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civil money penalty) shall apply to a 
civil money penalty under this clause 
in the same manner as such provi-
sions apply to a penalty or proceeding 
under section 1128A(a).’’. 
(B) CONFORMING
AMENDMENT.—Section 
1919(h)(8) of the Social Security Act (42 
U.S.C. 1396r(h)(5)(8)) is amended by inserting 
‘‘and in paragraph (3)(C)(ii)’’ after ‘‘paragraph 
(2)(A)’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 1 year after the date of the 
enactment of this Act. 
SEC. 1422. NATIONAL INDEPENDENT MONITOR PILOT PRO-
GRAM. 
(a) ESTABLISHMENT.— 
(1) IN GENERAL.—The Secretary, in consulta-
tion with the Inspector General of the Department 
of Health and Human Services, shall establish a 
pilot program (in this section referred to as the 
‘‘pilot program’’) to develop, test, and implement use 
of an independent monitor to oversee interstate and 
large intrastate chains of skilled nursing facilities 
and nursing facilities. 
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(2) SELECTION.—The Secretary shall select 
chains of skilled nursing facilities and nursing facili-
ties described in paragraph (1) to participate in the 
pilot program from among those chains that submit 
an application to the Secretary at such time, in such 
manner, and containing such information as the Sec-
retary may require. 
(3) DURATION.—The Secretary shall conduct 
the pilot program for a 2-year period. 
(4) IMPLEMENTATION.—The Secretary shall 
implement the pilot program not later than one year 
after the date of the enactment of this Act. 
(b) REQUIREMENTS.—The Secretary shall evaluate 
chains selected to participate in the pilot program based 
on criteria selected by the Secretary, including where evi-
dence suggests that one or more facilities of the chain are 
experiencing serious safety and quality of care problems. 
Such criteria may include the evaluation of a chain that 
includes one or more facilities participating in the ‘‘Special 
Focus Facility’’ program (or a successor program) or one 
or more facilities with a record of repeated serious safety 
and quality of care deficiencies. 
(c) RESPONSIBILITIES OF THE INDEPENDENT MON-
ITOR.—An independent monitor that enters into a con-
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tract with the Secretary to participate in the conduct of 
such program shall— 
(1) conduct periodic reviews and prepare root- 
cause quality and deficiency analyses of a chain to 
assess if facilities of the chain are in compliance 
with State and Federal laws and regulations applica-
ble to the facilities; 
(2) undertake sustained oversight of the chain, 
whether publicly or privately held, to involve the 
owners of the chain and the principal business part-
ners of such owners in facilitating compliance by fa-
cilities of the chain with State and Federal laws and 
regulations applicable to the facilities; 
(3) analyze the management structure, distribu-
tion of expenditures, and nurse staffing levels of fa-
cilities of the chain in relation to resident census, 
staff turnover rates, and tenure; 
(4) report findings and recommendations with 
respect to such reviews, analyses, and oversight to 
the chain and facilities of the chain, to the Secretary 
and to relevant States; and 
(5) publish the results of such reviews, anal-
yses, and oversight. 
(d) IMPLEMENTATION OF RECOMMENDATIONS.— 
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(1) RECEIPT OF FINDING BY CHAIN.—Not later 
than 10 days after receipt of a finding of an inde-
pendent monitor under subsection (c)(4), a chain 
participating in the pilot program shall submit to 
the independent monitor a report— 
(A) outlining corrective actions the chain 
will take to implement the recommendations in 
such report; or 
(B) indicating that the chain will not im-
plement such recommendations and why it will 
not do so. 
(2) RECEIPT
OF
REPORT
BY
INDEPENDENT 
MONITOR.—Not later than 10 days after the date of 
receipt of a report submitted by a chain under para-
graph (1), an independent monitor shall finalize its 
recommendations and submit a report to the chain 
and facilities of the chain, the Secretary, and the 
State (or States) involved, as appropriate, containing 
such final recommendations. 
(e) COST OF APPOINTMENT.—A chain shall be re-
sponsible for a portion of the costs associated with the 
appointment of independent monitors under the pilot pro-
gram. The chain shall pay such portion to the Secretary 
(in an amount and in accordance with procedures estab-
lished by the Secretary). 
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(f) WAIVER AUTHORITY.—The Secretary may waive 
such requirements of titles XVIII and XIX of the Social 
Security Act (42 U.S.C. 1395 et seq.; 1396 et seq.) as 
may be necessary for the purpose of carrying out the pilot 
program. 
(g) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section. 
(h) DEFINITIONS.—In this section: 
(1) FACILITY.—The term ‘‘facility’’ means a 
skilled nursing facility or a nursing facility. 
(2) NURSING
FACILITY.—The term ‘‘nursing 
facility’’ has the meaning given such term in section 
1919(a) of the Social Security Act (42 U.S.C. 
1396r(a)). 
(3) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services, acting 
through the Assistant Secretary for Planning and 
Evaluation. 
(4) SKILLED
NURSING
FACILITY.—The term 
‘‘skilled nursing facility’’ has the meaning given such 
term in section 1819(a) of the Social Security Act 
(42 U.S.C. 1395(a)). 
(i) EVALUATION AND REPORT.— 
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(1) EVALUATION.—The Inspector General of 
the Department of Health and Human Services shall 
evaluate the pilot program. Such evaluation shall— 
(A) determine whether the independent 
monitor program should be established on a 
permanent basis; and 
(B) if the Inspector General determines 
that the independent monitor program should 
be established on a permanent basis, rec-
ommend appropriate procedures and mecha-
nisms for such establishment. 
(2) REPORT.—Not later than 180 days after 
the completion of the pilot program, the Inspector 
General shall submit to Congress and the Secretary 
a report containing the results of the evaluation con-
ducted under paragraph (1), together with rec-
ommendations for such legislation and administra-
tive action as the Inspector General determines ap-
propriate. 
SEC. 1423. NOTIFICATION OF FACILITY CLOSURE. 
(a) SKILLED NURSING FACILITIES.— 
(1) IN GENERAL.—Section 1819(c) of the So-
cial Security Act (42 U.S.C. 1395i–3(c)) is amended 
by adding at the end the following new paragraph: 
‘‘(7) NOTIFICATION OF FACILITY CLOSURE.— 
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‘‘(A) IN GENERAL.—Any individual who is 
the administrator of a skilled nursing facility 
must— 
‘‘(i) submit to the Secretary, the State 
long-term care ombudsman, residents of 
the facility, and the legal representatives of 
such residents or other responsible parties, 
written notification of an impending clo-
sure— 
‘‘(I) subject to subclause (II), not 
later than the date that is 60 days 
prior to the date of such closure; and 
‘‘(II) in the case of a facility 
where the Secretary terminates the fa-
cility’s participation under this title, 
not later than the date that the Sec-
retary determines appropriate; 
‘‘(ii) ensure that the facility does not 
admit any new residents on or after the 
date on which such written notification is 
submitted; and 
‘‘(iii) include in the notice a plan for 
the transfer and adequate relocation of the 
residents of the facility by a specified date 
prior to closure that has been approved by 
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the State, including assurances that the 
residents will be transferred to the most 
appropriate facility or other setting in 
terms of quality, services, and location, 
taking into consideration the needs and 
best interests of each resident. 
‘‘(B) RELOCATION.— 
‘‘(i) IN
GENERAL.—The State shall 
ensure that, before a facility closes, all 
residents of the facility have been success-
fully relocated to another facility or an al-
ternative home and community-based set-
ting. 
‘‘(ii) CONTINUATION
OF
PAYMENTS 
UNTIL RESIDENTS RELOCATED.—The Sec-
retary may, as the Secretary determines 
appropriate, continue to make payments 
under this title with respect to residents of 
a facility that has submitted a notification 
under subparagraph (A) during the period 
beginning on the date such notification is 
submitted and ending on the date on which 
the resident is successfully relocated.’’. 
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(2) 
CONFORMING
AMENDMENTS.—Section 
1819(h)(4) of the Social Security Act (42 U.S.C. 
1395i–3(h)(4)) is amended— 
(A) in the first sentence, by striking ‘‘the 
Secretary shall terminate’’ and inserting ‘‘the 
Secretary, subject to subsection (c)(7), shall 
terminate’’; and 
(B) in the second sentence, by striking 
‘‘subsection (c)(2)’’ and inserting ‘‘paragraphs 
(2) and (7) of subsection (c)’’. 
(b) NURSING FACILITIES.— 
(1) IN GENERAL.—Section 1919(c) of the So-
cial Security Act (42 U.S.C. 1396r(c)) is amended 
by adding at the end the following new paragraph: 
‘‘(9) NOTIFICATION OF FACILITY CLOSURE.— 
‘‘(A) IN GENERAL.—Any individual who is 
an administrator of a nursing facility must— 
‘‘(i) submit to the Secretary, the State 
long-term care ombudsman, residents of 
the facility, and the legal representatives of 
such residents or other responsible parties, 
written notification of an impending clo-
sure— 
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‘‘(I) subject to subclause (II), not 
later than the date that is 60 days 
prior to the date of such closure; and 
‘‘(II) in the case of a facility 
where the Secretary terminates the fa-
cility’s participation under this title, 
not later than the date that the Sec-
retary determines appropriate; 
‘‘(ii) ensure that the facility does not 
admit any new residents on or after the 
date on which such written notification is 
submitted; and 
‘‘(iii) include in the notice a plan for 
the transfer and adequate relocation of the 
residents of the facility by a specified date 
prior to closure that has been approved by 
the State, including assurances that the 
residents will be transferred to the most 
appropriate facility or other setting in 
terms of quality, services, and location, 
taking into consideration the needs and 
best interests of each resident. 
‘‘(B) RELOCATION.— 
‘‘(i) IN
GENERAL.—The State shall 
ensure that, before a facility closes, all 
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residents of the facility have been success-
fully relocated to another facility or an al-
ternative home and community-based set-
ting. 
‘‘(ii) CONTINUATION
OF
PAYMENTS 
UNTIL RESIDENTS RELOCATED.—The Sec-
retary may, as the Secretary determines 
appropriate, continue to make payments 
under this title with respect to residents of 
a facility that has submitted a notification 
under subparagraph (A) during the period 
beginning on the date such notification is 
submitted and ending on the date on which 
the resident is successfully relocated.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 1 year after the date of the 
enactment of this Act. 
PART 3—IMPROVING STAFF TRAINING 
SEC. 1431. DEMENTIA AND ABUSE PREVENTION TRAINING. 
(a) 
SKILLED
NURSING
FACILITIES.—Section 
1819(f)(2)(A)(i)(I) of the Social Security Act (42 U.S.C. 
1395i–3(f)(2)(A)(i)(I)) is amended by inserting ‘‘(includ-
ing, in the case of initial training and, if the Secretary 
determines appropriate, in the case of ongoing training, 
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dementia management training and resident abuse preven-
tion training)’’ after ‘‘curriculum’’. 
(b) 
NURSING
FACILITIES.—Section 
1919(f)(2)(A)(i)(I) of the Social Security Act (42 U.S.C. 
1396r(f)(2)(A)(i)(I)) is amended by inserting ‘‘(including, 
in the case of initial training and, if the Secretary deter-
mines appropriate, in the case of ongoing training, demen-
tia management training and resident abuse prevention 
training)’’ after ‘‘curriculum’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 1 year after the date of the 
enactment of this Act. 
SEC. 1432. STUDY AND REPORT ON TRAINING REQUIRED 
FOR CERTIFIED NURSE AIDES AND SUPER-
VISORY STAFF. 
(a) STUDY.— 
(1) IN GENERAL.—The Secretary shall conduct 
a study on the content of training for certified nurse 
aides and supervisory staff of skilled nursing facili-
ties and nursing facilities. The study shall include an 
analysis of the following: 
(A) Whether the number of initial training 
hours for certified nurse aides required under 
sections 
1819(f)(2)(A)(i)(II) 
and 
1919(f)(2)(A)(i)(II) of the Social Security Act 
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(42 
U.S.C. 
1395i–3(f)(2)(A)(i)(II); 
1396r(f)(2)(A)(i)(II)) should be increased from 
75 and, if so, what the required number of ini-
tial training hours should be, including any rec-
ommendations for the content of such training 
(including training related to dementia). 
(B) Whether requirements for ongoing 
training 
under 
such 
sections 
1819(f)(2)(A)(i)(II) and 1919(f)(2)(A)(i)(II) 
should be increased from 12 hours per year, in-
cluding any recommendations for the content of 
such training. 
(2) CONSULTATION.—In conducting the anal-
ysis under paragraph (1)(A), the Secretary shall 
consult with States that, as of the date of the enact-
ment of this Act, require more than 75 hours of 
training for certified nurse aides. 
(3) DEFINITIONS.—In this section: 
(A) NURSING FACILITY.—The term ‘‘nurs-
ing facility’’ has the meaning given such term 
in section 1919(a) of the Social Security Act 
(42 U.S.C. 1396r(a)). 
(B) SECRETARY.—The term ‘‘Secretary’’ 
means the Secretary of Health and Human 
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Services, acting through the Assistant Secretary 
for Planning and Evaluation. 
(C) SKILLED
NURSING
FACILITY.—The 
term ‘‘skilled nursing facility’’ has the meaning 
given such term in section 1819(a) of the Social 
Security Act (42 U.S.C. 1395(a)). 
(b) REPORT.—Not later than 2 years after the date 
of the enactment of this Act, the Secretary shall submit 
to Congress a report containing the results of the study 
conducted under subsection (a), together with rec-
ommendations for such legislation and administrative ac-
tion as the Secretary determines appropriate. 
SEC. 1433. QUALIFICATION OF DIRECTOR OF FOOD SERV-
ICES OF A SKILLED NURSING FACILITY OR 
NURSING FACILITY. 
(a) MEDICARE.—Section 1819(b)(4)(A) of the Social 
Security Act (42 U.S.C. 1395i–3(b)(4)(A)) is amended by 
adding at the end the following: ‘‘With respect to meeting 
the staffing requirement imposed by the Secretary to carry 
out clause (iv), the full-time director of food services of 
the facility, if not a qualified dietitian (as defined in sec-
tion 483.35(a)(2) of title 42, Code of Federal Regulations, 
as in effect as of the date of the enactment of this sen-
tence), shall be a Certified Dietary Manager meeting the 
requirements of the Certifying Board for Dietary Man-
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agers, or a Dietetic Technician, Registered meeting the 
requirements of the Commission on Dietetic Registration 
or have equivalent military, academic, or other qualifica-
tions (as specified by the Secretary).’’. 
(b) MEDICAID.—Section 1919(b)(4)(A) of the Social 
Security Act (42 U.S.C. 1396r(b)(4)(A)) is amended by 
adding at the end the following: ‘‘With respect to meeting 
the staffing requirement imposed by the Secretary to carry 
out clause (iv), the full-time director of food services of 
the facility, if not a qualified dietitian (as defined in sec-
tion 483.35(a)(2) of title 42, Code of Federal Regulations, 
as in effect as of the date of the enactment of this sen-
tence), shall be a Certified Dietary Manager meeting the 
requirements of the Certifying Board for Dietary Man-
agers, or a Dietetic Technician, Registered meeting the 
requirements of the Commission on Dietetic Registration 
or have equivalent military, academic, or other qualifica-
tions (as specified by the Secretary).’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on the date that is 180 days 
after the date of enactment of this Act. 
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Subtitle C—Quality Measurements 
SEC. 1441. ESTABLISHMENT OF NATIONAL PRIORITIES FOR 
QUALITY IMPROVEMENT. 
Title XI of the Social Security Act, as amended by 
section 1401(a), is further amended by adding at the end 
the following new part: 
‘‘PART E—QUALITY IMPROVEMENT 
‘‘ESTABLISHMENT OF NATIONAL PRIORITIES FOR 
PERFORMANCE IMPROVEMENT 
‘‘SEC. 1191. (a) ESTABLISHMENT OF NATIONAL PRI-
ORITIES BY THE SECRETARY.—The Secretary shall estab-
lish and periodically update, not less frequently than tri-
ennially, national priorities for performance improvement. 
‘‘(b) RECOMMENDATIONS
FOR NATIONAL PRIOR-
ITIES.—In establishing and updating national priorities 
under subsection (a), the Secretary shall solicit and con-
sider recommendations from multiple outside stake-
holders. 
‘‘(c) CONSIDERATIONS IN SETTING NATIONAL PRI-
ORITIES.—With respect to such priorities, the Secretary 
shall ensure that priority is given to areas in the delivery 
of health care services in the United States that— 
‘‘(1) contribute to a large burden of disease, in-
cluding those that address the health care provided 
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to patients with prevalent, high-cost chronic dis-
eases; 
‘‘(2) have the greatest potential to decrease 
morbidity and mortality in this country, including 
those that are designed to eliminate harm to pa-
tients; 
‘‘(3) have the greatest potential for improving 
the 
performance, 
affordability, 
and 
patient- 
centeredness of health care, including those due to 
variations in care; 
‘‘(4) address health disparities across groups 
and areas; and 
‘‘(5) have the potential for rapid improvement 
due to existing evidence, standards of care or other 
reasons. 
‘‘(d) DEFINITIONS.—In this part: 
‘‘(1) CONSENSUS-BASED
ENTITY.—The term 
‘consensus-based entity’ means an entity with a con-
tract with the Secretary under section 1890. 
‘‘(2) QUALITY
MEASURE.—The term ‘quality 
measure’ means a national consensus standard for 
measuring the performance and improvement of pop-
ulation health, or of institutional providers of serv-
ices, physicians, and other health care practitioners 
in the delivery of health care services. 
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‘‘(e) FUNDING.— 
‘‘(1) IN GENERAL.—The Secretary shall provide 
for the transfer, from the Federal Hospital Insur-
ance Trust Fund under section 1817 and the Fed-
eral Supplementary Medical Insurance Trust Fund 
under section 1841 (in such proportion as the Sec-
retary determines appropriate), of $2,000,000, for 
the activities under this section for each of the fiscal 
years 2010 through 2014. 
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
For purposes of carrying out the provisions of this 
section, in addition to funds otherwise available, out 
of any funds in the Treasury not otherwise appro-
priated, there are appropriated to the Secretary of 
Health and Human Services $2,000,000 for each of 
the fiscal years 2010 through 2014.’’. 
SEC. 1442. DEVELOPMENT OF NEW QUALITY MEASURES; 
GAO EVALUATION OF DATA COLLECTION 
PROCESS FOR QUALITY MEASUREMENT. 
Part E of title XI of the Social Security Act, as added 
by section 1441, is amended by adding at the end the fol-
lowing new sections: 
‘‘SEC. 1192. DEVELOPMENT OF NEW QUALITY MEASURES. 
‘‘(a) AGREEMENTS WITH QUALIFIED ENTITIES.— 
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‘‘(1) IN GENERAL.—The Secretary shall enter 
into agreements with qualified entities to develop 
quality measures for the delivery of health care serv-
ices in the United States. 
‘‘(2) FORM OF AGREEMENTS.—The Secretary 
may carry out paragraph (1) by contract, grant, or 
otherwise. 
‘‘(3) 
RECOMMENDATIONS
OF
CONSENSUS- 
BASED ENTITY.—In carrying out this section, the 
Secretary shall— 
‘‘(A) seek public input; and 
‘‘(B) take into consideration recommenda-
tions of the consensus-based entity with a con-
tract with the Secretary under section 1890(a). 
‘‘(b) DETERMINATION OF AREAS WHERE QUALITY 
MEASURES ARE REQUIRED.—Consistent with the na-
tional priorities established under this part and with the 
programs administered by the Centers for Medicare & 
Medicaid Services and in consultation with other relevant 
Federal agencies, the Secretary shall determine areas in 
which quality measures for assessing health care services 
in the United States are needed. 
‘‘(c) DEVELOPMENT OF QUALITY MEASURES.— 
‘‘(1) PATIENT-CENTERED
AND
POPULATION- 
BASED
MEASURES.—In entering into agreements 
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under subsection (a), the Secretary shall give pri-
ority to the development of quality measures that 
allow the assessment of— 
‘‘(A) health outcomes, presence of impair-
ment, and functional status of patients; 
‘‘(B) the continuity and coordination of 
care and care transitions for patients across 
providers and health care settings, including 
end of life care; 
‘‘(C) patient experience and patient en-
gagement; 
‘‘(D) the safety, effectiveness, and timeli-
ness of care; 
‘‘(E) health disparities including those as-
sociated with individual race, ethnicity, age, 
gender, place of residence or language; and 
‘‘(F) the efficiency and resource use in the 
provision of care. 
‘‘(2) USE OF FUNDS.—An entity that enters 
into an agreement under subsection (a) shall develop 
quality measures that— 
‘‘(A) to the extent feasible, have the ability 
to be collected through the use of health infor-
mation technologies supporting better delivery 
of health care services; and 
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‘‘(B) are available free of charge to users 
for the use of such measures. 
‘‘(3) AVAILABILITY OF MEASURES.—The Sec-
retary shall make quality measures developed under 
this section available to the public. 
‘‘(4) TESTING OF PROPOSED MEASURES.—The 
Secretary may use amounts made available under 
subsection (f) to fund the testing of proposed quality 
measures by qualified entities. Testing funded under 
this paragraph shall include testing of the feasibility 
and usability of proposed measures. 
‘‘(5) UPDATING
OF
ENDORSED
MEASURES.— 
The Secretary may use amounts made available 
under subsection (f) to fund the updating (and test-
ing, if applicable) by consensus-based entities of 
quality measures that have been previously endorsed 
by such an entity as new evidence is developed, in 
a manner consistent with section 1890(b)(3). 
‘‘(d) QUALIFIED ENTITIES.—Before entering into 
agreements with a qualified entity, the Secretary shall en-
sure that the entity is a public, private, or academic insti-
tution with technical expertise in the area of health quality 
measurement. 
‘‘(e) APPLICATION FOR GRANT.—A grant may be 
made under this section only if an application for the 
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grant is submitted to the Secretary and the application 
is in such form, is made in such manner, and contains 
such agreements, assurances, and information as the Sec-
retary determines to be necessary to carry out this section. 
‘‘(f) FUNDING.— 
‘‘(1) IN GENERAL.—The Secretary shall provide 
for the transfer, from the Federal Hospital Insur-
ance Trust Fund under section 1817 and the Fed-
eral Supplementary Medical Insurance Trust Fund 
under section 1841 (in such proportion as the Sec-
retary determines appropriate), of $25,000,000, to 
the Secretary for purposes of carrying out this sec-
tion for each of the fiscal years 2010 through 2014. 
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
For purposes of carrying out the provisions of this 
section, in addition to funds otherwise available, out 
of any funds in the Treasury not otherwise appro-
priated, there are appropriated to the Secretary of 
Health and Human Services $25,000,000 for each 
of the fiscal years 2010 through 2014. 
‘‘SEC. 1193. GAO EVALUATION OF DATA COLLECTION PROC-
ESS FOR QUALITY MEASUREMENT. 
‘‘(a) GAO EVALUATIONS.—The Comptroller General 
of the United States shall conduct periodic evaluations of 
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the implementation of the data collection processes for 
quality measures used by the Secretary. 
‘‘(b) CONSIDERATIONS.—In carrying out the evalua-
tion under subsection (a), the Comptroller General shall 
determine— 
‘‘(1) whether the system for the collection of 
data for quality measures provides for validation of 
data as relevant and scientifically credible; 
‘‘(2) whether data collection efforts under the 
system use the most efficient and cost-effective 
means in a manner that minimizes administrative 
burden on persons required to collect data and that 
adequately protects the privacy of patients’ personal 
health information and provides data security; 
‘‘(3) whether standards under the system pro-
vide for an appropriate opportunity for physicians 
and other clinicians and institutional providers of 
services to review and correct findings; and 
‘‘(4) the extent to which quality measures are 
consistent with section 1192(c)(1) or result in direct 
or indirect costs to users of such measures. 
‘‘(c) REPORT.—The Comptroller General shall sub-
mit reports to Congress and to the Secretary containing 
a description of the findings and conclusions of the results 
of each such evaluation.’’. 
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SEC. 1443. MULTI-STAKEHOLDER PRE-RULEMAKING INPUT 
INTO SELECTION OF QUALITY MEASURES. 
Section 1808 of the Social Security Act (42 U.S.C. 
1395b–9) is amended by adding at the end the following 
new subsection: 
‘‘(d) MULTI-STAKEHOLDER PRE-RULEMAKING INPUT 
INTO SELECTION OF QUALITY MEASURES.— 
‘‘(1) LIST OF MEASURES.—Not later than De-
cember 1 before each year (beginning with 2011), 
the Secretary shall make public a list of measures 
being considered for selection for quality measure-
ment by the Secretary in rulemaking with respect to 
payment systems under this title beginning in the 
payment year beginning in such year and for pay-
ment systems beginning in the calendar year fol-
lowing such year, as the case may be. 
‘‘(2) CONSULTATION
ON
SELECTION
OF
EN-
DORSED
QUALITY
MEASURES.—A consensus-based 
entity that has entered into a contract under section 
1890 shall, as part of such contract, convene multi- 
stakeholder groups to provide recommendations on 
the selection of individual or composite quality meas-
ures, for use in reporting performance information 
to the public or for use in public health care pro-
grams. 
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‘‘(3) MULTI-STAKEHOLDER INPUT.—Not later 
than February 1 of each year (beginning with 
2011), the consensus-based entity described in para-
graph (2) shall transmit to the Secretary the rec-
ommendations of multi-stakeholder groups provided 
under paragraph (2). Such recommendations shall 
be included in the transmissions the consensus-based 
entity makes to the Secretary under the contract 
provided for under section 1890. 
‘‘(4) REQUIREMENT
FOR
TRANSPARENCY
IN 
PROCESS.— 
‘‘(A) IN
GENERAL.—In convening multi- 
stakeholder groups under paragraph (2) with 
respect to the selection of quality measures, the 
consensus-based entity described in such para-
graph shall provide for an open and transparent 
process for the activities conducted pursuant to 
such convening. 
‘‘(B) SELECTION OF ORGANIZATIONS PAR-
TICIPATING
IN
MULTI-STAKEHOLDER 
GROUPS.—The process under paragraph (2) 
shall ensure that the selection of representatives 
of multi-stakeholder groups includes provision 
for public nominations for, and the opportunity 
for public comment on, such selection. 
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‘‘(5) USE OF INPUT.—The respective proposed 
rule shall contain a summary of the recommenda-
tions made by the multi-stakeholder groups under 
paragraph (2), as well as other comments received 
regarding the proposed measures, and the extent to 
which such proposed rule follows such recommenda-
tions and the rationale for not following such rec-
ommendations. 
‘‘(6) MULTI-STAKEHOLDER GROUPS.—For pur-
poses of this subsection, the term ‘multi-stakeholder 
groups’ means, with respect to a quality measure, a 
voluntary collaborative of organizations representing 
persons interested in or affected by the use of such 
quality measure, such as the following: 
‘‘(A) Hospitals and other institutional pro-
viders. 
‘‘(B) Physicians. 
‘‘(C) Health care quality alliances. 
‘‘(D) Nurses and other health care practi-
tioners. 
‘‘(E) Health plans. 
‘‘(F) Patient advocates and consumer 
groups. 
‘‘(G) Employers. 
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‘‘(H) Public and private purchasers of 
health care items and services. 
‘‘(I) Labor organizations. 
‘‘(J) Relevant departments or agencies of 
the United States. 
‘‘(K) Biopharmaceutical companies and 
manufacturers of medical devices. 
‘‘(L) Licensing, credentialing, and accred-
iting bodies. 
‘‘(7) FUNDING.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
provide for the transfer, from the Federal Hos-
pital Insurance Trust Fund under section 1817 
and the Federal Supplementary Medical Insur-
ance Trust Fund under section 1841 (in such 
proportion as the Secretary determines appro-
priate), of $1,000,000, to the Secretary for pur-
poses of carrying out this subsection for each of 
the fiscal years 2010 through 2014. 
‘‘(B) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—For purposes of carrying out the provi-
sions of this subsection, in addition to funds 
otherwise available, out of any funds in the 
Treasury not otherwise appropriated, there are 
appropriated to the Secretary of Health and 
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Human Services $1,000,000 for each of the fis-
cal years 2010 through 2014.’’. 
SEC. 1444. APPLICATION OF QUALITY MEASURES. 
(a) 
INPATIENT
HOSPITAL
SERVICES.—Section 
1886(b)(3)(B) of such Act (42 U.S.C. 1395ww(b)(3)(B)) 
is amended by adding at the end the following new clause: 
‘‘(x)(I) Subject to subclause (II), for purposes of re-
porting data on quality measures for inpatient hospital 
services furnished during fiscal year 2012 and each subse-
quent fiscal year, the quality measures specified under 
clause (viii) shall be measures selected by the Secretary 
from measures that have been endorsed by the entity with 
a contract with the Secretary under section 1890(a). 
‘‘(II) In the case of a specified area or medical topic 
determined appropriate by the Secretary for which a fea-
sible and practical quality measure has not been endorsed 
by the entity with a contract under section 1890(a), the 
Secretary may specify a measure that is not so endorsed 
as long as due consideration is given to measures that 
have been endorsed or adopted by a consensus organiza-
tion identified by the Secretary. The Secretary shall sub-
mit such a non-endorsed measure to the entity for consid-
eration for endorsement. If the entity considers but does 
not endorse such a measure and if the Secretary does not 
phase-out use of such measure, the Secretary shall include 
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SEC. 1446. QUALITY INDICATORS FOR CARE OF PEOPLE 
WITH ALZHEIMER’S DISEASE. 
(a) QUALITY INDICATORS.—The Secretary of Health 
and Human Services shall develop quality indicators for 
the provision of medical services to people with Alz-
heimer’s disease and other dementias and a plan for im-
plementing the indicators to measure the quality of care 
provided for people with these conditions by physicians, 
hospitals, and other appropriate providers of services and 
suppliers. 
(b) REPORT.—The Secretary shall submit a report to 
the Committees on Energy and Commerce and Ways and 
Means of the United States House of Representatives and 
to the Committees on Finance and Health, Education, 
Labor, and Pensions of the United States Senate not later 
than 24 months after the date of the enactment of this 
Act setting forth the status of their efforts to implement 
the requirements of subsection (a). 
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Subtitle D—Physician Payments 
Sunshine Provision 
SEC. 1451. REPORTS ON FINANCIAL RELATIONSHIPS BE-
TWEEN 
MANUFACTURERS 
AND 
DISTRIBU-
TORS 
OF 
COVERED 
DRUGS, 
DEVICES, 
BIOLOGICALS, 
OR 
MEDICAL 
SUPPLIES 
UNDER MEDICARE, MEDICAID, OR CHIP AND 
PHYSICIANS AND OTHER HEALTH CARE ENTI-
TIES AND BETWEEN PHYSICIANS AND OTHER 
HEALTH CARE ENTITIES. 
(a) IN GENERAL.—Part A of title XI of the Social 
Security Act (42 U.S.C. 1301 et seq.), as amended by sec-
tion 1631(a), is further amended by inserting after section 
1128G the following new section: 
‘‘SEC. 1128H. FINANCIAL REPORTS ON PHYSICIANS’ FINAN-
CIAL RELATIONSHIPS WITH MANUFACTUR-
ERS 
AND 
DISTRIBUTORS 
OF 
COVERED 
DRUGS, DEVICES, BIOLOGICALS, OR MEDICAL 
SUPPLIES UNDER MEDICARE, MEDICAID, OR 
CHIP AND WITH ENTITIES THAT BILL FOR 
SERVICES UNDER MEDICARE. 
‘‘(a) REPORTING OF PAYMENTS OR OTHER TRANS-
FERS OF VALUE.— 
‘‘(1) IN GENERAL.—Except as provided in this 
subsection, not later than March 31, 2011, and an-
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nually thereafter, each applicable manufacturer or 
distributor that provides a payment or other transfer 
of value to a covered recipient, or to an entity or in-
dividual at the request of or designated on behalf of 
a covered recipient, shall submit to the Secretary, in 
such electronic form as the Secretary shall require, 
the following information with respect to the pre-
ceding calendar year: 
‘‘(A) With respect to the covered recipient, 
the recipient’s name, business address, physi-
cian specialty, and national provider identifier. 
‘‘(B) With respect to the payment or other 
transfer of value, other than a drug sample— 
‘‘(i) its value and date; 
‘‘(ii) the name of the related drug, de-
vice, or supply, if available, to the level of 
specificity available; and 
‘‘(iii) a description of its form, indi-
cated (as appropriate for all that apply) 
as— 
‘‘(I) cash or a cash equivalent; 
‘‘(II) in-kind items or services; 
‘‘(III) stock, a stock option, or 
any other ownership interest, divi-
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dend, profit, or other return on invest-
ment; or 
‘‘(IV) any other form (as defined 
by the Secretary). 
‘‘(C) With respect to a drug sample, the 
name, number, date, and dosage units of the 
sample. 
‘‘(2) 
AGGREGATE
REPORTING.—Information 
submitted by an applicable manufacturer or dis-
tributor under paragraph (1) shall include the ag-
gregate amount of all payments or other transfers of 
value provided by the manufacturer or distributor to 
covered recipients (and to entities or individuals at 
the request of or designated on behalf of a covered 
recipient) during the year involved, including all pay-
ments and transfers of value regardless of whether 
such payments or transfer of value were individually 
disclosed. 
‘‘(3) SPECIAL RULE FOR CERTAIN PAYMENTS 
OR
OTHER
TRANSFERS
OF
VALUE.—In the case 
where an applicable manufacturer or distributor pro-
vides a payment or other transfer of value to an en-
tity or individual at the request of or designated on 
behalf of a covered recipient, the manufacturer or 
distributor shall disclose that payment or other 
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transfer of value under the name of the covered re-
cipient. 
‘‘(4) DELAYED
REPORTING
FOR
PAYMENTS 
MADE
PURSUANT
TO
PRODUCT
DEVELOPMENT 
AGREEMENTS.—In the case of a payment or other 
transfer of value made to a covered recipient by an 
applicable manufacturer or distributor pursuant to a 
product development agreement for services fur-
nished in connection with the development of a new 
drug, device, biological, or medical supply, the appli-
cable manufacturer or distributor may report the 
value and recipient of such payment or other trans-
fer of value in the first reporting period under this 
subsection in the next reporting deadline after the 
earlier of the following: 
‘‘(A) The date of the approval or clearance 
of the covered drug, device, biological, or med-
ical supply by the Food and Drug Administra-
tion. 
‘‘(B) Two calendar years after the date 
such payment or other transfer of value was 
made. 
‘‘(5) DELAYED
REPORTING
FOR
PAYMENTS 
MADE PURSUANT TO CLINICAL INVESTIGATIONS.—In 
the case of a payment or other transfer of value 
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made to a covered recipient by an applicable manu-
facturer or distributor in connection with a clinical 
investigation regarding a new drug, device, biologi-
cal, or medical supply, the applicable manufacturer 
or distributor may report as required under this sec-
tion in the next reporting period under this sub-
section after the earlier of the following: 
‘‘(A) The date that the clinical investiga-
tion is registered on the website maintained by 
the National Institutes of Health pursuant to 
section 671 of the Food and Drug Administra-
tion Amendments Act of 2007. 
‘‘(B) Two calendar years after the date 
such payment or other transfer of value was 
made. 
‘‘(6) 
CONFIDENTIALITY.—Information 
de-
scribed in paragraph (4) or (5) shall be considered 
confidential and shall not be subject to disclosure 
under section 552 of title 5, United States Code, or 
any other similar Federal, State, or local law, until 
or after the date on which the information is made 
available to the public under such paragraph. 
‘‘(7) PHYSICIANS
IN
SELF-INSURED
HEALTH 
PLANS.—Nothing in this subsection shall be con-
strued to require the disclosure of a payment or 
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other transfer of value to a physician by a self-in-
sured health plan. 
‘‘(b) REPORTING OF OWNERSHIP INTEREST BY PHY-
SICIANS.— 
‘‘(1) HOSPITALS AND OTHER ENTITIES THAT 
BILL MEDICARE.—Not later than March 31 of each 
year (beginning with 2011), each hospital or other 
health care entity (not including a Medicare Advan-
tage organization) that bills the Secretary under 
part A or part B of title XVIII for services shall re-
port on the ownership shares (other than ownership 
shares described in section 1877(c)) of each physi-
cian who, directly or indirectly, owns an interest in 
the entity. 
‘‘(2) ADDITIONAL
PHYSICIAN
OWNERSHIP.— 
Not later than March 31 of each year (beginning 
with 2011), in addition to the requirement under 
subsection (a)(1), any applicable manufacturer, ap-
plicable group purchasing organization, or applicable 
distributor shall submit to the Secretary, in such 
electronic form as the Secretary shall require, the 
following information regarding any ownership or in-
vestment interest (other than an ownership or in-
vestment interest in a publicly traded security and 
mutual fund, as described in section 1877(c)) held 
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by a physician (or an immediate family member of 
such physician (as defined for purposes of section 
1877(a))) in the applicable manufacturer, applicable 
group purchasing organization or applicable dis-
tributor during the preceding year: 
‘‘(A) The dollar amount invested by each 
physician holding such an ownership or invest-
ment interest. 
‘‘(B) The value and terms of each such 
ownership or investment interest. 
‘‘(C) Any payment or other transfer of 
value provided to a physician holding such an 
ownership or investment interest (or to an enti-
ty or individual at the request of or designated 
on behalf of a physician holding such an owner-
ship or investment interest), including the infor-
mation described in clauses (i) through (iii) of 
paragraph (a)(1)(B), and information described 
in subsection (f)(8)(A) and (f)(8)(B). 
‘‘(D) Any other information regarding the 
ownership or investment interest the Secretary 
determines appropriate. 
‘‘(3) DEFINITIONS.—In this subsection: 
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‘‘(A) PHYSICIAN.—The term ‘physician’ in-
cludes a physician’s immediate family members 
(as defined for purposes of section 1877(a)). 
‘‘(B) APPLICABLE GROUP PURCHASING OR-
GANIZATION.—The term ‘applicable group pur-
chasing organization’ means any organization 
or other entity (as defined by the Secretary) 
that purchases, arranges for, or negotiates the 
purchase of a covered drug, device, biological, 
or medical supply. 
‘‘(4) STUDY OF PRACTICE PATTERNS IN AD-
VANCED DIAGNOSTIC IMAGING AND RADIATION ON-
COLOGY SERVICES.—The Comptroller General of the 
United States shall conduct a study to evaluate the 
extent of use of physician self-referral arrangements 
and the effects of such arrangements on the cost of 
providing advanced diagnostic imaging and radiation 
oncology services to Medicare beneficiaries under 
title XVIII. The study shall be completed and sub-
mitted to Congress not later than July 1, 2011. 
‘‘(c) PUBLIC AVAILABILITY.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish procedures to ensure that, not later than Sep-
tember 30, 2011, and on June 30 of each year be-
ginning thereafter, the information submitted under 
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subsections (a) and (b), other than information re-
gard drug samples, with respect to the preceding 
calendar year is made available through an Internet 
website that— 
‘‘(A) is searchable and is in a format that 
is clear and understandable; 
‘‘(B) contains information that is pre-
sented by the name of the applicable manufac-
turer or distributor, the name of the covered re-
cipient, the business address of the covered re-
cipient, the specialty (if applicable) of the cov-
ered recipient, the value of the payment or 
other transfer of value, the date on which the 
payment or other transfer of value was provided 
to the covered recipient, the form of the pay-
ment or other transfer of value, indicated (as 
appropriate) under subsection (a)(1)(B)(ii), the 
nature of the payment or other transfer of 
value, indicated (as appropriate) under sub-
section (a)(1)(B)(iii), and the name of the cov-
ered drug, device, biological, or medical supply, 
as applicable; 
‘‘(C) contains information that is able to 
be easily aggregated and downloaded; 
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‘‘(D) contains a description of any enforce-
ment actions taken to carry out this section, in-
cluding any penalties imposed under subsection 
(d), during the preceding year; 
‘‘(E) contains background information on 
industry-physician relationships; 
‘‘(F) in the case of information submitted 
with respect to a payment or other transfer of 
value described in subsection (a)(5), lists such 
information separately from the other informa-
tion submitted under subsection (a) and des-
ignates such separately listed information as 
funding for clinical research; 
‘‘(G) contains any other information the 
Secretary determines would be helpful to the 
average consumer; and 
‘‘(H) provides the covered recipient an op-
portunity to submit corrections to the informa-
tion made available to the public with respect to 
the covered recipient. 
‘‘(2) ACCURACY OF REPORTING.—The accuracy 
of the information that is submitted under sub-
sections (a) and (b) and made available under para-
graph (1) shall be the responsibility of the reporting 
entity reporting under subsection (a) or (b), as ap-
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plicable. The Secretary shall establish procedures to 
ensure that the covered recipient is provided with an 
opportunity to submit corrections to the applicable 
reporting entity with regard to information made 
public with respect to the covered recipient and, 
under such procedures, the corrections shall be 
transmitted to the Secretary. 
‘‘(3) SPECIAL RULE FOR DRUG SAMPLES.—In-
formation relating to drug samples provided under 
subsection (a) shall not be made available to the 
public by the Secretary but may be made available 
outside the Department of Health and Human Serv-
ices by the Secretary for research or legitimate busi-
ness purposes pursuant to data use agreements. 
‘‘(4) SPECIAL RULE FOR NATIONAL PROVIDER 
IDENTIFIERS.—Information relating to national pro-
vider identifiers provided under subsection (a) shall 
not be made available to the public by the Secretary 
but may be made available outside the Department 
of Health and Human Services by the Secretary for 
research or legitimate business purposes pursuant to 
data use agreements. 
‘‘(d) PENALTIES FOR NONCOMPLIANCE.— 
‘‘(1) FAILURE TO REPORT.— 
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‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), except as provided in paragraph (2), 
any reporting entity that fails to submit infor-
mation required under subsection (a) or (b), as 
applicable, in a timely manner in accordance 
with regulations promulgated to carry out such 
applicable subsection shall be subject to a civil 
money penalty of not less than $1,000, but not 
more than $10,000, for each payment or other 
transfer of value or ownership or investment in-
terest not reported as required under such sub-
section. Such penalty shall be imposed and col-
lected in the same manner as civil money pen-
alties under subsection (a) of section 1128A are 
imposed and collected under that section. 
‘‘(B) LIMITATION.—The total amount of 
civil money penalties imposed under subpara-
graph (A), with respect to each annual submis-
sion of information under subsection (a) by a 
reporting entity, shall not exceed $150,000. 
‘‘(2) KNOWING FAILURE TO REPORT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), any reporting entity that knowingly 
fails to submit information required under sub-
section (a) or (b), as applicable, in a timely 
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HR 3962 PCS 
manner in accordance with regulations promul-
gated to carry out such applicable subsection, 
shall be subject to a civil money penalty of not 
less 
than 
$10,000, 
but 
not 
more 
than 
$100,000, for each payment or other transfer of 
value or ownership or investment interest not 
reported as required under such subsection. 
Such penalty shall be imposed and collected in 
the same manner as civil money penalties under 
subsection (a) of section 1128A are imposed 
and collected under that section. 
‘‘(B) LIMITATION.—The total amount of 
civil money penalties imposed under subpara-
graph (A) with respect to each annual submis-
sion of information under subsection (a) or (b) 
by an applicable reporting entity shall not ex-
ceed $1,000,000, or, if greater, 0.1 percentage 
of the total annual revenues of the reporting en-
tity. 
‘‘(3) USE OF FUNDS.—Funds collected by the 
Secretary as a result of the imposition of a civil 
money penalty under this subsection shall be used to 
carry out this section. 
‘‘(4) ENFORCEMENT THROUGH STATE ATTOR-
NEYS GENERAL.—The attorney general of a State, 
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SEC. 3102. NATIVE AMERICAN HEALTH AND WELLNESS 
FOUNDATION. 
(a) IN GENERAL.—The Indian Self-Determination 
and Education Assistance Act (25 U.S.C. 450 et seq.) is 
amended by adding at the end the following: 
‘‘TITLE VIII—NATIVE AMERICAN 
HEALTH 
AND 
WELLNESS 
FOUNDATION 
‘‘SEC. 801. DEFINITIONS. 
‘‘In this title: 
‘‘(1) BOARD.—The term ‘Board’ means the 
Board of Directors of the Foundation. 
‘‘(2) 
COMMITTEE.—The 
term 
‘Committee’ 
means the Committee for the Establishment of Na-
tive American Health and Wellness Foundation es-
tablished under section 802(f). 
‘‘(3) FOUNDATION.—The term ‘Foundation’ 
means the Native American Health and Wellness 
Foundation established under section 802. 
‘‘(4) SECRETARY.—The term ‘Secretary’ means 
the Secretary of Health and Human Services. 
‘‘(5) SERVICE.—The term ‘Service’ means the 
Indian Health Service of the Department of Health 
and Human Services. 
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