Healthcare Regulations

Boston, MA Mayor Thomas Menino is calling for investigation into Humana's pricing policies, in response to the health plan's posting a 130 percent premium increase this year for its standard Part D coverage. Menino, who characterizes the tactic as "bait and switch," plans to bring his concerns to an upcoming meeting of the United States Conference of Mayors, as he believes that government leaders across the U.S. should know about the problem. In practical terms, the price differences …

A University of Cincinnati researcher lured into town by a million-dollar private grant is under scrutiny by university and federal officials, dogged by charges that he failed to disclose a lucrative financial relationship with a medical device manufacturer. As a result of the controversy the researcher, Dr. Randall Wolf, has stepped down from his post as principal investigator of the heart device research program.

Dr. Wolf says that a recent FDA warning was triggered by confusion …

Has drugmaker Eli Lilly been promoting the off-label use of antipsychotic Zyprexa for elderly patients with dementia symptoms? According to an investigation by The New York Times, Lilly has been doing just that since late 2000, despite FDA rules to the contrary. Materials given to the NYT outline a campaign called Viva Zyprexa, in which sales reps are told to suggest the drug for older dementia patients. However, such marketing would run afoul of FDA rules, as Zyprexa is …

Nobody is suggesting that you shouldn't take HIPAA complaints seriously. But it might be a relief to know that less than 25 percent of the complaints lodged with HHS were ultimately found eligible for additional investigation--and that none have been targeted for formal action. That's the conclusion drawn by an analysis from Melamedia, an industry research firm, which examined 22,664 complaints received by HHS from April …

Don't be surprised if your patients are not only deluged with drug ads, but pumped full of misinformation, too. With direct-to-consumer drug advertising volume already hitting $4.2 billion per year--and growing at 20 percent per year--the FDA has too few resources to respond to ads that violate its rules, according to a new report from the Government Accountability Office. According to GAO research, between 2002 and 2005 it took FDA staffers an average of four months to get out warning …

With health system restructuring and hospital closures already on the way, health reform fever is in the air in New York. Now, it's taking the form of a state Assembly hearing on consolidation of New York's health plans. All told, mergers, acquisitions or affiliation agreements have impacted 12 million New Yorkers over the past three years. The Assembly's committees on Health and Insurance are meeting today to consider whether such consolidation has throttled providers' ability to …

The federal Office of the Inspector General has released a work plan for 2007--among the most detailed in recent years--that targets a wide range of activities and reimbursement areas important to hospitals, home care services, laboratories, rehab providers and psych facilities. Two important issues to be studied include:

• Supplemental payments to hospitals: The OIG is taking a closer look at adjustments for graduate medical education permits, nursing and allied …

You think your budget is tight?  Try being a New York state-based non-profit hospital. The state's 218 non-profit facilities lost a collective $95.4 million in 2005, putting them at 49th in the country for operating margins, according to the Healthcare Association of New York State (HANYS). HANYS said that 56 percent of the state's non-profits are losing money, breaking even or running margins of less than 1 percent, a dismal situation given …

The FDA has announced plans to tighten up regulations governing several medical devices, including stents, pacemakers, implantable defibrillators and other medical devices it regulates. The move was prompted, in part, by concerns over last year's massive defibrillator recalls, which concerned more than 200,000 devices. Among other steps, the FDA would like to see devices marked with a unique …

After years of debate over how to help dying patients with no other options, the Food and Drug Administration is looking at broadening experimental drug access for patients with serious illnesses. FDA officials have said that they're trying to strike a balance between denying gravely ill patients a shot at better health and endangering the public with untested drugs. Under a new proposal, the FDA would allow pharmacos to make certain experimental drugs available to extremely sick patients …