Even in these times of divided government, you would think we’d all agree that finding a cure for disease is a good thing. You would be wrong.
Progressives, like President Biden, have been trying to implement socialized medicine in this country since the days of Teddy Roosevelt. They’ve never achieved this dream of full government control of your healthcare, but they’ve made significant strides in the last two Democratic presidencies; Obama and Biden.
The passage of the Affordable Care Act of 2010, better known as ObamaCare, was a major step forward to achieving their dreams, but they couldn’t call it socialized medicine because that was political suicide. Therefore, they have looked for ways to implement socialized medicine practices in more subtle ways.
The latest example of this is highlighted in a Wall Street Journal editorial. The editors say, “The Food and Drug Administration may soon approve two gene therapies with the potential to cure more than 100,000 Americans with debilitating sickle-cell disease. Now the bad news: The Centers for Medicare and Medicaid Services (CMS) may soon limit access to such breakthrough treatments.”
Gene therapies fix missing or defective genes. The one-time treatments have the potential to cure inherited disorders with early death sentences. The FDA has approved nine gene therapies for such diseases as Duchenne muscular dystrophy, spinal muscular atrophy and retinal dystrophy. Next up are two gene therapies for sickle-cell disease, which is caused by a genetic mutation that disfigures red blood cells. Patients require repeat blood infusions and can suffer strokes and organ damage. One of the treatments would be the first ever for any disease using the gene-editing tool CRISPR.
FDA chief of biologics Peter Marks has pressed the agency to expedite gene-therapy approvals since the earlier children receive treatment, the better their prognosis. Gene therapies would reduce healthcare spending over time, the way hepatitis C treatments did when they came to market a decade ago. Children cured of sickle-cell disease won’t need blood transfusions or organ transplants.
Yet state Medicaid officials have been slow to cover the treatments because of their high upfront costs—some upward of $1 million. Hence, CMS is seeking to bludgeon gene-therapy developers into accepting lower prices that don’t take into account their lasting therapeutic value and would limit access to treatments.
In other words, the Biden administration doesn’t want to spend the money to cure sickle-cell disease. It would be racist to assume this might be because sickle-cell disease predominately occurs in black Americans; or that a majority of the patients needing this treatment might be on Medicaid. But these are incontrovertible facts.
A proposed rule would require manufacturers with the highest drug Medicaid spending per claim to turn over confidential information justifying their prices. CMS would post the information online, seek public comment, and compel manufacturers to “address” their pricing in a public forum. The goal is to browbeat companies to reduce prices.
As the Alliance for Regenerative Medicine noted in a comment on the rule, “the improper disclosure of confidential, proprietary and competitively sensitive information can pose significant risks to a company’s commercial viability.” CMS would let manufacturers avoid the public show trial and disclosures by paying state Medicaid programs “supplemental rebates,” on top of the program’s mandatory statutory 23.1% discount. Such payments in Medicaid are supposed to be prohibited.
The Alliance for Regenerative Medicine rightly notes that CMS is trying “to administer de facto price controls on behalf of state Medicaid programs.” But manufacturers may decide it’s not worth selling drugs to Medicaid because the prices are too low. About a quarter of gene and cell therapies approved in Europe have been withdrawn from that market because they weren’t commercially viable at the prices that government payers demanded. That could happen with Medicaid if CMS finalizes its rule as it is expected to do. The victims in the case of sickle cell will mostly be minority children.
The business model of every socialized medicine system in the world is to limit access to care, by increasing waiting times, and withholding treatment for diseases and conditions that are too expensive. That way they save money – at the expense of lives. The Biden administration is just following that template for our healthcare system – without calling it socialized medicine.
