Dolor Technologies: The Migraine Pitch and the Medicare Claim

The Dolor Technologies SphenoCath settlement required payments based on the company’s ability to pay to resolve allegations that it caused false Medicare claims for migraine procedures. The government alleged that Dolor supplied more than the device: it coached providers on improper billing codes. The alleged sales effort reached into the provider’s Medicare bill.

The Justice Department announced the agreement with the Utah-based company on December 11, 2023. A physician brought the whistleblower case. The announcement gave no dollar figure for Dolor’s settlement.

What the Government Alleged About SphenoCath

Dolor allegedly caused medical providers to submit false Medicare claims for SphenoCath procedures between July 2013 and July 2017. The government connected the company’s promotion of an unauthorized headache treatment with its instructions about how providers should bill for it.

SphenoCath was intended to administer a nerve block to the sphenopalatine ganglion, a collection of nerves deep in the midface, to treat migraine headaches. The government alleged that the Food and Drug Administration had not approved or authorized the device for that use. It also alleged that Dolor instructed, coached and encouraged medical providers to submit improper Medicare billing codes for services using the device.

That last allegation explains why a device manufacturer faced a claim about a provider’s bill. Dolor sold the product. A clinician used it in a procedure. A provider submitted the Medicare claim. The government’s allegation connected those decisions through the manufacturer’s billing advice.

For a device sales representative or a clinic employee, the connection is concrete. The product’s promoted use belongs beside the reimbursement instructions that accompanied it. The question we examine is how those instructions reached the people who billed the procedure and what those people submitted. That is where the manufacturer’s commercial message can become a claim against public money.

How the Device Pitch Reached the Medicare Bill

In the Dolor case, the government alleged problems on both sides: an unauthorized intended use and improper codes encouraged by the manufacturer.

Noridian’s SphenoCath billing article in the Medicare Coverage Database, in its revision effective September 25, 2025, identifies CPT 64999 for SphenoCath and similar delivery devices, citing the July 2014 CPT Assistant. It also cites Medicare’s instruction against a separate moderate-sedation payment when the physician performing the procedure supplies only local or topical anesthesia.

For an insider, the useful comparison brings the manufacturer’s coding material together with the procedure performed, the provider’s claim and the applicable payer instructions. Those records describe different parts of the transaction. We work with the person who can explain how they connected in practice, including who supplied the advice and how the billing office used it.

Can a Whistleblower Take Legal Action Against a Medical Device Company?

Yes. A physician brought the False Claims Act case that led to Dolor’s civil settlement over claims submitted by medical providers.

The 2020 Journal of Forensic and Investigative Accounting paper A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud describes how knowledgeable whistleblowers supplement the government’s investigative resources. In a case about manufacturer billing advice, that is the person who can connect a device pitch to a billing instruction. A claim describes what a provider asked Medicare to pay. An insider may be able to explain where that description came from.

The Same Complaint Reached Jet Medical

The physician’s qui tam case also produced a separate civil settlement involving Jet Medical. In the resolution announced on January 4, 2023, Jet Medical participated in a civil settlement totaling $545,133 over the Allevio SPG Nerve Block Catheter.

The Allevio allegations followed a similar path. The qui tam case alleged that the device lacked Food and Drug Administration authorization for headache nerve blocks, that the procedure was not covered by Medicare, and that Jet coached providers to submit improper billing codes. The product promotion and the reimbursement advice appeared together again.

Under its deferred prosecution agreement, Jet admitted distributing misbranded devices. The same physician’s action reached both products, with each company’s conduct addressed in its own resolution.

The Former Chief Executive’s Misdemeanor Plea

Dolor’s former chief executive pleaded guilty on October 11, 2023, to misdemeanor charges involving the distribution of misbranded and adulterated devices. As the Justice Department described his guilty plea, he admitted that Dolor did not seek Food and Drug Administration approval or clearance to distribute SphenoCath for treating headaches. He also admitted that Dolor never conducted the investigational study the agency recommended and continued marketing the device for migraine nerve blocks.

The government’s misdemeanor information gives the commercial detail behind the criminal charges. It alleged that SphenoCath was Dolor’s only product and that the chief executive personally directed its marketing, supplied materials and communicated with purchasers and potential purchasers. It described a catheter with a specially curved tip, intended to deliver anesthetic to the nerve target.

Listed for the Nose, Marketed for a Nerve Block

The criminal information alleged a mismatch between Dolor’s device listing and its intended use. Dolor listed SphenoCath as a Class I exempt ear, nose and throat drug-administration device. The exemption covered devices such as droppers, ear wicks and nasal inhalers for treating ear, nose and throat disorders. The government charged that the claimed exemption did not fit a device intended to treat a neurological disorder at a neurological site.

The filing described provider-facing marketing in concrete terms:

According to that criminal filing, the company also sent unsolicited directions for filling the catheter with lidocaine or other anesthetic and flooding the nasal cavity to reach the nerve and trigger the block. The promoted purpose was present in both the sales materials and the directions sent to clinicians.

FDA Recommended Studies, and the Marketing Continued

The criminal information says Dolor asked the Food and Drug Administration about product classification in April 2014. It dates the agency’s response to June 13, 2014: the agency could not give a definitive classification answer and recommended investigational studies.

The government charged that neither Dolor nor its chief executive responded to that recommendation, submitted a premarket clearance notification or sought premarket approval. Instead, the filing alleged, they continued marketing SphenoCath for migraine nerve blocks.

The agency recommended studying the device. Dolor kept marketing the device for migraines, as the former chief executive admitted in his plea. An employee who knew the Food and Drug Administration correspondence and the sales materials could see the gap. The civil case then followed a further step: what Dolor allegedly told providers to bill Medicare.

A Settlement Based on What Dolor Could Pay

The government alleged a pattern of improper billing advice. Dolor’s financial obligation turned on what the company could pay.

The Justice Department said the physician whistleblower would receive a share of the False Claims Act settlement proceeds.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. For a device or clinic insider, the starting point is the connection they can explain between the marketing, the procedure and the claim.

You Know How the Procedure Was Sold

If you saw device marketing turn into instructions for billing Medicare, talk with our whistleblower experts about what happened inside the business. We build the case with you, bring in medical device fraud whistleblower lawyers who understand manufacturer promotion and provider billing, and stay beside you throughout the case.