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SubtitleB

SubtitleB

Note: this is a hand enrollment pursuant to Public Law 105-32.

H.R.2015

One Hundred Fifth Congress

of the

United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday,
the seventh day of January, one thousand nine hundred and
ninety-seven


An Act


Subtitle B–Prevention
Initiatives

SEC. 4101. SCREENING MAMMOGRAPHY.

(a) Providing Annual Screening Mammography for Women Over Age
39.– Section 1834(c)(2)(A) (42 U.S.C. 1395m(c)(2)(A)) is amended–
(1) in clause (iii), to read as follows: (iii) In the case of a woman
over 39 years of age, payment may not be made under this part for
screening mammography performed within 11 months following the month
in which a previous screening mammography was performed.”; and (2) by
striking clauses (iv) and (v).

(b) Waiver of Deductible.–The first sentence of section 1833(b)
(42 U.S.C. 1395l(b)) is amended– (1) by striking “and” before “(4)”,
and (2) by inserting before the period at the end the following: ,
and (5) such deductible shall not apply with respect to screening
mammography (as described in section 1861(jj))”.

(c) Conforming Amendment.–Section 1834(c)(1)(C) (42 U.S.C.
1395m(c)(1)(C)) is amended by striking “, subject to the deductible
established under section 1833(b),”.

(d) Effective Date.–The amendments made by this section shall
apply to items and services furnished on or after January 1, 1998.


SEC. 4102. SCREENING PAP SMEAR AND PELVIC EXAMS.

(a) Coverage of Pelvic Exam; Increasing Frequency of Coverage of
Pap Smear.–Section 1861(nn) (42 U.S.C. 1395x(nn)) is amended– (1)
in the heading, by striking “Smear” and inserting “Smear; Screening
Pelvic Exam”; (2) by inserting “or vaginal” after “cervical” each
place it appears; (3) by striking “(nn)” and inserting “(nn)(1)”; (4)
by striking “3 years” and all that follows and inserting “3 years, or
during the preceding year in the case of a woman described in
paragraph (3).”; and (5) by adding at the end the following new
paragraphs: (2) The term ‘screening pelvic exam’ means a pelvic
examination provided to a woman if the woman involved has not had
such an examination during the preceding 3 years, or during the
preceding year in the case of a woman described in paragraph (3), and
includes a clinical breast examination.

(3) A woman described in this paragraph is a woman who– (A) is of
childbearing age and has had a test described in this subsection
during any of the preceding 3 years that indicated the presence of
cervical or vaginal cancer or other abnormality; or (B) is at high
risk of developing cervical or vaginal cancer (as determined pursuant
to factors identified by the Secretary).”.

(b) Waiver of Deductible.–The first sentence of section 1833(b)
(42 U.S.C. 1395l(b)), as amended by section 4101(b), is amended– (1)
by striking “and” before “(5)”, and (2) by inserting before the
period at the end the following: , and (6) such deductible shall not
apply with respect to screening pap smear and screening pelvic exam
(as described in section 1861(nn))”.

(c) Conforming Amendments.–Sections 1861(s)(14) and 1862(a)(1)(F)
(42 U.S.C. 1395x(s)(14), 1395y(a)(1)(F)) are each amended by
inserting “and screening pelvic exam” after “screening pap smear”.

(d) Payment Under Physician Fee Schedule.–Section 1848(j)(3) (42
U.S.C. 1395w-4(j)(3)) is amended by striking “and (4)” and inserting
“(4) and (14) (with respect to services described in section
1861(nn)(2))”.

(e) Effective Date.–The amendments made by this section shall
apply to items and services furnished on or after January 1, 1998.


SEC. 4103. PROSTATE CANCER SCREENING TESTS.

(a) Coverage.–Section 1861 (42 U.S.C. 1395x) is amended– (1) in
subsection (s)(2)– (A) by striking “and” at the end of subparagraphs
(N) and (O), and (B) by inserting after subparagraph (O) the
following new subparagraph: (P) prostate cancer screening tests (as
defined in subsection (oo)); and”; and (2) by adding at the end the
following new subsection:

~ Prostate Cancer Screening Tests
~

(oo)(1) The term ‘prostate cancer screening test’ means a test
that consists of any (or all) of the procedures described in
paragraph (2) provided for the purpose of early detection of prostate
cancer to a man over 50 years of age who has not had such a test
during the preceding year.

(2) The procedures described in this paragraph are as follows: (A)
A digital rectal examination.

(B) A prostate-specific antigen blood test.

(C) For years beginning after 2002, such other procedures as the
Secretary finds appropriate for the purpose of early detection of
prostate cancer, taking into account changes in technology and
standards of medical practice, availability, effectiveness, costs,
and such other factors as the Secretary considers appropriate.”.

(b) Payment for Prostate-specific Antigen Blood Test Under
Clinical Diagnostic Laboratory Test Fee Schedules.–Section
1833(h)(1)(A) (42 U.S.C. 1395l(h)(1)(A)) is amended by inserting
after “laboratory tests” the following: (including prostate cancer
screening tests under section 1861(oo) consisting of
prostate-specific antigen blood tests)”.

(c) Conforming Amendment.–Section 1862(a) (42 U.S.C. 1395y(a)) is
amended– (1) in paragraph (1)– (A) in subparagraph (E), by striking
“and” at the end, (B) in subparagraph (F), by striking the semicolon
at the end and inserting “, and”, and (C) by adding at the end the
following new subparagraph: (G) in the case of prostate cancer
screening tests (as defined in section 1861(oo)), which are performed
more frequently than is covered under such section;”; and (2) in
paragraph (7), by striking “paragraph (1)(B) or under paragraph
(1)(F)” and inserting “subparagraphs (B), (F), or (G) of paragraph
(1)”.

(d) Payment Under Physician Fee Schedule.–Section 1848(j)(3) (42
U.S.C. 1395w-4(j)(3)), as amended by section 4102, is amended by
inserting “, (2)(P) (with respect to services described in
subparagraphs (A) and (C) of section 1861(oo)(2),” after “(2)(G)” (e)
Effective Date.–The amendments made by this section shall apply to
items and services furnished on or after January 1, 2000.


SEC. 4104. COVERAGE OF COLORECTAL SCREENING.

(a) Coverage.– (1) In general.–Section 1861 (42 U.S.C. 1395x),
as amended by section 4103(a), is amended– (A) in subsection
(s)(2)– (i) by striking “and” at the end of subparagraph (P); (ii)
by adding and” at the end of subparagraph (Q); and (iii) by adding at
the end the following new subparagraph: (R) colorectal cancer
screening tests (as defined in subsection (pp)); and”; and (B) by
adding at the end the following new subsection:

~ Colorectal Cancer Screening Tests
~

(pp)(1) The term ‘colorectal cancer screening test’ means any of
the following procedures furnished to an individual for the purpose
of early detection of colorectal cancer: (A) Screening fecal-occult
blood test.

(B) Screening flexible sigmoidoscopy.

(C) In the case of an individual at high risk for colorectal
cancer, screening colonoscopy.

(D) Such other tests or procedures, and modifications to tests and
procedures under this subsection, with such frequency and payment
limits, as the Secretary determines appropriate, in consultation with
appropriate organizations.

(2) In paragraph (1)(C), an ‘individual at high risk for
colorectal cancer’ is an individual who, because of family history,
prior experience of cancer or precursor neoplastic polyps, a history
of chronic digestive disease condition (including inflammatory bowel
disease, Crohn’s Disease, or ulcerative colitis), the presence of any
appropriate recognized gene markers for colorectal cancer, or other
predisposing factors, faces a high risk for colorectal cancer.”.

(2) Deadline for publication of determination on coverage of
screening barium enema.–Not later than the earlier of the date that
is January 1, 1998, or 90 days after the date of the enactment of
this Act, the Secretary of Health and Human Services shall publish
notice in the Federal Register with respect to the determination
under paragraph (1)(D) of section 1861(pp) of the Social Security Act
(42 U.S.C. 1395x(pp)), as added by paragraph (1), on the coverage of
a screening barium enema as a colorectal cancer screening test under
such section.

(b) Frequency Limits and Payment.– (1) In general.–Section 1834
(42 U.S.C. 1395m) is amended by inserting after subsection (c) the
following new subsection: (d) Frequency Limits and Payment for
Colorectal Cancer Screening Tests.– (1) Screening fecal-occult blood
tests.– (A) Payment amount.–The payment amount for colorectal
cancer screening tests consisting of screening fecal-occult blood
tests is equal to the payment amount established for diagnostic
fecal-occult blood tests under section 1833(h).

(B) Frequency limit.–No payment may be made under this part for a
colorectal cancer screening test consisting of a screening
fecal-occult blood test– (i) if the individual is under 50 years of
age; or (ii) if the test is performed within the 11 months after a
previous screening fecal-occult blood test.

(2) Screening flexible sigmoidoscopies.– (A) Fee schedule.–With
respect to colorectal cancer screening tests consisting of screening
flexible sigmoidoscopies, payment under section 1848 shall be
consistent with payment under such section for similar or related
services.

(B) Payment limit.–In the case of screening flexible
sigmoidoscopy services, payment under this part shall not exceed such
amount as the Secretary specifies, based upon the rates recognized
for diagnostic flexible sigmoidoscopy services.

(C) Facility payment limit.– (i) In general.–Notwithstanding
subsections (i)(2)(A) and (t) of section 1833, in the case of
screening flexible sigmoidoscopy services furnished on or after
January 1, 1999, that–

(I) in accordance with regulations, may be performed in an
ambulatory surgical center and for which the Secretary permits
ambulatory surgical center payments under this part, and (II) are
performed in an ambulatory surgical center or hospital outpatient
department,

payment under this part shall be based on the lesser of the amount
under the fee schedule that would apply to such services if they were
performed in a hospital outpatient department in an area or the
amount under the fee schedule that would apply to such services if
they were performed in an ambulatory surgical center in the same
area.

(ii) Limitation on deductible and coinsurance.– Notwithstanding
any other provision of this title, in the case of a beneficiary who
receives the services described in clause (i)–

(I) in computing the amount of any applicable deductible or
copayment, the computation of such deductible or coinsurance shall be
based upon the fee schedule under which payment is made for the
services, and (II) the amount of such coinsurance is equal to 25
percent of the payment amount under the fee schedule described in
subclause (I).

(D) Special rule for detected lesions.–If during the course of
such screening flexible sigmoidoscopy, a lesion or growth is detected
which results in a biopsy or removal of the lesion or growth, payment
under this part shall not be made for the screening flexible
sigmoidoscopy but shall be made for the procedure classified as a
flexible sigmoidoscopy with such biopsy or removal.

(E) Frequency limit.–No payment may be made under this part for a
colorectal cancer screening test consisting of a screening flexible
sigmoidoscopy– (i) if the individual is under 50 years of age; or
(ii) if the procedure is performed within the 47 months after a
previous screening flexible sigmoidoscopy.

(3) Screening colonoscopy for individuals at high risk for
colorectal cancer.– (A) Fee schedule.–With respect to colorectal
cancer screening test consisting of a screening colonoscopy for
individuals at high risk for colorectal cancer (as defined in section
1861(pp)(2)), payment under section 1848 shall be consistent with
payment amounts under such section for similar or related services.

(B) Payment limit.–In the case of screening colonoscopy services,
payment under this part shall not exceed such amount as the Secretary
specifies, based upon the rates recognized for diagnostic colonoscopy
services.

(C) Facility payment limit.– (i) In general.–Notwithstanding
subsections (i)(2)(A) and (t) of section 1833, in the case of
screening colonoscopy services furnished on or after January 1, 1999,
that are performed in an ambulatory surgical center or a hospital
outpatient department, payment under this part shall be based on the
lesser of the amount under the fee schedule that would apply to such
services if they were performed in a hospital outpatient department
in an area or the amount under the fee schedule that would apply to
such services if they were performed in an ambulatory surgical center
in the same area.

(ii) Limitation on deductible and coinsurance.– Notwithstanding
any other provision of this title, in the case of a beneficiary who
receives the services described in clause (i)–

(I) in computing the amount of any applicable deductible or
coinsurance, the computation of such deductible or coinsurance shall
be based upon the fee schedule under which payment is made for the
services, and (II) the amount of such coinsurance is equal to 25
percent of the payment amount under the fee schedule described in
subclause (I).

(D) Special rule for detected lesions.–If during the course of
such screening colonoscopy, a lesion or growth is detected which
results in a biopsy or removal of the lesion 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.

(E) Frequency limit.–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 previous
screening colonoscopy.”.

(c) Conforming Amendments.–(1) Paragraphs (1)(D) and (2)(D) of
section 1833(a) (42 U.S.C. 1395l(a)) are each amended by inserting
“or section 1834(d)(1)” after “subsection (h)(1)”.

(2) Section 1833(h)(1)(A) (42 U.S.C. 1395l(h)(1)(A)) is amended by
striking “The Secretary” and inserting “Subject to section
1834(d)(1), the Secretary”.

(3) Section 1862(a) (42 U.S.C. 1395y(a)), as amended by section
4103(c), is amended– (A) in paragraph (1)– (i) in subparagraph (F),
by striking “and” at the end, (ii) in subparagraph (G), by striking
the semicolon at the end and inserting “, and”, and (iii) by adding
at the end the following new subparagraph: (H) in the case of
colorectal cancer screening tests, which are performed more
frequently than is covered under section 1834(d);”; and (B) in
paragraph (7), by striking “or (G)” and inserting “(G), or (H)”.

(d) Payment Under Physician Fee Schedule.–Section 1848(j)(3) (42
U.S.C. 1395w-4(j)(3)), as amended by sections 4102 and 4103, is
amended by inserting “(2)(R) (with respect to services described in
subparagraphs (B) , (C), and (D) of section 1861(pp)(1)),” before
“(3)”.

(e) Effective Date.–The amendments made by this section shall
apply to items and services furnished on or after January 1, 1998.


SEC. 4105. DIABETES SELF-MANAGEMENT BENEFITS.

(a) Coverage of Diabetes Outpatient Self-management Training
Services.– (1) In general.–Section 1861 (42 U.S.C. 1395x), as
amended by sections 4103(a) and 4104(a), is amended– (A) in
subsection (s)(2)– (i) by striking “and” at the end of subparagraph
(Q); (ii) by adding and” at the end of subparagraph (R); and (iii) by
adding at the end the following new subparagraph: (S) diabetes
outpatient self-management training services (as defined in
subsection (qq)); and”; and (B) by adding at the end the following
new subsection:

~ Diabetes Outpatient
Self-Management Training Services ~

(qq)(1) The term ‘diabetes outpatient self-management training
services’ means educational and training services furnished (at such
times as the Secretary determines appropriate) to an individual with
diabetes by a certified provider (as described in paragraph (2)(A))
in an outpatient setting by an individual or entity who meets the
quality standards described in paragraph (2)(B), but only if the
physician who is managing the individual’s diabetic condition
certifies that such services are needed under a comprehensive plan of
care related to the individual’s diabetic condition to ensure therapy
compliance or to provide the individual with necessary skills and
knowledge (including skills related to the self-administration of
injectable drugs) to participate in the management of the
individual’s condition.

(2) In paragraph (1)– (A) a ‘certified provider’ is a physician,
or other individual or entity designated by the Secretary, that, in
addition to providing diabetes outpatient self-management training
services, provides other items or services for which payment may be
made under this title; and (B) a physician, or such other individual
or entity, meets the quality standards described in this paragraph if
the physician, or individual or entity, meets quality standards
established by the Secretary, except that the physician or other
individual or entity shall be deemed to have met such standards if
the physician or other individual or entity meets applicable
standards originally established by the National Diabetes Advisory
Board and subsequently revised by organizations who participated in
the establishment of standards by such Board, or is recognized by an
organization that represents individuals (including individuals under
this title) with diabetes as meeting standards for furnishing the
services.”.

(2) Payment Under Physician Fee Schedule.–Section 1848(j)(3) (42
U.S.C. 1395w-4(j)(3)) as amended in sections 4102, 4103, and 4104, is
amended by inserting “(2)(S),” before “(3),”.

(3) Consultation with organizations in establishing payment
amounts for services provided by physicians.–In establishing payment
amounts under section 1848 of the Social Security Act for physicians’
services consisting of diabetes outpatient self- management training
services, the Secretary of Health and Human Services shall consult
with appropriate organizations, including such organizations
representing individuals or medicare beneficiaries with diabetes.

(b) Blood-testing Strips for Individuals With Diabetes.– (1)
Including strips and monitors as durable medical equipment.–The
first sentence of section 1861(n) (42 U.S.C.

1395x(n)) is amended by inserting before the semicolon the
following: , and includes blood-testing strips and blood glucose
monitors for individuals with diabetes without regard to whether the
individual has Type I or Type II diabetes or to the individual’s use
of insulin (as determined under standards established by the
Secretary in consultation with the appropriate organizations)”.

(2) 10 percent reduction in payments for testing strips.– Section
1834(a)(2)(B)(iv) (42 U.S.C. 1395m(a)(2)(B)(iv)) is amended by adding
before the period the following: (reduced by 10 percent, in the case
of a blood glucose testing strip furnished after 1997 for an
individual with diabetes)”.

(c) Establishment of Outcome Measures for Beneficiaries With
Diabetes.– (1) In general.–The Secretary of Health and Human
Services, in consultation with appropriate organizations, shall
establish outcome measures, including glysolated hemoglobin (past
90-day average blood sugar levels), for purposes of evaluating the
improvement of the health status of medicare beneficiaries with
diabetes mellitus.

(2) Recommendations for modifications to screening benefits.–
Taking into account information on the health status of medicare
beneficiaries with diabetes mellitus as measured under the outcome
measures established under paragraph (1), 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.– (1) In general.–Except as provided in
paragraph (2), the amendments made by this section shall apply to
items and services furnished on or after July 1, 1998.

(2) Testing strips.–The amendment made by subsection (b)(2) shall
apply with respect to blood glucose testing strips 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), and 4105(a), is amended– (1) in
subsection (s)– (A) in paragraph (12)(C), by striking “and” at the
end, (B) by striking the period at the end of paragraph (14) and
inserting “; and”, (C) by redesignating paragraphs (15) and (16) as
paragraphs (16) and (17), respectively, and (D) by inserting after
paragraph (14) the following new paragraph: (15) bone mass
measurement (as defined in subsection (rr)).”; and (2) by inserting
after subsection (qq) the following new subsection:

~ Bone Mass Measurement ~

(rr)(1) The term ‘bone mass measurement’ means a radiologic or
radioisotopic procedure or other procedure approved by the Food and
Drug Administration performed on a qualified individual (as defined
in paragraph (2)) for the purpose of identifying bone mass or
detecting bone loss or determining bone quality, and includes a
physician’s interpretation of the results of the procedure.

(2) For purposes of this subsection, the term ‘qualified
individual’ means an individual who is (in accordance with
regulations prescribed by the Secretary)– (A) an estrogen-deficient
woman at clinical risk for osteoporosis; (B) an individual with
vertebral abnormalities; (C) an individual receiving long-term
glucocorticoid steroid therapy; (D) an individual with primary
hyperparathyroidism; or (E) an individual being monitored to assess
the response to or efficacy of an approved osteoporosis drug therapy.

(3) The Secretary shall establish such standards regarding the
frequency with which a qualified individual shall be eligible to be
provided benefits for bone mass measurement under this title.”.

(b) Payment under Physician Fee Schedule.–Section 1848(j)(3) (42
U.S.C. 1395w-4(j)(3)), as amended by sections 4102, 4103, 4104 and
4105, is amended– (1) by striking “(4) and (14)” and inserting “(4),
(14)” and (2) by inserting “and (15)” after “1861(nn)(2))”.

(c) Conforming Amendments.–Sections 1864(a), 1902(a)(9)(C), and
1915(a)(1)(B)(ii)(I) (42 U.S.C. 1395aa(a), 1396a(a)(9)(C), and
1396n(a)(1)(B)(ii)(I)) are amended by striking “paragraphs (15) and
(16)” each place it appears and inserting “paragraphs (16) and (17)”.

(d) Effective Date.–The amendments made by this section shall
apply to bone mass measurements performed on or after July 1, 1998.


SEC. 4107. VACCINES OUTREACH EXPANSION.

(a) Extension of Influenza and Pneumococcal Vaccination
Campaign.– In order to increase utilization of pneumococcal and
influenza vaccines in medicare beneficiaries, the Influenza and
Pneumococcal Vaccination Campaign carried out by the Health Care
Financing Administration in conjunction with the Centers for Disease
Control and Prevention and the National Coalition for Adult
Immunization, is extended until the end of fiscal year 2002.

(b) Authorization of Appropriation.–There are hereby authorized
to be appropriated for each of fiscal years 1998 through 2002,
$8,000,000 for the Campaign described in subsection (a). Of the
amount so authorized to be appropriated in each fiscal year, 60
percent of the amount so appropriated shall be payable from the
Federal Hospital Insurance Trust Fund, and 40 percent shall be
payable from the Federal Supplementary Medical Insurance Trust Fund.


SEC. 4108. STUDY ON PREVENTIVE AND ENHANCED BENEFITS.

(a) Study.–The Secretary of Health and Human Services shall
request the National Academy of Sciences, and as appropriate in
conjunction with the United States Preventive Services Task Force, to
analyze the expansion or modification of preventive or other benefits
provided to medicare beneficiaries under title XVIII of the Social
Security Act. The analysis shall consider both the short term and
long term benefits, and costs to the medicare program, of such
expansion or modification.

(b) Report.– (1) Initial report.–Not later than 2 years after
the date of the enactment of this Act, the Secretary shall submit a
report on the findings of the analysis conducted under subsection (a)
to the Committee on Ways and Means and the Committee on Commerce of
the House of Representatives and the Committee on Finance of the
Senate.

(2) Contents.–Such report shall include specific findings with
respect to coverage of at least the following benefits: (A) Nutrition
therapy services, including parenteral and enteral nutrition and
including the provision of such services by a registered dietitian.

(B) Skin cancer screening.

(C) Medically necessary dental care.

(D) Routine patient care costs for beneficiaries enrolled in
approved clinical trial programs.

(E) Elimination of time limitation for coverage of
immunosuppressive drugs for transplant patients.

(3) Funding.–From funds appropriated to the Department of Health
and Human Services for fiscal years 1998 and 1999, the Secretary
shall provide for such funding as the Secretary determines necessary
for the conduct of the study by the National Academy of Sciences
under this section.


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