201 
against a health care provider, health care organiza-
tion, or the manufacturer, distributor, supplier, mar-
keter, promoter, or seller of a medical product, in-
cluding, but not limited to, third-party claims, cross- 
claims, counter-claims, or contribution claims, which 
are based upon the provision of, use of, or payment 
for (or the failure to provide, use, or pay for) health 
care services or medical products, regardless of the 
theory of liability on which the claim is based, or the 
number of plaintiffs, defendants, or other parties, or 
the number of causes of action. 
(11) HEALTH CARE ORGANIZATION.—The term 
‘‘health care organization’’ means any person or en-
tity which is obligated to provide or pay for health 
benefits under any health plan, including any person 
or entity acting under a contract or arrangement 
with a health care organization to provide or admin-
ister any health benefit. 
(12) HEALTH
CARE
PROVIDER.—The term 
‘‘health care provider’’ means any person or entity 
required by State or Federal laws or regulations to 
be licensed, registered, or certified to provide health 
care services, and being either so licensed, reg-
istered, or certified, or exempted from such require-
ment by other statute or regulation. 
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(13) HEALTH CARE GOODS OR SERVICES.—The 
term ‘‘health care goods or services’’ means any 
goods or services provided by a health care organiza-
tion, provider, or by any individual working under 
the supervision of a health care provider, that relates 
to the diagnosis, prevention, or treatment of any 
human disease or impairment, or the assessment or 
care of the health of human beings. 
(14) MALICIOUS
INTENT
TO
INJURE.—The 
term ‘‘malicious intent to injure’’ means inten-
tionally causing or attempting to cause physical in-
jury other than providing health care goods or serv-
ices. 
(15) MEDICAL PRODUCT.—The term ‘‘medical 
product’’ means a drug, device, or biological product 
intended for humans, and the terms ‘‘drug’’, ‘‘de-
vice’’, and ‘‘biological product’’ have the meanings 
given such terms in sections 201(g)(1) and 201(h) 
of the Federal Food, Drug and Cosmetic Act (21 
U.S.C. 321(g)(1) and (h)) and section 351(a) of the 
Public Health Service Act (42 U.S.C. 262(a)), re-
spectively, including any component or raw material 
used therein, but excluding health care services. 
(16) MEDICAL TREATMENT.—The term ‘‘med-
ical treatment’’ means the provision of any goods or 
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services by a health care provider or by any indi-
vidual working under the supervision of a health 
care provider, that relates to the diagnosis, preven-
tion, or treatment of any human disease or impair-
ment, or the assessment or care of the health of 
human beings. 
(17) 
NONECONOMIC
DAMAGES.—The 
term 
‘‘noneconomic damages’’ means damages for losses 
for physical and emotional pain, suffering, inconven-
ience, physical impairment, mental anguish, dis-
figurement, loss of enjoyment of life, loss of society 
and companionship, loss of consortium, hedonic 
damages, injury to reputation, and any other non-
pecuniary losses. 
(18) PUNITIVE DAMAGES.—The term ‘‘punitive 
damages’’ means damages awarded, for the purpose 
of punishment or deterrence, and not solely for com-
pensatory purposes, against a health care provider, 
health care organization, or a manufacturer, dis-
tributor, or supplier of a medical product. Punitive 
damages are neither economic nor noneconomic 
damages. 
(19) RECOVERY.—The term ‘‘recovery’’ means 
the net sum recovered after deducting any disburse-
ments or costs incurred in connection with prosecu-
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tion or settlement of the claim, including all costs 
paid or advanced by any person. Costs of health care 
incurred by the plaintiff and the attorneys’ office 
overhead costs or charges for legal services are not 
deductible disbursements or costs for such purpose. 
(20) STATE.—The term ‘‘State’’ means each of 
the several States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, 
Guam, American Samoa, the Northern Mariana Is-
lands, the Trust Territory of the Pacific Islands, and 
any other territory or possession of the United 
States, or any political subdivision thereof. 
SEC. 512. EFFECT ON OTHER LAWS. 
(a) VACCINE INJURY.— 
(1) To the extent that title XXI of the Public 
Health Service Act establishes a Federal rule of law 
applicable to a civil action brought for a vaccine-re-
lated injury or death— 
(A) this title does not affect the application 
of the rule of law to such an action; and 
(B) any rule of law prescribed by this title 
in conflict with a rule of law of such title XXI 
shall not apply to such action. 
(2) If there is an aspect of a civil action 
brought for a vaccine-related injury or death to 
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which a Federal rule of law under title XXI of the 
Public Health Service Act does not apply, then this 
title or otherwise applicable law (as determined 
under this title) will apply to such aspect of such ac-
tion. 
(b) OTHER FEDERAL LAW.—Except as provided in 
this section, nothing in this title shall be deemed to affect 
any defense available to a defendant in a health care law-
suit or action under any other provision of Federal law. 
SEC. 
513. 
STATE 
FLEXIBILITY 
AND 
PROTECTION 
OF 
STATES’ RIGHTS. 
(a) HEALTH CARE LAWSUITS.—The provisions gov-
erning health care lawsuits set forth in this title preempt, 
subject to subsections (b) and (c), State law to the extent 
that State law prevents the application of any provisions 
of law established by or under this title. The provisions 
governing health care lawsuits set forth in this title super-
sede chapter 171 of title 28, United States Code, to the 
extent that such chapter— 
(1) provides for a greater amount of damages 
or contingent fees, a longer period in which a health 
care lawsuit may be commenced, or a reduced appli-
cability or scope of periodic payment of future dam-
ages, than provided in this title; or 
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(2) prohibits the introduction of evidence re-
garding collateral source benefits, or mandates or 
permits subrogation or a lien on collateral source 
benefits. 
(b) PROTECTION OF STATES’ RIGHTS AND OTHER 
LAWS.—(1) Any issue that is not governed by any provi-
sion of law established by or under this title (including 
State standards of negligence) shall be governed by other-
wise applicable State or Federal law. 
(2) This title shall not preempt or supersede any 
State or Federal law that imposes greater procedural or 
substantive protections for health care providers and 
health care organizations from liability, loss, or damages 
than those provided by this title or create a cause of ac-
tion. 
(c) STATE FLEXIBILITY.—No provision of this title 
shall be construed to preempt— 
(1) any State law (whether effective before, on, 
or after the date of the enactment of this title) that 
specifies a particular monetary amount of compen-
satory or punitive damages (or the total amount of 
damages) that may be awarded in a health care law-
suit, regardless of whether such monetary amount is 
greater or lesser than is provided for under this title, 
notwithstanding section 4(a); or 
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(2) any defense available to a party in a health 
care lawsuit under any other provision of State or 
Federal law. 
SEC. 514. APPLICABILITY; EFFECTIVE DATE. 
This title shall apply to any health care lawsuit 
brought in a Federal or State court, or subject to an alter-
native dispute resolution system, that is initiated on or 
after the date of the enactment of this title, except that 
any health care lawsuit arising from an injury occurring 
prior to the date of the enactment of this title shall be 
governed by the applicable statute of limitations provisions 
in effect at the time the injury occurred. 
TITLE VI—WELLNESS AND 
PREVENTION 
SEC. 601. PROVIDING FINANCIAL INCENTIVES FOR TREAT-
MENT COMPLIANCE. 
(a) LIMITATION
ON EXCEPTION
FOR WELLNESS 
PROGRAMS UNDER HIPAA DISCRIMINATION RULES.— 
(1) ERISA AMENDMENT.—Section 702(b)(2) of 
the Employee Retirement Income Security Act of 
1974 (29 U.S.C. 1182(b)(2)) is amended by adding 
after and below subparagraph (B) the following: 
‘‘In applying subparagraph (B), a group health plan 
(or a health insurance issuer with respect to health 
insurance coverage) may vary premiums and cost- 
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sharing by up to 50 percent of the value of the bene-
fits under the plan (or coverage) based on participa-
tion (or lack of participation) in a standards-based 
wellness program.’’. 
(2) PHSA AMENDMENT.—Section 2702(b)(2) 
of the Public Health Service Act (42 U.S.C. 300gg– 
1(b)(2)) is amended by adding after and below sub-
paragraph (B) the following: 
‘‘In applying subparagraph (B), a group health plan 
(or a health insurance issuer with respect to health 
insurance coverage) may vary premiums and cost- 
sharing by up to 50 percent of the value of the bene-
fits under the plan (or coverage) based on participa-
tion (or lack of participation) in a standards-based 
wellness program.’’. 
(3) IRC AMENDMENT.—Section 9802(b)(2) of 
the Internal Revenue Code of 1986 is amended by 
adding after and below subparagraph (B) the fol-
lowing: 
‘‘In applying subparagraph (B), a group health plan 
may vary premiums and cost-sharing by up to 50 
percent of the value of the benefits under the plan 
based on participation (or lack of participation) in a 
standards-based wellness program.’’. 
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(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to plan years beginning more 
than 1 year after the date of the enactment of this Act. 
TITLE VII—TRANSPARENCY AND 
INSURANCE REFORM MEASURES 
SEC. 701. RECEIPT AND RESPONSE TO REQUESTS FOR 
CLAIM INFORMATION. 
(a) IN GENERAL.—Title XXVII of the Public Health 
Service Act is amended by inserting after section 2713 the 
following new section: 
‘‘SEC. 2714. RECEIPT AND RESPONSE TO REQUESTS FOR 
CLAIM INFORMATION. 
‘‘(a) REQUIREMENT.— 
‘‘(1) IN GENERAL.—In the case of health insur-
ance coverage offered in connection with a group 
health plan, not later than the 30th day after the 
date a health insurance issuer receives a written re-
quest for a written report of claim information from 
the plan, plan sponsor, or plan administrator, the 
health insurance issuer shall provide the requesting 
party the report, subject to the succeeding provisions 
of this section. 
‘‘(2) EXCEPTION.—The health insurance issuer 
is not obligated to provide a report under this sub-
section regarding a particular employer or group 
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health plan more than twice in any 12-month period 
and is not obligated to provide such a report in the 
case of an employer with fewer than 50 employees. 
‘‘(3) DEADLINE.—A plan, plan sponsor, or plan 
administrator must request a report under this sub-
section before or on the second anniversary of the 
date of termination of coverage under a group health 
plan issued by the health insurance issuer. 
‘‘(b) FORM OF REPORT; INFORMATION TO BE IN-
CLUDED.— 
‘‘(1) IN GENERAL.—A health insurance issuer 
shall provide the report of claim information under 
subsection (a)— 
‘‘(A) in a written report; 
‘‘(B) through an electronic file transmitted 
by secure electronic mail or a file transfer pro-
tocol site; or 
‘‘(C) by making the required information 
available through a secure Web site or Web por-
tal accessible by the requesting plan, plan spon-
sor, or plan administrator. 
‘‘(2) INFORMATION TO BE INCLUDED.—A re-
port of claim information provided under subsection 
(a) shall contain all information available to the 
health insurance issuer that is responsive to the re-
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quest made under such subsection, including, subject 
to subsection (c), protected health information, for 
the 36-month period preceding the date of the report 
or the period specified by subparagraphs (D), (E), 
and (F) of paragraph (3), if applicable, or for the 
entire period of coverage, whichever period is short-
er. 
‘‘(3) REQUIRED
INFORMATION.—Subject to 
subsection (c), a report provided under subsection 
(a) shall include the following: 
‘‘(A) Aggregate paid claims experience by 
month, including claims experience for medical, 
dental, and pharmacy benefits, as applicable. 
‘‘(B) Total premium paid by month. 
‘‘(C) Total number of covered employees 
on a monthly basis by coverage tier, including 
whether coverage was for— 
‘‘(i) an employee only; 
‘‘(ii) an employee with dependents 
only; 
‘‘(iii) an employee with a spouse only; 
or 
‘‘(iv) an employee with a spouse and 
dependents. 
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‘‘(D) The total dollar amount of claims 
pending as of the date of the report. 
‘‘(E) A separate description and individual 
claims report for any individual whose total 
paid claims exceed $15,000 during the 12- 
month period preceding the date of the report, 
including the following information related to 
the claims for that individual— 
‘‘(i) a unique identifying number, 
characteristic, or code for the individual; 
‘‘(ii) the amounts paid; 
‘‘(iii) dates of service; and 
‘‘(iv) applicable procedure codes and 
diagnosis codes. 
‘‘(F) For claims that are not part of the 
information described in a previous subpara-
graph, a statement describing precertification 
requests for hospital stays of 5 days or longer 
that were made during the 30-day period pre-
ceding the date of the report. 
‘‘(c) LIMITATIONS ON DISCLOSURE.— 
‘‘(1) IN GENERAL.—A health insurance issuer 
may not disclose protected health information in a 
report of claim information provided under this sec-
tion if the health insurance issuer is prohibited from 
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disclosing that information under another State or 
Federal law that imposes more stringent privacy re-
strictions than those imposed under Federal law 
under the HIPAA privacy regulations. To withhold 
information in accordance with this subsection, the 
health insurance issuer must— 
‘‘(A) notify the plan, plan sponsor, or plan 
administrator requesting the report that infor-
mation is being withheld; and 
‘‘(B) provide to the plan, plan sponsor, or 
plan administrator a list of categories of claim 
information that the health insurance issuer has 
determined are subject to the more stringent 
privacy restrictions under another State or Fed-
eral law. 
‘‘(2) PROTECTION.—A plan sponsor is entitled 
to receive protected health information under sub-
paragraph (E) and (F) of subsection (b)(3) and sub-
section (d) only after an appropriately authorized 
representative of the plan sponsor makes to the 
health insurance issuer a certification substantially 
similar to the following certification: ‘I hereby certify 
that the plan documents comply with the require-
ments of section 164.504(f)(2) of title 45, Code of 
Federal Regulations, and that the plan sponsor will 
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safeguard and limit the use and disclosure of pro-
tected health information that the plan sponsor may 
receive from the group health plan to perform the 
plan administration functions.’. 
‘‘(3) RESULTS.—A plan sponsor that does not 
provide the certification required by paragraph (2) is 
not entitled to receive the protected health informa-
tion described by subparagraphs (E) and (F) of sub-
section (b)(3) and subsection (d), but is entitled to 
receive a report of claim information that includes 
the information described by subparagraphs (A) 
through (D) of subsection (b)(3). 
‘‘(4) INFORMATION.—In the case of a request 
made under subsection (a) after the date of termi-
nation of coverage, the report must contain all infor-
mation available to the health insurance issuer as of 
the date of the report that is responsive to the re-
quest, including protected health information, and 
including the information described by subsection 
(b)(3), for the period described by subsection (b)(2) 
preceding the date of termination of coverage or for 
the entire policy period, whichever period is shorter. 
Notwithstanding this subsection, the report may not 
include the protected health information described 
by subparagraphs (E) and (F) of subsection (b)(3) 
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unless a certification has been provided in accord-
ance with paragraph (2). 
‘‘(d) REQUEST FOR ADDITIONAL INFORMATION.— 
‘‘(1) REVIEW.—On receipt of the report re-
quired by subsection (a), the plan, plan sponsor, or 
plan administrator may review the report and, not 
later than the 10th day after the date the report is 
received, may make a written request to the health 
insurance issuer for additional information in ac-
cordance with this subsection for specified individ-
uals. 
‘‘(2) REQUEST.—With respect to a request for 
additional information concerning specified individ-
uals for whom claims information has been provided 
under subsection (b)(3)(E), the health insurance 
issuer shall provide additional information on the 
prognosis or recovery if available and, for individuals 
in active case management, the most recent case 
management information, including any future ex-
pected costs and treatment plan, that relate to the 
claims for that individual. 
‘‘(3) RESPONSE.—The health insurance issuer 
must respond to the request for additional informa-
tion under this subsection not later than the 15th 
day after the date of such request unless the re-
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216 
questing plan, plan sponsor, or plan administrator 
agrees to a request for additional time. 
‘‘(4) LIMITATION.—The health insurance issuer 
is not required to produce the report described by 
this subsection unless a certification has been pro-
vided in accordance with subsection (c)(2). 
‘‘(5) COMPLIANCE
WITH
SECTION
DOES
NOT 
CREATE LIABILITY.—A health insurance issuer that 
releases information, including protected health in-
formation, in accordance with this subsection has 
not violated a standard of care and is not liable for 
civil damages resulting from, and is not subject to 
criminal prosecution for, releasing that information. 
‘‘(e) LIMITATION ON PREEMPTION.—Nothing in this 
section is meant to limit States from enacting additional 
laws in addition to the provisions of this section, but not 
in lieu of such provisions. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) The terms ‘employer’, ‘plan administrator’, 
and ‘plan sponsor’ have the meanings given such 
terms in section 3 of the Employee Retirement In-
come Security Act of 1974. 
‘‘(2) The term ‘HIPAA privacy regulations’ has 
the meaning given such term in section 1180(b)(3) 
of the Social Security Act. 
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217 
‘‘(3) The term ‘protected health information’ 
has the meaning given such term under the HIPAA 
privacy regulations.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect on the date of the enact-
ment of this Act. 
TITLE VIII—QUALITY 
SEC. 801. PROHIBITION ON CERTAIN USES OF DATA OB-
TAINED FROM COMPARATIVE EFFECTIVE-
NESS RESEARCH; ACCOUNTING FOR PERSON-
ALIZED MEDICINE AND DIFFERENCES IN PA-
TIENT TREATMENT RESPONSE. 
(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, the Secretary of Health and Human Serv-
ices— 
(1) shall not use data obtained from the con-
duct of comparative effectiveness research, including 
such research that is conducted or supported using 
funds appropriated under the American Recovery 
and Reinvestment Act of 2009 (Public Law 111–5), 
to deny coverage of an item or service under a Fed-
eral health care program (as defined in section 
1128B(f) of the Social Security Act (42 U.S.C. 
1320a–7b(f))); and 
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(2) shall ensure that comparative effectiveness 
research conducted or supported by the Federal 
Government accounts for factors contributing to dif-
ferences in the treatment response and treatment 
preferences of patients, including patient-reported 
outcomes, genomics and personalized medicine, the 
unique needs of health disparity populations, and in-
direct patient benefits. 
(b) CONSULTATION
AND APPROVAL REQUIRED.— 
Nothing the Federal Coordinating Council for Compara-
tive Effectiveness Research finds can be released in final 
form until after consultation with and approved by rel-
evant physician specialty organizations. 
(c) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as affecting the authority of the 
Commissioner of Food and Drugs under the Federal 
Food, Drug, and Cosmetic Act or the Public Health Serv-
ice Act. 
SEC. 
802. 
ESTABLISHMENT 
OF 
PERFORMANCE-BASED 
QUALITY MEASURES. 
Not later than January 1, 2012, the Secretary of 
Health and Human Services shall submit to Congress a 
proposal for a formalized process for the development of 
performance-based quality measures that could be applied 
to physicians’ services under the Medicare program under 
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title XVIII of the Social Security Act. Such proposal shall 
be in concert and agreement with the Physician Consor-
tium for Performance Improvement and shall only utilize 
measures agreed upon by each physician specialty organi-
zation. 
TITLE IX—STATE 
TRANSPARENCY PLAN PORTAL 
SEC. 901. PROVIDING INFORMATION ON HEALTH COV-
ERAGE OPTIONS AND HEALTH CARE PRO-
VIDERS. 
(a) STATE-BASED PORTAL.—A State (by itself or 
jointly with other States) may contract with a private enti-
ty to establish a Health Plan and Provider Portal Web 
site (referred to in this section as a ‘‘plan portal’’) for 
the purposes of providing standardized information— 
(1) on health insurance plans that have been 
certified to be available for purchase in that State; 
and 
(2) on price and quality information on health 
care providers (including physicians, hospitals, and 
other health care institutions). 
(b) PILOT PROGRAM.— 
(1) IN GENERAL.—Not later than 90 days after 
the date of the enactment of this Act the Secretary 
of Health and Human Services shall work with 
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States to establish no later than January 1, 2013, 
consistent with this title, a Web site that will serve 
as a pilot program for a national portal for informa-
tion structured in a manner so individuals may di-
rectly link to the State plan portal for the State in 
which they reside. 
(2) CONTRACTS WITH STATE.—The Secretary 
shall enter into contracts with States, in a number 
and distribution determined by the Secretary, to de-
velop State plan portals that follow the applicable 
standards and regulations under this section. 
(3) COMMON
STANDARDS
FOR
PLAN
POR-
TALS.— 
(A) IN GENERAL.—In connection with such 
Web site, the Secretary shall establish stand-
ards for interoperability and consistency for 
State plan portals so that individuals can access 
and view information in a similar manner on 
plan portals of different States. Such standards 
shall include standard definitions for health in-
surance plan benefits so that individuals can ac-
curately compare health insurance plans within 
such portals and standards for the inclusion of 
information described in subsection (c). 
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(B) CONSULTATION.—The Secretary shall 
consult with a group consisting of a balanced 
representation of the critical stakeholders (in-
cluding States, health insurance issuers, the 
National Association of Insurance Commis-
sioners, qualified health care provider-based en-
tities (including physicians, hospitals, and other 
health care institutions), and a standards devel-
opment organization) to develop such stand-
ards. 
(C) ISSUANCE.— 
(i) IN GENERAL.—Not later than 6 
months after the date of the enactment of 
this Act, the Secretary shall issue, by regu-
lation, after notice and opportunity for 
public comment, standards that are con-
sistent with the recommendations made by 
the group under subparagraph (B). 
(ii) DISSEMINATION.—The Secretary 
shall broadly disseminate the standards so 
issued. 
(D) REVIEW.—One year after the date of 
establishment of the pilot program under this 
subsection, the Secretary, in consultation with 
stakeholder group described in subparagraph 
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222 
(B), shall review the standards established and 
make such changes in such standards as may 
be appropriate. 
(4) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to the Sec-
retary such amounts as may be necessary for— 
(A) the development and operation of the 
national Web site under this subsection; and 
(B) contracts with States under paragraph 
(2) to assist in the development and initial op-
eration of plan portals in accordance with 
standards established under paragraph (3) and 
other applicable provisions of this section. 
(c) INFORMATION IN PLAN PORTALS.—The stand-
ards for plan portals under subsection (b)(3) shall include 
the following: 
(1) HEALTH INSURANCE INFORMATION.—Each 
plan portal shall meet the following requirements 
with respect to information on health insurance 
plans: 
(A) The plan portal shall present complete 
information on the costs and benefits of health 
insurance plans (including information on 
monthly premium, copayments, deductibles, and 
covered benefits) in a uniform manner that— 
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