According to a local news paper under the new health care reform law Connecticut will be facing a serious shortage of physicians to treat all the newly insured patients.
In an effort that will only exacerbate this situation the state legislature is considering a bill which would seriously limit a physician’s ability to receive education on medications and devices.
A number of states have been considering various laws regarding gifts from industry to physicians. In Connecticut, one of those laws prohibits meals at informational sessions from pharmaceutical and medical device manufacturing companies to health care providers.
A summary of provisions in Substitute Bill No. 270, are below. All of the new sections would go into effect July 1, 2010. In addition, not later than July 1, 2011, and annually thereafter, each pharmaceutical and medical device manufacturing company must certify to the Department of Consumer Protection that the company has external verification procedures in place to monitor compliance with the act.
We reported earlier on a hearing they held on this issue where the restaurant industry discuss the troubles these rules could case them.
Marketing
All pharmaceutical or medical device manufacturing company that employs or contracts with a pharmaceutical or medical device manufacturer agent must:
(1) Adopt a marketing code of conduct;
(2) Submit an annual copy of its marketing code beginning on or before July 1, 2011;
(3) Submit to the department a description of its training program to provide regular training to appropriate employees including, but not limited to, all sales and marketing staff, on the marketing code of conduct (also begins on or before July 1, 2011.
The training program must be designed so that all company representatives can give health care providers “sufficient knowledge” of the marketing code of conduct, and general science and product-specific information in order to provide accurate, up-to-date information, consistent with state law and federal FDA requirements. Each pharmaceutical or medical device manufacturing company must also:
(1) Certify they are in compliance with all sections of the act;
(2) Submit to the department policies and procedures for investigating noncompliance with the act, and actions taken in response to noncompliance and reporting instances of noncompliance to the appropriate state authorities; and
(3) Submit to the department the name, title, address, telephone number and electronic mail address of the compliance officer it has identified as responsible for certifying compliance with act and implementing, monitoring and enforcing the company’s marketing code of conduct.
Prescriber Data
Pharmaceutical or medical device manufacturing companies that use prescriber data unrelated to the identity of a patient to facilitate communications with health care providers must:
(1) Maintain the confidential nature of prescriber data;
(2) Develop policies regarding the use of the data;
(3) Educate company employees and pharmaceutical or medical device manufacturer agents concerning such policies and designate an internal contact person to handle inquiries regarding the use of the data;
(4) Identify appropriate disciplinary actions for misuse of the data; and
(5) Comply with the request of any health care provider who requests that prescriber data not be made available to company sales representatives.
Companies must also give health care providers the opportunity to request that their prescriber data be withheld from company sales representatives and not be used for marketing purposes. The new legislation does not prohibit pharmaceutical or medical device manufacturing companies from using prescriber data to:
– Impart important safety and risk information to prescribers of a particular drug or device;
– Conduct research; and
– Comply with federal FDA mandated risk management plans that require manufacturers to identify and interact with health care providers who prescribe certain drugs or devices or track adverse events of marketed prescription drugs, biologics or devices.
Speaking
In all speaker and commercial consultant contracts, pharmaceutical or medical device manufacturing companies must require any health care provider who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee:
– The nature and existence of the provider’s relationship with the company
The disclosure requirement must extend for not less than two years following the date of the termination of any speaker or consultant arrangement.
Gifts
No pharmaceutical or medical device manufacturing company may provide or pay for meals for health care providers that are:
(1) Part of an entertainment or recreational event;
(2) Offered without an informational presentation made by a pharmaceutical or medical device marketing agent or without such an agent being present;
(3) Offered, consumed or provided outside of the health care provider’s office or a hospital setting; or
(4) Provided to a healthcare provider’s spouse or other guest.
Companies are also prohibited from providing:
(1) Entertainment or recreational items of any value, including, but not limited to, tickets to the theater, concerts or sporting events, sporting equipment or leisure or vacation trips, to any health care provider who is not a salaried employee of the pharmaceutical or medical device manufacturing company;
(2) Payments of any kind, including cash or cash equivalents, equity, in kind or tangible items, including any complimentary items such as pens, coffee mugs or gift cards to health care providers either directly or indirectly, except as compensation for bona fide services; or
(3) Any grants, scholarships, subsidies, supports, consulting contracts or educational or practice related items in exchange for prescribing, disbursing or using prescription drugs, biologics or medical devices or for a commitment to continue prescribing, disbursing or using prescription drugs, biologics or medical devices.
With regards to gifts, the legislation does not prohibit:
(1) Reasonable compensation for bona fide services or the reimbursement of other reasonable out-of-pocket costs incurred by the health care provider directly as a result of the performance of such services, where the compensation and reimbursement is specified in, and paid for under, a written agreement;
(2) Payment or reimbursement for the reasonable expenses, including travel and lodging-related expenses necessary for technical training of health care providers on the use of a medical device if the commitment to provide such expenses and the amounts or categories of reasonable expenses to be paid are described in the written agreement between the health care provider and the device vendor for the purchase of the device;
(3) The provision of items that are designed for the education of health care providers, such as pamphlets, brochures and posters, provided the value of such items does not exceed one hundred dollars and such items have no value to the health care provider outside of his or her professional responsibility;
(4) The provision, distribution, dissemination or receipt of peer reviewed academic, scientific or clinical information;
(5) The purchase of advertising in peer reviewed academic, scientific or clinical journals;
(6) The provision of prescription drugs to a health care provider solely and exclusively for use by the health care provider’s patients;
(7) The provision of reasonable quantities of medical device demonstration and evaluation units provided to a health care provider to assess the appropriate use and functionality of the product and determine whether or not and when to use or recommend the product in the future;
(8) The provision of medical text books or anatomical models that are designed for the education of health care providers;
(9) The provision of price concessions, such as rebates or discounts, in the normal course of business;
(10) The provision of reimbursement information regarding products, including (A) identifying appropriate coverage, coding or billing of products, (B) procedures for using such products and information, in support of accurate and responsible billing to Medicare and other payors, and (C) information designed to offer technical or other support intended to aid in the appropriate and efficient use or installation of products (this support is not for the purpose of inducing health care providers to purchase, lease, recommend, use or arrange for the purchase, lease or prescription of such products);
(11) The provision of payments or the provision of free outpatient prescription drugs to health care providers for the benefit of low income individuals, through established patient assistance programs in accordance with federal law;
(12) The provision of charitable donations provided the donation is not provided in exchange for prescribing, disbursing or using prescription drugs, biologics or medical devices or for a commitment to continue prescribing, disbursing or using prescription drugs, biologics or medical devices, and does not violate the act.
Continuing Medical Education (CME)
No pharmaceutical or medical device manufacturing company may provide:
(1) Financial support for the costs of travel, lodging or other personal expenses of nonfaculty health care providers attending any CME event, third-party scientific or educational conference or professional meetings, either directly to the individuals participating in the event or indirectly to the event’s sponsor;
(2) Funding to compensate for the time spent by health care providers participating in any CME event, third-party scientific or educational conferences or professional meetings;
(3) Payment for meals directly to a health care provider at any CME event, third-party scientific or educational conferences or professional meetings; or
(4) Sponsorship or payment for CME or independent medical education, that does not meet the Standards for Commercial Support as established by the Accreditation Council for Continuing Medical Education or equivalent commercial support standards of the relevant continuing education accrediting body.
A CME provider or conference or meeting organizer may, at its own discretion, apply any financial support provided by a pharmaceutical or medical device manufacturing company for the event to provide meals for all participants.
Pharmaceutical and medical device manufacturing companies must also separate its CME grant-making functions from its sales and marketing divisions.
Companies may not provide any advice or guidance to the CME provider regarding the content or faculty for a particular CME program funded by the company. In addition, the legislation does not prohibit:
(1) Compensation or reimbursement made to a health care provider serving as a speaker or providing actual and substantive services as a faculty organizer or academic program consultant for a CME event, third-party scientific or educational conference or professional meeting, provided the payment is “reasonable, based on fair market value and complies with the standards for commercial support as established by the relevant accreditation entity;”
(2) Sponsorship or payment for any portion of a third-party scientific or educational conference, charitable conference or meeting or professional meeting, where the payment is made directly to the conference or meeting organizers; or
(3) The use of hotel facilities, convention center facilities or other special event venues for CME or other third-party scientific, educational or professional meetings or conferences.
The legislation also prohibits companies from firing or refusing to hire a person or taking adverse action against an employee, for reporting violations of the act. Additionally, a person who knowingly and willfully violates the act is liable for a civil fine of not more than $5,000 for each transaction, occurrence or event that constitutes a violation.
Comment
Given the current crisis of healthcare in the state and the short time frame for enacting and developing Medicaid services for the uninsured, perhaps the state government should consider these higher priorities than penalizing their physicians.