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AB-1723 Pharmacy: clinics: purchasing drugs at wholesale.(2019-2020)

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Date Published: 03/18/2019 09:00 PM
AB1723:v98#DOCUMENT

Amended  IN  Assembly  March 18, 2019

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Assembly Bill
No. 1723


Introduced by Assembly Member Wood

February 22, 2019


An act to amend Section 14184.60 of the Welfare and Institutions Code, relating to Medi-Cal. An act to amend Section 4180 of the Business and Professions Code, relating to pharmacy.


LEGISLATIVE COUNSEL'S DIGEST


AB 1723, as amended, Wood. Medi-Cal: Whole Person Care pilot program. Pharmacy: clinics: purchasing drugs at wholesale.
Existing law, the Pharmacy Law, provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy within the Department of Consumer Affairs. Existing law authorizes certain clinics to purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic, including, among others, a clinic operated by a primary care community or free clinic, operated on separate premises from a licensed clinic, that is open no more than 20 hours per week.
This bill would increase the number of hours the above-specified clinic is authorized to be open to not more than 40 hours per week.

Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive healthcare services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law requires the department to establish and operate the Whole Person Care pilot program, a component of the Medi-Cal 2020 demonstration project, under which counties, Medi-Cal managed care plans, and community providers that elect to participate in the pilot program are provided an opportunity to establish a new model for integrated care delivery that incorporates healthcare needs, behavioral needs, and social support, including housing and other supportive services, for the state’s most high-risk, high-utilizing populations.

This bill would make technical, nonsubstantive changes to that provision.

Vote: MAJORITY   Appropriation: NO   Fiscal Committee: NOYES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Section 4180 of the Business and Professions Code is amended to read:

4180.
 (a) (1) Notwithstanding any provision of this chapter, any of the following clinics may purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic:
(A) A licensed nonprofit community clinic or free clinic as defined in paragraph (1) of subdivision (a) of Section 1204 of the Health and Safety Code.
(B) A primary care clinic owned or operated by a county as referred to in subdivision (b) of Section 1206 of the Health and Safety Code.
(C) A clinic operated by a federally recognized Indian tribe or tribal organization as referred to in subdivision (c) of Section 1206 of the Health and Safety Code.
(D) A clinic operated by a primary care community or free clinic, operated on separate premises from a licensed clinic, and that is open no more than 20 the number of hours per week as referred to in subdivision (h) of Section 1206 of the Health and Safety Code.
(E) A student health center clinic operated by a public institution of higher education as referred to in subdivision (j) of Section 1206 of the Health and Safety Code.
(F) A nonprofit multispecialty clinic as referred to in subdivision (l) of Section 1206 of the Health and Safety Code.
(2) The clinic shall keep records of the kind and amounts of drugs purchased, administered, and dispensed, and the records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel.
(b) No clinic shall be entitled to the benefits of this section until it has obtained a license from the board. A separate license shall be required for each clinic location. A clinic shall notify the board of any change in the clinic’s address on a form furnished by the board.
(c) The board shall synchronize license renewal dates and aggregate fees for multiple clinics under common nonprofit ownership at the request of the parent organization.

SECTION 1.Section 14184.60 of the Welfare and Institutions Code is amended to read:
14184.60.

(a)(1)(A)The department shall establish and operate the Whole Person Care pilot program as authorized under the Medi-Cal 2020 demonstration project to allow for the development of WPC pilots focused on target populations of high-risk, high-utilizing Medi-Cal beneficiaries in local geographic areas.

(B)The overarching goal of the program is the coordination of health, behavioral health, and social services, as applicable, in a patient-centered manner to improve beneficiary health and well-being through a more efficient and effective use of resources.

(2)The Whole Person Care (WPC) pilots shall provide an option to a county, a city and county, a health or hospital authority, or a consortium of any of the above entities serving a county or region consisting of more than one county, to receive support to integrate care for particularly vulnerable Medi-Cal beneficiaries who have been identified as high users of multiple systems and who continue to have or are at-risk of poor health outcomes. Through collaborative leadership and systematic coordination among public and private entities, pilot entities will identify common beneficiaries, share data between systems, coordinate care in real time, and evaluate individual and population progress in order to meet the goal of providing comprehensive coordinated care for the beneficiary resulting in better health outcomes.

(3)Investments in the localized pilots will build and strengthen relationships and systems infrastructure and will improve collaboration among WPC lead entities and WPC participating entities. The results of the WPC pilots will provide learnings for potential future local efforts beyond the term of the demonstration.

(4)(A)WPC pilots shall include all of the following specific strategies:

(i)To increase integration among local governmental agencies, health plans, providers, and other entities that serve high-risk, high-utilizing beneficiaries.

(ii)To increase coordination and appropriate access to care for the most vulnerable Medi-Cal beneficiaries; reduce inappropriate inpatient and emergency room utilization.

(iii)To improve data collection and sharing among local entities.

(iv)To improve health outcomes for the WPC target population.

(B)WPC pilots may include other strategies to increase access to housing and supportive services.

(5)WPC pilots shall be approved by the department through the process outlined in the Special Terms and Conditions.

(6)Receipt of Whole Person Care services is voluntary. Individuals receiving these services shall agree to participate in the WPC pilot, and may opt out at any time.

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

(1)“Medi-Cal managed care plan” means an organization or entity that enters into a contract with the department pursuant to Article 2.7 (commencing with Section 14087.3), Article 2.8 (commencing with Section 14087.5), Article 2.81 (commencing with Section 14087.96), Article 2.91 (commencing with Section 14089), or Chapter 8 (commencing with Section 14200).

(2)“WPC community partner” means an entity or organization identified as participating in the WPC pilot that has significant experience serving the target population within the pilot’s geographic area, including physician groups, community clinics, hospitals, and community-based organizations.

(3)“WPC lead entity” means the entity designated for a WPC pilot to coordinate the Whole Person Care pilot and to be the single point of contact for the department. WPC lead entities may be a county, a city and county, a health or hospital authority, a designated public hospital, a district and municipal public hospital, or an agency or department thereof, a federally recognized tribe, a tribal health program operated under a Public Law 93-638 contract with the federal Indian Health Service, or a consortium of any of these entities.

(4)“WPC participating entity” means those entities identified as participating in the WPC pilot, other than the WPC lead entity, including other local governmental entities, agencies within local governmental entities, Medi-Cal managed care plans, and WPC community partners.

(5)“WPC target population” means the population or populations identified by a WPC pilot through a collaborative data approach across partnering entities that identifies common Medi-Cal high-risk, high-utilizing beneficiaries who frequently access urgent and emergency services, including across multiple systems. At the discretion of the WPC lead entity, and in accordance with guidance as may be issued by the department during the application process and approved by the department, the WPC target population may include individuals who are not Medi-Cal patients, subject to the funding restrictions in the Special Terms and Conditions regarding the availability of federal financial participation for services provided to these individuals.

(c)(1)WPC pilots shall have flexibility to develop financial and administrative arrangements to encourage collaboration with regard to pilot activities subject to the Special Terms and Conditions, the provisions of any WPC pilot agreements with the department, and the applicable provisions of state and federal law, and any other guidance issued by the department.

(2)The WPC lead entity shall be responsible for operating the WPC pilot, conducting ongoing monitoring of WPC participating entities, arranging for the required reporting, ensuring an appropriate financial structure is in place, and identifying and securing a permissible source of the nonfederal share for WPC pilot payments.

(3)A WPC pilot shall include, at a minimum, all of the following entities as WPC participating entities in addition to the WPC lead entity. If a WPC lead entity cannot reach an agreement with a required participant, the WPC lead entity may request an exception to this requirement from the department.

(A)At least one Medi-Cal managed care plan operating in the geographic area of the WPC pilot to work in partnership with the WPC lead entity when implementing the pilot specific to Medi-Cal managed care beneficiaries.

(B)The health services agency or agencies or department or departments for the geographic region where the WPC pilot operates, or any other public entity operating in that capacity for the county or city and county.

(C)The local entities, agencies, or departments responsible for specialty mental health services for the geographic area where the WPC pilot operates.

(D)At least one other public agency or department, which may include county alcohol and substance use disorder programs, human services agencies, public health departments, criminal justice or probation entities, and housing authorities, regardless of how many of these fall under the same agency head within the geographic area where the WPC pilot operates.

(E)At least two other community partners serving the target population within the applicable geographic area.

(4)The department shall enter into a pilot agreement with each WPC lead entity approved for participation in the WPC pilot program. The information and terms of the approved WPC pilot application shall become the pilot agreement between the department and the WPC lead entity submitting the application.

(A)The pilot agreement shall set forth, at a minimum, the amount of funding that will be available to the WPC pilot and the conditions under which payments will be made, how payments may vary or under which the pilot program may be terminated or restricted.

(B)The pilot agreement shall include a data sharing agreement that is sufficient in scope for purposes of the WPC pilot, and an agreement regarding the provision of the nonfederal share.

(C)The pilot agreement shall specify reporting of universal and variant metrics that shall be reported by the pilot on a timeline specified by the department and projected performance on them.

(D)The pilot agreement may include additional components and requirements as issued by the department during the application process.

(E)Modifications to the WPC pilot activities and deliverables may be made on an annual basis in furtherance of WPC pilot objectives, to incorporate learnings from the operation of the WPC pilot as approved by the department.

(5)Notwithstanding any other law, including Section 5328 of this code, and Sections 11812 and 11845.5 of the Health and Safety Code, the sharing of health information, records, and other data with and among WPC lead entities and WPC participating entities shall be permitted to the extent necessary for the activities and purposes set forth in this section. This provision shall also apply to the sharing of health information, records, and other data with and among prospective WPC lead entities and WPC participating entities in the process of identifying a proposed target population and preparing an application for a WPC pilot.

(d)WPC pilots may target the focus of their pilot on individuals at risk of or experiencing homelessness who have a demonstrated medical need, including behavioral health needs, for housing or supportive services, subject to the restrictions on funding contained in the Special Terms and Conditions. In these instances, WPC participating entities may include local housing authorities, local continuum of care (CoCs) programs, community-based organizations, and others serving the homeless population as entities collaborating and participating in the WPC pilot. WPC pilot housing interventions may include the following:

(1)Tenancy-based care management services. For purposes of this section, “tenancy-based care management services” means supports to assist the target population in locating and maintaining medically necessary housing. These services may include the following:

(A)Individual housing transition services, such as individual outreach and assessments.

(B)Individual housing and tenancy-sustaining services, including tenant and landlord education and tenant coaching.

(C)Housing-related collaborative activities, such as services that support collaborative efforts across public agencies and the private sector that assist WPC participating entities in identifying and securing housing for the target population.

(2)Countywide housing pools.

(A)WPC pilots may establish a countywide housing pool (housing pool) that will directly provide needed support for medically necessary housing services, with the goal of improving access to housing and reducing churn in the Medi-Cal population.

(B)The housing pool may be funded through WPC pilot payments or direct contributions from community entities, or from state or local government. WPC pilot payments for the operation of a housing pool shall be subject to the restrictions in the Special Terms and Conditions and other applicable provisions of federal law. Housing pool funds that are not WPC pilot payments shall be maintained separately from WPC pilot payments and may be allocated to fund support for long-term housing, including rental housing subsidies. The housing pool may leverage local resources to increase access to subsidized housing units. The housing pool may also incorporate a financing component to reallocate or reinvest a portion of the savings from the reduced utilization of healthcare services into the housing pool. As applicable to an approved WPC pilot, WPC investments in housing units or housing subsidies, including any payment for room and board, shall not be eligible for federal financial participation, unless recognized as reimbursable under federal Centers for Medicare and Medicaid Services policy.

(e)(1)Payments to WPC pilots shall be disbursed twice a year to the WPC lead entity following the submission of the reports required pursuant to subdivision (f), to the extent all applicable requirements are met. The amount of funding for each WPC pilot and the timing of the payments shall be specified by the department upon the department approving a WPC application, consistent with the Special Terms and Conditions. During the 2016 calendar year only, payments shall be available for the planning, development, and submission of a successful WPC pilot application, including the submission of deliverables as set forth in the WPC pilot application and the WPC pilot annual report, to the extent authorized under the demonstration project and approved by the department.

(2)The department shall issue a WPC pilot application and selection criteria consistent with the Special Terms and Conditions, under which applicants shall demonstrate the ability to meet the goals of the WPC pilots as outlined in this section and the Special Terms and Conditions. The department shall approve applicants that meet the WPC pilot selection criteria established by the department, and shall allocate available funding to those approved WPC pilots up to the full amount of federal financial participation authorized under the demonstration project for WPC pilots during each calendar year from 2016 to 2020, inclusive, to the extent there are sufficient numbers of applications that meet the applicable criteria. In the event that otherwise unallocated federal financial participation is available after the initial award of WPC pilots, the department may solicit applications for the remaining available funds from WPC lead entities of approved WPC pilots or from additional applicants, including applicants not approved during the initial application process.

(3)In the event a WPC pilot does not receive its full annual payment amount, the WPC lead entity may request that the remaining funds be carried forward into the following calendar year, or may amend the scope of the WPC pilot, including, services, activities, or enrollment, for which this unallocated funding may be made available, subject to the Special Terms and Conditions and approval by the department. If the department denies a WPC lead entity request to carry forward unused funds and funds are not disbursed in this manner, the department may make the unexpended funds available for other WPC pilots or additional applicants not approved during the initial application process, to the extent authorized in the Special Terms and Conditions.

(4)Payments to the WPC pilot are intended to support infrastructure to integrate services among local entities that serve the WPC target population, to support the availability of services not otherwise covered or directly reimbursed by Medi-Cal to improve care for the WPC target population, and to foster other strategies to improve integration, reduce unnecessary utilization of healthcare services, and improve health outcomes. WPC pilot payments shall not be considered direct reimbursement for expenditures incurred by WPC lead entities or WPC participating entities in implementing these strategies or reforms. WPC pilot payments shall not be considered payments for services otherwise reimbursable under the Medi-Cal program, and shall not offset or otherwise supplant payment amounts otherwise payable by the Medi-Cal program, including payments to and by Medi-Cal managed care plans, for Medi-Cal covered services.

(5)WPC pilots are not intended as, and shall not be construed to constitute, healthcare coverage for individuals receiving services. WPC pilots may determine the scope, type, and extent to which services are available, to the extent consistent with the Special Terms and Conditions.

(6)For purposes of the WPC pilots, WPC lead entities shall be exempt from Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code, and shall not be considered Medi-Cal managed care health plans subject to the requirements applicable to the two-plan model and geographic managed care plans, as contained in Article 2.7 (commencing with Section 14087.3), Article 2.81 (commencing with Section 14087.96), and Article 2.91 (commencing with Section 14089), and the corresponding regulations, and shall not be considered prepaid health plans, as defined in Section 14251.

(f)WPC lead entities shall submit mid-year and annual reports to the department, in accordance with the schedules and guidelines established by the department and consistent with the Special Terms and Conditions. No later than 60 days after submission, the department shall determine the extent to which pilot requirements were met and the associated interim or annual payment due to the WPC pilot.

(g)The department, in collaboration with WPC lead entities, shall facilitate learning collaboratives to allow WPC pilots to share information and lessons learned from the operation of the WPC pilots, best practices with regard to specific beneficiary populations, and strategies for improving coordination and data sharing among WPC pilot entities.

(h)The nonfederal share of any payments under the WPC pilot program shall consist of voluntary intergovernmental transfers of funds provided by participating governmental agencies or entities, in accordance with this section and the terms of the pilot agreement.

(1)The Whole Person Care Pilot Special Fund is hereby established in the State Treasury. Notwithstanding Section 13340 of the Government Code, moneys deposited in the Whole Person Care Pilot Special Fund pursuant to this section shall be continuously appropriated, without regard to fiscal years, to the department for the purposes specified in this section. All funds derived pursuant to this section shall be deposited in the State Treasury to the credit of the Whole Person Care Pilot Special Fund.

(2)The Whole Person Care Pilot Special Fund shall consist of moneys that a participating governmental agency or entity elects to transfer to the department into the fund as a condition of participation in the WPC pilot program, to the extent permitted under Section 433.51 of Title 42 of the Code of Federal Regulations, the Special Terms and Conditions, and any other applicable federal Medicaid laws. Except as provided in paragraph (3), moneys derived from these intergovernmental transfers in the Whole Person Care Pilot Special Fund shall be used as the nonfederal share of Whole Person Care pilot payments authorized under the demonstration project. Any intergovernmental transfer of funds provided for purposes of the WPC pilot program shall be made as specified in this section. Upon providing any intergovernmental transfer of funds, each transferring entity shall certify that the transferred funds qualify for federal financial participation pursuant to applicable federal Medicaid laws and the Special Terms and Conditions, and in the form and manner as required by the department.

(3)The department shall claim federal financial participation for WPC pilot payments using moneys derived from intergovernmental transfers made pursuant to this section and deposited in the Whole Person Care Pilot Special Fund to the full extent permitted by law. The moneys disbursed from the fund, and all associated federal financial participation, shall be distributed to WPC lead entities in accordance with paragraph (1) of subdivision (e). If federal financial participation is not available with respect to a payment under this section and either is not obtained, or results in a recoupment of funds from one or more WPC lead entities, the department shall return any intergovernmental transfer fund amounts associated with the payment for which federal financial participation is not available to the applicable transferring entities within 14 days from the date of the associated recoupment or other determination, as applicable.

(4)This section shall not be construed to require any local governmental agency or entity, or any other provider, plan, or similar entity, to participate in the WPC pilot program. As a condition of participation in the WPC pilot program, participating governmental agencies or entities agree to provide intergovernmental transfers of funds necessary to meet the nonfederal share obligation for any Whole Person Care pilot program payment made pursuant to this section and the Special Terms and Conditions. Any intergovernmental transfer of funds made pursuant to this section shall be considered voluntary for purposes of all federal law. State General Fund moneys shall not be used to fund the nonfederal share of any WPC pilot program payment.