ProMedica’s ‘Non-Growth Market’ Spurred HCR ManorCare Acquisition

The nonprofit health system’s CEO talks about the acquisition of the nation’s second-largest post-acute care company and expectations of surging demand for long-term care and home health services.

ProMedica Health System President and CEO Randy Oostra spoke with HealthLeaders Media about the Toledo-based health system’s $3.3 billion acquisition of HCR ManorCare in a joint partnership with Welltower, the real estate investment trust.

The following is a lightly edited transcript.

HLM: What makes this a good time to acquire HCR ManorCare?

Oostra: Like most systems, we are looking at the future and all the disruption going on, and you realize a lot of the lines are blurred between what we have traditionally done.

Randy Oostra

We are in a non-growth market. How do we grow as a system? How do we begin to diversify? We have a health plan, we have hospitals, we have a physician group. Being more diversified in this space made sense.

Then you look at the trends, whether it’s the number of 85-year-olds, or the numbers of people who are going to get Alzheimer’s, home health numbers, hospice numbers, etc. You see all this massive growth, but the people moving in that space are venture capital companies.

The more we talked to ManorCare as they were going through their issues, it made a lot of sense.  It went from an interesting idea to “why didn’t we do this before?” Plus, they are a locally based company. It gives us scale and opportunities that we hadn’t had before.

HLM: Is ProMedica venturing into post-acute care because of the demographics pressures, or because you anticipate a change in the way care is delivered to seniors?

Oostra: It’s both. Not many Baby Boomers want to go to a hospital. They want to stay home. Who is going to develop those services? Why wouldn’t that be hospitals? The expectations are going to change, so as we delivery these services we are going to have to change as well. It’s exciting to think about, this blurring of the lines.

HLM: Did you buy ManorCare because it was bankrupt, or were you looking to move into post-acute services beforehand?

Oostra: We started discussions two or three years ago, before their more recent issues. We did a partnership on one of our campuses here in Sylvania, Ohio. They have a Heartland facility on our Flower hospital campus. We began discussions even back then that maybe we ought to work together and maybe you ought to be a nonprofit. Their initial reaction was “are you people crazy?”

ManorCare is one of the best operators in this space in the country. We think there are opportunities to get more efficient. We think there are ways to get together through telehealth and urgent care through our physician group, maybe exploring some options with our health plan.

Overnight we went from a $3 billion system to a $7 billion system, from 17,000 to 70,000 employees, from facilities in five states to 30 states. We put a lot of emphasis on the skilled nursing piece, but there are other pieces. The home health piece, assisted living, rehab and hospice pieces are incredibly profitable. We have some ideas about how to grow that.

When we look at what we were able to structure on the SNFs with Welltower, the reduction in lease rates, the balance of what we are able to provide with our current system and the growth in other areas, we became comfortable that in a short period of time we can drive that 3% to 4% operating margin on a larger scale, and that is how we got comfortable that this was a great strategic step for us.

HLM: ManorCare was in Chapter 11. What will you do differently to make it profitable?

Oostra: Right now, with everything from sales taxes to real estate taxes, we’ve done a fair amount of research on how to convert to nonprofit status. We are fairly proximate to one another. In a $7 billion company there are some great opportunities for synergies. Also, the lease rates we will be paying are significantly lower than they were paying in the past. It only takes a couple of those factors to turn them profitable.

In some ways this is not that different as when hospitals merge. You have to look at the same areas, the same management services.

HLM: ManorCare has a significantly larger footprint. How will you coordinate care in outlying facilities that might be several states away from your Ohio base?

Oostra: In some of the states where they have a smaller footprint, maybe we will exit certain markets. In each case we will look at what we can bring that’s consistent with our system and in other cases we will partner locally. It’s going to be on a one-by-one, market-by-market basis. As we work over the next year those are the things we’ll look at.

HLM: What is the status of ManorCare under ProMedica?

Oostra: They are fully part of ProMedica. They will be one of our divisions. They will be our employees. We will own 100% of HCR ManorCare. On the real estate side, we will own 20% of the real estate in a joint venture with Welltower. HCR will be fully integrated in our system.

HLM: Are you in uncharted waters with this acquisition?

Oostra: I hate to say we are in uncharted waters here, but it seems to be a unique, first-of-its-kind partnership. A nonprofit health system, a large post-acute provider and a real estate investment trust as partners is unique.

This is different from other deals we’ve done where you talk through mission, vision, values and culture and then you come to the business model. This was all about the business model, and it had to work because of where they were with this bankruptcy. It’s the opposite of what we’ve done in the past, where you build up to the financial model and that’s toward the end. This was first, and this was all about the economic model. Does it work? Can we exit bankruptcy?

But, we know ManorCare and Welltower. We are confident that we will figure out some of the other stuff as we move along.

HLM: With this acquisition, you will more than double in size. Are there any particular areas in this deal that you view as potentially problematic, and what are you doing about it?

Oostra: The fear is the fear of the unknown. We are all at the mercy of reimbursements. I don’t think the post-acute world can face further reimbursement cuts, especially when you see what’s happened in the past. That’s the sort of thing we worry about the most.

We are comfortable that we can operate and grow, unless something further happens to devastate the financials of skilled nursing facilities.

On the other side, the home health, hospice, assisted living, rehab, memory care, those are all more profitable and if we can grow those while managing the skilled nursing at a break even or better margin we are going to be fine.

HLM: What metrics will you use to determine if you’re succeeding?

Oostra: Right now we are taking a hard look at quality and safety. We would look at many of the metrics for performance in the nursing home world. We’re looking to grow, so financial metrics are important. We talk about balancing out between skilled vs. nonskilled. We will be cognizant in growing in some of the nonskilled areas to balance out the financial portfolio. Those are the first pass metrics.

HLM: Are you nervous about being in the vanguard?

Oostra: We talk a lot in healthcare about how we need to change, how we need to disrupt. But some of the people who would say that would be the first people who will criticize us for doing this. We are in a non-growing market. We have to think nontraditionally.

For most of our careers, once you left the hospital, good luck! We didn’t pay attention until it hit our finances and all of a sudden we were worried about readmissions. We look at this as the next step. If we are going to care for all these people beyond our traditional hospital walls, why wouldn’t we move into that space? Why wouldn’t we do it quicker and why don’t we move in even more. It makes sense to us.

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States Simplifying Physician Health Plan Credentialing

Texas is the latest state to create a simplified physician credentialing system for health plans. The goal is to draw more physicians into Medicaid programs.

The bureaucratic hassle of applying to different health plans is enough to keep some physicians from participating in Medicaid programs where reimbursement levels are lower than private plans, so some state health plan associations are finding ways to streamline the process.

The Texas Association of Health Plans (TAHP) is collaborating with the Texas Medical Association and 19 Medicaid health insurance plans to launch a credential verification organization (CVO) to reduce paperwork for Texas physicians.

Medicaid health plans in the state initiated the effort, responding to physician requests for a simpler process, says Amanda Hudgens, director of special projects with TAHP. The Texas Credentialing Alliance participants include Aetna, Centene, Cigna, UnitedHealth Group, and Blue Cross and Blue Shield of Texas.

“We want to simplify the credentialing process for physicians here in Texas and we’re focusing on Medicaid providers because we understand they have a lot of paperwork burdens and administrative requirements to become a Medicaid provider,” Hudgens says.

She continues, “The intent is to make their lives a little easier. If providers applied to all 19 plans before this program, they would have had to go through 19 different credentialing processes.”

The CVO became operational in April and is required for all Medicaid plans in the state but it is open to commercial plans as well. Participating insurers are expanding it to their commercial health plans, Hudgens says.

Physician participation in the Medicaid program varies across the country, with about 70% of office-based physicians accepting Medicaid, according to data from the Kaiser Family Foundation.

The percentage of physicians accepting new Medicaid patients ranges from 39% in New Jersey to 97% in Nebraska. Texas is in line with the national averages.

The Texas Credentialing Alliance allows physicians and providers to submit credentialing paperwork with multiple Medicaid insurance companies at one time, Hudgens says.

TAHP is working with Aperture, which provides credentialing verification services to the healthcare industry.

The program is expected to lower administrative costs for providers and Medicaid health insurance plans, save time by eliminating paperwork for providers who credential and
recredential separately with multiple Medicaid health insurance plans, and streamline recredentialing dates across multiple health insurance plans for providers.

“Aperture will provide the primary verification on behalf of all the plans, verifying the providers’ credentials, education, [and] malpractice history; vetting that all the information the providers are sending to the plan are accurate,” Hudgens explains. “They will send that information back to the plans and the plans are still going to make the final credentialing decision.”

A key benefit will be creating a single recredentialing date for the provider, Hudgens explains. Rather than the provider having a different expiration and recredentialing date for each health plan, the Texas CVO will create a single date.

“Providers have to be recredentialed every three years and if they were credentialed with 19 different health plans, they probably would have had 19 different dates to keep up with,” Hudgens says. “Aperture consolidates those dates so they only have to keep up with one date moving forward.”

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DOJ Investigating Genomic Health for Compliance Issues With Medicare Billing

In a filing with US Securities and Exchange Commission last week, Genomic Health disclosed that it is being investigated by the United States Department of Justice related to its compliance with the Medicare Date of Service billing regulation.

According to the firm’s 10-Q report, Genomic Health received a civil investigative demand in connection with the matter, and said it “has produced specific documents in response to the CID.”

Under Medicare billing rules, payment for laboratory tests performed on Medicare beneficiaries who were hospital patients at the time that a sample was obtained, and whose tests were ordered less than 14 days from discharge, must be bundled into the payment that the hospital receives for all services provided. In other words, if a doctor takes a sample from a Medicare patient who is in the hospital, and then sends that sample to Genomic Health for an OncotypeDx test more than two weeks after the patient is discharged, the company can bill Medicare directly.  If the test is ordered before then, the hospital is paid by Medicare, and Genomic Health must seek payment from the hospital.

“Such hospitals have generally been unwilling to enter into written agreements with us to assume the financial responsibility for these tests ordered for Medicare beneficiaries and consequently we generally cancel such orders when received within the 14-day timeframe when written agreements from such hospitals are not in place,” Genomic Health wrote in its filing.

Medicare billing rules have also changed recently. Genomic Health wrote that the switch, effective January 1, means that it may now bill Medicare directly for tests performed on beneficiaries who were hospital outpatients at the time the tumor tissue samples were obtained.  But the rule remains unchanged with respect to payment for tests performed on Medicare beneficiaries who were inpatients.

Genomic Health declined to comment further on whether the DOJ investigation relates at all to this shift, or to its practices regarding cancelling test orders as described above. In an email to GenomeWeb, however, a spokesperson said that the company stands by the belief that its billing practices “have always been appropriate and compliant” with Medicare regulations, including the date of service rule that is the focus of this investigation.

“Orders initially submitted within the Medicare date of service rule period and subject to the rule have historically represented less than 3 percent of total Oncotype DX test volume,” and following the changes to the rule that went into effect on January 1, “we anticipate that the percentage of orders impacted will shrink to less than 1 percent of total business for Oncotype DX,” the spokesperson added.

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Big Ag turns to peas to meet soaring global protein demand

Cargill, the global grains trader, sees the future of protein in the humble pea.

In a joint venture at a Wisconsin plant, flour milled from Iowa yellow peas is mixed with water and spun at high speed through stainless steel drums, separating the protein from starch and fiber.

The resulting powder ends up blended into waffle mixes, sports drinks, nutrition bars and protein shakes – small examples of a much larger push by the world’s biggest agriculture firms to find alternative plant-based proteins to feed people and livestock worldwide.

“When we looked at where is the future going, the pea is the up-and-coming thing,” said David Henstrom, Cargill Inc’s vice-president of starches, sweeteners and texturizers.

Peas are in many ways the ideal modern American food: protein-rich, plant-based and gluten-free. While the market remains relatively small, the demand for pea powder and other emerging protein sources is soaring, from the middle classes in China and the health-conscious in California to livestock producers and fish farmers who need to fatten animals on ever-tighter budgets.

Cargill and its competitors – such as Archer Daniels Midland and Richardson International, the biggest Canadian grain handler – are investing in specialty ingredients in search of higher profit margins than they can extract from bigger commodity crops such as soybeans, corn and wheat.

(For a graphic on rising global protein consumption and demand for peas, see: https://tmsnrt.rs/2Hc8Wjw )

Cargill invested an undisclosed sum in January in a joint venture with PURIS, a family-run company that started in Iowa as a seed company and now owns the Wisconsin pea-powder plant. The two firms are also working to boost the protein content in peas through cross-breeding, which has not been previously reported.

Cargill rival ADM is building its own pea processing plant in North Dakota and signing contracts with farmers to buy and grow yellow peas, Ken Campbell, ADM’s president of specialty ingredients, said in a statement to Reuters. Company researchers are also studying another 30 types of protein options, including nuts and seeds.

Other firms are trying draw more protein from canola, oats and many other so-called emerging proteins, and Cargill has explored insect-based feed for fish and poultry.

Seed and chemical firm DowDuPont Inc told Reuters it plans to launch a canola seed supercharged with protein through traditional cross-breeding as soon as next year.

Richardson International started construction in April of a C$30-million ($23 million) laboratory in Winnipeg to study proteins and other food ingredients. The firm is exploring a move into pea and oat protein concentrates that could start next year, senior vice-president of technology Chuck Cohen said in an interview. France-based food ingredient company Roquette is building plant in Manitoba to produce pea proteins in North America, which currently imports from Europe.

SOARING DEMAND

Projections for soaring sales from alternative plant proteins have enticed large grain traders that make money by buying, selling, storing, shipping and trading crops. Years of oversupplied grain markets and thin margins have squeezed the trading operations of ADM, Bunge Ltd, Cargill and Louis Dreyfus Co – known collectively as the “ABCDs” – although conditions have improved recently.

Global demand for protein – whether from meat, aquaculture or plant sources – is booming in part due to rising incomes in emerging markets in Asia and Africa, industry analysts say. In North America, consumers are shifting their diet preferences to include more protein, and 35 percent of U.S. households last year said they follow a specific protein-focused diet, such as Paleo or low-carbohydrate, according to research conducted by Nielsen.

The trend is driving a shift in grocery shopping. In the year ended July 8, 2017, sales of plant-based food and beverages in the U.S. increased 14.7 percent over the previous period, according to Nielsen. Sales of meat alternatives are growing especially within prepared foods, an indication that consumers are trying options once only available in niche stores.

Global pea protein sales amounted to $73.4 million in 2016, according to research firm Grand View Research, but are forecast to quadruple by 2025, reaching $313.5 million in sales, helped by popular diets free of gluten and lactose and an expanding middle class in developing nations.

Even with such explosive growth, pea proteins would have high potential upside because they would account for a fraction of the projected $48.77 billion global animal and plant protein ingredients market by 2025, which is led by meat, according to Grand View.

POWERING UP THE PEA

Cargill’s partnership with PURIS includes breeding pea crops for higher protein content. Standard peas contain 18 to 22 percent protein, but PURIS this year will start selling peas packed with 28 percent protein for planting by farmers in the northern Plains and Midwest, said PURIS president Tyler Lorenzen. Once processed, pea powders can contain about 80 percent protein.

Creating new varieties of protein-packed peas, however, can take seven years or more because it is done through conventional breeding rather than genetic modification, Lorenzen said. The lack of genetic modification, however, also attracts many consumers who prefer more organic foods, said Pascal Leroy, head of Roquette’s pea and new protein business line.

In Canada, one of the world’s biggest pea exporters, at least three pea protein plants are planned or increasing production, including Verdient Foods in Saskatchewan, whose investors include Titanic director James Cameron. That gives farmers an incentive to vary plantings that are now dominated by wheat and canola.

Roquette is building what it says will be the world’s biggest pea plant in Manitoba, on the belief the vegetable has unique consumer appeal. German company Canadian Protein Innovation plans a plant in Moose Jaw, Saskatchewan.

Illinois-based ADM told Reuters it is building a new pea protein processing plant at the site of one of its soybean processing complexes in Enderlin, North Dakota. The location gives the company proximity to yellow pea producers and transportation to domestic and international customers, according to ADM’s Campbell.

ADM will launch its line of pea powders as an ingredient for food manufacturers early next year and introduce other plant-based protein product lines in the following two years, the company said, declining to give further details.

Unlike Cargill, ADM is seeking to boost pea protein levels in the processing plant – rather than through crop breeding – and is buying most of its supplies from nearby North Dakota farmers, the company said. ADM officials declined to detail how it can boost protein in a factory, citing competitive concerns.

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Canada marijuana industry — now worth $31 billion — looks abroad for growth

Countries like Spain, Italy, and Colombia are likely the next growth opportunities for Canadian cannabis companies after a flurry of consolidation at home.

The marijuana industry saw its largest deal to date on Monday with Aurora Cannabis Inc. agreeing to acquire MedReleaf Corp. for $2.9 billion. That followed Edmonton, Alberta-based Aurora’s deal to buy CanniMed Therapeutics Inc. in January for roughly $1 billion and several smaller deals.

Canada has emerged as a global leader in the pot industry as it becomes the first Group of Seven country to legalize the drug for recreational use later this year while a ban at the federal level keeps pure-play U.S. pot companies from major exchanges south of the border. There are now 90 publicly listed companies in Canada with a market value of about $31 billion.

Recent mergers and acquisitions have given the companies the scale to start looking internationally for growth, said Dan Daviau, chief executive officer of Canaccord Genuity Group Inc., the leading Canadian investment bank in the sector. Countries like Germany, for example, allow patients to be reimbursed for medical marijuana to treat a variety of symptoms, he said.

“It’s not just about population,” Daviau said. “It’s also about the governments’ realization that the product is good for lots of different indications.” Canadian firms have the right cost of capital and industry knowledge to add value, he said.

At the same time, there’s still plenty of options for smaller Canadian firms, he said.

“The smaller guys and the guys in the middle need to decide what their strategy is,” Daviau said. “Biggest isn’t always the best. There are going to be some more big guys and some smaller niche guys.”

U.S. cannabis companies are increasingly looking to raise capital and list in Canada because of the sophisticated investor base here, said Graham Saunders, Canaccord’s vice chairman and head of capital markets origination.

“All these companies are in a race,” he said. “The faster you can use capital and deploy it properly and accretively, the better off you’re going be.”

Los-Angeles-based MedMen Enterprises, for example, raised $50 million in subscription receipts last month in Canada ahead of its planned reverse takeover of Vancouver-based Ladera Ventures Corp.

Saunders said the U.S. capital markets for cannabis are where Canada was two or three years ago. “It’s easier here. We don’t have listing problems for cannabis assets that there is in the U.S.”

Canaccord is hosting a cannabis conference in New York this week and has about 700 attendees enrolled.

The broadening investor base in Canada has started attracting the country’s biggest banks, lead by Bank of Montreal which landed a mandate to advise Aurora on its takeover of MedReleaf.

Daviau said he wasn’t concerned about the big banks coming into the space, in part because Canaccord has a two-year lead in the sector.

“It’s good for us, honestly,” he said. “It continues to legitimize the industry and broaden the investor base.”

https://bit.ly/2rXgygb

E. coli toxin linked with inflammatory bowel disease

New research suggests that a toxin produced by the bacteria E. coli may be what triggers inflammation in inflammatory bowel disease.

The painful symptoms of IBD may be caused by a toxin produced by E. coli bacteria.

The term inflammatory bowel disease (IBD) describes conditions characterized by chronic inflammation in the gastrointestinal tract, such as Crohn’s disease and ulcerative colitis.

In the United States, 3 million people are estimated to live with the condition.

While the precise cause of IBD is unknown, researchers do know that it is caused by an overreaction of the immune system to the gastrointestinal tract, which causes inflammation.

This reaction tends to occur in people who are genetically predisposed to the condition. However, there are also environmental factors at play that trigger this immune response — and these factors remain a mystery.

Now, scientists may have stumbled upon an interesting discovery that clues us in on one such potential trigger.

Researchers at the John Innes Centre, in Norwich, United Kingdom, working in collaboration with the Brigham and Women’s Hospital (BWH) in Boston, MA, think that by-products of a toxin called microcin B17 may cause inflammation in IBD.

Microcin B17 is produced by E. coli (Escherichia coli) — a bacterium that is often found in the guts of humans and other animals.

E. coli produces microcin B17 in order to fight off other bacteria in the gut. This has made the toxin potentially useful in the search for a new antibiotic — something that the team of U.K.-based researchers had been investigating for some time before the Boston group contacted them.

The first author of the new paper is Shankar S. Iyer of the BWH and Harvard Medical School in Boston, and the findings were published in the journal Cell.

A ‘chance discovery’ may explain IBD

Prof. Tony Maxwell, who led the U.K.-based team, explains how they came across the link:

“This is largely a chance finding. We have been studying this toxin for its antibacterial properties and we were contacted by Prof. Richard Blumberg who leads the Boston group for quite different reasons — they thought there might be a connection between the toxin and IBD.”

To see if this was the case, the researchers experimented using mouse models of colitis and colon cell cultures. They also designed a synthetic version of microcin B17 to see if it would induce inflammation in the mice’s colon.

The scientists found that indeed, microcin B17 induces intestinal inflammation in vivo. This inflammation was dependent on CD1d proteins.

CD1d proteins are molecules which “mediate the presentation of primarily lipid and glycolipid antigens” to T cells — a type of white blood cell that plays a key role in immunity.

Prof. Maxwell explains the findings further, saying “The bacteria that live inside us have a lot of impact on well-being.”

“[T]he twist here is that it’s not the E. coli bacteria but the toxin that’s produced by the bacteria that appears to have an effect.”

Prof. Tony Maxwell

“They produce these toxins to kill their neighbors in their fight for ecological niches, but it appears that the breakdown products of the toxin can initiate gut inflammation,” the researcher adds.

Furthermore, the research also suggests that dietary and microbial oxazoles, in general, trigger intestinal inflammation.

Oxazoles are a class of aromatic organic compounds that have antibacterial, antifungal, and anti-inflammatory properties, which makes them a good basis for several antibiotics, among other applications.

Fred Collin, a postdoctoral researcher in Prof. Maxwell’s lab and a co-author of the study says, “These findings will advance our understanding of how gut inflammation associated with IBD may be triggered and offer new hope of potential future therapy.”

https://bit.ly/2wXwtkk

Lowering cholesterol improves cancer-fighting immunotherapy

A new study has found that when cholesterol levels are reduced, cancer immunotherapy becomes more effective. The findings offer a simple way to improve this fledgling technology.

Lowering cholesterol may improve cancer outcomes in the future.

Immunotherapy is a fairly new but successful method of treating cancer. It uses the body’s own immune system to fight cancerous cells.

Scientists are currently investigating a range of immunotherapies that use a variety of tactics.

Some types work to enhance the body’s natural immune response against cancer cells, and this is known as passive immunization.

Other versions actively direct the immune system to attack specific proteins on cancer cells, and these are called active immunotherapies.

One type of passive immunization — adoptive T cell transfer — involves engineering T cells to home in on a specific cancer type before transplanting them into the patient.

Boosting immunotherapy

Adoptive T cell transfer is still a relatively new technology. In fact, the first two procedures of this type to be used in the United States were only approved by the Food and Drug Administration (FDA) in 2017.

As such, scientists are still working out how to enhance the therapy and make it as effective as possible. For instance, researchers are currently investigating the use of different methods to transplant the T cells, as well as how combining the therapy with other drugs might improve outcomes.

Dr. Qing Yi, Ph.D., from the Cleveland Clinic Lerner Research Institute in Ohio, is approaching this question from a slightly different angle. He is interested in how cholesterol may play a part in the success of adoptive T cell transfer.

The latest study from his laboratory is now published in the Journal of Experimental Medicine.

In previous work, Dr. Yi identified that a specific subtype of T cell — Tc9 cells — were more fiercely anti-cancer than others. Tc9 cells are known to excrete interleukin 9 (IL 9), a signaling molecule with anti-tumor properties.

Building on this finding, Dr. Yi wanted to understand whether Tc9 cells could be enhanced further.

Cholesterol may be the key

Using gene profiling — a technique that allows scientists to see which genes are “switched on” in a cell — they compared Tc9 cells with other subtypes of T cell. They found that Tc9 cells contained significantly less cholesterol.

This, they thought, might be key to their improved cancer-fighting ability. So, they took their hunch to the laboratory and put it to the test.

To investigate, they added cholesterol-lowering drugs to cancer cells before treating them. As they expected, this had the effect of turning on anti-cancer pathways.

In a second part of the study, they used a tumor-bearing animal model. They discovered that, when cholesterol levels were reduced before the course of immunotherapy began, there was a greater expression of IL 9, and its anti-tumor effects were more pronounced.

As the study authors explain, “Our study identifies cholesterol as a critical regulator of Tc9 cell differentiation and function.”

Dr. Yi is excited about the findings. He says, “Our studies suggest a relatively simple, cost-effective way to enhance T cell transfer therapy.” The scientists plan to continue their line of investigation and embark on clinical trials as soon as possible.

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