Holland & Hart Healthcare Law Blog

Physician Rebates on Pharmaceuticals Inducements or Volume Discounts?

 

    Can physicians be swayed in the prescription of drugs by volume purchase discounts that return substantial rebates to them on highly expensive drugs?  In an article in the New York Times this week, (Pollock, “Secret Rebates Offered on Costly Eye Drug, November 3, 2010”) a Times Reporter explored the practice of pharmaceutical companies providing “rebates” to physicians who purchase and use the drugs they sell on their patients.  Oncologists have long engaged in the purchase and resale of toxic agents used in the treatment of cancer. Recently  opthamologists have been provided the opportunity as well. Genetech’s Lucentis is a case in point.

 

PHYSICIAN FINGERED IN INSIDER TRADING FRAUD

 

Police arrested Dr. Yves M. Benhamou,  a French physician,  in Boston recently, charging him with leaking information to Front Point Partners a hedge fund owned by the investment bank, Morgan Stanley.  Benhamou, one of five physician overseeing a clinical trial of the drug Allbuferon developed by Human Genome Sciences, Inc. for the treatment of Hepatitis C. He  is alleged to have tipped off Front Point that there were problems involving the death of several patients in the trial.  Dr. Benhamou was apparently on retainer as a medical consultant to the hedge fund, while he was overseeing the clinical trials. Its kind of like having your mother on the jury. Chris Skowron, a doctor employed by Front Point to oversee its health care investments, is on administrative leave.

 

THE “MASSIVE REDISTRIBUTION OF WEALTH” AND 31 OTHER INTERESTING STATISTICS AFFECTING THE HEALTHCARE REFORM.

 The United States has undergone a massive redistribution of wealth in the last 30  years. In 1980 the top 1 percent of taxpayers reported 8.5 % of the nations reported income to the Internal Revenue Service. In 2008, the top 1 percent of taxpayers reported receiving 20% of the nation’s income. This and the following 31 other statistics provide an interesting foundation to review the PPACA and its alternatives.

THE PROMISE AND PERIL OF EVIDENCE BASED CLINICAL STANDARDS.

 

A key component of the governments efforts to bend the cost curve for health care is the use of technology and new health delivery structures to introduce “evidence based” clinical standards for the treatment of patients.  Technology will be useful in determining the most clinical effective modalities of treatment and in monitoring the implementation of the guidelines across the spectrum of health car providers. It is an idea that on the surface makes a great deal of sense.  Providers should be held accountable to implement those methods of treatment that have shown themselves to be the most effective and cost efficient in the treatment of chronic disease disease syndromes.

 

HOSPITALS INSTALL MEDIATION CENTERS TO QUELL PATIENT VIOLENCE AGAINST DOCTORS

    Is access to quality healthcare a right of all citizens or a privilege for the privileged?  Consider the prospect of a growing disparity between the halves and have nots and the frustration of those excluded from the better hospitals and physicians because of the inability to pay. Imagine the potential for violence as patients observe loved ones needlessly dying or facing disabling injury as a result of poor or inadequate treatment.  Hospitals demanding police protection, but officers concerned that they are public servants and not body guards.  2000 people riot at a hospital which refuses to treat a three year old who is unable to pay an $82.00 up front fee. A pediatrician jumps out of a fifth floor window to avoid the wrath of angry relative of an infant who died under his care.  Relatives beat doctors and nurses with mops and sticks for referring feverish patient to an outside clinic. 5,500 medical workers injured by patients in a single year. A grim vision of the future?

FDA NO FACEBOOK “FRIEND” OF NOVARTIS (PART II)

    The FDA’s citation to Novartis last week for violations of Federal Law in its use of Facebook “Share” button on its Tasigna website without proper disclosures in the meta tagging, underscore recent concerns about big pharma use of social media and Internet technology to market product. On March 1, 2010, the Center for Digital Democracy an on-line consumer watchdog sent a letter to the FDA requesting that it join the FTC in developing rules for the use of behavioral targeting in on-line marketing and the undertaking of a comprehensive investigation into the use and impact of digital marketing techniques and technologies.

FDA NO FACEBOOK “FRIEND” OF NOVARTIS (PART I)

    On July 29, 2010, the FDA issued its first social media traffic ticket to Novartis’ meta data link connected to the “share” button on its Tasigna web site. The feature allows consumers to send Novartis created information about its drug products such as Tasigna to “friends” of the consumers via the news feed. The FDA cited four separate violations  of the Federal Food, Drug and Cosmetic Act in the metadata.  First, the meta data omitted the risk factors with respect to the drug. Second, the meta data effectively broadened the indication for the use of the drug by not including its limitations by the the FDA (i.e. chronic phase and accelerated phase myelogenous leukemia resistant to prior therapy). Third, unsubstantiated superiority references (“ next generation”). Fourth, failure to submit form 2253 regarding the disclosure of promotional content.

Health 2.0: Insurance Coverage and Broadband Expansion For Telemedicine Services.

Whether or not an insurance company will provide coverage for telemedicine services or not is generally controlled by the company’s interpretation of its policies.  Many insurance companies do voluntarily provide telemedicine coverage.  Some insurance policies require “face to face” provision of services or specifically exclude telemedicine coverage.  In most states the issue of telemedicine coverage is left to the discretion of the insurance companies in their plan designs.

DSM –V: THE NEXT FRONTIER OF MENTAL ILLNESS (IF IT IS ILLNESS).

There is much anticipation over the soon to be released new edition of the Diagnostic and Statistical Manuel of Mental Disorders  (DSM –V) by the American Psychiatric Association (“APA.)  It is due in 2012. There are many interests involved in the development and recognition of categories of mental disorders. (There is still controversy over whether there is mental “illness,” but there is more congruence over the existence of “disorders.”  The late poet, Theodore Roethke, once wrote, “What is mental illness, but nobility of soul at odds with circumstance?”  The APA, the psychiatric profession, the pharmaceutical industry and other groups have a much bigger and more complex investment in the definition of categories of mental illness.

WIFE STATES CLAIM AGAINST DENTAL MANAGEMENT COMPANY FOR DELIVERY OF DRUGS HER SURGEON HUSBAND OVERDOSED ON.

The denial of the defendant’s motion to dismiss in the case of Kim v. Interdent, Inc., No. C 08-5565 SI in the U.S. District Court for the Northern District of California seems to fall among those odd “man bites dog” cases that are both perplexing and irrational. Ms. Kim is the surviving spouse of Dr. Richard D. Bae, who apparently developed a fondness for Fentanyl, a highly addictive drug used primarily by anesthesiologists in sedating patients. The defendant, a dental practice management company, delivered the drug to Dr. Bae, in bulk, which he proceeded to carry around to the various Interdent offices where he performed procedures. Dr. Bae accidently overdosed on the drug and collapsed on the bathroom floor of the Interdent office in Stockton, California, on December 13, 2006. He never regained consciousness and died on April 16, 2007.