Implementation of Disclosure Legislation in Massachusetts National Disclosure Summit March 6, 2009...
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Transcript of Implementation of Disclosure Legislation in Massachusetts National Disclosure Summit March 6, 2009...
![Page 1: Implementation of Disclosure Legislation in Massachusetts National Disclosure Summit March 6, 2009 Allan Coukell, Director of Policy.](https://reader036.fdocuments.net/reader036/viewer/2022062516/56649e2d5503460f94b1d3f0/html5/thumbnails/1.jpg)
Implementation of Disclosure Implementation of Disclosure Legislation in MassachusettsLegislation in Massachusetts
National Disclosure SummitNational Disclosure SummitMarch 6, 2009March 6, 2009
Allan Coukell, Director of Policy Allan Coukell, Director of Policy
![Page 2: Implementation of Disclosure Legislation in Massachusetts National Disclosure Summit March 6, 2009 Allan Coukell, Director of Policy.](https://reader036.fdocuments.net/reader036/viewer/2022062516/56649e2d5503460f94b1d3f0/html5/thumbnails/2.jpg)
Sources of funding: The Pew Sources of funding: The Pew Charitable TrustsCharitable Trusts
Conflicts of interest: noneConflicts of interest: none
![Page 3: Implementation of Disclosure Legislation in Massachusetts National Disclosure Summit March 6, 2009 Allan Coukell, Director of Policy.](https://reader036.fdocuments.net/reader036/viewer/2022062516/56649e2d5503460f94b1d3f0/html5/thumbnails/3.jpg)
Recent State Activity Recent State Activity on Disclosureon Disclosure
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Current State Laws on Current State Laws on DisclosureDisclosure
• Minnesota (1993): Public disclosure of all payments over $100. Ban on gifts over $50; education and other exemptions.
• Vermont (2002): Disclosure of individual MD payments to Attorney General; aggregated for public.
• Maine (2003): Not yet implemented. Non-public disclosure of individual payments >$25.
• West Virginia (2004): Broad disclosure but no individual MD names.
• Washington DC (2005): Non-public disclosure. Annual reports to DPH.
• Massachusetts (2008, rules pending): Public disclosure of all payments except research. Ban on gifts, meals, entertainment, travel & expenses.
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Physician Payments Sunshine ActPhysician Payments Sunshine Act
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Past Action in MA Past Action in MA
• 2005-6 Fair Pricing Act –Sponsored by Sen. Montigny
–Discount program for seniors
–Statewide uniform PDL, PA protections, bulk purchasing
–Gifts ban and disclosure
–Did not pass
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Massachusetts Cost & Quality Massachusetts Cost & Quality LawLaw
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Massachusetts Cost & Quality Massachusetts Cost & Quality LawLaw
• Requires DPH to write a marketing code of conduct that is "no less restrictive" than PhRMA and AdvaMed codes
• Requires public disclosure of all payments over $50 made to doctors (with certain exclusions)
• Funds an evidence-based prescriber education program
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Cost & Quality TimelineCost & Quality Timeline
• Jan 07: MA Cost and Quality bill initially introduced
• Feb 08: Reintroduction. MA Senate President files 17-point cost and quality bill including disclosure and gifts ban and academic detailing program
• Apr 08: C&Q bill passed Senate with gifts ban and prescriber education
• Prescriber education in final budget
• Jul 08: C&Q bill passed House with prescriber education; no gifts ban or disclosure; industry codes to be submitted; ban on data mining
• In Conference, gifts ban, disclosure, and prescriber education are preserved, data mining ban is dropped.
• Aug 08: Bill passes legislature and is signed into law
• Dec 08: DPH releases set of draft regulations.
![Page 10: Implementation of Disclosure Legislation in Massachusetts National Disclosure Summit March 6, 2009 Allan Coukell, Director of Policy.](https://reader036.fdocuments.net/reader036/viewer/2022062516/56649e2d5503460f94b1d3f0/html5/thumbnails/10.jpg)
C&Q Law: Gifts & MealsC&Q Law: Gifts & Meals
• Sponsored meals must accompany an informational presentation and must be conducted in the doctors office or hospital setting.
• Industry may not pay for meals that are part of a recreational event.
• Industry may not provide any recreational items.
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C&Q Law : CME & EventsC&Q Law : CME & Events
• Industry may not sponsor CME that does not meet ACCME standards.
• Industry may not provide payment for attendance or travel support to attendees of off-site CME or other events.
• Industry may not provide direct payment for meals during CME, professional meetings, and events.
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C&Q Law: Allowed C&Q Law: Allowed
• Distribution of peer-reviewed information
• Samples for patient use
• Compensation for substantial professional or consulting services in conjunction with research or a clinical trial
• Training on devices
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C&Q Law: DisclosureC&Q Law: Disclosure
• Annual disclosure of payments to prescribers/ purchasers. Made public on a searchable website.
• What: fee, payment, subsidy, other economic benefit Greater than $50, provided directly or through a company’s agents
• To: Physician, hospital, nursing home, pharmacist, health benefit plan administrator, heath care practitioner, any other authorized to prescribe, dispense or purchase prescription drugs or devices.
• Including: value, nature, purpose, particular recipient
• Funding: user-fee based (to be established by DPH)
• Enforcement: DPH will report any payment in violation of the code of conduct to the AG. Penalties of not more than $5000 per violating transaction
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C&Q Law: Industry must…C&Q Law: Industry must…
• Institute mechanisms for complying with the code of conduct by July 1, 2009
• Provide a regular training program for employees on code of conduct compliance
• Conduct annual audits to monitor compliance among employees
• Adopt policies and procedures for investigating noncompliance and take corrective action
• Identify a compliance officer for operating and monitoring code of conduct
• Submit an annual report to DPH including: a description of its training program; name and contact for its compliance officer; and certification it has completed its annual audit.
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DPH Draft RegulationsDPH Draft Regulations
• Released December 12, 2008 for comment
• Further specify Code of Conduct and disclosure requirements.
• Largely conform to the PhRMA guidelines
• DPH is waiting to see if further budget cuts are made before proceeding with the prescriber education program.
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Expanded in DPH Draft Expanded in DPH Draft Regulations: Regulations:
• Gifts & Meals
– All meals provided must be modest and occasional
– Industry may not provide payments or “complimentary” items either directly or indirectly except as compensation for bona fide services
• CME
– Companies must separate its CME grant-making functions from its sales/ marketing dept.
– Companies must not have any input on the content or faculty for funded programs
– make payments for events directly to the conference or meeting organizers
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• Payments for Services (may be provided if:)
– the compensation is subject to a written contract
– the compensation is fair market value
– There is a legitimate need for the service
– There is a connection between the competence/expertise of the consultant and the purpose of the arrangement
– Only the number of consultants needed are retained
– The company retains records about the arrangement and makes appropriate use of the services provided
– The venue and circumstances of any meeting are appropriate
Expanded in DPH Draft Expanded in DPH Draft Regulations: Regulations:
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• Disclosure
– Payments in connection with the company’s sales and marketing activities will be disclosed. This excludes compensation related to research or clinical trials, and gifts given for educational and practice-related purposes, such as textbooks and computers.
– The disclosure must be accompanied by a fee of $2000
– Reports must be made on a standardized reporting form
– The first report will cover July 1, 2009 through Dec 31, 2009
– Companies shall not knowingly structure payments to circumvent the disclosure requirement
Expanded in DPH Draft Expanded in DPH Draft Regulations: Regulations:
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• Other Disclosures
– Industry must require speakers and commercial consultants to disclose their roles as such if they are also members of formulary/clinical guideline committees.
• Use of Prescribing Information
– All companies that use prescriber-identifiable prescribing information for marketing must:
• Maintain the confidentiality of the data
• Develop policies re: the use of the data, educate employees agents about the policies and identify disciplinary actions for violations
• Comply with requests of providers to not provide his/her data to sales reps
Expanded in DPH Draft Expanded in DPH Draft Regulations: Regulations:
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Issues being discussedIssues being discussed
• General business environment
• Payments related to research
• Small gifts
• Gifts with educational value
• Industry support of CME, professional meetings, and events
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General Business EnvironmentGeneral Business Environment
• Concern: The C&Q measures will drive business from the state
• Response: Since Minnesota’s gift ban and disclosure legislation passed in the early 1990s, pharmaceutical industry jobs there grew by over 36%, compared with 19.7% nationwide.
• Disclosure of all relationships will allow the state and the public to understand the financial relationships between physicians and companies.
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Payments Related to ResearchPayments Related to Research
• Concern: disclosing payments made to researchers will harm a company’s competitive edge.
• Response: The information being disclosed is not private. Pharmaceutical companies and providers already disclose information about clinical trials to the FDA and NIH. The FDA publishes this information on a public database.
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Small Gifts and Educational Small Gifts and Educational GiftsGifts
• Concern: Banning small gifts will harm the relationship between industry and doctors, and will harm businesses that manufacture these gift-products.
• Response: The power of small, repeated gifts to influence decision-making has been extensively documented.
• Concern: Banning educational gifts does a disservice to patients and prevents industry from sharing information.
• Response: Educational gifts are still part of marketing. The law does not impede information sharing. Sales representatives can continue to visit doctor’s offices and provide information about their products.
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One appeal to the MA HouseOne appeal to the MA House
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Industry Support of CME & Industry Support of CME & eventsevents
• Concern: Prohibiting industry from providing direct sponsorship to CME or from directly providing meals at professional meetings and events will drive symposia from the state. Caterers claim they will lose $40 million.
• Response: ACCME regulations and PhRMA guidelines already largely conform with the C&Q law. The Minnesota Convention Center Bureau say they have not seen any dip in convention attendance since enactment of MN’s gift ban and disclosure legislation in 1993.
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Thank youThank youQuestions, discussion?Questions, discussion?
Allan Coukell, Director of PolicyTel: 617-275-2870
[email protected] www.prescriptionproject.org