November 20th

COVID-19
TESTING BRIEF

from Avalon Healthcare Solutions

Avalon is an expert in lab management with a foundation in science. Clinically-driven lab strategies are transforming lab testing into actionable intelligence for value-driven care. Avalon’s core program includes full delegation of Routine Testing Management, Genetic Testing Management, Independent Laboratory Network Management, and Medical Specialty Rx Management. You can learn more about our impact here and the latest news here.

CONTENTS

Lab Testing Update

Policy Update

For More Information, Please Contact Us:

Barry S. Davis, Chief Growth Officer
201-218-3425 | barry.davis@avalonhcs.com
Fred Barry, VP, Business Development
714-615-1889 | fred.barry@avalonhcs.com
Sara Sabin, VP, Business Development
845-591-4725 | sara.sabin@avalonhcs.com
Joy Harris, Dir. Business Development
813-751-3814 | joydana.harris@avalonhcs.com
Angelo Devita, VP, Business Development
215-872-2202 | angelo.devita@avalonhcs.com

Lab Testing Update

Avalon Laboratory Network Capacity and Turnaround Time Report

Lab RT-PCRY/N Multiple Platforms Capacity (per day) TAT
Quest Y Y 215,000 2 days
LabCorp Y Y 210,000 1 day
BioReference Y Y 70,000 1 day
Eurofins-Diatherix Y N 60,000 1-3 days
Premier Medical Lab Y Y 50,000 1-2 days
GenetWorx Y Y 40,000 2 days
Mako Medical Lab Y Y 35,000 1-2 days
AIT (American Institute of Tox) Y Y 20,000 1-2 days
Sonic-CPL Y Y 20,000 1-3 days
Genesis DX (DNA Analytical) Y Y 16,000 1-2 days
MDL(Medical Diagnostic Lab) Y N 12,000 2-3 days
LabTech Y Y 10,000 2 days
Aegis Y Y 10,000 2 days
AccuReference Y N 10,000 2 days
PathGroup Y Y 8,000 2-3 days
Luxor Y Y 5,000 1 day
Transplant Genomics Y N 5,000 1-2 day
Neogenomics Y Y 5,000 1-4 day
Precision Genetics Y N 4,000 1-2 day
BAKO Y N 2,500 1-2 day
Radeas Y Y 2,400 1-2 day
Wake Medical Lab Consultants Y Y 1,500 1 day

Avalon encourages all health plans and providers to be aware of the weekly capacity of their COVID-19 lab network, and to be prepared to utilize the capacity of laboratories with excess capacity.

COVID-19 Antigen Testing Volume is Increasing

Accessing the data from Avalon’s current clients, the Avalon Analytics team notes that antigen testing for the detection of COVID-19 is on the rise. While the chart displayed represents only 2% of all current COVID-19 claims, the trend is significant. Most of the antigen testing claims are coming from hospitals, urgent care centers and physician offices. Avalon does not anticipate a high volume of antigen testing within the independent lab space. The previous Avalon COVID-19 bulletin noted the current CPT codes for antigen testing; 87426 (machine read) and 87811 (optical).

The NY Times published the following article detailing a study of one antigen test by the University of Arizona:
https://www.nytimes.com/2020/11/02/health/coronavirus-testing-quidel-sofia.html

COVID Testing Has Arrived at the Big Box Stores

In the previous Avalon COVID-19 bulletin, the current list of FDA-EUA approved kits for “at-home” collection was displayed. Costco is distributing one of those kits via the telehealth company, AZOVA Health. This is an unsupervised, sputum-based collection kit. The kit is not available in the Costco stores. It is available online via the Costco website or the AZOVA Health website. The performing laboratory is P23 Labs, located in Little Rock, Arkansas. P23 is listed among the FDA-approved home collection kits.

First At-Home Rapid Results Test Now Available

The FDA on Tuesday (Nov 17) authorized the first rapid coronavirus test that consumers can take at home and get their results within 30 minutes. The “All-In-One” single-use test kit by Lucira Health, Inc. is the latest nasal-swab test to be granted emergency use authorization. The molecular test works by looking for the virus’s genetic material in a self-collected sample swab, offering results in 30 minutes or less on a light-up display. The test currently requires a physician’s prescription.

Policy Update

Now What? A Post-Election Update

COVID-19 challenges have dominated policy discussions for so much of 2020 that it seems like the other issues are distant secondary priorities. In this post-election update, we will address the new political landscape, how the election impacts health care policy in the near and longer-term, and the U.S. Supreme Court’s review of the Affordable Care Act case.

Who Won and What’s Next

WHO WON THE PRESIDENCY: After winning Pennsylvania’s 20 electoral votes and passing the required 270-vote threshold, it became clear on November 9, 2020, that Joe Biden will be the 46th President of the United States, and Kamala Harris will be the first woman, and first person of color, to become Vice President. As of this writing, major news organizations declared that President-elect Biden will win Georgia and President Trump will win North Carolina, the final two states left to be called in the 2020 Presidential Election. Accordingly, Mr. Biden is set to receive 306 Electoral College votes and Mr. Trump 232. To secure this win, Mr. Biden “flipped” five states that Mr. Trump won in 2016 -- Arizona, Georgia, Michigan, Pennsylvania and Wisconsin. Despite pending litigation, there is no mathematical possibility for President Donald Trump to secure a second term.

WHO WON THE SENATE: In the U.S. Senate, Republicans have won 50 Senate seats so far, and the Democrats have a total of 48. It will not be known which party has majority control of the U.S. Senate until after Georgia hosts its two runoffs on January 5, 2020. One of the Georgia contests will determine who finishes the remainder of retired Senator Johnny Isakson’s term -- Kelly Loeffler (R) or Raphael Warnock (D). The other is between Republican Sen. David Perdue and Democrat Jon Ossoff. If Democrats win both Georgia elections, it would create an even split of Senators between the parties, giving Vice President-elect Kamala Harris a tiebreaking vote, and the ability of Democrats to command some control over the White House and both chambers of Congress. Even one Republican win of the Georgia Senate runoffs means that the Republican Party will maintain control over the Senate, creating a divided Congress that will reduce the opportunity for legislating major policy changes.

WHO WON THE HOUSE: In the U.S. House of Representatives, the Democrats will have a slim majority. As of this writing, the Associated Press has called 422 of the 435 seats up for election. Democrats won 219 seats with Republicans winners of 203 seats -- there are 13 races outstanding, with Democratic candidates leading in only two of them. If all 13 seats went to the party leading in them right now, Democrats would have 221 seats to the Republicans' 214 seats in the next House.

WHAT NOW FOR CONGRESS: Congress is in its so-called “lame duck” session that will bring an end to the 116th Congress. With just 14 legislative days left on the calendar, Congress will try to avoid a government shutdown and pass a funding bill before December 11th -- when the current funding expires.

Congress is also expected to attempt to pass an economic relief bill during the lame duck session. As COVID-19 infection rates are hitting record levels across the country, it is anticipated that there will be a shortage of testing equipment and testing delays. Despite this backdrop, the parties continue to be far apart on their relief proposals. Democrats are proposing trillions of dollars in new spending and Republicans are focused on a much narrower bill. While both parties want to pass a new economic relief package -- it is uncertain whether they will be able to find common ground in the weeks ahead.

WHAT NOW FOR BIDEN ADMINISTRATION: President-elect Joe Biden is pushing forward with his agenda and has already announced his top priorities: pandemic, economic recovery, race and climate change issues. He launched a transition website, appointed a large task force to oversee the pandemic response, published the names of team members who will assess the staffing needs of each federal agency, and announced that his next Chief of Staff is Ron Klain.

How The Election Impacts Health Care

Until control of the U.S. Senate is decided, the likelihood of new health care legislation will be difficult to predict. We know that some issues already enjoy wide bipartisan support and have momentum from recent activity, so we may expect at least some movement on:

  • Drug Pricing
  • Surprise Billing
  • Telehealth
  • Price Transparency
  • Health Data Exchange

Issues that are more politically difficult is funding for the CDC and other public health authorities. That said, improving the exchange of data on lab results and vaccine-related information between the agencies and the states will likely have bipartisan support.

Expect more health care-related regulatory reform, rather than legislative reform, in the near future. Bigger health care policy proposals, like lowering the Medicare eligibility age to 55, instituting a government-run “public option” or extending premium subsidies to middle-income workers are unlikely to be achievable with a divided Congress. Any effort to expand the Affordable Care Act (ACA) would require congressional action.

It is possible that President-elect Biden would try to address provider consolidation, something that is possible without congressional approval. Retroactive review of approved mergers and acquisitions are probable, and it is logical to expect increased antitrust scrutiny of new moves to consolidate the health care market.

U.S. Supreme Court Review of the ACA

(California v. Texas)

On November 10, 2020, the U.S. Supreme Court heard oral arguments for the third time on the ACA in California v. Texas. The Court’s decision on the case will decide the future of the ACA, and could have a range of consequences for individuals, employers, health plans, providers, and pharmaceutical manufacturers, among others, depending on the outcome -- which will not come until the spring of next year. The Court will decide the following questions:

  1. Whether the plaintiffs have legal standing to bring the lawsuit to challenge the individual mandate;
  2. Whether reducing the individual mandate penalty to zero has rendered the requirement to purchase insurance unconstitutional, and
  3. If the individual mandate is ruled unconstitutional, whether it can be severed from the rest of the ACA -- leaving the remainder of the law intact.

The Court could make several different decisions, leading to five potential outcomes:

  • The Court could find the Texas plaintiffs do not have standing to bring the lawsuit and dismiss the case, leaving the ACA in place as it currently stands;
  • The Court could rule the individual mandate unconstitutional due to no longer having a non-compliance penalty but could find this policy severable from the rest of the law and leave the rest of the ACA intact, essentially maintaining the status quo;
  • The Court could rule the mandate unconstitutional and inseverable from the rest of the ACA thereby striking down the entire law;
  • The Court could rule the mandate unconstitutional and could strike down some of the ACA provisions most closely tied to the mandate, such as its insurance reforms, and leave the rest of the statute for lower courts to conduct further severability analyses, restarting a multi-year process; and
  • The Court could overturn the lower courts’ rulings and uphold $0 the mandate as constitutional, leaving the law unaffected.

WHY THE ACA CASE MATTERS: If the ACA is struck down in its entirety, it would wreak serious havoc with our current health care system. It is not only a health insurance expansion law, it is the legal authority for coverage of the Medicare Part D ”donut hole,” mental health parity, the HHS Centers for Medicare and Medicaid Innovation, and the ability for HHS to regulate health care price transparency.

Conclusion

The election of 2020 was like no other election, which is fitting for a year that was like no one before it. These are challenging times for policymaking, the management of the pandemic, and the economic recovery we hope to achieve over the next couple of years. Avalon Healthcare Solutions will keep its customers apprised of the changing landscape that impact the lab testing industry.