Medicaid Sterilization Policy Causes Unwanted Pregnancies

Here's an interesting article from the New England Journal of Medicine on Medicaid's policy regarding voluntary tubal ligation. Borrero et al. claim that Medicaid policy is preventing poor women who desire sterilization from receiving the procedure, resulting in tens of thousands of unintended pregnancies annually.

A surprising number of women desire tubal ligation immediately after giving birth; the procedure is conveniently done while they're still in the delivery room. More than 70% of sterilization procedures done within two years after delivery are in fact done in the immediate postpartum period.

Because of our nation's appalling experience with coercive and non-consensual sterilization of minority and poor women in the mid-20th century, however, the US government in the 1970s developed regulations designed to protect vulnerable women. Among these was a requirement for Medicaid patients of a 30-day waiting period between informed consent to sterilization and the actual sterilization procedure.

This well-intentioned regulation, unchanged since 1978, is today preventing women from receiving sterilizations that they actually desire. Some women request sterilization too late in pregnancy to fulfill the 30-day Medicaid waiting period; some are denied sterilization because they do not have their consent form present at the time of delivery; some give birth early, before the mandatory waiting period elapses.

The results of denial of sterilization services to Medicaid patients are very real. Almost half of women who are denied tubal ligation get pregnant within one year after delivery. The authors have found that "Medicaid-policy–related barriers lead to approximately 62,000 unfulfilled requests for postpartum sterilization annually, resulting in an estimated 10,000 abortions and 19,000 unintended births in the subsequent year...."

Both the financial and the emotional costs of these unintended pregnancies are very high. The authors estimate the cost to American taxpayers of the pregnancies at over $215 million annually. And wealthier, privately-insured women face no such policy barriers to receiving the sterilization procedure they desire. It might be time to revisit a policy that is harming the people it was originally implemented to protect.

Pharma and Phraud

Here's a report from Public Citizen summarizing the recent trend in payments by the pharmaceutical industry of civil and criminal monetary penalties. It seems that pharma has now eclipsed the defense industry as the leading defrauder of the US government under the False Claims Act. Some of the report's findings:

In the last twenty years, pharma firms have made 165 settlements for $19.8 billion in penalties. Three-quarters of these (both in terms of numbers of settlements and in terms of fines paid) have occurred in the last five years. GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough accounted, together, for more than half of the twenty years' penalties. Illegal off-label promotion of drugs has triggered the largest number of federal fines. Overcharging state Medicaid programs triggered the largest state-level fines. Actions initiated by industry whistleblowers gave rise to 67 percent of payouts over the last decade.

The report concludes that fines are probably not sufficient motivation to get high-profit-margin firms to behave. It recommends the application of the "Park Doctrine" to pharma executives--a doctrine under which individual executives can be convicted of criminal misdemeanors based on corporate misbehavior, even if they weren't personally aware of the problem. The doctrine is designed to motivate executives to become pro-active in preventing their firms from engaging in criminal misconduct.

The report's call for the FDA to revive the long-neglected Park Doctrine in fact follows recent signals from the FDA that it intends to do just that. The law firm of Hyman, Phelps and McNamara has an informative powerpoint presentation on the FDA's past and future use of the Park doctrine, here. The clear message from the FDA has been, "Expect some prosecutions of pharma executives soon!"