Double, triple, quadruple jeopardy for the ACA

A weekly roundup where I read the literature so you don't have to

This week, I am introducing a new feature: a weekly roundup of studies and opinion pieces I find interesting, and think you might, too.

Double, triple, quadruple jeopardy for the ACA

Sometime in the next few weeks, the U.S. Supreme Court will determine if the entire Affordable Care Act is invalid simply because Congress reduced the tax for violating its individual mandate to zero. Republican state attorneys general, led by Texas, made the claim in a suit filed in 2018. Ultra-conservative Texas district court judge Reed O’Connor agreed with their logic. Twenty-one Democratic state attorneys general, led by newly confirmed HHS Secretary Xavier Becerra, appealed to the high court to reverse O’Connor’s decision in California v. Texas.

Washington and Lee University emeritus law professor Timothy Jost, a leading expert on ACA law, expects the high court will uphold almost all of the law and further predicts we may never see another challenge to the entire law. Yet, he warns in his commentary on the Commonwealth Fund website, the law isn’t out of the woods yet.

The same judge is lining up new cases that challenge the ACA and other laws involving public health. In late February, Judge O’Connor refused to dismiss a challenge to the ACA’s mandate requiring insurers cover preventive services without cost-sharing. Another case in his court would allow employment discrimination against physicians who perform abortions. A different Texas judge recently ruled the evictions moratorium in the first pandemic relief bill was unconstitutional violation of the interstate commerce clause.

Jost says the strategy is clear. Rightwing state AGs first challenge progressive laws as unconstitutional in courts run by rightwing judges; after winning a positive judgment, they easily defend the ruling, no matter how objectionable, in the Fifth Circuit Court of Appeals, which is also controlled by rightwing judges. Their strategy is to get the rulings before the Supreme Court, which they believe, with its newly installed conservative majority, will uphold rulings that on their face appear to have no constitutional merit.

We should expect numerous legal challenges to progressive changes enacted by the Biden administration. “This trend strongly contradicts the notion that a favorable decision in California v. Texas is the end of the line in ACA litigation,” Jost writes.

Is there a ticking time bomb in your body?

In 2019, the Food and Drug Administration received 1.2 million reports of adverse events reports about patients harmed by medical devices like pacemakers, artificial hips and breast implants. Yet just 1.6% of those reports contained a unique device identifier – think of it as a bar code – that would allow regulators to track overall device performance by manufacturer and model.

The unique device identifier (UDI) system was designed to enhance the FDA’s ability to monitor device performance and order recalls when necessary. It also gives physicians and hospitals an easy method for rapidly identifying which patients received the faulty products.

Yet the healthcare system has barely begun making use of a technology that has long been used to track inventories by other industries like food, manufacturing and warehousing. Imagine an auto recall notification system where the carmakers had no idea who owned the recalled cars.

The problem isn’t the medical device industry. The government required manufacturers put UDIs on all their implantable products in 2013. In September 2022 they will start putting a UDI on every low-risk, non-implantable device.

Rather, many health systems are failing to record the UDIs in their electronic health records, a recent Viewpoint article in JAMA Internal Medicine noted. Moreover, the health claims forms used by most insurers do not include a field for UDIs, even though an industry committee promised to include one three years ago.

We need a comprehensive tracking system for implantable devices because many are put into widespread use without rigorous clinical trials. Under the FDA’s 510(k) approval process, a medical device can enter the market with mere bench-testing if the device is deemed similar to something that’s already been approved. In such cases, the only way to assure the devices’ long-term safety is to accurately track malfunctions after they are inserted in patients by surgeons.  

“Until the CMS facilitates and requires the use of the UDI by clinicians and healthcare facilities, its full promise for improving device performance and patient safety will not be achieved,” wrote Madris Kinard, whose firm, Device Events, writes software for tracking device problems. Her co-author Lisa McGiffert staffs the Patient Safety Action Network for Consumer Reports.

No more surprise bills – a good example of PBR

Last December’s No Surprises Act, which bans balanced billing, is a good example of a performance-based regulation. Its passage also demonstrates why pursuing PBRs to provide financial relief to patients and families is a winning political strategy.

The legislation won bipartisan support despite opposition from hospitals, insurers and the hedge funds that control the physician groups most responsible for engaging in the predatory practice. Under balance billing, an out-of-network provider, all too often a hedge fund-owned physician specialty practice, bills a patient for the portion of the bill not paid by an insurer.

The ban doesn’t go into effect until next January. When it does, no patient receiving an out-of-network emergency service can be billed more than what is charged by an in-network provider. The same holds true for non-emergency services delivered by an out-of-network physician working at an in-network facility.

Moreover, in non-emergency cases, the patient must receive notice at least three days before a scheduled procedure that tells them what their out-of-pocket costs will be; whether the attending physician is out-of-network; and whether there are in-network alternatives at a lower price. Patients also must give written consent before they can be billed for the higher-cost service.

“Despite some flaws, the No Surprises Act is a major victory for the public,” a new Perspective in the New England Journal of Medicine declares. “Like any compromise, it is imperfect and will require close scrutiny as it unfolds. Yet in a time of tremendous economic uncertainty, it represents an important step toward reducing financial harm to patients and restoring trust in the health care system.”

Last week, in my article calling for performance-based regulation of insurance plans as the next chapter in healthcare reform, I noted that, given current political realities, it would be smarter for progressives to push for outcomes-based regulations of insurers rather than to push for a public plan to compete in the insurance marketplace. The No Surprises Act is a good example of a law mandating such regulations.