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.
Florida
The Department of Business and Professional Regulation issued a notice to announce its intentions to amend regulations under FAC 61N-1 regarding drug and device labeling requirements to make technical revisions to conform to statutes. The Department will be accepting comments but no due date has been specified.
Also in Florida, the Department of Health issued an emergency rule to adopt regulations under FAC 64DER21-4 to require all health care practitioners and other enrolled COVID-19 vaccine providers to report to the online immunization information system within 24 hours the administration of any COVID-19 vaccine with an emergency use authorization from the FDA. The rule replaces a December 15 rule on the same topic. The rule is effective March 15 and expires June 13, 2021.
Lastly, in Florida, the Department of Health issued an emergency rule to adopt regulations under FAC 64DER21-5 to authorize redistribution of the COVID vaccine between vaccine providers within the state. The rule requires providers to receive approval from the Florida Vaccines for Children and Adults Program and requires tracking of vaccine redistribution between enrolled providers. The rule is a readoption of a December 21 emergency rule. The rule is effective March 17 and expires June 15, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Iowa
The Board of Pharmacy issued guidance on a recent amendment to the federal PREP Act that added retired and inactive pharmacists and pharmacy interns and certain student pharmacists to the list of health care professionals authorized to administer COVID-19 vaccines. The PREP Act provides immunity from liability for covered persons.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
Maryland
Effective March 22, the Office of Pharmacy Services (OPS) will be updating the incentive fee for all FDA-approved COVID-19 vaccines administered by pharmacy providers. The new incentive fee will be $40 for the administration of each dose of the vaccine. The incentive fee will be the same regardless of the vaccine and the number of doses required for the vaccination. Payment for the ingredient cost should be $ 0.01. See Advisory 224 for more information.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Mississippi
The Division of Medicaid published a final rule to amend regulations under Title 23, Part 224, Chapter 1, to provide for coverage of vaccine administration by pharmacists. The rule is effective April 1, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
North Carolina
The North Carolina Medicaid Department issued a proposed rule to require Medicaid recipients to get a 90-day supply of non-controlled, maintenance medications and remove the requirement that Medicaid (or a managed care company after July 1, 2021) would have to pay NADAC or the State MAC Price for the prescription. More details can be found at the above link on page 8. Comments can be submitted here and are due April 12, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Ohio
Outpatient pharmacies in Ohio must now store all schedule II controlled substance dangerous drugs in a “securely locked, substantially constructed cabinet or safe,” which must remain locked and secured when not in use. Ohio Admin. Code 4729:5-5-23(A)(5). Schedule II substances can no longer be dispersed among a pharmacy’s stock of dangerous drugs. Pharmacies may store schedule III through V controlled substance dangerous drugs with schedule II controlled substance dangerous drugs in a safe or cabinet or continue to disperse them among non-controlled substances. For more detail see page 45 of the updated Inspection Guide. Though it was originally effective December 1, 2020, the Board of Pharmacy delayed implementation of this new requirement until March 31, 2021, because of COVID-19.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Pennsylvania
NACDS has learned that the PALS application process for the Authorization to Administer Injectables for Pharmacy Interns has been released. Interns should log into or create a PALS account and select Board of Pharmacy then “Authorization to Administer Injectables for Pharmacy Interns.” The Board is asking that pharmacy interns who previously submitted an intent to immunize also now register through this process.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
South Carolina
The South Carolina Department of Health and Human Services (SCDHHS) is updating guidance on how providers should submit requests and inquiries related to Medicaid eligibility. The Eligibility Administrative Support Team (EAST) will no longer process inquiries via its fax or email address. Effective immediately, all provider updates and inquiries should only be submitted via the procedures outlined in this ALERT.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Wyoming
The Board of Pharmacy published a proposed rule to revise Chapter 16 of the Wyoming Pharmacy Act Rules to include the COVID-19 vaccines, ease requirements for administering vaccines, and update the incorporated CDC recommended vaccination schedules. The proposal currently is in effect as an emergency rule, expiring April 8, 2021. Comments are due May 8, 2021.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
Alabama
The Board of Pharmacy published a proposed rule that would amend regulations under AAC 680-X-2 to clarify provisions on the non-disciplinary administrative penalty for late renewal of a license, permit, registration, certification, or similar document. A hearing is scheduled for April 21, 2021, in Birmingham. Comments are due April 10, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
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:
- Self-administered hormonal contraception.
- Emergency contraception.
- Vaccinations.
- Travel medications.
- Nicotine replacement therapy.
- Naloxone.
- HIV preexposure prophylaxis (PrEP).
- 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.
Colorado
After months of promoting making permanent Prep Act guidance allowing pharmacy technicians to administer immunizations, the Board of Pharmacy issued a final rule effective March 17, 2021.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
District of Columbia
The Department of Health published a final rule amending regulations to waive the requirement for pharmacists to complete 10 continuing education (CE) credits through live in-person courses for the licensure period ending February 28. The rule, which allows pharmacists to meet CE requirements through online courses, is in response to the COVID pandemic. The rule became effective on February 26.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Florida
Under Executive Order 21-47, additional groups are now eligible to receive a COVID-19 vaccine. These groups are in addition to persons deemed to be extremely vulnerable to COVID-19, as determined by a physician. Such physician determination shall include a statement that the patient meets the defined eligibility criteria established by a form prescribed by the Florida Department of Health.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Kentucky
HB 48, legislation that would mandate commercial insurance payments for clinical services to pharmacists has passed both Chambers unanimously and is headed to the Governor for signature. The bill was introduced by Rep. Danny Bentley (R), and mandates payment for services within a pharmacists’ scope of practice and would otherwise be paid if performed by a physician, advanced practice nurse, or physician assistant. NACDS advocated in favor of the passage of the bill.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Mississippi
Effective, March 1, pharmacy providers are now able to bill all vaccines which are listed on the Centers for Disease Control and Prevention (CDC) Immunization Schedules via NCPDP D.0 pharmacy claims for fee-for-service (FFS) and MSCAN beneficiaries. Also, reimbursement has changed in that vaccine administration fees, equal to those paid to primary care providers, will be paid instead of professional dispensing fees. PCP vaccine administration fees can be found on the Division of Medicaid’s (DOM) Fee Schedule and Rates Website page on the ‘Increased Primary Care Provider’ fee schedule tab.
These changes apply to beneficiaries aged 19 and over and vaccines administered to beneficiaries aged 10 through 18 must be administered by pharmacy providers who are enrolled in the Vaccines for Children (VFC) program. Further guidance will be issued for this age group at a later date.
Also in Mississippi, the Division of Medicaid published a final rule to amend regulations under Title 23, Part 224, Chapter 1, to provide for coverage of vaccine administration by pharmacists. The rule is effective April 1, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
New Mexico
The Office of Superintendent of Insurance issued a notice to health insurers regarding the use of telehealth services during the COVID pandemic, clarifying that the HIPAA penalty waiver relating to the use by providers of certain communications technologies will continue through the calendar year 2021 and that the coverage parity requirements that apply to behavioral health services are not linked to the declaration of the COVID-19 public health emergency.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
North Carolina
The Board of Pharmacy published a final rule which amends regulations under 21 NCAC 46 to establish a list of restricted drugs during the coronavirus (Covid-19) public health emergency. The rule also establishes that pharmacists can fill the prescriptions on the list only if the prescription bears a written diagnosis consistent with the evidence for its use.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Ohio
NACDS authored and the Ohio Council of Retail Merchants presented joint testimony in support of HB 6 before the House State and Local Government Committee. The bill, sponsored by Rep. Bill Roemer (R), would permanently allow pharmacists to provide COVID-19 and flu vaccines under protocols; as well as immunizations for “any other disease” by prescription to patients aged 7 and older. NACDS will continue working with key legislators to amend the bill to mirror pharmacists’ immunization authority under the Prep Act. Our testimony urged that the General Assembly strongly consider maintaining their constituents’ current access to pharmacy-based vaccine services as the bill moves forward in the process.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Oklahoma
Two bills supported by chain pharmacies are advancing through the committee process in the first house. SB 398 would eliminate the statutory requirement for pharmacists to have an order from a licensed prescriber to administer an immunization, making it consistent with the current practices in place during the pandemic. SB 392 is payment parity legislation that would provide reimbursement to a pharmacist for services if the insurer pays for those same services when provided by other health care professionals.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
Pennsylvania
Gov. Tom Wolf (D) announced that he has nominated Dr. Denise A. Johnson, M.D., FACOG, FACHE, to serve as Pennsylvania’s physician general. Dr. Johnson will serve as acting physician general until she is confirmed by the Senate. Dr. Johnson was most recently Chief Medical Officer at Meadville Medical Center. She is board certified in Obstetrics and Gynecology by the American Board of Obstetricians and Gynecologists and is a Fellow of the American College of Healthcare Executives. She also serves on the Governor’s Commission for Women.
Also in Pennsylvania, the Department of Insurance (DOI) published a bulletin urging health insurers providing coverage to residents in the Commonwealth to continue exercising flexibility to make both COVID-related services and non-COVID-related services available to enrollees, including COVID testing, immunization, and telehealth.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
South Carolina
The Joint Pharmacist Administered Vaccines Committee revised the Protocol for Pharmacist Administered Vaccines. This revision has been reviewed and approved by the SC Board of Medical Examiners. The updated protocol moves flu to age 3 and up and adds the COVID vaccine to the list of approved vaccines. The protocol can be found here.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Tennessee
TennCare has released a new provider notice regarding COVID-19 vaccine pharmacy claims. This notice contains two important updates. One includes the addition of Johnson & Johnson vaccines and the single-dose administration payment. The other update involves a newly established Collaborative Pharmacy Practice Agreement (CPPA) to order and administer COVID-19 vaccines for the State’s TennCare population, which includes CoverKids and CoverRx.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Texas
The Board of Pharmacy issued two final rules that went into effect on March 14. One final rule amends the notification requirements for pharmacists who sign prescription orders for dangerous drugs under a written protocol, and another final rule clarifies that the requirement to consult the Prescription Monitoring Program before dispensing opioids, benzodiazepines, barbiturates, or carisoprodol is limited to outpatient prescriptions.
For more information, contact NACDS’ Mary Staples at 817-442-1155.