Life Spine’s Commitment to Compliance
Life Spine, Inc. (“Life Spine” or the “Company”) is committed to conducting business in an ethical, lawful, and compliant manner. Life Spine follows and shall continue to abide by the Advanced Medical Technology Association (“AdvaMed”) Code of Ethics on Interactions with Healthcare Professionals (AdvaMed Code of Ethics) and be guided by the voluntary compliance guidance issued by the Department of Health and Human Services Office of the Inspector General, regulations and guidance issued by the Food and Drug Administration (“FDA”), and applicable case law.
Life Spine has had a compliance program in place since 2007. Life Spine will continue to prioritize compliance to ensure it will be a market leader in ethics and compliance. As such, Life Spine has updated its Compliance Policies and Procedures and Code of Conduct to facilitate and enforce lawful, compliant, and ethical interactions within our business practice.
Life Spine does not tolerate any form of unlawful, non-compliant, or unethical behavior by anyone performing on behalf of the Company. All Life Spine employees, board members, distributors and related parties are expected to abide by the ethical and legal standards set forth in these policies and programs, as well as abide by the applicable laws and regulations in every country where we conduct business. To ensure that these expectations are met, Life Spine has developed, implemented, and will continue to update a comprehensive Compliance Policies and Procedures and Code of Conduct. The Compliance Policies and Procedures and Code of Conduct are designed to assist all impacted individuals in navigating the various compliance obligations of the highly regulated industry in which Life Spine operates.
All Life Spine employees, board members, distributors and related parties are expected to report suspected violations of any Federal health care program or FDA requirements. Life Spine has established a complaint reporting process for the receipt of compliance-related complaints. If you have a compliance-related concern or complaint, please contact:
Jenn Jesse, Compliance Officer
Phone: 847-884-6117, Extension 243
You may also report suspected violations anonymously using the below independent, third-party options.
- Website: www.lighthouse-services.com/lifespine
- Anonymous Reporting App: Keyword: lifespine
- Detailed app instructions here
- Toll-Free Telephone:
- English speaking USA and Canada: 855-222-3722
- Spanish speaking USA and Canada: 800-216-1288
- Spanish speaking Mexico: 01-800-681-5340
- French speaking Canada: 855-725-0002
- E-mail: firstname.lastname@example.org (must include Company name with report)
- Fax: 215-689-3885 (must include Company name with report)
In the event a complaint is received, the Compliance Officer shall promptly investigate and take appropriate corrective action, if necessary, to address the concern and take corrective action. Life Spine has implemented strict non-retribution, non-retaliation, and confidentiality policies to encourage and protects individuals for reports made in good faith.
Physician Payments/Sunshine Act
The Federal Open Payments program, also commonly known as the Sunshine Act (“Open Payments”) requires manufacturers of products reimbursed by Medicare or Medicaid States to track and annually report to the Centers for Medicare and Medicaid Services (“CMS”) information about payments or other transfers of value they provide to U.S. physicians and teaching hospitals (“Covered Recipients”).
As a result of its collaboration with physicians in the development, clinical use, and training on the safe and effective uses of Life Spine products, Life Spine may make payments reportable under Open Payments. Some examples are of the types of payments Life Spine may make to physicians and other Covered Recipients are consulting fees associated with product development, service fees for providing medical education, food and beverage, travel and lodging, research-related payments and items, purchases of intellectual property, and royalties associated with product development. Life Spine complies with the tracking and reporting obligations under the Open Payments program. This data publicly available at www.cms.gov/openpayments.