The Board of Pharmacy issued a reminder that the following Pharmacy Law Waivers will expire on October 31:

• Duty to Consult (Title 16, California Code of Regulations, section 1707.2(a))
• Prelicensure Inspection at Proposed Location of an Automated Drug Delivery System (ADDS) – Business and Professions Code sections 4119.11(a)(9) and BPC 4427.2(e)

To request a site-specific waiver, use the guidelines posted at How to Request a Pharmacy Law Waiver under “COVID-19 Updates and Resources” on the Board’s website.

Also in California, last week, NACDS and the California Retailers Association sent a joint letter to Gov. Gavin Newsom (D) requesting that California authorize pharmacy technicians to administer flu vaccines to adults in accordance the eighth amendment to the federal declaration under the Public Readiness and Emergency Act (PREP Act). We also shared the letter with the Department of Consumer Affairs and the Board of Pharmacy.

Also in California, the Board of Pharmacy published a Notice of Proposed Action to amend sections 1793.5 and 1793.6 and to add 1793.65 to Title 16 of the California Code of Regulations related to Pharmacy Technicians. Written comments on the proposed text are due December 6.

Also in California, this week, Magellan released this webinar Q&A as an additional resource for pharmacy providers. Other resources from the Medi-Cal Rx webinar held on October 13 include both the presentation and the audio recording are available. To access the recording, use this link and click on “↓ Download (3 files)” in the upper right corner of the webpage. If your company would like to schedule its own training, please contact NACDS’ Sandra Guckian at 703-774-4801 or sguckian@nacds.org, and we will connect you directly to Magellan and the Department of Health Care Services to schedule the training.

Finally in California, the Department of Health Care Services issued a 60-day beneficiary letter to inform Medi-Cal members about Medi-Cal Rx, the transition of pharmacy services from Managed Medicaid to Fee-for-Service effective January 1, 2022.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

The Board of Pharmacy posted the following:

• October 27 Communication and Public Education Committee meeting agenda and meeting materials and
• October 27-28 Full Board Meeting agenda and meeting materials.

Also in California, the Board of Pharmacy maintains an index of precedential decisions and makes it available annually to the public by email subscription.  Go to www.pharmacy.ca.gov to join the Board’s email list.

Also in California, NACDS and the California Retailers Association worked with Magellan and the Department of Health Care Services (DHCS) to conduct an informational webinar on October 13 for chain pharmacies to learn about the important elements related to implementation of Medi-Cal Rx (start date of January 1, 2022). Both the presentation and the audio recording are available.  To access the recording, use this link and click on “↓ Download (3 files)” in the upper right corner of the webpage. If your company would like to schedule its own training, please contact NACDS’ Sandra Guckian at 703-774-4801 or sguckian@nacds.org, and we will connect you directly to Magellan and DHCS to schedule the training.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

Gov. Gavin Newsom (D) signed the following bills:

• AB 1064 (Chapter 655), authorizing a pharmacist to independently initiate and administer any vaccine that has been approved or authorized by the FDA and received an ACIP individual vaccine recommendation published by the CDC for persons 3 years of age and older and
• AB 1533 (Chapter 629), extending the operation of the Board of Pharmacy until January 1, 2026. It also requires the Board to convene a workgroup to discuss whether moving to a standard of care enforcement model would be feasible and make recommendations to the Legislature about the outcome of these discussions through a report submitted to the Legislature; authorizes a pharmacist to initiate, adjust, or discontinue drug therapy for a patient under a collaborative practice agreement with any health care provider with prescriptive authority and authorizes a pharmacist to provide MAT pursuant to a state protocol; and authorizes an advanced practice pharmacist to initiate, adjust, or discontinue drug therapy without specifying the manner of such actions. Finally, it allows the Board to fine chain community pharmacy companies up to $100,000 for three or more repeated violations within five years, or a maximum of $150,000 for violations demonstrated to be the result of a written policy or which was expressly encouraged by the common owner or manager. In California, a chain community pharmacy is defined as a chain of 75 or more stores under the same ownership.

Also in California, the Board of Pharmacy has posted the following agendas and meeting materials for committee meetings on October 20:

• Enforcement and Compounding Committee Meeting Agenda and Meeting Materials
• Licensing Committee Meeting Agenda and Meeting Materials

Also in California, NACDS and the California Retailers Association worked with Magellan and the Department of Health Care Services (DHCS) to conduct an informational webinar on October 13 for chain pharmacies to learn about the important elements related to implementation of Medi-Cal Rx (start date of January 1, 2022). The presentation is currently available and an audio recording will be available soon. If your company would like to schedule its own training, please contact NACDS’ Sandra Guckian at 703-774-4801 or sguckian@nacds.org, and we will connect you directly to Magellan and DHCS to schedule the training.

Also in California, the Department of Health Care Services (DHCS) is working toward full Assumption of Operations (AOO) of all pharmacy services on January 1, 2022, to Medi-Cal Rx.  DHCS will transfer previously established Electronic Fund Transfer (EFT) account information from the existing Medi-Cal fee-for-service Fiscal Intermediary to Medi-Cal Rx.  If a pharmacy does not wish to have their EFT account information transferred to Medi-Cal Rx, there is an “opt out” option available until close of business on November 8, 2021. Pharmacy Providers may also provide new or modified EFT account information.  Details are available in the “Medi-Cal Rx Pharmacy Providers Electronic Fund Transfer Set Up and Opt Out provider bulletin.

Finally in California, the Board of Pharmacy amended and reissued several waivers related to staffing ratio and supervision associated with immunization-related activities. These will expire March 31, 2022, or until 30 days after the emergency declaration is lifted, whichever is sooner.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

Gov. Gavin Newsom (D) signed SB 409, the Board of Pharmacy’s legislation that would permit pharmacists to perform a list of CLIA-waived tests, including SARS-CoV-2or other respiratory illness, condition or disease and strep throat, plus any additional tests approved by the Board of Pharmacy, in conjunction with the Medical Board of California and Laboratory Field Services.

Also in California, the Department of Health Care Services (DHCS) has created a flyer to assist pharmacy providers to prepare for the Medi-Cal Rx implementation date of January 1, 2022. Note the inclusion of readiness survey; the results will be used to tailor training sessions to prepare providers for the transition to Medi-Cal Rx.

Also in California, NACDS and the California Retailers Association worked with Magellan and the Department of Health Care Services (DHCS) to schedule a webinar for chain pharmacies to hear first-hand from these entities about the important elements related to implementation of Medi-Cal Rx (start date of January 1, 2022). The webinar will be held on Wednesday, October 13 at 5:00 p.m. EDT, 4:00 p.m. CDT, 3:00 p.m. MDT and 2:00 p.m. PDT; T; for information to access the webinar, click here.  During the webinar, Magellan and DHCS will share information about portal registration, interacting with the new system and other key items. Please be prepared to ask questions. If your company would like to schedule its own training after October 13, please contact NACDS’ Sandra Guckian at 703-774-4801 or sguckian@nacds.org, and we will connect you directly to Magellan and DHCS to schedule the training.

Finally in California, Ashkan Soltani will lead the California Privacy Protection Agency (CPPA) as its Executive Director. He helped to shape the California Consumer Privacy Act and the California Privacy Rights Act of 2020.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

Last week, Gov. Gavin Newsom (D) released California’s COVID-19 Vaccine Action Plan outlining the following priorities given the potential of both the approval of boosters and the eligibility of children under the age of 12 years.

1. Vaccinate those that are unvaccinated or not fully vaccinated while closing the equity gaps;
2. Ensure enough capacity to administer booster shots; and
3. Vaccinate children under age 12 [years] as they become eligible.

Also in California, due to the Fawn Fire, Gov. Gavin Newsom (D) declared a state of emergency on September 27 in Shasta County.  The Board of Pharmacy issued an alert reminding pharmacies and pharmacists of provisions in Business and Professions Code section 4062(b) and section 4064 to help provide prescriptions for displaced residents. The Board’s formal policy for filling prescriptions during an emergency is available in its Board Policy Statement: Disaster Response.

Also in California, Gov. Gavin Newsom (D) signed Executive Order N-16-21 extending the telehealth services expansion.  This Executive Order also extends the previous order’s provisions related to relaxing certain state and security laws for medical providers.

Also in California, Gov. Gavin Newsom(D) signed several bills related to workers and working conditions, including SB 362, legislation sponsored by the United Food and Commercial Workers and the California Pharmacists Association, that prohibits chain community pharmacies (75 or more stores under one ownership in California) from establishing pharmacy quotas as defined in the bill with certain exceptions.

Also in California, the Department of Public Health recently released the COVID-19 vaccine State Public Health Officer Order with an effective date of November 30.  Please note the August 5, 2021, State Public Health Officer Order still applies, and facilities must be in full compliance with this order by September 30.

Also in California, the Board of Pharmacy is currently accepting written comments on the following proposed regulations.

• Title 16, CCR Section 1704 related to providing addresses, specifically electronic mail address.
  • Notice of Proposed Regulatory Action
  • Proposed text
  • Comment deadline: October 18
• Title 16, CCR Section 1784 related to self-assessment of a wholesaler/third-party logistics provider by the designated representative-in-charge or responsible manager
  • Notice of Proposed Regulatory Action
  • Proposed Text
  • Self-assessment form
  • Comment deadline: November 1
• Title 16, CCR 1715. 65 related to Inventory Activities and Inventory Reconciliation Reports of Controlled Substances
  • Notice of Proposed Regulatory Action
  • Proposed Text
  • Comment deadline: November 1

Finally in California, the Board of Pharmacy distributed the September 2021 issue of its newsletter, “The Script”.  Highlights include the FAQs related to the e-prescribing requirement effective January 1, 2022, and the new regulations for automated drug delivery systems.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

NACDS and the California Retailers Association (CRA) submitted the following letters to Gov. Gavin Newsom (D):

• a joint letter urging the governor to sign into law AB 1064, legislation authorizing a pharmacist to independently initiate and administer any vaccine that has been approved or authorized by the FDA and received an ACIP individual vaccine recommendation published by the CDC for persons 3 years of age and older,
• a joint letter urging the governor to sign into law SB 409, the Board of Pharmacy’s legislation permanently authorizing pharmacists to perform CLIA-waived testing services, including COVID-19 and flu tests and
• a joint letter expressing significant concerns with specific provisions AB 1533, the Board of Pharmacy sunset legislation.  These provisions would allow the Board of Pharmacy to levy penalties of up to $150,000 on chain community pharmacies that would be excessive and disproportionate to the violations in question, which may jeopardize access to critical healthcare services.

Also in California, NACDS submitted a joint letter with the California Retailers Association to the Board of Pharmacy on an issue pertaining to the state’s electronic prescribing mandate that will go into effect in 2022.  Specifically, chain pharmacy encouraged the Board to clarify compliance requirements for the transfer of unfilled electronic controlled substances between pharmacies considering the federal DEA requirements and existing NCPDP standards for Electronic Prescribing of Controlled Substances that constrain what pharmacies can currently do.

Also in California, SB 362, legislation sponsored by the United Food and Commercial Workers and the California Pharmacists Association, that prohibits chain community pharmacies (75 or more stores under one ownership in California) from establishing pharmacy quotas as defined in the bill with certain exceptions, passed both chambers and was sent to the governor for signature.  Capitol Advocacy, on behalf of NACDS and CRA, advocated for amendments refining the definition of “quota” and creating exceptions related to measurement and evaluation of performance, competence or quality of care provided to patients by a pharmacist or pharmacy technician.

Finally in California, Both the agenda and meeting materials for the Board of Pharmacy meeting on September 23 are posted.  Note: Agenda Item VI. Strategic Planning Session will include the results of the 2021 Environmental Scan conducted earlier this year.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

In an emergency meeting, the Board of Pharmacy voted to re-instate the remote processing waiver until December 31 or 30 days after the emergency declaration is lifted, whichever is later. NACDS and the California Retailers Association submitted a joint letter requesting the board to take this action in accordance with Gov. Gavin Newsom’s (D) Executive Order N-39-20 to reissue the remote processing waiver that expired on June 30, 2021.

Also in California, due to Cache Fire, Gov. Gavin Newsom (D) declared a state of emergency on September 7, 2021, in Lake County.  The Board of Pharmacy issued an alert reminding pharmacies and pharmacists of provisions in Business and Professions Code section 4062 and section 4064 to help provide prescriptions for displaced residents.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

The Department of Health Care Services issued an All Plan providing guidance to Medi-Cal managed care health plans related to the Medi-Cal COVID-19 Vaccination Incentive Program.  Effective September 1, participating Medi-Cal managed care health plans may be eligible to participate in the Medi-Cal COVID-19 Vaccination Incentive Program. 

In California, the Board of Pharmacy published an updated list of prescribers (effective August 27) whose authority to prescribe controlled substances has been restricted by the Medical Board of California. This information is intended to prevent dispensing of controlled substances prescribed by restricted prescribers. 

Also in California, the Department of Consumer Affairs issued several waiver extensions including the following. A list of current waivers is available on the DCA website. 

• Order Waiving License Reactivation or Restoration Requirements  
• Order Waiving Restrictions on Telemedicine and Extending Time to Refill Prescriptions  

Also in California, NACDS and the California Retailers Association sent a joint letter to the Department of Consumer Affairs (DCA), Board of Pharmacy and Governor’s Office requesting a pharmacy law waiver to allow pharmacy technicians to administer flu vaccines to adults.  We await a response from DCA.   

Lastly in California, the Department of Health Care Services (DHCS) published its Medi-Cal Rx Monthly Bulletin (September 1).  This month’s issue includes changes to the Contract Drugs List, effective September 1, and Medi-Cal Rx Provider Training Information. As a reminder, full Medi-Cal Rx implementation is scheduled to go-live January 1, 2022 moving the prescription drug benefit from Medi-Cal managed care to Medi-Cal fee-for-service. Please review opportunities for training. 

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

Due to fires, Gov. Gavin Newsom (D) declared states of emergency on July 16 in Siskiyou, Lassen and Plumas counties and on July 23 in Plumas, Butte, Lassen and Alpine counties. The Board of Pharmacy issued alerts reminding pharmacies and pharmacists of provisions in Business and Professions Code section 4062 and section 4064 to help provide prescriptions for displaced residents.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.