By Leah Voigt Romano*
September 18, 2009
FDA Approves H1N1 Influenza Virus Vaccine
On Tuesday, the Food and Drug Administration (FDA) announced that it approved four vaccines against the 2009 H1N1 influenza virus. Calling the vaccines an "important tool to fight pandemic," the FDA announced the vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.
The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines, and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes. Based on preliminary data from adults participating in multiple clinical studies, 2009 H1N1 vaccines have been demonstrated to induce a robust immune response in most healthy adults eight to ten days after a single dose, as occurs with the seasonal influenza vaccine.
FDA expects that clinical studies presently under way will provide additional information about the optimal dose for children. The recommendations for dosing will be updated if indicated by findings from those studies. As with the seasonal influenza vaccines, 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.
U.S. Food & Drug Administration, Press Release: FDA Approves Vaccines for 2009 H1N1 Influenza Virus (Sep. 15, 2009).
Democrats, Republicans Look to Amend Baucus Bill
Democrats and Republicans alike are taking issue with affordability, funding, and the physician pay fix found in a healthcare reform package released Wednesday by Senate Finance Committee Chairman Max Baucus (D-MT). Lawmakers from both sides of the aisle said they are readying a host of amendments due by week's end.
Baucus' proposed bill requires all individuals to carry some level of health insurance and offers federal subsidies to help offset the cost to individuals and families making up to 300% of the federal poverty level (or $66,150 for a family of four). The tax credit is based on the percentage of income the cost of premiums represent, rising from 3% for those at 100% of the federal poverty level (or $22,050 for a family of four) to 13% of those at 300%.
Other issues center on an excise tax on insurance plans that offer high-end plans valued at $8,000 for an individual and $21,000 for families. Lawmakers said they are concerned that the insurance companies would pass on the costs to middle-class workers. Senator John Kerry (D-MA), who proposed the tax on so-called Cadillac plans, said he would offer an amendment to tweak the values to $9,000 for an individual and $24,000 for families.
While the proposed bill replaces a scheduled 21% pay cut to doctors with a 0.5% increase for 2010, it does so only for one year. The Congressional Budget Office said that under Baucus' proposal, physicians would be on the hook for about a 25% pay cut in 2011. Senator Orrin Hatch (R-UT), a member of the Finance Committee, told reporters that the lack of a permanent, sustainable, growth-rate fix skews any savings being predicted over the next decade under the legislation.
Matthew DoBias, Democrats, Republicans Look to Amend Baucus Bill, Modern Healthcare's Daily Dose (Sep. 17, 2009) (note: registration is required to view this content).
Health Policy Experts Urge Congress to Abandon Ideological Differences on Overhaul
Veteran health policy experts on Thursday urged lawmakers to put aside ideological differences and take immediate action to create broad-based changes in the nation's healthcare system.
The group, which included leading economists, analysts, and healthcare administrators, spoke at an event organized by the nonprofit advocacy group Health Reform USA. The event coincided with the group's publication of an open letter to Congress, which was signed by more than 400 healthcare leaders and identified eight specific policy changes that the leaders said are central to effective health reform legislation. Those changes include efforts to expand coverage to the uninsured, promote competition in healthcare insurance, assure affordability, and cover preventive services.
Many of the panelists, who were involved in past failed healthcare reform efforts, warned that the financial security of the middle class is in danger if Congress does not act. Princeton economist Uwe Reinhardt, who was among the co-signers, noted in a statement that a typical privately insured American family now pays $16,700 for healthcare, which will double again by 2019 while wages and salaries rise at less than 3% per year. "Many middle-class Americans seem unaware that they are sailing into a perfect storm," he said.
Overall, the group emphasized that the proposal unveiled yesterday by Senate Finance Committee Chairman Max Baucus (D-MT) is a strong framework that moves toward the goal of meaningful healthcare reform. Although the panelists questioned some specific provisions—especially the bill's ability to expand affordable health coverage while also slowing the growth of cost increases—they advised lawmakers to fight the urge to walk away from the increasingly difficult legislative process.
The group emphasized the need to stay open to compromise, focus on the big picture, and think about how proposals will work in the real world.
Jessica Marcy, Health Policy Experts Urge Congress To Abandon Ideological Differences On Overhaul, Kaiser Daily Health Policy Report, Henry J. Kaiser Fam. Fdn. (Sep. 17, 2009).
Americans at Low Cardiac Risk Are 'Vanishing Breed'
According to a report published online this week by Circulation, Journal of the American Heart Association, Americans considered at low risk for heart disease now make up less than 8% of the population. Researchers at the Center for Disease Control and Prevention's (CDC's) Division of Adult and Community Health say that, although cardiovascular risk and mortality has declined since the 1970s, possibly in response to public health campaigns aimed at smoking and cholesterol, primary prevention efforts appear to be stymied at best. The researchers used data from four national surveys of twenty-five to seventy-four-year-old adults to estimate the proportion of Americans who have a low-risk factor burden. That means adults who are unlikely to develop cardiovascular disease or risk factors for cardiovascular disease.
The study revealed that whites were more likely to be living heart-healthy lives than were blacks except for the period from 1976 to 1980, when there was no racial difference in low-risk factor burden. The findings, however, did not surprise cardiologists on the other side of the Atlantic, and the European Society of Cardiology quickly issued a comment on the state of prevention in the United States.
Peggy Peck, Americans at Low Cardiac Risk are Vanishing Breed, MedPage Today (Sep. 14, 2009).
American Hospital Association Urges Review of Meaningful Use Definition
Officials with the American Hospital Association (AHA) recently urged the federal Health Information Technology Standards Committee (Standards Committee) to reconsider its proposed definition of the term "meaningful use" in the context of the American Recovery and Reinvestment Act of 2009.
The stimulus bill made more than $17 billion available to hospitals and physicians to purchase health information technology systems, but said healthcare providers must show that they have put the new technology to meaningful use to qualify for the funds. Because the bill did not define the term, the Standards Committee has become one of two federal groups left to advise the Department of Health and Human Services on what it means.
Beth Feldpush, a senior associate director of policy with the AHA, told the committee Tuesday that AHA believes meaningful use should be defined by the ability to use the systems to improve patient care, according to an AHA publication. Yet, Feldpush said many of the proposed metrics to measure the usage would not take that into account.
Lawrence Hughes, assistant general counsel with the AHA, also told the committee that its recommendations would change medical-data privacy restrictions contained in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) by mandating a uniform set of requirements for certain aspects of HIPAA compliance, the publication said. Current regulations allow HIPAA-covered entities to assess on their own whether certain security specifications are reasonable and appropriate.
Joe Carlson, AHA Urges Review of 'Meaningful Use' Definition, Modern Healthcare's Daily Dose (Sep. 16, 2009) (note: registration is required to view this content).
New York Laws Clarify Rules on Organ Exchanges, Who May Consent
Late last month, Governor David Paterson of New York signed bill A.4216 to explicitly exempt so-called paired kidney exchanges and other similar arrangements from the state law prohibiting the sale or purchase of human organs. Under the bill, which took effect immediately, paired kidney exchanges and similar arrangements would not be considered "valuable consideration" under the Public Health Law.
The bill authorizes the New York Health Department to promulgate regulations to establish safeguards and limits to ensure that arrangements are fair and equitable. "While arguments can be made that such exchanges are not 'valuable consideration,' the lack of universal agreement on the application of this provision to paired kidney exchanges and potential for criminal prosecution by district attorneys based upon their interpretations of this law serve as a significant deterrent to physicians, centers, and potential donors participating in such exchanges," the sponsors of the bill said in a memo supporting the measure.
State law currently prohibits the sale or transfer of a human organ for "valuable consideration." Under paired kidney exchanges and other so-called conditional organ donations, donors who are not a match with their intended recipients are paired with other donors and recipients, in an exchange arrangement that matches compatible donors and recipients. In a separate bill, A.904, Paterson signed a measure that expands the statutory list of who may provide consent for the donation of a deceased patient's organs. Under the bill, which takes effect sixty days after it was signed, a patient's designated healthcare proxy agent, disposition-of-remains agent, and domestic partner are added to the list.
The bill also sets the order of priority for consent, starting with the healthcare proxy, and then the disposition-of-remains agent, spouse or domestic partner, son or daughter, parent, sibling, guardian, and, finally, any other person authorized to dispose of the body.
New York Laws Clarify Rules On Organ Exchanges, Who May Consent, BNA'S HEALTH L. REP. (Sep. 17, 2009) (note: registration is required to view this content).
*We would like to thank Leah Voigt Romano, Esquire (Hall Render Killian Heath & Lyman PLLC, 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.