Retail medicine has directly challenged the role of physicians as gatekeepers to prescription medications and medical procedures and as fiduciaries to their patients.
Some providers in the current IV hydration market are operating in a manner that may not comply with Texas law and Texas Medical Board rules. Physicians participating in IV hydration services should remain vigilant about maintaining compliance at both the state and federal levels.
Medical Necessity Is Not Just for Medicare
If you own or participate in an IV hydration clinic, be alert for these compliance issues:
- IV Hydration companies may not sell access to prescription drugs like any retail business might sell its products. Physicians must ensure that any drugs prescribed or ordered, including IV hydration therapies, have a valid medical purpose. While important, checking for contraindications is not enough to justify medical treatment, including IV hydration.
- When administering drugs in an office setting, the physician may only authorize the administration of drugs that are, in the physician’s medical judgment, therapeutically beneficial or necessary for the patient’s treatment.
- For each patient, the ordering practitioner must document, at a minimum: (1) the reason for the encounter and relevant history, physical examination findings, and prior diagnostic test results; (2) an assessment, clinical impression, or diagnosis; (3) plan for care; and (4) the date and identify of the observer.
- Standing delegation orders are, by definition, intended to be used for certain actions prior to the patient being examined or evaluated by the physician. Standing delegation orders may not contain pre-signed prescriptions for any IV hydration cocktail.
- IV hydration treatments are generally safe, but there are instances in which IV hydration can cause harm. Potassium, for example, regularly used in IV Hydration bars, can cause muscle weakness, slowed heart rate, and abnormal heart rhythm in too high doses. A physician may only delegate medical acts to a qualified and properly trained person acting under the physician’s supervision if those medical acts can be properly and safely performed by the delegate.
- A physician may delegate prescriptive authority to an advanced practice registered nurse or physician assistant. However, a physician may not delegate prescriptive authority, including the ability to order or select IV cocktails, to RNs, LVNs, cosmetologists, estheticians, or patients.
- Informed consent requires a physician to advise a patient of the risks and benefits of various treatment options (including non-treatment). Make sure the risks and benefits of various IV hydration cocktails are disclosed to patients prior to treatment.
Several Texas statutes authorize the Texas Medical Board (TMB) to take disciplinary action on physicians who fail to fulfill their obligations. Even if you accept out-of-pocket payments, you still must comply with state laws governing your professional license.
The following are key statutes and regulations that specifically prohibit medically unnecessary treatments and limit the scope of a physician’s prescriptive authority.
Texas Occupations Code Sec. 164.053. “Unprofessional or Dishonorable Conduct”
Texas law has codified standards of conduct for physicians and authorizes the Texas Medical Board to enforce those standards.
Conduct considered unprofessional or dishonorable and “likely to deceive or defraud the public” includes conduct in which a physician:
- Prescribes or administers a drug or treatment that is nontherapeutic in nature or nontherapeutic in the manner the drug or treatment is administered or prescribed;
- Fails to supervise adequately the activities of those acting under the supervision of the physician; or
- Delegates professional medical responsibility or acts to a person if the delegating physician knows or has reason to know that the person is not qualified by training, experience, or licensure to perform the responsibility or acts.
In other words, physicians are responsible for protecting the welfare of their patients by only ordering medically necessary treatments, and by ensuring that all delegated medical acts are safely and properly provided.
22 Texas Administrative Code Sec. 190.8 “Violation Guidelines”
The Texas Administrative Code is a compilation of all rules and regulations made by Texas state agencies, departments, and commissions, including the Texas Medical Board.
Rule §190.8, states that “when substantiated by credible evidence, the following acts, practices, and conduct are considered to be violations of the Act,” including “unprofessional and dishonorable conduct that is likely to deceive, defraud, or injure the public.”
“Providing medically unnecessary services to a patient” is cited as an example of unprofessional and dishonorable conduct.
22 Texas Administrative Code Sec. 169.3 “Administration of Drugs”
Rule §169.3 states that a physician may “personally administer those drugs to his or her patients, which are, in the physician's medical judgment, therapeutically beneficial or necessary for the patient's treatment. A physician may delegate to any qualified and properly trained person the authority to administer drugs.”
This rule also requires physicians licensed by the Texas Medical Board to comply with “all appropriate record-keeping requirements applicable to the drugs administered, or shall assure compliance with said record-keeping requirements by persons acting under the physician's direction and supervision.”
What are “appropriate record-keeping requirements applicable to the drugs administered”?
Medical records for the administration of IV hydration infusions should include:
- Patient’s medical history;
- Proof of informed consent;
- Signed & dated physician order with drug name, dose, and route of administration;
- Start/stop time; and
- Any adverse reactions or complications that may have occurred during or after the procedure.
22 Texas Administrative Code Sec. 193.2 Defines the Scope of Standing Delegation Orders
Rule §193.2 defines a standing delegation order as “written instructions, orders, rules, regulations, or procedures prepared by a physician and designed for a patient population with specific diseases, disorders, health problems, or sets of symptoms.”
“These instructions, orders, rules, regulations or procedures are to provide authority for and a plan for use with patients presenting themselves prior to being examined or evaluated by a physician to assure that such acts are carried out correctly and are distinct from specific orders written for a particular patient, and shall be limited in scope of authority to be delegated as provided in §193.4 of this title (relating to Scope of Standing Delegation Orders).”
Rule §193.4 limits the scope of standing delegation orders to “the administration or providing of drugs ordered by direct personal or voice communication by the authorizing physician who shall assume responsibility for the patient's welfare, providing such administration or provision of drugs shall be in compliance with other state or federal laws…”
Pre-signed prescriptions should only be used under the following conditions:
- The prescription shall be prepared in full compliance with the Texas Health and Safety Code, §483.001(13) except for the inclusion of the name of the patient and the date of issuance.
- The prescription shall be for one of the following classes or types of drugs:
- oral contraceptives;
- diaphragms and contraceptive creams and jellies;
- topical anti-infectives for vaginal use;
- oral anti-parasitic drugs for treatment of pinworms;
- topical anti-parasitic drugs; or
- antibiotic drugs for treatment of venereal disease.
- The prescriptions may not be issued for any controlled substance.
- The providing of the drugs shall be in compliance with the Texas Pharmacy Act and rules adopted by the Texas State Board of Pharmacy.
In addition, standing medical orders are defined as “orders, rules, regulations or procedures prepared by a physician or approved by a physician or the medical staff of an institution for patients which have been examined or evaluated by a physician…”
In summary, the Texas Medical Board has strict guidelines for standing delegation orders and standing medical orders, including the types of medicines that may be provided.
Texas Civil Practice And Remedies Code Sec. 74.104. “Duty of Physician or Health Care Provider”
The legal doctrine of informed consent gives patients the right to make their own healthcare decisions, but not the right to direct medical decision-making. In a broad sense, the informed consent process requires a physician to educate the patient about the potential risks and benefits of a proposed treatment, alternative treatments, and non-treatment. Once informed of their treatment options, the patient has the right to select which treatment they would prefer to receive.
The patient’s right to be informed about their treatment options does not grant the patient access to any drug or procedure that they want; a physician may only recommend and provide treatments that are therapeutically beneficial or necessary for the patient. When the patient chooses their IV hydration cocktail from a menu prior to medical evaluation, the patient is directing physician decision-making rather than exercising informed consent.
The law places the duty to obtain informed consent upon the physician and it cannot be delegated.
Monitor Your Prescriptive Authority in an IV Hydration Business
State law authorizes TMB to take disciplinary action on physicians who violate TMB standards of conduct and other rules, such as:
- Revoke or suspend a license;
- Place on probation a person whose license is suspended; or
- Reprimand a license holder.
Consult a healthcare attorney to check if your delivery of IV therapy is compliant, or you could put your medical license at risk.