Our Response to House Oversight Committee
As we all continue to navigate through these unique and evolving challenges, we want you to know that Carbon Health is here for you. Since March 9th, our team has been channeling all of its resources to tackle the coronavirus pandemic. All of our California clinics are currently collecting specimens for COVID-19 testing and we continue to leverage our technology to provide accessible care and information to the public. Last Friday we announced our latest development: a COVID-19 Home Collection Kit. Unfortunately, due to pushback from the Food and Drug Administration, we have had to put our kits on hold until further notice.
Shortly thereafter, the Oversight Committee sent us a letter condemning us for trying to profit off of a public health crisis. Their tweet and our response is here for you to read.
March 25, 2020
Dear Chairman Raja Krishnamoorthi and Congresswoman Katie Porter,
Thank you for the opportunity to respond to the House’s Committee on Oversight and Reform (the Committee) and to the members of our communities. By way of background, Carbon Health is a San Francisco based healthcare provider, with 11 medical clinics across the SF Bay Area and Los Angeles.
Our mission at Carbon Health has always been to make world-class healthcare accessible to everyone. We are disappointed that our actions are being interpreted by the Committee as anything but altruistic and in the best interests of our patients.
We saw our first patient who was at risk of carrying the coronavirus on February 15th, 2020, and even at that time faced the frustration of the inability to access testing for the patient. Since then, we have been channeling all of our resources to tackle the pandemic and have taken several significant actions to address this problem in our communities.
On March 9th, when COVID-19 testing became commercially available, all of our California clinics have been assessing patients for signs associated with COVID-19, issuing requisitions for testing, collecting patient specimens and shipping the specimens to LabCorp and Quest for testing. In addition, to lower the risk of exposure for patients and healthcare providers, we have built and distributed an online assessment tool to risk-stratify patients based on CDC criteria, which we provide at no-cost to everyone located in California. We have also been providing telemedicine screenings, at no cost, to patients who need further evaluation. We have rolled out this assessment tool to all of our patients and three major hospital partners, and to date, over 7,500 patients have completed this assessment with more utilizing it every day.
Carbon Health was one of the first clinics in our communities to offer testing, and we have completed 2.5% of all COVID-19 tests in California between our 11 clinics as of March 25th. (Source: covidtracking.com/data) However, given that the scope of our reach is limited, we developed a public database of testing locations throughout California and the country to provide patients outside of our communities with this vital information. We have an internal team ensuring that this database is up-to-date, and have shared widely with public health departments, health organizations, and the media. We are also actively searching for ways to expand testing while reducing the strain on testing and PPE supplies, one of which was home collection kits.
On March 19th, our high complexity CLIA certified lab partner, Curative Inc., notified Carbon Health that they could begin specimen testing for COVID-19, pursuant to the FDA guidance issued on March 16, 2020. FDA’s guidance did not preclude obtaining the test sample via a home sampling kit prescribed and issued by a licensed health provider. In fact, FDA has historically permitted the commercialization of laboratory developed tests, or LDTs, where test kits could be delivered to patients at home for sample collection. Under FDA’s established policy, once the patient provided the sample using the at home collection kit, it would then be sent to an approved CLIA-certified laboratory for analysis. In strict compliance with FDA’s guidance and long-standing policy, Carbon Health began distributing the sample collection kits to a limited number of patients that were prescribed the kits following a COVID-19 assessment.
In a surprise move, on March 21, 2020, FDA issued an updated FAQ on COVID-19 testing and clarified that home sample collection kits were not covered by Emergency Use approvals. Based on that updated FAQ, we immediately suspended distribution of the home sample collection kits on March 22, 2020. We then contacted all patients who had been distributed a sample collection kit, refunded their payment, asked them to destroy the sample collection kit if they had not returned them, and offered them testing in our clinics through LabCorp or Quest Diagnostics.
We distributed 41 home collection kits in total, and had already charged $167.50 for 20 of them. This price is at-cost with the cost of the sample collection kit itself at $150 and the shipping fee at $17.50. We did not charge for the healthcare provider assessment time or follow up.
We requested Curative Inc. destroy all samples that they have received with standard biohazard disposal procedures, and requested patients who have not yet received their kits to discard it upon receipt. We are working with Curative Inc. to validate that the samples are destroyed.
Provided response to the questions directly below.
- When did your company start offering at-home coronavirus test kits for sale to consumers, and when did you stop?
Carbon Health never offered at-home testing. Rather, we began distribution of the home sample collection kits to a limited number of patients on Thursday March 19, 2020. All home sample collection kits were sent to a patient only after an assessment by a licensed clinician, resulting in an order for COVID-19 testing. We were notified by our lab partner Curative Inc. on Sunday March 22nd that the FDA (on Saturday March 21) updated their FAQ to stipulate that home collection tests were not covered by the EUA, and immediately suspended distribution of the home sample collection kits.
2. How many at-home coronavirus test kits did your company sell, how much did you charge, and how many consumers returned test kits with their samples?
Again, Carbon Health never offered at-home testing. Rather, we distributed 41 home sample collection kits. We had already collected $167.50 for 20 of them, which we refunded on Sunday March 22nd. The cost of the sample collection kit itself is $150 and the shipping fee at $17.50, we provided the clinician assessment and video visits at no cost to the patient*. We have offered all patients who ordered the kits to come into our clinics for testing.
*note: Effective April 1st, 2020, all Coronavirus-related virtual visits will have a $0 copay with insurance. The cost is $49 without insurance.
3. Do you intend to destroy all consumer samples received, and if so, when and how will you do so?
We do not have possession of patient samples. They are shipped from the patient directly to Curative Inc. We requested Curative Inc. to destroy all samples that they received with standard biohazard disposal procedures. We requested patients who have not received their sample collection kits yet to discard it upon receipt. We are working with Curative Inc. to validate that the samples are destroyed.
4. Do you intend to refund all consumers all amounts they paid for at-home coronavirus test kits, and if so, when and how will you do so?
We refunded all patients on Sunday, March 22nd, when we immediately suspended distribution. Any patients who had been charged were refunded their full amount to their original form of payment.
5. How many nasopharyngeal swabs does your company possess, and will you donate them for use with FDA-approved coronavirus tests?
We appreciate your interest and recognition of the current supply constraint. We have only 60 nasopharyngeal swabs left in our 11 clinics as of March 23rd. We continue to administer COVID-19 testing through Labcorp and Quest Diagnostics. This amount is less than the number of patients in our clinics requiring a test each day. We are actively working with lab companies and supply partners to increase the amount of testing supplies available, however, they have been in limited supply. We would sincerely welcome the support of Federal, State and Local agencies, including the Committee on Oversight and Reform, in gaining access to more supplies for the clinical staff on the front lines.
The test in question does NOT use nasopharyngeal swabs. It uses an oral swab, that is not used with the current in-clinic testing methods, which is part of the appeal to us. The tests are developed and distributed by Curative Inc. who has possession of the oral swabs. A small number of these swabs are currently stored at our distributor — we are working with Curative to determine their appropriate use and disposition.
We deeply respect the sensitivity of the Committee on this subject. While we cannot speak on behalf of every company that has offered home collection or home testing solutions, our continued commitment is to make world-class healthcare accessible for everyone in our communities. We can assure you that Carbon Health has and will continue to place an overabundance of consideration and clinical oversight into the care protocols we have created in response to the COVID-19 pandemic.
Respectfully yours,
Eren Bali
CEO / Co-founder, Carbon Health
