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Guidehouse Healthcare Experts Outline Six Ways COVID-19 Pandemic Is Accelerating Healthcare Transformation

Financial losses for hospitals and health systems due to cancelled procedures and coronavirus expenses will lead to changes in healthcare delivery, operations, and clinical laboratory test ordering

COVID-19 is reshaping how people work, shop, and go to school. Is healthcare the next target of the coronavirus-induced transformation? According to two experts, the COVID-19 pandemic is pushing hospitals and health systems toward a “fundamental and likely sustained transformation,” which means clinical laboratories must be prepared to adapt to new provider needs and customer demands.

In “Industry Voices—6 Ways the Pandemic Will Remake Health Systems,” published in Fierce Healthcare, authors David Burik, Partner, and Brian Fisher, Director, at Guidehouse (formerly Navigant Consulting and a “portfolio company of Veritas Capital”), stated that COVID-19 has wreaked havoc with the finances of America’s hospitals and healthcare systems.

Burik and Fisher called attention to the staggering $50 billion-per-month loss for hospitals and health systems that was first revealed in an American Hospital Association (AHA) report published in May. The AHA report estimated a $200 billion loss from March 1, 2020, to June 30, 2020, due to increased COVID-19 expenses and cancelled elective and non-elective surgeries.

Adding to the financial carnage is the expectation that patient volumes will be slow to return. In “Hospitals Forecast Declining Revenues and Elective Procedure Volumes, Telehealth Adoption Struggles Due to COVID-19,” Burik said, “Healthcare has largely been insulated from previous economic disruptions, with capital spending more acutely affected than operations. But this time may be different since the COVID-19 crisis started with a one-time significant impact on operations that is not fully covered by federal funding.

“Providers face a long-term decrease in commercial payment, coupled with a need to boost caregiver and consumer-facing digital engagement, all during the highest unemployment rate the US has seen since the Great Depression,” he continued. “For organizations in certain locations, it may seem like business as usual. For many others, these issues and greater competition will demand more significant, material change.”

A Guidehouse analysis of a Healthcare Financial Management Association (HFMA) survey, suggests one-in-three provider executives expect to end 2020 with revenues at 15% below pre-pandemic levels, while one-in-five of them anticipate a 30% or greater drop in revenues. Government aid, Guidehouse noted, is likely to cover COVID-19-related costs for only 11% of survey respondents.

“The figures illustrate how the virus has hurled American medicine into unparalleled volatility. No one knows how long patients will continue to avoid getting elective care or how state restrictions and climbing unemployment will affect their decision making once they have the option,” Burik and Fisher wrote. “All of which leaves one thing for certain: Healthcare’s delivery, operations, and competitive dynamics are poised to undergo a fundamental and likely sustained transformation.”

As a result, the two experts predict these pandemic-related changes to emerge:

  • Payer-Provider Complexity on the Rise; Patients Will Struggle. As the pandemic has shown, elective services are key revenues for hospitals and health systems. But the pandemic also will leave insured patients struggling with high deductibles, while the number of newly uninsured will grow. Furthermore, upholding of the hospital price transparency ruling will add an unwelcomed spotlight on healthcare pricing and provider margins.
  • Best-in-Class Technology Will Be a Necessity, Not a Luxury. COVID-19 has been a boon for telehealth and digital health usage, creating what is likely to be a permanent expansion of virtual healthcare delivery. But only one-third of executives surveyed say their organizations currently have the infrastructure to support such a shift, which means investments in speech recognition software, patient information pop-up screens, and other infrastructure to smooth workflows will be needed.
Chuck Peck, MD
“Through all the uncertainty COVID-19 has presented, one thing hospitals and health systems can be certain of is their business models will not return to what they were pre-pandemic,” Guidehouse Partner Chuck Peck, MD (above), a former health system CEO, said in a statement. “A comprehensive consumer-facing digital strategy built around telehealth will be a requirement for providers. Moreover, shifting hardware and physical assets to the cloud, and use of robotic process automation, has proven to be successful in improving back-office operations in other industries. Providers will need to follow suit.” Clinical laboratories and anatomic pathology groups should track these developments and respond appropriately to meet the changing needs of the hospitals and physicians they serve with diagnostic testing services. (Photo copyright: Athens Banner-Herald.)
  • The Tech Giants Are Coming. Both major retailers and technology stalwarts, such as Amazon, Walmart, and Walgreens, are entering the healthcare space. In January, Dark Daily reported on Amazon’s roll out of Amazon Care, a 24/7 virtual clinic, for its Seattle-based employees. Amazon (NASDAQ:AMZN) is adding to a healthcare portfolio that includes online pharmacy PillPack and joint-venture Haven Healthcare. Meanwhile, Walmart is offering $25 teeth cleaning and $30 checkups at its new Health Centers. Dark Daily covered this in an e-briefing in May, which also covered a new partnership between Walgreens and VillageMD to open up to 700 primary care clinics in 30 US cities in the next five years.
  • Work Location Changes Mean Construction Cost Reductions. According to Guidehouse’s analysis of the HFMA COVID-19 survey, one-in-five executives expect some jobs to remain virtual post-pandemic, leading to permanent changes in the amount of real estate needed for healthcare delivery. The need for a smaller real estate footprint could reduce capital expenditures and costs for hospitals and healthcare systems in the long term.
  • Consolidation is Coming. COVID-19-induced financial pressures will quickly reveal winners and losers and force further consolidation in the healthcare industry. “Resilient” healthcare systems are likely to be those with a 6% to 8% operating margins, providing the financial cushion necessary to innovate and reimagine healthcare post-pandemic.
  • Policy Will Get More Thoughtful and Data-Driven. COVID-19 reopening plans will force policymakers to craft thoughtful, data-driven approaches that will necessitate engagement with health system leaders. Such collaborations will be important not only during this current crisis, but also will provide a blueprint for policy coordination during any future pandemic.

As Burik and Fisher point out, hospitals and healthcare systems emerged from previous economic downturns mostly unscathed. However, the COVID-19 pandemic has proven the exception, leaving providers and health systems facing long-term decreases in commercial payments, while facing increased spending to bolster caregiver- and consumer-facing engagement.

“While situations may differ by market, it’s clear that the pre-pandemic status quo won’t work for most hospitals or health systems,” they wrote.

The message for clinical laboratory managers and surgical pathologists is clear. Patients may be permanently changing their decision-making process when considering elective surgery and selecting a provider, which will alter provider test ordering and lab revenues. Independent clinical laboratories, as well as medical labs operated by hospitals and health systems, must be prepared for the financial stresses that are likely coming.

—Andrea Downing Peck

Related Information:

Industry Voices–6 Ways the Pandemic Will Remake Health Systems

Amazon Care, the Company’s Virtual Medical Clinic, Is Now Live for Seattle Employees

Checkup for $30, Teeth Cleaning $25: Walmart Gets into Health Care

Walgreens and VillageMD to Open 500 to 700 Full-Service Doctor Offices within Next Five Years in a Major Industry First

New AHA Report Finds Financial Impact of COVID-19 on Hospitals and Health Systems to be Over $200 Billion through June

Hospitals Forecast Declining Revenues and Elective Procedure Volumes, Telehealth Adoption Struggles Die to COVID-19

Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services That Include Clinical Laboratory Testing

Walmart Opens Second Health Center Offering Clinical Laboratory Tests and Primary Care Services

Whistleblower Lawsuit Alleges Massive Fraud in Cigna Medicare Advantage Plans

A former officer of a Cigna contractor claims the insurer hatched a scheme to submit invalid diagnostic codes and filed the now-unsealed qui tam action in 2017

In a case that could provide a cautionary tale for clinical laboratories, a federal whistleblower lawsuit alleges that Cigna, through its HealthSpring subsidiary, “received billions in overpayments from the federal government” in a scheme involving the insurer’s Medicare Advantage plans. The Qui tam (whistleblower) lawsuit was filed by Robert A. Cutler, a former officer of Cigna contractor Texas Health Management LLC (THM), under the federal False Claims Act.

Cutler alleged that “Cigna-HealthSpring has knowingly defrauded the United States through an intentional and systematic pattern and practice of submitting to CMS invalid diagnosis codes derived from in-home health assessments.” He claimed this took place “from at least 2012 until at least 2017,” and likely thereafter.

Cigna has denied the allegations. “We are proud of our industry-leading Medicare Advantage program and the manner in which we conduct our business,” the insurer stated in an email to HealthPayerIntelligence. “We will vigorously defend Cigna against all unjustified allegations,” Cigna stated.

As the lawsuit explains, Medicare Advantage (MA) plans are administered by private insurers under Medicare Part C. “Rather than pay providers directly based on the medical services provided, Medicare Part C pays MA Organizations a monthly capitated rate for each covered beneficiary, and tasks the MA Plan with paying providers for services rendered to plan members,” the lawsuit states. “MA insurers are generally paid more for providing benefits to beneficiaries with higher-risk scores—generally older and sicker people—and less for beneficiaries with lower-risk scores, who tend to be younger and healthier.”

The lawsuit notes that CMS relies on information—specifically ICD codes—from the insurers to calculate the risk scores.

Cigna’s 360 Program as Described in Lawsuit

Cutler alleged that Cigna defrauded CMS through its “360 Program,” in which primary care providers (PCPs) were encouraged to perform enhanced annual wellness visits that included routine physical exams. He claimed that “Cigna-HealthSpring designed the program so that, in practice, the 360 assessment was a mere data-gathering exercise used to improperly record lucrative diagnoses to fraudulently raise risk scores and increase payments from CMS.”

Cigna-HealthSpring, he alleged in the court documents, offered PCPs financial bonuses to perform the 360 program exams, especially on patients deemed most likely to yield high-risk scores. However, many clinicians declined, so the insurer recruited third-party contract providers, including THM, to send nurse practitioners (NPs) or registered nurses (RNs) to the homes of MA plan members.

For each visit, the NPs and RNs were given health reports listing the beneficiary’s previous diagnoses. “Cigna-HealthSpring intended the document to serve as a ‘cheat-sheet’ list of conditions and diagnoses it expected 360 contractors to capture during the in-home visit,” Cutler alleges. “The list of diagnoses did not indicate the date they were reported or any other information concerning their status.”

During each visit, which typically lasted 30-60 minutes, “NPs and RNs relied primarily on the patient’s self-assessment, i.e., subjectively reported information, as well as current medications to the extent available and, during certain time periods and for certain plan members, limited [clinical] laboratory findings,” Cutler alleged.

NPs were expected to record 20 or more diagnoses per visit, he wrote, including diagnoses based on “weak links” involving medications. “For example, Cigna-HealthSpring encouraged contractors to record atrial fibrillation, deep vein thrombosis, and pulmonary embolus based on the presence of certain classes of anti-coagulation medications on members’ medication lists or in their homes,” he stated.

He also alleged that “Cigna-HealthSpring, in purposeful violation of CMS rules, designed its 360 form to force NPs to capture diagnoses that were uncertain, probable, or merely suspected.”

These diagnoses were subsequently submitted as risk-adjustment data to CMS, he alleged, adding up to “hundreds of thousands of false claims from its six contractors during the relevant period. Although the exact amount will be proven at trial, the United States has paid billions of dollars in improper, inflated payments to Defendants under the MA Plan as a result of this scheme.”

Medicare Under Assault from Fraudsters graphic
The graphic above is taken from an AARP article, titled, “Medicare Under Assault from Fraudsters,” which states, “The amount of tax dollars that are lost each year to Medicare fraud and waste is greater than the entire annual budget of some of the federal government’s most important programs and departments.” Clinical laboratories also are in danger of being drawn into the federal government’s fraud investigations which can be disruptive to business and revenues. (Graphic copyright: AARP.)

The False Claims Act Explained

Cutler, an attorney who is representing himself, originally filed the lawsuit under seal in 2017, in the US District Court for the Southern District of New York. An amended version was unsealed on August 4, 2020.

The Federal False Claims Act “allows a private citizen to step into the shoes of and pursue a claim on behalf of the government,” explained the Boyers Law Group of Coral Gables, Fla., in an article for HG.org, which states, the lawsuit “may proceed with or without the assistance of the government.”

If the government chooses to intervene, the whistleblower, known formally as the “relator,” can receive 15% to 25% of the proceeds recovered in the action, the law firm explained in another article for HG.org, adding that, in most cases, the government does not intervene, which increases the potential award to 30%.

In the Cigna case, the US Attorney’s office notified the court on Feb. 25, 2020, that the government had decided not to intervene “at this time.”

Significance for Clinical Laboratories

Regardless of how this case proceeds, medical laboratory managers should remember that they are subject to legal action if internal whistleblowers identify policies or procedures that violate federal fraud and abuse laws. And because it involves coding, it is also a reminder of the importance of documenting diagnoses and clinical laboratory test orders as protection against fraud allegations.

Another benefit of carefully documenting each lab test order is that labs can make the information available when auditors from government or private payers show up and want documentation on the medical necessity of each lab test claim.

—Stephen Beale

Related Information:

DOJ Sues Cigna, Alleging $1.4B in Medicare Advantage Fraud

Cigna Bilked Medicare Advantage For $1.4B, FCA Suit Says

Cigna Faces Whistleblower Lawsuit Over $1.4 Billion in Fraudulent Medicare Advantage Billings

Suit against Cigna is Latest Attempt by DOJ to Crack Down on Medicare Advantage Fraud

Cigna Embroiled in Lawsuit Over Wellness Program Risk Adjustment

Tex. Health Management V. HealthSpring Ins. Co.

FTC Orders Hospital, Health System, and Five Insurers in Two States to Share Vast Amounts of Data on Their Customers and on Past Acquisitions and Mergers

Lab leaders may recall similar requests for data from other government agencies and wonder if FTC will take steps to investigate pricing and competition among clinical laboratories as well

It appears that the Federal Trade Commission (FTC) is ready to look into hospital consolidation, as evidenced by the extent of data—including pricing and managed care contracts—it requested from healthcare providers and health insurers last fall. This may not seem unusual to clinical laboratory leaders who remember having to respond to similar requests for information back in 2011. 

In October of 2019, the federal agency took the unusual action of ordering two healthcare provider systems in Tennessee and West Virginia, as well as five health insurers, to share vast amounts of data “to study the effects of Certificates of Public Advantage (COPAs) on prices, quality, access, and innovation of healthcare services. The FTC also intends to study the impact of hospital consolidation on employee wages,” stated a news release.

Tale of Two COPAs

On its website, the Tennessee Department of Health describes a COPA as a “written approval by the Tennessee Department of Health (TDH) that governs a Cooperative Agreement (a merger) among two or more hospitals. A COPA provides state action immunity to the hospitals from state and federal antitrust laws by replacing competition with state regulation and Active Supervision. The goal of the COPA process is to protect the interests of the public in the region affected and the State.”

However, in its news release, the FTC described COPAs as “regulatory regimes adopted by state governments intended to displace competition among healthcare providers,” and said that, “COPAs purport to immunize mergers and collaborations from antitrust scrutiny under the state action doctrine. FTC staff are engaged in an ongoing policy project to assess the effects of COPAs, which includes the study of COPAs recently approved for Ballad Health in Tennessee and Virginia, and Cabell Huntington Hospital in West Virginia.”

In its 32-page “Order to File Special Report,” the FTC required the two healthcare organizations to provide “aggregated patient billing and discharge data; health system employee wage data; and other information relevant for analyzing the health systems’ prices, quality, access, and innovation,” the news release states.

The five health insurers required to respond to the FTC’s order included:

  • Aetna, Inc.
  • Anthem, Inc.
  • BlueCross BlueShield of Tennessee
  • Cigna Corporation
  • United Healthcare

From these insurers, the FTC required “patient-level commercial claims data,” states the news release.

Is the FTC conducting a study to determine if mergers and acquisitions are giving pricing power to hospitals at the expense of health insurers and patients? The FTC said that it plans to report the study’s findings, as appropriate, and use information to better understand COPAs, inform advocacy, and guide states involved in COPAs, the news release states.

“In the big picture, the FTC is potentially looking out for buyers. In this case, the insurers are the buyers. It’s the health systems that, if the FTC concludes that COPAs are bad for consumers, it would be the hospitals that would stand to lose,” Jonathan Grossman, antitrust attorney and partner at international law firm Cozen O’Conner, told Modern Healthcare. (Photo copyright: Cozen O’Connor.)

What Are COPAs and Do They Circumvent Antitrust Laws?

In a statement, the American Hospital Association (AHA) said COPA laws allow merging providers to make agreements that “might otherwise be subject to antitrust scrutiny.” COPA laws are coming about, AHA added, due to the FTC’s “overly harsh treatment of efficiencies claims made by merging hospitals.”

Big Data Order from FTC

In its order, the FTC required the health systems, providers, and insurer to provide massive amounts of information by January 1, 2020, including:

  • Patient records related to admissions, outpatient visits, skilled nursing visits, hospice, and other care in the COPA market since Jan 1, 2011;
  • Billed charges, diagnosis codes, and insurance coverage for the records;
  • Inpatient admissions, Jan. 1, 2011 to the present, aggregated on a monthly basis;
  • Data computed separately for Medicaid, Medicare, commercial, and other patients;
  • Patient totals, their billed charges, and payment by insurers and patients;
  • Changes in prices since Jan 1, 2011, which Modern Healthcare said is an effort to find “efficiencies, cost savings, and benefits as a result of COPAs”;
  • Facilities the provider opened, closed, or expanded since Jan. 1, 2011;
  • Changes in ownership and select capital investments;
  • Copies of health plan contracts effective since Jan. 1, 2011;
  • Salary, hours, and benefits of each person employed since Jan. 1, 2011;
  • And more.

Should Clinical Laboratory Leaders Be Concerned?

Medical lab leaders within hospital multi-lab systems will want to take note of the FTC’s interest in so much information. It was just a few years ago when US Senators Chuck Grassley and Max Baucus asked medical laboratory testing companies and health insurers for similar information, notes a 2011 news release from the office of Iowa Senator Chuck Grassley. Dark Daily reported on this in a November 2011 e-briefing.

The lab testing companies were:

  • Quest Diagnostics Incorporated (NYSE:DGX)
  • Laboratory Corporation of America (NYSE:LH)
  • UnitedHealth Group, Inc. (NYSE:UNH)
  • Aetna, Inc. (NYSE:AET)
  • Cigna Corp. (NYSE:CI)

According to the news release, Senators Baucus and Grassley requested “information about a practice where insurers receive discounted pricing from labs in exchange for referrals, including testing for Medicare beneficiaries.” In the letters to the lab companies, the senators described this pricing practice as “pull-through.”

Lab leaders also may recall the federal Department of Health and Human Services (HHS) collecting payment data in 2011 from 50 state Medicaid programs as part of a report on Competitive Bidding for Medicare Part B clinical laboratory services. 

Could the FTC’s data request lead to other agencies taking steps that limit how providers set prices and reach out to markets, including clinical laboratories?

Put Prices Out There, President Says

Perhaps all this data collection is about price transparency in healthcare. The Trump Administration took action on healthcare price and quality transparency through the Improving Price and Quality Transparency in American Healthcare executive order. Under the order, the CMS has released two rules requiring hospital pricing information to be publicly available, noted a statement by the HHS.

So, there is a lot of data being shared. It is likely the FTC will share data it collects with other federal healthcare regulatory bodies as well. Therefore, medical laboratory managers would be well advised to stay abreast of mergers and acquisitions in their markets and be ready for future information requests from federal authorities.   

—Donna Marie Pocius

Related Information:

FTC to Study the Impact of COPAs: The Commission Issues Seven Orders for Provision of Information

Health Systems Unlikely to Prevail If They Challenge FTC’s COPA Demands

FTC Orders Health Systems, Insurers to Provide Data for COPA Study

FTC Likely to Prevail in Demands That Health Systems Report Information on Certificates of Public Advantage

AHA Comments for FTC Workshop on Certificates of Public Advantage

A Health Check on COPAs: Assessing the Impact of Certificates of Public Advantage in Healthcare Markets

FTC Issues Sweeping Demands for Information on Providers, Insurers

Grassley, Baucus Scrutinize Practice by Health Insurers and Testing Labs

Congressional Request on Healthcare Provider Consolidation

Hospital Merger Benefits: Views from Hospital Leaders and Econometric Analysis—An Update Report  

Executive Order on Improving Price and Quality Transparency in American Healthcare

Trump Administration Announces Historic Price Transparency and Lower Healthcare Costs for All Americans

Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings

Federal Government Is Sending Nearly $11 Billion to States for COVID-19 Clinical Laboratory Testing and Testing-Related Activities

Questions remain, however, over how much of the funding will actually reach hospital and health system clinical laboratories

For many cash-strapped clinical laboratories in America, the second round of stimulus funds cannot come soon enough. Thus, lab leaders are encouraged by news that Congress’ $484-billion Paycheck Protection Program and Healthcare Enhancement Act (H.R.266) includes almost $11 billion that will go to states for COVID-19 testing. But how much of that funding will reach the nation’s hospital and health system clinical laboratories?

Dark Daily previously reported on the deteriorating financial conditions at clinical and pathology laboratories nationwide. (See, “COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse,” May 4, 2020.) This critical situation is the result of a severe decline in the flow of specimens for routine testing to medical laboratories which, at the same time, are struggling with increasing costs to meet the demand for COVID-19 testing.

The Department of Health and Human Services (HHS) announced the new influx of money to the states on May 18. In a news release outlining the initiative, the HHS said the Centers for Disease Control and Prevention (CDC) will deliver $10.25 billion to states, territories, and local jurisdictions to expand testing capacity and testing-related activities.

To qualify for the additional funding, governors or “designee of each State, locality, territory, tribe, or tribal organization receiving funds” must submit to HHS its plan for COVID-19 testing, including goals for the remainder of calendar year 2020, to include:

  • “Number of tests needed, month-by-month to include diagnostic, serological, and other tests, as appropriate;
  • “Month-by-month estimates of laboratory and testing capacity, including related to workforce, equipment and supplies, and available tests;
  • “Description of how the resources will be used for testing, including easing any COVID-19 community mitigation policies.”
“As the nation cautiously begins the phased approach to reopening, this considerable investment in expanding both testing and contact tracing capacity for states, localities, territories, and tribal communities is essential,” said CDC Director Robert R. Redfield, MD, in the HHS statement. “Readily accessible testing is a critical component of a four-pronged public health strategy—including rigorous contact tracing, isolation of confirmed cases, and quarantine.” (Photo copyright: Center for Disease Control and Prevention.)

Funding Should Go Directly to Clinical Laboratories, Says ACLA

The American Clinical Laboratory Association (ACLA), argues the funding needs to go directly to clinical laboratories to help offset the “significant investments” labs have made to ramp up testing capacity during the pandemic.

“Direct federal funding for laboratories performing COVID-19 testing is critical to meet the continued demand for testing,” ACLA President Julie Khani, MPA, said in a statement. “Across the country, laboratories have made significant investments to expand capacity, including purchasing new platforms, retraining staff, and managing the skyrocketing cost of supplies. To continue to make these investments and expand patient access to high-quality testing in every community, laboratories will need designated resources. Without sustainable funding, we cannot achieve sustainable testing.”

Some States Are Increasing Testing, While Others Are Not

Since the first cases of COVID-19 were reported in January, the United States has slowly but significantly ramped up testing capacity. As reported in the Washington Post, states such as Georgia, Oklahoma, and Utah are encouraging residents to get tested even if they are not experiencing coronavirus symptoms. But other states have maintained more restrictive testing policies, even as their testing capacity has increased.

“A lot of states put in very, very restrictive testing policies … because they didn’t have any tests. And they’ve either not relaxed those or the word is not getting out,” Ashish Jha, MD, MPA, Director of the Harvard Global Health Institute, told the Washington Post. “We want to be at a point where everybody who has mild symptoms is tested. That is critical. That is still not happening in a lot of places.”

Meanwhile, Quest Diagnostics and LabCorp continue to expand their diagnostic and antibody testing capabilities.

On May 18, Quest announced it had performed approximately 2.15 million COVID-19 molecular diagnostic tests since March 9 and had a diagnostic capability of 70,000 test each day. The company said it expected to have the capacity to perform 100,000 tests a day in June.

LabCorp’s website lists its molecular test capacity at more than 75,000 tests per day as of May 22, with a capacity for conducting at least 200,000 antibody tests per day. Unlike molecular testing that detects the presence of the SARS-CoV-2 coronavirus, antibody tests detect proteins produced by the body in response to a COVID-19 infection.

As states reopen, and hospitals and healthcare systems resume elective surgeries and routine office visits, clinical laboratories and anatomic pathology groups should begin to see a return to normal specimen flow. Nonetheless, the federal government should continue to compensate laboratories performing COVID-19 testing for the added costs associated with meeting the ongoing and growing demand.

—Andrea Downing Peck

Related Information:

HHS Delivers Funding to Expand Testing Capacity for States, Territories, Tribes

As Coronavirus Testing Expands a New Problem Arises: Not Enough People to Test

Quest Diagnostics Performs and Reports Results of 2.15 Million COVID-19 Diagnostic Tests and 975,000 Antibody Tests to Date

ACLA Statement on Expanding Access to Testing

COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse

Because of the COVID-19 Outbreak, AACC Reschedules Its Annual Conference to December in Chicago and Executive War College Reschedules Its Conference in New Orleans to July

Two major clinical laboratory conferences reschedule, as the SARS-CoV-2 pandemic continues to disrupt long-planned events; Many labs are losing money as fewer patients visit physicians

This week, the ongoing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic was responsible for two important developments in the clinical laboratory industry. Both involved the rescheduling of major annual conferences. In both cases, conference organizers are placing different bets on when they think the COVID-19 outbreak, the illness caused by the SARS-CoV-2 coronavirus, will have passed and when they believe some semblance of normalcy will return to both social interaction and business activities.

On Monday, the American Association of Clinical Chemistry (AACC) announced that it would reschedule its 2020 AACC annual meeting and exhibition—originally scheduled for July 26-30, 2020, at McCormick Place in Chicago—to Dec. 13-17, 2020, also at McCormick Place.

On the same day, Dark Daily’s sister publication, The Dark Report, announced it had rescheduled the 25th annual Executive War College on Laboratory and Pathology Management to new dates and to a new hotel. This conference will now take place on July 14-15, 2020, at the Hyatt Regency Hotel in New Orleans. This is a change from the originally scheduled date of April 28-29, 2020, and from the original location, the Sheraton New Orleans Hotel.

On its website, AACC stated: “Based on input from all stakeholder groups, and in close collaboration with host city officials, the organization is pleased to announce that AACC will be able to preserve the complete Annual Scientific Meeting and Clinical Lab Expo experience to which its members, exhibitors, and the entire laboratory medicine community have been looking forward. The 2020 AACC Annual Scientific Meeting and Clinical Lab Expo will now be held December 13-17, 2020, at McCormick Place in Chicago, IL, USA.”

Each conference claims to be “the largest” in some dimension. Each year, AACC’s annual conference attracts more than 20,000 attendees, as measured by clinical chemists and other visitors to its Expo, which features more than 750 lab companies.

While the Executive War College claims to be the largest conference serving the business, management, operations, and financial health needs of clinical laboratories and pathology groups. Each year, it hosts almost 900 attendees—generally senior administrators, lab executives, pathologist-business leaders, consultants, and in vitro diagnostics (IVD) manufacturers. The conference is supported by more than 50 corporate benefactors and sponsors. 

AACC’s rescheduling of its conference from July to December will delay two important activities:

  • Many lab scientists planning to attend were hoping to participate in the first assessments of the novel coronavirus pandemic, assuming that the pandemic had passed by mid-summer.
  • During AACC is when the nation’s major IVD manufacturers and companies that sell lab automation, instruments, test kits, reagents, and other products introduce their latest-generation solutions. Now, many of those product launches will be pushed back to December.

Meanwhile, organizers of the Executive War College are betting that the novel coronavirus pandemic will taper down, possibly synchronized with the end of the annual influenza season in North America, which is typically sometime in April or early May.

If this proves true, then conducting the conference on July 14-15, 2020, will give lab leaders the opportunity to gather and share lessons learned during this COVID-19 outbreak in time to prepare for a possible second outbreak of COVID-19 when the next influenza season arrives in the fall. It will also be an important opportunity for lab managers and pathologists to learn ways to restore revenue lost during the pandemic.

Clinical Laboratories, Pathology Groups, Hospitals, at Brink of Financial Ruin

“What has gone unrecognized by the national news media is how the novel coronavirus pandemic is causing financial devastation to the finances of the nation’s clinical laboratories and anatomic pathology groups,” stated Robert L. Michel, Editor-in-Chief of The Dark Report and Founder of the Executive War College. “In absolute terms, the pandemic is a growing financial disaster to the medical lab industry, and it will take years for many labs to rebuild the staff that they have laid off or terminated in recent months in order to stay operational.

“Why are all labs losing money at this time?” asked Michel. “The answer is simple—beginning early in March, patients stopped visiting their doctors. Hospitals ceased to admit patients for elective procedures. Fewer patients per day means fewer lab test referrals per day and loss of the revenue generated by those claims that pays the salaries and expenses of the labs performing those tests. Laying off or furloughing staff is one way labs lower costs in response to lower income.

“Many clinical labs, pathology groups, and the hospitals they serve are steadily approaching financial ruin,” he continued. “Every week the pandemic continues, and North American citizens are advised to shelter in place, forces labs to draw down their dwindling financial reserves to keep their doors open.” 

Robert Michel (above), Editor-in-Chief of The Dark Report and Dark Daily and Founder of The Dark Intelligence Group, will host the 25th anniversary Executive War College on Lab and Pathology Management on July 14-15, 2020, in New Orleans. Attendees from clinical laboratories and pathology groups will gain critical insights from such learning opportunities as: “Preparing Your Lab for a Second Outbreak of COVID-19,” and “Rapidly Building Cash Flow and Restoring Your Lab’s Financial Stability Post-Pandemic.” (Photo copyright: The Dark Report.)

This crisis has created three big questions that labs need to answer:

  • How much longer will the COVID-19 pandemic last before some degree of normalcy is restored (meaning patient office visits resume and physicians begin ordering lab tests every day)?
  • If there is a second outbreak of SARS-CoV-2 this fall, what does every lab need to know to be ready?
  • As American society and business return to normal, how can labs quickly build up cash flow, collect more revenue, and restore financial stability?

“Given the unknown aspects of the SARS-CoV-2 coronavirus, the answer to the first question is a crap-shoot. But to reschedule the Executive War College to dates that are 14 weeks away seems a reasonable bet,” noted Michel. “The pay-off to that bet is the ability to provide the owners and leaders of the nation’s labs answers to the second and third questions.

“The 14 weeks between now and mid-July give us the opportunity to organize sessions and invite speakers who can provide answers and information to help labs with their two most pressing needs: to be prepared for another COVID-19 outbreak later this year, and to restore cash flow and financial health as soon as possible,” said Michel. “This will be the very first opportunity for lab managers and pathologists to assemble, learn the COVID-19 lessons from successful labs, gain financial insights, and network with their peers.”

The Executive War College team is inviting suggestions for speakers and session topics for the July 14-15 conference. The original agenda that was taking shape for the planned dates of April 28-29 will be revised so as to include presentations now directly relevant to the state of the clinical lab and pathology professions for mid-year 2020. Send your suggestions for topics and speakers to info@darkreport.com.

Information on registering for the 25th annual Executive War College, and on placing reservations at the Hyatt Regency Hotel in New Orleans, is available on the EWC website (or copy and paste this URL in your browser: https://www.executivewarcollege.com.)

People already registered for Executive War College 2020 will have their registrations automatically applied to the new July 14-15 dates.

—Michael McBride

Related Information:

25th Annual Executive War College, July 14-15, 2020

2020 AACC Annual Scientific Meeting and Clinical Lab Expo

CDC Coronavirus 2019 (COVID-19) Guidelines

This Coronavirus Outbreak Will Change Lab Industry

The Dark Report Special Issue: Labs Respond to Coronavirus Pandemic

Clinical Laboratories Should Be Aware of Potential Airborne Transmission of SARS-CoV-2, the Coronavirus That Causes COVID-19

Taiwan’s Containment of COVID-19 Outbreak Demonstrates Importance of Rapid Response, Including Fast Access to Clinical Laboratory Tests

AccuWeather Asks: ‘Will COVID-19 Subside as Temperatures Climb?’ Some Pathology Experts Say Yes, Others Are Skeptical

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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