Justin,
Strangely enough, the guidance for compliance programs originates from the Federal Sentencing Guidelines for Corporations. Establishing a compliance program that follows the standards provides corporations that do business with the federal government (such as FDA, IRS, OIG, etc.) some relief if they get into trouble. Establishing a Quality System is critical if you need to build a medical device. Establishing a compliance program is essential if you need to build a medical device organization. It's the corporate equivalent of an effective CAPA system. I find that elements of an effective QMS are reuseable for corporate compliance such as document control. A medical device organization needs a QMS but also needs a financial accounting system, a sales force trained in SOP's, legal authority to do business in all states, sales and income tax licenses, medical device or pharmacy distribution licenses, etc. It depends on your level of responsibility and the resources available. I see regulatory professionals in some organizations like mine wearing multiple hats and getting involved in all of these areas.
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David Empey
Director, Regulatory and Compliance
Zynex Medical
Lone Tree CO
United States
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Original Message:
Sent: 05-09-2013 10:18
From: Justin Baker
Subject: Health Care Compliance
David-
Thank you for this information. Is this guidance for a corporate compliance (healthcare compliance) program based on some law or regulation or is it a "best practices" or a code of ethics that should be followed when claiming that one follows some association or level of standard or is registered to some ISO level (ex. ISO 31000 like you mentioned)? For example, those wanting to be certified by AdvaMed would be required to have a healthcare compliance program that complies with their code of ethics?
Obviously having a corporate compliance program is going to be a good thing. However, when first implementing a Quality System it may be easier to get the required areas addressed and then to expand into the "extra credit" areas such as corporate compliance?
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Justin Baker PHD
Custom Orthopaedic Solutions
Cleveland OH
United States
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Original Message:
Sent: 05-08-2013 11:27
From: David Empey
Subject: Health Care Compliance
Justin,
You should establish a compliance program based on the OIG guidelines for a DMEPOS supplier if your company has a Medicare NPI number and bills health insurance plans for your products. If you don't bill health insurance you should still establish a compliance program but there is a different OIG guidance for pharmaceutical and medical device manufacturers. The official publication in the Federal Register is titled " OIG Compliance Program Guidance for Pharmaceutical Manufacturers" but also references medical device manufacturers. (Federal Register / Vol. 68, No. 86 / Monday, May 5, 2003 / Notices 23731, copy is attached). It isn't part of the QMS regulations but is a key part of a corporate compliance program. Compare the ISO 14971 Risk Management standard for medical device manufacturing to the new enterprise risk management standard ISO 31000. I think you'll find the OIG guidelines falling into the enterprise classification. A good resource is AdvaMed, the Advanced Medical Technology Association (http://advamed.org/). According to their web site, "The AdvaMed Code of Ethics on Interactions with Health Care Professionals ("The AdvaMed Code" ) facilitates ethical interactions between MedTech companies and health care professionals to ensure that medical decisions are based on the best interests of the patient."
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David Empey
Director, Regulatory and Compliance
Zynex, Inc.
Lone Tree CO
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Original Message:
Sent: 05-07-2013 13:53
From: Justin Baker
Subject: Health Care Compliance
I've recently come across some guidance from the Office of the Inspector General regarding Healthcare Compliance programs. I am wondering if medical device manufacturers are required to implement a Healthcare Compliance Program. I have not seen this mentioned in the QSRs. On OIG's website they list guidance for hospitals, nursing facilities, third-party medical billing companies, and there is a guidance for Durable Medical Equipment, Prosthetics, Orthotics, and Supply Industry. Do all medical device manufacturers fall under this Durable Medical Equipment, Prosthetics, Orthotics, and Supply guidance?
I am currently implementing our Quality Management System and would like to know whether I need to create a Healthcare Compliance program with related SOPs or whether this is not required. How have medical device manufacturers or consultants for medical device manufacturers dealt with this aspect of healthcare compliance and quality systems? My understanding is that these are SOPs or policies that deal with how physicians are paid consulting fees, educational grants, etc. to separate the practice of medicine from undue influence by healthcare corporations.
Thanks in advance!
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Justin Baker PHD
Regulatory & Quality Manager
Custom Orthopaedic Solutions
Cleveland OH
United States
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