Friday, May 21, 2010

Can We Afford to Keep Our Promises?

On June 1, Congress will decide whether to cut Medicare reimbursements to health care providers. This time, providers are looking at - and fighting - a 21% cut. If the cut goes through, providers who accept Medicare patients will need to choose between getting by with less income (Medicare already reimburses at lower rates than private plans), or dropping Medicare patients.

Realistically, with the powerful American Medical Association and other organizations lobbying hard to block the cuts, Medicare reimbursements probably will not be cut right now. As an alternative, Congress might freeze the current reimbursement rates for five years.

Unfortunately, the drama of threats to cut Medicare and lobbying to restore these cuts has been going on for years in Washington, with three delays in the proposed cut this year alone. Medicare reimbursement rates are based on a much-criticized GDP-based formula. As Robert Lowes explains in a cogent Medscape article on the cuts:
Right now, reimbursement is determined by the so-called sustainable growth rate (SGR) formula, which sets an annual target for Medicare spending on physician services based partly on the growth of the gross domestic product. If actual spending tops the target, Medicare is supposed to decrease physician pay the next year to recoup the difference. Congress has called off annual SGR-triggered cuts going back to 2003, so the gap between actual and targeted spending on physician services has continued to grow, resulting in the 21.2% decrease for 2010.
Congress has been slow to revise this formula to reflect the true cost of providing health care to seniors because it would be expensive to do so.

At the same time, President Obama is spearheading an international health initiative to prevent or treat certain tropical diseases such as river blindness and hookworm, reports Sabin Vaccine Institute President Peter J. Hotez in a New York Times Op-Ed. These "neglected tropical diseases" torment over one billion people in the poorest nations, but they are rare in the developed world, and as a result there has been little financial incentive to eliminate them.

Treating and preventing these diseases is not just an act of altruism. Because these diseases affect children's physical and mental development, preventing the diseases makes it easier for the world's poorest citizens to stay healthy enough to gain an education and care for their families. As a result, the economic and political stability of many troubled regions improves, ultimately improving our own national security.

But can we really have it both ways: provide health care coverage for U.S. seniors and the disabled, and help improve health care for the poor in other countries, while our unemployment rate is 9.9% nationwide, raising taxes scares politicians, and about 80 million Baby Boomers are poised to retire and draw on their federal benefits? Have we promised more than we can deliver? And if we have, what will we change to make it right?

Saturday, May 15, 2010

Health IT Hits a Wall

It's hard (for me, at least) not to click on the headline "Up to half of Spanish-translated prescriptions include dangerous mistakes" as a May 12 Fierce Healthcare post declared. The post cited a recent Pediatrics study that found that translation programs used by pharmacies to create Spanish-language instructions for patients were deeply flawed.

The Pediatrics study evaluated Spanish medicine labels from 209 pharmacies in the Bronx, New York; most of the pharmacies used computer programs to translate instructions for patients from English into Spanish. Half of the the translated labels used a mixture of Spanish and English, or had grammatical or spelling mistakes, resulting in "inconsistent and potentially hazardous" translations, according to the authors.

"Phrases that were not translated included 'dropperfuls,' 'apply topically,' 'for 7 days,' 'for 30 days,' 'apply to affected areas,' with juice,' 'take with food,' and 'once a day,'" the Pediatrics study's authors wrote. Mistranslated phrases included the substitution of "eleven times a day" for the phrase "once a day."

The move toward e-prescribing, electronic medical records, and other technological advances is supposed to make the practice of medicine safer and cheaper. The famous 1999 Institute of Medicine report, "To Err is Human: Building a Safer Health System" which found that up to 100,000 people die in hospitals each year from medical errors, helped shift the needle toward more standardization and digitization of medicine.

The Centers for Medicare and Medicaid (CMS) encourages the adoption of electronic medical records (EMR) and will soon provide financial incentives to health care providers who adopt them. In February, FierceHealthIT pointed out that "a healthy $20 billion in IT spending [from the stimulus bill]... will largely be funneled through CMS to provide incentives for EMR adoption."

All good, if you support health care reform and patient safety. But throwing technology at problems has its limitations, as the Pediatrics study makes clear. The study's authors suggested more regulation of and funding for better translation programs. Meanwhile, other unresolved IT issues, such as ensuring the electronic security of patients' health information, will continue to pose challenges for health IT for a long time to come.

Friday, May 7, 2010

Understanding the Children's Medicine Recall

When I read that the FDA is recalling 40+ children's medicines manufactured by McNeil Consumer Healthcare, including some lots (batches) of children's Tylenol, Motrin, Zyrtec, and Benadryl, I had one of those "oh, crap!" parenting moments. What parents of young children don't have a bottle of one of these products kicking around the medicine cabinet?

In a news release on May 1, the FDA described the reasons for the voluntary recall. To quote from the release:

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.
Let me parse this vaguely-worded statement: during a plant inspection, McNeil and/or the FDA found that some of the products have too much medicine in them. Some of the products have contaminated or ineffective ingredients. And some of the products contain tiny particles - of what? Plastic? Metal?

I found the bottle of children's Benadryl that we bought recently and checked the NDC number (printed above the name) in McNeil's online database of recalled products. Fortunately, the lot of the Benadryl we bought was not on the recall list.

I'm relieved, but the larger question remains: what happened? McNeil is owned by Johnson & Johnson, and an employee blog designed to improve customer relations briefly discussed the recalls. Some comments on the blog, however, blamed the problems on plant managers for not listening to safety concerns raised by workers, and others said that the timing of the recall announcement was designed to minimize the problem.

It turns out that this is the second recall this year of medicines manufactured by McNeil.

In January, McNeil recalled hundreds of lots of over-the-counter products, including Children's Motrin, Children's Tylenol, Benadryl, and Extra-Strength Tylenol, in response to consumer complaints that the products had a "moldy, musty, or mildew-like odor" and the products gave some people gastrointestinal problems. Company investigations found that these products were contaminated with a chemical used to treat wood pallets used in manufacturing facilities.

McNeil dragged its feet for over a year on recalling the moldy medicine. As Natasha Singer explains in an excellent analysis of the January recall, written on January 18 for The New York Times:

According to a federal inspection report, the response was anything but swift. The recall came 20 months after McNeil first began receiving consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to a warning letter sent by the Food and Drug Administration to the company on Friday.

Safety first? I don't think so. It sounds like some people at McNeil were either not doing their jobs, or not putting the consumer first. People still need medicines such as Tylenol and Benadryl, and Singer points out that they will abandon brand names for generics if they don't trust the brand. So if McNeil/Johnson & Johnson can't (quickly) fix their manufacturing problems, it will harm the company as well as consumers.

Maybe McNeil should take a lesson from parents: do your best, and try to keep the kids safe.