Frequently Asked Questions
What are the ethical and legal issues in receiving compensation for moving patients from brand name drugs to generics?
American Medical Association (AMA) Policy H-125.984 recognizes that generic drugs can be less costly alternatives to brand name products. H-125.984 also states that physicians should be free to use either the generic or brand name in prescribing drugs for their patients. However, physicians should always consider what is best for the health and well-being of their patients ahead of cost concerns when making decisions about patient care. Furthermore, financial benefits a physician may receive from an insurer for switching patients to generic drugs should not factor into a physician’s decision regarding patient prescriptions. Any benefits a physician may receive from an insurer or drug manufacturer as a result of switching patients to generic medications should conform to not only pharmaceutical industry guidelines but also the medical profession’s ethical guidelines.
According to PhRMA’s Code on Interactions with Healthcare Professionals, “[t]he giving of any subsidy directly to a healthcare professional by a company may be viewed as an inappropriate cash gift.” PhRMA Code on Interactions with Healthcare Professionals, page 6, www.phrma.org/sites/default/files/108/phrma_marketing_code_2008.pdf. Furthermore, the Code warns against companies using benefits such as consultant arrangements as “inducements [or] awards for prescribing or recommending a particular medicine or course of treatment.” Id. at 8. PhRMA’s Code further suggests that “[p]ayments in cash or cash equivalents should not be offered to healthcare professionals either directly or indirectly, except as compensation for bona fide services.” Id. at 12. Finally, PhRMA’s Code cautions that no form of compensation or benefits “should be provided or offered to a health care professional in exchange for prescribing products or for a commitment to continue prescribing products…nothing should be offered or provided in a manner or on conditions that would interfere with independence of a healthcare professional’s prescribing practices.” Id. at 13.
According to the AMA Code of Medical Ethics, physicians should be aware that “monetary incentives may be judged in part on the basis of their size.” AMA Code of Medical Ethics, Opinion 8.054(2)(a). The Code warns that “[l]arge incentives may create conflicts of interest that can in turn compromise clinical objectivity.” Id. Furthermore, the Code suggests that the “proximity of large financial incentives to individual treatment decisions should be limited in order to prevent physicians’ personal financial concerns from creating a conflict with their role as individual patient advocates.” AMA Code of Medical Ethics, Opinion 8.054(2)(b). Finally, “patients must be informed of financial incentives that could impact the level or type of care they receive.” AMA Code of Medical Ethics, Opinion 8.054(4). Therefore, physicians “must be prepared to discuss with patients any financial arrangements that could impact patient care.” Id.
Physicians should be aware that any gifts of compensation they receive is likely to implicate the federal anti-kickback statute. According to the federal anti-kickback statute, physicians who knowingly and willfully receive any remuneration in return for recommending that a patient purchase, lease, or order “any good…or item for which payment may be made in whole or in part under a Federal health care program shall be guilty of a felony and upon conviction thereof, shall be fined not more than $25,000 or imprisoned for not more than 5 years, or both. 42 U.S.C. 1320a-7b(b)(2)(B).
Given the potentially severe legal and ethical ramifications of compensation arrangements with insurers, physicians should strongly consider consulting with a legal advisor experienced in these types of agreements prior to entering into a compensation agreement.
What can I do if I think my patient is too old to drive?
Some states have mandatory reporting laws. You are advised to contact the state department of motor vehicles for specific requirements.
In addition to any state requirement, the physician can evaluate and counsel the patient who may be at risk for driving and document the assessment and recommendation.
Can the AMA help me with my employment contract?
While the AMA cannot provide personal legal advice to physicians, the AMA does offer several free membership services that can enhance a physician's understanding and negotiating position as they navigate employment contracts and opportunities in various practice settings. Physician Employment Agreements
Am I covered under the "Good Samaritan" law if I provide medical care at a sporting event or community event?
Good Samaritan laws vary by state, so you should consult with your attorney or state medical society. However, generally, if a physician comes upon an emergency situation and provides assistance, that would generally be a "Good Samaritan" situation. If the physician is a team physician, then that may not necessarily be a "Good Samaritan" situation.
Am I required to provide an interpreter for a deaf patient in my office?
Under the Americans with Disabilities Act, a physician is required to make a reasonable accommodation to patients. However, if there is another means to communicate with a hearing impaired patient (family interpreters, lip reading, writing) and the patient agrees, then an interpreter may not be necessary. The situation calls for "reasonableness." If an interpreter is needed, the physician is responsible for payment for those services.
I'm leaving the employment of a physician group practice, can I take my patients and patient records with me? Can I notify patients I am leaving?
The records belong to the practice. Unless your employment agreement provides otherwise, you may be able to notify patients that you are leaving the practice and notify them of your new address. However, you should be very clear about what you are allowed to do regarding notification of patients when leaving the practice. It is recommended that you discuss/negotiate the process by which you will exit the practice. Request the right to notify your patients of your new address of your departure and information on how to contact you at your new location.
Patients are not prohibited from requesting that their medical record be forwarded to another physician, however, a physician should be very careful to avoid breach of an employment agreement, breach of privacy or patient confidentiality in accessing, copying, or taking patient records.
What are the legal requirements for medical record retention, release of information, storage, etc. for my medical practice?
State laws generally address medical record requirements, such as retention storage, so you may contact your personal attorney or the state medical society if are not familiar with the law in your state. There are federal laws that address privacy and release of health information, including psychiatric and alcohol treatment records (HIPAA) which are very specific.
What should I do if a parent asks me to examine their minor child to determine illegal drug use, sexual activity or STD?
Generally, parents may authorize treatment for their minor children. However, tests like these are often requested for minors who are perhaps "mature minors" who object to the test. State laws vary regarding age of majority, disclosure of patient information to a parent as well as testing minors for STDs. Some state laws allow physicians to treat minors for some conditions without parental consent. However, you should contact your attorney to verify state law regarding this. A physician is not obligated to perform these tests or examinations.
How can I "terminate" a patient from my practice?
In order to terminate a patient/physician relationship, it is recommended that you notify the patient in writing of your decision and give the patient their recommendations for physicians who can be contacted. If the patient is currently being treated by the physician for an acute illness, it is recommended that the physician wait to discharge the patient until the patient has completed treatment and is stable.
Am I required to report abuse that I suspect has occurred to a patient?
State law may require a report of abuse — child, elder, or spousal. You should call your state medical society if you are unfamiliar with the law in your state.
Am I responsible for my office nurse if she is administering injections, vaccinations or other treatments?
This depends upon the law in your state regarding the practice of nursing. If a nurse is practicing within the scope of nursing, as defined by state law, the nurse is responsible for his/her actions. So, if the nurse is within the law by administering injections — and you have no reason or knowledge that he/she is not capable/competent to provide the services, then the nurse is responsible for his/her actions. However, you should consult your professional liability insurer or attorney if you have questions regarding the treatments your office nurse is performing.
Can I refer my patients to an ambulatory surgery center (or MRI or cancer treatment center, etc.) that I own?
The AMA cannot provide individual legal advice to physicians. You are strongly encouraged to seek legal counsel regarding business ventures. However, this law is complex and legal counsel is advised.
The Stark law prohibits a physician from ordering "designated health services" (DHS) for Medicare patients from entities with which the physician (or an immediate family member) has a financial relationship.
Designated Health Services
- clinical laboratory services
- physical therapy services
- occupational therapy services
- radiology, including MRI, computerized axial tomography scans, and ultrasound services
- radiation therapy services
- durable medical equipment and supplies
- parenteral and enteral nutrients, equipment, and supplies
- prosthetics, ortbotics, and prothetic devices
- home health services and supplies
- outpatient prescription drugs
- inpatient and outpatient services
What should I do if someone has stolen my prescription pad and writes a prescription using my name and DEA number?
If you know the identity of the person, you can report it to local authorities. If you don't know the identity, then you may notify local pharmacies where you suspect the prescription may be filled, but you are not required to do this.
When can a physician prescribe medications without an in-person meeting with the patient?
As the result of technological advances in “telemedicine” (commonly defined as the use of electronic information and communications technologies to provide and support health care when distance separates participants), physicians are increasingly called upon to prescribe medications without an in-person visit at the time the prescription is issued. This memorandum recaps AMA policy concerning the proper standard of medical care and summarizes selected state requirements incident to such services.
Proper Standard of Medical Care
Under AMA policy guidelines, a patient-physician relationship must generally be established before medication can be prescribed through a telemedicine contact. As part of this relationship, the physician must (i) obtain a reliable medical history and perform a physical examination of the patient, adequate to establish the diagnosis for which the drug is being prescribed and to identify underlying conditions and/or contraindications to the treatment recommended/provided; (ii) have sufficient dialogue with the patient regarding treatment options and the risks and benefits of treatment(s); (iii) as appropriate, follow up with the patient to assess the therapeutic outcome; (iv) maintain a contemporaneous medical record that is readily available to the patient and, subject to the patient’s consent, to his or her other health care professionals; and (v) include the prescription information as part of the patient medical record.
If telemedicine technology is used to establish a physician-patient relationship, a video component is needed to facilitate a face-to-face encounter. Thus, under AMA guidelines, ordinary telephone calls and email communications are insufficient to establish the relationship needed to prescribe medications.
Exceptions to these requirements can arise in on-call or cross-coverage situations, emergency medical treatment, or other circumstances that have become recognized as meeting or improving the standard of care. A further exception can arise if the medication is prescribed in consultation with another physician who has an ongoing professional relationship with the patient and who has agreed to supervise the patient’s treatment, including use of any prescribed medications.
Additional information regarding the proper standard of medical care in prescribing medications without in-person patient meetings can be found in AMA Policy H-120.949, Guidance for Physicians on Internet Prescribing and in AMA Policy H-480.956, Commercialized Medical Screening.
In all instances, physicians must satisfy any state licensure laws applicable to the practice of medicine; this requirement may be of concern if the patient is located in a state other than that in which the physician is located. Beyond this general consideration, specific medical board requirements for prescribing in the absence of an in-person meeting vary from state to state. A review of selected state requirements follows; this should not be deemed exhaustive:
Florida: Telemedicine technology used to prescribe medication must be able to convey the information necessary to meet the standard of care used for in-person encounters, and physicians are responsible for the quality of this technology. Controlled substances may not be prescribed through telemedicine. Patient relationships can be established through telemedicine alone. Fla. Admin. Code R.64B8-9.014.
New Hampshire: A physician-patient relationship can only be established with an in-person examination, history, diagnosis, and treatment plan. Physicians cannot prescribe medication without such a relationship unless it involves: (a) an admission order for a newly hospitalized patient, (b) a patient of another physician for whom the physician is taking call, (c) a patient having been examined by a physician assistant, nurse practitioner, or other licensed practitioner, or (d) a prescription for a new patient who needs medication on a short-term basis prior to the first scheduled appointment. N.H. Rev. Stat. Ann. § 321:1-1-c.
Idaho: Idaho does not have specific telemedicine laws. However, a physician was disciplined for calling in antibiotics over the phone for a patient who described having flu-like symptoms. This was cited as a breach of the standard of care which requires physicians to examine a patient in-person before prescribing medication. Idaho board disapproves of telemedicine (Idaho Press-Tribune, April 28, 2014).
California: Physicians may prescribe medications based on telemedicine encounters. Cal. Bus. & Prof. Code § 2290.5(a)(6). Before beginning any telemedicine procedures, the patient must verbally consent to the use of telemedicine and this consent must be marked in the patient’s file. Cal. Bus. & Prof. Code § 2290.5(b).
Hawaii: Hawaii specifically permits the issuing of prescriptions based on telemedicine encounters. H.R.S. § 453-1.3.
Texas: Texas law allows physicians to issue prescriptions based on telemedicine encounters. 22 TX A.D.C. § 174.8. Texas law draws a distinction between telemedicine services provided to a patient who is at an established medical site and services provided to a patient who is not at an established medical site. 22 TX A.D.C. § 174.2. An established medical site is defined as a location where there is “a patient site presenter and sufficient technology and medical equipment to allow for an adequate physical evaluation, as appropriate for the patient's presenting complaint” and does not include a private residence. 22 TX A.D.C. § 174.2. If the patient is at an established medical site a distant-site physician may use telemedicine to establish, diagnose, and treat a patient. 22 TX A.D.C. § 174.6. When the patient is not at an established medical site Texas law requires that the physician and patient have had at least one prior face-to-face encounter before providing treatment, including issuing prescriptions, where face-to-face is defined as either in-person or remotely with the patient at an established medical site. 22 TX A.D.C. § 174.7. Texas law also requires that the physician using telemedicine inform the patient of all the risks and benefits of telemedicine before beginning treatment. 22 TX A.D.C. § 174.5.
The above information is based on general principals and does not constitute clinical or legal advice. It is aimed at the general practice of prescribing medicine and does not contemplate special circumstances such as drugs related to reproductive health or scheduled substances. The reader should consult an appropriate professional advisor for specific clinical or legal guidance.