SENATE, NO. 618
        By Mr. Moore, a petition (accompanied by bill, Senate, No.618) of
        Richard T. Moore, Susan ...
relationships may influence the practice of health care with regard to objectivity

or integrity.


SECTION 2. Section 2 o...
"Donor", a person who manufactures, sells, markets or distributes prescription

drugs or medical devices.


"Gift", a paym...
(2) intended for use in the diagnosis of disease or other conditions, or in the cure,

mitigation, treatment, or preventio...
confirmation statement for the 2 preceding years with their respective boards of

registration at the time each such healt...
SECTION 5. Section 9F of said chapter 112, as so appearing, is hereby amended

by adding the following paragraph:- The boa...
SECTION 7. Section 24A of said chapter 112, as so appearing, is hereby amended

by adding the following paragraph:-


The ...
SECTION 9. Section 68 of said chapter 112, as so appearing, is hereby amended

by adding the following paragraph:-


The b...
SECTION 11. Twenty-four months after the effective date of this act, each board

listed in subsection (b), in consultation...
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MA: Prescription Ethics and Responsibility Confirmation ...

  1. 1. SENATE, NO. 618 By Mr. Moore, a petition (accompanied by bill, Senate, No.618) of Richard T. Moore, Susan W. Pope, Marie J. Parente, Brian A. Joyce and other members of the General Court for legislation to require a physician to submit a completed prescription ethics and responsibility confirmation statement. Health Care The Commonwealth of Massachusetts In the Year Two Thousand and Three. AN ACT REQUIRING CERTAIN HEALTH CARE PROFESSIONALS TO FILE PRESCRIPTION ETHICS AND RESPONSIBILITY CONFIRMATION STATEMENTS . Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows: SECTION 1. The purpose of this act is to ensure balance, independence, integrity, professional objectivity and scientific rigor in all prescriber-patient relationships. All prescribers receiving gifts or honoraria from persons who manufacture, sell, market or distribute prescription drugs or medical devices are expected to publicly disclose such benefits. The intent of this disclosure is not to prevent a prescriber from receiving such gift or honoraria, but rather to provide patients and the general public with information on which they can make their own judgments. It remains for the patient to determine whether the prescriber's interests or
  2. 2. relationships may influence the practice of health care with regard to objectivity or integrity. SECTION 2. Section 2 of chapter 112 of the General Laws, as appearing in the 2000 Official Edition, is hereby amended by inserting after the words "inactive practitioner.", in line 120, the following sentence:- A physician shall also submit a completed prescription ethics and responsibility confirmation statement as set forth in section 5N with the renewal application. The renewal application shall not be deemed complete unless the physician files said statement. SECTION 3. The sixth paragraph of section 5 of said chapter 112, as so appearing, is hereby amended by inserting after clause (q) the following clause:- (r) a summary of the contents of the prescription ethics and responsibility confirmation statement, including donor names, addresses and the amount of any reported gift or honoraria made to the physician as required under section 5N. SECTION 4. Said chapter 112 is hereby amended by inserting after section 5M the following section:- Section 5N. (a) For purposes of this section, the following words shall have the following meanings: "Close relative", a person whose relationship to the reporting person or said reporting person's spouse is that of parent, grandparent, great-grandparent, child, grandchild, great-grandchild, aunt, uncle, brother, sister, niece, nephew or first cousin.
  3. 3. "Donor", a person who manufactures, sells, markets or distributes prescription drugs or medical devices. "Gift", a payment, entertainment, travel, lodging, meal, subscription, advance, discount, product, service, or anything of value, unless consideration of equal or greater value is received for it. "Gift" shall not include a commercially reasonable loan made in the ordinary course of business, anything of value received by inheritance; a gift received from a close relative of the reporting person, so long as a close relative is not acting either directly or indirectly as a donor as defined under this section and if the gift is intended to influence or control the use and precurement of medical devices or prescription drugs of the health care professional listed in subsection (b); a scholarship; or drug samples given to a health care professional listed in subsection (b) for the purpose of providing said samples to patients. "Honoraria", a payment of money or anything of value as consideration for an appearance, speech, product endorsement or article. "Medical device", an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part, or accessory, which is: (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
  4. 4. (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, or (3) intended to affect the structure or any function of the body of humans or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. "Person", a business, individual, corporation, union, association, firm, partnership, committee, or other organization or group of persons. "Prescription drugs", any and all drugs upon which the manufacturer or distributor has placed or must, in compliance with federal law and regulations, place the following or a comparable warning: "Caution federal law prohibits dispensing without prescription." (b) Every physician and physician assistant required to register with the board of registration in medicine, every kind of nurse authorized to prescribe prescription drugs by the board of registration in nursing and required to register with said board, every pharmacist and assistant pharmacist required to register with the board of registration in pharmacy, every dentist required to register with the board of registration of dentistry, every optometrist required to register with the board of registration in optometry, every podiatrist required to register with the board of registration of podiatry shall file a prescription ethics and responsibility
  5. 5. confirmation statement for the 2 preceding years with their respective boards of registration at the time each such health care professional listed in this subsection applies for a renewal registration or license on or after January 1, 2005, provided that such statement shall include only gifts or honoraria received on or after November 1, 2004. (c) The prescription ethics and responsibility confirmation statement shall contain the name and address of the donor, and the fair market value, or a reasonable estimate, of any gift or honoraria with a value of more than $50 received in the 2 preceding calendar years, if the source of such gifts or honoraria is a person who manufactures, sells, markets or distributes prescription drugs or medical devices for use by health care professionals listed under subsection (b) or their patients. This provision shall apply to a health care professional in subsection (b) who receives gifts or honoraria directly or by a group practice or professional association with which they are affiliated. (d) Health care professionals listed under subsection (b) who fail to file a completed prescription ethics and responsibility confirmation statement with their respective board of registration may be subject to the revocation or suspension of their licenses or registrations to practice or a fine of up to $5,000. Intentional omissions of gifts and honoraria are subject to penalties of perjury, and willful, wanton or subsequent violations shall additionally be subjected to fines amounting to treble the retail value of the gifts and honoraria not reported.
  6. 6. SECTION 5. Section 9F of said chapter 112, as so appearing, is hereby amended by adding the following paragraph:- The board shall require that every physician assistant submit a completed prescription ethics and responsibility confirmation statement along with any application for renewal of a certificate of registration or license pursuant to section 5N. The renewal application shall not be deemed complete unless the physician assistant files said prescription ethics and responsibility confirmation statement. Upon an oral or written request, the board shall provide a written or electronic summary of the contents of the prescription ethics and responsibility confirmation statement filed by the physician assistant, including donor names, addresses and the amount of any reported gift or honoraria made to the physician assistant as required under section 5N. SECTION 6. Section 16 of said chapter 112, as so appearing, is hereby amended by adding the following paragraph:- The board shall require that every podiatrist submit a completed prescription ethics and responsibility confirmation statement along with any application for renewal of a certificate of registration or license pursuant to section 5N. The renewal application shall not be deemed complete unless the podiatrist files said prescription ethics and responsibility confirmation statement. Upon an oral or written request, the board shall provide a written or electronic summary of the contents of the prescription ethics and responsibility confirmation statement filed by the podiatrist, including donor names, addresses and the amount of any reported gift or honoraria made to the podiatrist as required under section 5N.
  7. 7. SECTION 7. Section 24A of said chapter 112, as so appearing, is hereby amended by adding the following paragraph:- The board shall require that a pharmacist and assistant pharmacist submit a completed prescription ethics and responsibility confirmation statement along with any application for renewal of a certificate of registration or license pursuant to section 5N. The renewal application shall not be deemed complete unless the pharmacist or assistant pharmacist files said statement. Upon an oral or written request, the board shall provide a written or electronic summary of the contents of the prescription ethics and responsibility confirmation statement filed by the pharmacist or assistant pharmacist, including donor names, addresses and the amount of any reported gift or honoraria made to the pharmacist or assistant pharmacist as required under section 5N. SECTION 8. Section 45 of said chapter 112, as so appearing, is hereby amended by adding the following paragraph:- The board shall require that every dentist submit a completed prescription ethics and responsibility confirmation statement along with any application for renewal of a certificate of registration or license pursuant to section 5N. The renewal application shall not be deemed complete unless the dentist files said statement. Upon an oral or written request, the board shall provide a written or electronic summary of the contents of the prescription ethics and responsibility confirmation statement filed by the dentist, including donor names, addresses and the amount of any reported gift or honoraria made to the dentist as required under section 5N.
  8. 8. SECTION 9. Section 68 of said chapter 112, as so appearing, is hereby amended by adding the following paragraph:- The board shall require that every optometrist submit a completed prescription ethics and responsibility confirmation statement along with any application for renewal of a certificate of registration or license pursuant to section 5N. The renewal application shall not be deemed complete unless the optometrist files said statement. Upon an oral or written request, the board shall provide a written or electronic summary of the contents of the prescription ethics and responsibility confirmation statement filed by the optometrist, including donor names, addresses and the amount of any reported gift or honoraria made to the optometrist as required under section 5N. SECTION 10. Section 74A of said chapter 112, as so appearing, is hereby amended by adding the following paragraph:- The board shall require that every kind of nurse authorized to prescribe prescription drugs shall submit a completed prescription ethics and responsibility confirmation statement along with any application for renewal of a certificate of registration or license pursuant to section 5N. The renewal application shall not be deemed complete unless the nurse files said statement. Upon an oral or written request, the board shall provide a written or electronic summary of the contents of the prescription ethics and responsibility confirmation statement filed by the said nurse, including donor names, addresses and the amount of any reported gift or honoraria made to said nurse as required under section 5N.
  9. 9. SECTION 11. Twenty-four months after the effective date of this act, each board listed in subsection (b), in consultation with the department of public health, shall create a uniform prescription ethics and responsibility confirmation statement, and annually compile and prepare for the public, a summary of the gifts and honoraria reported to the different boards of registration pursuant to subsection (b) of section 5N of Chapter 112 of the General Laws, aggregated by profession, by the type of gift and honoraria and by the donor. Said report shall also be filed with the Clerk of the Senate and the Clerk of the House of Representatives and the Joint Committee on Health Care.

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