North Carolina
In April 2020 the DEA announced its intent to deschedule Epidiolex (previously a Schedule V controlled substance). On August 21 the DEA concluded that rulemaking process. Accordingly, under federal law, Epidiolex is no longer a controlled substance. However, for now, in North Carolina, Epidiolex remains a Schedule V controlled substance under state law.
Also in North Carolina. The next Board of Pharmacy election is scheduled to begin November 1, 2020. The Southeastern District seat presently held by J. Andrew Bowman is the only position on the Board that will be filled. Dr. Bowman will complete his first five-year term on April 30, 2021 and is eligible to run for a second term. All pharmacists actively licensed by the Board and living in North Carolina at the time of the election will be eligible to vote. Beginning November 1, 2020 pharmacists can simply log in to the Board’s Licensure Gateway and select from the list of candidates. To be eligible to run, the candidate must be an actively licensed pharmacist residing in one of the listed counties at the time of the election. Candidates who wish to stand for election will be required to submit a petition signed by ten (10) pharmacists residing in the Southeastern district to the Board office by October 1, 2020. Please contact Kristin Moore at the Board office for petition/signature logistics.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Oklahoma
Two rules recently approved by the state Board of Pharmacy go into effect on September 11, 2020.
- Final rule correcting a statutory citation regarding requirements for pharmacists prescribing naloxone.
- Final rule updating standards for pharmacy operations. The rule prohibits pharmacists from serving as a pharmacist in charge at more than one pharmacy at a time, adds refrigerator and freezer temperature requirements, clarifies requirements for shipments of pharmaceuticals, and revises hospital pharmacy provisions.
Also in Oklahoma. The Office of the Bureau of Narcotics (OBN) recently approved five rules of interest to pharmacies.
- Final rule of the Bureau of Narcotics and Dangerous Drugs Control adopts regulations under OAC 475:25-1 to establish reporting requirements for manufacturers and distributors of controlled dangerous substances. The rule also differentiates between the reporting requirements for pharmaceutical manufacturers and distributors and Schedule I medical marijuana manufacturers and distributors. The rule is effective Sept. 11, 2020.
- Final rule of the Bureau of Narcotics and Dangerous Drugs Control amends regulations under OAC 475:30-1 to update requirements for the transmission of prescriptions to pharmacies. The rule also clarifies when a pharmacy is authorized to fill a Schedule II-IV prescription and when identification is required for purchasers of controlled dangerous substances. The rule is effective Sept. 11, 2020.
- Final rule of the Bureau of Narcotics and Dangerous Drugs Control amends regulations under OAC 475:45-1 to clarify the information required to be submitted to the central repository for dispensation of Schedule II-V drugs. The rule is effective Sept. 11, 2020.
- Emergency rule of the State Department of Health amends regulations under OAC 310:535-1 to remove the requirement that those seeking a religious or personal exemption from immunization requirements must first view an instructional presentation by a local county health department on the benefits and risks of immunizations. The rule is effective Sept. 12, 2020 and expires Sept. 14, 2021.
- Final rule of the State Department of Health amends regulations under OAC 310:535-1 to establish an expiration date for vaccine exemptions submitted before the student enters the seventh grade and requires the submission of a new exemption form. The rule also requires those seeking a religious or personal exemption from immunization requirements to first view an instructional presentation by a local county health department on the benefits and risks of immunizations. The rule is effective Sept. 11, 2020.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Tennessee
The requirements listed in the Third Amendment to the PREP Act for pharmacists administering vaccines to children include the completion of two hours of ACPE-approved immunization-related CE during each licensing period. Completion of the Tennessee Pharmacy Association’s 2020 Annual Immunization and OSHA Update appears to fulfill this requirement. Click here for more information and registration.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Texas
In response to Secretary Azar’s PREP Act declaration, the Board of Pharmacy posted on their website a guidance document confirming the conditions under which pharmacists and pharmacist-interns acting under the supervision of a pharmacist are allowed to order and administer immunizations to children 3-18 years of age.
Also in Texas. According to the Louisiana Department of Health, pharmacies serving Louisiana patients that evacuated because of Hurricane Laura must enroll with Louisiana Medicaid for reimbursement of prescriptions. Please refer to the “Hurricane Laura Provider Assistance FAQs” in the Louisiana Department of Health Informational Bulletin 20-17 (Aug. 30) for more information.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Wisconsin
It was recently announced that the regulatory changes made to the Pharmacy Practice Act (Phar 7) will be effective on January 1, 2021. The Pharmacy Society of Wisconsin (PSW) is offering its members Online CE opportunities about the implementation of these regulatory changes. Please contact PSW for more information.
Also in Wisconsin. The Department of Health Services announced a grant opportunity for community organizations to increase awareness about the flu and the importance of getting flu vaccines.
For more information, contact NACDS’ Joel Kurzman at 847-905-0555.
District of Columbia
The Department of Health Care Finance (DHCF) online Quarterly Pharmacy Forum will take place on September 22, 2020, at 10 am and September 23, 2020, at 1 pm. The forum will be held to discuss pharmacy-related updates and is open to all pharmacy providers under the fee-for-service Medicaid Program. To attend, RSVP by September 21, 2020, to AnWilliams1@magellanhealth.com.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Florida
The Florida Department of Health; 850-488-0595; claudia.kemp2@flhealth.gov
has issued a notice to announce the intention of the Board of Medicine to amend regulations under FAC 64B8-13 to add an additional entity as a provider for continuing education for prescribing controlled substances. A comment due date has not been specified.
Also in Florida, The Agency for Health Care Administration has posted a proposed rule to amend regulations under FAC 59G-4 to incorporate by reference the 2020 Florida Medicaid fee schedules and billing codes. A hearing is scheduled for September 22, 2020, via webinar. Comments are due September 18, 2020.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Indiana
Indiana Health Coverage Programs (IHCP) has announced a new requirement that pharmacies use the Quantity Prescribed field for schedule II drugs on payer sheets beginning September 21, 2020.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Maryland
The Board of Pharmacy and Health Department has released a statement which recognizes the third amendment to the PREP Act declaration, authorizing pharmacists to administer pediatric vaccines subject to requirements under the declaration, supersedes state law, and is effective in the state.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Michigan
The Michigan Board of Pharmacy’s Rules Committee will meet on September 23, 2020, to discuss its Controlled Substance rule. The amended agenda and meeting information can be found here.
Also in Michigan, the Board of Pharmacy’s General Rules and Continuing Education Rules will have a public hearing on October 4, 2020. Hearing information can be found here.
For more information, contact NACDS’ Joel Kurzman at 847-905-0555.
Minnesota
The Minnesota Board of Pharmacy updated its COVID-19 Frequently Asked Questions document to include information in response to the third amendment of the PREP Act declaration.
For more information, contact NACDS’ Joel Kurzman at 847-905-0555.
Missouri
Missouri’s MOHealthNet began accepting ICD10 diagnosis codes on pharmacy claims on August 16. Updated information about billing codes and other instructions can be found here.
Also in Missouri, MOHealthNet issued a reminder that the final rule CMS-0055-F from the U.S. Department of Health and Human Services requires the reporting of the NCPDP Quantity Prescribed (460-ET) field for all Schedule II drugs on pharmacy claims by September 21, 2020.
Also in Missouri, the Board of Pharmacy’s final rules on technician non-dispensing duties away from the pharmacy, technician supervision, and remote data entry sites became effective August 30.
For more information, contact NACDS’ Joel Kurzman at 847-905-0555.
Nebraska
With the passage of Initiative 427, the Medicaid expansion program called Heritage Health Adult will become effective October 1, 2020. More information about Medicaid expansion can be found here
Also in Nebraska, the Nebraska Pharmacists Association (NPA) is looking for member pharmacists to participate in a Pharmacy Benefit Manager workgroup to continue progress on last year’s legislative effort. Please contact NPA Chief Executive Office Marica Mueting for more information.
For more information, contact NACDS’ Joel Kurzman at 847-905-0555.
Ohio
Two bills that would expand pharmacy scope of practice have been adopted by the General Assembly and are on their way to Governor DeWine (R) for signature:
- HB 203 expands the current law around Collaborative Practice Agreements to allow pharmacies to partner with clinical nurse specialists, certified nurse midwives, certified nurse practitioners, and physician assistants.
- HB 341 authorizes pharmacists to administer long-acting or extended-release drugs for addiction treatment
Also in Ohio. The Board of Pharmacy’s Rules Committee will meet virtually on September 10, 2020, at 9:30 am to review proposed changes and new rules governing pharmacy technicians, as well as new remote prescription and order entry rules. More information and instructions to access the meeting are on the agenda.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Pennsylvania
HB 943 has been signed by Governor Wolf (D). The bill, sponsored by Representative Valerie Gaydos (R), prohibits PBM gag clauses in contracts and provides pharmacies the right to provide patients with information about the cost of a drug, including the patient cost share. NACDS supported efforts to pass this bill.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
South Carolina
According to the South Carolina Department of Health and Human Services (SCDHHS), the state plans to transition its pharmacy reimbursement methodology to include an average acquisition cost (AAC) component. The state has contracted with Mercer to conduct the survey, which will be emailed to a randomly selected group of pharmacies between September 1st – 11th and it will be requesting August data. The new AAC rates will be published and effective on November 2, 2020.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
West Virginia
At the Board of Pharmacy’s recent meeting, the Board voted to release a statement regarding the Third Amendment to the Federal PREP Act declaration: A WV immunizing pharmacist who orders and administers pediatric vaccines in compliance with DHHS’ declaration during the federally-declared COVID-19 public health emergency shall not be deemed by the WV Board of Pharmacy to be in violation of the WV Pharmacy Practice Act or §15-12. The statement also offers a comparison of the requirements of the Federal Law v. WV Law.
Also in WV. The Board of Pharmacy published an emergency rule amending regulations under 15 WVCSR 1 to remove dispensing requirements for chloroquine and hydroxychloroquine established under a previous emergency rule, as the drugs are no longer facing supply shortages. The rule also defines activities that are not “compounding” to distinguish between compounding and combining prescriptions. In addition, the rule allows practitioners 15 days to provide an original prescription for emergency oral prescriptions and specifies acceptable methods for delivery, including electronically. Portions of the rule are in response to the Covid-19 pandemic. The rule is effective on approval by the Secretary of State or October 7, 2020, whichever occurs first.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Wisconsin
A final rule of the Department of Safety and Professional Services, Controlled Substances Board, amends the Prescription Drug Monitoring Program (PDMP) effective September 1. The rule requires drug dosage units and the partial fill indicator to be submitted to the program and clarifies that health care professionals may access PDMP reports for scientific research purposes if the patient is a direct patient and gave informed consent.
For more information, contact NACDS’ Joel Kurzman at 847-905-0555.
Arkansas
The Insurance Department posted a notice to announces the issuance of Bulletin No. 29-2020 on the extension of portions of certain coronavirus (COVID-19) bulletins issued under Executive Order 20-03, as amended by executive orders 20-25, -37, and -45 to extend the suspension of the consumer signature requirement for pharmacist services and certain obligations of pharmacy benefit manager (PBM) under the state price-gouging law. This extension became effective August 14 and will remain for the duration of the public health emergency.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
California
For the past four months, NACDS jointly with the California Retailers Association, the California Pharmacists Association and Board of Pharmacy, has been urging Governor Gavin Newsom’s Administration to remove existing barriers to allow pharmacies to fully engage in COVID testing. In early May, the Governor granted authority allowing pharmacies to only collect test specimens, due to limited restrictions of requirements to have a laboratory director. Finally, on August 24, the Governor signed an Executive Order increasing the availability of CLIA-waived COVID-19 testing by pharmacies. The order directs the Department of Consumer Affairs, in consultation with the California Department of Public Health, to issue waivers (DCA-20-45) permitting pharmacies with CLIA-waived certificates to have their pharmacists and pharmacy technicians to conduct CLIA-waived COVID-19 tests — order tests, collect specimens, process with the appropriate equipment and quickly provide patients with the results.
Also in California. The Department of Resources Recycling and Recovery has opened the comment period for the third draft of the Pharmaceutical and Sharps Waste Stewardship Proposed Regulations. The 15-day comment period is opened on August 21 and will close on September 4, 2020. Written comments can be submitted to pharmasharps@calrecycle.ca.gov.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Georgia
The Board of Pharmacy will hold a public hearing on the eleven (11) proposed rules and amendments provided here via conference call at its upcoming meeting scheduled for Wednesday, September 16, 2020. Comments to the proposed amendments are due to the Board by September 9, 2020.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Kentucky
Effective January 1, 2021, the Kentucky Cabinet for Health and Family Services (CHFS) will utilize Version 4.2B of the American Society for Automation in Pharmacy (ASAP) Prescription Drug Monitoring Program Standard for reporting controlled substance data to KASPER. Members may want to take the following actions to prepare:
- Review the implementation guide for Version 4, Release 2B of the ASAP Prescription Drug Monitoring Program Standard
- Review the KASPER Controlled Substance Reporting Guide:
- By Jan. 1, 2021, ensure your pharmacy systems are reporting two newly required fields:
1. DSP12 Transmission Form of Rx Origin Code.
2. DSP13 Partial Fill Indicator. CHFS will require this field for all prescription records reported to KASPER.
Additionally, effective January 1, 2021, when the PAT02 value is 07 for Social Security Number, the vast majority of records, the PAT03 value must be nine numeric digits or the record will be rejected with a fatal error and will need to be corrected.
Lastly, to support EPCS, KASPER will track the DSP20 – Electronic Prescription Reference Number, and DSP21 – Electronic Prescription Order Number fields. Reporting these fields is optional, but KASPER is requesting that pharmacies report this if capable. For further detail, please contact KASPER administration at (502) 564-2815 or eKASPER.admin@ky.gov.
Also in KY. NACDS reminds members that Kentucky Revised Statute 218A.182 mandates the electronic prescribing of controlled substances (EPCS) effective January 1, 2021. The Kentucky mandate is similar to the federal Medicare Part D EPCS mandate effective January 1, 2021, but applies to all controlled substances prescribed in Kentucky. Click here for more information, including criteria and process for an exemption.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
North Carolina
For all pharmacies that have received a Cost of Dispensing Survey response request, North Carolina Medicaid has extended its Cost of Dispensing Survey deadline from August 18th to September 1st.
Also in North Carolina. The Medical Board has issued a proposed rule which would amend regulations under 21 NCAC 32S to remove the physician’s assistant’s license number and authorized primary or back-up physician’s name and telephone number from the required information in the physician assistant prescription. A hearing is scheduled for October 16, 2020, via teleconference. Comments on the proposed rule are also due on October 16, 2020.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Texas
As two hurricanes headed for the Texas Gulf coast, earlier this week Governor Greg Abbott declared a disaster in multiple counties which automatically triggered emergency procedures for dispensing of medications. Additional information on the declared state of emergency can be found here.
Also in Texas. The Department of Insurance, Division of Workers’ Compensation issued an emergency rule waiving certain CMS distant site practitioner requirements during the COVID-19 outbreak that would allow health care providers licensed to perform physical medicine and rehabilitation services to bill and receive reimbursement for services allowed under current CMS telemedicine and telehealth billing codes. Under this emergency rule, these waivers will be extended until October 9, 2020.
Also in Texas. The Health and Human Services Vendor Drug Program (VDP) issued three announcements:
- Opioid-Related Clinical Prior Authorization Criteria Updates – VDP regularly updates clinical prior authorization criteria to better align drug policies and prior authorization approval criteria with the latest information available on drug information packets, the federal or state regulations. Opioid-related prior authorizations are scheduled for revision on September 1, 2020, to align with the uniform opioid policy.
- Insulin Products Return to Non-Preferred Status – VDP temporarily removed the non-preferred status on April 1 in response to reported drug shortages for insulin products in the “Hypoglycemics, Insulins” drug class. VDP will reverse this change in status because of sufficient availability in the market. Beginning September 18, 2020, the Medicaid formulary will reflect the Preferred Drug List status changes for all non-preferred insulin products.
- Inhaled Glucocorticoids Products Return to Non-Preferred Status – VDP temporarily removed the non-preferred status on April 1 in response to reported drug shortages for medications in the “Glucocorticoids, Inhaled” drug class. VDP will reverse this change in status because of sufficient availability in the market. Beginning September 18, 2020, the formulary will reflect the Preferred Drug List status changes for all non-preferred inhaled glucocorticoid products.
Also in Texas. On September 1, 2020, the Health and Human Services Commission (HHSC) will expand the Medicaid and CHIP benefit to allow and reimburse pharmacists for administering certain medications in a pharmacy setting, including the administration of certain long-acting anti-psychotics, opiate dependence treatments and emergency treatment for known or suspected opioid overdoses, and flu vaccines. Under this benefit, pharmacies must be reimbursed for the ingredient cost, administration fee, and applicable dispensing fee for each claim processed. Pharmacies will also be reimbursed for the administration of flu vaccines for ingredient cost and the administration fee. To prepare pharmacies for changes to the claims submission process an addendum (PDF) to the NCPDP B1 Transaction Billing Request Payer Sheet is available showing changes to three existing fields in the Drug Use Review/Professional Pharmacy Service segment and addition of one new field to the Pricing segment. Pharmacies should refer to the addendum for more information on how this change impact claims processing. VDP will revise the full B1 payer sheet upon implementation. More information can be found here.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Alabama
The Department of Public Health has issued a proposed rule that would amend regulations under AAC 420-7-2 to add tianeptine to the Schedule II list of controlled substances. The rule also would remove Epidiolex® from the list of Schedule V controlled substances. Comments to the proposed rule are due September 4, 2020.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.