datamatters24/research-document-archive huggingface dataset:
‘‘(3) ANDA FILER.—The term ‘ANDA filer’ 
means a party that owns or controls an ANDA filed 
with the Commissioner of Food and Drugs or has 
the exclusive rights under such ANDA to distribute 
the ANDA product. 
‘‘(4) ANDA 
PRODUCT.—The term ‘ANDA 
product’ means the product to be manufactured 
under the ANDA that is the subject of the patent 
infringement claim. 
‘‘(5) DRUG PRODUCT.—The term ‘drug prod-
uct’ has the meaning given such term in section 
314.3(b) of title 21, Code of Federal Regulations (or 
any successor regulation). 
‘‘(6) NDA.—The term ‘NDA’ means a new 
drug application filed under section 505(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)). 
‘‘(7) PATENT
INFRINGEMENT
CLAIM.—The 
term ‘patent infringement claim’ means any allega-
tion made to an ANDA filer, whether or not in-
cluded in a complaint filed with a court, that the 
ANDA filer’s ANDA or ANDA product may infringe 
any of the following held by, or exclusively licensed 
to, the NDA holder of the drug product: 
‘‘(A) Any patent. 
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HR 1359 RFS
use, especially in countries in which social norms 
limit such adoption and use by women and girls, and 
otherwise encourage or support Internet deployment, 
competition, and adoption; and 
(5) conduct outreach and explore partnership 
opportunities with the private sector on activities 
that advance the policy described in this Act. 
SEC. 5. COST LIMITATION. 
No additional funds are authorized to be appro-
priated to carry out the provisions of this Act. 
SEC. 6. RULE OF CONSTRUCTION. 
Nothing in this Act may be construed to infringe 
upon the related functions of any Executive agency (as 
defined in section 105 of title 5, United States Code) vest-
ed in such agency under any other provision of law. 
Passed the House of Representatives May 20, 2019. 
Attest: 
CHERYL L. JOHNSON, 
Clerk. 
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‘‘(B) Any filed patent application. 
‘‘(C) Any extension, reissue, renewal, divi-
sion, continuation, continuation in part, or reex-
amination of a patent. 
‘‘(D) Any patent term restoration, patents 
of addition, or extensions thereof. 
‘‘(E) Any other patent interest. 
‘‘(8) STATUTORY
EXCLUSIVITY.—The term 
‘statutory exclusivity’ means those prohibitions on 
the approval of drug applications under clauses (ii) 
through (iv) of section 505(c)(3)(E) (5- and 3-year 
data exclusivity), section 527 (orphan drug exclu-
sivity), section 505A (pediatric exclusivity), or sec-
tion 505E (qualified infectious disease product ex-
clusivity) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(c)(3)(E), 360cc, 355a, 355f).’’. 
(b) APPLICABILITY.—Section 27 of the Federal 
Trade Commission Act, as added by this section, shall 
apply to any agreement described in section 27(a)(2)(A) 
of that Act entered into after June 17, 2013. Section 27(f) 
of the Federal Trade Commission Act, as added by this 
section, shall apply to agreements entered into on or after 
the date of enactment of this Act. 
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SEC. 5. NOTICE AND CERTIFICATION OF AGREEMENTS. 
(a) 
NOTICE
OF
ALL
AGREEMENTS.—Section 
1112(c)(2) of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 (21 U.S.C. 355 
note) is amended by— 
(1) striking ‘‘the Commission the’’ and insert-
ing the following: ‘‘the Commission— 
‘‘(A) the’’; 
(2) striking the period and inserting ‘‘; and’’; 
and 
(3) inserting at the end the following: 
‘‘(B) any other agreement the parties enter 
into within 30 days after entering into an 
agreement covered by subsection (a) or (b).’’. 
(b) CERTIFICATION OF AGREEMENTS.—Section 1112 
of such Act is amended by adding at the end the following: 
‘‘(d) CERTIFICATION.—The Chief Executive Officer 
or the company official with primary responsibility for ne-
gotiating any agreement under subsection (a) or (b) that 
is required to be filed under subsection (c) shall execute 
and file with the Assistant Attorney General and the Com-
mission a certification as follows: ‘I declare that the fol-
lowing is true, correct, and complete to the best of my 
knowledge: The materials filed with the Federal Trade 
Commission and the Department of Justice under section 
1112 of subtitle B of title XI of the Medicare Prescription 
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Drug, Improvement, and Modernization Act of 2003, with 
respect to the agreement referenced in this certification— 
‘‘ ‘(1) represent the complete, final, and exclu-
sive agreement between the parties; 
‘‘ ‘(2) include any ancillary agreements that are 
contingent upon, provide a contingent condition for, 
or are otherwise related to, the referenced agree-
ment; and 
‘‘ ‘(3) include written descriptions of any oral 
agreements, representations, commitments, or prom-
ises between the parties that are responsive to sub-
section (a) or (b) of such section 1112 and have not 
been reduced to writing.’.’’. 
SEC. 6. COMMISSION LITIGATION AUTHORITY. 
Section 16(a)(2) of the Federal Trade Commission 
Act (15 U.S.C. 56(a)(2)) is amended— 
(1) in subparagraph (D), by striking ‘‘or’’ after 
the semicolon; 
(2) in subparagraph (E), by inserting ‘‘or’’ 
after the semicolon; and 
(3) by inserting after subparagraph (E) the fol-
lowing new subparagraph: 
‘‘(F) under section 27;’’. 
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because of the application of the definition in clause (i), 
any supplemental security income benefits otherwise pay-
able shall be withheld until such time as the individual 
is no longer either in custody pending disposition of 
charges or an inmate of a public institution or shall be 
paid to the individual’s estate if the individual dies before 
the pending charges are disposed of or while the individual 
is an inmate of a public institution.’’. 
(d) CHIP.—Section 2110(b)(2)(A) of the Social Se-
curity Act (42 U.S.C. 1397jj(b)(2)(A)) is amended by in-
serting ‘‘(except as an individual in custody pending dis-
position of charges)’’ after ‘‘inmate of a public institu-
tion’’. 
(e) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on the first day of the first 
calendar quarter beginning more than 60 days after the 
date of the enactment of this Act and shall apply to items 
and services furnished, and supplemental security income 
benefits paid, for periods beginning on or after such date. 
Æ 
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‘‘(1) IN GENERAL.—There is hereby created on 
the books of the Treasury of the United States a 
trust fund to be known as the ‘Medicare Buy-In 
Trust Fund’ (in this subsection referred to as the 
‘Trust Fund’). The Trust Fund shall consist of such 
gifts and bequests as may be made as provided in 
section 201(i)(1) and such amounts as may be de-
posited in, or appropriated to, such fund as provided 
in this title. 
‘‘(2) PREMIUMS.—Premiums collected under 
subsection (d) shall be transferred to the Trust 
Fund. 
‘‘(3) INCORPORATION
OF
PROVISIONS.—Sub-
sections (b) through (i) of section 1841 shall apply 
with respect to the Trust Fund and this title in the 
same manner as they apply with respect to the Fed-
eral Supplementary Medical Insurance Trust Fund 
and part B, respectively, except that in applying 
such section 1841, any reference in such section to 
‘this part’ shall be construed to be a reference to 
this section and any reference in section 1841(h) to 
section 1840(d) and in section 1841(i) to sections 
1840(b)(1) and 1842(g) are deemed to be references 
to comparable authority exercised under this section. 
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‘‘(f) CLARIFICATION.—Nothing in this section shall 
affect the benefits or eligibility under this title of individ-
uals who would otherwise be entitled to or eligible for ben-
efits under this title or title XIX, or both. 
‘‘(g) ELIGIBILITY FOR FINANCIAL ASSISTANCE.— 
‘‘(1) IN GENERAL.—Individuals enrolled in cov-
erage under this section shall, from amounts trans-
ferred under paragraph (2), receive financial assist-
ance for such coverage that is substantially similar 
to the assistance the individual would have received 
if the individual were enrolled in a qualified health 
plan through an Exchange. 
‘‘(2) TRANSFER OF FUNDS TO MEDICARE BUY- 
IN TRUST FUND.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
transfer to the Medicare Buy-In Trust Fund 
under subsection (d) for each plan year the 
amount determined under paragraph (C) for 
such year. 
‘‘(B) USE
OF
FUNDS.—The amounts 
transferred to the Medicare Buy-In Trust Fund 
under subparagraph (A) shall only be used to 
reduce the premiums and cost-sharing for cov-
erage under this section of individuals enrolled 
under such coverage who would be eligible for 
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cost-sharing reductions under section 1402 of 
the Patient Protection and Affordable Care Act 
and premium assistance under section 36B of 
the Internal Revenue Code of 1986 if such indi-
vidual were enrolled in a qualified health plan. 
‘‘(C) AMOUNT OF TRANSFER.— 
‘‘(i) IN GENERAL.—The amount de-
termined under this subparagraph for any 
plan year is the aggregate amount the Sec-
retary determines is equal to 100 percent 
of the premium tax credits under section 
36B of the Internal Revenue Code of 
1986, and 100 percent of the cost-sharing 
reductions under section 1402 of the Pa-
tient Protection and Affordable Care Act, 
that would have been provided for the plan 
year to eligible individuals who meet speci-
fied income criteria and are enrolled for 
such plan year in coverage provided 
through enrollment under this section if 
such individuals were enrolled for such 
year in a qualified health plan through an 
Exchange. 
‘‘(ii) SPECIFIC REQUIREMENTS.—The 
Secretary shall make the determination 
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under clause (i) on a per enrollee basis and 
shall take into account all relevant factors 
necessary to determine the value of the 
premium tax credits and cost-sharing re-
ductions that would have been provided to 
eligible individuals described in section 
1331 of the Patient Protection and Afford-
able Care Act, including the age and in-
come of the enrollee, geographic differences 
in average spending for health care across 
rating areas, the health status of the en-
rollee for purposes of determining risk ad-
justment payments and reinsurance pay-
ments that would have been made if the 
enrollee had enrolled in a qualified health 
plan through an Exchange, and whether 
any reconciliation of the credit or cost- 
sharing reductions would have occurred if 
the enrollee had been so enrolled. This de-
termination shall take into consideration 
the experience of other States with respect 
to participation in an Exchange and such 
credits and reductions provided to resi-
dents of the other States, with a special 
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focus on enrollees with income below 200 
percent of poverty. 
‘‘(D) CERTIFICATION.— 
‘‘(i) IN GENERAL.—The Chief Actuary 
of the Centers for Medicare & Medicaid 
Services, in consultation with the Office of 
Tax Analysis of the Department of the 
Treasury, shall certify whether the method-
ology used to make determinations under 
subparagraph (C), and such determina-
tions, meet the requirements of this para-
graph. Such certifications shall be based 
on sufficient data from the federal ex-
change and from comparable States about 
their experience with programs created by 
the Basic Health Plan. 
‘‘(ii) CORRECTIONS.—The Secretary 
shall adjust the payment to the Trust 
Fund for any plan year to reflect any error 
in the determinations under subparagraph 
(C) for any preceding plan year. 
‘‘(iii) APPLICATION.—Coverage pro-
vided through enrollment under this part 
and parts B and D pursuant to this sec-
tion shall be treated as coverage under a 
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qualified health plan in the silver level of 
coverage in the individual market offered 
through an Exchange and the Secretary 
shall be treated as the issuer of such plan. 
‘‘(h) TREATMENT IN RELATION TO THE AFFORD-
ABLE CARE ACT.— 
‘‘(1) TREATMENT AS MINIMUM ESSENTIAL COV-
ERAGE.—For purposes of applying section 5000A of 
the Internal Revenue Code of 1986, the coverage 
provided through enrollment under this section con-
stitutes minimum essential coverage under sub-
section (f)(1)(A)(i) of such section. 
‘‘(2) USE OF EXCHANGES.—Coverage provided 
through enrollment under this section shall be 
deemed to be coverage under a qualified health plan 
for purposes of section 1311(d)(4)(C) of the Patient 
Protection and Affordable Care Act and shall be 
made available for enrollment, information compari-
son, and otherwise as such a plan through any inter-
net website maintained by an Exchange established 
under title I of such Act (as described in such sec-
tion). 
‘‘(3) MEDICAID
MANAGED
CARE.—States are 
prohibited from buying their Medicaid beneficiaries 
ages 50 to 64 into Medicare under this section, and 
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lation as published in the Federal Register on December 
4, 1998, and as subsequently updated by the National As-
sociation of Insurance Commissioners to reflect previous 
changes in law and the reference to ‘date of enactment 
of this subsection’ deemed a reference to the date of enact-
ment of this subsection (aa).’’. 
SEC. 4. MEDICARE DIRECT SUPPLEMENTAL INSURANCE 
OPTION. 
(a) IN GENERAL.—Title XVIII of the Social Security 
Act is amended by inserting after section 1882 (42 U.S.C. 
1395ss) the following new section: 
‘‘SEC. 1882A. MEDICARE DIRECT SUPPLEMENTAL INSUR-
ANCE OPTION. 
‘‘(a) IN GENERAL.—The Secretary shall provide for 
the offering under this section of a voluntary program to 
supplement the benefits provided to individuals under 
parts A and B of this title. 
‘‘(b) ELIGIBILITY; ENROLLMENT.—The Secretary 
shall provide procedures for the enrollment under the pro-
gram under this section of individuals who are entitled to 
benefits under part A and enrolled under part B, but who 
are not enrolled in a Medicare Advantage plan (or in a 
plan under section 1876). Such procedures shall be con-
sistent with the following: 
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‘‘(1) There shall be an initial enrollment period 
during the last calendar quarter of 2020 that per-
mits all individuals who are eligible to enroll at that 
time under this subsection to enroll and obtain bene-
fits effective on January 1, 2021. 
‘‘(2) For individuals who are not eligible to en-
roll at such time but who subsequently become eligi-
ble, there shall be an individual enrollment period 
which is the 6-month period described in section 
1882(s)(2)(A). 
‘‘(3) The Secretary shall permit eligible individ-
uals to enroll at other times (and not less frequently 
than annually) in a uniform manner, but such en-
rollment shall be subject to a late enrollment penalty 
under subsection (d)(2)(B). 
‘‘(c) BENEFITS.— 
‘‘(1) IN
GENERAL.—The benefits provided 
under the program under this section shall consist of 
payment of the cost of deductibles, copayments, and 
other cost-sharing amounts (including amounts at-
tributable to and permitted as balance billing) other-
wise imposed or permitted under this title, subject to 
an annual deductible of $100. 
‘‘(2) ADMINISTRATION.—The Secretary shall 
coordinate payment of benefits under this part with 
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those under parts A and B and may, for such pur-
pose, enter into appropriate arrangements with 
qualified entities (which may include fiscal inter-
mediaries and carriers). 
‘‘(3) NO
PRE-EXISTING
CONDITION
LIMITA-
TIONS.—The benefits under this section shall not be 
subject to any pre-existing condition or similar un-
derwriting limitation. 
‘‘(d) PREMIUMS.— 
‘‘(1) ACTUARIAL
COST.—The Secretary shall, 
during September of each year beginning with 2020, 
determine a monthly actuarial rate for all enrollees 
under this section, which rate shall be applicable for 
months in the succeeding calendar year. Such actu-
arial rate shall be the amount the Secretary esti-
mates to be necessary so that the aggregate amount 
for such calendar year with respect to those enrollees 
will equal the total amount which the Secretary esti-
mates will be payable under this section for benefits 
accrued (including services performed and related 
administrative costs incurred) in such calendar year 
under the program under this section. In calculating 
the monthly actuarial rate, the Secretary shall make 
adjustments to take into account errors in esti-
mations under this paragraph for previous years and 
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shall include an appropriate amount for a contin-
gency margin. 
‘‘(2) PREMIUM.— 
‘‘(A) IN GENERAL.—The monthly premium 
of each individual enrolled under this section 
for a month in a year shall be the monthly ac-
tuarial rate determined under paragraph (1) for 
months in such year. Such premium shall be 
community-rated and shall not vary among en-
rollees based upon the age, place of residence, 
or any other factors, except as provided under 
subparagraph (B). 
‘‘(B) PENALTY FOR LATE ENROLLMENT.— 
In the case of an individual who does not enroll 
under this section in a period provided under 
paragraph (1) or (2) of subsection (b), the Sec-
retary shall increase the monthly premium (in 
a manner similar to that applied under part B 
pursuant to section 1839(b)) of 10 percent for 
each full 12 months in which the individual 
could have been but was not so enrolled. In ap-
plying such an increase— 
‘‘(i) the aggregate percentage increase 
may not exceed 100 percent; and 
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‘‘(ii) periods of time in which an indi-
vidual is enrolled under an employee wel-
fare benefit plan described in section 
1882(s)(3)(B)(i), under a Medicare Advan-
tage plan, with an organization described 
in section 1882(s)(3)(B)(iii), or under a 
PACE program under section 1894 shall 
not be taken into account. 
‘‘(3) COLLECTION.—The Secretary shall pro-
vide for the collection of premiums for enrollees 
under this part in the same manner as premiums 
under part B are collected under section 1840, ex-
cept that any reference in such section to the Fed-
eral Supplementary Medical Insurance Trust Fund 
shall be deemed a reference to an account (to be 
known as the ‘Direct Medicare Supplemental Insur-
ance Account’) to be established in the Treasury by 
the Secretary to carry out the program under this 
section. Amounts in such account may be invested 
and draw interest in the same manner as such Trust 
Fund under section 1840(c). 
‘‘(4) USE OF FUNDS.—Premium amounts de-
posited into the account established under paragraph 
(3) shall be available without regard to appropria-
tions to the Secretary to make payment for benefits 
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and administrative costs incurred in carrying out 
this section. 
‘‘(e) NONDUPLICATION
OF COVERAGE.—For pur-
poses of applying section 1882(d)(3)(A), coverage under 
this section shall be treated as coverage under a Medicare 
supplemental policy.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect on the date of the enact-
ment of this Act and shall apply to benefits for months 
beginning with January 2020. 
SEC. 5. NEGOTIATION OF LOWER COVERED PART D DRUG 
PRICES ON BEHALF OF MEDICARE BENE-
FICIARIES. 
(a) NEGOTIATION BY SECRETARY.—Section 1860D– 
11 of the Social Security Act (42 U.S.C. 1395w–111) is 
amended by striking subsection (i) (relating to noninter-
ference) and inserting the following: 
‘‘(i) NEGOTIATION OF LOWER DRUG PRICES.— 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of law, the Secretary shall negotiate with 
pharmaceutical manufacturers the prices (including 
discounts, rebates, and other price concessions) that 
may be charged to PDP sponsors and MA organiza-
tions for covered part D drugs for part D eligible in-
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dividuals who are enrolled under a prescription drug 
plan or under an MA–PD plan. 
‘‘(2) 
NO
CHANGE
IN
RULES
FOR 
FORMULARIES.— 
‘‘(A) IN GENERAL.—Nothing in paragraph 
(1) shall be construed to authorize the Sec-
retary to establish or require a particular for-
mulary. 
‘‘(B) CONSTRUCTION.—Subparagraph (A) 
shall not be construed as affecting the Sec-
retary’s authority to ensure appropriate and 
adequate access to covered part D drugs under 
prescription drug plans and under MA–PD 
plans, including compliance of such plans with 
formulary requirements under section 1860D– 
4(b)(3). 
‘‘(3) CONSTRUCTION.—Nothing in this sub-
section shall be construed as preventing the sponsor 
of a prescription drug plan, or an organization offer-
ing an MA–PD plan, from obtaining a discount or 
reduction of the price for a covered part D drug 
below the price negotiated under paragraph (1). 
‘‘(4) SEMI-ANNUAL REPORTS TO CONGRESS.— 
Not later than June 1, 2022, and every 6 months 
thereafter, the Secretary shall submit to the Com-
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