[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6752 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 6752

 To amend the Public Health Service Act to provide grants or contracts 
 for prescription drug education and outreach for healthcare providers 
                          and their patients.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 31, 2008

Mr. Pallone (for himself and Mr. Waxman) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to provide grants or contracts 
 for prescription drug education and outreach for healthcare providers 
                          and their patients.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Independent Drug Education and 
Outreach Act of 2008''.

SEC. 2. PRESCRIPTION DRUG EDUCATION AND OUTREACH.

    Part A of title IX of the Public Health Service Act (42 U.S.C. 299 
et seq.) is amended by adding at the end the following:

``SEC. 904. PRESCRIPTION DRUG EDUCATION AND OUTREACH.

    ``(a) In General.--The Secretary, acting through the Director, 
shall establish a program to award grants or contracts--
            ``(1) under subsection (b) for the development and 
        production of educational materials concerning the evidence 
        available on the relative safety, relative effectiveness, and 
        relative cost of prescription drugs, non-prescription drugs, 
        and non-drug interventions for treating selected conditions, 
        for distribution to healthcare providers who prescribe such 
        drugs and their patients; and
            ``(2) under subsection (c) for the development and 
        implementation of a program to appropriately train and deploy 
        health professionals to educate physicians and other drug 
        prescribers concerning the relative safety, relative 
        effectiveness, and relative cost of prescription drugs, non-
        prescription drugs, and non-drug interventions for treating 
        selected conditions.
    ``(b) Educational Material Grants or Contracts.--
            ``(1) In general.--The Secretary, acting through the 
        Director, shall award grants or contracts to eligible entities 
        for the development and production of educational materials 
        concerning the evidence available on the relative safety, 
        relative effectiveness, and relative cost of prescription 
        drugs, non-prescription drugs, and non-drug interventions for 
        treating selected conditions, for presentation to healthcare 
        providers who prescribe such drugs and their patients.
            ``(2) Eligible entities.--To be eligible to receive a grant 
        or contract under paragraph (1) an entity shall--
                    ``(A) be a non-profit or governmental entity that 
                is able to demonstrate clinical expertise, including--
                            ``(i) a medical school;
                            ``(ii) an academic medical center;
                            ``(iii) a school of pharmacy;
                            ``(iv) a medical society;
                            ``(v) a pharmacist society;
                            ``(vi) a research institute; and
                            ``(vii) any other entity determined 
                        appropriate by the Secretary;
                    ``(B) receive no support from any entity that 
                manufactures products used to treat the medical 
                conditions discussed, or from any organization funded 
                by such entities, during the period beginning 1 year 
                prior to the submission of an application under this 
                paragraph and ending 1 year after the date on which the 
                grant or contract is received; and
                    ``(C) submit to the Secretary an application at 
                such time, in such manner, and containing such 
                information as the Secretary may require, including--
                            ``(i) information on the conditions for 
                        which the entity will develop and produce 
                        educational materials using grant or contract 
                        funds; and
                            ``(ii) a plan for ensuring the 
                        effectiveness of such education materials and 
                        for interacting with entities receiving grants 
                        or contracts under subsection (c).
            ``(3) Criteria for awarding grants or contracts.--In 
        evaluating grant or contract applications received under this 
        subsection, the Secretary shall take into consideration--
                    ``(A) the capacity of the entities to perform the 
                activities described in paragraph (4);
                    ``(B) the conditions that the educational materials 
                involved will relate to, with a preference for 
                minimizing redundancy; and
                    ``(C) the quality of the proposed educational 
                materials involved, including--
                            ``(i) whether materials are based upon 
                        peer-reviewed sources or based upon scientific 
                        research which conforms to the accepted 
                        standards of experimental design, data 
                        collection, analysis, and interpretation;
                            ``(ii) the likelihood that the materials 
                        will accurately reflect the comprehensive body 
                        of available evidence that is accepted within 
                        the practice of medicine; and
                            ``(iii) the adequacy of the methods to be 
                        used to analyze the studies proposed to be 
                        relied upon.
            ``(4) Use of funds.--An entity shall use amounts received 
        under a grant or contract under this subsection to--
                    ``(A) develop educational materials of the type 
                described in paragraph (1), including monographs, 
                brochures, readily available reference cards, handouts 
                for patients, and other materials in either written or 
                electronic formats (including electronic formats 
                compatible with e-prescribing) determined appropriate 
                by the Secretary;
                    ``(B) conduct tests concerning the effectiveness of 
                such educational materials with healthcare providers 
                and their patients; and
                    ``(C) prepare and submit to the Director the 
                educational materials by condition, and a report that 
                provides evidence supporting the accuracy of the 
                information and findings in the educational materials, 
                including studies relied upon to prepare such 
                materials, a description of the methods used to analyze 
                those studies, and any studies with conflicting 
                findings that were not included in the educational 
                materials.
            ``(5) Review of educational materials.--
                    ``(A) In general.--The Director shall review and 
                approve proposed educational materials submitted under 
                paragraph (4)(C) within 90 days of the receipt of such 
                materials.
                    ``(B) Clearance of educational materials.--With 
                respect to educational materials that have been 
                reviewed and approved by the Director, the Secretary 
                shall permit the grantee or contractor involved to 
                include on such educational materials the following 
                statement: `These materials were compiled under a grant 
                issued by the Department of Health and Human 
                Services.'.
                    ``(C) Update of materials.--As needed, but not 
                later than 2 years after the date on which the 
                educational materials were approved by the Director, 
                the grantee or contractor involved shall submit updated 
                materials to the Director, including the studies used 
                to develop such updates.
            ``(6) Availability.--The Director shall ensure that 
        educational materials and reports developed under a grant or 
        contract under this subsection shall be made publicly available 
        and accessible, including through the Internet website of the 
        Agency.
    ``(c) Prescriber Education and Outreach Program.--
            ``(1) In general.--The Secretary, acting through the 
        Director, shall award 10 grants or contracts to eligible 
        entities for the development and implementation of programs to 
        appropriately train and deploy healthcare professionals to 
        educate physicians and other drug prescribers concerning the 
        relative safety, relative effectiveness, and relative cost of 
        prescription drugs and their alternatives as described in 
        subsection (a)(2), and to distribute the educational materials 
        developed under subsection (b) to physicians and other drug 
        prescribers.
            ``(2) Eligible entities.--To be eligible to receive a grant 
        or contract under paragraph (1) an entity shall--
                    ``(A) be--
                            ``(i) a public entity, including a State or 
                        county;
                            ``(ii) a non-profit private entity;
                            ``(iii) a partnership between a public 
                        entity and a non-profit private entity; or
                            ``(iv) an academic institution;
                    ``(B) receive no support from any entity that 
                manufactures products used to treat the medical 
                conditions discussed, or from any organization funded 
                by such entities, during the period beginning 1 year 
                prior to the submission of an application under this 
                paragraph and ending 1 year after the date on which the 
                grant or contract is received; and
                    ``(C) submit to the Secretary an application at 
                such time, in such manner, and containing such 
                information as the Secretary may require.
            ``(3) Criteria for awarding grants or contracts.--In 
        evaluating grant or contract applications received under this 
        subsection, the Secretary shall take into consideration--
                    ``(A) the capacity of the entities to perform the 
                activities described in paragraph (4);
                    ``(B) the service areas of the entity's programs, 
                in order to minimize overlap;
                    ``(C) the plans of the entities involved to provide 
                incentives for physicians and other prescribers to 
                participate in the education program, such as the 
                availability of continuing medical education credits; 
                and
                    ``(D) the methods proposed to provide the 
                educational materials through outreach and interaction 
                with prescribers in a setting, and with a 
                communications plan, designed to enhance the likelihood 
                that prescribers will participate, and will use the 
                information to improve the relative safety, relative 
                effectiveness, and relative cost of medication 
                utilization.
            ``(4) Use of funds.--An entity shall use amounts received 
        under a grant or contract under this subsection to carry out 
        the following activities:
                    ``(A) To hire and provide training to nurses, 
                pharmacists, or other individuals with an appropriate 
                clinical background to enable such individuals to 
                provide information and educational outreach concerning 
                the relative safety, relative effectiveness, and 
                relative cost of prescription drugs and their 
                alternatives as described in subsection (a)(2) to 
                healthcare providers who prescribe drugs in a manner 
                that prescribers find useful, convenient, and time 
                efficient.
                    ``(B) To identify healthcare providers who will 
                receive office visits from individuals who receive 
                training under this subsection. Preference for such 
                office visits shall be given to healthcare providers 
                with a large number of total patients or large number 
                of patients receiving care through Federal health 
                programs including the Medicare and Medicaid programs 
                under titles XVIII and XIX of the Social Security Act.
                    ``(C) To conduct office visits to healthcare 
                providers who prescribe drugs.
                    ``(D) To conduct other educational outreach 
                activities with respect to healthcare providers who 
                prescribe drugs, as approved by the Secretary.
                    ``(E) To conduct an evaluation of the effectiveness 
                of the program involved in changing prescribing 
                behavior and improving the quality of medication use.
    ``(d) Regulations.--The Secretary shall promulgate such regulations 
as may be required to carry out this section, including regulations to 
prevent conflicts of interest, to ensure the accuracy and timeliness of 
the information in the educational materials, and to promote the 
effectiveness of the prescriber education and outreach program.
    ``(e) Evaluation.--The Secretary shall conduct an evaluation of the 
effectiveness of the educational materials and the prescriber education 
and outreach program under this section.
    ``(f) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.
                                 <all>