Relates to prohibiting certain gifts and payments to prescribers and requiring disclosure of other such gifts and payments

Section 2 of the bill adds a new Public Health Law (PHL) § 279 to prohibit certain payments from drug manufacturers to physicians and other prescribers. In particular, PHL § 279 defines terms such as "health care provider" and "payment." PHL § 279 also prohibits pharmaceutical manufacturers from giving health care providers, and health care providers from accepting, payments that exceed $50 in value in the aggregate each calendar year. Exemptions from this prohibition are made for: (1) drug samples that the prescriber provides to patients free of charge; (2) grants made for specific educational, research or clinical purposes which are documented in a proposal to be submitted to the manufacturer, with a follow-up report to be made available to the Department of Health (DOH); (3) reductions in the cost of the manufacturer's products; (4) reasonable remuneration or travel reimbursement to a prescriber for bona fide teaching, research, writing or consulting services, where the remuneration or reimbursement is consistent with the fair market value of the services provided; (5) reimbursement to a doctor-in-training for reasonable travel expenses associated with attendance at a bona fide medical conference, where the doctor-in-training is not informed of the source of such reimbursement; and (6) gifts from manufacturers' representatives who are related to the prescriber. Any payments that fall within the enumerated exceptions, other than free samples and gifts from family members, must be disclosed on an annual basis.

Section 2 of the bill also authorizes the Commissioner of Health (Commissioner) to assess civil penalties between $5,000 and $50,000 per violation on manufacturers. and between $5,000 and $ 0,000 per violation on health care providers.

Section 3 and 4 of the bill add new Education Law §§ 6509(15) and 6530(50) to provide that a prescriber's failure to comply with the new requirements constitutes professional misconduct under the Education Law.

Section 5 of the bill adds new PHL §§ 2999-g, 2999-h and 2999-i to require presenters at continuing medical education (CME) programs to make certain disclosures of financial relationships. New PHL § 2999-g sets forth relevant definitions.

New PHL § 2999-h requires presenters of continuing professional education programs conducted in the State to: (1) refrain from knowingly presenting any continuing professional education materials that are false or misleading; (2) refrain from claiming authorship of materials unless the presenter has sufficiently participated in the development of the materials and has made significant contributions to the intellectual content; (3) disclose to the provider any financial relationships he or she has with a drug manufacturer or distributor; and (4) disclose to the provider any materials to be used by the presenter which are disseminated on behalf of a manufacturer or distributor.

New PHL § 2999-h also requires providers of continuing professional education programs conducted in the state to: (1) inform presenters of their disclosure obligations; (2) act prudently to obtain the disclosure information from presenters; (3) disclose to program attendees presenters' information regarding financial relationships with manufacturers or distributors; (4) disclose to attendees the materials disseminated on behalf of a manufacturer or distributor; and (5) disclose the nature of any financial or other support the program received from a manufacturer or distributor, and the fair market value of the support.

New PHL § 2999-i authorizes the Commissioner to assess civil penalties of up to $2,500 per violation for presenters, and up to $ 10,000 per violation for providers who violate provisions of the section.

Sections 6 and 7 of the bill add new Education Law §§ 6509(16) and 6530(51) to provide that a presenter's failure to disclose a financial relationship with a manufacturer or distributor constitutes professional misconduct.

Section 8 of the bill provides that the bill takes effect on January 1, 2011.

Existing law

Education Law S 6509 sets forth general definitions of professional misconduct.

Education Law § 6530 sets forth definitions of professional misconduct applicable to physicians, physician assistants and specialist assistants.

Education Law § 6816-a requires a pharmacist to substitute a less expensive drug product containing the same active ingredients, dosage form and strength as the drug product prescribed, ordered or demanded, if certain criteria are met.

Legislative history

The provisions of the bill were included in Governor's Program Bill 55 and were introduced during the 2007-08 legislative session as A.11187/S.8556. These provisions were also included in the 2009-10 Executive Budget (A.158-A/S.58-A) but were not included in the enacted budget.

Statement in support

A. Payments to Prescribers

Pharmaceutical manufacturers reportedly spend billions of dollars annually in gifts and other payments to doctors, which range from gifts of nominal value to those worth tens of thousands of dollars. Studies have shown that the provision of even low-value items, such as meals in the workplace, influences prescribing patterns,

Accordingly, this bill will prohibit a drug manufacturer from giving to a health care provider and prohibit a health care provider from accepting payments that exceed $50 in aggregate value each calendar year. Exceptions are made for certain payments that benefit patients, particularly drug samples that a prescriber provides to patients free of charge and reductions in drug prices, which potentially get passed on to patients. Other exceptions are made for payments made to prescribers and doctors-in-training so that they may participate in legitimate educational, research or clinical activities. However, the bill establishes criteria to ensure that such payments are for bona fide purposes, and requires that they be disclosed to DOH.

B. Continuing Medical Education

Drug manufacturers spend more than $1 billion annually to support or sponsor at least half of all CME events, but there is virtually no oversight of such programs. Neither the State nor the FDA regulates CME, and although there is a national accrediting organization, it accredits the CME providers but not the presenters or the content of the CME program. Evidence from various fraud investigations has shown that some drug manufacturers have controlled the content of CME programs through financial relationships with presenters and providers and by contributing to the substance of the presentations themselves. This has resulted in physicians receiving misleading information about the risks and benefits of various drugs.

Many providers of CME and other continuing professional education programs follow guidelines such as the Standards for Commercial Support used by the Accreditation Council for Continuing Medical Education (ACCME) to ensure that educational grants are used for proper purposes. The ACCME standards require the content of CME programs to be independent and not controlled by the commercial sponsor. However, a report by the United States Senate Committee on Finance in April 2007 found that in 2005 and 2006, 24 percent of CME providers reviewed by ACCME did not comply with at least one of those standards.

This bill would require all providers of continuing professional education programs to obtain from the presenters, and disclose to the attendees, information on the presenters' financial relationships with drug manufacturers and a description of any material that will be disseminated on behalf of a manufacturer. The presenters would be prohibited from knowingly presenting false or misleading information. The monetary penalties that may be imposed against providers and presenters and, in the case of presenters, the potential for misconduct charges, should discourage violations.

Budget implications

This bill will have no fiscal impact to the State.

Effective date

This bill will take effect on January 1, 2011.