By: Martin Merritt, esq.
Past President, Texas Health Lawyers Association
Past Chair, DBA Health Law Section
“Please Tell Me you Didn’t. . . How to Keep Clients Out of the Jailhouse, Poorhouse and Lawyers Out of the Nuthouse”
As you can tell, I love talking about health law issues, if you have any health law questions or better yet, need to refer a case, just call or drop me an email and I will happily talk.
My DEA Visit. Yesterday morning, as usual, I was lost in thought, watching the sun rise out the 49th floor window of Chase Tower. The planes were taking off and landing at Love Field. And I wondered where all those people were going.
But then, a rustling and “ahem” to my right, brought my attention back to the two United States Department of Justice DEA agents, who were sitting with me. (They were not happy.)
I should own up to it, on Saturday, three days earlier, I did go to “Disco Night” at the Stoneleigh Hotel, (because it was the 21st of September), as in the Earth Wind and Fire Song, “Do you remember, the 21st of September. . .”
While I admit my disco dancing was appalling, and possibly “offensive,” as far as I know, it was not a federal offense.
So, I asked the DEA agents, “how can I help you?”
And while I cannot talk about an active case, I can generally talk about the law, “the problem” and how physicians need to be more careful with prescriptive authority agreements and collaborative agreements when it comes to telehealth, med spas, and other forms of cash-only cosmetic clinics.
What’s a “Collaborative” and “Prescriptive Authority Agreement?” Time was, only doctors could establish a physician-patient relationship and, after a good faith exam, then physicians could write orders for drugs, devices or other care. Everyone else who worked at the facility, more or less, followed doctors’ orders.
Then, it was decided that persons with advanced education and training, could be licensed as what are called “Mid-Level Practitioners.” Most of the time, but not always, these are PAs and NPs.
In some states, these Mid-Level Practitioners (MLPs) can practice completely independently of physician supervision. In other states like Texas, MLPs can practice “semi-autonomously.”
What this usually means, is that because it is cheaper to hire a Mid-Level to do the work, we want more of them doing work, but the government wants a physician to blame, if anything goes wrong.
This also means, if you haven’t figured it out, that the physician doesn’t need to work in the same place as the Mid-Level. The supervision is often a “retrospective” review of a certain number of charts at a regular meeting, once a month. The physician otherwise, just stands by the mailbox, waiting for a check to arrive for handling the supervision.
In Texas, the term is a “collaborative agreement,” which is a legal contract between the physician and the Mid-Level Practitioner, filed with the Texas Medical Board. (Emphasis on “legally binding contract”.) The physician is contracting to do a job. This isn’t just “mailbox” money.
The physician and Mid-Level Practitioner can also enter into a “Prescriptive Authority Agreement” which can contractually allow the Mid-Level Practitioner to prescribe some medications.
But there are limits. In Texas, physicians can only have a total of 7 prescriptive authority agreements with a Mid-Level Practitioner. What drugs can be prescribed is determined by state law which is informed by the FDA and DEA list of controlled substances.
Drugs are classified as either “over the counter,” “dangerous” (meaning “prescription required,”) and “controlled,” the latter of which are covered by the DEA Schedules at Level I, II, III, IV or V. Level I has no medical use, like street heroin. Level II is prescription pain killer narcotics, like Oxycontin. Level III and higher are for things which have a lower likelihood of abuse, like valium or codeine in cough syrup.
What drugs a Mid-Level can prescribe varies by state (just Google, “Mid-Level Practitioners Authorization by State”) and a wonderful DOJ DEA Diversion Control chart will pop up, that tells you everything you ever wanted to know about MLPs and “who can prescribe what” in each state under 21 CFR 1300.01 et seq.
So, what’s the problem? People who run med spas, telehealth programs, and other cosmetic clinics are sometimes “knuckleheads.”
The collaborative agreement with prescriptive authority spells out the duties of the physician, in supervising people who are sometimes legally classifiable as “idiots.” And if anything goes wrong, the physician can be in very big trouble.
So the message is, “Physicians, read your contracts and do what the contracts call for.”