text:
(a) The California Initiative to Advance Precision Medicine is hereby established in the California Health and Human Services Agency. In establishing the initiative, the California Health and Human Services Agency shall incorporate agreements and partnerships regarding precision medicine entered into prior to January 1, 2016.

(b) (1) The California Health and Human Services Agency shall develop, implement, and evaluate demonstration or nondemonstration projects on precision medicine in collaboration with public, nonprofit, and private entities. A demonstration project may focus on one or more disease areas or a subset of a population, and an award of funds under any appropriation of funds to the office for precision medicine may be based on criteria that include, but are not limited to, the following:

(A) The potential for tangible benefit to patients within two to five years, including the likelihood that the study will have an immediate impact on patients.

(B) The prospects of preventing or alleviating the impact of a pandemic through pathways including, but not limited to, tracking of emerging pathogens, early infectious disease outbreak detection, rapid outbreak response, and transmission reduction.

(C) The depth and breadth of data available in the disease focus areas across institutions.

(D) The prospects for efficient and effective data integration and analysis.

(E) The expertise of potential team members.

(F) The resources available for the project outside of the initiative, including the potential for leveraging nonstate funding.

(G) The clinical and commercial potential of the project.

(H) The potential to reduce health disparities.

(I) The potential to scale and leverage multiple electronic health records systems.

(J) The potential to develop the use of tools, measurements, and data, including publicly generated and available data.

(2) A demonstration project that is selected by the California Health and Human Services Agency shall advance greater understanding in at least one of the following areas, or in another area that is determined by the California Health and Human Services Agency to be necessary to advance precision medicine:

(A) The application of precision medicine to specific disease areas.

(B) The feasibility of the technology in preventing, mitigating, or monitoring pandemics or other large-scale disease outbreaks.

(C) The challenges of system interoperability.

(D) Economic analysis.

(E) Standards for sharing data or protocols across institutions.

(F) The federal and state regulatory environment.

(G) The clinical environment.

(H) Challenges relating to data, tools, and infrastructure.

(I) The protection of privacy and personal health information.

(J) The potential for reducing health disparities.

(K) Methods and protocols for patient engagement.

(3) The California Health and Human Services Agency shall develop concrete metrics and goals for demonstration projects, monitor their progress, and comprehensively evaluate projects upon completion.

(4) (A) The California Health and Human Services Agency shall annually submit a report to the Legislature that provides an update of the demonstration projects selected. Upon completion of a demonstration project, the California Health and Human Services Agency shall submit an evaluation of the demonstration project to the Legislature. A demonstration project is deemed complete when it has completed the agreed upon tasks and deliverables, and the project funding has been completed.

(B) A written report made pursuant to subparagraph (A) shall be made in compliance with Section 9795 of the Government Code.

(c) The California Health and Human Services Agency shall develop an inventory of precision medicine assets, including projects, data sets, and experts. In developing the inventory, the California Health and Human Services Agency shall assemble knowledge across broad disease areas. The California Health and Human Services Agency shall use the inventory to inform strategic areas for the future development of precision medicine-related projects.

(d) The California Health and Human Services Agency may enter into agreements with public entities, or with nonprofit or not-for-profit organizations for the purpose of jointly administering the programs established under the initiative or to administer any provision of this section.

(e) The California Health and Human Services Agency shall create and post on a publicly available internet website guidelines for an award of funds made under any appropriation of funds to the California Health and Human Services Agency for precision medicine. The guidelines shall include, but are not limited to, the following:

(1) Eligibility requirements.

(2) A competitive, merit-based application process that allows public and private academic and nonprofit institutions to submit proposals as principal investigators.

(3) A comprehensive peer-reviewed selection process.

(4) Requirements regarding the use of awarded funds.

(5) Requirements regarding the use and sharing of research data and findings.

(6) Requirements for the protection of privacy and personal health information.

(f) The California Health and Human Services Agency shall solicit public, nonprofit, and private sector input for any additional guidelines for an award of funds made pursuant to this section.

(g) The California Health and Human Services Agency shall establish standards that require a grant to be subject to an intellectual property agreement that balances the opportunity of the state to benefit from the patents, royalties, and licenses that result from basic research, therapy development, and clinical trials against the need to ensure that the agreement does not unreasonably hinder essential medical research.

(h) (1) The California Health and Human Services Agency may receive nonstate funds in furtherance of the initiative. “In furtherance of the initiative” means that funds may be used to award additional demonstration projects under the same terms and conditions as state funds in the initiative, held in reserve for follow-on funding of any awardees, or used to fund other nondemonstration project activities in a proportion no greater than 20 percent of the total of nonstate funds received over the term of the commitment.

(2) The California Health and Human Services Agency may work with external stakeholders to receive nonstate funds that enable the initiative to develop new demonstration projects that look to prevent or mitigate future infectious disease outbreaks and pandemics.

(i) Up to 30 percent of any amount appropriated for precision medicine may be held by the California Health and Human Services Agency until an equivalent amount of nonstate matching funds is identified and received. Amounts subject to nonstate match may be released in increments as determined by the California Health and Human Services Agency.

(j) Up to 10 percent of any amount appropriated to the California Health and Human Services Agency for precision medicine for demonstration projects may be used by the California Health and Human Services Agency for administrative costs.

(k) The California Health and Human Services Agency shall recruit a precision medicine expert selection committee to represent various precision medicine-related skills, such as bioinformatics, statistics, health economics, patient engagement, and genomics. The Legislature may make nominations for the selection committee to the California Health and Human Services Agency for consideration.

(l) Members of the selection committee shall be deemed to not be interested in any contract, including any award of funds by the committee, pursuant to this section.

(m) Prior to the selection committee’s deliberative process, the California Health and Human Services Agency shall notify the Legislature of the selection of the committee members.

(n) The selection committee established in subdivision (k) shall comply with the Bagley-Keene Open Meeting Act (Article 9 (commencing with Section 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government Code), except during the deliberative process as it relates to reviewing and ranking proposals and making final selections.

(o) The selection committee shall report on the justification for selecting the demonstration projects that are awarded funding and provide a list of the demonstration projects that were not selected. This report shall be posted on the internet website created in subdivision (e).

(p) Notwithstanding the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code), the California Health and Human Services Agency may implement or interpret this division without taking any regulatory action.


kind: section

code: HSC

text:
It is the intent of the Legislature that the office make awards in compliance with the following:

(a) The awards are made to demonstration projects in California.

(b) The awards are prioritized for public and private nonprofit entities.

(c) The awards include, but are not limited to, awards to public institutions in both northern and southern California.

history: (History: Added by Stats. 2024, Ch. 41, Sec. 54. (SB 164) Effective June 29, 2024. Repealed as of June 30, 2029, pursuant to Sec. 130304.)

division: 110. CALIFORNIA INITIATIVE TO ADVANCE PRECISION MEDICINE


text: This division shall remain in effect only until June 30, 2029, and as of that date is repealed.

history: (History: Added by Stats. 2024, Ch. 41, Sec. 54. (SB 164) Effective June 29, 2024. Repealed as of June 30, 2029, by its own provisions. Note: Repeal affects Division 110, commencing with Section 130300.)

path: 110. CALIFORNIA INITIATIVE TO ADVANCE PRECISION MEDICINE


text:
(a) This division shall be known, and may be cited as, the Golden Bear State Pharmacy Assistance Program.

(b) As used in this division:

(1) “Department” means the State Department of Health Services.

(2) “Fund” means the Golden Bear State Pharmacy Assistance Program Rebate Fund.

(3) “Medicare beneficiary” means a Medicare beneficiary who is a California resident.

history: (History: Amended by Stats. 2002, Ch. 542, Sec. 3. Effective January 1, 2003.)

division: 111. GOLDEN BEAR STATE PHARMACY ASSISTANCE PROGRAM


text:
(a) In addition to participating in the program provided for under Article 24 (commencing with Section 4425) of Chapter 9 of Division 2 of the Business and Professions Code, any Medicare beneficiary may participate in the program provided for under this division.

(b) The department shall conduct an outreach program to inform Medicare beneficiaries of their right to participate in this program. Medicare beneficiaries shall be informed of the method by which the prescription drug discount is determined and that the discount shall periodically fluctuate. No outreach material shall contain a likeness of an elected state official.

(c) In order to participate in the program provided for under this division, a Medicare beneficiary shall be required to register on a one-time basis. Registration may be made at any pharmacy participating in this program. In order to register for the program, the Medicare beneficiary shall pay to the pharmacy an administrative fee, which the pharmacy shall retain, in an amount to be established by the department. Upon payment of this fee, the pharmacy shall issue a program registration card, which shall be prepared and provided to the pharmacy by the department, to the Medicare beneficiary.

history: (History: Amended by Stats. 2002, Ch. 542, Sec. 4. Effective January 1, 2003.)

path: 111. GOLDEN BEAR STATE PHARMACY ASSISTANCE PROGRAM


text:
(a) The department may accept on behalf of the state any gift, bequest, or donation of outreach services or materials to inform eligible Medicare beneficiaries of their right to participate in this program. Neither Section 11005 of the Government Code nor any other law requiring approval by a state officer of a gift, bequest, or donation shall apply to these gifts, bequests, or donations. For purposes of this section, outreach services may include, but not be limited to, coordinating and implementing outreach efforts and plans, and outreach materials may include, but not be limited to, brochures, pamphlets, fliers, posters, advertisements, and other promotional items.

(b) An advertisement provided as a gift, bequest, or donation pursuant to this section shall be exempt from the provisions of Article 5 (commencing with Section 11080) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government Code.

history: (History: Added by Stats. 2002, Ch. 542, Sec. 5. Effective January 1, 2003.)


text:
(a) Any pharmacy may participate in the program provided for under this division. However, this division shall apply only to prescriptions dispensed to noninstitutionalized Medicare beneficiaries.

(b) Any drug manufacturer may participate in the program provided for under this division.

history: (History: Added by Stats. 2001, Ch. 693, Sec. 2. Effective January 1, 2002.)


text:
(a) The department shall attempt to negotiate rebate amounts with drug manufacturers for all prescription drugs purchased by Medicare beneficiaries. As part of these agreements, the department shall negotiate a separate fee in an amount required to administer each pharmacy claim reimbursement submitted to the department pursuant to Section 130405.

(b) If the department determines that it is unable to negotiate rebates with a sufficient number of drug manufacturers, it may cease to continue the implementation or operation of this division.

history: (History: Amended by Stats. 2002, Ch. 542, Sec. 6. Effective January 1, 2003.)


text:
(a) With respect to any prescription drug for which a rebate amount has been negotiated pursuant to Section 130403, upon presentation of a program registration card issued pursuant to Section 130401, a participating pharmacy shall charge Medicare beneficiaries a price for a prescription drug that does not exceed the following computed price:

(1) The Medi-Cal reimbursement rate for the prescription drug, and an amount, as set by the department, to cover electronic transmission charges.

(2) The amount ascertained pursuant to paragraph (1) shall be reduced by the rebate amount negotiated by the department pursuant to Section 130403.

(b) The pharmacy shall request, and the department shall provide, through electronic means, the price to be charged pursuant to this section.

(c) This division shall not apply to any prescription that is covered by insurance.

history: (History: Amended by Stats. 2002, Ch. 542, Sec. 7. Effective January 1, 2003.)


text: Whenever a pharmacy provides a prescription drug to an individual pursuant to Section 130404, the pharmacy shall bill the department for the amount computed pursuant to paragraph (2) of subdivision (a) of Section 130404 and the department shall pay that amount.


text:
(a) The department may collect prospective rebates from drug manufacturers for payment to pharmacies pursuant to Section 130405.

(b) The department shall notify a drug manufacturer of all instances in which it has paid a rebate amount pursuant to Section 130405 with respect to one of the manufacturer’s drugs.

(c) A drug manufacturer shall pay the department the amount of any rebate of which the drug manufacturer is notified pursuant to subdivision (b) that exceeds the amount collected by the department pursuant to subdivision (a).

history: (History: Amended by Stats. 2002, Ch. 542, Sec. 8. Effective January 1, 2003.)


text:
(a) As part of the program provided in this division, the department may establish a system to provide a Medicare beneficiary access to a drug discount program operated by a drug manufacturer that would provide greater prescription drug discounts than are otherwise available through the program provided in this division. The program registration card issued pursuant to Section 130401 shall serve as the single point of entry to the private drug discount programs of participating manufacturers.

(b) To establish the system described in subdivision (a), the department may negotiate a contract with a drug manufacturer that operates a prescription drug discount program. To assist in these negotiations, the department may contract with a public or private entity.

(c) (1) A Medicare beneficiary shall not in any circumstance be required to participate in, or to disclose information that would determine his or her eligibility to participate in, these private drug discount programs in order to participate in the program provided in this division.

(2) Notwithstanding paragraph (1), a Medicare beneficiary may voluntarily disclose or provide information that may be necessary to determine eligibility for participation in a private drug discount program.

history: (History: Added by Stats. 2002, Ch. 542, Sec. 9. Effective January 1, 2003.)


text:
(a) The department shall deposit all payments received pursuant to Sections 130406 and 130410 into the Golden Bear State Pharmacy Assistance Program Rebate Fund, which is hereby created in the State Treasury.

(b) Notwithstanding Section 13340 of the Government Code, the fund is hereby continuously appropriated to the department without regard to fiscal years for the purpose of paying rebates pursuant to Section 130405 and for defraying the costs of administering this division. Notwithstanding any other law, no money in the fund is available for expenditure for any other purpose or for loaning or transferring to any other fund, including the General Fund.

history: (History: Amended by Stats. 2002, Ch. 542, Sec. 10. Effective January 1, 2003.)


text: The department shall repay the General Fund the loan in the amount of one million dollars ($1,000,000), which was appropriated to the department for startup costs associated with the program provided in this division.

history: (History: Added by Stats. 2002, Ch. 542, Sec. 11. Effective January 1, 2003.)


text: The department shall develop a program to prevent the occurrence of fraud under this division. An individual or entity that violates any provision of the fraud prevention program may be precluded from participating in the Golden Bear State Pharmacy Assistance Program. The department shall adopt regulations setting forth a procedure for precluding participation in the program on this basis.

history: (History: Amended by Stats. 2002, Ch. 542, Sec. 12. Effective January 1, 2003.)


text: The department may hire any staff needed for the implementation of this division. The department may also use the contract with the Medi-Cal fiscal intermediary or contract with another public or private entity to implement or administer the program and to enroll Medicare beneficiaries who are eligible to participate in the program, to collect rebates, and to pay claims, only if services provided under this program are specifically identified and reimbursed in a manner that does not claim federal financial reimbursement. For purposes of this division, use of the Medi-Cal program fiscal intermediary shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. This division shall not be implemented unless and until the director executes a declaration, which shall be retained by the director, stating that all federal approvals necessary for implementation of this division have been received.

history: (History: Amended by Stats. 2002, Ch. 542, Sec. 13. Effective January 1, 2003.)


text: A contract executed for the purposes of this division is exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code.

history: (History: Added by Stats. 2002, Ch. 542, Sec. 14. Effective January 1, 2003.)


text:
(a) This division shall be known, and may be cited, as the California Discount Prescription Drug Program.

(b) This division shall become operative on and after July 1, 2010.

(c) The California Discount Prescription Drug Program shall be implemented only if, and to the extent that, a Budget Act or other statute that is enacted on or before February 1, 2015, includes or makes an appropriation of moneys to the department to implement this program.

(d) Notwithstanding any other provision of this division, if the California Discount Prescription Drug Program is not implemented pursuant to subdivision (c), this division shall become inoperative on February 1, 2015, and as of January 1, 2016, is repealed, unless a later enacted statute, that is enacted before January 1, 2016, deletes or extends the dates on which it becomes inoperative and is repealed.

history: (History: Amended by Stats. 2010, Ch. 717, Sec. 22. (SB 853) Effective October 19, 2010. Repealed conditionally on January 1, 2016, by its own provisions. Note: Control provisions in this section relate to operation, implementation, and termination of Division 112, comprising Sections 130500 to 130544.)

chapter: 1. General Provisions

path: 112. CALIFORNIA DISCOUNT PRESCRIPTION DRUG PROGRAM > 1. General Provisions


text:
For purposes of this division, the following definitions shall apply:

(a) “Average manufacturer’s price” has the same meaning as this term is defined in Section 1927(k)(1) of the federal Social Security Act (42 U.S.C. Sec. 1396r-8(k)(1)).

(b) “Department” means the State Department of Health Care Services.

(c) “Eligible Californian” means a resident of the state who meets any one or more of the following:

(1) Has total unreimbursed medical expenses equal to at least 10 percent of his or her family’s income where the family’s income does not exceed the state median family income.

(2) To the extent allowed by federal law, is enrolled in the Medicare Program, but whose prescription drugs are not covered by the Medicare Program.

(3) Has a family income that does not exceed 300 percent of the federal poverty guidelines and who does not have outpatient prescription drug coverage paid for by any one of the following:

(A) In whole by the Medi-Cal program.

(B) In whole or in part by the Healthy Families Program or other programs funded by the state.

(C) In whole or in part by another third-party payer, provided that the individual has not reached the annual limit on his or her prescription drug coverage.

(4) For purposes of this subdivision, the cost of drugs provided under this division is considered an expense incurred by the family for eligibility determination purposes.

(d) “Fund” means the California Discount Prescription Drug Program Fund.

(e) “Manufacturer” means a drug manufacturer as defined in Section 4033 of the Business and Professions Code.

(f) “Manufacturer’s rebate” means the rebate for an individual drug or aggregate rebate for a group of drugs necessary to make the price for the drug ingredients equal to or less than the applicable benchmark price.

(g) “Medicaid best price” has the same meaning as this term is defined in Section 1927(c)(1)(C) of the Social Security Act (42 U.S.C. Sec. 1396r-8(c)(1)(C)).

(h) “Multiple-source drug” has the same meaning as this term is defined in Section 1927(k)(7) of the Social Security Act (42 U.S.C. Sec. 1396r-8(k)(7)).

(i) “National drug code” or “NDC” means the unique 10-digit, three-segment number assigned to each drug product listed under Section 510 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360). This number identifies the labeler or vendor, product, and trade package.

(j) “National sales data” means prescription data obtained from a national-level prescription tracking service.

(k) “Participating manufacturer” means a drug manufacturer that has contracted with the department to provide an individual drug or group of drugs for the program.

(l) “Participating pharmacy” means a pharmacy that has executed a pharmacy provider agreement with the department for this program.

(m) “Pharmacy contract rate” means the negotiated per prescription reimbursement rate for drugs dispensed to eligible Californians. The department shall establish a single, basic pharmacy rate, but may contract at different rates with pharmacies in order to provide access throughout the state.

(n) “Prescription drug” means any drug that bears the legend: “Caution: federal law prohibits dispensing without prescription,” “℞ only,” or words of similar import.

(o) “Private discount drug program” means a prescription drug discount card or manufacturer patient assistance program that provides discounted or free drugs to eligible individuals. For the purposes of this division, a private discount drug program is not considered insurance or a third-party-payer program.

(p) “Program” means the California Discount Prescription Drug Program.

(q) “Single-source drug” has the same meaning as this term and the term innovator multiple-source drug are defined in Section 1927(k)(7) of the Social Security Act (42 U.S.C. Sec. 1396r-8(k)(7)).

(r) “Therapeutic category” means a drug or a grouping of drugs determined by the department to have similar attributes and to be alternatives for the treatment of a specific disease or condition.

(s) “Volume weighted average discount” means the aggregated average discount for the drugs of a manufacturer, weighted by each drug’s percentage of the total prescription volume of that manufacturer’s drugs. For purposes of this calculation, discounts shall include any rebate amounts used to fund program costs pursuant to Section 130542.1. Drugs excluded from contracting by the department, pursuant to subdivision (d) of Section 130506 and in a manner consistent with subdivision (c) of Section 130506, shall be excluded from the calculation of the volume weighted average discount. National sales data shall be used to calculate the volume weighted average discount pursuant to Section 130506. Program utilization data shall be used to calculate the volume weighted average discount pursuant to Section 130507.

history: (History: Amended by Stats. 2009, Ch. 140, Sec. 123. (AB 1164) Effective January 1, 2010. Provisions operative and implemented on or after July 1, 2010, as prescribed in Section 130500. Conditionally inoperative on February 1, 2015. Repealed conditionally on January 1, 2016, pursuant to Section 130500.)

division: 112. CALIFORNIA DISCOUNT PRESCRIPTION DRUG PROGRAM


text: The California Discount Prescription Drug Program is hereby established within the department.

history: (History: Added by Stats. 2006, Ch. 619, Sec. 2. Effective January 1, 2007. Provisions operative and implemented on or after July 1, 2010, as prescribed in Section 130500. Conditionally inoperative on February 1, 2015. Repealed conditionally on January 1, 2016, pursuant to Section 130500.)


text:
(a) The amount a participating, eligible Californian pays for a drug through the program shall be equal to the lower of the participating pharmacy’s usual and customary charge or the pharmacy contract rate pursuant to subdivision (c), less a program discount for the specific drug or an average discount for a group of drugs or all drugs covered by the program.

(b) In determining program discounts on individual drugs, the department shall take into account the rebates provided by the drug’s manufacturer.

(c) The department may contract with participating pharmacies for a rate other than the pharmacies’ usual and customary rate for prescription drugs, including multiple-source drugs.

(d) This division shall apply only to prescription drugs dispensed to eligible Californians on an outpatient basis.

chapter: 2. Prescription Drug Discounts

path: 112. CALIFORNIA DISCOUNT PRESCRIPTION DRUG PROGRAM > 2. Prescription Drug Discounts


text:
(a) The department shall negotiate drug discount agreements with manufacturers to provide discounts for single-source and multiple-source prescription drugs through the program. The department shall attempt to negotiate the maximum possible discount for an eligible Californian. The department shall attempt to negotiate, with each manufacturer, discounts to offer single-source prescription drugs under the program at a volume weighted average discount that is equal to or below any one of the following benchmark prices:

(1) Eighty-five percent of the average manufacturer price for a drug, as published by the federal Centers for Medicare and Medicaid Services.

(2) The lowest price provided to any nonpublic entity in the state by a manufacturer to the extent that the Medicaid best price exists under federal law.

(3) The Medicaid best price, to the extent that this price exists under federal law.

(b) The department may require the drug manufacturer to provide information that is reasonably necessary for the department to carry out its duties pursuant to this division.

(c) The department shall pursue manufacturer discount agreements to ensure that the number and type of drugs available through the program is sufficient to give an eligible Californian a formulary comparable to the Medi-Cal list of contract drugs, or if this information is available to the department, a formulary that is comparable to that provided to CalPERS enrollees.

(d) To obtain the most favorable discounts, the department may limit the number of drugs available through the program.

(e) The drug discount agreements negotiated pursuant to this section shall be used to reduce the cost of drugs purchased by program participants and to fund program costs pursuant to Section 130542.1.

(f) All information reported by a manufacturer to, negotiations with, and agreements executed with, the department or its third-party vendor pursuant to this section, shall be considered confidential and corporate proprietary information. This information shall not be subject to disclosure under the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code). The California State Auditor’s Office and the Controller shall have access to pricing information in a manner that is consistent with their access to this information under the Medi-Cal program and under law. The California State Auditor’s Office and the Controller may use this information only to investigate or audit the administration of the program. Neither the California State Auditor’s Office, the Controller, nor the department may disclose this information in a form that identifies a specific manufacturer or wholesaler or prices charged for drugs of this manufacturer or wholesaler. Information provided to the department pursuant to subdivision (e) of Section 130530 shall not be affected by the confidentiality protections established by this subdivision.

(g) (1) Any pharmacy licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code may participate in the program.

(2) Any manufacturer may participate in the program.

history: (History: Amended by Stats. 2021, Ch. 615, Sec. 295. (AB 474) Effective January 1, 2022. Operative January 1, 2023, pursuant to Sec. 463 of Stats. 2021, Ch. 615.)


text:
(a) On August 1, 2017, the department shall determine whether manufacturer participation in the program has been sufficient to meet both of the following benchmarks:

(1) The number and type of drugs available through the program are sufficient to give eligible Californians a formulary comparable to the Medi-Cal list of contract drugs or, if this information is available to the department, a formulary comparable to that provided to CalPERS enrollees.

(2) The volume weighted average discount of single-source prescription drugs offered pursuant to this program is equal to or below any one of the benchmark prices described in subdivision (a) of Section 130506.

(b) On and after August 1, 2017, the department shall reassess program outcomes, at least once every year, consistent with the benchmarks described in subdivision (a).

history: (History: Amended by Stats. 2010, Ch. 717, Sec. 23. (SB 853) Effective October 19, 2010. Provisions operative and implemented on or after July 1, 2010, as prescribed in Section 130500. Conditionally inoperative on February 1, 2015. Repealed conditionally on January 1, 2016, pursuant to Section 130500.)


text: To the maximum extent possible, the department shall assure that enrollment and other administrative actions are seamless to all eligible Californians.


text:
(a) The department may require prior authorization in the Medi-Cal program for any drug of a manufacturer if the manufacturer fails to agree to a volume weighted average discount for single-source prescription drugs that is equal to or below any one of the benchmark prices described in subdivision (a) of Section 130506 and only to the extent that this requirement does not increase costs to the Medi-Cal program, as determined pursuant to subdivision (c).

(b) If prior authorization is required for a drug pursuant to this section, a Medi-Cal beneficiary shall not be denied the continued use of a drug that is part of a prescribed therapy until that drug is no longer prescribed for that beneficiary’s therapy. The department shall approve or deny requests for prior authorization necessitated by this section as required by state or federal law.

(c) The department, in consultation with the Department of Finance, shall determine the fiscal impact of placing a drug on prior authorization pursuant to this section. In making this determination, the department shall consider all of the following:

(1) The net cost of the drug, including any rebates that would be lost if the drug is placed on prior authorization.

(2) The projected volume of purchases of the drug, before and after the drug is placed on prior authorization, considering the continuity of care provisions set forth in subdivision (b).

(3) The net cost of comparable drugs to which volume would be shifted if a drug is placed on prior authorization, including any additional rebates that would be received.

(4) The projected volume of purchases of comparable drugs, before and after the drug is placed on prior authorization.

(5) Any other factors determined by the department to be relevant to a determination of the fiscal impact of placing a drug on prior authorization.

(d) This section shall be implemented only to the extent permitted under federal law, and in a manner consistent with state and federal laws.

(e) This section may apply to any manufacturer that has not negotiated with the department.

(f) The department shall notify the Speaker of the Assembly and the President pro Tempore of the Senate that the department is requiring prior authorization no later than five days after making this requirement.

(g) (1) Subject to paragraph (2), this section shall be implemented on and after August 1, 2017.

(2) This section shall be implemented only if the department determines that participation by manufacturers has been insufficient to meet both of the benchmarks identified in Section 130507.

history: (History: Amended by Stats. 2010, Ch. 717, Sec. 24. (SB 853) Effective October 19, 2010. Provisions operative and implemented on or after July 1, 2010, as prescribed in Section 130500. Conditionally inoperative on February 1, 2015. Repealed conditionally on January 1, 2016, pursuant to Section 130500.)


text: The names of manufacturers of single-source drugs that do or do not enter into discount agreements with the department pursuant to this division shall be public information and shall be posted on the department’s Internet Web site when the discount agreements are reached or the manufacturer ends negotiations, commencing within six months after the initial implementation date of this division and updated on the first of each month thereafter.


text:
(a) Each drug discount agreement shall do all of the following:

(1) Specify which of the manufacturer’s drugs are included in the agreement.

(2) Permit the department to remove a drug from the agreement if there is a dispute over the drug’s utilization.

(3) Permit a manufacturer to audit claims for the drugs the manufacturer provides under the program. Claims information provided to manufacturers shall comply with all federal and state privacy laws that protect a program participant’s health information.

(b) In addition to the requirements of subdivision (a), each drug discount agreement with a single-source manufacturer shall do all of the following:

(1) Require the manufacturer to make a rebate payment to the department for each drug described in paragraph (1) of subdivision (a) dispensed to a program participant.

(2) Require the manufacturer to make the rebate payments to the department on at least a quarterly basis.

(3) Require the manufacturer to provide, upon request, documentation to validate the rebate.

(c) The department may collect prospective rebates from single-source manufacturers for payment to pharmacies. The amount of the prospective discount shall be specified in the drug rebate agreements.

(d) (1) Manufacturers shall calculate and pay interest on late or unpaid rebates. The interest shall not apply to any prior period adjustments of unit rebate amounts or department utilization adjustments.

(2) For rebate payments to the program, manufacturers shall calculate and pay interest on late or unpaid rebates for quarters that begin on or after January 1, 2007.

(e) Interest required by subdivision (d) shall begin accruing 38 calendar days from the date of mailing of the invoice, including supporting utilization data sent to the manufacturer. Interest shall continue to accrue until the date of mailing of the manufacturer’s payment. Interest rates and calculations for purposes of this section shall be at 10 percent.

(f) A participating manufacturer shall clearly identify all rebates, interest, and other payments, and payment transmittal forms for the program, in a manner designated by the department.


text:
(a) The department shall generate a monthly report that, at a minimum, provides all of the following:

(1) Drug utilization information.

(2) Amounts paid to pharmacies.

(3) Program discounts compared to the usual customary price.

(4) Aggregate amounts of rebates collected from manufacturers.

(5) A summary of the problems or complaints reported regarding the program.

(b) Information provided in paragraphs (1), (2), and (3) of subdivision (a) shall be at the national drug code level.

(c) The department shall generate an annual report that, in addition to the information described in subdivision (a), reports on the number of all of the following:

(1) Individuals enrolled.

(2) Individuals receiving a prescription under the program.

(3) Participating pharmacies.

(4) Participating manufacturers.

(d) All reports shall be made available on the department’s Internet Web site.


text:
(a) The department shall establish and maintain a claims processing system that complies with all of the following requirements:

(1) Charges a price that meets the requirements of this division.

(2) Provides the pharmacy with the dollar amount of the discount to be returned to the pharmacy.

(3) Provides drug utilization review warnings to pharmacies consistent with the drug utilization review standards provided in federal law.

(b) The department shall pay a participating pharmacy the discount provided to program participants pursuant to this division by a date that is not later than two weeks after the claim is received.

(c) The department shall develop a mechanism for the program participants to report problems or complaints.


text:
(a) The department shall develop an application and reapplication form for the determination of a resident’s eligibility for the program. An applicant, or a guardian or custodian of an applicant, may apply or reapply on behalf of the applicant and the applicant’s spouse and children.

(b) The application shall, at a minimum, do all of the following:

(1) Specify the information that an applicant or the applicant’s representative must include in the application.

(2) Require that the applicant, or the applicant’s guardian or custodian, attest that the information provided in the application is accurate to the best knowledge and belief of the applicant or the applicant’s guardian or custodian.

(3) Specify that the application fee due upon submission of the applicable form is ten dollars ($10) annually.

(c) In assessing the income requirement for eligibility, the department shall use the income information reported on the application and not require additional documentation.

(d) An application may be completed at any pharmacy, physician office, or clinic participating in the program through an Internet Web site or call center staffed by trained operators approved by the department. A pharmacy, physician’s office, clinic, or nonprofit community organization that completes the application may keep the application fee as reimbursement for its processing costs. If it is determined that the applicant is already enrolled in the program, the fee shall be returned to the applicant and the applicant shall be informed of his or her current status as a program participant.

(e) The department shall utilize a secure electronic application process that can be used by a pharmacy, physician’s office, or clinic, by an Internet Web site, by a call center staffed by trained operators, by a nonprofit community organization, or through the third-party vendor to enroll applicants in the program.

(f) During the department’s normal working hours, the department shall make a determination of eligibility within 24 hours of receipt by the program of a completed application. The department shall mail the program participant an identification card no later than seven days after eligibility has been determined.

(g) For applications submitted through a pharmacy, the department may issue a participant identification number for eligible applicants to the pharmacy for immediate access to the California Discount Prescription Drug Program.

(h) Any program participant that has been determined to be eligible shall be enrolled for 12 months or until the program participant notifies the department of an intent to end enrollment.

(i) The department shall notify a program participant of termination of enrollment 30 days prior to the termination.

(j) A person shall be required to apply pursuant to this section for each 12-month period of eligibility.

path: 112. CALIFORNIA DISCOUNT PRESCRIPTION DRUG PROGRAM > 3. Application, Enrollment, and Outreach


text:
(a) The department may conduct an outreach program to inform California residents of their opportunity to participate in the program. The department shall coordinate outreach activities with the California Department of Aging, the Employment Development Department, and other state and local agencies, and nonprofit organizations that serve residents who may be eligible for the program. No outreach material shall contain the name or likeness of a drug.

(b) The department may accept on behalf of the state any gift, bequest, or donation of outreach services or materials to inform residents about the program. The name of the organization sponsoring the materials shall in no way appear on the material but shall be reported to the public and the Legislature as otherwise provided by law.

chapter: 3. Application, Enrollment, and Outreach


text:
(a) The department shall encourage a participating manufacturer to maintain those private discount drug programs that are comparable to or more extensive than those provided prior to the enactment of this division. To the extent possible, the department shall encourage a participating manufacturer to simplify the application and eligibility processes for its private discount drug program.

(b) The department may execute agreements with drug manufacturers and other private patient assistance programs to provide a single point of entry for eligibility determination and claims processing for drugs available through those programs to the extent permitted by state and federal law.

(c) The department shall develop a system to provide a program participant under this division with the best discounts on prescription drugs that are available to the participant through this program or through a drug manufacturer or other private patient assistance program.

(d) (1) The department may require an applicant to provide additional information to determine the applicant’s eligibility for other discount card and patient assistance programs.

(2) The department shall not require an applicant to participate in a drug manufacturer patient assistance program or to disclose information that would determine the applicant’s eligibility to participate in a drug manufacturer patient assistance program in order to participate in the California Discount Prescription Drug Program.

(e) In order to verify that California residents are being served by drug manufacturer patient assistance programs, the department shall require drug manufacturers to provide the department annually with all of the following information:

(1) The total value of the manufacturer’s drugs provided at no or very low cost to California residents during the previous year.

(2) The total number of prescriptions or 30-day supplies of the manufacturer’s drugs provided at no or very low cost to California residents during the previous year.

(f) The California Discount Prescription Drug Program card issued pursuant to this division shall serve as a single point of entry for drugs available pursuant to subdivision (a), and shall meet all legal requirements for a health benefit card.

path: 112. CALIFORNIA DISCOUNT PRESCRIPTION DRUG PROGRAM > 4. Pharmaceutical Manufacturer Patient Assistance Programs


text:
(a) Contracts, contract amendments, change orders, change requests, and any project or systems development notices, entered into for purposes of this division, shall be subject to the same exemptions provided for in the Medi-Cal drug program and those provided to the department in paragraph (4) of subdivision (c) of Section 124977. In addition, contracts, contract amendments, change orders, change requests, and any project or systems development notices, entered into for purposes of this division, are specifically exempt from:

(1) Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code.

(2) The competitive bidding requirements of State Administrative Manual Management Memo 03-10.

(3) The project authority requirements of State Administrative Manual, Section 4800 et seq.

(4) Section 11.00 and Provision 6 of Item 4260-001-0001 of Section 2 of the Budget Act of 2006 and related Budget letters.

(b) Contracts with pharmacies and drug manufacturers may be entered into on a bid or nonbid basis.

(c) Change orders entered into pursuant to this division shall not require a contract amendment.

(d) To the extent that any exemption set forth in this section conflicts with exemptions set forth in paragraph (4) of subdivision (c) of Section 124977, the exemption in this section shall govern over the conflicting provision in Section 124977.

chapter: 5. Administration

path: 112. CALIFORNIA DISCOUNT PRESCRIPTION DRUG PROGRAM > 5. Administration


text: To implement the program, the department may contract with a third-party vendor or utilize existing health care service provider enrollment and payment mechanisms, including the Medi-Cal program’s fiscal intermediary. Drug discount agreements negotiated by a third party shall be subject to review by the department. The department may cancel a contract that it finds not in the best interests of the state or program participants. Participating pharmacy contracts entered into pursuant to Section 130505 shall be considered contracts between the participating pharmacy and the department and shall not be associated with, or leveraged against, other third-party agreements.


text:
(a) The department shall deposit all payments the department receives pursuant to this division into the California Discount Prescription Drug Program Fund, which is hereby established in the State Treasury.

(b) Notwithstanding Section 13340 of the Government Code, the fund is hereby continuously appropriated to the department without regard to fiscal year for the purpose of providing payment to participating pharmacies pursuant to this division and for defraying the costs of administering this division.

(c) Notwithstanding any other provision of law, no money in the fund is available for expenditure for any other purpose or for loaning or transferring to any other fund, including the General Fund, except as provided in Section 130542.1. The fund shall also contain any interest accrued on moneys in the fund.

history: (History: Amended by Stats. 2008, Ch. 758, Sec. 14. Effective September 30, 2008. Provisions operative and implemented on or after July 1, 2010, as prescribed in Section 130500. Conditionally inoperative on February 1, 2015. Repealed conditionally on January 1, 2016, pursuant to Section 130500.)


text:
(a) It is the intent of the Legislature that the program shall be self-financing and that General Fund moneys provided to the fund shall be repaid within five years after implementation of the program begins. The department shall provide the Legislature with a five-year projection of program revenues and expenditures as part of its annual budget request. The projection shall include a projected General Fund repayment schedule.

(b) The department may use up to 25 percent of manufacturer rebate revenues to administer the program, including the funding of a float account to finance payments to participating pharmacies in advance of the receipt of manufacturer rebates.

history: (History: Added by Stats. 2008, Ch. 758, Sec. 15. Effective September 30, 2008. Provisions operative and implemented on or after July 1, 2010, as prescribed in Section 130500. Conditionally inoperative on February 1, 2015. Repealed conditionally on January 1, 2016, pursuant to Section 130500.)


text:
(a) The director may adopt regulations as are necessary to implement and administer this division.

(b) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the director may implement this division, in whole or in part, by means of a provider bulletin or other similar instructions, without taking regulatory action, provided that no bulletin or other similar instructions shall remain in effect after August 1, 2015. It is the intent that regulations adopted pursuant to this section shall be adopted on or before August 1, 2015.

history: (History: Amended by Stats. 2010, Ch. 717, Sec. 25. (SB 853) Effective October 19, 2010. Provisions operative and implemented on or after July 1, 2010, as prescribed in Section 130500. Conditionally inoperative on February 1, 2015. Repealed conditionally on January 1, 2016, pursuant to Section 130500.)


text: If any provision of this division, or the application thereof, is for any reason, held invalid, ineffective, or unconstitutional by a court of competent jurisdiction, the remainder of this division, or the application of this provision, shall not be affected thereby, and to this end the provisions of this division are severable.


text: There is in the California Health and Human Services Agency a State Department of Public Health.

history: (History: Added by Stats. 2006, Ch. 241, Sec. 34. Effective January 1, 2007. Operative July 1, 2007, by Sec. 37 of Ch. 241.)

division: 112. PUBLIC HEALTH

part: 1. GENERAL PROVISIONS

path: 112. PUBLIC HEALTH > 1. GENERAL PROVISIONS > 1. Organization of the State Department of Public Health


text:
(a) There is in state government an executive officer known as the State Public Health Officer, who shall be appointed by the Governor, subject to confirmation by the Senate, and hold office at the pleasure of the Governor. The State Public Health Officer shall receive the annual salary provided by Article 1 (commencing with Section 11550) of Chapter 6 of Part 1 of Division 3 of Title 2 of the Government Code.

(b) The State Public Health Officer shall serve as the director of, and have control over, the State Department of Public Health.

(c) Any statutory reference to “director,” “the Director of Health Services,” “the Director of Public Health,” or the “Director of the State Department of Public Health,” regarding a function transferred to the State Department of Public Health pursuant to Chapter 2 (commencing with Section 131050), is deemed to, instead, refer to the State Public Health Officer.

(d) Any statutory reference to “department” or “state department” regarding a function transferred to the State Department of Public Health pursuant to Chapter 2 (commencing with Section 131050), shall refer to the State Department of Public Health.

(e) The director shall be a licensed physician and surgeon pursuant to Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code, who has demonstrated medical, public health, and management experience.

chapter: 1. Organization of the State Department of Public Health


text: Upon recommendation of the director, the Governor may appoint, not to exceed, two chief deputies of the State Department of Public Health, subject to confirmation by the Senate, who shall hold office at the pleasure of the Governor. The salaries of the chief deputies shall be fixed in accordance with law.

history: (History: Amended by Stats. 2007, Ch. 483, Sec. 37.5. Effective January 1, 2008.)


text: The director shall have the powers of a head of the department pursuant to Chapter 2 (commencing with Section 11150) of Part 1 of Division 3 of Title 2 of the Government Code.


text: There is in the State Department of Public Health an Office of AIDS. The State Department of Public Health, Office of AIDS, shall be the lead agency within the state, responsible for coordinating state programs, services, and activities relating to the human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), and AIDS related conditions (ARC). Among its responsibilities, the State Department of Public Health, Office of AIDS, shall coordinate Sections 120875, Section 120880, Chapter 2 (commencing with Section 120800), Chapter 4 (commencing with Section 120900), Chapter 6 (commencing with Section 120950), Chapter 8 (commencing with Section 121025), Chapter 9 (commencing with Section 121050), Chapter 10 (commencing with Section 121075), Chapter 11 (commencing with Section 121150), Chapter 12 (commencing with Section 121200), Chapter 13 (commencing with Section 121250), and Chapter 14 (commencing with Section 121300), of Part 4 of Division 105. Any reference in those provisions to the State Department of Health Services or the State Department of Public Health shall be deemed to be a reference to the Office of AIDS within the State Department of Public Health.

history: (History: Added by renumbering Section 100119 by Stats. 2006, Ch. 241, Sec. 17. Effective January 1, 2007. Operative July 1, 2007, by Sec. 37 of Ch. 241.)


text:
(a) For purposes of this section, the following definitions shall apply:

(1) “Determinants of equity” means social, economic, geographic, political, and physical environmental conditions that lead to the creation of a fair and just society.

(2) “Health equity” means efforts to ensure that all people have full and equal access to opportunities that enable them to lead healthy lives.

(3) “Health and mental health disparities” means differences in health and mental health status among distinct segments of the population, including differences that occur by gender, age, race or ethnicity, sexual orientation, gender identity, education or income, disability or functional impairment, or geographic location, or the combination of any of these factors.

(4) “Health and mental health inequities” means disparities in health or mental health, or the factors that shape health, that are systemic and avoidable and, therefore, considered unjust or unfair.

(5) “Vulnerable communities” include, but are not limited to, women, racial or ethnic groups, low-income individuals and families, individuals who are incarcerated and those who have been incarcerated, individuals with disabilities, individuals with mental health conditions, children, youth and young adults, seniors, immigrants and refugees, individuals who are limited-English proficient (LEP), and lesbian, gay, bisexual, transgender, queer, and questioning (LGBTQQ) communities, or combinations of these populations.

(6) “Vulnerable places” means places or communities with inequities in the social, economic, educational, or physical environment or environmental health and that have insufficient resources or capacity to protect and promote the health and well-being of their residents.

(b) The State Department of Public Health shall establish an Office of Health Equity for the purposes of aligning state resources, decisionmaking, and programs to accomplish all of the following:

(1) Achieve the highest level of health and mental health for all people, with special attention focused on those who have experienced socioeconomic disadvantage and historical injustice, including, but not limited to, vulnerable communities and culturally, linguistically, and geographically isolated communities.

(2) Work collaboratively with the Health in All Policies Task Force to promote work to prevent injury and illness through improved social and environmental factors that promote health and mental health.

(3) Advise and assist other state departments in their mission to increase access to, and the quality of, culturally and linguistically competent health and mental health care and services.

(4) Improve the health status of all populations and places, with a priority on eliminating health and mental health disparities and inequities.

(c) The duties of the Office of Health Equity shall include all of the following:

(1) Conducting policy analysis and developing strategic policies and plans regarding specific issues affecting vulnerable communities and vulnerable places to increase positive health and mental health outcomes for vulnerable communities and decrease health and mental health disparities and inequities. The policies and plans shall also include strategies to address social and environmental inequities and improve health and mental health. The office shall assist other departments in their missions to increase access to services and supports and improve quality of care for vulnerable communities.

(2) Establishing a comprehensive, cross-sectoral strategic plan to eliminate health and mental health disparities and inequities. The strategies and recommendations developed shall take into account the needs of vulnerable communities to ensure strategies are developed throughout the state to eliminate health and mental health disparities and inequities. This plan shall be developed in collaboration with the Health in All Policies Task Force. This plan shall establish goals and benchmarks for specific strategies in order to measure and track disparities and the effectiveness of these strategies. This plan shall be updated periodically, but not less than every two years, to keep abreast of data trends, best practices, promising practices, and to more effectively focus and direct necessary resources to mitigate and eliminate disparities and inequities. This plan shall be included in the report required under paragraph (1) of subdivision (d). The Office of Health Equity shall seek input from the public on the plan through an inclusive public stakeholder process.

(3) Building upon and informing the work of the Health in All Policies Task Force in working with state agencies and departments to consider health in appropriate and relevant aspects of public policy development to ensure the implementation of goals and objectives that close the gap in health status. The Office of Health Equity shall work collaboratively with the Health in All Policies Task Force to assist state agencies and departments in developing policies, systems, programs, and environmental change strategies that have population health impacts in all of the following ways, within the resources made available:

(A) Develop intervention programs with targeted approaches to address health and mental health inequities and disparities.

(B) Prioritize building cross-sectoral partnerships within and across departments and agencies to change policies and practices to advance health equity.

(C) Work with the advisory committee established pursuant to subdivision (f) and through stakeholder meetings to provide a forum to identify and address the complexities of health and mental health inequities and disparities and the need for multiple, interrelated, and multisectoral strategies.

(D) Provide technical assistance to state and local agencies and departments with regard to building organizational capacity, staff training, and facilitating communication to facilitate strategies to reduce health and mental health disparities.

(E) Highlight and share evidence-based, evidence-informed, and community-based practices for reducing health and mental health disparities and inequities.

(F) Work with local public health departments, county mental health or behavioral health departments, local social services, and mental health agencies, and other local agencies that address key health determinants, including, but not limited to, housing, transportation, planning, education, parks, and economic development. The Office of Health Equity shall seek to link local efforts with statewide efforts.

(4) Consult with community-based organizations and local governmental agencies to ensure that community perspectives and input are included in policies and any strategic plans, recommendations, and implementation activities.

(5) Assist in coordinating projects funded by the state that pertain to increasing the health and mental health status of vulnerable communities.

(6) Provide consultation and technical assistance to state departments and other state and local agencies charged with providing or purchasing state-funded health and mental health care, in their respective missions to identify, analyze, and report disparities and to identify strategies to address health and mental health disparities.

(7) Provide information and assistance to state and local departments in coordinating projects within and across state departments that improve the effectiveness of public health and mental health services to vulnerable communities and that address community environments to promote health. This information shall identify unnecessary duplication of services.

(8) Communicate and disseminate information within the department and with other state departments to assist in developing strategies to improve the health and mental health status of persons in vulnerable communities and to share strategies that address the social and environmental determinants of health.

(9) Provide consultation and assistance to public and private entities that are attempting to create innovative responses to improve the health and mental health status of vulnerable communities.

(10) Seek additional resources, including in-kind assistance, federal funding, and foundation support.

(d) In identifying and developing recommendations for strategic plans, the Office of Health Equity shall, at a minimum, do all of the following:

(1) Conduct demographic analyses on health and mental health disparities and inequities. The report shall include, to the extent feasible, an analysis of the underlying conditions that contribute to health and well-being. The first report shall be due July 1, 2014. This information shall be updated periodically, but not less than every two years, and made available through public dissemination, including posting on the department’s Internet Web site. The report shall be developed using primary and secondary sources of demographic information available to the office, including the work and data collected by the Health in All Policies Task Force. Primary sources of demographic information shall be collected contingent on the receipt of state, federal, or private funds for this purpose.

(2) Based on the availability of data, including valid data made available from secondary sources, the report described in paragraph (1) shall address the following key factors as they relate to health and mental health disparities and inequities:

(A) Income security such as living wage, earned income tax credit, and paid leave.

(B) Food security and nutrition such as food stamp eligibility and enrollment, assessments of food access, and rates of access to unhealthy food and beverages.

(C) Child development, education, and literacy rates, including opportunities for early childhood development and parenting support, rates of graduation compared to dropout rates, college attainment, and adult literacy.

(D) Housing, including access to affordable, safe, and healthy housing, housing near parks and with access to healthy foods, and housing that incorporates universal design and visitability features.

(E) Environmental quality, including exposure to toxins in the air, water, and soil.

(F) Accessible built environments that promote health and safety, including mixed-used land, active transportation such as improved pedestrian, bicycle, and automobile safety, parks and green space, and healthy school siting.

(G) Health care, including accessible disease management programs, access to affordable, quality health and behavioral health care, assessment of the health care workforce, and workforce diversity.

(H) Prevention efforts, including community-based education and availability of preventive services.

(I) Assessing ongoing discrimination and minority stressors against individuals and groups in vulnerable communities based upon race, gender, gender identity, gender expression, ethnicity, marital status, language, sexual orientation, disability, and other factors, such as discrimination that is based upon bias and negative attitudes of health professionals and providers.

(J) Neighborhood safety and collective efficacy, including rates of violence, increases or decreases in community cohesion, and collaborative efforts to improve the health and well-being of the community.

(K) The efforts of the Health in All Policies Task Force, including monitoring and identifying efforts to include health and equity in all sectors.

(L) Culturally appropriate and competent services and training in all sectors, including training to eliminate bias, discrimination, and mistreatment of persons in vulnerable communities.

(M) Linguistically appropriate and competent services and training in all sectors, including the availability of information in alternative formats such as large font, braille, and American Sign Language.

(N) Accessible, affordable, and appropriate mental health services.

(3) Consult regularly with representatives of vulnerable communities, including diverse racial, ethnic, cultural, and LGBTQQ communities, women’s health advocates, mental health advocates, health and mental health providers, community-based organizations and advocates, academic institutions, local public health departments, local government entities, and low-income and vulnerable consumers.

(4) Consult regularly with the advisory committee established by subdivision (f) for input and updates on the policy recommendations, strategic plans, and status of cross-sectoral work.

(e) The Office of Health Equity shall be organized as follows:

(1) A Deputy Director shall be appointed by the Governor or the State Public Health Officer, and is subject to confirmation by the Senate. The salary for the Deputy Director shall be fixed in accordance with state law.

(2) The Deputy Director of the Office of Health Equity shall report to the State Public Health Officer and shall work closely with the Director of Health Care Services to ensure compliance with the requirements of the office’s strategic plans, policies, and implementation activities.

(f) The Office of Health Equity shall establish an advisory committee to advance the goals of the office and to actively participate in decisionmaking. The advisory committee shall be composed of representatives from applicable state agencies and departments, local health departments, community-based organizations working to advance health and mental health equity, vulnerable communities, and stakeholder communities that represent the diverse demographics of the state. The chair of the advisory committee shall be a representative from a nonstate entity. The advisory committee shall be established by no later than October 1, 2013, and shall meet, at a minimum, on a quarterly basis. Subcommittees of this advisory committee may be formed as determined by the chair.

(g) An interagency agreement shall be established between the State Department of Public Health and the State Department of Health Care Services to outline the process by which the departments will jointly work to advance the mission of the Office of Health Equity, including responsibilities, scope of work, and necessary resources.

history: (History: Added by Stats. 2012, Ch. 23, Sec. 43. (AB 1467) Effective June 27, 2012.)


text: All officers or employees of the department employed after July 1, 2007, shall be appointed by the director.


text:
(a) The Legislature finds that having access to a statewide stockpile of personal protective equipment in the event of a pandemic, wildfire smoke event, or other health emergency is vital to the health and safety of its health care and essential workers, as well as the general population, which both relies on this workforce and is susceptible to disease transmission should members of this workforce needlessly be infected with transmissible disease.

(b) The following definitions apply for purposes of this section:

(1) “Department” means the State Department of Public Health.

(2) “Office” means the Office of Emergency Services.

(3) “Agricultural worker” means a person employed in any of the following:

(A) An agricultural occupation, as defined in Wage Order No. 14 of the Industrial Welfare Commission.

(B) An industry preparing agricultural products for the market, on the farm, as defined in Wage Order No. 13 of the Industrial Welfare Commission.

(C) An industry handling products after harvest, as defined in Wage Order No. 8 of the Industrial Welfare Commission.

(4) “Essential workers” means primary and secondary school workers, workers at detention facilities, as defined in Section 9500 of the Penal Code, in-home support providers, childcare providers, government workers whose work with the public continues throughout the crisis, and workers in other positions that the State Public Health Officer or the Director of the Office of Emergency Services deems vital to public health and safety, as well as economic and national security, including, but not limited to, agricultural workers.

(5) “Health care worker” means any worker who provides direct patient care and services directly supporting patient care, including, but not limited, to physicians, pharmacists, clinicians, nurses, aides, technicians, janitorial and housekeeping staff, food services workers, and nonmanagerial administrative staff.

(6) “Personal protective equipment” or “PPE” means protective equipment for eyes, face, head, and extremities, protective clothing, respiratory devices, and protective shields and barriers, including, but not limited to, N95 and other filtering facepiece respirators, elastomeric air-purifying respirators with appropriate particulate filters or cartridges, powered air purifying respirators, disinfecting and sterilizing devices and supplies, medical gowns and apparel, face masks, surgical masks, face shields, gloves, shoe coverings, and the equipment identified by or otherwise necessary to comply with Section 5199 of Title 8 of the California Code of Regulations.

(7) “Provider” means a licensed clinic, as described in Chapter 1 (commencing with Section 1200), an outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of, a health facility as described in Chapter 2 (commencing with Section 1250) of, or a county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of, Division 2, a home health agency, a physician’s office, a professional medical corporation, a medical partnership, a medical foundation, a rural health clinic, as defined in Section 1395x(aa)(2) of Title 42 of the United States Code, or a federally qualified health center, as defined in Section 1395x(aa)(4) of Title 42 of the United States Code, and any other entity that provides medical services in California.

(8) “Stockpile” means the personal protective equipment stockpile created pursuant to subdivision (c).

(c) Within one year of the effective date of this section, the department and office, in coordination with other state agencies, shall establish a PPE stockpile, upon appropriation and as necessary.

(d) The department shall also establish guidelines for procurement, management, and distribution of PPE from the department. The department and office shall consider the recommendations of the Personal Protective Equipment Advisory Committee created pursuant to subdivision (f) in developing these guidelines. At a minimum, the guidelines shall take into account all of the following:

(1) The various types of PPE that may be required during a pandemic or other health emergency, including, but not limited to, wildfire smoke events.

(2) The shelf life of each type of PPE that may be obtained from the department and how to restock a portion of each type of PPE to ensure the procurements consist of unexpired PPE.

(3) The amount of each type of PPE that would be required for all health care workers and essential workers in the state during a 90-day pandemic or other health emergency, including, but not limited to, wildfire smoke events.

(4) Lessons learned from previous pandemics and state emergencies, including, but not limited to, supply procurement, management, and distribution.

(5) Guidance on how to define essential workers based upon different hazards.

(6) Geographical distribution of PPE storage.

(7) Guidance on how to establish policies and standards for PPE surge capacity to ensure that workers have access to an adequate supply of PPE during a pandemic or other health emergency, including, but not limited to, wildfire smoke events.

(8) The policies and funding that would be required for the state to establish a PPE stockpile.

(9) How distribution from any procurement shall be prioritized in the event that there is insufficient PPE to meet the needs of providers or employers of essential workers, including consideration of the following:

(A) The provider or employer is in a location with a high share of low-income residents.

(B) The provider or employer is in a medically underserved area, as designated by the United States Department of Health and Human Services, Health Resources and Services Administration.

(C) The provider or employer disproportionately serves a medically underserved population, as designated by the United States Department of Health and Human Services, Health Resources and Services Administration.

(D) The provider or employer is in a county with a high infection rate or high hospitalization rate related to the declared emergency.

(e) The development of the guidelines shall be informed by the recommendations of the Personal Protective Equipment Advisory Committee pursuant to subdivision (f). The guidelines shall not establish policies or standards that are less protective or prescriptive than any federal, state, or local law on PPE standards.

(f) The Personal Protective Equipment Advisory Committee is hereby established. The advisory committee shall consist of the following:

(1) One representative of an association representing multiple types of hospitals and health systems.

(2) One representative of an association representing skilled nursing facilities.

(3) One representative of an association representing primary care clinics.

(4) One representative of a statewide association representing physicians.

(5) Two representatives of labor organizations that represent health care workers.

(6) Two representatives of labor organizations that represent nonagricultural essential workers, as defined by paragraph (4) of subdivision (b).

(7) One representative of a labor organization that represents agricultural workers, as defined by paragraph (3) of subdivision (b).

(8) One representative of an organization that represents agricultural employers.

(9) One representative from the personal protective equipment manufacturing industry.

(10) One consumer representative.

(11) One representative from an association representing counties.

(12) One representative from the State Department of Public Health.

(13) One representative from the Office of Emergency Services.

(14) One representative from the Emergency Medical Services Authority.

(15) One representative from the State Department of Social Services.

(g) The Director of the Office of Emergency Services or their designee shall appoint the representatives from paragraphs (1) through (11), inclusive, of subdivision (f).

(h) The Personal Protective Equipment Advisory Committee shall make recommendations to the office and department necessary to develop the guidelines required pursuant to subdivision (d).

(i) Nothing in this section alters an employer’s duty to provide respirators as required by Section 5141.1 of Title 8 of the California Code of Regulations.

(j) The department shall report to the Legislature, within six months of the effective date of the amendments to this section made by the act adding this subdivision, with regard to the amount of PPE in the stockpile, the amount of PPE from the stockpile that has been used, and the amount of anticipated future usage. The report shall be made pursuant to Section 9795 of the Government Code.

history: (History: Amended by Stats. 2021, Ch. 322, Sec. 1. (AB 73) Effective September 27, 2021.)


text:
(a) As set forth in this article, the State Department of Public Health shall succeed to and be vested with all the duties, powers, purposes, functions, responsibilities, and jurisdiction of the former State Department of Health Services as they relate to public health, licensing and certification of health facilities, and any other functions performed immediately preceding the operative date of this section by, or under the supervision of, all of the following:

(1) The Deputy Director for Prevention Services of the former State Department of Health Services, excluding the Office of Clinical Preventive Medicine.

(2) The Deputy Director for Licensing and Certification.

(3) The Deputy Director for Health Information and Strategic Planning.

(4) The Deputy Director for Public Health Emergency Preparedness.

(5) The California Conference of Local Health Officers.

(6) The Deputy Director for Primary Care and Family Health as follows: Maternal, Child and Adolescent Health as set forth in Part 2 excluding Articles 5, 5.5, 6, and 6.5 of Chapter 3, Part 3, Part 5 excluding Articles 1 and 2 of Chapter 2, Part 7 and Part 8, of Division 106.

(b) It is the intent of the Legislature that, in implementing this article, the duties, powers, purposes, and responsibilities transferred to the State Department of Public Health shall include those formerly performed by the programs of the former State Department of Health Services set forth in this article, provided, however, that nothing in this article shall be construed to require that the State Department of Public Health be organized according to programs described in this article, or to limit the authority or discretion of the State Public Health Officer pursuant to Section 11152 of the Government Code to organize the State Department of Public Health, unless that organization is otherwise required by law. Nothing in this article shall be construed to require that the State Department of Public Health maintain, or refrain from terminating, any program described in this article except to the extent that maintenance of the program is otherwise required by law. Nothing in this article shall be construed to limit or expand the authority of any program described in this article.

chapter: 2. General Powers of the Department

article: 1. General Provisions

path: 112. PUBLIC HEALTH > 1. GENERAL PROVISIONS > 2. General Powers of the Department > 1. General Provisions