Included in this newsletter
- DSCSA Compliance Deadline
- Cybersecurity Awareness
- FDA warns on Safety Issue with Philips CPAP Device
- CVS Plans to Overhaul How Much Drugs Cost
- eLearning Center and Personnel Folders (Policy Change)
- Purified Water, Emulsification, and USP 795
- Non-Sterile Compounding Compliance
- CBD, Expert Advice for Getting Started
- Enforcement
- Holiday Schedule
- Time for a Change- Color
- Compliance Corner- Training
- 401K Multiple-Employer Plan
- Merry Christmas from R.J. Hedges & Associates
- Updated and New Forms
- Updated and New Policies & Procedures
- Meet our staff- Sherry Martin
DSCSA Compliance Deadline
Even though the FDA is giving the supply chain an extra year to stabilize data exchange and operations, pharmacies should proceed with plans to comply with verification requirements and use this time to stabilize operations and data exchange with trading partners.
Pharmacies need to begin preparing now. Please review our Partnership Series: DSCSA with RxScan. This can be found in the presentation tab on the Compliance Portal® home page.
Cybersecurity Awareness
Resource Documents on Telehealth: OCR issued two resource documents to promote cybersecurity in telehealth for different audiences.
- The first is tailored for healthcare providers: "Educating Patients about Privacy and Security Risks to Protected Health Information when Using Remote Communication Technologies for Telehealth". In plain language, healthcare providers can use this resource to explain to patients the health information privacy and security risks of using remote communication technologies such as video conferencing websites and applications ("apps") for telehealth. The information in this resource expands on the Department's existing resources for healthcare providers to prepare patients for telehealth, focusing on privacy and security.
- The second telehealth resource tailored for patients is: "Telehealth Privacy and Security Tips for Patients". It provides real-life tips to the public about protecting and securing their health information when accessing telehealth.
FDA warns on Safety Issue with Philips CPAP Device
FDA is notifying the public about a specific model of continuous positive airway pressure (CPAP) machine, a device used to treat sleep apnea. The product in question — the DreamStation 2, manufactured by Philips Respironics — reportedly is prone to overheating. FDA said users have reported fire, smoke, burns, and other thermal issues with the machines, with a surge in complaints pouring in since August. According to a safety communication from the regulator, consumers can still use the devices safely if they follow the instructions and monitor the equipment for problems.
CVS Plans to Overhaul How Much Drugs Cost
On December 5th, CVS announced their new plans for pharmacy reimbursement with their new model. DIR fees will change to be deducted at the point of sale. CVS is still a PBM and they are not willing to pay providers and suppliers higher reimbursements. Do not get too excited about any positive possibilities concerning increased reimbursements. There is no reason other than public relations announcements for CVS to do this. As the PBM, what incentive would CVS have to reduce its stranglehold on the pharmacies? Extreme caution is needed. Always remember, if it seems too good to be true, it is usually not true.
eLearning Center and Personnel Folders (Policy Change)
Please be advised beginning June1, 2024 employee personnel folders being prepared will no longer have individual training certificates, training logs, and exams printed and placed into the folder. The eLearning Center automatically prepares these documents when the new employee completes each training course.
The eLearning Center maintains all training documents within the Compliance Portal® and is available to the user and Compliance Officer anytime. Blank training logs and certificates are available within the specific program’s section of the Compliance Portal® and will continue to be available for the foreseeable future.
We strongly advise all clients to enroll their employees into the eLearning Center to utilize this program and it’s features. Some clients have questioned emails being used as usernames. They are only used to send initial log in credentials and complete password resets. Your agreement with us includes a confidentiality agreement. We have not, will not, and do not share or sell employee email addresses.
Purified Water, Emulsification, and USP 795
Questions concerning amoxicillin and magic mouthwash continue to come in. The following are clarifications regarding these items. In the United States, purified water is tap water because of the U.S. standards for clean water. Using a broad definition of compounding, mixing a powder with water is compounding. However, adding purified water to a manufacturer's bottle to reconstitute the drug in every instance in the U.S. would be considered permissible in retail. There is one exception: California. We recommend the pharmacy defer to the state board to clarify the state regulation.
Can the pharmacy use distilled water instead of purified (tap) water? Absolutely.
Non-Sterile Compounding Compliance
Several states are informing their pharmacies that they have no plans to implement or enforce USP <795> and USP <800>. USP guidelines are part of the Food, Drug, and Cosmetic Act, Title 21 CFR Chapter 5. Despite the state Board of Pharmacy's intentions, if a federal agency, i.e., FDA, HHS, or DEA, inquires about a pharmacy's compounding practices, the state board must investigate and enforce USP guidelines. In addition, if a compounded medication harms a patient or employee, the pharmacy owner is liable for not following USP guidelines.
CBD, Expert Advice for Getting Started
Our CBD books are a great way to help educate staff and patients on the benefits of incorporating CBD into their wellness routines. We recently received a book review on our CBD book from Elissa Kerpen, Brand Director at Ananda Professional:
“I found the book to be a great resource for the industry, especially for those grasping how it can be used daily. You have covered many key learning topics in detail, and I found the information accurate and well-presented. I am particularly impressed with your ability to condense complex concepts into easy-to- understand explanations, often our biggest challenge when building our education collateral items.
It is a go-to for those keen to get a detailed breakdown of what to look for and what to reach for regarding quality CBD products!”
If you would like to order copies for your pharmacy, please visit our website to order https://www.rjhedges.com/buy-cbd-book
Enforcement
Holiday Schedule @ R.J. Hedges & Associates
Our company will have a limited work schedule through the holiday season as we enjoy this time with our families. Please note our office will be closed:
- December 25-26 - Merry Christmas!
- January 1, 2024 - Happy New Year!
We will have limited staffing December 27-29 to meet any urgent maters and any CMS application requests.
Time for a Change - Color
A new segment is going to be added to our newsletter. As times change, so must our marketing strategies and processes. Each month, Jeff will share two items that can be evaluated and possibly implemented at your pharmacy or DME facility. He has been compiling a list of great ideas from clients across the country and at conferences that will hopefully get you thinking outside the box. Here are two items to consider in December.
- Front windows – consider using see-through window coverings to advertise seasonal items or vaccinations.
- Drive-up window – the bare walls are boring and offer advertising space. What do you look at while waiting in the drive-up window? Your patient has entered your opportunity zone!
Compliance Corner- Training
As this calendar year comes to an end, now is a great time to ensure all trainings have been finished, certificates and logs have been completed, and items are placed in personnel folders and/or compliance binders.
If you are utilizing the eLearning Center and are an Admin User, log in to view company training reports by toggling from “Personal” to “Admin” (#1).
Click “View More” (#2) under “Due & Past Due Training” to determine which employees have outstanding trainings. Each line will show you the name of the training and the # of employees that still need to complete the training. If you click the “Training Name” (#3) it will generate a report listing all employees that need to take the exam.
Training Certificates and Logs are found under “Completed Training”, select the training name, year, and click “Get Data” (#4), from there you can print or save any certificates. To print Logs click the Excel icon (#5) to generate the report.
401K Multiple-Employer Plan
As the year ends, it is a great time to review your Simple IRA or 401K plan. R.J. Hedges & Associates has developed a Multiple-Employer 401K Plan to aid our clients in having and providing a long-term retirement plan for the owners and their employees. With the current tax credits, setting up a 401K plan has no costs.
Joining a multiple-employer plan enables the company to enjoy the buying power of a larger plan, which reduces fees and helps more funds to be applied to the individual 401K plan. The 401K contribution limit in 2024 is $23,000 for employees and $69,000 for the combined employee and employer contributions. If you're 50 or older, you're eligible for an additional $7,500 catch-up contribution, raising your employee contribution limit to $30,500. Remember, 401K funds are 100% tax deductible. Call Jeff Hedges or Tim Caldwell at 724-838-8900 concerning the R.J. Hedges & Associates 401K MEP Plan.
Merry Christmas from R.J. Hedges & Associates
We greatly appreciate your business and continued trust as we help keep you all Stress Free and In Compliance! Our staff wishes you, your families, and your businesses much joy, good health, and prosperity this Holiday Season and a very Happy New Year!!!
New and Updated Policies
- DMEPOS
- Documentation
- Identity Theft Prevention Program
- Compounding
- Creating Master Formulation Records
- Documentation
- Internal and External Recalls
- Introduction and Scope
- Notification About and Recall of Dispensed Products
- Procedures and Documentation
- Scope
- Shipping Procedures
- Pharmacy
- Documentation
- Facility Licensure
- Identity Theft Prevention Program
- Shipping ProceduresPharmacy
New and Updated Policies and Procedures
- DMEPOS
- Therapeutic Shoe Fitting Assessment
- FWA
- Conflict of Interest Certification
- HIPAA
- Workforce Assessment for PHI Access
- Workforce Assessment for PHI Access
Meet our Staff- Sherry Martin
Sherry has been a Project Manager with R.J. Hedges & Associates for 10 years. Married for 26 years, she and her husband have raised a daughter who recently embarked on a career as a Cardiology Pharmacist in New York. Sherry beams with pride at her daughter's accomplishments.
Beyond the office, Sherry leads a vibrant life filled with diverse hobbies. She's a seasoned traveler, a dedicated gardener, and a culinary enthusiast perfecting her barbecuing skills. Sherry is also the regular host for spirited Steeler game day parties in her husband's Steelers fan cave, a project he's been diligently working on for years, adorned with jerseys and signatures from his favorite players.
Looking ahead to this summer, Sherry is eagerly taking charge of planning their annual beach trip. The group of 25, including two dogs, gears up for a week of sun, sand, and shared memories.
At RJ Hedges, Sherry plays a pivotal role in various aspects, from updating checklists to facilitating new employee training. Her meticulous approach shines in the final program review and her assistance with Medicare applications. Her commitment to excellence makes her an invaluable asset to our team.
Sherry's 10-year journey at RJ Hedges is a testament to her dedication and expertise. We're honored to have such a well-rounded individual as a part of our team, bringing her unique blend of professional and personal experiences.
