This emergency adoption of amendments provides additional means for obtaining consent for medical treatment to address the immediate need and high volume of reviews needed for Willowbrook class members and for individuals who lack capacity to consent on their own behalf and also lack the support of involved family to help make the decision to receive a potentially lifesaving vaccine. This regulation must be issued by emergency regulation to assure consent for, and timely immunization of, this cohort of individuals with developmental disabilities. Emergency adoption is necessary to protect the immediate health, safety, and welfare of individuals with developmental disabilities who live in congregate settings and are awaiting a lifesaving vaccine.

(iii) Informed consent may be obtained for those persons who are residents of a facility operated or certified by OPWDD as follows:

(a) If a person is less than 18 years of age, consent shall be obtained from one of the surrogates listed, in the order stated:

(1) a guardian lawfully empowered to give such consent;

(2) an actively involved (see section 633.99 of this Part) spouse;

(3) a parent;

(4) an actively involved adult sibling (see section 633.99 of this Part);

(5) an actively involved adult family member (see section 633.99 of this Part);

(6) a local commissioner of social services with custody over the person pursuant to the Social Services Law or Family Court Act (if applicable); [or]

(7) the Informed Consent Committee (see section 633.16 of this Part), convened by an individual’s residential provider, for the limited purpose of providing consent for a COVID-19 vaccine; or

(8) a surrogate decisionmaking committee (SDMC) (see section 633.99 of this Part) or a court of competent jurisdiction.

• Existing subparagraph 633.11(a)(1)(iii)(b)(7) is amended and added to read as follows:

(b) If a person is 18 years of age or older, but lacks capacity to understand appropriate disclosures regarding proposed professional medical treatment or a determination of insufficient capacity has been made pursuant to clause (g) of this subparagraph, informed consent to such proposed professional medical treatment shall be obtained from one of the surrogates listed, in the order stated:

(1) a guardian lawfully empowered to give such consent or the person’s duly appointed health care agent or alternative agent (see section 633.20 of this part and Article 29-C of the Public Health Law);

(2) an actively involved spouse;

(3) an actively involved parent;

(4) an actively involved adult child;

(5) an actively involved adult sibling;

(6) an actively involved adult family member;

(7) the Consumer Advisory Board (see section 633.99 of this part) for the Willowbrook Class [only for class members it fully represents];[or]

(8) the Informed Consent Committee (see section 633.16 of this Part), convened by an individual’s residential provider, for the limited purpose of providing consent for a COVID-19 vaccine; or

(9) a surrogate decision making committee (SDMC) or a court of competent jurisdiction.

1. Statutory authority:

a. The Office for People With Developmental Disabilities (OPWDD) has the statutory responsibility to provide and encourage the provision of appropriate programs, supports, and services in the areas of care, treatment, habilitation, rehabilitation, and other education and training of persons with intellectual and developmental disabilities, as stated in the New York State (NYS) Mental Hygiene Law (MHL) Section 13.07.

b. OPWDD has the authority to adopt rules and regulations necessary and proper to implement any matter under its jurisdiction as stated in the NYS MHL Section 13.09(b).

c. OPWDD has the statutory authority to adopt regulations concerned with the operation of programs and the provision of care and services, as stated in the NYS MHL Section 16.00. The regulation also ensures compliance by OPWDD certified and operated residences with the proper provision of care and services.

2. Legislative objectives: The proposed regulations further legislative objectives embodied in MHL sections 13.07, 13.09(b), and 16.00. The regulations amend Title 14 New York Codes Rules and Regulations (NYCRR) Part 633.11 in order provide an additional method for obtaining consent for medical treatment, specifically the COVID-19 vaccine, for individuals who lack capacity to consent on their own behalf and lack the support of a guardian or involved family. The amendment expands access to the Consumer Advisory Board for Willowbrook class members and broadens the jurisdiction of a surrogate decision-making panel which already exists in law and in operation, providing efficient access to consent review to this population statewide. These changes are necessary to ensure equal access to a potentially lifesaving vaccine, for individuals who lack capacity to consent on their own behalf, during a global pandemic.

3. Needs and benefits: The proposed regulation amends Title 14 NYCRR Part 633.11 to set forth additional means for obtaining consent for the administration of the COVID-19 vaccination for individuals with developmental disabilities who lack capacity to consent on their own behalf and who lack the support of a family member to assist. These changes are necessary to ensure equal access to a potentially lifesaving vaccine, for individuals who lack capacity to consent on their own behalf, during a global pandemic. The Surrogate Decision Making Committee, generally reserved for much more significant medical decisions, does not have the resource capacity for the volume of reviews that would be needed to ensure access to COVID vaccines for the OPWDD population.

4. Costs:

a. Costs to the agency and to the State and its local governments: No additional costs to OPWDD. Informed consent committees already exist as required by OPWDD regulations. Additional costs to the NYS Justice Center will be avoided by promulgation of this emergency regulation, by reducing what would otherwise become a sudden onset and high volume of consent reviews requiring review by the Surrogate Decision Making Committee.

b. Costs to private regulated parties: No additional costs to regulated providers. Informed consent committees are already required to be empaneled by these same providers within pre-existing OPWDD regulations and these providers already have access to the necessary documents and records.

5. Local government mandates: No service, duty or responsibility are imposed on local governments as a result of this rule.

6. Paperwork: OPWDD residential providers are already required to be able to empanel Informed Consent Committees for purposes of providing consent on behalf of individuals in other circumstances. The majority of the paperwork involved is already in the possession of the residential providers, and accessible to the Consumer Advisory Board, which will enable a much more streamlined process than relying on the Surrogate Decision Making Committee.

7. Duplication: The proposed regulations do not duplicate any existing State or Federal requirements on this topic.

8. Alternatives: The alternative to increasing consent-giving capacity of the Informed Consent Committees is to rely exclusively on the Surrogate Decision Making Committee and/or bringing applications for review to a Court of competent jurisdiction, which is a very time consuming and costly proposition. These regulations are necessary to ensure equity of the COVID-19 vaccines for public health, public welfare, and public safety.

9. Federal standards: The proposed amendments do not exceed any minimum standards of the federal government for the same or similar subject areas.

10. Compliance schedule: OPWDD plans to adopt the regulations as an Emergency Adoption. The effective date for enforcement of the regulation will be upon filing. The proposed regulations were discussed with and reviewed by representatives of providers, the NYS Justice Center, on behalf of the Surrogate Decision Making Committee, Mental Hygiene Legal Services and the Willowbrook Consumer Advisory Board in advance of this proposal. OPWDD expects that providers will be in compliance with the proposed requirements at the time of their effective date(s).

A regulatory flexibility analysis for small businesses and local governments is not being submitted because these amendments will not impose any adverse economic impact or reporting, record keeping or other compliance requirements on small businesses. There are no professional services, capital, or other compliance costs imposed on small businesses as a result of these amendments.

The emergency/proposed regulations amend Title 14 NYCRR Subpart 633.11 to allow an additional means of obtaining consent for individuals to receive the COVID-19 vaccine, in situations where there is no other person to make that election for them, such as lack of a guardian or incapacity. The amendments will not result in costs or new compliance requirements for regulated parties and consequently, the amendments will not have any adverse effects on providers of small business and local governments.

A Rural Area Flexibility Analysis for these amendments is not being submitted because the regulation will not impose any adverse impact or significant reporting, record keeping or other compliance requirements on public or private entities in rural areas. There are no professional services, capital, or other compliance costs imposed on public or private entities in rural areas as a result of the proposed regulation.

The proposed regulation amends Title 14 NYCRR Part 633.11 in order to provide an additional way to obtain consent for medical treatment, specifically the COVID-19 vaccine. The regulation will not result in an adverse impact on rural communities because the regulation applies to all providers of these services. The proposed regulation will not result in costs for regulated parties. Therefore, the amendments will not have any adverse effects on providers in rural areas and local governments.

A Job Impact Statement for the proposed regulation is not being submitted because it is apparent from the nature and purpose of the regulation that they will not have a substantial adverse impact on jobs and/or employment opportunities.

The proposed regulation amends Title 14 NYCRR Part 633.11 in order to provide for additional means of consent to medical treatment in response to the Public Health Emergency. The regulation expands the jurisdiction of a surrogate decision-making panel, which already exists in regulation and in operation, in order to obtain consent for the COVID-19 vaccine. The regulation will not have a substantial impact on jobs or employment opportunities in New York State.