Health Care Compliance (HCC)
Basics of the AdvaMed Code
The Advanced Medical Technology Association (“AdvaMed”) represents companies that develop, produce, manufacture, and market medical products, technologies and related services and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities (“Medical Technologies”) in order to enable patients to live longer and healthier lives(collectively “Companies,” and individually “Company”).
On December 18, 2008 AdvaMed approved a major update of its Code of Ethics on Interactions with Health Care Professionals (the “Code”). It is crucial for all Medical Technology Companies to understand the guidelines and how they impact interactions with Health Care Professionals.
The term “Health Care Professional” (“HCP”) is defined broadly in the Code and includes persons and entities involved in the provision of patient care and involved in the decision to purchase, lease, or recommend a Medical Technology. These individuals may include purchasing agents, physician practice managers and management within group purchasing organizations.
It is also important to remember that some HCPs are also government employees. More restrictive legal restrictions may apply to such individuals.
After completing this course, you will understand how the AdvaMed Code guides your interactions with HCPs. This updated Code contains important revisions and new provisions including: Further clarifies and distinguishes between appropriate and inappropriate interactions between HCPs and representatives of Medical Technology Companies; A new Code compliance section that will list Companies that certify their adoption of the Code. This list will be available on the AdvaMed website; A prohibition on providing entertainment or recreation to HCPs, as well as a prohibition on gifts; Guidelines for entering into royalty arrangements with HCPs; Parameters for the provision of evaluation and demonstration products; An expanded section addressing the provision of objective reimbursement, coverage and health economics information to HCPs.
- AdvaMed Code
- Company Conducted Product Training and Education
- 3rd Party Educational Conferences and Business Meetings
- Consulting Arrangements
- Evaluation and Demonstration Products
- Modest Meals, Prohibition on Entertainment and Gifts
- Coverage and Reimbursement
- Grants and Donations
Basics of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct
The Massachusetts Department of Public Health promulgated the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation 105 CMR 970.000 to implement the provisions of an Act enacted by the legislature to promote cost containment, transparency and efficiency in the delivery of quality health care. The regulation is intended to benefit patients, enhance the practice of medicine, and ensure that the relationship between manufacturers and health care practitioners does not interfere with the independent judgment of health care practitioners.
Although the 105 CMR 970.000 Regulation has similar provisions to the recently revised AdvaMed and PhRMA Codes of Ethics, it imposes a number of additional restrictions on pharmaceutical and medical device manufacturing companies’ (including distributors’) interactions with health care practitioners. The regulation also requires these companies to disclose annually certain payments to health care practitioners. These changes will directly affect how you and your company conduct business with Massachusetts-licensed health care practitioners.
The Massachusetts Regulation has the full force of law, including significant fines for non-compliance. You may be required to certify to the Massachusetts Department of Public Health that it has a Code of Conduct in compliance with the regulation, has adopted training programs, and has procedures for conducting investigations of non-compliance. Your company must also provide the Department with the contact information of the Compliance Officer responsible for certifying compliance with the Regulation.
- Prescriber Data
- Contracts, Audits, and Meals
- Other Payments
- Disclosure of Payments
Introduction to Medical Device Health Care Compliance
This course provides high level introduction and background regarding the compliance environment affecting the medical device industry. These topics are especially important in our industry, as the development of medical device products involves a close collaboration between the industry and healthcare professionals, and their use may require the interaction and skill of medically trained personnel.
This course is designed to make employees aware of pertinent laws, regulations and industry guidance that regulate the medical device industry.
- Food and Drug Administration (FDA) regulations
- The Federal Anti-Kickback Statute
- The Office of the Inspector General (OIG) Compliance Program Guidance
- AdvaMed Code of Ethics
- Foreign Corrupt Practices Act (FCPA)
- False Claims Act
- State Ethics and Compliance Legislation