October 25, 2021 – A pair of new pharmacy-benefit management (PBM) companies are being launched to tackle high drug costs – The Mark Cuban Cost Plus Drug Company PBC and the Purchaser Business Group on Health (PBGH), a nonprofit coalition of nearly 40 large public and private employers.
PBGH is led by CEO Elizabeth Mitchell and The Mark Cuban Cost Plus Drug Company PBC is led by radiologist Alex Oshmyansky.
Mark Cuban, the billionaire investor and owner of the Dallas Mavericks, is funding the new company with the aim of selling generic drugs at a transparent fixed-rate markup. To do so, it is creating an all-in-one pharmaceutical supplier, combining manufacturing, wholesale distribution and pharmacy services under one roof.
Cuban’s PBM is building a plant in Dallas to manufacture certain drugs, and hopes to open the facility in September 2022, said CEO Dr. Alex Oshmyansky. The company will start bidding for clients next year and aims to be operational in 2023. Cuban’s company plans to soon launch an online pharmacy that will sell 100 of the most commonly prescribed generic medications. The pharmacy is buying drugs directly from generic manufacturers including Amneal Pharmaceuticals Inc., and will charge customers a 15% markup plus a $3 dispensing fee.
PBGH’s new PBM, EmsanaRx, will be housed under an independent for-profit company called Emsana Health. The PBM will start operating next year with a small number of regional medical centers with about 3,000 employees total, said Chief Executive Greg Baker. It aims to negotiate rebates directly with drugmakers, and will allow its clients to examine invoices showing the dollar amounts it receives in rebates. The PBM intends to share 98.5% to 99% of the rebates with its clients, with the remainder going to cover administrative expenses, said Mr. Baker.
The ultimate aim of the new pharmacy-benefit managers, their executives said, was to be more transparent about drug costs and share with their clients more of any negotiated savings.
The new companies are the result of employer frustration with the lack of transparency and lack of savings from the current PBMs. Transparency in the PBM industry typically means charging a flat fee for services and passing along to the employer 100% of the rebates and discounts paid by drugmakers to the PBM. In theory, PBMs are supposed to pass along these large savings to their customers. In practice, the PBMs failing to disclose all the rebates and keeping too much of the savings some employers say.
According to a Wall Street Journal report, nearly 80% of U.S. prescriptions are managed by three PBMs:
October 20, 2021 – With supply chain issues expected to stretch well into next year and beyond, lawmakers are looking to centralize Washington’s response and encourage more companies to bring manufacturing processes closer to home to better protect the U.S. from future catastrophic disruptions.
A bipartisan group of legislators introduced the Supply CHAIN Act earlier this month to create an Office of Supply Chain Resiliency and Crisis Response within the U.S. Department of Commerce to monitor the supply chains of critical goods and respond to disruptions.
With a $500 million annual budget from 2022-2027, the office would bring together private-sector stakeholder groups, monitor critical supply chain issues and present recommendations every four years to improve supply chain security and resiliency.
The proposal follows steps taken by the Biden administration to address supply chain weaknesses exposed by the pandemic, reports Supply Chain Dive. The White House issued a 250-page report outlining goals for reviving domestic production of semiconductors, large capacity batteries, critical minerals and pharmaceuticals amid shortages along every stage of the supply chain.
Cheaper labor in China, India and other countries has long presented inherent barriers to reshoring, and many U.S. companies have limited domestic inventories to maximize profits, said Sanjay L. Ahire, co-director of the Operations and Supply Chain Center at the University of South Carolina’s Darla Moore School of Business.
Ahire told Supply Chain Dive companies are realizing the need to look beyond the “sticker price,” as he called it, to what’s known as the “total cost of ownership,” which includes hidden costs of faraway manufacturing.
The bill will need to go before both the House of Representatives and Senate for a vote.
A federal judge in New York ruled on Tuesday that religious exemptions for health care workers must be upheld in spite of the state’s sweeping COVID-19 vaccine mandate.
The governor’s office said on Aug. 16 that “all healthcare workers in New York State, including staff at hospitals and long-term care facilities… including nursing homes, adult care, and other congregate care settings, will be required to be vaccinated against COVID-19 by Monday, September 27.”
When COVID ambushed New York last year, New Yorkers acted, while the Federal Government denied the problem,” Cuomo said at the time. “Now, the Delta variant is spreading across the nation and across New York …”
“Our healthcare heroes led the battle against the virus, and now we need them to lead the battle between the variant and the vaccine.
“I have strongly urged private businesses to implement vaccinated-only admission policies, and school districts to mandate vaccinations for teachers. Neither will occur without the state legally mandating the actions — private businesses will not enforce a vaccine mandate unless it’s the law, and local school districts will be hesitant to make these challenging decisions without legal direction.”
Health care workers filed a lawsuit over the mandate, which led to Tuesday’s ruling that religious exemptions must be allowed, Spectrum News reported.
U.S. District Judge David Hurd of the Northern District of New York, in a 27-page ruling, banned any retaliation by state health officials against health care workers who do not want to be vaccinated due to religious reasons.
“The Department of Health is barred from taking any action, disciplinary or otherwise, against the licensure, certification, residency, admitting privileges or other professional status or qualification of any of the plaintiffs on account of their seeking or having obtained a religious exemption from mandatory COVID-19 vaccination,” Hurd said in his decision.
The ruling also protects companies from facing any punishment from the state for employing unvaccinated health care workers who do receive an exemption.
The lawsuit against the state was led by 17 health anonymous care professionals, WROC-TV reported.
It argued that “[p]laintiffs hold the sincere religious belief that they ‘cannot consent to be inoculated … with vaccines that were tested, developed or produced with fetal cell[ ] line[s] derived from procured abortions.
Melanie Franco, the attorney for the plaintiffs, commented on the lawsuit in September.
“Health care workers could still get medical exemptions, but not religious exemptions. Their arguments are that it goes against not only the constitution but also the New York State Human Rights Law,” Franco said, according to WROC.
The outlet reported that Hurd said he would welcome an appeal to his decision in favor of the state’s health care workers.
“[The ruling has] nothing to do with how an individual employer should handle an individual employee’s religious objection to a workplace vaccination requirement. But they have everything to do with the proper division of federal and state power,” the judge said.
“Because the issues in dispute are of exceptional importance to the health and the religious freedoms of our citizens, an appeal may very well be appropriate,” he said.
Democratic New York Gov. Kathy Hochul was listed as a defendant in the lawsuit, as was state Attorney General Letitia James.
By JIM VERTUNO, Associated Press – Yesterday 10-11-21 6:54 PM
AUSTIN, Texas (AP) — Texas Gov. Greg Abbott issued an executive order Monday to prohibit any entity, including private business, from enforcing a COVID-19 vaccine mandate on workers and called on state lawmakers to pass a similar ban into law.
The move comes as the Biden administration is set to issue rules requiring employers with more than 100 workers to be vaccinated or test weekly for the coronavirus. Several major companies, including Texas-based American Airlines and Southwest Airlines, have said they would abide by the federal mandate.
“No entity in Texas can compel receipt of a COVID-19 vaccine by any individual, including an employee or a consumer, who objects to such vaccination for any reason of personal conscience, based on a religious belief, or for medical reasons, including prior recovery from COVID-19,” Abbott wrote in his order.
Abbott, who was previously vaccinated and also later tested positive for COVID-19, noted in his order that “vaccines are strongly encouraged for those eligible to receive one, but must always be voluntary for Texans.”
Texas has seen a recent decrease in newly reported COVID-19 cases and hospitalizations. But a rising death toll from the recent surge caused by the delta variant has the state rapidly approaching 67,000 total fatalities since the pandemic began in 2020.
The governor added the issue to the agenda for lawmakers to address during the ongoing special session Abbott called for redrawing voting maps and new restrictions on transgender student athletes. Montana has passed a law preventing employers from mandating workers get vaccines, and a number of states have explicitly said schools cannot require vaccinations.
Abbott previously barred vaccine mandates by state and local government agencies, but until now had let private companies make their own rules for their workers. It was not immediately clear if Abbott’s latest executive order would face a quick court challenge.
Abbott’s new order also carries political implications. The two-term Republican is facing pressure from two candidates in next year’s GOP primary, former state Sen. Don Huffines and former Florida Congressman and Texas state party chairman Allen West, have attacked Abbott’s COVID-19 policies and have strongly opposed vaccine mandates.
“He knows which the way the wind is blowing. He knows conservative Republican voters are tired of the vaccine mandates and tired of him being a failed leader,” Huffines tweeted.
West recently tested positive for COVID-19. He was briefly hospitalized, but also tweeted he remains opposed to vaccine mandates. West announced Monday on his social media accounts that he had returned home.
October 11, 2021 – The beginning of the traditional flu season is upon us, and experts are urging Americans to get their flu shots to prevent further potential strain on hospitals in the coming months.
“None of us can predict whether it will be mild, moderate or severe flu season, but we are certain that there will be flu activity. We certainly don’t want a twindemic, both COVID and influenza,” William Schaffer, medical director of the National Foundation for Infectious Diseases, told The Washington Post.
A survey conducted by the National Foundation of Infectious Diseases found that 44% of US adults are “unsure or do not plan to get vaccinated against flu, including 1 in 4 of those at higher risk of flu complications.” With some evidence pointing to a potentially severe flu season, health authorities are concerned about the potential ramifications of people not getting the flu vaccine.
There are even more opportunities for the flu virus to spread this year in reopened schools and workplaces, especially if there are no active mask mandates. Additionally, hospitals are strained more than ever before with workforce shortages and supply disruptions.
In a briefing on flu vaccination efforts, Centers for Disease Control and Prevention Director Rochelle Walensky said, “This low flu activity was likely due to the widespread implementation of COVID-19 preventive measures like masks, physical distancing and staying home. Because of so little disease last year, population immunity is likely lower, putting us all at risk of increased disease this year.”
September 24, 2021 – Shortages of medical supplies like masks and gloves that marked the early days of the COVID-19 pandemic have spread to a host of other items needed at medical facilities in the U.S., from exam tables and heart defibrillators to crutches and IV poles, reports Reuters.
It can now take up to five months to get some types of exam tables, for instance, compared to three to six weeks before the pandemic, according to CME Corp (Warwick, RI), a distributor of medical equipment that handles over 2 million products.
Shortages of raw materials, including plastics, metals, glass, and electronics, have hampered production. In the case of exam tables, tight supplies of electronic controllers, metal, and even the foam padding used to build them are hampering producers, Cindy Juhas, chief strategy officer for CME Corp said.
The shortfalls – which coincides with a hospital staffing squeeze that is forcing some facilities to ration care during the latest surge in COVID cases – are part of a larger supply-chain disruption that has hampered the movement of goods around the world in the wake of the pandemic.
Many of the items in short supply have nothing to do with treating COVID. At CME, heart defibrillators that used to take two weeks to deliver now require three months.
“They normally have all the parts, so they put them together and put it on a truck,” she said. “But now they’re just waiting for parts.”
Even mundane items are snagged. Portable plastic toilets – used in hospital rooms so patients don’t have to walk to the bathroom – now are back-ordered three to four months. “That’s an item you usually can order and get right away,” said Juhas, who said she expects the larger array of supply problems to linger well into next year.
CARLSBAD, Calif., Sept. 1, 2021 /PRNewswire/ — Thermo Fisher Scientific’s clinical sequencing business and AstraZeneca today announced they will co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca’s expanding portfolio of targeted therapies. The companies will collaborate under a multiyear, global agreement.
“As the pipeline of targeted therapies expands, the availability of diagnostic tools that can interrogate multiple biomarkers simultaneously will ensure patients can be matched with the right therapies more rapidly – this is the promise of precision medicine,” said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “Introduction of diagnostic tools early in the process of drug development can further facilitate the success of companion diagnostic development – and that’s what we’re doing with AstraZeneca.”
NGS-based companion diagnostics are increasingly used to match patients with new therapies for cancer and other diseases. More than 90 percent of AstraZeneca’s clinical pipeline, across all main areas from oncology, cardiovascular and renal to metabolic and respiratory disease, are targeted precision medicine therapies.
“Using the latest diagnostic science allows us to match the best treatment to the patient,” said Ruth March, senior vice president, precision medicine and biosamples, AstraZeneca. “This collaboration with Thermo Fisher offers the technology, expertise and ability to decentralize CDx tests to local healthcare providers across our global markets, which will help us identify more patients around the world who may benefit from treatments and effective patient care.”
Thermo Fisher currently offers the only globally distributable NGS CDx solution approved and reimbursed by government and commercial insurers in more than 15 countries, including the U.S., multiple European nations, Japan, South Korea and the Middle East, and covering more than 550 million lives globally.
To expand global access to a growing list of precision medicine therapies, in 2019 Thermo Fisher introduced the Ion Torrent Genexus System*, the first fully-integrated NGS platform featuring an automated specimen-to-report workflow that economically delivers results in a single day. The company’s complete NGS workflow, powered by Ion AmpliSeq technology, includes multiple solutions for solid tumor biomarkers and liquid biopsy testing.
*Currently for Research Use Only. Not for use in diagnostic procedures.
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
CARLSBAD, Calif., Aug. 16, 2021 /PRNewswire/ — Thermo Fisher Scientific, the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0, both highly accurate assays designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants.
Both PCR-based kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes COVID-19. This built-in redundancy helps ensure accuracy of results in situations where gene expression in the virus vary as new mutations emerge.
“The Delta variant is just the latest example of how SARS-CoV-2 mutations can have a major impact on the efficacy of global pandemic management,” said Manoj Gandhi, senior medical director for genetic testing solutions, Thermo Fisher Scientific. “We are working to keep laboratories, public health officials and communities one step ahead of the virus, and these tests play a key role, alongside our full menu of diagnostic solutions, in supporting that effort.”
The TaqPath COVID-19 Fast PCR Combo Kit 2.0 assesses raw saliva and uses a simple workflow from sample collection direct to PCR to help preserve supplies. Results are returned in about two hours to enable broad, high-frequency testing.
The TaqPath COVID-19 RNase P Combo Kit 2.0 is designed with an approximate three-hour turnaround time and can detect SARS-CoV-2 from individuals suspected of COVID-19 by their health care provider, as well as from patients who are asymptomatic.*
The first generation TaqPath COVID-19 Combo Kit received EUA from the FDA in March 2020. For more information on the TaqPath platform, please visit: www.thermofisher.com/covid19evolved
For In Vitro Diagnostic Use. For Emergency Use Authorization Only | Rx Only
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
* when tested twice over 2 or 3 days with at least 24 hours (and no more than 36 hours) between tests.
RICHMOND, Va.–(BUSINESS WIRE)–Aug. 16, 2021– Owens & Minor today announced a new online emergency tracker as part of its comprehensive emergency preparedness and response offerings. Owens & Minor piloted the new feature in early July to support customers in their advance preparations as Tropical Storm Elsa gained strength in Florida and up the east coast. Now, with Tropical Storm Fred causing rain and flooding in the Florida panhandle, and Tropical Depression Grace threatening the Atlantic, the tracker is once again live to serve customers who may be impacted. The emergency preparedness tracker features a scrolling alert that includes up-to-date storm information and impacts as well as additional content detailing Owens & Minor’s preparedness and response plans enacted to support healthcare customers.
The Richmond-based company has consistently made emergency readiness and response a point of pride, with the safety of frontline teammates a top priority that enables its ongoing ability to serve the healthcare community. Beyond its emergency response activities during hurricanes, floods, wildfires, and other natural disasters, Owens & Minor has protocols to navigate other uncertain or evolving situations. For example, in instances when customers experience cybersecurity threats at their location, Owens & Minor has protocols that facilitate medical supply orders outside the system so that product flow is not interrupted.
“What’s extraordinary about Owens & Minor is the level of preparation and resourcefulness we use for any contingency, no matter how uncertain or unpredictable,” said Jeff Jochims, EVP, Chief Operating Officer and President, Medical Distribution at Owens & Minor. “Many years ago, during Hurricane Katrina, our distribution team rented amphibious duck boats to navigate flooded roads and deliver products to our hospital customers. Throughout COVID-19, O&M teammates worked around the clock to manufacture and distribute critical supplies through multiple hurricanes that severely impacted large portions of the United States.”
The emergency tracker adds to Owens & Minor’s suite of proactive, customized, and actionable preparedness offerings that enhance customer response capabilities and help minimize disruptions. The tracker appears on Owens & Minor’s website on an as-needed basis to keep customers informed throughout rapidly changing situations.
“As a healthcare company, our emergency response and preparedness plans are foundational to our ability to deliver on our Mission of Empowering Our Customers to Advance Healthcare™,” said Jochims. “We believe that our thorough and advanced preparation empowers our ability to maintain business continuity and to serve our customers. This latest tool in our emergency protocol will bring valuable, timely updates to customers and members of the healthcare industry as we collectively focus on supporting patient care in every situation.”
Owens & Minor, Inc. (NYSE: OMI) is a global healthcare solutions company that incorporates product manufacturing, distribution support and innovative technology services to deliver significant and sustained value across the breadth of the industry – from acute care to patients in their home. Aligned to its Mission of Empowering Our Customers to Advance Healthcare™, more than 15,000 global teammates serve over 4,000 healthcare industry customers. A vertically-integrated, predominantly Americas-based footprint enables Owens & Minor to reliably supply its self-manufactured surgical and PPE products. This seamless value chain integrates with a portfolio of products representing 1,200 branded suppliers. Operating continuously since 1882 from its headquarters in Richmond, Virginia, Owens & Minor has grown into a FORTUNE 500 company with operations located across North America, Asia, Europe, and Latin America. For more information about Owens & Minor, visit owens-minor.com, follow @Owens_Minor on Twitter and connect on LinkedIn at www.linkedin.com/company/owens-&-minor.
August 2, 2021 – COVID infections in the United States spiked at an unprecedented rate during July. At one point mid-month, new cases surged 70% from one week to the next. The South suffered greater than the rest of the country, with Florida and Texas accounting for nearly one-third of all new infections reported during July. Nonetheless, underlying trends point to slowing infection spread and perhaps declining new daily cases within a few weeks.
The following charts illustrate the rapid growth in new infections. Since reaching a pandemic low on June 21, new daily infections increased more than five-fold in 40 days. The current rate exceeds last summer’s peak yet, remains only a third of its early January peak.
Infections have surged across the country. Comparing infection rates from just two weeks ago to now demonstrates how quickly the virus has spread.
Fortunately, surging infections have not resulted in comparable spikes in hospitalizations or deaths with COVID. The daily average death total rose by one-third in the past three weeks – a pace 70% slower than the preceding infection growth. Similarly, despite infections more than five times higher than a month ago, COVID hospital census “only” doubled.
Still, the virus is stressing hospitals and staff in several parts of the country.
Eight states are devoting at least one of every five inpatient beds to treating COVID patients. Nevada (49% of inpatient beds occupied by COVID patients) and Florida (46%) are under the most significant stress.
In Alabama, Arkansas, Georgia, Louisiana, Missouri, and Texas, rates vary between 20-24%.
Nationwide, 14% of inpatient beds are in use by COVID patients.
How long will this surge last?
Over the weekend, Dr. Anthony Fauci posited that infections would continue to spike in the United States. Conversely, Dr. Scott Gottlieb, former head of the FDA, hypothesized those daily infections would recede within two to three weeks.
They both may be right.
Each COVID infection surge has followed a similar pattern: infections accelerate for several weeks before falling back to pre-surge levels. The most prolonged surge in the United States occurred from September 2020 through early January. Notably, there were no vaccines available to moderate this surge. Most waves here and in other countries have lasted one to two months.
The Delta variant produced intense surges in both India and the United Kingdom. In both countries, the waves lasted about two months. Further, both countries experienced rapid ascending infections, followed by similarly quick descending infections.
The following chart illustrates infection rates in Israel, the United Kingdom, and the United States. The infection surge in the United Kingdom commenced about one month earlier than in Israel and the United States. Lasting about two months, the United Kingdom’s wave peaked on July 21. New infections then plunged by half in just eleven days.
Will the United States (and Israel) follow a similar pattern as the United Kingdom? Doing so would mean that infections would surge for another three weeks or so, with daily infections significantly higher than today (supporting Dr. Fauci’s projection). Nonetheless, these countries could gain relief in the form of declining new infections by the third week of August (supporting Dr. Gottlieb’s expectation).
We found evidence corroborating Drs. Fauci’s and Gottlieb’s views. When analyzing past surges, we discovered that a coming peak in new cases is “telegraphed” weeks in advance. The key comes in watching the rate at which new cases increase each day. Early in each surge, new cases grow at an increasing rate every day (no doubt reflecting the high transmission rate of the virus). However, this rate starts decelerating during the middle of the surge. The deceleration point is the signal that declining new cases are on the horizon. (Of course, new cases still increase for several weeks, just at a slower rate. Ultimately, this slowdown translates to declining new cases.)
The chart below illustrates how this pattern is underway in the United States. The rate of increase in new cases began dropping on July 15. This followed four weeks of accelerating new cases. Should this pattern continue, we can reasonably assume that new cases could peak in the next few weeks.
We also depict the experiences in Florida and Texas, as these states accounted for one-third of all new cases in the United States in July. Like the United States as a whole, Florida saw its rate of infection increase peak on July 15. Texas’s peak occurred a few days later.
Of note, the Institute for Health Metrics and Evaluation’s (IHME’s) latest projection has Florida’s new cases peaking this Wednesday and Texas’ by August 13. Stress on the healthcare system continues for another few weeks: IHME predicts that the COVID census in each state will not peak until at least two weeks after new infections begin to fall.
In sum, the Delta variant will continue to drive new infections in the United States for at least a few more weeks. However, by mid-to-late August, we could begin to see some relief.
Contributing writer:
Mark A. Van Sumeren, strategic advisor, Medical Devices & Integrated Delivery Networks
Health Industry Advisor LLC, provides a regular report on COVID-19 numbers for the health care industry.
