California

The Department of Health Care Service posted the following alerts and monthly bulletin on the Medi-Cal Rx Web Portal. Please review the “Reminder: Medi-Cal Rx Pharmacy Claim Reimbursement” as it relates to “Now Active: NCPDP Field 426-DQ Usual and Customary Charge Requirement”.  Also note the mass adjustments for commercial COVID-19 vaccines; see alert below for details.

Also in California, the Board of Pharmacy provided this August 1 update regarding the

California Medication Error Reporting (CAMER) Pursuant to Business and Professions Code section 4113.1.

Business and Professions Code (BPC) section 4113.1 establishes requirements for a community pharmacy to report medication errors to an entity approved by the Board. The Board refers to this as the California Medication Error Reporting (CAMER) system. The statute requiring reporting to CAMER can be viewed at BPC section 4113.1.

In September 2024, the Board approved the Institute for Safe Medication Practices (ISMP), an ECRI Company, as the entity to receive and review medication error reports under BPC section 4113.1. Please note while ECRI and ISMP operate a Patient Safety Organization (PSO), event reports submitted pursuant to BPC section 4113.1 are not submitted to the ECRI and ISMP PSO.

Following the Board’s decision in June 2025 to withdraw the Quality Assurance (QA) rulemaking, questions have arisen regarding its impact on reporting to CAMER. It is important to note that QA and CAMER are two distinct requirements under pharmacy law. The withdrawal of the QA rulemaking does not affect the statutory requirement for community pharmacies to report to CAMER. For more information, please refer to the Board’s CAMER website.

As a reminder, community pharmacies may register for CAMER online. Additionally, the Board advises licensees that medication errors that occur on or after September 1 must be reported to the CAMER system consistent with legal requirements established.

Finally in California, the Board of Pharmacy posted its News Roundup – August 2025 and includes the following: Upcoming Meetings, Rite Aid Closures, California Medication Error Reporting (CAMER), Self-Assessment Forms: July 1, 2025 Deadline, Report a Drug Theft/Drug Loss Online Portal and NEW PIC Training Webinar.

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

2025-08-07T13:13:54-04:00August 7, 2025|California|

California

On June 19, the Board of Pharmacy (Board) received notification from the Office of Administrative Law (OAL) that the Board's compounding regulation changes were approved. The Notice of Approval provides that the new regulations will become effective on October 1. 

As required by law, the Board conducted a comprehensive review of its compounding regulations and identified necessary changes after United States Pharmacopoeia (USP) General Chapters became compendial. These efforts resulted in the Board voting, as part of its April 2023 Board meeting, to promulgate new regulations. Since that time, and after five formal comment periods, a regulation hearing and extensive review and discussion over the course of multiple public meetings, the Board completed the formal rulemaking process. With the recent approval by the OAL of the updated compounding regulations promulgated by the Board, the Board wishes to update its stakeholders on its policy related to licensees transitioning to the updated USP General Chapters and updated regulations. 

During this intervening period, the Board encourages licensees to continue transitioning to the new standards established in USP and to take steps to establish compliance with the Board's updated regulations.

Source: View the policy statement. Revised July 28.  

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

2025-07-31T15:04:21-04:00July 31, 2025|California|

California

Medi-Cal Rx shared the following information for pharmacy providers. The US Food and Drug Administration has asked the four companies that have teriparatide products (FOREO by Lilly and generics by Prasco, Teva, and Apotex) to change the package size on the label of the products. Changing package size will affect claims billing while labels with both package sizes are in distribution. Note, the product NDCs were not changed to account for the change in package size. However, the reimbursement rate was updated to account for the reduction in package size from 2.4 ml to 2.24 ml.  

The Department of Health Care Services would also like to request pharmacy providers update their POS systems to allow these claims to be submitted for 2.24 ml as this change took effect on March 29. Medi-Cal Rx also asks pharmacy providers to submit claims for 2.24 ml regardless of the package size displayed on the package. This will prevent overpayment. If the pharmacy POS system does not allow the claim to be submitted for 2.24 ml, please resubmit the claim and call Medi-Cal Rx Customer Service Center for assistance.  

Also in California, the Department of Health Care Service posted the following alerts on the Medi-Cal Rx Web Portal: 

Finally in California, the Board of Pharmacy issued the following: NOTICE OF DECISION NOT TO PROCEED - Pursuant to Government Code section 11347 

Re: Notice of Proposed Rulemaking concerning Quality Assurance Programs 

Pursuant to Government Code Section 11347, the California Board of Pharmacy (Board) hereby gives notice that it has decided not to proceed with the rulemaking action published in the California Regulatory Notice Register on August 9, 2024, Register 2024, No. 32-Z. The proposed rulemaking concerned Quality Assurance Programs (OAL Notice Z2024-0725-02). 

Any interested person with questions concerning this rulemaking should contact Lori Martinez at 916-244-6648 or by e-mail at: PharmacyRulemaking@dca.ca.gov. 

The Board will also post this Notice of Decision Not to Proceed on its website. 

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

2025-07-25T11:15:33-04:00July 25, 2025|California|

California

The Board of Pharmacy is sponsoring a training program, "Inspection Expectations, Diversion Trends, Loss Prevention, Legal Updates and CURES," on August 8 via WebEx. Pharmacists who participate will receive six hours of continuing education (CE) credit. 

The event is free, but space is limited and preregistration is required. The board has transitioned its registration and CE certification to PharmEd, its new learning management system. To register for the event, you will need to create an account in PharmEd if you do not already have one. To create an account please go to https://pharmed.thinkific.com/. Training attendees who do not use PharmEd will not be given CE credit. 

For information on how to register for the event, visit the Board's website at www.pharmacy.ca.gov, scroll down to "Important Information for Licensees," and click on "Free CE Training Registration".  

For questions about the event, email the Board at pharmacy.ce@dca.ca.gov. 

Also in California, the Department of Health Care Services posted the following:  

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

2025-07-25T11:05:53-04:00July 18, 2025|California|

California

Gov. Gavin Newsom (D) signed AB 116, the health omnibus trailer bill that contains the specific statutory language to implement the governor's PBM reform policies as outlined in the state's main budget bill. AB 116 requires PBMs to be licensed and regulated by the Department of Managed Health Care (DMHC), the same agency that also regulates health plans in the state. PBMs must obtain and maintain a license with DMHC on or after January 1, 2027, or the date on which DMHC has established the licensure process.  DMHC is authorized to charge an annual fee on PBMs to support the department's actual and reasonably necessary expenses to implement PBM licensure and oversight.  DMHC is also authorized to suspend or revoke a PBM license or assess administrative penalties if the director determines the licensee has committed acts or omissions constituting grounds for disciplinary action.  The Pharmacy Benefit Manager Fund will be established to receive fees, fines, penalties and reimbursements to support regulation of PBMs.  DMHC is authorized to conduct periodic routine and non-routine examinations of the fiscal and administrative affairs of any PBM. Furthermore, PBMs must inform its contracted pharmacists of the right to submit complaints to DMHC and must provide certain data to the Department of Health Care Access and Information (HCAI). A PBM also has a fiduciary duty to its payer client that includes a duty to be fair and truthful toward the payer, to act in the payer's best interests, and to perform its duties with care, skill, prudence and diligence. 

Also in California, the Department of Health Care Services (DHCS) is establishing Medi-Cal provider enrollment requirements and procedures for pharmacy providers that hold a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver. Effective August 1, 2025, pharmacy providers that hold a valid Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver and current Certificate of California Clinical Laboratory Registration may bill for CLIA-waived tests provided within the pharmacist's scope of practice as defined by the Board of Pharmacy and authorized in Business and Professions Code Section 4052.4. Pharmacy providers must apply to enroll in the Medi-Cal program by submitting a Medi-Cal provider enrollment online application, along with all supporting documentation. Providers can access Medi-Cal provider enrollment information on the DHCS Provider Enrollment Division webpage. 

Finally in California, the Department of Health Care Service posted the following alerts and monthly bulletin on the Medi-Cal Rx Web Portal.  

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

2025-07-11T09:13:44-04:00July 11, 2025|California|

California

The Department of Health Care Service posted the following alerts on the Medi-Cal Rx Web Portal. As previously announced in the alert titled 60-Day Countdown: NCPDP Field 426-DQ Usual and Customary Charge Requirement, pharmacy providers submitting claims to Medi-Cal Rx with a date of service (DOS) on or after July 18 will be required to include their Usual and Customary (U&C) charge in NCPDP Field 426-DQ (Usual and Customary Charge). Claims submitted for the DOS on or after July 18 with a blank dollar amount or a value of $0.00 will be denied by Medi-Cal Rx with Reject Code DQ – M/I Usual and Customary Charge with the supplemental message "Resubmit claim with U&C charge in field 426-DQ."  

 Also in California, the Board of Pharmacy issued the following update regarding the California Medication Error Reporting (CAMER) system. An orientation webinar is being offered by the Institute for Safe Medication Practices (ISMP) at 1:00 pm Pacific on July 9. Also, medication errors that occur on or after September 1 must be reported to the CAMER system. For your convenience, here's a link to the CA Board of Pharmacy Medication Error Reporting System website hosted by ISMP. 

Business and Professions Code (BPC) section 4113.1 establishes requirements for a community pharmacy to report medication errors to an entity approved by the Board. The statute requiring medication error reporting by community pharmacies can be viewed at BPC section 4113.1. The Board approved ISMP, an ECRI Company, as the entity to receive and review medication error reports under BPC section 4113.1.  

Consistent with its commitment to keep licensees apprised of implementation activities related to the California Medication Error Reporting (CAMER) system, the Board is providing the following updates: 

  • ISMP will be holding an orientation webinar at 1:00 p.m. Pacific Time on July 9. Registration for the orientation webinar is available online. To view, go to FAQ and then "Will there be training or orientation sessions for how to use the reporting system and submit reports?". 
  • ISMP posted additional information related to reporting data elements. To view, go to FAQ and then "Which data elements will be built into the reporting system?". 

Also in California, the Office of Administrative Law approved the Board of Pharmacy's updated compounding regulations. The regulations describe the Board's requirements for nonsterile compounding, sterile compounding, hazardous drug and radiopharmaceutical preparations. 

The regulation is effective October 1. The Board will be releasing an updated policy statement regarding its expectations during the transition period. The Order of Adoption for the approved regulation regarding the compounding regulations has been posted.  

Also in California, the Board of Pharmacy proposes taking rulemaking action related to "Medication-Assisted Treatment Protocol". The proposed text is available for review on the Board's website. Written comments must be received by the Board no later than August 4 or must be received by the Board at the hearing, if one is scheduled. Inquiries or comments may be addressed to:  

  • Lori Martinez Address: 2720 Gateway Oaks Drive, Ste. 100, Sacramento, CA 95833; Phone: (916) 518-3100; Fax.: (916) 574-8618; or e-Mail Address: PharmacyRulemaking@dca.ca.gov   
  • The backup contact person is: Debbie Damoth Address: 2720 Gateway Oaks Drive, Ste. 100, Sacramento, CA 95833; Phone: (916) 518-3100; Fax.: (916) 574-8618; or e-Mail Address: PharmacyRulemaking@dca.ca.gov  

Finally in California, the Department of Health Care Services (DHCS) has been formally approved by the Centers for Medicare and Medicaid Services (CMS) to participate in the federal Cell and Gene Therapy (CGT) Access Model, with implementation effective July 1. This model is designed to improve access to high-cost, high-impact gene therapies for Medi-Cal members with complex conditions, starting with sickle cell disease (SCD). The initial therapies included in this model are Casgevy and Lyfgenia.  

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

2025-06-26T14:36:52-04:00June 26, 2025|California|

California

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

2025-06-12T12:28:25-04:00June 12, 2025|California|

California

This week, the Board of Pharmacy issued the following communication: As you may be aware, Rite Aid filed for bankruptcy in October 2023, resulting in the closure of several locations nationwide. On May 5, Rite Aid filed for bankruptcy again and is in the process of selling assets, including prescriptions, to other pharmacies. 

The Board is closely monitoring the Rite Aid bankruptcy proceedings and anticipated pharmacy closures in California.  The Board strongly encourages pharmacies to consider if they may be impacted by Rite Aid closures in their respective areas and, if so, to begin taking steps to assist patients who may be seeking pharmacy services.  

The Board also reminds licensees that Business and Professions Code section 4064 establishes provisions for emergency refill of prescriptions without prescriber authorization under specified conditions.  It may be helpful to recommend patients bring in their prescription containers when seeking an emergency refill.  

As more information is received, updates will be shared on the Board's website https://www.pharmacy.ca.gov/. 

Also in California, the Board of Pharmacy posted to its website a Fact Sheet about the California Medication Error Reporting (CAMER) Pursuant to Business and Professions Code section 4113.1 including high level data reporting elements. Please note: the Board advises licensees that medication errors that occur on or after September 1, 2025, must be reported to the CAMER system. To view, visit www.pharmacy.ca.gov, scroll down to "What's New" and click on the link "California Medication Error Reporting (CAMER) Pursuant to Business and Professions Code section 4113.1". 

Also in California, the Department of Health Care Service posted the following alerts on the Medi-Cal Rx Web Portal: 

Also in California, the Department of Health Care Services posted the following: 

Finally in California, Gov. Gavin Newsom (D) released the revised 2025-26 State Budget, known as the May Revision. The May Revision proposes multiple programmatic changes to the pharmacy benefit by implementing a pharmacy rebate aggregator to secure rebates for the undocumented immigrant population; eliminating over-the-counter (OTC) coverage of certain drug classes, including COVID-19 antigen tests, OTC vitamins, and certain antihistamines including dry eye products; eliminating glucagon-like peptide-1 coverage (GLP-1) for weight loss effective January 1, 2026; and implementing utilization management and prior authorization for prescription drugs in Medi-Cal. It also proposes statutory changes to establish licensure and data reporting requirements for PBMs with the aim to increase transparency, understand cost drivers, and develop approaches to improve prescription drug affordability; details will be available in the Department of Managed Health Care's trailer bill language. Also, Gov. Newsom announced changes in coverage for undocumented immigrants beginning in 2026, just a year after expanding Medi-Cal access to undocumented immigrants of all ages.  

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

2025-05-22T16:51:00-04:00May 22, 2025|California|
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