Compliance

As the market leader worldwide, Fresenius Medical Care is aware of our responsibility to ourselves and our stakeholders, and we take it seriously. Our company is committed to complying with local laws and regulations that apply to our business. We seek to demonstrate professionalism, honesty and integrity in our business relationships with patients, customers, suppliers, the government and other payors, as well as fellow employees, investors and the general public.

Based on Fresenius Medical Care’s code of conduct, we have implemented within all of our business regions corresponding codes, which include the same compliance standards and address in their provisions the specific requirements of local laws. A copy of Fresenius Medical Care North America's Code of Business Conduct is downloadable below under “General compliance documents.”

Each of our employees is included in our compliance program. Effectively engaging them on a regular basis involves periodic training and internal communication.

The compliance program incorporates regional distinctions and Fresenius Medical Care periodically reviews and modifies the program to confirm that its content and implementation procedures are in line with industry standards and local legal requirements.

Additionally, Fresenius Medical Care has implemented business ethics and principles for business partners that outline the principles for all third parties acting on behalf of Fresenius Medical Care. The emphasis is on environmentally sound and resource-efficient production as well as fair and humane working conditions on the part of our suppliers.

Declaration of Compliance

Notice: California Health and Safety Code 119402

On September 29, 2004, California Governor Arnold Schwarzenegger signed into effect California Health and Safety Code §119402 requiring pharmaceutical companies, including FMCNA, to adopt comprehensive compliance programs (CCPs) relating to their interactions with health care professionals (HCPs). The statute requires that the CCPs must be in accordance with both the PhRMA Code and with the guidance issued by the Office of Inspector General (OIG) within the United States Department of Health and Human Services. The statute also requires each pharmaceutical company to:

  • Establish in its CCP “a specific annual dollar limit on gifts, promotional materials, or items or activities that the pharmaceutical company may give or otherwise provide to a health care professional”
  • Make its compliance program and its annual declaration of compliance available to the public on its website
  • Provide a toll-free number to obtain a copy of the CCP and the annual written declaration
  • As changes are made to either the OIG Guidance or the PhRMA Code, the company's CCP must be updated with corresponding modifications within six months

Click the download links in the “General compliance documents” section below to access the Fresenius Medical Care NA Code of Business Conduct and the 2015 Annual Declaration of Compliance. If you are unable to print the documents, requests for copies can be made by calling toll-free 1-800-662-1237, ext 9099.

General compliance documents

Declaration of compliance
Fresenius Medical Care North America compliance declaration

Code of business conduct
Fresenius Medical Care North America compliance program

Notice of privacy practices
How medical information about you may be used and disclosed, and how you can get access to this information

Vendor relationships policy
Compliance standards for Fresenius Medical Care vendors, suppliers, and contractors

Deficit Reduction Act

DRA Policy
Compliance with Applicable Federal and State Laws—False Claims Act and Similar Laws

State Law Summary
State-by-state summary of False Claim Acts, and other state fraud and false statement laws related to health care items and services

Research compliance

Financial Conflict of Interest
Clinical Research Policy

VAWD Accreditation


Verified-Accredited Wholesale Distributors (VAWD) is an accreditation for pharmaceutical wholesale distribution facilities. 
VAWD accreditation plays a key role in preventing counterfeit drugs from entering the United States drug supply. 

Fresenius Medical Care North America achieved accreditation as a wholesale distributor that is in compliance with state and federal laws and VAWD criteria and proudly displays the VAWD Seal.

Company profile

Learn more about FMCNA here.

Responsibility

Learn more about FMCNA's commitments.


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