The shortage of radiologists, coupled with an increase in imaging studies ordered per patient and improved technology, has assured the meteoric rise of teleradiology. It is clearly a burgeoning field in the healthcare delivery system.
The shortage of radiologists, coupled with an increase in imaging studies ordered per patient and improved technology, has assured the meteoric rise of teleradiology. It is clearly a burgeoning field in the healthcare delivery system.
Teleradiology can provide many advantages: timely interpretation of studies, increased access to consultations, easy sharing of unusual studies to educate physicians, better access to radiology services in rural areas, and improved patient care. It benefits radiologists by decreasing the number of hours they must work onsite, permitting interventional radiologists to devote more time to hands-on cases, improving turnaround and timely reporting, permitting experienced radiologists to work the hours they choose from distant sites, and increasing access to second opinions.
Establishing a teleradiology services company or seeking to contract with teleradiology providers involves important legal and contractual considerations to ensure that quality and safety remain in the forefront. Those considerations include technical standards, quality of reads and readers, turnaround time, types of reads performed, hours of coverage, volume, pricing, third-party payments, credentialing and licensing, and liability issues (Table 1).
Technical standards. Physicians providing teleradiology services and facilities contracting for teleradiology services must be aware of the standard of care for teleradiology services. The American College of Radiology has established practice guidelines that may be cited by litigants in a professional liability action.1 The ACR guidelines do not constitute the law but, rather, provide recommendations for personnel qualifications, equipment, licensing and credentialing, documentation, quality control, and patient safety.
The sending facility and the teleradiology provider must ensure the integrity of network security, while ensuring that the images are stored securely to prevent modification and/or editing. Sending sites and teleradiology companies must comply with state and federal privacy and security regulations such as the Health Insurance Portability and Accountability Act,2 as well as document retention regulations as they apply to teleradiology.
Contracting issues. Negotiating a teleradiology agreement involves several important considerations. The quality of the read is dependent on the training of the readers and the technology employed in sending and receiving images. Other considerations include type of reads to be performed, hours of coverage requested and available, and type of turnaround time the sender requires. Negotiators must also determine whether the readers can handle the volume of the sending site or if the sending site has too few images to make the contract worthwhile for the readers. Pricing is, of course, dependent on all these factors.
Third-party payments. Many third-party payers have not yet modified standard contract provisions to address the increased prevalence of teleradiology. Teleradiology providers traditionally have billed the sending facility per read, perhaps with a guaranteed minimum, and have not billed third-party carriers. Most teleradiology reads have been limited to off-hour or night coverage. Most teleradiology reads have been limited to off-hour or night coverage. If teleradiologists expand their hours of coverage to include daytime reads, however, this may create problems due to state and federal regulations.
Teleradiologists primarily perform preliminary reads, with onsite radiologists filing final reports the following day. The sending facility then bills the third-party payers globally for the radiology services. Increased volume of purchased services may alter this model. Medicare and Medicaid regulations still deny (with limited exceptions) payment for medical services rendered to Medicare recipients that are not provided within the U.S.3 Additionally, the so-called Stark regulations may limit teleradiology options for interpretations if ordering physicians wish to fall within the in-office ancillary services exception to Stark.4 With increasing threats of false claims (both civil and criminal)5,6 actions, facilities must remain vigilant to comply with Medicare and Medicaid regulations.
Licensing and credentialing. Licensing and credentialing for readers are paramount concerns. The ACR recommends that physicians providing telereads maintain licenses at both the sending and the receiving sites. Technically, however, readers are deemed to be practicing medicine only in the sending site state, which is where the patient is located.
National licensure of physicians could theoretically streamline this process, but the U.S. Constitution permits individual states to regulate professional licensure. The dichotomy between the commerce clause of the U.S. Constitution, which prevents each state from limiting trade among the other states, and the concept of federalism, which reserves certain rights to the states that promote public health and safety, has not been addressed by the U.S. Supreme Court. There are strong sentiments against allowing the federal government to license physicians, and federal medical licensure remains unlikely for the foreseeable future (Table 2).7,8
Because foreign teleradiology providers may not always be properly licensed or certified, a facility looking for teleradiology services should verify that the readers meet its standards prior to contracting.
Physician credentialing is similar to licensing. Facilities should review their bylaws to determine if physicians who provide telereads must be credentialed by their institution. Some facilities credential readers by reciprocity if their company is accredited by the Joint Commission on Accreditation of Healthcare Organizations. If facilities rely on JCAHO accreditation only, however, they should ascertain that this type of credentialing is acceptable to third-party payers.
Reads. Facilities must comply with the requirements of third-party payers, conditions of Medicare and Medicaid participation, and institutional bylaws to minimize liability concerns. Provisions addressing modality, volume, turnaround, consultation, and reporting are important considerations when contracting. With teleradiology groups providing overflow reads and possibly performing final interpretations-not just preliminary reads-facilities will need to pay even closer attention to the physicians' licenses, training, board certification, credentialing, and liability coverage.
Liability. Teleradiologists must have adequate liability insurance. Foreign-based and -trained physicians may have no or inadequate malpractice coverage, or they may actually be unlicensed providers. If a teleradiologist misses an obvious abnormality such as a pneumothorax and does not alert the sending emergency department physicians, he or she and the employer will be vulnerable to a lawsuit. If the facility picked the teleradiology group, did not credential the teleradiologists, or did not determine that the reading teleradiologist was properly licensed, the facility may be liable for corporate negligence or negligent credentialing. It may even find itself without liability insurance at all in the matter because it assisted a person to practice medicine without a license.
What location a suit can be brought in (venue) and what state law will be applied are other contracting issues to consider, and the choice of law need not be the same as the choice of venue. Equally important is determining whether the reader is subject to legal jurisdiction in the sending state.
Contracts should provide choice of law (state law for interpreting and enforcing the contract), location for and type of dispute settlement (litigation or arbitration), and information regarding whether readers must submit to jurisdiction in the sending state, whether teleradiology groups must produce the reader(s) at trial, and whether readers are covered by adequate malpractice insurance, including "nose" or "tail" coverage. Since teleradiology is a relatively new science, the body of case law is minimal but will no doubt develop with the expansion of services.
Healthcare providers in the U.S. must continue to place the quality of their patients' medical care ahead of pricing concerns, even though the lure of cheap telereads from non-U.S.-trained physicians working offshore may entice them to do otherwise.
With careful contracting, the quality of patient care should improve as the technology expands geographically. Facilities using teleradiology services should develop checklists or template documents. Physicians who provide teleradiology services must be aware of the requirements for facilities, regulators, and licensing boards when contracting. While some barriers to providing efficient teleradiology services remain, as telemedicine plays an ever-increasing role in the global market, regulatory bodies will no doubt offer legal solutions to these concerns.
Drs. Possanza and Murphy practice health law with Sunstein Murphy & Associates in West Chester, PA.
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