Last week, I was speaking in Strafford live webinar, “Prescription Audits: When the DEA or AG Come Knocking.” Our panel discussed the increased scrutiny of healthcare providers’ prescribing and dispensing practices by the DEA, audit preparation, and enforcement actions.
After the webinar, I received several questions regarding some of the points discussed and decided to address them in this blog post.
All principal places of business should have separate registrations, unless providers only prescribe at that location. If providers store or administer any controlled substances – separate registration for that place of business is required.
Since DEA registration is based on state licensure, separate registration is required in a different state even if a provider just prescribes.
Employees do not have to have separate registration if acting within the scope of their employment.
Corresponding responsibility still remains a leading cause for discipline and DEA enforcement actions. I usually see pharmacies run into this problem when they do not run PDMP reports on new and existing patients or they are filling scripts coming from problematic prescribers who are already on the DEA radar.
The best way to avoid any corresponding responsibility is to run PDMP reports on all new and existing patients (4-6 months is a good time-frame). Many states have laws requiring pharmacies and prescribers to run such reports. For example, California enacted a regulation (which becomes effective on October 2, 2018) requiring mandatory use of CURES prior to prescribing, ordering, administering or furnishing Schedules II-IV. (Several exceptions apply).
Dispensing pharmacists should screen every patient (including known patients) on red flags and document how the red flags were cleared. For example, I currently have a case in which DEA claims that the red flags were not resolved. After interviewing the client, we learned that the pharmacist actually screened his patients. Many of them were established with the pharmacy, some were paying cash due to Medicaid non-coverage and that the pharmacist interviewed the patients who were traveling longer distances (for example, one patient was living 30 miles away but was working close by). However, the pharmacist did not document these inquires and therefore DEA now claims failure to exercise corresponding responsibility. Remember to document every single conversation you have with a prescriber or a patient. It might not be very practical but it helps to avoid potential problems and questions from the Board of Pharmacy and the DEA.
There are two types of monetary penalties in the DEA’s arsenal:
One is a hefty fine of $64,820 per violation, found in Sec. 842(a) (all subsections other than 5, 10, 16). Most commonly cited violations under this section are failure to exercise corresponding responsibility, dispensing on invalid prescription blanks, purchasing controlled substances under invalid or missing power of attorney.
Another one is a smaller monetary penalty of $15,040 for violations of Sec. 842(a)(5) and (10) only. These are all record-keeping errors, such as failure to list patient addresses or failure to keep complete and accurate records. It is not uncommon that such record-keeping violations add up to millions of dollars.
Voluntary Surrender of DEA Registration:
During the webinar we discussed some of the tactics employed by the DEA to urge voluntary surrender. If such tactics do not work, a Diversion Investigator may offer a partial surrender of Schedule II registration only. It may sound like a great deal as many practitioners already shy away from Schedule II drugs. However, a partial surrender may cause collateral consequences, such as contractual termination by PBMs. Most PBM contracts require that their in-network pharmacies have non-restricted full DEA registrations. A provider should not surrender the registration (in full or partially) before discussing the case with the attorney specializing in this type of work. And keep in mind that you can always surrender the registration at a later date.
New DEA pharmacy cases:
There were two significant pharmacy DEA cases this year: Trinity Pharmacy and Zion Clinic Pharmacy. Both pharmacies failed to resolve red flags prior to dispensing controlled substances. Both pharmacies did not run PDMP reports and did not document conversations with patients and prescribers.
Interestingly, the DEA became interested in Zion Clinic pharmacy due to a large ordering of hydromorphone. A regular pharmacy orders about 5,900 dosage units of hydromorphone in a year and Zion Clinic ordered 41,700.
I encourage you to read both of the opinions as they describe “willful blindness,” “red flags,” and DEA’s administrative procedure:
If you would like to review the slides from the DEA webinar, please click here.