Healthcare Mess

The US healthcare system is under considerable strain. My view from the trenches is that the system is undergoing a sort of slow-motion collapse. Costs, including out-of-pocket costs to beneficiaries, are rising despite centralized mandated systems that were supposed to control them (e.g., the Affordable Care Act, which, as most things federal, has the opposite effect of its name). Insurers are acting as draconian gatekeepers, such that serious medical care is denied to beneficiaries. News articles extol the fact that premiums have not risen dramatically as predicted by Democrats in their effort to extend subsidies, but fail to point out that deductibles, copays and costs to beneficiaries have risen dramatically, to the point that patients with good control of chronic health problems, like diabetes for example, are no longer able to afford the medications necessary to control their disease, risking serious complications. Health insurance is becoming a vehicle for denying rather than covering care.

My area of medicine is hit hard, perhaps harder than any other specialty. I am an endocrinologist and primarily see patients with diabetes, most with type 2 diabetes, the disorder for which GLP-1 analogs like Ozempic and Mounjaro are the most effective medications. Despite the backlash against these medications, they are now the mainstay of treatment for most patients with type 2 diabetes. Many patients cannot tolerate them. There are potential risks that are not well established, such as non-ischemic optic arterial obstruction. This is a disorder for which diabetes is a risk factor, and it is not yet clear if the reported increased risk of this disorder — which can result in sudden vision loss that is usually permanent in patients taking these agents — is real and related to these agents. Some patients are now declining to use the medications based on fear of this potential complication. If it is a real complication, it is, as far as is known now, rare. Others fear loss of muscle mass, which is unavoidable with weight loss that occurs regardless of the manner of weight loss (by diet and exercise or with medications), and is not specific to the medications. Such fears, as of "Ozempic face," are misconstrued, as the same phenomenon would occur if the weight loss were achieved by diet and exercise. The medications do not induce disproportionate loss of muscle mass.

The problem is that patients who are not obese, or even overweight, use them for weight loss that is often not necessary or even harmful. The patient with a BMI of 25 who wants a BMI of 19, without other medical conditions, has no need for the medications. The patient who has a BMI of 40 with sleep apnea, PCOS, or steatohepatitis, and pre diabetes, all conditions that have serious health consequences, and for which standard of care includes use of these medications, has a definite indication for use of the medications. Unfortunately, such a patient will often be denied coverage by their insurance carrier if they do not also have type 2 diabetes uncontrolled with other medications.

Of note is that pre diabetes can be halted, or reversed, and diabetes prevented in 95% of patients with this disorder, with the use of GLP-1 analogs. Currently it is estimated that 40% of adult Americans have pre diabetes. This is an epidemic in process. The efficacy of diet and exercise in preventing progression to overt type 2 diabetes is about 60%. The prevalence of pre diabetes is related to the progressive increase in the percentage of the population that is overweight or obese (Overweight, BMI 25-30; Obese, BMI 30 or above, by current definitions). That percent is now at almost 75% among adult Americans.

I mostly see patients with ACA coverage, that is, "marketplace" insurance. In Georgia this is Ambetter or Oscar. The State of Georgia has most recently taken over these ACA products (an option that the state initially declined, permitting the federal government to run the exchange). Most endocrinologists in my area won't take these insurance products, as the hassles of dealing with them are immense. Virtually everything that I prescribe for my patients with diabetes is initially denied by these insurance companies, and I have to spent a lot of time appealing denials, requesting so-called peer to peer discussions ("so-called," because these are supposed to be discussions with other endocrinologists who supposedly understand the specialty and can legitimately discuss the need for the medications, but rather are discussions with a pharmacist, or even a technician, who simply follows a checklist and has no idea of the medical issues of concern.) The supposed efficiency of the process is nonexistent. It is cumbersome, frustrating, and rigged, and the companies are intransigent to the point of criminality. They refuse to accept legitimate medical history information or the FDA-approved indications for the meds.

For example, Wegovy (the weight loss version of Ozempic) is FDA-approved for the treatment of steatohepatitis (liver inflammation induced by excess fat accumulation in the liver). The insurance companies will not cover Wegovy for this indication, labelling it a weight loss medication that is excluded from coverage. Or the insurer will insist on a 6-month trial of diet and exercise, disregarding the medical notes indicating that the patient has been following a diet program for a decade, or has had orthopedic surgery or a neurological problem that precludes exercise. Or insurers will insist that a treating gastroenterologist prescribe the medication. As it turns out, GI docs are unfamiliar with the management of patients on GLP-1 analogs and don't like to prescribe them. Endocrinologists like myself who have extensive experience with the medication are barred from prescribing it. Unfortunately, steatohepatitis progresses to cirrhosis, liver failure, high risk for hepatocellular cancer, and (if the patient is fortunate) liver transplant, or (if the patient is not fortunate) death. Still, the insurance company forbids this treatment. There are other treatments available (Actos, or Pioglitazone, an analog of Rezulin that was taken off the market in 2000 because it supposedly caused liver failure, when it was actually preventing liver failure; and Rezdiffra, an inactive analog of liothyronine-or T3 that has a beneficial effect on liver fibrosis in steatohepatitis) but the GLP-1 analogs appear to be the most effective, with effects that are at least additive to the other treaments. Thus combined treatment is rational. But forbidden. This area of medicine has become Orwellian: Everything that is not permitted is forbidden.

Similarly, Zepbound (the weight loss iteration of Mounjaro) has an FDA indication for the treatment of obstructive sleep apnea. Insurers will deny this as a weight loss treatment (the way Zepbound helps obstructive sleep apnea is by assisting weight loss; obesity is directly related to the incidence and severity of sleep apnea). Or they will demand that the patient try and fail NCPAP, which is beyond absurd. Simultaneous treatment, with improvement in sleep apnea from weight loss, is the standard of care. Or that patients have a 6-month trial of diet and exercise, before allowing Zepbound treatment. And, as with Wegovy and steatohepatitis, insurers will insist that pulmonologists or sleep medicine doctors managing sleep apnea prescribe the medications, which they mostly decline to do, and bar endocrinologists from doing so. Simultaneous treatment (NCPAP, Zepbound, diet, exercise, all of the above) is standard. Government insurance products are blocking standard of care treatment of serious medical disorders.

A third specific disorder for which GLP-1 analogs are effective treatments is Polycystic Ovary Syndrome (PCOS). The basis of this disorder is insulin resistance, which is directly addressed by GLP-1 analogs. PCOS has associated problems of obesity, lipid disorders, hypertension, cardiovascular disease, and other associated complications of obesity. An integral part of that disorder is impaired fertility, which has frustrated many would-be mothers. The pharmaceutical companies have not sought FDA approval for this indication, but it is a clearly beneficial treatment, except in the circumstance of attempted pregnancy. There is no experience with the medications during pregnancy. Current practice is to stop the GLP-1 analog at least 2 months before attempting pregnancy, which is sufficient time for the drug to be completely out of the system.

The population cohort most affected by obesity and steatohepatitis is Black women. Next are Black men and Hispanics. So with the virtual ban on use of these meds for obesity, steatohepatitis, sleep apnea, and PCOS, the hardest hit are, as they say, women and minorities, and minority women in particular. I am hardly a fan of the concept of disparate impact, but it is a problem here.

The reason insurers can deny these treatments is the Medicare (CMS) policy. Private insurers are allowed to follow Medicare policies in their coverage. Medicare bans medical treatment of obesity. Medicare refuses to categorize obesity as a disease state. It is the most prevalent disease state in the nation, yet the federal government will not recognize it as a disease. Complications of obesity include the above disorders: dementia, cancer of various types, cardiovascular disease, and arthritic disease. There are ICD-10 codes for the medical disorder of obesity. There are institutes established to study and treat obesity. There are sections and departments of obesity in medical schools. The denial of obesity as a chronic disease is an affront to the nation and an intentional harm imposed by the federal bureaucracy. It is an indication that when the federal government is permitted to define diseases and their treatment, as Medicare is able to do, the health of the nation is at risk.

When the GLP-1 analog first became available, insurers covered them for what were then off-label uses (and in the case of PCOS, still are). Many medicines are covered by insurance for off-label uses, and these were no exception. They were also covered for on-label uses, such as obesity and type 2 diabetes, and in some cases even for pre diabetes. However, large employers, who foot the bulk of the premiums for employee health insurance, decided that they did not want to incur the increased costs associated with covering these very expensive medications, and, as a group, went to the insurers and demanded that they stop covering the medications for anything but type 2 diabetes. The insurers complied, cutting off coverage of these meds for these other indications.

While I and others in my circumstance struggle — and mostly fail — to get appropriate treatment for patients, the rest of the nation is unaware, or indifferent to these problems. The politicians certainly are. And most everyone else. I see this as a harbinger, however, of ongoing problems with centralized healthcare. One might expect such problems to metastasize as expensive new treatments become available for other diseases. We are in the midst of a renaissance in healthcare that is accelerating. But the centralized healthcare system is obstructing, and it stands a good chance of derailing such a revolution in healthcare.

The supposed good news of rising healthcare employment is not a favorable indicator. Those new hires are most likely to wind up in the obstructive system of limiting or barring treatment, decreasing the productivity and benefits available from medical innovation. While increasing costs for everyone.