Over here at No Rules Strategic Consulting*, we've taken on the task of designing alternative in vitro fertilization (IVF) program models. Our first model: a program dedicated exclusively to the prevention of genetic disease.
Why make this a new type of IVF business? A few good reasons: 1) the current IVF industry does very little IVF for disease prevention, having been built for and filled with infertility patients, a worthy and important, but distinct population. 2) Disease prevention patients are a different type of IVF patient: most of them are not infertile. 3) With IVF for disease prevention, we proactively affect the long-term future of an extended family, rather than that of a single nuclear family. 4) The journey from diagnosis to fertility management is separate and parallel from that of patients with infertility. 5) The infertility population is huge: 7-8 million in the United States. The genetic disease population, if limited strictly to precisely defined gene-to-disease risk (monogenic disease) is smaller: the approximately 30,000 affected babies born per year, implying between 60,000 and 120,000 pregnancies created at risk per year.
To start the No Rules process we identify underlying assumptions that industry incumbents define as givens, constraints or fundamental parameters, then consider what would happen if we altered those assumptions.
For disease prevention IVF, lets play around with two assumptions: 1) that reproductive endocrinologists (RE's) own and operate the programs and 2) that the billing/payment/risk management aspect is between the patient and the clinic, sometimes with an insurance company in the middle and sometimes working within state mandate laws.
For step one, lets transfer operation and ownership from the physicians as operating equity holders to embryologists as operating equity holders, leaving strategic and/or private equity partners unchanged (I recognize that a combination of physician and embryologist ownership is a more likely change, but lets keep it simple.)
This move makes sense because 1) the smaller patient population has not yet and may never attract the full-time attention of reproductive endocrinologists, but is large enough to support a smaller number of specialized centers with very large catchment areas 2) patient identifaction and the gate-keeping process for disease prevention patients is different than the all-in-the-obgyn family referral process for infertility 3) technology and automation may facilitate egg retrieval and vitrification outside of IVF labs, possibly being performed by other specialists, leaving the embryologist-intensive lab work the primary focus, independent of the more RE-intensive workup done for infertility. Since most of these patients are not infertile, they may do very well under the care of physicians with a broader expertise, particularly if the patient needing IVF has the disease that she is trying to prevent in her children. Think, for example, of a sickle cell anemia IVF clinic run under the guidance of hematologists.
So while RE's are the best (maybe not only, but certainly the ideal) doctors to tease out the endocrine and anatomic nuances that result in infertility patients' inability to conceive, their success in that population could be complemented by physicians outside the specialty covering the smaller population of disease prevention patients, while concentrating scarce resources like genetic counselling where they are most needed. The concentration of a specific group of patients, proactively managing their family building for reasons apart from subfertility, also provides an opportunity for creative financing options, which we will address later.
Can hematologists or pediatricians or primary care doctors perform IVF? I would certainly not recommend it for infertility patients. But for fertile couples, maybe. Non-RE's, with the help of data-derived stimulation algorithms and short training in oocyte retrieval (I would trust physicians who routinely place subclavian central venous access lines with simpler, ultrasound-guided egg retrievals) should do just fine. Would an RE be better? Of course, but for now the RE-or-nothing choice leaves the disease prevention patients largely untreated.
Moving the epicenter for IVF activity from the RE's to an embryologist-centric (supplemented by an alternative group of non-RE physicians) model is admittedly a provocative suggestion. But that's what No Rules Strategic Consulting does.
Lets toggle the switches on our second assumption: that the transaction underlying IVF treatment is a patient to clinic transaction on a per cycle (or, in risk management programs,a multiple cycle) process.
Disease prevention is a more complex public and population health dynamic than single family infertility. Diseases that are not prevented result in pain and suffering and healthcare costs in the future; further, the discovery of one patient who needs genetic disease prevention leads to other members of the extended family who should be screened, counselled and offerred treatment as well. This creates an aggregate family need, a large group of IVF "frequent flyers" that, viewed through the lens of sales and marketing, could be met, profitably, from creative risk management and pricing strategies.
One possibility is a subscription, gym-membership type of model, where a family at risk for a genetic dominant disease, for example, could subscribe to an embryology clinic that would accept the cryopreserved eggs from different sites retrieved proactively from all of the sisters and cousins at risk in their reproductive lifetimes in an extended family.
These transactions need not be limited to families. Well-organized rare disease patient advocacy organizations are large virtual families who share a genetic disease risk, and they could then negotiate management contracts that rationally allocate risk between the virtual family and the clinic, and find an efficient pricing model that meets the needs of both over time.
Again, a provocative idea, but one that requires no government intervention, can operate within any state mandate, and can work in concert with -- or independent from -- traditional insurance; in other words, a free market approach that matches a proven and cost effective solution to an unmet need.
Just a thought.
*Pro bono thought experiments only
