Company: INGN
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029993
Chunk: 21

Company: Inogen Inc
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 21
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 Payments Sunshine Act to physician assistants, nurse practitioners and other mid-level practitioners, with reporting requirements going into effect in 2022 for payments made in 2021. Failure to submit required ownership and investment interest information may result in civil monetary penalties of up to an aggregate of $211,000 per year (or up to an aggregate of $1.4 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission. Certain states also mandate implementation of compliance programs, impose restrictions on device manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians and other healthcare professionals.

The Patient Protection and Affordable Care Act also requires healthcare providers to voluntarily report and return an identified Medicare or Medicaid overpayment within 60 days after identifying the overpayment. Failure to repay the overpayment within 60 days will result in the claim being considered a “false claim” and the healthcare provider will be subject to False Claims Act liability. 

International regulation 

International sales of medical devices are subject to foreign governmental regulations, which vary substantially from country to country. The time required to obtain clearance or approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may be different. 

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In the European Union, medical devices are regulated by the European Union Medical Devices Regulation (EU) 2017/745, or MDR, which became applicable on May 26, 2021 and replaced the EU MDD, with the EU MDD still applying to certain products that were approved under that process. The MDR and its associated guidance documents and harmonized standards to regulate the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices. Devices that comply with the requirements of the MDR will be entitled to bear the European Conformity Marking, or CE Mark, indicating that the device conforms to the essential requirements of the MDR and, accordingly, can be commercially distributed throughout the Member States of the European Union, and additional Members States of the European Economic Area, or EEA, (i.e., Norway, Lichtenstein and Iceland). The method of assessing conformity under the MDR varies depending on the type and class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a notified body, an independent and neutral institution designated by a Member State country to conduct the conformity assessment. This