S.Amdt. 3131

SA 3131. Mr. KOHL (for himself and Mr. Durbin) submitted an amendment
intended to be proposed to amendment SA 2786 proposed by Mr. Reid (for
himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590,
to amend the Internal Revenue Code of 1986 to modify the first-time
homebuyers credit in the case of members of the Armed Forces and
certain other Federal employees, and for other purposes; which was
ordered to lie on the table; as follows:

At the appropriate place, insert the following:

TITLE __--PROHIBITION ON DATA MINING

SEC. _01. PURPOSE.

(a) In General.--It is the purpose of this title to--
(1) safeguard the confidentiality of prescribing
information;
(2) protect the integrity of the doctor-patient
relationship;
(3) maintain the integrity and public trust in the medical
profession;
(4) combat vexatious and harassing sales practices;
(5) restrain undue influence exerted by pharmaceutical
industry marketing representatives over prescribing
decisions; and
(6) improve the quality and lower the cost of health care.
(b) Rule of Construction.--Nothing in this title shall be
construed to regulate the monitoring of prescribing practices
for uses other than marketing (such as quality control,
research unrelated to marketing, or use by governments or
other entities not in the business of selling health care
products).

SEC. _02. DEFINITIONS.

In this title:
(1) Bona fide clinical trial.--The term ``bona fide
clinical trial'' means any research project that--
(A) prospectively assigns human subjects to intervention
and comparison groups to study the cause and effect
relationship between a medical intervention and a health
outcome;
(B) has received approval from an appropriate Institutional
Review Board; and
(C) has been registered at ClinicalTrials.Gov prior to
commencement.
(2) Company making or selling prescribed products.--The
term ``company making or selling prescribed products'' means
a pharmacy, a pharmacy benefit manager, a pharmaceutical
manufacturer, pharmaceutical wholesaler, or any other entity
whose primary purpose is the marketing of pharmaceutical
product for financial gain. Such term does not include health
plans, health care providers, or State or Federal public
health programs and research organizations.
(3) Individual identifying information.--The term
``individual identifying information'' means information that
directly or indirectly identifies a prescriber or a patient,
where the information is derived from or relates to a
prescription for any prescribed product.
(4) Health care provider.--The term ``health care
provider'' means a provider of services (as defined in
section 1861(u) of the Act, 42 U.S.C. 1395x(u)), a provider
of medical or health services (as defined in section 1861(s)
of the Act, 42 U.S.C. 1395x(s)), and any other person or
organization who furnishes, bills, or is paid for health care
in the normal course of business.
(5) Health plan.--

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(A) In general.--The term ``health plan'' means an
individual or group plan that provides, or pays the cost of,
medical care (as defined in section 2791(a)(2) of the Public
Health Service Act (42 U.S.C. 300gg-91(a)(2))). Such term
includes the following (singly or in combination):
(i) A group health plan, as defined in section 2791 of the
Public Health Service Act (42 U.S.C. 300gg-91).
(ii) A health insurance issuer, as defined in section 2791
of the Public Health Service Act (42 U.S.C. 300gg-91).
(iii) A health maintenance organization, as defined in
section 2791 of the Public Health Service Act (42 U.S.C.
300gg-91).
(iv) Part A or part B of the Medicare program under title
XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).
(v) The Medicaid program under title XIX of the Act, 42
U.S.C. 1396, et seq.
(vi) An issuer of a Medicare supplemental policy (as
defined in section 1882(g)(1) of the Act, 42 U.S.C.
1395ss(g)(1))).
(vii) An issuer of a long-term care policy, excluding a
nursing home fixed-indemnity policy.
(viii) An employee welfare benefit plan or any other
arrangement that is established or maintained for the purpose
of offering or providing health benefits to the employees of
two or more employers.
(ix) The health care program for active military personnel
under title 10, United States Code.
(x) The veterans health care program under chapter 17 of
title 38, United States Code.
(xi) The Civilian Health and Medical Program of the
Uniformed Services (CHAMPUS) (as defined in section 1072(4)
of title 10, United States Code).
(xii) The Indian Health Service program under the Indian
Health Care Improvement Act (25 U.S.C. 1601, et seq).
(xiii) The Federal Employees Health Benefits Program under
chapter 89 of title 5, United States Code.
(xiv) An approved State child health plan under title XXI
of the Social Security Act, providing benefits for child
health assistance that meet the requirements of section 2103
of such Act (42 U.S.C. 1397, et seq).
(xv) The Medicare+Choice program under Part C of title
XVIII of the Social Security Act (42 U.S.C. 1395w-21 et
seq.).
(xvi) A high risk pool that is a mechanism established
under State law to provide health insurance coverage or
comparable coverage to eligible individuals.
(xvii) Any other individual or group plan, or combination
of individual or group plans, that provides or pays for the
cost of medical care (as defined in section 2791(a)(2) of the
Public Health Service Act (42 U.S.C. 300gg-91(a)(2))).
(B) Limitation.--Such terms shall not include the
following:
(i) Any policy, plan, or program to the extent that it
provides, or pays for the cost of, excepted benefits that are
listed in section 2791(c)(1) of the Public Health Service Act
(42 U.S.C. 300gg-91(c)(1)).
(ii) A government-funded program (other than a program
listed in clauses (i) through (xvi) of subparagraph (A)--

(I) whose principal purpose is other than providing, or
paying the cost of, health care; or
(II) whose principal activity is--

(aa) the direct provision of health care to persons; or
(bb) the making of grants to fund the direct provision of
health care to persons.
(6) Marketing.--The term ``marketing'' means any activity
advertising, promoting, or selling a prescribed product for
commercial gain, including--
(A) identifying individuals to receive a message promoting
use of a particular product;
(B) identifying individuals to receive any form of gift,
product sample, consultancy, or any other item, service,
compensation or employment of value;
(C) planning the substance of a sales representative visit
or communication or the substance of an advertisement or
other promotional message or document; or
(D) evaluating or compensating sales representatives.
(7) Person.--The term ``person'' means a natural person,
trust or estate, partnership, corporation, professional
association or corporation, or other entity, public or
private.
(8) Pharmacy.--The term ``pharmacy'' means any person
licensed under State or Federal law to dispense prescribed
products.
(9) Prescribed product.--The term ``prescribed product''
includes a biological product as defined in section 351 of
the Public Health Service Act (42 U.S.C. 262) and a device or
a drug as defined in section 201 of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 321).
(10) Regulated record.--The term ``regulated record'' means
information or documentation from a prescription.

SEC. _03. PRIVACY PROTECTIONS.

(a) Prohibition.--No company or person in possession of
regulated records, or their agents, or those acting on their
behalf shall knowingly disclose, sell, or use regulated
records containing individual identifying information for
marketing a prescribed product.
(b) Permitted Transfers.--A regulated record containing
individual identifying information may be transferred to
another entity, including to another branch or subsidiary of
the same entity, only if the transfer provides satisfactory
assurance that the recipient will safeguard the records from
being disclosed or used for a marketing purpose prohibited
under this section.
(c) Permitted Uses.--
(1) In general.--Regulated records containing individual
identifying information may be disclosed, sold, transferred,
exchanged, or used for any purpose other than marketing a
prescribed product, including--
(A) to fill a valid prescription, including communication
by a pharmacist about patient safety or generic substitution,
or in response to patient or physician questions about a
medication, as well as any transfer necessary for billing or
pharmacy reimbursement;
(B) to conduct of a bona fide clinical trial;
(C) to disseminate safety warnings, labeling changes, risk
evaluation and mitigation strategies (REMS) compliance
communications, or to facilitate adverse event reporting, or
to otherwise implement a REMS;
(D) for the purposes of academic detailing or public health
communications;
(E) for the administration of a patient's health insurance
or benefits plan, including determining compliance with the
terms of coverage or medical necessity; or
(F) to comply with existing State or Federal law.
(2) Rules of construction.--This section shall not be
construed to--
(A) prohibit any communication between a health care
provider and patients under his or her care, or any
communication between health care providers for the purpose
of patient care;
(B) prohibit the use of data by a health plan or a pharmacy
benefit manager where such plan or manager is acting in the
fiduciary interest of such organizations, for purposes of
planning, conducting, or evaluating formulary compliance or
quality assurance program based on evidence based prescribing
or cost-containment goals;
(C) prohibit conduct that involves the collection, use,
transfer, or sale of regulated records for marketing purposes
if--
(i) the data involved does not contain individually
identifying information; and
(ii) there is no reasonable basis to believe that the data
can be used to obtain individually identifying information;
and
(D) prevent any person from disclosing regulated records to
the identified individual as long as the information does not
include protected information pertaining to any other person.
(d) Regulations.--The Attorney General may promulgate
regulations as necessary to implement this title.
(e) Enforcement.--Any person who knowingly fails to comply
with the requirements of this title, or regulations
promulgated pursuant to this title, by using or disclosing
regulated records in a manner not authorized by this title,
or regulations, shall be subject to an civil penalty of at
least $10,000, and not more than $50,000, per violation, as
assessed by the Attorney General. Each disclosure of a
regulated record shall constitute a violation of this title.
The Attorney General shall take necessary action to enforce
the payment of penalties assessed under this section.

SEC. _04. SEVERABILITY.

If any provision of this title, or its application to any
person or circumstance, is held invalid, the remainder of
this title, or the application of the provision, to other
persons or circumstances shall not be affected.

SEC. _05. NO EFFECT ON TRUTHFUL SPEECH TO DOCTORS OR
PATIENTS.

Nothing in this title shall be construed to regulate the
content, time, place, or manner of any discussion between a
prescriber and their patient, or a prescriber and any person
representing a prescription drug manufacturer.
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