Tag Archives: telehealth

Lessons from France: Successful French Telehealth Company Showcases Business Opportunities for Hospitals and Network Operators

Too often, companies try to re-invent the wheel.  This is especially true in the telehealth sector where new models of care are constantly being tried and tested.  Fortunately for U.S. hospitals, health systems, and companies, however, we have great examples of telehealth models from around the world that have built successful business models in telehealth.

Take the example of Calydial, a company based in Lyon, France, that specializes in remote dialysis. Launched in 2006, Calydial started with 25 patients with renal impairment who needed remote treatment and monitoring. Today, Calydial has 230 patients, and performs 30,000 dialysis acts per year.  “When we started in 2006, there was no regulatory framework in France for telemedicine,” said Mr. Gérald Huguet, Chief Information Officer, “so we just had to learn on the job”.

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E.U. Way Ahead of the Game on Telehealth

Telehealth is expanding rapidly outside of the U.S. in both developed and developing countries.  Not surprisingly, the expanded use of telehealth presents many of the same regulatory and reimbursement challenges abroad that it does here in the U.S.  One region in particular that has taken steps to expand telehealth across borders is Europe, where in an effort to confront the legal issues raised by telehealth, the E.U. has removed and revisited existing regulations.  The E.U. has also issued guidance through the European Commission (an institution that is responsible for ensuring that E.U. law is applied and adhered to by all Member States and therefore a key player in regulating the use of telehealth), regarding how best to comply with the regulations in place.  In order to provide timely and effective guidance on rapidly evolving technologies, the Commission publishes staff working documents which interpret the law and provide compliance guidance, but are not legally binding themselves.  One such document is the “Commission Staff Working Document on the applicability of the existing E.U. legal framework to telehealth services”, dated June 12, 2012.  The Document provides guidance on how to comply with E.U. law, but for those in the U.S., reading this guidance also brings to light where the E.U. and the U.S. diverge with respect to key legal issues such as licensure and reimbursement.

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Corporate Practice of Medicine: The Unseen Hurdle in Telehealth

When evaluating the various legal and regulatory hurdles associated with telehealth—such as licensure, reimbursement, and privacy—one hurdle that often goes overlooked is the corporate practice of medicine.  Many states have enacted laws which directly or indirectly are viewed as prohibiting the “corporate practice” of medicine.  While variations exist among states, the doctrine generally forbids a person or entity, such as a general business corporation, other than a licensed physician, professional corporation (“PC”) or a professional limited liability company (“PLLC”), from owning an interest in a medical practice or employing physicians for the purpose of practicing medicine.  These laws against the corporate practice of medicine are generally designed to prevent non-clinicians from interfering with or influencing the physician’s professional judgment, and will affect the ability of business entities to enter into agreements with physicians and other health professionals. 

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Progress in Telehealth: Recent Activity A Cause for Optimism

We are all too familiar with the many hurdles that stand in the way of the greater proliferation of telehealth.  This blog has examined various legal and regulatory stumbling blocks such as licensure, reimbursement, and privacy that continue to stand in the way of telehealth fulfilling its great promise—at least in the United States.  Other countries are increasingly embracing telehealth.  A recent spate of legislative and other activities, however, point to an evolving environment in which legislators and regulators are beginning to understand and grapple with the many legal and regulatory issues that stand in way of the greater use of telehealth.  Here is a sampling of that activity

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Healthcare Alert: Provision of electronic interfaces to physicians

On December 12, 2012, the Office of the Inspector General (OIG) issued OIG Advisory Opinion 12-20. This opinion was based upon a request by a hospital regarding the implications under the Medicare and Medicaid anti-kickback law if the hospital provides free access to an electronic interface to community physicians and practices. The hospital would offer free access to the interface which would be utilized by the physicians to order laboratory and diagnostic services performed by the hospital, and to receive the results of those services. In addition, the hospital would provide support services necessary to maintain the interface, including software updates. The physicians would remain responsible for their own electronic health records systems, but would be able to utilize the interface for the sole purpose to transmit orders and receive results of laboratory and other diagnostic testing. 

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Remote Monitoring and the Interstate Practice of Telehealth

The rapid development and utilization of remote patient monitoring tools in health care exposes the limitations of state licensure laws that generally require physicians to be licensed in states where their patients are located.  These laws are predicated on the physician and patient being in the same jurisdiction.  However, when using mobile-devices to actively monitor patients (such as a device sensor with 4G chipset that can directly connect to cellular networks), there is no single geographic anchor or fixed moment in time from which to define the encounter, episode or point of service.

Rather, the encounter can be viewed as more continuous and spread out over time.  Even if one can break down the services into discrete units (e.g. each instance where a physician is reading and interpreting remote monitoring data, advising the patient, or adjusting prescriptions based on such data) it will be difficult if not impossible for the physician to ensure that during each such instance the patient is physically located in a state where the physician is licensed.  While the program of care may begin on site at a medical center or physician’s office, it may continue offsite for weeks or months during which the patient may be outside the state where the physician is licensed.

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Beyond HIPAA: Other Privacy Laws That Telehealth Companies Need to Be Aware Of

While tech companies looking to provide health solutions must figure out early on whether they are HIPAA-regulated, HIPAA is not the be-all and end-all of privacy law. Even entities not regulated under HIPAA must abide by other privacy rules, including a wide array of state privacy laws. On December 6, 2012, in the state’s first legal action under its online privacy law, California Attorney General Kamala Harris filed a lawsuit against a major airline for not including a privacy policy in its smartphone app. The complaint alleges violation of California’s Online Privacy Protection Act, which requires certain operators of commercial websites and online services that collect personally identifiable information to conspicuously post privacy policies. Such laws that cover personally identifiable information in general have a much broader focus than HIPAA, which only targets covered entities and business associates exchanging medical information. Even companies not regulated under HIPAA must therefore take such state laws into consideration, and given the potentially severe penalties, noncompliance could be devastating—for example, California seeks penalties of $2,500 per violation, which the complaint defines as each copy of the app downloaded by California consumers. Moreover, simply having a privacy policy will not be enough. While the lawsuit targets the airline for not posting a privacy policy, state legislation and enforcement will be augmenting their focus on the content of such policies to ensure the adequate protection of consumer information.

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Prescription Drug Laws Create Challenges for Telehealth

While tremendous strides continue to be made in the growth and adoption of telehealth services, significant legal obstacles remain.  Among these obstacles are state drug prescribing laws.  In many states, physicians cannot lawfully prescribe drugs during a telehealth encounter, except in very limited circumstances.  For example, California requires that physicians perform a “physical exam” before prescribing drugs, and explicitly outlaws prescribing on “the internet” without a prior examination.  These restrictions vary from state to state, but many share certain characteristics, such as the following:

  1. In several states the law says that physicians cannot prescribe medication without first performing a “physical” examination (e.g. Alabama, Massachusetts, Tennessee and California).   This physical examination requirement is generally interpreted to mean that the physician must have an in-person encounter with the patient, but this is not necessarily the case everywhere. 
  2. Some states only limit telehealth prescribing to certain classes of drugs.  For example, Minnesota’s prescribing law requires that the physician complete an “in person examination” before prescribing controlled substances, muscle relaxants, and certain other classes of medication.  Louisiana has a similar restriction for certain controlled substances, but not other classes of drugs. 
  3. Many states now have prescribing laws that explicitly prohibit prescribing solely based on an internet questionnaire (e.g.  Louisiana and Mississippi) or internet consultation (e.g. Oregon).  
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TechHealth Perspectives 2012-11-05 11:10:55

THE REAL ISSUE IN TELEHEALTH: HOW CAN I GET PAID?

As telehealth continues to grow, there are a number of legal, regulatory, and operational issues that threaten to stall its progress.  We have tackled many of these issues in previous blog posts.  But no obstacle looms larger than the issue of payment.  How can providers get consistently and appropriately reimbursed by payers for use of telehealth?  Absent a clear answer, telehealth will likely find it difficult to fulfill its great promise—at least in the United States.  Other countries are pulling ahead.  Here is a look at the current reimbursement landscape facing providers and what could change in the coming years.

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States Jumping on the Telehealth Bandwagon

A significant yet little-noticed trend is underway. And its effects could be far-reaching.  A growing number of states are enacting so-called telehealth parity statutes. These laws generally require health insurers to pay for services provided via telehealth the same way they would for services provided in-person. Almost a third of all states have enacted these statutes, and I predict more states will be jumping on the bandwagon. Telehealth is indeed going mainstream.

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