We expect the best from our people conducting business with, or on behalf of, US WorldMeds. US WorldMeds' drive for excellence begins and ends with a commitment to ethical conduct and compliance with law.
The environment in which US WorldMeds operates is both highly regulated and demanding. Our commitment as individuals to standards that are ethical and fair provides the basis for dealing with our various constituents: the public, customers, and each other.
The US WorldMeds Code of Conduct ("Code") contains principles and standards to guide our business behavior. Irrespective of any other changes in our business, US WorldMeds commits to practice the highest standards of business conduct. The Code of Conduct is intended to assist in the fulfillment of our commitment to integrity and to act as the basic guide to our program of compliance with the laws under which we operate.
Concerns or questions about violations of laws, rules, regulations or the Code should be directed to our compliance hotline, 855-247- 7800, or if employed by US WorldMeds you may contact our Manager, Human Resources.
Comprehensive Compliance Program
US WorldMeds, LLC ("US WorldMeds"), and its wholly-owned subsidiary, Solstice Neurosciences, LLC ("Solstice"), is a specialty biopharmaceutical company focused on the development, manufacture, sales and marketing of specialty biopharmaceutical products. US WorldMeds and Solstice employees are committed to applying ethical standards in our dealings with patients, physicians and the community-at- large. As such, US WorldMeds has developed a Compliance Program as a central component of our commitment to high standards of corporate conduct.
US WorldMeds' Compliance Officer is charged with overseeing its Compliance Program. The Compliance Officer has direct access to both the CEO and COO and is charged with developing the standards of conduct issued as part of the Compliance Program, directing auditing and monitoring activities, as appropriate, and implementing corrective measures, as necessary.
Comprehensive Compliance Program
The primary purpose of the US WorldMeds Compliance Program, and that of its affiliated companies, is to communicate and deploy the standards of ethical conduct and to help detect and prevent violations of applicable laws or company policy. The Compliance Program is based on the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and will address the specific risk areas identified therein, as well as others identified by the Compliance Officer. However, as the OIG Guidance explicitly recognizes, the implementation of a Compliance Program cannot guarantee that all improper employee conduct will be eliminated. Nonetheless, it is US WorldMeds' expectation that its employees will comply with the Compliance Program.
US WorldMeds has developed a Code of Conduct, as well as additional policies that have been established in support of the Code of Conduct. The Code of Conduct applies to all US WorldMeds and affiliated company employees. While US WorldMeds is not a member of the Pharmaceutical and Research Manufacturers of America ("PhRMA"), US WorldMeds has adopted and does adhere to the tenets of the PhRMA Code on Interactions with Healthcare Professionals (the "PhRMA Code") in the states where it has been codified by state law. All of US WorldMeds' personnel are expected to adhere to the corporate Code of Conduct, the PhRMA Code in states where it is required, and all other applicable compliance policies.
US WorldMeds will provide effective compliance training for all of its employees on all elements of the Compliance Program as well as on applicable laws and regulations. In addition, the Company will conduct internal auditing and monitoring as necessary to evaluate compliance with company standards.
It is expected that employees will report any compliance-related concerns. As such, a non-retaliation policy is in effect at US WorldMeds. Employees may report their concerns either anonymously or directly to the Compliance Officer, any manager, or the Human Resources Department.
In the event that US WorldMeds becomes aware of a violation of law, regulation, or company policy, US WorldMeds is committed to investigating the matter, and where appropriate, taking disciplinary action, and implementing corrective measures to prevent further such violations.
In accordance with and as explicitly recognized in the OIG Guidance, US WorldMeds has tailored its Compliance Program to fit its unique environment and size. Additionally, the US WorldMeds Compliance Program is a living program, involving regular assessments and adjustments to ensure the Program is responsive to the Company's evolving business and associated compliance risks.
Annual California Spending Limit
US WorldMeds has established annual spending limits as per California Business and Professional Code §119402(d)(1) for certain promotional activities directed toward healthcare professionals in California. This annual dollar limit is $2,000 excluding reasonable payment and reimbursement for legitimate professional services. Spending limits are established as the maximum boundaries for spending, and do not represent a spending "goal" or "average." In most cases, the Company spends significantly less per California physician than the stated spending limit.
California Senate Bill No. 1765 Declaration
As part of our ongoing efforts in the area of compliance, US WorldMeds has developed a Compliance Program that is reasonably designed to prevent and detect violations of law or company policy. To the best of our knowledge, and based on our good faith understanding of the statutory requirements, we have established a Compliance Program that is compliant with the requirements of Cal. Health & Saf Code §§119400- 119402.
In making this Declaration of compliance, US WorldMeds is not asserting or making any representation that every employee, agent, contractor or partner will always fully comply with its Compliance Program or that US WorldMeds can prevent individual employees from engaging in improper conduct. While we are routinely reassessing our Compliance Program to improve it, government standards on compliance programs recognize that no program can completely prevent individual employees from improper conduct.
Based upon our good faith understanding of the statutory requirement, and to the best of US WorldMeds' knowledge, US WorldMeds declares that, as of the date of this declaration, we are, in all material respects, in compliance with our Compliance Program, as described here, and with California Health & Safety Code §§119400- 119402.
Ensuring ethical and legal conduct is an ongoing company commitment. The Compliance Program is a program that will continue to evolve to meet the company's compliance needs. US WorldMeds will assess its program as often as necessary, but at least once each year.
US WorldMeds, LLC
Amy Yuda, Compliance Officer
July 1, 2018
To obtain a copy of this written declaration please email email@example.com or call toll-free, 1-855-247-7800.
Payments to Physicians
Why We Work with Healthcare Professionals
Working with healthcare professionals (HCPs) allows us to gather and share critical, real-world information, feedback, and insight. This is essential to fulfilling our commitment to develop, license, and market healthcare products that improve lives.
There are three main ways in which HCPs help us gather and share information:
- Research and Development
HCPs, hospitals, and research institutions collaborate with US WorldMeds and others to research the safety and effectiveness of new medicines and treatment options, develop new uses for existing medicines, and conduct in-depth studies of how medicines may help patients.
- Professional Advising and Consulting
Input, advice, and feedback from HCPs is not only critical to advancing our research and development activities, but also helps us better understand treatment landscapes and the needs of patients and healthcare providers. Consulting relationships help ensure we’re developing medicines that are safe and effective, and that meet the needs of the patients we serve.
- Expert-Led Forums
US WorldMeds engages knowledgeable, experienced HCPs to assist with educating their peers, other professionals, patients, and caregivers about health conditions, treatment landscapes, and, when appropriate, our products.
How We Disclose Payments to Healthcare Professionals
The Physician Payments Sunshine Act (the “Sunshine Act”) was enacted by Congress in 2010 to create more transparency around the relationships between pharmaceutical companies and HCPs in the United States. The Sunshine Act requires companies to report to the federal government certain payments and other “transfers of value” made to HCPs and specific teaching hospitals, and further requires those reports be made available to the public. Even without this requirement, US WorldMeds is generally committed to transparency around our payments and other "transfers of value" to HCPs.
We believe that the requirements of the Sunshine Act, and the transparency the Sunshine Act has created, helps foster trust with patients, healthcare professionals, and government officials and helps reinforce adherence to high ethical standards throughout the industry.
To view US WorldMeds' disclosure of payments and transfers of value to HCPs and specific teaching hospitals:
- Go to https://openpaymentsdata.cms.gov
- Click in the “Search Physician, Teaching Hospital, or Company by Name” field
- Type in “US WorldMeds, LLC” or any part thereof and click "Search"
- Select “US WorldMeds, LLC” by clicking on it in the Search Results
The CMS Search Tool will display a summary of US WorldMeds’ overall payment information. You will also have the ability to search and view more detailed information for payments made to individual HCPs and/or teaching hospitals.