1528 
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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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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‘‘(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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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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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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(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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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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‘‘(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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‘‘(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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would otherwise be paid under this part for 
purposes of section 1834(g)(2)(B).’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 1833 of such Act (42 U.S.C. 
1395l(m)) is amended by redesignating paragraph 
(4) as paragraph (5) and by inserting after para-
graph (3) the following new paragraph: 
‘‘(4) The provisions of this subsection shall not be 
taken into account in applying subsections (m) or (u) and 
any payment under such subsections shall not be taken 
into account in computing payments under this sub-
section.’’. 
(2) Section 1848(m)(5)(B) of such Act (42 
U.S.C. 1395w–4(m)(5)(B)) is amended by inserting 
‘‘, (p),’’ after ‘‘(m)’’. 
(3) Section 1848(o)(1)(B)(iv) of such Act (42 
U.S.C. 1395w–4(o)(1)(B)(iv)) is amended by insert-
ing ‘‘primary care’’ before ‘‘health professional 
shortage area’’. 
SEC. 1304. INCREASED REIMBURSEMENT RATE FOR CER-
TIFIED NURSE-MIDWIVES. 
(a) IN GENERAL.—Section 1833(a)(1)(K) of the So-
cial Security Act (42 U.S.C.1395l(a)(1)(K)) is amended 
by striking ‘‘(but in no event’’ and all that follows through 
‘‘performed by a physician)’’. 
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(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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‘‘(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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‘‘(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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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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(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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(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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‘‘(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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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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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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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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‘‘(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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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 L—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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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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‘‘(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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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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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 compliance 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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‘‘(i) exercises operational, financial, or 
managerial control over the facility or a 
part thereof, or provides policies or proce-
dures for any of the operations of the facil-
ity, or provides financial or cash manage-
ment services to the facility; 
‘‘(ii) leases or subleases real property 
to the facility, or owns a whole or part in-
terest equal to or exceeding 5 percent of 
the total value of such real property; 
‘‘(iii) lends funds or provides a finan-
cial guarantee to the facility in an amount 
which is equal to or exceeds $50,000; or 
‘‘(iv) provides management or admin-
istrative services, clinical consulting serv-
ices, or accounting or financial services to 
the facility. 
‘‘(B) FACILITY.—The term ‘facility’ means 
a disclosing entity which is— 
‘‘(i) a skilled nursing facility (as de-
fined in section 1819(a)); or 
‘‘(ii) a nursing facility (as defined in 
section 1919(a)). 
‘‘(C) MANAGING
EMPLOYEE.—The term 
‘managing employee’ means, with respect to a 
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facility, an individual (including a general man-
ager, business manager, administrator, director, 
or consultant) who directly or indirectly man-
ages, advises, or supervises any element of the 
practices, finances, or operations of the facility. 
‘‘(D) ORGANIZATIONAL STRUCTURE.—The 
term ‘organizational structure’ means, in the 
case of— 
‘‘(i) a corporation, the officers, direc-
tors, and shareholders of the corporation 
who have an ownership interest in the cor-
poration which is equal to or exceeds 5 
percent; 
‘‘(ii) a limited liability company, the 
members and managers of the limited li-
ability company (including, as applicable, 
what percentage each member and man-
ager has of the ownership interest in the 
limited liability company); 
‘‘(iii) a general partnership, the part-
ners of the general partnership; 
‘‘(iv) a limited partnership, the gen-
eral partners and any limited partners of 
the limited partnership who have an own-
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propensity to engage in criminal, civil, 
and administrative violations under 
this Act. 
‘‘(IV) The organization must 
have taken steps to communicate ef-
fectively its standards and procedures 
to all employees and other agents, 
such as by requiring participation in 
training programs or by disseminating 
publications that explain in a practical 
manner what is required. 
‘‘(V) The organization must have 
taken reasonable steps to achieve com-
pliance with its standards, such as by 
utilizing monitoring and auditing sys-
tems reasonably designed to detect 
criminal, civil, and administrative vio-
lations under this Act by its employ-
ees and other agents and by having in 
place and publicizing a reporting sys-
tem whereby employees and other 
agents could report violations by oth-
ers within the organization without 
fear of retribution. 
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‘‘(12) conspires to commit a violation of this 
section; or 
‘‘(13) knowingly makes, uses, or causes to be 
made or used, a false record or statement material 
to an obligation to pay or transmit money or prop-
erty to a Federal health care program, or knowingly 
conceals or knowingly and improperly avoids or de-
creases an obligation to pay or transmit money or 
property to a Federal health care program;’’; and 
(E) in the matter following paragraph 
(13), as inserted by subparagraph (D), by strik-
ing ‘‘or in cases under paragraph (11), $50,000 
for each such violation’’ and inserting ‘‘in cases 
under paragraph (11), $50,000 for each such 
violation, in cases under paragraph (12), 
$50,000 for any violation described in this sec-
tion committed in furtherance of the conspiracy 
involved; or in cases under paragraph (13), 
$50,000 for each false record or statement, or 
concealment, avoidance, or decrease’’; and 
(F) in the second sentence, by striking 
‘‘such false statement or misrepresentation)’’ 
and inserting ‘‘such false statement or mis-
representation, in cases under paragraph (12), 
an assessment of not more than 3 times the 
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