Compliance Program

General

Arthrosurface, Inc. has established an effective compliance program that is designed to comply with applicable federal and state laws as well as industry standards including the AdvaMed Code of Ethics. 

As encouraged by industry standard, the Arthrosurface compliance program consists of the following seven elements and includes policies and procedures that foster compliance with the Code with respect to interactions with Health Care Professionals related to Medical Technologies. 

1.    Written Policies and Procedures

Arthrosurface, Inc. has established the following policies as part of its compliance program:

Company-Conducted Product Training and Education

Arthrosurface, Inc. product training and educational programs and events are to be conducted in settings that are conducive to the effective transmission of information, including clinical, educational or conference settings.  Hands-on customer training is to be held at training facilities, medical institutions, laboratories or other appropriate clinical setting.  Training may be provided at the Health Care Professional’s location. 

Business Meals & Travel Expenses

Arthrosurface, Inc. may provide a modest meal as part of product training, an educational presentation or a business discussion.  The meal should be incidental to the bona fide presentation of scientific, educational or business information and should be provided in a venue that is conducive to the effective transmission of information. 

Arthrosurface, Inc. may pay reasonable travel costs of attendees associated with attendance at company-conducted product training and educational programs. 

Arthrosurface, Inc. does not pay for the meals, refreshments, travel or other expenses for guests of Health Care Professionals or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.


Research & Educational Grants and Charitable Donations

Research Grants
Arthrosurface, Inc. may provide research grants to support independent medical research with scientific merit where activities have well-defined objectives and milestones and are not linked to the purchase of Medical Technologies

Educational Grants
Arthrosurface, Inc. may provide educational grants for legitimate purposes, including the advancement of medical education and public education.  Educational grants may be made to conference sponsors or training institutions promoting scientific knowledge, medical advancement and the delivery of effective health care.  Educational grants may not be made to individual Health Care Providers.

Charitable Donations
Arthrosurface, Inc. may make monetary or medical technology donations for charitable purposes where the proceeds are intended for charitable purposes. 

Consulting Agreements with Health Care Professionals

Arthrosurface, Inc. may engage Health Care Professionals to provide valuable, bona fide consulting services through various types of arrangements, such as contracts for research, product development, development and/or transfer of intellectual property, marketing, participation on advisory boards, presentations at company-sponsored training and other services.  A written agreement must be in place describing the services to be performed.  Fair market value compensation may be paid for the services provided and should not be based on the volume or value of the consultant’s past, present or anticipated business. 

Arthrosurface, Inc. may enter into a royalty arrangement with a Health Care Professional only where the Health Care Professional is expected to make or has made a novel, significant, or innovative contribution to, for example, the development of a product, technology, process, or method. 

Prohibition on Entertainment and Recreation

Arthrosurface, Inc. may not provide or pay for any entertainment or recreational events, activities or items for non-employee Health Care Professionals regardless of their value. 

Arthrosurface, Inc. may provide items to Health Care Professionals that benefit patients or serve a genuine educational function, such as anatomical models. 

Noncompliance Procedure

Arthrosurface, Inc. has established a written procedure for investigating instances of noncompliance with the compliance program, taking corrective action in response to noncompliance and reporting of instances of noncompliance to the appropriate state authorities. 


Provisions for the Commonwealth of Massachusetts per 105 CMR 970.000

Note:  Activities occurring outside of Massachusetts are subject to the regulation if they involve a MA-licensed HCP or covered recipient. 

Provision of Meals

Arthrosurface, Inc. may not provide or pay for meals for MA Health Care Professionals that are offered, consumed or provided outside of the Health Care Practitioner’s office or a hospital setting.

Continuing Medical Education (CME), Third-Party Scientific or Educational Conferences, or Professional Meetings

Arthrosurface, Inc. may not provide financial support for the costs of travel, lodging, or other personal expenses of non-faculty Health Care Professionals attending any CME event, third-party scientific or educational conference, or professional meetings, either directly to the individuals participating in the event or indirectly to the event’s sponsor.  Compensation or reimbursement made to a Health Care Professional servicing as a speaker or providing actual and substantive services is allowable. 

Reporting

Arthrosurface, Inc. shall report to the Commonwealth of Massachusetts Department of Public Health the value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50, which the company provides, directly or through its agents, to any covered recipient in connection with the company’s sales and marketing activities. 

 

2.    Compliance Officer and Compliance Committee

Compliance Officer:
Dawn Wilson, VP Quality & Regulatory

The Arthrosurface, Inc. compliance committee consists of the Compliance Officer and senior management staff. 

3.    Training & Education

Arthrosurface, Inc. conducts periodic training and education for appropriate employees regarding its Compliance Program.

4.    Communication

Arthrosurface, Inc. encourages effective communication between management and employees regarding any compliance concerns.  Any concerns can be reported to the Compliance Officer or member of the senior management team. 
Anonymous reporting can be conducted by calling 508.520.3003 ext. 111.

5.    Internal Auditing and Monitoring

Arthrosurface, Inc. performs periodic audits to ensure compliance with its policies and procedures. 

6.    Enforcement & Disciplinary Guidelines

Arthrosurface, Inc. will conduct appropriate investigations and take disciplinary actions as necessary in response to violation of the company’s compliance policies or procedures. 

7.    Response to Detected Problems and Corrective Action

Arthrosurface, Inc. requires a documented response in connection with detected problems associated with violation of the company’s compliance program inclusive of corrective actions taken.