduct:
(1) any sort of kickback or making or
					 receiving a referral for a fee, except for fair market value fees paid by a
					 surrogacy program to an employee or independent contractor of the surrogacy
					 program solely for promoting the surrogacy program and identifying potential
					 surrogates;
(2)
					 fee-splitting;
(3) financially
					 benefitting from a referral, including a family member benefitting from a
					 referral;
(4) ordering or arranging
					 for excessive tests, treatment, or use of treatment facilities not warranted by
					 the condition of the patient;
(5)
					 making self-referrals, that is, referrals to health care providers with which
					 the surrogacy program has financial relationships (other than financial
					 relationships that would be commercially reasonable even if no referrals were
					 made between the parties); and
(6)
					 entering into an arrangement with a clinical laboratory under which the
					 clinical laboratory does not directly bill the patient as required by Public
					 Health Law section 586.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.5 - Surrogacy program informed consent

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Surrogacy programs shall obtain written informed consent from all prospective
					 parties to the surrogacy agreement prior to entering into such agreement and
					 shall develop and implement an informed consent form. The informed consent form
					 shall be written in plain language and available in English, or the language
					 the individual giving consent is most proficient in reading, and shall include,
					 at a minimum, the following:
(1) a statement
					 that the surrogate has been informed that their name and address will be kept
					 on file by the surrogacy program;
(2) a statement that the surrogate has been
					 advised of the option to voluntarily share their information with the surrogacy
					 registry upon completion of the surrogacy agreement;
(3) HIPAA-compliant authorization for
					 disclosure of the surrogate's relevant medical history information to
					 prospective intended parent(s) and their physicians, consistent with statutory
					 requirements for the disclosure of medical information;
(4) a statement that the surrogate has the
					 right to terminate the surrogacy agreement prior to becoming pregnant by means
					 of assisted reproduction pursuant to Article 5-C of the Family Court
					 Act;
(5) a statement regarding the
					 surrogacy program's screening of prospective surrogates, and the criteria
					 assessed therein; and
(6) a copy of
					 the Surrogates' Bill of Rights, as set forth in Article 5-C of the Family Court
					 Act.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.6 - Gestational surrogacy guidelines

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Each surrogacy program shall, as a
					 condition of licensure, ensure that all assisted reproduction service providers
					 who work with surrogacy programs are registered with the Department in
					 accordance with this Subpart.
(b)
					 Policies and procedures for screening of gestational surrogates must be
					 consistent with the Department's guidelines and best practices, which shall be
					 published on the Department's website.
(c) Policies and procedures for screening and
					 evaluation of intended parents must be consistent with clinical best
					 practices.
(d) The Department shall
					 develop, and make available in electronic form maintained on the Department's
					 website, informational material relating to gestational surrogacy, which shall
					 be made available in hard copy by the surrogacy program and at no cost to all
					 prospective surrogates and prospective intended parents who contact the
					 surrogacy program or seek to enter into a surrogacy agreement with the
					 surrogacy program.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.7 - Surrogacy registry

Current through Register Vol. 46, No. 28, July 10, 2024
(a) At
					 such time as the surrogacy program obtains a license, the surrogacy program
					 shall, as a condition of licensure, enroll in the Department's surrogacy
					 registry, the central tracking registry of surrogates in New York
					 State.
(b) Upon enrollment in the
					 surrogacy registry, the surrogacy program shall be provided with a unique
					 surrogacy program identifier code, which shall identify only the surrogacy
					 program's business name and business address.
(c) Upon completion of a surrogacy agreement,
					 the surrogacy program shall ask the surrogate whether they would like to
					 participate in the surrogacy registry. The surrogacy program shall make such
					 inquiry upon the completion of each new surrogacy agreement, regardless of the
					 surrogate's prior participation in, or refusal to participate in, the surrogacy
					 registry. The surrogate shall be provided with written informational material,
					 written in plain language, regarding the surrogacy registry which shall
					 indicate, at a minimum, the following:
(1)
					 participation in the surrogacy registry is voluntary and consent can be
					 revoked;
(2) information will be
					 de-identified; and
(3) the
					 surrogacy program shall adhere to all state and federal laws regarding
					 confidentiality of private health information, and the surrogate may pursue
					 remedies against the surrogacy program under such laws for any illegal
					 disclosure of their confidential health information.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.8 - Effective date for surrogacy program licensure

Current through Register Vol. 46, No. 28, July 10, 2024
Any agency, business, person or entity that is required
						to be licensed as a surrogacy program under this Subpart shall apply and must
						be approved for licensure pursuant to this prior to commencing
						operations.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.9 - Surrogacy program licensure fees and renewals

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Fees. Upon the filing of an initial
					 application for a license pursuant to this Subpart, the owner shall pay an
					 application fee to the Department in the amount of $1,000.
(b) Renewals. Surrogacy program licensees
					 shall renew their license annually by submitting the information required to be
					 submitted under this Subpart and a renewal fee in the amount of $200.
					 Applications for renewal shall be filed with the Department, in the form and
					 manner prescribed by the Department, 90 days prior to expiration of the current
					 license.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.10 - Continuation of surrogacy program licensure

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Licenses are not transferable or
					 assignable. A licensee may invalidate any license by delivering it to the
					 Department, in the form and manner prescribed by the Department, but such
					 delivery does not affect any civil or criminal liability or the authority to
					 enforce this Subpart for acts committed in violation thereof.
(b) A licensee who is the subject of a
					 voluntary or involuntary bankruptcy filing must report such filing to the
					 Department within seven business days after the filing date.
(c) A surrogacy program's license may be
					 revoked, suspended, limited or annulled by the Department upon a finding that:
(1) the owner misrepresented or failed to
					 disclose information required to be provided by this Subpart;
(2) the owner, or any employees, contractors,
					 or other personnel under the direction and control of the surrogacy program,
					 failed to adhere to any requirements of Article 44 of the General Business Law
					 or this Part; or
(3) the owner, or
					 any employees, contractors, or other personnel under the direction and control
					 of the surrogacy program, through action or act of omission, placed parties to
					 a surrogacy agreement or the Child intended to be born under the surrogacy
					 agreement in danger of harm of any kind, or otherwise violated the requirements
					 of this Subpart or any guidelines or standards required to be issued by the
					 Department pursuant to law.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.11 - Assisted reproduction service provider registration

Current through Register Vol. 46, No. 28, July 10, 2024
(a) An assisted reproduction service provider
					 is prohibited from performing any medical procedures for a gestational
					 surrogacy agreement unless such assisted reproduction service provider is
					 registered with the Department. In order to register with the Department as an
					 assisted reproduction service provider, an assisted reproduction service
					 provider shall provide to the Department in a form acceptable to the
					 Department:
(1) information demonstrating that
					 the assisted reproduction service provider is licensed to operate as a tissue
					 bank under 10 NYCRR section
					 52-2.1;
(2) information regarding any other health
					 care practitioner or health care facility licenses held by the assisted
					 reproduction service provider or the health care practitioners who work for the
					 assisted reproduction service provider;
(3) information regarding the assisted
					 reproduction service provider's health commerce system account; and
(4) the types of procedures, and an estimate
					 of the number of each type of procedure that will be performed annually, to
					 effectuate gestational surrogacy agreements.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.12 - Assisted reproduction service provider conflicts of interest

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The assisted
					 reproduction service providers shall develop and maintain policies to avoid
					 conflicts of interest while facilitating, arranging, and engaging in the
					 services contemplated in a surrogacy agreement.
(b) The assisted reproduction service
					 provider's conflict of interest policy shall apply to all personnel of the
					 assisted reproduction service provider, including but not limited to owners,
					 employees, and contractors.
(c)
					 Such conflict of interest policies shall prohibit, at a minimum, the following
					 conduct:
(1) any sort of kickback or making
					 or receiving a referral for a fee under Education Law section 6530(18) or any
					 other state or federal law;
(2)
					 fee-splitting under Education Law section 6530(19);
(3) financially benefitting from a referral
					 under Education Law section 6530(17);
(4) ordering or arranging for excessive
					 tests, treatment, or use of treatment facilities not warranted by the condition
					 of the patient under Education Law section 6530(35);
(5) making self-referrals under Public Health
					 Law Article 2, Title 2-D; and
(6)
					 entering into an arrangement with a clinical laboratory under which the
					 clinical laboratory does not directly bill the patient as required by Public
					 Health Law section 586.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.13 - Assisted reproductive service provider informed consent and applicability of reproductive tissue bank regulations

Current through Register Vol. 46, No. 28, July 10, 2024
All assisted reproduction service providers shall adhere
						to all applicable tissue bank regulations set forth in Part 52 of this Title,
						including but not limited to the informed consent requirements
						therein.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.14 - Ova donation guidelines

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Assisted reproduction service providers shall develop policies and procedures
					 relating to the selection and evaluation of prospective ova donors as set forth
					 in Part 52 of this Title.
(b) Such
					 policies and procedures must adhere to the Department's guidelines and best
					 practices relating to screening of ova donors, which shall be published on the
					 Department's website.
(c) The
					 Department shall develop and distribute, in printed and electronic form
					 maintained on the Department's website, informational material relating to ova
					 donation, which shall be made available by the assisted reproduction services
					 provider in hard copy to all prospective donors who contact such
					 provider.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter H - Family Health › Part 69 - Family Health › Subpart 69-11 - NYS Medical Indemnity Fund › Section 69-11.15 - Ova donation registry

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Any
					 assisted reproduction service provider that performs ova donor evaluation and
					 selection shall enroll in the Department's ova donation registry, the central
					 tracking registry of ova donors in New York State who have voluntarily agreed
					 to participate in such registry.
(b) Upon enrollment in the ova donation
					 registry, the assisted reproduction service provider shall be provided with a
					 unique identifier code, which shall identify only the assisted reproduction
					 service provider's facility identification number as issued by the Department,
					 business name, and business address.
(c) Following retrieval of oocytes from the
					 donor who is not also the intended parent, the assisted reproduction service
					 provider shall ask the donor whether they would like to participate in the ova
					 donation registry. The donor shall be provided with written informational
					 material regarding the ova donation registry which shall indicate, at a
					 minimum, the following:
(1) participation in
					 the ova donation registry is voluntary and consent can be withdrawn at any
					 time;
(2) information will be
					 de-identified; and
(3) the assisted
					 reproduction service provider shall adhere to all state and federal laws
					 regarding confidentiality of private health information, and the donor may
					 pursue remedies against the assisted reproduction service provider under such
					 laws for any unwarranted disclosure of their confidential health
					 information.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-1 - Application And Definitions › Section 70-1.1 - Application

Current through Register Vol. 46, No. 28, July 10, 2024
The requirements of this Part shall apply to hospitals,
						residential health care facilities, and diagnostic and treatment centers (see
						section 2801  of the Public Health Law) and clinical
						laboratories (see section 571  of the Public Health
						Law).
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-2 - Management Of Regulated Medical Waste › Section 70-2.1 - Waste management plan

Current through Register Vol. 46, No. 28, July 10, 2024
Each facility shall develop, document and implement
						policies and procedures specific to the management of regulated medical waste
						generated on-site and/or treated at the facility. Such policies and procedures
						shall minimally include, but not be limited to: a description of the types, and
						method(s) for treatment and disposal, of regulated medical waste; procedures
						for safe handling and transport of the waste within the facility from the point
						of generation or intake to the point of storage and/or treatment; a description
						of storage areas, including, as applicable, patient care areas, which details
						the location, ventilation and capacity of each storage area, and the length of
						time waste is to be retained in each area; and the titles and contact
						information for persons responsible for monitoring compliance. Facilities that
						treat regulated medical waste on-site shall include in their regulated medical
						waste management plan an operation plan for each treatment system
						employed.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-2 - Management Of Regulated Medical Waste › Section 70-2.2 - Containment and storage

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Regulated medical waste shall be separated from other waste as soon as
					 practicable at the point of generation prior to storage, treatment or disposal.
					 Containers holding regulated medical waste containing or mixed with hazardous
					 waste, radioisotopes and/or toxic drug waste shall be so labeled to identify
					 waste types contained therein and so as to provide other information, including
					 but not limited to isotope and level of radioactivity pertinent to determining
					 whether specific procedures for management and/or disposal are applicable.
					 Radiological medical waste shall be stored until decayed to a background
					 radiation level prior to transport off-site of the generating facility and/or
					 treatment.
(b) Containment of
					 regulated medical waste for handling, storage, and treatment shall be
					 accomplished with a primary container for protection from the elements and
					 limiting exposure to employees and the public. Each primary container holding
					 regulated medical waste shall be:
(1) marked
					 prominently with the universal warning sign or the word "biohazard";
(2) impervious to moisture, be secured and
					 situated so as to prevent leakage or preclude loss of contents during handling,
					 storage and/or transport; and
(3)
					 be located away from pedestrian traffic, be vermin and insect free, and shall
					 be maintained in a sanitary condition.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-2 - Management Of Regulated Medical Waste › Section 70-2.3 - Treatment and disposal

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Except as provided in subdivisions (b) and (c) of this section, treatment of
					 regulated medical waste shall be by:
(1)
					 discharge into a sanitary sewerage system connected to a secondary treatment
					 facility, if the waste is liquid or semi-liquid, except as specifically
					 prohibited by the Commissioner of Health, or by local law or
					 ordinance;
(2) incineration in a
					 regulated medical waste incineration facility under permit pursuant to article
					 19 of the Environmental Conservation Law;
(3) decontamination by autoclaving in
					 conformance with the requirements of Subpart 70-3 of this Part; or
(4) an alternative regulated medical waste
					 treatment system approved by the Commissioner of Health.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-2 - Management Of Regulated Medical Waste › Section 70-2.4 - Transfer of regulated medical waste for off-site treatment

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Generators of
					 regulated medical waste shall transfer such waste for off-site treatment only
					 to a regulated medical waste transporter permitted by the Department of
					 Environmental Conservation; provided, however, that a generator of under 50
					 pounds of regulated medical waste per month registered with the Department of
					 Environmental Conservation pursuant to 6 NYCRR Part 364 may transport its own
					 waste for off-site treatment.
(b) A
					 facility that generates waste and arranges transport for off-site treatment or
					 disposal, or otherwise participates in the transport of regulated medical waste
					 shall ensure that a regulated medical waste tracking form prescribed by the
					 Department of Environmental Conservation accompanies each load.
(c) All solid waste transported in a load
					 containing regulated medical waste shall be treated as regulated medical waste,
					 unless the regulated medical waste is separately contained in a secondary
					 container meeting the requirements of section
					 70-2.2(h) 
					 of this Subpart or is otherwise kept separate from the solid waste by
					 leak-proof barriers.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-2 - Management Of Regulated Medical Waste › Section 70-2.5 - Recordkeeping

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A record of
					 regulated medical waste by quantity and categories as defined in Public Health
					 Law 1389-aa and for disposition of treated waste on-site shall be maintained
					 and retained on-site by the generator for three years from the date of
					 disposition of the waste, and shall be available for inspection and copying by
					 the department. Documentation of corrective action related to a commingling
					 incident shall be retained three years.
(b) A report of the regulated medical waste
					 generated annually, by quantities and categories as defined in Public Health
					 Law 1389-aa shall be submitted to the Commissioner of Environmental
					 Conservation upon request.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-3 - Requirements For Autoclaves Used To Treat Regulated Medical Waste › Section 70-3.1 - Validation testing

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Prior
					 to using an autoclave to treat regulated medical waste, a facility shall
					 conduct validation testing under conditions, including, but not limited to load
					 configuration, composition and volume, that simulate conditions anticipated
					 during actual waste treatment. Validation testing protocols shall be included
					 in the facility's autoclave operation plan submitted to the department pursuant
					 to section
					 70-3.2 
					 of this Subpart.
(b)
(1) Validation testing shall employ spores of
					 Geobacillus stearothermophilus at a minimum concentration of 6 log
					 10 spores per indicator unit placed in the center of the
					 load or otherwise coldest point in the autoclave chamber as identified by the
					 manufacturer; provided, however, the department may require alternative and/or
					 supplemental indicators as necessary to demonstrate effectiveness of
					 treatment.
(2) Effective treatment
					 of regulated medical waste shall be demonstrated by a 4 log
					 10 reduction in viable Geobacillus stearothermophilus
					 spore concentration, or other measure of effectiveness for alternative and/or
					 supplemental indicators as specified by the department.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-3 - Requirements For Autoclaves Used To Treat Regulated Medical Waste › Section 70-3.2 - Operational requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Each
					 facility seeking to operate an autoclave shall develop an operation plan, and
					 shall submit such plan to the department for review and approval prior to using
					 the autoclave to treat regulated medical waste. Any change in procedures
					 related to the operation of the autoclave shall be reflected in a modified
					 plan, which shall be dated with each revision.
(b) No autoclave shall be used to treat
					 regulated medical waste without department approval of the facility's operation
					 plan and any modifications made to such plan on or after the effective date of
					 this regulation.
(c) The operation
					 plan shall be designed to promote safe and effective operation of the
					 autoclave. The operation plan shall include, minimally, procedures to ensure:
(1) the autoclave meets department criteria
					 for effective treatment of regulated medical waste (i.e., the protocol for
					 validation testing and a summary of the results);
(2) loads contain only those items or types
					 of waste for which effective treatment has been demonstrated by validation
					 testing; and exclude waste materials for which effective treatment by the
					 system has not been demonstrated and/or is prohibited pursuant to section
					 70-2.3  of
					 this Part, and, as applicable, materials expressly excluded in the
					 commissioner's notice of approval;
(3) each load is treated using residence
					 time, temperature and pressure that have been validated as effective for the
					 treatment of regulated medical waste, and conditions of treatment are monitored
					 and documented for each load;
(4)
					 the effectiveness of treatment is maintained, by including, as applicable,
					 procedures for and frequency of: calibration verification and recalibration of
					 parametric controls; monitoring by challenge testing or other demonstration
					 that treatment has been attained; and preventative maintenance of engineering
					 controls (e.g., charcoal and/or HEPA filters) and diagnostic procedures for
					 electronic controls (e.g., integrated computers and mechanical
					 components);
(5) occupational
					 exposure is minimized, and physical injury to operators is prevented during
					 loading, the cycle, and unloading the autoclave; and
(6) personnel are knowledgeable about routine
					 operation of the autoclave, are kept current with manufacturer recommendations
					 for operation, and have been instructed in emergency procedures for handling
					 malfunctioning systems and untreated waste. Training programs shall mandate
					 initial training and retraining at least once per calendar year and as
					 necessary for presenting updates on operational information.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-3 - Requirements For Autoclaves Used To Treat Regulated Medical Waste › Section 70-3.3 - Generally accepted and alternative operating parameters

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Unless other operating parameters have
					 been approved pursuant to subdivision (c) of this section, operating parameters
					 for treating of regulated medical waste in a gravity-feed autoclave shall be:
(1) at least 60 minutes residence time at a
					 temperature at least 121° C and a pressure of 15 pounds per square inch (15
					 psig); or
(2) at least 45 minutes
					 residence time at a temperature at least 135° C and a pressure of 31 pounds per
					 square inch (31 psig).
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-3 - Requirements For Autoclaves Used To Treat Regulated Medical Waste › Section 70-3.4 - Recordkeeping

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Each facility
					 shall retain for three years records of: validation testing and challenge
					 testing, including protocols and test results; routine system's monitoring;
					 and, where applicable, department approval as an alternative treatment
					 technology.
(b) Each facility shall
					 document each employee's participation in training and/or retraining in
					 autoclave operations, and shall retain such records for three years.
(c) Documentation of corrective action,
					 including that required by section 70- 3.2 of this Subpart, shall be retained
					 for three years.
(d) Documentation
					 of any modification to an approved operation plan, regardless of whether the
					 modification is subject to department approval pursuant to this section, shall
					 be retained three years from discontinuance of the modified plan.
(e) Documentation of the residence time,
					 pressure and temperature of each load treated shall be retained for three
					 years.
(f) All records required
					 pursuant to this section shall be made available for inspection and copying by
					 the department.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-3 - Requirements For Autoclaves Used To Treat Regulated Medical Waste › Section 70-3.5 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024