Included in this newsletter
- HIPAA Eligibility Transaction System (HETS)
- Hazardous Drugs Assessments of Risk
- CDC: Do NOT administer any remaining doses of ANY 2023-2024 COVID Vaccines
- Drug Enforcement Agency (DEA) Change of Ownership (CHOW)
- Partnership with Pharmacies helps make improvements
- DSCSA Exemption for Small Dispensers
- Possibly CMS Delay for Revalidations
- Reminder to Report Changes to Medicare within 30 days
- Checklist Check Up- CMS On-Site Inspections
- Tell Us How You Feel
- Moving Sale: Hazardous Drug Spill Kits
- New & Updated P&P, Forms & Support Documents
HIPAA Eligibility Transaction System (HETS)
We may have been too early to report this, but in January 2023 we reported A HIPAA Change with the Eligibility Transaction System HETS. In January 2024 HETS replaced Medicare’s Common Working File (CWF) and provides access to Medicare eligibility data for certain Medicare Fee-for-Service (FFS) activities in real time. Use of HETS aids in preparing accurate Medicare claims, determining beneficiary liability, or checking eligibility for specific services. It is for health care providers and suppliers who submit Medicare claims to a Medicare Administrative Contractor (MAC). Providers using HETS must have an EDI enrollment to submit claims transactions to the MAC. Click here for more information.
HETS should not be used to determine eligibility or coverage for Medicare Part C or Part D plans because it does not have that plan coverage and paid claims information.
If you have established a relationship with a third party to exchange transactions in HETS, it must be recertified on an annual basis. Recertification must be completed online. The recertification period started on August 1, 2024 and will end on December 31, 2024. Click here to recertify. Unfortunately, we cannot complete this for you.
To obtain a HETS user ID, a Trading Partner Agreement (TPA) will need to be completed. You can find the agreement here: Medicare HETS Trading Partner Agreement.
In addition, pharmacists, along with the patient’s physician, significantly improved the patient’s health and the pharmacy’s EQuiPP Scores, Star Ratings, and DIR fee reimbursements. In today’s environment, the pharmacy must achieve a 70% medication adherence (MedSync) rate or higher.
Hazardous Drugs Assessments of Risk
These documents are required to be reviewed and signed annually by the pharmacist-in-charge or another qualified pharmacist and in some cases a knowledgeable pharmacy technician. Since USP <800> guidelines do not specifically state the signature must be an original “wet” signature it is permissible to use a signature “stamp”. Please remember, the use of a signature stamp is still legally binding and there may be some additional restrictions by your state board of pharmacy.
Please note we recently updated all Hazardous Drugs Assessment of Risk (AoR) in anticipation of the NIOSH List Draft 2020 hopefully being officially adopted soon.
You asked- we listened! After several requests, we’re pleased to announce we have a Print All link for each of the tables within the Hazardous Drugs Assessment of Risk (AoR) Table of Contents. A combined pdf will allow for printing all AoR to be printed at once. Please review the HD inventories, print the AoR’s, Sign, and Retain.
CDC: Do NOT administer any remaining doses of ANY 2023-2024 COVID Vaccines
On August 23, CDC posted interim clinical considerations for COVID-19 vaccines for the current season. Do not administer any remaining doses of any 2023–24 COVID-19 vaccine; if you have any, remove them from storage units and dispose of them or return them as appropriate.
Drug Enforcement Agency (DEA) Change of Ownership (CHOW)
DEA has updated its Change of Ownership processes again. These significantly impact the timeline and complexity of acquiring or selling a pharmacy. Below is a summary of the key points and potential effects for buyers and sellers.
After the pharmacy license has been approved and issued, the next step is applying for a DEA license. DEA will issue a new DEA license for every CHOW regardless of the type of sale or to whom it may transfer to, i.e., parent to child. In addition, DEA’s investigative process will consider the new owner’s background, including personal and business history. If any negative aspects are found, such as past legal or regulatory issues, the investigation could extend to a minimum of six months and potentially result in legal actions.
The impact of these changes on acquiring a pharmacy are massive. Commercial loans are taking up to a year to be approved. Every state board of pharmacy has its own licensing requirements and some states in the mid-west treat a stock sale as an asset sale and issues a new pharmacy license number. Once the pharmacy license is issued, the DEA application process begins.
The next hurdle is with the PSAO and 3rd party contracts. This is a long process; however, third party contracts can be completed within 60 days. If you are contemplating selling or buying a pharmacy, these changes affect both parties. The Power of Attorney (POA) for pharmacy operations must be re-issued every six months.
Partnership with Pharmacies helps make improvements
Thank you to everyone that continues to share things they are seeing in their home states for regulatory changes, sharing information about inspections, and looping us in when they see items that need updated. The information provided not only helps our collective pool of clients, but also helps others across the country. We recently had a client point out a discrepancy within a rebate program that didn’t list BOC as an Accreditation Organization. We were able to take the information to BOC, they were able to work with the drug company and get their name added. We greatly appreciate our partnerships with our clients and with all our business partners to continue to bring updates and awareness to the world of regulatory compliance.
DSCSA Exemption for Small Dispensers
The Food & Drug Administration (FDA) is allowing exemption from certain DSCSA system requirements for small dispensers (25 or fewer full-time employees licensed as pharmacists or qualified pharmacy technicians) until November 27, 2026. This determination is due to comments from small dispensers regarding their readiness to implement requirements at the end of the stabilization period on November 27, 2024.
This exemption is not intended to justify a delay in the preparation for the DSCSA requirements. Small dispensers are strongly encouraged to continue implementation measures to ensure the requirements for enhanced drug distribution security are met.
If your facility qualifies as a small dispenser, no further action is needed. Read more here…
For information about exemptions issued by the FDA to accommodate the additional time needed for small dispensers, Click here.
CMS possibly delaying Revalidations due in November, December, and January 2025
Due to backlogs in processing it is possible that applications due for November and December 2024, and January 2025 may be postponed to allow for contractors to catch up. It is still best to ensure you have updated support documentation and, if you receive a revalidation notice, contact your Project Manager for completion.
Reminder to Report Changes to Medicare within 30 days
Just a reminder that all of the following should be reported within 30 days to avoid potential revocations:
- Ownership
- Managing employees
- Authorized Officials
- Delegated Officials
- Change in address
- Change of insurance, surety bond, and licensure.
Checklist Check Up- CMS On-Site Inspections
We provide several checklists on the Compliance Portal® to help with various surveys, audits, inspections, and attestations. Be sure to look under “Compliance Tools & Resources” on the Portal under “Checklist for Inspections and Surveys” Let’s check out the CMS On-Site Checklist.
What is it?
On-Site inspections occur when a CMS 855S is submitted for either an initial, revalidation, or re-activation application. They usually occur within 7 to 30 days following the application submission. The CMS On-Site Checklists (there are 2, one for DME facilities and one for Pharmacy) outline the requirements needed for a live, in person visit from a CMS inspector and gives you the corresponding location of where to find the necessary support item in either the Compliance Portal or in the Compliance Binders.
Why is it Important?
CMS contracts these inspections to one of three contractors within the U.S. The inspection is without notice, and the “supplier”, that’s you, must be prepared and provide all requested documentation at the time of the inspection. Any item that is missing will result in the application being denied.
How do I use it?
When the 855S application is submitted, the supplier must prepare for the on-site inspection. Print either the DMEPOS or Pharmacy CMS On-Site Inspection Checklist. The checklist is broken down into three columns. The first column is the inspector's question/request. The middle column is where the answer is located, either in the Compliance Binder or posted within the pharmacy or facility. The right column is where the answer is located within the Compliance Portal® by program, chapter, and item number.
Once your application is submitted, we recommend you print and review the checklist, then print all documents listed on the checklist. Place all these documents in a folder and let the staff know an inspector will be coming, when they arrive- present this folder. By taking 15 minutes to prepare, you’ve set yourself up for a much easier inspection. Any member of your staff can provide the required documentation. The inspector may ask for additional items, but they usually stick to this list. Please note, the inspector will request to see 3 to 5 patient files and will take several pictures within the pharmacy or facility.
Important: When the inspector arrives, ask for identification. Use a phone to take a picture of the identification with the date/time stamp on it. Ensure you document the time of departure. Call your Project Manager immediately if the inspector refuses to accept a document or asks questions you do not understand. If the inspector leaves without the “required” documentation, the entire application will be revoked! Please be sure to notify R.J. Hedges & Associates if you need help during an inspection.
Tell Us How You Feel
We’d love to hear from you! We are always looking for feedback about your experiences with R.J. Hedges & Associates as a company, your Project Manager, or a staff member. Please send any thoughts to: karly.lupacchini@rjhedges.com If you’re feeling super helpful, we’re also trying to grow our Google Reviews.
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.
New and Updated Policies & Procedures
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New and Updated Forms & Support Documents
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