443 
TITLE 
III—PROMOTING 
PRI-
MARY 
CARE, 
MENTAL 
HEALTH SERVICES, AND CO-
ORDINATED CARE 
SEC. 1301. ACCOUNTABLE CARE ORGANIZATION PILOT 
PROGRAM. 
Title XVIII of the Social Security Act is amended by 
inserting after section 1866C the following new section: 
‘‘ACCOUNTABLE CARE ORGANIZATION PILOT PROGRAM 
‘‘SEC. 1866D. (a) IN GENERAL.—The Secretary shall 
conduct a pilot program (in this section referred to as the 
‘pilot program’) to test different payment incentive mod-
els, including (to the extent practicable) the specific pay-
ment incentive models described in subsection (c), de-
signed to reduce the growth of expenditures and improve 
health outcomes in the provision of items and services 
under this title to applicable beneficiaries (as defined in 
subsection (d)) by qualifying accountable care organiza-
tions (as defined in subsection (b)(1)) in order to— 
‘‘(1) promote accountability for a patient popu-
lation and coordinate items and services under parts 
A and B; 
‘‘(2) encourage investment in infrastructure and 
redesigned care processes for high quality and effi-
cient service delivery; and 
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‘‘(3) reward physician practices and other phy-
sician organizational models for the provision of high 
quality and efficient health care services. 
‘‘(b) QUALIFYING ACCOUNTABLE CARE ORGANIZA-
TIONS (ACOS).— 
‘‘(1) QUALIFYING ACO DEFINED.—In this sec-
tion: 
‘‘(A) IN GENERAL.—The terms ‘qualifying 
accountable care organization’ and ‘qualifying 
ACO’ mean a group of physicians or other phy-
sician organizational model (as defined in sub-
paragraph (D)) that— 
‘‘(i) is organized at least in part for 
the purpose of providing physicians’ serv-
ices; and 
‘‘(ii) meets such criteria as the Sec-
retary determines to be appropriate to par-
ticipate in the pilot program, including the 
criteria specified in paragraph (2). 
‘‘(B) INCLUSION OF OTHER PROVIDERS.— 
Nothing in this subsection shall be construed as 
preventing a qualifying ACO from including a 
hospital or any other provider of services or 
supplier furnishing items or services for which 
payment may be made under this title that is 
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affiliated with the ACO under an arrangement 
structured so that such provider or supplier 
participates in the pilot program and shares in 
any incentive payments under the pilot pro-
gram. 
‘‘(C) PHYSICIAN.—The term ‘physician’ in-
cludes, except as the Secretary may otherwise 
provide, any individual who furnishes services 
for which payment may be made as physicians’ 
services. 
‘‘(D) OTHER PHYSICIAN ORGANIZATIONAL 
MODEL.—The term ‘other physician organiza-
tion model’ means, with respect to a qualifying 
ACO any model of organization under which 
physicians enter into agreements with other 
providers for the purposes of participation in 
the pilot program in order to provide high qual-
ity and efficient health care services and share 
in any incentive payments under such program. 
‘‘(E) OTHER SERVICES.—Nothing in this 
paragraph shall be construed as preventing a 
qualifying ACO from furnishing items or serv-
ices, for which payment may not be made under 
this title, for purposes of achieving performance 
goals under the pilot program. 
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‘‘(2) QUALIFYING CRITERIA.—The following are 
criteria described in this paragraph for an organized 
group of physicians to be a qualifying ACO: 
‘‘(A) The group has a legal structure that 
would allow the group to receive and distribute 
incentive payments under this section. 
‘‘(B) The group includes a sufficient num-
ber of primary care physicians for the applica-
ble beneficiaries for whose care the group is ac-
countable (as determined by the Secretary). 
‘‘(C) The group reports on quality meas-
ures in such form, manner, and frequency as 
specified by the Secretary (which may be for 
the group, for providers of services and sup-
pliers, or both). 
‘‘(D) The group reports to the Secretary 
(in a form, manner and frequency as specified 
by the Secretary) such data as the Secretary 
determines appropriate to monitor and evaluate 
the pilot program. 
‘‘(E) The group provides notice to applica-
ble beneficiaries regarding the pilot program (as 
determined appropriate by the Secretary). 
‘‘(F) The group contributes to a best prac-
tices network or website, that shall be main-
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tained by the Secretary for the purpose of shar-
ing strategies on quality improvement, care co-
ordination, and efficiency that the groups be-
lieve are effective. 
‘‘(G) The group utilizes patient-centered 
processes of care, including those that empha-
size patient and caregiver involvement in plan-
ning and monitoring of ongoing care manage-
ment plan. 
‘‘(H) The group meets other criteria deter-
mined to be appropriate by the Secretary. 
‘‘(c) SPECIFIC PAYMENT INCENTIVE MODELS.—The 
specific payment incentive models described in this sub-
section are the following: 
‘‘(1) PERFORMANCE
TARGET
MODEL.—Under 
the performance target model under this paragraph 
(in this paragraph referred to as the ‘performance 
target model’): 
‘‘(A) IN
GENERAL.—A qualifying ACO 
qualifies to receive an incentive payment if ex-
penditures for applicable beneficiaries are less 
than a target spending level or a target rate of 
growth. The incentive payment shall be made 
only if savings are greater than would result 
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from normal variation in expenditures for items 
and services covered under parts A and B. 
‘‘(B) COMPUTATION
OF
PERFORMANCE 
TARGET.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall establish a performance target for 
each qualifying ACO comprised of a base 
amount (described in clause (ii)) increased 
to the current year by an adjustment fac-
tor (described in clause (iii)). Such a tar-
get may be established on a per capita 
basis, as the Secretary determines to be 
appropriate. 
‘‘(ii) BASE AMOUNT.—For purposes of 
clause (i), the base amount in this sub-
paragraph is equal to the average total 
payments (or allowed charges) under parts 
A and B (and may include part D, if the 
Secretary determines appropriate) for ap-
plicable beneficiaries for whom the quali-
fying ACO furnishes items and services in 
a base period determined by the Secretary. 
Such base amount may be determined on 
a per capita basis. 
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‘‘(iii) 
ADJUSTMENT
FACTOR.—For 
purposes of clause (i), the adjustment fac-
tor in this clause may equal an annual per 
capita amount that reflects changes in ex-
penditures from the period of the base 
amount to the current year that would rep-
resent an appropriate performance target 
for applicable beneficiaries (as determined 
by the Secretary). Such adjustment factor 
may be determined as an amount or rate, 
may be determined on a national, regional, 
local, or organization-specific basis, and 
may be determined on a per capita basis. 
Such adjustment factor also may be ad-
justed for risk as determined appropriate 
by the Secretary. 
‘‘(iv) REBASING.—Under this model 
the Secretary shall periodically rebase the 
base expenditure amount described in 
clause (ii). 
‘‘(C) MEETING TARGET.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), a qualifying ACO that meet or exceeds 
annual quality and performance targets for 
a year shall receive an incentive payment 
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for such year equal to a portion (as deter-
mined appropriate by the Secretary) of the 
amount by which payments under this title 
for such year relative are estimated to be 
below the performance target for such 
year, as determined by the Secretary. The 
Secretary may establish a cap on incentive 
payments for a year for a qualifying ACO. 
‘‘(ii) 
LIMITATION.—The 
Secretary 
shall limit incentive payments to each 
qualifying ACO under this paragraph as 
necessary to ensure that the aggregate ex-
penditures with respect to applicable bene-
ficiaries for such ACOs under this title (in-
clusive of incentive payments described in 
this subparagraph) do not exceed the 
amount that the Secretary estimates would 
be expended for such ACO for such bene-
ficiaries if the pilot program under this 
section were not implemented. 
‘‘(D) REPORTING
AND
OTHER
REQUIRE-
MENTS.—In carrying out such model, the Sec-
retary may (as the Secretary determines to be 
appropriate) 
incorporate 
reporting 
require-
ments, incentive payments, and penalties re-
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lated to the physician quality reporting initia-
tive (PQRI), electronic prescribing, electronic 
health records, and other similar initiatives 
under section 1848, and may use alternative 
criteria than would otherwise apply under such 
section for determining whether to make such 
payments. The incentive payments described in 
this subparagraph shall not be included in the 
limit described in subparagraph (C)(ii) or in the 
performance target model described in this 
paragraph. 
‘‘(2) PARTIAL CAPITATION MODEL.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), a partial capitation model described 
in this paragraph (in this paragraph referred to 
as a ‘partial capitation model’) is a model in 
which a qualifying ACO would be at financial 
risk for some, but not all, of the items and serv-
ices covered under parts A and B, such as at 
risk for some or all physicians’ services or all 
items and services under part B. The Secretary 
may limit a partial capitation model to ACOs 
that are highly integrated systems of care and 
to ACOs capable of bearing risk, as determined 
to be appropriate by the Secretary. 
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‘‘(B) NO ADDITIONAL PROGRAM EXPENDI-
TURES.—Payments to a qualifying ACO for ap-
plicable beneficiaries for a year under the par-
tial capitation model shall be established in a 
manner that does not result in spending more 
for such ACO for such beneficiaries than would 
otherwise be expended for such ACO for such 
beneficiaries for such year if the pilot program 
were not implemented, as estimated by the Sec-
retary. 
‘‘(3) OTHER PAYMENT MODELS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Secretary may develop other 
payment models that meet the goals of this 
pilot program to improve quality and efficiency. 
‘‘(B) NO ADDITIONAL PROGRAM EXPENDI-
TURES.—Subparagraph (B) of paragraph (2) 
shall apply to a payment model under subpara-
graph (A) in a similar manner as such subpara-
graph (B) applies to the payment model under 
paragraph (2). 
‘‘(d) APPLICABLE BENEFICIARIES.— 
‘‘(1) IN GENERAL.—In this section, the term 
‘applicable beneficiary’ means, with respect to a 
qualifying ACO, an individual who— 
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‘‘(A) is enrolled under part B and entitled 
to benefits under part A; 
‘‘(B) is not enrolled in a Medicare Advan-
tage plan under part C or a PACE program 
under section 1894; and 
‘‘(C) meets such other criteria as the Sec-
retary determines appropriate, which may in-
clude criteria relating to frequency of contact 
with physicians in the ACO. 
‘‘(2) 
FOLLOWING
APPLICABLE
BENE-
FICIARIES.—The Secretary may monitor data on ex-
penditures and quality of services under this title 
after an applicable beneficiary discontinues receiving 
services under this title through a qualifying ACO. 
‘‘(e) IMPLEMENTATION.— 
‘‘(1) STARTING DATE.—The pilot program shall 
begin no later than January 1, 2012. An agreement 
with a qualifying ACO under the pilot program may 
cover a multi-year period of between 3 and 5 years. 
‘‘(2) WAIVER.—The Secretary may waive such 
provisions of this title (including section 1877) and 
title XI in the manner the Secretary determines nec-
essary in order implement the pilot program. 
‘‘(3) PERFORMANCE RESULTS REPORTS.—The 
Secretary shall report performance results to quali-
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fying ACOs under the pilot program at least annu-
ally. 
‘‘(4) LIMITATIONS ON REVIEW.—There shall be 
no administrative or judicial review under section 
1869, section 1878, or otherwise of— 
‘‘(A) the elements, parameters, scope, and 
duration of the pilot program; 
‘‘(B) the selection of qualifying ACOs for 
the pilot program; 
‘‘(C) the establishment of targets, meas-
urement of performance, determinations with 
respect to whether savings have been achieved 
and the amount of savings; 
‘‘(D) determinations regarding whether, to 
whom, and in what amounts incentive payments 
are paid; and 
‘‘(E) decisions about the extension of the 
program under subsection (g), expansion of the 
program under subsection (h) or extensions 
under subsection (i). 
‘‘(5) ADMINISTRATION.—Chapter 35 of title 44, 
United States Code shall not apply to this section. 
‘‘(f) EVALUATION; MONITORING.— 
‘‘(1) IN GENERAL.—The Secretary shall evalu-
ate the payment incentive model for each qualifying 
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ACO under the pilot program to assess impacts on 
beneficiaries, providers of services, suppliers and the 
program under this title. The Secretary shall make 
such evaluation publicly available within 60 days of 
the date of completion of such report. 
‘‘(2) MONITORING.—The Inspector General of 
the Department of Health and Human Services shall 
provide for monitoring of the operation of ACOs 
under the pilot program with regard to violations of 
section 1877 (popularly known as the ‘Stark law’). 
‘‘(g) EXTENSION OF PILOT AGREEMENT WITH SUC-
CESSFUL ORGANIZATIONS.— 
‘‘(1) REPORTS TO CONGRESS.—Not later than 
2 years after the date the first agreement is entered 
into under this section, and biennially thereafter for 
six years, the Secretary shall submit to Congress 
and make publicly available a report on the use of 
authorities under the pilot program. Each report 
shall address the impact of the use of those authori-
ties on expenditures, access, and quality under this 
title. 
‘‘(2) EXTENSION.—Subject to the report pro-
vided under paragraph (1), with respect to a quali-
fying ACO, the Secretary may extend the duration 
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of the agreement for such ACO under the pilot pro-
gram as the Secretary determines appropriate if— 
‘‘(A) the ACO receives incentive payments 
with respect to any of the first 4 years of the 
pilot agreement and is consistently meeting 
quality standards; or 
‘‘(B) the ACO is consistently exceeding 
quality standards and is not increasing spend-
ing under the program. 
‘‘(3) TERMINATION.—The Secretary may termi-
nate an agreement with a qualifying ACO under the 
pilot program if such ACO did not receive incentive 
payments or consistently failed to meet quality 
standards in any of the first 3 years under the pro-
gram. 
‘‘(h) EXPANSION TO ADDITIONAL ACOS.— 
‘‘(1) TESTING AND REFINEMENT OF PAYMENT 
INCENTIVE MODELS.—Subject to the evaluation de-
scribed in subsection (f), the Secretary may enter 
into agreements under the pilot program with addi-
tional qualifying ACOs to further test and refine 
payment incentive models with respect to qualifying 
ACOs. 
‘‘(2) EXPANDING USE OF SUCCESSFUL MODELS 
TO PROGRAM IMPLEMENTATION.— 
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‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Secretary may issue regulations 
to implement, on a permanent basis, 1 or more 
models if, and to the extent that, such models 
are beneficial to the program under this title, as 
determined by the Secretary. 
‘‘(B) CERTIFICATION.—The Chief Actuary 
of the Centers for Medicare & Medicaid Serv-
ices shall certify that 1 or more of such models 
described in subparagraph (A) would result in 
estimated spending that would be less than 
what spending would otherwise be estimated to 
be in the absence of such expansion. 
‘‘(i) TREATMENT OF PHYSICIAN GROUP PRACTICE 
DEMONSTRATION.— 
‘‘(1) EXTENSION.—The Secretary may enter in 
to an agreement with a qualifying ACO under the 
demonstration under section 1866A, subject to re-
basing and other modifications deemed appropriate 
by the Secretary, until the pilot program under this 
section is operational. 
‘‘(2) TRANSITION.—For purposes of extension 
of an agreement with a qualifying ACO under sub-
section (g)(2), the Secretary shall treat receipt of an 
incentive payment for a year by an organization 
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under the physician group practice demonstration 
pursuant to section 1866A as a year for which an 
incentive payment is made under such subsection, as 
long as such practice group practice organization 
meets the criteria under subsection (b)(2). 
‘‘(j) ADDITIONAL PROVISIONS.— 
‘‘(1) AUTHORITY
FOR
SEPARATE
INCENTIVE 
ARRANGEMENTS.—The Secretary may create sepa-
rate incentive arrangements (including using mul-
tiple years of data, varying thresholds, varying 
shared savings amounts, and varying shared savings 
limits) for different categories of qualifying ACOs to 
reflect natural variations in data availability, vari-
ation in average annual attributable expenditures, 
program integrity, and other matters the Secretary 
deems appropriate. 
‘‘(2) ENCOURAGEMENT OF PARTICIPATION OF 
SMALLER ORGANIZATIONS.—In order to encourage 
the participation of smaller accountable care organi-
zations under the pilot program, the Secretary may 
limit a qualifying ACO’s exposure to high cost pa-
tients under the program. 
‘‘(3) INVOLVEMENT
IN
PRIVATE
PAYER
AR-
RANGEMENTS.—Nothing in this section shall be con-
strued as preventing qualifying ACOs participating 
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in the pilot program from negotiating similar con-
tracts with private payers. 
‘‘(4) ANTIDISCRIMINATION
LIMITATION.—The 
Secretary shall not enter into an agreement with an 
entity to provide health care items or services under 
the pilot program, or with an entity to administer 
the program, unless such entity guarantees that it 
will not deny, limit, or condition the coverage or pro-
vision of benefits under the program, for individuals 
eligible to be enrolled under such program, based on 
any health status-related factor described in section 
2702(a)(1) of the Public Health Service Act. 
‘‘(5) CONSTRUCTION.—Nothing in this section 
shall be construed to compel or require an organiza-
tion to use an organization-specific target growth 
rate for an accountable care organization under this 
section for purposes of section 1848. 
‘‘(6) FUNDING.—For purposes of administering 
and carrying out the pilot program, other than for 
payments for items and services furnished under this 
title and incentive payments under subsection (c)(1), 
in addition to funds otherwise appropriated, there 
are appropriated to the Secretary for the Center for 
Medicare & Medicaid Services Program Management 
Account $25,000,000 for each of fiscal years 2010 
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through 2014 and $20,000,000 for fiscal year 2015. 
Amounts appropriated under this paragraph for a 
fiscal year shall be available until expended.’’. 
SEC. 1302. MEDICAL HOME PILOT PROGRAM. 
(a) IN GENERAL.—Title XVIII of the Social Security 
Act is amended by inserting after section 1866D, as in-
serted by section 1301, the following new section: 
‘‘MEDICAL HOME PILOT PROGRAM 
‘‘SEC. 1866E. (a) ESTABLISHMENT AND MEDICAL 
HOME MODELS.— 
‘‘(1) ESTABLISHMENT OF PILOT PROGRAM.— 
The Secretary shall establish a medical home pilot 
program (in this section referred to as the ‘pilot pro-
gram’) for the purpose of evaluating the feasibility 
and advisability of reimbursing qualified patient-cen-
tered medical homes for furnishing medical home 
services (as defined under subsection (b)(1)) to high 
need 
beneficiaries 
(as 
defined 
in 
subsection 
(d)(1)(C)) and to targeted high need beneficiaries 
(as defined in subsection (c)(1)(C)). 
‘‘(2) SCOPE.—Subject to subsection (g), the 
pilot program shall include urban, rural, and under-
served areas. 
‘‘(3) MODELS
OF
MEDICAL
HOMES
IN
THE 
PILOT PROGRAM.—The pilot program shall evaluate 
each of the following medical home models: 
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‘‘(A) INDEPENDENT
PATIENT-CENTERED 
MEDICAL HOME MODEL.—Independent patient- 
centered medical home model under subsection 
(c). 
‘‘(B) COMMUNITY-BASED
MEDICAL
HOME 
MODEL.—Community-based 
medical 
home 
model under subsection (d). 
‘‘(4) PARTICIPATION OF NURSE PRACTITIONERS 
AND PHYSICIAN ASSISTANTS.— 
‘‘(A) Nothing in this section shall be con-
strued as preventing a nurse practitioner from 
leading a patient centered medical home so long 
as— 
‘‘(i) all the requirements of this sec-
tion are met; and 
‘‘(ii) the nurse practitioner is acting 
consistently with State law. 
‘‘(B) Nothing in this section shall be con-
strued as preventing a physician assistant from 
participating in a patient centered medical 
home so long as— 
‘‘(i) all the requirements of this sec-
tion are met; and 
‘‘(ii) the physician assistant is acting 
consistently with State law. 
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‘‘(b) DEFINITIONS.—For purposes of this section: 
‘‘(1) 
PATIENT-CENTERED
MEDICAL
HOME 
SERVICES.—The 
term 
‘patient-centered 
medical 
home services’ means services that— 
‘‘(A) provide beneficiaries with direct and 
ongoing access to a primary care or principal 
care by a physician or nurse practitioner who 
accepts responsibility for providing first contact, 
continuous and comprehensive care to such ben-
eficiary; 
‘‘(B) coordinate the care provided to a ben-
eficiary by a team of individuals at the practice 
level across office, institutional and home set-
tings led by a primary care or principal care 
physician or nurse practitioner, as needed and 
appropriate; 
‘‘(C) provide for all the patient’s health 
care needs or take responsibility for appro-
priately arranging care with other qualified pro-
viders for all stages of life; 
‘‘(D) provide continuous access to care and 
communication with participating beneficiaries; 
‘‘(E) provide support for patient self-man-
agement, proactive and regular patient moni-
toring, support for family caregivers, use pa-
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tient-centered processes, and coordination with 
community resources; 
‘‘(F) integrate readily accessible, clinically 
useful information on participating patients 
that enables the practice to treat such patients 
comprehensively and systematically; and 
‘‘(G) implement evidence-based guidelines 
and apply such guidelines to the identified 
needs of beneficiaries over time and with the in-
tensity needed by such beneficiaries. 
‘‘(2) PRIMARY CARE.—The term ‘primary care’ 
means health care that is provided by a physician or 
nurse practitioner who practices in the field of fam-
ily medicine, general internal medicine, geriatric 
medicine, or pediatric medicine. 
‘‘(3) PRINCIPAL
CARE.—The term ‘principal 
care’ means integrated, accessible health care that is 
provided by a physician who is a medical sub-
specialist that addresses the majority of the personal 
health care needs of patients with chronic conditions 
requiring the subspecialist’s expertise, and for whom 
the subspecialist assumes care management. 
‘‘(c) INDEPENDENT PATIENT-CENTERED MEDICAL 
HOME MODEL.— 
‘‘(1) IN GENERAL.— 
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‘‘(A) PAYMENT
AUTHORITY.—Under the 
independent patient-centered medical home 
model under this subsection, the Secretary shall 
make payments for medical home services fur-
nished by an independent patient-centered med-
ical home (as defined in subparagraph (B)) 
pursuant to paragraph (3)(B) for a targeted 
high need beneficiaries (as defined in subpara-
graph (C)). 
‘‘(B) INDEPENDENT
PATIENT-CENTERED 
MEDICAL HOME DEFINED.—In this section, the 
term ‘independent patient-centered medical 
home’ means a physician-directed or nurse- 
practitioner-directed practice that is qualified 
under paragraph (2) as— 
‘‘(i) providing beneficiaries with pa-
tient-centered medical home services; and 
‘‘(ii) meets such other requirements as 
the Secretary may specify. 
‘‘(C) TARGETED HIGH NEED BENEFICIARY 
DEFINED.—For purposes of this subsection, the 
term ‘targeted high need beneficiary’ means a 
high need beneficiary who, based on a risk score 
as specified by the Secretary, is generally within 
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the upper 50th percentile of Medicare bene-
ficiaries. 
‘‘(D) BENEFICIARY ELECTION TO PARTICI-
PATE.—The Secretary shall determine an ap-
propriate method of ensuring that beneficiaries 
have agreed to participate in the pilot program. 
‘‘(E) IMPLEMENTATION.—The pilot pro-
gram under this subsection shall begin no later 
than 6 months after the date of the enactment 
of this section. 
‘‘(2) STANDARD SETTING AND QUALIFICATION 
PROCESS
FOR
PATIENT-CENTERED
MEDICAL 
HOMES.—The Secretary shall review alternative 
models for standard setting and qualification, and 
shall establish a process— 
‘‘(A) to establish standards to enable med-
ical practices to qualify as patient-centered 
medical homes; and 
‘‘(B) to initially provide for the review and 
certification of medical practices as meeting 
such standards. 
‘‘(3) PAYMENT.— 
‘‘(A) 
ESTABLISHMENT
OF
METHOD-
OLOGY.—The Secretary shall establish a meth-
odology for the payment for medical home serv-
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ices furnished by independent patient-centered 
medical homes. Under such methodology, the 
Secretary shall adjust payments to medical 
homes based on beneficiary risk scores to en-
sure that higher payments are made for higher 
risk beneficiaries. 
‘‘(B) PER BENEFICIARY PER MONTH PAY-
MENTS.—Under such payment methodology, the 
Secretary shall pay independent patient-cen-
tered medical homes a monthly fee for each tar-
geted high need beneficiary who consents to re-
ceive medical home services through such med-
ical home. 
‘‘(C) PROSPECTIVE
PAYMENT.—The fee 
under subparagraph (B) shall be paid on a pro-
spective basis. 
‘‘(D) AMOUNT
OF
PAYMENT.—In deter-
mining the amount of such fee, the Secretary 
shall consider the following: 
‘‘(i) The clinical work and practice ex-
penses involved in providing the medical 
home services provided by the independent 
patient-centered medical home (such as 
providing increased access, care coordina-
tion, population disease management, and 
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teaching self-care skills for managing 
chronic illnesses) for which payment is not 
made under this title as of the date of the 
enactment of this section. 
‘‘(ii) Allow for differential payments 
based on capabilities of the independent 
patient-centered medical home. 
‘‘(iii) Use appropriate risk-adjustment 
in determining the amount of the per bene-
ficiary per month payment under this 
paragraph in a manner that ensures that 
higher payments are made for higher risk 
beneficiaries. 
‘‘(4) ENCOURAGING
PARTICIPATION
OF
VARI-
ETY OF PRACTICES.—The pilot program under this 
subsection shall be designed to include the participa-
tion of physicians in practices with fewer than 10 
full-time equivalent physicians, as well as physicians 
in larger practices, particularly in underserved and 
rural areas, as well as federally qualified community 
health centers, and rural health centers. 
‘‘(5) NO
DUPLICATION
IN
PILOT
PARTICIPA-
TION.—A physician in a group practice that partici-
pates in the accountable care organization pilot pro-
gram under section 1866D shall not be eligible to 
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participate in the pilot program under this sub-
section, unless the pilot program under this section 
has been implemented on a permanent basis under 
subsection (e)(3). 
‘‘(d) COMMUNITY-BASED MEDICAL HOME MODEL.— 
‘‘(1) IN GENERAL.— 
‘‘(A) AUTHORITY FOR PAYMENTS.—Under 
the community-based medical home model 
under this subsection (in this section referred to 
as the ‘CBMH model’), the Secretary shall 
make payments for the furnishing of medical 
home services by a community-based medical 
home (as defined in subparagraph (B)) pursu-
ant to paragraph (5)(B) for high need bene-
ficiaries. 
‘‘(B) COMMUNITY-BASED MEDICAL HOME 
DEFINED.—In this section, the term ‘commu-
nity-based medical home’ means a nonprofit 
community-based or State-based organization 
that is certified under paragraph (2) as meeting 
the following requirements: 
‘‘(i) The organization provides bene-
ficiaries with medical home services. 
‘‘(ii) The organization provides med-
ical home services under the supervision of 
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and in close collaboration with the primary 
care or principal care physician or nurse 
practitioner designated by the beneficiary 
as his or her community-based medical 
home provider. 
‘‘(iii) The organization employs com-
munity health workers, including nurses or 
other 
non-physician 
practitioners, 
lay 
health workers, or other persons as deter-
mined appropriate by the Secretary, that 
assist the primary or principal care physi-
cian or nurse practitioner in chronic care 
management activities such as teaching 
self-care skills for managing chronic ill-
nesses, transitional care services, care plan 
setting, medication therapy management 
services for patients with multiple chronic 
diseases, or help beneficiaries access the 
health care and community-based resources 
in their local geographic area. 
‘‘(iv) The organization meets such 
other requirements as the Secretary may 
specify. 
‘‘(C) HIGH NEED BENEFICIARY.—In this 
section, the term ‘high need beneficiary’ means 
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470 
an individual who requires regular medical 
monitoring, advising, or treatment. 
‘‘(2) QUALIFICATION
PROCESS
FOR
COMMU-
NITY-BASED MEDICAL HOMES.—The Secretary shall 
establish a process— 
‘‘(A) for the initial qualification of commu-
nity-based or State-based organizations as com-
munity-based medical homes; and 
‘‘(B) to provide for the review and quali-
fication of such community-based and State- 
based organizations pursuant to criteria estab-
lished by the Secretary. 
‘‘(3) DURATION.—The pilot program for com-
munity-based medical homes under this subsection 
shall start no later than 2 years after the date of the 
enactment of this section. Each demonstration site 
under the pilot program shall operate for a period 
of up to 5 years after the initial implementation 
phase, without regard to the receipt of a initial im-
plementation funding under subsection (i). 
‘‘(4) PREFERENCE.—In selecting sites for the 
CBMH model, the Secretary may give preference 
to— 
‘‘(A) applications from geographic areas 
that propose to coordinate health care services 
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for chronically ill beneficiaries across a variety 
of health care settings, such as primary care 
physician practices with fewer than 10 physi-
cians, specialty physicians, nurse practitioner 
practices, Federally qualified health centers, 
rural health clinics, and other settings; 
‘‘(B) applications that include other payors 
that furnish medical home services for chron-
ically ill patients covered by such payors; and 
‘‘(C) applications from States that propose 
to use the medical home model to coordinate 
health care services for individuals enrolled 
under this title, individuals enrolled under title 
XIX, and full-benefit dual eligible individuals 
(as defined in section 1935(c)(6)) with chronic 
diseases across a variety of health care settings. 
‘‘(5) PAYMENTS.— 
‘‘(A) 
ESTABLISHMENT
OF
METHOD-
OLOGY.—The Secretary shall establish a meth-
odology for the payment for medical home serv-
ices furnished under the CBMH model. 
‘‘(B) PER BENEFICIARY PER MONTH PAY-
MENTS.—Under such payment methodology, the 
Secretary shall make two separate monthly pay-
ments for each high need beneficiary who con-
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472 
sents to receive medical home services through 
such medical home, as follows: 
‘‘(i) PAYMENT TO COMMUNITY-BASED 
ORGANIZATION.—One monthly payment to 
a community-based or State-based organi-
zation. 
‘‘(ii) PAYMENT TO PRIMARY OR PRIN-
CIPAL CARE PRACTICE.—One monthly pay-
ment to the primary or principal care prac-
tice for such beneficiary. 
‘‘(C) PROSPECTIVE
PAYMENT.—The pay-
ments under subparagraph (B) shall be paid on 
a prospective basis. 
‘‘(D) AMOUNT
OF
PAYMENT.—In deter-
mining the amount of such payment, the Sec-
retary shall consider the following: 
‘‘(i) The clinical work and practice ex-
penses involved in providing the medical 
home services provided by the community- 
based medical home (such as providing in-
creased access, care coordination, care plan 
setting, population disease management, 
and teaching self-care skills for managing 
chronic illnesses) for which payment is not 
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473 
made under this title as of the date of the 
enactment of this section. 
‘‘(ii) Use appropriate risk-adjustment 
in determining the amount of the per bene-
ficiary per month payment under this 
paragraph. 
‘‘(6) INITIAL
IMPLEMENTATION
FUNDING.— 
The Secretary may make available initial implemen-
tation funding to a community based or State-based 
organization or a State that is participating in the 
pilot program under this subsection. Such organiza-
tion shall provide the Secretary with a detailed im-
plementation plan that includes how such funds will 
be used. 
‘‘(e) EXPANSION OF PROGRAM.— 
‘‘(1) EVALUATION
OF
COST
AND
QUALITY.— 
The Secretary shall evaluate the pilot program to 
determine— 
‘‘(A) the extent to which medical homes re-
sult in— 
‘‘(i) improvement in the quality and 
coordination of health care services, par-
ticularly with regard to the care of complex 
patients; 
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‘‘(ii) improvement in reducing health 
disparities; 
‘‘(iii) reductions in preventable hos-
pitalizations; 
‘‘(iv) prevention of readmissions; 
‘‘(v) reductions in emergency room 
visits; 
‘‘(vi) improvement in health outcomes, 
including patient functional status where 
applicable; 
‘‘(vii) improvement in patient satisfac-
tion; 
‘‘(viii) improved efficiency of care such 
as reducing duplicative diagnostic tests and 
laboratory tests; and 
‘‘(ix) reductions in health care ex-
penditures; and 
‘‘(B) the feasability and advisability of re-
imbursing medical homes for medical home 
services under this title on a permanent basis. 
‘‘(2) REPORT.—Not later than 60 days after 
the date of completion of the evaluation under para-
graph (1), the Secretary shall submit to Congress 
and make available to the public a report on the 
findings of the evaluation under paragraph (1). 
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475 
‘‘(3) EXPANSION OF PROGRAM.— 
‘‘(A) IN GENERAL.—Subject to the results 
of the evaluation under paragraph (1) and sub-
paragraph (B), the Secretary may issue regula-
tions to implement, on a permanent basis, one 
or more models, if, and to the extent that such 
model or models, are beneficial to the program 
under this title, including that such implemen-
tation will improve quality of care, as deter-
mined by the Secretary. 
‘‘(B) CERTIFICATION REQUIREMENT.—The 
Secretary may not issue such regulations unless 
the Chief Actuary of the Centers for Medicare 
& Medicaid Services certifies that the expansion 
of the components of the pilot program de-
scribed in subparagraph (A) would result in es-
timated spending under this title that would be 
no more than the level of spending that the 
Secretary estimates would otherwise be spent 
under this title in the absence of such expan-
sion. 
‘‘(f) ADMINISTRATIVE PROVISIONS.— 
‘‘(1) NO DUPLICATION IN PAYMENTS.—During 
any month, the Secretary may not make payments 
under this section under more than one model or 
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476 
through more than one medical home under any 
model for the furnishing of medical home services to 
an individual. 
‘‘(2) NO EFFECT ON PAYMENT FOR EVALUA-
TION
AND
MANAGEMENT
SERVICES.—Payments 
made under this section are in addition to, and have 
no effect on the amount of, payment for evaluation 
and management services made under this title. 
‘‘(3) ADMINISTRATION.—Chapter 35 of title 44, 
United States Code shall not apply to this section. 
‘‘(g) FUNDING.— 
‘‘(1) OPERATIONAL
COSTS.—For purposes of 
administering and carrying out the pilot program 
(including the design, implementation, technical as-
sistance for and evaluation of such program), in ad-
dition to funds otherwise available, there shall be 
transferred from the Federal Supplementary Medical 
Insurance Trust Fund under section 1841 to the 
Secretary for the Centers for Medicare & Medicaid 
Services Program Management Account $6,000,000 
for each of fiscal years 2010 through 2014. 
Amounts appropriated under this paragraph for a 
fiscal year shall be available until expended. 
‘‘(2) 
PATIENT-CENTERED
MEDICAL
HOME 
SERVICES.—In addition to funds otherwise available, 
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477 
there shall be available to the Secretary for the Cen-
ters for Medicare & Medicaid Services, from the 
Federal Supplementary Medical Insurance Trust 
Fund under section 1841— 
‘‘(A) $200,000,000 for each of fiscal years 
2010 through 2014 for payments for medical 
home services under subsection (c)(3); and 
‘‘(B) $125,000,000 for each of fiscal years 
2012 through 2016, for payments under sub-
section (d)(5). 
Amounts available under this paragraph for a fiscal 
year shall be available until expended. 
‘‘(3) INITIAL
IMPLEMENTATION.—In addition 
to funds otherwise available, there shall be available 
to the Secretary for the Centers for Medicare & 
Medicaid Services, from the Federal Supplementary 
Medical Insurance Trust Fund under section 1841, 
$2,500,000 for each of fiscal years 2010 through 
2012, under subsection (d)(6). Amounts available 
under this paragraph for a fiscal year shall be avail-
able until expended. 
‘‘(h) TREATMENT OF TRHCA MEDICARE MEDICAL 
HOME DEMONSTRATION FUNDING.— 
‘‘(1) In addition to funds otherwise available for 
payment of medical home services under subsection 
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478 
(c)(3), there shall also be available the amount pro-
vided in subsection (g) of section 204 of division B 
of the Tax Relief and Health Care Act of 2006 (42 
U.S.C. 1395b–1 note). 
‘‘(2) Notwithstanding section 1302(c) of the 
America’s Affordable Health Choices Act of 2009, in 
addition to funds provided in paragraph (1) and 
subsection (g)(2)(A), the funding for medical home 
services that would otherwise have been available if 
such section 204 medical home demonstration had 
been implemented (without regard to subsection (g) 
of such section) shall be available to the independent 
patient-centered medical home model described in 
subsection (c).’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall apply to services furnished on or after 
the date of the enactment of this Act. 
(c) CONFORMING REPEAL.—Section 204 of division 
B of the Tax Relief and Health Care Act of 2006 (42 
U.S.C. 1395b–1 note), as amended by section 133(a)(2) 
of the Medicare Improvements for Patients and Providers 
Act of 2008 (Public Law 110–275), is repealed. 
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479 
SEC. 1303. PAYMENT INCENTIVE FOR SELECTED PRIMARY 
CARE SERVICES. 
(a) IN GENERAL.—Section 1833 of the Social Secu-
rity Act is amended by inserting after subsection (o) the 
following new subsection: 
‘‘(p) PRIMARY CARE PAYMENT INCENTIVES.— 
‘‘(1) IN GENERAL.—In the case of primary care 
services (as defined in paragraph (2)) furnished on 
or after January 1, 2011, by a primary care practi-
tioner (as defined in paragraph (3)) for which 
amounts are payable under section 1848, in addition 
to the amount otherwise paid under this part there 
shall also be paid to the practitioner (or to an em-
ployer or facility in the cases described in clause (A) 
of section 1842(b)(6)) (on a monthly or quarterly 
basis) from the Federal Supplementary Medical In-
surance Trust Fund an amount equal 5 percent (or 
10 percent if the practitioner predominately fur-
nishes such services in an area that is designated 
(under section 332(a)(1)(A) of the Public Health 
Service Act) as a primary care health professional 
shortage area. 
‘‘(2) PRIMARY CARE SERVICES DEFINED.—In 
this subsection, the term ‘primary care services’— 
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480 
‘‘(A) means services which are evaluation 
and management services as defined in section 
1848(j)(5)(A); and 
‘‘(B) includes services furnished by another 
health care professional that would be described 
in subparagraph (A) if furnished by a physi-
cian. 
‘‘(3) 
PRIMARY
CARE
PRACTITIONER
DE-
FINED.—In this subsection, the term ‘primary care 
practitioner’— 
‘‘(A) means a physician or other health 
care practitioner (including a nurse practi-
tioner) who— 
‘‘(i) specializes in family medicine, 
general internal medicine, general pediat-
rics, geriatrics, or obstetrics and gyne-
cology; and 
‘‘(ii) has allowed charges for primary 
care services that account for at least 50 
percent of the physician’s or practitioner’s 
total allowed charges under section 1848, 
as determined by the Secretary for the 
most recent period for which data are 
available; and 
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481 
‘‘(B) includes a physician assistant who is 
under the supervision of a practitioner de-
scribed in subparagraph (A). 
‘‘(4) LIMITATION ON REVIEW.—There shall be 
no administrative or judicial review under section 
1869, section 1878, or otherwise, respecting— 
‘‘(A) any determination or designation 
under this subsection; 
‘‘(B) the identification of services as pri-
mary care services under this subsection; and 
‘‘(C) the identification of a practitioner as 
a primary care practitioner under this sub-
section. 
‘‘(5) 
COORDINATION
WITH
OTHER
PAY-
MENTS.— 
‘‘(A) WITH OTHER PRIMARY CARE INCEN-
TIVES.—The provisions of this subsection shall 
not be taken into account in applying sub-
sections (m) and (u) and any payment under 
such subsections shall not be taken into account 
in computing payments under this subsection. 
‘‘(B) WITH
QUALITY
INCENTIVES.—Pay-
ments under this subsection shall not be taken 
into account in determining the amounts that 
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483 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to services furnished on or after 
January 1, 2011. 
SEC. 1305. COVERAGE AND WAIVER OF COST-SHARING FOR 
PREVENTIVE SERVICES. 
(a) MEDICARE COVERED PREVENTIVE SERVICES DE-
FINED.—Section 1861 of the Social Security Act (42 
U.S.C. 1395x), as amended by section 1235(a)(2), is 
amended by adding at the end the following new sub-
section: 
‘‘Medicare Covered Preventive Services 
‘‘(iii)(1) Subject to the succeeding provisions of this 
subsection, the term ‘Medicare covered preventive services’ 
means the following: 
‘‘(A) Prostate cancer screening tests (as defined 
in subsection (oo)). 
‘‘(B) Colorectal cancer screening tests (as de-
fined in subsection (pp) and when applicable as de-
scribed in section 1305). 
‘‘(C) 
Diabetes 
outpatient 
self-management 
training services (as defined in subsection (qq)). 
‘‘(D) Screening for glaucoma for certain indi-
viduals (as described in subsection (s)(2)(U)). 
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484 
‘‘(E) Medical nutrition therapy services for cer-
tain 
individuals 
(as 
described 
in 
subsection 
(s)(2)(V)). 
‘‘(F) An initial preventive physical examination 
(as defined in subsection (ww)). 
‘‘(G) Cardiovascular screening blood tests (as 
defined in subsection (xx)(1)). 
‘‘(H) Diabetes screening tests (as defined in 
subsection (yy)). 
‘‘(I) Ultrasound screening for abdominal aortic 
aneurysm for certain individuals (as described in de-
scribed in subsection (s)(2)(AA)). 
‘‘(J) Pneumococcal and influenza vaccines and 
their administration (as described in subsection 
(s)(10)(A)) and hepatitis B vaccine and its adminis-
tration for certain individuals (as described in sub-
section (s)(10)(B)). 
‘‘(K) Screening mammography (as defined in 
subsection (jj)). 
‘‘(L) Screening pap smear and screening pelvic 
exam (as defined in subsection (nn)). 
‘‘(M) Bone mass measurement (as defined in 
subsection (rr)). 
‘‘(N) Kidney disease education services (as de-
fined in subsection (ggg)). 
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485 
‘‘(O) Additional preventive services (as defined 
in subsection (ddd)). 
‘‘(2) With respect to specific Medicare covered pre-
ventive services, the limitations and conditions described 
in the provisions referenced in paragraph (1) with respect 
to such services shall apply.’’. 
(b) PAYMENT
AND ELIMINATION
OF COST-SHAR-
ING.— 
(1) IN GENERAL.— 
(A) IN GENERAL.—Section 1833(a) of the 
Social Security Act (42 U.S.C. 1395l(a)) is 
amended by adding after and below paragraph 
(9) the following: 
‘‘With respect to Medicare covered preventive services, in 
any case in which the payment rate otherwise provided 
under this part is computed as a percent of less than 100 
percent of an actual charge, fee schedule rate, or other 
rate, such percentage shall be increased to 100 percent.’’. 
(B) APPLICATION
TO
SIGMOIDOSCOPIES 
AND COLONOSCOPIES.—Section 1834(d) of such 
Act (42 U.S.C. 1395m(d)) is amended— 
(i) in paragraph (2)(C), by amending 
clause (ii) to read as follows: 
‘‘(ii) NO COINSURANCE.—In the case 
of a beneficiary who receives services de-
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486 
scribed in clause (i), there shall be no coin-
surance applied.’’; and 
(ii) in paragraph (3)(C), by amending 
clause (ii) to read as follows: 
‘‘(ii) NO COINSURANCE.—In the case 
of a beneficiary who receives services de-
scribed in clause (i), there shall be no coin-
surance applied.’’. 
(2) ELIMINATION
OF
COINSURANCE
IN
OUT-
PATIENT HOSPITAL SETTINGS.— 
(A) EXCLUSION FROM OPD FEE SCHED-
ULE.—Section 1833(t)(1)(B)(iv) of the Social 
Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)) is 
amended by striking ‘‘screening mammography 
(as defined in section 1861(jj)) and diagnostic 
mammography’’ 
and 
inserting 
‘‘diagnostic 
mammograms and Medicare covered preventive 
services (as defined in section 1861(iii)(1))’’. 
(B) CONFORMING AMENDMENTS.—Section 
1833(a)(2) of the Social Security Act (42 
U.S.C. 1395l(a)(2)) is amended— 
(i) in subparagraph (F), by striking 
‘‘and’’ after the semicolon at the end; 
(ii) in subparagraph (G)(ii), by adding 
‘‘and’’ at the end; and 
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(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(H) with respect to additional preventive 
services (as defined in section 1861(ddd)) fur-
nished by an outpatient department of a hos-
pital, the amount determined under paragraph 
(1)(W);’’. 
(3) WAIVER OF APPLICATION OF DEDUCTIBLE 
FOR
ALL
PREVENTIVE
SERVICES.—The first sen-
tence of section 1833(b) of the Social Security Act 
(42 U.S.C. 1395l(b)) is amended— 
(A) in clause (1), by striking ‘‘items and 
services described in section 1861(s)(10)(A)’’ 
and inserting ‘‘Medicare covered preventive 
services (as defined in section 1861(iii))’’; 
(B) by inserting ‘‘and’’ before ‘‘(4)’’; and 
(C) by striking clauses (5) through (8). 
(4) APPLICATION
TO
PROVIDERS
OF
SERV-
ICES.—Section 1866(a)(2)(A)(ii) of such Act (42 
U.S.C. 1395cc(a)(2)(A)(ii)) is amended by inserting 
‘‘other than for Medicare covered preventive services 
and’’ after ‘‘for such items and services (’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to services furnished on or after 
January 1, 2011. 
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SEC. 1306. WAIVER OF DEDUCTIBLE FOR COLORECTAL 
CANCER SCREENING TESTS REGARDLESS OF 
CODING, SUBSEQUENT DIAGNOSIS, OR ANCIL-
LARY TISSUE REMOVAL. 
(a) IN GENERAL.—Section 1833(b) of the Social Se-
curity Act (42 U.S.C. 1395l(b)), as amended by section 
1305(b)(3), is amended by adding at the end the following 
new sentence: ‘‘Clause (1) of the first sentence of this sub-
section shall apply with respect to a colorectal cancer 
screening test regardless of the code that is billed for the 
establishment of a diagnosis as a result of the test, or for 
the removal of tissue or other matter or other procedure 
that is furnished in connection with, as a result of, and 
in the same clinical encounter as, the screening test.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to items and services furnished 
on or after January 1, 2011. 
SEC. 1307. EXCLUDING CLINICAL SOCIAL WORKER SERV-
ICES FROM COVERAGE UNDER THE MEDI-
CARE SKILLED NURSING FACILITY PROSPEC-
TIVE PAYMENT SYSTEM AND CONSOLIDATED 
PAYMENT. 
(a) IN GENERAL.—Section 1888(e)(2)(A)(ii) of the 
Social Security Act (42 U.S.C. 1395yy(e)(2)(A)(ii)) is 
amended by inserting ‘‘clinical social worker services,’’ 
after ‘‘qualified psychologist services,’’. 
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(b) 
CONFORMING
AMENDMENT.—Section 
1861(hh)(2) of the Social Security Act (42 U.S.C. 
1395x(hh)(2)) is amended by striking ‘‘and other than 
services furnished to an inpatient of a skilled nursing facil-
ity which the facility is required to provide as a require-
ment for participation’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to items and services furnished on 
or after July 1, 2010. 
SEC. 1308. COVERAGE OF MARRIAGE AND FAMILY THERA-
PIST SERVICES AND MENTAL HEALTH COUN-
SELOR SERVICES. 
(a) COVERAGE OF MARRIAGE AND FAMILY THERA-
PIST SERVICES.— 
(1) 
COVERAGE
OF
SERVICES.—Section 
1861(s)(2) of the Social Security Act (42 U.S.C. 
1395x(s)(2)), as amended by section 1235, is 
amended— 
(A) in subparagraph (EE), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (FF), by adding 
‘‘and’’ at the end; and 
(C) by adding at the end the following new 
subparagraph: 
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‘‘(GG) marriage and family therapist serv-
ices (as defined in subsection (jjj));’’. 
(2) DEFINITION.—Section 1861 of the Social 
Security Act (42 U.S.C. 1395x), as amended by sec-
tions 1235 and 1305, is amended by adding at the 
end the following new subsection: 
‘‘Marriage and Family Therapist Services 
‘‘(jjj)(1) The term ‘marriage and family therapist 
services’ means services performed by a marriage and 
family therapist (as defined in paragraph (2)) for the diag-
nosis and treatment of mental illnesses, which the mar-
riage and family therapist is legally authorized to perform 
under State law (or the State regulatory mechanism pro-
vided by State law) of the State in which such services 
are performed, as would otherwise be covered if furnished 
by a physician or as incident to a physician’s professional 
service, but only if no facility or other provider charges 
or is paid any amounts with respect to the furnishing of 
such services. 
‘‘(2) The term ‘marriage and family therapist’ means 
an individual who— 
‘‘(A) possesses a master’s or doctoral degree 
which qualifies for licensure or certification as a 
marriage and family therapist pursuant to State 
law; 
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‘‘(B) after obtaining such degree has performed 
at least 2 years of clinical supervised experience in 
marriage and family therapy; and 
‘‘(C) is licensed or certified as a marriage and 
family therapist in the State in which marriage and 
family therapist services are performed.’’. 
(3) PROVISION
FOR
PAYMENT
UNDER
PART 
B.—Section 1832(a)(2)(B) of the Social Security 
Act (42 U.S.C. 1395k(a)(2)(B)) is amended by add-
ing at the end the following new clause: 
‘‘(v) marriage and family therapist 
services;’’. 
(4) AMOUNT OF PAYMENT.— 
(A) IN GENERAL.—Section 1833(a)(1) of 
the Social Security Act (42 U.S.C. 1395l(a)(1)) 
is amended— 
(i) by striking ‘‘and’’ before ‘‘(W)’’; 
and 
(ii) by inserting before the semicolon 
at the end the following: ‘‘, and (X) with 
respect to marriage and family therapist 
services under section 1861(s)(2)(GG), the 
amounts paid shall be 80 percent of the 
lesser of the actual charge for the services 
or 75 percent of the amount determined 
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for payment of a psychologist under clause 
(L)’’. 
(B) DEVELOPMENT OF CRITERIA WITH RE-
SPECT
TO
CONSULTATION
WITH
A
HEALTH 
CARE PROFESSIONAL.—The Secretary of Health 
and Human Services shall, taking into consider-
ation concerns for patient confidentiality, de-
velop criteria with respect to payment for mar-
riage and family therapist services for which 
payment may be made directly to the marriage 
and family therapist under part B of title 
XVIII of the Social Security Act (42 U.S.C. 
1395j et seq.) under which such a therapist 
must agree to consult with a patient’s attending 
or primary care physician or nurse practitioner 
in accordance with such criteria. 
(5) EXCLUSION
OF
MARRIAGE
AND
FAMILY 
THERAPIST SERVICES FROM SKILLED NURSING FA-
CILITY
PROSPECTIVE
PAYMENT
SYSTEM.—Section 
1888(e)(2)(A)(ii) of the Social Security Act (42 
U.S.C. 1395yy(e)(2)(A)(ii)), as amended by section 
1307(a), is amended by inserting ‘‘marriage and 
family therapist services (as defined in subsection 
(jjj)(1)),’’ after ‘‘clinical social worker services,’’. 
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493 
(6) COVERAGE
OF
MARRIAGE
AND
FAMILY 
THERAPIST SERVICES PROVIDED IN RURAL HEALTH 
CLINICS AND FEDERALLY QUALIFIED HEALTH CEN-
TERS.—Section 1861(aa)(1)(B) of the Social Secu-
rity Act (42 U.S.C. 1395x(aa)(1)(B)) is amended by 
striking ‘‘or by a clinical social worker (as defined 
in subsection (hh)(1)),’’ and inserting ‘‘, by a clinical 
social worker (as defined in subsection (hh)(1)), or 
by a marriage and family therapist (as defined in 
subsection (jjj)(2)),’’. 
(7) INCLUSION
OF
MARRIAGE
AND
FAMILY 
THERAPISTS
AS
PRACTITIONERS
FOR
ASSIGNMENT 
OF CLAIMS.—Section 1842(b)(18)(C) of the Social 
Security Act (42 U.S.C. 1395u(b)(18)(C)) is amend-
ed by adding at the end the following new clause: 
‘‘(vii) A marriage and family therapist (as de-
fined in section 1861(jjj)(2)).’’. 
(b) COVERAGE OF MENTAL HEALTH COUNSELOR 
SERVICES.— 
(1) 
COVERAGE
OF
SERVICES.—Section 
1861(s)(2) of the Social Security Act (42 U.S.C. 
1395x(s)(2)), as previously amended, is further 
amended— 
(A) in subparagraph (FF), by striking 
‘‘and’’ at the end; 
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494 
(B) in subparagraph (GG), by inserting 
‘‘and’’ at the end; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(HH) mental health counselor services (as de-
fined in subsection (kkk)(1));’’. 
(2) DEFINITION.—Section 1861 of the Social 
Security Act (42 U.S.C. 1395x), as previously 
amended, is amended by adding at the end the fol-
lowing new subsection: 
‘‘Mental Health Counselor Services 
‘‘(kkk)(1) The term ‘mental health counselor services’ 
means services performed by a mental health counselor (as 
defined in paragraph (2)) for the diagnosis and treatment 
of mental illnesses which the mental health counselor is 
legally authorized to perform under State law (or the 
State regulatory mechanism provided by the State law) of 
the State in which such services are performed, as would 
otherwise be covered if furnished by a physician or as inci-
dent to a physician’s professional service, but only if no 
facility or other provider charges or is paid any amounts 
with respect to the furnishing of such services. 
‘‘(2) The term ‘mental health counselor’ means an 
individual who— 
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495 
‘‘(A) possesses a master’s or doctor’s degree 
which qualifies the individual for licensure or certifi-
cation for the practice of mental health counseling in 
the State in which the services are performed; 
‘‘(B) after obtaining such a degree has per-
formed at least 2 years of supervised mental health 
counselor practice; and 
‘‘(C) is licensed or certified as a mental health 
counselor or professional counselor by the State in 
which the services are performed.’’. 
(3) PROVISION
FOR
PAYMENT
UNDER
PART 
B.—Section 1832(a)(2)(B) of the Social Security 
Act (42 U.S.C. 1395k(a)(2)(B)), as amended by 
subsection (a)(3), is further amended— 
(A) by striking ‘‘and’’ at the end of clause 
(iv); 
(B) by adding ‘‘and’’ at the end of clause 
(v); and 
(C) by adding at the end the following new 
clause: 
‘‘(vi) mental health counselor serv-
ices;’’. 
(4) AMOUNT OF PAYMENT.— 
(A) IN GENERAL.—Section 1833(a)(1) of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
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496 
1395l(a)(1)), as amended by subsection (a), is 
further amended— 
(i) by striking ‘‘and’’before ‘‘(X)’’; 
and 
(ii) by inserting before the semicolon 
at the end the following: ‘‘, and (Y), with 
respect to mental health counselor services 
under 
section 
1861(s)(2)(HH), 
the 
amounts paid shall be 80 percent of the 
lesser of the actual charge for the services 
or 75 percent of the amount determined 
for payment of a psychologist under clause 
(L)’’. 
(B) DEVELOPMENT OF CRITERIA WITH RE-
SPECT TO CONSULTATION WITH A PHYSICIAN.— 
The Secretary of Health and Human Services 
shall, taking into consideration concerns for pa-
tient confidentiality, develop criteria with re-
spect to payment for mental health counselor 
services for which payment may be made di-
rectly to the mental health counselor under part 
B of title XVIII of the Social Security Act (42 
U.S.C. 1395j et seq.) under which such a coun-
selor must agree to consult with a patient’s at-
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497 
tending or primary care physician in accordance 
with such criteria. 
(5) EXCLUSION
OF
MENTAL
HEALTH
COUN-
SELOR SERVICES FROM SKILLED NURSING FACILITY 
PROSPECTIVE
PAYMENT
SYSTEM.—Section 
1888(e)(2)(A)(ii) of the Social Security Act (42 
U.S.C. 1395yy(e)(2)(A)(ii)), as amended by section 
1307(a) and subsection (a), is amended by inserting 
‘‘mental health counselor services (as defined in sec-
tion 1861(kkk)(1)),’’ after ‘‘marriage and family 
therapist 
services 
(as 
defined 
in 
subsection 
(jjj)(1)),’’. 
(6) COVERAGE
OF
MENTAL
HEALTH
COUN-
SELOR
SERVICES
PROVIDED
IN
RURAL
HEALTH 
CLINICS AND FEDERALLY QUALIFIED HEALTH CEN-
TERS.—Section 1861(aa)(1)(B) of the Social Secu-
rity Act (42 U.S.C. 1395x(aa)(1)(B)), as amended 
by subsection (a), is amended by striking ‘‘or by a 
marriage and family therapist (as defined in sub-
section (jjj)(2)),’’ and inserting ‘‘by a marriage and 
family therapist (as defined in subsection (jjj)(2)), 
or a mental health counselor (as defined in sub-
section (kkk)(2)),’’. 
(7) INCLUSION
OF
MENTAL
HEALTH
COUN-
SELORS
AS
PRACTITIONERS
FOR
ASSIGNMENT
OF 
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498 
CLAIMS.—Section 1842(b)(18)(C) of the Social Se-
curity Act (42 U.S.C. 1395u(b)(18)(C)), as amended 
by subsection (a)(7), is amended by adding at the 
end the following new clause: 
‘‘(viii) A mental health counselor (as defined in 
section 1861(kkk)(2)).’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to items and services furnished on 
or after January 1, 2011. 
SEC. 1309. EXTENSION OF PHYSICIAN FEE SCHEDULE MEN-
TAL HEALTH ADD-ON. 
Section 138(a)(1) of the Medicare Improvements for 
Patients and Providers Act of 2008 (Public Law 110–275) 
is amended by striking ‘‘December 31, 2009’’ and insert-
ing ‘‘December 31, 2011’’. 
SEC. 1310. EXPANDING ACCESS TO VACCINES. 
(a) IN
GENERAL.—Paragraph (10) of section 
1861(s) of the Social Security Act (42 U.S.C. 1395w(s)) 
is amended to read as follows: 
‘‘(10) federally recommended vaccines (as de-
fined in subsection (lll)) and their respective admin-
istration;’’. 
(b) FEDERALLY
RECOMMENDED
VACCINES
DE-
FINED.—Section 1861 of such Act is further amended by 
adding at the end the following new subsection: 
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‘‘Federally Recommended Vaccines 
‘‘(lll) The term ‘federally recommended vaccine’ 
means an approved vaccine recommended by the Advisory 
Committee on Immunization Practices (an advisory com-
mittee established by the Secretary, acting through the Di-
rector of the Centers for Disease Control and Preven-
tion).’’. 
(c) CONFORMING AMENDMENTS.— 
(1) Section 1833 of such Act (42 U.S.C. 1395l) 
is amended, in each of subsections (a)(1)(B), 
(a)(2)(G), (a)(3)(A), and (b)(1) (as amended by sec-
tion 1305(b)), by striking ‘‘1861(s)(10)(A)’’ or 
‘‘1861(s)(10)(B)’’ and inserting ‘‘1861(s)(10)’’ each 
place it appears. 
(2) Section 1842(o)(1)(A)(iv) of such Act (42 
U.S.C. 1395u(o)(1)(A)(iv)) is amended— 
(A) by striking ‘‘subparagraph (A) or (B) 
of’’; and 
(B) by inserting before the period the fol-
lowing: ‘‘and before January 1, 2011, and influ-
enza vaccines furnished on or after January 1, 
2011’’. 
(3) Section 1847A(c)(6) of such Act (42 U.S.C. 
1395w–3a(c)(6)) is amended by striking subpara-
graph (G) and inserting the following: 
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500 
‘‘(G) IMPLEMENTATION.—Chapter 35 of 
title 44, United States Code shall not apply to 
manufacturer provision of information pursuant 
to section 1927(b)(3)(A)(iii) for purposes of im-
plementation of this section.’’. 
(4) Section 1860D–2(e)(1)(B) of such Act (42 
U.S.C. 1395w–102(e)(1)(B)) is amended by striking 
‘‘such term includes a vaccine’’ and all that follows 
through ‘‘its administration) and’’. 
(5) Section 1861(ww)(2)(A) of such Act (42 
U.S.C. 1395x(ww)(2)(A))) is amended by striking 
‘‘Pneumococcal, influenza, and hepatitis B and ad-
ministration’’ and inserting ‘‘Federally recommended 
vaccines (as defined in subsection (lll)) and their re-
spective administration’’. 
(6) Section 1861(iii)(1) of such Act, as added 
by section 1305(a), is amended by amending sub-
paragraph (J) to read as follows: 
‘‘(J) Federally recommended vaccines (as de-
fined in subsection (lll)) and their respective admin-
istration.’’. 
(7) Section 1927(b)(3)(A)(iii) of such Act (42 
U.S.C. 1396r–8(b)(3)(A)(iii)) is amended, in the 
matter following subclause (III), by inserting 
‘‘(A)(iv) (including influenza vaccines furnished on 
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501 
or after January 1, 2011),’’ after ‘‘described in sub-
paragraph.’’ 
(d) EFFECTIVE DATES.—The amendments made 
by— 
(1) this section (other than by subsection 
(c)(7)) shall apply to vaccines administered on or 
after January 1, 2011; and 
(2) by subsection (c)(7) shall apply to calendar 
quarters beginning on or after January 1, 2010. 
TITLE IV—QUALITY 
Subtitle A—Comparative 
Effectiveness Research 
SEC. 1401. COMPARATIVE EFFECTIVENESS RESEARCH. 
(a) IN GENERAL.—title XI of the Social Security Act 
is amended by adding at the end the following new part: 
‘‘PART D—COMPARATIVE EFFECTIVENESS RESEARCH 
‘‘COMPARATIVE EFFECTIVENESS RESEARCH 
‘‘SEC. 1181. (a) CENTER FOR COMPARATIVE EFFEC-
TIVENESS RESEARCH ESTABLISHED.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish within the Agency for Healthcare Research and 
Quality a Center for Comparative Effectiveness Re-
search (in this section referred to as the ‘Center’) to 
conduct, support, and synthesize research (including 
research conducted or supported under section 1013 
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502 
of the Medicare Prescription Drug, Improvement, 
and Modernization Act of 2003) with respect to the 
outcomes, effectiveness, and appropriateness of 
health care services and procedures in order to iden-
tify the manner in which diseases, disorders, and 
other health conditions can most effectively and ap-
propriately be prevented, diagnosed, treated, and 
managed clinically. 
‘‘(2) DUTIES.—The Center shall— 
‘‘(A) conduct, support, and synthesize re-
search relevant to the comparative effectiveness 
of the full spectrum of health care items, serv-
ices and systems, including pharmaceuticals, 
medical devices, medical and surgical proce-
dures, and other medical interventions; 
‘‘(B) conduct and support systematic re-
views of clinical research, including original re-
search conducted subsequent to the date of the 
enactment of this section; 
‘‘(C) continuously develop rigorous sci-
entific methodologies for conducting compara-
tive effectiveness studies, and use such meth-
odologies appropriately; 
‘‘(D) submit to the Comparative Effective-
ness Research Commission, the Secretary, and 
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Congress appropriate relevant reports described 
in subsection (d)(2); and 
‘‘(E) encourage, as appropriate, the devel-
opment and use of clinical registries and the de-
velopment of clinical effectiveness research data 
networks from electronic health records, post 
marketing drug and medical device surveillance 
efforts, and other forms of electronic health 
data. 
‘‘(3) POWERS.— 
‘‘(A) OBTAINING
OFFICIAL
DATA.—The 
Center may secure directly from any depart-
ment or agency of the United States informa-
tion necessary to enable it to carry out this sec-
tion. Upon request of the Center, the head of 
that department or agency shall furnish that in-
formation to the Center on an agreed upon 
schedule. 
‘‘(B) DATA
COLLECTION.—In order to 
carry out its functions, the Center shall— 
‘‘(i) utilize existing information, both 
published and unpublished, where possible, 
collected and assessed either by its own 
staff or under other arrangements made in 
accordance with this section, 
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504 
‘‘(ii) carry out, or award grants or 
contracts for, original research and experi-
mentation, where existing information is 
inadequate, and 
‘‘(iii) adopt procedures allowing any 
interested party to submit information for 
the use by the Center and Commission 
under subsection (b) in making reports 
and recommendations. 
‘‘(C) ACCESS OF GAO TO INFORMATION.— 
The Comptroller General shall have unrestricted 
access to all deliberations, records, and non-
proprietary data of the Center and Commission 
under subsection (b), immediately upon request. 
‘‘(D) PERIODIC AUDIT.—The Center and 
Commission under subsection (b) shall be sub-
ject to periodic audit by the Comptroller Gen-
eral. 
‘‘(b) OVERSIGHT BY COMPARATIVE EFFECTIVENESS 
RESEARCH COMMISSION.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish an independent Comparative Effectiveness Re-
search Commission (in this section referred to as the 
‘Commission’) to oversee and evaluate the activities 
carried out by the Center under subsection (a), sub-
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505 
ject to the authority of the Secretary, to ensure such 
activities result in highly credible research and infor-
mation resulting from such research. 
‘‘(2) DUTIES.—The Commission shall— 
‘‘(A) determine national priorities for re-
search described in subsection (a) and in mak-
ing such determinations consult with a broad 
array of public and private stakeholders, includ-
ing patients and health care providers and pay-
ers; 
‘‘(B) monitor the appropriateness of use of 
the CERTF described in subsection (g) with re-
spect to the timely production of comparative 
effectiveness research determined to be a na-
tional priority under subparagraph (A); 
‘‘(C) identify highly credible research 
methods and standards of evidence for such re-
search to be considered by the Center; 
‘‘(D) review the methodologies developed 
by the center under subsection (a)(2)(C); 
‘‘(E) not later than one year after the date 
of the enactment of this section, enter into an 
arrangement under which the Institute of Medi-
cine of the National Academy of Sciences shall 
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conduct an evaluation and report on standards 
of evidence for such research; 
‘‘(F) support forums to increase stake-
holder awareness and permit stakeholder feed-
back on the efforts of the Center to advance 
methods and standards that promote highly 
credible research; 
‘‘(G) make recommendations for policies 
that would allow for public access of data pro-
duced under this section, in accordance with ap-
propriate privacy and proprietary practices, 
while ensuring that the information produced 
through such data is timely and credible; 
‘‘(H) appoint a clinical perspective advisory 
panel for each research priority determined 
under subparagraph (A), which shall consult 
with patients and advise the Center on research 
questions, methods, and evidence gaps in terms 
of clinical outcomes for the specific research in-
quiry to be examined with respect to such pri-
ority to ensure that the information produced 
from such research is clinically relevant to deci-
sions made by clinicians and patients at the 
point of care; 
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‘‘(I) make recommendations for the pri-
ority for periodic reviews of previous compara-
tive effectiveness research and studies con-
ducted by the Center under subsection (a); 
‘‘(J) routinely review processes of the Cen-
ter with respect to such research to confirm 
that the information produced by such research 
is objective, credible, consistent with standards 
of evidence established under this section, and 
developed through a transparent process that 
includes consultations with appropriate stake-
holders; and 
‘‘(K) make recommendations to the center 
for the broad dissemination of the findings of 
research conducted and supported under this 
section that enables clinicians, patients, con-
sumers, and payers to make more informed 
health care decisions that improve quality and 
value. 
‘‘(3) COMPOSITION OF COMMISSION.— 
‘‘(A) IN GENERAL.—The members of the 
Commission shall consist of— 
‘‘(i) the Director of the Agency for 
Healthcare Research and Quality; 
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‘‘(ii) the Chief Medical Officer of the 
Centers for Medicare & Medicaid Services; 
and 
‘‘(iii) 15 additional members who shall 
represent broad constituencies of stake-
holders including clinicians, patients, re-
searchers, third-party payers, consumers of 
Federal and State beneficiary programs. 
Of such members, at least 9 shall be practicing 
physicians, health care practitioners, con-
sumers, or patients. 
‘‘(B) QUALIFICATIONS.— 
‘‘(i) DIVERSE
REPRESENTATION
OF 
PERSPECTIVES.—The 
members 
of 
the 
Commission shall represent a broad range 
of perspectives and shall collectively have 
experience in the following areas: 
‘‘(I) Epidemiology. 
‘‘(II) Health services research. 
‘‘(III) Bioethics. 
‘‘(IV) Decision sciences. 
‘‘(V) Health disparities. 
‘‘(VI) Economics. 
‘‘(ii) DIVERSE
REPRESENTATION
OF 
HEALTH CARE COMMUNITY.—At least one 
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member shall represent each of the fol-
lowing health care communities: 
‘‘(I) Patients. 
‘‘(II) Health care consumers. 
‘‘(III) Practicing Physicians, in-
cluding surgeons. 
‘‘(IV) Other health care practi-
tioners engaged in clinical care. 
‘‘(V) Employers. 
‘‘(VI) Public payers. 
‘‘(VII) Insurance plans. 
‘‘(VIII) Clinical researchers who 
conduct research on behalf of pharma-
ceutical or device manufacturers. 
‘‘(C) LIMITATION.—No more than 3 of the 
Members of the Commission may be representa-
tives of pharmaceutical or device manufacturers 
and such representatives shall be clinical re-
searchers 
described 
under 
subparagraph 
(B)(ii)(VIII). 
‘‘(4) APPOINTMENT.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
appoint the members of the Commission. 
‘‘(B) CONSULTATION.—In considering can-
didates for appointment to the Commission, the 
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Secretary may consult with the Government Ac-
countability Office and the Institute of Medicine 
of the National Academy of Sciences. 
‘‘(5) CHAIRMAN; VICE
CHAIRMAN.—The Sec-
retary shall designate a member of the Commission, 
at the time of appointment of the member, as Chair-
man and a member as Vice Chairman for that term 
of appointment, except that in the case of vacancy 
of the Chairmanship or Vice Chairmanship, the Sec-
retary may designate another member for the re-
mainder of that member’s term. The Chairman shall 
serve as an ex officio member of the National Advi-
sory Council of the Agency for Health Care Re-
search and Quality under section 931(c)(3)(B) of 
the Public Health Service Act. 
‘‘(6) TERMS.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), each member of the Com-
mission shall be appointed for a term of 4 
years. 
‘‘(B) TERMS OF INITIAL APPOINTEES.—Of 
the members first appointed— 
‘‘(i) 8 shall be appointed for a term of 
4 years; and 
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‘‘(ii) 7 shall be appointed for a term 
of 3 years. 
‘‘(7) COORDINATION.—To enhance effectiveness 
and coordination, the Secretary is encouraged, to the 
greatest extent possible, to seek coordination be-
tween the Commission and the National Advisory 
Council of the Agency for Healthcare Research and 
Quality. 
‘‘(8) CONFLICTS OF INTEREST.— 
‘‘(A) IN
GENERAL.—In appointing the 
members of the Commission or a clinical per-
spective advisory panel described in paragraph 
(2)(H), the Secretary or the Commission, re-
spectively, shall take into consideration any fi-
nancial interest (as defined in subparagraph 
(D)), consistent with this paragraph, and de-
velop a plan for managing any identified con-
flicts. 
‘‘(B) EVALUATION AND CRITERIA.—When 
considering an appointment to the Commission 
or a clinical perspective advisory panel de-
scribed paragraph (2)(H) the Secretary or the 
Commission shall review the expertise of the in-
dividual and the financial disclosure report filed 
by the individual pursuant to the Ethics in Gov-
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ernment Act of 1978 for each individual under 
consideration for the appointment, so as to re-
duce the likelihood that an appointed individual 
will later require a written determination as re-
ferred to in section 208(b)(1) of title 18, United 
States Code, a written certification as referred 
to in section 208(b)(3) of title 18, United 
States Code, or a waiver as referred to in sub-
paragraph (D)(iii) for service on the Commis-
sion at a meeting of the Commission. 
‘‘(C) DISCLOSURES; 
PROHIBITIONS
ON 
PARTICIPATION; WAIVERS.— 
‘‘(i) DISCLOSURE OF FINANCIAL IN-
TEREST.—Prior to a meeting of the Com-
mission or a clinical perspective advisory 
panel described in paragraph (2)(H) re-
garding a ‘particular matter’ (as that term 
is used in section 208 of title 18, United 
States Code), each member of the Commis-
sion or the clinical perspective advisory 
panel who is a full-time Government em-
ployee or special Government employee 
shall disclose to the Secretary financial in-
terests in accordance with subsection (b) of 
such section 208. 
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‘‘(ii) PROHIBITIONS
ON
PARTICIPA-
TION.—Except as provided under clause 
(iii), a member of the Commission or a 
clinical perspective advisory panel de-
scribed in paragraph (2)(H) may not par-
ticipate with respect to a particular matter 
considered in meeting of the Commission 
or the clinical perspective advisory panel if 
such member (or an immediate family 
member of such member) has a financial 
interest that could be affected by the ad-
vice given to the Secretary with respect to 
such matter, excluding interests exempted 
in regulations issued by the Director of the 
Office of Government Ethics as too remote 
or inconsequential to affect the integrity of 
the services of the Government officers or 
employees to which such regulations apply. 
‘‘(iii) WAIVER.—If the Secretary de-
termines it necessary to afford the Com-
mission or a clinical perspective advisory 
panel described in paragraph 2(H) essen-
tial expertise, the Secretary may grant a 
waiver of the prohibition in clause (ii) to 
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permit a member described in such sub-
paragraph to— 
‘‘(I) participate as a non-voting 
member with respect to a particular 
matter considered in a Commission or 
a clinical perspective advisory panel 
meeting; or 
‘‘(II) participate as a voting 
member with respect to a particular 
matter considered in a Commission or 
a clinical perspective advisory panel 
meeting. 
‘‘(iv) LIMITATION
ON
WAIVERS
AND 
OTHER EXCEPTIONS.— 
‘‘(I) DETERMINATION OF ALLOW-
ABLE EXCEPTIONS FOR THE COMMIS-
SION.—The number of waivers grant-
ed to members of the Commission 
cannot exceed one-half of the total 
number of members for the Commis-
sion. 
‘‘(II) PROHIBITION
ON
VOTING 
STATUS
ON
CLINICAL
PERSPECTIVE 
ADVISORY PANELS.—No voting mem-
ber of any clinical perspective advisory 
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panel shall be in receipt of a waiver. 
No more than two nonvoting members 
of any clinical perspective advisory 
panel shall receive a waiver. 
‘‘(D) FINANCIAL
INTEREST
DEFINED.— 
For purposes of this paragraph, the term ‘fi-
nancial interest’ means a financial interest 
under section 208(a) of title 18, United States 
Code. 
‘‘(9) COMPENSATION.—While serving on the 
business of the Commission (including travel time), 
a member of the Commission shall be entitled to 
compensation at the per diem equivalent of the rate 
provided for level IV of the Executive Schedule 
under section 5315 of title 5, United States Code; 
and while so serving away from home and the mem-
ber’s regular place of business, a member may be al-
lowed travel expenses, as authorized by the Director 
of the Commission. 
‘‘(10) AVAILABILITY OF REPORTS.—The Com-
mission shall transmit to the Secretary a copy of 
each report submitted under this subsection and 
shall make such reports available to the public. 
‘‘(11) DIRECTOR
AND
STAFF; EXPERTS
AND 
CONSULTANTS.—Subject to such review as the Sec-
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516 
retary deems necessary to assure the efficient ad-
ministration of the Commission, the Commission 
may— 
‘‘(A) appoint an Executive Director (sub-
ject to the approval of the Secretary) and such 
other personnel as Federal employees under 
section 2105 of title 5, United States Code, as 
may be necessary to carry out its duties (with-
out regard to the provisions of title 5, United 
States Code, governing appointments in the 
competitive service); 
‘‘(B) seek such assistance and support as 
may be required in the performance of its du-
ties from appropriate Federal departments and 
agencies; 
‘‘(C) enter into contracts or make other ar-
rangements, as may be necessary for the con-
duct of the work of the Commission (without 
regard to section 3709 of the Revised Statutes 
(41 U.S.C. 5)); 
‘‘(D) make advance, progress, and other 
payments which relate to the work of the Com-
mission; 
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‘‘(E) provide transportation and subsist-
ence for persons serving without compensation; 
and 
‘‘(F) prescribe such rules and regulations 
as it deems necessary with respect to the inter-
nal organization and operation of the Commis-
sion. 
‘‘(c) RESEARCH REQUIREMENTS.—Any research con-
ducted, supported, or synthesized under this section shall 
meet the following requirements: 
‘‘(1) ENSURING TRANSPARENCY, CREDIBILITY, 
AND ACCESS.— 
‘‘(A) The establishment of the agenda and 
conduct of the research shall be insulated from 
inappropriate political or stakeholder influence. 
‘‘(B) Methods of conducting such research 
shall be scientifically based. 
‘‘(C) All aspects of the prioritization of re-
search, conduct of the research, and develop-
ment of conclusions based on the research shall 
be transparent to all stakeholders. 
‘‘(D) The process and methods for con-
ducting such research shall be publicly docu-
mented and available to all stakeholders. 
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‘‘(E) Throughout the process of such re-
search, the Center shall provide opportunities 
for all stakeholders involved to review and pro-
vide public comment on the methods and find-
ings of such research. 
‘‘(2) USE OF CLINICAL PERSPECTIVE ADVISORY 
PANELS.—The research shall meet a national re-
search 
priority 
determined 
under 
subsection 
(b)(2)(A) and shall consider advice given to the Cen-
ter by the clinical perspective advisory panel for the 
national research priority. 
‘‘(3) STAKEHOLDER INPUT.— 
‘‘(A) IN GENERAL.—The Commission shall 
consult with patients, health care providers, 
health care consumer representatives, and other 
appropriate stakeholders with an interest in the 
research through a transparent process rec-
ommended by the Commission. 
‘‘(B) SPECIFIC
AREAS
OF
CONSULTA-
TION.—Consultation 
shall 
include 
where 
deemed appropriate by the Commission— 
‘‘(i) recommending research priorities 
and questions; 
‘‘(ii) recommending research meth-
odologies; and 
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‘‘(iii) advising on and assisting with 
efforts to disseminate research findings. 
‘‘(C) OMBUDSMAN.—The Secretary shall 
designate a patient ombudsman. The ombuds-
man shall— 
‘‘(i) serve as an available point of con-
tact for any patients with an interest in 
proposed comparative effectiveness studies 
by the Center; and 
‘‘(ii) ensure that any comments from 
patients regarding proposed comparative 
effectiveness studies are reviewed by the 
Commission. 
‘‘(4) TAKING INTO ACCOUNT POTENTIAL DIF-
FERENCES.—Research shall— 
‘‘(A) be designed, as appropriate, to take 
into account the potential for differences in the 
effectiveness of health care items and services 
used with various subpopulations such as racial 
and ethnic minorities, women, different age 
groups (including children, adolescents, adults, 
and seniors), and individuals with different 
comorbidities; and 
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‘‘(B) seek, as feasible and appropriate, to 
include members of such subpopulations as sub-
jects in the research. 
‘‘(d) PUBLIC ACCESS TO COMPARATIVE EFFECTIVE-
NESS INFORMATION.— 
‘‘(1) IN
GENERAL.—Not later than 90 days 
after receipt by the Center or Commission, as appli-
cable, of a relevant report described in paragraph 
(2) made by the Center, Commission, or clinical per-
spective advisory panel under this section, appro-
priate information contained in such report shall be 
posted on the official public Internet site of the Cen-
ter and of the Commission, as applicable. 
‘‘(2) RELEVANT
REPORTS
DESCRIBED.—For 
purposes of this section, a relevant report is each of 
the following submitted by the Center or a grantee 
or contractor of the Center: 
‘‘(A) Any interim or progress reports as 
deemed appropriate by the Secretary. 
‘‘(B) Stakeholder comments. 
‘‘(C) A final report. 
‘‘(e) DISSEMINATION AND INCORPORATION OF COM-
PARATIVE EFFECTIVENESS INFORMATION.— 
‘‘(1) DISSEMINATION.—The Center shall pro-
vide for the dissemination of appropriate findings 
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produced by research supported, conducted, or syn-
thesized under this section to health care providers, 
patients, vendors of health information technology 
focused on clinical decision support, appropriate pro-
fessional associations, and Federal and private 
health plans, and other relevant stakeholders. In dis-
seminating such findings the Center shall— 
‘‘(A) convey findings of research so that 
they are comprehensible and useful to patients 
and providers in making health care decisions; 
‘‘(B) discuss findings and other consider-
ations specific to certain sub-populations, risk 
factors, and comorbidities as appropriate; 
‘‘(C) include considerations such as limita-
tions of research and what further research 
may be needed, as appropriate; 
‘‘(D) not include any data that the dis-
semination of which would violate the privacy of 
research participants or violate any confiden-
tiality agreements made with respect to the use 
of data under this section; and 
‘‘(E) assist the users of health information 
technology focused on clinical decision support 
to promote the timely incorporation of such 
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findings into clinical practices and promote the 
ease of use of such incorporation. 
‘‘(2) DISSEMINATION PROTOCOLS AND STRATE-
GIES.—The Center shall develop protocols and strat-
egies for the appropriate dissemination of research 
findings in order to ensure effective communication 
of findings and the use and incorporation of such 
findings into relevant activities for the purpose of in-
forming higher quality and more effective and effi-
cient decisions regarding medical items and services. 
In developing and adopting such protocols and strat-
egies, the Center shall consult with stakeholders con-
cerning the types of dissemination that will be most 
useful to the end users of information and may pro-
vide for the utilization of multiple formats for con-
veying findings to different audiences, including dis-
semination to individuals with limited English pro-
ficiency. 
‘‘(f) REPORTS TO CONGRESS.— 
‘‘(1) ANNUAL REPORTS.—Beginning not later 
than one year after the date of the enactment of this 
section, the Director of the Agency of Healthcare 
Research and Quality and the Commission shall sub-
mit to Congress an annual report on the activities 
of the Center and the Commission, as well as the re-
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search, conducted under this section. Each such re-
port shall include a discussion of the Center’s com-
pliance with subsection (c)(B)(4), including any rea-
sons for lack of complicance with such subsection. 
‘‘(2) RECOMMENDATION FOR FAIR SHARE PER 
CAPITA AMOUNT FOR ALL-PAYER FINANCING.—Be-
ginning not later than December 31, 2011, the Sec-
retary shall submit to Congress an annual rec-
ommendation for a fair share per capita amount de-
scribed in subsection (c)(1) of section 9511 of the 
Internal Revenue Code of 1986 for purposes of 
funding the CERTF under such section. 
‘‘(3) ANALYSIS AND REVIEW.—Not later than 
December 31, 2013, the Secretary, in consultation 
with the Commission, shall submit to Congress a re-
port on all activities conducted or supported under 
this section as of such date. Such report shall in-
clude an evaluation of the overall costs of such ac-
tivities and an analysis of the backlog of any re-
search proposals approved by the Commission but 
not funded. 
‘‘(g) FUNDING
OF COMPARATIVE EFFECTIVENESS 
RESEARCH.—For fiscal year 2010 and each subsequent 
fiscal year, amounts in the Comparative Effectiveness Re-
search Trust Fund (referred to in this section as the 
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ance, or changes in other metrics of 
resident quality of care. The Secretary 
shall submit to Congress a report on 
such evaluation and shall include in 
such report such recommendations re-
garding changes in the requirements 
for such programs as the Secretary 
determines appropriate. 
‘‘(iii) REQUIREMENTS
FOR
COMPLI-
ANCE
AND
ETHICS
PROGRAMS.—In this 
subparagraph, the term ‘compliance and 
ethics program’ means, with respect to a 
skilled nursing facility, a program of the 
operating organization that— 
‘‘(I) has been reasonably de-
signed, implemented, and enforced so 
that it generally will be effective in 
preventing and detecting criminal, 
civil, and administrative violations 
under this Act and in promoting qual-
ity of care; and 
‘‘(II) includes at least the re-
quired components specified in clause 
(iv). 
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‘‘(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 
transfer of value under the name of the covered re-
cipient. 
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838 
ported by a grant made to the State under this sec-
tion, the outcomes the programs are intended to 
achieve, and the evidence supporting the effective-
ness of the programs. 
‘‘(2) RESULTS OF NEEDS ASSESSMENT.—The 
results of a statewide needs assessment that de-
scribes— 
‘‘(A) the number, quality, and capacity of 
home visitation programs for families with 
young children and families expecting children 
in the State; 
‘‘(B) the number and types of families who 
are receiving services under the programs; 
‘‘(C) the sources and amount of funding 
provided to the programs; 
‘‘(D) the gaps in home visitation in the 
State, including identification of communities 
that are in high need of the services; and 
‘‘(E) training and technical assistance ac-
tivities designed to achieve or support the goals 
of the programs. 
‘‘(3) ASSURANCES.—Assurances from the State 
that— 
‘‘(A) in supporting home visitation pro-
grams using funds provided under this section, 
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