This week, Sen. Scott Weiner (D) introduced two bills in what he calls “the prescription drug affordability package, or PDA,” aimed at reducing the cost of prescription drugs for Californians.

• SB 40: Would cap monthly insulin co-pays at $35 a month for most private health plans.
• SB 41: Would
• Require PBMs to be licensed by the Department of Insurance by January 1, 2027.
• Impose duties and reporting requirements on PBMs, with violations subject to civil penalties.
• Prohibit a contract between a PBM and a health care service plan or insurer that is executed, amended or renewed on or after January 1, 2026, from authorizing spread pricing.
• Prohibit a health care service plan contract or health insurance policy issued, amended or renewed on or after January 1, 2026, from calculating an enrollee’s or insured’s cost sharing at an amount exceeding the actual rate paid for the drug and require the contract or policy to include cost-sharing provisions.

Also in California, the Department of Health Care Services posted the following alerts, weekly notice and monthly bulletin on the Medi-Cal Rx Web Portal.  Please note the maximum allowable ingredient cost notice with rates effective January 1, 2025. Also, on January 31, 2025, the Transition Policy will be retired and reinstatement of prior authorization (PA) requirements and other claim utilization management (UM) edits for members 21 years of age and younger will apply to both new start and continuation of therapy claims.

• Maximum Allowable Ingredient Cost 30-Day Pharmacy Provider Notice
• Medical Supplies: Updates of the List of Contracted Pen Needles, Effective January 1, 2025
• Updates to the List of Contracted Enteral Nutrition Products, Effective January 1, 2025
• Diabetic Supplies: Updates to the Contracted Disposable Insulin Delivery Devices, Effective January 1, 2025
• Diabetic Supplies: Updates to the List of Contracted Diabetic Testing Supplies, Effective January 1, 2025, and March 1, 2025
• Diabetic Supplies: Updates to the List of Contracted Continuous Glucose Monitoring (CGM) Systems, Effective January 1, 2025
• Updates to the List of Contracted COVID-19 Tests, Effective January 1, 2025
• Medi-Cal Rx Monthly Bulletin for December
• Changes to the Medi-Cal Rx Contract Drugs List
• Updates to the Medi-Cal Rx Provider Manual
• 60-Day Countdown: Pediatric Integration of Members 21 Years of Age and Younger
• Mass Adjustment for TPOXX Drug Reimbursement for Impacted Claims with a Date of Service August 20, 2022, through October 1, 2024
• Mass Adjustment for Mpox Vaccine Reimbursement for Impacted Claims with a Date of Service August 17, 2022, through October 11, 2024
• Medi-Cal Rx Weekly Wrap-up for November 15-21

Also in California, pursuant to Health and Safety Code section 11161.7(b), the Board of Pharmacy distributes a list of prescribers whose authority to prescribe controlled substances has been restricted by the Medical Board of California. This information is available to prevent the dispensing of prescriptions for controlled substances issued by restricted prescribers.

Questions or comments about the prescribers listed should be directed to the Medical Board of California.

Finally in California, the Board of Pharmacy issued a reminder. Starting January 1, 2025, licenses that are eligible for renewal will be processed online. Those who are eligible include:

• Pharmacist
• Advanced Practice Pharmacist
• Pharmacy Technician
• Designated Representative – Wholesaler
• Designated Representative – Veterinary Food-Animal Drug Retailer
• Designated Representative – 3PL (Third-Party Logistics)
• Designated Representative – Reverse Distributor

The Board of Pharmacy (Board) will no longer mail out a paper renewal application for the above licensees. In its place, a postcard reminder will be sent approximately six weeks prior to the license expiration date and the licensee will renew by going to www.pharmacy.ca.gov. The postcard is only a reminder, if the licensee does not receive a postcard, they are still required to submit their payment on-time to avoid a delinquency fee and possible cancellation of the license.

Renewal payment transactions must be completed prior to 5:00 pm Pacific Time on the date the license expires to avoid the delinquency fee. The Board recommends printing the payment confirmation at the end of this transaction for recordkeeping. Once the online payment is submitted, please allow two business days for processing.

The Board must be notified of any change in address within 30 days. Change of address may take between 7-10 business days to update in the system. If the correct address is not in the system at the time of renewal, the process may be delayed. Address changes can be made on-line or in writing to the board.

Fees are changing on January 1, 2025. The updated fee schedule with the new fees has been posted on the website.

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

The Department of Health Care Services posted the following:

• November 2024 Pharmacy Medi-Cal Update Bulletin
• November 2024 Durable Medical Equipment and Medical Services Medi-Cal Update Bulletin

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

• Mass Adjustment for COVID-19 Vaccine Incentive Fee for Impacted Claims with a Date of Service October 1, 2022, through December 31, 2023
• Medi-Cal Rx Weekly Wrap-up for November 8-14
• State of Emergency Override Activation: Submission Clarification Code 13

Finally in California, the Board of Pharmacy proposed the following rules:

• Discontinuation of Business
  • Notice of Proposed Action
  • Initial Statement of Reasons
  • Proposed Text
  • 45-Day Comment Period: November 15, 2024, to December 30, 2024
• Quality Assurance Programs
  • Notice of Proposed Action
  • Initial Statement of Reasons
  • Proposed Text
  • Notice of Modified Text
  • Modified Text
  • 15-Day Comment Period: November 15, 2024, to December 2, 2024
  • Please send your company’s comments on the modified text to Sandra Guckian by November 25, 2024.
• Compounded Drug Preparations
  • Notice of Proposed Action
  • Initial Statement of Reasons
  • Repealed Text
  • Proposed Text
  • Notice of Modified Text
  • Modified Initial Statement of Reasons
  • Modified Regulation Text

• • Board Requested Format for Submitting Comments
  • 30-day Comment Period: November 8, 2024, to December 9, 2024

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

The Department of Health Care Services posted the following alerts, weekly notice, and monthly bulletin on the Medi-Cal Rx Web Portal:

• Reminder: Dual Eligible Special Needs Plan Deeming Periods
• Medi-Cal Rx Weekly Wrap-up for November 1-7
• Medi-Cal Rx Finance Portal “Download All Files” Error – Issue Resolved
• How to Resolve Reject Code 16 – M/I Prescription/Service Reference Number
• Medi-Cal Rx Weekly Wrap-up for October 25-31
• Medi-Cal Rx Monthly Bulletin for November
• Changes to Medi-Cal Rx Contract Drugs List
• Updates to Medi-Cal Rx Provider Manual
• 90-Day Countdown: Pediatric Integration of Members 21 Years of Age and Younger

Also in California, Proposition 36, The Homelessness, Drug Addiction and Theft Reduction Act, passed resulting in various changes to criminal and drug laws, including increasing penalties for some offenses, and providing treatment programs for people with drug addictions. Proposition 36 increases punishment for some theft and drug crimes in three ways: 1) turns some misdemeanors into felonies; 2) lengthens some felony sentences; and 3) requires some felonies be served in prison.

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

A licensee is required to notify the Board of Pharmacy when ceasing to act as a pharmacist-in-charge (PIC), designated representative-in-charge (DRIC) or responsible manager (RMG). Disassociation forms are available on the website and intended to assist licensees in providing the required notification to the Board. No fee is required for the notification of disassociation. Completed forms may be submitted to the Board via mail or e-mail by using the email address provided on the form.  

Also in California, pursuant to Health and Safety Code section 11161.7(b), the Board of Pharmacy is distributing this list of prescribers whose authority to prescribe controlled substances has been restricted by the Medical Board of California. The Board of Pharmacy is making this information available to prevent the dispensing of prescriptions for controlled substances issued by restricted prescribers. Names with a strikeout indicate the restriction is no longer effective. Names in bold indicate there has been an update to the action the Medical Board of California took. Questions or comments about the prescribers listed should be directed to the Medical Board of California. 

Also in California, the Department of Health Care Services posted the following weekly notice on the Medi-Cal Rx Web Portal: Medi-Cal Rx Weekly Wrap-up for October 18-24. 

Finally in California, the Board of Pharmacy posted the agenda for its Full Board Meeting on November 6-7, 2024. 

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

The Department of Health Care Services posted the following alerts, weekly notice, and monthly bulletin on the Medi-Cal Rx Web Portal:

• Activation of Reject Code 16 – Medi-Cal Rx Program Integrity Update
• Medi-Cal Rx Claim and Prior Authorization Request System Outage – Issue Resolved
• Update: Medi-Cal Rx Claim and Prior Authorization Request System Outage
• Medi-Cal Rx Claim and Prior Authorization Request Submission Outage
• Medi-Cal Rx Weekly Wrap-up for October 11-17
• Commercial JYNNEOS® Vaccine Reimbursement
• Medi-Cal Rx Weekly Wrap-up for October 4-10
• Reminder: Verification of Member Name on Medi-Cal Rx Claims
• Revolved: Medi-Cal Rx Provider Portal Prior Authorization Attachments
• Justice-Involved Reentry Initiative Now Implemented in Inyo, Santa Clara, and Yuba Counties
• Coming Soon: Commercial JYNNEOS® Vaccine Reimbursement Correction
• State of Emergency Override Activation: Submission Clarification Code 13
• Medi-Cal Rx Weekly Wrap-up for September 27-October 3
• Deactivation of Override Code “55555” for All Drugs/Products – Medi-Cal Rx Program Integrity Update
• Medi-Cal Rx Monthly Bulletin for October
• Changes to the Medi-Cal Rx Contract Drugs List
• Changes to the Medi-Cal Rx Contract Drugs List – Over-the-Counter Drugs and Cough/Cold Preparations
• Changes to the Medi-Cal Rx Contract Drugs List – Authorized Drug Manufacturer Labeler Codes
• Changes to the Medi-Cal Rx Pharmacy Reimbursable Physician Administered Drugs
• Changes to the Medi-Cal Rx Family Planning, Access, Care, and Treatment Pharmacy Formulary
• Updates to the Medi-Cal Rx Provider Manual

Also in California, effective September 17, the opioid antagonist protocol was amended. The approved regulation text with changes has been posted by the Board of Pharmacy.

Also in California, starting January 1, 2025, personal license renewal applications will no longer be mailed and licenses that are eligible for renewal will be processed online.

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

• October 2024 Pharmacy Medi-Cal Update Bulletin
• October 2024 Durable Medical Equipment and Medical Services Medi-Cal Update Bulletin

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

On September 28, Gov. Gavin Newsom (D) vetoed SB 966, PBM reform legislation that would have required licensure by the Department of Insurance among other provisions supported by NACDS.  In his veto message, the Governor said the public and the Legislature need a clearer understanding of how PBM practices are driving up prescription drug costs and explained the need for more granular information to fully understand the cost drivers in the prescription drug market and the role that PMBs play in pricing.  Gov. Newsom directed the Health and Human Services Agency to propose a legislative approach to gather much needed data on PBMs next year, which can be considered in conjunction with data from the state’s Office of Health Care Affordability (OHCA) reflective of the state’s entire health care delivery system.

Also in California, effective for dates of service on or after October 1, 2024, the Department of Health Care Services announced Medi-Cal pharmacy providers are eligible to supervise and bill for Community Health Worker (CHW) services when billed with CPT^® codes 98960, 98961 and 98962. Modifier U2 is required when Pharmacy providers bill for claims for services rendered by CHWs.

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

• Updated COVID-19 Vaccine Reimbursement Rates
• Medi-Cal Rx Provider Portal Prior Authorization Submission Update: Member Validation Enhancement
• Medi-Cal Rx Weekly Wrap-up for September 20-26

Finally in California, the Board of Pharmacy posted the agendas for the following meetings:

• Enforcement Committee – October 16 – Agenda – Note review of 2024 legislation and discussion and consideration of FDA actions related to the Drug Supply Chain Security Act (DSCSA).
• Licensing Committee – October 17 – Agenda – The following items may be of interest:
  • Presentation by the California Pharmacists Association on Assembly Bill 317 (Chapter 322, Statutes of 2023) related to Pharmacist Service Coverage
  • Discussion and Consideration of Proposed Changes to Board-Provided Training for Furnishing HIV Preexposure and Postexposure Prophylaxis
  • Discussion and Consideration of Proposed Follow-up Survey on Working Conditions

Open Discussion on Payor Practices that Negatively Impact Patient Care

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

The Department of Health Care Services posted the following alerts and weekly notice on the Medi-Cal Rx Web Portal:

• Pemgarda™ (pemivibart) Now a Medi-Cal Rx Benefit
• User Administration Console (UAC) URL Update
• Medi-Cal Rx Weekly Wrap-up for September 13-19

Also in California, NACDS submitted a letter to the Board of Pharmacy expressing concerns with proposed rules updating the Board’s quality assurance program regulatory requirements. The primary concern is that these amendments could potentially put pharmacies that are members of Patient Safety Organizations (PSOs) at odds with the requirements set forth in the Patient Safety and Quality Improvement Act of 2005 (PSQIA) and recommended the Board further analyze these amendments. Additionally, we requested a one-year delayed implementation of this regulation to allow pharmacies sufficient time to update their policies and systems to comply.

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

Insurance Commissioner Ricardo Lara issued the following statement, urging Governor Newsom’s signature on SB 966, which reflects a shared commitment to making healthcare more affordable, accessible, and transparent for all Californians:

“Senate Bill 966 is a game-changer for California consumers. For too long, Pharmacy Benefit Managers (PBMs) have operated in the shadows, impacting drug prices and patient access with little oversight. SB 966 will bring much-needed transparency and accountability to this critical part of our healthcare system. I strongly urge Governor Newsom to sign this bill, which will help ensure that consumers—not corporate intermediaries—benefit from the savings PBMs negotiate with drug manufacturers.”

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

• State of Emergency Override Activation: Submission Clarification Code 13 (September 18)
• Medi-Cal Rx Weekly Wrap-up for September 6-12
• State of Emergency Override Actions: Submission Clarification Code 13 (September 12)
• Mass Adjustment for Professional Dispensing Fee Amount Decrease for Impacted Claims with a Date of Service July 1, 2022, through October 3, 2022
• Mass Adjustment for Impacted Paxlovid Renal Dose Claims with a Date of Service April 1, 2022, through January 17, 2024
• Mass Adjustment for COVID-19 Vaccine Incentive Fee for Impacted Claims with a Date of Service April 1, 2022, through September 31, 2022
• Medi-Cal Rx Weekly Wrap-up for August 30-September 5

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

• September 2024 Pharmacy Medi-Cal Update Bulletin
• September 2024 Durable Medical Equipment and Medical Services Medi-Cal Update Bulletin

Also in California, the Board of Pharmacy (Board) announced starting January 1, 2025, licenses that are eligible for renewal will be processed only online. Those who are eligible include:

• Pharmacist
• Advanced Practice Pharmacist
• Pharmacy Technician
• Designated Representative – Wholesaler
• Designated Representative – Veterinary Food-Animal Drug Retailer
• Designated Representative – 3PL
• Designated Representative – Reverse Distributor

Note: In most cases, the license expires at the end of the month of the licensee’s registered birthday for pharmacists, advanced practice pharmacists and pharmacy technicians. For designated representatives, the license expires on the first of the month.

The Board will no longer mail out a paper renewal application for the above licensees. In its place, a postcard reminder will be sent approximately six weeks prior to the license expiration date and the licensee will renew by going to www.pharmacy.ca.gov. The postcard is only a reminder, if the licensee does not receive a postcard, they are still required to submit their payment on-time to avoid a delinquency fee and cancellation of the license.

For Pharmacists and Advanced Practice Pharmacists, if your license expired more than two years ago, you are not eligible to renew your license online. Contact the Board at RenewalStatus@dca.ca.gov for assistance.

Renewal payment transactions must be completed prior to 5:00 pm Pacific Time on the date your license expires to avoid the delinquency fee.

Online payments made after 5:00 pm Pacific Time are not credited on the day of the transaction. The Board recommends you print your payment confirmation at the end of this transaction for your records. Once the online payment is submitted, please allow two business days for processing.

Reminder, confirm address is correct. You must notify the board of any change in your address within 30 days. Change of address may take between 7-10 business days to update the system. If the correct address is not in the system at the time of renewal, the process may be delayed. Address changes can be made on-line or in writing to the board.

When renewing online, the licensee must confirm that their address is correct before submitting the payment.

Finally in California, the Board of Pharmacy stated licensees continue to report being victimized by scam callers claiming to represent the Board of Pharmacy (Board).

In a recent attempt, the caller claimed to be a Board inspector who told the pharmacist they were charged with drug trafficking and money laundering in Texas. They told the licensee they needed to go to Texas to face charges. The caller insisted the licensee stop practicing immediately.

Two other individuals who claimed to be FBI agents were also on the phone call. And the licensee received an official looking letter of their suspension. Fortunately, this licensee contacted the Board and confirmed that they were in good standing and not part of any investigation.

Techniques used by fake callers include:

• A caller uses a caller ID that says “CA State Board of Pharmacy” with the Board’s phone number, (916) 518-3100.
• The caller claims a licensee is under investigation by the Board, the California Department of Consumer Affairs (DCA), the DEA, the FBI, or another government agency. In some cases, the caller also warns of discipline unless the licensee pays a “fine.”
• A caller warns a licensee not to report the call to anyone “or else you will jeopardize the investigation.”
• A caller requests a licensee’s cell phone number.
• A caller gives a fake call-back number.

In many cases, callers are attempting to extort money or elicit sensitive information – e.g., license numbers, DEA registration numbers, etc. – from licensees.

What can you do to protect yourself and your pharmacy?

Licensee security is important to the Board of Pharmacy. Be aware of these tips from the Board and DCA:

• If you have any doubts or questions about someone claiming – by phone or in person – to represent the California State Board of Pharmacy, call the Board at (916) 518-3100.
• To check the identity of a caller who claims to be conducting a DCA investigation, call DCA directly at (800) 952-5210.
• If a scam caller claims to represent the DEA or the FBI, report the call to the DEA’s Extortion Scam reporting program or the FBI’s Internet Crime Complaint Center.
• If a scam caller’s phone number appears to be a Board of Pharmacy or DCA telephone number, report the scam using the Federal Communications Commission’s consumer complaint form.

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

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.

For more information, contact NACDS’ Jill McCormack at 717-592-8977.

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

Last week, the State Assembly passed an amended version of SB 966, PBM Reform legislation, and the State Senate concurred with the amended version. Upon passage, the bill was ordered to “engrossing and enrolling” after which it will be presented to Gov. Gavin Newsom (D) for signature. The governor has until September 30 to act. The bill requires PBMs to apply for a licensure from the California Department of Insurance by January 1, 2027; clarifies the State Attorney General retains all authorities to maintain or restore competitive, fair and honest markets and prosecute state and federal antitrust and unfair competitive violations; prohibits retroactive fees; and would allow a pharmacy that is not owned by the PBM to participate in a PBM network as a preferred provider if the pharmacy is willing to accept the same terms and conditions. NACDS sent a letter to Gov. Gavin Newsom (D) urging him to sign SB 966 to help preserve and expand patient access to pharmacists, pharmacies of all sizes and the Californians they serve.

Also in California, last week, AB 3063 passed the state legislature and was ordered to “engrossing and enrolling” after which it will be presented to Gov. Gavin Newsom (D) who has until September 30 to act. This legislation states the addition of a flavoring agent to a conventionally manufactured product is not considered compounding if certain conditions are met. It also requires the addition of the flavoring agent to be documented in the prescription record.

Also in California, the Department of Health Care Services posted the following alerts and weekly notice and monthly bulletin on the Medi-Cal Rx Web Portal. Please note the MAIC 30-day pharmacy provider notice; rates will be effective October 1, 2024, and were to be posted to the Mercer Medi-Cal Rx website no later than September 1, 2024.

• COVID-19 Vaccines and Vaccine Administration Coverage for Family PACT End-Dated
• COVID-19 Antigen Over-the-Counter Test Coverage Updates, Effective October 1, 2024
• Updates to the List of Contracted Enteral Nutrition Products, Effective October 1, 2024
• Maximum Allowable Ingredient Cost 30-Day Pharmacy Provider Notice
• Medi-Cal Rx Monthly Bulletin for September
• Changes to the Medi-Cal Rx Contract Drugs List
• Changes to the Medi-Cal Rx Contract Drugs List – Over-the-Counter Drugs and Cough/Cold Preparations
• Updates to the Medi-Cal Rx Provider Manual
• Vaccines for Children Program Policy and Billing Guidance for Pharmacy Providers
• Medi-Cal Rx Weekly Wrap-up for August 23-29

Finally in California, the Board of Pharmacy posted the agenda and meeting materials for the Full Board Meeting on September 12, 2024. Please note the discussion and action related to awarding a contract for medication error reporting.

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