126 
any payment required under this subtitle within 10 days 
after the date on which such payment is due. 
(b) AMOUNT OF PENALTY.—The amount of the pen-
alty imposed by subsection (a) on any failure with respect 
to a manufacturer shall be an amount equal to 2 percent 
of the penalty owed under section 412 for each day during 
the noncompliance period. 
(c) NONCOMPLIANCE PERIOD.—For purposes of this 
section, the term ‘‘noncompliance period’’ means, with re-
spect to any failure to make the surcharge payment re-
quired under this subtitle, the period— 
(1) beginning on the due date for such pay-
ment; and 
(2) ending on the date on which such payment 
is paid in fall. 
(d) LIMITATIONS.—No penalty shall be imposed by 
subsection (a) on— 
(1) any failure to make a surcharge payment 
under this subtitle during any period for which it is 
established to the satisfaction of the Secretary that 
none of the persons responsible for such failure 
knew or, exercising reasonable diligence, would have 
known, that such failure existed; or 
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(2) any manufacturer that produces less than 1 
percent of cigarettes used by youth in that year (as 
determined by the annual survey). 
Subtitle C—Food Guidance 
SEC. 421. FRONT-LABEL FOOD GUIDANCE SYSTEMS. 
(a) IN GENERAL.—Not later than March 1, 2008, the 
Secretary of Health and Human Services (referred to in 
this section as the ‘‘Secretary’’) shall begin solicitation of 
public comments regarding— 
(1) the use of retail front-label food guidance 
systems to convey nutrition information to the public 
using logos, symbols, signs, emblems, insignia, or 
other graphic representations on the labeling of food 
intended for human consumption that are intended 
to provide simple, standardized, and understandable 
nutrition information to the public in graphic form; 
(2) appropriate nutrition standards by which a 
retail front-label food guidance system may convey 
the relative nutritional value of different foods in 
simple graphic form; and 
(3) whether American consumers would be bet-
ter served by establishing a single, standardized re-
tail front-label food guidance system regulated by 
the Food and Drug Administration, or by allowing 
individual food companies, trade associations, non-
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profit organizations, and others to continue to de-
velop their own retail front-label food guidance sys-
tems. 
(b) EFFECT ON NUTRITION FACTS PANEL.—In solic-
iting public comments under subsection (a), the Secretary 
shall inform the public that any retail front-label food 
guidance system is intended to supplement, not replace, 
the Nutrition Facts Panel that appears on food labels pur-
suant to section 403(q) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343(q)). 
(c) PROPOSED REGULATION.—Not later than 12 
months following the closure of the public comment solici-
tation period under subsection (a), the Secretary shall— 
(1) publish a notice in the Federal Register 
that summarizes the public comments and describes 
the suggested retail front-label food guidance sys-
tems received through such solicitation; and 
(2) publish proposed regulations that— 
(A) establish a single, standardized retail 
front-label food guidance system; or 
(B) establish the conditions under which 
individual food companies, trade associations, 
nonprofit organizations, and other persons may 
continue to develop their own retail front-label 
food guidance systems. 
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TITLE V—REIMBURSEMENT AND 
COVERAGE OF PREVENTIVE 
SERVICES 
SEC. 501. COVERAGE OF SUBSTANCE USE (OTHER THAN TO-
BACCO), DIET, EXERCISE, INJURY PREVEN-
TION, AND DENTAL HEALTH COUNSELING. 
(a) COVERAGE.— 
(1) IN
GENERAL.—Section 1861(s)(2) of the 
Social Security Act (42 U.S.C. 1395x(s)(2)), as 
amended by section 642(a) of the Medicare Prescrip-
tion Drug, Improvement, and Modernization Act of 
2003 (Public Law 108–173; 117 Stat. 2322), is 
amended— 
(A) in subparagraph (Y), by striking 
‘‘and’’ after the semicolon at the end; 
(B) in subparagraph (Z), by adding ‘‘and’’ 
after the semicolon at the end; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(AA) substance use (other than tobacco), diet, 
exercise, injury prevention, and dental health coun-
seling (as defined in subsection (bbb)(1));’’. 
(2) CONFORMING AMENDMENTS.—(A) Section 
1862(a)(12) of the Social Security Act (42 U.S.C. 
1395y(a)(12)) is amended by inserting ‘‘(except as 
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130 
otherwise 
allowed 
under 
subsection 
1861(s)(2)(AA))’’ after ‘‘directly supporting teeth’’. 
(B) 
Clauses 
(i) 
and 
(ii) 
of 
section 
1861(s)(2)(K) of the Social Security Act (42 U.S.C. 
1395x(s)(2)(K)), as amended by section 611(d)(2) of 
the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Public Law 108–173; 
117 Stat. 2304), are each amended by striking 
‘‘subsection (ww)(1)’’ and inserting ‘‘subsections 
(ww)(1) and (bbb)’’. 
(b) SERVICES DESCRIBED.—Section 1861 of the So-
cial Security Act (42 U.S.C. 1395x), as amended by sec-
tion 706(b) of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 (Public Law 108– 
173; 117 Stat. 2339), is amended by adding at the end 
the following new subsection: 
‘‘(bbb) SUBSTANCE USE (OTHER THAN TOBACCO), 
DIET, EXERCISE, INJURY PREVENTION, AND DENTAL 
HEALTH COUNSELING.—The term ‘substance use (other 
than tobacco), diet, exercise, injury prevention, and dental 
health counseling’ means therapy and counseling relating 
to substance use (other than tobacco), diet, exercise, in-
jury prevention, and dental health counseling that is fur-
nished— 
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‘‘(1) by or under the supervision of a physician; 
or 
‘‘(2) by any other health care professional 
who— 
‘‘(A) is legally authorized to furnish such 
services under State law (or the State regu-
latory mechanism provided by State law) of the 
State in which the services are furnished; and 
‘‘(B) is authorized to receive payment for 
other services under this title or is designated 
by the Secretary for this purpose.’’. 
(c) PAYMENT
AND ELIMINATION
OF COST-SHAR-
ING.— 
(1) PAYMENT AND ELIMINATION OF COINSUR-
ANCE.—Section 1833(a)(1) of the Social Security 
Act (42 U.S.C. 1395l(a)(1)), as amended by section 
302(b)(2) of the Medicare Prescription Drug, Im-
provement, and Modernization Act of 2003 (Public 
Law 108–173; 117 Stat. 2229), is amended— 
(A) in subparagraph (N), by inserting ‘‘or 
substance use (other than tobacco), diet, exer-
cise, injury prevention, and dental health coun-
seling (as defined in section 1861(bbb))’’ after 
‘‘(as defined in section 1848(j)(3))’’; 
(B) by striking ‘‘and’’ before ‘‘(V)’’; and 
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132 
(C) by inserting before the semicolon at 
the end the following: ‘‘and (W) with respect to 
substance use (other than tobacco), diet, exer-
cise, injury prevention, and dental health coun-
seling (as defined in section 1861(bbb) the 
amount paid shall be the lesser of the actual 
charge for the services or the amount deter-
mined under the payment basis determined 
under section 1848’’. 
(2) PAYMENT UNDER PHYSICIAN FEE SCHED-
ULE.—Section 1848(j)(3) of the Social Security Act 
(42 U.S.C. 1395w–4(j)(3)), as amended by section 
611(c) of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 (Public Law 
108–173; 117 Stat. 2304), is amended by inserting 
‘‘(2)(AA),’’ after ‘‘(2)(W),’’. 
(3) 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)), as 
amended by section 614(a) of the Medicare 
Prescription Drug, Improvement, and Mod-
ernization Act of 2003 (Public Law 108–173; 
117 Stat. 2306), is amended by striking ‘‘and 
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133 
diagnostic mammography’’ and inserting ‘‘, di-
agnostic mammography, or substance use 
(other than tobacco), diet, exercise, injury pre-
vention, and dental health counseling (as de-
fined in section 1861(bbb))’’. 
(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 strik-
ing the comma at the end and inserting ‘‘; 
and’’; and 
(iii) by inserting after subparagraph 
(G)(ii) the following new subparagraph: 
‘‘(H) with respect to substance use (other 
than tobacco), diet, exercise, injury prevention, 
and dental health counseling (as defined in sec-
tion 1861(bbb)) furnished by an outpatient de-
partment of a hospital, the amount determined 
under paragraph (1)(W),’’. 
(4) ELIMINATION OF DEDUCTIBLE.—The first 
sentence of section 1833(b) of the Social Security 
Act (42 U.S.C. 1395l(b)) is amended— 
(A) by striking ‘‘and’’ before ‘‘(6)’’; and 
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134 
(B) by inserting before the period at the 
end the following: ‘‘, and (7) such deductible 
shall not apply with respect to substance use 
(other than tobacco), diet, exercise, injury pre-
vention, and dental health counseling (as de-
fined in section 1861(bbb))’’. 
(d) APPLICATION OF LIMITS ON BILLING.—Section 
1842(b)(18)(C) of the Social Security Act (42 U.S.C. 
1395u(b)(18)(C)) is amended by adding at the end the 
following new clause: 
‘‘(vii) Any health care professional designated 
under section 1861(bbb)(2)(B) to perform substance 
use (other than tobacco), diet, exercise, injury pre-
vention, and dental health counseling that is not oth-
erwise described in this subparagraph.’’. 
(e) EFFECTIVE DATE.—The amendments made by 
this section shall take effect as if included in the enact-
ment of the Medicare Prescription Drug, Improvement, 
and Modernization Act of 2003 (Public Law 108–173; 117 
Stat. 2066) and shall apply to services furnished on and 
after January 1, 2008. 
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135 
SEC. 502. MEDICARE COVERAGE OF MEDICAL NUTRITION 
THERAPY SERVICES FOR PEOPLE WITH PRE- 
DIABETES. 
(a) COVERAGE OF MEDICAL NUTRITION THERAPY 
SERVICES.—Section 1861(s)(2)(V) of the Social Security 
Act (42 U.S.C. 1395x(s)(2)(V)) is amended by inserting 
after ‘‘beneficiary with diabetes’’ the following ‘‘, pre-dia-
betes or its risk factors, including hypertension, 
dyslipidemia, or obesity’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply with respect to services fur-
nished on or after the date of the enactment of this Act. 
SEC. 503. PREVENTIVE MENTAL HEALTH SCREENINGS. 
(a) COVERAGE.— 
(1) IN
GENERAL.—Section 1861(s)(2) of the 
Social Security Act (42 U.S.C. 1395x(s)(2)), as 
amended by section 501(a)(1), is amended— 
(A) in subparagraph (Z), by striking 
‘‘and’’ after the semicolon at the end; 
(B) in subparagraph (AA), by adding 
‘‘and’’ after the semicolon at the end; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(BB) screenings for clinical depression, anx-
iety, and impaired cognitive functioning (as defined 
in subsection (ccc)(1));’’. 
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136 
(2) CONFORMING
AMENDMENTS.—Clauses (i) 
and (ii) of section 1861(s)(2)(K) of the Social Secu-
rity Act (42 U.S.C. 1395x(s)(2)(K)), as amended by 
section 501(a)(2)(B), are each amended by striking 
‘‘and (bbb)’’ and inserting ‘‘(bbb), and (ccc)’’. 
(b) SERVICES DESCRIBED.—Section 1861 of the So-
cial Security Act (42 U.S.C. 1395x), as amended by sec-
tion 501(b), is amended by adding at the end the following 
new subsection: 
‘‘(ccc) SCREENINGS
FOR CLINICAL DEPRESSION, 
ANXIETY, AND IMPAIRED COGNITIVE FUNCTIONING.—(1) 
The term ‘screening for clinical depression, anxiety, and 
impaired cognitive functioning’ means a consultation for 
the purpose of detecting clinical depression, anxiety, and 
impaired cognitive functioning during which a qualified 
health professional (as defined in paragraph (2))— 
‘‘(A) uses a screening on the list established or 
identified under paragraph (3); 
‘‘(B) assesses the individual’s risk of clinical de-
pression, anxiety, and impaired cognitive func-
tioning; and 
‘‘(C) if the qualified health professional deter-
mines that the individual is at high risk for clinical 
depression, anxiety, or impaired cognitive func-
tioning, refers the individual for a full diagnostic 
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137 
evaluation and such additional treatment as may be 
required. 
Nothing in subparagraph (C) shall be construed as prohib-
iting a qualified health professional performing the screen-
ing for clinical depression, anxiety, and impaired cognitive 
functioning with respect to an individual from directly pro-
viding the diagnostic evaluation and additional treatment 
described in such clause to such individual if such profes-
sional is legally authorized to provide such an evaluation 
and additional treatment under State law (or the State 
regulatory mechanism provided by State law) of the State 
in which the screening is performed. 
‘‘(2) For purposes of this subsection, the term ‘quali-
fied health professional’ means an individual who— 
‘‘(A) is— 
‘‘(i) a physician (as defined in subsection 
(r)(1)); 
‘‘(ii) a nurse practitioner (as defined in 
subsection (aa)(5)); or 
‘‘(iii) a mental health care professional (in-
cluding clinical psychologists (as defined by the 
Secretary for purposes of section 1861(ii)) and 
clinical social workers (as defined in subsection 
1861(hh))) that is licensed or certified to per-
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138 
form mental health services by the State in 
which the screenings are performed; and 
‘‘(B) has an agreement in effect with the Sec-
retary to accept— 
‘‘(i) the amount determined under section 
1833(a)(1)(W) as full payment for screenings 
for clinical depression, anxiety, and impaired 
cognitive functioning; and 
‘‘(ii) an assignment described in section 
1842(b)(3)(B)(ii) with respect to payment for 
each screening furnished by the professional to 
an individual enrolled under part B. 
‘‘(3) The Secretary shall, in consultation with mental 
health professionals and other stakeholders with experi-
ence in screening for clinical depression, anxiety, and im-
paired cognitive functioning, shall establish or identify a 
list of approved screenings to be used under this para-
graph. The Secretary, in consultation with such profes-
sionals and stakeholders, shall review and update such list 
not less frequently than once every 5 years.’’. 
(c) PAYMENT
AND ELIMINATION
OF COST-SHAR-
ING.— 
(1) PAYMENT AND ELIMINATION OF COINSUR-
ANCE.—Section 1833(a)(1) of the Social Security 
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139 
Act (42 U.S.C. 1395l(a)(1)), as amended by section 
501(c)(1), is amended— 
(A) in subparagraph (N), by striking ‘‘or 
substance use (other than tobacco), diet, exer-
cise, injury prevention, and dental health coun-
seling (as defined in section 1861(bbb))’’ and 
inserting ‘‘substance use (other than tobacco), 
diet, exercise, injury prevention, and dental 
health 
counseling 
(as 
defined 
in 
section 
1861(bbb)), or screenings for clinical depres-
sion, anxiety, and impaired cognitive func-
tioning (as defined in section 1861(ccc))’’; and 
(B) in subparagraph (W), by inserting 
‘‘and screenings for clinical depression, anxiety, 
and impaired cognitive functioning (as defined 
in section 1861(ccc))’’ after ‘‘(as defined in sec-
tion 1861(bbb))’’. 
(2) PAYMENT UNDER PHYSICIAN FEE SCHED-
ULE.—Section 1848(j)(3) of the Social Security Act 
(42 U.S.C. 1395w–4(j)(3)), as amended by section 
501(c)(2), is amended by inserting ‘‘(2)(BB),’’ after 
‘‘(2)(AA),’’. 
(3) ELIMINATION
OF
COINSURANCE
IN
OUT-
PATIENT HOSPITAL SETTINGS.— 
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140 
(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)), as 
amended by section 501(c)(3)(A), is amended 
by striking ‘‘or substance use (other than to-
bacco), diet, exercise, injury prevention, and 
dental health counseling (as defined in section 
1861(bbb))’’ and inserting ‘‘substance use 
(other than tobacco), diet, exercise, injury pre-
vention, and dental health counseling (as de-
fined in section 1861(bbb)), or screenings for 
clinical depression, anxiety, and impaired cog-
nitive 
functioning 
(as 
defined 
in 
section 
1861(ccc))’’. 
(B) CONFORMING
AMENDMENT.—Section 
1833(a)(2)(H) of the Social Security Act (42 
U.S.C. 1395l(a)(2)(H)), as added by section 
501(c)(3)(B)(iii), is amended by inserting ‘‘and 
screenings for clinical depression, anxiety, and 
impaired cognitive functioning (as defined in 
section 1861(ccc))’’ after ‘‘(as defined in section 
1861(bbb))’’. 
(4) ELIMINATION
OF
DEDUCTIBLE.—Section 
1833(b)(7) of the Social Security Act (42 U.S.C. 
1395l(b)(7)), as amended by section 501(c)(4), is 
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141 
amended by inserting ‘‘or screenings for clinical de-
pression, anxiety, and impaired cognitive functioning 
(as defined in section 1861(ccc))’’ before the period 
at the end. 
(d) APPLICATION OF LIMITS ON BILLING.—Section 
1842(b)(18)(C) of the Social Security Act (42 U.S.C. 
1395u(b)(18)(C)), as amended by section 501(d), is 
amended by adding at the end the following new clause: 
‘‘(viii) A mental health care professional de-
scribed in section 1861(ccc)(2) that is authorized to 
perform screenings for clinical depression, anxiety, 
and impaired cognitive functioning (as defined in 
section 1861(ccc)(1)) that is not otherwise described 
in this subparagraph.’’. 
(e) FREQUENCY.—Section 1862(a)(1) of the Social 
Security Act (42 U.S.C. 1395y(a)(1)), as amended by sec-
tion 613(c) of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 (Public Law 108– 
173; 117 Stat. 2306), is amended— 
(1) in subparagraph (L), by striking ‘‘and’’ 
after the comma at the end; 
(2) in subparagraph (M), by striking the semi-
colon at the end and inserting ‘‘, and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
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142 
‘‘(N) in the case of screenings for clinical de-
pression, anxiety, and impaired cognitive functioning 
(as defined in section 1861(ccc)(1)), which is per-
formed more frequently than is covered under such 
section;’’. 
(f) EFFECTIVE DATE.—The amendments made by 
this section shall take effect as if included in the enact-
ment of the Medicare Prescription Drug, Improvement, 
and Modernization Act of 2003 (Public Law 108–173; 117 
Stat. 2066) and shall apply to services furnished on and 
after January 1, 2008. 
SEC. 504. ENCOURAGEMENT OF CESSATION OF TOBACCO 
USE. 
(a) MEDICARE COVERAGE
OF COUNSELING
AND 
PHARMACOTHERAPY
FOR
CESSATION
OF
TOBACCO 
USE.— 
(1) COVERAGE.— 
(A) IN GENERAL.—Section 1861(s)(2) of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395x(s)(2)), as amended by section 502(a)(1), 
is amended— 
(i) in subparagraph (AA), by striking 
‘‘and’’ after the semicolon at the end; 
(ii) in subparagraph (BB), by adding 
‘‘and’’ after the semicolon at the end; and 
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143 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(CC) counseling and pharmacotherapy for ces-
sation of tobacco use (as defined in subsection 
(ddd)(1));’’. 
(B) CONFORMING AMENDMENTS.—Clauses 
(i) and (ii) of section 1861(s)(2)(K) of the So-
cial Security Act (42 U.S.C. 1395x(s)(2)(K)), 
as amended by section 502(a)(2), are each 
amended by striking ‘‘and (ccc)’’ and inserting 
‘‘(ccc), and (ddd)’’. 
(2) SERVICES
DESCRIBED.—Section 1861 of 
the Social Security Act (42 U.S.C. 1395x), as 
amended by section 502(b), is amended by adding at 
the end the following new subsection: 
‘‘(ddd) COUNSELING AND PHARMACOTHERAPY FOR 
CESSATION
OF TOBACCO USE.—(1) Subject to para-
graphs 
(2) 
and 
(3), 
the 
term 
‘counseling 
and 
pharmacotherapy for cessation of tobacco use’ means diag-
nostic, 
therapy, 
and 
counseling 
services 
and 
pharmacotherapy (including the coverage of prescription 
and nonprescription tobacco cessation agents approved by 
the Food and Drug Administration) for cessation of to-
bacco use for individuals who use tobacco products or who 
are being treated for tobacco use which are furnished— 
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