October 2023 - Newsletter

Included in this newsletter

Class-Action Suit Against CVS Health, Aetna, to Recover DIR Fees

Independent pharmacist Matt Osterhaus (Osterhsaus Pharmacy, Maquoketa, IA) has filed a class action lawsuit against vertically consolidated CVS Health, Caremark, and Aetna that aims to recoup for all independent pharmacies millions of dollars in what his lawyers say are wrongfully assessed pharmacy DIR fees for Medicare Part D prescriptions.

Doug Hoey, CEO of NCPA – click to view video

DEA and Controlled Substances Compliance

A note from Jeff Hedges; I have been talking about the DEA physician requirements for C-IIs.  We just added a Hospice document to the Securing and Handling of Controlled Substances found in the DEA and Pharmacy Chapter 3 programs.  C-II documentation is one of the main reasons Rite-Aid has filed for bankruptcy and closed a minimum of 500 pharmacies.  We have several clients in this situation as well.

I cannot stress this enough: if you dispense any C-II medication, you must complete one of the treatment plans by a physician.  This applies when the MMEs are ≥50 MME/day, in combination with benzodiazepines or ≥90 MME/day.    If the physician has not completed, signed, and returned one of these forms by the third fill, DO NOT fill the prescription!  Chains and independents have started the process of not filling C-II's and even C-III through C-V.  These patients will be driven to your pharmacy in increasing numbers, and the pharmacy will not be able to maintain the ratio requirement.

If you do not want to complete and maintain these documents, you must stop filling all control substances.  I don't want another pharmacy to go down the DEA investigation route.  DEA will literally take everything from you, including your retirement savings.

Refer to the “Securing and Handling of Controlled Substances” policy and procedure in DEA and Pharmacy compliance programs.

Compliance Portal®  Documents

The Compliance Portal® policies and procedures, plans and forms are constantly changing as regulations are being updated.  We have had a number of facilities who have printed documents from the Compliance Portal® that have become obsolete because of changes and the facilities have been written up by state pharmacy board inspections.

We never encourage our clients to print documents in advance, especially policies and procedures.  The Compliance Portal® is the first place to go when there is an on-site inspection or audit occurring.

Compounding and Hazardous Drugs

The Non-Sterile Compound Program's policies and procedures are now on the portal.  ACHC is almost finished with their review of our non-sterile compounding program.

Enforcement

• Pharmacy Owner Pleads Guilty to $25M Health Care Fraud Scheme
• Physician and Two Pharmacists Charged for $170M Fraud Scheme

Compliance Corner: Making New Employee On-boarding a Breeze

Depending which programs you’ve purchased, we need certain employee information to keep your programs up-to-date. Adding users to the Compliance Portal is only 1 step. Please be sure to communicate all new hires with your Project Manager so they can get them added to things such as the OIG/SAM report, be added to your HIPAA documents, have personnel folders created, etc. 

Adding new employees to our system is easy when we have the information we need. To make things smoother and faster, we need you to give us a few key details when you're adding a new employee:

• Full Name: We need their full legal name to keep our records and for the OIG/SAM.
• Job Title: This helps us know what role they’ll have so we can prepare Job Descriptions.
• Phone Number: To list on the Employee Contact for HIPAA Disaster Recovery Plan
• Email Address: For setting up their client user account on the Compliance Portal.
• Professional Licenses: If they hold any licenses, like a Certified Pharmacy Technician Certificate (CPhT), we need copies to stay compliant and to help keep track of renewal dates.

Getting this info speeds up the process of adding new employees and keeps our records accurate.   Your help with this will make on-boarding a breeze and keep our records in tip-top shape. Thanks for working together with us to make things smoother for everyone!

P.S. Please remember to tell us when an employee leaves too, so we can remove them from all necessary places as well!

Rite-Aid Bankruptcy and DEA Opioid Enforcement

Rite-Aid Pharmacy has filed for Chapter 11 bankruptcy.  The main reason for the bankruptcy is the DEA enforcement action against the pharmacy corporation for improper dispensing and lack of documentation for opioid dispensing.  Rite-Aid is closing over 500 pharmacies throughout the country on their first cut.

DEA is aggressively enforcing their interpretation of the CDC guidelines for opioid dispensing.  Each regional office has their interpretation, making it hard to know the exact rules.  Please review the Securing and Handling of Controlled Substances Policies and Procedures and the treatment plan request forms.  This policy is found in the DEA and Pharmacy (chapter 3) Compliance Programs on the Compliance Portal®.

If a Rite-Aid in your neighborhood is closing, this is an opportunity to pick up additional patients.  Before accepting new patients, ensure their healthcare plan accepts your pharmacy and the reimbursement and DIR fees are not negative revenue prescriptions.

New and Updated Policies & Procedures

• DEA
  
  • Pseudoephedrine Program
• HIPAA
  
  • Transmission Security
    
• Pharmacy
  
  • Shipping Procedures
• Non-Sterile Compounding
  
  • Adverse Event Reporting
  • Introduction and Scope
  • Performance Improvement Program
  • Personnel Protective Equipment
  • Personnel Training and Evaluation
  • Procedures and Documentation
  • Quality Assurance and Quality Control
  • Release Inspections and Testing
  • Scope
  • Shipping Procedures

New and Updated Forms and Support Documents

• Compounding
  
  • Corrective Action Plan
  • Performance Improvement Study
  • Performance Improvement Activity/Audit Worksheet
  • Performance Improvement Program Annual Summary
• DEA
  
  • Biennial Inventory Schedule II
  • Biennial Inventory Schedule III, IV, V
  • Certification of Patient Enrolled in Hospice Care
• Human Resources
  
  • Acknowledgement of Background Checks and Substances Abuse Testing
• Immunizations
  
  • Standing Orders
    • Hemophilus Flu B Adults
    • HPV Adults
    • Influenza Vaccine Adult
    • Influenza Vaccine Children and Adolescents
    • IPV Children and Teens
    • Meningococcal to Adolescents and Adults
  • Emergency Protocols
    • Medical Management Vaccine Reaction Children and Teens
    • Medical Management Vaccine Reaction AdultStanding Orders
  • Notification of Vaccination Letter

Meet our Staff- Amy Miller

Amy Miller (Middle) has been a member of the R.J. Hedges & Associates team for over a decade. She is always smiling and a joy to be around.

She married her high school sweetheart, Jimbo, 35 years ago and raised two boys, Dalton and Dakota, into remarkable young men.

Amy is the go-to person for getting things done around the house. Her DIY skills are nothing short of impressive. Whether it's working with wood, operating heavy equipment (with a special fondness for the backhoe), or tearing down structures to make space for something new, Amy tackles it all with enthusiasm. Need a stubborn stump dug out? She's your gal!

As her boys have grown and ventured into the world, Amy's newest source of joy is raising her adorable Pomskies.  She says, “It's an extraordinary experience watching the dogs interact, mate, and care for their young.”   Amy's home is always buzzing with activity, ensuring that no dull moment ever graces her doorstep.

Amy has a hobby that makes her the family and friend go-to photographer. Her recent adventure as the "other" photographer at her niece and nephew's wedding showcased her talent for capturing those candid, off-script moments that professional photographers might miss. Now, she's focusing on creating lasting memories through graduation pictures for more family members, bringing smiles to their faces with each click of the camera.

Amy's professional role at R.J. Hedges & Associates is just as dynamic as her personal life. She's responsible for creating all essential forms for our programs. As a Project Manager, she assists our clients with various tasks, from Medicare support to handling new hires and program updates. In an ever-changing work environment, Amy is always ready to lend a hand and provide the assistance our clients need, ensuring they are well taken care of.

Amy's journey is a testament to unwavering dedication to family, a passion for the DIY world, and a remarkable ability to capture life's most cherished moments. We're honored to have Amy as a valuable member of our team!