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Title II — Access and Affordability

S. 1801 · 116th Congress · Jun 12, 2019 · Lineage

II Access and Affordability

Sec. 201 Negotiating fair prices for Medicare prescription drugs

(a)
Negotiating fair prices—
(1)
In general— Section 1860D–11 of the Social Security Act (42 U.S.C. 1395w–111) is amended by striking subsection (i) (relating to noninterference) and by inserting the following:

“(i) Negotiating fair prices with drug manufacturers

“(1) In general—Notwithstanding any other provision of law, in furtherance of the goals of providing quality care and containing costs under this part, the Secretary shall, with respect to applicable covered part D drugs, and may, with respect to other covered part D drugs, negotiate, using the negotiation technique or techniques that the Secretary determines will maximize savings and value to the government for prescription drug plans and MA–PD plans and for plan enrollees (in a manner that may be similar to Federal entities and that may include, but is not limited to, formularies, reference pricing, discounts, rebates, other price concessions, and coverage determinations), with drug manufacturers the prices that may be charged to PDP sponsors and MA organizations for such drugs for part D eligible individuals who are enrolled in a prescription drug plan or in an MA–PD plan. In conducting such negotiations, the Secretary shall consider the drug’s current price, initial launch price, prevalence of disease and usage, and approved indications, the number of similarly effective alternative treatments for each approved use of the drug, the budgetary impact of providing coverage under this part for such drug for all individuals who would likely benefit from the drug, evidence on the drug’s effectiveness and safety compared to similar drugs, and the quality and quantity of clinical data and rigor of the applicable process of approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act or a biological product under section 351 of the Public Health Service Act.

“(2) Use of lower of VA or big four price if negotiations fail—If, after attempting to negotiate for a price with respect to a covered part D drug under paragraph (1) for a period of 1 year, the Secretary is not successful in obtaining an appropriate price for the drug (as determined by the Secretary), the Secretary shall establish the price that may be charged to PDP sponsors and MA organizations for such drug for part D eligible individuals who are enrolled in a prescription drug plan or in an MA–PD plan at an amount equal to the lesser of—

“(A) the price paid by the Secretary of Veterans Affairs to procure the drug under the laws administered by the Secretary of Veterans Affairs; or

“(B) the price paid to procure the drug under section 8126 of title 38, United States Code.

“(3) Applicable covered part D drug defined—For purposes of this subsection, the term applicable covered part D drug means a covered part D drug that the Secretary determines to be appropriate for negotiation under paragraph (1) based on one or more of the following factors as applied to such drug:

“(A) Spending on a per beneficiary basis.

“(B) The proportion of total spending under this title.

“(C) Unit price increases over the preceding 5 years.

“(D) Initial launch price.

“(E) Availability of less expensive, similarly effective alternative treatments.

“(F) Status of the drug as a follow-on to previously approved drugs.

“(G) Any other criteria determined by the Secretary.

“(4) PDP sponsors and MA organization may negotiate lower prices—Nothing in this subsection shall be construed as preventing the sponsor of a prescription drug plan, or an organization offering 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) or the price established under paragraph (2).

“(5) No effect on existing appeals process—Nothing in this subsection shall be construed to affect the appeals procedures under subsections (g) and (h) of section 1860D–4.”

(2)
Effective date— The amendments made by this subsection shall take effect on the date of the enactment of this Act and shall first apply to negotiations and prices for plan years beginning on January 1, 2020.
(b)
Requirement To include a link to the Medicare Drug Spending Dashboard on the Medicare Plan Finder— Beginning not later than January 1, 2020, the Secretary of Health and Human Services shall ensure that the Medicare Plan Finder on the Medicare.gov internet website includes a link to the Medicare Drug Spending Dashboard on the CMS.gov internet website. Such link shall be easily accessible on the Medicare Plan Finder.
(c)
Reports to Congress—
(1)
Secretary of HHS—
(A)
In general— Not later than 3 years after the date of the enactment of this Act, and every 6 months thereafter, the Secretary of Health and Human Services shall submit to Congress a report on the following:
(i)
The price negotiations conducted by the Secretary under section 1860D–11(i) of the Social Security Act (42 U.S.C. 1395w–111(i)), as amended by subsection (a), including a description of—
(I)
how such price negotiations are achieving lower prices for covered part D drugs (as defined in section 1860D–2(e) of the Social Security Act (42 U.S.C. 1395w–102(e))) for Medicare beneficiaries;
(II)
how such lower prices are passed through to Medicare beneficiaries;
(III)
how such price negotiations are affecting drug prices in the private market; and
(IV)
how such price negotiations are affecting the list price of covered part D drugs.
(ii)
Data on spending under part D of the Medicare program on covered part D drugs, including data on covered part D drugs with—
(I)
spending on a per beneficiary basis that is above the median spending on other drugs in the same class or above the median spending of other drug classes; and
(II)
high unit cost increases over the past five years, especially where such increases are greater than the increases for covered part D drugs in general.
(iii)
A list of the covered part D drugs with no therapeutic substitute and data on spending under part D of the Medicare program on such drugs.
(iv)
Access to covered part D drugs and, where available, compliance rates and health outcomes associated with compliance rates.
(v)
Appeals by enrollees with respect to covered part D drugs not included on plan formularies.
(B)
Public availability of report— The Secretary of Health and Human Services shall publish on the internet website of the Centers for Medicare & Medicaid Services a copy of each report submitted under subparagraph (A), including the detailed tables, figures, and data published in the report and its appendices.
(2)
MedPAC—
(A)
Study— The Comptroller General of the United States shall conduct a study on the price negotiations conducted by the Secretary under section 1860D–11(i) of the Social Security Act (42 U.S.C. 1395w–111(i)), as amended by subsection (a), including an analysis of—
(i)
how such price negotiations are achieving lower prices for covered part D drugs (as defined in section 1860D–2(e) of the Social Security Act (42 U.S.C. 1395w–102(e))) for Medicare beneficiaries;
(ii)
who is benefiting from such lower prices, such as Medicare beneficiaries, the Federal Government, States, prescription drug plans and MA–PD plans, or other entities;
(iii)
how such price negotiations are a factor affecting drug prices in the private market; and
(iv)
how such price negotiations are a factor affecting the list price of covered part D drugs.
(B)
Report— Not later than January 1, 2022, the Comptroller General of the United States shall submit to Congress a report on the study conducted under subparagraph (A), together with recommendations for improving such price negotiations.
(d)
CMI testing of negotiating drug and biological prices To improve value— Section 1115A(b)(2) of the Social Security Act (42 U.S.C. 1315a(b)(2)) is amended—
(1)
in subparagraph (A), by adding at the end the following new sentence: “The models selected under this subparagraph shall include at least three of the models described in subparagraph (D), which shall be implemented by not later than 18 months after the date of the enactment of the Affordable Medications Act”; and
(2)
by adding at the end the following new subparagraph:

“(D) Models of negotiating drug and biological prices to improve value—The models described in this subparagraph are the following models for negotiating drug and biological prices under the applicable titles (including under both parts B and D of title XVIII) in order to improve the value of payments for such drugs and biologicals under such titles:

“(i) Discounting or eliminating patient cost-sharing on high-value drugs and biologicals.

“(ii) Value-based formularies.

“(iii) Indications-based pricing.

“(iv) Reference pricing.

“(v) Risk-sharing agreements based on outcomes.

“(vi) Pricing based on comparative effectiveness research.

“(vii) Episode-based payments for chemotherapy and other conditions determined appropriate by the Secretary.

“(viii) Alternative ways of paying for drugs and biologicals under part B of title XVIII.

“(ix) Other models determined appropriate by the Secretary.”

Sec. 202 Prescription drug price spikes

(a)
Identification of prescription drug price spikes—
(1)
Definitions— In this subsection:
(A)
Applicable entity— The term applicable entity means the holder of an application approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or of a license issued under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) for a drug described in paragraph (5)(A).
(B)
Average manufacturer price— The term average manufacturer price—
(i)
has the same meaning given such term under section 1927(k)(1) of the Social Security Act (42 U.S.C. 1396r–8(k)(1)); or
(ii)
with respect to a drug for which there is no average manufacturer price as so defined, such term shall mean the wholesale acquisition cost of the drug.
(C)
Commerce— The term commerce has the meaning given such term in section 4 of the Federal Trade Commission Act (15 U.S.C. 44).
(D)
Inspector General— The term Inspector General means the Inspector General of the Department of Health and Human Services.
(E)
Prescription drug—
(i)
In general— The term prescription drug means any drug (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g))), including a combination product whose primary mode of action is determined under section 503(g) of such Act (21 U.S.C. 353(g)) to be that of a drug, and that—
(I)
is subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)); and
(II)
is covered by a Federal health care program (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a–7b(f))).
(ii)
Treatment of reformulated drugs— For purposes of this subsection, a prescription drug with respect to which the Secretary of Health and Human Services has approved any minor reformulation that does not produce a meaningful therapeutic benefit, the drug that was approved prior to any such reformulation and the drug with any such reformulation shall be considered one prescription drug.
(F)
Price spike—
(i)
In general— The term price spike means an increase in the average manufacturer price in commerce of a prescription drug for which the price spike percentage is equal to or greater than applicable price increase allowance.
(ii)
Price spike percentage— The price spike percentage is the percentage (if any) by which—
(I)
the average manufacturer price of a prescription drug in commerce for the calendar year; exceeds
(II)
the average manufacturer price of such prescription drug in commerce for the calendar year preceding such year.
(iii)
Applicable price increase allowance— The applicable price increase allowance for any calendar year is the percentage (rounded to the nearest one-tenth of 1 percent) by which the C–CPI–U (as defined in section 1(f)(6) of the Internal Revenue Code of 1986) for that year exceeds the C–CPI–U for the preceding calendar year.
(G)
Price spike revenue—
(i)
In general— The price spike revenue for any calendar year is an amount equal to—
(I)
the gross price spike revenue; minus
(II)
the adjustment amount.
(ii)
Gross price spike revenue— The gross price spike revenue for any calendar year is an amount equal to the product of—
(I)
an amount equal to the difference between subclause (I) of subparagraph (F)(ii) and subclause (II) of such subparagraph; and
(II)
the total number of units of the prescription drug which were sold in commerce in such calendar year.
(iii)
Adjustment amount— The adjustment amount is the amount, if any, of the gross price spike revenue which the Inspector General has determined is due solely to an increase in the cost of the inputs necessary to manufacture the prescription drug subject to the price spike.
(2)
Submission by pharmaceutical companies of information to Inspector General—
(A)
In general— For each prescription drug, the applicable entity shall submit to the Inspector General a quarterly report that includes the following:
(i)
For each prescription drug of the applicable entity—
(I)
the total number of units of the prescription drug which were sold in commerce in the preceding calendar quarter;
(II)
the average and median price per unit of such prescription drug in commerce in the preceding calendar quarter, disaggregated by month; and
(III)
the gross revenues from sales of such prescription drug in commerce in the preceding calendar quarter.
(ii)
Such information related to increased input costs or public health considerations as the applicable entity may wish the Inspector General to consider in making a determination under subclause (II) of paragraph (3)(B)(ii) or an assessment in subclause (III) of such paragraph for the preceding calendar quarter.
(iii)
Such information related to any anticipated increased input costs for the subsequent calendar quarter as the applicable entity may wish the Inspector General to consider in making a determination under subclause (II) of paragraph (3)(B)(ii) or an assessment in subclause (III) of such paragraph for such calendar quarter.
(B)
Penalty for failure to submit—
(i)
In general— An applicable entity described in subparagraph (A) that fails to submit information to the Inspector General regarding a prescription drug, as required by such subparagraph, before the date specified in subparagraph (C) shall be liable for a civil penalty, as determined under clause (ii).
(ii)
Amount of penalty— The amount of the civil penalty shall be equal to the product of—
(I)
an amount, as determined appropriate by the Inspector General, which is—
(aa)
not less than 0.5 percent of the gross revenues from sales of the prescription drug described in clause (i) for the preceding calendar year, and
(bb)
not greater than 1 percent of the gross revenues from sales of such prescription drug for the preceding calendar year, and
(II)
the number of days in the period between—
(aa)
the applicable date specified in subparagraph (C), and
(bb)
the date on which the Inspector General receives the information described in subparagraph (A) from the applicable entity.
(C)
Submission deadline— An applicable entity shall submit each quarterly report described in subparagraph (A) not later than January 17, April 18, June 15, and September 15 of each calendar year.
(3)
Assessment by Inspector General—
(A)
In general— Not later than the last day in February of each year, the Inspector General, in consultation with other relevant Federal agencies (including the Federal Trade Commission), shall—
(i)
complete an assessment of the information the Inspector General received pursuant to paragraph (2)(A) with respect to sales of prescription drugs in the preceding calendar year; and
(ii)
in the case of any prescription drug which satisfies the conditions described in subparagraph (A) or (B) of paragraph (4), submit a recommendation to the Secretary of Health and Human Services that such drug be exempted from application of the tax imposed under section 4192 of the Internal Revenue Code of 1986 (as added by subsection (b) of this section) for such year.
(B)
Elements— The assessment required by subparagraph (A) shall include the following:
(i)
Identification of each price spike relating to a prescription drug in the preceding calendar year.
(ii)
For each price spike identified under clause (i)—
(I)
a determination of the price spike revenue;
(II)
a determination regarding the accuracy of the information submitted by the applicable entity regarding increased input costs; and
(III)
an assessment of the rationale of the applicable entity for the price spike.
(4)
Exemption of certain drugs—
(A)
In general— The Secretary of Health and Human Services, upon recommendation of the Inspector General pursuant to paragraph (3)(A)(ii), may exempt any prescription drug which has been subject to a price spike during the preceding calendar year from application of the tax imposed under section 4192 of the Internal Revenue Code of 1986 for such year, if the Secretary determines that—
(i)
based on information submitted pursuant to paragraph (2)(A)(ii), a for-cause price increase exemption should apply; or
(ii)
(I)
the prescription drug which has been subject to a price spike has an average manufacturer price of not greater than $10 for a 30-day supply; and
(II)
such drug is marketed by not less than three other holders of applications approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), where such applications approved under such subsection (j) use as a reference drug the drug so approved under such subsection (c).
(B)
Clarification— In considering, under subparagraph (A)(i), information submitted pursuant to paragraph (2)(A)(ii), the Secretary—
(i)
has the discretion to determine that such information does not warrant a for-cause price increase exemption; and
(ii)
shall exclude from such consideration any information submitted by the applicable entity threatening to curtail or limit production of the prescription drug if the Secretary does not grant an exemption from the application of the tax under section 4192 of the Internal Revenue Code of 1986.
(5)
Inspector General report to Internal Revenue Service—
(A)
In general— Subject to subparagraph (C), not later than the last day in February of each year, the Inspector General shall transmit to the Internal Revenue Service a report on the findings of the Inspector General with respect to the information the Inspector General received under paragraph (2)(A) with respect to the preceding calendar year and the assessment carried out by the Inspector General under paragraph (3)(A) with respect to such information.
(B)
Contents— The report transmitted under subparagraph (A) shall include the following:
(i)
The information received under paragraph (2)(A) with respect to the preceding calendar year.
(ii)
The price spikes identified under clause (i) of paragraph (3)(B).
(iii)
The price spike revenue determinations made under clause (ii)(I) of such paragraph.
(iv)
The determinations and assessments made under subclauses (II) and (III) of clause (ii) of such paragraph.
(C)
Notice and opportunity for hearing—
(i)
In general— No report shall be transmitted to the Internal Revenue Service under subparagraph (A) in regards to a prescription drug unless the Inspector General has provided the applicable entity with—
(I)
the assessment of such drug under paragraph (3)(A); and
(II)
notice of their right to a hearing in regards to such assessment.
(ii)
Notice— The notice required under clause (i) shall be provided to the applicable entity not later than 30 days after completion of the assessment under paragraph (3)(A).
(iii)
Request for hearing— Subject to clause (v), an applicable entity may request a hearing before the Secretary of Health and Human Services not later than 30 days after the date on which the notice under clause (ii) is received.
(iv)
Completion of hearing— In the case of an applicable entity which requests a hearing pursuant to clause (iii), the Secretary of Health and Human Services shall, not later than 12 months after the date on which the assessment under paragraph (3)(A) was completed by the Inspector General—
(I)
make a final determination in regards the accuracy of such assessment; and
(II)
provide the report described in subparagraph (B) to the Internal Revenue Service.
(v)
Limitation— An applicable entity may request a hearing under clause (iii) with respect to a particular prescription drug only once within a 5-year period.
(D)
Publication—
(i)
In general— Not later than the last day in February of each year, subject to clause (ii), the Inspector General shall make the report transmitted under subparagraph (A) available to the public, including on the internet website of the Inspector General.
(ii)
Proprietary information— The Inspector General shall ensure that any information made public in accordance with clause (i) excludes trade secrets and confidential commercial information.
(6)
Notification— The Secretary of the Treasury, in conjunction with the Inspector General, shall notify, at such time and in such manner as the Secretary of the Treasury shall provide, each applicable entity in regard to any prescription drug which has been determined to have been subject to a price spike during the preceding calendar year and the amount of the tax imposed on such applicable entity pursuant to section 4192 of the Internal Revenue Code of 1986.
(b)
Excise tax on prescription drugs subject to price spikes—
(1)
In general— Subchapter E of chapter 32 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:

“4192. Prescription drugs subject to price spikes

“(a) Imposition of tax

“(1) In general—Subject to paragraph (3), for each taxable prescription drug sold by an applicable entity during the calendar year, there is hereby imposed on such entity a tax equal to the greater of—

“(A) the annual price spike tax for such prescription drug, or

“(B) subject to paragraph (2), the cumulative price spike tax for such prescription drug.

“(2) Limitation—In the case of a taxable prescription drug for which the applicable period (as determined under subsection (c)(2)(E)(i)) is less than 2 calendar years, the cumulative price spike tax shall not apply.

“(3) Exemption—For any calendar year in which the Secretary of Health and Human Services has provided an exemption for a taxable prescription drug pursuant to section 202(a)(4) of the Affordable Medications Act, the amount of the tax determined under paragraph (1) for such drug or device for such calendar year shall be reduced to zero.

“(b) Annual price spike tax

“(1) In general—The amount of the annual price spike tax shall be equal to the applicable percentage of the price spike revenue received by the applicable entity on the sale of the taxable prescription drug during the calendar year.

“(2) Applicable percentage—For purposes of paragraph (1), the applicable percentage shall be equal to—

“(A) in the case of a taxable prescription drug which has been subject to a price spike percentage greater than the applicable price increase allowance (as defined in section 202(a)(1)(F)(iii) of the Affordable Medications Act) but less than 15 percent, 50 percent,

“(B) in the case of a taxable prescription drug which has been subject to a price spike percentage equal to or greater than 15 percent but less than 20 percent, 75 percent, and

“(C) in the case of a taxable prescription drug which has been subject to a price spike percentage equal to or greater than 20 percent, 100 percent.

“(c) Cumulative price spike tax

“(1) In general—The amount of the cumulative price spike tax shall be equal to the applicable percentage of the cumulative price spike revenue received by the applicable entity on the sale of the taxable prescription drug during the calendar year.

“(2) Applicable percentage

“(A) In general—For purposes of paragraph (1), the applicable percentage shall be equal to—

“(i) in the case of a taxable prescription drug which has been subject to a cumulative price spike percentage greater than the cumulative price increase allowance but less than the first multi-year percentage, 50 percent,

“(ii) in the case of a taxable prescription drug which has been subject to a cumulative price spike percentage equal to or greater than the first multi-year percentage but less than the second multi-year percentage, 75 percent, and

“(iii) in the case of a taxable prescription drug which has been subject to a cumulative price spike percentage equal to or greater than the second multi-year percentage, 100 percent.

“(B) Cumulative price spike percentage—The cumulative price spike percentage is the percentage (if any) by which—

“(i) the average manufacturer price of the taxable prescription drug in commerce for the preceding calendar year, exceeds

“(ii) the average manufacturer price of such prescription drug in commerce for the base year.

“(C) Cumulative price increase allowance—For purposes of clause (i) of subparagraph (A), the cumulative price increase allowance for any calendar year is the percentage (rounded to the nearest one-tenth of 1 percent) by which the C–CPI–U (as defined in section 1(f)(6)) for that year exceeds the C–CPI–U for the base year.

“(D) Multi-year percentages—For purposes of subparagraph (A), the first multi-year percentage and second multi-year percentage shall be determined in accordance with the following table:

“(E) Applicable period and base year

“(i) Applicable period—The applicable period shall be the lesser of—

“(I) the 5 preceding calendar years,

“(II) all calendar years beginning after the date of enactment of this section, or

“(III) all calendar years in which the taxable prescription drug was sold in commerce.

“(ii) Base year—The base year shall be the calendar year immediately preceding the applicable period.

“(3) Cumulative price spike revenue—For purposes of paragraph (1), the cumulative price spike revenue for any taxable prescription drug shall be an amount equal to—

“(A) an amount equal to the product of—

“(i) an amount (not less than zero) equal to—

“(I) the average manufacturer price of such prescription drug in commerce for the preceding calendar year, minus

“(II) the average manufacturer price of such prescription drug in commerce for the base year, and

“(ii) the total number of units of such prescription drug which were sold in commerce in the preceding calendar year, minus

“(B) an amount equal to the sum of the adjustment amounts, if any, determined under section 202(a)(1)(G)(iii) of the Affordable Medications Act for each calendar year during the applicable period.

“(d) Definitions—For purposes of this section—

“(1) Taxable prescription drug—The term taxable prescription drug means a prescription drug (as defined in section 202(a)(1)(E) of the Affordable Medications Act) which has been identified by the Inspector General of the Department of Health and Human Services, under section 202(a)(3)(B)(i) of such Act, as being subject to a price spike.

“(2) Other terms—The terms applicable entity, average manufacturer price, price spike, price spike percentage, and price spike revenue have the same meaning given such terms under section 202(a)(1) of the Affordable Medications Act.”

(2)
Clerical amendments—
(A)
The heading of subchapter E of chapter 32 of the Internal Revenue Code of 1986 is amended by striking “Medical devices” and inserting “Certain medical devices and prescription drugs”.
(B)
The table of subchapters for chapter 32 of such Code is amended by striking the item relating to subchapter E and inserting the following new item:
(3)
The table of sections for subchapter E of chapter 32 of such Code is amended by adding at the end the following new item:
(4)
Effective date— The amendments made by this section shall apply to sales after the date of the enactment of this Act.
(c)
Revenues collected— There are authorized to be appropriated to the Secretary of Health and Human Services such sums as are equal to any increase in revenue to the Treasury by reason of the provisions of this section or the amendments made by this section for the purposes of—
(1)
funding or conducting research on the economic and policy implications of price patterns of prescription drugs;
(2)
increasing amounts available to the National Institutes of Health for research and development of drugs;
(3)
reducing prescription drug cost-sharing for patients; or
(4)
reducing health insurance premiums.

Sec. 203 Importing affordable and safe drugs

(a)
In general— Section 804 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is amended to read as follows:

“804. Importation of safe and affordable drugs by wholesale distributors, pharmacies, and individuals

“(a) In general—Not later than 180 days after the date of enactment of the Affordable Medications Act, the Secretary shall promulgate regulations permitting the importation of qualifying prescription drugs into the United States, in accordance with this section.

“(b) Definitions—For purposes of this section:

“(1) Certified foreign seller—The term certified foreign seller means a licensed foreign pharmacy or foreign wholesale distributor that the Secretary certifies under subsection (d)(1)(B), that pays the fee required under subsection (d)(1)(C), and that is included on the list described in subsection (c).

“(2) Foreign wholesale distributor—The term foreign wholesale distributor means a person (other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or a repackager) engaged in wholesale distribution.

“(3) Importer—The term importer means a dispenser (as defined in section 581(3)) or wholesale distributor registered under section 503(e) who imports prescription drugs into the United States in accordance with this section.

“(4) Licensed foreign pharmacy—The term licensed foreign pharmacy means a pharmacy located in Canada, or subject to subsection (e), another applicable country, that—

“(A) operates in accordance with applicable pharmacy standards set forth by the provincial pharmacy rules and regulations enacted in Canada, or, subject to subsection (e), such applicable rules and regulations of the permitted country in which such seller is located; and

“(B) is licensed to operate and dispense prescription drugs to individuals in Canada, or, subject to subsection (e), the permitted country in which the pharmacy is located.

“(5) Qualifying prescription drug—The term qualifying prescription drug—

“(A) means a prescription drug that—

“(i) is approved for use in patients, and marketed, in Canada, or subject to subsection (e), approved for use in patients, and marketed, in another permitted country;

“(ii) is manufactured in a facility registered under subsection (b)(1) or (i) of section 510 that is in compliance with good manufacturing practices regulations of the Food and Drug Administration;

“(iii) has the same active ingredient or ingredients, route of administration, and strength as a prescription drug approved under chapter V, or, for purposes of subparagraph (B)(iv), is biosimilar to an approved biological product and has the same route of administration and strength as the approved biological product; and

“(iv) is labeled in accordance with—

“(I) the laws of Canada, or another country from which importation is permitted pursuant to subsection (e); and

“(II) the requirements promulgated by the Secretary, which shall include labeling in English;

“(B) with respect to importers only, includes—

“(i) peritoneal dialysis solution;

“(ii) insulin;

“(iii) a drug for which a risk evaluation and mitigation strategy is required under section 505–1;

“(iv) biological products, as defined in section 351 of the Public Health Service Act that are proteins (except any chemically synthesized polypeptides) or analogous products; and

“(v) intravenously infused drugs; and

“(C) does not include—

“(i) a controlled substance (as defined in section 102 of the Controlled Substances Act);

“(ii) an anesthetic drug inhaled during surgery; or

“(iii) a compounded drug.

“(6) Valid prescription—The term valid prescription means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—

“(A) a practitioner who has conducted at least one in-person medical evaluation of the patient; or

“(B) a covering practitioner.

“(c) Publication of certified foreign sellers—The Secretary shall publish on a dedicated internet website a list of certified foreign sellers, including the internet website address, physical address, and telephone number of each such certified foreign seller.

“(d) Additional criteria

“(1) Certified foreign sellers

“(A) In general—To be a certified foreign seller, such seller shall—

“(i) be certified by the Secretary in accordance with subparagraph (B);

“(ii) pay the registration fee established under subparagraph (C); and

“(iii) sell only qualifying prescription drugs to importers or individuals who import prescription drugs into the United States in accordance with this section.

“(B) Certification—To be a certified foreign seller, the Secretary shall certify that such seller—

“(i) is a foreign wholesale distributor or licensed foreign pharmacy operating an establishment, which may include an online foreign pharmacy, that is located in Canada, or, subject to subsection (e), another permitted country;

“(ii) is engaged in the distribution or dispensing of a prescription drug that is imported or offered for importation into the United States;

“(iii) has been in existence for a period of at least 5 years preceding the date of such certification and has a purpose other than to participate in the program established under this section;

“(iv) in the case of a certified foreign seller that is a licensed foreign pharmacy, agrees to dispense a qualifying prescription drug to an individual in the United States only after receiving a valid prescription, as described in paragraph (2)(C);

“(v) has processes established by the seller, or participates in another established process, to certify that the physical premises and data reporting procedures and licenses are in compliance with all applicable laws and regulations of Canada, or, subject to subsection (e), the permitted country in which the seller is located, and has implemented policies designed to monitor ongoing compliance with such laws and regulations;

“(vi) conducts or commits to participate in ongoing and comprehensive quality assurance programs and implements such quality assurance measures, including blind testing, to ensure the veracity and reliability of the findings of the quality assurance program;

“(vii) agrees that, pursuant to subsection (g), laboratories approved by the Secretary may be authorized to conduct product testing to determine the chemical authenticity of sample pharmaceutical products;

“(viii) agrees to notify the Secretary, importers, and individuals of product recalls in Canada, or pursuant to subsection (e), the permitted country in which the seller is located, and agrees to cease, or refrain from, exporting such product;

“(ix) has established, or will establish or participate in, a process for resolving grievances, as defined by the Secretary, and will be held accountable for violations of established guidelines and rules;

“(x) except as otherwise permitted under this section, does not sell products that the seller could not otherwise legally sell in Canada, or, subject to subsection (e), the permitted country in which such seller is located to customers in the United States; and

“(xi) meets any other criteria established by the Secretary.

“(C) Certification fee—Not later than 30 days before the start of each fiscal year, the Secretary shall establish a fee to be collected from foreign sellers for such fiscal year that are certified under subparagraph (B), in an amount that is sufficient, and not more than necessary, to pay the costs of administering the program under this section, and enforcing this section pursuant to section 303(h), for that fiscal year.

“(D) Recertification—A certification under subparagraph (B) shall be in effect for a period of 2 years, or until there is a material change in the circumstances under which the foreign seller meets the requirements under such subparagraph, whichever occurs earlier. A foreign seller may reapply for certification under such subparagraph (B), in accordance with a process established by the Secretary.

“(2) Individuals—An individual may import a qualifying prescription drug described in subsection (b) from Canada or another country pursuant to subsection (e) if such drug—

“(A) is dispensed, including through an online pharmacy, by a certified foreign seller that is a licensed foreign pharmacy;

“(B) is purchased for personal use by the individual, not for resale, in quantities that do not exceed a 90-day supply; and

“(C) is filled only after providing to the licensed foreign pharmacy a valid prescription issued by a health care practitioner licensed to practice in a State in the United States.

“(e) Importation from other countries—Beginning on the date that is 2 years after the date on which final regulations are promulgated to carry out this section, if, based on a review of the evidence obtained after such effective date, including the reports submitted under section 2(d) of the Affordable Medications Act, that importation of qualifying prescription drugs from Canada under this section resulted in cost savings for consumers in the United States and increased access to safe medication, the Secretary shall have the authority to permit importation of qualifying prescription drugs by importers and individuals from, in addition to Canada, any country that—

“(1) is a member of the Organisation for Economic Co-operation and Development; and

“(2) has statutory or regulatory standards for the approval and sale of prescription drugs that are comparable to the standards in the United States and that—

“(A) authorizes the approval of drugs only if a drug has been determined to be safe and effective by experts employed by or acting on behalf of a governmental entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs;

“(B) requires that any determination of safety and effectiveness described in subparagraph (A) be made on the basis of adequate and well-controlled investigations, including clinical investigations, as appropriate, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs;

“(C) requires the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of drugs in the country to be adequate to preserve the identity, quality, purity, and strength of the drugs; and

“(D) requires the reporting of adverse reactions to drugs and establish procedures to recall, and withdraw approval of, drugs found not to be safe or effective.

“(f) Labeling—Any qualifying prescription drug imported that meets the labeling requirements described in subsection (b)(5)(A)(iv) is deemed not misbranded for purposes of section 502.

“(g) Drug testing laboratories—The Secretary may approve one or more laboratories to conduct random testing of prescription drugs sold by certified foreign sellers to assess the chemical authenticity of such drugs.

“(h) Unfair and discriminatory Acts and practices—It is unlawful for a manufacturer, directly or indirectly (including by being a party to a licensing agreement or other agreement)—

“(1) to discriminate by charging a higher price for a prescription drug sold to a certified foreign seller that sells such drug to an importer in accordance with this section than the price that is charged, inclusive of rebates or other incentives to the country from which the drug is exported, to another person that is in the same country and that does not import such a drug into the United States in accordance with this section;

“(2) except with respect to a prescription drug on the drug shortage list under section 506E, discriminate by denying, restricting, or delaying supplies of a prescription drug to a certified foreign seller, on account of such seller's status as a certified foreign seller, that sells such drug to an importer in accordance with this section, or by publicly, privately, or otherwise refusing to do business with such a certified foreign seller on account of such seller's status as a certified foreign seller;

“(3) cause there to be a difference (including a difference in active ingredient, route of administration, bioequivalence, strength, formulation, manufacturing establishment, manufacturing process, or person that manufactures the drug) between a prescription drug for distribution in the United States and the drug for distribution in Canada or another permitted country, subject to subsection (e), for the purpose of avoiding sales by certified foreign sellers; or

“(4) except with respect to a prescription drug on the drug shortage list under section 506E, engage in any other action to restrict, prohibit, or delay the importation of a prescription drug under this section.

“(i) Information and records

“(1) Biannual reports—Each importer shall submit biannual reports to the Secretary which shall contain, for each qualifying prescription drug imported into the United States—

“(A) the unique facility identifier of the manufacturer of the drug, described in section 510;

“(B) the transaction information described in section 581(26) (other than the information described in subparagraph (C)); and

“(C) the price paid by the importer for the drug.

“(2) Maintenance of records by Secretary—The Secretary shall maintain information and documentation submitted under paragraph (1) for such period of time as the Secretary determines to be appropriate.

“(j) Suspension of importation

“(1) Patterns of noncompliance—The Secretary shall require that importation of a specific qualifying prescription drug or importation by a specific certified foreign seller or importer pursuant to this section be immediately suspended if the Secretary determines that there is a pattern of importation of such specific drug or by such specific seller or importer that involves counterfeit drugs, drugs that have been recalled or withdrawn, or drugs in violation of any requirement of this section, until an investigation is completed and the Secretary determines that importation of such drug or by such seller or importer does not endanger the public health.

“(2) Temporary suspension—The Secretary may require that importation of a specific qualifying prescription drug or importation by a specific certified foreign seller or importer pursuant to this section be temporarily suspended if, with respect to such drug, seller, or importer, there is a violation of any requirement of this section or if the Secretary determines that importation of such drug or by such seller or importer might endanger the public health. Such temporary suspension shall apply until the Secretary completes an investigation and determines that importation of such drug or by such seller or importer does not endanger the public health.

“(k) Supply chain security

“(1) Purchase from registered facilities and certified foreign sellers

“(A) In general—Except as provided in subparagraph (B), certified foreign sellers who sell qualifying prescription drugs for importation into the United States pursuant to this section may purchase such drugs only from manufacturers or entities registered under section 510 or other certified foreign sellers.

“(B) Exception—Certified foreign sellers who sell qualifying prescription drugs for importation into the United States pursuant to this section may purchase such drugs from foreign sellers in Canada or another permitted country, even if such foreign seller is not a manufacturer registered under section 510 or a certified foreign seller, if the Secretary enters into a memorandum of understanding or cooperative agreement with Canada, or such other permitted country, to ensure compliance, to the extent appropriate and feasible, with subchapter H of chapter V. The Secretary shall seek to enter into such a memorandum of understanding or cooperative agreement with Canada and each country from which importation is permitted under subsection (e).

“(2) Importation tracing—Certified foreign sellers shall provide importers with the unique facility identifier associated with the manufacturer registered under section 510 of the qualifying prescription drug and the information under paragraph (25), paragraph (26) (other than subparagraph (C)), and subparagraphs (D), (F), and (G) of paragraph (27) of section 581. Certified foreign sellers shall provide such information to individuals purchasing such drugs, upon request.

“(l) REMs—In the case of an importer that imports a qualifying prescription drug, where the drug with the same active ingredient or ingredients (or that is biosimilar to an approved biological product), route of administration, and strength that is approved under chapter V or section 351 of the Public Health Service Act is subject to elements to assure safe use under section 505–1, such importer shall be subject to such elements to assure safe use, as applicable and appropriate.

“(m) Construction—Nothing in this section limits the authority of the Secretary relating to the importation of prescription drugs, other than with respect to section 801(d)(1) as provided in this section.”

(b)
Penalties with respect to online pharmacies— Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following:

“(h) In the case of a person operating an internet website, whether in the United States or in another country, that violates section 301(aa) by—

“(1) selling, by means of the internet, with the intent to defraud or mislead or with reckless disregard for safety of the public, an adulterated or counterfeit drug to an individual in the United States; or

“(2) dispenses, by means of the internet, a drug to an individual in the United States who the person knows or has reasonable cause to believe, does not possess a valid prescription for that drug,”

(c)
No preemption— Nothing in this section, including the amendments made by this section, shall be construed to preempt, alter, displace, abridge, or supplant any remedy available under any State or Federal law, including common law, that provides a remedy for civil relief.
(d)
Reports—
(1)
HHS— Not later than 1 year after the date on which final regulations are promulgated to carry out section 804 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384), as amended by subsection (a), and every 2 years thereafter, the Secretary of Health and Human Services, after consultation with appropriate Federal agencies, shall submit to Congress and make public a report on the importation of drugs into the United States.
(2)
GAO report— Not later than 18 months after the first report is submitted under paragraph (1), the Comptroller General of the United States shall submit to Congress a report containing an analysis of the implementation of the amendments made by this section, including a review of drug safety and cost-savings and expenses, including cost-savings to consumers in the United States and trans-shipment and importation tracing processes, resulting from such implementation.

Sec. 204 Requiring drug manufacturers to provide drug rebates for drugs dispensed to low-income individuals

(a)
In general— Section 1860D–2 of the Social Security Act (42 U.S.C. 1395w–102) is amended—
(1)
in subsection (e)(1), in the matter preceding subparagraph (A), by inserting “and subsection (f)” after “this subsection”; and
(2)
by adding at the end the following new subsection:

“(f) Prescription drug rebate agreement for rebate eligible individuals

“(1) Requirement

“(A) In general—For plan years beginning on or after January 1, 2020, in this part, the term covered part D drug does not include any drug or biological product that is manufactured by a manufacturer that has not entered into and have in effect a rebate agreement described in paragraph (2).

“(B) 2020 plan year requirement—Any drug or biological product manufactured by a manufacturer that declines to enter into a rebate agreement described in paragraph (2) for the period beginning on January 1, 2020, and ending on December 31, 2020, shall not be included as a “covered part D drug” for the subsequent plan year.

“(2) Rebate agreement—A rebate agreement under this subsection shall require the manufacturer to provide to the Secretary a rebate for each rebate period (as defined in paragraph (6)(B)) ending after December 31, 2019, in the amount specified in paragraph (3) for any covered part D drug of the manufacturer dispensed after December 31, 2019, to any rebate eligible individual (as defined in paragraph (6)(A)) for which payment was made by a PDP sponsor or MA organization under this part for such period, including payments passed through the low-income and reinsurance subsidies under sections 1860D–14 and 1860D–15(b), respectively. Such rebate shall be paid by the manufacturer to the Secretary not later than 30 days after the date of receipt of the information described in section 1860D–12(b)(8), including as such section is applied under section 1857(f)(3), or 30 days after the receipt of information under subparagraph (D) of paragraph (3), as determined by the Secretary. Insofar as not inconsistent with this subsection, the Secretary shall establish terms and conditions of such agreement relating to compliance, penalties, and program evaluations, investigations, and audits that are similar to the terms and conditions for rebate agreements under paragraphs (3) and (4) of section 1927(b).

“(3) Rebate for rebate eligible Medicare drug plan enrollees

“(A) In general—The amount of the rebate specified under this paragraph for a manufacturer for a rebate period, with respect to each dosage form and strength of any covered part D drug provided by such manufacturer and dispensed to a rebate eligible individual, shall be equal to the product of—

“(i) the total number of units of such dosage form and strength of the drug so provided and dispensed for which payment was made by a PDP sponsor or an MA organization under this part for the rebate period, including payments passed through the low-income and reinsurance subsidies under sections 1860D–14 and 1860D–15(b), respectively; and

“(ii) the amount (if any) by which—

“(I) the Medicaid rebate amount (as defined in subparagraph (B)) for such form, strength, and period; exceeds

“(II) the average Medicare drug program rebate eligible rebate amount (as defined in subparagraph (C)) for such form, strength, and period.

“(B) Medicaid rebate amount—For purposes of this paragraph, the term Medicaid rebate amount means, with respect to each dosage form and strength of a covered part D drug provided by the manufacturer for a rebate period—

“(i) in the case of a single source drug or an innovator multiple source drug, the amount specified in paragraph (1)(A)(ii)(II) or (2)(C) of section 1927(c) plus the amount, if any, specified in subparagraph (A)(ii) of paragraph (2) of such section, for such form, strength, and period; or

“(ii) in the case of any other covered outpatient drug, the amount specified in paragraph (3)(A)(i) of such section for such form, strength, and period.

“(C) Average Medicare drug program rebate eligible rebate amount—For purposes of this subsection, the term average Medicare drug program rebate eligible rebate amount means, with respect to each dosage form and strength of a covered part D drug provided by a manufacturer for a rebate period, the sum, for all PDP sponsors under part D and MA organizations administering an MA–PD plan under part C, of—

“(i) the product, for each such sponsor or organization, of—

“(I) the sum of all rebates, discounts, or other price concessions (not taking into account any rebate provided under paragraph (2) or any discounts under the program under section 1860D–14A) for such dosage form and strength of the drug dispensed, calculated on a per-unit basis, but only to the extent that any such rebate, discount, or other price concession applies equally to drugs dispensed to rebate eligible Medicare drug plan enrollees and drugs dispensed to PDP and MA–PD enrollees who are not rebate eligible individuals; and

“(II) the number of the units of such dosage and strength of the drug dispensed during the rebate period to rebate eligible individuals enrolled in the prescription drug plans administered by the PDP sponsor or the MA–PD plans administered by the MA organization; divided by

“(ii) the total number of units of such dosage and strength of the drug dispensed during the rebate period to rebate eligible individuals enrolled in all prescription drug plans administered by PDP sponsors and all MA–PD plans administered by MA organizations.

“(D) Use of estimates—The Secretary may establish a methodology for estimating the average Medicare drug program rebate eligible rebate amounts for each rebate period based on bid and utilization information under this part and may use these estimates as the basis for determining the rebates under this section. If the Secretary elects to estimate the average Medicare drug program rebate eligible rebate amounts, the Secretary shall establish a reconciliation process for adjusting manufacturer rebate payments not later than 3 months after the date that manufacturers receive the information collected under section 1860D–12(b)(8)(B).

“(4) Length of agreement—The provisions of paragraph (4) of section 1927(b) (other than clauses (iv) and (v) of subparagraph (B)) shall apply to rebate agreements under this subsection in the same manner as such paragraph applies to a rebate agreement under such section.

“(5) Other terms and conditions—The Secretary shall establish other terms and conditions of the rebate agreement under this subsection, including terms and conditions related to compliance, that are consistent with this subsection.

“(6) Definitions—In this subsection and section 1860D–12(b)(8):

“(A) Rebate eligible individual—The term rebate eligible individual means—

“(i) a subsidy eligible individual (as defined in section 1860D–14(a)(3)(A));

“(ii) a Medicaid beneficiary treated as a subsidy eligible individual under clause (v) of section 1860D–14(a)(3)(B); and

“(iii) any part D eligible individual not described in clause (i) or (ii) who is determined for purposes of the State plan under title XIX to be eligible for medical assistance under clause (i), (iii), or (iv) of section 1902(a)(10)(E).

“(B) Rebate period—The term rebate period has the meaning given such term in section 1927(k)(8).”

(b)
Reporting requirement for the determination and payment of rebates by manufacturers related to rebate for rebate eligible Medicare drug plan enrollees—
(1)
Requirements for PDP sponsors— Section 1860D–12(b) of the Social Security Act (42 U.S.C. 1395w–112(b)) is amended by adding at the end the following new paragraph:

“(8) Reporting requirement for the determination and payment of rebates by manufacturers related to rebate for rebate eligible Medicare drug plan enrollees

“(A) In general—For purposes of the rebate under section 1860D–2(f) for contract years beginning on or after January 1, 2020, each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan shall require that the sponsor comply with subparagraphs (B) and (C).

“(B) Report form and contents—Not later than a date specified by the Secretary, a PDP sponsor of a prescription drug plan under this part shall report to each manufacturer—

“(i) information (by National Drug Code number) on the total number of units of each dosage, form, and strength of each drug of such manufacturer dispensed to rebate eligible Medicare drug plan enrollees under any prescription drug plan operated by the PDP sponsor during the rebate period;

“(ii) information on the price discounts, price concessions, and rebates for such drugs for such form, strength, and period;

“(iii) information on the extent to which such price discounts, price concessions, and rebates apply equally to rebate eligible Medicare drug plan enrollees and PDP enrollees who are not rebate eligible Medicare drug plan enrollees; and

“(iv) any additional information that the Secretary determines is necessary to enable the Secretary to calculate the average Medicare drug program rebate eligible rebate amount (as defined in paragraph (3)(C) of such section), and to determine the amount of the rebate required under this section, for such form, strength, and period.

“(C) Submission to Secretary—Each PDP sponsor shall promptly transmit a copy of the information reported under subparagraph (B) to the Secretary for the purpose of audit oversight and evaluation.

“(D) Confidentiality of information—The provisions of subparagraph (D) of section 1927(b)(3), relating to confidentiality of information, shall apply to information reported by PDP sponsors under this paragraph in the same manner that such provisions apply to information disclosed by manufacturers or wholesalers under such section, except—

“(i) that any reference to “this section” in clause (i) of such subparagraph shall be treated as being a reference to this section;

“(ii) the reference to the Director of the Congressional Budget Office in clause (iii) of such subparagraph shall be treated as including a reference to the Medicare Payment Advisory Commission; and

“(iii) clause (iv) of such subparagraph shall not apply.

“(E) Oversight—Information reported under this paragraph may be used by the Inspector General of the Department of Health and Human Services for the statutorily authorized purposes of audit, investigation, and evaluations.

“(F) Penalties for failure to provide timely information and provision of false information—In the case of a PDP sponsor—

“(i) that fails to provide information required under subparagraph (B) on a timely basis, the sponsor is subject to a civil money penalty in the amount of $10,000 for each day in which such information has not been provided; or

“(ii) that knowingly (as defined in section 1128A(i)) provides false information under such subparagraph, the sponsor is subject to a civil money penalty in an amount not to exceed $100,000 for each item of false information.”

(2)
Application to MA organizations— Section 1857(f)(3) of the Social Security Act (42 U.S.C. 1395w–27(f)(3)) is amended by adding at the end the following:

“(E) Reporting requirement related to rebate for rebate eligible Medicare drug plan enrollees—Section 1860D–12(b)(8).”

(c)
Deposit of rebates into Medicare Prescription Drug Account— Section 1860D–16(c) of the Social Security Act (42 U.S.C. 1395w–116(c)) is amended by adding at the end the following new paragraph:

“(6) Rebate for rebate eligible Medicare drug plan enrollees—Amounts paid under a rebate agreement under section 1860D–2(f) shall be deposited into the Account.”

(d)
Exclusion from determination of best price and average manufacturer price under Medicaid—
(1)
Exclusion from best price determination— Section 1927(c)(1)(C)(ii)(I) of the Social Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)(I)) is amended by inserting “and amounts paid under a rebate agreement under section 1860D–2(f)” after “this section”.
(2)
Exclusion from average manufacturer price determination— Section 1927(k)(1)(B)(i) of the Social Security Act (42 U.S.C. 1396r–8(k)(1)(B)(i)) is amended—
(A)
in subclause (IV), by striking “and” after the semicolon;
(B)
in subclause (V), by striking the period at the end and inserting “; and”; and
(C)
by adding at the end the following:

“(VI) amounts paid under a rebate agreement under section 1860D–2(f).”

Sec. 205 Cap on prescription drug cost-sharing

(a)
Qualified health plans— Section 1302(c) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(c)) is amended—
(1)
in paragraph (3)(A)(i), by inserting “, including cost-sharing with respect to prescription drugs covered by the plan” after “charges”; and
(2)
by adding at the end the following:

“(5) Prescription drug cost-sharing

“(A) 2020—For plan years beginning in 2020, the cost-sharing incurred under a health plan with respect to prescription drugs covered by the plan shall not exceed $250 per month for each enrolled individual, or $500 for each family.

“(B) 2021 and later

“(i) In general—In the case of any plan year beginning in a calendar year after 2020, the limitation under this paragraph shall be equal to the applicable dollar amount under subparagraph (A) for plan years beginning in 2020, increased by an amount equal to the product of that amount and the medical care component of the consumer price index for all urban consumers (as published by the Bureau of Labor Statistics) for that year.

“(ii) Adjustment to amount—If the amount of any increase under clause (i) is not a multiple of $5, such increase shall be rounded to the next lowest multiple of $5.”

(b)
Group health plans— Section 2707(b) of the Public Health Service Act (42 U.S.C. 300gg–6(b)) is amended—
(1)
by striking “annual”; and
(2)
by striking “paragraph (1) of section 1302(c)” and inserting “paragraphs (1) and (5) of section 1302(c) of the Patient Protection and Affordable Care Act”.
(c)
Effective date— The amendments made by subsections (a) and (b) shall take effect with respect to plans beginning after December 31, 2019.

Sec. 206 Modification of trade negotiating objectives relating to intellectual property rights to ensure access to biological products

Section 102(b)(5)(C) of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015 (19 U.S.C. 4201(b)(5)(C)) is amended by striking the end period and inserting the following: “, including by ensuring that trade agreements do not require a party to provide biological product exclusivity of more than 7 years.” .