A new study finds an opt-out strategy reduces health system costs

Interview by Steve Halasey

Routine chlamydia screening for sexually active young women has long been recommended in guidelines issued by both the US Centers for Disease Control and Prevention (CDC) and the US Preventive Services Task Force (USPSTF). Nevertheless, the rate of screening coverage has always been low—even in the face of alarming increases in the prevalence of sexually transmitted infections.1

In a search for alternative methods to increase the rate of screening coverage, CDC researchers recently explored the potential and cost-effectiveness of a “patient-directed, universal, opportunistic opt-out testing strategy” for chlamydia screening.2 While acknowledging that their novel approach would still leave some gaps in coverage, the researchers concluded that the strategy would be cost saving, “improving health outcomes at a lower net cost than current testing.”

To find out more about chlamydia screening from the practitioner’s point of view, CLP recently spoke with Michael D. Randell, MD, FACOG, a board certified obstetrician and gynecologist at Emory St. Joseph’s Hospital, Atlanta.

CLP: Nationwide, compliance with screening recommendations for chlamydia is low—and lowest among young women with the greatest prevalence of infection. Why is that the case?

Michael D. Randell, MD, FACOG, Emory St. Joseph’s Hospital.

Michael D. Randell, MD, FACOG, Emory St. Joseph’s Hospital.

Michael D. Randell, MD: One reason may be that many providers are unaware of the recommendations. Another may be the resistance that some providers feel toward having a discussion with their patients about this topic. They don’t feel comfortable having a discussion about sexual activity with individual patients, so if they don’t bring it up they won’t have to worry about it.

CLP: CDC’s recent report on chlamydia screening notes that even taking a sexual history can be a barrier—particularly when patients’ responses are often incorrect or not true.

Randell: I perform a lot of gynecological surgery, and as part of my regular patient intake I always take a sexual history to find out whether the woman is sexually active, and whether she’s ever had a sexually transmitted infection. But patients deny a lot of things. When it comes to pelvic inflammatory disease (PID), or prior pelvic infections, or an STD, they’ll say they haven’t had one.

But when I use a laparoscope to look inside a woman’s pelvis and abdomen, I can often see the signs of a prior infection. And when I say something like, ‘it looks like you have probably had a pelvic infection, or pelvic inflammatory disease,’ then the story changes, and they confess, ‘well, yeah, when I was young, I was treated for chlamydia.’ Even patients who have had a diagnosis of chlamydia often aren’t honest about revealing that information when they are providing their sexual history.

So you can imagine that when a physician asks such questions of women without a diagnosis, the responses may not be as revealing as one might expect—even though one would hope that they would be more honest in a private setting with their doctor. Relying on history alone may not be enough, and the barriers that we have to getting accurate information may be a major reason that a lot of providers have just stopped asking the questions.

CLP: Why do current screening recommendations focus so heavily on women between 15 and 24 years of age if the infection and its sequelae are also apparent among older women?

Randell: The most important reasons arise from the epidemiology of chlamydia. The purpose of screening is to identify and diagnose infections in specific individuals, so that they can be treated and won’t pass the infection on to somebody else. So that’s the first thing.

The next thing is that we know there’s a higher prevalence of chlamydial infections among young women aged 15 to 24, and we know that a chlamydial infection can have a tremendous and lifelong impact on a woman’s reproductive future. One episode of a chlamydial infection with PID can reduce a woman’s fertility rate by as much as 50%. So, to prevent the sequelae of chlamydial infections, it’s important to get these young women diagnosed and treated.

Nevertheless, it’s true that older women who are sexually active, and especially those with multiple sexual partners, are also at risk for chlamydial infections. So CDC and USPSTF recommendations focus on screening women between the ages of 15 and 24, and then looking at at-risk patients older than age 24.

CLP: The recent CDC publication is based on a cost-effectiveness study, taking into account the percentages of women who have insurance coverage, utilize healthcare each year, and will not opt out. The researchers calculate that their strategy can reduce the overall incidence of chlamydia by more than 55%. Do you think the researchers considered all of the important factors needed to develop their recommendations?

Randell: This is a modeling study that is intended to reflect what will happen in the real world. But there are always challenges when extrapolating modeling data to predict what will happen in the real world, because there are so many potentially relevant variables. For me, the study findings that put all of this into perspective are those that show total costs with no screening versus the equivalent costs for risk-based screening and for opt-out screening.

Although the authors of this study didn’t do a really good job of defining what is meant by ‘total costs,’ common sense will tell you that it’s not just the cost of the test kits required to perform testing. When compared to the zero cost for tests when no screening is performed, both the risk-based and opt-out strategies will result in higher costs because some greater number of tests will be performed. At the end of the day, total costs need to include everything related to a patient having a chlamydial infection, including the costs of testing, the costs of treatment, and the costs of subsequent patient outcomes.

CLP: This kind of study has become increasingly common as a guide for relevant stakeholders. In this case, are the results meant to sway payors, providers, patients—or perhaps all of the above?

Randell: So far as clinicians are concerned, the opt-out strategy described by this study really fits within current recommendations. The current recommendation is to screen all women between the ages of 15 and 24 on an annual basis. And, of course, everyone always has the opportunity to opt out. But offering the opt-out approach is still useful as part of the routine recommendations that a clinician can use when counseling patients.

Individual practitioners think about these issues with a focus on the patient’s health. My concern is to make sure my patients don’t have an STD that they’re going to pass on to someone else, or an infection that’s going to cause infertility. Those are my concerns, and I think about them at whatever cost.

So, at the end of the day, I don’t think studies such as this one affect practitioners so much as they affect payors. This study enables payors to say ‘we stand behind this, and we’re going to support annual chlamydial screening of all patients between the ages of 15 and 24.’ And this study also enables payors to point to the bottom line, which is that there is a cost savings to be found.

Sometimes, when looking at these questions based only on the costs of a test, we fail to take into account the long-term consequences of not testing, or the missed opportunities that testing provides to avoid adverse outcomes, such as the results of a long course of IV antibiotics, or surgical intervention to drain a tubo-ovarian abscess. In this study, the researchers didn’t really go into that level of detail.

But as someone who is in the trenches every day seeing these patients, I think that a study such as this can help to provide the rationale for finding that testing is certainly cost-effective, that it certainly brings about cost savings, and that payors should certainly be paying for it. Payors shouldn’t even question whether this benefit is something they should be offering to their members. Certainly they should be, because there will be cost savings.

CLP: It seems that if there were a groundswell of demand from women—as there has been in the case of annual mammography for breast cancer—there would be a lot more testing for chlamydia being done.

Randell: Oh, absolutely. The primary focus of chlamydia screening efforts should be to detect and treat chlamydia, prevent complications, and test and treat patients’ partners.

CLP: Can healthcare professionals use a study meant mostly for payors also to encourage women to request that they be tested?

Randell: I believe in the empowered patient, and I think it’s important that patients ask their providers to perform tests that will reveal their health status. For young women between the ages of 15 and 24, STD testing should be something that’s done at the woman’s annual visit.

There has been some recent disagreement about whether an annual visit actually provides any benefit to a patient, and whether we should even be offering annual visits. But I would take the position that we certainly should. Some of the tests that are performed during an annual visit may not be required every year. For instance, we used to screen women for cervical cancer every year, but we now know that it is adequate to perform that testing just once every 3 years or, if testing for human papilloma virus (HPV) infection is performed and found to be negative, once every 5 years.

These studies are important, but the average individual cannot understand or interpret them, or what it means for a particular test to be cost-effective. If a patient is required to pay for testing that she can’t afford, it’s too much to expect that she’ll agree to undergo testing on the basis that it could be much more expensive to deal with a condition that hasn’t even been diagnosed yet—never mind treated.

For the average consumer, we’ve got to keep the message simple. We need to talk about what is the standard of care, and what are the recommendations of organizations such as CDC and USPSTF. And we need to encourage patients to get tested—whether that involves STD testing and cervical cancer screening for young women, mammography for middle-aged women, or colonoscopy for older women. These tests have ultimately been shown to save lives. And while we know that chlamydia doesn’t kill people, it can certainly wreak havoc with the reproductive systems of both men and women.

I see this in my practice every day. I see women who are having difficulty conceiving because their fallopian tubes are blocked, and I sometimes have to tell them that their tubes are damaged beyond repair, probably as a result of an infection sometime in their past. Sometimes the patient will admit, ‘yes, I’ve had an infection; I didn’t realize it was going to do this.’ But just as often they are in denial, and even actually shocked when antibody testing demonstrates that they have, in fact, been exposed to chlamydia at some time in their life. Then, perhaps, they will think back and say, ‘there was a time in college when I had severe pelvic pain, and my doctor told me I had endometriosis.’

That raises another serious issue. Women with chlamydial infections who present with pelvic pain are often misdiagnosed as having a urinary tract infection, or irritable bowel syndrome, or endometriosis—just because no one did the appropriate test to diagnose the chlamydial infection and to treat them appropriately for pelvic inflammatory disease.

And it’s also surprising how many women test positive for chlamydial infections who otherwise had no idea that they had an infection. There are a lot of asymptomatic but infected women, and screening is really important for identifying them.

CLP: The CDC study does not go into detail about the type of tests that are being used. From your point of view, are there particular types of tests or particular test protocols that are more useful than others?

Randell: Based on its improved sensitivity and specificity, I like Hologic’s Aptima Combo 2 CT/NG assay—a second-generation nucleic acid amplification test that amplifies target rRNA to detect Chlamydia trachomatis and Neisseria gonorrhoeae—rather than such older methods of chlamydia testing as cell culture, direct fluorescent antibody testing, enzyme immunoassays, or DNA probe assays.

CLP: Is there anything special about the way those tests need to be performed? For instance, is compliance better when a swab is self-collected as opposed to the patient having to visit the doctor?

Randell: Chlamydia testing can be performed by means of a urine-based test, and some practitioners use this method. But, most of us initiate this testing using endocervical specimens or vaginal swab specimens in a ThinPrep collection vial.

Patients come to me for their detection, so I’ve never dealt with a scenario in which a patient is doing self-collection. It’s easy for me to collect the sample in my office, and then the test is just performed from the same ThinPrep collection vial that we’re sending off for the Pap test and the HPV test.

CLP: Do you perform any of these tests in your office?

Randell: No. We don’t perform any type of testing like this in the office. We do the collection, but we don’t do any processing. We send the sample off to one of the national reference laboratories, such as LabCorp or Quest.

CLP: The CDC study also mentions reinfection by an untreated partner as a limiting factor on the effectiveness of treatment. What has been your experience in dealing with that part of the equation?

Randell: I tell my patients that they have a sexually transmitted infection, that they need to be treated, and that their partners should also seek diagnosis and treatment. I also explain to my patients that there’s no benefit to treating only them, because their untreated partner is just going to reinfect them. There is an assumption made that if one partner is positive, the other partner’s going to be positive as well.

As a gynecologist, I don’t treat men. But I encourage the male partner to go to his physician—whether that’s a urologist, a family physician, or the public health department—and to get diagnosed and treated.

CLP: CDC has recently reported that the rates of chlamydia, gonorrhea, and syphilis are all rising. Would an opt-out testing strategy be of use against all such STDs?

Randell: Yes, of course. Adopting the opt-out strategy means that the physician has at least opened the door, and that there’s a conversation happening. The harm arises when physicians don’t open the door, don’t have the conversation with the patient, and don’t do the testing. Conversely, the benefit occurs from having the discussion, and allowing the patient to make the decision.

What I think is a barrier, is one of the first questions that will arise from any patient when they are offered testing: ‘Is it covered by my insurance?’ If the patient knows that there is not going to be an additional cost to them, or that the additional cost will be negligible, most patients want to know their status, and most patients will opt in for testing. But when they believe there’s going to be a significant additional cost to them, they may become concerned and opt out—even though they should be tested. That’s always a challenge.

Costs are obviously important, and today there are more costs being passed on to the individual member of an insurance plan. Sometimes it’s hard to know that when a patient is seen in the office.

For example, we have a new patient who sent an email wanting us to precertify her coverage for BRCA testing. But in order to precertify BRCA testing, we need to have her come in and be seen as a patient, so that we can take her history. This patient is trying to get everything done at no cost to her (and no reimbursable charges for us), but what should happen is for the patient to come into our office and pay the going rate for her initial visit.

During that visit, we would then take the patient’s personal and family history of cancer, identify any red flags, and determine whether she is a patient who should undergo BRCA testing to help her know her chance of getting breast cancer and ovarian cancer. Then we could seek approval and bring her back for testing.

Cost plays a factor, and it’s daunting for us to actually know what’s going to be covered and what’s not going to be covered. Under the Affordable Care Act, most STD testing as part of an annual well-woman examination is a covered benefit provided at no cost to the individual patient. There are some instances where that’s not true, but for the most part that testing is covered. And under those circumstances, patients want it.

CLP: The CDC study treats insurance coverage as one of the factors that can limit the effectiveness of opt-out testing for chlamydia. Could this limitation be reduced if payors and public health authorities agreed to make the test available on request, without any further requirements?

Randell: I’m not familiar with the way that public health clinics work. There may be government funding and subsidies to cover the costs of STD testing. So I assume that coverage for testing would be provided to a patient who met certain income criteria. No doubt, that would be a very motivated patient, a patient who wants to be tested.

But among the general population, there’s a lot of denial. Many people, especially young people, believe that they’re not at risk and that they can’t get an STD. That’s certainly not true, and they’re shocked when they’re diagnosed. The reality of it is that anyone having unprotected sex is at risk for an STD. So anything we can do to make the testing available—providing access to clinics, access to physician offices, supplying test kits, making them affordable, or having testing covered by insurance—would certainly be a step in the right direction.

The CDC study supports the proposition that chlamydia screening should be covered, should be performed, is cost-effective, and can end up costing less by using an opt-out strategy. I’ve worked with companies trying to get tests covered, and I’ve worked with insurance companies. Sometimes those insurance companies can be very myopic, looking only at the additional costs of performing the test. They don’t look downstream to understand the total costs, or the effective costs of not performing the test.

In the case of ovarian cancer screening, for example, there is a blood test called OVA1, by Vermillion Inc, Fremont, Calif, that can help providers know, prior to operating on a patient, whether a pelvic mass may be malignant. Some insurance companies don’t understand why they should pay for such a test. But they’re not looking at the cost of a missed case of ovarian cancer, or the cost of upstaging a case of ovarian cancer during surgery because the surgeon wasn’t prepared and spilled the contents of the mass. There are a lot of considerations such as these that need to be considered as part of a cost-effectiveness model.

There are probably some health economists at payor organizations who do not view modeling studies in this light. Instead, they see only the absolute cost of the test, without projecting across their members’ lives. So any information we have that supports the cost-effectiveness of testing is helpful.

The take home message for physicians, those in the trenches seeing patients, is that we should be performing universal screening for chlamydia and we should apply the opt-out approach for patients between the ages of 15 and 24.

CLP: Many STIs are now found in antibiotic-resistant strains that are causing serious international concern. Can use of the opt-out strategy help to forestall further spread of such resistant strains?

Randell: I don’t know if we can do anything about those strains that are mutating, or those that are already resistant to current antibiotics. There’s always the risk of prescribing antibiotics for patients who don’t actually have a clinical infection. But for patients who have been diagnosed with a chlamydial infection, clinicians need to use what they have available, starting with the most common antibiotics in the hope that they will kill off the majority of those organisms.

Adherence with multiday dosing is always a concern, so my first line of therapy for such patients is a one-time oral dose of 1 g of azithromycin. Physicians should choose a treatment that is clinically effective, cost-effective, well tolerated, and doesn’t involve a complicated regimen. The 1 g azithromycin dose seems to fit this bill and is highly effective with these patients.

CLP: That’s an argument that the lay public can understand pretty readily.

Randell: The efficacy of any medication is directly related to the patient’s ability to tolerate its side effects and the complexity of the dosing regimen. For example, a medication that causes gastrointestinal upset, and has to be taken two times a day for 7 days, may not result in the same efficacy as a medication that is highly effective when taken just once.

But finding the patients who need treatment is what is really important. And even though the CDC, USPSTF, and American College of Obstetrics and Gynecology guidelines and recommendations for screening have been widely publicized, a lot of providers aren’t necessarily familiar with them and don’t adopt them within their practice. But if we’re not looking for infected patients, we’re not going to find them. That’s why it’s important to do the right workup for these patients, and the opt-out strategy definitely supports that goal.

The opt-out terminology is new for this issue, and it will need to be implemented with some care.  Just a single line in a consent form that says, ‘there may be a charge for testing,’ is all that a patient would need to opt out. But if the consent form said, ‘this testing is included in the cost of your care today, do you want it?’ the truth is that most would say ‘yes.’ Most people want to know.

CLP: Do you think that the findings of this CDC study will be convincing to payors, as intended?

Randell: I think so. But I believe most payors are already paying for STD testing. It’s a covered benefit under their plans. I don’t know if the argument that it should be covered needs further strengthening.

CLP: What about instances where the testing is covered, but those who should be tested still aren’t utilizing that benefit?

Randell: This study isn’t going to change whether people have insurance coverage, nor will it change whether people utilize their healthcare benefits. But as a modeling study, it confirms much of what we have already known, and demonstrates that routine screening for chlamydia with an opt-out testing strategy would be cost-effective and result in cost savings.

CLP: Beyond publishing the results of this CDC study, what message needs to be conveyed to build interest in chlamydia testing among women who should be tested, as well as others who might influence them to do so?

Randell: We need to emphasize that women should be tested for STDs. Even though a woman may not think she is at risk, if she is having sex, she is at risk. By not getting tested and allowing a chlamydial infection to go untreated, a woman is at further risk for developing pelvic inflammatory disease, which can be catastrophic to reproductive health. That’s the bottom line. And that’s the message.

To providers, the message is that it’s important that they screen their patients. By screening their patients, they can detect infections that would otherwise lead to catastrophic outcomes for the patients’ reproductive health.

To payors, the message is simply that they should be paying for chlamydia screening, because if they don’t pay for screening, they’re going to be paying more later. It’s going to cost more to treat the sequelae of an infection.

The messages from this study really are for the individual, the provider, and the insurer. The study crosses all of those stakeholders.

Steve Halasey is chief editor of CLP.


  1. Sexually Transmitted Disease Surveillance, 2015. Atlanta: Division of STD Prevention, Centers for Disease Control and Prevention, 2016. Available at: www.cdc.gov/std/stats15/std-surveillance-2015-print.pdf. Accessed October 27, 2016.
  1. Owusu-Edusei K Jr, Hoover KW, Gift TL. Cost-effectiveness of opt-out chlamydia testing for high-risk young women in the US. Am J Prev Med. 2016;51(2):216–224; doi: 10.1016/j.amepre.2016.01.007.