HR 4743 IH

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.

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

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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE- This Act may be cited as the `Drug Availability and Health Care Access Improvement Act of 2000'.

(b) TABLE OF CONTENTS- The table of contents of this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I--MEDICAID PRESCRIPTION DRUG COVERAGE FOR LOW-INCOME 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.

TITLE I--MEDICAID PRESCRIPTION DRUG COVERAGE FOR LOW-INCOME MEDICARE BENEFICIARIES

SEC. 101. MEDICAID PRESCRIPTION DRUG COVERAGE FOR LOW-INCOME MEDICARE BENEFICIARIES.

(a) IN GENERAL- Section 1902(a)(10) of the Social Security Act (42 U.S.C. 1396a(a)(10)) is amended--

(1) by striking `and' at the end of subparagraph (F);

(2) by adding `and' at the end of subparagraph (G); and

(3) by inserting after subparagraph (G) the following new subparagraph:

`(H) for making medical assistance available for prescribed drugs (in the same amount, duration, and scope as for individuals described in subparagraph (A)) for qualified medicare beneficiaries described in section 1905(p)(1) and for individuals who would be such qualified medicare beneficiaries but for the fact that their income exceeds the income level established by the State under section 1905(p)(2) but is less than 175 percent of the official poverty line (referred to in such section) for a family of the size involved;'.

(b) 100 PERCENT FEDERAL FINANCING OF ADDITIONAL COSTS- Section 1903(a) of such Act (42 U.S.C. 1396b(a)) is amended--

(1) by redesignating paragraph (7) as paragraph (8); and

(2) by adding after paragraph (6) the following new paragraph:

`(7) an amount equal to 100 percent of amounts as expended as medical assistance for prescribed drugs described in section 1902(a)(10)(H) to individuals who are eligible for such assistance only on the basis of such section; and'.

(c) PERMITTING CHARGING OF SLIDING SCALE PREMIUMS FOR QUALIFYING INDIVIDUALS WITH INCOMES ABOVE 135 PERCENT OF POVERTY LINE- Section 1916 of such Act is amended--

(1) in subsection (b), by striking `or (E)' and inserting `, (E), or (H)'; and

(2) in subsection (d)--

(A) by inserting `(1)' after `(d)', and

(B) by adding at the end the following new paragraph:

`(2)(A) With respect to an individual described in section 1902(a)(10)(H) whose income (as determined under section 1905(p)(1)(B)) exceeds 135 percent of the official poverty line referred to in that section, the State plan of a State shall provide for the charging of a premium (expressed as a percentage of the average actuarial cost of the benefits described in section 1902(a)(10)(H) provided with respect to individuals described in such section) according to a sliding scale under which such percentage increases from 0 percent to 100 percent, in reasonable increments (as determined by the Secretary), as the individual's income increases from 135 percent of such poverty line to 175 percent of such poverty line.

`(B) A State shall not require prepayment of a premium imposed pursuant to subparagraph (A) and shall not terminate eligibility of an individual for medical assistance under this title on the basis of failure to pay any such premium until such failure continues for a period of not less than 60 days. The State may waive payment of any such premium in any case where the State determines that requiring such payment would create an undue hardship.

`(C) A State may permit State or local funds available under other programs to be used for payment of a premium imposed under subparagraph (A). Payment of a premium with such funds shall not be counted as income to the individual with respect to whom such payment is made.'.

(d) EFFECTIVE DATE- The amendments made by this section take effect on January 1, 2001.

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.

(a) IN GENERAL- Section 1853(c)(1)(B)(ii) of the Social Security Act (42 U.S.C. 1395w-23(c)(1)(B)(ii)) is amended--

(1) by striking `(ii) For a succeeding year' and inserting `(ii)(I) Subject to subclause (II), for a succeeding year'; and

(2) by adding at the end the following new subclause:

`(II) For 2001 for any of the 50 States and the District of Columbia, $600.'.

(b) EFFECTIVE DATE- The amendments made by subsection (a) apply to years beginning with 2001.

Subtitle B--Access of the Self-Employed

SEC. 211. DEDUCTION FOR 100 PERCENT OF HEALTH INSURANCE COSTS OF SELF-EMPLOYED INDIVIDUALS.

(a) IN GENERAL- Paragraph (1) of section 162(l) of the Internal Revenue Code of 1986 is amended to read as follows:

`(1) ALLOWANCE OF DEDUCTION- In the case of an individual who is an employee within the meaning of section 401(c)(1), there shall be allowed as a deduction under this section an amount equal to 100 percent of the amount paid during the taxable year for insurance which constitutes medical care for the taxpayer and the taxpayer's spouse and dependents.'.

(b) CLARIFICATION OF LIMITATIONS ON OTHER COVERAGE- The first sentence of section 162(l)(2)(B) of such Code is amended to read as follows: `Paragraph (1) shall not apply to any taxpayer for any calendar month for which the taxpayer participates in any subsidized health plan maintained by any employer (other than an employer described in section 401(c)(4)) of the taxpayer or the spouse of the taxpayer.'.

(c) EFFECTIVE DATE- The amendments made by this section shall apply to taxable years beginning after December 31, 1999.

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.

(a) USE OF UNIFORM APPLICATION AND COORDINATED ENROLLMENT PROCESS-

(1) SCHIP PROGRAM- Section 2102 of the Social Security Act (42 U.S.C. 1397bb) is amended by adding at the end the following new subsection:

`(d) DEVELOPMENT AND USE OF UNIFORM APPLICATION FORMS AND COORDINATED ENROLLMENT PROCESS- A State child health plan shall provide, by not later than the first day of the first month that begins more than 6 months after the date of the enactment of this subsection, for--

`(1) the development and use of a uniform, simplified application form which is used both for purposes of establishing eligibility for benefits under this title and also under title XIX;

`(2) an enrollment process that is coordinated with that under title XIX so that a family need only interact with a single agency in order to determine whether a child is eligible for benefits under this title or title XIX; and

`(3) acceptance and timely response to telephone inquiries and other electronic communications received through the national toll-free system established under section 222 of the Drug Availability and Health Care Access Improvement Act of 2000.'.

(2) MEDICAID CONFORMING AMENDMENT-

(A) IN GENERAL- Section 1902(a) of such Act (42 U.S.C. 1396a(a)) is amended--

(i) by striking the period at the end of paragraph (65) and inserting `; and', and

(ii) by inserting after paragraph (65) the following new paragraph:

`(66) provide, by not later than the first day of the first month that begins more than 6 months after the date of the enactment of this paragraph, in the case of a State with a State child health plan under title XXI for--

`(A) the development and use of a uniform, simplified application form which is used both for purposes of establishing eligibility for benefits under this title and also under title XXI;

`(B) establishment and operation of an enrollment process that is coordinated with that under title XXI so that a family need only interact with a single agency in order to determine whether a child is eligible for benefits under this title or title XXI; and

`(C) acceptance and timely response to telephone inquiries and other electronic communications received through the national toll-free system established under section 222 of the Drug Availability and Health Care Access Improvement Act of 2000.'.

(B) EFFECTIVE DATE- The amendments made by subparagraph (A) apply to calendar quarters beginning more than 6 months after the date of the enactment of this Act.

(b) NATIONAL TOLL-FREE INFORMATION LINE- The Secretary of Health and Human Services shall establish, in coordination with State agencies responsible for administration of State medicaid and child health insurance programs and by not later than the first day of the first month that begins more than 6 months after the date of the enactment of this subsection, for a national toll-free telephone number that individuals may access to obtain information on coverage of children under such programs.

(c) FINANCIAL INCENTIVES TO PROMOTE APPROPRIATE ENROLLMENT-

(1) EXPANDED AVAILABILITY OF FUNDING FOR ADMINISTRATIVE COSTS RELATED TO OUTREACH AND ELIGIBILITY DETERMINATIONS- Section 1931(h) of the Social Security Act (42 U.S.C. 1396u-1(h)) is amended--

(A) in the matter preceding paragraph (1), by striking `TRANSITIONAL' and all that follows through `COSTS' and inserting `INCREASED FEDERAL MATCHING RATE FOR ADMINISTRATIVE COSTS RELATED TO CERTAIN OUTREACH AND ELIGIBILITY DETERMINATIONS';

(B) in paragraph (2), by inserting `either' after `attributable' and by inserting before the period at the end the following: `or to administrative costs of determinations of the eligibility of children and pregnant women for benefits under the State plan under this title or title XXI, outreach to children and pregnant women likely to be eligible for such benefits, and such other outreach- and eligibility-related activities as the Secretary may approve';

(C) in paragraph (3), by striking `and ending with fiscal year 2000'; and

(D) by striking paragraph (4) and inserting the following:

`(4) ENCOURAGING USE OF LOCAL AND COMMUNITY-BASED ORGANIZATIONS IN OUTREACH AND ENROLLMENT ACTIVITIES- The Secretary shall establish a procedure under which, if States do not otherwise obligate the amounts made available under this subsection, local and community-based public or nonprofit organizations (including local and county governments, public health departments, community health centers, children's hospitals, and disproportionate share hospitals) may seek to have administrative costs relating to outreach and enrollment of children and pregnant women under this title and title XXI be treated as administrative costs of a State described in section 1903(a)(7), if such organizations have the permission of the State involved. A State may require such an organization to provide

payment of such amounts as the State would otherwise be responsible for in order to obtain payment under this paragraph.'.

(2) USE OF 3 PERCENT OF SCHIP FUNDS AT 90 PERCENT FEDERAL MATCH FOR ENROLLMENT AND OUTREACH ACTIVITIES- Section 2105(b) of such Act (42 U.S.C. 1397ee(b)) is amended--

(A) by designating the matter following the dash as a paragraph (1) with appropriate indentation and with the heading `(1) IN GENERAL';

(B) by inserting `subject to paragraph (2)' after `(a)';

(C) by striking `(1)' and `(2)' and inserting `(A)' and `(B)', respectively; and

(D) by adding at the end the following paragraph:

`(2) SPECIAL RULE FOR CERTAIN ENROLLMENT AND OUTREACH ACTIVITIES-

`(A) IN GENERAL- For purposes of subsection (a), in the case of a State that meets the requirement of subparagraph (B), and subject to subparagraph (C), the `enhanced FMAP' is equal to 90 percent with respect to amounts expended on enrollment and outreach activities.

`(B) REQUIREMENTS- Subparagraph (A) shall only apply to a State if the State meets the following requirements:

`(i) NO ASSET TEST- The State does not impose an asset test for eligibility under the State child health plan or under section 1902(l) with respect to children.

`(ii) COMPLIANCE WITH OUTSTATIONING REQUIREMENT- The Secretary finds that the State is providing for the receipt and initial processing of applications of certain individuals at facilities defined as disproportionate share hospitals under section 1923(a)(1)(A) and Federally-qualified health centers described in section 1905(1)(2)(B) consistent with the requirements of section 1902(a)(55).

`(iii) COMPLIANCE WITH SIMPLIFIED OUTREACH AND ENROLLMENT PROVISIONS- The Secretary finds that the State is providing for outreach and enrollment under this title and title XIX consistent with the requirements of sections 2102(c), 2102(d), and 1902(a)(66).

`(C) LIMITATION TO 3 PERCENT OF ANNUAL ALLOTMENT- Subparagraph (A) shall not apply to amounts expended by a State in a fiscal year in excess of 3 percent of the amount of the amount of its allotment under section 2104 for that fiscal year.'.

(3) EFFECTIVE DATE- The amendments made by this subsection take effect on the date of the enactment of this Act and apply to expenditures made on or after the date of the enactment of this Act.

(d) ADDITIONAL ENTITIES QUALIFIED TO DETERMINE MEDICAID PRESUMPTIVE ELIGIBILITY FOR LOW-INCOME CHILDREN- Section 1920A(b)(3)(A)(i) of such Act (42 U.S.C. 1396r-1a(b)(3)(A)(i)) is amended--

(1) by striking `or (II)' and inserting `, (II)'; and

(2) by inserting `eligibility of a child for medical assistance under the State plan under this title, or eligibility of a child for child health assistance under the program funded under title XXI, (III) is an elementary school or secondary school, as such terms are defined in section 14101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 8801), an elementary or secondary school operated or supported by the Bureau of Indian Affairs, a State child support enforcement agency, a child care resource and referral agency, or a State office or private contractor that accepts applications for or administers a program funded under part A of title IV or that determines eligibility for any assistance or benefits provided under any program of public or assisted housing that receives Federal funds, including the program under section 8 or any other section of the United States Housing Act of 1937 (42 U.S.C. 1437 et seq.), or (IV) any other entity the State so deems' before the semicolon.

SEC. 222. FAMILY FRIENDLY COVERAGE AND ENROLLMENT.

(a) ASSURING COORDINATION OF PEDIATRIC PROVIDERS WITHIN A FAMILY-

(1) IN GENERAL- Section 2103 of the Social Security Act (42 U.S.C. 1397cc) is amended by adding at the end the following new subsection:

`(g) STEPS TAKEN TO COORDINATE PROVISION OF PEDIATRIC CARE WITHIN A FAMILY- To the extent a State child health plan provides coverage other than through providing benefits under the State's medicaid plan under title XIX, the State child health plan--

`(1) shall specify methods being used to ensure that children within a family who are eligible for assistance under the plan are allowed to be seen by the same pediatric provider or group of pediatric providers in a manner that permits the coordinated receipt of care by children in the same family; and

`(2) shall include a description of such methods in each annual report submitted under section 2108(a).'.

(2) EFFECTIVE DATE- The amendment made by paragraph (1) applies on the date of the enactment of this Act and to reports submitted for years beginning with 2001.

(b) Reduction in Burden of Administering Cost-Sharing Provisions-

(1) STATE RESPONSIBLE FOR ASSURING CAP ON COST-SHARING NOT EXCEEDED- Section 2103(e)(3) of such Act (42 U.S.C. 1397cc(e)(3)) is amended by adding at the end the following new subparagraph:

`(C) STATE AND CONTRACTORS RESPONSIBLE FOR APPLYING LIMITATIONS ON COST-SHARING- The State child health plan shall provide that responsibility for assuring compliance with the limitations on cost-sharing under this paragraph falls on the State and on its contractors, and not on beneficiaries and their families.'.

(2) STATE OPTION OF FLAT LIMIT ON OUT-OF-POCKET EXPENDITURES- Section 2103(e)(3)(B) of such Act (42 U.S.C. 1397cc(e)(3)(B)) is amended by inserting before the period at the end the following: `(or, at the option of a State, a limiting amount which is not greater $500)'.

(3) EFFECTIVE DATE- The amendment made by paragraph (1) takes effect on the date that is 30 days after the date of the enactment of this Act.

(c) Prohibition of Waiting Periods-

(1) IN GENERAL- Section 2102(b)(1)(B) of such Act (42 U.S.C. 1397bb(b)(1)(B)) is amended--

(A) by striking `and' at the end of clause (i);

(B) by striking the period at the end of clause (ii) and inserting `; and'; and

(C) by adding at the end the following new clause:

`(iii) shall not permit the use of any mandatory waiting period (including any such period in order to carry out paragraph (3)(C)), unless the Secretary finds that the imposition of such a period would

not be contrary to the provisions of this title.'.

(2) EFFECTIVE DATE- The amendments made by paragraph (1) apply to assistance furnished on or after the date of the enactment of this Act.

(d) GRACE PERIOD BEFORE DISENROLLMENT FOR NONPAYMENT OF PREMIUMS-

(1) IN GENERAL- Section 2103(e) of such Act (42 U.S.C. 1397ee(e)) is amended by adding at the end the following new paragraph:

`(5) DISENROLLMENT FOR NONPAYMENT OF PREMIUMS-

`(A) NOTICE OF NONPAYMENT- If a State child health plan requires the payment of a premium for enrollment and such a premium is not paid on a timely basis, the State shall provide, before terminating coverage under the plan, for--

`(i) notice of nonpayment at such time and at the beginning of the last month of the State specified enrollment period described in subparagraph (C) if the premium is still unpaid at that time; and

`(ii) an opportunity for a hearing and a grace period (described in subparagraph (B)) in which the premium may be paid and no penalty will apply for the late payment.

`(B) GRACE PERIOD- The grace period under this subparagraph, in the case of nonpayment for a month--

`(i) before the last month of a State specified enrollment period described in subparagraph (C), is for the remainder of the State specified enrollment period; or

`(ii) for the last month of such period, is for a period of at least 1 month.

`(C) STATE SPECIFIED ENROLLMENT PERIOD- For purposes of applying this paragraph--

`(i) the State child health plan shall specify an enrollment period, which shall be a period of at least 3 months; and

`(ii) after each such enrollment period for an individual (if coverage is not terminated under the plan during such period), a new enrollment period (of the length specified in clause (i)) shall start again for the individual at the end of the previously specified enrollment period.

`(D) GOOD CAUSE WAIVER- The State child health plan shall establish rules allowing waiver for good cause of termination of enrollment for nonpayment of premiums.

`(E) PERMITTING APPLICATION OF WAITING PERIOD IN CERTAIN REENROLLMENT CASES- In the case of a child whose coverage under a State child health plan has been terminated under this paragraph for nonpayment of premiums and whose period of coverage under the plan without premium payment exceeded 1 month, the plan may require, as a condition of reenrollment under the plan, a waiting period that equals the number of months of such coverage without premium payment, but in no case may such a waiting period exceed 3 months.'.

(2) EFFECTIVE DATE- The amendment made by paragraph (1) applies to disenrollments occurring on or after the date that is 30 days after the date of the enactment of this Act.

SEC. 223. EXPANDED COVERAGE OPTIONS.

(a) AUTOMATIC REASSESSMENT OF ELIGIBILITY FOR SCHIP AND MEDICAID BENEFITS FOR CHILDREN LOSING MEDICAID OR SCHIP ELIGIBILITY-

(1) LOSS OF MEDICAID ELIGIBILITY- Section 1902(a)(66) of the Social Security Act (42 U.S.C. 1396a(a)(66)), as inserted by section 221(a)(2), is amended--

(A) by striking `and' at the end of subparagraph (B),

(B) by striking the period at the end of subparagraph (C) and inserting `; and'; and

(C) by adding at the end the following new subparagraph:

`(D) the automatic assessment, in the case of a child who loses eligibility for medical assistance under this title on the basis of changes in income, assets, or age, of whether the child is eligible for benefits under title XXI.'.

(2) LOSS OF SCHIP ELIGIBILITY- Section 2102(b)(3) of such Act (42 U.S.C. 1397bb(b)(3)) is amended by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively, and by inserting after subparagraph (C) the following new subparagraph:

`(D) that there is an automatic assessment, in the case of a child who loses eligibility for child health assistance under this title on the basis of changes in income, assets, or age, of whether the child is eligible for medical assistance under title XIX;'.

(3) EFFECTIVE DATE- The amendments made by paragraphs (1) and (2) apply to children who lose eligibility under the medicaid program under title XIX, or under a State child health insurance plan under title XXI, respectively, of the Social Security Act on or after the date that is 30 days after the date of the enactment of this Act.

(b) OPTIONAL COVERAGE OF LOW-INCOME, UNINSURED PREGNANT WOMEN UNDER A STATE CHILD HEALTH PLAN-

(1) IN GENERAL- Title XXI of the Social Security Act is amended by adding at the end the following new section:

`SEC. 2111. OPTIONAL COVERAGE OF LOW-INCOME, UNINSURED PREGNANT WOMEN.

`(a) OPTIONAL COVERAGE- Notwithstanding any other provision of this title, a State child health plan may provide for coverage of pregnancy-related assistance for targeted low-income pregnant women in accordance with this section, but only if the State has established an income eligibility level under section 1902(l)(2)(A) for women described in section 1902(l)(1)(A) that is 185 percent of the income official poverty line.

`(b) DEFINITIONS- For purposes of this section:

`(1) PREGNANCY-RELATED ASSISTANCE- The term `pregnancy-related assistance' has the meaning given the term child health assistance in section 2110(a) as if any reference to targeted low-income children were a reference to targeted low-income pregnant women, except that the assistance shall be limited to services related to pregnancy (which include prenatal, delivery, and postpartum services) and to other conditions that may complicate pregnancy and shall not include prepregnancy services and supplies.

`(2) TARGETED LOW-INCOME PREGNANT WOMAN- The term `targeted low-income pregnant woman' has the meaning given the term targeted low-income child in section 2110(b) as if any reference to a child were deemed a reference to a woman during pregnancy and through the end of the month in which the 60-day period (beginning on the last day of her pregnancy) ends.

`(c) REFERENCES TO TERMS AND SPECIAL RULES- In the case of, and with respect to, a State providing for coverage of pregnancy-related assistance to targeted low-income pregnant women under subsection (a), the following special rules apply:

`(1) Any reference in this title (other than subsection (b)) to a targeted low income child is deemed to include a reference to a targeted low-income pregnant woman.

`(2) Any such reference to child health assistance with respect to such women is deemed a reference to pregnancy-related assistance.

`(3) Any such reference to a child is deemed a reference to a woman during pregnancy and the period described in subsection (b)(2).

`(4) The medicaid applicable income level is deemed a reference to the income level established under section 1902(l)(2)(A).

`(5) Subsection (a) of section 2103 (relating to required scope of health insurance coverage) shall not apply insofar as a State limits coverage to services described in subsection (b)(1) and the reference to such section in section 2105(a)(1) is deemed not to require, in such case, compliance with the requirements of section 2103(a).

`(6) There shall be no exclusion of benefits for services described in subsection (b)(1) based on any pre-existing condition and no waiting period (including any waiting period imposed to carry out section 2102(b)(3)(C)) shall apply.

`(d) NO IMPACT ON ALLOTMENTS- Nothing in this section shall be construed as affecting the amount of any initial allotment provided to a State under section 2104(b).

`(e) APPLICATION OF FUNDING RESTRICTIONS- The coverage under this section (and the funding of such coverage) is subject to the restrictions of section 2105(c).

`(f) AUTOMATIC ENROLLMENT FOR CHILDREN BORN TO WOMEN RECEIVING PREGNANCY-RELATED ASSISTANCE- Notwithstanding any other provision of this title or title XIX, if a child is born to a targeted low-income pregnant woman who was receiving pregnancy-related assistance under this section on the date of the children's birth, the child shall be deemed to have applied for child health assistance under the State child health plan and to have been found eligible for such assistance under such plan (or, in the case of a State that provides such assistance through the provision of medical assistance under a plan under title XIX, to have applied for medical assistance under such title and to have been found eligible for such assistance under such title) on the date of such birth and to remain eligible for such assistance until the child attains 1 year of age so long as the child is a member of the woman's household and the woman remains (or would remain if pregnant) eligible for such assistance. During the period in which a child is deemed under the preceding sentence to be eligible for child health or medical assistance, the child health or medical assistance eligibility identification number of the mother shall also serve as the identification number of the child, and all claims shall be submitted and paid under such number (unless the State issues a separate identification number for the child before such period expires).'.

(2) STATE OPTION TO USE ENHANCED FMAP FOR COVERAGE OF ADDITIONAL PREGNANT WOMEN UNDER THE MEDICAID PROGRAM- Section 1905 of such Act (42 U.S.C. 1396d) is amended--

(A) in subsection (b), by inserting `and in the case of a State plan that meets the condition described in subsections (u)(1) and (u)(4)(A), with respect to expenditures described in subsection (u)(4)(B) for the State for a fiscal year' after `for a fiscal year,';

(B) by redesignating paragraph (4) of subsection (u) as paragraph (5); and

(C) by inserting after paragraph (3) of subsection (u) the following new paragraph:

`(4)(A) The condition described in this subparagraph for a State plan is that the plan has established an income level under section 1902(l)(2)(A) with respect to individuals described in section 1902(l)(1)(A) that is 185 percent of the income official poverty line.

`(B) For purposes of subsection (b), the expenditures described in this paragraph are expenditures for medical assistance for women described in section 1902(l)(1)(A) whose income exceeds the income level established for such women under section 1902(l)(2)(A)(i) as of the date of the enactment of this paragraph but does not exceed than 185 percent of the income official poverty line.'.

(3) CONFORMING AMENDMENTS- Section 2102(b)(1)(B) of such Act (42 U.S.C. 1397bb(b)(1)(B)) is amended--

(A) by striking `and' at the end of clause (i);

(B) by striking the period at the end of clause (ii) and inserting `; and'; and

(C) by adding at the end the following new clause:

`(iii) may not apply a waiting period (including a waiting period to carry out paragraph (3)(C)) in the case of a targeted low-income child who is pregnant, if the State provides for coverage of pregnancy-related assistance for targeted low-income pregnant women in accordance section 2111.'.

(4) EFFECTIVE DATE- The amendments made by this subsection take effect on the date of the enactment of this Act and apply to allotments for all fiscal years.

(c) STATE OPTION FOR COVERAGE OF QUALIFIED ALIEN CHILDREN UNDER MEDICAID AND CHILDREN'S HEALTH INSURANCE PROGRAMS-

(1) MEDICAID-

(A) CATEGORICALLY NEEDY- Section 1902(a)(10)(a)(ii) of the Social Security Act (42 U.S.C. 1396a(a)(10)(A)(ii)) is amended--

(i) by striking `or' at the end of subclause (XIII);

(ii) by adding `or' at the end of subclause (XIV); and

(iii) by adding at the end the following new subclause:

`(XV) who are described in section 1905(a)(i) and who would be eligible for medical assistance (or for a greater amount of medical assistance) under the State plan under this title but for the provisions of section 403 or section 421 of Public Law 104-193, but the State may not exercise the option of providing medical assistance under this subclause with respect to a subcategory of individuals described in this subclause;'.

(B) MEDICALLY NEEDY- Section 1902(a)(10)(C)(i)(I) of such Act (42 U.S.C. 1396a(a)(10)(C)(i)(I)) is amended by inserting `(and such criteria may provide for eligibility of individuals described in subparagraph (A)(ii)(XV))' after `medical assistance'.

(2) CHILDREN'S HEALTH INSURANCE PROGRAM- Section 2110(b) of such Act (42 U.S.C. 1397jj(b)) is amended--

(A) in paragraph (1)(A), by inserting before the semicolon `(including, at the option of the State, a child described in paragraph (3)(B))'; and

(B) in paragraph (3)--

(i) by striking `SPECIAL RULE- ' and inserting `SPECIAL RULES-

`(i) HEALTH INSURANCE COVERAGE- ' by indenting the remainder of the text accordingly; and

(ii) by adding at the end the following new subparagraph:

`(B) ELIGIBILITY FOR QUALIFIED ALIEN CHILDREN- For purposes of paragraph (1)(A), a child is described in this subparagraph if--

`(i) the child would be determined eligible for child health assistance under this title but for any or all of the provisions of sections 403 and 421 of Public Law 104-193; and

`(ii) the State exercises the option to provide medical assistance to the category of individuals described in section 1902(a)(10)(A)(ii)(XV).'.

(3) PROHIBITION ON SEEKING SUPPORT FROM SPONSOR- Section 213A(b) of the Immigration and Nationality Act (8 U.S.C. 1183a(b)) is amended by adding at the end the following new paragraph:

`(4) EXCEPTION FOR CHILD MEDICAID OR SCHIP ASSISTANCE- The preceding provisions of this subsection shall not apply to--

`(A) medical assistance furnished under the State plan under title XIX of the Social Security Act to an individual eligible for such assistance because of subclause (XV) of paragraph (10)(A)(ii) of section 1902(a) of such Act (42 U.S.C. 1396a(a)) or because of the reference to such subclause in paragraph (10)(C) of such section; or

`(B) child health assistance furnished under the State child health plan under title XXI of such Act to a child eligible for such assistance because of the provisions of section 2110(b)(3)(B) of such Act (42 U.S.C. 1397jj(b)(3)(B)).'.

(d) CLARIFICATION OF COVERAGE UNDER VACCINE FOR CHILDREN PROGRAM-

(1) IN GENERAL- Section 1928(b)(2)(A)(ii) of the Social Security Act (42 U.S.C. 1396s(b)(2)(A)(ii) is amended by inserting `, except that for purposes of this paragraph a child who is only insured under title XXI shall be considered as being not insured' after `not insured'.

(2) EFFECTIVE DATE- The amendment made by paragraph (1) shall take effect as if included in the enactment of the Balanced Budget Act of 1997.

(e) ELIMINATION OF FUNDING OFFSET FOR EXERCISE OF PRESUMPTIVE ELIGIBILITY OPTION-

(1) IN GENERAL- Section 2104(d) of such Act (42 U.S.C. 1397dd(d)) is amended by striking `shall be reduced by the sum of' and all that follows through `(2) the amount of payments under such section' and inserting `shall be reduced by the amount of payments under section 1903(a)(1)'.

(2) EFFECTIVE DATE- The amendment made by paragraph (1) first applies for allotments for fiscal year 2001.

(f) PROGRAM COORDINATION WITH THE MATERNAL AND CHILD HEALTH PROGRAM (TITLE V)-

(1) IN GENERAL- Section 2102(b)(3) of such Act (42 U.S.C. 1397bb(b)(3)) is amended--

(A) by striking `and' at the end of subparagraph (D);

(B) by striking the period at the end of subparagraph (E) and inserting `; and'; and

(C) by adding at the end the following new subparagraph:

`(F) that operations and activities under this title are developed and implemented in consultation and coordination with the program operated by the State under title V in areas including outreach and enrollment, benefits and services, service delivery standards, public health and social service agency relationships, and quality assurance and data reporting.'.

(2) CONFORMING MEDICAID AMENDMENT- Section 1902(a)(11) of such Act (42 U.S.C. 1306a(a)(11)) is amended--

(A) by striking `and' before `(C)'; and

(B) by inserting before the semicolon at the end the following: `, and (D) provide that operations and activities under this title are developed and implemented in consultation and coordination with the program operated by the State under title V in areas including outreach and enrollment, benefits and services, service delivery standards, public health and social service agency relationships, and quality assurance and data reporting'.

(3) EFFECTIVE DATE- The amendments made by this subsection take effect on January 1, 2000.

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.

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following subsection:

`(g)(1) With respect to a drug being imported or offered for import into the United States, the Secretary may not send a warning notice to a person (including a pharmacist or wholesale importer) unless the following conditions are met:

`(A) The notice specifies, as applicable to the importation of the drug, that the Secretary has made a determination that--

`(i) importation is in violation of section 801(a) because the drug is or appears to be adulterated, misbranded, or in violation of section 505;

`(ii) importation is in violation of section 801(a) because the drug is forbidden or restricted in sale in the country in which it was produced or from which it was exported;

`(iii) importation by any person other than the manufacturer of the drug is in violation of section 801(d); or

`(iv) importation is otherwise in violation of Federal law.

`(B) The notice does not specify any provision described in subparagraph (A) that is not applicable to the importation of the drug.

`(C) The notice states the reasons underlying such determination by the Secretary, including a brief application to the principal facts involved of the provision of law described in subparagraph (A) that is the basis of the determination by the Secretary.

`(2) The term `warning notice', with respect to the importation of a drug, means a communication from the Secretary (written or otherwise) notifying a person, or clearly suggesting to the person, that importing the drug is, or appears to be, a violation of this Act.'.

SEC. 302. INCREASED CONSUMER INFORMATION IN PRESCRIPTION DRUG ADVERTISING.

Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended--

(a) by striking `in brief summary relating to side effects' and inserting `in comprehensive summary relating to side effects'; and

(b) by inserting before `except that' the following: `except that the regulations shall require that such comprehensive summary constitute not less than 50 percent of the content of an advertisement, and the regulations may not exempt reminder advertisements from the requirement of providing the comprehensive summary, and'.

SEC. 303. EDUCATION ABOUT MANUFACTURER PROGRAMS FOR FREE DRUGS TO PATIENTS.

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall in cooperation with manufacturers of prescription drugs carry out activities to inform patients of the existence of programs that are operated by such manufacturers to provide prescription drugs to patients without any charge to the patients.

SEC. 304. SENSE OF CONGRESS REGARDING MERGERS OF DRUG MANUFACTURERS.

It is the sense of the Congress that--

(1) the increased merger of drug manufacturers has resulted in a decrease in price competition in the prescription drug market and increased the potential for collusion in setting prices; and

(2) the Antitrust Division of the Department of Justice and the Federal Trade Commission should give increased scrutiny to the anti-competitive effects of such mergers.

END