Envista Holdings Corporation
COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
Compliance & Transparency
ENVISTA HOLDINGS CORPORATION’S STATEMENT OF COMPLIANCE WITH THE FEDERAL PHYSICIAN SUNSHINE ACT
The Open Payments/Physician Payments Sunshine Act (“Open Payments”) was signed into law as part of the Affordable Care Act in March 2010. Official guidance on this law can be found on the Centers for Medicare and Medicaid Services (“CMS”) website https://www.cms.gov/OpenPayments For your convenience, the following was prepared from the official materials published by CMS and does not constitute legal advice.
What is Open Payments (Physician Payment Sunshine Provision)?
Section 6002 of the Federal Affordable Care Act includes the establishment of a transparency program, known as the National Physician Payment Transparency Program (commonly referred to as the Sunshine Act but officially referred to as “Open Payments”). Open Payments requires applicable manufacturers to report annually to CMS certain payments and other transfers of value provided to covered recipients.
Who is a “covered recipient” under Open Payments?
A covered recipient is defined as a physician, physician assistant (PA), nurse practitioner (NP), clinical nurse specialist (CNS), certified registered nurse anesthetist (CRNA), anesthesiologist assistants (AA), certified nurse-midwife (CNM) or teaching hospital. Physician includes doctors of medicine and osteopathy, dentists, dental surgeons, podiatrists, optometrists, and chiropractors with an active state license – whether or not they are currently treating patients. Medical residents, students, and pharmacists are not considered covered recipients.
CMS has committed to publishing a list of teaching hospitals annually. The current list of teaching hospitals can be found at https://www.cms.gov/files/document/2021-reporting-cycle-teaching-hospital-listp.pdf
What transfers of value are reportable under Open Payments?
Beginning August 1, 2013, payments made to covered recipients, both directly and indirectly, must be captured and eventually reported to CMS. Reportable payments or transfers of value include but are not limited to: consulting fees; speaker fees; honoraria and other compensation; gifts; entertainment; food and drinks; travel; lodging reimbursement; educational materials for physician use; research; clinical trial and grant payments; royalty or license payments; charitable contributions made on behalf of a Covered Recipient; fees paid to Teaching Hospitals; and current or prospective ownership or investment interest.
Who is responsible for reporting information under Open Payments to CMS?
Applicable manufacturers (engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply having a physical office in or conducting actives in the United States, or in a territory, possession, or commonwealth of the United States or under common ownership and which provides assistance or support to such entity) of covered products (drugs, devices, biologicals, and medical supplies that are reimbursed or reimbursable under Medicare/Medicaid/CHIP and that require FDA approval, licensure, or clearance) are required to report information to CMS.
Dealers and resellers that take title to a covered product are also generally responsible to report transfers of value under Open Payments.
When are the first reports due to CMS?
On March 31, 2014, aggregate spend reports are due from applicable manufacturers to CMS for the period of August 1 through December 31, 2013. In May 2014, detailed spend reports are due from applicable manufacturers to CMS for the same time period. These payments will then be made available on a public, searchable website published by CMS on or around September 30, 2014.
Will Covered Recipients have the opportunity to review reported payments made to them?
Yes, Covered Recipients will be able to review any reportable information before the data is made public, and to dispute any data they believe to be inaccurate. CMS is providing a 45-day review and correction period, during which covered recipients may register and then sign into the CMS secure website and review the data submitted by applicable manufacturers on their behalf and choose to dispute certain payments or other transfers of value. As soon as a dispute is initiated, applicable manufacturers may begin resolving the dispute and correcting the data. Following the end of the review and correction period, applicable manufacturers will have an additional 15 days to correct data for purposes of resolving disputes. Undisputed data will be finalized for publication after the close of the annual 45-day review and correction period. The correction and review period will begin no later than August 1, 2014.
What is our company doing to help with the review process?
We are tracking all applicable payments and transfers of value to physicians and teaching hospitals. In order to provide a correct representation of our physicians as well as our company, it is imperative that this data be accurate. Therefore, we are working to create an internal system in which covered recipients can communicate directly with our businesses to confirm or dispute any transactions. Additional information will be provided when this system is live.
Where can additional information be found?
We encourage all healthcare professionals to familiarize themselves with Open Payments and to register with CMS in order to receive updates regarding the program. The link to register with CMS is https://www.cms.gov/OpenPayments.
Where can I find more information about Open Payments?
Below are some additional reference materials for your convenience:
-Open Payments Final Rule from CMS: The document can be found at https://www.cms.gov/OpenPayments
- Frequently Asked Questions: CMS maintained FAQ document pertaining to Open Payments. The document can be found at https://www.cms.gov/OpenPayments/FAQs
- CMS Physician Fact Sheet: A summary of Open Payments for physicians directly from the Centers for Medicare and Medicaid Services (CMS), the regulatory agency responsible for implementing this law. The document can be found at https://www.cms.gov/OpenPayments/Program-Participants/Physicians-and-Teaching-Hospitals/Physicians-and-Teaching-Hospitals.html
- CMS Teaching Hospital Fact Sheet: A summary of Open Payments for teaching hospitals directly from CMS. The document can be found at https://www.cms.gov/OpenPayments/Program-Participants/Physicians-and-Teaching-Hospitals/Physicians-and-Teaching-Hospitals.html
- AdvaMed Brochure for Physicians: A communication for physicians/dentists/orthodontists that provides more information about Open Payments from a partner and trusted source: https://www.advamed.org/member-center/resource-library/sunshine-act-brochure-for-health-care-professionals/
- AdvaMed Brochure for Teaching Hospitals:A communication for hospitals that provides more information about Open Payments from a partner and trusted source: https://www.advamed.org/member-center/resource-library/brochure-for-teaching-hospitals-on-the-sunshine-act/
COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
Updated July 2022
The Envista Holdings Corporation and its companies1 (hereinafter referred to as “Envista” or “Company”) are committed to doing business in accordance with the highest standards of business conduct and ethics. We consider our reputation for ethical and compliant behavior to be a valuable corporate asset. Each employee of Envista is charged with the responsibility for safeguarding and strengthening that asset.
Envista is dedicated to complying with U.S. federal and state laws and regulations that place certain restrictions and reporting requirements on interactions the Company has with U.S. health care professionals and related organizations. Most notably, the Federal Physician Payment Sunshine Act requires the Company to annually report to the U.S. Centers for Medicare and Medicaid Services information about payments and other transfers of value that are provided to U.S. physicians and teaching hospitals. Payment types that are subject to reporting under this transparency law include, but are not limited to consulting fees, meals, travel, charitable donations, payments related to clinical trials and research, and physician educational materials, The Company is committed to fulfilling its obligations to track and report these payments and transfers of value as required by U.S. law.
In addition to complying with its obligations under U.S. federal and state transparency laws, our Company has established a Compliance Program in accordance with California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400‐119402 (the “Statute”), based on our good faith understanding of the requirements of the Statute as it may apply to a dental/medical device manufacturer. Our Company has developed a Compliance Program consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers (which is expressly applicable to medical device manufacturers) published by the Office of Inspector General of the U.S. Department of Health and Human Services. Our Compliance Program is tailored to the size, organizational structure, nature of our business as a dental/medical device manufacturer, and resources of our Company. The medical device industry has established, and our Company’s Compliance Program is designed in accordance with, the AdvaMed Code of Ethics on Interactions with Health Care Professionals (the “AdvaMed Code”). The AdvaMed Code is a voluntary ethical code established by the medical device industry. It is substantially similar to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals but reflects the unique interactions between medical device manufacturers and health care professionals.
While adoption of appropriate policies does not necessarily guarantee that improper employee conduct will be entirely eliminated, it is our Company’s expectation that employees will comply with our Code of Conduct, healthcare compliance policies and other policies adopted in support of the AdvaMed Code. Furthermore, our Compliance Program has been designed to prevent and detect violations. In the event our Company becomes aware of potential violations of law or Company policy, the Company will, where appropriate, investigate the matter, take disciplinary action, and/or implement corrective measures to prevent future violations. This description of our Compliance Program reflects the plan we have implemented. We will periodically reassess the program to improve it and may refine the elements as necessary. Our Company is committed to upholding the highest standards of business conduct and ethics in its relationships with customers, employees, shareholders, the business community, and state and federal governments.
Annual Description of Comprehensive Compliance Program
California Health & Safety Code §§ 119400-119402
I. Overview of Envista’s Compliance Program
A. Leadership and Structure
Our Company Compliance Program has been developed by the Envista Compliance Department. Our Company holds regular Compliance Committee meetings and is audited and monitored by a corporate compliance department.
B. Policies and Procedures
Our Company has enacted written policies and procedures implementing its high ethical standards and meeting its healthcare compliance obligations under applicable laws, regulations, and industry codes of conduct. These policies apply to all Company employees and compliance with those policies is a condition of employment.
One such policy is the Envista Code of Conduct, revised and updated in 2018. Each employee is required annually to certify that he/she has read, understands and agrees to comply with the Code of Conduct, and to disclose knowledge of any suspected or actual ethics or compliance issues, concerns or violations.
Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professional, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
C. Training and Education
We provide ethics and compliance training to all sales, marketing and research and development associates. We train on our Code of Conduct, company policies and applicable compliance laws, regulations, and industry codes. We provide training to new employees, include compliance training in our initial sales training curriculum, and provide both annual and ad hoc compliance training as appropriate. We provide compliance guidance at company meetings and respond to compliance questions from employees.
D. Compliance Communications
Our Company is committed to maintaining a work environment where all individuals encourage and embrace open discussion across both geographical and operational boundaries. Employees are encouraged to seek guidance in resolving ethics and compliance questions. They can do so directly with the Compliance Department. They are required to report suspected or actual unethical or non-compliant conduct, violations of law or regulation and violations of the Code of Conduct or Company policies. Access is provided to an independent, third-party operated, Compliance Helpline where employees and third parties can make such reports anonymously and without retaliation (www.envistaintegrity.com).
E. Auditing and Monitoring
Our Company performs compliance gap analyses, process reviews and data analysis to identify and address potential issues and opportunities to enhance its processes and practices. These are collaborative efforts between the Compliance Department and the business which have generated the development of new and revised policies, new training and communications initiatives and corrective action.
F. Investigating and Responding to Potential Violations
Our Compliance Department monitors company functions and activities for potential violations of law, regulation, industry codes, the Code of Conduct and company policies. Potential violations are promptly, and thoroughly investigated and appropriate corrective action taken.
G. Corrective Action
In determining the appropriate response to an established violation, our Company considers various options for corrective action. These options include closing any gaps in policies, practices or training that may have led or contributed to the violation and the imposition of disciplinary action, up to and including termination.
A copy of our Company’s Compliance Program and this declaration may be obtained by calling 844-570-6698.
1 Companies include Allesee Orthodontic Appliances, Inc., Aribex, Inc., Dental Equipment, LLC, Dental Imaging Technologies Corporation, Implant Direct Sybron International, LLC, Kerr Corporation, Metrex Research, LLC, Nobel Biocare USA, LLC, and Ormco Corporation