The week in review, October 14-20, 2012
medwireNews: This week's news includes more fallout from the fungal meningitis outbreak, Walmart invests employee health dollars in centers of excellence, a presidential commission weighs in on genomic privacy, and medical societies urge Congress to give the Medicare sustained growth formula the boot.
Fungal meningitis outbreak
The Centers for Disease Control and Prevention (CDC) announced that as many as 14,000 people may have been exposed to the infection of the central nervous system from epidural injections of methylprednisolone acetate contaminated with fungi. The drugs were distributed in one of three lots prepared at the New England Compounding Center (NECC) in Framingham, Massachusetts.
NECC has closed its compounding pharmacy facility and has voluntarily recalled all of its compounded products in addition to the contaminated steroids. The CDC, working with the Food and Drug Administration (FDA), jointly recommend "out of an abundance of caution" that neither clinicians nor patients use any products from the NECC.
The CDC advised clinicians to determine whether they have administered a potentially contaminated dose of drugs from the NECC; the lot numbers of the suspected products are available on the CDC and NECC websites.
Other products from Mass compounding pharmacy at risk
The FDA has advised clinicians not to use any injectable medications, ophthalmic solutions, or cardioplegic medications from the Massachusetts pharmacy implicated in the current multistate fungal meningitis outbreak.
In addition to patients being exposed to potentially contaminated methylprednisolone, surveillance efforts also identified a patient with possible meningitis following an epidural injection with a different steroid, triancinolome acetonide, also prepared by the NECC. Furthermore, an organ transplant recipient has developed an Aspergillus fumigates infection after receiving an intraoperative cardioplegic solution prepared by the NECC.
"At this point in FDA's investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection," the agency said in a statement.
Walmart offers employees high quality care at a steep discount
In other news, Walmart, the world's largest retailer, announced that it will offer its qualified employees healthcare with no out-of-pocket cost for heart, spine, and transplant surgeries at one of six designated Center of Excellence health systems.
Walmart employees (or "associates" as they are known in company parlance) who are eligible for the company's health insurance plans, as well as their dependents, will receive consultations and medical/surgical care for specified conditions at nationwide institutes including the Cleveland Clinic in Ohio and Mercy Hospital Springfield in Missouri.
The company will cover the employees' deductibles and co-payments for eligible procedures, as well as travel, lodging, and meals for the patient and one caregiver.
Covered cardiac procedures will include open heart surgery for coronary artery bypass grafting, heart valve replacement/repair, heart defect repairs, thoracic and aortic aneurysm repair, and other complex cardiac surgeries. Cardiac services will be offered in Ohio, Pennsylvania, Texas, and Washington.
Designated Centers of Excellence in Missouri, Texas, and Washington will offer specialized orthopedic and musculoskeletal surgery, including cervical and lumbar spinal fusion, total disc arthroplasty, spine surgery revisions, and other complex spine surgeries.
The program is an expansion of a service begun by the company in 1996 in cooperation with the Mayo Clinic to provide a centralized facility for organ transplants.
Psst buddy, want to buy a cheap genome?
In a report titled: "Privacy and Progress in Whole Genome Sequencing," Amy Gutmann (University of Pennsylvania, Philadelphia) and James Wagner (Emory University, Atlanta, Georgia), and colleagues in the clinical sciences, medical ethics, and government security offer 12 recommendations for improving the sharing of genomic data among clinicians and researchers while protecting the privacy of individuals and their families.
Among their recommendations is a call for funders, policy makers, and managers of research, clinical, and commercial databases to establish and maintain policies that clearly define access and permissible use of whole genome sequencing data, and that privacy protections should consistently protect data no matter how they are acquired.
Additionally, the aforementioned parties must be guided by professional ethical standards and be held accountable for breaches of privacy as defined by state and federal laws, including being subject to fines, sanctions, or imprisonment as specified under the applicable laws, the commission recommends.
The panel also states that individuals whose genomes are sequenced must be informed that incidental findings are likely in the course of sequencing, and call for studies to determine the best way to communicate incidental findings (such as genetic risks for cancer, heart disease, or other disorders) to those who choose to have their innermost genetic secrets revealed.
Medical societies to Congress: 'Cut it out!'
In a letter to the Senate Committee on Finance, Chairman Max Baucus (D-Montana) and ranking member Orrin Hatch (R-Utah), 62 medical associations, and 48 state medical societies call the Medicare sustained growth rate (SGR) formula "an enormous impediment to successful healthcare delivery and payment reforms that can improve the quality of patient care while lowering growth in costs."
The SGR formula, implemented under the Balanced Budget Act of 1997, is designed as a check on the growth of aggregate Medicare payments for physician services. The formula is calculated according to estimated percentage changes in fees for physician services and in the average number of Medicare fee-for-service beneficiaries, the estimated 10-year average annual percentage change in real gross domestic product per capita, and the estimated percentage change in expenditures due to changes in law or regulations.
But as payment systems move away from fee-for-service toward accountable care organizations (ACOs), patient-centered medical homes, and other models, the cuts to Medicare payments under the SGR are hampering efforts to redesign care, the organizations maintain.
They call for scrapping the SGR, and replacing it with a transition plan that incorporates reform of service-delivery systems, supports physician infrastructure, and reflects the costs of providing care and complying with quality improvement and cost management efforts.
By Neil Osterweil, medwireNews Reporter