Florida
The Board of Pharmacy issued a Final rule to repeal regulations under FAC 64B16-28 to remove outdated requirements for automated pharmacy systems in community pharmacies. The rule is effective June 24, 2021.
Also in Florida, the Board of Pharmacy issued a Final rule to amend regulations under FAC 64B16-28 to increase to 120 days the maximum beyond-use date requirement for labels of customized patient medication packages. The rule also requires pharmacies using customized patient medication packages to have policies and procedures addressing patient medication regimens. The rule is effective June 24, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Indiana
Gov. Eric Holcomb (R) signed Executive Order 21-14 to extend the public health emergency to June 30 and Executive Order 21-15 to adjust COVID-19 requirements effective June 1st. Each directive from executive orders continued throughout the public health emergency will cease on June 30th. The following directives relating to pharmacy practice will no longer be in effect:
- EO 20-05: Suspended the requirement that a healthcare provider holds an Indiana license if he or she: (1) has an equivalent license from another State, and (2) is not suspended or barred from practice in that State or any State. Authorized the head of any state agency (including PLA) to waive, suspend, or modify any existing rule where the enforcement of which would be detrimental to the public welfare during the emergency.
- EO 20-12: Non-controlled substances as maintenance medications permitted a one-time 90-day emergency refill.
- EO 20-13: Retired health care professionals who, within the past 5 years, retired or surrendered their license, may provide health care services in Indiana without reinstatement or approval by the relevant license board.
- EO 20-21: Pharmacy students who have completed all required course work, applied for a pharmacist license, and supplied a certificate of completion, may practice as a pharmacist without first taking and passing the MPJE and NAPLEX.
- EO 20-27 and 20-31: Any license set to expire during the public health emergency is extended for the duration of the public health emergency.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Iowa
Gov. Kim Reynolds (R) sent a letter to Paul Pate, Secretary of State of Iowa, directing the Department of Human Services to amend current Medicaid managed care contracts to authorize a $10.38 dispensing fee per prescription across-the-board for all pharmacies under Section 31 of HF 891. This action is in response to a meeting and letter NACDS sent to the Governor requesting a veto of language in HF 891 directing the department to amend Medicaid managed care organization contracts to authorize the establishment of a managed care pharmacy dispensing fee that is based on the current fee-for-service dispensing fee of $10.38 or a dispensing fee that is not to exceed the current fee-for-service rate and determined contractually by mutual agreement between the managed care organization and a participating pharmacy with more than 30 locations in the state and headquarters outside the state. The Governor agreed with industry stakeholders that this policy creating differential dispensing fees for certain pharmacies raises significant constitutional concerns. NACDS acknowledges the collaborative efforts of the Iowa Retail Federation and the Iowa Pharmacy Association staff.
Also in Iowa, below are highlights from the June issue of the Iowa Board of Pharmacy newsletter. See the newsletter for additional details and more information.
- The law authorizing pharmacists to administer vaccinations via a practitioner-signed protocol will expire on June 30, 2021. Beginning July 1, 2021, pharmacists may order and administer vaccinations under the Iowa Board of Pharmacy's statewide protocol or according to a patient-specific prescription issued by a practitioner.
- 2021 Regular Session of the Iowa Legislature
- The Board's bill amending the Iowa Controlled Substances Act (CSA) to include nine substances that had been temporarily scheduled via rulemaking and provide conforming text to match federal CSA structure was signed into law.
- The Board's bill (HF 514) eliminating the one-year limitation of a technician trainee registration, revising delegation of functions to pharmacy technicians and pharmacy support personnel, and including other provisions relating to pharmacy practice was also signed into law.
- REMINDER: As of May 12, 2021, Schedule V controlled prescriptions must be reported to the Iowa Prescription Monitoring Program (PMP). Also, newly adopted rulemaking includes nonprescription sales of codeine-containing cough suppressants as reportable transactions.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
Kentucky
The Board of Pharmacy has published guidance for prescribers and dispensers of controlled substances on how to correct records submitted to the Kentucky All-Schedule Prescription Electronic Reporting (KASPER) system.
Also, in Kentucky, NACDS reminds members that effective July 1, 2021, MedImpact will be the single pharmacy benefits manager for the managed care program. For more information including provider notices and updates go to the Kentucky Medicaid Pharmacy Program page.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Maine
As the Maine Legislature moves toward adjournment two key pieces of legislation have been signed into law. First, Governor Janet Mills (D) signed into law Legislative Document (LD) 603 — critical legislation that will help enhance patients’ access to convenient and affordable pharmacy-based care by recognizing pharmacists as providers of healthcare services in the state of Maine. The Governor also signed into law Legislative Document (LD) 8, the prescription drug disposal proposal that would expand the collection of unwanted prescription drugs for proper disposal and will be fully funded by the drug manufacturers.
For more information, please contact NACDS’ Mike Sargent at 207-272-6435.
Maryland
The Department of Health published the Final Rule increasing the Medicaid Pharmacy Dispensing Fee from $11.49 to $11.67. The increase is retroactive to Feb. 1, 2021.
Also in Maryland, HB14 has taken effect without the Governor's signature. Pharmacists may now utilize the manufacturer's expiration date on prescription drugs issued in the original manufacturer's packaging.
Also in Maryland, On June 15 the Department of Health issued an Amended Directive and Order Regarding Vaccination Matters that supersedes and replaces previous orders. Notably, it recognizes the ability of trained personnel to administer vaccines at vaccination sites under supervision.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Minnesota
The Department of Health (MDH) has given notice of intent to adopt guidance on the implementation of the Prescription Drug Price Transparency Act of 2020. MDH will accept written, electronic comments until 4:30 PM CT on June 24. Questions may be sent to health.Rx@state.mn.us. For additional information or to sign up for email updates go to MDH’s Prescription Drug Transparency Webpage.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Mississippi
A Proposed rule of the Board of Pharmacy would amend regulations under Title 30, Part 3001, Article XII to specify that medication orders in long-term care settings are considered prescriptions. Comments are due June 29, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Missouri
In response to a request from the State Board of Pharmacy Executive Director Kimberly Grinston, NACDS and the Missouri Retailers Association submitted several pharmacists and pharmacy technicians’ names for consideration to serve on the new task force to study working conditions.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
New Jersey
Governor Phil Murphy (D) signed into law A5820/S3866 ending the COVID 19 Public Health Emergency that has been in place since March 9, 2020. Many of the executive orders issued under the Public Health Emergency will expire by July 4, 2021. Only Executive Orders that govern vaccinations and testing will remain in effect until January 11, 2022.
For more information, please contact NACDS’ Mike Sargent at 207-272-6435.
New York
The New York State Legislature adjourned on June 11 after passing a flurry of proposals in the last hours. Of particular interest to pharmacy are four bills:
- A6476A/S4807A authorizes pharmacists to provide current immunizations, which are recommended by the federal Centers for Disease Control and Prevention to patients eighteen years or older according to a standing order with a physician or NP. The bill also creates a regulatory process for vaccines approved in the future through the State Health Department and Education Department.
- A7598/S6603 allows patients to utilize their pharmacy of choice under Medicaid managed care and have a choice in receiving medications by delivery or mail from their local pharmacy across insurance lines. The bill would also make the Fee for Service reimbursement rate for pharmacies apply to Medicaid managed care.
- A1396/S3762 requires licensure for pharmacy benefit managers (PBMs) and specifies their duties and obligations as service providers, regulated to the State Department of Financial Services and Department of Health.
- A5854A/S3566 clarifies and strengthens provisions in current law to ensure that patients have the option to access every covered medication from a local network participating pharmacy and are not forced into mandatory mail order if the pharmacy accepts the same reimbursement.
Governor Andrew Cuomo (D) has until December 31, 2021, to sign the proposals into law.
For more information, please contact NACDS’ Mike Sargent at 207-272-6435.
North Carolina
Beginning July 1, North Carolina will transition from a fee-for-service Medicaid program to Managed Care. More information on this transition can be found here. You may also find the June 16, 2021, Managed Care Transformation update for pharmacy stakeholders presentation here. Of note, 90-day fills and mail and delivery fees from local/community pharmacies, which were flexibilities granted during the COVID State of Emergency have been made permanent. Also Slide 18 on the presentation contains important Medicaid billing updates.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Pennsylvania
Last week, the General Assembly voted to terminate the Governor’s disaster declaration. Both chambers then subsequently passed legislation, which Governor Wolf (D) signed, that extends all statutory and regulatory waivers until September 30, 2021. We anticipate further legislative action in the fall related to the continuation of some waivers and flexibilities beyond September 30 and will continue to update members on those efforts.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
South Carolina
The Centers for Medicare and Medicaid Services (CMS) has informed the South Carolina Department of Health and Human Services (SCDHHS) that the South Carolina Healthy Connections Medicaid program will participate in the Payment Error Rate Measurement (PERM) program for State Fiscal Year 2022. CMS’ PERM program was developed to measure the accuracy of Medicaid and Children’s Health Insurance Program (CHIP) payments made by states. Each state is reviewed once every three years. Samples of claims with paid dates of July 1, 2021, through June 30, 2022, will be subject to review. You can review the entire bulletin here.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Texas
NACDS continues to strongly advocate, through social media messaging and pharmacists contacting Gov. Greg Abbott (R) before Sunday, June 20, 2021, that the governor sign into law HB 1919, legislation that would help maintain patients’ right to choose a pharmacy provider by prohibiting health benefit plans and pharmacy benefit managers from “steering” patients to use any in-network pharmacy provider over another.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Alabama
Stakeholders were recently made aware that at least one PSAO has sent communications to its pharmacy members that it would begin charging sales tax on its services in June. The Alabama Department of Revenue (DOR) has confirmed that the collection of sales taxes for PSAO services is not in compliance with the sales tax law. The DOR further stated that if additional PSAOs attempt to collect sales tax for their services, pharmacies should contact the DOR to resolve the issue.
Also in Alabama, the Board of Pharmacy has proposed the below rules.
- Proposed rule of the Board of Pharmacy would amend regulations under AAC 680-X-2 to replace “inspectors” with “investigators” in the provisions on revealing sources of information related to violations. A hearing is scheduled for July 21, 2021, in Birmingham. Comments are due July 10, 2021.
- Emergency rule of the Board of Pharmacy adopts regulations under AAC 680-X-2 to allow the board to issue temporary pharmacist practice permits during the coronavirus (Covid-19) public health emergency. The rule applies to applicants licensed in another state who meet specified criteria. The rule readopts the April 30, 2020, emergency rule and became effective April 28, 2021, and expires August 26, 2021.
- Proposed rule of the Board of Pharmacy would repeal and readopt regulations under AAC 680-X-2 to update the physician and pharmacist collaborative practice requirements. A hearing is scheduled for July 21, 2021, in Birmingham. Comments are due July 10, 2021.
- Proposed rule of the Board of Pharmacy would amend regulations under AAC 680-X-2 to include supervising pharmacists and technicians in the disciplinary provisions for violation of the pharmacy technician training requirements. A hearing is scheduled for July 21, 2021, in Birmingham. Comments are due July 10, 2021.
- Proposed rule of the Board of Pharmacy would amend regulations under AAC 680-X-2 to revise requirements for registered pharmacists to notify the board of a change of supervising pharmacist. A hearing is scheduled for July 21, 2021, in Birmingham. Comments are due July 10, 2021.
- Emergency rule of the Board of Pharmacy amends regulations under AAC 680-X-2 to allow pharmacists to provide emergency prescription refills for a 30-day supply of maintenance medications under certain circumstances during the COVID-19 public health emergency. The rule readopts a March 31, 2020, emergency rule and became effective April 21, 2021, and expires August 26, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Arkansas
The Department of Human Services issued two new proposed rules:
- Proposed rule amending Medicaid provider regulations to remove references to the Arkansas Foundation for Medical Care, Inc. as the vendor used for approval, denial, or extension of Medicaid benefits.
- Proposed rule amending regulations to revise the Pharmacy Provider Manual to update the Place of Service Code to “01,” effective for dates of service on August 1, 2021.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
California
The State Board of Pharmacy published its agenda for the June 17, 2021, teleconference public board meeting that includes discussion and consideration of adoption of board approved regulation, Section 1717.5 related to automatic refill program, and discussion and consideration of public comments received during the 15-day comment period on the proposed new modifications to the regulation.
Also in California, the Department of Managed Health Care released an All Plan Letter 21-016 to provide information and guidance on when health care service plans must cover COVID-19 diagnostic testing. The letter specifies that health plans must continue to cover testing as required by federal law and guidance that is still in effect and to refer to COVID-19 testing guidance issued by the California Department of Public Health.
Lastly in California, the Board of Pharmacy issued a notice amending regulations under 16 CCR 1715.6 to revise drug loss reporting requirements to establish a minimum reporting threshold and align with federal standards. Hearing requests are due July 5, 2021, and comments are due July 19, 2021
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
District of Columbia
Mayor Muriel Bowser (D) signed B24-257 to allow emergency refills under certain conditions. The bill was introduced and passed as a “gap filler” between the expiration of the previous emergency amendment act, B24- 139, and B24-140 as it will be under Congressional Review for another 2 weeks before becoming law.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Florida
Effective October 1, 2021, any fee-for-service (FFS) claim submitted with a National Provider Identifier (NPI) for a provider not enrolled with Florida Medicaid will be denied, and the provider will not receive reimbursement for services. This includes claims that list a Referring, Ordering, Prescribing, or Attending (ROPA) provider. ROPA providers must be enrolled with Florida Medicaid following Title 42, Code of Federal Regulations, Section 455.410(b). Starting October 1, 2021, claims will not be paid for any practitioner, group practice, facility, or pharmacy providing services to Florida Medicaid recipients based on a ROPA provider’s referral, order, prescription, or attending services, unless the ROPA provider identified by NPI on the FFS claim is actively enrolled with Florida Medicaid.
Florida Medicaid features a quick and easy, automated ROPA provider enrollment application on the Florida Medicaid Web Portal Enrollment Application Wizard page. Please visit the ROPA Provider Enrollment page of the Web Portal for updated information, including the recently created Unenrolled ROPA Provider List, ROPA Providers Frequently Asked Questions, and Quick Reference Guides on ROPA provider enrollment and claims billing. Providers may call the Provider Services Contact Center at 1-800-289-7799, option 7, for billing assistance and option 4 for enrollment assistance.
Also in Florida, the Department of Business and Professional Regulation has proposed the below rules.
- Proposed rule of the Department of Business and Professional Regulation would amend regulations under FAC 61N-1 regarding drug and device labeling requirements to revise the references to federal regulations incorporated by reference. Comments and hearing requests are due June 28, 2021.
- Proposed rule of the Department of Business and Professional Regulation would amend regulations under FAC 61N-1 to update the application forms incorporated by reference for permits to be a diethyl ether manufacturer, distributor, dealer, or purchaser. Comments and hearing requests are due June 28, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Louisiana
The Board of Pharmacy recently approved several rules effective May 20, 2021.
- Final rule increases the amount of medication that may be dispensed under an emergency prescription to a 90-day supply. The rule also provides for special permitting of pharmacists licensed outside the state to allow participation in disaster relief.
- Final rule establishes standards for licensure of pharmacy benefit managers engaged in certain activities. The rule establishes procedures for board review of applications for the initial issuance of the permit, the renewal of the permit, applications for the reinstatement of disciplined permits, and the permanent closure of a permit.
Also in Louisiana, the Department of Health (LDH) is reviewing the current transportation services and pharmacy benefit delivery models for its Medicaid managed care program. LDH is seeking input by June 21, 2021, on the key factors that must be considered when improving these models. This feedback can be provided at: https://ldh.la.gov/index.cfm/form/241.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Minnesota
The Department of Health expects to issue guidance on how to comply with the Prescription Drug Price Transparency Act by early summer 2021, which will include technical definitions and reporting requirements for the act. MDH will share information related to the act’s implementation and opportunities for public feedback on this page, through GovDelivery bulletins, and via State Register announcements. Stakeholders interested in receiving announcements on implementation of the act may subscribe to Prescription Drug Price Transparency updates.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
Mississippi
The Division of Medicaid has issued the below final rules.
- Final rule of the Division of Medicaid amends regulations under Title 23, Part 224, Chapter 1 to set the fees for immunizations to those in effect for the state fiscal year 2021. The rule is effective July 1, 2021.
- Final rule of the Division of Medicaid amends regulations under Title 23, Part 200, Chapters 1, 3, and 4 to increase to 90 days the time period for providers to request an administrative review for claims. The rule also revises beneficiary cost-sharing and 340B provider requirements to comply with federal standards. The rule is effective July 1, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Missouri
Gov. Mike Parson (R) signed SB 63 into law, which makes it the 50th state to create a statewide prescription drug monitoring program. The bill establishes the Joint Oversight Task Force of Prescription Drug Monitoring, responsible for collecting and maintaining the prescription and dispensation of prescribed controlled substances to patients within the state. It also extends the expiration date of the RX Cares for Missouri Program to August 28, 2026.
Also in Missouri, the Department of Social Services, MO HealthNet Division, issued two new proposed rules requesting comments by July 1, 2021. Both are currently in effect as emergency rules expiring February 24, 2022.
- Proposed rule removes obsolete provisions and references new provisions establishing the payment methodology for covered entities under the 340B drug pricing program that choose to carve in Medicaid.
- Proposed rule establishes the payment methodology for covered entities under the 340B drug pricing program that chooses to carve in Medicaid.
Also in Missouri, the Board of Pharmacy issued a final rule effective June 30, 2021, removing the limit on the number of intern pharmacist practice hours that may be earned per week.
Also in Missouri, the Department of Commerce and Insurance issued a proposed rule to establish the license application process and a $1,000 application fee for pharmacy benefit managers. The rule replaces a September 15, 2020, proposed rule. Comments are due on June 16th, and a public hearing will be held on June 17, 2021.
Also in Missouri, the Board of Pharmacy is soliciting comments on two proposed rules:
- Proposed rule rescinds regulations regarding pharmacy operating procedures during declared disasters. A concurrent proposed rule would readopt the provisions to address both disasters and state/federal emergencies. Comments are due June 16, 2021.
- Proposed rule adopts regulations establishing guidelines for temporary pharmacy operations during an emergency or declared disaster. The rule would replace pharmacy disaster operation procedures that are proposed for repeal concurrently.
Also in Missouri, the Board of Pharmacy recently approved two final rules 20 CSR 2150-5.025 and 20 CSR 2220-6.050 which allows pharmacy technicians to administer vaccines under the supervision of a state-licensed pharmacist according to a written protocol with a licensed physician who is actively engaged in the practice of medicine. The rule is issued in response to the COVID-19 pandemic effective July 30, 2021.
Lastly in Missouri, the Department of Social Services, MO HealthNet Division issued three final rules effective July 30, 2021.
- Final rule adds an exception to the 31-day supply maximum restriction on medications reimbursed by the division on behalf of participants eligible for the fee-for-service programs, and an exception to allow for a 90-day supply requirement for select medications established in a concurrent rule. The rule also replaces references to “recipient” and “patient” with “participant.”
- Final rule adopts a 90-day supply requirement per dispensing on select medications reimbursed by the division on behalf of participants eligible for Medicaid fee-for-service programs.
- Final rule revises the amount of the professional dispensing fee reimbursable for MO HealthNet covered prescriptions by pharmacy providers.
For more information, contact NACDS’ Mary Staples at 817-442-1155.
Montana
SB 395 Chapter Number: 501, establishing licensure, reporting, marketing, and advertising, network adequacy requirements, and 340B related provisions for PBMs, was signed by Gov. Greg Gianforte (R) on May 12, 2021.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.