Healthcare Regulations

The Joint Commission announced its 2008 National Patient Safety Goals yesterday. Some major changes include a new requirement to cut the risks of patient harm associated with the use of anticoagulants, and is applicable to hospitals, critical access hospitals, ambulatory care and office-based surgery centers, home care and long term care facilities.

The Joint Commission also established a new goal and requirement that calls for providers to recognize and respond to unexpected …

Right now, pharmacies are allowed to transfer or sell off assets--including prescribing information, Social Security numbers and medical data--to anyone they choose, thanks to a loophole in HIPAA. This is a sharp contrast with other areas of medicine; for example, doctors are required by federal law to let patients know whenever they share that patient's information. But this doesn't sit well with Sen. Charles Schumer (D-NY). He's asking HHS secretary Michael Leavitt to push for changes …

After surviving years of scandals over questionable care, Martin Luther King Jr.-Harbor Hospital may be out of time. California regulators have set plans to revoke the hospital's license, something they haven't done to any hospital in the state since 2004. The hospital can appeal the decision, a process which could take as long as a year, but at least some of the county supervisors aren't sure they should fight. Two of the five members of the Los Angeles County Board of Supervisors say …

Another group of doctors is taking arms against a sea of retail clinics (though there's little hope that by opposing they'll end them). Illinois physicians are already lobbying for a new state law that would regulate retail clinic operations, ostensibly to protect the public, though it would be silly to suggest they weren't concerned about competition as well. Now, working with …

The state of Pennsylvania has released a new cardiac surgery performance report which for the first time includes hospital-specific payment data. According to the report, which was issued by the Pennsylvania Health Care Cost Containment Council, the average payment for heart bypass procedures by commercial health plans was $30,247, and for valve-only procedures $41,651 during 2005. Medicare paid $29,175 for bypasses and $42, 433 for valve-only procedures. The state's hospital association …

There's a hepatitis C scare on in New York City, where authorities have asked 4,500 people to get tested after their contact with a local anesthesiologist. The anesthesiologist, who hasn't been named, may have spread the disease as he or she put patients under. To date, three people treated by the physician have been diagnosed with hep C. Tests suggest that the patients picked up the illness while getting intravenous anesthesia meds during outpatient procedures. However, it's not clear …

On the one hand, everyone would like to see potentially beneficial drugs approved as soon as possible. On the other, no one wants to see the FDA speed heedlessly through the approval process either. As scandals blow up on Capitol Hill over Avandia and other drugs, critics are beginning to question whether the FDA is striking the right balance between speed and safety. Evidence increasingly suggests that the FDA has a habit of silencing internal and external critics--and that safety may be …

A bill making the rounds in the U.S. Senate would open up Medicare data to private organizations that want to use it for research and analysis. The bill, sponsored by Sens. Hillary Clinton (D-NY) and Judd Gregg (R-NJ), would make claims, enrollment, survey, assessment and other available to private groups hoping to measure care quality, efficiency and effectiveness. Other stakeholders would then have the right to request reports from the research organizations. The research organizations …

Momentum seems to be building for a New York state bill which would require drug makers to report when they give doctors gifts valued at over $75. This week, a wide range of physician and consumer groups expressed support for the measure, including the AARP, National Physicians Alliance, Center for Medical Consumers and Consumer Reports publisher Consumers Union. The bill targets the $7 billion per year pharmas spend in physician gifts, which includes everything from meals, trips and …

A researcher and early critic of Avandia told Congress yesterday that a GlaxoSmithKline executive threatened him with dire financial consequences when he raised concerns about the drug. Dr. John Buse, who testified before a House panel yesterday, told investigators that Glaxo executive Dr. Tadataka Yamada suggested that he should be responsible for the $4 billion drop in stock value Glaxo suffered after Avandia safety concerns came to light. In light of similar findings by …