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Alia Paavola – Friday, May 28th, 2021

Several large employers, including Amazon, JPMorgan Chase and Walmart, have deepened their presence in healthcare. 

Below is a breakdown of the most recent stories about those moves, as reported by Becker’s Hospital Review. 

Amazon

1. Amazon considering building brick-and-mortar pharmacies, report says
Amazon is considering building brick-and-mortar pharmacies, according to a May 26 report from Insider that cited three anonymous people familiar with the matter.  

2. Amazon plans expansion into diagnostics
Amazon is planning to launch a business that will offer at-home medical tests.

3. Amazon launches digital mental health program for US employees: 5 details
Amazon rolled out a new mental health benefit May 20 for its 950,000 U.S. employees, giving them and their families access to services such as virtual counseling. The program is dubbed Resources for Living.

4. Amazon to roll out health, wellness program to all US employees by 2022 
Amazon will launch WorkingWell, a program that gives employees physical, mental and nutritional support, across its entire U.S. operations network by the end of 2021.

5. Amazon Care secures first enterprise client
Amazon Care, the e-commerce giant’s new healthcare venture, signed its first enterprise client.

Google

1. Google, HCA partner for health algorithms: 7 things to know
HCA Healthcare inked a multiyear collaboration with Google Cloud focused on building a health data analytics platform to support the Nashville, Tenn.-based system’s clinical and operational workflow.

2. Google, Northwestern Medicine partner to develop AI tool to triage breast cancer patients
Google and Chicago-based Northwestern Medicine are teaming up to develop an artificial intelligence tool to support clinician work by triaging mammography patients.

3. Google, Gilead, Morehouse & more launch health disparity tracker
Atlanta-based Morehouse School of Medicine on May 26 launched its Health Equity Tracker, a data platform showing the disparate effects COVID-19 has brought upon people of color and those with a lower socioeconomic status. The data tracker is funded by Google, Gilead, Annie E. Casey Foundation and CDC Foundation. 

JPMorgan Chase

1. JPMorgan launches healthcare company, Morgan Health
JPMorgan Chase on May 20 unveiled its new healthcare company, dubbed Morgan Health, which its top executive told Becker’s Hospital Review can be viewed as a continuation of Haven, an ambitious healthcare venture that recently disbanded. 

2. JPMorgan seeks finance leader for new health business
JPMorgan Chase is seeking a vice president of finance and business management for Morgan Health, its new healthcare company focused on improving the quality of healthcare in the U.S.

Tyson Foods

1. Tyson Foods opens 1st medical clinic for employees
Tyson Foods opened its first medical clinic for employees in Dyersburg, Tenn., the company said May 5.

Walmart

1. Walmart to bring telehealth nationwide with acquisition of MeMD: 8 details
Walmart Health has entered an agreement to acquire on-demand, multispecialty telehealth provider MeMD, the retailer said May 6.

2. Walmart partners with telehealth startup Ro: 4 things to know
Ro, a direct-to-consumer telehealth app for pharmacy services, inked its first retail collaboration with Walmart, the companies announced April 28. 

3. Walmart to launch digital records for COVID-19 vaccine recipients
Walmart will make COVID-19 vaccination records available digitally for those who receive shots at Walmart and Sam’s Club, the retailer announced March 17.

4. Walmart heir to build medical school in Arkansas
Walmart heir Alice Walton said she plans to finance and build a medical school in northwest Arkansas. The Whole Health School of Medicine in Bentonville will be a nonprofit, independent entity.

Morgan Haefner  Becker Healthcare News

May, 17, 2021

Texas Attorney General Ken Paxton filed a lawsuit against the Biden administration May 14, alleging that its decision to revoke a state Medicaid funding waiver was an unlawful “power grab.” 

In April, CMS rescinded approval for a Section 1115 waiver amendment that would have extended reimbursement to Texas hospitals for uncompensated care through September 2030. The Biden administration said that under the previous administration, CMS and Texas failed to adhere to public comment period requirements in the approval process. CMS argued that the public comment period is necessary for stakeholders to share feedback.

In a May 14 news release accompanying the lawsuit, Mr. Paxton said, “the Biden Administration cannot simply breach a contract and topple Texas’s Medicaid system without warning. … Not only does this violate agency regulations and threaten to rip a $30 billion hole in Texas’s budget, it was clearly intended to force our state into inefficiently expanding Medicaid under the Patient Protection and Affordable Care Act.”

Texas has had an extension for its 1115 waiver agreement since 2011, according to The Texas Tribune. The current waiver is set to expire in October 2022.

Maia Anderson Becker Healthcare

Pfizer said May 4 that it will file for full FDA-approval of its COVID-19 vaccine by the end of this month. But what does full approval mean, and will it change the vaccine rollout? 

Seven things to know: 

1. To get full FDA approval, drugmakers have to submit six months of data, according to ABC 10News San Diego.
2. It typically takes the FDA about six months to review an application for full approval of a high-priority drug. Pfizer has said it expects a decision from the FDA in the second half of this year.
3. Gaining full approval would allow Pfizer to market the vaccine directly to consumers.
4.  Full approval will allow the vaccine to remain on the market after the pandemic is over, according to The New York Times.
5. Colleges, universities and companies are legally allowed to require their students or employees to get the vaccine if it’s fully approved, ABC 10News reported. The University of California and California State University school systems have said that once COVID-19 vaccines are fully approved, they will require students, faculty and staff members to be vaccinated, the Times reported. The U.S. military has also said it wouldn’t make vaccines mandatory as long as they only have emergency authorization.
6. Full approval could make it harder for other drug companies to get an emergency use authorization for their COVID-19 vaccines. Federal law says companies can only get emergency authorization if there’s “no adequate, approved and available alternative,” according to ABC 10News. To get emergency authorization for a new COVID-19 vaccine, drugmakers would have to prove their shot is better at tackling virus variants or better for certain populations.
7. Full approval could help boost confidence in the vaccine, especially in people who are worried about how quickly it was developed, according to the Times.

   “I think people still have concerns about it, even if they know that no corners were cut. It will nudge people to say, ‘OK, it’s been thoroughly vetted,'” Rupali Limaye, a public health researcher at Johns Hopkins, told the Times. 

April 12, 2021 — CHELMSFORD, MASS. — ZOLL^® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that it has acquired Respicardia, Inc., a provider of novel implantable neurostimulators for the treatment of moderate to severe Central Sleep Apnea (CSA). CSA is a serious condition that is often associated with heart failure, coronary artery disease, and certain cardiac arrhythmias.

Respicardia’s remedē^® System is a revolutionary treatment for CSA, and is the only implantable device approved by the U.S. Food and Drug Administration (FDA) to treat moderate to severe CSA in adult patients with reduced cardiac function.¹ CSA results in shallow or disrupted breathing during sleep, and many patients with CSA also have heart disease, especially heart failure.² Within this population, patients with CSA are at increased risk for hospitalizations and even death.^3,4

“ZOLL and Respicardia both develop innovative therapies for conditions with large unmet clinical needs, and we share a deep commitment to improving patient outcomes,” said Jon Rennert, CEO of ZOLL Medical. “With this acquisition, ZOLL will combine its expertise in cardiac and respiratory care with Respicardia’s novel remedē^® System to make a meaningful difference in the health and quality of life for many patients.”

CSA occurs when the brain fails to send appropriate signals to the breathing muscles that stimulate a regular breathing pattern. CSA symptoms include chronic fatigue, excessive daytime sleepiness, cognitive impairment and inability to get restful sleep. CSA is distinct from Obstructive Sleep Apnea (OSA), which results from a blockage of the upper airway.⁵

Respicardia’s remedē^® System is implanted by a cardiac electrophysiologist during a minimally invasive outpatient procedure. The remedē^® System delivers electrical pulses to one of the phrenic nerves, which send signals to the diaphragm, restoring a more normal breathing pattern during sleep. Respicardia estimates there are more than one million CSA patients in the U.S. alone who could benefit from the remedē^® System,⁶ which has been shown to improve sleep, enhance well-being, and reduce daytime sleepiness, enabling better overall health.⁷

“Respicardia is excited to be joining the ZOLL family,” said Peter Sommerness, CEO of Respicardia. “As an innovator of safe and effective therapies that address the unmet needs of respiratory and cardiovascular patients, we see tremendous potential ahead with the support of ZOLL’s strong brand and global reach.”

ZOLL, which has been a significant investor in Respicardia for more than three years, will welcome all Respicardia employees into its global workforce, and will maintain Respicardia’s current headquarters in Minnetonka, Minnesota.

About ZOLL Medical Corporation

ZOLL Medical Corporation, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.

Copyright © 2021 ZOLL Medical Corporation. All rights reserved. ZOLL is a registered trademark of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

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April 12, 2021  –  Thermo Fisher Scientific Inc. (Waltham, MA) announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit.

The Amplitude Solution enables clinical and public health laboratories to scale gold standard PCR testing and process up to 8,000 samples in a single day with minimal staffing resources and a secured supply of kits, reagents and consumables to meet their testing needs.

“For population-wide testing programs, lab-based PCR is the best fitting technology, providing confidence in results, capacity to process thousands of samples a day, and consistent, reliable turnaround times. The Amplitude Solution can help support a systematic testing strategy by enabling labs to quickly scale their testing and begin processing high-volume samples, even with limited personnel,” said Mark Stevenson, EVP and COO of Thermo Fisher Scientific.

The Amplitude Solution is a molecular diagnostic testing system that helps clinical labs expand testing capacity by combining Thermo Fisher’s extraction and real-time PCR instruments with liquid handling products from Tecan Group.

The company says that the modular system utilizes a high-throughput version of Thermo Fisher’s Applied Biosystems TaqPath COVID-19 Combo Kit, which received EUA in March 2020, to process samples in four steps with minimal hands-on time and laboratory space requirements.

The kit’s multi-gene target design and updated interpretive software may help labs detect SARS-CoV-2 variants, Thermo Fisher Scientific said.

Learn More

Filed Under: Repertoire’s Dail-eNews

WSJ April 12, 2021

A deal could value medical-supply company at as much as $30 billion

Medline Industries Inc. is exploring a sale that could value the big medical-supply company at as much as $30 billion and mark the latest in a recent string of large leveraged-buyout bids.

The family-owned company has hired Goldman Sachs GS +0.08% Group Inc. to run the process, according to people familiar with the matter. There is no guarantee the company will ultimately be sold. The process is at an early stage, the people said, with some adding that an IPO or minority investment is also a possibility.

Northfield, Ill.-based Medline is likely to attract private-equity bidders, partly because industry players could struggle to swallow such a big rival, the people said.

Blackstone Group Inc., BX +0.03% KKR KKR +0.80% & Co. and Carlyle Group Inc. CG -0.24% are among those expected to consider bids, some of the people said, and they could ultimately partner up given the size of the deal.

Medline manufactures and distributes medical equipment and supplies used in hospitals, surgery centers, acute-care and other medical facilities in over 125 countries. It had $17.5 billion in annual sales, according to its website.

The company’s products include surgical gowns, examination gloves and diagnostic equipment used in medical settings as well as a few consumer-facing brands such as Curad bandages. The company says its drapes and gowns are used in eight million procedures in the U.S. a year.

Founded in 1966 by brothers James and Jon Mills, the company’s roots date to 1910 when their grandfather, A.L. Mills, started sewing butcher aprons in Chicago. He was approached by nuns who worked at a nearby hospital and he offered to help them with sewing surgeons’ gowns and nurses’ uniforms, according to the website.

The company went public in 1972, but the Mills brothers bought back the shares five years later after concluding investors were undervaluing it.

James Mills, who served for many years as Medline’s CEO, died in 2019. His son Charlie took over as CEO in 1997 and currently holds the position.

Write to Miriam Gottfried at Miriam.Gottfried@wsj.com and Cara Lombardo at cara.lombardo@wsj.com

Copyright ©2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

Appeared in the April 12, 2021, print edition as ‘Medline Explores Sale With Value Near $30 Billion.’

Katie Adams – Monday, March 22nd, 2021

A cost-cutting change in Medicare policy will reduce payments to hospitals for some surgical procedures and increase costs for patients, according to a March 21 report from the The Washington Post.

Before the change, CMS categorized 1,740 surgeries and other services as “inpatient only,” meaning they were eligible for Medicare payments only if they were performed on beneficiaries who were admitted to the hospital as inpatients.

The new rule phases out this requirement. On Jan. 1, 266 musculoskeletal surgeries were taken off the inpatient-only list, and by the end of 2023, the list is scheduled to no longer exist. 

Then-CMS Administrator Seema Verma said the change would give seniors and their physicians more care options “without micromanagement from Washington,” according to the Post.

Although the government is phasing out the inpatient-only list, CMS has yet to approve many of the services on the list to be performed in other settings. As a result, patients will still visit hospitals to receive these services. However, with the reclassification, patients who have the procedures in hospitals would be billed for the services on an outpatient basis. 

The agency pays hospitals less for services provided to outpatients, so the elimination of the list means CMS can pay less than it has been for the same surgeries at the same hospitals. Most of the time, it also means Medicare beneficiaries will be responsible for a larger portion of the bill, according to the Post.

Patients who are admitted to a hospital usually receive a package of services and are responsible to pay for 20 percent of physicians’ charges and Medicare’s hospital deductible, which is $1,484 for a stay of up to 60 days this year. 

On the other hand, patients receiving outpatient services typically pay 20 percent of the Medicare-approved rate for each service and 20 percent of physicians’ charges, according to the Post. 

In most cases, each charge cannot exceed the Medicare deductible, but CMS told beneficiaries that “the total copayment for all outpatient services may be more than the inpatient hospital deductible.”

Patients who receive care as outpatients at hospitals could also be hit with a separate fee for overhead costs and higher charges for drugs because Medicare prescription drug plans don’t pay for routine medications ordered for hospital patients, according to the report.

Editor’s note: This article was updated at 12:15 p.m. central March 23. 

Beckers Hospital Review

March 26, 2021  –  Thermo Fisher Scientific Inc. (Waltham, MA) has launched the Thermo Scientific AerosolSense Sampler, a new surveillance solution designed to deliver fast and highly reliable insight into the presence of in-air pathogens, including SARS-CoV-2.

The AerosolSense Sampler is an in-air pathogen surveillance solution, which collects representative aerosol samples of ambient air and traps in-air pathogens on a collection substrate. The sample can be readily analyzed through subsequent laboratory testing using polymerase chain reaction (PCR) methodology.

“Such factors as emerging variants, semi-vaccinated populations and varying levels of compliance with COVID-19 personal safety protocols, continue to pose risks to a society looking to return to life as it was before the pandemic,” said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. “It is important that easy-to-use, highly reliable solutions be available to allow hospitals, nursing homes, schools, businesses and government institutions to identify the presence of in-air pathogens quickly, so safety protocols can be put into action, validated, or strengthened.”

Thermo Fisher designed the AerosolSense Sampler to capture a wide variety of in-air pathogens and has specifically validated it for the SARS-CoV-2 pathogen.

 Repertoire’s Dail-eNews

IRVING, Texas, March 1, 2021 — As a centralized distribution partner for the U.S. government’s COVID vaccine distribution effort, McKesson today began distributing the COVID-19 vaccine received from Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The Janssen vaccine received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on Feb. 27 and is the first one-shot COVID-19 vaccine to be authorized for use in the United States.

McKesson was selected by the U.S. government in August 2020 to operate as the centralized distributor for frozen and refrigerated COVID-19 vaccines and ancillary supply kits needed to administer them. In December 2020, McKesson began distributing the ancillary supply kits for Pfizer BioNTech’s COVID-19 vaccine. Later that month, the company began distributing Moderna’s COVID-19 vaccine and ancillary supply kits.

McKesson has established four dedicated distribution centers which will be specifically used to distribute the Johnson & Johnson COVID-19 vaccine and future refrigerated vaccines. The U.S. government makes all program administration decisions, including where, when and how many vaccine doses McKesson will distribute.

Key facts include:

• McKesson, a global leader in healthcare and supply chain management, is managing two different aspects of the distribution efforts in coordination with the U.S. government. The company is producing all supply kits for COVID-19 vaccines, as well as distributing frozen and refrigerated COVID-19 vaccines. McKesson is not distributing the Pfizer ultra-frozen vaccine.
• From a distribution perspective, McKesson continues to stay on target to meet the U.S. government’s plan to ultimately distribute hundreds of millions of frozen and refrigerated vaccine doses.
• Regardless if it is a frozen or refrigerated vaccine, maintaining the cold chain is a priority. Upon arrival at a McKesson vaccine distribution center, McKesson will verify that the vaccines were maintained at the proper temperature while in transit and will place the vaccines inside either a large-scale, pharmaceutical-grade refrigerator or freezer designed to maintain proper temperatures.
• Both the refrigerators and freezers are equipped with sophisticated controls, monitoring systems and alarms intended to ensure the vaccines remain within the appropriate temperature ranges.

After receiving orders from the Centers for Disease Control and Prevention (CDC), vaccine doses will be packed inside insulated coolers which are designed differently for frozen and refrigerated vaccines. A temperature monitor is placed inside the coolers so the administration site can verify that the vaccine doses stayed within the required temperature range during transit.

• For the Johnson & Johnson and Moderna COVID-19 vaccines, the ancillary supply kit normally will be sent before or at the same time as the vaccines. The kits include alcohol prep pads, face shields, surgical masks, needles and syringes, a vaccine administration sheet, and a vaccine record and reminder card.
• Once McKesson receives new vaccine and ancillary supply kit orders from the U.S. government, most orders are shipped by our partners FedEx or UPS within 1-2 business days to the specified point-of-care facilities nationwide. McKesson works seven days a week to fulfill all orders.
• McKesson’s medical and pharmaceutical supply chain operates separately from the COVID-19 vaccine program – allowing us to provide the focused support needed to meet the needs to vaccinate Americans throughout the country.
• McKesson has a long history of managing the pharmaceutical and medical supply chain in the U.S., as well as handling vaccines. The company has been the centralized distributor for the CDC’s Vaccines for Children program since 2006 and during the H1N1 public health crisis in 2009.

McKesson partners closely with the CDC and the U.S. Department of Health and Human Services (HHS). For the ancillary supply kit production and distribution, McKesson has partnered with the Strategic National Stockpile, which is part of the Office of the Assistant Secretary for Preparedness and Response within HHS

By MIKE STOBBE

NEW YORK (AP) — February 25, 2021

February is usually the peak of flu season, with doctors’ offices and hospitals packed with suffering patients. But not this year.

Flu has virtually disappeared from the U.S., with reports coming in at far lower levels than anything seen in decades.

Experts say that measures put in place to fend off the coronavirus — mask wearing, social distancing and virtual schooling — were a big factor in preventing a “twindemic” of flu and COVID-19. A push to get more people vaccinated against flu probably helped, too, as did fewer people traveling, they say.

Another possible explanation: The coronavirus has essentially muscled aside flu and other bugs that are more common in the fall and winter. Scientists don’t fully understand the mechanism behind that, but it would be consistent with patterns seen when certain flu strains predominate over others, said Dr. Arnold Monto, a flu expert at the University of Michigan.

Nationally, “this is the lowest flu season we’ve had on record,” according to a surveillance system that is about 25 years old, said Lynnette Brammer of the U.S. Centers for Disease Control and Prevention.

Hospitals say the usual steady stream of flu-stricken patients never materialized.

At Maine Medical Center in Portland, the state’s largest hospital, “I have seen zero documented flu cases this winter,” said Dr. Nate Mick, the head of the emergency department.

Ditto in Oregon’s capital city, where the outpatient respiratory clinics affiliated with Salem Hospital have not seen any confirmed flu cases.

“It’s beautiful,” said the health system’s Dr. Michelle Rasmussen.

The numbers are astonishing considering flu has long been the nation’s biggest infectious disease threat. In recent years, it has been blamed for 600,000 to 800,000 annual hospitalizations and 50,000 to 60,000 deaths.

Across the globe, flu activity has been at very low levels in China, Europe and elsewhere in the Northern Hemisphere. And that follows reports of little flu in South Africa, Australia and other countries during the Southern Hemisphere’s winter months of May through August.

The story of course has been different with coronavirus, which has killed more than 500,000 people in the United States. COVID-19 cases and deaths reached new heights in December and January, before beginning a recent decline.

Flu-related hospitalizations, however, are a small fraction of where they would stand during even a very mild season, said Brammer, who oversees the CDC’s tracking of the virus.

Flu death data for the whole U.S. population is hard to compile quickly, but CDC officials keep a running count of deaths of children. One pediatric flu death has been reported so far this season, compared with 92 reported at the same point in last year’s flu season.

“Many parents will tell you that this year their kids have been as healthy as they’ve ever been, because they’re not swimming in the germ pool at school or day care the same way they were in prior years,” Mick said.

Some doctors say they have even stopped sending specimens for testing, because they don’t think flu is present. Nevertheless, many labs are using a CDC-developed “multiplex test” that checks specimens for both the coronavirus and flu, Brammer said.

More than 190 million flu vaccine doses were distributed this season, but the number of infections is so low that it’s difficult for CDC to do its annual calculation of how well the vaccine is working, Brammer said. There’s simply not enough data, she said.

That also is challenging the planning of next season’s flu vaccine. Such work usually starts with checking which flu strains are circulating around the world and predicting which of them will likely predominate in the year ahead.

“But there’s not a lot of (flu) viruses to look at,” Brammer said.

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