Included in this newsletter
- Federal Court Says Pharmacists Can Use Independent Judgment in Filling Prescriptions
- Blue Shield Of Calif. Dumps Aetna/CVS PBM in a Bid To Reduce Drug Costs
- FDA Delaying the November 23rd implementation date for DSCSA
- Medicare Part D Open Enrollment
- Negative Margin Scripts
- Immunizations - Adult RSV Vaccine, Adjuvanted
- Chain Pharmacies Update
- Compliance Portal – Non-Sterile Compounding Update
- Enforcement
- Non-prescription Birth Control
- Come See Us!
- Updated and New Policies & Procedures and Forms
- Compliance Corner- Navigating Pharmacy Compliance
- Meet Our Staff- Alisa Isenberg
Federal Court Says Pharmacists Can Use Independent Judgment in Filling Prescriptions
Judges with the 8th U.S. Circuit Court of Appeals backed two pharmacies in Albert Lea, MN, that in 2021 refused to fill prescriptions for ivermectin and hydroxychloroquine for treating COVID-19. Based on guidance from leading medical authorities and government agencies, the pharmacies did not consider the medications appropriate for the condition. A Missouri physician prescribed the medication to a couple in Minnesota who had contracted COVID-19. When they sought to fill their prescriptions at Walmart and, subsequently, Hy-Vee in Albert Lea, pharmacists at both locations refused to dispense the drugs. The couple contends that the pharmacies infringed on their right to self-determination and what they could do with their bodies by not filling their prescriptions. The federal appeals court sided with the pharmacies, asserting that pharmacists have the right to "exercise independent judgment in filling prescriptions." The court affirmed that healthcare providers in Minnesota cannot be compelled to participate in a plan of care that contradicts their professional judgment.
Blue Shield Of CA Dumps Aetna/CVS PBM To Reduce Drug Costs
Blue Shield of California has announced its intentions to stop using most of CVS Health's PBM services by early 2025 and open their doors to others, including Amazon.com's struggling pharmacy dispensing service and entrepreneur Mark Cuban's firm Cost Plus Drugs. Read more
Blue Shield's decision can potentially change the landscape of PBM control in the reimbursement market. Their decision has a better chance of change than Congress's proposed bills.
FDA Delays November 23rd implementation date for DSCSA
FDA has delayed the Drug Supply Chain Security Act (DSCSA) implementation by one year so the supply chain trading partners can comply with the final enhanced drug distribution security requirements under the DSCSA scheduled to take effect on November 27, 2023.
FDA has delayed the final step with DSCSA twice. We recommend you not wait until next year to implement software that can complete the required steps. There are two primary vendors, RxScan and Infinitrak.
Medicare Part D Open Enrollment
Medicare open enrollment starts Oct 15 and ends Dec 7, 2023. Find the best plans for your patients as well as the pharmacy. Plans with high DIR fees should be discouraged by explaining the plan's fees. As we have seen in past years, patients have a hard time understanding all the available plans and don't understand their selection could prohibit the pharmacy from filling their prescriptions.
Negative Margin Scripts
It seems like everyone is experiencing severe reimbursement cuts with negative margins. Here is a five-step process that can decrease the burden:
- Calculate and track your negative margin percentage.
- Don't step over dollars to pick up pennies
- Stop chasing brand rebates with super-high generic purchase requirements.
- Sign up for RetailMyMeds - seriously, today!
- Ensure your employees know what you want them to do when they get a negative reimbursement and what mitigation steps you want them to take. They may not be as clear as you think they are.
- Shop the open market for lower COGS, especially for generics. Source:
- Dr Lisa Faast
Immunizations - Respiratory Syncytial Virus (RSV) Vaccine for Adults Adjuvanted
RSV Standing Order for adults has been added to the Immunization Program, Chapter 1. In addition, a number of standing orders have been updated. Check your signed orders against the version on the Compliance Portal® and verify the form date to ensure you have the most recent version.
Chain Pharmacies Update
Chain pharmacies are now facing money shortages. The Drug Store News just announced that Rite-Aid is preparing to file bankruptcy. Walgreens CEO has left. Both Walgreens and CVS pharmacies are closing pharmacies and cutting hours. Wal-Mart just announced they are cutting pharmacists wages.
Compliance Portal – Non-Sterile Compounding Update
We have completed the Non-Sterile Compound Program's policies and procedures. ACHC is in the process of reviewing our program in preparation for their certification.
Enforcement
- Aiken, SC Man Sentenced to Federal Prison for Role in Scheme to Defraud TRICARE
- Three charged in prescription fraud scheme in Troy, MI (pharmacist and pharmacy technician)
- Lincare Holdings Agrees to Pay $29 Million
Non-prescription Birth Control
The U.S. FDA's approval of Opill; an over-the-counter oral birth control pill, has been welcomed by health providers in Durango, CO as an additional contraceptive option. However, concerns about the pill's cost remain, as its manufacturer, Perrigo, has not disclosed the price yet. Access to Opill will depend on its affordability, with hopes that it will be more reasonably priced than prescription birth control options. Additionally, education on proper usage is crucial, as the pill's effectiveness relies on strict daily intake and health professionals emphasize the importance of proper education for users. Read full article here
Come See Us
NCPA’s Ownership Workshop
- Orlando, FL October 12-13, 2023
New and Updated Policies & Procedures
- DEA
- Counterfeit Suspect or Illegitimate Drugs
- Hazardous Drugs (Retail & LTC)
- List of Hazardous Drugs
- Pharmacy
- Patient Intake – Pharmaceuticals
- Counterfeit Suspect or Illegitimate Drugs
- Non-Sterile Compounding
- Adverse Event Reporting
- Complaint Handing
- Compounding Documentation
- Continuous Quality Improvement
- Disposal
- Evaluation of Complaints
- Introduction and Scope
- Labeling, Packaging, Transport and Disposal
- Notification About and Recall of Dispensed Products
- Packaging of CNSPs & HD
- Patient Counseling Products
- Patient Safety
- Performance Improvement Program
- Personal Protective Equipment
- Personnel Training and Evaluation
- Pharmacy Compounding Definitions
- Procedures and Documentation
- Quality Assurance and Quality Control
- Release Inspections and Testing
- Scope
- Shipping Procedures
- Spill Control
- Storage
- Transport
New and Updated Forms and Support Documents
- Compounding
- Corrective Action Plan
- Performance Improvement Activity/Audit Worksheet
- Performance Improvement Program Annual Summary
- Performance Improvement Study
- Root Cause Analysis
- DEA & Pharmacy
- Quarantined, Suspect & Illegitimate Product
- DEA Controlled Substances Audit Checklist
- HIPAA
- Breach Response Checklist
- Notification of a Breach of PHI
- Unsecured PHI Breach Reporting Checklist
- Immunizations
- Immunization Client Checklist
- Standing Order - Respiratory Syncytial Virus (RSV) Vaccine
- Standing Order - Influenza Vaccine Children and Adolecents
- Standing Order - Influenza Vaccine Adults
Compliance Corner- Navigating Pharmacy Compliance, A Vital Step for Success
In the ever-evolving world of pharmacy operations, staying compliant with the stringent requirements of insurance companies and Pharmacy Benefit Managers (PBMs) is crucial. Having a robust pharmacy compliance program in place is not just advisable, it's essential.
Compliance programs encompass specific policies and procedures that cover various aspects of pharmacy operations, from medication handling to return-to-stock processes. Failure to meet these requirements can lead to dire consequences, including contract loss.
To tackle this complex landscape, consider partnering with Pharmacy Services Administrative Organizations (PSAOs) for guidance on reviewing contracts, credentialing, and more. Additionally, enrolling patients in Medication Adherence or Sync programs can streamline operations and enhance patient care, while participating in Continuous Quality Improvement (CQI) programs demonstrates a commitment to patient safety and error prevention.
If navigating this compliance maze seems overwhelming, R.J. Hedges & Associates can provide the necessary support, ensuring that your pharmacy remains in good standing with insurers and PBMs. Ultimately, establishing a pharmacy compliance program is a testament to your commitment to delivering high-quality products and ensuring patient safety in today's ever-changing pharmacy landscape.
Take our “Pharmacy Credentialing Assessment” to see how your pharmacy is doing.
Meet our Staff- Alisa Isenberg
Alisa (4th from the right) has been a member of the R.J. Hedges & Associates team for over a decade. Her commitment to our organization is truly remarkable.
Her life is centered around family. As a loving mother of three and a proud “Grammie" to four, family is at the core of everything she does. She's been married to her hard-working husband, Bret, for an impressive 34 years.
She finds solace in the great outdoors. Whether it's tending to her garden, taking long walks, or spending time with her loved ones, she cherishes the tranquility that nature brings. And when she has a spare minute, can often be found engrossed in a good book.
Alisa and her husband, reside on his family's 89-acre farm. Here, they cultivate corn and hay, raise beef cattle, and care for 40 pigs destined for custom butchering. Working together on the farm is a shared joy and their favorite spot is by the bonfire in "the grove.“
While at work Miss Alisa wears many hats. She's the go-to person for printing, assembling, and shipping client programs and personnel folders. She excels at editing and formatting policies, procedures, and forms, ensuring they're ready for upload to the portal. And she maintains meticulous records of the items she oversees. If you’ve called the main line, she is the friendly voice that answers and directs incoming phone calls.
In addition to her various roles, Alisa takes on project management duties, efficiently completing new client programs. She goes the extra mile to assist clients with their compliance needs by promptly responding to emails and phone calls.
Alisa's dedication, love for her family, and passion for the outdoors make her an exceptional team member. We are privileged to have her as a part of our R.J. Hedges and Associates family.
