DEA’s Dangerous New Agenda

Looks like the DEA has run out of valid reasons to go after some parts of the controlled meds distribution system.  According to this article, it suggests that the DEA is going after missing “i’s” being dotted and/or “t’s” being crossed. Clerical errors that does not have a single thing to do with the diversion of controlled meds. Pt may start getting a lot of being told that “the med they need is in backorder and/or out of stock”  What the Pharmacist is hoping that the pt doesn’t know about is that all pharmacies are required by state/federal law to keep a hard copy perpetual C-2 inventory.  Of course, the pt can’t see those inventory sheets, as a lot of protected pt HIPAA information there, but the pt – under such circumstances – asked the pharmacist, if the inspector from the state board of pharmacy came in and wanted to check on the particular day that the pt was told there was no inventory in the store for the particular med/strength the pt’s Rx was for on a particular date/time. What would the inspector find?  Some BOP’s consider lying to pts as unprofessional conduct. There is also some state pharmacy practice acts that require a pharmacy to keep in inventory Rx meds that is normally prescribed in their market area. It is anyone’s guess what a BOP will or will not enforce or take action on. Pharmacists within the state.

DEA’s Dangerous New Agenda

Although DEA has long targeted wholesalers as the “choke-point” for stemming diversion, the Agency has now shifted its focus to downstream physician and pharmacy registrants. Providers who thought they understood DEA risk need to rethink and better-prepare because the enforcement paradigm has changed dramatically.

As a former federal prosecutor for DEA cases beginning in 2008, the Agency’s shift has been gradual but remarkable. Back in the days before the Ryan Haight Act, the DEA was dealing with internet-based pharmacies that dispensed huge volumes of controlled substances from second-floor, strip mall locations. Similarly, the opioid epidemic in Florida was particularly rampant, with so-called “pill mills” that attracted patients up and down the I-95 corridor from Kentucky to West Virginia and beyond. That’s when Joe Rannazzisi, the DEA’s whistleblower from the 60-Minutes television show, launched the “Distributor Initiative” because DEA believed that downstream registrants, like pharmacies and physicians, were too numerous for DEA to effectively regulate.

Times have now changed. The Nation’s opioid epidemic has educated all of us about the pitfalls associated with miracle drugs that restore daily function and quality of life to millions of patients but overlap with difficult-to-manage scenarios involving addiction and misuse. In addition, many of the major wholesalers operate under compliance decrees and settlements that require them to police their customers closely. I helped build McKesson’s suspicious order monitoring program for independent and chain pharmacies and dispensing practices; these algorithms are incredible. As a result, we see less and less of those DEA cases involving lines around the block, hand-to-hand exchanges in parking lots, and security guards in waiting rooms.

But DEA is still attempting to recover from the scathing criticism and blame the Agency received as a result of the opioid epidemic. Was some of that blame unjustified? Yes, of course. But some of it wasn’t. Either way, the so-called pendulum has now swung dramatically towards stricter enforcement, and registrants better heed this trend because it marks a significant departure from DEA’s prior approach. For example, it has always been extremely difficult for law enforcement to pierce the doctor-patient visit and a pharmacy’s ability to rely on a physician’s order. Historically, this has limited the number of traditional “diversion” cases that can be brought.

DEA’s new approach, however, eliminates the need to prove actual “diversion” or “over-prescribing” to impose sanctions.

Specifically, DEA’s clever new agenda is to target registrants through routine DEA inspections or administrative warrants for “record-keeping” violations. In years past, such record-keeping violations would be resolved through letters of admonition (LOA) or minor civil and administrative fines. Not anymore.

Under DEA’s latest regime, alleged record-keeping violations are now the genesis of revocation and suspension proceedings brought by the DEA’s Office of Chief Counsel, and business-ending, death penalty fines imposed by U.S. Attorney’s Offices around the country. In short, a registrant need not “divert” a single pill to be stripped of his or her DEA registration, and a waterfall of board and licensing proceedings that will follow.

Finally, one reason that DEA’s new agenda is so scary is that DEA regulations are opaque, and DEA agents and diversion investigators each have their own interpretations of what those regulations require. As a result, we have been forced to defend pharmacists and physicians against DEA record-keeping allegations that were completely arbitrary and made-up. In short, if you have any concerns whatsoever about compliance with complex DEA rules and regulations, you need to get buttoned-up immediately. We are here to help with that ounce of prevention if needed.

5 Responses

  1. When will this insane agency be reigned in? They are using terror tactics and every cpp should be very worried!

  2. So is it your opinion that smaller pharmacies, mom and pop type stores may be more under the gun than the big chains?

    • YEP, the DEA is obviously trying to reduce the number of control meds available by various means. The independent pharmacies/pharmacists have less financial resources to fight the DEA and hiring a law firm. The DEA can probably basically bankrupt these independent pharmacies from legal fees trying to fight the DOJ/DEA off. What no one is talking about, as all these hundreds of chain stores that are being scheduled to close. I would suspect that the controlled meds that are allocated to these stores, will just “disappear” from the distribution system and tens or hundreds of thousands of pts from those closed stores will be tossed to the curb – or thrown under the bus – No other pharmacy will be able to purchase enough controlled meds through our drug wholesalers system to take care of these pts that have a valid medical necessity for these meds. It is not going to be a pretty picture… the covert genocide that has been going on for years, will go into HYPER-DRIVE.

      • I agree Steve their seems to be no thought at all for the abandoned patients nor the pharmacy owner who has put their life into building their business.

        • I had my own independent pharmacy for 20 yrs. I had also developed a very sizeable home medical equipment business. I had opened the pharmacy in 1976 and added HME in early 80’s. By 1995 the PBM’s were reducing reimbursements so much that every $1 less on the top line of the P&L, $0.90 came off the bottom line.. Can’t run a pharmacy working on a 10% gross profit. In 1995, I saw rumors that my HME “cash cow” was going to be slaughtered – reimbursements reduced dramatically. I was not going to cut back on service to pts, if/when they cut what was being paid. They had not changed reimbursement since we first started doing HME in the early 80’s. I decided to sell the pharmacy & HME business and retire. I was physically & emotionally exhausted, going 24/7 can really wear on a person. Two yrs later “they” cut HME reimbursement by 40%. By 2013, they were only paying abt 23% of what I was being paid when we started in early 80’s. Recently I chronic pain pt told me that her Mother had received a order for home Oxygen and it was going to be THREE DAYS before they could get it delivered to her. When we were a HME vendor, the only reason that a pt did not get the equipment the same day ordered, was because we could not get the medical information that we needed to bill their insurance and/or the insurance had some sort of prior authorization issues.

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