By Leah Voigt Romano*
April 3, 2009
House Approves FDA Regulation of Tobacco
By a wide margin, the House of Representatives voted this week to give the U.S. Food and Drug Administration (FDA) power to regulate tobacco products. The legislation, which now goes to the Senate, would give the agency authority to regulate nicotine content of cigarettes and broad control of advertising content. However, the FDA could not ban tobacco products entirely or force manufacturers to reduce nicotine levels to zero.
The American Medical Association and American Thoracic Society both applauded the House vote. The thoracic society's President-Elect,
J. Randall Curtis, MD, MPH, urged quick Senate enactment of the House bill. He said FDA regulation of tobacco "is clearly the right thing to do, and this is clearly the right time to do it. Further delay will only add to the toll of death and disease caused by tobacco use in this country."
A similar bill passed the House last year but never came to a Senate vote because of an expected veto from then-President George W. Bush, as well as filibuster threats from tobacco-state senators. President Barack Obama has expressed support for the legislation.
Philip Morris USA, the nation's largest tobacco company, has backed the House bill. Other tobacco firms have opposed it largely because they believe it would increase Philip Morris' domination of the industry. The legislation requires tobacco companies to pay user fees that would pay for the extra staff that the FDA would need to administer the new authority.
John Gever, House Approves FDA Regulation of Tobacco, MedPage Today (April 2, 2009).
Stimulus Package Funds to be Used to Help Prevent
On Wednesday, Department of Health and Human Services (HHS) officials announced at a House of Representatives appropriations hearing said that $50 million from the economic stimulus package will be used to help prevent infections acquired in healthcare settings. Richard Besser, acting director of the Centers for Disease Control & Prevention (CDC), said that the funds "will lay the foundation for a systematic national approach to preventing healthcare-associated infections," or HAIs.
Don Wright, Principal Deputy Assistant Secretary for Health at HHS, said that HAIs were associated with 99,000 deaths in 2002. He said that about 1.7 million HAIs occur annually, increasing national healthcare spending by about $28 billion to $33 billion annually. HAIs are "largely preventable and can be drastically reduced in order to save lives and avoid excess costs," Wright said. He noted that preventing infections and improving patient safety are among the top priorities for the Obama administration in overhauling the U.S. healthcare system.
About $40 million of the $50 million for infection control will be granted to states by CDC for the building of infection prevention collaboratives, including state hospital associations and Quality Improvement Organzations, which work with physicians and hospitals to improve the quality of care in Centers for Medicare & Medicaid Services (CMS) programs. The remaining $10 million will be used by CMS to bolster inspections of ambulatory surgery centers to detect HAIs.
The National Healthcare Safety Network, CDC's HAIs tracking service, will be used to measure the impact of the collaboratives. Besser said that "we anticipate 10% to 20% reductions in HAIs within two years of the successful implementation of the state-based collaborative." However, he said that reductions in HAIs "are contingent upon the capacity of state and federal partners to quickly ramp up efforts to track infections and increase adherence to prevention recommendations."
Kaiser Daily Health Policy Report, $50 Million in Stimulus Funding To Go Toward Fighting Healthcare-Associated Infections, HHS Officials Say, Henry J. Kaiser Fam. Fdn (April 2, 2009).
Workers Fired for Improper Access of Octoplet Mom's Records
Fifteen employees of Kaiser Permanente Bellflower Medical Center Kaiser in California lost their jobs after snooping in the electronic medical records of Nadya Suleman, who delivered octoplets at the 218-bed hospital. Kaiser spokesman Jim Anderson said the hospital conducted a review of Suleman's records because of the extraordinary level of interest and discovered that twenty-three employees "had looked at her records without having a good reason to do so." Two were fired and another thirteen resigned "in lieu of termination." Another eight received another form of discipline that Anderson declined to specify. He also declined to characterize their positions, saying only that they "run the gamut of healthcare workers."
Suleman delivered the octoplets on January 26, and the hospital, at Suleman's request, initially reported the unusual procedure without naming her, but within days she was an international celebrity. The hospital reported the breaches to the California Public Health Department and has added extra layers of security to selected records, with new prompts asking users to identify their purpose and enter additional information about themselves. "It also serves as kind of a reminder: Are you sure you want to look at this record?" Anderson said.
Anderson said Kaiser has no reason to believe that any of Suleman's medical information was sold, as has been the motivation in other cases of celebrity snooping.
Gregg Blesch, Workers Fired for Snooping Octuplet Mom's Records, Modern Healthcare's Daily Dose (March 31, 2009) (note: registration is required to view this content).
Stanford Medical School to Post Information About Physicians' Industry Ties
The Stanford University School of Medicine said it will begin posting outside consulting activities of its affiliated physicians and faculty on a public website. Industry ties of Stanford's 1,200 affiliated physicians and faculty members will be listed as part of their online profiles on the Palo Alto, CA, school's website.
This information already is released annually as part of Stanford's conflict-of-interest policy. Stanford officials said the new policy—to go into effect later this year—is part of an effort to increase transparency in medicine. "Industry collaborations are critical to furthering research efforts and innovative patient care, but at the same time, concerns over these activities are eroding public trust," said Philip Pizzo, dean of the Stanford medical school, in a written statement.
Consulting payments or other honoraria of $5,000 or more per year from a commercial organization for professional activities will be disclosed through the online profiles. The webpages will also list company affiliations. These affiliations include royalty agreements for inventions or discoveries, equity holdings, and the holding of formal positions such as a director or other fiduciary officer. The information will be updated annually. The Cleveland Clinic announced a similar policy in December.
Rebecca Vesely, Stanford Med School to Post Docs' Industry Ties, Modern Healthcare's Daily Dose (April 2, 2009) (note: registration is required to view this content).
FDA Warns: Don't Eat Pistachios Until Salmonella Source is Found
The FDA is warning Americans not to eat pistachio products until it locates a million pounds of roasted nuts from a California producer that may be contaminated with salmonella.
Federal and California regulators said Setton Pistachio of Terra Bella, CA, which describes itself as the nation's second largest pistachio producer, had voluntarily recalled a million pounds of nuts shipped to as many as thirty-six wholesalers around the country. Officials immediately noted that this recall has nothing to do with a salmonella outbreak earlier this winter involving peanut products from a Georgia processing plant that sickened almost 700 people in forty-six states and is suspected in at least eight deaths. That outbreak resulted in the recall of hundreds of products from manufacturers supplied by the Virginia-based Peanut Corporation of America.
There have been no confirmed cases of consumers sickened by salmonella-contaminated pistachios. Two consumers, one on each coast, have recently complained to the FDA of gastric distress after eating pistachio nuts, but officials don't know if they are related to the current recall. In fact, regulators said the salmonella bacteria were discovered during routine testing of pistachios by Kraft Foods, whose branded products use nuts produced by Setton Pistachio.
David Acheson, MD, the FDA's associate commissioner for foods, said Kraft reported the findings to his agency on March 24. They were able to trace the source of the products and called in California regulators to help deal with Setton, whose officials have cooperated fully, Acheson said. The problem will be determining which nuts are contaminated and where they are.
Dr. Acheson said the CDC is looking for salmonella outbreaks that might involve the four serotypes Kraft has identified. He said Kraft has also sent samples from its tests to FDA labs, while both federal and California inspectors are going over the Setton Pistachio plant in California in an effort to find the source of the contamination. Officials said the process of roasting pistachios normally kills off salmonella bacteria, so they suspect that the recalled nuts may have been cross contaminated with unroasted nuts or some other source of salmonella after roasting.
Michael J. Himowitz, FDA: Don't Eat Pistachios Till Salmonella Source Found, MedPage Today (March 31, 2009).
Study Finds Up to One-Fifth of Medicare Beneficiaries are Readmitted to Hospitals within Thirty Days of Discharge
According to a study published this week in the New England Journal of Medicine, as many as one-fifth of Medicare beneficiaries are readmitted to a hospital within thirty days of being discharged, costing the U.S. healthcare system billions of dollars for care that could be prevented. For the study, Mark Williams, chief of hospital medicine at Northwestern University's Feinberg School of Medicine, and colleagues analyzed Medicare claims data for nearly twelve million beneficiaries between October 1, 2003, and December 31, 2004.
The study found that 19.6% of beneficiaries were readmitted within thirty days of their initial discharge, 34% within ninety days, and 56.1% within twelve months. The study also found that about half of the beneficiaries who were readmitted in the first month did not see a physician prior to returning to the hospital. Researchers noted that about 10% of the readmissions likely were scheduled in advance for a planned surgical procedure (Nano, AP/Austin American-Statesman, 4/1). According to the study, readmission rates also varied among states. Idaho had the lowest readmission rate at 13%, while Washington, DC, had the highest rate at 23%.
The study estimated that the unplanned readmissions cost Medicare about $17.4 billion in 2004. Overall, Medicare paid hospitals $103 billion that year. The top five common medical conditions that required readmission were heart failure, pneumonia, chronic obstructive pulmonary disease, psychoses, and gastrointestinal problems. The top five common surgical procedures requiring readmission were cardiac stent placement, major hip or knee surgery, vascular surgery, major bowel surgery, and other hip or femur surgery. "Rehospitalization is a frequent, costly and sometimes life-threatening event that is associated with gaps in follow-up care," the study stated.
According to the study, patients need to schedule follow-up appointments with their physicians before they leave the hospital. Study co-author Stephen Jencks said failure to follow up with a physician is "unsafe because, as this study shows, almost all of these patients are high-risk." In addition, Jencks said hospitals should provide patients with a list of medications, instructions for what to do at home, and information about whom to call if there is a problem. Hospitals also should check on patients within two days of their discharge and inform patients' physicians that they were in the hospital.
Access an abstract of the study online.
Kaiser Daily Health Policy Report, Up to One-Fifth of Medicare Beneficiaries Are Readmitted to Hospitals Within 30 Days of Being Discharged, Study Finds, Henry J. Kaiser Fam. Fdn (April 2, 2009).
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.
*We would like to thank Leah Voigt Romano, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for writing this email alert.