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.

On April 20, the Department of Consumer Affairs issued an order waiving the staffing ratio of pharmacist to pharmacy technicians related to the administration of COVID-19 vaccinations.  The following language is included in the order: Accordingly, for pharmacists engaged exclusively in initiating and administering COVID-19 vaccines, and pharmacy technicians engaged exclusively in administering COVID-19 vaccines under the direct supervision and control of such pharmacists, the Director waives Business and Professions Code section 4115, subdivision (f)(1) to the extent it limits pharmacies with only one pharmacist to having no more than one pharmacy technician working, subject to the condition that such pharmacies may have no more than two pharmacy technicians working.

Also in California, the Medi-Cal Update Bulletin 989 – April 2019 includes the following items of interest.

• REMINDER: On April 1, the online attestation period 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. The attestation period for the 2020 calendar year is open until 11:59 pm April 30, 2021, and no attestations will be accepted after that time.
• Effective for dates of service on or after March 1, 2021,pen needles quantity limits without authorization have been updated to allow 100 pen needles per claim with no more than three (3) claims in 90 days. Pen needles are billed on a pharmacy claim using the contracted product’s National Drug Code (NDC).

Also in California, the Medi-Cal Update – Part 1 – Program and Eligibility Bulletin – April 2021 highlights information related to drug code limitations and Medi-Cal suspended and ineligible provider list among other program elements and eligibility requirements and updates.

Also in California, Medi-Cal announced a System Update beginning at midnight on April 25, 2021, continuing through 6:00 a.m.  Point of Service (POS) network Leased line Eligibility and Share of Cost (SOC) transactions may not be available during this time.

Lastly in California, additional agendas have been posted for the following Board of Pharmacy teleconferenced meetings:

• Legislation and Regulation Committee’s April 29, 2021
• Communication and Public Education Committee’s April 29, 2021
• Full Board’s April 29 and 30, 2021

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

NACDS and the California Retailers Association submitted a joint letter to the Assembly Business and Professions Committee in support of AB 1328, legislation allowing pharmacists to perform all CLIA-waived tests.

Also in California, the Board of Pharmacy’s teleconferenced Licensing Committee’s April 21, 2021, meeting agenda and meeting materials have been posted along with information to participate.  Also, the teleconferenced Enforcement and Compounding Committee’s April 22, 2021, meeting agenda has been posted along with information to participate.

Also in California, the Division of Workers’ Compensation’s Pharmacy and Therapeutics (P&T) Committee will meet on April 21, 2021, from 12:30 to 2:30 p.m. via video/audio conference only. To attend the meeting via video conference, please use the P&T Meeting Link. To join the meeting via teleconference, please use the call-in phone number: 1 (619) 407-9860 and enter phone conference ID: 520 391 953#.

Also in California, on April 1, the online attestation period 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 communication that includes the URL for the online attestation portal, as well as a unique login ID and password, by email, fax, or mail. If you have not received this communication, please call the Attestation Survey Hotline at 1-844-294-9982 or email CODSurvey@mercer.com.  The attestation period for the 2020 calendar year is open until 11:59 pm April 30, 2021, and no attestations will be accepted after that time. The attestation for the 2020 calendar year reporting period determines the professional dispensing fee component of the pharmacy claim reimbursement for claims with dates of service from July 1, 2021, through June 30, 2022. For additional information, providers can refer to the Pharmacy Provider Self-Attestation FAQs or may call the Attestation Survey Hotline at 1-844-294-9982, or email their questions to CODSurvey@mercer.com.

Also in California, Medi-Cal Rx Transition and Resources Training announced three sessions covering important Medi-Cal Rx changes for pharmacy providers and prescribers. For registration, all the training sessions are posted on the Education & Outreach Calendar within the Saba Learning Management System (LMS); you must be logged into the User Administration Console (UAC) to access the Education & Outreach Calendar in Saba.

Lastly in California, the Board of Pharmacy is beginning the development of its new strategic plan and is seeking stakeholder feedback. The Department of Consumer Affairs, SOLID Planning Solutions (SOLID), is assisting the Board with its strategic planning process.  Completed surveys will provide input as to how the Board is doing by identifying strengths, challenges, and current trends to consider for the future direction of the Board. All responses are anonymous. This survey will be open until April 30, 2021. For your convenience, NACDS is providing a PDF file of the survey.

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

NACDS and the California Retailers Association (CRA) submitted a joint letter to the Assembly Business & Professions Committee to register our “oppose unless amended” position on AB 1430, legislation requiring pharmacies to dispense Schedule II prescription drugs in lockable vials.  NACDS requested the bill be amended to be voluntary and to remove the onerous administrative requirements (i.e. maintaining patients’ combination codes for locking-cap closure mechanisms).  The bill also fails to extend the same liability protection against failure of a particular lockable vial to prevent unauthorized access and/or a particular patient’s inability to access medication in a lockable via that is otherwise afforded to prescribers under the bill; we requested his omission must be remedied.

Also in California, NACDS and CRA submitted a letter to the California Senate Appropriations Committee opposing SB 362 due to the fiscal pressure on the state created by new enforcement costs for the Board of Pharmacy. This is in addition to a similar recent joint letter to the California Senate Business, Professions & Economic Development Committee voicing opposition to this bill which would prohibit community pharmacies from utilizing metrics to evaluate the performance of employees.  While SB 362 may be well-intentioned, it contains ambiguous and onerous requirements that are impossible for pharmacies to meet and may ultimately threaten access to pharmacy services and jeopardize patient safety.

Also in California, SB 409, legislation permitting pharmacists to perform SARS-CoV-2 and influenza testing and adding pharmacist-in-charge in the definition of a laboratory director, passed the Senate and was read for the first time in the Assembly.

Also in California, the Department of Consumer Affairs (DCA) issued the following waivers via authority under Governor Gavin Newsom’s Executive Orders N-39-20. A list of current waivers is available on the DCA website.

• DCA Waiver DCA-21-139 Order Waiving Restrictions On Healthcare Students Administering COVID-19 Vaccines In Association With State or Local Vaccination Efforts
• DCA Waiver DCA-21-140 Order Waiving Restrictions On Healthcare Providers With Expired, Inactive Or Lapsed Licenses Ordering And Administering COVID-19 Vaccines In Association With State or Local Vaccination Efforts

Also in California, due to the delayed Go Live date for Medi-Cal Rx, the following events have been postponed.  Also, the Department of Health Care Services (DHCS) anticipates providing further information about the Medi-Cal Rx implementation in May.

• The April 14 public forum is being postponed. The next scheduled Medi-Cal Rx public forum is May 19 via webinar. Information will be posted on the DHCS website. For questions or comments related to Medi-Cal Rx, please email RxCarveOut@dhcs.ca.gov.
• The March 22 Medi-Cal Rx Advisory Workgroup meeting was postponed. The next scheduled meeting for this workgroup is May 28 via webinar. These sessions are intended to help facilitate and further inform DHCS’s ongoing efforts to implement pharmacy services improvements through Medi-Cal Rx. Information on how to participate in the next webinar will be provided on the DHCS website.

Also in California, on April 7, 2021, the DHCS posted this Provider Registration and FAQs bulletin on the Medi-Cal Rx Web Portal.

Lastly in California, the Board of Pharmacy is beginning the development of its new strategic plan and is seeking stakeholder feedback. The Department of Consumer Affairs, SOLID Planning Solutions (SOLID), is assisting the Board with its strategic planning process.  Completed surveys will provide input as to how the Board is doing by identifying strengths, challenges, and current trends to consider for the future direction of the Board. All responses are anonymous. This survey will be open until April 30, 2021.

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

The Department of Managed Health Care announced All Plan Letter 21-011 to provide an overview of new guidance from the federal Departments of Labor, Health and Human Services, and the Treasury that address the implementation of the Families First Coronavirus Response Act (FFCRA), the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), and other health coverage issues related to COVID-19. The letter discusses coverage of diagnostic testing, especially public health surveillance testing.

Also in California, The Board of Pharmacy posted its monthly news roundup.  Among the items of interest are the March 2021 issue of “The Script” with articles about new pharmacy laws, new requirements for controlled substance prescription forms and for reporting to CURES, tips on how to avoid processing delays for pharmacy technician license applications, and a reminder that pharmacists-in-charge are required to complete a self-assessment of the pharmacy’s compliance with state and federal laws before July 1 of each odd-numbered year. Current forms and draft versions under review for possible adoption are available online under “Facility License Information/Renewal.” Effective April 1, 2021, the CURES fee will increase from $6 to $11 annually for two years in which most licensees will see a $22 CURES fee due to the biennial renewal cycle.

Also in California. The Board of Pharmacy posted “Guidance on Eligible Personnel for Vaccines Administered in Pharmacies.” Please visit the above link for more information.

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

Effective July 1, 2021, the Board of Pharmacy will adopt amended regulations to consolidate the renewal license types into two categories: (1) a premises or facility license, and (2) a license issued to an individual, other than a pharmacist or an advanced practice pharmacist.  This regulatory action amends and repeals regulations under 16 CCR 1702, 1702.1, 1702.2, and 1702.5 to consolidate standards for various board license types. The rule also requires disclosure of all continuing education requirements to renew a pharmacist or advanced pharmacist license as required by section 1732.5.

Also in California, the Board of Pharmacy readopts regulations originally adopted in emergency action 2020 – 0420 – 02E relating to the independent initiation and furnishing of HIV pre-exposure and post-exposure prophylaxis to patients as authorized by Statutes 2019, chapter 532 (SB 159). The rule is effective February 25 and expires August 24, 2021.

Also in California, NACDS and the California Retailers Association (CRA) submitted a joint letter to the California Senate Business, Professions & Economic Development Committee in opposition of SB 362 which would prohibit community pharmacies from utilizing metrics to evaluate the performance of employees.  NACDS and CRA commented that while SB 362 is well-intentioned, it contains ambiguous and onerous requirements that are impossible for pharmacies to meet and maya ultimately threaten access to pharmacy services and jeopardize patient safety.

Also in California, NACDS and the California Retailers Association (CRA) submitted a joint letter to the California Senate Business, Professions & Economic Development Committee supporting AB 671, which will require the Department of Health Care Services (DHCS) to provide disease management or similar payment to DHCS contracted pharmacies dispensing specialty drugs to Medi-Cal beneficiaries.

Also in California, the Department of Health Care Services issued the Medical Rx Pharmacy Provider and Prescriber Readiness Survey to survey pharmacies on their current process to conducting business for Medi-Cal pharmacy services. The data in the survey will be held confidential and the results will be used by the Education & Outreach team to design training offerings for Medi-Cal Rx to prepare providers for the upcoming Medi-CAl Rx Transition.

Also in California, the Department of Justice, Office of the Attorney General announced the Office of Administrative Law’s (OAL) approval of new rules to strengthen the language of the California Consumer Privacy Act (CCPA) regulations approved by OAL in August 2020, including protecting consumers from unlawful business practices that may be deceptive or misleading.

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