Lab Soft News

Medical Tourism Business Model in Thailand Extends to Airport Facilities

I have posted a number of previous notes about medical tourism. Because I have been interested in this topic for some time, I have had the opportunity to watch the business model evolve in various countries. A recent article discusses how, at least in Thailand, the industry is now incorporating airport facilities into the business model (see: Samitivej Srinakarin to open first private medical centre at airport). Below is an excerpt from the article (boldface emphasis mine):

Despite the host of problems at Suvarnabhumi Airport, private hospitals are moving to maximise its potential to bring in new business. Bumrungrad International last week opened a new airport service centre at Suvarnabhumi, while Samitivej Srinakarin Hospital is scheduled to open the first medical centre to be run by a private hospital at the airport next week....[T]he Bumrungrad Airport Service Centre provides mainly information and ground support services for its inbound patients in a stylish, business-class lounge setting. The centre complements a long list of services the hospital currently offers international patients, which include on-site serviced apartments, visa extensions and interpreters. Bumrungrad ...treated an estimated 450,000 foreign patients in 2006, a rise from 400,000 a year earlier. If domestic patients are included, the hospital treated more than one million patients in 2006....Mack Banner, Bumrungrad's CEO, said the hospital's aim was to provide inbound medical tourists with a complete door-to-door service....Under a plan to expand its foreign patient base, Bumrungrad plans to set up about four representative offices in foreign countries this year, three due to be established by the first quarter of this year in the Republic of Seychelles, Mongolia, and Ethiopia.The company currently operates 14 overseas offices.

I have the following comments about this article:

• Two Thai healthcare organizations are setting up an airport service center and a hospital at the new Bangkok international airport, Suvarnabhumi. This make sense from a supply chain perspective. Patients can fly into the airport, undergo various surgical procedures, and then fly home. Alternatively, incoming patients can be expedited through customs and passport control at the airport and then transported to a hospital in the city.
• I have posted notes about Bumrungrad Hospital in Thailand in the past. Note that the company will soon have 17 overseas offices to solicit and facilitate new business. Also note the locations of the three newest offices: Republic of Seychelles, Mongolia, and Ethiopia. It appears to me that Bumrungrad is establishing itself as a tertiary care provider for developing countries around the world. Although many have been assuming that the developing medical tourism industry was being designed primary to serve patients in Western countries, it may be the case that the majority of patients will originate in less developed countries where there is little competition for the tertiary healthcare services provides by Bumrungrad.
• As I have mentioned before, look for the medical tourism industry in Thailand and India to begin to solicit patients with relatively acute problems who may be transported to Thailand on charter flights with medical attendants. Such patients can be stabilized at the airport medical facilities before being taken by ambulance to a nearby hospital for definitive surgical procedures.

Shipping a Blood Specimen to a U.S. Reference Lab from Abroad

I just came across an interesting lab issue raised by a blogger. She discusses below the problems that she encountered trying to ship her blood specimen to Mayo Medical Laboratories from Ghana (see: The test I couldn’t get):

For us in the developing world, getting diagnostic tests from some developed countries is made impossible. I found out from the website of Mayo Medical Laboratories (MML) in Minnesota in the US that they have a definitive test for diagnosing Devic’s Disease. I wrote to them and they kindly sent me the detailed procedure and forms for getting my blood sample to them. Since they said I could ship it by courier, I contacted both Fedex and DHL but they both said they are not permitted to transport blood samples to the US. They said the only samples they accept are from the US embassy here for DNA testing. Obviously, MML has been receiving samples by this method from other parts of the world; otherwise they would have said straightaway that it’s not done. So I’m still not sure whether I have Devic’s or Multiple Sclerosis, when this test would have ruled out one, to make my life easier.

First of all, I needed to familiarize myself with Devic's Syndrome. Here is a brief description of it:

Devic's syndrome (also known as Devic's disease and Neuromyelitis Optica) is a rare, chronic, inflammatory and demyelinating disease of the central nervous system (CNS) which resembles Multiple Sclerosis in several ways....Neurologists argue as to whether Devic's syndrome is a completely different disease to MS or whether it a variant of it. Many authors consider Devic's syndrome to be a variant of post-viral Acute Disseminated EncephaloMyelitis (ADEM) perhaps related to the varicella zoster virus. Other believe that, like MS, Devic's disease is an autoimmune condition.

For additional information about shipping blood specimens, I turned to the Fedex web site. Blood and urine are considered dangerous substances but apparently can be transported if they meet the packing requirements described in their brochure(see: Clinical Samples, Biological Substance Category B (UN 3373) and Environmental Test Samples). This document indicates that  blood may be shipped if attention is paid to the following four basis requirements:

1. Watertight Primary Receptacles
2. Watertight Secondary Receptacles
3. Absorbent Material
4. Sturdy Outer Packaging

Mayo Medical Laboratories provides a Specimen Preparation, Supplies, and Shipping Guide on the web but it is clearly designed for use by hospital lab personnel who submit specimens to MML. My guess is that an individual who wants to ship a specimen to the lab from abroad might have difficulty satisfying both the shipping and the receiving lab requirements. Perhaps there is a reference lab in Ghana with an established relationship with MML which she could use as both a shipping intermediary and for phlebotomy services.

FDA's Public Meeting on IVDMIAs

I have posted a number of previous notes about IVDMIAs and the FDA's public meeting that took place on February 8 in Gaithersburg, Maryland. The proceedings of this meeting have now been posted on the web site of the FDA's Office of In Vitro Device Evaluation and Safety (OIVD). Most of the names of the various presenters have links to narratives of their remarks. The affiliation of each is also shown in the meeting agenda page.

This is a very valuable resource. I would welcome comments from any of the readers of this blog who are interested in summarizing or distilling these remarks in a manner that will illustrate the various points of view about this topic for the readers of this blog.

Sharing the Knowledge Underlying IVDMIAs

In a recent note (see: Comparing IVDMIAs to Histopathologic Exams), I discussed the similarity between the interpretation of tissue microarray (TMA) results and a standard surgical pathology report, although a histopathologic exam is not considered by the FDA to be a "medical device." A reader of this blog note emailed the following comment to me:

Regarding your histopath example,  I have made the same point frequently in my talks---an ANA slide is an array--people have been reading ANA slides for years of course. The distinction between an ANA reading  and in IVDMIA has to do with whether or not there is a textbook, article, etc. that shares knowledge as to how to interpret....In the case of your pathologist [example], I suspect that the knowledge used to interpret the stained section is not private to that physician.  Further, I assume that if the ordering physician requested it, the pathologist could and would "explain his/her thought process."   Can you say the same of those private labs that are running analyses using tissue microarrays? 

These are very important points to which I have the following responses:

• Let's start with the idea that a pathologist can and should be able to "explain his thought processes" about a diagnosis when asked by a clinician. This is absolutely true. All pathologists will sit down with a clinician in front of a double-headed microscope and discuss how and why any tissue diagnosis was rendered. However, there is also the intangible "art" or subtlety of surgical pathology that cannot necessarily be shared and that frequently distinguishes the skill of a "marquee" pathologist from others in the field. However, the point is still valid that the morphologic criteria used to develop a diagnosis must be known, transparent, and understood by the clinician.
• It has been announced that the MammaPrint test has been cleared by the FDA for marketing even though the FDA's IVDMIA rules have are still in draft form. I will take this to mean that Agendia, the Dutch company that developed the test, has been able to satisfy the FDA as to the reliability of the science that underlies this TMA test. In fact, I would be very surprised if most of this same knowledge is not available in the TMA/breast cancer literature. Nevertheless and at least for the time being, the hurdle is not unattainable or undesirable from both a technical and business perspective.
• For any IVDMIA/TMA test available in the market, I am not opposed to having the scientific knowledge underlying the test being made publicly available. In fact, this is a requirement for assessing the clinical validity of the test and thereby gaining its acceptance in the marketplace. My objection is having a federal regulatory body such as the FDA as the judge and arbiter of clinical validity. The interposition of the FDA in this process causes two problems. The first is that it retards the entry of new tests into the market. Secondly, it favors the large IVD companies with their large staffs of personnel who are skilled in shepherding new tests through the regulatory process.
• If the FDA is not the arbiter of the clinical validity of those IVDMIAs that come to market and this information needs to be publicly available, what is the appropriate channel for publishing and communicating this information? It seems to me that such data need to be contained in articles published in reputable laboratory and clinical journals. This is the current process for other "home brew" tests and I can't think of a good reason why the process should be changed.

Intellectual Property Issues Relating to Biomedical Standards (First in a Series)

Dr. Jules Berman, a noted pathologist informatician, has published a number of previous notes in Lab Soft News about diverse topics. He is one of the country's leading authorities about healthcare software standards and intellectual property (IP) issues. This is the first in a series of notes by him as a guest blogger about IP issues as they relate to healthcare standards.

Bruce Friedman and I have informally discussed an emerging problem in health informatics: the insinuation of intellectual property via licenses and patents into healthcare data standards. Both industry and government experts agree that we need to have standard ways of describing, organizing, and exchanging data. In the U.S., there are thousands of standards development organizations (SDOs) busily creating new standards and revising existing standards. In the healthcare industry, it is likely that a small number of standards will emerge as the "winners" in this evolutionary struggle. A great deal of money will be invested in the development of software and other implementing technologies in support of those standards that are recommended or required by the U.S. government.

Unfortunately, the implementation of standards in commercial systems, or even standards that have been recommended or required by the government, may put commercial entities at some legal risk.

• The standard may contain methods that are covered by existing patents
• The standard may itself be "owned" by entities that require a license to use it
• The use of the standard but not the standard itself may be patented

I will be writing a series of blogs over the next few weeks that describe some of the challenging IP issues relating to biomedical standards. The blogs will include practical examples and will suggest some common-sense approaches intended to reduce risk and expense and maximize interoperability and flexibility. Comments about this note and any of the others that will be published in this series are highly encouraged.

:: Update on March 3, 2007 @ 10:35 a.m.

Jules Berman has a personel web site that contains resources and information relevant to his two book publications: Biomedical Perl and Perl Programming for Biology and Medicine. Among the resources available are:

• The Developmental Lineage Classification of Neoplasms, containing over 6,000 types of neoplasms and over 146,000 unique names of neoplasms. This classification is the largest neoplasm nomenclature in existence and is currently available as a public domain document.
• A compilations of all the lists included in Biomedical Informatics (about 240).These lists can be used in PowerPoint demonstrations.
• Links to information (such as Table of Contents) describing both books.
• Links to many of Jules' prior publications.
• Hundreds of "factoid" web pages containing interesting information in the related fields of pathology and biomedical computation.
• The web site currently contains several hundred web pages and is rapidly growing.

Free Webinar on Clinical Lab Rules

A free webinar on the development and deployment of clinical lab rules will be offered on Monday, March 5, under the sponsorship of Roche Diagnostics Middleware Solutions. The event is a live webcast of one of the two workshops being presented as part of Lab InfoTech Summit in Las Vegas, Nevada. Here are the details:

Title: “Technical and Human Factors Associated with the Implementation of Lab Rules.”  and “Simple Lab Rules You May Never Have Considered”

Date & Time: Monday, March 5th: 9 a.m.–10:40 a.m. PST

Course Description:

The Middleware Solutions Best Practices education series was designed based on feedback from our laboratory partners around the country. We found that our laboratory customers want more opportunities to interact and learn from their peers who have achieved significant accomplishments in laboratory efficiency.

Our first education series features speaker Frank Polito who was responsible for driving the implementation of Middleware Solutions at Dartmouth Hitchcock Medical Center ’s laboratory. Frank led his team to 85%+ autoverification in just over 90 days by understanding the dynamics of empowering people and building the foundation for long term support of Middleware Solutions from his seasoned staff.

The second presentation features Frank Polito and Mark Shearer, Chemistry Director for CompuNet Clinical Laboratories. In this session both Mark and Frank will demonstrate many of the simple lab rules that have contributed to efficiency and quality gains at both Compunet and Dartmouth Hitchcock. Take this opportunity to learn best practices from two prolific Middleware users.

Key Learning Objectives:

• To learn how the Dartmouth Hitchcock team tightened their focus to 5 key rule types to best achieve their goals.
• To learn how the Dartmouth Hitchcock team’s tight focus allowed for fast, efficient propagation of rules to achieve their autoverification goals in just over three months.
• To observe simple lab rules engaged by both Mark and Frank that allowed them to achieve key efficiency gains and quality improvements.

Speaker Information:

• Frank Polito, MBS , MT (ASCP)SC; Chemistry Manager, Dartmouth Hitchcock Medical Center Department of Pathology

• Mark Shearer, MCLT, MT (ASCP); Chemistry Director, CompuNet Clinical Laboratories

Registration link (registration is limited)

Accent Credits: Credits have been applied for and credit information will be provided for at the time of the event.

Comparing IVDMIAs to Histopathologic Exams

I have written a number of previous notes about in-vitro multivariate indexed assays, a type of test currently under consideration for regulation by the FDA. As noted previously, the FDA recently held a public meeting to discuss this topic. This meeting, as well as the larger topic of genetic testing, was addressed in a recent article in the New York Times (see: Genetic Tests Offer Promise, but Raise Questions, Tool). Below is an excerpt from it:

The Food and Drug Administration's Center for Devices and Radiological Health held a public meeting on Feb. 8 to discuss guidelines to regulate the safety and effectiveness of a type of test called in-vitro diagnostic multivariate index assays [IVDMIAs]. One such test is Mammaprint...which was the first product approved by the F.D.A. under draft guidelines, measures the activity of 70 genes in a cancer tumor after a surgeon removes it from a patient's breast. It then calculates a score that estimates the risk of the cancer spreading to another part of the patient's body....[N]ews coverage of the F.D.A. meeting indicated that agency representatives got an earful from angry diagnostics manufacturers, denouncing the F.D.A.'s draft guidelines. They complained that the guidance was confusing, untenable and a "disincentive to innovation," and even suggested that the F.D.A. had no legal authority to regulate these particular tests as "devices." Instead, they want these in-vitro diagnostic multivariate index assays to be subject to the same rules as "homebrew" tests developed by individual labs.

These tests are regulated today by the Centers for Medicare and Medicaid Services, a Health and Human Services agency separate from the F.D.A. Under H.H.S. guidelines, called Clinical Laboratory Improvement Amendments [CLIA], tests developed by individual labs do not require regulatory review. What's more, the guidelines require only technical proficiency; they do not require labs to prove their tests are clinically valid, said [an FDA spokesman]. He said in-vitro diagnostic multivariate index assays "are based on algorithms that don't permit even a well-trained physician to really understand whether or not the results are accurate and meaningful or not."

I have the following thoughts about this article as well as IVDMIAs in general:

• It's important to first emphasize that both Mammaprint and a similar test that came to market earlier called Oncotype DX are based on tissue microarray (TMA) technology. TMAs are used to evaluate the expression of proteins by tumor genes in cancer tissue. To perform this type of test, a core sample of a tumor is embedded in a large paraffin block and compared with multiple core samples of known tumors in the same block. Neither of these two tests measures proteins circulating in the serum. Rather, immunohistochemistry and fluorescent in situ hybridization techniques are used to analyze the proteins expressed by the tumor tissue.
• The term "indexed" that is part of the IVDMIA acronym was probably chosen to refer to TMA tests such as these two that compare the expression of proteins in the test tissue with cores from known tumors, all embedded in the same paraffin block. The term IVDMIA seems less relevant for large panels of in-vitro assays.
• Because FDA spokespersons constantly refer to the pressing need for physicians to review and understand the algorithms used to interpret the results of IVDMIA tests, let me put this argument to rest. Very few clinicians, will ever have a sufficient depth of understanding to interpret all of the TMA tests that will eventually appear in the market. In fact, I suspect that few Ph.D. clinical chemists, who rarely work with tissue, can interpret TMA results. What the clinicians care about is the clinical validity of these tests.
• So, work with me here with the following scenario. A pathologist examines a paraffin section of a breast tumor under the microscope that has been stained with H&E but may also be examined with immunohistochemistry stains. This may be the very same paraffin block from which the tissue cores are removed for subsequent TMA exams. The pathologist diagnoses the lesion and may suggest a prognosis for the patient using criteria (i.e., algorithms) which may be unfamiliar to the clinician submitting the specimen. Is this histopathologic exam not very similar to the Oncotype DX and Mammaprint TMA tests discussed above? If so, why then is the histopathologic examination of a breast tumor not a "device" that is regulated by the FDA?

West Virginia Legislature Considers Formal Support for Medical Tourism

I have blogged frequently about medical tourism, suggesting that economic considerations may make it irresistible to legislators, particularly in countries with national health systems and long queues for surgical procedures. A recent blog note (see: The Sad State of Our Health Industry) indicates that formal support for medical tourism is now being debated in the West Virginia legislature (boldface emphasis mine):

Legislators are considering a bill providing incentives for state employees to go to other countries for medical procedures. But state officials are not sure if the incentives would save any money. The West Virginia Hospital Association says such a measure could financially harm the state's hospitals and put patients in danger. Nationally, it's becoming a popular way of getting cheaper health care. According to the National Coalition on Health Care, an estimated half-million Americans engaged in "medical tourism" in 2005. Ten state delegates, including House Majority Leader Joe DeLong, D-Hancock, recognize the trend. They are sponsoring a bill that authorizes the Public Employees Insurance Agency to waive co-payments and deductibles and provide round-trip airfare and lodging expenses to the foreign country where the patient has the procedure done. The bill is meant to reduce the state's costs for medical care. The bill says the incentives would be offered only if the foreign procedure were cheaper than the procedure here.

UnitedHealth Moves Spark "Doc Fight"

I have written a number of previous notes about the switch of the UnitedHealth lab contract from Quest Diagnostics to LabCorp. I also posted a note discussing how UnitedHealth intends to fine those doctors who permit their patients to use out-of-plan labs for testing (see: UnitedHealth Threatens to Fine Doctors for Sending Specimens to Quest). A recent article (see: Doctors protest being told what labs to use) suggests that there may be a rebellion brewing among physicians directed against UnitedHealth and other healthcare payers regarding reimbursement. The basis for the discontent is that payers are perceived as being too "directive" about how physicians run their practices. Below is an excerpt from the article:

Some doctor groups are protesting moves by the nation's largest insurer, UnitedHealth Group, for what they say is dictating where they can send patients for lab tests and where they can perform certain procedures....United warned doctors in its network they could be fined or dropped if they continue to refer patients to other labs, with the exception of some contracted local and regional labs....In a nationwide policy updated in August that has also prompted concern from doctors, UnitedHealth dropped [emphasis mine] an extra "facility fee" paid to gastroenterologists who perform some procedures, such as colonoscopies, in hospitals or ambulatory surgery centers. The insurer will make higher payments to doctors who do the procedures in their offices....Connecticut doctors say the move amounts to a 30% pay cut because most doctors prefer to do the procedures in surgery centers or hospitals...."From a philosophical point of view, at what level should a health plan be able to dictate where medical services are provided?" asks Jeanine Freeman, senior vice president of legal affairs for the Iowa Medical Society, whose members are concerned about the required switch from Quest labs to LabCorp.

There is certainly an undercurrent of discontent about UnitedHealth policies on the part of consumers (see: UnitedHealth sued for racketeering) and physicians but I am not sure if this exceeds the animus directed toward any third-party payer these days. Putting this question aside, I am interested in the idea of how or when a payer begins to be too "directive" on the basis of its policies. All payers, governmental or private, are continuously motivated to reduce their costs and physicians strive to maintain or increase their incomes. The charges of reduced quality and patient safety can be leveled against any cost-saving directive by payers with variable degrees of sincerity.

Returning to the Quest/LabCorp discussion, it will be interesting in this cat-and-mouse game to see whether Quest announces its intention to perform testing for UnitedHealth patients for the same fee schedule as that negotiated by LabCorp. This would perhaps allow the company to maintain more of its physician office relationships and test pull-through. In addition, it would also undercut the UnitedHealth argument that the performance of tests by LabCorp is necessary to hold the line on soaring healthcare costs.

For the time being, however, Quest is quite content to foment physician unrest by playing the "doctor autonomy"  and "provider agreement" angles. Snake Oil Sam reports (see: Quest Diagnostics Counters with a Left Hook!) that Quest is sending a flyer to physicians in New Jersey that makes the following points, among others:

• United has, in effect, implemented administrative policies that may change the terms of your provider agreement and limit your ability to practice medicine as you see fit. What will be the next medical decision that will be removed from your discretion if United is successful in its action?
• The selection of what laboratory to use for PPO, POS and indemnity patients is one we believe physicians expect to have when they sign physician provider agreements that are not restricted to HMO closed network products. Would you have executed your provider agreement with United if you had known that your ability to recommend which providers your patients should see would be limited by the imposition of these penalties?

Irish Pap Smears Imported by Quest

In an effort to allay the anxiety of a large number of Irish lasses, Quest Diagnostics has begun to import pap smears from the auld sod (see: Cervical smears sent to US for testing). Below is an excerpt from the article (boldface emphasis mine):

The cervical smears of up to 30,000 Irish women are being sent to the United States for testing in a bid to avert a crisis in Irish laboratories....[T]he National Hospitals Office ...has signed a contract with Quest Diagnostics Laboratory in Dallas,Texas, [to process these tests]....In Cork hospitals, there is a backlog of between 10,000 and 12,000 tests and HSE South said the maximum waiting time for results was six months. [The] medical director of Well Woman Clinics in Dublin, said that the waiting time for results from the Royal College of Surgeons in Ireland (RCSI) was currently four months, but that a one month turnaround for cervical smear results is best practice. By sending the tests to the US, the NHO claims the entire backlog will be cleared in the first half of this year. Quest Diagnostics processes 55 million smear tests a year.

I have the following comments about this article:

• Don't you just love this statement: "a one month turnaround for cervical smear results is best practice [in Ireland]." How long would a cytology lab last in the U.S. with that kind of TAT?
• My guess is that the Irish health system will rapidly adapt to the convenience of shipping their pap smears to Texas and that this is more apt to be a permanent arrangement than the stopgap approach to clear up the backlog in Ireland, as it is described in the article.
• I have written a previous note (see: Need for Pap Test May Be Fading) about how the HPV vaccine will reduce the incidence of cervical carcinoma among women in the U.S. and hence the demand for pap smears. Perhaps this Irish pap smear initiative will be a "dress rehearsal" for a more generalized phenomenon with pap smears shipped to the U.S. from multiple other countries.
• How about this yearly pap smear volume for Quest -- 55 million!