November 20th
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.
| 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 | 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.
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
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.
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.
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 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.
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:
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.
(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:
The Court could make several different decisions, leading to five potential outcomes:
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.
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.