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High numbers, Bankruptcies, and Fraud Impede Proton Therapy DevelopmentsOctober 9, 2017 Cost of treatment After deciding on proton therapy to treat my prostate cancer, I began to investigate cost. United Healthcare made it clear they wouldn’t be paying for it. When I called the University of Florida in Jacksonville and asked what I would need to pay out-of-pocket, they offered a cash reduction from $164,000 to $134,000. When I called Provision CARES Proton Therapy Center in Knoxville, Tennessee, they quoted a personal cost of $93,000. For a difference of forty grand, Provision is clearly the better choice. But first, I investigated proton centers abroad. I wasn’t attracted to the one in South Korea, but Prague sounded interesting. They have direct connections to England and have state of the art equipment. Going there, including travel and lodging would have been around $40,000. It turns out that I joined a registry at Provision so Medicare can track my results for life. In turn, they paid 80% of the cost. After United Health care then pitched in for the remaining 20%, my co-pays, treatments not covered (hydro gel), and living expenses ended up totaling about $15,000. While not nothing, it was manageable. I didn’t have to refinance our home. (The majority of bankruptcies are caused by the burden of medical payments.) Insurance payments But then began the insurance game. It is apparently par for the course to bill insurance companies and Medicare a higher amount than they are likely willing to pay. For example, $2,500 per proton therapy fraction, when coverage is less than one-third of that. Perhaps there is a tax benefit for billing the full amount and then getting a deduction for funds not received. Through all of the complicated billing, it seems to me that the actual amount received by Provision was around the $93,000 that they would have otherwise billed me. To confuse the issue, a year later I still get monthly insurance statements that reflect on-going billing by Provision. There is no earthly reason to send me these documents, as they make no sense to me. These are the actual figures from “Totals for 2017” dated August 14, 2017: Amount providers have billed the plan: $304,582.42 Certainly this doesn’t mean that Provision was paid only $682.90. Within the document, there are details such as total billed this month ($10,345.00) and total paid ($238.53). On another page is states the charge is for “proton treatment delivery, intermediate (billing code 77523-Q0): $4,400. Total approved: $0.00.” That’s zero, zilch, nada. I added this report to my file, which is now two inches thick. I have noted in other articles that financial failure at proton centers is often exacerbated by the inability to collect from insurance companies and Medicare. The decommissioned proton center at the University of Indiana in Bloomington, for example. Provision has seven people in their insurance collections department. Before my treatment even started, they verified what United Healthcare would or wouldn’t cover. I hope they received fair payment. My treatment was excellent (and life saving). Overly Optimistic Financial Projections Back in the 1980s, I used to write prospectuses for group real estate investments. It was a very heady time in Texas (110% financing from banks in return for a piece of the ownership, etc.). Early on, the general partners had the expertise and the investors had the money. Further down the road, the general partners had the money and the investors were a whole lot wiser. But I digress. My point is, I regularly projected future growth at 10% a year and occupancy at 95%. That was the norm then. (Our methods were largely eliminated due to the 1986 changes in the tax laws.) In case after case, I see that proton therapy centers, having identified the huge need for this exciting technology, assume that business will be booming. If you build it, they will come. The reality, however, has been more modest. Looking at a website that gives financial returns for projects financed with public bonds, I found that Provision seemed to be 15 - 20% below their projected volume and budget. Fortunately for them, they are in an extremely strong financial position, with income from other sources and extensive depth. The proton therapy center at Hampton University, in Virginia, has acknowledged falling well short of their projections. An article in the Daily Press made this startling revelation. HU president William Harvey had predicted 2,000 patients annually, yet by their fifth anniversary in 2015, they had treated a total of 1,274 patients, less than 13% of their projection. Back in 2013, they billed Medicare for 212 "intermediate" treatments and 735 "simple" treatments. They claimed $2,700 to $3,200 respectively for each treatment, but Medicare allowed $815 to $847. Such projections are often provided by the developer or equipment manufacturer, who, to some degree, will make their profit and go on. An exception is Varian, which has invested in some of the centers. (See below, about Scripps in San Diego. The Scripps center never operated in the black prior to filing for bankruptcy earlier this year.) The potential is certainly out there. In my book I quote some statistics that seem to call for 300 more proton centers, based on the prevalence of all the cancers they could treat. But getting the patients through the door is an arduous task. Other modalities dig in to protect their turf. I haven’t tried to poll other proton centers regarding their projections, so I don’t know how many more, if any, are falling short. (Note: Since writing this piece I added another with relevant statistics. See: Proton Therapy: Go Publoc Or Else. High Cost of Development and Operation One of the biggest impediments identified for proton therapy has been the cost of planning, building, staffing, operating and maintaining facilities. Early on, it was not unusual to spend more than two hundred million dollars for a proton center. Most of those high-priced projects, as I describe below, have failed or are struggling. One hospital in Oregon decided to wait a couple of years for technology to get cheaper. And so it has. Their patience probably saved them a hundred million dollars. ProNova has three-room configurations for under a hundred million, while Mevion, IBA and Varian offer single-room facilities for less than half of that. ProTom International has a product that will even undercut those prices. Let’s look at Emory University in Atlanta. After a disastrous beginning with Advanced Particle Therapy, a developer out of San Diego who had a cost around $245 million, they have finally been bought out by Provident, a health system from Baton Rouge, LA, for three hundred and fifty million dollars. Note that I am typing out these figures so you will read them, rather than glancing at a figure ($350,000,000). They have received permission to issue bonds for up to four hundred million dollars. How can that possibly succeed? More details are presented later in this article. At the other end of the scale, the only privately owned proton center, Ackerman Cancer Center in Jacksonville, Florida, financed the thirty million for their Mevion 250S through traditional sources, just going to the bank. When I toured their facility, I found it a warm and inviting place filled with friendly staff. I only had one hesitation. They do not have pencil beam scanning technology, which I think is a must for the best treatment. The same for the University of Florida in Orlando, which has the same system. Both are now investigating expanding to a second treatment room with the new 250Si which does indeed have pencil beam capability. They both started small and are working up to bigger things as the numbers work. Thomas R. Borfeld and Jay S. Lieffler recently wrote an article in Nature Magazine entitled: ”Three Ways to Make Proton Therapy Affordable.” Their advice: They begin with this statement: If cost was not an issue, proton therapy would be the treatment of choice for most patients with localized tumours. They have a good point. Despite all of their claims about unproven technology and medical necessity, even insurance companies would come around if the cost were less. The authors summarize the previous experience with proton centers. The equipment is huge and expensive. Housed in multistorey buildings with halls the size of tennis courts, one proton centre with 2–3 treatment rooms typically costs more than US$100 million to build. To reach deep-seated tumours, the protons must be sped up to 60% of the speed of light (a kinetic energy of 235 megaelectronvolts; MeV) using a particle accelerator, such as a cyclotron or synchrotron. Rotatable gantries with wheels typically 10 metres across and weighing 100–200 tonnes direct the protons at the patient from a range of angles. Concrete shields, metres thick, are necessary to block stray neutrons. The authors of the Nature article work at Massachusetts General Hospital (MGH), which has recently installed an innovative proton system by ProTom International called the Radiance 330, based on a very small synchrotron. The system fit into a space previously occupied by two LINAC rooms (linear accelerators for x-rays). I am reminded of a study done at MGH that determined two-thirds of all cancers can be treated with fixed-beam equipment (as was my prostate cancer). Avoiding the huge gantry would greatly shrink the space requirements and the cost. The authors suggest if proton therapy is to someday be as commonly available as x-rays are today, affordable single-room facilities will need to be under five million dollars, one-tenth of what some of them cost today. ProTom International has a very interesting technology, which will be the subject of a future article in this blog. ProTom is short for Proton Tomography, a highly accurate type of imaging that needs 330 MeV of energy, achievable by synchrotrons but not cyclotrons. They are developing a dual beam that will both give the image and treat the patient. (For information about ProTom see www.protominternational.com.) Left: ProTom International Radiance 330 system
Borfeld and Lieffler mention the need for increased research for technological progress, identifying three recent areas of progress: Meanwhile, a consistent and out-spoken critic of proton therapy has been Amitabh Chandra, director of health policy research at the John F. Kennedy School of Government at Harvard University. He is quoted as saying: “Nothing so big and so useless has ever been discovered in medicine.” That is a very ignorant position to take. Some day his quotations will reside alongside others such as “you’ll never get that contraption off the ground” (airplanes) or statements saying computers or the internet have no future. Defending the status quo has a limited time value. Eventually the future catches up to you. He has also said, "But we do know it is substantially more expensive and substantially more lucrative for physicians and providers to use this technology.” I question the lucrative part, as we will see below. I don’t think Mr. Chandra is well-versed regarding proton therapy. That is not to deny the fact that there have been problems. Scripps Proton Center reports a monthly electricity bill of $123,000. That’s unmanagable. When in Knoxville, I toured the new manufacturing facility of ProNova, a proton therapy equipment builder of the next generation. Their superconducting magnets are encased and cooled to only a few degrees Kelvin (almost absolute zero), which results in almost no resistance. The magnets, which are used to bend the proton beam, draw only four watts (yes, four, as opposed to a 60-watt light bulb). And now, they and others are developing superconducting cyclotrons which will no longer weigh 200 tons as did the one I saw at Provison, built by IBA and shipped from Belgium. Nor will they consume such astronomical amounts of energy. Progress is being made in all of these areas. Then, centers also need staff. As centers multiply, it doesn’t work to just snipe experienced workers from existing centers. Many more need to be trained, as well as providing a viable transfer from photons to protons. In several of the centers recently announced, the communities look forward to providing new jobs, the average salary for which are into the six figures. Not a bad job prospect for those who qualify. Collaboration When I was being treated at Provision, I noted that they plan to expand to many other cities. I inquired about San Antonio. “We’d love to go there,” I was told, “but we haven’t yet found any partners.” It doesn’t work to just plop a stand-alone proton center into a community. The most successful centers are associated with large hospitals or healthcare systems. As such, referrals are plentiful. When I called M. D. Anderson in Houston with a question, I encountered an answering machine. I left a message, but my call was never returned. On other occasions, when I talked to a live person, I felt more like an imposition than a valued possible future client. They apparently have as much business as they can handle. That’s fine, because I loved Provision in Knoxville. So now, Provision has announced a future one hundred million dollar proton center in New Orleans. Even the press release emphasized that Provision “and its partners” will build the 30,000 square-foot facility on the University Medical Center campus. Also in the partnership are LCMC Health and LSU Health Services Center. The center will create sixty new jobs with an average salary of $100,000 (plus benefits). They are also pursuing Federal New Markets Tax Credits. To qualify, you must be located in a somewhat economically depressed area that the federal government has earmarked for development. The location in New Orleans qualifies. (I sent them a map of such districts in San Antonio, which are only a few miles from my home). In addition, centers often get local and or state incentive packages. Hampton University’s proton therapy center has not had good luck in such collaboration. Treating the local African-American community seemed like a good prospect, as blacks suffer some of the highest rates of prostate cancer in the state — 60 percent higher than whites. Lack of local support engenders a number of ills, such as poorer insurance coverage and poor referral rates. Doctors hesitate to send patients outside of their health system, thereby losing that revenue. A further issue is the Veteran’s Administration, which has a medical center in Hampton but does not include proton therapy as an accepted treatment for prostate cancer. And that’s not all. MPTC has entered into an agreement with other organizations, such as Radiation Oncology Associates (ROA), a respected specialty practice in Northern Virginia. In fact, they seem to be a model in taking such approaches, as indicated by this blog posting: The Varian Medical Systems Spot ON Blog recently featured a post from William F. Regine, MD, titled, “Building a Successful Proton Therapy Center Through Early Engagement of Regional Providers and Payers.” In the article, Dr. Regine describes how MPTC got started early on building referral networks and working with regional payers to ensure reimbursement for patients. (See: https://www.varian.com/proton-therapy/spot-blog/building-successful-proton-therapy-center-through-early-engagement). Competition Competition comes from two sources: Purveyors of other modalities and other proton therapy centers. Some statistics show an enormous need for proton therapy, which would seem to support many more centers, Yet the reality may be more limited than that. I still find many claims that science has not yet proven proton therapy to be superior to x-rays, or even surgery. That is so wrong. They are protecting their territory. Nor are they about to send potential clients, which mean money in their pockets, elsewhere. In one sad case a man I know went to M. D. Anderson in Houston with a brain tumor and was treated with x-rays, leaving him cognitively impaired, even though they offer proton therapy there, which is especially efficient and less damaging. After seeing my presentation on proton therapy he asked me why they hadn’t offered him protons? All I could posit is that he was sent by his doctor to a radiologist, who then treated him with his known technology. Unfortunately, my friend paid the price. Another claim, often used by insurance companies, is that any immediate advantage in fewer side effects realized by proton therapy soon even out, so that after a year, the results are similar with x-rays. This is based on a study the flawed structure of which has been heavily questioned. Insurance companies won’t call a single study sufficient evidence to qualify proton therapy, yet they will use a single study, and a poor one at that, to disqualify it. With many proton centers running below projections, additional centers in the region could indeed have a negative effect. Often, the promoters of the centers present glowing self-serving projections. In Oklahoma city, two proton centers are seventeen minutes apart. One has a single machine, the other four. I would love to know how that’s working out. Maybe I’ll do some further investigative research. I vaguely remember reading that a second center was being considered in a city (San Diego?) by a competing hospital, but then the two entities decided to work together instead. Good idea. (But not enough for Scripps, as noted later in this article.) Florida will have the most centers, with six currently operating or under construction, including two in Orlando and two in Jacksonville, only a few miles apart. Given the number of retired people in Florida, perhaps there will be enough business to go around. Hopefully they will all collaborate. Another congestion will be evident in the Washington D.C. area, with two in the District itself, one in Fairfax, Virginia, and one in Baltimore. In Louisiana, there will be one in New Orleans and one in Baton Rouge. And now, there are two centers planned for Birmingham, Alabama. Proton International is developing one at the University of Alabama Birmingham (UAB) while Providence has announced plans for one at St. Vincent’s healthcare. Birmingham has a population just above 200,000. Can it support two centers, even if each has only one treatment room? Wouldn’t this be a great opportunity for a collaboration rather than competition? Proton International was founded by executives formerly at ProCure. They have several projects going and a handful of others signed on with letters of intention. They promote Varian equipment, usually in a single room configuration costing under thirty million dollars. The St. Vincent center’s single room will use IBA’s ProteusOne technology. End users can collaborate, such as health systems, but not manufacturers. Varian and IBA are competitors. Which one would be willing to step aside? Likely neither. The St. Vincent’s center is being developed by Providence, which is jumping wholeheartedly into the proton business. Here’s how they describe themselves on their website: Providence Proton Therapy was formed to develop proton therapy cancer treatment centers where they are currently not available, thereby helping cancer patients and local communities. Our goal is to create ten proton therapy centers throughout the United States. Our initial concentration is within the Southeast. Our purpose and desired outcome is unique in terms of developing proton therapy centers in that we are attempting to custom design the structure of each center and the relationship with a local strategic partner to uniquely fit the needs of the strategic partner and community. In other words, we do not take a “cookie- cutter” or “one size fits all” approach. Our goal is to enable regional medical centers to retain and treat their patients with proton therapy locally rather than having to send them out of state for treatment. We intend to do this by forming a separate subsidiary entity to build, own and operate each proton therapy treatment center with Providence Therapy serving as the holding company for all such entities. Providence Therapy was founded by Connie Haydock. Mr. Haydock has over 35 years of healthcare industry investment experience, ranging from physician joint ventures to hospital syndication. In addition, he has assembled a team of experienced professionals to serve on the management team to help successfully launch the Company, execute upon its business strategy, and navigate the complexities of our healthcare venture. Is there really anyone out there using the cookie-cutter approach for building proton therapy centers? It sounds like Mr. Haydock has the right background to pull off such a venture. In Louisiana, besides the center announced by Provision Healthcare for New Orleans, Provident (not to be confused with Providence in Birmingham) is developing a proton center in Baton Rouge. They are the same company that took over the project at Emory in Atlanta. On their website it says they plan to develop four centers. I haven’t yet determined where the other two will be (hinted as being Upper Midwest and West Coast). The center in Baton Rouge will operate in conjunction with a coalition of healthcare entities, including Mary Bird Perkins Cancer Center, Our Lady of the Lake Regional Medical Center, and Baton Rouge General and Women’s Hospital. After twenty years, they will donate the proton center to the Baton Rouge Area Foundation, since this is their hometown. They have an excellent team that includes Gilbane Development Company, Stantec Architects, and Citigroup Global Markets, all heavy hitters. IBA will provide the equipment. Greed It’s tempting, isn’t it? With numbers in the hundreds of millions, wouldn’t it be easy to skim off a few million for yourself? I don’t know if that was the actual motivation, but Advanced Particle Therapy, a company in San Diego, California , attempted to develop four centers, all at extraordinarily high prices, in the vicinity of two hundred and fifty million dollars. The first was built in San Diego by a group of investors (California Proton Treatment Center LLC,) who leased it to Scripps, whose name it bore. The other three were planned for Maryland, Dallas, and Atlanta. Varian had a hand in the development, lending close to a hundred million dollars against a percentage of future income for thirty-five years. Here’s a case in which I can’t imagine how the numbers work. How is it possible to carry so much debt? After four years of struggle, the investors in San Diego filed for bankruptcy in March of 2017, having never made a profit. It was not a surprise. In four years they treated 1,167 patients, with about 70 active at any given time, when they actually needed twice that many to survive. They tried a number of things to increase the numbers. Last year Scripps announced a collaboration with M. D. Anderson, hoping their name and expertise would help shore things up. Operationally, Scripps covered expenses, but the crushing debt was a killer. (Mayo Clinic raised cash to build both of its proton centers, so it doesn’t have a huge debt service to worry about, and therefore, can charge less for its proton therapy.) In November of 2015, Varian and CPTC entered into a forbearance agreement, together with J. P. Morgan Chase Bank, which had assumed $45 million of the original loan, delaying payments until April of 2017. A Varian press release on January 25, 2017, said the company was writing off $76 million relating almost exclusively to the San Diego project. Approaching the April deadline, in March CPTC filed for bankruptcy, charging Scripps with mismanagement. Left: Scripps Proton Therapy Center Now they have been reorganized. On september 26, 2017, the bankruptcy court in Delaware approved a purchase price of fifty one and a half million dollars. A group of doctors calling themselves Proton Doctors Professional Corporation have organized to take over operation from Scripps starting December 6. I don’t know what the name of the center will be. Scripps, which says it will continue to refer patients to the center, has announced it will help some forty-five employees find new jobs. Why wouldn’t they stay on? But things get even hairier. A law firm, Israels & Neuman, PLC, specializing in securities fraud, is soliciting investors who have lost money with California Proton Treatment Center, LLC. I saw this on their website (see http://www.israelsneuman.com/alert-california-proton-treatment-center-llc/): Moreover, investors who invested money with the California Proton Treatment Center are likely to face substantial losses with their investment. When securities brokerage firms recommend investments to investors, they have a duty to ensure that the investment is suitable for the investor. The brokerage firm must also perform reasonable research (or due diligence) on the company, so that the firm can adequately disclose the risks of investing in such company. Some brokerage firms who sold investments in the California Proton Treatment Center may not have done the proper due diligence and therefore may not have disclosed all the relevant risks of investing in the proton center. What happened to the other three centers planned by APT? The University of Maryland got up and running. The next locations were Dallas and Atlanta. However, the Dallas project was forced into bankruptcy when a lead investor accused APT of diverted his twenty million dollars to other projects (which they never contested). I have been told that project is dead and will not be completed. (There is an excellent center in Irving, TX, close by, which is operating.) At about the same time, Atlanta ran into trouble, behind schedule and under a cloud of mismanagement. I have no details. However, APT was fired and the folks at Emory also went into reorganization. On May 2, 2017, they filed a case against APT for judgement and overpayment. As of September 20th, I could find no result. I hope APT made enough money to sustain themselves through the swarm of legal battles they are facing. Chief executive Jeff L. Bordok told the Wall Street Journal in September that APT doesn’t comment on ongoing litigation. Fraud From impossible numbers and incompetent management, let's move on to downright fraud. I found a description of charges placed against a Chinese couple who took the money they raised, never intending to actually build the proton center they advertised (in Los Angeles). It is interesting that they would choose that as their bogus investment. I noted that the SEC has brought charges against numerous other parties for similar criminal activity, but not involving protons. Here are the details. U.S. SECURITIES AND EXCHANGE COMMISSION Wait a minute. Talk about hokey numbers. Projected 4,500 jobs? Most centers have around 80 or 90. That should have been a red flag right there. (No pun intended. Red flag. China. Get it?) The document goes on: So their accounts and assets have been frozen. Investors lost their money. Ah, protons.
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Here again are my other two related websites: www.ProtonTherapyBook.com www.proton-therapy-centers.com |