H. R. 1—239
detection and includes education, counseling, and referral with
respect to screening and other preventive services described in
paragraph (2), but does not include clinical laboratory tests.
‘‘(2) The screening and other preventive services described in
this paragraph include the following:
‘‘(A) Pneumococcal, influenza, and hepatitis B vaccine and
administration under subsection (s)(10).
‘‘(B) Screening mammography as defined in subsection (jj).
‘‘(C) Screening pap smear and screening pelvic exam as
defined in subsection (nn).
‘‘(D) Prostate cancer screening tests as defined in subsection
(oo).
‘‘(E) Colorectal cancer screening tests as defined in sub-
section (pp).
‘‘(F) Diabetes outpatient self-management training services
as defined in subsection (qq)(1).
‘‘(G) Bone mass measurement as defined in subsection (rr).
‘‘(H) Screening for glaucoma as defined in subsection (uu).
‘‘(I) Medical nutrition therapy services as defined in sub-
section (vv).
‘‘(J) Cardiovascular screening blood tests as defined in sub-
section (xx)(1).
‘‘(K) Diabetes screening tests as defined in subsection (yy).’’.
(c) PAYMENT AS PHYSICIANS’ SERVICES.—Section 1848(j)(3) (42
U.S.C. 1395w–4(j)(3)) is amended by inserting ‘‘(2)(W),’’ after
‘‘(2)(S),’’.
(d) OTHER CONFORMING AMENDMENTS.—(1) Section 1862(a) (42
U.S.C. 1395y(a)), as amended by section 303(i)(3)(B), is amended—
(A) in paragraph (1)—
(i) by striking ‘‘and’’ at the end of subparagraph (I);
(ii) by striking the semicolon at the end of subpara-
graph (J) and inserting ‘‘, and’’; and
(iii) by adding at the end the following new subpara-
graph:
‘‘(K) in the case of an initial preventive physical examina-
tion, which is performed not later than 6 months after the
date the individual’s first coverage period begins under part
B;’’; and
(B) in paragraph (7), by striking ‘‘or (H)’’ and inserting
‘‘(H), or (K)’’.
(2) Clauses (i) and (ii) of section 1861(s)(2)(K) (42 U.S.C.
1395x(s)(2)(K)) are each amended by inserting ‘‘and services
described in subsection (ww)(1)’’ after ‘‘services which would be
physicians’ services’’.
(e) EFFECTIVE DATE.—The amendments made by this section
shall apply to services furnished on or after January 1, 2005,
but only for individuals whose coverage period under part B begins
on or after such date.
SEC. 612. COVERAGE OF CARDIOVASCULAR SCREENING BLOOD TESTS.
(a) COVERAGE.—Section 1861(s)(2) (42 U.S.C. 1395x(s)(2)), as
amended by section 611(a), is amended—
(1) in subparagraph (V)(iii), by striking ‘‘and’’ at the end;
(2) in subparagraph (W), by inserting ‘‘and’’ at the end;
and
(3) by adding at the end the following new subparagraph:
H. R. 1—240
‘‘(X) cardiovascular screening blood tests (as defined in
subsection (xx)(1));’’.
(b) SERVICES DESCRIBED.—Section 1861 (42 U.S.C. 1395x) is
amended by adding at the end the following new subsection:
‘‘Cardiovascular Screening Blood Test
‘‘(xx)(1) The term ‘cardiovascular screening blood test’ means
a blood test for the early detection of cardiovascular disease (or
abnormalities associated with an elevated risk of cardiovascular
disease) that tests for the following:
‘‘(A) Cholesterol levels and other lipid or triglyceride levels.
‘‘(B) Such other indications associated with the presence
of, or an elevated risk for, cardiovascular disease as the Sec-
retary may approve for all individuals (or for some individuals
determined by the Secretary to be at risk for cardiovascular
disease), including indications measured by noninvasive testing.
The Secretary may not approve an indication under subparagraph
(B) for any individual unless a blood test for such is recommended
by the United States Preventive Services Task Force.
‘‘(2) The Secretary shall establish standards, in consultation
with appropriate organizations, regarding the frequency for each
type of cardiovascular screening blood tests, except that such fre-
quency may not be more often than once every 2 years.’’.
(c) FREQUENCY.—Section 1862(a)(1) (42 U.S.C. 1395y(a)(1)), as
amended by section 611(d), is amended—
(1) by striking ‘‘and’’ at the end of subparagraph (J);
(2) by striking the semicolon at the end of subparagraph
(K) and inserting ‘‘, and’’; and
(3) by adding at the end the following new subparagraph:
‘‘(L) in the case of cardiovascular screening blood tests
(as defined in section 1861(xx)(1)), which are performed more
frequently than is covered under section 1861(xx)(2);’’.
(d) EFFECTIVE DATE.—The amendments made by this section
shall apply to tests furnished on or after January 1, 2005.
SEC. 613. COVERAGE OF DIABETES SCREENING TESTS.
(a) COVERAGE.—Section 1861(s)(2) (42 U.S.C. 1395x(s)(2)), as
amended by section 612(a), is amended—
(1) in subparagraph (W), by striking ‘‘and’’ at the end;
(2) in subparagraph (X), by adding ‘‘and’’ at the end; and
(3) by adding at the end the following new subparagraph:
‘‘(Y) diabetes screening tests (as defined in subsection
(yy));’’.
(b) SERVICES DESCRIBED.—Section 1861 (42 U.S.C. 1395x), as
amended by section 612(b), is amended by adding at the end the
following new subsection:
‘‘Diabetes Screening Tests
‘‘(yy)(1) The term ‘diabetes screening tests’ means testing fur-
nished to an individual at risk for diabetes (as defined in paragraph
(2)) for the purpose of early detection of diabetes, including—
‘‘(A) a fasting plasma glucose test; and
‘‘(B) such other tests, and modifications to tests, as the
Secretary determines appropriate, in consultation with appro-
priate organizations.
H. R. 1—241
‘‘(2) For purposes of paragraph (1), the term ‘individual at
risk for diabetes’ means an individual who has any of the following
risk factors for diabetes:
‘‘(A) Hypertension.
‘‘(B) Dyslipidemia.
‘‘(C) Obesity, defined as a body mass index greater than
or equal to 30 kg/m2.
‘‘(D) Previous identification of an elevated impaired fasting
glucose.
‘‘(E) Previous identification of impaired glucose tolerance.
‘‘(F) A risk factor consisting of at least 2 of the following
characteristics:
‘‘(i) Overweight, defined as a body mass index greater
than 25, but less than 30, kg/m2.
‘‘(ii) A family history of diabetes.
‘‘(iii) A history of gestational diabetes mellitus or
delivery of a baby weighing greater than 9 pounds.
‘‘(iv) 65 years of age or older.
‘‘(3) The Secretary shall establish standards, in consultation
with appropriate organizations, regarding the frequency of diabetes
screening tests, except that such frequency may not be more often
than twice within the 12-month period following the date of the
most recent diabetes screening test of that individual.’’.
(c) FREQUENCY.—Section 1862(a)(1) (42 U.S.C. 1395y(a)(1)), as
amended by section 612(c), is amended—
(1) by striking ‘‘and’’ at the end of subparagraph (K);
(2) by striking the semicolon at the end of subparagraph
(L) and inserting ‘‘, and’’; and
(3) by adding at the end the following new subparagraph:
‘‘(M) in the case of a diabetes screening test (as defined
in section 1861(yy)(1)), which is performed more frequently
than is covered under section 1861(yy)(3);’’.
(d) EFFECTIVE DATE.—The amendments made by this section
shall apply to tests furnished on or after January 1, 2005.
SEC. 614. IMPROVED PAYMENT FOR CERTAIN MAMMOGRAPHY SERV-
ICES.
(a) 
EXCLUSION
FROM
OPD 
FEE
SCHEDULE.—Section
1833(t)(1)(B)(iv) (42 U.S.C. 1395l(t)(1)(B)(iv)) is amended by
inserting before the period at the end the following: ‘‘and does
not include screening mammography (as defined in section 1861(jj))
and diagnostic mammography’’.
(b) CONFORMING
AMENDMENT.—Section 1833(a)(2)(E)(i) (42
U.S.C. 1395l(a)(2)(E)(i)) is amended by inserting ‘‘and, for services
furnished on or after January 1, 2005, diagnostic mammography’’
after ‘‘screening mammography’’.
(c) EFFECTIVE DATE.—The amendments made by this section
shall apply—
(1) in the case of screening mammography, to services
furnished on or after the date of the enactment of this Act;
and
(2) in the case of diagnostic mammography, to services
furnished on or after January 1, 2005.
H. R. 1—242
Subtitle C—Other Provisions
SEC. 621. HOSPITAL OUTPATIENT DEPARTMENT (HOPD) PAYMENT
REFORM.
(a) PAYMENT FOR DRUGS.—
(1) SPECIAL RULES FOR CERTAIN DRUGS AND BIOLOGICALS.—
Section 1833(t) (42 U.S.C. 1395l(t)), as amended by section
411(b), is amended by inserting after paragraph (13) the fol-
lowing new paragraphs:
‘‘(14) DRUG APC PAYMENT RATES.—
‘‘(A) IN GENERAL.—The amount of payment under this
subsection for a specified covered outpatient drug (defined
in subparagraph (B)) that is furnished as part of a covered
OPD service (or group of services)—
‘‘(i) in 2004, in the case of—
‘‘(I) a sole source drug shall in no case be
less than 88 percent, or exceed 95 percent, of the
reference average wholesale price for the drug;
‘‘(II) an innovator multiple source drug shall
in no case exceed 68 percent of the reference aver-
age wholesale price for the drug; or
‘‘(III) a noninnovator multiple source drug
shall in no case exceed 46 percent of the reference
average wholesale price for the drug;
‘‘(ii) in 2005, in the case of—
‘‘(I) a sole source drug shall in no case be
less than 83 percent, or exceed 95 percent, of the
reference average wholesale price for the drug;
‘‘(II) an innovator multiple source drug shall
in no case exceed 68 percent of the reference aver-
age wholesale price for the drug; or
‘‘(III) a noninnovator multiple source drug
shall in no case exceed 46 percent of the reference
average wholesale price for the drug; or
‘‘(iii) in a subsequent year, shall be equal, subject
to subparagraph (E)—
‘‘(I) to the average acquisition cost for the drug
for that year (which, at the option of the Secretary,
may vary by hospital group (as defined by the
Secretary based on volume of covered OPD services
or other relevant characteristics)), as determined
by the Secretary taking into account the hospital
acquisition cost survey data under subparagraph
(D); or
‘‘(II) if hospital acquisition cost data are not
available, the average price for the drug in the
year established under section 1842(o), section
1847A, or section 1847B, as the case may be, as
calculated and adjusted by the Secretary as nec-
essary for purposes of this paragraph.
‘‘(B) SPECIFIED COVERED OUTPATIENT DRUG DEFINED.—
‘‘(i) IN
GENERAL.—In this paragraph, the term
‘specified covered outpatient drug’ means, subject to
clause (ii), a covered outpatient drug (as defined in
section 1927(k)(2)) for which a separate ambulatory
H. R. 1—243
payment classification group (APC) has been estab-
lished and that is—
‘‘(I) a radiopharmaceutical; or
‘‘(II) a drug or biological for which payment
was made under paragraph (6) (relating to pass-
through payments) on or before December 31,
2002.
‘‘(ii) EXCEPTION.—Such term does not include—
‘‘(I) a drug or biological for which payment
is first made on or after January 1, 2003, under
paragraph (6);
‘‘(II) a drug or biological for which a temporary
HCPCS code has not been assigned; or
‘‘(III) during 2004 and 2005, an orphan drug
(as designated by the Secretary).
‘‘(C) PAYMENT FOR DESIGNATED ORPHAN DRUGS DURING
2004 AND 2005.—The amount of payment under this sub-
section for an orphan drug designated by the Secretary
under subparagraph (B)(ii)(III) that is furnished as part
of a covered OPD service (or group of services) during
2004 and 2005 shall equal such amount as the Secretary
may specify.
‘‘(D) ACQUISITION
COST
SURVEY
FOR
HOSPITAL
OUT-
PATIENT DRUGS.—
‘‘(i) ANNUAL GAO SURVEYS IN 2004 AND 2005.—
‘‘(I) IN GENERAL.—The Comptroller General of
the United States shall conduct a survey in each
of 2004 and 2005 to determine the hospital acquisi-
tion cost for each specified covered outpatient drug.
Not later than April 1, 2005, the Comptroller Gen-
eral shall furnish data from such surveys to the
Secretary for use in setting the payment rates
under subparagraph (A) for 2006.
‘‘(II) RECOMMENDATIONS.—Upon the comple-
tion of such surveys, the Comptroller General shall
recommend to the Secretary the frequency and
methodology of subsequent surveys to be conducted
by the Secretary under clause (ii).
‘‘(ii) SUBSEQUENT SECRETARIAL SURVEYS.—The Sec-
retary, taking into account such recommendations,
shall conduct periodic subsequent surveys to determine
the hospital acquisition cost for each specified covered
outpatient drug for use in setting the payment rates
under subparagraph (A).
‘‘(iii) SURVEY
REQUIREMENTS.—The surveys con-
ducted under clauses (i) and (ii) shall have a large
sample of hospitals that is sufficient to generate a
statistically significant estimate of the average hospital
acquisition cost for each specified covered outpatient
drug. With respect to the surveys conducted under
clause (i), the Comptroller General shall report to Con-
gress on the justification for the size of the sample
used in order to assure the validity of such estimates.
‘‘(iv) DIFFERENTIATION
IN
COST.—In conducting
surveys under clause (i), the Comptroller General shall
determine and report to Congress if there is (and the
extent of any) variation in hospital acquisition costs
H. R. 1—244
for drugs among hospitals based on the volume of
covered OPD services performed by such hospitals or
other relevant characteristics of such hospitals (as
defined by the Comptroller General).
‘‘(v) COMMENT
ON
PROPOSED
RATES.—Not later
than 30 days after the date the Secretary promulgated
proposed rules setting forth the payment rates under
subparagraph (A) for 2006, the Comptroller General
shall evaluate such proposed rates and submit to Con-
gress a report regarding the appropriateness of such
rates based on the surveys the Comptroller General
has conducted under clause (i).
‘‘(E) ADJUSTMENT IN PAYMENT RATES FOR OVERHEAD
COSTS.—
‘‘(i) MEDPAC REPORT ON DRUG APC DESIGN.—The
Medicare Payment Advisory Commission shall submit
to the Secretary, not later than July 1, 2005, a report
on adjustment of payment for ambulatory payment
classifications for specified covered outpatient drugs
to take into account overhead and related expenses,
such as pharmacy services and handling costs. Such
report shall include—
‘‘(I) a description and analysis of the data
available with regard to such expenses;
‘‘(II) a recommendation as to whether such
a payment adjustment should be made; and
‘‘(III) if such adjustment should be made, a
recommendation regarding the methodology for
making such an adjustment.
‘‘(ii) ADJUSTMENT
AUTHORIZED.—The Secretary
may adjust the weights for ambulatory payment classi-
fications for specified covered outpatient drugs to take
into account the recommendations contained in the
report submitted under clause (i).
‘‘(F) CLASSES OF DRUGS.—For purposes of this para-
graph:
‘‘(i) SOLE SOURCE DRUGS.—The term ‘sole source
drug’ means—
‘‘(I) a biological product (as defined under sec-
tion 1861(t)(1)); or
‘‘(II) a single source drug (as defined in section
1927(k)(7)(A)(iv)).
‘‘(ii) INNOVATOR
MULTIPLE
SOURCE
DRUGS.—The
term ‘innovator multiple source drug’ has the meaning
given such term in section 1927(k)(7)(A)(ii).
‘‘(iii) NONINNOVATOR MULTIPLE SOURCE DRUGS.—
The term ‘noninnovator multiple source drug’ has the
meaning given such term in section 1927(k)(7)(A)(iii).
‘‘(G) REFERENCE
AVERAGE
WHOLESALE
PRICE.—The
term ‘reference average wholesale price’ means, with
respect to a specified covered outpatient drug, the average
wholesale price for the drug as determined under section
1842(o) as of May 1, 2003.
‘‘(H) INAPPLICABILITY
OF
EXPENDITURES
IN
DETER-
MINING CONVERSION, WEIGHTING, AND OTHER ADJUSTMENT
FACTORS.—Additional expenditures resulting from this
paragraph shall not be taken into account in establishing
H. R. 1—245
the conversion, weighting, and other adjustment factors
for 2004 and 2005 under paragraph (9), but shall be taken
into account for subsequent years.
‘‘(15) PAYMENT FOR NEW DRUGS AND BIOLOGICALS UNTIL
HCPCS CODE ASSIGNED.—With respect to payment under this
part for an outpatient drug or biological that is covered under
this part and is furnished as part of covered OPD services
for which a HCPCS code has not been assigned, the amount
provided for payment for such drug or biological under this
part shall be equal to 95 percent of the average wholesale
price for the drug or biological.’’.
(2) REDUCTION
IN
THRESHOLD
FOR
SEPARATE
APCS
FOR
DRUGS.—Section 1833(t)(16), as redesignated section 411(b), is
amended by adding at the end the following new subparagraph:
‘‘(B) THRESHOLD FOR ESTABLISHMENT OF SEPARATE APCS
FOR DRUGS.—The Secretary shall reduce the threshold for
the establishment of separate ambulatory payment classi-
fication groups (APCs) with respect to drugs or biologicals
to $50 per administration for drugs and biologicals fur-
nished in 2005 and 2006.’’.
(3) EXCLUSION OF SEPARATE DRUG APCS FROM OUTLIER PAY-
MENTS.—Section 1833(t)(5) is amended by adding at the end
the following new subparagraph:
‘‘(E) EXCLUSION OF SEPARATE DRUG AND BIOLOGICAL
APCS
FROM
OUTLIER
PAYMENTS.—No additional payment
shall be made under subparagraph (A) in the case of
ambulatory payment classification groups established sepa-
rately for drugs or biologicals.’’.
(4) 
PAYMENT
FOR
PASS
THROUGH
DRUGS.—Section
1833(t)(6)(D)(i) (42 U.S.C. 1395l(t)(6)(D)(i)) is amended by
inserting after ‘‘under section 1842(o)’’ the following: ‘‘(or if
the drug or biological is covered under a competitive acquisition
contract under section 1847B, an amount determined by the
Secretary equal to the average price for the drug or biological
for all competitive acquisition areas and year established under
such section as calculated and adjusted by the Secretary for
purposes of this paragraph)’’.
(5) CONFORMING
AMENDMENT
TO
BUDGET
NEUTRALITY
REQUIREMENT.—Section 1833(t)(9)(B) (42 U.S.C. 1395l(t)(9)(B))
is amended by adding at the end the following: ‘‘In determining
adjustments under the preceding sentence for 2004 and 2005,
the Secretary shall not take into account under this subpara-
graph or paragraph (2)(E) any expenditures that would not
have been made but for the application of paragraph (14).’’.
(6) EFFECTIVE DATE.—The amendments made by this sub-
section shall apply to items and services furnished on or after
January 1, 2004.
(b) SPECIAL PAYMENT FOR BRACHYTHERAPY.—
(1) IN GENERAL.—Section 1833(t)(16), as redesignated by
section 411(b) and as amended by subsection (a)(2), is amended
by adding at the end the following new subparagraph:
‘‘(C) PAYMENT
FOR
DEVICES
OF
BRACHYTHERAPY
AT
CHARGES
ADJUSTED
TO
COST.—Notwithstanding the pre-
ceding provisions of this subsection, for a device of
brachytherapy consisting of a seed or seeds (or radioactive
source) furnished on or after January 1, 2004, and before
January 1, 2007, the payment basis for the device under
H. R. 1—246
this subsection shall be equal to the hospital’s charges
for each device furnished, adjusted to cost. Charges for
such devices shall not be included in determining any
outlier payment under this subsection.’’.
(2) 
SPECIFICATION
OF
GROUPS
FOR
BRACHYTHERAPY
DEVICES.—Section 
1833(t)(2) 
(42 
U.S.C. 
1395l(t)(2)) 
is
amended—
(A) in subparagraph (F), by striking ‘‘and’’ at the end;
(B) in subparagraph (G), by striking the period at
the end and inserting ‘‘; and’’; and
(C) by adding at the end the following new subpara-
graph:
‘‘(H) with respect to devices of brachytherapy consisting
of a seed or seeds (or radioactive source), the Secretary
shall create additional groups of covered OPD services that
classify such devices separately from the other services
(or group of services) paid for under this subsection in
a manner reflecting the number, isotope, and radioactive
intensity of such devices furnished, including separate
groups for palladium-103 and iodine-125 devices.’’.
(3) GAO REPORT.—The Comptroller General of the United
States shall conduct a study to determine appropriate payment
amounts under section 1833(t)(16)(C) of the Social Security
Act, as added by paragraph (1), for devices of brachytherapy.
Not later than January 1, 2005, the Comptroller General shall
submit to Congress and the Secretary a report on the study
conducted under this paragraph, and shall include specific rec-
ommendations for appropriate payments for such devices.
SEC. 622. LIMITATION OF APPLICATION OF FUNCTIONAL EQUIVA-
LENCE STANDARD.
Section 1833(t)(6) (42 U.S.C. 1395l(t)(6)) is amended by adding
at the end the following new subparagraph:
‘‘(F) LIMITATION
OF
APPLICATION
OF
FUNCTIONAL
EQUIVALENCE STANDARD.—
‘‘(i) IN GENERAL.—The Secretary may not publish
regulations that apply a functional equivalence
standard to a drug or biological under this paragraph.
‘‘(ii) APPLICATION.—Clause (i) shall apply to the
application of a functional equivalence standard to a
drug or biological on or after the date of enactment
of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 unless—
‘‘(I) such application was being made to such
drug or biological prior to such date of enactment;
and
‘‘(II) the Secretary applies such standard to
such drug or biological only for the purpose of
determining eligibility of such drug or biological
for additional payments under this paragraph and
not for the purpose of any other payments under
this title.
‘‘(iii) RULE
OF
CONSTRUCTION.—Nothing in this
subparagraph shall be construed to effect the Sec-
retary’s authority to deem a particular drug to be
H. R. 1—247
identical to another drug if the 2 products are pharma-
ceutically equivalent and bioequivalent, as determined
by the Commissioner of Food and Drugs.’’.
SEC. 623. PAYMENT FOR RENAL DIALYSIS SERVICES.
(a) INCREASE IN RENAL DIALYSIS COMPOSITE RATE FOR SERVICES
FURNISHED.—The last sentence of section 1881(b)(7) (42 U.S.C.
1395rr(b)(7)) is amended—
(1) by striking ‘‘and’’ before ‘‘for such services’’ the second
place it appears;
(2) by inserting ‘‘and before January 1, 2005,’’ after
‘‘January 1, 2001,’’; and
(3) by inserting before the period at the end the following:
‘‘, and for such services furnished on or after January 1, 2005,
by 1.6 percent above such composite rate payment amounts
for such services furnished on December 31, 2004’’.
(b) RESTORING COMPOSITE RATE EXCEPTIONS FOR PEDIATRIC
FACILITIES.—
(1) IN GENERAL.—Section 422(a)(2) of BIPA is amended—
(A) in subparagraph (A), by striking ‘‘and (C)’’ and
inserting ‘‘, (C), and (D)’’;
(B) in subparagraph (B), by striking ‘‘In the case’’ and
inserting ‘‘Subject to subparagraph (D), in the case’’; and
(C) by adding at the end the following new subpara-
graph:
‘‘(D) INAPPLICABILITY TO PEDIATRIC FACILITIES.—Sub-
paragraphs (A) and (B) shall not apply, as of October
1, 2002, to pediatric facilities that do not have an exception
rate described in subparagraph (C) in effect on such date.
For purposes of this subparagraph, the term ‘pediatric
facility’ means a renal facility at least 50 percent of whose
patients are individuals under 18 years of age.’’.
(2) CONFORMING AMENDMENT.—The fourth sentence of sec-
tion 1881(b)(7) (42 U.S.C. 1395rr(b)(7)) is amended by striking
‘‘The Secretary’’ and inserting ‘‘Subject to section 422(a)(2) of
the Medicare, Medicaid, and SCHIP Benefits Improvement and
Protection Act of 2000, the Secretary’’.
(c) INSPECTOR GENERAL STUDIES ON ESRD DRUGS.—
(1) IN GENERAL.—The Inspector General of the Department
of Health and Human Services shall conduct two studies with
respect to drugs and biologicals (including erythropoietin) fur-
nished to end-stage renal disease patients under the medicare
program which are separately billed by end stage renal disease
facilities.
(2) STUDIES ON ESRD DRUGS.—
(A) EXISTING DRUGS.—The first study under paragraph
(1) shall be conducted with respect to such drugs and
biologicals for which a billing code exists prior to January
1, 2004.
(B) NEW DRUGS.—The second study under paragraph
(1) shall be conducted with respect to such drugs and
biologicals for which a billing code does not exist prior
to January 1, 2004.
(3) MATTERS STUDIED.—Under each study conducted under
paragraph (1), the Inspector General shall—
(A) determine the difference between the amount of
payment made to end stage renal disease facilities under