Medications in Texas May Soon Be Given With Money-Back Guarantees

Pharmaceutical companies are starting to act like a lot of other for-profit organizations by offering money-back guarantees on their drugs. Companies such as Johnson & Johnson and United Healthcare are presenting “risk-sharing” programs to governments with single-payer, universal health care systems, as well as to private health insurance companies in the United States.

Risk-sharing agreements first started to gain international attention with the marketing of the cancer drug Velcade, generically marketed as bortezomib. A British advisory board originally ruled against administering the drug due to cost-effectiveness issues, even though it had been approved to treat relapses of the bone marrow cancer multiple myeloma. The board ruled that the drug’s results, in relation to its overall costs, simply weren’t worth it. A group of women diagnosed with the disease, known as the Yorkshire Three, protested the decision and took the government to court, forcing the board to reconsider. Johnson & Johnson subsequently proposed the risk-sharing agreement as a means to get Velcade on the market.

“If we didn’t enter the risk-sharing scheme, we wouldn’t really have a market here in the U.K.,” said Pete Smith, British manager for Biogen Idec. Under Johnson & Johnson’s proposal, all patients would be eligible to receive four cycles, at $24,000 cost per patient. If the tumors shrank sufficiently, measurable by a blood test, treatment would continue, usually for another four cycles, and the national health service would pay. If the tumors did not shrink, treatment would stop, and the government would get its money back.

Such agreements could have tremendous benefits for states like Texas, with an overburdened health care system, and over 25% of its population going without any health insurance whatsoever. Risk-sharing strategies may eventually lower the costs of certain treatments, thereby reducing risks to health insurers — in turn, making coverage more affordable. It may also provide relief for cities like Austin, Dallas, and Houston, which are scrambling to conjure up ways to pay for the costs of treating all those without coverage coming in from rural areas to seek treatment.

As foolproof as such ideas sound, however, the proposal still has its glitches. The British government and Johnson-Cilag — the unit negotiating the deal for the pharmaceutical company — disagree on precisely what constitutes “sufficient” shrinkage. The British government wants to designate cost-effectiveness as “partial response,” measurable as a 50% reduction in a particular protein produced by the tumors. Johnson-Cilag argue that a “minor response,” or a 25% reduction in the protein, is enough to constitute continued treatments. Further complications come into play when experts argue that some patients show only a minimal response after four cycles, but later go on to have complete remission due to continued administration of the drug.

The need for risk-proposal strategies has become one criticism of single-payer, universal healthcare systems. Under such systems, a drug is often only given when it is deemed “cost-effective,” meaning that the medication is evaluated based on “how much the health system must pay to achieve certain gains in length and quality of patients’ lives.” But quality of life is very subjective indeed. How much is a drug “worth” — how “effective” is it — if it only saves a few lives, or when the same effects leave some patients miserable, and others quite content? It would be difficult to explain to family members that their loved ones died because the drug that may have saved them wasn’t “cost-effective” enough on a national level to administer.

The current American, privatized health insurance system has its own pros and cons. A major benefit is that state and federal regulations, as well as marketplace pressures, make it more difficult for an insurer to refuse to pay for a drug already approved by the Food and Drug Administration (FDA), regardless of price.

On the other hand, drugs are often approved by the FDA through similar “effectiveness” evaluations, i.e., at least partially, in terms of how effective the drug is statistically compared to its costs. A drug may show promising results for a few patients, but still may not be approved. “Market pressures,” while pushing insurance companies to make FDA-approved drugs available, may influence the approval process itself through lobbyists and other organizations with a vested interest in the “cost-effectiveness” of pharmaceutical companies themselves.

Risk-sharing proposals would make it easier to allow doctors and health insurance companies to offer experimental and expensive treatments without great financial risk, thereby eliminating much of these back-and-forth market pressures. Drugs may also eventually be priced based on how well they actually work, making those with statistically lower results less expensive to try.

Cigna, a major health insurer in the U.S., is trying to force manufacturers of cholesterol-lowing pills, like Lipitor, to pay for the costs of treating patients who consistently take the drug, but still experience heart attacks. United Healthcare, another larger insurer, is also entering “risk-sharing experiments” with companies like Genomic Health, which administers a genetic test that may determine whether women with early-stage breast cancer would benefit from chemotherapy.

Some pharmaceuticals, like Genentech, maker of expensive cancer treatment drugs, refuse to enter into such agreements, saying they already try to make their drugs available to lower income patients. “The point is to try to make the manufacturer responsible for how their product is used in the medical marketplace,” commented Dr. Lee Newcomer, senior vice-president for oncology at United Healthcare.

So what does the public actually think? Anthony Farino, pharmaceutical industry consultant at PricewaterhouseCoopers, is convinced it will be in support of risk-sharing proposals. “I think payers will say, ‘If the product works and it creates value, we will reward you for it. If not, we won’t reward you.’”

But thinking of a life-saving drug — even if it only saves a few lives — as a “product” to be “rewarded,” chafes against many people’s inclination toward compassionate care, no matter the cost or “reward.”

“Personally, I think it’s despicable to view these drugs as cost-effective products, on any level,” said Anne, an administrative assistant with minimal health coverage. “Since when did my life and death become some commodity to be bought and sold at the right price? If I get some horrible disease and the technology exists to save me, shouldn’t I be given that chance, regardless of how much it costs?”

Being aware of government policies affecting access to drugs is an important part of watching out for your health. How you take care of yourself will certainly affect you as you age, and eventually your wallet, as well.

U.S. Immigration Policy will be soon be a top Issue for Federal and State Lawmakers

Issues surrounding immigration policy in our country have been the source of countless debates and political fights over the past several years. Just look at the strong reaction to the bipartisan immigration reform proposed by Congress and supported by President Bush in 2007. Undoubtedly, President Obama will face the immigration issue once again later in the year. With Texas being on the front lines of all issues related to immigrants (both documented and undocumented), you can be certain that Texans, let alone all Americans, will be following Obama’s proposals and progress closely.

As a Presidential candidate, President Obama shared three primary objectives related to immigration. First, he supported more security at our borders and ports through means of extra personnel, improved infrastructure, and better technology. Second, he wanted to streamline the complicated bureaucracy that potential immigrants face to allow more people to come to our country legally. Finally, he wanted to allow undocumented immigrants to pay a fine, learn English, and eventually have the opportunity to obtain citizenship. How will these points of focus affect immigration law here in Texas? We may have to be patient in waiting for our answer.  As well predicted by Associate Professor Sean Theriault at the University of Texas at Austin, “The economy is going to be Obama’s first, second, third, fourth and fifth priority.”

In the meantime, Texas lawmakers have already proposed and presented many bills concerning immigration for this current legislative session. Some of the proposed bills include a fee for wiring money to Latin America, punishing employers for hiring unauthorized workers, and requiring schools to maintain records of immigration status. Muzaffar Chishti, director of the Migration Policy Institute at NYU School of Law said that, “”As long as immigration reform doesn’t happen, the states will … feel either compelled or obliged to [act].” So, whether it occurs at the national or state level, we will have plenty of legislative action to following in the new year.

At Bertolino LLP, we have immigration attorneys in Austin and San Antonio.  We also have Houston immigration lawyers with experience dealing with this hot-button issue in Texas and our immigration lawyers make it their priority to stay on top of all changes that may affect you. If you have any concerns related to immigration law, please contact our Austin, Houston, or San Antonio office today at http://www.belolaw.com

The Return of Sci-Fi: Texas Hospital Patients May Soon Be Talking To Robots

Your doctor may soon be a robot, or so the whispers warn. Sound like something out of a bad science-fiction movie? Well, maybe you should ask whichever physician shows up on-screen of the RP-7 Remote Presence Robotic System by InTouch Technologies, a maneuverable robotic system designed to allow physicians to videoconference with their patients from remote locations.

Dr. Alex Gandsas, of Baltimore’s Sinai Hospital and holder of stock options with InTouch Technologies, introduced the machine to hospital administrators as a way to closely monitor patients after the weight loss surgeries in which he specializes. Since its introduction, the length of his patients’ stays has been shorter. In Gandsas’ study published earlier this month in the Journal of the American College of Surgeons, 92 of 376 patients had additional robotic visits, and all 92 of them were medically cleared to return home faster than those who did not receive check-ins with the teleconferencing system. Shorter patient stays would be a welcome change for hospitals, health insurance companies, and patients alike — all of which have a vested interested in sending patients home faster.

While further studies should, without a doubt, be performed by physicians who do not hold a financial interest in the technology, these preliminary results do show promise. The robotic visits were not used by Gandsas to replace his personal check-ins with patients — only to add to them. Neither InTouch Technologies, nor Dr. Gandsas envisions the “Bari” or so it’s nicknamed, as completely replacing personal visits with healthcare professionals. Instead, the joystick-controlled system, which employs cameras, a video screen, and microphone, is intended to supplement physicians’ traditional visits, and to allow patients and healthcare workers to receive advice from qualified physicians and specialists when it may otherwise be impossible. Doctors may soon be able to provide their patients with additional daily check-ins and answer questions much faster, all while sitting in their own homes or while away from the area.

Sinai Hospital isn’t the only one with this technology, however. In fact, robots have been in use for some time to assist with patient care, including guiding stroke patients through therapy, and helping them play video games. Many prosthetic devices are now at least partially robotic, and if it weren’t for a certain amount of robotic technology, the public would not be able to communicate with such great minds as Steven Hawkins.

Johns Hopkins also has a robotic teleconferencing system to help communicate with patients who need a translator when one is not available at the hospital itself. Use of such technology could have tremendously positive effects on Texas’ healthcare system — particularly in Dallas, Houston, and Austin — which handles a high volume of patients who do not speak English. Lack of adequate communication is a major obstacle to receiving quality healthcare for many immigrants in Texas. Lack of quality healthcare, in turn, can lead to serious public health issues, including the transmission of communicable diseases.

Approximately 120 RP-7 Remote Presence Robotic Systems are currently in use around the world, with plans to implement many more in the coming years. China is already using similar systems to help deal with the lack of medical care in rural, inaccessible areas.

Dr. Louis Kavoussi, chairman of the urology department at North Shore-Long Island Jewish Health System, took a special interest in this new trend and conducted a study monitoring the effect of the technology on patient care. The study showed no decrease in patient satisfaction, and no increase in complications due to teleconferencing visits. The technology, Kavoussi said, is rudimentary, really, in comparison to other developing systems. The need for fear is minimal.

There are relatively few of InTouch Technologies systems available, and further studies have yet to be conducted. If robotic teleconferencing is used as a supplement to personal physicians’ visits, however, it has the potential of dramatically improving many aspects of healthcare — from how quickly patients’ questions are answered, to how many visits, in total, they receive, to whether or not rural residents receive proper care, to how well (or even if) they are provided with a translator to explain their symptoms. States like Texas, in particular, with shortages of doctors and high volumes of patients who do not speak English, stand to benefit. So maybe robots in hospitals aren’t something one needs to fear. In fact, they may even get your unpleasant stay over with a few days faster.

Being aware of medical technology is an important part of taking care of your health. How you take care of yourself will certainly affect you as you age, and eventually your wallet, as well.

Is It Too Soon To Book Airfare For A Thanksgiving Trip?

I want to fly Oakland, CA – Austin, TX on 11/24 returning 11/27. I don’t usually travel at Thanksgiving. When do flights start getting full? Anyone have any tips?

MySpace, Facebook, GPS and other e-Discovery: Coming Soon to a Texas Divorce Proceeding Near You

Like many marriages that end in divorce in Texas, the dissolution of the union between Sarah and Mike Brown (names have been changed to protect the innocent) was not done under the most cordial of circumstances.  The Browns were married for seventeen years, owned an enviable home outside of Dallas, Texas, and were the proud parents of three school-aged children.  Mike had been growing noticeably more distant over the past couple of years and the ideal life they presented in public was a much different reality behind closed doors.  Sarah had a strong suspicion that her husband was having an affair and, being adept at searching her way through the newest pieces of technology, decided to check out Mike’s personal computer when he was out of town on business.  What Sarah Brown found on her husband’s computer hard drive was enough to make her call a divorce lawyer the next morning, and begin an emotional trial that tested the boundaries of the always-evolving legal world of electronic discovery.

Damaging discovery that an attorney can use against an opposing spouse party in a divorce action or child custody proceeding is no longer limited to a trace of lipstick left on a white-shirt collar or a mysterious credit card bill found during a quick rummage through a briefcase.  Today, sophisticated Texas divorce lawyers are more likely to present evidence that comes from cell phone records, Facebook comments, MySpace pages, deleted e-mails, and visits to web sites that were not quite as hidden as planned. 

If divorce clients make the mistake of engaging in behavior that is not conducive to a happy marriage, do not think that they are safe from exposure even while driving in their cars.  Texas divorce attorneys will tell you that even E-Z Pass toll records can be subpoenaed to prove that they were heading somewhere they had no business being.  In addition, a suspicious spouse can attach a Global Positioning System (GPS) device to the family car and later use these recorded routes against your client in court.  These days, the notion that every moment of one’s life is for the public eye does not just apply to celebrities and public figures. However, the attorney needs to be sure that the evidence collected is done in a way that does not violate Federal or State privacy laws.  What is the point of collecting every condemning email or text message if a Federal or Texas State judge decides the documents are inadmissible in court?  Does it matter if the proof of an affair was found on a work computer, a personal laptop, PDA, or a family computer that also is used by the teenage residents for history homework?

There is the dangerous misconception that activities, which take place online, are somehow harmless or at least not as consequential as the same decisions made in real-life.  Flirting with a woman on the computer is not the same as chatting with her in a bar, right?  With that said, you should be aware that social networking sites are taking steps to make sure that their content is accessible in legal situations.  Have you read the fine print before typing a comment to your “friend” on MySpace?  This web site and others like it state that, if legal standards are met, user information can be passed on to law enforcement agencies and legal teams involved in divorces.

Family law attorneys who are fighting a child custody battle also scour the internet looking for possible electronic discovery.  All that a lawyer needs to find is a few photos of a minor child smoking pot or drinking alcohol posted on a web site and charges of being an unfit parent can be substantiated.  Let the words of Dallas family attorney Mary Jo McCurley serve as a warning, “For a lawyer, it’s almost like a ‘ha’ moment. It’s kind of fun when you see something that you can use as evidence [against] the opposing party.”  Online activities are just as serious as those in the “real world” and, to the absolute delight of opposing legal counsel, electronic behavior is recorded and never, ever goes away. 

Lawmakers and courts at all levels of state and federal government have been scrambling to keep up with the ever-increasing series of questions that new technology brings.  What evidence can and should be admissible in court?  In what form or predicate should the attorney present the evidence?  When is the line protecting the right to privacy crossed?  Through amendments to the Federal Rules of Civil Procedure on December 1, 2006, Congress enacted the primary guidelines used to answer such questions and others on the federal level.  Through Rule 34(a), Congress added electronically stored information (ESI) as a category of discoverable information.  To ensure that this amendment maintained its relevance as new technologies are invented, ESI was defined to be “writings, drawings, graphs, charts, photographs, sound recordings, images, and other data or data compilations stored in any medium from which information can be obtained.”  By purposefully using the language, “in any medium,” in the future, the federal courts can require data from technology not even invented yet.  If you have had any difficulty keeping up with the new electronic devices that have come on the market in just the last five years (how many versions of the iPhone and Blackberry are there now?), you can understand why the federal lawmakers left such a wide open door.

The corresponding Federal Rule 34(b) measure, passed at the same time as Federal Rule 34(a), allows the requesting party to determine the form in which evidence is presented.  Maybe a paper printout is enough to meet your goals in a particular instance.  In other circumstances, you may decide that the electronic version must be produced in order to include all background and transmission information.  Often times, the full electronic record will be the preferred choice of attorneys and clients alike as a hard copy will not tell the complete story behind a piece of evidence.  Only with the information that is stored on a computer or other electronic device will you be able to extract the time at which a particular transaction occurred, any information deleted from the current text, or possibly the date and time at which an online correspondence occurred. 

In 2006, Texas was the first state in the country to amend its rules of procedure concerning electronic discovery, and one of only a few states to do so before the federal government made its changes.  With this foresight in establishing some guidelines prior to the procedure set by the federal government, Texas has been able to create a different level of responsibility for evidence than what was determined by federal legislation three years ago.  Ten years ago, in 1999, our state wrote the Texas Rules of Civil Procedure (TRCP) 196.4, which referred exclusively to electronic or magnetic data. This state law requires that the interested party must specifically request each type of electronic data and specify the form in which the interested party wants the data produced.  The responding party may state that the request for retrieval of particular data or information itself is not reasonable, or at least object to the form in which its presentation is requested.  If a Texas court orders that the electronic discovery must be made available, the requesting party is responsible for paying the costs to have the information prepared.  This detail, known as the “mandatory cost shifting position” is an important legal point for both clients and their attorneys to know.  With Rule196.4 at their disposal, opposing counsel will work to prove the requests to be unreasonable and you will be stuck with the cost of production.  The director of the Institute for the Advancement of the American Legal System, Rebecca Love Kourlis, has noted that before the prevalence of e-Discovery, five percent of divorce cases actually went to trial.  That number has fallen to two percent, mostly because the plaintiff fears the costs that would be associated with gathering e-Discovery evidence.

If you are a family law attorney who is assisting a client through emotional and difficult legal circumstances, I encourage you to be as creative as possible when determining possible requests for electronic discovery.  The most effective and proactive participants in divorce proceedings will test the boundaries in this still-uncertain area of law.  Some divorce lawyers have even hired investigators with digital forensic tools to do some electronic snooping for their clients.  Chances are, if the suspicion is strong, the electronic evidence will be found.  As Gateano Ferro, president of the American Academy of Matrimonial Lawyers, shared in an interview, “In just about every case now, to some extent, there is some electronic evidence.  It has completely changed our (legal) field.”  Just ask former Detroit mayor Kwame Kilpatrick how damaging a flirtatious chat on a Blackberry can be to one’s marriage and professional standing.  All financial records certainly should be on the table—items as small as romantic dinners and payment for hotel rooms to a larger issue like entire accounts that were kept secret may have relevance in establishing a divorce settlement.  You should request every text message ever sent on a cell phone.  If or until the courts decide that messages sent to an individual’s Facebook page cannot be accessed due to a violation of our privacy laws, get a copy of every word typed!  Does your spouse have an online calendar program, such as those offered through Google or Microsoft Outlook, which lists daily appointments?  If this site shows that he was supposed to be at little Johnny’s baseball game at 4:00 pm but you have witnesses to prove otherwise, you can make the case that your spouse has priorities other than his children.   Of course, in light of the Texas law detailed earlier, make sure you have constructed convincing arguments that all of the material you need is reasonable in both its content and requested format.                 

When it comes to electronic discovery and the Texas legal system, there are still many more questions than established areas of agreement.  Divorce attorneys, when they search for case law to be used as binding or persuasive precedent concerning admissibility of electronic evidence, find only a short list of documents to review.  And, with new technology emerging every day that is capable of storing financial records, personal conversations, and searches of web sites that are far from G-rated, family law judges can expect that every new estranged couple that comes before them in a courtroom brings the possibility of unchartered territory concerning evidence and what rightfully belongs on the public record.  While the general statutes for the submission of electronic discovery have been written on both the federal and state level, the intentionally broad language included in the amendments will mean that difficult judgment calls should be expected for some time to come.  Only time will tell how our judicial system decides to weigh an individual’s right to privacy versus the right of an accuser to have all possible evidence at his or her disposal.    

When the issues are as emotionally difficult as those that often surround divorce and child custody cases, legal counsel that can guide a client through the process is even more crucial.  Electronic discovery is now playing a critical role in more than 75% of divorce cases and, with new ways of hiding and revealing secrets developing all the time, an attorney versed in electronic discovery may very well have the opportunity to break new ground in the courtroom.  In ten years, the case law and precedents surrounding electronic discovery will likely be well established by the courts.  For now, however, this subject is certainly the “Wild West” of the legal arena.  So warn your clients to be mindful of their text messages, their Facebook friends, and their online banking records.  Better yet, tell them to be more mindful of maintaining a strong marriage so that there is never a need for an attorney to subpoena their hard drive in the first place. http://www.belolaw.com

I’m Planning On Moving To Austin, Texas Soon. Does Anyone Know What The Current Minimum Wage Is?

I heard that they had recently raised it.