November 2023 - Newsletter

Included in this newsletter

Medicare Part B Premiums

CMS announced that monthly Medicare Part A and B premiums will rise by 6% in 2023, from $164.90 to $174.70.

Ensure all Part B patients are billed the full allowable amount in January 2024 until the $174.70 deductible is met.  If you over-charge, refund the money to the patient or add the refund to the patient’s charge account.  Repaying funds to the patient is far easier than collecting the fee after dispensing. 

Medicare Open Enrollment

Medicare open enrollment is now open through December 7th.  Pharmacies must take an active roll in helping patients choose the best plan for them as well as for the pharmacy.  If you are using Amplicare or Prescribe Wellness, you should already know which of the plans work best for everyone.  Posting a sign/notice in the public area or a bag stuffer, indicating what plans are being excepted for 2024, will aid patients on their selections.  If you can, assist them as much as possible.  Seniors are bombarded with information and you are their trusted source of information.

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  and Drug Diversion Due Diligence Policies and Procedures and the treatment plan request forms.  These policies are 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.

Non-Sterile Compounding

USP <795> Non-Sterile Compounding and USP <797> Sterile Compounding rules are now in place.  The Food and Drug Administration has trained every state board to enforce this regulation.  Our Non-Sterile Compounding Program is complete and posted on the Compliance Portal. 

ACHC is in its final review of our compliance program, and we are applying for their certification.  In addition, ACHC’s Pharmacy Compounding Accreditation Board (PCAB) released its updated accreditation standards on November 1, 2023.  Our program has these requirements within our policy and procedure program.  If you are required to or want to go through ACHC PCAB accreditation, and have the R.J. Hedges & Associates Compounding Compliance Program, you will have less items to submit.  Stay tuned for details!

In addition, PCCA spoke with us at the NCPA convention regarding our compounding program.  PCCA is very interested as our program has always complimented its SOPs and PK software.  More details coming. Here is a podcast we completed last month with DiversifyRx on these subjects. https://youtu.be/d-f97jPXS_g?si=HrZ9BskjcwTOOTdo

Hazardous Drugs

• Community/Retail and LTC Pharmacies must have Assessments of Risk (AoR) for all hazardous drugs found in their facility and use separate, specifically marketed counting tools that will only be used for hazardous drugs.
• Pharmacies that create Non-sterile and Sterile compounds with hazardous drug ingredients have very specific requirements. Some examples include: wearing Personal Protective Equipment (PPE) as required in the Safety Data Sheets (SDS) per drug, preparing compounds in Negative Pressure Room with a minimum of 12 Air Changes per Hour (ACPH), storing all hazardous drug ingredients in the negative pressure room, having spill kits and processes in place to deal with spills, maintaining Master Formularies or monograms, compounding records and much more.

Updated Respiratory Syncytial Virus (RSV) Vaccine Information

Two new RSV standing order templates have been released for the following:

• RSV vaccination for 32-36 weeks and 6 days of pregnancy
• RSV preventive Antibody to Infants (2023-24 Season only)

Due to strong early demand and limited supply of nirsevimab (Beyfortus, Sanofi), particularly 100-mg manufacturer-filled syringes (MFS), on October 24, 2023, CDC issued a Health Advisory with revised recommendations for use of nirsevimab during the 2023-24 season (see CDC Health Alert at https://emergency.cdc.gov/han/2023/han00499.asp  For Adults ≥ 60, RSV vaccination remains a Shared Clinical Decision made between the patient and physician.

ACIP recommendations for infants weighing less than 5 kg are unchanged. This template follows CDC’s limited nirsevimab recommendations for infants weighing 5 kg or more for the 2023-24 season. A routine template will be posted once restricted use is no longer recommended by CDC. Interim CDC recommendations are subject to change as new information becomes available.

OCR Releases Cybersecurity Video: How the HIPAA Security Rule Can Help Defend Against Cyber-Attacks

In recognition of National Cybersecurity Awareness Month, OCR has produced a new video this October for organizations covered under the HIPAA Rules on how the HIPAA Security Rule can help regulated entities defend against cyber-attacks.

This presentation intends to educate the healthcare industry on real-world cyber-attack trends from OCR breach reports and investigations and explore how implementing appropriate HIPAA Security Rule safeguards can help detect and mitigate common cyber-attacks.  Topics include:

• OCR breach and investigation trend analysis
• Common attack vectors
• OCR investigations of weaknesses that led to or contributed to breaches
• How Security Rule compliance can help regulated entities defend against cyber-attacks

Click here to view OCR’s webinar on YouTube: http://youtube.com/watch?v=VnbBxxyZLc8

Enforcement

• Compounding pharmacy owner sentenced to 18 months and over $6 million in restitution

• Pharmacist and Clinic Owner Sentenced for $6M Pill Mill Scheme

• Federal Court Orders San Antonio-Area Pharmacy and Pharmacist to Pay $275,000 Civil Penalty in Case Alleging Unlawful Opioid Distribution

Time for a Change

A new segment is going to be added to our newsletter.  As time 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 the first two items to consider in December.

1. Signage – Are your signs in need of an update?  If you want to GRAB someone's attention, White Letters on a dark background.  The font needs to be HIGHWAY- if it works for Interstates it will work for you too! Learn more about this font
2. Does your name need a little update? Consider adding “Wellness” to your Doing Business As (d/b/a) name.  A name that focuses on “health” instead of “drugs” creates more powerful and positive feelings. Consider whether your pharmacy wants to convey more than prescription medication. If health and wellness drives your pharmacy, make sure you get that across in the name.  It can also help your SEO.

Compliance Corner

Our eLearning Center has been live for a few months, and we are so glad many of you are utilizing this area to take and track your trainings!  If you are unsure how the system works, here’s a quick video to show you how to use the eLearning Center including how to view trainings, print and share certificates, and generate training logs.

Some users have had issues getting the “Green Checkmark” to appear and finalize their trainings.  Please be sure you are clicking the “Next Component” button in the top Right corner to advance through all the sections.  This will lead you to the final review, any test questions, and ultimately your certificate.

https://vimeo.com/780505945/9477b3d23c?share=copy

Updated and New Policies & Procedures

• Compounding
  
  • Evaluation of Complaints
  • Shipping Procedures
• Pharmacy
  
  • Securing and Handling of Controlled Substances
  • Identity Theft Prevention Program
  • Notification About and Recall of Dispensed Products
• Compounding, Pharmacy, and Hazardous Drugs
  
  • Responsibilities of Personnel Handling Hazardous Drugs
  • Personal Protective Equipment
  • Disposal
  
  

Updated and New Forms and Support Documents

• Diabetic Shoe
  
  • Therapeutic Shoe Fitting Assessment
• DEA
  
  • Opioid Treatment Plan
• Compounding
  
  • NSP Complaint Record
  • Compounding Competency Review
  • Temperature Humidity Excursion Report
  • Compounding Equipment Calibration and Maintenance Record
  • Compounding Record
  • Compounding Compliance Tas Assignment

Meet our Staff- Becky Templeton

With an ability to take concepts to market and fine tune processes, overseeing the Business Development and Operations of R.J. Hedges & Associates, Becky has helped diversify and streamline the company over the past several years.  She serves as our Vice President and is a partial owner of the company.

Becky is a Board Certified DME Specialist and Accredited Business Intermediary. Her education and training background fuels her desire to understand how things work, while trying to get the simplest answers and best methods for implementation. She is the go-to woman for R.J. Hedges’ training and the voice of many of our videos and podcasts.

Becky is a Lifetime Alumni with Penn State. As a graduate from Penn State with a BS in Education, she considered teaching in a high school setting, but instead has spent the last 15 years working in sales and marketing both as a trainer, educator, and content developer.

The proud mom of 2 spunky, fun loving kids, Miles (7) & Lane (5); she and her husband Dave enjoy spending time with their family outdoors. She is involved in her community serving as the President and Budget Committee Chair for her town council, serves on the PA FFA Foundation Board of Directors, and volunteers for numerous community activities throughout the year. She is also part of Templeton Auctioneers and enjoys helping with their public sale business, working livestock auctions, and volunteering for numerous charity auctions.

A lifelong animal lover, she is the “fur mom” to rescue dog Dee-Dee, and cats Murray, C.C., and Callie.