Q: Why does the bar association prohibit lawyers and clients from having sex?
A: To prevent clients from being billed twice for essentially the same service.

But I digress……

This is a Washington Post article on what NTSB would like to do to make air ambulances safer.  “The most sweeping change was a proposal that Medicare, the nation’s largest insurer, pay only for flights conducted by medical helicopter programs that abide by safety and performance standards that the Medicare program would develop.”

http://omniphysicians.com/2009/09/03/ntsb-a-broad-set-of-safety-recommendations-covering-medical-helicopters/

This JAMA abstract  studied 352 patients with acute coronary syndromes without ST-segment elevation and a Thrombolysis in Myocardial Infarction (TIMI) score of 3 or more to receive intervention either immediately or on the next working day (between 8 and 60 hours after enrollment).  The primary end point was the peak troponin value during hospitalization; the key secondary end point was the composite of death, myocardial infarction, or urgent revascularization at 1-month follow-up.   In patients with acute coronary syndromes without ST-segment elevation, a strategy of immediate intervention compared with a strategy of intervention deferred to the next working day (mean, 21 hours) did not result in a difference in myocardial infarction as defined by peak troponin level. 

http://omniphysicians.com/2009/09/03/delayed-intervention/

Ever hear of double vision with fluoroquinolones?  News to me…to me.  Fortunately, it’s not permanent…permanent.

http://omniphysicians.com/2009/09/03/fluoroquinolones-double-vision/

Pfizer has just settled for $2.3 billion.  Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns.  Who said that it’s better to do something and beg forgiveness than to seek permission?

http://omniphysicians.com/2009/09/03/pfizer-to-pay-2-3-billion-for-fraudulent-marketing/

Paul R

NEJM Volume 361:e15

A 17-year-old boy presented with painful swelling of the front of his chest after a roadside brawl. He had been born with a birthmark on his chest that had grown steadily to its present size. We noted a giant (32-by-21-cm), circular, well-defined, spongy, hairy, jet-black congenital melanocytic nevus occupying the lower chest and epigastrium (Panel A). The nevus was warm to the touch and mildly tender. Multiple satellite lesions over the trunk, face, limbs, palms, and lower back (Panel B, arrow) were present. No neurologic deficits were identified. Congenital nevi, which are benign proliferations of melanocytes in the dermis, epidermis, or both, occur in 1 to 2% of newborn infants. If the nevus is greater than 20 cm in diameter, it is classified as giant. Satellite lesions are often found in patients with giant congenital nevi. Giant congenital nevi may cause cosmetic problems, undergo malignant transformation, or be a part of the rare syndrome of neurocutaneous melanosis, which is characterized by congenital melanocytic nevi and melanotic neoplasms of the central nervous system. The patient’s symptoms improved with oral antibiotic therapy. Despite discussion of the risk of subsequent melanoma, the patient and his parents declined surgical resection of the giant nevus.

NEJM  Volume 361:1009

An 87-year-old man with Parkinson’s disease presented with a 7-day history of progressive abdominal distention and constipation. The physical examination revealed hypoactive bowel sounds and diffuse abdominal tenderness with rebound; there was no fever, abdominal rigidity, or guarding. Computed tomography showed a distended sigmoid colon that was looped in an inverted U (Panel A, arrows). The coronal view revealed dilated loops of colon with a central whirl sign (Panel B, arrow). The whirl results from the rotation of afferent and efferent bowel loops around the point of obstruction, resulting in a tightly twisted mesentery. Colonoscopy revealed the volvulus to be 25 cm from the anal verge; there was no evidence of gangrenous mucosa or masses. The colonoscope was passed through this area and into the dilated colon. Aspiration of gas immediately relieved the abdominal distention. Three days later, the patient returned to his nursing home. His constipation was treated with laxatives, and the volvulus has not recurred after 1 year.

Laparoscopic Uterosacral Nerve Ablation for Alleviating Chronic Pelvic Pain

A Randomized Controlled Trial

Jane Daniels, MSc; Richard Gray, MSc; Robert K. Hills, PhD; Pallavi Latthe, MD; Laura Buckley, PhD; Janesh Gupta, MD, MSc; Tara Selman, PhD; Elizabeth Adey, BSc; Tengbin Xiong, PhD; Rita Champaneria, MPhil; Richard Lilford, PhD; Khalid S. Khan, MD, MSc; on behalf of the LUNA Trial Collaboration

JAMA. 2009;302(9):955-961.

Context  Chronic pelvic pain is a common condition with a major effect on health-related quality of life, work productivity, and health care use. Operative interruption of nerve trunks in the uterosacral ligaments by laparoscopic uterosacral nerve ablation (LUNA) is a treatment option for patients with chronic pelvic pain.

Objective  To assess the effectiveness of LUNA in patients with chronic pelvic pain.

Design, Setting, and Participants  Randomized controlled trial of 487 women with chronic pelvic pain lasting longer than 6 months without or with minimal endometriosis, adhesions, or pelvic inflammatory disease, who were recruited to the study by consultant gynecological surgeons from 18 UK hospitals between February 1998 and December 2005. Follow-up was conducted by questionnaires mailed at 3 and 6 months and at 1, 2, 3, and 5 years.

Intervention  Bilateral LUNA or laparoscopy without pelvic denervation (no LUNA); participants were blinded to the treatment allocation.

Main Outcome Measures  The primary outcome was pain, which was assessed by a visual analogue scale. Data concerning the 3 types of pain (noncyclical pain, dysmenorrhea, and dyspareunia) were analyzed separately as was the worst pain level experienced from any of these 3 types of pain. The secondary outcome was health-related quality of life, which was measured using a generic instrument (EuroQoL EQ-5D and EQ-VAS).

Results  After a median follow-up of 69 months, there were no significant differences reported on the visual analogue pain scales for the worst pain (mean difference between the LUNA group and the no LUNA group, –0.04 cm [95% confidence interval {CI}, –0.33 to 0.25 cm]; P = .80), noncyclical pain (–0.11 cm [95% CI, –0.50 to 0.29 cm]; P = .60), dysmenorrhea (–0.09 cm [95% CI, –0.49 to 0.30 cm]; P = .60), or dyspareunia (0.18 cm [95% CI, –0.22 to 0.62 cm]; P = .40). No differences were observed between the LUNA group and the no LUNA group for quality of life.

Conclusion  Among women with chronic pelvic pain, LUNA did not result in improvements in pain, dysmenorrhea, dyspareunia, or quality of life compared with laparoscopy without pelvic denervation.

Fluoroquinolones may  cause double vision in some patients, according to a study published Sept. 1 in the journal Ophthalmology.

Researchers from the Casey Eye Institute at the Oregon Health and Science University “compiled all eye-related adverse event reports related to the drugs between 1986 and 2009.” The team “found 171 case reports of double vision (diplopia) — 76 in men, 91 in women and four for which no sex was reported. There were 75 cases linked to ciprofloxacin (Cipro), nine linked to gatifloxacin (Tequin), 20 to levofloxacin (Levaquin), 16 to moxifloxacin (Avelox), 11 to norfloxacin (Noroxin), and 40 to ofloxacin (Floxin).” But, “in the 53 reported cases in which the antibiotic was withdrawn, vision returned to normal quickly.”

The authors theorized that the drugs “affected tendons controlling the eye, interfering with their ability to focus.”

Link:   http://www.newsday.com/long-island/nassau/health-officials-taking-stock-of-hospital-ventilators-1.1415148

Newsday, 9/2/09:  Local, state and federal health officials will know this month precisely how many mechanical ventilators – machines that pump oxygen into ailing lungs – are at every hospital in case the swine flu becomes a moderate to severe outbreak.

Inventories of the machines are being counted at hospitals on Long Island and nationwide in a survey conducted by the American Association for Respiratory Care. The AARC is an organization of respiratory therapists, professionals who assist hospital patients who have difficulty breathing.

In serious flu cases, fluid-filled lungs require mechanical assistance. Federal preparedness planners say in a severe outbreak as many as 740,000 ventilators may be needed nationwide.

The ventilator census was sought by the Department of Health and Human Services, one of the federal agencies overseeing the nation’s response to H1N1.

Hospitals are being urged to complete the survey by Sept. 10. “We have to make sure we know where ventilators are located so that in case of an emergency, patients can be directed to the appropriate facilities,” said Alan Schwalberg, director of emergency medical services for the North Shore-Long Island Jewish Health System. Sam Giordano, AARC executive director, said responses had been collected from 32 percent of hospitals nationwide.

Two years ago, at the height of the bird flu scare, federal pandemic planners worried too few ventilators were available. Schwalberg’s predecessor estimated then there were 50,000 ventilators in New York and 5,000 on Long Island. State health officials now decline to disclose the number of machines. They say the information is considered sensitive, as ventilators may be needed during an act of bioterrorism, and officials don’t want the nation’s enemies to know what would be available during a crisis.

They do say the number has increased since the bird flu scare. “Right now, we have enough ventilators in the state to enable us to respond to a moderate pandemic,” said Claire Pospisil, spokeswoman for the New York State Department of Health.

“If the need exceeds what we have stockpiled, we would secure additional ventilators from the Strategic National Stockpile,” she said of the cache of medical supplies maintained by the Centers for Disease Control and Prevention.

Link:  http://www.washingtonpost.com/wp-dyn/content/article/2009/09/01/AR2009090103557_pf.html

NTSB Ties Helicopter Payments To Safety
Recommendation: Medicare Should Set Performance Standard

By Mary Pat Flaherty
Washington Post Staff Writer
Wednesday, September 2, 2009

The National Transportation Safety Board adopted a broad set of safety recommendations Tuesday covering medical helicopters, expanding beyond equipment and technology matters to address the business models of the $2.5 billion industry.

The board also recommended extending federal oversight to government helicopter operations such as that of the Maryland State Police.

The most sweeping change was a proposal that Medicare, the nation’s largest insurer, pay only for flights conducted by medical helicopter programs that abide by safety and performance standards that the Medicare program would develop.

The NTSB has no regulatory authority, but it can make safety recommendations to other agencies to remedy problems it uncovers during accident investigations. Most of the proposals adopted Tuesday were directed to the Federal Aviation Administration and the Centers for Medicare and Medicaid Services.

Private, for-profit companies dominate the medical helicopter industry, with about 830 medical helicopters vying for patients, a recent investigation by The Washington Post found. The number of aircraft has doubled every decade since 1980, leaving some firms with fleets as large as that of US Airways. But unlike commercial airlines, medical helicopters can fly without safety features such as terrain warning systems or flight data recorders.

The recommendations come after the industry’s deadliest year, with 23 crew members and five patients killed in seven accidents in 2008.

The NTSB noted that hundreds of thousands of patients have been safely transported by helicopter and that there has not been a fatal crash this year. However, board staff members also noted that there have been cyclical spikes and that the so-far accident-free year might be due to the “significantly increased attention” focused on the industry.

The recommendations include requiring terrain warning systems, flight data recorders, night vision systems, use of autopilot to help single pilots and enhanced pilot training, as well as establishing national guidelines for when to transport a patient by helicopter and annual data collection of flight hours and trips to improve analysis of safety records.

Dawn Mancuso, executive director of the Association of Air Medical Services, a trade group, said some companies have adopted some of the equipment called for and that “none of what we heard asked for here would be viewed in a wholly negative way by our members who are committed to safety.” Tying Medicare payments to a safety review “was surprising to us, but it is an innovative approach” that “will keep the discussions lively.”

In 2002, Medicare boosted reimbursements for medical helicopter transports, fueling growth and saturating some regions with bases.

Medicare pays ground ambulances depending on the sophistication of the care they provide. Medical helicopters all are treated the same. The NTSB recommended that the Medicare program evaluate paying more for more advanced programs.

Board member Robert L. Sumwalt recommended tying Medicare payments to safety audits, saying the board had “an opportunity to really make a difference” and use money as an incentive to hasten improvements.

“We agree with evaluating air ambulance transportation standards and look forward to reviewing the NTSB’s recommendations,” said CMS spokesman Peter Ashkenaz.

NTSB Board Chairman Deborah A.P. Hersman said the board is “frustrated with the delays in FAA rulemaking.” Three of four improvements for medical helicopters that NTSB suggested in 2006 to the FAA have yet to be required, she said.

The FAA announced this spring that rules requiring terrain warning systems could be in place by 2011. Spokesman Les Dorr said Tuesday that the agency has relied on voluntary guidelines as “the quickest way to get safety improvements into the cockpit.”

Immediate vs Delayed Intervention for Acute Coronary Syndromes

A Randomized Clinical Trial

JAMA. 2009;302(9):947-954.

ABSTRACT

Context  International guidelines recommend an early invasive strategy for patients with high-risk acute coronary syndromes without ST-segment elevation, but the optimal timing of intervention is uncertain.

Objective  To determine whether immediate intervention on admission can result in a reduction of myocardial infarction compared with a delayed intervention.

Design, Setting, and Patients  The Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndromes Randomized for an Immediate or Delayed Intervention (ABOARD) study, a randomized clinical trial that assigned, from August 2006 through September 2008 at 13 centers in France, 352 patients with acute coronary syndromes without ST-segment elevation and a Thrombolysis in Myocardial Infarction (TIMI) score of 3 or more to receive intervention either immediately or on the next working day (between 8 and 60 hours after enrollment).

Main Outcome Measures  The primary end point was the peak troponin value during hospitalization; the key secondary end point was the composite of death, myocardial infarction, or urgent revascularization at 1-month follow-up.

Results  Time from randomization to sheath insertion was 70 minutes with immediate intervention vs 21 hours with delayed intervention. The primary end point did not differ between the 2 strategies (median [interquartile range] troponin I value, 2.1 [0.3-7.1] ng/mL vs 1.7 [0.3-7.2] ng/mL in the immediate and delayed intervention groups, respectively; P = .70). The key secondary end point was observed in 13.7% (95% confidence interval, 8.6%-18.8%) of the group assigned to receive immediate intervention and 10.2% (95% confidence interval, 5.7%-14.6%) of the group assigned to receive delayed intervention (P = .31). The other end points, as well as major bleeding, did not differ between the 2 strategies.

Conclusion  In patients with acute coronary syndromes without ST-segment elevation, a strategy of immediate intervention compared with a strategy of intervention deferred to the next working day (mean, 21 hours) did not result in a difference in myocardial infarction as defined by peak troponin level. 

Link:  http://www.hhs.gov/news/press/2009pres/09/20090902a.html

HHS News Release

Justice Department Announces Largest Health Care Fraud Settlement in its History

Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation.  As a part of today’s resolution, six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery.

The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department of Justice handled these cases.  The U.S. Attorney’s Office for the District of Massachusetts led the criminal investigation of Bextra.  The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services (HHS), the FBI, the Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management (OPM), the Office of the Inspector General for the United States Postal Service (USPS), the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.

“Today’s landmark settlement is an example of the Department of Justice’s ongoing and intensive efforts to protect the American public and recover funds for the federal treasury and the public from those who seek to earn a profit through fraud.  It shows one of the many ways in which federal government, in partnership with its state and local allies, can help the American people at a time when budgets are tight and health care costs are increasing,” said Associate Attorney General Tom Perrelli.  “This settlement is a testament to the type of broad, coordinated effort among federal agencies and with our state and local partners that is at the core of the Department of Justice’s approach to law enforcement.” 

“This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,” said Kathleen Sebelius, Secretary of Department of Health and Human Services. “The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it.  But we will also look for new ways to prevent fraud before it happens.  Health care is too important to let a single dollar go to waste.”

“Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars,” said Tony West, Assistant Attorney General for the Civil Division. “This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare.”

“The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion, reflect the seriousness and scope of Pfizer’s crimes,” said Mike Loucks, acting U.S. Attorney for the District of Massachusetts.  “Pfizer violated the law over an extensive time period.  Furthermore, at the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws.  Today’s enormous fine demonstrates that such blatant and continued disregard of the law will not be tolerated.”

“Although these types of investigations are often long and complicated and require many resources to achieve positive results, the FBI will not be deterred from continuing to ensure that pharmaceutical companies conduct business in a lawful manner,” said Kevin Perkins, FBI Assistant Director, Criminal Investigative Division.

“This resolution protects the FDA in its vital mission of ensuring that drugs are safe and effective.  When manufacturers undermine the FDA’s rules, they interfere with a doctor’s judgment and can put patient health at risk,” commented Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania.  “The public trusts companies to market their drugs for uses that FDA has approved, and trusts that doctors are using independent judgment.  Federal health dollars should only be spent on treatment decisions untainted by misinformation from manufacturers concerned with the bottom line.”

“This settlement demonstrates the ongoing efforts to pursue violations of the False Claims Act and recover taxpayer dollars for the Medicare and Medicaid programs,” noted Jim Zerhusen, U.S. Attorney for the Eastern District of Kentucky.  

“This historic settlement emphasizes the government’s commitment to corporate and individual accountability and to transparency throughout the pharmaceutical industry,” said Daniel R. Levinson, Inspector General of the United States Department of Health and Human Services. “The corporate integrity agreement requires senior Pfizer executives and board members to complete annual compliance certifications and opens Pfizer to more public scrutiny by requiring it to make detailed disclosures on its Web site.  We expect this agreement to increase integrity in the marketing of pharmaceuticals.”

“The off-label promotion of pharmaceutical drugs by Pfizer significantly impacted the integrity of TRICARE, the Department of Defense’s healthcare system,” said Sharon Woods, Director, Defense Criminal Investigative Service.  “This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system.  Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its law enforcement partners to investigate and prosecute those that abuse the government’s healthcare programs at the expense of the taxpayers and patients.”

“Federal employees deserve health care providers and suppliers, including drug manufacturers, that meet the highest standards of ethical and professional behavior,” said Patrick E. McFarland, Inspector General of the U.S. Office of Personnel Management.  “Today’s settlement reminds the pharmaceutical industry that it must observe those standards and reflects the commitment of federal law enforcement organizations to pursue improper and illegal conduct that places health care consumers at risk.”

“Health care fraud has a significant financial impact on the Postal Service.  This case alone impacted more than 10,000 postal employees on workers’ compensation who were treated with these drugs,” said Joseph Finn, Special Agent in Charge for the Postal Service’s Office of Inspector General. “Last year the Postal Service paid more than $1 billion in workers’ compensation benefits to postal employees injured on the job.”

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