The Department of Managed Health Care amended regulations under 28 CCR 1300.67 to clarify when health care service plans must cover diagnostic testing for COVID-19 and specified how quickly testing must be provided for employees, and the process for reimbursement. The emergency rule will expire on January 13, 2021.

Also in California. The Public Health Director Sonia Angell abruptly resigned amid a major data glitch affecting hundreds of thousands of COVID -19 test records, which has hampered counties’ response to the virus. The California Reportable Disease Information Exchange (CalREDIE) currently has a backlog of 250,000 to 300,000 records.

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

The California Board of Pharmacy held a two-day virtual meeting to discuss pending legislation, AB 1710 which the Board voted to support, which would allow pharmacists to administer FDA-authorized COVID immunizations.  The Board also discussed proposed rules on automatic refills, pharmacists working alone, and removing the barriers that restrict the use of CLIA-waived COVID tests at pharmacies.  The Board voted to pursue a proposal to amend BPC 4052.8 related to pharmacist authority to administer vaccines approved by the FDA and approved amendments to initial proposed text for Title 16, CCR section 1746.6, Independent HIV Preexposure and Postexposure Prophylaxis Furnishing.

Also in California. NACDS sponsored and participated in the California Pharmacists Association’s Virtual Advocacy Day virtual meeting with Chairman Evan Low, Assembly Member Cecelia Aguiar-Curry, and Assembly Member Jim Wood, sponsor of AB 1710 and the Medi-Cal reimbursement fix bill that would address below acquisition cost reimbursement issues (AB 2100).

Also in California. The Department of Public Health’s (CDPH) issued updated COVID-19 Industry Guidance for testing, outlining different tiers to help determine who should be tested. Additionally, the Department of Consumer Affairs (DCA) developed a testing priority flyer to be placed in provider offices to provide additional guidance.

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

On July 23, the Board of Pharmacy issued a waiver temporarily increasing the ratio, allowing one additional intern pharmacist for each supervising pharmacist under the following conditions: (1) the additional intern pharmacist is administering immunizations consistent with the provisions of Pharmacy Law, and (2) the pharmacy maintains a readily retrievable record documenting the date and time when the ratio is increased according to this waiver and the staff operating under the waiver. Records must be maintained for one year following the end of the declared emergency. The waiver is set to expire on October 20, 2020.

Also in California. NACDS’ in-state partner, the California Retailers Association, signed a coalition letter to the California Department of Resources Recycling and Recovery (CalRecycle) requesting a 30-day extension to the public comment period on the Second Draft of the Proposed Regulations for the Pharmaceutical and Sharps Waste Stewardship Program, now scheduled to expire on August 3, 2020.

Also in California. In advance of the Senate Business and Professions Committee meeting on August 8, 2020, NACDS and the California Retailers Association submitted a joint letter supporting AB 1710 by Assembly Member Jim Wood, which would allow pharmacists to administer all FDA authorized or approved vaccines.

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

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.