California

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.

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.

2021-04-09T10:07:27-04:00April 9, 2021|California|

California

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.

2021-04-02T09:02:08-04:00April 2, 2021|California|

California

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.

2021-03-26T12:19:19-04:00March 26, 2021|California|

California

In response to Gov. Gavin Newsom’s emergency declaration and consistent with the authority of the Board of Pharmacy to waive Pharmacy Law or the regulations, the Board president Greg Lippe extended the previously approved limited waiver on pharmacists initiating and administering vaccines through May 29, 2021. More information can be found at the following link. Pharmacists Initiating and Administering Vaccines, CCR section 1746.4(d)

Also in California, On March 24, 2021, CalRecycle staff will conduct a webinar to present the statutory and regulatory requirements, submittal process, and timing for covered drugs and home-generated sharps waste stewardship plans and initial program budgets as required by the Pharmaceutical and Sharps Waste Stewardship law and its implementing regulations.

Also in California, The Senate Budget Subcommittee #3 on Health and Human Services held a hearing this week to review the Governor’s proposal to provide $12 million in funding Medi-Cal coverage of continuous glucose monitors. NACDS is part of a Coalition supporting Medi-Cal coverage of CGMs.

Also in California, The Board of Pharmacy created a voluntary online registry to help consumers find specific health care services that qualified pharmacists may provide to patients without a prescription.

The health services are:

  1. Self-administered hormonal contraception.
  2. Emergency contraception.
  3. Vaccinations.
  4. Travel medications.
  5. Nicotine replacement therapy.
  6. Naloxone.
  7. HIV preexposure prophylaxis (PrEP).
  8. HIV postexposure prophylaxis (PEP).

Also in California, The Medi-Cal web portal Provider Registration and Training FAQs are now available and can be accessed here.

Also in California, The Board of Pharmacy will hold a Teleconference Public Meeting on Thursday, March 18, 2021.  The agenda includes discussion and consideration of Title 16 CCR Section 1747, related to HIV Prep and PEP, and proposed regulations related to pharmacy technician application, training requirements, and certification programs.

Also in California, The Board of Pharmacy adopted a final rule that modifies the Pharmacy Technician Application (Form 17A – 5) to add information regarding expedited licensure for applicants who meet certain criteria regarding their immigration status and military service. This change without regulatory effect was filed on February 8.

Also in California, the Department of Health Care Services’ Education & Outreach team is surveying providers to learn more about how pharmacies currently conduct business for Medi-Cal Pharmacy Claims. The results of the Medi-Cal Rx Pharmacy Provider and Prescriber Readiness Survey will be used to tailor training offerings for Medi-Cal Rx to ensure pharmacies are prepared for the upcoming transition.

Also in California. Beginning March 15, healthcare providers may use their clinical judgment to vaccinate individuals age 16-64 who are deemed to be at high risk from COVID-19 as the direct result of certain conditions and settings:

  • Individuals with one or more severe health conditions
  • Individuals with developmental or other severe disabilities or illness
  • Individuals who live or work in a high risk congregate residential setting
  • Public transit workers

Healthcare providers should thoroughly read the California Department of Public Health’s Provider Bulletin, Fact Sheet, and COVID-19 Vaccine Allocation Guidelines. Additional information is at California’s COVID-19 vaccine website here.

Also in California. Effective April 1, 2021, the Controlled Substance Utilization Review and Evaluation System (CURES) fee will increase from $6 to $11 annually for two years for all the Board’s that prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances. More information is available here.

Lastly in California, NACDS and the California Retailers Association submitted a joint letter to the Senate Business, Professions & Economic Development Committee in support of SB 409 with proposed amendments to include pharmacy technician testing authority as well as authority for pharmacists to initiate treatment according to the test result.

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

2021-03-19T14:34:29-04:00March 19, 2021|California|

California

NACDS, jointly with the California Retailers Association and the California Pharmacists Association sent Gov. Gavin Newsome (D) a letter requesting no further delays in the April 1, 2021, planned implementation of the Medi-Cal Rx program. In the letter, we questioned why some providers continue to seem ill-prepared given the nearly two years of lead time given all the collaboration and planning that has been taking place. Further, we stated that both patients and providers are counting on a benefit that is easier to navigate, improves access to pharmacies, and improves California’s drug-price negotiating power. Despite these efforts, the Department of Health Care Services (DHCS) subsequently announced that the transition of Medi-Cal pharmacy services from managed care to fee-for-service is being delayed again and will NOT occur on April 1, 2021, due to the need to review conflict avoidance protocols with respect to the Centene acquisition of Magellan. DHCS stated that they plan to announce further info in May. More information on the announcement can be found here.

Also in California, CalAIM is a multi-year initiative by the Department of Health Care Services (DHCS) to improve the quality of life and health outcomes of Californians by implementing broad delivery system, program, and payment reform across Medi-Cal. The DHCS released for public comment draft requirements documents for two components of CalAIM, (1) Enhanced Care Management (ECM) and (2) In Lieu of Services (ILOS). More information can be found on the CalAIM webpage. The public comment ends on March 12, 2021. Comments should be submitted to CalAIMECMILOS@dhcs.ca.gov.

Also in California, The Board of Pharmacy’s Enforcement and Compounding Committee held a virtual meeting on February 18 on white bagging. More information on the meeting can be found here.

Lastly in California, effective February 2, the state Department of Justice issued a final rule amending provisions on 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.

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

2021-03-19T13:52:16-04:00February 19, 2021|California|

California

The Department of Health Care Services (DHCS) submitted a disaster relief SPA to the Centers for Medicare & Medicaid Services requesting an increase in reimbursement rates for DME oxygen and respiratory equipment, retroactively effective for dates of service beginning on or after March 1, 2020, or at a later date when DHCS implements the new procedure code. DHCS seeks reimbursement rates for 100 percent of the corresponding Medicare rate. The federal fiscal impact for the rate increase is estimated at $3.4 million.

Also in California. The Department of Health Care Services (DHCS) will not resume retroactive pharmacy claim adjustments on February 11. The retroactive pharmacy claim adjustments due to a change in the reimbursement methodology for covered outpatient drugs in 2017 will continue to be paused until further notice. This pause will apply to all pharmacy claims billed through the Medi-Cal fee-for-service Fiscal Intermediary and includes those claims that were also subject to an alternative payment arrangement.

Also in California. The Board of Pharmacy issued a proposed rule establishing training requirements for pharmacists to independently initiate and provide to patients HIV preexposure and postexposure prophylaxis. The rule also would establish related recordkeeping requirements.

Lastly in California. NACDS co-signed a Coalition letter supporting Gov. Gavin Newsom’s (D) budget proposal authorizing Medi-Cal coverage for Continuous Glucose Monitoring Systems.

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

2021-02-12T09:14:59-05:00February 12, 2021|California|

California

The Department of Public Health issued new guidance regarding COVID-19 vaccine administration and a notice from the Board of Pharmacy about the new guidance was posted in the “COVID-19 Information Box” on the Board’s website.

Also in California. CalAIM is a multi-year initiative by the Department of Health Care Services (DHCS) to improve the quality of life and health outcomes of our Medi-Cal population by implementing a broad delivery system, program, and payment reform. The major components are (1) the Whole Person Care Pilots, (2) Health Homes, and the (3) Coordinated Care Initiative, and will result in a better quality of life for Medi-Cal members as well as long-term cost savings. At the January 28 virtual meeting, DHCS presented a revised CalAIM proposal. DHCS also released a revised Executive Summary that includes a summary of major changes from the original proposal.

Also in California. DHCS, the California Department of Public Health (CDPH), and the California Department of Social Services (CDSS) are co-facilitating a new all-behavioral health provider call that is held every Wednesday at 8 AM PT to discuss topics such as COVID-19 vaccination updates, emergency staffing, and facility flexibilities. It also includes updates from DHCS, CDPH, CDSS, and the California Health and Human Services Agency. More information about the behavioral health all-provider call, including call-in information, meeting notes, and frequently asked questions (FAQs), can be found on the DHCS website.

Also in California. The DHCS released its telehealth policy recommendations consisting of broad-based telehealth policy changes that would remain permanent fixtures following the eventual termination of the COVID-19 public health emergency (PHE). DHCS is seeking to modify or expand the use of synchronous telehealth, asynchronous telehealth, telephonic/audio-only, other virtual communication and to add remote patient monitoring to create greater alignment and standardization across delivery systems, as indicated. DHCS’ proposal includes advancing the following telehealth policy recommendations effective July 1, 2021. For more information relative to DHCS’ full post-PHE telehealth policy recommendations, please review the telehealth policy recommendations document, which is available on both DHCS’ Telehealth webpage and DHCS’ COVID-19 Response page. DHCS is also proposing trailer bill legislation (TBL), which will be posted on the Department of Finance’s TBL webpage.

Also in California. The DHCS released the “Medi-Cal Specialty Disease Pharmacy Reimbursement Study” aimed at analyzing specialty disease state drug reimbursement to Medi-Cal fee-for-service (FFS) pharmacy providers. The purpose of the two-part survey was to compare the National Average Drug Acquisition Cost (NADAC) price benchmark against Average Acquisition Cost (AAC) in California for a select group of specialty drugs. Additionally, the survey asked specialty pharmacy providers to list specialized services provided to Medi-Cal beneficiaries to ensure adherence and compliance and to monitor positive and negative outcomes from the drug therapy. The survey report memo, report, and appendices are available on the DHCS website.

Lastly in California. Gov. Gavin Newsom (D) signed an Executive Order aimed at bolstering efforts to vaccinate as many Californians as possible as quickly as possible by protecting certain health care professionals and providers from legal liability when they render services at the request of state or local officials during a state of emergency.

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

2021-02-05T08:29:38-05:00February 5, 2021|California|

California

The Board of Pharmacy voted to pursue legislation in 2021-22 to make the Department of Consumer Affairs (DCA) temporary waiver allowing pharmacists to order and administer CLIA-waived tests for COVID and influenza permanent.

Also in California. The Department of Health Care Services (DHCS) continues to make significant progress and movement toward a full assumption of operations of all pharmacy services on April 1, 2021, to Medi-Cal Rx.

  • To facilitate the transition for Medi-Cal pharmacy providers, DHCS will be transferring previously established Electronic Fund Transfer (EFT) account information from the existing Medi-Cal fee-for-service (FFS) Fiscal Intermediary to Medi-Cal Rx. For those pharmacy providers that do not wish to have their EFT account information transferred over to Medi-Cal Rx for use after April 1, 2021, assumption of operations, an option to “opt-out” is available. Registered users who wish to provide new or modified EFT account information to Medi-Cal Rx for use after the Medi-Cal Rx assumption of operations may do so at the following link: https://medi-calrx.dhcs.ca.gov/.
  • The Medi-Cal Rx website will be fully operational by April 1, 2021. DHCS encourages Medi-Cal providers to sign up for the Medi-Cal Rx Subscription Service (MCRxSS) so that interested parties can receive Medi-Cal Rx updates.

Also in California. Pharmacies can submit batch and hard copy claims for COVID-19 vaccine administration. More information can be found about claims submission can be found here.

Also in California. In 2019, the Department of Health Care Services (DHCS) had temporarily suspended retroactive pharmacy claim adjustments. DHCS will resume retroactive pharmacy claim adjustments beginning in February of 2021. Refer to Frequently Asked Questions on the Medi-Cal Website for additional information.

Also in California. In response to members’ requests, NACDS submitted a joint letter with the California Retailers Association to the San Diego County Health and Human Services Agency urging them to remove the Vaccines-for-Children enrollment barrier so citizens can receive COVID vaccines at their local convenient community pharmacies.

Also in California. The Department of Managed Care provided notice and guidance on Covid-19 vaccine coverage and administration for the Medi-Cal managed care program. Please visit the above link for more information.

Also in California. Gov. Gavin Newsom (D) issued an Executive Order extending liability protections for healthcare providers during state and local emergencies to healthcare providers participating in the state’s vaccine administration program.  The Order applies to both pharmacists and pharmacy technicians.  More information can be found here.

Also in California. The DHCS issued guidance reminding Medi-Cal providers that they are prohibited from illegally discriminating against Medi-Cal members. Also, in the context of the COVID-19 PHE, providers are prohibited from illegally discriminating against Medi-Cal members in determining how to allocate scarce resources for the treatment of COVID-19. DHCS’ Office of Civil Rights has an established discrimination complaint process for Medi-Cal consumers to file grievances of alleged discrimination. More information is available on the DHCS website.

Lastly, in California. The DHCS held a webinar to provide an overview of the relaunch of the California Advancing and Innovating Medi-Cal (CalAIM) initiative.  CalAIM builds upon prior successes in health care delivery and proposes to provide more services and supports for patients with complex needs. Key goals of CalAIM include promoting whole-person care, reducing program complexity, and modernizing systems. For more information, please visit the CalAIM webpage.

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

2021-01-29T10:56:10-05:00January 29, 2021|California|

California

The Department of Health Care Services (DHCS) Medi-Cal is on track for April 1, 2021, to move from managed care to fee-for-service. DHCS has received approval from the Centers for Medicare & Medicaid Services (CMS) for numerous projects, including the transition of the Medi-Cal pharmacy benefit from managed care to fee-for-service. For more information about Medi-Cal Rx, please visit DHCS’ dedicated Medi-Cal Rx Transition website: Medi-Cal Rx: Transition

Also in California. DHCS submitted a State Plan Amendment (SPA) 20-0046 to CMS, which seeks to set reimbursement for COVID-19 testing administered to Medi-Cal students in schools at 70 percent of the Medicare reimbursement rates. The effective date of this SPA is February 1, 2021.

Also in California. The California Department of Public Health released new guidance on vaccine prioritization on January 7. The guidance recognizes the need to balance the prioritization of scarce vaccine resources to achieve community immunity for all Californians by noting situations in which the health departments and providers may offer doses promptly to people in lower priority groups, including provider flexibility to eliminate vaccine spoilage.

Also in California. The Board of Pharmacy reminded pharmacies that they must register their mobile vaccination clinics/hubs where their pharmacist and pharmacy technicians are providing vaccinations outside the pharmacy. All that is required is the pharmacy name and license, and records related to vaccinations should be kept at the pharmacy to be made available if needed for an inspection. Chain companies can provide one list of all their licensed pharmacies in California where there is a mobile COVID vaccine clinic or COVID vaccine administration outside the pharmacy. For more information contact Amber Dillon at Amber.Dillon@dca.ca.gov.

Also in California. The Board of Pharmacy provided guidance on new compliant security prescription forms for instances where a prescriber may not have utilized a compliant security prescription form for a controlled substance on and after January 1, 2021, as required by Assembly Bill 149 (Statutes of 2019). For additional information, go to the Joint Statement and FAQs from the California Department of Justice, the California State Board of Pharmacy, and the Medical Board of California.

Also in California. On January 7, the Office of Administrative Law (OAL) approved the Pharmaceutical and Sharps Waste Stewardship Program Regulations, which are effective immediately.

Also in California. The Administration’s Medi-Cal reform initiative that got delayed last year due to COVID was revised and released last week. The CalAIM executive summary is attached and here is a link to the website.

Lastly in California. In case you missed it, before the holidays, the California Department of Consumer Affairs (DCA) issued an order waiving restrictions on pharmacy technicians related to administering COVID-19 vaccinations with specific conditions: DCA Waiver DCA-20-103 Order Waiving Restrictions on Pharmacy Technicians Relating to Administering COVID-19 Vaccines.

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

2021-01-15T10:40:12-05:00January 15, 2021|California|
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