The OIG advisory provides lessons for digital health sites – food, drug, healthcare and life sciences

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The US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion 21-20 on December 16, 2021, which discusses a number of issues of importance to digital health providers, such as those offering online provider directories. The applicant may only rely on opinion, but discuss legal concepts relevant to financial arrangements for certain healthcare applications and websites.

opinion overview

The opinion relates to the electronic platform proposed by the applicant that would allow users to search for and contact home health care providers (the Platform). The applicant will charge the listed service providers on a per click basis and publish a newsletter through which third parties can purchase advertising space. The Office of the Inspector General determined that the proposed arrangement would generate a bonus prohibited under the Federal Anti-bribery Act (AKS) if the requisite intent to induce referrals existed.

The OIG has found that it can also generate rewards that are prohibited by the Act Banning Solicitations of Beneficiaries (Beneficial Incentives), which provides for civil financial penalties if the person providing the reward knew or should have known that it was likely to influence the recipient’s choice of a particular provider. From Medicare or Medicaid. However, the Office of the Inspector General chose not to impose sanctions on the applicant under the specific facts as described. Other than the applicant, no person shall assume that similar arrangements will escape penalties unless he requests his or her own advisory opinion from the Office of the Inspector General.

The platform will allow users to search for home care providers who meet certain criteria and include a clear notice that the search results show only those who have paid a fee to be included in the list. The platform will not direct users to any particular providers who have paid to be included in the list. If any providers that meet the user’s search criteria are not paid to be included in the list, the platform will include providers that have not paid but may meet the user’s criteria. Users can access the platform for free, rate providers on a one to five-star scale and post reviews. Providers will pay a monthly fee to be listed, as well as a flat fee per click or per contact. The charges will not be adjusted for the account of users who have already purchased the services of the Service Provider.

The applicant also suggested providing a free newsletter to users who request it through the platform. Healthy and unhealthy entities can purchase advertising space in the publication, with the applicant selling on a first-come-first-served basis. Advertisers will be charged a fixed monthly fee, and the applicant will not make use of user data to target specific ads to specific users.

The OIG found that the proposed arrangement would affect the AKS because of the pay-per-click that an applicant might charge to “recommend” listed providers. Interestingly, the AUD also found that allowing users to access the platform at no charge would constitute a “reward” for such users, which “could be intended to induce users to refer themselves to registered service providers for the provision of items and services that could be compensated by the program.” Federal health care. The opinion does not provide details as to why simply offering a free internet search engine is a bonus to its users. Due to a number of specific parameters related to newsletter advertisements, the SIGIR concluded that the applicant would not recommend entities that advertise in the newsletter, so “this aspect of the proposed arrangement would not involve federal anti-bribery law.”

OIG provided the following reasons for not imposing sanctions under the AKS or CMP-beneficiary incentives:

  1. The applicant has assured that the fees to be charged will be fixed, will not vary by registered provider and will be consistent with the fair market value. The applicant may charge a connection fee to the service providers regardless of whether the user has received services from the provider, and the fee will not increase or decrease based on the number of contacts received by the provider. Additionally, the fee will not affect the Service Provider’s placement in the Platform’s listings or the duplication of such listings. Instead, providers will be listed based on user specific criteria.
  2. The applicant is not the same as a provider or supplier and is not affiliated with any provider that may be listed, even though one of the applicant’s owners is authorized to provide certain health care services. There is no “white coat” marketing, where a doctor or other specialist in a trusted position can influence the user.
  3. Anyone from the general public can use the platform, regardless of insurance status or payment source. Users will not receive any remuneration other than for free use of the platform.
  4. The Platform included other ways to reduce the risk of fraud and abuse, including, among other things, refraining from promoting certain items or services to Service Providers – including all Service Providers that meet the user’s search criteria – and notifying Users that the Listed Providers may They paid the cost.

Conclusion and considerations

A key point from this OIG advisory opinion is that financial arrangements involving health care providers and referral sources can lead to uninformed defaults. Any kind of financial arrangement that involves advertising or recommending health care providers can implicate the AKS and its state counterparts. Simply providing an online platform to enable the general public to identify service providers can be a bonus.

Firms involved in such arrangements should carefully review the advisory opinion, consider seeking their own opinions and ensure that their arrangements comply with relevant laws and rules.

The content of this article is intended to provide a general guide to the topic. It is recommended to take the advice of specialists in such circumstances.

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