H. R. 3590—894 
time for dispute resolution, and the availability and price of 
liability insurance. 
‘‘(f) TECHNICAL ASSISTANCE.— 
‘‘(1) IN GENERAL.—The Secretary shall provide technical 
assistance to the States applying for or awarded grants under 
subsection (a). 
‘‘(2) REQUIREMENTS.—Technical assistance under para-
graph (1) shall include— 
‘‘(A) guidance on non-economic damages, including the 
consideration of individual facts and circumstances in 
determining appropriate payment, guidance on identifying 
avoidable injuries, and guidance on disclosure to patients 
of health care errors and adverse events; and 
‘‘(B) the development, in consultation with States, of 
common definitions, formats, and data collection infrastruc-
ture for States receiving grants under this section to use 
in reporting to facilitate aggregation and analysis of data 
both within and between States. 
‘‘(3) USE
OF
COMMON
DEFINITIONS, FORMATS, AND
DATA 
COLLECTION
INFRASTRUCTURE.—States not receiving grants 
under this section may also use the common definitions, for-
mats, and data collection infrastructure developed under para-
graph (2)(B). 
‘‘(g) EVALUATION.— 
‘‘(1) IN GENERAL.—The Secretary, in consultation with the 
review panel established under subsection (d)(2), shall enter 
into a contract with an appropriate research organization to 
conduct an overall evaluation of the effectiveness of grants 
awarded under subsection (a) and to annually prepare and 
submit a report to Congress. Such an evaluation shall begin 
not later than 18 months following the date of implementation 
of the first program funded by a grant under subsection (a). 
‘‘(2) CONTENTS.—The evaluation under paragraph (1) shall 
include— 
‘‘(A) an analysis of the effects of the grants awarded 
under subsection (a) with regard to the measures described 
in paragraph (3); 
‘‘(B) for each State, an analysis of the extent to which 
the alternative developed under subsection (c)(1) is effective 
in meeting the elements described in subsection (c)(2); 
‘‘(C) a comparison among the States receiving grants 
under subsection (a) of the effectiveness of the various 
alternatives developed by such States under subsection 
(c)(1); 
‘‘(D) a comparison, considering the measures described 
in paragraph (3), of States receiving grants approved under 
subsection (a) and similar States not receiving such grants; 
and 
‘‘(E) a comparison, with regard to the measures 
described in paragraph (3), of— 
‘‘(i) States receiving grants under subsection (a); 
‘‘(ii) States that enacted, prior to the date of enact-
ment of the Patient Protection and Affordable Care 
Act, any cap on non-economic damages; and 
‘‘(iii) States that have enacted, prior to the date 
of enactment of the Patient Protection and Affordable 
Care Act, a requirement that the complainant obtain
H. R. 3590—895 
an opinion regarding the merit of the claim, although 
the substance of such opinion may have no bearing 
on whether the complainant may proceed with a case. 
‘‘(3) MEASURES.—The evaluations under paragraph (2) shall 
analyze and make comparisons on the basis of— 
‘‘(A) the nature and number of disputes over injuries 
allegedly caused by health care providers or health care 
organizations; 
‘‘(B) the nature and number of claims in which tort 
litigation was pursued despite the existence of an alter-
native under subsection (a); 
‘‘(C) the disposition of disputes and claims, including 
the length of time and estimated costs to all parties; 
‘‘(D) the medical liability environment; 
‘‘(E) health care quality; 
‘‘(F) patient safety in terms of detecting, analyzing, 
and helping to reduce medical errors and adverse events; 
‘‘(G) patient and health care provider and organization 
satisfaction with the alternative under subsection (a) and 
with the medical liability environment; and 
‘‘(H) impact on utilization of medical services, appro-
priately adjusted for risk. 
‘‘(4) FUNDING.—The Secretary shall reserve 5 percent of 
the amount appropriated in each fiscal year under subsection 
(k) to carry out this subsection. 
‘‘(h) MEDPAC AND MACPAC REPORTS.— 
‘‘(1) MEDPAC.—The Medicare Payment Advisory Commis-
sion shall conduct an independent review of the alternatives 
to current tort litigation that are implemented under grants 
under subsection (a) to determine the impact of such alter-
natives on the Medicare program under title XVIII of the Social 
Security Act, and its beneficiaries. 
‘‘(2) MACPAC.—The Medicaid and CHIP Payment and 
Access Commission shall conduct an independent review of 
the alternatives to current tort litigation that are implemented 
under grants under subsection (a) to determine the impact 
of such alternatives on the Medicaid or CHIP programs under 
titles XIX and XXI of the Social Security Act, and their bene-
ficiaries. 
‘‘(3) REPORTS.—Not later than December 31, 2016, the 
Medicare Payment Advisory Commission and the Medicaid and 
CHIP Payment and Access Commission shall each submit to 
Congress a report that includes the findings and recommenda-
tions of each respective Commission based on independent 
reviews conducted under paragraphs (1) and (2), including an 
analysis of the impact of the alternatives reviewed on the 
efficiency and effectiveness of the respective programs. 
‘‘(i) OPTION TO PROVIDE FOR INITIAL PLANNING GRANTS.—Of 
the funds appropriated pursuant to subsection (k), the Secretary 
may use a portion not to exceed $500,000 per State to provide 
planning grants to such States for the development of demonstration 
project applications meeting the criteria described in subsection 
(c). In selecting States to receive such planning grants, the Secretary 
shall give preference to those States in which State law at the 
time of the application would not prohibit the adoption of an alter-
native to current tort litigation. 
‘‘(j) DEFINITIONS.—In this section:
H. R. 3590—896 
‘‘(1) HEALTH CARE SERVICES.—The term ‘health care serv-
ices’ means any services provided by a health care provider, 
or by any individual working under the supervision of a health 
care provider, that relate to— 
‘‘(A) the diagnosis, prevention, or treatment of any 
human disease or impairment; or 
‘‘(B) the assessment of the health of human beings. 
‘‘(2) HEALTH CARE ORGANIZATION.—The term ‘health care 
organization’ means any individual or entity which is obligated 
to provide, pay for, or administer health benefits under any 
health plan. 
‘‘(3) HEALTH CARE PROVIDER.—The term ‘health care pro-
vider’ means any individual or entity— 
‘‘(A) licensed, registered, or certified under Federal or 
State laws or regulations to provide health care services; 
or 
‘‘(B) required to be so licensed, registered, or certified 
but that is exempted by other statute or regulation. 
‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 
to be appropriated to carry out this section, $50,000,000 for the 
5-fiscal year period beginning with fiscal year 2011. 
‘‘(l) CURRENT STATE EFFORTS TO ESTABLISH ALTERNATIVE TO 
TORT LITIGATION.—Nothing in this section shall be construed to 
limit any prior, current, or future efforts of any State to establish 
any alternative to tort litigation. 
‘‘(m) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed as limiting states’ authority over or responsibility 
for their state justice systems.’’. 
SEC. 10608. EXTENSION OF MEDICAL MALPRACTICE COVERAGE TO 
FREE CLINICS. 
(a) IN GENERAL.—Section 224(o)(1) of the Public Health Service 
Act (42 U.S.C. 233(o)(1)) is amended by inserting after ‘‘to an 
individual’’ the following: ‘‘, or an officer, governing board member, 
employee, or contractor of a free clinic shall in providing services 
for the free clinic,’’. 
(b) EFFECTIVE DATE.—The amendment made by this section 
shall take effect on the date of enactment of this Act and apply 
to any act or omission which occurs on or after that date. 
SEC. 10609. LABELING CHANGES. 
Section 505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)) is amended by adding at the end the following: 
‘‘(10)(A) If the proposed labeling of a drug that is the subject 
of an application under this subsection differs from the listed drug 
due to a labeling revision described under clause (i), the drug 
that is the subject of such application shall, notwithstanding any 
other provision of this Act, be eligible for approval and shall not 
be considered misbranded under section 502 if— 
‘‘(i) the application is otherwise eligible for approval under 
this subsection but for expiration of patent, an exclusivity 
period, or of a delay in approval described in paragraph 
(5)(B)(iii), and a revision to the labeling of the listed drug 
has been approved by the Secretary within 60 days of such 
expiration; 
‘‘(ii) the labeling revision described under clause (i) does 
not include a change to the ‘Warnings’ section of the labeling;
H. R. 3590—897 
‘‘(iii) the sponsor of the application under this subsection 
agrees to submit revised labeling of the drug that is the subject 
of such application not later than 60 days after the notification 
of any changes to such labeling required by the Secretary; 
and 
‘‘(iv) such application otherwise meets the applicable 
requirements for approval under this subsection. 
‘‘(B) If, after a labeling revision described in subparagraph 
(A)(i), the Secretary determines that the continued presence in 
interstate commerce of the labeling of the listed drug (as in effect 
before the revision described in subparagraph (A)(i)) adversely 
impacts the safe use of the drug, no application under this sub-
section shall be eligible for approval with such labeling.’’. 
Subtitle G—Provisions Relating to Title 
VIII 
SEC. 10801. PROVISIONS RELATING TO TITLE VIII. 
(a) Title XXXII of the Public Health Service Act, as added 
by section 8002(a)(1), is amended— 
(1) in section 3203— 
(A) in subsection (a)(1), by striking subparagraph (E); 
(B) in subsection (b)(1)(C)(i), by striking ‘‘for enroll-
ment’’ and inserting ‘‘for reenrollment’’; and 
(C) in subsection (c)(1), by striking ‘‘, as part of their 
automatic enrollment in the CLASS program,’’; and 
(2) in section 3204— 
(A) in subsection (c)(2), by striking subparagraph (A) 
and inserting the following: 
‘‘(A) receives wages or income on which there is 
imposed a tax under section 3101(a) or 3201(a) of the 
Internal Revenue Code of 1986; or’’; 
(B) in subsection (d), by striking ‘‘subparagraph (B) 
or (C) of subsection (c)(1)’’ and inserting ‘‘subparagraph 
(A) or (B) of subsection (c)(2)’’; 
(C) in subsection (e)(2)(A), by striking ‘‘subparagraph 
(A)’’ and inserting ‘‘paragraph (1)’’; and 
(D) in subsection (g)(1), by striking ‘‘has elected to 
waive enrollment’’ and inserting ‘‘has not enrolled’’. 
(b) Section 8002 of this Act is amended in the heading for 
subsection (d), by striking ‘‘INFORMATION ON SUPPLEMENTAL COV-
ERAGE’’ and inserting ‘‘CLASS PROGRAM INFORMATION’’. 
(c) Section 6021(d)(2)(A)(iv) of the Deficit Reduction Act of 
2005, as added by section 8002(d) of this Act, is amended by 
striking ‘‘and coverage available’’ and all that follows through ‘‘that 
program,’’. 
Subtitle H—Provisions Relating to Title IX 
SEC. 10901. MODIFICATIONS TO EXCISE TAX ON HIGH COST EMPLOYER- 
SPONSORED HEALTH COVERAGE. 
(a) LONGSHORE WORKERS TREATED AS EMPLOYEES ENGAGED 
IN HIGH-RISK PROFESSIONS.—Paragraph (3) of section 4980I(f) of 
the Internal Revenue Code of 1986, as added by section 9001 
of this Act, is amended by inserting ‘‘individuals whose primary