LabCorp Has At-home Covid-19 Testing Kit – No Prescription Required

LabCorp, a leading global life sciences company, has announced that the U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the use of its Covid-19 home test.

The Pixel by LabCorp Covid-19 Test Home Collection Kit will be the first to be available over-the-counter without requiring a prescription. The RT-PCR (reverse transcription polymerase chain reaction) test does not detect antibodies or immunity.

“With the first over-the-counter at-home collection kit ever authorized by the FDA for Covid-19, we are empowering people to learn about their health and make confident decisions,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics.

“With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”

The kit is currently available through the Pixel by LabCorp website and this approval will enable LabCorp to potentially distribute the kit through retail channels.

The kit can be billed to insurance or covered by federal funds if uninsured. For those who choose not to have the test covered by an insurance company, the cost is $119.

The kit allows consumers to self-collect their sample in the privacy of their own home, which helps minimize transmission of the virus. Users then send the sample for processing at LabCorp.

Upon purchase, users register their Pixel by LabCorp Covid-19 collection kit at the Pixel by LabCorp website and follow the instructions included.

The at-home test has a five-step process:

Complete a short eligibility survey
Choose a billing option
Receive sample collection kit via FedEx
Collect and send sample back to laboratory for testing
Access results online via Pixel by LabCorp portal

Test results are securely delivered to the consumer via the Pixel by LabCorp portal. A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and further actions.

The Pixel by LabCorp Covid-19 collection kit is not a substitute for visits to a healthcare professional and is for use by adults 18 and older.

Although LabCorp’s Covid-19 PCR test has not been FDA cleared or approved, it has been authorized by FDA under an Emergency Use Authorization (EUA) and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The test is only authorized for the duration of the emergency declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of Covid-19, unless the authorization is terminated or revoked sooner.

Retailers interested in selling Pixel by LabCorp Covid-19 collection kits can contact the company.

From the Triangle Business Journal:
https://www.bizjournals.com/triangle/news/2020/12/10/labcorp-at-home-covid-testing-no-prescription.html

Trajan Warren
Reporter
Triad Business Journal

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How much will your visit to the doctor cost? UNC Health app lets you know.

One of the largest health care systems in the state has released an online “cost estimator” tool it says will provide greater price transparency in the murky world of medical billing.

On Wednesday, UNC Health unveiled its new online tool, saying the goal is to “improve transparency for consumers who struggle with rising medical costs, and provide more information to help inform their medical care and decisions.”

“UNC Health is a leader in providing innovative care and services for our patients,” CEO Dr. Wesley Burks said in a statement. “We understand the importance of price transparency in health care. This estimator is about improving our patients’ experience and giving them more control in managing their health.”

According to the system, the estimator is, for now, designed for “services such as office visits, simple procedures and some inpatient services.” Inpatient services include some at UNC Rex Health Care in Raleigh and UNC Medical Center in Chapel Hill.

The company says future plans include expanding the services covered and adding more hospitals and clinics affiliated with UNC Health across the state.

At release, the service can provide estimates for out-of-pocket costs for 50 services, including cardiology, orthopedics, rehabilitation, sleep studies and some office visits.

The tool works through the system’s “My UNC Chart” application and website and automatically takes into account insurance benefits and other factors from a patient’s account to generate a cost estimate.

The service comes amid years of national and international concern about the inadequacies of health care billing in the U.S. with many complaining that its system leaves patients with no way to understand how much they’ll be billed until after the fact.

Price transparency also became a central topic after North Carolina Treasurer Dale Folwell launched a redesign of the state’s employee insurance plan following complaints about a lack of transparency with the major health systems in the state.

From the Triangle Business Journal:
https://www.bizjournals.com/triangle/news/2020/12/10/unchealth-cost-estimator-health-care-bill.html

Seth Thomas Gulledge
Staff Writer
Triangle Business Journal

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The Mental Health Parity and Addiction Equity Act of 2008

MEDICAL PLANS

The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) is a federal law that generally prevents group health plans and health insurance issuers that provide mental health and substance use disorder (MH/SUD) benefits from imposing less favorable benefit limitations on those benefits than on medical and surgical coverage.

On Nov. 13, 2013, the Departments of Labor, Health and Human Services and the Treasury jointly issued a final rule implementing the MHPAEA. The final rule increases parity between MH/SUD benefits and medical and surgical benefits in group and individual health plans. The final rule applies for plan years beginning on or after July 1, 2014 (Jan. 1, 2015 for calendar year plans).

BACKGROUND

The MHPAEA was enacted on Oct. 3, 2008, to strengthen federal mental health parity requirements for health coverage. The MHPAEA supplemented the Mental Health Parity Act of 1996 (MHPA), which required parity with respect to aggregate lifetime and annual dollar limits for mental health benefits. The MHPAEA also extended the parity requirements to substance use disorder benefits. The MHPAEA became effective for plan years beginning after Oct. 3, 2009.

Under the MHPAEA, the financial requirements and treatment limits that group health plans and health insurance issuers apply to MH/SUD benefits generally cannot be more restrictive than those applicable to medical and surgical benefits.

AFFECTED HEALTH PLANS

The MHPAEA generally applies to plans sponsored by employers with more than 50 employees, including self-insured plans and fully-insured arrangements.

The MHPAEA does not require large group health plans and their health insurance issuers to cover MH/SUD benefits.The MHPAEA’s requirements apply only to large group health plans and their health insurance issuers that choose to include MH/SUD benefits in their benefit packages. However, other state and federal laws may require a plan to provide these benefits.

The Affordable Care Act (ACA), builds on the MHPAEA and requires some plans to cover MH/SUD services as an essential health benefit. Specifically, non-grandfathered health plans in the individual and small group markets are required to provide essential health benefits (which include MH/SUD services), as well as comply with the federal parity law requirements, beginning in 2014.

The MHPAEA contains the following parity requirements:The financial requirements (such as deductibles, copayments, coinsurance and out-of-pocket limits) applicable to MH/SUD benefits cannot be more restrictive than the predominant financial requirements applied to substantially all medical and surgical benefits.

Treatment limitations (such as frequency of treatment, number of visits, days of coverage or other similar limits on the scope or duration of coverage) must also comply with the MHPAEA’s parity requirements.

Nonquantitative treatment limitations (such as medical management standards, formulary design and determinations of usual, customary or reasonable amounts) are subject to a separate parity requirement.

If medical and surgical benefits are offered on an out-of-network basis, a plan or issuer must also offer MH/SUD benefits on an out-of-network basis.

In addition, the MHPAEA requires plans to make certain information available with respect to MH/SUD benefits, such as the criteria for medical necessity determinations and the reason for any denial of reimbursement or payment for MH/SUD services.

ENFORCEMENT

The MHPAEA’s provisions are included under ERISA. The Department of Labor (DOL) and the Internal Revenue Service (IRS) generally have enforcement authority over private sector employment-based plans that are subject to ERISA.

While ERISA does not contain a specific penalty for violations of the MHPAEA, plan participants and beneficiaries and the DOL may use ERISA’s civil enforcement provisions to enforce the MHPAEA. Also, when the DOL audits an ERISA covered health plan, it will often investigate the plan’s compliance with federal mental health parity requirements.

In addition, employers that violate the MHPAEA may be subject to an IRS excise tax. Generally, an excise tax of $100 per individual, per day will apply to MHPAEA violations, unless an exception applies. Any applicable excise taxes must be reported on IRS Form 8928, “Return of Certain Excise Taxes under Chapter 43 of the Internal Revenue Code.”

MORE INFORMATION

More information on the MHPAEA is available on the DOL’s website, including FAQs and a self-compliance tool.

This Legislative Brief is not intended to be exhaustive nor should any discussion or opinions be construed as legal advice. Readers should contact legal counsel for legal advice.
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