Physician Payment Sunshine Act Compliance

  • All employees, agents and other personnel of Alevio (“Alevio Personnel”) shall not engage in any conduct or provide any inducement to an HCP that is designed or specifically intended to:
    • Reward HCPs or others for ordering products from Alevio or
    • Induce HCPs or others to order products from, or generate business for Alevio

 

  • When there are legitimate needs of the company, Alevio may contract with HCPs for personal services, such as consulting, clinical work and/or design input.
    • The following factors support the existence of a bona fide consulting arrangement (not all factors may be relevant to any particular arrangement):
      • A written contract specifies the nature of the services to be provided and the basis for payment of those services;
      • A legitimate need for the services has been clearly identified in advance of requesting the services and entering into arrangement with the prospective consultants;
      • The criteria for selecting consultants are directly related to the identified purpose and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria;
      • The number of healthcare professionals retained is not greater than the number reasonably necessary to achieve the identified purpose;
      • The retaining company maintains records concerning and makes appropriate use of the services provided by consultants;
      • The venue and circumstances of any meeting with consultants are conducive to the consulting services and activities related to the services are the primary focus of the meeting, and any social or entertainment events are clearly subordinate in terms of time and emphasis.
    • Cadaver Labs/Training Meetings

It is appropriate for health care professionals who participate in programs intended to train and educate others at company sponsored cadaver labs/training engagements to be offered reasonable compensation for their time, considering the value of the type of services provided, and to be offered reimbursement for reasonable travel, lodging and meal expenses, when (1) the HCP fills out all necessary documents for reimbursement within 60 days of the Cadaver Labs/Training Meetings (2) has a W-9 on file (3) has a resume on file that meets the criteria for consultants.

  • Alevio Personnel may engage HCPs in a business meeting that involve a meal paid for by Alevio. Such Meals must be “modest” in value as judged by local standards, held in a location conducive to the furtherance of the business discussion and attended only by individuals with a legitimate business interest in the meeting.  In determining the nature of any such meal, Alevio will take into consideration the geographic factors and specifics regarding the nature of the business and the number of attendees. The meal shall never be part of an entertainment or recreational event.

 

  • Alevio uses the term “modest” for all meals for their employees, agents and business partners. Modest implies as judged by local standards.

 

  • Alevio Personnel will not pay for entertainment or recreational events for HCPs. Interactions with HCPs shall be professional and focused on legitimate business needs.

 

  • Alevio Personnel shall not provide reimbursement for HCPs to attend meetings where there are Continuing Medical Education (CME) credits provided.

 

  • Alevio Personnel shall not provide gifts or other things in value to any HCP without approval of the Compliance Officer. All gifts shall have educational value and a fair market value of $100.00 or less, excepting anatomical models and textbooks, which may be more than $100.00.  Prohibited gifts include:
    • Pens, mugs and pads of paper
    • Flowers
    • Wines and fruit baskets

 

  • No Personnel shall provide donations to a charitable organization at the request of HCP or a charitable organization with whom an HCP or an HCPs family member is involved as an officer, member of the board of directors, or advisory board without permission of the Compliance Officer.