Compliance

 

Our commitment to compliance is a key component of our business strategy. It starts at the top, with leaders setting expectations around 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.

We have adopted a Code of Ethics and Business Conduct that requires all employees to comply with all applicable laws, regulations, and rules. To assist us in meeting this commitment, our Compliance Program is focused on key healthcare risk areas, with dedicated ethics and compliance officers partnering with business leaders and a robust compliance monitoring function.

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 us, to adopt comprehensive compliance programs (CCPs) relating to their interactions with healthcare 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 healthcare 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 links in the “General compliance documents” section below to access our 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 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

Deficit Reduction Act (DRA) Policy - Compliance with Applicable Federal and State Laws—False Claims Acts and Similar Laws

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

RESEARCH COMPLIANCE

Financial Conflict of Interest - Clinical Research Policy  

 

NABP Drug Distributor Accreditation 

NABP’s Drug Distributor Accreditation (formerly known as Verified-Accredited Wholesale Distributor®) is a resource for industry and regulatory bodies that establish uniform safeguards meant to protect the public health. Drug Distributor Accreditation plays a pivotal role in preventing counterfeit drugs from entering the United States drug supply and protects the public from drugs that have been contaminated, diverted, or counterfeited. This accreditation process required FMCNA to demonstrate compliance to a comprehensive set of regulatory standards and best practices in safely distributing prescription drugs from manufacturers to various pharmaceutical establishments and healthcare institutions.

About the National Association of Boards of Pharmacy
The National Association of Boards of Pharmacy (NABP) is the impartial professional organization that supports its member regulatory state boards of pharmacy in creating uniform regulations to protect public health. Founded in 1904, NABP aims to ensure the public’s health and safety through its pharmacist competence assessment programs, license transfer and verification services, as well as through pharmacy inspection and accreditation programs. For more information, please visit www.nabp.pharmacy.