CHAPTER 368dd

OFFICE OF HEALTH STRATEGY

Table of Contents

Secs. 19a-750 to 19a-754. Health Information Technology Exchange of Connecticut; definitions; powers of the authority; board of directors; chief executive officer; grants; advisory committee on patient privacy and security; reports. Establishment of subsidiaries. State pledge to contractors. Tax exemption. Lead health information exchange organization for the state; responsibilities.

Sec. 19a-754a. Office of Health Strategy established.

Sec. 19a-754b. (Note: This section is effective January 1, 2020.) Notices to office re sponsor applications to the Food and Drug Administration. Studies of pharmaceutical manufacturers and outpatient prescription drugs. Penalty. Regulations.


Secs. 19a-750 to 19a-754. Health Information Technology Exchange of Connecticut; definitions; powers of the authority; board of directors; chief executive officer; grants; advisory committee on patient privacy and security; reports. Establishment of subsidiaries. State pledge to contractors. Tax exemption. Lead health information exchange organization for the state; responsibilities. Sections 19a-750 to 19a-754, inclusive, are repealed, effective July 1, 2014.

(P.A. 09-232, S. 75; P.A. 10-117, S. 82–86; P.A. 11-51, S. 76; 11-242, S. 74; P.A. 12-197, S. 46; P.A. 13-208, S. 9; P.A. 14-217, S. 259.)

Sec. 19a-754a. Office of Health Strategy established. (a) There is established an Office of Health Strategy, which shall be within the Department of Public Health for administrative purposes only. The department head of said office shall be the executive director of the Office of Health Strategy, who shall be appointed by the Governor in accordance with the provisions of sections 4-5 to 4-8, inclusive, with the powers and duties therein prescribed.

(b) The Office of Health Strategy shall be responsible for the following:

(1) Developing and implementing a comprehensive and cohesive health care vision for the state, including, but not limited to, a coordinated state health care cost containment strategy;

(2) Promoting effective health planning and the provision of quality health care in the state in a manner that ensures access for all state residents to cost-effective health care services, avoids the duplication of such services and improves the availability and financial stability of such services throughout the state;

(3) Directing and overseeing the State Innovation Model Initiative and related successor initiatives;

(4) (A) Coordinating the state's health information technology initiatives, (B) seeking funding for and overseeing the planning, implementation and development of policies and procedures for the administration of the all-payer claims database program established under section 19a-775a, (C) establishing and maintaining a consumer health information Internet web site under 19a-755b, and (D) designating an unclassified individual from the office to perform the duties of a health information technology officer as set forth in sections 17b-59f and 17b-59g;

(5) Directing and overseeing the Health Systems Planning Unit established under section 19a-612 and all of its duties and responsibilities as set forth in chapter 368z; and

(6) Convening forums and meetings with state government and external stakeholders, including, but not limited to, the Connecticut Health Insurance Exchange, to discuss health care issues designed to develop effective health care cost and quality strategies.

(c) The Office of Health Strategy shall constitute a successor, in accordance with the provisions of sections 4-38d, 4-38e and 4-39, to the functions, powers and duties of the following:

(1) The Connecticut Health Insurance Exchange, established pursuant to section 38a-1081, relating to the administration of the all-payer claims database pursuant to section 19a-755a; and

(2) The Office of the Lieutenant Governor, relating to the (A) development of a chronic disease plan pursuant to section 19a-6q, (B) housing, chairing and staffing of the Health Care Cabinet pursuant to section 19a-725, and (C) (i) appointment of the health information technology officer, and (ii) oversight of the duties of such health information technology officer as set forth in sections 17b-59f and 17b-59g.

(d) Any order or regulation of the entities listed in subdivisions (1) and (2) of subsection (c) of this section that is in force on July 1, 2018, shall continue in force and effect as an order or regulation until amended, repealed or superseded pursuant to law.

(June Sp. Sess. P.A. 17-2, S. 164; P.A. 18-91, S. 1.)

History: June Sp. Sess. P.A. 17-2 effective January 1, 2018; P.A. 18-91 amended Subsec. (b) by deleting reference to July 1, 2018, adding new Subdiv. (2) re promoting effective health planning and provision of quality health care, redesignating existing Subdiv. (2) as Subdiv. (3) and amending same by deleting Subpara. (A) re all-payer claims database program and deleting Subpara. (B) designator, redesignating Subdiv. (3) as Subdiv. (4) and amending same by designating existing provision re coordinating state's health information technology initiatives as Subpara. (A), adding Subparas. (B) to (D) re administration of all-payer claims database program, consumer health information Internet web site, and duties of health information technology officer, respectively, redesignating Subdiv. (4) as Subdiv. (5) and amending same by replacing reference to Office of Health Care Access with reference to Health Systems Planning Unit, and redesignating Subdiv. (5) as Subdiv. (6), and amended Subsec. (c)(2) by deleting reference to Secs. 19a-755, 17b-59 and 17b-59a and adding reference to Sec. 17b-59g, effective May 14, 2018.

Sec. 19a-754b. (Note: This section is effective January 1, 2020.) Notices to office re sponsor applications to the Food and Drug Administration. Studies of pharmaceutical manufacturers and outpatient prescription drugs. Penalty. Regulations. (a) For the purposes of this section:

(1) “Accelerated approval” has the same meaning as provided in 21 USC 356, as amended from time to time;

(2) “Biologics license application” means an application filed pursuant to Section 601.2 of Title 21 of the Code of Federal Regulations, as amended from time to time;

(3) “Breakthrough therapy” has the same meaning as provided in 21 USC 356, as amended from time to time;

(4) “Drug” has the same meaning as provided in section 21a-92;

(5) “Fast track product” has the same meaning as provided in 21 USC 356, as amended from time to time;

(6) “New drug application” has the same meaning as provided in Section 314.3 of Title 21 of the Code of Federal Regulations, as amended from time to time;

(7) “New molecular entity” has the same meaning as such term is used in 21 USC 355-1, as amended from time to time;

(8) “Orphan drug” has the same meaning as provided in Section 316.3 of Title 21 of the Code of Federal Regulations, as amended from time to time;

(9) “Pipeline drug” means a drug containing a new molecular entity for which a sponsor has filed a new drug application or biologics license application with, and received an action date from, the federal Food and Drug Administration;

(10) “Prescription drug” means a drug prescribed by a health care provider to an individual in this state;

(11) “Priority review” has the same meaning as such term is used in 21 USC 356, as amended from time to time;

(12) “Rebate” has the same meaning as provided in section 38a-479ooo;

(13) “Research and development cost” means a cost that a pharmaceutical manufacturer incurs in researching and developing a new product, process or service, including, but not limited to, a cost that a pharmaceutical manufacturer incurs in researching and developing a product, process or service that the pharmaceutical manufacturer has acquired from another person by license;

(14) “Sponsor” has the same meaning as provided in Section 316.3 of Title 21 of the Code of Federal Regulations, as amended from time to time; and

(15) “Wholesale acquisition cost” has the same meaning as provided in 42 USC 1395w-3a, as amended from time to time.

(b) Beginning on January 1, 2020, each sponsor shall submit to the Office of Health Strategy, established in section 19a-754a, in a form and manner specified by the office, written notice informing the office that such sponsor has filed with the federal Food and Drug Administration:

(1) A new drug application or biologics license application for a pipeline drug, not later than sixty days after such sponsor receives an action date from the federal Food and Drug Administration regarding such application; or

(2) A biologics license application for a biosimilar drug, not later than sixty days after such sponsor's receipt of an action date from the federal Food and Drug Administration regarding such application.

(c) (1) Beginning on January 1, 2020, the executive director of the Office of Health Strategy may conduct a study, with the assistance of the Comptroller and not more frequently than once annually, of each pharmaceutical manufacturer of a pipeline drug that, in the opinion of the executive director in consultation with the Comptroller and the Commissioner of Social Services, may have a significant impact on state expenditures for outpatient prescription drugs. The office may work with the Comptroller to utilize existing state resources and contracts, or contract with a third party, including, but not limited to, an accounting firm, to conduct such study.

(2) Each pharmaceutical manufacturer that is the subject of a study conducted pursuant to subdivision (1) of this subsection shall submit to the office, or any contractor engaged by the office or the Comptroller to perform such study, the following information for the pipeline drug that is the subject of such study:

(A) The primary disease, condition or therapeutic area studied in connection with such drug, and whether such drug is therapeutically indicated for such disease, condition or therapeutic area;

(B) Each route of administration studied for such drug;

(C) Clinical trial comparators, if applicable, for such drug;

(D) The estimated year of market entry for such drug;

(E) Whether the federal Food and Drug Administration has designated such drug as an orphan drug, a fast track product or a breakthrough therapy; and

(F) Whether the federal Food and Drug Administration has designated such drug for accelerated approval and, if such drug contains a new molecular entity, for priority review.

(d) (1) On or before March 1, 2020, and annually thereafter, the executive director of the Office of Health Strategy, in consultation with the Comptroller, Commissioner of Social Services and Commissioner of Public Health, shall prepare a list of not more than ten outpatient prescription drugs that the executive director, in the executive director's discretion, determines are (A) provided at substantial cost to the state, considering the net cost of such drugs, or (B) critical to public health. The list shall include outpatient prescription drugs from different therapeutic classes of outpatient prescription drugs and at least one generic outpatient prescription drug.

(2) The executive director shall not list any outpatient prescription drug under subdivision (1) of this subsection unless the wholesale acquisition cost of the drug, less all rebates paid to the state for such drug during the immediately preceding calendar year, (A) increased by at least (i) twenty per cent during the immediately preceding calendar year, or (ii) fifty per cent during the immediately preceding three calendar years, and (B) was not less than sixty dollars for (i) a thirty-day supply of such drug, or (ii) a course of treatment of such drug lasting less than thirty days.

(3) (A) The pharmaceutical manufacturer of an outpatient prescription drug included on a list prepared by the executive director pursuant to subdivision (1) of this subsection shall provide to the office, in a form and manner specified by the executive director, (i) a written, narrative description, suitable for public release, of all factors that caused the increase in the wholesale acquisition cost of the listed outpatient prescription drug, and (ii) aggregate, company-level research and development costs and such other capital expenditures that the executive director, in the executive director's discretion, deems relevant for the most recent year for which final audited data are available.

(B) The quality and types of information and data that a pharmaceutical manufacturer submits to the office under this subdivision shall be consistent with the quality and types of information and data that the pharmaceutical manufacturer includes in (i) such pharmaceutical manufacturer's annual consolidated report on Securities and Exchange Commission Form 10-K, or (ii) any other public disclosure.

(4) The office shall establish a standardized form for reporting information and data pursuant to this subsection after consulting with pharmaceutical manufacturers. The form shall be designed to minimize the administrative burden and cost of reporting on the office and pharmaceutical manufacturers.

(e) The office may impose a penalty of not more than seven thousand five hundred dollars on a pharmaceutical manufacturer or sponsor for each violation of this section by the pharmaceutical manufacturer or sponsor.

(f) The office may adopt regulations, in accordance with the provisions of chapter 54, to carry out the purposes of this section.

(P.A. 18-41, S. 10.)

History: P.A. 18-41 effective January 1, 2020.