Public Health Emergency Extended, Comments to FTC on PBMs, BOP to Expand Tech Duties & More

COVID-19 Public Health Emergency Declaration Extended

The Department of Health and Human Services Secretary Xavier Becerra has issued an order extending the public health emergency related to the current pandemic.  The order effective April 16^th will expire on July 15, 2022 unless renewed.  Members are reminded that the Public Health Emergency Preparedness Act (PREP) included a number of amendments that provided the ability for pharmacists to test and treat patients with COVID-19 as well as granting the ability for pharmacy technicians to administer vaccines.  The Florida legislature has already revised the pharmacy practice act giving technicians vaccine administration authority (see article in the March 2022 issue of Florida Pharmacy Today).  The Board of Pharmacy also has ordered a minor revision to rule 64B16-26.1032 to broaden the administration certification application to cover all licensees under F.S. 465

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FTC Asking for Comments on PBMs

The Federal Trade Commission is soliciting for public comments on the business practices of pharmacy benefit managers and their impact on independent pharmacies and consumers.  The FTC staff is studying a wide array of PBM business practices and issues including but not limited to the following:

• The impact of PBM rebates and fees on net drug prices to patients, employers, and other payers.
• The impact of PBM rebates and fees on formulary design and patients’ ability to access prescribed medications without endangering their health, creating unnecessary delay, or imposing administrative burdens for patients or prescribers.
• Whether patients are being forced to substitute different prescription drugs to maximize PBM rebates and fees.
• PBMs’ use of potentially unfair, deceptive, or anticompetitive contract terms and all related practices when calculating pharmacy reimbursements and disbursements, including the use of Average Wholesale Price, Wholesale Acquisition Cost, Maximum Allowable Cost, and Usual and Customary Pricing as well all types of claw backs, fees, discounts, and performance metrics, such as Direct and Indirect Renumeration, Generic Effective Rate, Brand Effective Rate, Dispense Fee Effective Rate and all other similar provisions.
• PBMs’ use of other potentially unfair, deceptive, or anticompetitive practices, including audit provisions; pharmacy network design and exclusions; use of gag clauses, confidentiality clauses, and non-disparagement clauses; and other potentially unfair provisions.
• PBMs’ use of methods to steer patients away from unaffiliated pharmacies and methods of distribution and toward PBM-affiliated specialty, mail-order, and retail pharmacies.
• PBMs’ policies and practices related to specialty drugs and pharmacies, including criteria for designating specialty drugs, reimbursements to specialty pharmacies, practices for encouraging the use of PBM-affiliated specialty pharmacies, and practices relating to dispensing high-cost specialty drugs over alternatives.
• Potential conflicts of interest and anticompetitive effects arising from horizontal and vertical consolidation of PBMs with insurance companies, specialty pharmacies, and providers.

This is an opportunity for our members who are concerned to share their stories with the federal agency that should be looking at this issue.  You have until May 25, 2022 to file your comments. Please visit our “Empower Patients” web portal on the FPA web site for more information.

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FPA Joining with National and other State Pharmacy Associations on Payment for COVID-19 Vaccinations

The Health Resources and Services Administration (HRSA) issued a notice to pharmacists and other health care practitioners that the uninsured program for COVID-19 vaccinations will not be accepting claims due to a lack of funds.  Congress had been working to provide additional funding however the proposal got entangled with the debate over the U.S. boarder.  Pharmacists have been the biggest provider of COVID vaccines throughout the pandemic and should be reimbursed for their services.  We understand that a provider contract agreement between HHS and pharmacies require the provision of COVID-19 services regardless of the recipient’s ability to pay.  The FPA joined in with our sister state associations, NASPA, ACCP, ASCP, ASHP, NCPA and NPhA to call on Congress to fix this issue.

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FPA Offering Test and Treat Certificate Training Program

At the beginning of the pandemic, the Florida legislature recognized the need to deploy additional practitioners on the health care battlefield and order revisions to the pharmacy practice act.  These changes would allow a pharmacist to test for and treat patients with certain non-chronic health conditions.  The requirement is for pharmacists to complete a Board of Pharmacy approved training program.  The FPA is pleased to be working with the National Alliance of State Pharmacy Associations to bring this program to our members.  We are offering this program as part of our 2022 pre-convention offering in July.  While you are there, consider adding the FPA annual meeting as part of your educational plans for the summer.

APhA House of Delegates Action Items

Last month the House of Delegates of the American Pharmacists Association met in San Antonio, Texas to evaluate a number of policy statements.  Some policy statements include (but are not limited to) the following:

• Standard of Care Regulatory Model for State Pharmacy Practice Acts
• Data Security in Pharmacy Practice
• Data Use and Access Rights in Pharmacy Practice
• Access and Reimbursement for Diabetes Education, Support, and Prevention Services
• Pharmacists’ Application of Professional Judgment
• Addressing American Medical Association’s Policy Related to Pharmacists Scope of Practice

FPA members serving at the 2022 APhA House of Delegates include, Daniel Buffington, William Mincy, Carol Motycka, Katherine Petsos and Matt Schneller with Angela Garcia serving as the alternate delegate for Florida.  The 2023 meeting of the APhA House of Delegates will be in Phoenix, Arizona, March 24^th through the 27^th.

Meningococcal Disease and Vaccines in Florida
from Florida Department of Health

Tallahassee, Fla. — The Florida Department of Health (FDOH) is responding to an outbreak of meningococcal disease in some areas of Florida. However, it can be prevented and treated. Getting vaccinated is the best way to protect against meningococcal disease.

Thus far, the number of cases identified in 2022 surpasses the 5-year average of meningococcal disease cases in Florida. FDOH epidemiologists are investigating each case as well as contacting people with potential or direct exposure to known cases to provide them with information and treatment options.

The following groups should consider vaccination with a meningococcal conjugate (MenACWY) vaccine during this outbreak:

• College and university students;
• Immunocompromised individuals;
• People living with HIV;
• Men who have sex with men;
• People in any groups listed above who received their MenACWY vaccine more than 5 years ago.

Find meningococcal vaccines, including the MenACWY vaccine, by contacting a health care provider, county health department, or pharmacy. FDOH County Health Departments offer meningococcal vaccines. For more information, contact your local health department.

This is a serious disease caused by bacteria called Neisseria meningitidis. Fortunately, these bacteria are not as contagious as germs that cause the common cold or flu. People do not catch the bacteria through casual contact or by breathing air where someone with meningococcal disease has been. It requires close contact over a period of time, or direct contact such as kissing or sharing drinks.

Early symptoms of the disease include fever, headache, stiff neck, nausea, vomiting, light sensitivity, confusion, and rash. Anyone who has been exposed or develops symptoms should be evaluated by a health care provider immediately. This is a rare but potentially devastating disease.

For more information about meningococcal disease, please visit the Centers for Disease Control and Prevention website or the FDOH website.

Florida Board of Pharmacy to Entertain
Technician Rule Revision

The Florida Board of Pharmacy has received a letter from CVS requesting a review of rule 64B16-27.420 related to delegable and non-delegable tasks.  The inquiry asks the Board to consider allowing Florida registered technicians the authority to transfer prescriptions verbally.  This is being allowed by some other states.  The current rule language here in Florida lists the transferring of prescriptions by technicians as a “non-delegable task which means that it must be performed by a pharmacist or pharmacy intern under the supervision of a pharmacist.  This issue will be placed on the agenda of a future Board of Pharmacy meeting.