Category: Daily News

Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. The idea that drugs expire on specified dates goes back at least a half-century, when the FDA began requiring manufacturers to add this information to the label. Meanwhile the FDA has long known that many remain safe and potent for years longer.

Federal and state laws prohibit pharmacists from dispensing expired drugs and The Joint Commission, which accredits thousands of health care organizations, requires facilities to remove expired medication from their supply. Outdated drugs are shunted to shelves in the back of the pharmacy and marked with a sign that says: “Do Not Dispense.” The piles grow for weeks until they are hauled away by a third-party company that has them destroyed. And then the bins fill again.

Though the government requires pharmacies to throw away expired drugs, it doesn’t always follow these instructions itself. Instead, for more than 30 years, it has pulled some medicines and tested their quality. The story on ProPublica claims that the federal government has stockpiled massive stashes of medication for decades, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.

The federal agencies that stockpile drugs – including the military, the Centers for Disease Control and Prevention and the Department of Veterans Affairs – have long realized the savings in revisiting expiration dates.

In 1986, the Air Force, hoping to save on replacement costs, asked the FDA if certain drugs’ expiration dates could be extended. In response, the FDA and Defense Department created the Shelf Life Extension Program. The program authorizes governmental stockpiling and use of expired drugs.

FDA’s Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions.

Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.

A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.

The billion dollar question asks why it is this research has not extended to the private sector? Pharmacists and researchers say there is no economic “win” for drug companies to investigate further. They ring up more sales when medications are tossed as “expired” by hospitals, retail pharmacies and consumers despite retaining their safety and effectiveness.

Some medical providers have pushed for a changed approach to drug expiration dates – with no success. In 2000, the American Medical Association, foretelling the current prescription drug crisis, adopted a resolution urging action. The shelf life of many drugs, it wrote, seems to be “considerably longer” than their expiration dates, leading to “unnecessary waste, higher pharmaceutical costs, and possibly reduced access to necessary drugs for some patients.”

No one remembers the details of the AMA resolution – just that the effort fell flat. “Nothing happened, but we tried,” says rheumatologist Roy Altman, now 80, who helped write the AMA report.  Experts estimate such squandering eats up about $765 billion a year – as much as a quarter of all the country’s health care spending.

CSAC Excess Insurance Authority is a joint powers authority formed to cover the workers’ compensation obligations of its member counties through a combination of risk retention and excess insurance. It had secured retention ($500,000) with a now defunct insurer – the Protective National Insurance Company of Omaha.

On behalf of member Fresno County and member Mendocino County, CSAC paid workers’ compensation benefits for an employee injury. The total amount of payments in each of the two cases exceeded the $500,000 retention. Claims were made for the payments to the excess carrier, Protective National, but a Nebraska court filed a declaration of insolvency with respect to Protective in February 2004. Thus, Protective forwarded CSAC’s claims to the California Insurance Guarantee Association (CIGA) for payment.

CIGA is a statutory nonprofit unincorporated association to which insurance companies must belong as a condition of doing business in California. Its primary objective is to pay “covered claims” arising from the failure of an insolvent insurer to meet its obligations under its policies.CIGA assesses the costs of covering an insolvent’s obligations against its membership, which in turn recovers this cost through premium surcharges on policies; this spreads the costs of insolvency across the entirety of the insurance market

CIGA denied the claims essentially asserting that these were not “covered claims” within the meaning of a growing body of law embellishing the definition of what is, and is not a “covered claim.”.

CSAC sought a declaration from the Superior Court that its payments for two of its members in excess of the agreed retention are within the statutory definition of unpaid “covered claims” that CIGA has an obligation to reimburse. The trial court issued a ruling in favor of CSAC that CIGA had breached its statutory duty to reimburse CSAC for the excess workers’ compensation coverage due under the Protective policy.

CIGA appealed. The Court of Appeal affirmed the ruling in the unpublished case of CSAC Excess Insurance Authority v California Insurance Guarantee Association.

On appeal, CIGA contends that Protective did not “incur” an “obligation” to indemnify until the retention limits were reached, which did not occur until after the drop-dead date for presenting claims to CIGA specified in Insurance Code section 1063.1(c)(1)(D) and thus were not “covered claims.” The Court of Appeal rejected this argument and concluded that the obligation for excess insurance is incurred on the date of injury, not on the date of the exhaustion of the retention.

CIGA also contends that even if the Mendocino and Fresno workers’ compensation payments were covered excess claims within the meaning of section 1063.1(c), they “ceased to be” once the liquidator ended Protective’s existence and cut off any further claims against it. The Court of Appeal found no authority for this contention and concluded that a liquidation termination order does not extinguish CIGA’s obligations under California law.

Senate Bill 1160, which became effective January 1, requires all lien claimants who filed a lien between January 1, 2013 and December 31, 2016, and paid a filing fee, to file the “Supplemental Lien Form and 4903.05(c) Declaration” form.

Labor Code section 4903.05(c) was amended as part of the bill’s reform measures to combat fraud in the workers’ compensation system.

The Division of Workers’ Compensation (DWC) reports that 441,070 supplemental lien declaration forms were filed as required by Labor Code section 4903.05(c). This represents half of the 882,648 liens filed in California’s workers’ compensation system between January 1, 2013 and December 31, 2016 for which a filing fee was paid.

Lien claimants who failed to file the “Supplemental Lien Form and 4903.05(c) Declaration” will have their liens dismissed. This would be approximately 441,578 liens.

DWC is currently reviewing and evaluating filed declarations for compliance with the legislation and with WCAB rules and procedures.

The Division is holding hearings to determine whether the declarations are accurate and comply with the requirements of section 4903.05(c).

Radiologists, who receive years of training and are some of the highest paid doctors, are among the first physicians who will have to adapt as artificial intelligence expands into health care.

Precise numbers are hard to come by, but most estimates place radiology as an $8 billion industry in the U.S. Globally, the market is expected to grow from $28 billion to $36 billion by 2021. And the tech and radiology communities expect artificial intelligence to transform medical imaging, providing better services at lower costs. For example, if you’re getting an MRI, an AI program can improve the analysis, leading to better treatment.

“This is going to be transformational,” said Keith Dreyer, vice chairman of radiology computing and information sciences at Massachusetts General Hospital. “Every month there’s going to be a new algorithm that we’re going to use and integrate into our solutions. When you look back we’ll say, ‘How did I ever live without this?'”

Today radiologists face a deluge of data as they serve patients. When Jim Brink, radiologist in chief at Massachusetts General Hospital, entered the field in the late 1980s, radiologists had to examine 20 to 50 images for CT and PET scans. Now, there can be as many as 1,000 images for one scan.

The work can be tedious, making it prone to error. The added imagery also makes it harder for radiologists to use their time efficiently. Brink expects artificial intelligence to act as a diagnostic aid, flagging specific images that a human should spend more time examining.

Arterys, a medical imaging startup,reads MRIs of the heart and measures blood flow through its ventricles. The process usually takes a human 45 minutes. Arterys can do it in 15 seconds.

The remarkable power of today’s computers has raised the question of whether humans should even act as radiologists. Geoffrey Hinton, a legend in the field of artificial intelligence, went so far as to suggest that schools should stop training radiologists.

Those on the front lines are less dramatic.

“There’s a misunderstanding that someone can program a bot that will take over everything the radiologist does,” said Carla Leibowitz, head of strategy and marketing at Arterys. “Radiologists still use the product and still make judgment calls. [We’re] trying to make products to make their lives easier.”

According to Dreyer, a radiologist spends about half the day examining images. The rest is spent communicating with patients and other physicians. There’s only so much that automated systems can take over.

“Our desire to have somebody in control, I don’t think that will go away anytime soon,” said General Leung, cofounder of MIMOSA Diagnostics, which is testing a smartphone device that uses AI to aid diabetics. “Someone’s always going to want a person to have made the decision.”

The future for radiologists may be similar to airline pilots. While planes generally fly on auotpilot, there’s still a human in the cockpit.

Dreyer’s hospital is enthusiastically embracing the potential of AI to transform radiology. They’ve bulked up their computing power and are organizing their data to train algorithms. But there’s a long road ahead. Artificial intelligence will need to be able to respond to thousands of situations to match the image interpretation that a radiologist does. Right now, Massachusetts General Hospital is focusing on 25 of them.

“The foreseeable future is not going to be human vs. machine, but human plus machine vs. a human without a machine,” Dreyer said. “The human plus machine is going to win.”

The future of radiologists appears to offer a lesson for any worker concerned about automation. If you can’t beat the machines, join them.

July 13 was a big day for California workers’ compensation law being tested in a downtown Los Angeles federal courtroom where Judge George H. Wu was schedule to hear arguments for and against imposing a preliminary injunction halting the implementation of newly adopted SB 1160. This new law provides for a stay on lien claims filed by indicted medical providers until after their case has been resolved.

Dr. Eduardo Anguizola is facing multiple counts of insurance fraud filed by Orange County prosecutors. His federal lawsuit claims that SB 1160 and Labor Code 4615, the anti-fraud law that took effect January 1, violates his rights to due process of law and to make a contract and to hire and pay his criminal defense attorneys. His request for a preliminary injunction was scheduled for hearing on July 13

Dr. Anguizola is alleging that Senate Bill 1160 and Labor Code 4615 violate the 5th, 6th, and 14th amendments of the United States Constitution. He also claims the legislation violates the Supremacy clause, and California contracts clause.

The July 13 oral arguments on the preliminary injunction request took about 16 minutes of the crowded court calendar. Judge Wu focused the case on issues surrounding the distinction between “procedural” as opposed to “substantive” due process requirements of constitutional law.

Plaintiff attorney, M. Chris Arminta, had argued that there were problems with procedural due process while Judge Wu seemed more interested in the law on substantive due process.

Procedural Due Process aims to protect individuals from the coercive power of government by ensuring that adjudication processes under valid laws are fair and impartial (e.g., the right to sufficient notice, the right to an impartial arbiter, the right to give testimony and admit relevant evidence at hearings, etc.).

In contrast, Substantive Due Process aims to protect individuals against majoritarian policy enactments which exceed the limits of governmental authority – that is, courts find the majority’s enactment is not law, and cannot be enforced as such, regardless of how fair the process of enforcement actually is.

In other words, procedural due process consists of the restrictions that the law places on the legal process; substantive due process is the determination of whether or not the law itself exceeds government authority.

Judge Wu was concerned that attorney Arminta had not adequately briefed the issue of substantive due process. Thus the court gave the plaintiff attorney 3 days to prepare and file an amended brief addressing the issue of substantive due process,

The California Attorney General who appeared for the defense would then have until August 8th to respond, and then the plaintiff would have until August 15th to respond to the AG response.

There was no preliminary injunction ordered at this time. Another hearing was set for August 24th.