GE Healthcare has a comprehensive Compliance Program that follows the guidelines set forth in the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the United States Department of Health and Human Services, Office of Inspector General (“OIG”), the Pharmaceutical Research Manufacturers of America (“PhRMA”) Code on Interactions with Healthcare Professionals, and the Advanced Medical Technology Association (“AdvaMed”) insofar as they apply to pharmaceutical companies and/or certain medical device manufacturers, respectively.
The following is an overview of the fundamental elements of our Compliance Program.
II. Policies and Procedures
GE Healthcare has established a comprehensive Compliance Program, which includes The General Electric Company’s The Spirit and The Letter, GE Healthcare’s U.S. Customer Relationships Codes of Conduct, and policies and procedures. These documents address applicable provisions of U.S. federal and state laws and regulations as well as industry guidelines, including for example the National Electronic Manufacturers Association (NEMA) Code, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code of Ethics, the Medical Imaging Technology Alliance (“MITA”) Code of Ethics, and the Office of the Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers.
GE Healthcare has dedicated significant time and resources to implementing a Compliance Program that includes a comprehensive framework of compliance controls throughout various segments of our business operations. Our Compliance Program is a representation of our commitment to the highest standards of corporate conduct and integrity.
III. Compliance Organization
As a global company, GE Healthcare’s Compliance Program reflects our overall compliance with U.S. Federal and state laws, including the elements specifically implemented to comply with California law.
GE Healthcare’s compliance organization is comprised of Compliance Directors and Compliance Managers representing each of its businesses and global regions. As recommended by the OIG Guidance, this compliance team assists with the implementation of the compliance program for GE Healthcare. The team reports to and meets regularly with the Chief Compliance Counsel of GE Healthcare. The compliance team reviews and modifies the company’s policies and procedures as the business and industry change. The compliance team has the authority to recommend and effectuate changes within the Company as needed.
IV. Effective Training and Education
Training and education of our employees on their legal and ethical obligations under applicable healthcare laws and Company policy are critical components of our Compliance Program. GE Healthcare’s employee education program consists of mandatory business based and global training and education on our company’s policies and procedures, with annual refresher courses via online learning modules.
V. Effective Lines of Communication
GE Healthcare is committed to fostering dialogue between management and employees. GE Healthcare requires every employee, officer and director to, raise concerns regarding potential violations of applicable laws or GE policy. Reports of integrity concerns can be made by any employee, officer or director to his or her supervisor, to the Legal Department or through GE Healthcare’s Global Ombuds Program.
GE Healthcare supports open reporting and a prompt response for any business concern. GE Healthcare has established a robust compliance communications mechanism, including a global Ombuds Program, which provides a process for reporting potential ethical and/or integrity concerns. GE Healthcare’s Ombuds Program advocates for Fairness, Equality, and Compliance in the workplace. From these principles, the Ombuds Program offers a confidential, impartial and non-retaliatory channel for employees to freely communicate their opinions, concerns and questions regarding GE Healthcare and its policies.
VI. Monitoring and Auditing
GE Healthcare’s Compliance Program includes monitoring and auditing of the compliance policies and procedures implemented throughout the business.
VII. Responding to Potential Violations & Corrective Action
GE Healthcare investigates all reported business concerns, including potential compliance violations in a timely manner, and, where appropriate, will implement corrective action and preventive measures. GE Healthcare employees who violate Company policies and procedures or applicable federal and state laws are subject to disciplinary action, up to and including termination.
VIII. California Spend Limit
GE Healthcare has established that the explicit annual aggregate limit on potential transfers of value provided to California medical or health care professionals is $3,000. California defines a medical or health care professional as (1) a person licensed by state law to prescribe drugs for human patients; (2) a medical student; or (3) a member of a drug formulary committee.
It is important to note that GE Healthcare’s annual aggregate limit represents a maximum limit and is not a spending goal. This limit does not represent a usual, customary, average or typical amount for health care professionals; it is the annual aggregate limit. In tracking expenditures, the Company excludes from its limit the following items that are exempt under California law: (1) drug samples given to health care professionals for free distribution to patient; (2) financial support for continuing medical education forums; (3) financial support for health educational scholarships; and (4) payments made at fair market value for legitimate professional services provided by healthcare professionals.
In setting this limit, we have taken into account the size of GE Healthcare’s global business and the size of our product portfolio. As the size of the Company and product portfolio changes, this limit may be revised by GE Healthcare.
Annual Declaration of Compliance
California Health and Safety Code § 119402
GE Healthcare declares that, to the best of our knowledge and based upon our good faith understanding of the statutory requirements as of the date of this declaration, our Compliance Program complies with the requirements of California Health and Safety Code § 119402 insofar as they apply to pharmaceutical and/or certain medical device companies.
GE Healthcare is comprised of pharmaceutical and medical device manufacturing entities. Although the Statute’s legislative history appears to indicate that it was not intended to apply to medical device manufacturers, GE Healthcare has provided information on its compliance program in accordance with the requirements imposed by the Statute on pharmaceutical companies, since it is possible California may interpret the Statute to apply to medical device manufacturers.
GE Healthcare also declares that the structure of our Compliance Program, and the guidelines articulated in our policies governing interactions with health care professionals, incorporate the principles provided in the OIG Guidance and the PhRMA Code to the extent the principles apply to GE Healthcare. In addition to developing policies and procedures that address specific risks related to pharmaceutical marketing and sales practices, GE Healthcare has modified certain policies and procedures that regulate interactions health care professionals in the State of California.
It is GE Healthcare's expectation that all employees and contractors comply with our Compliance Program. In the event that GE Healthcare becomes aware of violations of law or company policy, we will investigate and, where appropriate, take disciplinary action and/or implement corrective measures to prevent future violations.
We are constantly reassessing our Compliance Program and this Declaration to assure compliance and we will continue to update the content of our program, as necessary.
Copies of GE Healthcare’s Comprehensive Compliance Program Summary or Written Declaration of Compliance may be obtained by calling 855-786-9010.