House Committee Approves Tobacco Legislation The House Energy and Commerce Committee on April 2 approved legislation (H.R. 1108) strongly supported by the ACC that would grant FDA authority over tobacco products. The bill, which was approved by a 38-12 vote, would subject all new tobacco products to FDA review; allow FDA to restrict the sale, distribution, advertising and promotion of tobacco products; allow FDA to establish standards for tobacco products and take action against companies that market unreasonably harmful products; and require FDA to establish a Tobacco Products Scientific Advisory Committee. Prior to the vote, the ACC and several cardiovascular societies sent a letter to the committee urging passage. The bill must be approved by the full House. The Senate version of the bill (S. 625) was approved in August 2007 by the Senate Health, Education, Labor and Pensions Committee. ACC members are encouraged to contact their lawmakers and express their support for the bill. To contact your lawmakers directly, call the ACC toll-free grassroots hotline at 1-800-210-7193.
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CMS Issues Final Rule on E-Prescribing Standards The Centers for Medicare and Medicaid Services (CMS)
on April 2 issued a final rule on e-Prescribing standards
for Medicare's prescription drug benefit. The standards, which
are effective as of June 6, 2008, apply to four types of information:
formulary and benefits, medication history, fill status notification
and identification of individual health care providers. CMS
said that the e-Prescribing standards will increase safety
for beneficiaries by preventing adverse prescription drug
interactions, increase the use of generic equivalents and
will result in more efficient communication between physicians
and pharmacies. Although providers are not required to implement
e-Prescribing software, those who choose to must comply with
the standards for Part D beneficiaries. Additional information
about e-Prescribing, along with the final rule on standards,
is available online at http://www.cms.hhs.gov/EPrescribing/.
FDA News Updates Covidien on March 28 initiated a recall of 32 lots of Heparin Sodium USP because two of the lots, which were supplied by Scientific Protein Laboratories LLC, contained a heparin-like contaminant. As of April 2, Covidien had not received any adverse event reports linked to the contaminant. FDA recommends that use of the product be discontinued immediately. Patients should contact their physician if they experience any problems with the use of the product, according to FDA.
FDA recently published an article in the journal Nursing2008 that makes recommendations to medical professionals about protecting patients against potentially fatal arrhythmias that result from forgetting to reactivate an implantable cardioverter defibrillator (ICD) after an elective surgery. The article recommends that providers document in the patient's medical record information about the ICD; communicate with all relevant staff about the presence of an ICD and whether it is on or off; provide continuous cardiac monitoring with emergency equipment nearby during times when the ICD is off; and ensure that the ICD is reactivated following the completion of the surgery.
quality
Health Care Coalition Supports Initiative to Standardize Physician Ratings Programs The Wall Street Journal last week reported that a coalition of insurers, companies and physician groups has unveiled a nationwide initiative to standardize programs that rate physicians. The purpose of the initiative is to set a nationwide standard that is streamlined, and has greater transparency and consistency in how the programs reach their conclusions. Programs supported by the coalition would need to have the following traits: publicly available measurement information; vetting by a reviewer that is independent from the insurer; and utilization of quality and cost data – not just cost – in rating physicians. The initiative supports the use of national standards, such as those crafted by the National Quality Forum, whenever possible to encourage consistency among rating systems.
The ACC supports the concept of this effort; however, it is the development and implementation phases that will be critical to the initiative's success. The ACC plans to take an active role during these phases to ensure that the ratings programs adequately take into account the needs of cardiovascular professionals. For additional coverage of the initiative by the New York Times, click here.
