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Accreditation & Certification

Legal Issues in Obtaining and Providing Healthcare Internationally

Accreditation & Certification

Perhaps you are in the international healthcare field in some capacity-as a provider , insurer, project developer, or a medical tourism facilitator. When it comes to the myriad of laws that may impact a medical tourism patient’s experience in travelling internationally for medical procedures and related services, you may ask, among other questions: What should I know about, and more specifically, what regulatory health care legal issues are relevant to the international/cross border healthcare experience? This article is intended to present, in a general, broad overview, those regulatory subject issues which U.S.-based and other health care consumers might confront or want answers to in planning their medical tourism experience.

Informed Consent

What procedure exists, if any, for obtaining the informed consent of the patient? Informed consent is the process whereby the patient is informed of the risks, benefits and treatment alternatives available so as to allow the patient to make an informed decision electing the care and treatment provided.

It is generally the duty of the licensed professionals and facilities as a condition of their licensure to obtain the patient’s informed consent before performing medical treatments and procedures, and whereas the governing rules generally arise from the location where the licensed provider or facility are rendering the services, the informed consent rules and laws of the provider’s jurisdiction are likely to control in the case of medical tourism services.

It is worth noting however that issues of jurisdiction and choice of controlling law could arise with regard to any of the legal issues and subjects addressed herein.

With regard to informed consent generally, it should be understood whether the informed consent, to be effective, must be in written form. Does the patient have an understanding of the actual risks and benefits of a procedure or treatment, and any available alternatives?

Must the informed consent be provided and documented in the language that is the patient’s primary language? Are providers required to have interpreters available to explain the procedures and throughout the medical care experience, as needed?

Finally, given the significant investment of time and money involved by both patients and providers, the informed consent process should be substantially addressed well before funds are invested for travel and procedures are scheduled by the provider, even if the final written consent forms are not presented to the patient until their initial in-country meeting with their surgeon and hospital intake staff.

Patient Travel Issues

For the medical tourist, it is also important to know what travel documentation laws and requirements apply? What passports or visas are required for the patient and any travelling companion? Are there limits to the patient’s length of stay in the country where the medical procedure is being performed?

If so, what impact might such rules have if medical complications prolong the patient’s need to stay in country longer? Is special permission required for extended stays? What actions should the patient take if a travel or visa issue arises related to the length of stay-should the patient or their advocate contact their home embassy, the in-country immigration authority, or both?

What are the options if the patient is unable to leave with medical clearance for travel before their original visa expires, such as when flying is against medical advice?

Licensing and Regulation of Facilities and Professionals

The local licensing requirements of your professionals and facilities rendering the service may be of interest to the patient considering medical tourism? In terms of licensure, governing rules may often be local (such as the rules of a state or province) and not national laws which govern. For the patient, this means that requirements from region to region of a destination country may differ in what they require.

Medical tourists, facilitators, and insurers in the U.S. and elsewhere have come to ask whether the destination medical facility is accredited? In the U.S., foreign health care facility accreditation by the Joint Commission International (JCI) is considered a reliable badge of quality, akin to a facility having Joint Commission (a JCI “sister organization”) accreditation in the United States.

When JCI facility accreditation is present, potential medical tourists, their facilitators, and increasingly, group health benefit plan insurers in the United States, begin to look seriously at and compare the costs of performing a surgical procedure in a U.S. facility compared to costs (including travel and supporting services) of the same procedure if performed at a JCI accredited hospital.

Where JCI accreditation is present, it helps the travelling patient, their facilitators, family members, local providers, and insurers gain confidence in and choose the medical tourism option, including providing insurance coverage benefits for the patient’s out of country health care services.

Surrogate Decision-Makers

A patient travelling for medical procedures should also inquire and understand whether and how patients have the right to designate a surrogate decision-maker if the patient becomes unable to voice his or her care preference at some point in the process.

If such rights exist, a medical tourist and their travelling companion should understand under what circumstances do they arise, and what are the limitations on the extent of authority which is given to a surrogate decision-maker? What forms and procedures are required to establish such a back up decision-maker?

Does the destination country have different rules than the patient’s home country? If so, which laws will control- those of the patient’s home country or the laws of the site of the provider?

If no local laws exist, will the patient’s existing documentation be honored, or can the patient and provider contractually agree to honor and permit the surrogate decision-maker to step in if the same conditions exist which would vest authority in the patient’s country should arise, such as during the patient’s loss of capacity (due to heavy anesthesia, unconsciousness, or other condition)?

Payment and Insurance Benefits

Whether or not insurance payment benefits are available is important to all parties when expensive health care procedures and treatment are involved. Will the patient’s health insurance or related benefits apply outside of the patient’s home country borders, as in the European Union currently?

Medical tourists, their providers and insurers should understand how the local rules in the patient’s and the provider’s jurisdictions affect payment and claims processing. Can health coverage benefits be assigned to providers to bill insurers directly, or must the patient bear the burden of paying all expenses out of pocket and submitting a claim to his or her insurer for reimbursement?

Providers and patients should know if there are auditing procedures after payment (“post-payment review”) that require timely response, submission of supporting documentation, and which potentially place payments made at risk of recoupment or demand for repayment.

Medical Records Issues

Other practical considerations exist with regard to sharing and providing medical records to the out of country providers in advance of treatment. Are certain portions of the patient’s historical medical record needed in order to authorize and ultimately deliver care and perform procedures (such as diagnostic tests, imaging scans, or history and physical notation of certain diagnostic codes/disease states under the international classification of diseases system)?

What authorizations are required by the providers and the patient’s governing laws as a condition of releasing records to other providers, to insurers-for payment or reimbursement of patient’s charges, and to the patients or their advocates?

What technical mechanisms are present to exchange and share records of the patient’s care, including for proper after care coordination and follow up back in the patient’s home country? How can the out of country medical records become a part of the medical record of the patient and available to their home country providers for access later?

Patient Privacy and Other Patient Rights

How is personal patient data (which the United States health care regulators and their HIPAA regulations refer to as “individually identifiable health information”) protected? This data can include financial and other very personal and private information above and beyond medical care and conditions. Is there a right to privacy and protection with regard to the use and disclosure of patient information?

Does the provider’s jurisdiction have a Patient Bill of Rights? What rights are provided to patients under the laws of the provider’s jurisdiction? Does each patient have the right to be informed and participate in their care decisions, the right to have advance notice of their payment obligations, the right to have visitors, and a right to access and have complete copies of their own medical records?

Dispute Resolution

One very common question raised by U.S. outbound medical tourists is :What happens if something goes wrong? Can I sue the provider here (in the U.S.)? Medical tourists should determine what range of optional and mandatory dispute resolution methods are available?

Is there a system of litigation of personal injury claims? What procedures govern disputes between the patient and any provider of care? Do they vary with the type of dispute, such as a payment dispute versus a liability claim for a bad result?

Remedies may be limited and governed by agreement in advance. Are claims limited to return or forgiveness of fees, or are there rights to recover consequential damages, such as lost earnings? Is it possible to recover monetary damages for claims of permanent harm or disfigurement?

Are there limits or caps on recoveries? Are there governmental immunity defenses or limits specially available in the case of a governmental (municipal, state, federal, or other subdivision) facility or provider?

Finally, are there any treaties and conventions between the nations of the participants that limit remedies, direct dispute resolution to certain forums and bodies, or otherwise impact resolution of disputes and the remedies available?

Controversial Treatments and Procedures

As if the above legal and regulatory issues material to cross-border health care/medical tourism are not enough, some of the most complex issues (though not necessarily legal in nature) can arise when controversial issues are involved, such as use of stem cell therapies, organ transplant, (organ donation, harvest/ and transplantation), fertility and conception-including genetic screening, gene therapy/genetic code splicing, and use of certain pharmaceutical, biological agents, or medical devices which are not approved for use in the medical tourist’s home country.

Often there are fewer rules and prohibitions when it comes to the most cutting edge of therapies, treatments and procedures; and opportunities often exist where the medical community is “out front”.

Although payers often deny payment of innovative or controversial treatments and therapies as being “experimental”, it does not mean that the patient does not have the choice (provided that the patient has the means) to obtain such cutting edge treatments.

As a procedure or treatment moves into and becomes “evidence-based medicine”, it often also becomes a covered service under payment and insurance benefits, and part of the accepted and ever changing landscape of medical care.

Medical tourism has a place at the forefront, given that with the myriad of geographic locations and governments, and cultural and religious diversity around our world, there are always going to be places where a meritorious, innovative treatment or procedure can be obtained by those medical tourists of our time in search of excellence in health care.

About the Author

Tracy J. Mabry, Esq., is a practicing health law attorney with his law practice based in the Orlando, Florida office of the international law firm of Greenberg Traurig P.A., which is a member of Medical Tourism AssociationTM. He is in his 26th year of law practice, is licensed to practice in the states of Texas and Florida and is recognized by the Florida Bar Board of Legal Specialization as a Board Certified Specialist in Health Law. The views stated in the article above are the authors own personal views, and are not necessarily the views of the law firm of Greenberg Traurig, P.A.

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