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Routine Testing Genetic Testing Independent Network
September 22, 2020
Avalon Healthcare SolutionsCOVID-19 Testing Update
Avalon is the leader in Laboratory Benefit Management
2Confidential – Not to be distributed or shared with outside parties
Before We Start
This meeting is being recorded
The slides and recording will be available tomorrow on Avalon’s website Avalonhcs.com
WE will be MUTING Everyone except the presenter to make sure the AUDIO is clean and clear.
Q&A will be done by using the “Chat” feature at the bottom of your screen• Please identify your full name and plan in the Chat when asking a question
3Confidential – Not to be distributed or shared with outside parties
Avalon’s COVID-19 August 31st Testing Brief is on our website Avalonhcs.com
If you would like to be added to our newsletter distribution, please contact:
Clients Contact: Kerri Fritsch / 813-751-3832 / [email protected] Contact: Barry Davis / 201-218-3425 / [email protected]
4Confidential – Not to be distributed or shared with outside parties
Agenda
• Introduction & Meeting Overview Barry DavisChief Growth Officer
• Lab Testing- Policy Perspective Julie Barnes Principal, Maverick Health Policy
• Clinical Advisory Board Insights Tatiana Souslova, MSc, PhD, DABCCVice President, Medical Policy
• Lab Testing Capacity Mike SnyderEVP Network Management
• Closing Bill Kerr, MDCEO
Policy UpdateSeptember 22, 2020
Julie BarnesPrincipal, Maverick Health Policy
OVERVIEW
6www.maverickhealthpolicy.com
• FDA Activity and Jurisdiction Debate• At-home test momentum• Reimbursement of Lab Testing
7www.maverickhealthpolicy.com
FDA identifies which molecular diagnostic COVID tests provide best results
• Developers must assess traceability as a condition of a EUA• The FDA created a reference panel to determine test sensitivity• 9/15/20 reference panel shows wide range of performance for 55
tests • Best-performing / most sensitive tests are the PerkinElmer New
Coronavirus Nucleic Acid Detection Kit, and tests made by ScienCell Research Laboratories, Hologic, DiaCarta, BioCore, and Seasun Biomaterials
8www.maverickhealthpolicy.com
Controversy Over FDA’s Oversight of LDTs
Lab-developed tests (LDTs) are the primary response to broad testing needs for the pandemic.
JANUARY: HHS Secretary Azar declared a public health emergency, the FDA did not require reviews of LDTs when they asked for emergency use authorizations.
• 82 of 125 tests had design or validation problems• Similar problems were associated with non-reviewed antibody tests
APRIL : FDA recalled faulty or inaccurate tests and began requiring scientific reviews
AUGUST: HHS revoked FDA’s oversight authority of LDTs. FDA had no plan for communicating the shift to manufacturers or the broader public. Top FDA officials refused to publicly announce the change themselves.
9www.maverickhealthpolicy.com
• Gauss and Cellex announced the first rapid COVID-19 test that can be fully performed by people at home without involving a lab. • Cellex was the first company to get an EUA for its rapid antibody testing • When paired with a mobile app from Gauss, it enables non-expert users to perform and interpret
the test with an iPhone or Android phone
• Quest’s at-home diagnostic test: take sample at home and to the lab through FedEx or take the collection kit to Walmart to use the test under a pharmacist's supervision
• Sona Nanotech is awaiting FDA approval for its rapid detection antigen test, using a nasopharyngeal swab and provides results in 15 minutes
• Rep. David Schweikert (R-AZ) will be introducing the Safe Testing at Residence Telehealth (START) Act to facilitate COVID testing for Medicare beneficiaries at home.
AT HOME TESTING MOMENTUMWill tests collected or performed at home reduce testing delays and fill the need for more widespread testing to help contain the coronavirus pandemic?
LAB TEST REIMBURSEMENT
10www.maverickhealthpolicy.com
• MEDICARE: $100• CARES ACT COMMERCIAL PLAN MANDATE:
• Pay whatever, but labs must be transparent• Providers get a 20% bonus payment for each COVID-19 admission, but
patients must have a documented positive lab test (effective Sept 1st) • EXPERTS: Only pay labs if test results are returned within 24 hours; there
should be a federal fund for pandemic-related lab testing; MedPAC is discussing
• LABS: Everyone should pay, including consumers• POLITICIANS: Testing should be free
12Confidential – Not to be distributed or shared with outside parties
Clinical Advisory Board Insights
Tatiana Souslova, MSc, PhD, DABCC
Vice President, Medical Policy
13Confidential – Not to be distributed or shared with outside parties
Coronavirus Testing-Avalon Policy Update
AHS-G2174 Coronavirus Testing in the Outpatient Setting
Initial Presentation: 05/26/2020Revision Date: 09/08/2020
Guideline Updates• World Health Organization• Centers for Disease Control and Prevention• National Institutes of Health• American Medical Association• Infectious Diseases Society of America• American Academy of Pediatrics
CAB Recommendation Changes• Antigen Testing• Neutralizing Antibodies Testing
Coding Updates• CPT: 86413 effective date 9/8/2020• Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (Coronavirus disease [COVID-19])
antibody, quantitative
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CAB Recommendations
• Targeted nucleic acid test is the preferred test to diagnose acute COVID-19 infection
• Large Molecular Panels are not recommended
• Diagnostic Antigen Test is acceptable for symptomatic patients
• Antibody testing is not recommended with one exception for children with multisystem inflammatory syndrome in children (MIS-C)
• Neutralization Antibody Testing is not recommended
15Confidential – Not to be distributed or shared with outside parties
09/18/2020 CDC COVID-19 Testing Guidance Update
• If you have symptoms of COVID-19• Your healthcare provider (physician, nurse practitioner, pharmacist, etc.) may advise a SARS-CoV-2 test.
• If you have been in close contact, such as within 6 feet of a person with documented SARS-CoV-2 infection for at least 15 minutes and do not have symptoms.• You need a test.
• If you do not have COVID-19 symptoms and have not been in close contact with someone known to have SARS-CoV-2 infection (meaning being within 6 feet of an infected person for at least 15 minutes).• You do not need a test unless recommended or required by your healthcare provider or public health official.
• If you are in a high SARS-CoV-2 transmission zone and attended a public or private gathering of more than 10 people (without universal mask wearing and/or physical distancing).• Your healthcare provider or public health official may advise a SARS-CoV-2 test.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html
16Confidential – Not to be distributed or shared with outside parties
Laboratory Developed Tests
https://www.hhs.gov/coronavirus/testing/recission-guidances-informal-issuances-premarket-review-lab-tests/index.html
17Confidential – Not to be distributed or shared with outside parties
COVID-19
18Confidential – Not to be distributed or shared with outside parties
COVID-19 Molecular Tests (196)
Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the Cobas
Liat System
ID NOW COVID-19 Accula SARS-Cov-2 Test
Xpert Xpress SARS-CoV-2 test
Roche Molecular Systems, Inc.
Abbott Diagnostics Scarborough, Inc.
Mesa Biotech Inc. Cepheid
09/14/20 03/27/20 03/23/20 03/20/20
19Confidential – Not to be distributed or shared with outside parties
Antigen Tests (4)
Test Name Manufacturer Complexity PPV NPV Date EUA issued
Sofia 2 SARS Antigen FIA
Quidel Corporation HighModerateWaived
Study 1: 100% (47/47)
Study 2: 100% (4/4)
Study 1: 88% (84/96)
Study 2: 97.7% (43/44)
05/08/20
BD Veritor System for Rapid Detection of SARS-CoV-2
Becton, Dickinson and Company (BD)
HighModerateWaived
84% (26/31) 100% (195/195) 07/02/20
LumiraDx SARS-CoV-2 Ag Test
LumiraDx UK Ltd. HighModerateWaived
93.1% (81/87) 98.8% (168/170) 08/18/20
BinaxNOW COVID-19 Ag Card
Abbott Diagnostics Scarborough, Inc.
HighModerateWaived
97.1% (34/35) 98.5% (66/67) 08/26/20
20Confidential – Not to be distributed or shared with outside parties
Antibody Tests (45)
Neutralizing Antibody Tests:
09/17/20 Axim Biotechnologies has filed EUA FDA for measuring COVID-19 neutralizing antibodies in plasma and serum through its rapid diagnostic test.1-Screening plasma2-Vaccine efficacy3-”Immunity passports”https://aximbiotech.com/science-canna/covid-19-diagnostic-research/
ROCHESTER, Minn. — Mayo Clinic has launched a new SARS-CoV-2 neutralizing antibody test in support of the national Expanded Access Program for Convalescent Plasma and other critical research efforts to establish effective therapies and vaccines for COVID-19. The test will be available through Mayo Clinic Laboratories to select labs, blood banks, and biopharma clients in late June.https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-launches-neutralizing-antibody-test-to-advance-covid-19-therapies/
21Confidential – Not to be distributed or shared with outside parties
Home Collection Kits (15)
22Confidential – Not to be distributed or shared with outside parties
At-Home Tests
Received FDA EUA as high or moderate complexity
100% PPA and 100% NPA30 POS 30 NEG
No FDA EUA
23Confidential – Not to be distributed or shared with outside parties
COVID-19 Testing Update
Mike Snyder
Avalon, EVP Network Management
24Confidential – Not to be distributed or shared with outside parties
Avalon Network Capacity and Turnaround Time ReportLab HealthPlan
RT-PCR
Y/N
Multiple
Platforms
Capacity
(per day)TAT
Antibody
Testing
Y/N
FDA EUACapacity
(per day)TAT
LabCorp SC,NC Y Y 200,000 1 day Y Y 300,000 1-3 days
Quest SC, NC, CBC, VT Y Y 200,0001 day priority
2 days all Y Y 200,000 1-2 days
BioReference SC, NC, CBC, VT Y Y 70,000 1 day Y Y 260,000 3 days
Premier Medical Lab SC Y Y 50,000 1-2 days Y Y 50,000 1-2 days
GenetWorx SC, NC Y Y 40,000 2 days Y 1,000 1 day
Mako Medical Lab SC, NC Y Y 35,000 1-2 days Y Y 20,000 1 day
Eurofins-Diatherix SC, NC, CBC, VT Y N 30,000 1-2 days Y Y 15,000 2-4 days
Sonic-CPL SC Y Y 20,000 1-3 days Y Y 100,000 1 day
MDL(Medical Diagnostic Lab) SC, NC, CBC, VT Y N 12,000 2-3 days Y Y 1,000 3 days
LabTech SC,NC Y Y 10,000 2 days Y y 3,000 1 day
Aegis SC, NC, CBC, VT Y Y 10,000 2 days Y N
PathGroup NC Y Y 8,000 2-3 days Y Y 1000 1 day
AccuReference CBC Y N 5,000 2 days Y Y 1,700 1 day
Luxor SC Y Y 5,000 1 day Y Y 1,000 1-2 days
Neogenomics SC, NC, CBC, VT Y Y 5,000 1-2 days N NA
Precision Genetics SC, NC Y N 4,000 1-2 days Y Y 1250 2-4 days
Neogenomics SC, NC, CBC, VT Y Y 3,400 1-4 days N NA
AIT (American Institute of Tox) SC, NC, CBC Y Y 3,000 1-2 days N
BAKO SC, NC, CBC, VT Y N 2,500 1-2 days N NA
Radeas SC, NC Y Y 2,400 1-2 days Y Y 4,000 1 day
Wake Medical Lab Consultants NC Y Y 1,500 1 day Y Y 4,800 1day
• Current Avalon RT-PCR capacity is >700,000/day
• Nearly all labs TAT is currently 1-2 days
• Most labs report excess capacity for RT-PCR testing
• Current overall positive rate: 8%
25Confidential – Not to be distributed or shared with outside parties
Intel from the Laboratory Industry
• COVID-19/Flu panels• LabCorp announced on Sept 8 the launch of a combined test for C-19, Flu A/B and RSV• Quest has indicated that they will soon announce a similar panel• This panel can be described by the existing, non-C-19 specific CPT code 87631• Health plans will need to recognize this test combination via C-19 related diagnoses codes to
avoid member responsibility• COVID-19 test charges has a wide range
• Modern Healthcare reports a study that pegs charges for C-19 testing between $0.01 and $14,750• Average bill to insurers for RT-PCR testing is $144• Average bill to insurers for antibody testing is $64
• Managing the cost of COVID-19 testing• CARES Act requires insurers to cover the cost of C-19 testing with no OOP expense to the patient• The Act does not set a range for pricing; however, the Act does require all labs to post the cost of
their C-19 testing on their website• C-19 diagnostic testing (RT-PCR) costs above the CMS rate ($100) should be investigated
26Confidential – Not to be distributed or shared with outside parties
COVID-19 Summary
Bill Kerr, MD
Avalon, CEO
27Confidential – Not to be distributed or shared with outside parties
Wearing a Mask: Impact on Influenza
28Confidential – Not to be distributed or shared with outside parties
The webinar slides, recording and all our COVID-19 materials are on our website
If you would like to be added to our newsletter distribution, please contact:
Clients Contact: Kerri Fritsch / 813-751-3832 / [email protected] Contact: Barry Davis / 201-218-3425 / [email protected]
https://www.avalonhcs.com Next Tentative COVID-19 Testing Webinar: 10/20/20 @ 2:00pm est.
