Telemedicine, in general, and teleradiology, in particular, will
dramatically and irreversibly change the way that we practice
radiology. This may seem like a bold statement, but the effects of
telemedicine are upon us. It is now quite common to transmit
electrocardiograms over the telephone lines, but other information,
such as imaging studies, can be transmitted not only over telephone
lines, but also by cellular telephones, radio transmissions, and
satellite communications. We truly are in the electronic age of
medicine.
Teleradiology is defined by the American College of Radiology
(ACR) as the electronic transmission of radiological images from
one location to another for the purposes of interpretation and/or
consultation. The ACR document not only discusses qualifications of
personnel and equipment guidelines, but also addresses licensing,
credentialing, and liability.
Electronic transmission of radiologic images has been in use for
some time to provide a preliminary interpretation by the
radiologist or to transmit an image from the operating room to the
radiology department or even from one area of the department to
another. This article does not address that type of teleradiology,
but it does address recent legislation involving the primary
interpretation of radiologic images across state boundaries.
State attempts at licensure
In late September of 1996, the California Telemedicine
Development Act was signed by the Governor; it allowed a
registration program for out-of-state physicians wanting to
practice telemedicine in California. The act also addressed several
key issues, including informed consent, medical records, and
reimbursement. The act requires that the physician be licensed in
the residing state and meet specified educational standards.
The four main components of this act concern provider
reimbursement, patient confidentiality, physician licensure, and
protections regarding informed consent. The act was designed to
bring quality health care to underserved areas at reduced cost and
to help bring specialty expertise to the patient rather than moving
the patient to the specialist.
What is most important is the intent of the California
legislature to recognize the practice of telemedicine as a
legitimate means by which an individual may receive medical
services from a health care provider. This act also prohibits an
out-of-state physician from having the ultimate authority over the
primary care or primary diagnosis of a California patient.
Over the past three years, 29 states have introduced
legislation, passed legislation, or made determinations by their
state medical board, state regulatory board, or their state
Attorney General with regards to the practice of telemedicine
within their states (tables 1 to 4).
Many states have passed laws or regulations requiring that
out-of-state physicians be fully licensed prior to engaging in the
practice of medicine across state lines. Several other states
(Florida, New Hampshire, North Carolina, and Ohio) have recently
introduced legislation that would require licensure for
out-of-state physicians utilizing telemedicine to diagnose or treat
patients within their state.
The medical board in ten states (Arizona, Florida, Iowa, Kansas,
Maine, Massachusetts, New Mexico, New York, Pennsylvania, and
Virginia) have determined that legislation was not necessary, as
their current licensure statutes already require that out-of-state
physicians be fully licensed.
Two states (Maryland and North Dakota) have considered a limited
license that would require the out-of-state physician to be
licensed in their residing state and to register in the state where
the telemedicine image was produced. This approach is similar to
that suggested by the Federation of State Medical Boards. A limited
license requirement was recently enacted by the state of
Alabama.
Two states refused to require licensing of an out-of-state
physician. By statute, Florida requires only that the referring
physician be licensed in Florida. Although not by legislation, the
Attorney General of Mississippi has determined that an out-of-state
physician may render a diagnosis on a Mississippi patient, provided
that the physician is licensed in another state.
Florida is the only state that specifically allows out-of-state
physicians to practice telemedicine in Florida without a license.
In fact, the physician does not have to be licensed in any state as
long as the referring physician is licensed in Florida. Recent
efforts by the Florida Radiological Society and The Florida Medical
Association have resulted in a teleradiology bill prohibiting the
continued provision of medical services by referral to a physician
unlicensed in the State of Florida.
By statute, Florida already allows a physician who is lawfully
licensed in another state, territory, or foreign country, who
engages in consultation with a physician duly licensed in Florida
and does not exercise primary authority over the patient's care and
diagnosis, to be exempt from licensure.
However, this new teleradiology bill provides that, in the case
of electronic transmission of radiographic images, a physician who,
through an ongoing regular arrangement, provides official
authenticated interpretations of radiologic images to health care
practitioners or patients located in the state of Florida should be
regarded as exercising primary authority over the diagnosis or the
involved patients and subject to licensure.
The bill was strongly opposed by Florida HMOs and certain
orthopaedic clinics currently shipping radiology images to
out-of-state organizations. Neither the House bill (HB 1855) nor
the Senate bill (SB 1308) reached committee this session and will
be studied by committee this summer and carried over into the 1998
session.
Meanwhile, the Florida Board of Medicine has just determined
that a physician providing the primary interpretation of a
diagnostic test or study for a patient located in Florida must be
licensed to practice medicine in Florida.
This creates a very interesting situation for Florida. By
statute, a physician who is not licensed in Florida and wishes to
practice primary telemedicine in Florida may do so as long as the
patient is referred by a physician licensed in Florida. The
proposed teleradiology bill has not even gone to committee, and the
regular legislative session has adjourned for the year.
Although the Florida Board of Medicine has determined that the
out-of-state physician needs to be licensed in the state of
Florida, it does not have the impact of a statute, as the Medical
Board does not have the ability to sanction an out-of-state
physician who is not licensed in Florida. Although this is a
positive trend for requiring state licensure, it will still be
necessary for the teleradiology bill to be passed to afford the
best protection to patients within the state.
Consultation exception
Many states have an exemption to the rule requiring a physician
to be licensed in the state of practice, often called consultation
exception. These exceptions vary from states that have a very
liberal consultation exception, without any limitation, to those
with a limited consultation exception, even specifying the number
of hours, days, or months that the physician may consult in that
state.
The point of contention here is not the consultation exception;
rather, it is the primary interpretation of images across state
boundaries. Requiring full licensure in every state or territory
from which an image is transmitted as well as in every receiving
state is just one more hoop through which to jump. When that has
been accomplished, we can get down to the real issue in
teleradiology: economics.
Federal influence on licensure
Senator Kent Conrad (D) of North Dakota authored a bill (SB
2171) entitled Comprehensive Telehealth Act of 1996, which includes
specific provisions for Medicare reimbursement and acknowledges the
existing licensure barriers. This proposed legislation will
certainly be revisited in 1997 during the 105th Congress.
The U.S. Department of Health and Human Services recently
announced funding for 19 telemedicine projects involving rural,
intercity, and suburban areas, with $42 million being allocated for
these projects. They also announced that the Health Care Financing
Administration (HCFA) was initiating a three-year demonstration
project in which Medicare will pay for telemedicine services at 57
Medicare certified sites. This represents a significant change in
Medicare law; until this project, Medicare would only pay for
face-to-face consultations, not for telemedicine consultation.
The results of these projects may not be known for three years,
but the implications are immense because HCFA is so powerful and
its Medicare population is so large. There are over 33 million
people insured by Medicare, 4.5 million of whom are enrolled in
Health Maintenance Organizations (HMOs). Enrollment in HMOs is
expected to grow by approximately 80,000 every month. The trend is
for HCFA to shift its beneficiaries into capitated plans, which
will severely reduce, if not eliminate, fee-for-service Medicare
payment for telemedicine.
A recent telemedicine market report projects a total market
worth of $283 million by the year 2000, with teleradiology
equipment sales almost two-thirds of all telemedicine sales. With
this type of unbridled growth, it is easy to understand why
physicians who earn a living interpreting imaging studies,
especially radiologists, have reason to be concerned.
AMA position
Initially, the American Medical Association (AMA) Council on
Medical Education and Council on Medical Services had jointly
recommended limited licensure for physicians who practiced
telemedicine. At the annual meeting of the AMA in June 1996, the
House of Delegates ultimately adopted an amendment offered by
Richard Bagby, M.D., a Florida Radiologist and President of the
Florida Medical Association, requiring full and unrestricted state
licensure for telemedicine.
The House of Delegates specifically recommended that the AMA
"adopt as policy that states and their medical board should require
a full and unrestricted license in that state for physicians, with
no differentiation by specialty, who wish to regularly practice
telemedicine in that state."
At the interim AMA meeting held in January 1997, the Council of
Medical Education and Council on Medical Services provided a
follow-up joint report with policy recommendations on professional
liability, confidentiality, security, supervision of mid-level
practitioners and technologists, coding, and the medical education
implications of telemedicine. Both councils acknowledged the
difficulties associated with the rapid growth and proliferation of
digital medicine.
Although there has been a problem with equipment compatibility,
the ACR and the National Electrical Manufacturers Association
(NEMA) have helped to facilitate a common standard for medical
imaging by the development of the Digital Imaging and
Communications in Medicine (DICOM) standard. This has the potential
for minimizing cost due to equipment incompatibility. A resolution
submitted by the North Carolina Medical Society at the interim
meeting raised concerns about credentialing physicians involved in
telemedicine.
The AMA policy is to require practitioners to meet credentialing
standards and to participate in quality review procedures that are
at least equivalent to those at the site of care delivery. The
Board of Trustees of the AMA will discuss a referred resolution
that would encourage medical organizations and hospitals to develop
a medical staff membership category for telemedicine
physicians.
Turf battles
Turf battles between radiologists and other specialties, such as
obstetrics, gynecology, urology, and cardiology have always
existed. Unfortunately, referrals in this turf usually are not
dependent upon quality-of-care issues but rather economic issues.
Absent legislation involving this specific issue, this type of
self-referral probably will continue in the telemedicine era.
Radiologists have always been involved in turf battles with
fellow radiologists competing for outpatient services. Here,
traditional values such as quality of service and convenience were
most important. Unfortunately, it often was service and convenience
for the referring physician, rather than the patient, that
determined to which facility an outpatient would be referred.
Historically, most radiologists were hospital-based and rarely
competed against one another for referrals. Most patients would go
to local hospitals rather than seek out the best expertise
available. Hospital contracts with radiologists often were
exclusive and did not allow other radiologists to compete
successfully. Most procedures were done only on an inpatient basis,
so there was little incentive to provide outpatient services.
With favorable reimbursement for outpatient services, there
began a healthy competition for outpatient diagnostic radiology.
Other radiology groups could successfully compete for outpatient
referrals, often on the doorstep of hospitals. This was made even
more competitive by the advent of hospital satellite offices. The
effect of opening satellite offices was to compete with other
existing radiology groups, not as a program to reach out to
underserved areas. Teleradiology represents a further extension of
the satellite office, often with implications of crossing state
boundaries.
Rather than exert efforts trying to curtail the advance of
teleradiology (it cannot be stopped), radiologists should
concentrate more on providing the types of services for which they
were able to compete in the first place. Ultimately, these services
will center upon the best interests of the patient, but they will
consider interests of the referring physician as well. As before,
close contact with the patient as well as with the referring
physicians will have the most meaningful results.
The major battles to be fought in teleradiology will be turf
battles with our own brethren. A free-enterprise market place
encourages competition and individual initiative. However, the
Tenth Amendment gives states the power to protect the health and
safety of their citizens.
On the other hand, the states use this power to fulfill their
duty by regulating licensure of the practice of medicine within
their state. It would be highly unlikely for this ever to change
without a constitutional amendment. Therefore, we should expect to
see more legislative attempts at regulating telemedicine, not only
on the federal level, but also on the state level.
Other considerations
Some have tried to simplify teleradiology's ramifications and
complexities by distilling them down to a single principle: put the
needs of the patient first. Although this is laudatory, it is a
gross oversimplification of a very complex problem. In all our
endeavors, we should always put the needs of the patient first.
However, this does not explain or address the multiple issues
involving privacy and confidentiality, licensure, credentialing,
fraud, abuse, and malpractice.
Also, the fear that managed care plans may use teleradiology to
establish their own networks and exclude local physicians is not
just a perceived fear but a reality. This already has occurred in
Florida, where a large corporation requires its employees and
dependents to use their network for outpatient imaging while the
images are interpreted in California. There also is fear that many
of the large hospital networks may replace some or all of the local
radiologists by using a system connected with an out-of-state
radiology group or even a large in-state radiology group.
This is really the crux of the problem. Confidentiality,
credentialing, fraud, and standard-of-care issues have always been
present and have been addressed by each state. States are presently
wrestling with the problem of licensure for telemedicine. This has
been going on for the past three years and will continue to go on
for several more years.
However, the trend is clear: states are gravitating towards full
licensure requirements for physicians practicing telemedicine
within their state. Privacy laws, even though they vary from state
to state, will probably be resolved by Congress allowing a minimal
level of privacy protection for interstate telemedicine yet
allowing states to supplement it with additional state
protections.
Credentialing may not really be a major issue at all. Several
large hospital corporations have now incorporated statewide or
national credentialing of their physicians. A similar system of
credentialing also has been in place for radiologists who provide
temporary coverage. Standard-of-care issues concerning telemedicine
are a burgeoning area which, ultimately, will be decided by the
courts.
Economic issues increase the potential for allegations of
antitrust violations. In fact, a case has been filed by an Oklahoma
radiologist alleging such violations, restricting his right to
practice.
Conclusion
Although there will be federal attempts to regulate
telemedicine, these attempts will be largely by state legislation
or interpretation of existing state legislation. The federal role
will be mainly in terms of setting standards and reimbursement, and
the federal government will clearly stay away from licensure, which
rightly should be regulated by the states.
The competition for teleradiology services will be driven by a
combination of quality of interpretation, convenience to the
patient and referring physician, and economic factors. Only by
optimizing these factors will the radiology group practicing
teleradiology be able to survive in the ensuing battle.
This article is not intended to portray a situation of doom and
gloom for the future of radiology. Rather, it is intended to be a
wake-up call to those who are not keeping up with technology and
the advances in teleradiology. Technology will only advance and
improve; federal and state laws will follow. Will you be ready for
the future? AR
Suggested readings
1. Berger SB, Cepelewicz BB: Medical-legal issues in
teleradiology. AJR 166:505-510, 1996.
2. Grande PF, Sanders JH: Implementing telemedicine nationwide:
Analyzing the legal issues. Defense Counsel J 64:67-94, 1996.
3. Lee CD: Teleradiology. Radiology 201:15-17, 1996.
4. McMenamin JP: Telemedicine and the law. Virginia Med Q
123:184-189, 1996.