178 
SEC. 306. IMPROVED AND EXPANDED MEDICAL HOME DEM-
ONSTRATION PROJECT. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’) shall establish under title XVIII of the Social Secu-
rity Act an expanded medical home demonstration project 
(in this section referred to as the ‘‘expanded project’’) under 
this section. The expanded project supersedes the project 
that was initiated under section 204 of the Medicare Im-
provement and Extension Act of 2006 (division B of Public 
Law 109–432). The purpose of the expanded project is— 
(1) to guide the redesign of the health care deliv-
ery system to provide accessible, continuous, com-
prehensive, and coordinated, care to Medicare bene-
ficiaries; and 
(2) to provide care management fees to personal 
physicians delivering continuous and comprehensive 
care in qualified medical homes. 
(b) NATURE AND SCOPE OF PROJECT.— 
(1) DURATION; SCOPE.—The expanded project 
shall operate during a period of three years, begin-
ning not later than October 1, 2009, and shall include 
a nationally representative sample of physicians serv-
ing urban, rural, and underserved areas throughout 
the United States. 
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(2) ENCOURAGING
PARTICIPATION
OF
SMALL 
PHYSICIAN PRACTICES.— 
(A) IN
GENERAL.—The expanded project 
shall be designed to include the participation of 
physicians in practices with fewer than four full- 
time equivalent physicians, as well as physicians 
in larger practices particularly in rural and un-
derserved areas. 
(B) TECHNICAL ASSISTANCE.—In order to 
facilitate the participation under the expanded 
project of physicians in such practices, the Sec-
retary shall make available additional technical 
assistance to such practices during the first year 
of the expanded project. 
(3) SELECTION OF HOMES TO PARTICIPATE.— 
The Secretary shall select up to 500 medical homes to 
participate in the expanded project and shall give 
priority to— 
(A) the selection of up to 100 HIT-enhanced 
medical homes; and 
(B) the selection of other medical homes that 
serve communities whose populations are at 
higher risk for health disparities, 
(4) BENEFICIARY
PARTICIPATION.—The Sec-
retary shall establish a process for any Medicare bene-
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ficiary who is served by a medical home participating 
in the expanded project to elect to participate in the 
project. Each beneficiary who elects to so participate 
shall be eligible— 
(A) for enhanced medical home services 
under the project with no cost sharing for the ad-
ditional services; and 
(B) for a reduction of up to 50 percent in 
the coinsurance for services furnished under the 
physician fee schedule under section 1848 of the 
Social Security Act by the medical home. 
The Secretary shall develop standard recruitment ma-
terials and election processes for Medicare bene-
ficiaries who are electing to participate in the ex-
panded project. 
(c) STANDARDS
FOR MEDICAL HOMES, HIT-EN-
HANCED MEDICAL HOMES.— 
(1) STANDARD
SETTING
AND
CERTIFICATION 
PROCESS.—The Secretary shall establish a process for 
selection of a qualified standard setting and certifi-
cation organization— 
(A) to establish standards, consistent with 
this section, for medical practices to qualify as 
medical homes or as HIT-enhanced medical 
homes; and 
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(B) to provide for the review and certifi-
cation of medical practices as meeting such 
standards. 
(2) BASIC STANDARDS FOR MEDICAL HOMES.— 
For purposes of this subsection, the term ‘‘medical 
home’’ means a physician-directed practice that has 
been certified, under paragraph (1), as meeting the 
following standards: 
(A) ACCESS AND COMMUNICATION WITH PA-
TIENTS.—The practice applies standards for ac-
cess to care and communication with partici-
pating beneficiaries. 
(B) MANAGING PATIENT INFORMATION AND 
USING INFORMATION IN MANAGEMENT TO SUP-
PORT PATIENT CARE.—The practice has readily 
accessible, clinically useful information on par-
ticipating beneficiaries that enables the practice 
to treat such beneficiaries comprehensively and 
systematically. 
(C) MANAGING
AND
COORDINATING
CARE 
ACCORDING TO INDIVIDUAL NEEDS.—The prac-
tice maintains continuous relationships with 
participating beneficiaries by implementing evi-
dence-based guidelines and applying them to the 
identified needs of individual beneficiaries over 
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time and with the intensity needed by such bene-
ficiaries. 
(D) PROVIDING ONGOING ASSISTANCE AND 
ENCOURAGEMENT
IN
PATIENT
SELF-MANAGE-
MENT.—The practice— 
(i) 
collaborates 
with 
participating 
beneficiaries to pursue their goals for opti-
mal achievable health; and 
(ii) assesses patient-specific barriers to 
communication and conducts activities to 
support patient self-management. 
(E) RESOURCES
TO
MANAGE
CARE.—The 
practice has in place the resources and processes 
necessary to achieve improvements in the man-
agement and coordination of care for partici-
pating beneficiaries. 
(F) 
MONITORING
PERFORMANCE.—The 
practice monitors its clinical process and per-
formance (including outcome measures) in meet-
ing the applicable standards under this sub-
section and provides information in a form and 
manner specified by the Secretary with respect to 
such process and performance. 
(3) ADDITIONAL STANDARDS FOR HIT-ENHANCED 
MEDICAL HOME.—For purposes of this subsection, the 
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term ‘‘HIT-enhanced medical home’’ means a medical 
home that has been certified, under paragraph (1), as 
using a health information technology system that in-
cludes at least the following elements: 
(A) ELECTRONIC HEALTH RECORD (EHR).— 
The system uses, for participating beneficiaries, 
an electronic health record that meets the fol-
lowing standards: 
(i) IN GENERAL.—The record— 
(I) has the capability of interoper-
ability with secure data acquisition 
from health information technology 
systems of other health care providers 
in the area served by the home; or 
(II) the capability to securely ac-
quire clinical data delivered by such 
other health care providers to a secure 
common data source. 
(ii) The record protects the privacy 
and security of health information. 
(iii) The record has the capability to 
acquire, manage, and display all the types 
of clinical information commonly relevant 
to services furnished by the medical home, 
such as complete medical records, radio-
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graphic image retrieval, and clinical lab-
oratory information. 
(iv) The record is integrated with deci-
sion support capacities that facilitate the 
use of evidence-based medicine and clinical 
decision support tools to guide decision- 
making at the point-of-care based on pa-
tient-specific factors. 
(B) E-PRESCRIBING.—The system supports 
e-prescribing and computerized physician order 
entry. 
(C) OUTCOME MEASUREMENT.—The system 
supports the secure, confidential provision of 
clinical process and outcome measures approved 
by the National Quality Forum to the Secretary 
for use in confidential manner for provider feed-
back and peer review and for outcomes and clin-
ical effectiveness research. 
(D) PATIENT EDUCATION CAPABILITY.—The 
system actively facilitates participating bene-
ficiaries engaging in the management of their 
own health through education and support sys-
tems and tools for shared decision-making. 
(E) SUPPORT OF BASIC STANDARDS.—The 
elements of such system, such as the electronic 
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health record, email communications, patient 
registries, and clinical-decision support tools, are 
integrated in a manner to better achieve the 
basic standards specified in paragraph (2) for a 
medical home. 
(4) USE OF DATA.—The Secretary shall use the 
data submitted under paragraph (1)(F) in a con-
fidential manner for feedback and peer review for 
medical homes and for outcomes and clinical effective-
ness research. After the first two years of the expanded 
project, these data may be used for adjustment in the 
monthly medical home care management fee under 
subsection (d)(2)(E). 
(d) MONTHLY MEDICAL HOME CARE MANAGEMENT 
FEE.— 
(1) IN GENERAL.—Under the expanded project, 
the Secretary shall provide for payment to the per-
sonal physician of each participating beneficiary of a 
monthly medical home care management fee. 
(2) AMOUNT OF PAYMENT.—In determining the 
amount of such fee, the Secretary shall consider the 
following: 
(A) OPERATING EXPENSES.—The additional 
practice expenses for the delivery of services 
through a medical home, taking into account the 
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additional expenses for an HIT-enhanced med-
ical home. Such expenses include costs associated 
with— 
(i) structural expenses, such as equip-
ment, maintenance, and training costs; 
(ii) enhanced access and communica-
tion functions; 
(iii) population management and reg-
istry functions; 
(iv) patient medical data and referral 
tracking functions; 
(v) provision of evidence-based care; 
(vi) implementation and maintenance 
of health information technology; 
(vii) reporting on performance and im-
provement conditions; and 
(viii) patient education and patient 
decision support, including print and elec-
tronic patient education materials. 
(B) ADDED VALUE SERVICES.—The value of 
additional physician work, such as augmented 
care plan oversight, expanded e-mail and tele-
phonic consultations, extended patient medical 
data review (including data stored and trans-
mitted electronically), and physician supervision 
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of enhanced self management education, and ex-
panded follow-up accomplished by non-physician 
personnel, in a medical home that is not ade-
quately taken into account in the establishment 
of the physician fee schedule under section 1848 
of the Social Security Act. 
(C) RISK ADJUSTMENT.—The development 
of an appropriate risk adjustment mechanism to 
account for the varying costs of medical homes 
based upon characteristics of participating bene-
ficiaries. 
(D) HIT ADJUSTMENT.—Variation of the 
fee based on the extensiveness of use of the health 
information technology in the medical home. 
(E) PERFORMANCE-BASED.—After the first 
two years of the expanded project, an adjustment 
of the fee based on performance of the medical 
home in achieving quality or outcomes stand-
ards. 
(3) PERSONAL PHYSICIAN DEFINED.—For pur-
poses of this subsection, the term ‘‘personal physi-
cian’’ means, with respect to a participating Medi-
care beneficiary, a physician (as defined in section 
1861(r)(1) of the Social Security Act (42 U.S.C. 
1395x(r)(1)) who provides accessible, continuous, co-
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ordinated, and comprehensive care for the beneficiary 
as part of a medical practice that is a qualified med-
ical home. Such a physician may be a specialist for 
a beneficiary requiring ongoing care for a chronic 
condition or multiple chronic conditions (such as se-
vere asthma, complex diabetes, cardiovascular disease, 
rheumatologic disorder) or for a beneficiary with a 
prolonged illness. 
(e) FUNDING.— 
(1) USE
OF
CURRENT
PROJECT
FUNDING.— 
Funds otherwise applied to the demonstration under 
section 204 of the Medicare Improvement and Exten-
sion Act of 2006 (division B of Public Law 109–432) 
shall be available to carry out the expanded project 
(2) ADDITIONAL
FUNDING
FROM
SMI
TRUST 
FUND.— 
(A) IN GENERAL.—In addition to the funds 
provided under paragraph (1), there shall be 
available, from the Federal Supplementary Med-
ical Insurance Trust Fund (under section 1841 
of the Social Security Act), the amount of 
$500,000,000 to carry out the expanded project, 
including payments to of monthly medical home 
care management fees under subsection (d), re-
ductions in coinsurance for participating bene-
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ficiaries under subsection (b)(4)(B), and funds 
for the design, implementation, and evaluation 
of the expanded project. 
(B) MONITORING
EXPENDITURES; EARLY 
TERMINATION.—The Secretary shall monitor the 
expenditures under the expanded project and 
may terminate the project early in order that ex-
penditures not exceed the amount of funding pro-
vided for the project under subparagraph (A). 
(f) EVALUATIONS AND REPORTS.—. 
(1) ANNUAL
INTERIM
EVALUATIONS
AND
RE-
PORTS.—For each year of the expanded project, the 
Secretary shall provide for an evaluation of the 
project and shall submit to Congress, by a date speci-
fied by the Secretary, a report on the project and on 
the evaluation of the project for each such year. 
(2) FINAL EVALUATION AND REPORT.—The Sec-
retary shall provide for an evaluation of the expanded 
project and shall submit to Congress, not later than 
18 months after the date of completion of the project, 
a report on the project and on the evaluation of the 
project. 
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SEC. 307. REPEAL OF PHYSICIAN ASSISTANCE AND QUALITY 
INITIATIVE FUND. 
Subsection (l) of section 1848 of the Social Security 
Act (42 U.S.C. 1395w–4) is repealed. 
SEC. 308. ADJUSTMENT TO MEDICARE PAYMENT LOCAL-
ITIES. 
Section 1848(e) of the Social Security Act (42 
U.S.C.1395w–4(e)) is amended by adding at the end the 
following new paragraph: 
‘‘(6) FEE SCHEDULE GEOGRAPHIC AREAS.— 
‘‘(A) IN GENERAL.— 
‘‘(i) REVISION.—Subject to clause (ii), 
for services furnished on or after January 1, 
2008, the Secretary shall revise the fee 
schedule areas used for payment under this 
section applicable to the State of California 
using the county-based geographic adjust-
ment factor as specified in option 3 (table 
9) in the proposed rule for the 2008 physi-
cian fee schedule published at 72 Fed. Reg. 
38,122 (July 12, 2007). 
‘‘(ii) TRANSITION.—For services fur-
nished during the period beginning Janu-
ary 1, 2008, and ending December 31, 2010, 
after calculating the work, practice expense, 
and malpractice geographic indices de-
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scribed in clauses (i), (ii), and (iii) of para-
graph (1)(A) that would otherwise apply, 
the Secretary shall increase any such geo-
graphic index for any county in California 
that is lower than the geographic index used 
for payment for services under this section 
as of December 31, 2007, in such county to 
such geographic index level. 
‘‘(B) SUBSEQUENT REVISIONS.— 
‘‘(i) TIMING.—Not later than January 
1, 2011, the Secretary shall review and 
make revisions to fee schedule areas in all 
States for which more than one fee schedule 
area is used for payment of services under 
this section. The Secretary may revise fee 
schedule areas in States in which a single 
fee schedule area is used for payment for 
services under this section using the same 
methodology applied in the previous sen-
tence. 
‘‘(ii) LINK WITH GEOGRAPHIC INDEX 
DATA REVISION.—The revision described in 
clause (i) shall be made effective concur-
rently with the application of the periodic 
review of geographic adjustment factors re-
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quired under paragraph (1)(C) for 2011 
and subsequent periods.’’. 
SEC. 309. PAYMENT FOR IMAGING SERVICES. 
(a) PAYMENT UNDER PART B OF THE MEDICARE PRO-
GRAM FOR DIAGNOSTIC IMAGING SERVICES FURNISHED IN 
FACILITIES CONDITIONED ON ACCREDITATION OF FACILI-
TIES.— 
(1) SPECIAL PAYMENT RULE.— 
(A) IN GENERAL.—Section 1848(b)(4) of the 
Social Security Act (42 U.S.C. 1395w–4(b)(4)) 
is amended— 
(i) in the heading, by striking ‘‘RULE’’ 
and inserting ‘‘RULES’’; 
(ii) in subparagraph (A), by striking 
‘‘IN
GENERAL’’ and inserting ‘‘LIMITA-
TION’’; and 
(iii) by adding at the end the following 
new subparagraph: 
‘‘(C) PAYMENT ONLY FOR SERVICES PRO-
VIDED IN ACCREDITED FACILITIES.— 
‘‘(i) IN GENERAL.—In the case of im-
aging services that are diagnostic imaging 
services described in clause (ii), the pay-
ment amount for the technical component 
and the professional component of the serv-
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ices established for a year under the fee 
schedule described in paragraph (1) shall 
each be zero, unless the services are fur-
nished at a diagnostic imaging services fa-
cility that meets the certificate requirement 
described in section 354(b)(1) of the Public 
Health Service Act, as applied under sub-
section (m). The previous sentence shall not 
apply with respect to the technical compo-
nent if the imaging equipment meets certifi-
cation standards and the professional com-
ponent of a diagnostic imaging service that 
is furnished by a physician. 
‘‘(ii) 
DIAGNOSTIC
IMAGING
SERV-
ICES.—For purposes of clause (i) and sub-
section (m), the term ‘diagnostic imaging 
services’ means all imaging modalities, in-
cluding diagnostic magnetic resonance im-
aging 
(‘MRI’), 
computed 
tomography 
(‘CT’), 
positron 
emission 
tomography 
(‘PET’), nuclear medicine procedures, x- 
rays, sonograms, ultrasounds, echocardio-
grams, and such emerging diagnostic imag-
ing technologies as specified by the Sec-
retary.’’. 
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(B) EFFECTIVE DATE.— 
(i) IN
GENERAL.—Subject to clause 
(ii), the amendments made by subpara-
graph (A) shall apply to diagnostic imaging 
services furnished on or after January 1, 
2010. 
(ii) 
EXTENSION
FOR
ULTRASOUND 
SERVICES.—The amendments made by sub-
paragraph (A) shall apply to diagnostic im-
aging services that are ultrasound services 
on or after January 1, 2012. 
(2) CERTIFICATION OF FACILITIES THAT FUR-
NISH DIAGNOSTIC IMAGING SERVICES.—Section 1848 
of the Social Security Act (42 U.S.C. 1395w-4) is 
amended by adding at the end the following new sub-
section: 
‘‘(m) CERTIFICATION OF FACILITIES THAT FURNISH 
DIAGNOSTIC IMAGING SERVICES.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(b)(4)(C)(i), except as provided under paragraphs (2) 
through (8), the provisions of section 354 of the Public 
Health Service Act (as in effect as of June 1, 2007), 
relating to the certification of mammography facili-
ties, shall apply, with respect to the provision of diag-
nostic imaging services (as defined in subsection 
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(b)(4)(C)(ii)) and to a diagnostic imaging services fa-
cility defined in paragraph (8) (and to the process of 
accrediting such facilities) in the same manner that 
such provisions apply, with respect to the provision 
of mammograms and to a facility defined in sub-
section (a)(3) of such section (and to the process of ac-
crediting such mammography facilities). 
‘‘(2) TERMINOLOGY
AND
REFERENCES.—For 
purposes of applying section 354 of the Public Health 
Service Act under paragraph (1)— 
‘‘(A) any reference to ‘mammography’, or 
‘breast imaging’ is deemed a reference to ‘diag-
nostic imaging services (as defined in section 
1848(b)(4)(C)(ii) of the Social Security Act)’; 
‘‘(B) any reference to a mammogram or 
film is deemed a reference to an image, as de-
fined in paragraph (8); 
‘‘(C) any reference to ‘mammography facil-
ity’ or to a ‘facility’ under such section 354 is 
deemed a reference to a diagnostic imaging serv-
ices facility, as defined in paragraph (8); 
‘‘(D) any reference to radiological equip-
ment used to image the breast is deemed a ref-
erence to medical imaging equipment used to 
provide diagnostic imaging services; 
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‘‘(E) any reference to radiological proce-
dures or radiological is deemed a reference to 
medical imaging services, as defined in para-
graph (8) or medical imaging, respectively; 
‘‘(F) any reference to an inspection (as de-
fined in subsection (a)(4) of such section) or in-
spector is deemed a reference to an audit (as de-
fined in paragraph (8)) or auditor, respectively; 
‘‘(G) any reference to a medical physicist 
(as described in subsection (f)(1)(E) of such sec-
tion) is deemed to include a reference to a mag-
netic resonance scientist or the appropriate 
qualified expert as determined by the accrediting 
body; 
‘‘(H) in applying subsection (d)(1)(A)(i) of 
such section, the reference to ‘type of each x-ray 
machine, image receptor, and processor’ is 
deemed a reference to ‘type of imaging equip-
ment’; 
‘‘(I) in applying subsection (d)(1)(B) of 
such section, the reference that ‘the person or 
agent submits to the Secretary’ is deemed a ref-
erence that ‘the person or agent submits to the 
Secretary, through the appropriate accreditation 
body’; 
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‘‘(J) in applying subsection (d)(1)(B)(i) of 
such section, the reference to standards estab-
lished by the Secretary is deemed a reference to 
standards established by an accreditation body 
and approved by the Secretary; 
‘‘(K) in applying subsection (e) of such sec-
tion, relating to an accreditation body— 
‘‘(i) in paragraph (1)(A), the reference 
to ‘may’ is deemed a reference to ‘shall’; 
‘‘(ii) in paragraph (1)(B)(i)(II), the 
reference to ‘a random sample of clinical 
images from such facilities’ is deemed a ref-
erence to ‘a statistically significant random 
sample of clinical images from a statis-
tically significant random sample of facili-
ties’; 
‘‘(iii) in paragraph (3)(A) of such sec-
tion— 
‘‘(I) the reference to ‘paragraph 
(1)(B)’ in such subsection is deemed to 
be a reference to ‘paragraph (1)(B) 
and subsection (f)’; and 
‘‘(II) the reference to the ‘Sec-
retary’ is deemed a reference to ‘an ac-
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creditation body, with the approval of 
the Secretary’; and 
‘‘(iv) in paragraph (6)(B), the ref-
erence to the Committee on Labor and 
Human Resources of the Senate is deemed 
to be the Committee on Finance of the Sen-
ate and the reference to the Committee on 
Energy and Commerce of the House of Rep-
resentatives is deemed to include a reference 
to the Committee on Ways and Means of the 
House of Representatives; 
‘‘(L) in applying subsection (f), relating to 
quality standards— 
‘‘(i) each reference to standards estab-
lished by the Secretary is deemed a ref-
erence to standards established by an ac-
creditation body involved and approved by 
the Secretary under subsection (d)(1)(B)(i) 
of such section; 
‘‘(ii) in paragraph (1)(A), the reference 
to ‘radiation dose’ is deemed a reference to 
‘radiation dose, as appropriate’; 
‘‘(iii) in paragraph (1)(B), the ref-
erence to ‘radiological standards’ is deemed 
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a reference to ‘medical imaging standards, 
as appropriate’; 
‘‘(iv) in paragraphs (1)(D)(ii) and 
(1)(E)(iii), the reference to ‘the Secretary’ is 
deemed a reference to ‘an accreditation body 
with the approval of the Secretary’; and 
‘‘(v) in each of subclauses (III) and 
(IV) of paragraph (1)(G)(ii), each reference 
to ‘patient’ is deemed a reference to ‘pa-
tient, if requested by the patient’; and 
‘‘(M) in applying subsection (g), relating to 
inspections— 
‘‘(i) each reference to the ‘Secretary or 
State or local agency acting on behalf of the 
Secretary’ is deemed to include a reference 
to an accreditation body involved; 
‘‘(ii) in the first sentence of paragraph 
(1)(F), the reference to ‘annual inspections 
required under this paragraph’ is deemed a 
reference to ‘the audits carried out in facili-
ties at least every three years from the date 
of initial accreditation under this para-
graph’; and 
‘‘(iii) in the second sentence of para-
graph (1)(F), the reference to ‘inspections 
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carried out under this paragraph’ is deemed 
a reference to ‘audits conducted under this 
paragraph during the previous year’. 
‘‘(3) DATES
AND
PERIODS.—For purposes of 
paragraph (1), in applying section 354 of the Public 
Health Service Act, the following applies: 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B)— 
‘‘(i) any reference to ‘October 1, 1994’ 
shall be deemed a reference to ‘January 1, 
2010’; 
‘‘(ii) the reference to ‘the date of the en-
actment of this section’ in each of sub-
sections (e)(1)(D) and (f)(1)(E)(iii) is 
deemed to be a reference to ‘the date of the 
enactment of the Children’s Health and 
Medicare Protection Act of 2007’; 
‘‘(iii) the reference to ‘annually’ in 
subsection (g)(1)(E) is deemed a reference to 
‘every three years’; 
‘‘(iv) the reference to ‘October 1, 1996’ 
in subsection (l) is deemed to be a reference 
to ‘January 1, 2011’; 
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‘‘(v) the reference to ‘October 1, 1999’ 
in subsection (n)(3)(H) is deemed to be a 
reference to ‘January 1, 2012’; and 
‘‘(vi) the reference to ‘October 1, 1993’ 
in the matter following paragraph (3)(J) of 
subsection (n) is deemed to be a reference 
‘January 1, 2010’. 
‘‘(B) ULTRASOUND
SERVICES.—With re-
spect to diagnostic imaging services that are 
ultrasounds— 
‘‘(i) any reference to ‘October 1, 1994’ 
shall be deemed a reference to ‘January 1, 
2012’; 
‘‘(ii) the reference to ‘the date of the en-
actment of this section’ in subsection 
(f)(1)(E)(iii) is deemed to be a reference to 
‘7 years after the date of the enactment of 
the Children’s Health and Medicare Protec-
tion Act of 2007’; and 
‘‘(iii) the reference to ‘October 1, 1996’ 
in subsection (l) is deemed to be a reference 
to ‘January 1, 2013’. 
‘‘(4) PROVISIONS
NOT
APPLICABLE.—For pur-
poses of paragraph (1), in applying section 354 of the 
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Public Health Service Act, the following provision 
shall not apply: 
‘‘(A) Subsections (e) and (f) of such section, 
in so far as the respective subsection imposes any 
requirement for a physician to be certified, ac-
credited, or otherwise meet requirements, with re-
spect to the provision of any diagnostic imaging 
services, as a condition of payment under sub-
section (b)(4)(C)(i), with respect to the profes-
sional or technical component, for such service. 
‘‘(B) Subsection (e)(1)(B)(iv) of such sec-
tion, insofar as it applies to a facility with re-
spect to the provision of ultrasounds. 
‘‘(C) Subsection (e)(1)(B)(v). 
‘‘(D) Subsection (f)(1)(H) of such section, 
relating to standards for special techniques for 
mammograms of patients with breast implants. 
‘‘(E) Subsection (g)(6) of such section, relat-
ing to an inspection demonstration program. 
‘‘(F) Subsection (n)(3)(G) of such section, 
relating to the national advisory committee. 
‘‘(G) Subsection (p) of such section, relating 
to breast cancer screening surveillance research 
grants. 
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‘‘(H) Paragraphs (1)(B) and (2) of sub-
section (r) of such section, related to funding. 
‘‘(5) ACCREDITATION BODIES.—For purposes of 
paragraph (1), in applying section 354(e)(1) of the 
Public Health Service, the following shall apply: 
‘‘(A) APPROVAL
OF
TWO
ACCREDITATION 
BODIES FOR EACH TREATMENT MODALITY.—In 
the case that there is more than one accreditation 
body for a treatment modality that qualifies for 
approval under this subsection, the Secretary 
shall approve at least two accreditation bodies 
for such treatment modality. 
‘‘(B) ADDITIONAL
ACCREDITATION
BODY 
STANDARDS.—In addition to the standards de-
scribed in subparagraph (B) of such section for 
accreditation bodies, the Secretary shall establish 
standards that require— 
‘‘(i) the timely integration of new tech-
nology by accreditation bodies for purposes 
of accrediting facilities under this sub-
section; and 
‘‘(ii) the accreditation body involved to 
evaluate the annual medical physicist sur-
vey (or annual medical survey of another 
appropriate qualified expert chosen by the 
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accreditation body) of a facility upon onsite 
review of such facility. 
‘‘(6) ADDITIONAL
QUALITY
STANDARDS.—For 
purposes of paragraph (1), in applying subsection 
(f)(1) of section 354 of the Public Health Service— 
‘‘(A) the quality standards under such sub-
section shall, with respect to a facility include— 
‘‘(i) standards for qualifications of 
medical personnel who are not physicians 
and who perform diagnostic imaging serv-
ices at the facility that require such per-
sonnel to ensure that individuals, prior to 
performing medical imaging, demonstrate 
compliance with the standards established 
under subsection (a) through successful com-
pletion of certification by a nationally rec-
ognized professional organization, licensure, 
completion of an examination, pertinent 
coursework or degree program, verified per-
tinent experience, or through other ways de-
termined appropriate by an accreditation 
body (with the approval of the Secretary, or 
through some combination thereof); 
‘‘(ii) standards requiring the facility to 
maintain records of the credentials of physi-
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cians and other medical personnel described 
in clause (i); 
‘‘(iii) standards for qualifications and 
responsibilities of medical directors and 
other personnel with supervising roles at the 
facility; 
‘‘(iv) standards that require the facil-
ity has procedures to ensure the safety of 
patients of the facility; and 
‘‘(v) standards for the establishment of 
a quality control program at the facility to 
be implemented as described in subpara-
graph (E) of such subsection; 
‘‘(B) the quality standards described in sub-
paragraph (B) of such subsection shall be deemed 
to include standards that require the establish-
ment and maintenance of a quality assurance 
and quality control program at each facility that 
is adequate and appropriate to ensure the reli-
ability, clarity, and accuracy of the technical 
quality of diagnostic images produced at such fa-
cilities; and 
‘‘(C) the quality standard described in sub-
paragraph (C) of such subsection, relating to a 
requirement for personnel who perform specified 
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services, shall include in such requirement that 
such personnel must meet continuing medical 
education standards as specified by an accredita-
tion body (with the approval of the Secretary) 
and update such standards at least once every 
three years. 
‘‘(7) 
ADDITIONAL
REQUIREMENTS.—Notwith-
standing any provision of section 354 of the Public 
Health Service Act, the following shall apply to the 
accreditation process under this subsection for pur-
poses of subsection (b)(4)(C)(i): 
‘‘(A) Any diagnostic imaging services facil-
ity accredited before January 1, 2010 (or Janu-
ary 1, 2012 in the case of ultrasounds), by an 
accrediting body approved by the Secretary shall 
be deemed a facility accredited by an approved 
accreditation body for purposes of such sub-
section as of such date if the facility submits to 
the Secretary proof of such accreditation by 
transmittal of the certificate of accreditation, in-
cluding by electronic means. 
‘‘(B) The Secretary may require the accred-
itation under this subsection of an emerging 
technology used in the provision of a diagnostic 
imaging service as a condition of payment under 
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subsection (b)(4)(C)(i) for such service at such 
time as the Secretary determines there is suffi-
cient empirical and scientific information to 
properly carry out the accreditation process for 
such technology. 
‘‘(8) DEFINITIONS.—For purposes of this sub-
section: 
‘‘(A) AUDIT.—The term ‘audit’ means an 
onsite evaluation, with respect to a diagnostic 
imaging services facility, by the Secretary, State 
or local agency on behalf of the Secretary, or ac-
creditation body approved under this subsection 
that includes the following: 
‘‘(i) Equipment verification. 
‘‘(ii) Evaluation of policies and proce-
dures for compliance with accreditation re-
quirements. 
‘‘(iii) Evaluation of personnel quali-
fications and credentialing. 
‘‘(iv) Evaluation of the technical qual-
ity of images. 
‘‘(v) Evaluation of patient reports. 
‘‘(vi) Evaluation of peer-review mecha-
nisms and other quality assurance activi-
ties. 
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‘‘(vii) Evaluation of quality control 
procedures, results, and follow-up actions. 
‘‘(viii) Evaluation of medical physi-
cists (or other appropriate professionals 
chosen by the accreditation body) and mag-
netic resonance scientist surveys. 
‘‘(ix) Evaluation of consumer com-
plaint mechanisms. 
‘‘(x) Provision of recommendations for 
improvement based on findings with respect 
to clauses (i) through (ix). 
‘‘(B) DIAGNOSTIC IMAGING SERVICES FACIL-
ITY.—The term ‘diagnostic imaging services fa-
cility’ has the meaning given the term ‘facility’ 
in section 354(a)(3) of the Public Health Service 
Act (42 U.S.C. 263b(a)(3)) subject to the ref-
erence changes specified in paragraph (2), but 
does not include any facility that does not fur-
nish diagnostic imaging services for which pay-
ment may be made under this section. 
‘‘(C) IMAGE.—The term ‘image’ means the 
portrayal of internal structures of the human 
body for the purpose of detecting and deter-
mining the presence or extent of disease or in-
jury and may be produced through various tech-
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