(1) If the chair determines that any member of the board is not in compliance with the requirements of the code of conduct or this Part, then the member shall not take any part in any business of the board until the member comes into compliance.

(1) All appointments shall expire on the same date three years following the appointment date of the first member of the board.

(2) In the event of any vacancy on the board, the superintendent may appoint a person to fill the remainder of the term.

(1) The location of the meeting shall be determined by the chair.

(1) Notwithstanding the requirements of this subdivision, the chair may call a meeting on less than ten business days’ notice in the event of unusual or extraordinary circumstances.

(1) Pursuant to Insurance Law section 202, the meetings of the board shall be private and not subject to disclosure.

(2) No recordings of the meetings of the board shall be made by any person; however, an official set of minutes for the meetings may be recorded by a representative of the office.

(3) No person shall be permitted to attend, view, or listen to any meeting of the board unless the person is:

(i) a member of the board;

(ii) a member of the office; or

(iii) an expert engaged by the office to provide a briefing to the board.

(4) The board may request a presentation on any subject relevant to any inquiry before the board from any state agency or authority. Such request shall be reviewed by the office and if the director approves the request, the office shall arrange an expert briefing to the board.

(1) Not less than seven days before the board adopts a report, the office may convey to the person that was required to submit a written statement under subsection (a) of Insurance Law section 111 anticipated findings provided by the board. Such person shall keep the proposed findings confidential and, pursuant to Insurance Law sections 111 and 202, such anticipated findings shall not be subject to disclosure. Such person may convey a response to the anticipated findings, and such response must be received by the board within seven days after the proposed findings are conveyed.

(2) No report of the board shall be adopted except by a majority vote of the non-recused members of the board.

(3) Any adopted report shall be an advisory report.

A revised Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement are not required for the adoption of new Part 450 to 11 NYCRR (Insurance Regulation 219) because the non-substantive revisions to the regulation do not require a change to the previously published Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement.

As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2024, which is no later than the 3rd year after the year in which this rule is being adopted.

The Department of Financial Services (“Department”) received comments from one entity that represents pharmaceutical manufacturers.

Comment

The commenter expressed concerns about the protection of highly-sensitive confidential information and requested that the Department amend the proposed regulation to include additional process safeguards to protect confidential and proprietary data from being publicly disclosed.

Response

Section 450.3 references a “Code of Conduct” that individuals are required to sign in order to be appointed to the Drug Accountability Board (“DAB”). The Code of Conduct sets strict ethical protocols and responsibilities for DAB members. The Code of Conduct includes provisions specifically addressing conflicts of interest, confidential information and a recusal process. DAB Members are required to complete a financial disclosure and may access information only through the Department’s secure platform. DAB members are required to attend an ethics training session.

Notably, Insurance Law Section 111 requires that any information obtained in an investigation shall be confidential and shall not be subject to disclosure by the Department, except to the drug accountability board, which may review the information and, as necessary, include any such information in its report. Section 202 also provides that information reviewed by the DAB is subject to confidential treatment. The Department finds that including additional confidentiality protections to the regulation is unnecessary given the protections already provided by statute and the Code of Conduct. Finally, DFS will perform outreach to the commenter inviting discussions on the contents of the Code of Conduct to ensure any concerns they have are adequately addressed. Thus, no changes are necessary in response to these comments.

Comment

The commenter commented on the Department’s recusal authority being vested in the Chairperson of the Board.

Response

The Department’s decision to provide the Chairperson with ultimate recusal authority provides a check on the self-recusal requirements contained in the Code of Conduct. While DAB members are required to recuse themselves, the Chairperson has final authority on recusal of a member. Providing the Chairperson with final authority to determine whether and when recusal is required is consistent with the governing rules for similar state drug review boards. This measure prevents abuses that could occur under an unchecked self-recusal policy. Thus, no changes are necessary in response to this comment.

Comment

The commenter requested that the regulation include more detail on the processes by which the Office of Pharmacy Benefits (OPB) and the DAB operate.

Response

Insurance Law Sections 111 and 202 provide the mechanism by which the OPB and DAB operate. This regulation establishes rules to operate the OPB and the DAB and includes provisions for, among other things, the adoption of by-laws related to the conduct of board operations, which can provide additional details about the internal operations of the DAB. Given the confidential deliberations provided for in the statute, the Department has determined this is the appropriate manner to handle detailed operational questions. Thus, no changes were necessary in response to this comment.

Comment

The commenter suggested that the subject of an investigation should have access into the information reviewed and presentations to the DAB or Department and an opportunity to respond.

Response

Providing the subject of an investigation an opportunity to respond to anticipated conclusions of the board will ensure the DAB members have balanced input. Such an opportunity to comment is consistent with the Department’s intent in proposing the rule. The final rule contains a provision that will enable the subject of an investigation to respond to a set of anticipated findings of the DAB before the report is finally adopted.