The Board of Pharmacy recently adopted emergency regulations implementing SB 159, the PEP/PrEP law passed in 2019, and agreed to move forward with rulemaking to permanently adopt rules. These emergency regulations were sent to the Office of Administrative Law (OAL) which has ten days to approve and file the regulations with the Secretary of State. Emergency rules are only effective for 180 days but can be readopted until permanent rules are adopted.

For more information, contact NACDS’ Mary Staples at 817-442-1155.

The California Pharmacists Association (CPhA) announced that after a nationwide search, they hired former state legislator Susan Bonilla as their new President and Chief Executive Officer to run the largest statewide pharmacy association.  

Also in California... The Department of Health Care Services (DHCS) announced that they will not resume retroactive adjustments beginning February 10, 2020. The recoupment of pharmacy retroactive claim adjustments is paused until further notice. 

Also in California... Gov. Gavin Newsom (D) named primary care doctor and former CEO for the Inland Empire Health Plan Bradley Gilbert as director of the state Department of Health Care Services, which administers California’s $104 billion Medi-Cal program. Gilbert will take over for Richard Figueroa, who will transition back to his primary role as deputy cabinet secretary.  

Also in California... The Department of Health Care Services is hosting its third Medi-Cal Rx Public Forum in Sacramento on February 18, 2020 from 2- 3 PM to engage stakeholders in discussions on the Governor’s Executive Order N-01-19 which requires DHCS to transition pharmacy services for Medi-Cal managed care to fee-for-service (FFS) by January 1, 2021. DHCS will provide status updates about Medi-Cal Rx implementation activities and timelines. Please note that DHCS will only take questions and comments from those participants attending in person. Participants may also choose to join the meeting via webinar. To register for Medi-Cal Rx Public Forum February 18, 2020. For questions and/or comments, please email RxCarveOut@dhcs.ca.gov.

For more information, contact NACDS’ Mary Staples at 817-442-1155.

At the January 2020 Board of Pharmacy meeting, Anne Sodergren was hired as the Board’s Executive Officer. 

Also in California... In response to the Department of Health Care Services (DHCS) announcement that they would be reinstituting the Medi-Cal reimbursement clawback process effective February 10, 2020, that has been on hold since June 14, 2019, the California Pharmacist Association (CPhA) intends to file for a temporary restraining order this week against DHCS to suspend the clawbacks on pharmacies who serve Medi-Cal patients.

For more information, contact NACDS’ Mary Staples at 817-442-1155.

On January 15th, the online attestation portal opened for fee-for-service Medi-Cal Pharmacy providers seeking the higher of two professional dispensing fees as part of the reimbursement for covered outpatient drugs. Medi-Cal Pharmacy providers should have received a mailer that includes the URL for the online attestation portal as well as a unique login ID and password. The two-tiered professional dispensing fee is based on a Pharmacy provider’s total (Medi-Cal and non-Medi-Cal) annual pharmacy claim volume ($13.20 if fewer than 90,000 claims per year; $10.05 if 90,000 or more). Reporting the claim volume is a self-attestation process, which must be submitted electronically and must be repeated annually. 

The attestation period for the calendar year 2019 is open from January 15, 2020, through February 29, 2020. The attestation for the 2019 calendar year reporting period will determine the professional dispensing fee component of the pharmacy claim reimbursement for claims with dates of service within the state’s following fiscal year (dates of service from July 1, 2020, through June 30, 2021). For additional information, providers may refer to the Pharmacy Provider Self-Attestation FAQs on the Medi-Cal website or the Pharmacy Reimbursement Project page of the DHCS website.  

Also in California... The Department of Health Care Services renamed its multi-year reform initiative aimed at improving the health outcomes and quality of life for California’s population in Medi-Cal. Effective immediately, the broad-based effort to transform the Medi-Cal delivery system, program and payment structure formerly called California Advancing and Innovating Medi-Cal (CalAIM), will be known as Medi-Cal Healthier California for All. 

Also in California... Gov. Gavin Newsom (D) appointed Jacey Cooper to serve as the state Medicaid Director and Chief Deputy Director of Health Care Programs at the Department of Health Care Services. Cooper has been Assistant Deputy Director of Health Care Delivery Systems at the Department of Health Care Services since 2016.   

Also in California... Earlier this month, Gov. Gavin Newsom (D) signed into law several bills adding or amending laws that govern the practice of pharmacy in California. Unless specified otherwise, the new laws took effect on January 1, 2020. Many of the key provisions are summarized below.  

• AB 528 Controlled Substances: CURES Database Effective January 1, 2021, this law expands the CURES reporting requirements to include Schedule V drugs and reduces the reporting deadline to one working day from the date the prescription was released to the patient.  
• AB 690 Pharmacies: Relocation: Remote Dispensing Site Pharmacy: Pharmacy Technician: Qualifications. Effective upon signing by the Governor, this law creates a limited exemption to the licensure transferability requirements for a pharmacy to relocate because of damage caused by a declared disaster. The law also establishes specific requirements for a pharmacy technician working in a remote dispensing site pharmacy.  

• AB 973 Pharmacies: Compounding. This law requires that compounding of drug preparations by a pharmacy must be done consistent with the relevant compounding chapters of the United States Pharmacopeia-National Formulary (USP). The board recently released a policy statement regarding California legal requirements for compounding pharmacies pending information from USP regarding implementation of chapters 795, 797, and 800. The policy statement is available on the board’s website.  
• AB 1723 Clinics: Purchasing Drugs at Wholesale. This law increases the maximum hours of operation for a primary care community clinic or free clinic from 20 hours to 40 hours per week.  
• SB 159 HIV Preexposure and Postexposure Prophylaxis. This comprehensive law authorizes pharmacists to independently initiate and furnish HIV preexposure and postexposure prophylaxis under specific conditions. Key provisions also require the Board of Pharmacy, in consultation with the Medical Board of California (MBC), to approve training programs that pharmacists must complete before furnishing either preexposure or postexposure prophylaxis. In addition, the law specifies guidelines issued by the federal Centers for Disease Control and Prevention (CDC) that the Board of Pharmacy must use to establish the drug or drug combinations to be furnished:  

o   For HIV preexposure prophylaxis: “2017 Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update: A Clinical Practice Guideline,” or any subsequent guidelines published by the CDC.  

o   For HIV postexposure prophylaxis: “Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV–United States, 2016,” or any subsequent guidelines published by the CDC.  

The law also requires the Board of Pharmacy to consult with the medical Board in developing emergency regulations to be adopted by July 1, 2020, to implement the law. The board’s Licensing Committee held a meeting in early January with stakeholders regarding implementation of SB 159, and the committee will report its recommendations at the January 29-30 board meeting in Glendale.  

• SB 569 Controlled Substances: Prescriptions: Declared Local, State, or Federal Emergency. This law authorizes a pharmacist to fill a prescription for a controlled substance that does not conform to the controlled substances security form requirements under specific conditions.

For more information, contact NACDS’ Mary Staples at 817-442-1155.

Gov. Gavin Newsom (D) appointed Jacey Cooper to serve as the state Medicaid Director and Chief Deputy Director of Health Care Programs at the Department of Health Care Services. Cooper has been Assistant Deputy Director of Health Care Delivery Systems at the Department of Health Care Services since 2016.  

Also in California... Earlier this month, Gov. Gavin Newsom (D) signed into law several bills adding or amending laws that govern the practice of pharmacy in California. Unless specified otherwise, the new laws took effect on January 1, 2020. Many of the key provisions are summarized below. 

• AB 528 Controlled Substances: CURES Database Effective January 1, 2021, this law expands the CURES reporting requirements to include Schedule V drugs and reduces the reporting deadline to one working day from the date the prescription was released to the patient. 
• AB 690 Pharmacies: Relocation: Remote Dispensing Site Pharmacy: Pharmacy Technician: Qualifications. Effective upon signing by the Governor, this law creates a limited exemption to the licensure transferability requirements for a pharmacy to relocate because of damage caused by a declared disaster. The law also establishes specific requirements for a pharmacy technician working in a remote dispensing site pharmacy. 
• AB 973 Pharmacies: Compounding. This law requires that compounding of drug preparations by a pharmacy must be done consistent with the relevant compounding chapters of the United States Pharmacopeia-National Formulary (USP). The board recently released a policy statement regarding California legal requirements for compounding pharmacies pending information from USP regarding implementation of chapters 795, 797, and 800. The policy statement is available on the board’s website. 
• AB 1723 Clinics: Purchasing Drugs at Wholesale. This law increases the maximum hours of operation for a primary care community clinic or free clinic from 20 hours to 40 hours per week. 
• SB 159 HIV Preexposure and Postexposure Prophylaxis. This comprehensive law authorizes pharmacists to independently initiate and furnish HIV preexposure and postexposure prophylaxis under specific conditions. Key provisions also require the Board of Pharmacy, in consultation with the Medical Board of California (MBC), to approve training programs that pharmacists must complete before furnishing either preexposure or postexposure prophylaxis. In addition, the law specifies guidelines issued by the federal Centers for Disease Control and Prevention (CDC) that the Board of Pharmacy must use to establish the drug or drug combinations to be furnished: 

• For HIV preexposure prophylaxis: “2017 Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update: A Clinical Practice Guideline,” or any subsequent guidelines published by the CDC. 
• For HIV postexposure prophylaxis: “Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV–United States, 2016,” or any subsequent guidelines published by the CDC. 

The law also requires the Board of Pharmacy to consult with the medical Board in developing emergency regulations to be adopted by July 1, 2020, to implement the law. The board’s Licensing Committee held a meeting in early January with stakeholders regarding implementation of SB 159, and the committee will report its recommendations at the January 29-30 board meeting in Glendale. 

• SB 569 Controlled Substances: Prescriptions: Declared Local, State, or Federal Emergency. This law authorizes a pharmacist to fill a prescription for a controlled substance that does not conform to the controlled substances security form requirements under specific conditions.  

For more information, contact NACDS’ Mary Staples at 817-442-1155.

In advance of the Board of Pharmacy’s Licensing Committee meeting January 9th, NACDS submitted a comment letter providing suggestions for a training program for pharmacist furnishing pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). 

Also in California… legislative session convened on January 6th.   

Also in California... Gov. Gavin Newsom’s (D) budget released last week proposes $107.4 billion in total funds for Department of Health Care Services programs and other spending.  It includes significant funding for the Medi-Cal Healthier California for All initiative (formerly known as CalAIM); funding to support quality improvements in county-operated behavioral health systems; expanded Medi-Cal coverage for adults age 65 and older, regardless of their documentation status; and funding for efforts to control costs and create incentives for better quality care. For more details, please refer to the links posted on the DHCS website. 

Also in California... The Department of Health Care Services is renaming its multi-year reform initiative aimed at improving the health outcomes and quality of life for California’s population in Medi-Cal. Effective immediately, the broad-based effort to transform the Medi-Cal delivery system, program and payment structure will be known as Medi-Cal Healthier California for All. 

For more information, contact NACDS’ Mary Staples at 817-442-1155.

In advance of the Board of Pharmacy’s Licensing Committee meeting January 9, NACDS submitted a comment letter providing suggestions for a training program for pharmacist furnishing pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

For more information, contact NACDS’ Mary Staples at 817-442-1155.

The Office of Environmental Health Hazard Assessment’s (OEHHA) Carcinogen Identification Committee (CIC) postponed their December 5 meeting on whether to add acetaminophen (APAP) to the state’s it’s list of carcinogens under the Proposition 65 law until the Spring of 2020. If they decide to add it, that would then require businesses to provide warnings notices to California consumers about exposures to chemicals that cause cancer, birth defects or other reproductive harm.

Also in California … In 2020, DHCS plans to host quarterly Medi-Cal Rx public forums, webinars and in-person meetings to ensure that the stakeholder community is kept apprised of Medi-Cal Rx implementation activities and timelines for the transition back to Fee-For-Service. DHCS posted a FAQ document—“Medi-Cal Rx: Transitioning Medi-Cal Pharmacy Services from Managed Care to Fee-For-Service”—to the Medi-Cal Rx: Transition webpage that provides additional guidance and clarification to Medi-Cal beneficiaries, providers, plan partners, tribal health programs, and other interested parties regarding the transition of Medi-Cal’s pharmacy benefit. 

Also in California… The Board of Pharmacy’s Licensing Committee will be meeting on December 12 to discuss rulemaking implementing SB 159, a new law allowing pharmacists to furnish HIV Preexposure and Postexposure Prophylaxis medications. Also on the Committee’s agenda is a discussion on advanced pharmacy technicians requirements and functions. The following day, December 13, the full Board will be meeting but that agenda is not yet available, but will be posted on the Board Meetings page.

Also in California… the Board of Pharmacy issued a formal statement regarding compounding requirements pending appeals and postponement of USP Chapters 795, 797, and 825. 

Also in California … Advancing and Innovating Medi-Cal (CalAIM) is a multi-year initiative by the Department of Health Care Services (DHCS) to improve the quality of life and health outcomes of the Medi-Cal population by implementing broad delivery system, program, and payment reforms across the Medi-Cal program. Due to the comprehensive scope of the CalAIM initiative, stakeholder engagement is critical – memo. During the month of December 2019, DHCS will convene four workgroup sessions for Population Health & Annual Health Plan Open Enrollment, Behavioral Health – Payment Reform, Enhanced Care Management & In-Lieu-of Services, and Behavioral Health. For more information about CalAIM, please visit the DHCS webpage. 

Also in California … Department of Health Care Services (DHCS) submitted SPA 19-0015 to CMS, with a proposed effective date of July 1, 2020, to establish a new methodology for blood factor reimbursement for Hemophilia Treatment Centers (HTCs) and non-HTC specialty pharmacies.

• For HTCs, the proposed methodology will be the lower of either their actual acquisition cost (AAC), which is invoice price minus discounts, rebates, or chargebacks, plus a $0.14 per unit dispensing fee; or Average Sales Price (ASP) plus 20 percentn.
• Non-HTCs will be reimbursed at the lower of either the AAC for the drug equal to invoice price minus any discounts (excluding a prompt pay discount of no more than 2 percent), rebates, or chargebacks, plus a $0.04 per unit dispensing fee; or ASP plus 20 percent

Implementation of DHCS’ new reimbursement methodology and provider reimbursement will be prospective from the date of CMS final approval. The SPA package is available on the DHCS State Plan webpage. 

For more information, contact NACDS’ Mary Staples at 817-442-1155.

The Department of Health Care Services (DHCS) posted a document titled “Medi-Cal Rx: Transitioning Medi-Cal Pharmacy Services from Managed Care to Fee-For-Service Frequently Asked Questions,” to the DHCS’ Medi-Cal Rx: Transition webpage. The document provides additional guidance and clarification to Medi-Cal beneficiaries, providers, plan partners, tribal health programs and other interested parties, regarding the Friday, January 1, 2021, transition of Medi-Cal’s pharmacy benefit (collectively referred to as “Medi-Cal Rx”).  

Also in California… Chain pharmacies interested in filing for the DHCS’ retroactive Medi-Cal rate recoupments and the alternative rate recoupment process must submit an application by this Friday, November 22. Applications will not be considered past that date. More information on the application process can be accessed online. For chain pharmacies not participating in the alternative payment rate process, please refer to the Pharmacy Retroactive Claim Adjustments FAQs on DHCS’ website – #5 explains the timeframe for recoupments for pharmacies, #7 explains how DHCS will handle the recoupments via different potential scenarios and #17 explains how pharmacies can estimate their outstanding balance due to DHCS.

For more information, contact NACDS’ Mary Staples at 817-442-1155.