Rising Maternal Death Rate: A Sentinel Event

California Watch, a project of the Center for Investigative Reporting, reported earlier this month that the rate of maternal deaths directly related to pregnancy and birth nearly tripled in California between 1996 and 2006– from 5.6 maternal deaths per 100,000 live births to 16.9 per 100,000.  Even after accounting for improved information gathering, the rate has more than doubled and “[c]hanges in the population — obese mothers, older mothers and fertility treatments — cannot completely account for the rise … said Dr. Elliott Main, the principal investigator for the task force” that prepared the report.  While the reason or reasons for the rise in deaths are not yet understood, Dr. Main notes that the rate of Cesarean sections increased by 50 percent over the 1996-2006 time period.

Sadly, California is unlikely to be unique in this regard.  Maternal death rates have probably increased in other states and in the country as a whole as well.  On January 26th, the Joint Commission issued a Sentinel Event Alert to hospitals, notifying them that “current trends and evidence suggest that maternal mortality rates may be increasing in the U.S.”  The Commission acknowledged that that incidence of maternal death remains low — at an estimated 13.3 deaths per 100,000 live births — and that a possible reason for the increases seen is better identification of women who die during or shortly after pregnancy.  Still, the Commission quoted the CDC’s Dr. William M. Callaghan as follows: “[T]here clearly has been no decrease in maternal mortality in recent years, and we are not moving toward the U.S. government’s Healthy People 2010 target of no more than 3.3 maternal deaths per 100,000 live births[].”  Moreover, “[m]aternal deaths are the tip of the iceberg for they are a signal that there are likely bigger problems beneath — some of which are preventable,” says Dr. Callaghan. “It is important to consider the women who get very, very sick and do not die, because for every woman who dies, there are 50 who are very ill, suffering significant complications of pregnancy, labor and delivery.”

Not all maternal deaths are preventable, of course.  To reduce the rate of those that are, the Joint Commission suggests a number of actions for hospitals and physicians to take, including participating in state-level maternal mortality reviews and developing protocols (and holding drills to train staff on the protocols) for responding to conditions such as hemorrhage and pre-eclampsia.  More concretely, the Commission quotes Dr. Steven L. Clark of the Hospital Corporation of America who argues that the “only cause of maternal death amenable to nationwide systematic prevention efforts is pulmonary embolism [a blood clot in the lung].”  Disappointingly, while nearly all adult patients undergoing major surgery receive prophylactic measures for the prevention of venous thromboembolism (VTE) — even patients with no risk factors for the condition — pregnant women undergoing Cesarean delivery traditionally do not, despite the fact that they are at increased risk.   In light of the Commission’s Sentinel Event Alert, it seems to me that hospitals would be well-advised to adopt VTE prophylactic measures for all pregnant women undergoing Cesarean sections at once.  Is there a downside I am missing?

New Breast Cancer Screening Recommendations Cause Controversy

Rarely do medical recommendations or clinical guidelines receive such immediate and passionate attention as those released this month by the U.S. Preventive Services Task Force (USPSTF), an independent panel of doctors and scientists who make recommendations to the Department of Health & Human Services.  In a striking detour from prior recommendations by the Task Force and those of the American Cancer Society (ACS) that women over 40 receive a mammogram every one to two years, the Task Force now recommends:

• “against routine screening mammography in women aged 40 to 49 years”;
• “biennial screening mammography for women aged 50 to 74 years”;
• “against teaching breast self-examination (BSE)” (emphasis added).

In a radio interview on the new guidance, Dr. Bruce Calonge, chair of the Task Force, was asked about the USPSTF recommendation against routine screening for women in their 40’s and “the possibility that some women may die as a
result of not having routine mammograms.”  Calonge’s astonishing answer:

“what women really need to understand in that decade is that overall reduction in mortality, which is for all comers in that age group, only about 15%, because breast cancer is relatively rare in that age group, that benefit is really quite small…”

Although he claimed that cost analysis had no place in the Task Force’s recommendations, later, focusing on early detection generally, he repeated,

“I think one of the things that is important to say… that mammography’s benefit is only a 15% reduction in mortality.”

Kathleen Sebelius, HHS Secretary, has clarified that the federal policy on breast cancer screening has not changed, despite the Task Force’s recommendations.   In response to concerns that patients who seek mammograms before the age of 50 would not be covered by health insurance, Sebelius stated that she “would be very surprised if any private insurance company changed its mammography coverage decisions as a result of this action.”  Despite such assurances, if past experience is a guide insurance companies will use these criteria to determine coverage.

A number of professional and advocacy groups have responded to the Task Force’s November 16 recommendation.   The ACS continues to recommend annual screening using mammography and clinical breast examination for all women beginning at age 40.  The American College of Radiology issued a frankly titled statement, “USPSTF Mammography Recommendations Will Result in Countless Unnecessary Breast Cancer Deaths Each Year” and labeled the recommendations “cost cutting.”  And the American Congress of Obstetricians and Gynecologists continues to recommend a screening mammography every 1-2 years for women aged 40-49 years and every year for women 50 and over, as well as to recommend BSE.

So what would the task force’s mammography recommendations mean for patients?  The changes to the recommendations extend beyond the age at which they recommend beginning mammography screening.  For example, the 2002 USPSTF recommendations explained, “[t]he precise age at which the benefits from screening mammography justify the potential harms is a subjective judgment and should take into account patient preferences” (emphasis added).  The elimination of the term “preferences” and the focus on “patient context” and the “patient’s values regarding specific benefits and harms” indicates a move toward evidence-based medicine, whereby a patient’s inclinations and personality are taken less into consideration or play a less significant role in predicting outcomes.  In a November 17 New York Times article, the author asks,

Are you the sort for whom shivering in a paper gown, enduring discomfort and waiting a week for results is so unnerving that you are thrilled for a decade-long reprieve? Or are you that woman who gets an extra breast sonogram with your gynecologist even when it is not medically indicated? Do you trust scientists or prefer your own gut?

These concerns seem more like preferences than medically-supported decision-making factors.   The 2009 recommendations instruct that “the patient’s values regarding specific benefits and harms” be taken into account — but do not explain how far “patient context” be considered.  The recommendations do not apply to women with “known underlying genetic mutation or a history of chest radiation.”  Beyond these two exceptions, how will doctors and patients make individual decisions to start regular, biennial screening mammography?  The recommendations should be appreciated for confirming — to an extent — that the decision to begin regular screening mammography is individual.  The doctor and patient, in collaboration, should consider the patient’s risk tolerance, family history, and any other applicable factors.  Sebelius recommends that patients “[k]eep doing what you have been doing for years — talk to your doctor about your individual history, ask questions, and make the decision that is right for you.”  It is unclear how the Task Force’s recommendations could affect the decision to begin mammography in an educated and reasoned way.

The Task Force’s self-examination recommendation is also worrisome.  The USPSTF states that “there is moderate or high certainty that [BSE] has no net benefit or that the harms outweigh the benefits.”  However, discouraging the use of self-examination — a short, free, easy, and non-invasive process — might seem astonishing to many, particularly those who have known someone for whom a BSE has been the means by which breast cancer was first discovered.  Appreciating the concern about BSE leading to higher incidences of biopsies, additional screenings, and false-positive test results, with the increasing focus on disease prevention, this recommendation seems, at best, counter-intuitive, particularly when taking into account those who are uninsured and may not pursue other methods of breast cancer screening.

Short Shrift for Stillbirth in Health Reform?

Short Shrift for Stillbirth?[1]

The health reform bill that cleared the Senate Finance Committee earlier this month — S. 1796 — incorporates at least two pieces of pending legislation relating to maternal and infant health.  Section 1631 of the bill, authorizing Medicaid coverage for services provided at freestanding birth centers, adopts the text of S. 1423, while Section 1802, authorizing grants to fund services to new mothers struggling with postpartum depression or psychosis, is derived from the Melanie Blocker Stokes MOTHERS Act, which the House passed in March.  Not making the cut was legislation currently pending in the House — H.R. 521 and H.R. 3212 — and Senate — S. 1445 — aimed at reducing the number of stillbirths and sudden unexpected infant and child deaths.

According to the Centers for Disease Control, there are about 25,000 stillbirths — defined by the CDC as the death of a fetus after 20 weeks of gestation or, if the gestational age is unknown, weighing 350 grams or more — in the United States each year.  About 1 in every 160 deliveries in this country ends in a stillbirth.  (Per the CDC, these numbers may be low estimates, because they are based on information contained in death certificates, which studies have shown underestimate the true incidence of stillbirth.)   All too frequently in these cases, no cause of death can be determined.  As Alan Goldenbach put it in a moving essay in the Washington Post: “[T]he most common result after a stillbirth is a doctor telling grieving parents, ‘I don’t have an answer for you.’”

Better data is a necessary first step to finding answers.  As the American Congress of Obstetricians & Gynecologists explains, inconsistencies in the evaluation and classification of stillbirths across jurisdictions frustrate data collection efforts.  The United States has the lowest stillbirth autopsy rate among developed countries, and other important elements of a thorough post mortem evaluation, including analysis of the placenta and umbilical cord and genetic testing, may be left undone.  In addition, recordkeeping is inadequate.  Death certificates are often filled out — incompletely — before any investigation into the cause of death is done.  All of these factors hinder research.

First introduced in June 2008 by then-Senator Barack Obama, and now sponsored by Senator Frank Lautenberg (D-NJ) and Representative Frank Pallone, Jr. (D-NJ), the Stillbirth and SUID Prevention, Education, and Awareness Act of 2009 (H.R. 3212 and S. 1445; H.R. 521 is similar) would, among other things, (1) establish “a task force to develop a national research plan to determine the causes of, and how to prevent, stillbirth” and (2) require the CDC to develop guidelines for increasing the performance of thorough postmortem stillbirth evaluations and to continue its efforts to develop and disseminate a standard protocol for stillbirth data collection and surveillance.  The Act would also expand pilot programs in metropolitan Atlanta and Iowa which supplement the current passive information-gathering system — which relies on death certificates — with an active system in which trained staff make regular visits to clinics and hospitals to gather data.  A study published in 2007 in Public Health Reports demonstrated that Atlanta’s active surveillance system captured more stillbirths than were reflected in death certificates and gathered better data about each one. Expanding the Atlanta and Iowa programs to additional jurisdictions and taking the other steps provided for by the Act would put us on the road to answers to the countless painful questions posed by each unexplained stillbirth.

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[1] Credit for the idea and background research for this post goes to Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy.  On November 10, 2008, Cathy’s first and only grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation.

Another Call for Women’s Action on Health Care Reform

Just a little over a month ago, Michelle Obama called upon women to take action to make sure their representatives would vote for health care reform.  This past week, Michelle made another request for women to respond to the national health reform debate during a breast cancer event at the White House.  As the debate seemingly winds towards a conclusion of reform, still, women are unsure that health care reform will actually accomplish that which really needs to be done to help women access better, more comprehensive health care.  While mom’s of America are saying the current health care reform proposals do not include their needs, the National Women’s Law Center exclaims “I am not a preexisting condition.”

The National Women’s Law Center released a second report this month on the affect of gender bias and discrimination in health insurance on women’s lives.  Their report includes an analysis of the discrepancies in health care access between men and women as well as an updated state-by-state comparative chart of states that still allow gender-rating and pre-existing condition discrimination in their health care plans.  Another interesting aspect of the report is the information on states that have, as of late,  reformed their health care systems to be more inclusive of women’s access to health care. One might wonder if the reformation was spurred or enabled in part as a result of the initial report’s publicity.

If you’re wondering about how your state fares in relation to women’s health care issues, be sure to check the most recent NWLC Report as well as Kaiser’s www.statehealthfacts.org.  Also, the Commonwealth Fund has just released a new report comparing the various Congressional health reform bills of 2009.  The report shows that the proposals which seem to pay most (though not enough) attention to women’s health care needs are that of the Senate Health, Labor, and Pensions Committee and the House of Representatives Tri-Committee, which both hope to establish an Office of Women’s Health.  All of these online resources are a great way to get more information and find out where holes in the health reform bills still need to be filled.

To be able to voice direct concerns, the organization Women of Color United for Health Care Reform is hosting a call-in day on Tuesday, October 27^th that will directly connect women to their respective Senators and Representatives.  The calls will be a chance for women to tell their Congress members what they want from health care reform and why allowance of pre-existing conditions denials and gender-rating are not acceptable.  Such calls worked well earlier this month in an event organized by Organizing for America, which enabled callers to tell Congress that they wanted health care reform– with many saying they that really wanted a public option.

Action needs to be taken– and the Obama Administration is asking for exactly that from women.  Though women are most often the health care decision makers in the family unit, men are also needed to voice their concerns:  why their mothers, daughters, wives, and sisters deserve a health care plan that serves their needs.  Call in on Tuesday, the 27^th and let Congress know what’s on your mind.

Maternity Care and Health Care Reform

In the last few weeks, health reform has been receiving more public attention than it had before, much of which can be attributed to President Obama’s efforts to unify Congress in passing a bill.  For consumers, the politics of reform have helped to blur the defining components of each reform bill, leaving them unsure of what their health care insurance will or will not cover (let alone how they will pay for it) if reform is passed.  This is a real frightening thought considering that consumers will be the ones directly affected by whatever Congress decides.  In most American family units, the women make the majority of health care decisions for the rest of the family; women also have a lot at stake when it comes to their own health care access.  For these reasons, it is essential for women to understand and know what their legislators are planning for their health.

One of the areas of women’s health care that certainly needs to be reformed is maternity care.  Currently, women in the individual market can be denied health coverage if they seek coverage after becoming pregnant.  And that’s not the only  pregnancy related preexisting condition out there - if you’ve had a C-section before, you could be charged far greater premiums or even denied health coverage altogether.  It may seem that women who are uninsured are the only ones that would have to deal with such scenarios; however, women with insurance from the individual market or employer-based insurance face similar challenges in accessing care.  Read this story about a woman who had coverage through a private insurer and still had to pay $22,000 for having a baby.

Among the different types of private insurance that women have (or can have), there are major discrepancies with regard to maternal health coverage.  You are most likely best-off if you have employer-based insurance; best being a relative term.  Protection from discrimination in employer-based coverage exists through the Pregnancy Discrimination Act of 1978, which made any pregnancy-based discrimination unlawful.  However, the individual market is another story altogether.  The Pregnancy Discrimination Act and a number of other consumer safeguard regulations do not apply to the individual market.  States allow for insurance companies in the individual market to calculate premiums based on categories like gender, age, and pregnancy status.

The issue of access to maternity care for uninsured women, however,  is surely the case of the worst-off.  The obvious translation here is poor prenatal care, which is a vital aspect of not only the mother’s health but the child’s as well.  Considering the fact that our country has one of the highest infant mortality rates among developed nations, the need for reform to address maternity care for the uninsured is a serious one.  While Medicaid is able to assist in covering some of these uninsured women, a large overhaul of the maternity health care services of public programs like Medicaid should be requisite within national health care reform.

Congressional health reform proposals have not yet fully revealed what they will do to ameliorate the maternity health challenges that women face in our country.  However, we do know that certain systems have historically served women’s maternity health care needs better than others.  At this point in the national health care reform stage, women should be particularly concerned with the type of reform that Congress will pass.

Any health reform or insurance plan legislation which fails to provide access to care to ensure healthy pregnancies should be seen as strongly suspect-as this fundamental disregard for the basic needs of women (and children), dire in itself, would surely be a harbinger for a further disregard of women’s rights going forward.