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.
California
NACDS and representatives from members operating in California met virtually with the Department of Health Care Services (DHCS) Medi-Cal team and the Department of Public Health (CDPH) Immunization Branch to discuss the ways that pharmacies can expedite expanded access to flu and COVID vaccines this fall. Chain members advocated for the use of trained pharmacy technicians to help administer the vaccines, requested that the state’s PPE stockpile be accessible to pharmacies, and identified some potential challenges on reimbursement that should be streamlined. The state pledged to work closely with chain pharmacies to resolve these issues.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Colorado
The final rule approved by the Board of Pharmacy that suspends certain requirements regarding closure and minimum hours of operation of prescription drug outlets, consultant pharmacist inspections, and drug therapy management will become effective August 30, 2020. The rule removes certain requirements for sterile compounding and shortages around garbing supplies, eliminates certain requirements for remote practice and hospital satellite pharmacies, and allows pharmacists to administer COVID-19 tests authorized by the FDA.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
District of Columbia
Mayor Muriel Bowser (D) has signed legislation allowing pharmacists to substitute interchangeable biological products. The bill includes prescriber notification language that is aligned with the model language supported by NACDS in other states. The measure will now be sent to Congress for the standard 30-day review period as required by DC regulation.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Florida
The Florida Department of Health announced a notice of change to a May 15th proposed rule that would adopt regulations under FAC 64B-3 to provide a form and procedure to request a waiver of electronic prescribing requirements for prescribers facing economic hardship or technological limitations. The changes revise the form to require the location of the waiver site, a detailed description of the need for the waiver, a description of the practitioner’s current electronic prescribing capabilities, and the expected date the practitioner will be fully operational.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Kentucky
The Department for Public Health published an order relating to the COVID-19 public health emergency. The order specifies that a clinician’s order is not required for a laboratory services provider to perform and bill for a molecular diagnostic test, that insurers will not require an order as a precondition for coverage, and that clinicians are not required to have established a formal clinician-patient relationship unless professional medical advice beyond providing this testing service is otherwise explicitly provided. The order also addresses cost sharing and in vitro diagnostic products.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Louisiana
NACDS, alongside with the Public Health Department’s Immunization Director Stacy Hall, presented to public health officers around the country on the importance of flu and COVID vaccines. This presentation focused on the ways in which community pharmacies can be ready to expedite expanded access to flu and COVID vaccines, when available
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Maryland
The Board of Pharmacy, by a vote of 8-3, approved a draft regulation allowing Technician Product Verification in the community pharmacy setting. Prior to the vote, an amendment was adopted to clarify that the same technician could not do both verification’s. The regulation will now go to the Secretary of Health for approval prior to being published for public comment. NACDS will share an amended draft as soon as it become available.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Pennsylvania
Under new policy changes, pharmacists can now provide and bill tobacco cessation services under Medicaid’s UnitedHealth/Optum plan. For more information click here.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
South Carolina
The South Carolina Department of Health and Human Services (SCDHHS) plans to transition its pharmacy reimbursement methodology to include an average acquisition cost (AAC) component. Per SCDHHS, the goal of this transition is to ensure that pharmacy reimbursement rates are responsive to drug pricing fluctuations in the South Carolina market. To support the development and maintenance of AAC rates, SCDHHS has contracted with Mercer Government Health Consulting to establish and maintain the AAC program. Starting September 2020, pharmacy providers will receive a survey requesting copies of pharmacy invoice records to be sent to SCDHHS. Per SCDHHS, this survey will allow the agency to measure the drug acquisition costs incurred by Healthy Connections Medicaid pharmacy providers. A pharmacy stakeholder information session to discuss the AAC survey process and project timeline will be held via webinar Tuesday, August 25, 2020, at 3 p.m. (EST). Providers and stakeholders can register for the webinar here.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Texas
To advance our 2021 legislative agenda, NACDS and the Texas Federation of Drug Stores continue to schedule virtual meetings with lawmakers, advocating for increased access to immunizations (including the future COVID-19 vaccine), expanded pharmacists scope of practice, and fair Medicaid reimbursement. In support of these initiatives, NACDS and pharmacists from HEB and Walgreens that live and work key districts recently met with Senator Kelly Hancock (R) (Chair of the Business and Commerce Committee), Representative Geanie Morrison (R), Representative Julie Johnson (D), Representative John Kuempel (R), and Representative Eddie Lucio III (D).
Also in Texas. On September 15th , the Health and Human Service Commission Vendor Drug Program will extend the non-preferred prior authorization duration for macrolides from 30 days to 90 days for people with a diagnosis of Gastroparesis, Cerebral Palsy Gastroparesis, or GERD Gastrostomy complications. Managed Care Organizations are required to comply with this PDL prior authorization criteria, including duration. More information can be found here.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
California
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.
Colorado
Concerned about pharmacies’ capacity to provide flu vaccines this fall during a time when the health care system is stressed due to COVID, the Department of Public Health and Environment (CDPHE) is asking pharmacies to complete a readiness survey by Monday, August 17, 2020. This survey is intended to gather information from pharmacies about their capacity to provide influenza vaccine for the 2020/2021 influenza season.
Also in Colorado. The Department of Regulatory Agencies (DORA) Division of Insurance adopted an emergency rule establishing coverage and cost-sharing requirements for claims related to testing and treatment of the coronavirus (COVID-19). The rule also adds requirements for access to prescription drugs during the COVID-19 public health emergency allowing covered persons to obtain refills of up to 90 days of prescription drugs before the scheduled refill date so that covered persons are ensured an adequate supply of medications. Pursuant to the rule, carriers shall not apply a different cost-sharing amount for an early refill of a prescription. The rule expires on November 15, 2020.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Kentucky
The Board of Pharmacy has published a final rule amending regulations under 201 KAR 2 to update the responsibilities of pharmacists and pharmacist interns under supervision. The rule also removes references to “immediate” supervision and clarifies language. The rule was effective July 3.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Louisiana
Medicaid open enrollment for Healthy Louisiana, the Medicaid managed care program, begins on October 15, 2020, and runs through November 30, 2020. During this time, beneficiaries have an opportunity to choose a new health plan or remain with their current plan.
Also in Louisiana. On August 13, the Board of Pharmacy discussed NACDS supported proposed rules regarding technician ratios and technicians administering immunizations.
Also in Louisiana. The Department of Health issued an informational bulletin summarizing temporary changes in provider policies and managed care practices. This bulletin is to inform all providers rendering services to Louisiana Medicaid members, including members of all Medicaid managed care organizations (MCO) on issues including but not limited to, Laboratory Testing of Suspected Patients, Laboratory Testing using High Throughput Technology, Testing and Treatment Coverage, and COVID-19 Counseling and Evaluation and Management Services.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Maryland
The Maryland Department of Health has released a bulletin that added the NCPDP-recommended billing code to its approved codes for billing for COVID-19 specimen collection. Details on the bulletin can be found here.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Mississippi
The Board of Pharmacy issued a proposed rule that amends regulations under Title 30, Part 3001, Article IV to change the number of required continuing education hours that a licensed pharmacist must take that address opioid abuse to two hours. Comments on these proposed changes are due August 21, 2020.
Also in Mississippi. The Board of Pharmacy also issued a proposed rule that amends regulations under Title 30, Part 3001, Article VII, to require a pharmacist in charge to be physically present at a facility for at least 50% of the time or 20 hours per week. The rule also would require that a permit for a pharmacy becomes inactive if an application for a new pharmacist in charge is not submitted within 15 days. Comments to the proposed changes are due August 21, 2020.
Lastly in Mississippi. The Board of Pharmacy issued a proposed rule to adopt regulations under Title 30, Part 3001, Article XLVIII to establish standards and procedures for delivering pharmacy services through a telehealth system that monitors the dispensing of prescription drugs and provides for related drug use review and patient counseling services by an electronic method including audio, video, still image capture, and store and forward. Comments are due August 21, 2020.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Nevada
The Board of Pharmacy issued a proposed rule to amend regulations under NAC 453 adding certain substances to schedule I; providing that certain drug products that contain CBD are not a controlled substance; removing certain drug products that contain CBD from the list of controlled substances on Schedule V, and providing other matters properly relating thereto. Comments on these proposed changes will be accepted but no due date has been specified by the state.
Also in Nevada. On August 6, the legislature adjourned the 6-day special session. Only 11 bills were passed, most notably a bill expanding access to mail-in ballots for the November general election, providing limited liability protections from COVID for businesses, and certain government entities and non-profit organizations.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
New Mexico
On August 5, the Environment Department (NMED) filed an emergency amendment to require employers to report positive COVID-19 cases in the workplace to the NMED Occupational Health and Safety Bureau within four hours of being notified of the case. The emergency rule is effective for 120-days, or until December 3, 2020, unless NMED proposes and the Environmental Improvement Board adopts a permanent rule. Guidance documents can be found here.
Also in New Mexico. The Board of Pharmacy approved the recommendations by the Board’s Practice Committee for a new protocol allowing pharmacists to treat patients with a positive CLIA-waived result. The five treatment areas under the new protocol are flu, strep, HIV PEP, and COVID-19. Notably, the new protocol includes language allowing the treatments to be FDA approved or FDA Emergency Use Authorizations (EAU). Certain COVID-19 tests have received authorization from the FDA that classify them as CLIA-waived tests. The protocol must now gain approval from both the Medical and Nursing Boards in August who may then return the revised protocol to the Board of Pharmacy for final approval. Protocols can be found here.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Ohio
The Board of Pharmacy posted guidance to remind pharmacies about their Pharmacy Personnel Licensure and Registration Requirements. Guidance can be found here.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Texas
The Health and Human Services Commission announced that effective September 1, 2020, the Vendor Drug Program (VDP) will implement a uniform opioid policy across fee-for-service and managed care programs to encourage appropriate use and reduce opioid over-prescribing. The opioid policy does not apply to people receiving hospice care or palliative care, treatment for cancer, residents of a long-term care facility or another facility for which residents receive opioid substitution therapy for the treatment of opioid use disorder (OUD), or other people they elect to exempt based on an objective, confirmable physical pathology known to cause severe chronic pain not ameliorated by other therapies and for which opioid treatment is appropriate. According to the announcement, if diagnoses are not available in the medical data, exemptions will be handled on a case-by-case basis through the prior authorization process. More information can be found here.
Also in Texas. The Department of Insurance adopted an emergency rule that requires health benefit plans to extend established prior authorization approvals for drugs by 90 days and requires plans to authorize payment for a one-time additional 90-day supply of a covered drug. The rule also requires plans to cover prescription drugs from out-of-network pharmacies with no additional cost-sharing when the enrollee cannot obtain them in-network, requires plans to make alternative drugs available in the event of shortages, and prohibits plans from requiring an enrollee signature at the point of delivery. Also, the rule prohibits plans from refusing or reducing payment for a prescription drug based on the fact such a drug was delivered by a local pharmacy. The rule expires on September 27, 2020 (see page 2378 in the link: https://www.sos.state.tx.us/texreg/pdf/backview/0410/0410is.pdf).
Also in Texas. On August 8, Governor Greg Abbott extended his Disaster Declaration for all Texas counties in response to COVID-19 for another 30-days. Originally issued on March 13, 2020, the Disaster Declaration provides the state with a variety of resources to effectively serve Texans as the Lone Star State continues to mitigate the spread of COVID-19.
For more information, contact NACDS’ Mary Staples at 817-442-1155.