Included in this newsletter
- Announcement: Exciting News for R.J. Hedges & Associates
- Medicare Open Enrollment and DMEPOS Choices
- Medicare Part B - NP East and NP West Changes Notifications in 2025
- Chain Pharmacies Are Set to Close More Pharmacies
- Tuberculosis Resurges as Top Infectious Disease Killer
- ISMP Releases Bi-Annual Report on Vaccination Errors that Reveals Mistakes with Newer Vaccines
- Physicians Continue to Refuse DEA Requirements for Opioid Treatment Plan
- Changes to DSCSA Exemption Requirements
- GoodRx, PBMs Accused of Suppressing Reimbursements to Independent Pharmacies
- FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness
- Moving Sale: Hazardous Drug Spill Kits
- Important Posts
- Enforcement
- New & Updated P&P, Forms & Support Documents
Announcement: Exciting News for R.J. Hedges & Associates
I am thrilled to share that, as of October 1st, R.J. Hedges & Associates has officially joined the Harris Computers family. Headquartered in Ottawa, Canada, Harris Computers is an internationally renowned, publicly traded company working across numerous sectors. Under Harris's healthcare division, R.J. Hedges & Associates will maintain its name and continue delivering the trusted service our clients have come to expect.
This new partnership with Harris Computers brings a wealth of benefits for our clients and team. Their support enhances our potential for growth, visibility, and efficiency—key factors as we build on our commitment to excellence in compliance. Harris is deeply invested in long-term relationships and does not sell acquired businesses, ensuring that our values and dedication remain intact.
With this change, I am entering semi-retirement, assuming the role of “Senior Advisor.” I’ll remain involved in technical writing and overseeing any major issues, supporting our clients and team as we move forward. I’m also delighted to announce that Becky Templeton, my eldest daughter, has transitioned from her role as President to Director of Operations. Together, Becky and I worked tirelessly to find the right partner who would uphold our standards and values, and we’re confident that Harris Computers is the perfect fit for both our clients and staff.
To our clients, colleagues, and team: compliance is a challenging field, yet working with each of you has been one of the most rewarding experiences of my career. I’m grateful for the support and dedication shown over the years, and I look forward to this next chapter. I will be thrilled to see how R.J. Hedges & Associates continues to grow and serve you with the same commitment.
Thank you all,
Jeff
Medicare Open Enrollment and DMEPOS Choices
Open enrollment started on October 15th. Know who has the best Part C plan available to your facility. Ensure you are aware of what plan has the lowest DIR fees. You can place a sign at the prescription counter stating, “We are accepting the following plans …”. In addition, review the DMEPOS requirements. Billing companies are backed up because of the Change Healthcare cyber attack back in February. DME dispensed through a Part C plan does not get billed through Medicare. Click here to boost patient engagement.
Medicare Part B - NP East and NP West Changes Notifications in 2025
In last week's NSCAC meeting with the NPE East - Novitas Solutions and NPE West - Palmetto GBA, the contractors reported that suppliers should look for a postcard from the NPE Contractor about the open enrollment period starting Nov 15. This period allows suppliers to update their participating/non-participating status.
NSCAC Member Kelly S. Grahovac, General Manager, the Van Halem Group – a Division of VGM Group, Inc., has written a blog about “Medicare Participation for 2025 is open...Don’t risk a PTAN Revocation!” on the upcoming participation window: check correspondence address to ensure it is correct and to avoid revocations/deactivations. See Van Halem Group blog post here.
Chain Pharmacies Are Set to Close More Pharmacies
Walgreens plans to close 1,200 pharmacies over the next three years. Rite-Aid continues to close pharmacies nationwide as it emerges from bankruptcy. CVS Health is laying off more than 400 Aetna employees. Independent and small grocery chain pharmacies also continue to operate with low reimbursements. CVS, Rite-Aid, and Walgreens are consolidating and moving patients to mail-order delivery. Keep your U.S. Representatives and Senators informed and ask for their support.
Tuberculosis Resurges as Top Infectious Disease Killer
Tuberculosis (TB) has supplanted COVID-19 to once again become the most deadly infectious disease in circulation, the World Health Organization (WHO) reports. The agency's data shows that the number of people with a new TB diagnosis climbed to about 8.2 million in 2023 — the highest incidence since WHO began surveillance almost 30 years ago — from 7.5 million in 2022. See More…
ISMP Releases Bi-Annual Report on Vaccination Errors that Reveals Mistakes with Newer Vaccines
As this year’s cold and flu season is underway and new COVID variants continue to emerge, the Institute for Safe Medication Practices (ISMP) is raising awareness that more needs to be done to reduce the risk of vaccination-related errors. Though immunization is one of the greatest public health achievements, the continued success of immunization programs relies on the proper prescribing, dispensing, storage, and administration of vaccines. The recently released 2022-2023 Bi-Annual Report from the ISMP National Vaccine Errors Reporting Program shows that errors continue to be an issue, with newer vaccines adding new opportunities for confusion and mistakes. See More…
Physicians Continue to Refuse DEA Requirements for Opioid Treatment Plan
We continue to field calls from our clients about Opioid Treatment plans where the physician refuses to complete the specific form sent by the pharmacy. We recommend that you provide the following support information to the physician when this occurs, starting with the podcast.
References with the Compliance Portal®:
- Compliance Portal®, Presentations - DEA Clarity Recording Oct 31, 2023
- Compliance Portal®, DEA Program, Item #1, Drug Diversion Due Diligence (Corresponding Responsibility)
- Compliance Portal®, DEA Program, Item # 2, Securing and Handling of Controlled Substances (Applicable Standard)
- CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016
- CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 | MMWR
- Compliance Portal®, Message Center – August Newsletter, Physician Mandatory Training for Prescribing Controlled Substances Safely – A DEA Requirement
Changes to DSCSA Exemption Requirements
Additional waivers and exemptions from FDA beyond the stabilization period to comply with Drug Quality and Security Act requirements under the law (to track a product from the drug manufacturer to the dispenser) for almost all members of the supply chain who completed or documented efforts to complete data connections with immediate trading partners with data challenges, including:
- Small dispensers (pharmacies) that have 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians and, where applicable, their trading partners until November 27, 2026.
- Dispensers (pharmacies) with 26 or more full-time employees until November 27, 2025.
- Wholesale distributors until August 27, 2025.
- Manufacturers and repackagers until May 27, 2025.
GoodRx, PBMs Accused of Suppressing Reimbursements to Independent Pharmacies
This story never changes. Complain to your US Senators and Congressman/woman.
Three class-action lawsuits filed since October 30 claim that GoodRx, a drug coupon aggregator, colluded with PBMs to undercut reimbursements to small community pharmacies. Under an arrangement that began last year, the PBMs allegedly used GoodRx's software to compare pharmacy discounts for patient’s generic drug prescriptions. See More…
FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness
FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical offices and clinics.
Fullerton Wellness is a facility that compounds drugs intended to be sterile, including semaglutide and tirzepatide injections. See More…
Moving Sale: Hazardous Drug Spill Kits
R.J. Hedges & Associates is having a Moving Sale for our Hazardous Drug Spill Kits. These kits can be used for Hazardous Drugs, Hazardous Chemicals, and Bio-Hazards containment and cleanup. Get yours while they last for $65.00 + shipping. Email sales@rjhedges.com or order online https://www.rjhedges.com/usp-800-hazardous-drugs-compliance-retail-pharmacies.
Important Posts
- RJH Bulletin 2024-003 - Enhancements to the Controlled Substance Ordering System (CSOS)
- Temporary Policies for Compounding Certain Parenteral Drug Products
Enforcement
- Pharmacist and Brother Convicted of $15M Medicare, Medicaid, and Private Insurer Fraud Scheme
- Compound Ingredient Supplier Medisca Inc., to Pay $21.75M to Resolve Allegations of False and Inflated Average Wholesale Prices for Ingredients Used in Compounded Prescriptions
New and Updated Policies & Procedures
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Hazardous Drugs |
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New and Updated Forms & Support Documents
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Compounding |
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