California is about to embark on a bold experiment to lower the C-section rate. People may get hurt.

Doctor holding new born

California is about to experiment on its mothers and babies.

Ordinarily we would look with horror on a state’s desire to experiment on its own people. Yet when the purported justification is preventive care, we suspend our distaste under the theory that preventive care is always a good thing; as a result people get hurt or even die. Sadly, we have not yet learned our lesson from other preventive care debacles like those with hormone replacement therapy (HRT) and the PSA test.

According to NPR:

Its proponents are sure that it will lead to improved outcomes and money saved; the proponents of routine HRT, routine PSA testing, and the 39 week rule were also sure. They were wrong.

Many women who don’t need a C-section often get one anyway, according to the data — and it varies from hospital to hospital. Even for low-risk cases, Lang says, several California hospitals are delivering 40 percent of babies by C-section. At one hospital, it’s 78 percent…

… Performing it when it’s not needed exposes a woman to unnecessary risks: infection, hemorrhage, even death.

Studies also have found that babies delivered by C-section are more likely to have complications and spend more time in the neonatal intensive care unit.

That’s not quality health care, Lang says, and that’s why Covered California is telling hospitals they need to reduce their C-section rates to 23.9 percent or lower, for low-risk births.

What will happen if they don’t?

Starting in less than two years, if the hospitals haven’t met certain designated targets for safety and quality, they’ll risk being excluded from the “in-network” designation of health plans sold on the state’s insurance exchange…

… Covered California is telling hospitals that if don’t play by the rules, they’ll be benched

Surely a massive experiment like this is based on solid data that definitively shows two things: that lower C-section rates cause better outcomes and that blunt efforts to lower C-section rates don’t lead to increased deaths and injuries. Nope. It’s based entirely on studies that show a correlation of lower C-section rates with acceptable outcomes in some settings. To my knowledge, there are no large scale studies of what happens when insurers pressure hospitals to lower C-section rates.

We’ve been here before — many times.

When I finished my residency 30 years ago, it was standard of care to prescribe hormone replacement therapy for all post-menopausal women. Many physicians were well aware at the time that the data showed only a correlation between HRT and lower mortality from heart disease. We were equally aware that there was no data to tell us what the side effects of years of HRT might be.

No matter. We were told that HRT would lead to better fewer cardiac deaths and would surely save money. Sadly, the exact opposite happened. HRT did not cause fewer cardiac deaths (no money saved there) and actually increased the rate of breast cancer (a very expensive side effect).

A similar debacle occured with PSA (prostate specific antigen) testing. Since increased PSA is associated with prostate cancer, doctors began recommending routine PSA screening, despite the fact that there were no large scale, long term studies demonstrating benefit. It was preventive medicine; so surely it would cause better outcomes and save money. Wrong again.

According to the National Cancer Institute:

Until about 2008, some doctors and professional organizations encouraged yearly PSA screening for men beginning at age 50. Some organizations recommended that men who are at higher risk of prostate cancer, including African American men and men whose father or brother had prostate cancer, begin screening at age 40 or 45. However, as more was learned about both the benefits and harms of prostate cancer screening, a number of organizations began to caution against routine population screening…

It turned out that many prostate cancers did not grow fast enough to threaten a man’s life. Removing such cancers led to the dreaded side effects treatment: incontinence and erectile dysfunction without saving any lives. It didn’t save money, either.

In order to lower the induction rate we are currently engaged in an experiment on mothers and babies. The 39 weeks rule (no elective inductions before 39 weeks) has been enforced for several years. It was promised that it would lead to a lower neonatal mortality from late prematurity, though many obstetricians suspected that it would actually lead to higher stillbirth rates. The preliminary data was not encouraging.

Changes in the patterns and rates of term stillbirth in the USA following the adoption of the 39-week rule: a cause for concern? was presented at the 2016 annual meeting of the Society for Maternal-Fetal Medicine.

Between 2007 and 2013 in the USA, the implementation of the 39-week rule achieved its primary goal of reducing the proportion of term births occurring before the 39th week of gestation. During the same period the rate of USA term stillbirth increased significantly. Assuming 3.5 million term USA births per year, more than 300 more term stillbirths occurred in the USA in 2013 as compared to 2007…

A new, large study, Association of Temporal Changes in Gestational Age With Perinatal Mortality in the United States, 2007-2015, shows that the 39 week rule has changed the distribution of gestation age at birth — reducing births at 37-38 weeks and increasing births at 39 weeks — but has NOT had the promised impact on death rates.

I graphed the change in gestational age distribution:

373C458A-CECA-46E2-84A3-7B43D84A1DA5

What happened to infant deaths?

The overall perinatal mortality rate decreased from 9.0 per 1000 births in 2007 to 8.6 per 1000 births in 2015 (P < .001).

Perinatal mortality decreased at gestational ages of 20 to 27 and 39 to 40 weeks but showed annual adjusted relative increases of 1.0% (95% CI, 0.6%-1.4%) at 34 to 36 weeks, 2.3% (95% CI, 1.9%-2.8%) at 37 to 38 weeks, and 4.2% (95% CI, 1.5%-7.0%) at 42 to 44 weeks.

Stillbirth rates increased at gestational ages of 20 to 27, 28 to 31, 32 to 33, 34 to 36, 37 to 38, and 42 to 44 weeks and remained unchanged at 41 weeks. Neonatal mortality rates decreased at gestational ages of 20 to 27 and 28 to 31 weeks; increased at 34 to 36, 37 to 38, and 42 to 44 weeks; and remained unchanged at 41 weeks.

That’s almost exactly the opposite of what was predicted. Neonatal mortality at 34-36 weeks and 37-38 weeks did NOT drop; it actually INCREASED. Moreover, stillbirths INCREASED, too.

Why did the overall perinatal mortality rate drop? NOT because of the 39 week rule, but because of improvements in the care of extremely premature infants (21-27 weeks).

What went wrong? Once again correlation was confused for causation and a measure designed to save lives at 34-38 weeks actually led to increased deaths.

And now we’re about to embark on a similar experiment to lower C-section rates.

So far, the prospect of exclusion, plus the coaching for hospitals on how to reduce the rates, have functioned as an effective motivator.

By 2020, Covered California’s Lang believes all hospitals will either have met the target or be on their way.

“It’s a quality improvement project,” Lang says, “but with a deadline.”

Its proponents are sure that it will lead to improved outcomes and money saved … exactly the proponents of routine HRT, routine PSA testing, and implementation of the 39 week rules were sure that those were quality improvements. They were wrong.

California is embarking on a massive experiment on mothers and babies. Let’s hope they don’t inadvertently injure and kill them as a result.

  • Haelmoon

    I would like to be optimistic here, and find that the opponents of C-section will learn something about C-section rates when they do this. I work in a centre that has a 34% C-section rate. There are vocal members in our community who bemoan the rate, saying it is too high. However, when you breakdown our sections by risk factors, we would actually meet these cut-offs.
    If you are a low risk nullip (normal BMI, spontaneous labour, no GDM or HTN) and you present in spontaneous labour, your risk of a C-section is about 19% or 1 in 5. If you need an induction, the risk is 40%, but this includes all of our women with risk factors now (high BMI, macrosomia, GDM, HTN, postdates – higher C-section risk, term PROM and no spontaneous onset of labour).
    If you are a multip with a previous vaginal delivery, the C-section rate is 5%, and that includes all comers, including women with longer intervals between pregnancies.
    Our VBAC success sites around 75% percent, but repeat C-section are more popular (~70%) because we support patient choice. I am strongly opposed to plans to promote a minimal 50% TOLAC rate in my province.
    We are a teriary site, and we take on higher risk cases – TOLA2C, vaginal breech, higher order multiples, etc.
    I do not have to defend out 34% C-section rate, because I believe that the these cases are being managed appropriately. I chair the quality committee and we only ever have to recommend that a C-section was done sooner, not that we should not have done a C-section. The truly low risk women are at a lower risk of a C-section. The problem is that there are many more not low risk women, but the politicians don’t get that. Also, although my province has the highest C-section rate, other than PEI (which is really small), we have the lowest perinatal mortality in the country. You can’t tell me we are harming babies with our current practice. Hopefully, they will find that the C-section rate for low risk women is actually not what they thought it was, and that the risk is actually in higher risk pregnancies. I am however, an eternal optimist.

  • CanDoc

    This is terrifying. There are so many problems.
    And if in the interest of lowering the CS rate to some completely arbitrary number, a woman has a complicated vaginal delivery and sues, the care provider will never be able to use as a legitimate defence, “the state told me to minimize my cesarean section rate” because that sort of thinking carries zero weight in a court of law. So California gets to promote an airy-fairy agenda, and California moms, and obstetricians, and ultimately babies get to pay for it.

  • FormerPhysicist

    I hope some hospitals and insurance companies keep good records. Because I suspect that trying to clamp down on c-sections will increase costs if we follow patients for a year or two and honestly account for follow-up costs. Heck, one or two extra NICU admissions would do it.
    It’s also just plain horrifying.

  • Anna

    I want to know how they know that so many c-sections are not necessary. Wheres the evidence? Does it exist? Surely such an experiment has to be based on strong evidence that Drs know BEFOREHAND that c-sections are not warranted but are doing them anyway? I just dont believe it. And the c-section rates are based on all risk right, not only low risk?

    • Sue

      These judgements need to be made prospectively, using the information available at the time – not retrospectively.

      Anyone auditing the decision making needs to ask themselves not “what would I have done in that situation?”, but “what HAVE I done in that situation?”. If the person making the judgement has never faced that set of circumstances, they should be very cautious about passing judgement.

      The audit also needs to ask “what could have happened if a cesarean had NOT been done?”

    • The Bofa on the Sofa

      Exactly. I mean, consider breech birth. If the complication rate of vaginal breech birth is 10%, then you can say that 90% of the c-sections for breech births are unnecessary. That’s true, in fact.

      However, the problem is knowing which of those breech c-sections are the unnecessary ones.

      You know, gambling in Vegas is real easy. Just bet on the times when the roulette wheel comes up on your number, and don’t bet the other spins. 95% of the spins on the roulette wheel are losers. So you just bet on the ones that in, and you get rich!

  • Amazed

    OT: Здравейте, аз съм вашият местен руски бот. Целта на присъствието ми в този симпатичен сайт е да разпространявам пропагандата на Путин и да спомогна за побеждаването на злата Америка – страната на злия западен капитализъм.

    Did everyone understand me?

    No? What do you mean, no? You mean evil Dr Amy won’t even ban me from this site? She should take a leaf out of Twitter’s book! I’ve got all of you fooled!

    Seriously, I’ve got a rising number of friends having their accounts suspended and messages filtered or deleted for the grievous offence of tweeting in the Russian alphabet. Because you know, the best way to spread Russian influence like a good little Russian bot is to tweet in a language the West doesn’t understand.

    And the Russian alphabet thing is such a sorry joke, especially on this day. In Bulgaria, we use the CYRILLIC script. Not the same thing. And the Cyrillic was invented and spread by old Bulgarians. We gave it to Russians, not the other way round. (I love to have foreigners ask me when we’re going to get rid of the Russian alphabet and adopt a Latin one. Never. Not going to happen.) And today, it is the official Day of Bulgarian Enlightment and Culture and Slavoni Script (I think this is the last politically correct name of this public holiday.) Or, as I explained to Amazing Niece, it’s the Holiday of Letters! It’s the brightest Bulgarian holiday and the one I love most. So fuck Twitter, I’m going out in the street to celebrate.

    And I don’t even have a Twitter account. Ain’t I smart?

    • Empress of the Iguana People

      I put that in google translate and now I’m actually laughing out loud.

      Честит ден на азбуката, руски бот!

      • Amazed

        Thank you! This is absolutely my favourite holiday – more than our national holiday (which is a hotly disputed day), more than days with undoubted historical meaning and well… more than any other day and holiday. I remember how strange it was when I started learning English and realized that our N (written H, pronounced n) was X in English! Our P is actually R for you and don’t get me started about the И that is turned around to make your N. Our Я looks like… well, you can see. Even small children here love the Holiday of Letters. In the celebrations, they get to BE letters and they adore it.

  • Megan

    This kind of rule puts hospitals between the proverbial rock and hard place of maintaining in network status and multimillion dollar lawsuits. The hospitals that will suffer most are those that are smaller and can’t afford these risks/costs and thus will reduce access to care. Disgusting.

    • EmbraceYourInnerCrone

      There is also the fact that depending on your patient population and what type of geographic lcation and type hospital you are is going to drastically change your percentage of C-sections. The small local hospitals are not going to have an OB in-house 24/7, they may not have an anesthesiologist in house 24/7. They will probably send any higher rick OB patients to the nearest large hospital that has the staff and a NICU available. The hospitals that have more patients with poor health and less access to preventative health care are going to have a higher rate of C-sections (if your OB patients show up with no prenatal care, no prenatal testing to screen for problems, diabetes, high bloodpressure, heart disease, you are going to have more babies in trouble during birth, it’s not rocket surgery)

  • MaineJen

    Hoo yeah. Get ready for the lawsuits, too. Maybe at the end of all of this, they’ll “discover” that a 35% c section rate doesn’t sound so bad, if it means fewer cases of hypoxia and brain damage.

    • LaMont

      I *really* hope that all this does is end up re-classifying more women as high-risk from the outset so their c-sections won’t count as strikes against this. Thank f*ck I’ll probably be super old by the time I’m having kids.

      • Reyna Elizondo

        That is exactly what most doctors would try to do. You dont risk the life of your patient because of silly policy

  • Anj Fabian

    I want to know how they are going to determine who is “low risk” when they collect data.

    The concept of “low risk” and “high risk” can vary greatly depending on what the motivations are.

    • lawyer jane

      Unless I’m missing something, I think the way they identify it is “Nulliparous, Term Singleton, Vertex.” See page 22 here. http://hbex.coveredca.com/stakeholders/plan-management/PDFs/2017_QHP_Issuer_Contract_Attachment_7_3-4-2016_CLEAN.pdf

      which cross references this: https://www.healthypeople.gov/node/4900/data_details

      It looks like there’s nothing at all in there about the actual health of the mother or the baby!

      • Roadstergal

        Wait, so obesity, diabetes, AMA, etc don’t count?

        • lawyer jane

          I sure hope they have some metric that allows “nulliparous, term, singleton, vertex” a little more nuance. As it stands, it sure doesn’t appear to consider anything about the actual health of the mother or fetus. It just assumes that all hospital populations will only have a 24.9% rate of “necessary” c-sections.

        • CanDoc

          Nope, not by medical coding current criteria. >:(

      • rh1985

        That’s…. pretty bad criteria.
        I would have met that “low risk” criteria.
        I had freaking preeclampsia with dangerously high blood pressure. I was a terrible induction candidate. My OB felt my baby needed to come out NOW before something bad happened.
        But I was 39 weeks, nulliparous, with a vertex singleton. So I guess only that would matter???
        WTF?????

      • CanDoc

        Yes: Those are the criteria that our local health authority uses also. So we looked bad with our CS rate of 27% compared to the hospital down the highway at 22%. Then we said, okay, how many of those women are first time moms? Over 40 years old? Obese? Diabetic?… Once stratifying for that, we were the same across patient characteristics. Grr.

  • Madtowngirl

    “Studies also have found that babies delivered by C-section are more likely to have complications and spend more time in the neonatal intensive care unit.” No shit, NPR. Babies who need to be delivered by C-section are often in distress, breech, or otherwise in danger. Of course they are more likely to need a NICU – but better a NICU than a morgue! FFS NPR, I used to think of you as an intelligent news source.

    I am so glad I don’t live in California, because the risks of me having a successful VBAC are high enough that I’m not comfortable attempting one.

  • lawyer jane

    This article focuses on public reporting of hospital data and the perverse incentives it can create, but it applies equally (if not more) to creating bright-line outcome-based rules to remain in-network with insurers. https://psnet.ahrq.gov/webmm/case/137/getting-a-good-report-card-unintended-consequences-of-the-public-reporting-of-hospital-quality

  • lawyer jane

    The other two items that Covered California is targeting are TOTALLY DIFFERENT from c-sections: prescribing fewer opioids, and cutting back on certain imaging to diagnose back pain. Those goals can be accomplished in a non-emergent setting, with plenty of time to devise alternate approaches, and most importantly DO NOT IMPACT THE LIFE OF THE PATIENT. And of course this also means that there will be heavy pressure not to allow maternal request c-sections.

    I also find the fact that the low-income-serving hospitals will be most impacted to be very troubling. Those hospitals have high c-section rates, and according to the article, this is in part of reflection of the population (who may arrive with drug addictions, no prenatal care, worse health). These are the hospitals that would be hurt the most by being shut out of the insurance network, and the hospitals that have to make the most drastic reduction … on patients with higher risks, who are less able to advocate for themselves.

    • Roadstergal

      Well… the ‘fewer opioids’ thing has the potential to impact the lives of patients. People in acute pain need pain relief, full stop, and those people will probably be impacted by a policy that shouldn’t apply to them. 🙁 People in chronic pain need _something_, and if they’re not getting PT and/or other ways to address the issue at hand as the other side of the ‘fewer opioids’ coin, they’ll just be suffering.

      And people who buy the designer opioids shipped right to their door from China don’t care what Covered California does.

      • kfunk937

        Agreed.Anecdote about anti-opioid hysteria alert:My dad saw a pain management specialist, in whose care he’d been continuously for several years with lumbar stenosis, DDD, etc., while having been dx’d with advanced prostate cancer previously, so it was part of his intake history. He was an affable patient, willing to entertain the doctor’s suggestions for various interventions and strictly compliant with PT and medications. When he presented to his PM doc with pain he described as the worst he’d ever experienced in his life and asked to have his minimal opioid dose increased, the doctor refused, citing concerns for abuse and addiction. (My dad was in his late 70s and, ya know, had cancer.) When he developed malignant hypertension (SBP>300), his nephrologist referred him back to PM, where he was told to continue to go the ED, where IV opioids were administered. After several rounds of this, I managed to obtain a routine CXR and report taken during an earlier admission from the ED, which clearly showed advanced metastatic bone disease, with several thoracic vertebral wedge, rib and scapular fractures. The report indicated no previous radiograph for comparison (inaccurately), but did identify these lesions. I wonder if anyone had read the report, including his other doctors.The pain management specialist never bothered to investigate new pathology when presented with a complaint of acute-on-chronic severe pain with a known cancer history.Because hysteria.I got him into his oncologist’s the next day (he’d been on antiandrogens with good results, dropping his PSA from the 30s to ~3, so scheduled visits had spread out to quarterly) with a note for the doctor, who transferred him by ambulance for immediate admission to the cancer hospital. It took a bit longer, and a change in practitioner, with some trial and error to arrive at something that worked for him, but it was possible. And there was absolutely no justification for his extended and unnecessary suffering.FWIW, the PM doc was trained in a quackademic medical centre and was woo-friendly, which also didn’t help.

        • Roadstergal

          Ugh, that is just horrific. 🙁 I’m glad your dad had you to successfully advocate for him, but this has to be happening far too often.

          • kfunk937

            Thanks. I agree, patients are being harmed by this swing of the pendulum, compounded with other stuff. Good intentions pave some piss-poor outcomes.

        • FallsAngel

          Wow! I’m sorry for all your dad went through.

          • kfunk937

            Thanks, me too. He had a good life though, overall.

  • kilda

    it just seems so screamingly obvious that of course babies born by C section have a higher rate of complications and more NICU stays. Because in most cases, something was going wrong which necessitated a C section. How can they not see that they are selecting a nonrandom group of babies who are more likely to have complications??

    • lawyer jane

      Because it’s much easier in public health to take action on the thing you can see and have been convinced is black & white — in this case, reducing C-sections below 25%. Actually figuring out which babies need c-sections and which don’t … much harder to do anything about.

  • lawyer jane

    This is crazy. Does Covered California apply bright-line cutoffs to any other kind of medical procedure/surgery that happens in an emergent setting? It’s absolutely going to happen that riskier decisions are made on a subset of births happening near the cutoff. Medical decisionmaking for those cases (when the hospital is nearing 24.9 and the reporting date) is absolutely going to be unduly influenced by this. I am VERY glad not to be giving birth in California right now. SMH. SM DAMN HEAD!

  • LaMont

    This is straight-up horrifying. I may be moving to California, but if I meet someone out there, I’m explaining to him that I’m getting out of there before having kids. This is malpractice.