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.

The agenda for the November 5 & 6, 2019 Board of Pharmacy meeting in Sacramento has been posted on-line – https://pharmacy.ca.gov/meetings/agendas/2019/19_nov_bd.pdf 

Also in California… State Senator Jeff Stone, PharmD, announced his resignation from the California State Senate this week where has served since being elected in 2014. As the only pharmacist in the legislature, he served as Vice-Chair of Senate Health Committee and Senate Human Services Committee. 

Also in California… for a limited time period, the Department of Health Care Services (DHCS) Pharmacy Benefits Division will have an online application for the Alternative Payment Option for Pharmacy Retroactive Payment Adjustments. An online form for alternative payment arrangement applications will be open from October 28 through November 22, 2019. The online form will close on November 22, 2019. Applications will not be accepted after that time. Chain pharmacies must complete individual forms specific to each National Provider Identifier (NPI) for which they are seeking this arrangement. Providers may refer to the Pharmacy Reimbursement Project web page of the DHCS website for additional information regarding this project. 

Also in California… during the current state of emergency declared by Gov. Gavin Newsom (D) earlier this week, treatment authorization requests (TARs) for medications (new, refill or replacement) will be automatically approved if the TAR indicates that the beneficiary is impacted by fire or by power shutoffs. The situation of being impacted by fire/power shutoff alone will meet the criteria of medical necessity and the TAR will be approved.

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

The Department of Health Care Services (DHCS) Pharmacy Benefits Division announced that for a limited time period – October 28 through November 22, 2019, DHCS will have an online application for the Alternative Payment Option for Pharmacy Retroactive Payment Adjustments. 

1. Provider mailers were sent out on October 17th to the Pharmacy Providers mailing address. 
2. The October Medi-Cal Pharmacy Bulletin introduced the option and timeframes to the providers – http://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/ph201910.asp#a1 
3. The Retroactive Claim Adjustment Frequently Asked Questions have also been updated to reflect the new option.  http://files.medi-cal.ca.gov/pubsdoco/ncpdp/Pharmacy_Retroactive_Claim_Adjustments_faq.asp 

Also in California… Assembly Speaker Anthony Rendon (D) appointed Anthony Wright to Gov. Gavin Newsom’s (D) 18-member single-payer health care commission called the “Healthy Californians for All Commission” that is tasked with making health care more affordable, transparent and assessible.  

Additionally in California… Jon R. Roth, MS, CAE, CEO of the California Pharmacists Association (CPhA), announced his resignation, effective, January 10, 2020.  Mr. Roth is moving to the Dallas County Medical Society as its Executive Vice President & CEO.

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