2013 DEA REGULATORY ENFORCEMENT UPDATE

Transcription

1 2013 DEA REGULATORY ENFORCEMENT UPDATE Ronald J. Friedman, JD Lane Powell, PC - Seattle CHARACTERIZING DEA ACTION IN CONTINUED FOCUS & PREOCCUPATION WITH PRESCRIPTION DRUG ABUSE USING AS A THEME & BASIS FOR GREATER REGULATION THERE IS A SERIOUS PROBLEM WE ALL NEED TO RECOGNIZE THAT PROBLEM AND RECOGNIZE REALITY OF GREATER REGULATION 2012 DEA ACTION VERY HEAVY ENFORCEMENT ACTION Up 25% INCREASED FOCUS ON TOP DOWN APPROACH DISTRIBUTORS AND PHARMACIES 1

2 FOCUS ON DISTRIBUTORS Obligation under CFRs to Report Suspicious Orders and Exercise Due Diligence To Prevent Diversion. 21 CFR (b) Responsibility to Monitor Pharmacies and Note Spikes and Investigate to Ensure Proper Accountability and that No Diversion is Occurring Easier Said than Done. Distributors required to have protocols. Cannot simply focus on amount of $ to be made. DISTRIBUTORS Cardinal Health has especial focus Activity in Florida Tri-State Connection. (Fla/Ala/Ga) Early 2012, DEA obtained ISO Cardinal Lakeland Division, Followed by MOA: 2 Year Suspension Stepped Up Diligence and Reporting of Pharmacies. Amerisource, & Others, Under Current Investigation by Feds and State Authorities HOW IMPACT PHARMACIES? Ds Under Heavy Focus Paranoia, Fear = Changing Behavior with Customer Pharmacies More Questions Raised Limitations of Quantities Reporting to DEA 2013? Focus on Manufacturers? 2

3 THEORY? Trickle Down Theory of Law Enforcement Apply pressure at the top and somehow things will change at the bottom Manufacturer/Distributor Pharmacies-Pharmacies-Pharmacies Doctor-Patient PHARMACIES FAR GREATER USE OF ADMINISTRATIVE INSPECTION WARRANTS (AIWs) AND RESULTING ENFORCEMENT ACTIONS AGAINST PHARMACIES NATIONWIDE FOR A MULTITUDE OF VIOLATIONS GALVANIZED & EXPECTED TO INCREASE AS RESULT OF DEA DECISION IN HOLIDAY CVS CASE CVS DECISION 10/12/12 Federal Register. DEA Diversion Web site. (77 Fed. Reg ) (Holiday CVS) FACTS ISO and Order to Show Cause HEARING. PROCESS. DECISION. Registration of Both Pharmacies Revoked 3

4 CVS DECISION Extraordinary Decision (Old Saying) Corresponding Responsibility turned on its head. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. 21 CFR (a) Traditional verification of prescriptions called complete abdication of responsibility CVS DECISION RED FLAG DISCUSSION Certain prescriptions raise Red Flags. Pharmacist must resolve Red Flags before dispensing. If cannot resolve, do not dispense. Certain prescriptions raise Unresolvable Red Flags You cannot rely upon prescriber or prescriber office for verification because they may be in cahoots. CVS RED FLAGS RF: Out of State; Distance travelled by patient. RF: Repetitive Prescription Pattern of Physician RF: Combos of drugs: Suggests Unresolvable Red Flag (Attack on Benzos in combo with Opiates = COCKTAIL ) 4

5 CVS DECISION Not enough to call the doctor and get a diagnosis CVS was doing that. Instead, pharmacies must conduct own independent inquiry of narc scripts to determine legitimacy of prescription. And if cannot resolve, then do not dispense. STUNNING IN ITS POTENTIAL RAMIFICATION VERY TROUBLING QUESTIONS Pain physicians prescribe pain medications Quantities & Types may be consistent Are they therefore Suspect? Short-term term and long-term opioids are part of legitimate treatment? Suspect? Why do you call that a drug cocktail? Suspect? Why is my judgment superior to that of the prescribing physician? What criterion do I use to second-guess? What legal liability do I take on by second-guessing? VERY TROUBLING QUESTIONS This patient traveled from Seattle to Tacoma? Is he/she suspect? Why is the patient travelling a distance to visit me? Could it be superior service? The patient looks grubby. Is that relevant? The patient came in with another patient with similar prescription. Is that drug- seeking behavior? This patient has a little more giddy-up in his step. Should I not fill? If a physician prescribes more than others, is he/she suspect? Should I not fill? Will the government come after me? 5

6 IS THERE A BETTER ANSWER? Distributor Supplies Pharmacy Manufacturer Supplies Drug To Fill Demand Pharmacy Fills Order Doctor treating patient: What Informs Decision? The ONLY one to See the Patient! = Best Opp. for Demand Reduction Prescription ANSWER Demand reduction. Reducing the PSI level in the Ball of Demand. Serious Physician Education and Re-Direction Clearer Rules for Physicians Public Education Pharmacies have zero interest in opiate proliferation. CVS DECISION IMPLICATIONS CVS Decision Places Pharmacies in Crosshairs Very Difficult and Subjective Model. Eye of Beholder. Suggests cutting off prescriber for fear of losing DEA registration. Legitimate access to pain treatment is threatened Question: Do I care? That was Florida after all What happens in Florida STAYS in Florida????????? 6

7 FLORIDA REVERBERATES IN SEATTLE DEA executes Several AIWS. Same method of investigation. Strictly Numbers Driven Profile. You are immediately suspect based upon VOLUME. Explain Yourself!!!! AIW Process: Filed with Court. 2 Ways for DEA to Visit. Detailed inspections. Number audits. Required to Explain high Oxy/Hydro/Morphine numbers. FLORIDA REVERBERATES IN SEATTLE 1 LTC Pharmacy 1 Retail Located in Major Medical building housing More than 100 physicians 2 Retail Pharmacies with Great Prices outside Seattle. Very difficult experience for all. Reward for having successful business. Even if you satisfy DEA, drug distributor action can destroy your business. LOCAL AIWS All Involved Direct application of Holiday. Suggestion that Pharmacies Not Doing Enough Need to adopt Written Due Diligence Protocols ( Second- Guessing Protocol) Focus on highest prescriber (DEA calls outlier ) What did patients look like. Suggestion that because the patients travelled long distance there must be something wrong. Faulted pharmacy for filling cocktail Pharmacies Response: What do you want us to do? We call the office and Dr. says: that s right 7

8 FALLACY OF OUTLIER FOCUS Dr. D Dr. C Dr. Access to Meds CVS DECISION TAKE-AWAYS Beware the Weary Traveler Beware the Patient from the Doc in the Box Pain clinic. Beware the Outlier Physicians. If you think the quantities are too high, don t fill or seek guidance. Consult PDMPs and cut off doctor shoppers. Cut off any patients showing signs of unlawful use or distribution. Beyond that, hard to know. OTHER MATTERS ARISING DURING AIWS Refills forms (Omnicare $40M) Incomplete prescriptions Especially Oral Incomplete or pre-signed 222s Not separating SII records from SIII-V Failing to obtain follow-up written for an emergency CII call-in prescription Failure to verify new patient oral-call in where caller from physician office is not known Filling prescriptions beyond authority of prescribers (EG, naturopaths have III-V authority only and only testosterone and codeine, not diazepines or Adderall) 8

9 OTHER MATTERS ARISING DURING AIWS Audits that are off Out-of-State prescriptions Mailing drugs out of country Not doing distributions right Creating a prescription to distribute to doctor (SIII- V), rather than treating on invoice. Distributing in other than NDC quantity Exceeding 5% rule APRIL 2013 CVS CIVIL SETTLEMENT: $11 MILLION Filling Prescriptions for Expired DEA Numbers ($25,000/per) Having Incorrect DEA # on Prescription ($10,000/per) Labeling Prescription and Reporting to Monitoring Program under Name of Supervising Physician rather than Prescriber (Physician Assistant and Nurse Practitioner) ($10,000/per) DEA and CMS False Claims Exposure To Avoid: Adopt P&Ps, plus Regular Protocol of Random Selfaudits and maintain results for DEA inspection. TAKEAWAY DEA expects strict observance of CFRs, as strictly construed and interpreted. Failure to get it right is punishable by fine, restriction of registration, or surrender of registration. 9

10 CHANGES IN 2013 Hydrocodone to Schedule II Drop boxes at pharmacies and LTCFs for waste and returns. Oral call in, phone message, not acceptable? Increased use of AIWs and other actions challenging increasing regulation of pharmacies. Comment from DEA Head of Diversion. ADVOCACY FOR MORE COLLABORATIVE APPROACH Partnership among stakeholders is key. We are not gatekeepers vs. the villagers. We are all in this together. We all have the same objective. Being the proper dispensing of medication and public health. And we ALL need to honor our responsibilities. And if we treat each other fairly, and with respect, much more becomes possible. We become a team, rather than adversaries. ADVOCACY FOR MORE COLLABORATIVE APPROACH And the only way to solve prescription drug epidemic is through team work among all players. And creativity. And education. And by harmonizing our interests, without threatening and doing unnecessary economic injury to the other, and without compromising the ability of patients to receive needed medication. Otherwise, we all lose. 10

11 QUESTIONS Contact: Ronald J. Friedman