SAN DIEGO — This is an official press release from the U.S. Department of Justice (USAO - California, Southern), published as received.

SAN DIEGO — A skin cancer testing company formerly known as DermTech Inc., which was headquartered in San Diego, has agreed to settle allegations that it violated the False Claims Act by knowingly submitting false claims for unreliable skin cancer tests to the Medicare program. DermTech is now liquidating as DTech Liquidating Inc. after filing for Chapter 11 bankruptcy in the District of Delaware in June 2024. As part of the resolution announced today, the United States received an Allowed Class Three General Unsecured Claim of $5,038,011 in the bankruptcy proceeding.

The settlement resolves allegations that DermTech submitted claims to Medicare for skin cancer tests despite knowing the tests had quality control issues. First, from October 2022 to March 2023, DermTech billed Medicare for skin cancer tests that it conducted after switching to an unvalidated positive control range for one of the test’s two key melanoma markers. Without a validated positive control range, it is impossible to confirm that the positive control is working and thus impossible to verify whether the test results are accurate. Second, from January 2020 to February 2022, DermTech billed Medicare for skin cancer tests that did not contain enough patient RNA to be tested but still generated positive or negative test results. For both categories of tests, DermTech reported results to patients. When concerns were raised about these tests, DermTech neither retracted the test results nor adequately refunded Medicare.

“The Justice Department is committed to protecting Medicare patients, especially in an area as serious as skin cancer testing,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “We will hold accountable health care providers who put patients at risk by billing Medicare for grossly substandard services.”

“This company billed Medicare for unreliable tests that may have misled patients and their doctors,” said U.S. Attorney Adam Gordon for the Southern District of California. “This settlement is a perfect example of why the Department’s focus on fraud against the taxpayer directly leads to improved health and safety for Medicare patients.”

“Patients must be able to rely on the accuracy and integrity of diagnostic testing when making critical healthcare decisions,” said Acting Deputy Inspector General for Investigations Miranda L. Bennett of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “Submitting claims to Medicare for tests that fail to meet established clinical standards undermines patient safety and public trust. HHS-OIG remains committed to ensuring that healthcare providers deliver services that meet federal requirements and to pursuing accountability for alleged misconduct.”

“DermTech Inc. allegedly administered inadequate skin cancer tests that led to the fraudulent billing of Medicare, raising serious concerns about the company’s practices,” said Special Agent in Charge Mark Remily of the FBI San Diego Field Office. “FBI San Diego, along with our law enforcement partners, remains committed to investigating any company whose illicit actions may undermine the integrity of our healthcare system and ensure they are held accountable.”

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by a former DermTech employee. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The qui tam case is captioned U.S. ex rel. Luong v. DermTech, Inc. et al., No. 3:23-cv-01404 (S.D. Cal.). Ms. Luong will receive 20% of the recovery received from the bankruptcy court in connection with the settlement.

The claims resolved by the settlement pertain to DermTech Inc., a company that is now bankrupt. These claims do not pertain to DermTech LLC, a company that purchased DermTech Inc.’s assets in 2024 as part of the bankruptcy proceedings.

The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the U.S. Attorney’s Office for the Southern District of California, with assistance from the Federal Bureau of Investigation and the Department of Health and Human Services, Office of the Inspector General.

This year the Administration launched the Task Force to Eliminate Fraud and the National Fraud Enforcement Division to enhance the Administration’s war on fraud, waste, and abuse in federal programs. When unscrupulous actors exploit these programs for their own financial gain, they defraud the government, harm the people these programs are designed to aid and protect, and undermine American businesses that play by the rules. The Civil Division’s FCA enforcement plays a critical role in combatting such fraudulent schemes, recovering billions of dollars for the American taxpayers, and holding wrongdoers accountable. FCA matters will continue to be on the forefront of the battle against fraud, and the Civil Division’s FCA work will support and advance the mission of the Task Force to Eliminate Fraud and the National Fraud Enforcement Division.

This matter was handled by Assistant U.S. Attorney Stephen H. Wong for the Southern District of California and Department of Justice Trial Attorney Clare Elizondo.

The claims resolved by the settlement are allegations only and there has been no determination of liability.