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Massachusetts Marketing Code of Conduct Laws and

Regulations

A Medical Device Company Perspective

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Overview of Massachusetts Legislation

• 8/10/08 Massachusetts enacted “An Act To Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care”.

• Currently may be the most detailed and strictest health care compliance requirements of any federal or state law.

• Requires Massachusetts Department of Health (DPH) to adopt a marketing code that is no less restrictive than the most recent versions of the AdvaMed code, which has an effective date of 7/1/09.

• Also contains prohibitions related to companies interactions with healthcare professionals.

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Overview of DPH Regulations

• Issued regulations on March 11, 2009.• July 1, 2009 initial compliance date required.• Annually, beginning on July 1, 2010,

companies must certify to the DPH that audits to monitor compliance with the Marketing Code have been conducted.

• Penalty is a fine of not more than $5,000 for each transaction, occurrence or event.

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Significance of Massachusetts Legislation

• Only state to require that companies adopt and comply with a state-authored Code of Conduct;

• Only state to require disclosure of industry payments to health care practitioners by both pharmaceutical and medical device companies;

• The state with the broadest definition of “sales and marketing”;

• Only one of two states to make disclosure data part of the public record. DPH will provide a web database that will be searchable by health care provider name and by company.

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Requirements of Medical Device Companies Marketing Codes

• Must be in compliance with DPH’s Marketing Code of Conduct, which is based, in part, on the AdvaMed code; and

• Must implement a corporate compliance program, with reporting and certifications to Massachusetts, and

• Annual certifications and disclosures of financial relationships to Massachusetts.

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Intent is to prevent undue influence in the relationship between health care practitioners and manufacturers.

“There Ain’t No Such Thing As a Free Lunch.”

Author Unknown

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DPH Implementation Goals

Limit Interactions That Influence Prescribing Patterns

Not Restrict Beneficial Industry Interactions

(Research and Training)

Increase TransparencyOf Industry Payments

Safeguard Confidentiality of Trade Secrets and

Proprietary Information

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What is a Sales and Marketing Activity?

• Influencing the prescribing behavior of a health care provider.

• Marketing of a medical device.

• Influencing a purchasing decision or market share.

• Evaluating the effectiveness of a sales force.

• Product education• Training• Research projects

designed or sponsored by a company marketing group.

• Research projects that have marketing, product promotion or advertising as a purpose.

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Excluded from Sales and Marketing Activities

• Clinical trials and genuine research payments;• Demonstration or evaluation units;• In-kind items used for the provision of charity care; and• Confidential price concessions established in contracts.

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Prohibitions in the Marketing Code

• Entertainment or recreational items of any value and meals associated with such activities;

• Meals outside of the health care providers office or hospital setting, and meals without an in-person informational presentation;

• Sponsorship or payment for continuing medical education that does not meet certain standards, or that provides payment directly to a health care practitioner for continuing medical education;

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Prohibitions in the Marketing Code-Continued

• Advice or guidance to a continuing medical education provider regarding the content or faculty for an educational event funded by the company;

• Payments for:– Meals provided to a health care provider,– Compensation for time spent,– Non-faculty health care providers expenses,– Travel, lodging or other personal expenses,– Third-party scientific or educational conferences, or– Professional meetings.

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Prohibitions in the Marketing Code-Continued

• Law is intended to apply to medical device distributors since they represent companies.

• Any payment or activity that is prohibited under “applicable federal or state ‘fraud and abuse’ laws or regulations including the federal ‘Anti-Kickback Statute.’ ”

• Payments of any kind to health care practitioners, except as compensation for “bona fide services”.

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Permitted Activities• Distribution of peer-reviewed academic, scientific or

clinical information.

• Purchasing advertising in peer reviewed journals.

• Payment for reasonable expenses necessary for technical training on the use of a medical device if that expense is part of the vendor’s purchase contract for the device.

• Compensation for consulting services in connection with a genuine research project or a clinical trial.

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Bona Fide Services• Must have a written agreement for identified services.• Compensation established based on fair market value.• Services need to be identified in advance, i.e. budgeted.• Connection between the competence and expertise of the

health care provider and the purpose of the arrangement.• The number of health care providers retained is not greater

than the number reasonably necessary to achieve the purpose.

• Company must retain records.• Venue and circumstances of any meeting is conducive to

the services and activities of the services.• Decision to retain a health care provider is not unduly

influenced by sales personnel.

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What is a Hospital Setting- Where Meals Can Be Provided?

• Facility specially designed to approximate the conditions of a surgical suite or a working clinical laboratory, or

• To provide medical training on large and/or technical medical devices.

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When Can Meals Be Sponsored?

• Third party organizers of continuing medical education or other meetings may use general funds from companies to provide meals.

• Application of sponsorship funds towards meals must be made at the continuing medical education providers discretion.

• Continuing medical education events can be held in Massachusetts.

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Intellectual Property Payments

• Regulations do not apply to intellectual property agreements and related documents.– Generally would follow bona fide research activities.– Royalty payments.– Not considered to a be loophole and must be

structured appropriately.

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Applicability in Other States

• Applies only to those health care providers licensed in Massachusetts.

• However, does apply to Massachusetts licensed health care providers for activities outside of Massachusetts.

• Example, if a company sponsored a meal at a restaurant in connection with a conference in New York or conducted product training at an adjacent hotel restaurant, Massachusetts licensed health care providers could not attend.

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Coverage Requirements for Policies and Procedures

• Consulting services “needs assessment”.• Selecting and retaining health care providers as

consultants.• Meetings and ongoing requirements of consultants.• Support of third party conferences and meetings.• Providing of meals to health care providers.• Continued medical education, third-party scientific or

education conferences and professional meetings.

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Coverage Requirements for Policies and Procedures -

Continued• Gifts, entertainment and other items of value.• Scholarships, grants and other financial support.• Employee training.• Investigation of non-compliance.• Corrective action and voluntary reporting.• Compliance audits.• Capturing and disclosing payments to Massachusetts

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Training Requirements

• Required to provide regular training to company representatives who visit health care providers.

• Description of training programs must be submitted to DPH by 7/1/09.

• Training must cover:– The company’s marketing code of conduct– General science– Product-specific information

• Companies must regularly assess its representatives to ensure that they comply with the Marketing Code.– Companies might want to “test” employees.

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Role of Compliance Officer

• Responsible for operating and monitoring the marketing code of conduct.

• Name and contact information provided to DPH.• Certification that in compliance with marketing code.• Certification that the company has conducted annual

audits.

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Required Disclosures and Certifications to Massachusetts

DPH by 7/1/09

• Policies and procedures for the investigation, resolution and corrective actions for instances of noncompliance.

• Company compliance officer name, address, email address and telephone number.

• Certification of compliance with the marketing Code, to the best of the company’s knowledge.

• Annual fee of $2,000.

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Required Disclosures and Certifications to Massachusetts

DPH by 7/1/10• Certification that the company has conducted annual

audits in compliance with the Marketing Code.• Report the nature, value, purpose and recipient of

anything that has a value greater than $50.• Individual payments greater than $50 - not aggregate

payments.• Initial reporting period 7/1/09 to 12/31/09.

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Other State Laws • Other existing or proposed state laws for

medical device companies (as of March 13, 2009): Connecticut IowaMinnesotaNew YorkTexas Vermont

• Require adoption and disclosure of compliance program:CaliforniaNevada

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Federal Legislation

• Federal law “Physician Payments Sunshine Act of 2009” pending:– Introduced 1/22/09.– Will require spending disclosure on a national basis.– Individual payments in excess of $100.– May result in uniform national standard?

• Interrelationship with Stark Laws and Anti-Kickback Statute.• Interrelationship with the Foreign Corrupt Practices Act.

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Hospital Codes of Conduct

• Many hospitals have established codes of conduct with similar provisions.

• Personnel may be restricted in what they can accept or services they can provide to companies.

• Personnel have been sanctioned or dismissed for noncompliance.

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Disclaimers• This presentation is a summary only and may not be all

inclusive.• Regulations may be subject to interpretation and

refinement.• This summary is not a legal analysis. Consult your

compliance and legal advisors.