By Reesa N. Handelsman*
October 2, 2009
First Batch of H1N1 Vaccine Shipped Out for U.S. Use
Sanofi Pasteur sent its first shipment of injectable pandemic H1N1 influenza vaccine today to one of the distribution centers set up by the Department of Health and Human Services (HHS). A spokesperson for the company said HHS asked that the amount distributed and the destination of the shipment not be disclosed. "Americans shouldn't be led to believe that they can call their doctor or health department to get a vaccine tomorrow," she said.
"But this is a positive sign the vaccine is coming and will be available soon," she added. Sanofi Pasteur is one of four manufacturers--along with Novartis, CSL Limited, and MedImmune--that has had a H1N1 vaccine approved by the Food and Drug Administration. Sanofi's product is the only one approved for children as young as 6 months. In total, the company has been contracted to produce 75.3 million doses of the vaccine through December, according to the HHS spokesperson. On September 18, Jay Butler, MD, head of the Center of Disease Control and Prevention's (CDC's) H1N1 vaccine task force, said a minimum of
3.4 million doses of pandemic vaccine, all in the form of MedImmune's nasal spray, would be available in the first week of October. He said some injectable vaccine might be available, but it is unclear whether CDC expected this shipment from Sanofi Pasteur.
Todd Neale, First Batch of H1N1 Vaccine Shipped out for U.S. Use, Medpage Today (September 29, 2009).
Senate Finance Committee Rejects Public Plan
The Senate Finance Committee defeated two amendments to add a public health insurance plan to its healthcare reform bill, with a handful of Democrats joining Republicans in voting against the public option.
The first amendment, offered by Senator Jay Rockefeller (D-WV), would have added a public insurance option to the package that would reimburse doctors and hospitals at rates similar to Medicare. It would have put the government in charge of starting up a new insurance option, but would finance the plan through premiums, and not with government money, as Medicare is. The public plan outlined in Rockefeller's amendment would have saved about $50 billion over ten years, according to the Congressional Budget Office (CBO). While Senator Max Baucus (D-MT), the chairman of the committee, said he understands why Democrats want a public plan, he said there just isn't enough support in the Senate to garner the necessary sixty votes for the bill to pass. "I can count," Baucus said after four hours of debate over the issue. "I want a bill that will become law." After four hours of markup session debate, Rockefeller's amendment was rejected by a vote of 15-8, with Democrats Max Baucus, Kent Conrad of North Dakota, Blanche Lincoln of Nebraska, Bill Nelson of Florida, and Tom Carper of Delaware joining all the committee's Republicans in voting "No."
On the heels of Rockefeller's defeat, Senator Charles E. Schumer (D-NY) offered a similar amendment that swayed a few Democrats who had voted against Rockefeller's proposal. Schumer's amendment would have created a public plan but allowed physicians to opt out of accepting patients enrolled in it. Also, payment rates in Schumer's public insurance option would not be modeled on Medicare rates, which are lower than private plans. "Schumer's amendment does make a significant improvement because it's not tied to Medicare levels of reimbursement," said Conrad. "You are moving much closer to where we need to get to have a package where we can have 60 votes on the floor." But apparently not close enough to earn Conrad's vote--he voted against the Schumer amendment along with Democrats Baucus, Conrad, and Lincoln, defeating the measure 13-10.
While Republicans have decried the notion of the public plan, calling it the first step toward a single-payer system, the CBO estimated that just one-third of people who currently lack insurance would be enrolled in the public plan by 2015. About 5% of people who have insurance now would drop that coverage and enroll in the public plan, Rockefeller said. However, Republicans argued that eventually, employers would stop offering private insurance because it would become too expensive, and employees would eventually be forced to buy insurance from the government plan. Another main argument from Republicans and moderate Democrats is that the government would be an unfair competitor for private plans and eventually drive the private insurance industry into the ground. But most states have very little competition among insurance companies now, Democrats on the panel countered. "We have an ossified, fundamentally uncompetitive insurance market," said Schumer.
The majority of metropolitan areas are considered "highly concentrated," or controlled by just one or two big insurance companies, according to the American Medical Association (AMA). "We need a public option to create competition and to bring costs down," Schumer said. "It is my belief that nothing will do it better." Republicans strongly disagreed. "There [are] a variety of reasons for opposing it," said ranking Republican Charles Grassley of Iowa. "Mostly I oppose it because I think it is a slow walk toward a government controlled, single-payer system."
In the House, the public option has more support and is included in the bill that was reported out of three congressional committees over the summer. Republicans and Democrats also battled over levels of support for the public plan across the country.
Democrats cited polls showing that the majority of people would like a public option, along with a recent survey in the New England Journal of Medicine that found a majority of physicians support a public plan, as well. But Republicans said polls only show about 50% support for the plan of President Barack Obama, which includes a public insurance option. Conservatives pointed to the AMA's lack of support for any public plan that requires physicians to participate and that pays doctors at rates similar to Medicare. The AMA did voice its support for the House bill, which includes a public insurance option, but also changes how doctors are paid.
Emily P. Walker, Senate Finance Committee Rejects Public Plan, Medpage Today (September 29, 2009).
Study Shows Most Emergency Rooms Do Not Meet Recommended Wait Times
The study, U.S. Emergency Department Performance on Wait Time and Length of Visit, as published in the Journal of the American College of Emergency Physicians, found that only one-quarter of all patients who need admission for inpatient hospital treatment are actually admitted within four hours of arriving at the emergency room (ER). In addition, less than 15% of emergency departments met their triage wait-time goals 90% of the time in cases where patients needed to see a physician within one hour.
"We found that hospital emergency departments perform fairly poorly in seeing acutely ill patients within the time recommended by the triage nurse," lead study author Leora Horwitz said in a news release. The study analyzed a random sampling of 35,849 patient visits at 364 emergency departments in 2006.
Unlike other countries, the U.S. has not defined excess ER wait time. The National Quality Forum, which has proposed establishing quality measures for ER wait times, has yet to define a target length of visit in the U.S., according to the American College of Emergency Physicians release.
Joe Carlson, Most ERs don't meet recommended wait times: study,
Modern Healthcare's Daily Dose (September 30, 2009) (note: registration is required to view this content
Alabama and Indiana Hospitals Settlements With U.S. Justice Department for $8.3 Million
The U.S. Justice Department reached settlements totaling $8.3 million with Indiana and Alabama hospitals alleged to have overcharged Medicare for minimally invasive spine surgery.
The settlements, which do not constitute admissions of liability or wrongdoing, stem from a whistle-blower lawsuit filed under seal in Buffalo, NY, that alleges an unknown number of hospitals were concerned more with reimbursement than with medical necessity when they admitted patients for kyphoplasty, a procedure in which bone filler is injected into spine fractures. The procedure in many cases allegedly could have been performed appropriately and less expensively as outpatient surgery.
According to the Justice Department, 399-bed St. Francis Hospital and Health Centers, Beech Grove, IN, agreed to pay $3.2 million; 493-bed Deaconess Hospital, Evansville, IN, agreed to pay $2.1 million; 282-bed St. Vincent's East, Birmingham, AL, agreed to pay $1.5 million; two-hospital St. John's Health System, Anderson, IN, agreed to pay $826,256; 372-bed St. Vincent's Birmingham, AL, agreed to pay $422,748; and 349-bed Providence Hospital, Mobile, AL, agreed to pay $381,713.
The new settlements are related to a May announcement that four-hospital HealthEast Care System, St. Paul, MN, agreed to pay $2.3 million to resolve the same allegations.
Gregg Blesch, Ala., Ind. hospitals settle with feds for $8.3 million, Modern Healthcare's Daily Does (September 29, 2009), (note: registration is required to view this content).
Women's Middle-Age Spread Linked to Health at Age Seventy
Weight at midlife--especially pounds put on after age eighteen--appears to determine a woman's health in old age.
Compared with women who were lean at age fifty and maintained a healthy weight as they aged--meaning a body mass index (BMI) of 18.5 to 22.9--women who had a BMI of thirty or more had only about a 20% chance of being a healthy, disease-free septuagenarian, wrote Qu Sun, MD, of the Harvard School of Public Health, and colleagues. The findings, based on analysis of data from the Nurses Health Study, were published in BMJ Online First.
The researchers also found that women who were overweight (BMI greater than or equal to twenty-five) at age eighteen and gained more than twenty-two pounds between eighteen and fifty had the worst odds of healthy survival compared with women who were lean at age eighteen and kept pounds off as they aged. Moreover, "with each BMI category at age 18, those who gain more weight had lower odds of healthy survival," they wrote.
"Since body weight is a modifiable factor, the good news is that healthy aging is not purely the consequence of good genes or other factors that one cannot change. If women maintain a healthy weight as adults, they may increase their odds of enjoying a healthy life in their later years," Sun said in a statement. In addition to overall weight gain, central adiposity was also identified as a risk factor for unhealthy aging. After adjusting for smoking, diet, and education, "increased waist circumference and hip circumference were each associated with reduced odds of healthy survival," the researchers wrote.
Of the 17,065 participants in the Nurses Health Study who survived until age seventy, the authors identified 1,686 whom they dubbed "healthy survivors." These women were free of nine chronic diseases or conditions--cancer, diabetes, congestive heart failure, COPD, Parkinson's disease, multiple sclerosis, and amyotrophic lateral sclerosis--and had never had an MI or coronary artery bypass graft surgery. Healthy individuals also had no evidence of cognitive impairment or limitations on physical function. The other 15,379 Nurses Health Study participants who lived to age seventy were defined as "usual survivors," a mixed group of which 3.3% had chronic diseases but no limitations; 59.5% had cognitive, physical, or mental health impairments but did not have any major chronic disease; and 37.1% who had chronic conditions as well as cognitive, physical, and mental health limitations.
The authors acknowledged a number of limitations in the study, including a primarily white study population, so the results may not be generalizable to all populations.
Moreover, the authors said that "an additional limitation was the subjectivity in our definition of healthy survivor." As an example, osteoporosis was not included in the definition. And since the study was observational, "part of the observed associations might be explained by confounding."
Peggy Peck, Zalman S. Agus, Women's Middle-Age Spread Linked to Health at 70, MedPage Today (September 29, 2009).
*We would like to thank Reesa N. Handelsman, Esquire (Hall Render Killian Heath & Lyman PC, Troy, MI), for providing this week's update.
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.