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.

The House Democrats’ Health Care Plan Unveiled, Questions on Women’s Access to Health Care Remain

Last Thursday, October 29^th, House Democrats announced their bill for health care reform, the Affordable Health Care for America Act.  The House bill includes provisions such as a public option and employer mandates.  For women, the House bill has been a controversial issue; though the bill contains provisions that will expand women’s access to certain areas of health care, other areas have been neglected.

On the plus side is the bill’s prohibition of domestic violence being categorized as a pre-existing condition for health insurance purposes.  Ms. Pelosi was able to follow through on her promise to women that such a discriminative practice would be ended through the House bill.  Meanwhile, U.S. News attributes the inclusion of women’s health needs in the bill to the widespread women-led activism for health care reform.  Still, as significant aspects of women’s access to health are yet left unaddressed, some advocates wonder if we should have asked for more.

One issue of contention is that an amendment to the the bill allows for 12 years of exlcusivity for biologic drugs– some of which have been found particularly efficacious in the treatment of breast cancer. In addition to the 12 year exculsivity period, manufacturers will also be able still to engage in the process known as “evergreening,” the practice of changing a drug slightly–such as altering the time release mechanism– and thereby garnering additional periods of exclusivity. These periods of exclusivity prohibit cheaper generic versions of the drug– known as “follow-on biologics” or “biosimilars” from entering the marketplace. (To read more about the biologic exclusivity debate read here and here.) The end result would seem to point– if money matters (and when does it not?),  to a decrease in the availability of breast cancer biosimilars and thus a decrease in available efficacious treatment.  One of the bill’s sponsors, Anna Eschew of California, defends the proposal on the grounds that it does not interfere with women’s access to breast cancer treatment, and that it only curbs the ability of bio-pharmaceutical generic competitors to freely utilize the costly, extensive research and development of the original bio-pharmaceutical innovators.  Eschew believes that lesser periods of exclusivity will have a chilling effect on biologic research and development– as lesser exclusivity would make it more difficult for the original developers of the drugs to recoup the large expenses associated with such development.

Reproductive health care issues have also come to the forefront of the debate, but with a clear consensus yet to have emerged on what the bill does or does not cover within the various exchanges, options and subsidies within the bill.

While political groups are preparing to battle out these issues, one thing remains constant, women are a force that both democrats and republicans want on their side.  The House Democrats were paying attention when drafting their health plan, but the holes still left in women’s health care access might mean that women need to make themselves heard again–and this time, maybe a little louder.

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.

Because She Said So: Michelle Obama Wants Women to Stand Up for Health Care Reform

Last Friday, First Lady Michelle Obama addressed the nation’s women, asking them to mobilize in support for health care reform.  Similar to the sentiments expressed in my post last week, Obama presented health care as a woman’s issue– further stating that health care is most important to what she called the “sandwich generation,” those who have the responsibilities to care for the elderly in their family as well as the children.  Obama calls the current health care system “unacceptable,” and one that needs reform to “ensure women have opportunities that they deserve.”  Included in such opportunities for women, as the First Lady said, is the freedom and ability to care for their families.

Further complicating the situation, many women find themselves earning more than is allowed to be eligible for public insurance yet not enough to purchase private insurance.  Women are also less likely than men to secure employer-based insurance, which can be attributed to the fact that women are more likely to work part-time and have lower incomes.  Employment equality issues ring a bell?  Check out this New York Times web tool, which gives a comparative analysis on how different individuals are affected by health care reform.  It is interesting in that it shows that for women, especially those who are unmarried, the current system leaves them largely to fend for themselves in the individual market; it also shows the potential benefits of a public plan option.  As I detailed last week, the individual market in health insurance, not subject to a host of anti-discriminatory legislation and regulation, poses significant problems to women when it comes to supplying affordable and reliable insurance.

One of the biggest issues Michelle Obama seemed to have with the current system was gender rating; it continues to force women to pay much higher premiums than men in private insurance plans.  The actuarial argument, that women’s health care needs require regular preventive care (which in reality, women and men alike should be getting) is significantly undermined by the research which shows the ultimate cost benefits of preventive care–for both women and men. It seems both ironic and counter-productive that this justification is used to punish with higher premiums those who embark upon the proactive health maintenance which so many agree is both the key to ultimate health care cost control and one of the primary goals of health care reform. Hopefully, Obama’s optimism that such gender rating will be removed through the current reform process will prove true.

With so many challenges aligned against women, it is apparent that, as stated by the Congressional Joint Economic Committee, “The status-quo health insurance system is serving women poorly.” Perhaps this is why the Obama administration, in its drive to convince Americans that the issue of health care can no longer be pushed aside, is turning to women.  A smart choice, whichever way you look at it, since women as a whole are one of the groups most strongly supporting health care reform.

So what can women do to get active in the health care reform movement, as Michelle Obama asks of us?  For now, make sure you stay on top of what the language of health reform bills says about health care for women and families.  The National Women’s Law Center is a great organization to get connected to for updates and summaries of the effects of new legislation on women’s access to health.   Through the National Women’s Law Center, you can also contact your Members of Congress to let them know that you support health care reform that addresses women’s needs.  Spread the word to your mothers, daughters, sisters, and friends; tell them Michelle Obama needs our help.