On June 11, 2021, Gov. Gavin Newsom (D) signed Executive Order (EO) N-08-21, rolling back the provisions of numerous Executive Orders previously issued in response to the COVID-19 Public Health Emergency. Among these is the provision in paragraph 4 of EO N-55-20 that included the pharmacy waived delivery restriction that will expire June 30, 2021. Effective July 1, 2021, beneficiaries and clients, or their representatives, will need to sign for medications in person from their home or sign onsite at their provider location for all Department of Health Care Services programs. 

Also in California, as a reminder, the Remote Processing (BPC section 4071.1(a)) limited waiver will expire on June 30, 2021.  Note: although the waiver is expiring, persons or entities may request a site-specific waiver from the Board. 

Also in California, on June 11, 2021, the Department of Health issued the State Public Health Officer Order of June 11, 2021, mandating various requirements as of June 15, 2021. The order replaces the previous pandemic public health orders with limited requirements related to face coverings, mega events and child and youth environments. 

Also in California, NACDS and the California Retailers Association submitted a letter to the Senate Business, Professions & Economic Development Committee expressing opposition to AB 1533, the Board of Pharmacy sunset bill, unless it is amended to modify and clarify the provisions allowing the Board of Pharmacy to levy penalties of up to $1 million on chain pharmacies that would be excessive and disproportionate to the violations in question.  

Also in California, the Office of Administrative Law has approved a proposal to add section 1747 to Title 16 of the Code of Regulations, regarding independent authority to furnish HIV Preexposure and Postexposure Prophylaxis and the order of adoption has been posted. The new regulation was effective June 8, 2021. 

Also in California, the Office of Administrative Law has approved a proposal to add section 1717.5 in Article 2 of Division 17 of Title 16 of the Code of Regulations, regarding Automatic Refill Programs and the order of adoption has been posted. The new regulation is effective July 1, 2022. 

Lastly in California, the California Privacy Protection Agency Board, created by Proposition 24, held its first board meeting on June 14, 2021. The meeting focused on how to staff the agency as they organize it to get up and running. All board members agreed that a monthly meeting was necessary; however, no specific meeting date was provided.

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

NACDS and the California Retailers Association submitted a joint letter to the Senate Budget Committee and the Senate Budget & Fiscal Review Committee in support of Gov. Gavin Newsom’s (D) May Revise budget proposal to provide medication therapy management payments to the Department of Health Care Services’ contracted pharmacies dispensing specialty drugs and services to Medi-Cal beneficiaries and urged its passage.

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

The State Board of Pharmacy published its agenda for the June 17, 2021, teleconference public board meeting that includes discussion and consideration of adoption of board approved regulation, Section 1717.5 related to automatic refill program, and discussion and consideration of public comments received during the 15-day comment period on the proposed new modifications to the regulation.

Also in California, the Department of Managed Health Care released an All Plan Letter 21-016 to provide information and guidance on when health care service plans must cover COVID-19 diagnostic testing. The letter specifies that health plans must continue to cover testing as required by federal law and guidance that is still in effect and to refer to COVID-19 testing guidance issued by the California Department of Public Health.

Lastly in California, the Board of Pharmacy issued a notice amending regulations under 16 CCR 1715.6 to revise drug loss reporting requirements to establish a minimum reporting threshold and align with federal standards. Hearing requests are due July 5, 2021, and comments are due July 19, 2021

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

The Medi-Cal Rx Monthly Bulletin dated June 1, 2021, includes a summary of previously shared updates and serves as a reminder of upcoming changes, deadlines, and opportunities as outlined below:

• Changes to the Contract Drugs List, Effective June 1, 2021
• Medi-Cal Rx Training Information
• UAC Registration Troubleshooting
• Medi-Cal Rx UAC Application Roles
• Provider Registration and FAQs
• Medi-Cal Rx Transition and Resources Training

Also in California, the Department of Health Care Services (DHCS) delayed the planned Go-Live date for Medi-Cal Rx.  On May 28, 2021, DHCS posted an update for providers and will continue to communicate additional information as it becomes available.

Also in California, the Medi-Cal Update Bulletin 992 – May 2021 includes updates to the List of Enteral Nutrition Products, effective for dates of service on or after July 1, 2021, and various provider manual updates. See bulletin for additional information.

Also in California, on May 27, 2021, the DUR Board Meeting Minutes for February 23, 2021, were posted to the DUR: Board Meetings page of the Medi-Cal website.

Also in California, as the June 30 end of the fiscal year approaches, the Board of Pharmacy expects a delay in processing payments for license renewals submitted by mail during the last week of June and the first week of July and provided guidance to licensees.

Lastly in California, the Office of Administrative Law approved regulations regarding automated drug delivery systems and off-site storage of records that take effect July 1, 2021.

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

AB 1430, legislation requiring pharmacies to dispense Schedule II prescription drugs in lockable vials, was held on the Assembly Appropriations Suspense File and will not advance.

Also in California, the following bills failed the policy/legislative deadline and have become two-year bills.  They may not be acted upon until January 2022.

• AB 458, legislation creating the Affordable Prescription Drug Importation Program in the California Health and Human Services Agency (CHHSA), under which the state would be a licensed wholesaler that imports prescription drugs for the exclusive purpose of dispensing those drugs to program participants upon federal approval for the importation program.
• AB 933, legislation requiring an enrollee’s or insured’s defined cost-sharing for each prescription drug to be calculated at the point-of-sale based on a price that is reduced by an amount equal to 90% of all rebates received, or to be received, in connection with the dispensing or administration of the drug. It would also prohibit a health care service plan, health insurer, or a plan’s or insurer’s agents from publishing or otherwise revealing information regarding the actual amount of rebates the health care service plan or health insurer receives on a product-specific, manufacturer-specific, or pharmacy-specific basis.

Also in California, the Office of Administrative Law has approved the following proposals.  The amended and new regulations are effective July 1, 2021.

• To amend sections 1711 and 1713, and add section 1715.1, in Article 2 of Division 17 of Title 16 of the California Code of Regulations, regarding Automated Drug Delivery Systems.
• To amend section 1707 in Article 2 of Division 17 of Title 16 of the California Code of Regulations, regarding Waiver Requirements for Off-site Storage of Records.

Lastly in California, the Department of Health Care Services posted the User Administration Console (UAC) Registration Troubleshooting bulletin on the Medi-Cal Rx web portal.  Additionally, DHSC issued the Medi-Cal Rx User Administration Console (UAC) Application Role bulletin to prepare pharmacies and prescribers for the upcoming Medi-Cal Rx transition by providing information on the currently available applications and their functionalities within the Medi-Cal Rx Secured Provider Portal.

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

NACDS and the California Retailers Association submitted a joint letter to the Assembly Appropriations Committee in opposition to AB 1341, which will prohibit the sale of over-the-counter dietary supplements to individuals under 18 years of age without a prescription and will also require retailers and pharmacies to store these products behind the counter.  We expressed concern this will create substantial workflow issues and take time away from patient care.  Additionally, this action will restrict access to these safe FDA-regulated products forcing many consumers to turn to less-regulated, misbranded, and dangerous supplements sold online.

Also in California, on May 14, Gov. Gavin Newsom (D) released the 2021-22 Governor’s May Revision related to the state’s budget process.  Included in the Health and Human Services section of the May Revision is funding to implement an MTM program for specialty pharmacy services in the Medi-Cal program, effective July 1, 2021.  Additionally, the May Revision is absent of a clear plan of implementation for the transition of the Medi-Cal Rx prescription drug benefit from managed care to fee-for-service.  The Department of Health Care Services continues to work with the contracted vendor to finalize the conflict avoidance plan.   In light of this uncertainty, the May Revision assumes that the transition will take place on January 1, 2022, for budgeting purposes only.  The state’s contracted vendor will continue meeting with pharmacy providers to working towards future implementation of the transition.

Also in California, the Assembly Budget Subcommittee on Health & Human Services has voted to approve the Governor’s proposal to cover continuous glucose monitors for adult Medi-Cal beneficiaries. The proposal is awaiting action in the Senate. If approved by both chambers, the proposal would be included in the state budget for approval by the Governor.

Also in California, the State Board of Pharmacy published its agenda for the May 27, 2021, teleconference public board meeting.

Also in California, the Board announced the following related to pharmacy law waivers issued during the coronavirus pandemic.

• Pharmacy Law Waivers – Notice of Extension
  • Pharmacists Initiating and Administering Vaccines (related to reporting requirements)- Expiration: August 27, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner
  • Remote Processing – Expiration: June 30, 2021
• Pharmacy Law Waivers – Set to Expire – Effective through May 31, 2021
  • Use of PPE in Certain Compounding Aseptic Isolators
  • USP 797 Requirements Related to Use of PPE

Also in California, the Department of Health Care Services posted a step-by-step user guide for the Coronavirus (COVID-19) Uninsured Group Web Application Web Portal on the Medi-Cal Providers website.  The Families First Coronavirus Response Act, Section 6004, authorized State Medicaid programs to provide access to COVID-19 diagnostic testing and testing-related services at no cost to the individual.

Also in California. The Medi-Cal Update – Part 1 – Program Eligibility Bulletin – May 2021 highlights information related to ICD-10 codes for individuals in aid code V2 (COVID-19 Uninsured Group) and updates to the ineligible provider list among other program elements and updates.  Also, the Medi-Cal Update – Durable Medical Equipment and Medical Supplies – May 2021 – Bulletin 548 includes information about the new NDC for Moderna COVID-19 vaccine, updates to the List of Enteral Nutrition Products and various coding changes and provider manual updates.

Lastly in California, Attorney General Rob Bonta issued an alert advising the public that they should not be charged for their COVID-19 vaccination and warning vaccination providers not to ask individuals to pay to receive their vaccine.

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

Medi-Cal has announced that it will accept pharmacy claims for dates of service on or after April 1, 2021, that use Moderna’s new National Drug Code (NDC) when billing for the administration of either dose of the Moderna COVID-19 vaccine.  Details have been posted to the Medi-Cal News area of each provider community page on the Medi-Cal Provider website

Also in California, the Department of Health Care Services issued an All Plan Letter 20-022 (Revised) to all Medi-Cal Managed Care Health Plans regarding COVID-19 vaccine administration.   In the letter, DHCS indicates, that in addition to arranging appointments for vaccines for homebound members via My Turn, Managed Care Health Plans may also continue to schedule vaccines for homebound members that work best for this population of patients.

Also in California, Medi-Cal announced a temporary increase in COVID-19 durable medical equipment (DME) oxygen and respiratory rates.  Effective for dates of service on or after March 1, 2020, and updated effective January 1, 2021, DME oxygen and respiratory rates are temporarily increased due to the ongoing COVID-19 Public Health Emergency.

Also in California, the Global Medi-Cal DUR Board will meet via webinar on May 18, 2021.  The following information has been posted to the DUR Board Meetings page of the Medi-Cal website including the Agenda, Meeting Packet, and Registration.

Also in California, the State Board of Pharmacy elected new officers for terms beginning June 1, 2021, They include the following:  Dr. Seung Oh, President; Dr. Maria Serpa, Vice President; Jignesh “Jig” Patel, Treasurer.

Lastly in California, the State Board of Pharmacy added a teleconference Board Meeting date scheduled for May 27, 2021. The agenda will be posted on the Board’s website 10 days before the meeting.

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

The COVID-19 Vaccine Administration Frequently Asked Questions (FAQs) page previously found on the Medi-Cal Provider website has been divided into separate FAQs for providers and beneficiaries. These documents are available on the COVID-19 Medi-Cal Response webpage under the FAQs section.  As a reminder, the Coronavirus (COVID-19) Uninsured Group FAQs are also available along with the providers and beneficiaries FAQs.

Also in California, the Department of Health Care Services launched its series of ongoing releases of enhancements, updates, and changes to improve and enhance its website navigation and user experience. A complete list of the enhancements, updates, and additional website changes can be viewed within the Medi-Cal Provider Website Release Change Log. Providers are also encouraged to subscribe to the free Medi-Cal Subscription Service (MCSS). The MCSS allows each subscriber to choose and tailor both the subject matters and types of communications they wish to receive from the Medi-Cal Program.

Lastly in California, the Board of Pharmacy recently distributed the following to licensees and stakeholders:

• Updated draft versions of self-assessment forms for pharmacies and wholesalers are now posted in addition to currently adopted versions on the Board of Pharmacy website. The Board is in the process of approving the draft versions through formal rulemaking. Board regulations require pharmacies and wholesalers to complete adopted versions of self-assessment forms. However, completion of either adopted or draft versions is acceptable. The Board believes updated draft versions provide a more helpful assessment of pharmacies and wholesalers. The drafts include references to statutory and regulatory changes that occurred between 2012 and the revision date of each draft form. Self-assessments must be performed before July 1 of every odd-numbered year. Completed self-assessment forms must remain at the facility unless the Board requests submission of the form. To find the forms, go to pharmacy.ca.gov. Under the “Licensees” tab, click on Facility License Information/Renewal and scroll down to the link for Self-Assessment Forms.
• The California State Board of Pharmacy extends its gratitude to all its licensees working to address the COVID-19 pandemic, including the most recent vaccination efforts underway in many pharmacies. As vaccine supplies continue to increase and vaccine eligibility expands, the Board would like to encourage pharmacies to plan appropriately when electing to provide COVID-19 vaccination services.  Such planning should include:

• • Ensuring sufficient staffing to maintain other pharmacy services while balancing vaccination services.
  • Ensuring sufficient space to provide vaccinations safely, and sufficient space and chairs for patients to remain seated during the recommended period of observation.
  • Ensuring appropriate staff is observing patients following administration of the vaccine.

• Ensuring vaccination appointments can safely be accommodated with the staffing resources available.

• In light of Governor Gavin Newsom’s declaration of emergency and the national declaration of emergency, and consistent with Business and Professions Code (BPC) section 4062, the California State Board of Pharmacy (Board) or the Board president through delegated authority has issued the following waivers.
  • Mass Vaccination Sites
    • Amended and Reissued:  April 21, 2021
    • Expiration: July 18, 2021

• • Supervision of Pharmacy Interns
    • Effective:  April 22, 2021
    • Expiration:  July 20, 2021

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