delegation, On the Job, Scope of Practice

Distributing vs. Dispensing Drugs

If you’re a medical assistant with questions about handing sample medications or drugs to patients, consider the following situation a CMA (AAMA) in Texas brought to my attention:

I am a CMA (AAMA) employed in a large, multispecialty clinic. I received an order from one of our licensed providers to distribute packets of sample medications to a patient. Is this legal in my state [Texas]? I thought only pharmacists and their staff were permitted to dispense medications.

To answer the question accurately, we have to define some terms. Note the following definitions from the Texas Pharmacy Act:

Sec. 551.003. DEFINITIONS. In Chapters 551-566:

(1) “Administer” means to directly apply a prescription drug to the body of a patient by any means, including injection, inhalation, or ingestion, …

(16) “Dispense” means to prepare, package, compound, or label, in the course of professional practice, a prescription drug or device for delivery to an ultimate user or the user ‘s agent under a practitioner ‘s lawful order.

(17) “Distribute” means to deliver a prescription drug or device other than by administering or dispensing.

Also, note the following from the Texas Occupations Code:

§157.002.General Delegation of Administration and Provision of Dangerous Drugs

(a) In this section:

(1) “Administering” means the direct application of a drug to the body of a patient by injection, inhalation, ingestion, or any other means.

(2) “Provision” means the supply of one or more unit doses of a drug, medicine, or dangerous drug.

(b) A physician may delegate to any qualified and properly trained person acting under the physician’s supervision the act of administering or providing dangerous drugs in the physician’s office, as ordered by the physician, that are used or required to meet the immediate needs of the physician’s patients. The administration or provision of the dangerous drugs must be performed in compliance with laws relating to the practice of medicine and state and federal laws relating to those dangerous drugs.

According to these definitions, “distributing” a drug is not the same as “dispensing” a drug.

Under the laws of most every state, physicians are permitted to distribute/provide sample medications to their patients. (This is also generally the case with nurse practitioners and physician assistants, although the laws vary from state to state.)

The laws of many states explicitly or implicitly permit physicians to assign to knowledgeable and competent medical assistants working under their direct/on-site supervision the distributing or providing of sample medications to patients of the physician.

In the scenario described, the CMA (AAMA) is being asked by a delegating licensed provider to distribute/provide sample medications to patients, not to dispense medications.

It is my legal opinion that, if there is a likelihood of significant harm to a patient if the sample medication is selected or distributed improperly, the delegating provider must verify the identity and the dosage of the sample medication before it is distributed to the patient by the medical assistant.

On the Job

Drug Disposal and Distribution

I sometimes receive questions that extend past the topic of medical assistants’ scope of practice but nevertheless concern issues many medical assistants may face. The following is one such situation that may serve as guidance for others in similar situations.

A handful of our patients in the infusion center [at which I work] have insurances that require their drugs come into our practice via specialty pharmacy, as opposed to our buying the drugs in quantity and storing in inventory. Twice in the past few months, we’ve had the situation arise where we have vials of very expensive infusion drugs no longer needed by the patient, but the pharmacy will not take them back or allow us to return them in any way. …

These drugs are very expensive, and the vials in question have never been in possession of the patient or general public. They have gone straight from the pharmacy to the office. We have other patients [who] struggle with their co-pays and deductibles. Are we able to use the remaining vials for the benefit of other patients? Or are we obligated to destroy [or] dispose of the medicine?

I responded as follows, with some information changed to maintain the correspondent’s privacy:

I understand the fact scenarios and your very good question. Are there any written terms of limitation of use of these infusion drugs? Specifically, does [the gastroenterology center at which you work] have a contractual relationship with the specialty pharmacies, and does [your workplace] have to agree—either explicitly or implicitly by virtue of taking possession of the infusion drugs—to not use the drugs for other patients? You indicate below that the specialty pharmacies do not permit [your workplace] to return the drugs. Are there any other conditions the pharmacies impose on [your workplace]?

If there are no such contractual (or quasi-contractual) limitations placed on [the center at which you work], and if the identity and dosage of the contents of the vials have virtually no likelihood of being incorrect, it is my legal opinion that the drugs may be used for other patients.

I hope this is helpful as a starting point. …  Please let me know how I can be of further assistance.

Centers for Medicare & Medicaid Services, delegation, On the Job, Scope of Practice

Conditions of Participation and Medical Assisting

The Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoPs) do not preempt or override state scope of practice laws. Moreover, state laws regarding provider delegation to medical assistants are not altered or nullified when medical offices and clinics are owned, operated, or on the premises of a hospital that is required to meet CMS CoPs.

Review the supporting evidence in the March/April 2019 Public Affairs article, “Conditions of Participation,” on the AAMA website.

delegation, On the Job, Scope of Practice

Delegation Authority of Nurse Practitioners vs. Physician Assistants

If you have been told that different health care professionals share identical authority to delegate to medical assistants, consider the following situation:

A practice management consultant is telling us that medical assistants working under the authority of a nurse practitioner (NP) have the identical scope of practice as medical assistants working under a physician assistant (PA). Is that legally accurate? The consultant is saying that this is the case because the educational and licensing requirements for NPs and PAs are the same.

The medical assisting scope of practice under nurse practitioner authority is not necessarily the same as the scope of practice under physician assistant authority. Nurse practitioners are governed by the state nurse practice act and the regulations of the state board of nursing, whereas physician assistants are governed by the physician assistant practice act (which is sometimes part of the medical practice act) and the regulations of the state board of medical examiners. Consequently, the NP legal delegation authority in a state often differs significantly from the PA legal delegation authority in the same state.

And although the educational and testing requirements for NPs and PAs are similar, they are not identical. I have read articles asserting that the “nursing model” under which NPs are trained is very different from the “medical model” under which PAs are trained. This is a debatable point. However, it is indisputable that the tasks delegable to unlicensed allied health professionals such as medical assistants by NPs and PAs practicing in the same state are sometimes very different.

Scope of Practice

Is Medical Assisting Governed by State Law or Federal Law?

Like most other health professions, medical assisting is governed primarily by state law. This is due to the wording of the Tenth Amendment to the United States Constitution:

The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

Because the power to regulate professions and occupations is not delegated to the United States Congress in Article I of the Constitution, it remains within the sovereign authority of each state. This authority includes establishing education and credentialing prerequisites for the practice of a profession, delineating legal and ethical responsibilities for the professionals, and issuing and enforcing disciplinary standards for breaches of these responsibilities.

Therefore, the legal scope of practice of medical assistants (which is coterminous with the legal authority of licensed health care providers to delegate to medical assistants) is established by state legislation, regulations and policies of state boards that regulate health professionals who delegate to medical assistants, and common law principles arising from court decisions and usual and customary practice. Federal law, however, sometimes impacts medical assisting scope of practice. The meaningful use regulations of the Centers for Medicare & Medicaid Services (CMS) are a current and significant example. Federal statute and CMS rule require a certain percentage of medication/prescription, laboratory, and diagnostic imaging orders to be entered into the computerized provider order entry (CPOE) system by licensed health care professionals or “credentialed medical assistants” in order for a licensed eligible professional to receive incentive payments under the Medicaid Electronic Health Record (EHR) Incentive Program.