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NEWS RISK MANAGEMENT

Trending Now in PBM Pharmacy Audits: related to rebate cards were Who Is In Your Backroom?
prevalent in 2014 and 2015 and,
due to new attempts by start-up
DSCSA Compliance and Rebate Card Programs companies, the PBMs are increasing CHASE READING | PHARMACIST MUTUAL COMPANIES
A
their investigations into this subject
BRIAN E. DICKERSON & ANTHONY CALAMUCCI | FISHERBROYLES, LLC matter again. Insurance providers
and PBMs are united in their distaste
for pharmacies using drug coupons,
primarily because insurance
companies sustain increased costs
representative from one of your wholesalers enters your pharmacy.
ttorneys within the pharmacy industry and pharmacies have been applied and if the discount or rebate A
and decreased profits when
responding to an increase in audits by Pharmacy Benefit Managers (PBMs) including consumers choose to purchase It’s Monday morning after a long holiday weekend and you are absolutely
Prime, OptumRx, Caremark, and ExpressScripts. Recent audits primarily focus on brand name drugs and decline use swamped. The rep wants to sit down; he says he has an offer that you can’t afford
compliance with the provisions of the Drug Supply Chain Security Act (DSCSA) of generic or other lower-cost to lose. You don’t want him standing out in your waiting room so you take him to
and related PBM contract provisions as well as requirements associated with the alternative medications. Audits are your backroom and tell him you’ll be right with him. As you close the door behind
use of drug discount and rebate cards. Properly structured compliance programs now focused on exposing prescrip- you, you think to yourself “I wonder what happened to the regular rep?” You don’t
Any perceived are invaluable in helping pharmacies avoid clawbacks and other penalties that tion fills where rebate cards were think much about leaving him alone in a room with your surveillance equipment
and safe because he’s employed by your wholesaler, he must be okay. What if he’s
invariably ensue when a pharmacy does not adhere to statutory, regulatory, and/or
failure, contractual requirements. card program was not approved by not? By letting him into your back room you’ve given him access to your security
the PBM before the prescription was system, he knows what type of safe you have and the layout of your pharmacy. Did
discrepancy, DSCSA COMPLIANCE AND INVENTORY TRACKING filled, it is very likely that the PBM you really gain anything by allowing him into your back room?
will clawback all funds paid for the
PBMs are regularly conducting audits of pharmacies and always include a demand
or inaccuracy for purchase verifications from wholesalers to substantiate pharmacy drug prescriptions that were distributed As surveillance and alarm technology improves, perpetrators are becoming more
and more savvy. They are in and out of pharmacies in under a few minutes, know-
with use of a rebate card.
inventories. Any perceived failure, discrepancy, or inaccuracy leads to, at a minimum,
ing exactly where they need to go to do the most damage. There are steps you
leads to, at a immediate clawbacks. As a result, strict compliance with the DSCSA not only Attorney opinion letters authorizing can take to protect yourself and one of the easiest and cheapest ways is by
ensures that pharmacies are compliant with the law and have documentation of a
implementing the following or similar procedures:
implementation of discount or
minimum, valid drug supply chain, but adherence to the rules and regulations also eliminates rebate programs are not a 1. Have a designated space away from any sensitive information and away
disastrous audit outcomes that include clawbacks, suspensions, or even termination.
guaranteed exculpation for the use
immediate In addition to the DSCSA’s drug tracing requirements, PBMs also mandate that all of rebates/discount cards as, from customers where your vendors, reps, family members, etc. can wait
and where you can discuss business.
historically, attorneys who are not
pharmacies maintain proper pedigrees to substantiate all purchases in their
clawbacks. inventory and prove that the source of each drug is a licensed wholesaler. All familiar with pharmacy PBM 2. Have a procedure in place to verify vendors or reps entering your pharma-
cy. Ask them to provide a business card and photo ID. Make a copy of both
contracts have authored many of
pharmacies need to verify that their wholesale distributor is licensed in their home
and have them sign and date.
state. Proof of this should be maintained with a pharmacy’s DSCSA compliance these opinions. If a pharmacy is 3. If someone has to go into your back room or behind your counter, provide
policies and procedures. In addition, some states also require licensure for any solicited for participation in a explicit instruction on where they can and cannot go.
pharmaceutical wholesaling activity (California, for example), while others permit discount or rebate card program, 4. Do not leave anyone alone inside your pharmacy. If a vendor is waiting to
wholesaling without licensure, if the transactions amount to less than 5% of a the pharmacy should have it talk with you, have a technician wait with them.
wholesaler’s revenue (New Jersey, for example). reviewed by a healthcare or
pharmacy law attorney who is 5. Do not give tours or show anyone around your pharmacy. With GPS
Intercompany transfers are another pitfall that, if not documented appropriately, qualified to decide as to whether or mapping, it doesn’t take long for someone to have the entire layout of your
pharmacy.
can lead to catastrophic consequences. Product transfers between related not the program will be honored by
pharmacies must be recognized in a formal process that maintains the integrity of a PBM under the terms of the 6. Limit employee access to specific areas of your pharmacy. A delivery driver
the pedigree, all purchase documentation from the wholesaler, and transfer existing contract and applicable shouldn’t have access to your surveillance footage.
documentation. Compliance with these requirements is compulsory, not Provider Manual. Fully vetting a 7. Cut down line of sight. Patients should not be able to see into secure areas
discretionary, and maintenance of all supporting documentation should be rebate/discount program with from the waiting room.
contained in your pharmacy’s DSCA compliance policies and procedures. competent and experience legal
counsel before implementation of There is a difference between being cynical and being precautious. The procedures
the program can help avoid listed above are about taking the precaution and not allowing the perpetrators to
DRUG DISCOUNT AND REBATE CARDS numerous PBM sanctions that can be a step ahead. You spend thousands of dollars on the security of your pharmacy
In addition to increased audits surrounding the pedigree of drugs, an increase in range from clawback of paid claims and the safety of your employees, do not risk that by letting an unauthorized
audit activity related to drug discount and rebate cards has been noticed. Audits to termination from the network. individual into secure areas of your pharmacy.

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