I

106TH CONGRESS

2D SESSION H. R. 4743

To amend the Social Security Act to improve access to prescription drugs

for low-income Medicare beneficiaries, the Internal Revenue Code and

other Acts to improve access to health care coverage for seniors, the

self-employed, and children, and to amend the Federal Food, Drug,

and Cosmetic Act to improve meaningful access to reasonably priced

prescription drugs.

IN THE HOUSE OF REPRESENTATIVES

JUNE 26, 2000

Mr. GANSKE introduced the following bill; which was referred to the Committee on Commerce, and in addition to the Committee on Ways and

Means, for a period to be subsequently determined by the Speaker, in

each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL

To amend the Social Security Act to improve access to prescription drugs for low-income Medicare beneficiaries, the

Internal Revenue Code and other Acts to improve access

to health care coverage for seniors, the self-employed,

and children, and to amend the Federal Food, Drug,

and Cosmetic Act to improve meaningful access to reasonably priced prescription drugs.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

2 (a) SHORT TITLE.—This Act may be cited as the

3 ‘‘Drug Availability and Health Care Access Improvement

4 Act of 2000’’.

5 (b) TABLE OF CONTENTS.—The table of contents of

6 this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I—MEDICAID PRESCRIPTION DRUG COVERAGE FOR LOWINCOME MEDICARE BENEFICIARIES

Sec. 101. Medicaid prescription drug coverage for low-income medicare beneficiaries.

TITLE II—IMPROVED ACCESS OF AMERICANS TO HEALTH

INSURANCE COVERAGE

Subtitle A—Access of Medicare Beneficiaries to Medicare+Choice Plans

Sec. 201. Improved access to Medicare+Choice plans through an increase in

the minimum Medicare+Choice capitation rate.

Subtitle B—Access of the Self-Employed

Sec. 211. Deduction for 100 percent of health insurance costs of self-employed

individuals.

Subtitle C—Improve the Coverage of Needy Children under the State

Children’s Health Insurance Program (SCHIP) and the Medicaid Program

Sec. 221. Simplified outreach and enrollment.

Sec. 222. Family friendly coverage and enrollment.

Sec. 223. Expanded coverage options.

TITLE III—IMPROVED ACCESS TO REASONABLY PRICED

PRESCRIPTION DRUGS

Sec. 301. Clarification of certain responsibilities of Food and Drug Administration with respect to importation of drugs into United States.

Sec. 302. Increased consumer information in prescription drug advertising.

Sec. 303. Education about manufacturer programs for free drugs to patients.

Sec. 304. Sense of Congress regarding manufacturer pricing practices.
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1 TITLE I—MEDICAID PRESCRIP2 TION DRUG COVERAGE FOR

3 LOW-INCOME MEDICARE

4 BENEFICIARIES

5 SEC. 101. MEDICAID PRESCRIPTION DRUG COVERAGE FOR

6 LOW-INCOME MEDICARE BENEFICIARIES.

7 (a) IN GENERAL.—Section 1902(a)(10) of the Social

8 Security Act (42 U.S.C. 1396a(a)(10)) is amended—

9 (1) by striking ‘‘and’’ at the end of subpara10 graph (F);

11 (2) by adding ‘‘and’’ at the end of subpara12 graph (G); and

13 (3) by inserting after subparagraph (G) the fol14 lowing new subparagraph:

15 ‘‘(H) for making medical assistance avail16 able for prescribed drugs (in the same amount,

17 duration, and scope as for individuals described

18 in subparagraph (A)) for qualified medicare

19 beneficiaries described in section 1905(p)(1)

20 and for individuals who would be such qualified

21 medicare beneficiaries but for the fact that

22 their income exceeds the income level estab23 lished by the State under section 1905(p)(2)

24 but is less than 175 percent of the official pov-
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1 erty line (referred to in such section) for a fam2 ily of the size involved;’’.

3 (b) 100 PERCENT FEDERAL FINANCING OF ADDI4 TIONAL COSTS.—Section 1903(a) of such Act (42 U.S.C.

5 1396b(a)) is amended—

6 (1) by redesignating paragraph (7) as para7 graph (8); and

8 (2) by adding after paragraph (6) the following

9 new paragraph:

10 ‘‘(7) an amount equal to 100 percent of

11 amounts as expended as medical assistance for pre12 scribed drugs described in section 1902(a)(10)(H) to

13 individuals who are eligible for such assistance only

14 on the basis of such section; and’’.

15 (c) PERMITTING CHARGING OF SLIDING SCALE PRE16 MIUMS FOR QUALIFYING INDIVIDUALS WITH INCOMES

17 ABOVE 135 PERCENT OF POVERTY LINE.—Section 1916

18 of such Act is amended—

19 (1) in subsection (b), by striking ‘‘or (E)’’ and

20 inserting ‘‘, (E), or (H)’’; and

21 (2) in subsection (d)—

22 (A) by inserting ‘‘(1)’’ after ‘‘(d)’’, and

23 (B) by adding at the end the following new

24 paragraph:
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1 ‘‘(2)(A) With respect to an individual described in

2 section 1902(a)(10)(H) whose income (as determined

3 under section 1905(p)(1)(B)) exceeds 135 percent of the

4 official poverty line referred to in that section, the State

5 plan of a State shall provide for the charging of a premium

6 (expressed as a percentage of the average actuarial cost

7 of the benefits described in section 1902(a)(10)(H) pro8 vided with respect to individuals described in such section)

9 according to a sliding scale under which such percentage

10 increases from 0 percent to 100 percent, in reasonable in11 crements (as determined by the Secretary), as the individ12 ual’s income increases from 135 percent of such poverty

13 line to 175 percent of such poverty line.

14 ‘‘(B) A State shall not require prepayment of a pre15 mium imposed pursuant to subparagraph (A) and shall

16 not terminate eligibility of an individual for medical assist17 ance under this title on the basis of failure to pay any

18 such premium until such failure continues for a period of

19 not less than 60 days. The State may waive payment of

20 any such premium in any case where the State determines

21 that requiring such payment would create an undue hard22 ship.

23 ‘‘(C) A State may permit State or local funds avail24 able under other programs to be used for payment of a

25 premium imposed under subparagraph (A). Payment of
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1 a premium with such funds shall not be counted as income

2 to the individual with respect to whom such payment is

3 made.’’.

4 (d) EFFECTIVE DATE.—The amendments made by

5 this section take effect on January 1, 2001.

6 TITLE II—IMPROVED ACCESS OF

7 AMERICANS TO HEALTH IN8 SURANCE COVERAGE

9 Subtitle A—Access of Medicare

10 Beneficiaries to

11 Medicare+Choice Plans

12 SEC. 201. IMPROVED ACCESS TO MEDICARE+CHOICE PLANS

13 THROUGH AN INCREASE IN THE MINIMUM

14 MEDICARE+CHOICE CAPITATION RATE.

15 (a) IN GENERAL.—Section 1853(c)(1)(B)(ii) of the

16 Social Security Act (42 U.S.C. 1395w–23(c)(1)(B)(ii)) is

17 amended—

18 (1) by striking ‘‘(ii) For a succeeding year’’ and

19 inserting ‘‘(ii)(I) Subject to subclause (II), for a suc20 ceeding year’’; and

21 (2) by adding at the end the following new sub22 clause:

23 ‘‘(II) For 2001 for any of the 50

24 States and the District of Columbia,

25 $600.’’.
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1 (b) EFFECTIVE DATE.—The amendments made by

2 subsection (a) apply to years beginning with 2001.

3 Subtitle B—Access of the Self4 Employed

5 SEC. 211. DEDUCTION FOR 100 PERCENT OF HEALTH IN6 SURANCE COSTS OF SELF-EMPLOYED INDI7 VIDUALS.

8 (a) IN GENERAL.—Paragraph (1) of section 162(l)

9 of the Internal Revenue Code of 1986 is amended to read

10 as follows:

11 ‘‘(1) ALLOWANCE OF DEDUCTION.—In the case

12 of an individual who is an employee within the

13 meaning of section 401(c)(1), there shall be allowed

14 as a deduction under this section an amount equal

15 to 100 percent of the amount paid during the tax16 able year for insurance which constitutes medical

17 care for the taxpayer and the taxpayer’s spouse and

18 dependents.’’.

19 (b) CLARIFICATION OF LIMITATIONS ON OTHER COV20 ERAGE.—The first sentence of section 162(l)(2)(B) of

21 such Code is amended to read as follows: ‘‘Paragraph (1)

22 shall not apply to any taxpayer for any calendar month

23 for which the taxpayer participates in any subsidized

24 health plan maintained by any employer (other than an
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1 employer described in section 401(c)(4)) of the taxpayer

2 or the spouse of the taxpayer.’’.

3 (c) EFFECTIVE DATE.—The amendments made by

4 this section shall apply to taxable years beginning after

5 December 31, 1999.

6 Subtitle C—Improve the Coverage

7 of Needy Children under the

8 State Children’s Health Insur9 ance Program (SCHIP) and the

10 Medicaid Program

11 SEC. 221. SIMPLIFIED OUTREACH AND ENROLLMENT.

12 (a) USE OF UNIFORM APPLICATION AND COORDI13 NATED ENROLLMENT PROCESS.—

14 (1) SCHIP PROGRAM.—Section 2102 of the So15 cial Security Act (42 U.S.C. 1397bb) is amended by

16 adding at the end the following new subsection:

17 ‘‘(d) DEVELOPMENT AND USE OF UNIFORM APPLI18 CATION FORMS AND COORDINATED ENROLLMENT PROC19 ESS.—A State child health plan shall provide, by not later

20 than the first day of the first month that begins more than

21 6 months after the date of the enactment of this sub22 section, for—

23 ‘‘(1) the development and use of a uniform, sim24 plified application form which is used both for pur-
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1 poses of establishing eligibility for benefits under

2 this title and also under title XIX;

3 ‘‘(2) an enrollment process that is coordinated

4 with that under title XIX so that a family need only

5 interact with a single agency in order to determine

6 whether a child is eligible for benefits under this

7 title or title XIX; and

8 ‘‘(3) acceptance and timely response to tele9 phone inquiries and other electronic communications

10 received through the national toll-free system estab11 lished under section 222 of the Drug Availability

12 and Health Care Access Improvement Act of 2000.’’.

13 (2) MEDICAID CONFORMING AMENDMENT.—

14 (A) IN GENERAL.—Section 1902(a) of

15 such Act (42 U.S.C. 1396a(a)) is amended—

16 (i) by striking the period at the end of

17 paragraph (65) and inserting ‘‘; and’’, and

18 (ii) by inserting after paragraph (65)

19 the following new paragraph:

20 ‘‘(66) provide, by not later than the first day of

21 the first month that begins more than 6 months

22 after the date of the enactment of this paragraph,

23 in the case of a State with a State child health plan

24 under title XXI for—
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1 ‘‘(A) the development and use of a uni2 form, simplified application form which is used

3 both for purposes of establishing eligibility for

4 benefits under this title and also under title

5 XXI;

6 ‘‘(B) establishment and operation of an en7 rollment process that is coordinated with that

8 under title XXI so that a family need only

9 interact with a single agency in order to deter10 mine whether a child is eligible for benefits

11 under this title or title XXI; and

12 ‘‘(C) acceptance and timely response to

13 telephone inquiries and other electronic commu14 nications received through the national toll-free

15 system established under section 222 of the

16 Drug Availability and Health Care Access Im17 provement Act of 2000.’’.

18 (B) EFFECTIVE DATE.—The amendments

19 made by subparagraph (A) apply to calendar

20 quarters beginning more than 6 months after

21 the date of the enactment of this Act.

22 (b) NATIONAL TOLL-FREE INFORMATION LINE.—

23 The Secretary of Health and Human Services shall estab24 lish, in coordination with State agencies responsible for

25 administration of State medicaid and child health insur-
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1 ance programs and by not later than the first day of the

2 first month that begins more than 6 months after the date

3 of the enactment of this subsection, for a national toll4 free telephone number that individuals may access to ob5 tain information on coverage of children under such pro6 grams.

7 (c) FINANCIAL INCENTIVES TO PROMOTE APPRO8 PRIATE ENROLLMENT.—

9 (1) EXPANDED AVAILABILITY OF FUNDING FOR

10 ADMINISTRATIVE COSTS RELATED TO OUTREACH

11 AND ELIGIBILITY DETERMINATIONS.—Section

12 1931(h) of the Social Security Act (42 U.S.C.

13 1396u–1(h)) is amended—

14 (A) in the matter preceding paragraph (1),

15 by striking ‘‘TRANSITIONAL’’ and all that fol16 lows through ‘‘COSTS’’ and inserting ‘‘IN17 CREASED FEDERAL MATCHING RATE FOR AD18 MINISTRATIVE COSTS RELATED TO CERTAIN

19 OUTREACH AND ELIGIBILITY DETERMINA20 TIONS’’;

21 (B) in paragraph (2), by inserting ‘‘either’’

22 after ‘‘attributable’’ and by inserting before the

23 period at the end the following: ‘‘or to adminis24 trative costs of determinations of the eligibility

25 of children and pregnant women for benefits
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1 under the State plan under this title or title

2 XXI, outreach to children and pregnant women

3 likely to be eligible for such benefits, and such

4 other outreach- and eligibility-related activities

5 as the Secretary may approve’’;

6 (C) in paragraph (3), by striking ‘‘and

7 ending with fiscal year 2000’’; and

8 (D) by striking paragraph (4) and insert9 ing the following:

10 ‘‘(4) ENCOURAGING USE OF LOCAL AND COM11 MUNITY-BASED ORGANIZATIONS IN OUTREACH AND

12 ENROLLMENT ACTIVITIES.—The Secretary shall es13 tablish a procedure under which, if States do not

14 otherwise obligate the amounts made available under

15 this subsection, local and community-based public or

16 nonprofit organizations (including local and county

17 governments, public health departments, community

18 health centers, children’s hospitals, and dispropor19 tionate share hospitals) may seek to have adminis20 trative costs relating to outreach and enrollment of

21 children and pregnant women under this title and

22 title XXI be treated as administrative costs of a

23 State described in section 1903(a)(7), if such orga24 nizations have the permission of the State involved.

25 A State may require such an organization to provide
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1 payment of such amounts as the State would other2 wise be responsible for in order to obtain payment

3 under this paragraph.’’.

4 (2) USE OF 3 PERCENT OF SCHIP FUNDS AT 90

5 PERCENT FEDERAL MATCH FOR ENROLLMENT AND

6 OUTREACH ACTIVITIES.—Section 2105(b) of such

7 Act (42 U.S.C. 1397ee(b)) is amended—

8 (A) by designating the matter following the

9 dash as a paragraph (1) with appropriate in10 dentation and with the heading ‘‘(1) IN GEN11 ERAL’’;

12 (B) by inserting ‘‘subject to paragraph

13 (2)’’ after ‘‘(a)’’;

14 (C) by striking ‘‘(1)’’ and ‘‘(2)’’ and in15 serting ‘‘(A)’’ and ‘‘(B)’’, respectively; and

16 (D) by adding at the end the following

17 paragraph:

18 ‘‘(2) SPECIAL RULE FOR CERTAIN ENROLL19 MENT AND OUTREACH ACTIVITIES.—

20 ‘‘(A) IN GENERAL.—For purposes of sub21 section (a), in the case of a State that meets

22 the requirement of subparagraph (B), and sub23 ject to subparagraph (C), the ‘enhanced FMAP’

24 is equal to 90 percent with respect to amounts

25 expended on enrollment and outreach activities.
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1 ‘‘(B) REQUIREMENTS.—Subparagraph (A)

2 shall only apply to a State if the State meets

3 the following requirements:

4 ‘‘(i) NO ASSET TEST.—The State does

5 not impose an asset test for eligibility

6 under the State child health plan or under

7 section 1902(l) with respect to children.

8 ‘‘(ii) COMPLIANCE WITH

9 OUTSTATIONING REQUIREMENT.—The Sec10 retary finds that the State is providing for

11 the receipt and initial processing of appli12 cations of certain individuals at facilities

13 defined as disproportionate share hospitals

14 under section 1923(a)(1)(A) and Feder15 ally-qualified health centers described in

16 section 1905(1)(2)(B) consistent with the

17 requirements of section 1902(a)(55).

18 ‘‘(iii) COMPLIANCE WITH SIMPLIFIED

19 OUTREACH AND ENROLLMENT PROVI20 SIONS.—The Secretary finds that the State

21 is providing for outreach and enrollment

22 under this title and title XIX consistent

23 with the requirements of sections 2102(c),

24 2102(d), and 1902(a)(66).
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1 ‘‘(C) LIMITATION TO 3 PERCENT OF AN2 NUAL ALLOTMENT.—Subparagraph (A) shall

3 not apply to amounts expended by a State in a

4 fiscal year in excess of 3 percent of the amount

5 of the amount of its allotment under section

6 2104 for that fiscal year.’’.

7 (3) EFFECTIVE DATE.—The amendments made

8 by this subsection take effect on the date of the en9 actment of this Act and apply to expenditures made

10 on or after the date of the enactment of this Act.

11 (d) ADDITIONAL ENTITIES QUALIFIED TO DETER12 MINE MEDICAID PRESUMPTIVE ELIGIBILITY FOR LOW-IN13 COME CHILDREN.—Section 1920A(b)(3)(A)(i) of such Act

14 (42 U.S.C. 1396r–1a(b)(3)(A)(i)) is amended—

15 (1) by striking ‘‘or (II)’’ and inserting ‘‘, (II)’’;

16 and

17 (2) by inserting ‘‘eligibility of a child for med18 ical assistance under the State plan under this title,

19 or eligibility of a child for child health assistance

20 under the program funded under title XXI, (III) is

21 an elementary school or secondary school, as such

22 terms are defined in section 14101 of the Elemen23 tary and Secondary Education Act of 1965 (20

24 U.S.C. 8801), an elementary or secondary school op25 erated or supported by the Bureau of Indian Affairs,
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1 a State child support enforcement agency, a child

2 care resource and referral agency, or a State office

3 or private contractor that accepts applications for or

4 administers a program funded under part A of title

5 IV or that determines eligibility for any assistance

6 or benefits provided under any program of public or

7 assisted housing that receives Federal funds, includ8 ing the program under section 8 or any other section

9 of the United States Housing Act of 1937 (42

10 U.S.C. 1437 et seq.), or (IV) any other entity the

11 State so deems’’ before the semicolon.

12 SEC. 222. FAMILY FRIENDLY COVERAGE AND ENROLL13 MENT.

14 (a) ASSURING COORDINATION OF PEDIATRIC PRO15 VIDERS WITHIN A FAMILY.—

16 (1) IN GENERAL.—Section 2103 of the Social

17 Security Act (42 U.S.C. 1397cc) is amended by add18 ing at the end the following new subsection:

19 ‘‘(g) STEPS TAKEN TO COORDINATE PROVISION OF

20 PEDIATRIC CARE WITHIN A FAMILY.—To the extent a

21 State child health plan provides coverage other than

22 through providing benefits under the State’s medicaid

23 plan under title XIX, the State child health plan—

24 ‘‘(1) shall specify methods being used to ensure

25 that children within a family who are eligible for as-
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1 sistance under the plan are allowed to be seen by the

2 same pediatric provider or group of pediatric pro3 viders in a manner that permits the coordinated re4 ceipt of care by children in the same family; and

5 ‘‘(2) shall include a description of such methods

6 in each annual report submitted under section

7 2108(a).’’.

8 (2) EFFECTIVE DATE.—The amendment made

9 by paragraph (1) applies on the date of the enact10 ment of this Act and to reports submitted for years

11 beginning with 2001.

12 (b) REDUCTION IN BURDEN OF ADMINISTERING

13 COST-SHARING PROVISIONS.—

14 (1) STATE RESPONSIBLE FOR ASSURING CAP

15 ON COST-SHARING NOT EXCEEDED.—Section

16 2103(e)(3) of such Act (42 U.S.C. 1397cc(e)(3)) is

17 amended by adding at the end the following new

18 subparagraph:

19 ‘‘(C) STATE AND CONTRACTORS RESPON20 SIBLE FOR APPLYING LIMITATIONS ON COST21 SHARING.—The State child health plan shall

22 provide that responsibility for assuring compli23 ance with the limitations on cost-sharing under

24 this paragraph falls on the State and on its
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1 contractors, and not on beneficiaries and their

2 families.’’.

3 (2) STATE OPTION OF FLAT LIMIT ON OUT-OF4 POCKET EXPENDITURES.—Section 2103(e)(3)(B) of

5 such Act (42 U.S.C. 1397cc(e)(3)(B)) is amended by

6 inserting before the period at the end the following:

7 ‘‘(or, at the option of a State, a limiting amount

8 which is not greater $500)’’.

9 (3) EFFECTIVE DATE.—The amendment made

10 by paragraph (1) takes effect on the date that is 30

11 days after the date of the enactment of this Act.

12 (c) PROHIBITION OF WAITING PERIODS.—

13 (1) IN GENERAL.—Section 2102(b)(1)(B) of

14 such Act (42 U.S.C. 1397bb(b)(1)(B)) is amended—

15 (A) by striking ‘‘and’’ at the end of clause

16 (i);

17 (B) by striking the period at the end of

18 clause (ii) and inserting ‘‘; and’’; and

19 (C) by adding at the end the following new

20 clause:

21 ‘‘(iii) shall not permit the use of any

22 mandatory waiting period (including any

23 such period in order to carry out para24 graph (3)(C)), unless the Secretary finds

25 that the imposition of such a period would
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1 not be contrary to the provisions of this

2 title.’’.

3 (2) EFFECTIVE DATE.—The amendments made

4 by paragraph (1) apply to assistance furnished on or

5 after the date of the enactment of this Act.

6 (d) GRACE PERIOD BEFORE DISENROLLMENT FOR

7 NONPAYMENT OF PREMIUMS.—

8 (1) IN GENERAL.—Section 2103(e) of such Act

9 (42 U.S.C. 1397ee(e)) is amended by adding at the

10 end the following new paragraph:

11 ‘‘(5) DISENROLLMENT FOR NONPAYMENT OF

12 PREMIUMS.—

13 ‘‘(A) NOTICE OF NONPAYMENT.—If a

14 State child health plan requires the payment of

15 a premium for enrollment and such a premium

16 is not paid on a timely basis, the State shall

17 provide, before terminating coverage under the

18 plan, for—

19 ‘‘(i) notice of nonpayment at such

20 time and at the beginning of the last

21 month of the State specified enrollment pe22 riod described in subparagraph (C) if the

23 premium is still unpaid at that time; and

24 ‘‘(ii) an opportunity for a hearing and

25 a grace period (described in subparagraph
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1 (B)) in which the premium may be paid

2 and no penalty will apply for the late pay3 ment.

4 ‘‘(B) GRACE PERIOD.—The grace period

5 under this subparagraph, in the case of non6 payment for a month—

7 ‘‘(i) before the last month of a State

8 specified enrollment period described in

9 subparagraph (C), is for the remainder of

10 the State specified enrollment period; or

11 ‘‘(ii) for the last month of such pe12 riod, is for a period of at least 1 month.

13 ‘‘(C) STATE SPECIFIED ENROLLMENT PE14 RIOD.—For purposes of applying this

15 paragraph—

16 ‘‘(i) the State child health plan shall

17 specify an enrollment period, which shall

18 be a period of at least 3 months; and

19 ‘‘(ii) after each such enrollment period

20 for an individual (if coverage is not termi21 nated under the plan during such period),

22 a new enrollment period (of the length

23 specified in clause (i)) shall start again for

24 the individual at the end of the previously

25 specified enrollment period.
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1 ‘‘(D) GOOD CAUSE WAIVER.—The State

2 child health plan shall establish rules allowing

3 waiver for good cause of termination of enroll4 ment for nonpayment of premiums.

5 ‘‘(E) PERMITTING APPLICATION OF WAIT6 ING PERIOD IN CERTAIN REENROLLMENT

7 CASES.—In the case of a child whose coverage

8 under a State child health plan has been termi9 nated under this paragraph for nonpayment of

10 premiums and whose period of coverage under

11 the plan without premium payment exceeded 1

12 month, the plan may require, as a condition of

13 reenrollment under the plan, a waiting period

14 that equals the number of months of such cov15 erage without premium payment, but in no case

16 may such a waiting period exceed 3 months.’’.

17 (2) EFFECTIVE DATE.—The amendment made

18 by paragraph (1) applies to disenrollments occurring

19 on or after the date that is 30 days after the date

20 of the enactment of this Act.

21 SEC. 223. EXPANDED COVERAGE OPTIONS.

22 (a) AUTOMATIC REASSESSMENT OF ELIGIBILITY FOR

23 SCHIP AND MEDICAID BENEFITS FOR CHILDREN LOS24 ING MEDICAID OR SCHIP ELIGIBILITY.—
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1 (1) LOSS OF MEDICAID ELIGIBILITY.—Section

2 1902(a)(66) of the Social Security Act (42 U.S.C.

3 1396a(a)(66)), as inserted by section 221(a)(2), is

4 amended—

5 (A) by striking ‘‘and’’ at the end of sub6 paragraph (B),

7 (B) by striking the period at the end of

8 subparagraph (C) and inserting ‘‘; and’’; and

9 (C) by adding at the end the following new

10 subparagraph:

11 ‘‘(D) the automatic assessment, in the case

12 of a child who loses eligibility for medical assist13 ance under this title on the basis of changes in

14 income, assets, or age, of whether the child is

15 eligible for benefits under title XXI.’’.

16 (2) LOSS OF SCHIP ELIGIBILITY.—Section

17 2102(b)(3) of such Act (42 U.S.C. 1397bb(b)(3)) is

18 amended by redesignating subparagraphs (D) and

19 (E) as subparagraphs (E) and (F), respectively, and

20 by inserting after subparagraph (C) the following

21 new subparagraph:

22 ‘‘(D) that there is an automatic assess23 ment, in the case of a child who loses eligibility

24 for child health assistance under this title on

25 the basis of changes in income, assets, or age,
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1 of whether the child is eligible for medical as2 sistance under title XIX;’’.

3 (3) EFFECTIVE DATE.—The amendments made

4 by paragraphs (1) and (2) apply to children who lose

5 eligibility under the medicaid program under title

6 XIX, or under a State child health insurance plan

7 under title XXI, respectively, of the Social Security

8 Act on or after the date that is 30 days after the

9 date of the enactment of this Act.

10 (b) OPTIONAL COVERAGE OF LOW-INCOME, UNIN11 SURED PREGNANT WOMEN UNDER A STATE CHILD

12 HEALTH PLAN.—

13 (1) IN GENERAL.—Title XXI of the Social Se14 curity Act is amended by adding at the end the fol15 lowing new section:

16 ‘‘SEC. 2111. OPTIONAL COVERAGE OF LOW-INCOME, UNIN17 SURED PREGNANT WOMEN.

18 ‘‘(a) OPTIONAL COVERAGE.—Notwithstanding any

19 other provision of this title, a State child health plan may

20 provide for coverage of pregnancy-related assistance for

21 targeted low-income pregnant women in accordance with

22 this section, but only if the State has established an in23 come eligibility level under section 1902(l)(2)(A) for

24 women described in section 1902(l)(1)(A) that is 185 per25 cent of the income official poverty line.
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1 ‘‘(b) DEFINITIONS.—For purposes of this section:

2 ‘‘(1) PREGNANCY-RELATED ASSISTANCE.—The

3 term ‘pregnancy-related assistance’ has the meaning

4 given the term child health assistance in section

5 2110(a) as if any reference to targeted low-income

6 children were a reference to targeted low-income

7 pregnant women, except that the assistance shall be

8 limited to services related to pregnancy (which in9 clude prenatal, delivery, and postpartum services)

10 and to other conditions that may complicate preg11 nancy and shall not include prepregnancy services

12 and supplies.

13 ‘‘(2) TARGETED LOW-INCOME PREGNANT

14 WOMAN.—The term ‘targeted low-income pregnant

15 woman’ has the meaning given the term targeted

16 low-income child in section 2110(b) as if any ref17 erence to a child were deemed a reference to a

18 woman during pregnancy and through the end of the

19 month in which the 60-day period (beginning on the

20 last day of her pregnancy) ends.

21 ‘‘(c) REFERENCES TO TERMS AND SPECIAL

22 RULES.—In the case of, and with respect to, a State pro23 viding for coverage of pregnancy-related assistance to tar24 geted low-income pregnant women under subsection (a),

25 the following special rules apply:
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1 ‘‘(1) Any reference in this title (other than sub2 section (b)) to a targeted low income child is deemed

3 to include a reference to a targeted low-income preg4 nant woman.

5 ‘‘(2) Any such reference to child health assist6 ance with respect to such women is deemed a ref7 erence to pregnancy-related assistance.

8 ‘‘(3) Any such reference to a child is deemed a

9 reference to a woman during pregnancy and the pe10 riod described in subsection (b)(2).

11 ‘‘(4) The medicaid applicable income level is

12 deemed a reference to the income level established

13 under section 1902(l)(2)(A).

14 ‘‘(5) Subsection (a) of section 2103 (relating to

15 required scope of health insurance coverage) shall

16 not apply insofar as a State limits coverage to serv17 ices described in subsection (b)(1) and the reference

18 to such section in section 2105(a)(1) is deemed not

19 to require, in such case, compliance with the require20 ments of section 2103(a).

21 ‘‘(6) There shall be no exclusion of benefits for

22 services described in subsection (b)(1) based on any

23 pre-existing condition and no waiting period (includ24 ing any waiting period imposed to carry out section

25 2102(b)(3)(C)) shall apply.
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1 ‘‘(d) NO IMPACT ON ALLOTMENTS.—Nothing in this

2 section shall be construed as affecting the amount of any

3 initial allotment provided to a State under section

4 2104(b).

5 ‘‘(e) APPLICATION OF FUNDING RESTRICTIONS.—

6 The coverage under this section (and the funding of such

7 coverage) is subject to the restrictions of section 2105(c).

8 ‘‘(f) AUTOMATIC ENROLLMENT FOR CHILDREN

9 BORN TO WOMEN RECEIVING PREGNANCY-RELATED AS10 SISTANCE.—Notwithstanding any other provision of this

11 title or title XIX, if a child is born to a targeted low-in12 come pregnant woman who was receiving pregnancy-re13 lated assistance under this section on the date of the chil14 dren’s birth, the child shall be deemed to have applied for

15 child health assistance under the State child health plan

16 and to have been found eligible for such assistance under

17 such plan (or, in the case of a State that provides such

18 assistance through the provision of medical assistance

19 under a plan under title XIX, to have applied for medical

20 assistance under such title and to have been found eligible

21 for such assistance under such title) on the date of such

22 birth and to remain eligible for such assistance until the

23 child attains 1 year of age so long as the child is a member

24 of the woman’s household and the woman remains (or

25 would remain if pregnant) eligible for such assistance.
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1 During the period in which a child is deemed under the

2 preceding sentence to be eligible for child health or med3 ical assistance, the child health or medical assistance eligi4 bility identification number of the mother shall also serve

5 as the identification number of the child, and all claims

6 shall be submitted and paid under such number (unless

7 the State issues a separate identification number for the

8 child before such period expires).’’.

9 (2) STATE OPTION TO USE ENHANCED FMAP

10 FOR COVERAGE OF ADDITIONAL PREGNANT WOMEN

11 UNDER THE MEDICAID PROGRAM.—Section 1905 of

12 such Act (42 U.S.C. 1396d) is amended—

13 (A) in subsection (b), by inserting ‘‘and in

14 the case of a State plan that meets the condi15 tion described in subsections (u)(1) and

16 (u)(4)(A), with respect to expenditures de17 scribed in subsection (u)(4)(B) for the State for

18 a fiscal year’’ after ‘‘for a fiscal year,’’;

19 (B) by redesignating paragraph (4) of sub20 section (u) as paragraph (5); and

21 (C) by inserting after paragraph (3) of

22 subsection (u) the following new paragraph:

23 ‘‘(4)(A) The condition described in this subparagraph

24 for a State plan is that the plan has established an income

25 level under section 1902(l)(2)(A) with respect to individ-
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1 uals described in section 1902(l)(1)(A) that is 185 percent

2 of the income official poverty line.

3 ‘‘(B) For purposes of subsection (b), the expenditures

4 described in this paragraph are expenditures for medical

5 assistance for women described in section 1902(l)(1)(A)

6 whose income exceeds the income level established for such

7 women under section 1902(l)(2)(A)(i) as of the date of

8 the enactment of this paragraph but does not exceed than

9 185 percent of the income official poverty line.’’.

10 (3) CONFORMING AMENDMENTS.—Section

11 2102(b)(1)(B) of such Act (42 U.S.C.

12 1397bb(b)(1)(B)) is amended—

13 (A) by striking ‘‘and’’ at the end of clause

14 (i);

15 (B) by striking the period at the end of

16 clause (ii) and inserting ‘‘; and’’; and

17 (C) by adding at the end the following new

18 clause:

19 ‘‘(iii) may not apply a waiting period

20 (including a waiting period to carry out

21 paragraph (3)(C)) in the case of a targeted

22 low-income child who is pregnant, if the

23 State provides for coverage of pregnancy24 related assistance for targeted low-income
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1 pregnant women in accordance section

2 2111.’’.

3 (4) EFFECTIVE DATE.—The amendments made

4 by this subsection take effect on the date of the en5 actment of this Act and apply to allotments for all

6 fiscal years.

7 (c) STATE OPTION FOR COVERAGE OF QUALIFIED

8 ALIEN CHILDREN UNDER MEDICAID AND CHILDREN’S

9 HEALTH INSURANCE PROGRAMS.—

10 (1) MEDICAID.—

11 (A) CATEGORICALLY NEEDY.—Section

12 1902(a)(10)(a)(ii) of the Social Security Act

13 (42 U.S.C. 1396a(a)(10)(A)(ii)) is amended—

14 (i) by striking ‘‘or’’ at the end of sub15 clause (XIII);

16 (ii) by adding ‘‘or’’ at the end of sub17 clause (XIV); and

18 (iii) by adding at the end the fol19 lowing new subclause:

20 ‘‘(XV) who are described in sec21 tion 1905(a)(i) and who would be eli22 gible for medical assistance (or for a

23 greater amount of medical assistance)

24 under the State plan under this title

25 but for the provisions of section 403
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1 or section 421 of Public Law 104–

2 193, but the State may not exercise

3 the option of providing medical assist4 ance under this subclause with respect

5 to a subcategory of individuals de6 scribed in this subclause;’’.

7 (B) MEDICALLY NEEDY.—Section

8 1902(a)(10)(C)(i)(I) of such Act (42 U.S.C.

9 1396a(a)(10)(C)(i)(I)) is amended by inserting

10 ‘‘(and such criteria may provide for eligibility of

11 individuals described in subparagraph

12 (A)(ii)(XV))’’ after ‘‘medical assistance’’.

13 (2) CHILDREN’S HEALTH INSURANCE PRO14 GRAM.—Section 2110(b) of such Act (42 U.S.C.

15 1397jj(b)) is amended—

16 (A) in paragraph (1)(A), by inserting be17 fore the semicolon ‘‘(including, at the option of

18 the State, a child described in paragraph

19 (3)(B))’’; and

20 (B) in paragraph (3)—

21 (i) by striking ‘‘SPECIAL RULE.—’’

22 and inserting ‘‘SPECIAL RULES.—

23 ‘‘(i) HEALTH INSURANCE COV24 ERAGE.—’’ by indenting the remainder of

25 the text accordingly; and
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1 (ii) by adding at the end the following

2 new subparagraph:

3 ‘‘(B) ELIGIBILITY FOR QUALIFIED ALIEN

4 CHILDREN.—For purposes of paragraph (1)(A),

5 a child is described in this subparagraph if—

6 ‘‘(i) the child would be determined eli7 gible for child health assistance under this

8 title but for any or all of the provisions of

9 sections 403 and 421 of Public Law 104–

10 193; and

11 ‘‘(ii) the State exercises the option to

12 provide medical assistance to the category

13 of individuals described in section

14 1902(a)(10)(A)(ii)(XV).’’.

15 (3) PROHIBITION ON SEEKING SUPPORT FROM

16 SPONSOR.—Section 213A(b) of the Immigration and

17 Nationality Act (8 U.S.C. 1183a(b)) is amended by

18 adding at the end the following new paragraph:

19 ‘‘(4) EXCEPTION FOR CHILD MEDICAID OR

20 SCHIP ASSISTANCE.—The preceding provisions of

21 this subsection shall not apply to—

22 ‘‘(A) medical assistance furnished under

23 the State plan under title XIX of the Social Se24 curity Act to an individual eligible for such as25 sistance because of subclause (XV) of para-
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1 graph (10)(A)(ii) of section 1902(a) of such Act

2 (42 U.S.C. 1396a(a)) or because of the ref3 erence to such subclause in paragraph (10)(C)

4 of such section; or

5 ‘‘(B) child health assistance furnished

6 under the State child health plan under title

7 XXI of such Act to a child eligible for such as8 sistance because of the provisions of section

9 2110(b)(3)(B) of such Act (42 U.S.C.

10 1397jj(b)(3)(B)).’’.

11 (d) CLARIFICATION OF COVERAGE UNDER VACCINE

12 FOR CHILDREN PROGRAM.—

13 (1) IN GENERAL.—Section 1928(b)(2)(A)(ii) of

14 the Social Security Act (42 U.S.C.

15 1396s(b)(2)(A)(ii) is amended by inserting ‘‘, except

16 that for purposes of this paragraph a child who is

17 only insured under title XXI shall be considered as

18 being not insured’’ after ‘‘not insured’’.

19 (2) EFFECTIVE DATE.—The amendment made

20 by paragraph (1) shall take effect as if included in

21 the enactment of the Balanced Budget Act of 1997.

22 (e) ELIMINATION OF FUNDING OFFSET FOR EXER23 CISE OF PRESUMPTIVE ELIGIBILITY OPTION.—

24 (1) IN GENERAL.—Section 2104(d) of such Act

25 (42 U.S.C. 1397dd(d)) is amended by striking ‘‘shall
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1 be reduced by the sum of’’ and all that follows

2 through ‘‘(2) the amount of payments under such

3 section’’ and inserting ‘‘shall be reduced by the

4 amount of payments under section 1903(a)(1)’’.

5 (2) EFFECTIVE DATE.—The amendment made

6 by paragraph (1) first applies for allotments for fis7 cal year 2001.

8 (f) PROGRAM COORDINATION WITH THE MATERNAL

9 AND CHILD HEALTH PROGRAM (TITLE V).—

10 (1) IN GENERAL.—Section 2102(b)(3) of such

11 Act (42 U.S.C. 1397bb(b)(3)) is amended—

12 (A) by striking ‘‘and’’ at the end of sub13 paragraph (D);

14 (B) by striking the period at the end of

15 subparagraph (E) and inserting ‘‘; and’’; and

16 (C) by adding at the end the following new

17 subparagraph:

18 ‘‘(F) that operations and activities under

19 this title are developed and implemented in con20 sultation and coordination with the program op21 erated by the State under title V in areas in22 cluding outreach and enrollment, benefits and

23 services, service delivery standards, public

24 health and social service agency relationships,

25 and quality assurance and data reporting.’’.
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1 (2) CONFORMING MEDICAID AMENDMENT.—

2 Section 1902(a)(11) of such Act (42 U.S.C.

3 1306a(a)(11)) is amended—

4 (A) by striking ‘‘and’’ before ‘‘(C)’’; and

5 (B) by inserting before the semicolon at

6 the end the following: ‘‘, and (D) provide that

7 operations and activities under this title are de8 veloped and implemented in consultation and

9 coordination with the program operated by the

10 State under title V in areas including outreach

11 and enrollment, benefits and services, service

12 delivery standards, public health and social

13 service agency relationships, and quality assur14 ance and data reporting’’.

15 (3) EFFECTIVE DATE.—The amendments made

16 by this subsection take effect on January 1, 2000.
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1 TITLE III—IMPROVED ACCESS

2 TO REASONABLY PRICED

3 PRESCRIPTION DRUGS

4 SEC. 301. CLARIFICATION OF CERTAIN RESPONSIBILITIES

5 OF FOOD AND DRUG ADMINISTRATION WITH

6 RESPECT TO IMPORTATION OF DRUGS INTO

7 UNITED STATES.

8 Section 801 of the Federal Food, Drug, and Cosmetic

9 Act (21 U.S.C. 381) is amended by adding at the end the

10 following subsection:

11 ‘‘(g)(1) With respect to a drug being imported or of12 fered for import into the United States, the Secretary may

13 not send a warning notice to a person (including a phar14 macist or wholesale importer) unless the following condi15 tions are met:

16 ‘‘(A) The notice specifies, as applicable to the

17 importation of the drug, that the Secretary has

18 made a determination that—

19 ‘‘(i) importation is in violation of section

20 801(a) because the drug is or appears to be

21 adulterated, misbranded, or in violation of sec22 tion 505;

23 ‘‘(ii) importation is in violation of section

24 801(a) because the drug is forbidden or re-
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1 stricted in sale in the country in which it was

2 produced or from which it was exported;

3 ‘‘(iii) importation by any person other than

4 the manufacturer of the drug is in violation of

5 section 801(d); or

6 ‘‘(iv) importation is otherwise in violation

7 of Federal law.

8 ‘‘(B) The notice does not specify any provision

9 described in subparagraph (A) that is not applicable

10 to the importation of the drug.

11 ‘‘(C) The notice states the reasons underlying

12 such determination by the Secretary, including a

13 brief application to the principal facts involved of the

14 provision of law described in subparagraph (A) that

15 is the basis of the determination by the Secretary.

16 ‘‘(2) The term ‘warning notice’, with respect to the

17 importation of a drug, means a communication from the

18 Secretary (written or otherwise) notifying a person, or

19 clearly suggesting to the person, that importing the drug

20 is, or appears to be, a violation of this Act.’’.

21 SEC. 302. INCREASED CONSUMER INFORMATION IN PRE22 SCRIPTION DRUG ADVERTISING.

23 Section 502(n) of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 352(n)) is amended—
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1 (a) by striking ‘‘in brief summary relating to side ef2 fects’’ and inserting ‘‘in comprehensive summary relating

3 to side effects’’; and

4 (b) by inserting before ‘‘except that’’ the following:

5 ‘‘except that the regulations shall require that such com6 prehensive summary constitute not less than 50 percent

7 of the content of an advertisement, and the regulations

8 may not exempt reminder advertisements from the re9 quirement of providing the comprehensive summary, and’’.

10 SEC. 303. EDUCATION ABOUT MANUFACTURER PROGRAMS

11 FOR FREE DRUGS TO PATIENTS.

12 The Secretary of Health and Human Services, acting

13 through the Commissioner of Food and Drugs, shall in

14 cooperation with manufacturers of prescription drugs

15 carry out activities to inform patients of the existence of

16 programs that are operated by such manufacturers to pro17 vide prescription drugs to patients without any charge to

18 the patients.

19 SEC. 304. SENSE OF CONGRESS REGARDING MERGERS OF

20 DRUG MANUFACTURERS.

21 It is the sense of the Congress that—

22 (1) the increased merger of drug manufacturers

23 has resulted in a decrease in price competition in the

24 prescription drug market and increased the potential

25 for collusion in setting prices; and
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1 (2) the Antitrust Division of the Department of

2 Justice and the Federal Trade Commission should

3 give increased scrutiny to the anti-competitive effects

4 of such mergers.

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