News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Sean Penn’s Foundation Partners with Healthcare Providers in Four States to Offer Drive-Thru COVID-19 Molecular and Serological Clinical Laboratory Specimen Collections

Goal of his foundation is to provide access to COVID-19 medical laboratory tests for first responders, as well as low-cost tests to the general public

Early in April, when many of the nation’s clinical laboratories were facing numerous challenges in their attempts to obtain adequate supplies for collecting, transporting, and testing for COVID-19, a Hollywood actor was funding his foundation and obtaining enough supplies for his foundation to offer access to COVID-19 testing to residents in his community of Malibu—as well as in other areas.

In many ways, local medical laboratories that offer COVID-19 tests are competing with actor/philanthropist Sean Penn’s Community Organized Relief Effort (CORE) foundation for the supplies they need to provide COVID-19 testing to the patients in their own communities. The non-profit organization says it is working with various healthcare providers to provide free coronavirus testing to first responders, and low-cost testing to the general public, in eleven cities and counties in California, Georgia, North Carolina, and Illinois.

In fact, the volume of COVID-19 testing CORE currently provides is large enough that The Hollywood Report published a story on June 3, titled, “How Sean Penn Made the Biggest COVID-19 Testing Site in U.S.” The article stated that, “In late May, Mayor Eric Garcetti announced the opening of a new COVID-19 testing site at Dodger Stadium in partnership with CORE, the Los Angeles Dodgers, Live Nation Entertainment, Red Rock Entertainment, and the Los Angeles Fire Department. Operated by CORE and LAFD, this site has capacity to test 6,000 residents a day free of charge––making it three times the size of any other location in L.A. County and said to be the largest testing site in the U.S.”

The Reporter did not make the distinction that the Dodger Stadium site is only collecting specimens. And, no news accounts of the CORE COVID-19 testing program names the clinical laboratories that CORE currently uses to perform the coronavirus tests for the specimens it collects.

CORE Partnered with Private Healthcare Provider Elevated Health

CORE first got underway in 2010 providing disaster relief following the catastrophic magnitude 7.0 earthquake in Haiti. It was known then as the Jenkins-Penn Haitian Relief Organization (J/P HRO). The foundation initiated its support of COVID-19 testing efforts in California in April, reported the Orange County Register (OCR). At that time, testing was much more limited than it is today and drive-thru testing in most areas in America was not available.

In Huntington Beach, Orange County, Calif., CORE partnered with Elevated Health to provide molecular polymerase chain reaction (PCR) tests and serological antibody tests for a fee at a drive-thru location in the city of Westminster, reported the OCR.

Elevated Health’s COVID Clinic website enables consumers to complete pre-test enrollment and payment before arriving at the drive-up testing site at the Westminster Mall. 

“Right now, hospitals have very strict guidelines on who can be tested. Public health departments are overwhelmed and possibly underfunded. That’s where I’m trying to bridge the gap,” Matthew Abinante, DO, a doctor of osteopathy and Elevated Health’s founder and CEO, told the OCR.

The coronavirus test kits Elevated Health uses are made in China and were purchased from Georgia-based HealthTrackRx. According to Abinante, they are “FDA authorized, but not FDA approved,” reported the OCR.

Clinical laboratory leaders may be intrigued to see consumers waiting their turn at drive-through testing lines as they take COVID-19 diagnosis into their own hands. Sites like the one above run by Elevated Health at the Westminster Mall demonstrate that people are willing to patronize providers that serve their needs directly. (Photo copyright: Orange County Register.)

CORE Aims to Be a Model for Partnering in Testing

Though CORE’s COVID-19 testing relief efforts are no longer limited to Los Angeles County, that is where it all began. Specimen collection at drive-through sites for COVID-19 tests initially prioritized first responders and essential workers. CORE funds provided for a staff of 70 people at four of the 35 drive-thru specimen collection sites in LA, reported CBS Los Angeles(CBSLA).

CORE-funded services also made it possible for Los Angeles city employees—who were running the drive-thru specimen collection sites—to return to their primary jobs as emergency first responders, reported the Associated Press (AP). 

“It’s something that we can adapt to very quickly with the training of the Los Angeles Fire Department initially. And we’re able to take all those firemen and put them back in to serve the people in the way that we need them to,” said Penn in the AP article.

At that time, city officials planned to perform 10,000 tests a day, Deputy Mayor Jeff Gorell, JD, told the LA Times. The City of Los Angeles purchased the tests and CORE covered the cost of staff, volunteers, and personal protective equipment (PPE), reported the LA Times.

“We have servers and people from the Peace Corps, actresses—a lot of people from the communities where the test site is. We’re trying to hire as much locally as possible,” Ann Lee, CORE’s Chief Executive Officer, told Business Insider.

CORE also partnered with the City of Malibu in western Los Angeles County to provide mobile COVID-19 testing services for the city’s 3,000 residents, first responders, and essential workers from April 6 to 17 at a testing site at Malibu City Hall.

“This is what I hope will be a model in terms of the government and community foundation partnerships that can be replicated not only in the city of Los Angeles and throughout California, but throughout the country,” Sean Penn (above at the COVID-19 drive-thru testing site in Malibu, Calif.), founder of CORE, told CBSLA. Since making that statement, CORE has gone on to partner with healthcare providers in three other states to provide coronavirus drive-thru specimen collection. (Photo copyright: Associated Press/ABC News.)

Should Drive-Through Testing Continue Post-Pandemic?

An April Dark Daily e-briefing reported on drive-thru COVID-19 specimen collection operations across 30 states. The e-briefing also noted that drive-thru collections protects medical laboratory professionals and emergency department staff from possible exposure to infectious agents.

It’s likely many industries—from education and retail to travel and restaurants—will be revamped as a result of the pandemic. Clinical laboratory leaders and pathologists will want to study the different approaches used to develop drive-through COVID-19 specimen collection; how some providers that ran them partnered with charitable organizations such as CORE; why drive-thru specimen collection appeals to consumers; and how it may improve phlebotomists’ safety and increase clinical laboratory business.

—Donna Marie Pocius

Related Information:

How Sean Penn Made the Biggest COVID-19 Testing Site in U.S.

Private Coronavirus Testing Sites Draw Crowds in Malibu and Westminster

Coronavirus: Mayor Garcetti and Sean Penn of CORE in Partnership

Sean Penn’s Non-Profit Helps Los Angeles, Malibu Expand Testing

Sean Penn Wants to “Save Lives” With Free COVID-19 Testing

Sean Penn’s Nonprofit Boosts COVID-19 Testing Efforts in Los Angeles  

Sean Penn Nonprofit, CORE, Provides Coronavirus Testing in Los Angeles

Drive-Through Coronavirus Testing Spreads Across 30 States Lowering Risk of Exposure to Phlebotomists and Clinical Laboratory Professionals

Direct Primary Care is Emerging as a New Healthcare Model in the US, But Are Clinical Laboratories Prepared to Bill Patients Directly?

If insurance plans are removed from the billing cycle for primary care, it’s not clear how clinical laboratories will be reimbursed for their services

Direct Primary Care (DPC) is gaining popularity in the United States. This emerging movement enables primary care providers to bill patients directly for services rendered, bypassing traditional health plans. On a large scale, employers can contract with primary care practices directly for their employees’ primary care coverage. The idea is to lower healthcare costs. But what exactly is DPC and how are clinical laboratories affected by it?

In operation, direct primary care is similar to concierge medicine, where a patient pays an annual retainer for direct access to a specific healthcare provider. DPC practices offer members unlimited, on-demand visits to primary care physicians for a flat, monthly fee.

The DPC movement has its own lobbying group—the Direct Primary Care Coalition—which supports physicians who opt to practice direct primary care. According to the group’s website, there are currently about 1,000 DPC practices in 48 states which serve over 300,000 patients. 

DPC has gained Senatorial support. In December, Senators Bill Cassidy, MD (R-LA), Doug Jones (D-AL), Jerry Moran (R-KS) and Jeanne Shaheen (D-NH) introduced legislation to “lower the cost of healthcare and expand patients’ access to their primary care providers.”

Their bill (H.R. 3708), titled the “Primary Care Enhancement Act of 2019,” would amend the Internal Revenue Code of 1986 to “allow individuals with direct primary care service arrangements to remain eligible individuals for purposes of health savings accounts, and for other purposes.”

A press release announcing the Senate version of the bill (S. 2999), described DPC as a model that “encourages patients to develop personal relationships with their primary care physician, including extending access to care beyond office visits and business hours and through telemedicine. It focuses on prevention and primary care, relying less on specialist and hospital referrals. It is a growing model used by more than 1,000 practices across 48 states and the District of Columbia.”

The press release also states, “DPC models replace copays and deductibles with flat, affordable monthly fees. Current law makes DPC incompatible with health savings accounts (HSAs) paired with high-deductible health plans (HDHPs).”

Direct Primary Care in Practice

Physicians seem to like the DPC model. It frees them, they say, from the unnecessary interference of insurance providers, the burdens of excessive paperwork, and ever-increasing administration costs, while allowing them to have a better patient-doctor relationship. 

“I know all my patients by name. I have time for them,” Matthew Abinante, DO, told The DO, a journal of the American Osteopathic Association (AOA). “I probably interact with about 20 patients a day when you factor in the electronic communication.”

Abinante is a board-certified family physician. He practices at Elevated Health, a direct primary care practice in Huntington Beach, CA. Patients pay an average of $75 per month for membership. This fee includes unlimited same day/next day appointments and the ability to talk to a doctor via telephone, e-mail, text, or video chat—24/7.

Matthew Abinante, DO, is shown above treating a patient at Elevated Health, a DPC practice in California. “Our goal is to keep you as healthy as possible, while saving you time and money. We remove the barriers of traditional insurance and provide you with a modern take on the personal, old-fashioned care missing in today’s healthcare industry,” he said. (Photo copyright: Elevated Health.)

At Elevated Health, some minor clinical laboratory tests and procedures are included in the monthly fee. They include:

Other medical laboratory testing, imaging, and medications are available to patients at contracted wholesale prices, which are quoted up front. This is consistent with the trend for price transparency in healthcare.

“What everyone really needs to know is that patients do get better care when their doctor is more satisfied with what they’re doing. And that takes time. What the [fee-for-service] system cannot provide us is time with the patient,” Tiffanny Blythe, DO, told The DO. Blythe runs Blue Lotus Family Medicine, a DPC practice in Kansas City, MO.

When Direct Primary Care Does Not Work

The DPC model has been tried before. In 2010, a DPC provider called Qliance was formed primarily on investment capital from Jeff Bezos of Amazon. The goal was to free doctors and patients from the constraints of traditional health insurance.

Qliance opened several clinics in the Seattle area and by 2014 had nearly 50,000 DPC patients—including employees of Expedia and Comcast. It also had a contract to provide primary care services with a state Medicaid insurer. Nevertheless, Qliance closed in 2017.

“We would open up a clinic and add a bunch of docs before we had enough patients to pay for it,” Nick Hanauer, a Seattle venture capitalist and investor in Qliance, told STAT.

“It’s just hard to get the customers because you had to break the paradigm that was in everyone’s heads about how healthcare had to work, and you had to disrupt the relationships people had with their insurance companies,” Hanauer explained.

“Somebody with more economic power than we had could do this—and should,” he added.

Not All Physicians Support Direct Primary Care

Since the DPC model is so new, there is little research or statistics to confirm it will have a positive effect on healthcare outcomes or lower healthcare costs. Some healthcare professionals have reservations about direct primary care. Their concerns include the potential for less oversight of practitioners and the possibility that patients will slight themselves regarding insurance coverage.

“What we don’t hear about are the people who need more than can cover and what happens to them when they fall into that gap,” Carolyn Engelhard, a health policy analyst and Assistant Professor at the University of Virginia School of Medicine. “We don’t know if they just don’t get care or then enter the traditional healthcare system and start over.”

There are also concerns that DPC plans could draw a large percentage of healthier patients, which could raise costs for those in traditional insurance plans, and that it may be more difficult for DPC patients to gain access to needed specialists and other services. 

“Healthcare is fragmented, and if we continue to have little carve-outs so some [doctors] can practice medicine the way they want, it is not helping to make the system more responsive and integrated,” Engelhard added.

Nonetheless, both Direct Primary Care and Concierge Medicine are growing in popularity in the US. And because it’s unclear how clinical laboratories would interact with or bill DPC practices, clinical laboratory leaders should keep a close eye on this trend.

As more patients opt for these models of care, healthcare organizations, pathology groups, and clinical laboratories will have to create ways to adapt. Since DPC practices are out of most networks, clinical labs may have to bill patients directly for their services. Not all clinical labs are prepared to do that, and those that are could experience a slowdown in the payment process. Labs may also have to contract with physicians to provide testing services on a pre-determined wholesale cost basis.

—JP Schlingman

Related Information:

Can Amazon Cut Insurers Out of Primary Care?

A Pioneer In ‘Flat-Fee Primary Care’ Had to Close Its Clinics. What Went Wrong?

5 Things to Know About Direct Primary Care

10 Differences Between Concierge Medicine and Direct Primary Care

Concierge Medicine Is Growing

Lessons from Qliance Closing Its Doors

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