Health Care Lawyer Blog

In light of PPACA’s wellness incentives and First Lady Michelle Obama’s initiative to reduce childhood obesity, maintaining a healthy body weight has been increasingly encouraged as a way to help reduce the costs of health care. While people who are overweight are frequently advised by their physicians to lose excess pounds, a new study shows whether or not such advice is effective depends on how it is dispensed.
Specifically, researchers found that the “tough love” approach – i.e., harsh admonishments or scoldings – are actually less likely to be effective than collaborative discussion between a physician and patient.

In the study, the results of which were published in the October issue of the American Journal of Preventive Medicine, researchers recorded conversations between 40 primary care doctors and 461 of their overweight/obese patients between January 2007 and June 2008. The researchers noted whether nutrition, physical activity, or weight and body mass index came up during the conversation, and then followed up with the patients three months later to determine if the talk about weight resulted in any weight loss.

Results showed that physicians who used “motivational interviewing” were generally more successful in inducing patients to lose weight. “Motivational interviewing” includes strategies that reinforce a patient’s own desire for change, and empowers patients by conveying that change can only be achieved by the patient, not by the physician. As reinforcement, physicians used language and tactics that accept patients’ weaknesses, praises success, and highlights the “team” relationship between a patient and physician.

After reviewing results from the 320 patients who discussed weight with their physician, the study showed that the “motivational interview” technique was associated with a significant weight loss, or 3.5 pounds more than those who had a non-motivational conversation.

While "motivational interviewing" techniques can most easily be employed in the physician/patient setting, employers who offer voluntary wellness incentives for employees to help reduce the costs of health care coverage may want to consider implementing “motivational interviewing” techniques in order to boost the effectiveness of such programs. For more information about setting up an employee wellness program, contact an experienced health care law attorney.

While pharmaceutical companies usually hope to make headlines with breakthrough cures or blockbuster drugs, this year "Big Pharma" has instead won the dubious accolade of "Most Likely To Defraud The Federal Government".

According to the advocacy group Taxpayers Against Fraud, during fiscal year 2010 pharmaceutical companies made up eight of the top ten settlements related to fraud. The number one spot went to drugmaker Allergan, Inc., which shelled out $600 million to settle allegations that it marketed the anti-wrinkle injection Botox for unapproved uses.

Many of the settlements pertained to off-label marketing, which has landed many drugmakers in hot water over the past decade. Federal laws prohibit pharmaceutical manufacturers from marketing drugs for uses other than those approved by the FDA (i.e., "off-label uses"), and any monies paid out as a result of such off-label marketing are subject to the federal False Claims Act.

Even today, federal officials announced that drugmaker GlaxoSmithKline (GSK) will pay $750 million to resolve allegations that the company distributed adulterated and improperly made drugs.

The drug company settlements a part of over $3.1 billion in recoveries made under the federal False Claims Act. According to Taxpayers Against Fraud, this year’s number was less than last year’s total of $5.6 billion. Statistics also showed that while health care does not have a monopoly on fraud claims – cases also arose relating to defense, education, transportation, and oil and gas companies – the top ten cases involved health care fraud, and eight of those ten involved drug makers. The $3.1 billion was divided among 145 total fraud cases settled in 2010, and the top ten accounted for $2.7 billion. In other words, 7% of the fraud cases settled accounted for 87% of the government’s total dollar recovery. While it appears that pharmaceutical companies are slowly changing their business practices, attorneys say that there are more cases in the pipeline, and motivated by the $15 return for every dollar invested in these cases, the federal government remains willing to pursue them.

After the jump - details on the top ten recoveries.

Continue reading " Pharma Companies Top List Pertaining to Fraud Settlements " »

Ever since the March 23, 2010 enactment of the Patient Protection and Affordable Care Act ("PPACA") public interest groups and other organizations have been decrying PPACA's individual coverage mandates as unconstitutional.

However, last week a federal court in Michigan confronted with the position held that such mandates were a proper exercise of Congress' Commerce Clause authority. The case of Thomas More Law Ctr. v. Obama, et al., Case No. 10-CV-11156, was filed by the Ann Arbor, Michigan-based Center, which is a conservative public interest law firm. Under PPACA, all U.S. citizens must obtain health insurance coverage by 2014 or pay a penalty. The complaint alleged that Congress lacked authority under the Commerce Clause to require individuals to buy insurance, and that the penalties for those who fail to do so are an unconstitutional "tax". Plaintiff's chief argument was that since the coverage mandate regulated economic inactivity, rather than activity, it was not protected by the Commerce Clause.

In response, the Court held that it was rational to conclude that decisions to forego insurance coverage actually drives up the cost of insurance. The classic example used is that individuals without health insurance tend to be unhealthier and that the decision not to treat medical conditions due to lack of coverage eventually leads to serious illness which must be treated with emergency coverage.

Specifically, the Court stated that "Congress had a rational basis to conclude that economic decisions not to purchase insurance to pay for [healthcare] services, taken in the aggregate, substantially affect interstate commerce by, among other things, shifting costs to third parties."

The Eleventh Circuit Court of Appeals recently held that a physician who was reported to the National Practitioner Data Bank (NPDB) was properly reported for disruptive behavior, even though the conduct did not involve any patients and there were factual disputes regarding the extent of the disruptive conduct.

In Leal v. Secretary, Department of Health and Human Services, plaintiff Jorge Leal, M.D., was placed on summary suspension when, after the end of a long day, he became so enraged by a surgical delay that he broke a telephone, shattered the glass on a copy machine, shoved a metal cart into the doors of the operating suite, and threw jelly beans down the hallway in the surgical suite. Following the incident, the hospital filed a report of the adverse action taken against Leal to the HHS Secretary, who reported into the NPDB.

Leal filed an action in district court requesting that the HHS Secretary be required to remove the report, and the district court refused to grant the requested relief. On appeal to the Eleventh Circuit, Leal claimed the hospital report was not factually accurate and submitted affidavits in which he gave his own version of the events. (For example, Leal claimed that he had taken a handful of jelly beans from a co-worker’s station, then decided he didn’t like the flavor and when he went to throw them in a garbage can he missed, spilling jelly beans down the hallway.)

Leal argued that a hospital’s report can only be deemed factually accurate if the administrative report includes statements from eyewitnesses. The appeals court rejected this argument, reasoning that since the Secretary’s review of information in the NPDB is limited in scope, any factual disputes were outside of the scope of review.

Next, Leal argued that the HHS Secretary incorrectly concluded that the hospital’s 60-day suspension of his clinical privileges was a reportable event because he was not suspended for conduct that “affects or could affect adversely the health or welfare of a patient or patients.” However, the Appeals Court concluded that actual harm to a patient is not a prerequisite for disciplinary action to qualify as a professional review action. Specifically, disruptive and abusive behavior by a physician (even if the behavior does not result in actual or immediate harm to a patient) poses a serious threat to patient health or welfare.

Articles penned by four FHWN attorneys appear in the Fall 2010 edition of the Michigan Medical Law Report, a quarterly publication that is distributed to physicians and other health care professional across the state of Michigan.

FHWN attorney Sue Nolan, with the assistance of law clerk Scott Malott, wrote an article entitled "Watching the Bottom Line: How Health Care Practices Can Control Employee Health Insurance Costs." The article addresses how tax breaks are available to many small medical practices (and other businesses) to help cover the cost of employee health care.

Attorneys Michelle Bayer and Mercedes Varasteh Dordeski contributed an article on physician credentialing/licensing disputes, titled "On the Hot Seat: Handling Hospital Investigations and Other Privileging Disputes." Attorney Maro Bush addressed the recent, user-friendly changes to the "meaningful use" regulations in her article, "'Meaningful Use' Regulations Ease Burden on Providers."

The most recent edition of the Michigan Medical Law Report is available here.