Michael Silber – Page 208

Oregon

Effective March 23, the Health Authority adopted a final rule amending regulations as follows:

Repeals Temporary 333-018-0005 from PH 3-2021 & Amends 333-018-0005: Requires reporting of out-of-state (non-Oregon) cases of COVID-19 to the jurisdictional public health authority of the patient’s residence, rather than to OHA. Housekeeping changes remove outdated reporting language.
Amends OAR 333-018-0015: Housekeeping changes clarify in all relevant places that “intoxications” are among the illnesses to be reported and removes outdated reporting language, which is no longer applicable.
Amends OAR 333-018-0016: Requires reporting of positive and negative COVID-19 laboratory reports of tests “waived” in accordance with the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), whether or not the tests were performed in a laboratory accredited for higher complexity testing.

Also in Oregon, Via a temporary rule effective March 24 and expiring September 19, 2021, the Board of Pharmacy amends regulations under OAR 855-041 to remove the limit of the number of epinephrine devices that may be dispensed to an entity. For COVID-19 vaccines, appropriate medical treatment for severe allergic reactions must be immediately available if an acute anaphylactic reaction occurs following administration of a COVID-19 vaccine.

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

Michael Silber2021-04-02T08:48:43-04:00April 2, 2021|Oregon|

Texas

NACDS is asking members to call Rep. Stephanie Klick’s office, the Chair of the House Public Health Committee, urging her to schedule a hearing as soon as possible for TX HB 678 by Rep. Phil Cortez (D). Our message is that “there is an urgent need to permanently remove the administrative barriers allowing pharmacists to independently order and administer all immunizations to anyone 3 years of age or older without a prescription. Passing HB 678 will guarantee Texans get much better access to convenient, preventive health care.” Capitol Phone: (512) 463-0599; District Phone: (817) 281-0079 & Public Health Committee Phone: (512) 463-0806

Also in Texas, As the state opens COVID-19 vaccine eligibility to everyone age 16 and older, the Texas Department of State Health Services (DSHS) launched the Texas Public Health Vaccine Scheduler, giving people one place to sign up for a COVID-19 shot through multiple public health departments, including the eight DSHS public health regions, which provide public health services in nearly 200 Texas counties, and more than a dozen local health entities across the state.

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

Michael Silber2021-04-02T08:46:18-04:00April 2, 2021|Texas|

West Virginia

HB 2263, relating to the regulation of PBMs, advances to the desk of Gov. Jim Justice (R) for signature. Both the House of Representatives and the Senate adopted the Joint House and Senate Conference Committee Report and passed the bill. Among the various provisions is language establishing a reimbursement rate floor of NADAC (or WAC, if NADAC is not available) plus a $10.49 professional dispensing fee.

Also in West Virginia, SB 182, legislation enacting the Board of Pharmacy’s emergency rule related to the pharmacist and pharmacy intern authority to immunize, was approved by Gov. Jim Justice (R) on April 1. The emergency rule permits pharmacists and pharmacy interns to administer vaccines to adults listed in the CDC’s Recommended Adult Immunization Schedule as well as to individuals ages 11-17 years of age listed in the CDC’s Recommended Child and Adolescent Schedule according to a prescription and parental consent if there are no contraindications to the vaccine.

For more information, contact NACDS’ Jill McCormack at 717-592-8977.

Michael Silber2021-04-20T15:57:59-04:00April 2, 2021|West Virginia|

Alabama

The Board of Medical Examiners issued a final rule to adopt regulations under AAC 540-X-26 to establish requirements for collaborative practice agreements between physicians and pharmacists. The rule adds requirements for collaborative drug therapy management agreements, standards for physicians, reporting, patient care protocols, and the formulary and is effective April 12, 2021.

Also in Alabama, The Board of Pharmacy issued a final rule to amend regulations under AAC 680-X-2 to further specify the standards and requirements for approval of hospital and non-hospital pharmacy remote or off-site order entry, where prescriptions are filled by remotely accessing another pharmacy’s electronic database from outside the pharmacy. The rule is effective April 12, 2021.

Lastly in Alabama, The Board of Pharmacy also published a proposed rule to 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 to the proposed rule are due April 10, 2021.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

Michael Silber2021-03-26T12:21:41-04:00March 26, 2021|Alabama|

Alaska

The Board of Pharmacy published emergency regulations to make permanent 12 AAC 52.110 related to emergency licensure to practice as a pharmacist, pharmacy intern, or pharmacy technician. The emergency rule is effective retroactively to November 19. For more information, please see the March 15, 2021, filing notice which can be found here.

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

Michael Silber2021-03-26T12:20:13-04:00March 26, 2021|Alaska|

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.

Michael Silber2021-03-26T12:19:19-04:00March 26, 2021|California|

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.

Michael Silber2021-03-26T12:18:02-04:00March 26, 2021|Florida|

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.

Michael Silber2021-03-26T12:16:51-04:00March 26, 2021|Iowa|

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.

Michael Silber2021-03-26T12:15:55-04:00March 26, 2021|Maryland|

About Michael Silber