NACDS and our in-state partners, the California Pharmacists Association and the California Retailers Association, are supporting AB 1710 by Assembly Member Wood, legislation that will leverage pharmacists to administer the COVID-19 vaccine as soon as it is viable.

Also in California. The Board of Pharmacy will be meeting virtually on July 29 and 30, 2020. The agenda and meeting materials are available here.

Also in California. Several temporary pharmacy waivers are set to expire.  Below is a list of those waivers that have expired or will be expiring in July.

• Pharmacist Direct Supervision of Interns – Expired July 19
• Prohibited Acts Involving Dangerous Drugs or Devices – Valid through July 24, 2020.
• Use of Alcohol Sanitizer Before Donning Sterile Gloves – Valid through July 24, 2020.

Also in California. The Board of Pharmacy extended three previously approved waivers through September 22, 2020.

• Remote Processing
• Requirements for Consulting Pharmacist to Make Quarterly Visits
• USP <797> Requirements Related to Use of PPE

Also in California. The Board of Pharmacy has published a final rule that amends regulations under 16 CCR 1707 to revise the duty to consult standards for pharmacists. The rule specifies the minimum time requirements a pharmacist must be available to speak to patients, and the maximum amount of time a consumer must wait before speaking to a pharmacist. The rule also expands the current requirements for when a pharmacist must provide oral consultation to all settings, effective October 1, 2020.

Also in California. The Department of Managed Health Care released a notice to announce its  All Plan Letter 20-024 to health care service plans in Riverside and Sonoma counties. The notice provides guidance on reporting requirements under a pilot project to assess the impact of health care service plans and pharmacy benefit manager prohibitions on the dispensing of certain amounts of prescription drugs by network retail pharmacies. All reporting will be required annually by July 1. The pilot project will be in effect until Jan. 1, 2023.

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

Last week, Assembly Member Jim Wood (D), chair of the Assembly Health Budget Committee, gutted and amended AB 1710 to allow pharmacists to initiate and administer FDA-approved vaccines. NACDS is seeking an amendment to allow FDA-authorized vaccines too.

Also in California. Prior to the July 1, 2020 deadline required in the state constitution, Gov. Gavin Newsom signed the 2020 Budget Act – a $202.1 billion spending plan that closed a $54.3 billion budget shortfall caused by the COVID-19 recession.

Also in California. Gov. Gavin Newsom extended for 60 more days, until September 9^th, his Executive Order issued on May 12, 2020, waiving the restrictions on pharmacists ordering and collecting specimens for COVID-19 tests.

Also in California. Because several legislators have tested positive for COVID, neither the Assembly nor Senate are returning to work at the Capitol next week. The legislature shutdown for two months earlier this year because of the pandemic.

Also in California. NACDS and the California Board of Pharmacy submitted the attached joint letter to the Senate Business, Professions, and Economic Development Committee opposing AB 2983 which imposes inefficient requirements that will impede that automated refill process causing delays in patient access.

Also in California. NACDS virtually presented to the Board of Pharmacy’s Licensing Committee and Legislative and Regulation Committee on pharmacists immunizations and COVID testing and the authority to perform CLIA-waived tests for COVID19. Presentations can be found here.

Also in California. NACDS sent a joint letter with the California Retailers Association and the California Pharmacists Association to Gov. Gavin Newsom urging him to issue an Executive Order removing the remaining barriers to expanding access to COVID testing by pharmacists.

Also in California. In response to the Governor’s emergency declaration and consistent with the authority of the Board to waive Pharmacy Law or the regulations adopted pursuant to it, last week the Board president extended the following previously approved limited waivers:

• Use of PPE in Certain Compounding Aseptic Isolators or Compounding Aseptic Containment Isolators– Effective through August 30, 2020
• Duty to Consult – Effective through September 29, 2020
• Restoration of Retired or Cancelled License – Effective through October 1, 2020
• Certification of Basic Life Support – Effective through August 5, 2020
• Prelicensure Inspection of Proposed ADDS Location – Effective through October 9, 2020
• Reassessment/Revalidation/Re-evaluation Requirements for Sterile Compounding Staff Competencies – Effective through August 12, 2020

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

In advance of the start of the new fiscal year on July 1, 2020, Gov. Gavin Newsom and the Legislature reached an agreement on the budget this week. Below are highlights of two budget trailer bills of interest to pharmacies. 

(AB 89/SB 121) contains language related to federal funding for contact tracing.  Specifically, it allows Department of Finance (DOF) to allocate those funds as directed by California Department of Public Health (CDPH), as long as the funds are not used by any state or local entity for applications that collect information relating to a person’s location and movement.  Please see below: 

SEC. 104. 

 Section 11.95 is added to the Budget Act of 2020, to read: 

SEC. 11.95. 

 (a) Federal legislation enacted between March 6, 2020, and April 24, 2020, is providing funding to the state to support testing and contact tracing in response to the COVID-19 public health emergency. The Department of Finance may allocate these funds to support testing and contact tracing as directed by the State Department of Public Health, provided that funds are not used by any state or local entity for applications that collect information related to an individual’s location and movement. This subdivision does not preclude a contact tracer from using a program to store, organize, or analyze any data otherwise affirmatively provided to the contact tracer by an individual. All testing and contact tracing must be conducted in compliance with applicable federal and state privacy laws. 

(b) Funds described in subdivision (a) may be allocated to offset or reduce appropriations in the 2019−20 and 2020−21 fiscal years that support the COVID-19 response between March 1, 2020 and June 30, 2021. If no item for a department currently exists to allow for adjustments for the additional federal funds allocation or additional reimbursements to be allocated, then an item may be created for this purpose. 

(c) The Department of Finance may adjust any item in Section 2.00 to account for additional federal funding or any additional reimbursements to support testing and contact tracing. If no item for a department currently exists in Section 2.00 of this Act to allow for adjustments for the additional federal funds allocation or additional reimbursements to be allocated, then an item may be created for this purpose. 

(d) Changes to any item in Section 2.00 may be authorized not sooner than 10 days after written notification to the Joint Legislative Budget Committee of the changes to the planned expenditures to support testing and contact tracing. The chairperson of the Joint Legislative Budget Committee or the chairperson’s designee may shorten the 10 days by written notification. 

AB 80/SB 102 does not include the proposed pharmacy reimbursement cuts for services such as providing self-administered hormonal contraceptives, vaccines, nicotine replacement products, travel medications, naloxone directly to patients and PEP/PrEP for HIV prevention. 

• Requires CalOSHA to establish the Health Care Payments Data Program to implement and administer the Health Care Payments Data System, including health care data submitted by health plans and insurers, cities or counties that offer plans and other mandatory or voluntary submitters. Provisions require the office to use the data to produce reports, analyses, studies, etc. to support goals for improving public health, reducing disparities, and reducing health care costs and specifies that personally identifiable data submitted are exempt from disclosure. 
• Authorizes CDPH to subsidize up to 30 days of PrEP and PEP medications without regard to whether a person was a victim of sexual assault. 
• Contains several pharmacy provisions, including removing the Rx copay in Medi-Cal and requiring DHCS to implement a supplemental payment pool for non-hospital 340B clinics.   
• Contains the “best price” language, specifically defining “best price” to mean the negotiated price for any specified entity, including entities both within and outside the USA.  
• Authorizes DHSC, upon approval of DOF, to seek the necessary federal approvals to establish and administer a drug rebate program to collect rebate payments from drug manufacturers for drugs furnished to select populations of CA residents who are ineligible for full-scope Medical.  
• Repeals the provision that limits prescribed drugs under the Medi-Cal program to not more than 6 drugs per month, unless prior authorization is obtained. 

Also in California... Legislation of interest to chain pharmacies passed the Assembly and was referred to the Senate Health Committee for further consideration. 

• AB 2077 (Ting) Hypodermic needles and syringes – NACDS supports 
• AB 2203 (Nazarian) Insulin cost-sharing cap – NACDS neutral 

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

The Board of Pharmacy is meeting via teleconference on June 18, 2020. https://pharmacy.ca.gov/about/meetings_full.shtml.  

Also in California... Effective July 1, 2020, the Department of Justice adopts a Final rule regarding access to and use of the Controlled Substance Utilization Review and Evaluation System (CURES), a database of Schedule II, III, and IV controlled substance prescriptions dispensed in the state. The rule establishes procedures for seeking and approving access to information in the CURES database and the purposes for which a prescriber, pharmacist, interstate prescriber or pharmacist, and other interested parties may access and use the data. The rule also establishes security and privacy requirements needed to facilitate interoperability between health information technology systems and CURES.  

Also in California... Comments are due on July 13, 2020 on a Board of Pharmacy Proposed rule updating licensing requirements for dangerous drug distributors, including third-party logistics providers (3PLs). The rule would add requirements for 3PLs that are similar to the requirements for drug wholesalers, establish when 3PLs must have a designated representative present and in control and require activity reporting.  

Also in California... The Board of Pharmacy announced that they were reopening their offices to the public on June 15th with normal hours of operation Monday through Friday from 8:00 a.m. to 5:00 p.m. 

Also in California... Gov. Gavin Newsom appointed Will Lightbourne to serve as Director of the California Department of Health Care Services. Previously, Lightbourne was the Director of the California Department of Social Services from 2011 to 2018.

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

The Board of Pharmacy is scheduled to meet via teleconference on June 18, 2020. Link to agenda – https://www.pharmacy.ca.gov/meetings/agendas/2020/20_jun_bd.pdf 

Also in California... The Department of Health Care Services that manages the Medi-Cal fee-for-service program announced the annual check-write two-week delay. Medi-Cal fee-for-service providers scheduled with a warrant date of June 18, 2020, will be deferred until July 2, 2020, a day after the start of the new fiscal year. 

Also in California… Assembly Member Jim Wood’s bill AB 2100 that NACDS, the California Retailers Association and the California Pharmacists Association strongly support passed off the Assembly floor on June 6th by a 62-0 vote. bill requires the Department of Health Care Services (DHCS) to contract with a vendor to survey specialty drug price information for the purpose of determining the actual acquisition costs (AACs) for specialty drugs. It also requires DHCS to provide a disease management payment to a pharmacy pursuant to a contract with DHCS for the costs and activities associated with dispensing specialty drugs. The bill corrects the “below-acquisition cost” reimbursement issue caused by the new methodology mandated by the Affordable Care Act in 2016. Further it repeals the Medi-Cal fee-for-service (FFS) limit of no more than six prescribed drugs per month unless prior authorization is received and repeals the Medi-Cal $1 copayment.  

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

NACDS is seeking member comments on Board of Pharmacy approved regulations changing pharmacist consultation requirements that now require either the consultation occur within 10 minutes or a return business call within one business hour.  The regulations are currently under final review at the Office of Administrative Law.   

Also in California... The Department of Health Care Services (DHCS) that oversees Medi-Cal announced that Director Brad Gilbert is retiring in June. 

Also in California... The Board of Pharmacy adopted an Emergency rule under 16 CCR 1747 to establish standards for initiating and providing to patients’ HIV preexposure and postexposure prophylaxis and related recordkeeping requirements. The rule was effective April 30th and expires October 27, 2020. 

Also in California... In advance of the June 2nd Assembly Appropriations Committee hearing, NACDS and the California Retailers Association weighed in on two issues important to chain pharmacies. We submitted a joint letter supporting legislation which will extend for five years the sunset on existing law that allows pharmacists to furnish sterile syringes without a prescription (AB 2077-Ting).  We also submitted a joint letter opposing a bill which would prohibit pharmacies from automatically contacting prescribers to authorize a prescription for any dangerous drug or device for more than a 7-day supply refill without authorization from the prescriber or patient. The bill also requires a pharmacy to obtain separate authorization for each prescription and would prohibit a pharmacy from requesting more than the number of refills authorized in the original prescription. (AB 2983-Holden). 

Also in California... The Board of Pharmacy posted important information for pharmacies that were vandalized, looted or set on fire during recent violence in California. 

Also in California... The Board of Pharmacy is scheduled to meet on June 18, 2020 via teleconference. The agenda and instructions on how to join the meeting will be posted on the meetings page at the Board’s website. 

Also in California...  Expecting a delay in processing payments for license renewals submitted by mail during the last week of June and first two weeks of July, the Board of Pharmacy recommends that if your license expires June 30 or July 1, 2020, you need to mail payment by June 11, 2020 to ensure the online verification system accurately reflects your renewal status process during the delay period. Alternatively, pharmacists, advance practice pharmacists, pharmacy technicians and designated representatives can renew your license online, and the processing of online renewal payments will not be delayed. 

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

NACDS continues to try to remove the remaining laboratory requirement in California that poses a barrier to pharmacies expanding COVID-19 testing. NACDS and our in-state partner, the California Retailers Association, followed up with the California Department of Public Health Testing Task Force and Health and Human Services Agency providing detailed information from other states on the safe administration of these tests by pharmacies not subject to such laboratory requirements.  

Also in California... As the June 30, 2020 end of the fiscal year approaches, the Board of Pharmacy is encouraging pharmacists, advance practice pharmacists, pharmacy technicians and designated representatives are encouraged to renew your license online to avoid a possible delay in processing.

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

Gov. Gavin Newson’s released his May Revised 2020-21 Budget last week projecting a $54.3 billion deficit. Since the state’s constitution requires that the legislature submit a balanced budget to the Governor by June 15, 2020, and that the Governor must sign it before the start of the next fiscal year on July 1, 2020, legislators are scrambling to hold hearings on the proposed massive cuts. NACDS and the California Retailers Association submitted a joint letter to both the Senate and Assembly Budget Committee Chairs strongly opposing the proposed elimination of Medi-Cal reimbursement of pharmacist-delivered services such as providing self-administered hormonal contraceptives, vaccines, nicotine replacement products, travel medications, naloxone directly to patients and PEP/PrEP for HIV prevention. 

Also in California... In advance of the Assembly Business & Professions Committee hearing, NACDS and the California Retailers Association submitted a joint letter opposing SB 2983 by Assembly Member Chris Holden, because it would prohibit pharmacies from automatically contacting prescribers to authorize a prescription for any dangerous drug or device for more than a 7-day supply refill without authorization from the prescriber or patient. Further, we objected to the requirement that a pharmacy obtain separate authorization for each prescription. 

Also in California... The Assembly Budget Subcommittee on Health and Human Services debated health care cuts proposed by the Department of Finance, which included cuts to the proposed Diabetes Prevention Program. NACDS is a member of a broad-based coalition building support to advance Medi-Cal funding for Continuous Glucose Monitors (CGMs). 

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

The Department of Finance announced that the state’s revenue decline, estimating late last week that the overall budget deficit is approximately $54.3 billion. 

Also in California... On May 12th, Gov. Gavin Newsom (D) announced efforts to expand the state’s ability to provide more COVID-19 testing, including using pharmacists to test. For pharmacists to help, the Department of Consumer Affairs (DCA) issued the following DCA waiver DCA-20-14 Restrictions on Pharmacists Ordering and Collecting Specimens for COVID-19 Tests.  

Also in California... Having received approval from the Centers for Medicare & Medicaid Services (CMS) of the Department of Health Care Services’ (DHCS) request for multiple Section 1135 flexibilities related to Medicaid and the Children’s Health Insurance Program (CHIP), new guidance was issued. To the extent applicable, the following modifications also apply to CHIP through the duration of the public health emergency: 

• Extending pre-existing authorizations. 
• Accommodating circumstances that require relocation to an alternative setting to ensure the continuation of needed home and community-based services (HCBS). 
• Temporarily waiving written consent under HCBS programs and permitting documented verbal consent as an alternative.  

Also in California... NACDS participated in the Zoom Board meeting on May 7th where the following actions were taken. 

• Re-elected President Greg Lippe, Vice President Debbie Veale, and Treasurer Maria Serpa to one-year terms as officers. 
• Delegated authority to the president to grant Pharmacy Law waivers for up to 90 days and to extend existing waivers for up to 90 additional days. 
• Approved a proposed regulation to add Title 16, CCR section 1714.3, Community Pharmacy Staffing without NACDS’ amendments.

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