382
‘‘(B) PAYMENT
LIMIT.—In the case of
screening colonoscopy services—
‘‘(i) the payment amount may not ex-
ceed such amount as the Secretary speci-
fies, based upon the rates recognized under
this part for diagnostic colonoscopy serv-
ices; and
‘‘(ii) that are performed in an ambula-
tory surgical center or hospital outpatient
department, the payment amount under
this part may not exceed the lesser of (I)
the payment rate that would apply to such
services if they were performed in a hos-
pital outpatient department, or (II) the
payment rate that would apply to such
services if they were performed in an am-
bulatory surgical center.
‘‘(C) SPECIAL RULE FOR DETECTED LE-
SIONS.—If during the course of such screening
colonoscopy, a lesion or growth is detected
which results in a biopsy or removal of the le-
sion or growth, payment under this part shall
not be made for the screening colonoscopy but
shall be made for the procedure classified as a
colonoscopy with such biopsy or removal.
383
‘‘(D) FREQUENCY LIMIT.—Subject to revi-
sion by the Secretary under paragraph (4)(B),
no payment may be made under this part for
a colorectal cancer screening test consisting of
a screening colonoscopy for individuals at high
risk for colorectal cancer if the procedure is
performed within the 23 months after a pre-
vious screening colonoscopy.
‘‘(4) REDUCTIONS IN PAYMENT LIMIT AND RE-
VISION OF FREQUENCY.—
‘‘(A) REDUCTIONS IN PAYMENT LIMIT FOR
SCREENING
FECAL-OCCULT
BLOOD
TESTS.—
The Secretary shall review from time to time
the appropriateness of the amount of the pay-
ment limit established for screening fecal-occult
blood tests under paragraph (1)(A). The Sec-
retary may, with respect to tests performed in
a year after 2000, reduce the amount of such
limit as it applies nationally or in any area to
the amount that the Secretary estimates is re-
quired to assure that such tests of an appro-
priate quality are readily and conveniently
available during the year.
‘‘(B) REVISION OF FREQUENCY.—
384
‘‘(i) REVIEW.—The Secretary shall re-
view periodically the appropriate frequency
for performing colorectal cancer screening
tests based on age and such other factors
as the Secretary believes to be pertinent.
‘‘(ii) REVISION OF FREQUENCY.—The
Secretary, taking into consideration the re-
view made under clause (i), may revise
from time to time the frequency with
which such tests may be paid for under
this subsection, but no such revision shall
apply to tests performed before January 1,
2001.
‘‘(5) LIMITING CHARGES OF NONPARTICIPATING
PHYSICIANS.—
‘‘(A) IN
GENERAL.—In the case of a
colorectal cancer screening test consisting of a
screening flexible sigmoidoscopy or a screening
colonoscopy provided to an individual at high
risk for colorectal cancer for which payment
may be made under this part, if a nonpartici-
pating physician provides the procedure to an
individual enrolled under this part, the physi-
cian may not charge the individual more than
385
the limiting charge (as defined in section
1848(g)(2)).
‘‘(B) ENFORCEMENT.—If a physician or
supplier knowing and willfully imposes a charge
in violation of subparagraph (A), the Secretary
may apply sanctions against such physician or
supplier 
in 
accordance 
with 
section
1842(j)(2).’’.
(2) SPECIAL
RULE
FOR
SCREENING
BARIUM
ENEMA.—If the Secretary of Health and Human
Services issues a determination under subsection
(a)(2) that screening barium enema should be cov-
ered as a colorectal cancer screening test under sec-
tion 1861(pp) (as added by subsection (a)(1)(B)),
the Secretary shall establish frequency limits (in-
cluding revisions of frequency limits) for such proce-
dure consistent with the frequency limits for other
colorectal cancer screening tests under section
1834(d) (as added by subsection (b)(1)), and shall
establish payment limits (including limits on charges
of nonparticipating physicians) for such procedure
consistent with the payment limits under part B of
title XVIII for diagnostic barium enema procedures.
(c) CONFORMING AMENDMENTS.—(1) Paragraphs
(1)(D) and (2)(D) of section 1833(a) (42 U.S.C. 1395l(a))
391
cluding glysolated hemoglobin (past 90-day average
blood sugar levels), for purposes of evaluating the
improvement of the health status of medicare bene-
ficiaries with diabetes mellitus.
(2) RECOMMENDATIONS
FOR
MODIFICATIONS
TO SCREENING BENEFITS.—Taking into account in-
formation on the health status of medicare bene-
ficiaries with diabetes mellitus as measured under
the outcome measures established under subpara-
graph (A), the Secretary shall from time to time
submit recommendations to Congress regarding
modifications to the coverage of services for such
beneficiaries under the medicare program.
(d) EFFECTIVE DATE.—The amendments made by
this section shall apply to items and services furnished on
or after January 1, 1998.
SEC. 4106. STANDARDIZATION OF MEDICARE COVERAGE OF
BONE MASS MEASUREMENTS.
(a) IN GENERAL.—Section 1861 (42 U.S.C. 1395x),
as amended by sections 4103(a), 4104(a), 4105(a), is
amended—
(1) in subsection (s)—
(A) in paragraph (12)(C), by striking
‘‘and’’ at the end,
830
[HVAC Reconciliation]
reconsideration by the MedicarePlus organiza-
tion regarding a matter described in paragraph
(2). The organization shall also permit the ac-
ceptance of such requests by physicians.
‘‘(B) ORGANIZATION PROCEDURES.—
‘‘(i) IN GENERAL.—The MedicarePlus
organization shall maintain procedures for
expediting organization determinations and
reconsiderations when, upon request of an
enrollee, the organization determines that
the application of normal time frames for
making a determination (or a reconsider-
ation involving a determination) could seri-
ously jeopardize the life or health of the
enrollee or the enrollee’s ability to regain
maximum function.
‘‘(ii) TIMELY RESPONSE.—In an ur-
gent case described in clause (i), the orga-
nization shall notify the enrollee (and the
physician involved, as appropriate) of the
determination (or determination on the re-
consideration) as expeditiously as the en-
rollee’s health condition requires, but not
later than 72 hours (or 24 hours in the
case of a reconsideration) of the time of re-
1279
[HVAC Reconciliation]
(A) IN
GENERAL.—(i) Punitive damages
shall not be awarded against a manufacturer or
product seller of a drug or medical device which
caused the claimant’s harm where—
(I) such drug or device was subject to
premarket approval by the Food and Drug
Administration with respect to the safety
of the formulation or performance of the
aspect of such drug or device which caused
the claimant’s harm, or the adequacy of
the packaging or labeling of such drug or
device which caused the harm, and such
drug, device, packaging, or labeling was
approved by the Food and Drug Adminis-
tration; or
(II) the drug is generally recognized
as safe and effective pursuant to conditions
established by the Food and Drug Admin-
istration and applicable regulations, includ-
ing packaging and labeling regulations.
(ii) Clause (i) shall not apply in any case
in which the defendant, before or after pre-
market approval of a drug or device—
(I) intentionally and wrongfully with-
held from or misrepresented to the Food