Author: WorkCompAcademy

Access to medical care, including pharmaceuticals is a critical task for workers’ compensation claim administrators. It may soon become a problem if supply chain issues interrupt the delivery of prescriptions written by the physicians treating injured workers.

As impossible as it may seem, pharmacies are reportedly running out of important prescription medications, and the U.S. Food and Drug Administration (FDA) shows there are about 111 drugs on backorder – including heart medications, antibiotics and cancer drugs.

The agency said on its website that it “continues to take steps to monitor the supply chain.”

“The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak,” it wrote.

The FDA highlights that there are a number of reasons why drug shortages can occur, including manufacturing and quality problems, delays and discontinuations.

“Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages,” it said, also reporting that about 80% of active pharmaceutical ingredients manufacturers are located outside the U.S.

A November survey released by the National Community Pharmacists Association (NCPA) found that the majority of independent pharmacy owners and managers are struggling to fill staff positions and deal with supply chain disruptions, in addition to market pressures.

Sixty percent of respondents said they are dealing with supply chain disruptions and nearly 70% reported struggling to fill staff positions.

According to the group, 76% reported being concerned about possible tax increases on small businesses and 64% were also worried about inflation.

Only 31% of respondents described the overall financial health of their business as very good or somewhat good, 28% described it as average and 41% described it as somewhat poor or very poor.

“Pharmacists have worked heroically throughout the pandemic so to have insurance middlemen push so many of these small business owners to the edge is troubling,” NCPA CEO B. Douglas Hoey said in an accompanying statement. “Policymakers in Congress, the Biden administration and in the states should keep this in mind. There are important policy changes they can make to lower drug prices for seniors and protect small businesses, like eliminating pharmacy DIR fees.”

“Between rollouts of COVID-19 vaccines for children, boosters, and seasonal flu shots – on top of their other existing patient care services – pharmacies are stretched very thin, while patients need them more than ever,” he said. “Independent pharmacies are the safety nets protecting their communities, and owners are working overtime, docking their own pay and doing everything they can to answer the call. Policymakers must repair the broken prescription drug payment model to better support pharmacy teams; successful pharmacies mean healthier, happier lives for patients.”

An American Society of Health-System Pharmacists report warned earlier this year that supply chain disruptions in the midst of the COVID-19 pandemic have the potential to negatively impact patient care.

Tom D’Angelo, chairman of the Pharmacists Society of the State of New York, told Long Island’s Newsday that “a lot of stuff is stuck on barges,” including generic blood pressure pills and cold and flu medication.

Public Health and Medical Professionals for Transparency (PHMPT) is a not-for-profit organization. It’s members include over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, UCSF, UCI and Brown.

These academics and scientists represent a cross section of every discipline relevant to the licensure of the Pfizer vaccine and include many of the best our country has to offer when it comes to reviewing and assessing the appropriateness and validity of the FDA’s decision-making in licensing of the Pfizer COVID Vaccine.

In furtherance of its mission, on August 27, 2021, PHMPT submitted the Freedom of Information Act (FOIA) Request to the FDA seeking all data and information pertaining to the application and approval of the Pfizer Vaccine. Federal law (21 C.F.R. § 601.51(e)) provides that: “After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown.” PHMPT desires to perform its own independent analysis of the safety and efficacy the the vaccine, especially in light of the vaccine mandates being promulgated at the federal and state levels.

FOIA provides for “expedited processing of request for records” upon a showing of “compelling need.”  PHMPT requested expedited processing of the FOIA Request, which was rejected by the FDA. Thus, PHMPT filed a lawsuit in federal court, seeking to obtain the data and information relied upon by the FDA to license the Pfizer Vaccine by way of expedited processing. The FDA denied the expedited processing request.

In the Second Joint Status Report following filing this case, the FDA assessed that there are more than 329,000 pages potentially responsive to the PHMPT FOIA request. The FDA asks that the Court limit the FOIA response to no more than 500 pages per month. This would be nearly 55 years or until about 2077.

PHMPT requests that the Court enter an order requiring the FDA to produce all documents on a rolling basis such that all of it shall be produced on or before March 3, 2022. The Court will at some point dictate the schedule.

Meanwhile, in the months following the August FOIA request, the FDA has managed to dribble out five documents by November 17, which are now on the PHMPT website. The most alarming of these is the “Cumulative Analysis Of Post-Authorization Adverse Event Reports Of Pf-07302048 (Bnt162b2) Received Through 28-Feb-2021.” This document covers just three months of Adverse Events after commencement of marketing of the Vaccine (December 1, 2020 through February 28, 2021.

In that short time span which was in the first few months of the Vaccine roll out, Table 1 shows that Pfizer became aware of 1,223 deaths reported as a result of the Vaccine administration. Moreover, there were 42,086 Adverse Events as a result of the vaccine in total, with various outcomes between death (1,223), recovered.with sequela (520) and “recovered” (19,582).

In Table 7, there are 69 cases of confirmed (57) or probable (12) cases of acute kidney injury and renal failure. In section 3.1.4 the U.S. topped the charts in medical errors with US (1201), France (171), UK (138), Germany (88), Czech Republic (87), Sweden (49), Israel (45), Italy (42), Canada (35), Romania (33), Finland (21), Portugal (20), Norway (14), Puerto Rico (13), Poland (12), Austria and Spain (10 each) with ten of these “medical errors” reported as fatal.

The next scheduling conference is set for December 14, 2021, and it remains to be seen if the FDA will be compelled to deliver documents in a more expedited manner.

In the insurance industry, frictional costs include claim adjustment, and administrative expenses that are not normal business expenses generally contemplated by fixing a premium amount by underwriting, but rather are consequences of extraordinary events that might put a strain on capital and profitability.

The WCIRB has released its Friction in the California Compensation System report, which details the primary drivers of California frictional costs, the impact of high frictional cost claims and recent trends in frictional costs.

Frictional costs in the California workers’ compensation system are much higher than other systems across multiple categories, despite some recent decreases in frictional costs in California. In California, it costs $0.48 in frictional costs to deliver $1 of benefits to injured workers. This is almost twice the median workers’ compensation system and significantly above other systems that deliver medical benefits

Recent favorable trends have moved California somewhat closer to the median state in the last 5 years, but it is still 61% higher than the median state in total defense costs per lost time claim at 36 months. Given the significantly longer claim duration in California, these differences are likely larger at later periods. Since 2015, total frictional costs in the California insured system declined by about $0.3 billion. This decline was largely concentrated in medical-legal costs.

The WCIRB has identified four primary drivers of California frictional costs, labeled the “Frictional Four”. They include the higher volume of permanent disability claims, the higher proportion of cumulative trauma injuries, the longer duration that claims remain open, and disproportionate levels of friction regionally within California.

California has by far the highest number of PPD claims filed compared to any other state and more than twice that of the median state. States that use the same version of the American Medical Association (AMA) guides to determine permanent disability as California do not have similar volumes of PPD claims. PPD claims are more complex, remain open longer, and incur more than three times the ALAE than temporary-only claims on average.

While data in other states is not readily available, CT claims are believed to be significantly more prevalent in California. The proportion of CT claims that involve nontrivial ALAE costs is significantly higher compared to that for specific injury claims. Prior WCIRB studies also indicate that the vast majority of CT claims are litigated with many filed later and on a post-termination basis.

Average ALAE costs differ significantly across the state with the highest costs in Southern California around the Los Angeles Basin. The average ALAE cost per indemnity claim in this region is approximately 29% higher than the rest of the state at 10th unit statistical report level.

The longer claim duration is estimated to have the most significant impact on California average ALAE costs, reducing it by over 30% when assuming an average duration similar to the median state.

On August 4th, the L.A. County Board of Supervisors issued an executive order mandating all County employees provide proof of vaccination against COVID-19, or face potential termination. L.A. County awarded a no-bid contract to Fulgent Genetics Corporation to provide testing/registration services.

Fulgent Genetics was also awarded a contract to provide COVID-19 testing for New York City public schools through the 2021 school year.

However, Los Angeles County Sheriff Alex Villanueva has notified the LA County Board of Supervisors that LASD will not work with a China-linked genetics firm hired by the county to conduct Covid-19 testing and registration, after the FBI shared “very concerning information” about Fulgent Genetics Corporation – which was awarded a no-bid contract for the work.

“This letter is to inform you the Los Angeles County Sheriff’s Department (Department) will not participate in COVID-19 registering or testing with Fulgent Genetics Corporation (Fulgent), due to the fact the DNA data obtained is not guaranteed to be safe and secure from foreign governments and “will likely be shared with the Republic of China,”” wrote Sheriff Alex Villanueva in a Monday letter.

Villanueva writes that on Nov. 24 he was contacted by the FBI’s Weapons of Mass Destruction Coordinator, who shared “very concerning information” about Fulgent.

“I was shocked to learn Fulgent had strong ties with BGl2, WuXi3, and Huawei Technology 4 , all of which are linked to the Chinese Academy of Medical Sciences, the Peoples Republic of China (PRC) State Council and are under the control of the PRC.” the letter continues. “I was even more shocked to learn Fulgent made no attempt to disguise the fact they will use the genetic information obtained in future studies.“

Villanueva claimed DNA data obtained through tests are “not guaranteed to be safe and secure from foreign governments” and said FBI officials advised him at the briefing that genetic information the company collects is likely to be shared with the Chinese government. Fulgent Genetics, he alleged in the letter, has “strong ties” with Chinese technology and genomics companies, but he did not elaborate on what those ties are.

Villanueva then blasted officials over how Fulgent was hired in the first place, writing “I am deeply concerned as to the vetting process which either failed to discover this, or discovered it, but chose to ignore it. A simple internet search would have uncovered all of the above facts.”

“Entering into a no-bid contract with Fulgent Genetics and allowing them to have the DNA data obtained from mandatory COVID-19 testing, for unknown purposes, has shattered all confidence my personnel have in this entire process under the County mandate. Many personnel have long suspected this information was being used in an unnecessary manner due to a rushed mandate that we now know will have long-term unintended consequences that will not be fully known for some time.

Villanueva also noted that the “FBI felt strongly enough regarding Fulgent being used to test County personnel that they held an emergency briefing to disclose their concerns.”

Villanueva said the county’s top attorney and chief executive also attended the recent FBI briefing at the agency’s Los Angeles office. An FBI spokesperson declined to comment when asked to confirm what was discussed at the meeting.

Fulgent’s chief commercial officer, Brandon Perthuis, dismissed the sheriff’s allegations as untrue. In a statement Tuesday, Perthuis wrote that the U.S.-based company was founded and is led by American citizens. He said the company does not share personal data about people who are tested with the Chinese government and that the company does not use samples collected during tests to sequence people’s unique DNA structure.

County employees are required to register their vaccination status with Fulgent, and those who are not vaccinated are required to submit to regular testing. Villanueva said the Sheriff’s Department would use its own registration system and work with vetted testing companies that are not associated with Fulgent.

The founder Fulgent Genetics is billionaire Ming Hsieh, who was born in China but is now a naturalized American citizen.

Of note, China’s ambitions to build the world’s largest DNA database are no secret to anyone listening to CBS News (60 Minutes), or the Wall Street Journal.

This Monday, the US District Court for the Eastern District of Missouri issued a preliminary injunction on the mandate, which requires health-workers to be vaccinated by Jan. 4, 2022.

This case concerns the Centers for Medicare and Medicaid Services’ (“CMS”) federal vaccine mandate on a wide range of healthcare facilities. Specifically, the mandate requires nearly every employee, volunteer, and third-party contractor working at fifteen categories of healthcare facilities to be vaccinated against COVID. and to have received at least a first dose of the vaccine prior to December 6, 2021

On November 10, Plaintiffs, the States of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire filed a Complaint challenging the mandate. They subsequently filed a motion for a preliminary injunction requesting that this Court issue a preliminary injunction enjoining Defendants from imposing the mandate.

In granting the motion, the Court concluded that Plaintiffs are likely to succeed in their argument that Congress has not provided CMS the authority to enact the regulation at issue here. “[A]n agency literally has no power to act, let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it.”

The Court agrees Congress has authorized the Secretary of Health and Human Services general authority to enact regulations for the “administration” of Medicare and Medicaid and the “health and safety” of recipients. But the nature and breadth of the CMS mandate requires clear authorization from Congress – and Congress has provided none. “It would be one thing if Congress had specifically authorized the action that the CDC has taken. But that has not happened.”.

Even if CMS has the authority to implement the vaccine mandate the mandate is likely an unlawful promulgation of regulations. Both the Administrative Procedure Act and the Social Security Act ordinarily require notice and a comment period before a rule like this one takes effect. CMS concedes it did not follow these requirements but attempts to justify its omission under the “good cause” exception. 86 Fed. Reg. at 61,583. Here, Plaintiffs are likely to succeed in their argument that CMS unlawfully bypassed the APA’s notice and comment requirements.

Use of the “good cause” exception is “limited to emergency situations” and is “necessarily fact-or context-dependent.” Here, CMS’s delay in requiring mandatory vaccination undermines its contention that COVID is an emergency such that it has the “good cause” necessary to dispense with notice and comment requirements.

Finally, the court noted that “Plaintiffs are likely to succeed in establishing that the CMS vaccine mandate is arbitrary or capricious.” …. “In general, the overwhelming lack of evidence likely shows CMS had insufficient evidence to mandate vaccination on the wide range of facilities that it did.” Another example, “CMS rejected daily or weekly testing – an option that even OSHA approved in its ETS – without citing any evidence for such a conclusion.”

While the preliminary injunction applies only in the states that are Plaintiffs in this action, multiple news sources say White House is telling federal agencies they can hold off on suspending or firing federal workers for not complying with the vaccine mandate until after the holidays, according to a memo obtained by ABC News.