For years, one of the biggest fears for pharmacy owners in this regulatory world is the OptumRx audit. Having shown up on the scene in 2010, at the time known as Catamaran audits, now known as OptumRx audits are impacting community pharmacies in a BIG way. To further keep you stress-free and in compliance, here’s a breakdown of what you and your pharmacy staff need to know to prepare for a OptumRx audit and avoid penalties.
1. What is a OptumRx audit?
OptumRx audits are a Medicare Part D auditor. The best way to explain a OptumRx audit is as a combination of a CMS onsite, state board inspection, and medicare accreditation survey all wrapped into one.
2. How do I know if I'm getting a OptumRx audit?
You’ll receive a postcard notice roughly two weeks before your scheduled audit with a specific date and time, generally 9am or 1pm, for when your auditors will visit your pharmacy.
3. What will the OptumRx auditor look for?
This list below will give you a good idea of the items you need to have in order right away and to avoid the severe penalties.
- Licensure for the staff and pharmacist-in-charge
- CMS-10147 Adherence - If you receive a 569 error from your computer system because the transaction was rejected and the patient was not eligible to receive Part D coverage, this CMS-10147 document needs to be given to the patient to share what their appeal rights are. The OptumRx auditor wants you to document that you gave the patient the 10147 form, either in their patient notes, prescription history or within your pharmacy software. If the individual prescription does not permit a note, then place it in the patient profile with the RX number, date and note that you offered the 10147 document. That’s all you need to do but be sure to add this to your to-do list!
- HIPAA Security - The OptumRx auditor will look at how your HIPAA Compliance program is established including if you have the proper policies and procedures and if you and your staff doing the required training. For more specifics on your HIPAA Compliance program, read our two posts: "HIPAA in 2013: What independent pharmacy owners need to know" & "HIPAA Enforcement has started: 4 documents you need to have now!"
- Fraud, Waste & Abuse Training - The OptumRx auditor will check that you and your staff have conducted your annual training and have your training certificates and training logs
- OIG/GSA Validation - The auditor will want to see that you have checked the OIG exclusions through both entities, OIG and GSA every month. You’ll also need to document that you have done these checks for every employee, every month. Fortunately, we have a very simple process within our Compliance Portal ® that shortens this task to only 20 seconds each month.
- Pharmacy Insurance Coverage
- AHCA Compliance (for Florida only) - If you are in the state of Florida, the OptumRx auditor is going to require you to have an accreditation and confirm that all criminal background checks have been completed. This is a Florida Medicaid requirement.
- Agreements with Wholesalers - Are your wholesalers listed in your Disaster Recovery Plan as required in your HIPAA Compliance program? Do you have an agreement between the pharmacy itself and the wholesalers that shows they are going to be your wholesaler? The auditor will also want to verify that your wholesalers as well as your business associates are listed on your OIG report for verification.
- Record Retention - The OptumRx auditor will also look at the record retention of your documents. Each organization has its own record retention requirement:
• 2 years - State Pharmacy Board
• 6 years - HIPAA Compliance
• 7 years - Medicare Part B
• 10 years - Medicare Part D
Your records don't have to be located onsite. You can have them in another offsite and secured storage location or you can scan the records after two years and store them electronically as long as you have a good backup system.
- Mail Order Volume and Compounding Volume - As the audit continues, the OptumRx auditor will look at your mail order volume, meaning how many prescriptions are you sending by mail. For compounding pharmacies, they will be looking at how much compounding you are doing in a percentage basis compared to the rest of your business.
- Specific Policies & Procedures - And lastly, the OptumRx auditor will verify that you have specific policies and procedures including ones for:
- inventory evaluation
- patient counseling
- mis-fill procedures
- medication refill procedures
- medication expiration procedures
- return to stock
- generic/brand price disclosures
- demographics and allergy captures
A big change for most pharmacies in the country is that they have never had specific policies and procedures for their day-to-day operations. OptumRx is constantly adding additional procedure requirements to their audit checklist that many pharmacies will need to add these specific policies and procedures.
4. What are the ramifications of failing a OptumRx audit?
If discrepancies are found during your OptumRx audit, you may find your pharmacy facing a simple warning to 100% of your reimbursements being pulled. The most severe penalties are for not conducting your Fraud, Waste and Abuse, HIPAA training and OIG exclusion verification. If you cannot prove that you are running the OIG exclusion every month, OptumRx will report it back and the third party can pull 100% of the Part D reimbursements that you received for the period of time you were not doing the OIG exclusion. The worst part of this situation is that there is no appeal. Most pharmacies could not withstand that loss and stay in business.
5. What can I do to confidently prepare for a OptumRx audit?
At R.J. Hedges & Associates, we have created a thorough checklist to prepare you for the OptumRx audit. Your R.J. Hedges Project Manager will guide you through this process. It’s ready for our clients to use immediately and included in our Fraud, Waste and Abuse Program. If you are not a current R.J. Hedges client and are not confident your pharmacy can pass a OptumRx audit, I invite you to speak to my team to find a solution you are looking for.
Preparing for a OptumRx audit is very important as the repercussions can be so drastic. Right now it’s just a matter of time... when will the OptumRx auditor walk into your pharmacy? Several of our clients have already been audited, and while one did receive a warning for not documenting the CMS-10147 form, none had any penalties. We’ll continue to keep you informed so you can pass the OptumRx audit seamlessly as well.
