Senate Bill S6015

2009-2010 Legislative Session

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

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Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Date of Action	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 06, 2010	referred to health
Jun 19, 2009	referred to rules

2009-S6015 (ACTIVE) - Details

Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §279, Art 29-D Title 4 §§2999-g - 2999-i, Pub Health L; amd §§6509 & 6530, Ed L

2009-S6015 (ACTIVE) - Summary

Relates to prohibiting certain gifts and payments to prescribers and requiring disclosure of other such gifts and payments; prohibits the presentation of information at continuing professional education programs that is false or misleading and requires disclosure of certain potential conflicts of interest in connection with such programs; provides for transparency in the business relationships between pharmacy benefit managers and health plans; and requires pharmacy benefit managers to provide certain information to health plan participants and their prescribers.

2009-S6015 (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S6015

 TITLE OF BILL :

An act to amend the public health law and the education law, in
relation to prohibiting certain payments to prescribers and requiring
the disclosure of other payments; prohibiting the presentation of
information at continuing professional education programs that is
false or misleading and requiring disclosure of certain potential
conflicts of interest in connection with such programs


 PURPOSE :

This bill will limit the influence of pharmaceutical manufacturers
over prescribing decisions by: (1) banning gifts and payments from
drug manufacturers to physicians and other prescribers in excess of
$50 per year, except for certain gifts and payments that must be
disclosed; and (2) requiring the providers of continuing professional
education events to disclose any financial relationship between
presenters and drug manufacturers.

 SUMMARY OF PROVISIONS :

Section 1 of the bill sets forth legislative findings.

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.

2009-S6015 (ACTIVE) - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  6015

                       2009-2010 Regular Sessions

                            I N  S E N A T E

                              June 19, 2009
                               ___________

Introduced by COMMITTEE ON RULES -- (at request of the Governor) -- read
  twice  and  ordered  printed,  and when printed to be committed to the
  Committee on Rules

AN ACT to amend the public health law and the education law, in relation
  to prohibiting certain  payments  to  prescribers  and  requiring  the
  disclosure of other payments; prohibiting the presentation of informa-
  tion  at  continuing  professional education programs that is false or
  misleading and requiring disclosure of certain potential conflicts  of
  interest in connection with such programs

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. Declaration of legislative findings and intent. The  legis-
lature  makes the following findings with respect to improper influences
exerted on prescribing decisions:
  1. The pharmaceutical, biological product and  medical  device  indus-
tries  spend  billions of dollars annually to attempt to influence pres-
cribers' decisions about which drugs or other treatment to prescribe  to
their  patients,  including  more  than  half  of  all formal continuing
medical education programs. Legislation is necessary  to  prohibit  drug
and  device  manufacturers  from  making  payments  to prescribers in an
attempt to influence their prescribing decisions and further to  require
prescribers  and  manufacturers to disclose the things of value that are
legitimately transferred from drug and device manufacturers to  prescri-
bers.
  2.  There  is compelling evidence that the vast majority of physicians
accept some type of gift or  payment  from  pharmaceutical  and  medical
device  manufacturers,  and  often such gifts and payments, even when of
little value, influence physicians to prescribe treatments that are more
expensive and no more effective or safe, and are sometimes  less  effec-
tive and more dangerous, than other available treatments.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD12047-01-9

S. 6015                             2

  3.  Legislation  is  necessary  to  prohibit  presenters at continuing
professional education  programs  from  providing  false  or  misleading
information  to  prescribers  and  to require all potential conflicts of
interest be disclosed to attendees of such programs.
  S  2.  The public health law is amended by adding a new section 279 to
read as follows:
  S 279. PROHIBITED ACTS AND DISCLOSURE REQUIREMENTS  RELATING  TO  DRUG
MANUFACTURERS'  PROVISION  OF  THINGS OF VALUE TO PRESCRIBERS.  1. DEFI-
NITIONS. AS USED IN THIS SECTION:
  (A) "DRUG" MEANS:   (I) ARTICLES RECOGNIZED  IN  THE  OFFICIAL  UNITED
STATES  PHARMACOPOEIA,  OFFICIAL HOMEOPATHIC PHARMACOPOEIA OF THE UNITED
STATES, OR OFFICIAL NATIONAL FORMULARY;
  (II) ARTICLES INTENDED FOR USE IN  THE  DIAGNOSIS,  CURE,  MITIGATION,
TREATMENT OR PREVENTION OF DISEASE IN HUMANS;
  (III)  ARTICLES  (OTHER THAN FOOD) INTENDED TO AFFECT THE STRUCTURE OR
ANY FUNCTION OF THE BODY OF HUMANS;
  (IV) ARTICLES INTENDED FOR USE AS A COMPONENT OF ANY ARTICLE SPECIFIED
IN SUBPARAGRAPH (I), (II) OR  (III)  OF  THIS  PARAGRAPH  BUT  DOES  NOT
INCLUDE DEVICES OR THEIR COMPONENTS, PARTS OR ACCESSORIES;
  (B)  "DEVICE" MEANS ANY INSTRUMENT, APPARATUS, OR CONTRIVANCE, INCLUD-
ING COMPONENTS, PARTS OR ACCESSORIES, INTENDED:
  (I)  FOR  USE  IN  THE  DIAGNOSIS,  CURE,  MITIGATION,  TREATMENT,  OR
PREVENTION OF DISEASE IN HUMANS; OR
  (II) TO AFFECT THE STRUCTURE OR ANY FUNCTION OF THE BODY OF HUMANS.
  (C)  "MANUFACTURER"  MEANS  (I)  A  PERSON  OR ENTITY THAT FABRICATES,
MAKES, COMPOUNDS, MIXES, PREPARES, PRODUCES, BOTTLES OR PACKS  DRUGS  OR
DEVICES FOR THE PURPOSE OF DISTRIBUTING OR SELLING TO PHARMACIES, HEALTH
CARE  PROVIDERS  OR  OTHER CHANNELS OF DISTRIBUTION, OR (II) A PERSON OR
ENTITY THAT, PURSUANT TO AN AGREEMENT WITH A PERSON OR ENTITY  DESCRIBED
IN  SUBPARAGRAPH (I) OF THIS PARAGRAPH, MARKETS A DRUG OR DEVICE UNDER A
DIFFERENT NAME OR LABELER CODE.
  (D) "PRESCRIBER" MEANS  A  PHYSICIAN,  DENTIST,  PHYSICIAN  ASSISTANT,
SPECIALIST'S  ASSISTANT,  NURSE  PRACTITIONER,  MIDWIFE, OPTOMETRIST AND
OTHER LICENSED HEALTH CARE PROVIDER AUTHORIZED UNDER TITLE EIGHT OF  THE
EDUCATION LAW TO PRESCRIBE DRUGS OR DEVICES.
  (E)  "HEALTH  CARE  PROVIDER"  MEANS (I) A PRESCRIBER WHO PRACTICES IN
THIS STATE IN  AN  INDIVIDUAL  PRACTICE,  GROUP  PRACTICE,  PARTNERSHIP,
PROFESSIONAL  CORPORATION OR OTHER AUTHORIZED FORM OF ASSOCIATION, OR IN
A HOSPITAL OR OTHER HEALTH CARE INSTITUTION ISSUED AN OPERATING  CERTIF-
ICATE  PURSUANT  TO  THIS  CHAPTER  OR THE MENTAL HYGIENE LAW; (II) SUCH
PRESCRIBER'S INDIVIDUAL PRACTICE, GROUP PRACTICE,  PARTNERSHIP,  PROFES-
SIONAL CORPORATION OR OTHER AUTHORIZED FORM OF ASSOCIATION; AND (III) AN
EMPLOYEE  OF A PERSON OR ENTITY DESCRIBED IN SUBPARAGRAPH (I) OR (II) OF
THIS PARAGRAPH.
  (F) "DOCTOR-IN-TRAINING" MEANS A PERSON ACTIVELY ENGAGED IN THE  STATE
IN  POST-BACCALAUREATE  EDUCATION  OR  PROFESSIONAL TRAINING DESIGNED TO
PREPARE PERSONS TO BE ELIGIBLE TO BE LICENSED AS A DOCTOR OF MEDICINE OR
DOCTOR OF OSTEOPATHY  AND  IS  NOT  AUTHORIZED  TO  PRESCRIBE  DRUGS  OR
DEVICES.
  (G) "PAYMENT" MEANS ANYTHING WITH AN ECONOMIC VALUE, INCLUDING BUT NOT
LIMITED TO MONEY, GOODS AND SERVICES.
  (H)  "BENEFIT" MEANS ONE OR MORE THINGS WITH AN AGGREGATED FAIR MARKET
VALUE FOR THE YEAR EQUAL TO OR GREATER THAN FIFTY DOLLARS, THAT WOULD BE
A PAYMENT, AS DEFINED IN PARAGRAPH (G) OF THIS SUBDIVISION, EXCEPT  THAT
IT  COMES WITHIN THE EXCEPTION SET OUT IN PARAGRAPH (B) OR (D) OF SUBDI-
VISION THREE OF THIS SECTION.

S. 6015                             3

  (I) "FAIR MARKET VALUE" MEANS THE VALUE IN ARMS  LENGTH  TRANSACTIONS,
CONSISTENT WITH THE GENERAL MARKET VALUE.
  (J)  "FINANCIAL  RELATIONSHIP" MEANS AN OWNERSHIP INTEREST, INVESTMENT
INTEREST OR COMPENSATION ARRANGEMENT. AN OWNERSHIP INTEREST  OR  INVEST-
MENT  INTEREST MAY BE THROUGH EQUITY, DEBT OR OTHER MEANS; BUT SHALL NOT
INCLUDE OWNERSHIP OF INVESTMENT SECURITIES, INCLUDING SHARES  OR  BONDS,
DEBENTURES,  NOTES  OR  OTHER  DEBT INSTRUMENTS, WHICH WERE PURCHASED ON
TERMS GENERALLY AVAILABLE TO THE PUBLIC AND WHICH ARE IN  A  CORPORATION
THAT  IS  LISTED  FOR  TRADING  ON THE NEW YORK STOCK EXCHANGE OR ON THE
AMERICAN STOCK EXCHANGE, OR IS A NATIONAL MARKET SYSTEM SECURITY  TRADED
UNDER AN AUTOMATED INTERDEALER QUOTATION SYSTEM OPERATED BY THE NATIONAL
ASSOCIATION  OF  SECURITIES  DEALERS,  AND HAD, AT THE END OF THE CORPO-
RATION'S MOST RECENT FISCAL YEAR, TOTAL  ASSETS  EXCEEDING  ONE  HUNDRED
MILLION DOLLARS.
  (K) "DISCOUNT" MEANS A REDUCTION IN THE AMOUNT A HEALTH CARE PROVIDER,
ACTING AS A BUYER OR PAYER, IS CHARGED FOR AN ITEM OR SERVICE, WHERE THE
REDUCTION IS OFFERED BY OR ON BEHALF OF A MANUFACTURER, AND INCLUDES ALL
SUCH  REDUCTIONS  WHENEVER THEY ARE GIVEN, INCLUDING BEFORE OR AFTER THE
TIME OF SALE, PROVIDED THAT SUCH  REDUCTIONS  GIVEN  TO  A  HEALTH  CARE
PROVIDER HAVE A FAIR MARKET VALUE AGGREGATED FOR THE CALENDAR YEAR EQUAL
TO  OR  GREATER  THAN FIFTY DOLLARS.  FOR THE PURPOSE OF THIS PARAGRAPH,
"REDUCTION" MEANS A DECREASE FROM THE AMOUNT THAT WOULD BE CHARGED BASED
ON AN ARMS-LENGTH TRANSACTION OR THAT IS REPRESENTED TO  THE  PRESCRIBER
AS CONSTITUTING SUCH A DECREASE.
  2.  PROHIBITED  ACTS.  (A) A MANUFACTURER SHALL NOT, DIRECTLY OR INDI-
RECTLY, GIVE OR OFFER TO GIVE ONE OR MORE PAYMENTS  WITH  AN  AGGREGATED
FAIR  MARKET VALUE IN EXCESS OF FIFTY DOLLARS DURING A CALENDAR YEAR, TO
ANY HEALTH CARE PROVIDER OR DOCTOR-IN-TRAINING.
  (B) A HEALTH CARE PROVIDER OR A DOCTOR-IN-TRAINING SHALL NOT, DIRECTLY
OR INDIRECTLY, REQUEST OR RECEIVE FROM  ANY  MANUFACTURER  ONE  OR  MORE
PAYMENTS WITH AN AGGREGATED FAIR MARKET VALUE IN EXCESS OF FIFTY DOLLARS
DURING A CALENDAR YEAR.
  3.  EXCEPTIONS.  THE  FOLLOWING PAYMENTS SHALL NOT BE PROHIBITED UNDER
SUBDIVISION TWO OF THIS SECTION AND SHALL BE DISCLOSED,  AS  APPLICABLE,
PURSUANT TO SUBDIVISION FOUR OF THIS SECTION:
  (A)  SAMPLES  OF  PRESCRIPTION  DRUGS THAT THE MANUFACTURER'S EMPLOYEE
PROVIDES DIRECTLY TO A  PRESCRIBER  WHO  PROVIDES  OR  ADMINISTERS  SUCH
SAMPLE TO A PATIENT WITHOUT CHARGE;
  (B)  ANY  PAYMENT TO SUPPORT A SPECIFIED AND BONA FIDE RESEARCH, CLIN-
ICAL OR EDUCATIONAL ACTIVITY IN CONNECTION WITH WHICH THE RECIPIENT  (I)
PRIOR  TO RECEIPT OF ANY SUCH PAYMENT, HAS SUBMITTED TO THE MANUFACTURER
A PROPOSAL THAT DESCRIBES THE PURPOSE AND METHODS TO BE USED IN CARRYING
OUT THE ACTIVITY, THE OUTCOMES OF THE ACTIVITY THAT WILL BE MEASURED AND
THE METHODS TO BE  USED  TO  MEASURE  SUCH  OUTCOMES,  A  PROCEDURE  FOR
ACCOUNTING  FOR  SUCH  PAYMENT  AND  A  DEADLINE  FOR  SUBMITTING TO THE
MANUFACTURER A FINAL REPORT CONCERNING THE ACTIVITY; (II) HAS  SUBMITTED
TO  THE  MANUFACTURER THE FINAL REPORT, WITH ALL REQUIRED INFORMATION AS
DESCRIBED IN ITS PROPOSAL AS SET FORTH IN SUBPARAGRAPH (I) OF THIS PARA-
GRAPH, WITHIN THE DEADLINE SET OUT IN SUCH PROPOSAL OR  AS  EXTENDED  IN
WRITING  BY  THE MANUFACTURER;  AND (III) MAKES SUCH FINAL REPORT AVAIL-
ABLE TO THE DEPARTMENT AND HEALTH CARE PROVIDERS UPON REQUEST;
  (C) A REDUCTION IN THE COST TO THE HEALTH CARE PROVIDER OF ONE OR MORE
OF THE MANUFACTURER'S DRUGS OR DEVICES;
  (D) REIMBURSEMENT FOR TRAVEL, LODGING AND PERSONAL EXPENSES OR  REMUN-
ERATION  PROVIDED  TO  A  PRESCRIBER OR SUCH REIMBURSEMENT PROVIDED TO A
DOCTOR-IN-TRAINING, THE AMOUNT OF WHICH REMUNERATION OR REIMBURSEMENT IS

S. 6015                             4

NOT DEPENDENT, DIRECTLY OR INDIRECTLY, ON THE AMOUNT OR  VOLUME  OF  THE
MANUFACTURER'S DRUGS OR DEVICES ANY PERSON OR ENTITY PRESCRIBES, IF:
  (I)  WITH RESPECT TO PRESCRIBERS, THE REMUNERATION OR REIMBURSEMENT IS
PROVIDED IN CONNECTION WITH BONA  FIDE  TEACHING,  SCIENTIFIC  RESEARCH,
WRITING  OR  CONSULTING  SERVICES  THE PRESCRIBER ACTUALLY PROVIDES, THE
NATURE AND PROVISION OF WHICH CAN BE VERIFIED BY DOCUMENTS THE  MANUFAC-
TURER  MAINTAINS  FOR  NOT  LESS THAN THREE YEARS, PROVIDED THAT (A) THE
AMOUNT OF BOTH THE REMUNERATION AND REIMBURSEMENT IS CONSISTENT WITH THE
FAIR MARKET VALUE OF THE SERVICES  THE  PRESCRIBER  PROVIDES  TO  OR  ON
BEHALF OF THE MANUFACTURER, (B) WITH RESPECT TO TEACHING ACTIVITIES, THE
PRESCRIBER  IS  PART  OF  THE  FACULTY  FOR  AN  EDUCATIONAL PROGRAM AND
PROVIDES ATTENDEES WITH SIGNIFICANT SCIENTIFIC OR CLINICAL  INFORMATION,
AND  (C)  WITH  RESPECT  TO  WRITING, THE PRESCRIBER IS IDENTIFIED AS AN
AUTHOR ONLY WHEN HE OR SHE HAS  HAD  UNRESTRICTED  ACCESS  TO  ALL  DATA
PERTAINING TO THE SUBJECT OF THE MANUSCRIPT, HAS GIVEN FINAL APPROVAL OF
THE MANUSCRIPT, HAS PARTICIPATED SUFFICIENTLY IN THE WORK TO TAKE PUBLIC
RESPONSIBILITY  FOR  AT LEAST PART OF THE CONTENT, AND HAS MADE SUBSTAN-
TIAL CONTRIBUTIONS TO THE INTELLECTUAL CONTENT OF THE  WRITTEN  WORK  IN
EITHER CONCEPTION AND DESIGN OR ACQUISITION OF DATA AND IN EITHER DRAFT-
ING  OR  CRITICAL  REVISION OF THE MANUSCRIPT FOR IMPORTANT INTELLECTUAL
CONTENT; AND
  (II)  WITH  RESPECT  TO  DOCTORS-IN-TRAINING,  THE  REIMBURSEMENT   IS
PROVIDED  IN  CONNECTION  WITH ATTENDANCE AT A BONA FIDE MEDICAL CONFER-
ENCE, THE PRINCIPAL PURPOSE OF WHICH IS TO IMPART SCIENTIFIC OR CLINICAL
INFORMATION, PROVIDED THAT  (A)  THE  AMOUNT  OF  ANY  REIMBURSEMENT  IS
CONSISTENT  WITH  THE  FAIR  MARKET  VALUE  OF  THE  TRAVEL, LODGING AND
PERSONAL EXPENSES BEING REIMBURSED, AND (B) THE  MANUFACTURER  TRANSFERS
ALL  SUCH  FUNDS  TO  THE DOCTOR'S-IN-TRAINING MEDICAL SCHOOL OR PROFES-
SIONAL EMPLOYER, THE MEDICAL SCHOOL OR PROFESSIONAL EMPLOYER SELECTS THE
DOCTORS-IN-TRAINING WHOSE ATTENDANCE THE MANUFACTURER WILL FUND AND  THE
MEDICAL  CONFERENCES  THEY  WILL  ATTEND,  AND  THE SCHOOL, EMPLOYER AND
MANUFACTURER DO NOT, DIRECTLY OR INDIRECTLY, INFORM THE DOCTOR-IN-TRAIN-
ING OF THE SOURCE OF SUCH FUNDS; AND
  (E) ANYTHING OF ECONOMIC VALUE GIVEN BY  A  PERSON  WITH  A  FINANCIAL
RELATIONSHIP  WITH  A  MANUFACTURER WHO IS RELATED BY BLOOD, MARRIAGE OR
ADOPTION WITHIN THREE DEGREES OF CONSANGUINITY TO THE RECIPIENT PRESCRI-
BER.
  4. DISCLOSURE. (A) ANNUAL DISCLOSURE.  ANNUALLY, AT A TIME  AND  IN  A
MANNER  TO BE DETERMINED BY THE DEPARTMENT, EACH HEALTH CARE PROVIDER OR
DOCTOR-IN-TRAINING AND EACH MANUFACTURER DOING BUSINESS  WITH  ANY  SUCH
HEALTH  CARE PROVIDER OR DOCTOR-IN-TRAINING SHALL PROVIDE TO THE DEPART-
MENT A REPORT THAT CONTAINS THE INFORMATION REQUIRED BY PARAGRAPHS  (B),
(C),  AND (D) OF THIS SUBDIVISION WHERE (I) SUCH HEALTH CARE PROVIDER OR
DOCTOR-IN-TRAINING OFFERED,  GAVE  OR  RECEIVED  A  BENEFIT;  (II)  SUCH
MANUFACTURER  GAVE  A  DISCOUNT  TO  A  HEALTH CARE PROVIDER; OR (III) A
FINANCIAL RELATIONSHIP EXISTED BETWEEN SUCH A MANUFACTURER  AND  SUCH  A
PROVIDER  OR  DOCTOR-IN-TRAINING.    ACCESS TO SUCH REPORTS SHALL NOT BE
DENIED, THE REPORTS SHALL NOT BE WITHHELD, AND  IDENTIFYING  INFORMATION
SHALL  NOT BE DELETED FROM SUCH REPORTS PURSUANT TO SECTION EIGHTY-SEVEN
OR EIGHTY-NINE OF THE PUBLIC OFFICERS LAW.
  (B) DISCLOSURE OF BENEFITS. EACH REPORT REQUIRED BY PARAGRAPH  (A)  OF
THIS  SUBDIVISION PERTAINING TO A BENEFIT TRANSFERRED DURING THE REPORT-
ING PERIOD SHALL DESCRIBE THE NATURE AND FAIR MARKET VALUE OF THE  BENE-
FIT  THAT  WAS OFFERED OR TRANSFERRED; THE NATURE OF ANY GOOD OR SERVICE
THAT WAS PROVIDED TO THE MANUFACTURER OR ANY OTHER PERSON OR  ENTITY  IN

S. 6015                             5

CONNECTION WITH THE PROVISION OF THE BENEFIT; AND SUCH OTHER INFORMATION
AS SHALL BE REQUIRED BY THE DEPARTMENT BY REGULATION.
  (C)  DISCLOSURE OF DISCOUNTS. THE REPORTS REQUIRED BY PARAGRAPH (A) OF
THIS SUBDIVISION SHALL NOT REQUIRE A MANUFACTURER TO  DISCLOSE  DISCOUNT
INFORMATION  SEPARATELY  FOR  EACH  TRANSACTION. THE DEPARTMENT SHALL BY
REGULATION SPECIFY THE MANNER IN WHICH THE VALUE OF THE  DISCOUNT  SHALL
BE  REPORTED, INCLUDING A THRESHOLD FOR THE VALUE OF DISCOUNTS THAT MUST
BE REPORTED.  THE MANUFACTURER SHALL REPORT ALL DISCOUNTS THAT  OCCURRED
DURING  THE  REPORTING  PERIOD,  INCLUDING  THOSE DISCOUNTS THE VALUE OF
WHICH WAS REALIZED BY THE PURCHASER  DURING  THE  REPORTING  PERIOD  BUT
PERTAIN TO SALES THAT OCCURRED AT A DIFFERENT TIME.
  (D) DISCLOSURE OF FINANCIAL RELATIONSHIPS. EACH REPORT A MANUFACTURER,
HEALTH  CARE PROVIDER OR DOCTOR-IN-TRAINING IS REQUIRED TO MAKE BY PARA-
GRAPH (A) OF THIS  SUBDIVISION  PERTAINING  TO  FINANCIAL  RELATIONSHIPS
SHALL CONTAIN SUCH INFORMATION AS IS REQUIRED BY THE DEPARTMENT BY REGU-
LATION,  WHICH  SHALL SPECIFY THE MANNER IN WHICH THE VALUE OF FINANCIAL
RELATIONSHIPS SHALL BE REPORTED, INCLUDING THE THRESHOLD VALUE OF FINAN-
CIAL RELATIONSHIPS THAT MUST BE REPORTED.
  5. VIOLATIONS.  THE  COMMISSIONER  MAY  ASSESS  A  CIVIL  PENALTY  FOR
VIOLATIONS  OF  THIS  SECTION IN AN AMOUNT THAT IS, FOR A MANUFACTURER'S
VIOLATION OF PARAGRAPH (A) OF SUBDIVISION TWO OF THIS SECTION OR  SUBDI-
VISION FOUR OF THIS SECTION, NOT LESS THAN FIVE THOUSAND DOLLARS AND NOT
MORE  THAN  FIFTY  THOUSAND DOLLARS PER VIOLATION, AND FOR A HEALTH CARE
PROVIDER'S VIOLATION OF PARAGRAPH (B) OF SUBDIVISION TWO OF THIS SECTION
OR SUBDIVISION FOUR OF THIS SECTION, NOT LESS THAN FIVE THOUSAND DOLLARS
AND NOT MORE THAN TEN THOUSAND DOLLARS PER VIOLATION.
  S 3. Section 6509 of the education law is  amended  by  adding  a  new
subdivision 15 to read as follows:
  (15)  A  VIOLATION  OF  SECTION TWO HUNDRED SEVENTY-NINE OF THE PUBLIC
HEALTH LAW.
  S 4. Section 6530 of the education law is  amended  by  adding  a  new
subdivision 50 to read as follows:
  50.  A  VIOLATION  OF  SECTION  TWO HUNDRED SEVENTY-NINE OF THE PUBLIC
HEALTH LAW.
  S 5. Article 29-D of the public health law is amended by adding a  new
title 4 to read as follows:
                                  TITLE 4
                    CONTINUING PROFESSIONAL EDUCATION
SECTION 2999-G. DEFINITIONS.
        2999-H.  REQUIREMENTS  FOR  CONDUCTING A CONTINUING PROFESSIONAL
                  EDUCATION PROGRAM.
        2999-I. VIOLATIONS.
  S 2999-G. DEFINITIONS. FOR THE PURPOSE OF THIS TITLE:
  1. "CONTINUING PROFESSIONAL EDUCATION PROGRAM" MEANS  COURSE  WORK  OR
TRAINING   PROVIDED   TO  PHYSICIANS,  DENTISTS,  PHYSICIAN  ASSISTANTS,
SPECIALIST ASSISTANTS, NURSE PRACTITIONERS,  MIDWIVES,  OPTOMETRISTS  OR
OTHER  LICENSED  HEALTH  CARE  PROVIDERS  AUTHORIZED BY LAW TO PRESCRIBE
DRUGS OR DEVICES, WHICH PERTAINS TO THE PRACTICE OF THEIR PROFESSION AND
FOR WHICH CONTINUING MEDICAL EDUCATION OR CONTINUING PROFESSIONAL EDUCA-
TION CREDITS MAY BE AWARDED.
  2. "PROVIDER" MEANS THE PERSON OR ENTITY THAT REPRESENTS TO MEMBERS OF
THE RELEVANT PROFESSION THAT IT IS THE ORGANIZER OF A CONTINUING PROFES-
SIONAL EDUCATION PROGRAM. A CONTINUING  PROFESSIONAL  EDUCATION  PROGRAM
CAN  HAVE  MORE  THAN  ONE PROVIDER, BUT EVERY SUCH PROGRAM MUST HAVE AT
LEAST ONE PROVIDER. MANUFACTURERS AND DISTRIBUTORS ARE NOT PROVIDERS.

S. 6015                             6

  3. "MANUFACTURER" MEANS (I) A PERSON OR ENTITY THAT FABRICATES, MAKES,
COMPOUNDS, MIXES, PREPARES, PRODUCES, BOTTLES OR PACKS DRUGS OR  DEVICES
FOR  THE  PURPOSE  OF DISTRIBUTING OR SELLING TO PHARMACIES, HEALTH CARE
PROVIDERS OR OTHER CHANNELS OF DISTRIBUTION, OR (II) A PERSON OR  ENTITY
THAT,  PURSUANT  TO  AN  AGREEMENT  WITH A PERSON OR ENTITY DESCRIBED IN
SUBPARAGRAPH (I) OF THIS PARAGRAPH, MARKETS A DRUG  OR  DEVICE  UNDER  A
DIFFERENT NAME OR LABELER CODE.
  4. "DISTRIBUTOR" MEANS A PERSON OR ENTITY THAT DELIVERS, OTHER THAN BY
DISPENSING, A DRUG PRODUCT TO ANY PERSON.
  5.  "DRUG"  MEANS:    (I)  ARTICLES  RECOGNIZED IN THE OFFICIAL UNITED
STATES PHARMACOPOEIA, OFFICIAL HOMEOPATHIC PHARMACOPOEIA OF  THE  UNITED
STATES, OR OFFICIAL NATIONAL FORMULARY;
  (II)  ARTICLES  INTENDED  FOR  USE IN THE DIAGNOSIS, CURE, MITIGATION,
TREATMENT OR PREVENTION OF DISEASE IN HUMANS;
  (III) ARTICLES (OTHER THAN FOOD) INTENDED TO AFFECT THE  STRUCTURE  OR
ANY FUNCTION OF THE BODY OF HUMANS;
  (IV) ARTICLES INTENDED FOR USE AS A COMPONENT OF ANY ARTICLE SPECIFIED
IN  SUBPARAGRAPH  (I),  (II)  OR  (III)  OF  THIS PARAGRAPH BUT DOES NOT
INCLUDE DEVICES OR THEIR COMPONENTS, PARTS OR ACCESSORIES;
  6. "DEVICE" MEANS ANY INSTRUMENT, APPARATUS, OR CONTRIVANCE, INCLUDING
COMPONENTS, PARTS OR ACCESSORIES, INTENDED:
  (I)  FOR  USE  IN  THE  DIAGNOSIS,  CURE,  MITIGATION,  TREATMENT,  OR
PREVENTION OF DISEASE IN HUMANS; OR
  (II) TO AFFECT THE STRUCTURE OR ANY FUNCTION OF THE BODY OF HUMANS.
  7.  "PRESENTER"  IS A NATURAL PERSON WHO CONDUCTS, TEACHES AND PARTIC-
IPATES, OTHER THAN SOLELY AS AN ATTENDEE, IN ANY ASPECT OF A  CONTINUING
PROFESSIONAL  EDUCATION  PROGRAM,  REGARDLESS OF WHETHER SUCH PROGRAM IS
PROVIDED IN PERSON OR BY ELECTRONIC OR OTHER MEANS.
  8. "FINANCIAL RELATIONSHIP" MEANS AN  OWNERSHIP  INTEREST,  INVESTMENT
INTEREST  OR  COMPENSATION ARRANGEMENT. AN OWNERSHIP INTEREST OR INVEST-
MENT INTEREST MAY BE THROUGH EQUITY, DEBT OR OTHER MEANS; BUT SHALL  NOT
INCLUDE  OWNERSHIP  OF INVESTMENT SECURITIES, INCLUDING SHARES OR BONDS,
DEBENTURES, NOTES OR OTHER DEBT INSTRUMENTS,  WHICH  WERE  PURCHASED  ON
TERMS  GENERALLY  AVAILABLE TO THE PUBLIC AND WHICH ARE IN A CORPORATION
THAT IS LISTED FOR TRADING ON THE NEW YORK  STOCK  EXCHANGE  OR  ON  THE
AMERICAN  STOCK EXCHANGE, OR IS A NATIONAL MARKET SYSTEM SECURITY TRADED
UNDER AN AUTOMATED INTERDEALER QUOTATION SYSTEM OPERATED BY THE NATIONAL
ASSOCIATION OF SECURITIES DEALERS, AND HAD, AT THE  END  OF  THE  CORPO-
RATION'S  MOST  RECENT  FISCAL  YEAR, TOTAL ASSETS EXCEEDING ONE HUNDRED
MILLION DOLLARS.
  9. "CONTINUING PROFESSIONAL EDUCATION MATERIAL" MEANS ANY  INFORMATION
CONCERNING  ANY  ASPECT  OF  THE  PRACTICE OF A PROFESSION REFERENCED IN
SUBDIVISION ONE OF THIS SECTION WHICH IS COMMUNICATED BY ORAL,  WRITTEN,
GRAPHIC,  AUDIO,  VISUAL,  ELECTRONIC OR OTHER MEANS DURING A CONTINUING
PROFESSIONAL EDUCATION PROGRAM AND IS NOT BEING DISSEMINATED  BY  OR  ON
BEHALF  OF  A  MANUFACTURER OR DISTRIBUTOR CONCERNING ONE OR MORE OF ITS
PRODUCTS.
  S 2999-H. REQUIREMENTS FOR CONDUCTING A CONTINUING PROFESSIONAL EDUCA-
TION PROGRAM.  1. IN CONNECTION WITH ANY CONTINUING PROFESSIONAL  EDUCA-
TION PROGRAM CONDUCTED IN THE STATE, A PRESENTER:
  (A)  SHALL NOT KNOWINGLY PRESENT ANY CONTINUING PROFESSIONAL EDUCATION
MATERIALS THAT ARE FALSE OR MISLEADING;
  (B) SHALL NOT REPRESENT,  EXPLICITLY  OR  BY  NOT  DISCLOSING  ANOTHER
AUTHOR,  THAT  HE  OR  SHE WAS THE AUTHOR OF ANY CONTINUING PROFESSIONAL
EDUCATION MATERIALS UNLESS THE PRESENTER HAS  GIVEN  FINAL  APPROVAL  OF
SUCH MATERIALS, HAS PARTICIPATED SUFFICIENTLY IN THE DEVELOPMENT OF SUCH

S. 6015                             7

MATERIALS  TO  TAKE  PUBLIC RESPONSIBILITY FOR THE CONTENT, AND HAS MADE
SUBSTANTIAL CONTRIBUTIONS TO THE INTELLECTUAL CONTENT OF SUCH  MATERIALS
EITHER  IN DRAFTING OR IN CRITICAL REVISION OF SUCH MATERIALS FOR IMPOR-
TANT INTELLECTUAL CONTENT;
  (C)  SHALL  DISCLOSE TO THE PROVIDER ALL FINANCIAL RELATIONSHIPS HE OR
SHE HAS WITH ANY MANUFACTURER OR DISTRIBUTOR, INCLUDING THE NAME OF SUCH
ENTITIES WITH WHICH HE OR SHE HAS A FINANCIAL RELATIONSHIP,  THE  NATURE
OF  THE  RELATIONSHIP, AND THE FAIR MARKET VALUE OF ANYTHING OF ECONOMIC
VALUE THE PRESENTER RECEIVED  DURING  THE  PRECEDING  TWELVE  MONTHS  IN
CONNECTION WITH OR AS A RESULT OF SUCH RELATIONSHIP; AND
  (D)  SHALL DISCLOSE TO THE PROVIDER ANY INFORMATION OR WRITTEN, GRAPH-
IC, AUDIO, VISUAL OR ELECTRONIC MATERIALS OF ANY KIND THAT THE PRESENTER
INTENDS TO COMMUNICATE AT THE CONTINUING PROFESSIONAL EDUCATION  PROGRAM
WHICH ARE EXEMPTED FROM THE DEFINITION OF CONTINUING PROFESSIONAL EDUCA-
TION  MATERIALS BECAUSE THEY ARE BEING DISSEMINATED BY OR ON BEHALF OF A
MANUFACTURER OR DISTRIBUTOR, WHICH INFORMATION OR MATERIALS THE  PRESEN-
TER SHALL DESCRIBE WITH SPECIFICITY.
  2.  IN  CONNECTION  WITH ANY CONTINUING PROFESSIONAL EDUCATION PROGRAM
CONDUCTED IN THE STATE, A PROVIDER:
  (A) SHALL INFORM EVERY PRESENTER  OF  HIS  OR  HER  OBLIGATIONS  UNDER
SUBDIVISION ONE OF THIS SECTION;
  (B)  SHALL ACT PRUDENTLY TO OBTAIN FROM EACH PRESENTER THE INFORMATION
HE OR SHE IS REQUIRED TO DISCLOSE BY PARAGRAPHS (C) AND (D) OF  SUBDIVI-
SION ONE OF THIS SECTION; AND
  (C)  SHALL DISCLOSE TO ALL PERSONS ATTENDING A CONTINUING PROFESSIONAL
EDUCATION PROGRAM:
  (I) THE INFORMATION REQUIRED BY PARAGRAPHS (C) AND (D) OF  SUBDIVISION
ONE OF THIS SECTION THAT EACH PRESENTER AT SUCH PROGRAM HAS DISCLOSED TO
THE PROVIDER; AND
  (II)  THE NATURE OF ANY SUPPORT FOR THE CONTINUING PROFESSIONAL EDUCA-
TION PROGRAM, WHETHER MONETARY OR IN KIND, PROVIDED BY A MANUFACTURER OR
DISTRIBUTOR, AND THE FAIR MARKET VALUE OF ALL SUCH SUPPORT.
  S 2999-I. VIOLATIONS.  THE COMMISSIONER MAY ASSESS A CIVIL PENALTY FOR
VIOLATIONS OF THIS SECTION IN AN AMOUNT THAT  IS,  FOR  A  VIOLATION  OF
SUBDIVISION  ONE  OF  SECTION  TWENTY-NINE HUNDRED NINETY-NINE-H OF THIS
TITLE, NOT MORE THAN TWENTY-FIVE HUNDRED DOLLARS PER VIOLATION AND,  FOR
A   VIOLATION   OF   SUBDIVISION  TWO  OF  SECTION  TWENTY-NINE  HUNDRED
NINETY-NINE-H OF THIS TITLE, NOT MORE  THAN  TEN  THOUSAND  DOLLARS  PER
VIOLATION.
  S  6.  Section  6509  of  the education law is amended by adding a new
subdivision 16 to read as follows:
  (16) A VIOLATION OF SUBDIVISION ONE  OF  SECTION  TWENTY-NINE  HUNDRED
NINETY-NINE-H OF THE PUBLIC HEALTH LAW.
  S  7.  Section  6530  of  the education law is amended by adding a new
subdivision 51 to read as follows:
  51. A VIOLATION OF SUBDIVISION  ONE  OF  SECTION  TWENTY-NINE  HUNDRED
NINETY-NINE-H OF THE PUBLIC HEALTH LAW.
  S  8.  This  act shall take effect January 1, 2011; provided, however,
that
  (a) the commissioner of health is authorized to promulgate such  rules
and regulations as are necessary to implement the provisions of this act
prior to such effective date; and
  (b)  the  amendment  to  article  2-A of the public health law made by
section two of this act shall not affect the repeal of such article  and
shall be deemed repealed therewith.

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Archive: Last Bill Status - In Senate Committee Health Committee

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