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Brainstorm Health Daily: May 8, 2017

The U.S. Constitution is notable for its focus on proscriptions rather than prescriptions. Most of what this masterful charter does is guarantee freedom from government interference in individual liberties “rather than impose any affirmative obligation of the government to provide for the health or welfare of its citizens,” writes Erin C. Fuse Brown, an associate professor of law at Georgia State University’s Center for Law Health and Society in a fascinating 2013 paper.

Contrary to what many might expect, for example, the Constitution does not explicitly require the federal government or the states to protect the health of citizens—and, in fact, does not mention the word “health” anywhere in its 4,543 words or in any of its amendments. In Brown’s very readable law review article, she explains why—and cites another scholar, Puneet K. Sandhu, who sums up a few reasons why it would be challenging to affirm even if the framers had hoped to do so. “The problem of defining and implementing a right to health is threefold,” says Sandhu: “indeterminacy (how to characterize it), justiciability (how to enforce it), and progressive realization (how to raise the standard over time).”

Had the founding fathers been joined by the founding mothers, perhaps they might have enshrined this human right in the charter—as lots of other nations have done—but it’s important to acknowledge that, in the U.S. Constitution, no such explicit right is specified.

I bring this up because this absence (or call it omission, if you like) underlies the staunch opposition of many conservative Republicans to the Affordable Care Act—and to previous government efforts to provide publicly funded health care and insurance coverage to their citizens going back to the passage of Medicare in 1965.

This adamant opposition to creating a health “entitlement” that the Constitution does not itself entitle has made the ACA—or at least the statutory “right” to healthcare that it hoped to engender—“structurally fragile,” Brown concludes:

Passed amidst bitter partisan division and an ambivalent public…the right depends on private actors, private health insurance companies, and willing states to administer and participate in a newly transparent, competitive, and streamlined private health insurance market, while these same actors hesitate to invest in the infrastructure of this market due to uncertainty from legal and political challenges to the ACA. All of these challenges make it more likely, in the short term, that the ACA’s right to health care will be ephemeral or hollow—a quasi-superstatute rather than a durable superstatute.”

Which takes us to the latest bill passed by House Republicans to repeal and replace the ACA. Should it somehow pass muster with the Senate (which, in the bill’s current form, I cannot imagine), it might end up doing what Republicans seem to fear most: enshrining a citizen right to basic health care.

Why? Because the deal that secured the votes of the conservative House sect known as the Freedom Caucus, allows states to seek waivers that let them opt out of basic protections for some citizens—rules, for example, that prevent insurers from charging virtually anything they want to “cover” those with preexisting conditions or that demand that insurers provide certain basic health and preventive care services. Were these provisions to become law, they could result in some states, legislatively, providing one level of care or protection to some of their citizens and a different level to others—which, could violate the equal protection and fairness requirements of the Fifth and Fourteenth Amendments to the Constitution.

And here’s the rub: Where the courts have found a Constitutional right to healthcare, it has been with regard to those two Amendments. (As the Fourteenth Amendment says, “nor shall any State…deny to any person within its jurisdiction the equal protection of the laws.”)

Such Constitutional protections have ensured that federal programs such as Medicare, the Veteran Administration’s TRICARE system (which provides benefits for active duty members of the military and their families), and the Emergency Medical Treatment and Active Labor Act (EMTALA) apply the same rules to everyone they cover. For instance, EMTALA, says Brown, “embodies the nonexcludable nature of the right to health care, because emergency care must be provided to anyone who shows up to an emergency room with an emergency medical condition in hospitals participating in Medicare.”

If Senate Republicans, against all odds, manage to narrowly pass a bill like that which passed the House of Representatives last week, they may end up doing what the ACA never could: getting the courts to say that basic healthcare for U.S. citizens is an enforceable right. That would be an ironic gift from Trumpcare indeed.

More news below.

Clifton Leaf, Editor in Chief, FORTUNE
@CliftonLeaf
clifton.leaf@fortune.com

DIGITAL HEALTH

The FDA is creating a digital health unit. The Food and Drug Administration (FDA) is crafting a special unit to focus on digital health and tackle thorny issues such as creating an appropriate approval/clearance pathway for mobile medical apps. The unit will be a part of the Center for Devices and Radiological Health (CDRH), RAPS reports, and will determine "what clinical validation looks like for software" (with an assist from thousands of public comments). In the meantime, the agency is encouraging device makers to follow through on their digital health ambitions even as the FDA continues to set its protocols. (RAPS)

Kite shares plunge after biotech reveals patient death in CAR-T trial. Kite Pharma, one of the companies chasing a new generation of cancer drugs called chimeric antigen receptor T-cell (CAR-T) therapies, announced a patient death in a clinical trial of its experimental KTE-C19. The patient died of cerebral edema (brain swelling)—a deadly adverse event that also afflicted Kite competitor Juno Therapeutics' rival drug in the space, which it was then forced to abandon. The biological technology at the heart of CAR-T involves extracting immune T-cells from the body and then engineering them to suss out and destroy blood cancers. Other than Kite and Juno, pharma giant Novartis is also making a play in the space. In March, the latter firm submitted the CAR-T drug CTL019 for FDA approval. Kite shares are down 13% in early Monday trading. (TheStreet)

INDICATIONS

FDA approves first new ALS drug in more than two decades. The FDA has approved Mitsubishi Tanabe Pharma America's Radicava, the first new therapy to treat amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, in 22 years. This is just the second U.S. approved treatment for the rare, progressive disease, which eats away at the body's motor functions; patients usually die of respiratory failure within five years of their first ALS symptoms. But the therapy may prove controversial for several reasons. First, its price: Mitsubishi Tanabe is reportedly seeking a $145,524 yearly list price for the treatment. Furthermore, the drug isn't a cure—it merely slows down the progression of the disease.

Sanofi/Regeneron's Dupixent launch is a big success. Sanofi and partner Regeneron's moderate-to-severe eczema drug Dupixent is off to a great start in the market. In fact, the number of written prescriptions is so high that Wall Street analysts are feeling compelled to boost their sales projections, predicting that Dupixent will bring in anywhere from $215 million to $320 million this year. The launch has been far more impressive than the two firms' previous blockbuster hopeful, the cholesterol-cutting medication Praluent. (FiercePharma)

THE BIG PICTURE

Obama calls for Congressional "courage" on health care. Former President Barack Obama on Sunday called for lawmakers to have "courage" when considering health care legislation that would significantly gut his signature domestic policy, the Affordable Care Act. "There was a reason why healthcare reform had not been accomplished before. It was hard, it involved a sixth of the economy and all manner of stakeholders and interests. It was easily subject to misinformation and fear-mongering," Obama said during his speech accepting the John F. Kennedy Library Foundation's "Profile in Courage" Award. The American Health Care Act (AHCA) passed the House of Representatives on a 217-213 vote last Thursday but faces a much tougher path in the Senate. (Fortune)

Health care hiring spikes in April. After a lull in March, health care hiring soared back in April, which saw an overall uptick in hiring to 211,000 new jobs. Health care made up 19,500 of those gains, making it (yet again) one of the major drivers of economic growth. The new jobs are largely spread between hospitals, home health workers, and physician's offices, and they signal that the medical industry may not be sweating despite the continued uncertainty around Obamacare. (Modern Healthcare)

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