Section 2719A(b) of the Public Health Service Act (42 U.S.C. 300gg–19a) is amended—

(1) in paragraph (1)—

(A) in the matter preceding subparagraph (A), by inserting “or a freestanding emergency room” after “hospital”; and

(B) in subparagraph (C)—

(i) in clause (ii)(I), by inserting “or emergency room” after “emergency department”; and

(ii) in subparagraph (C)(ii)(II), by adding, “a deductible,” after “(expressed as”; and

(2) in paragraph (2)(B)—

(A) in clause (i)—

(i) by inserting “or freestanding emergency room” after “hospital”; and

(ii) by inserting “or emergency room” after “emergency department”; and

(B) in clause (ii), by inserting “or emergency room” after “hospital”.

(a) PHSA.—Section 2719A of the Public Health Service Act (42 U.S.C. 300gg–19a) is amended by adding at the end the following:

“(e) Coverage of certain out-of-Network services.—

“(1) IN GENERAL.—Subject to subsection (h), in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives out-of-network, ancillary, non-emergency services at an in-network facility, including any referrals for diagnostic services—

“(A) the cost-sharing requirement (expressed as a copayment amount, coinsurance rate, or deductible) with respect to such services shall be the same requirement that would apply if such services were provided by an in-network practitioner, and any coinsurance or deductible shall be based on in-network rates; and

“(B) such cost-sharing amounts shall be counted towards the in-network deductible and in-network out-of-pocket maximum amount under the plan or coverage for the plan year.

“(2) DEFINITION.—For purposes of this subsection, the term ‘facility’ has the meaning given the term ‘health care facility’ in section 2729A(c).

“(f) Coverage of out-of-Network services for enrollees admitted after emergency services.—

“(1) NOTICE AND CONSENT.—Subject to subsection (h), in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives emergency services, or maternal care for a woman in labor, in the emergency department of an out-of-network facility and has been stabilized (within the meaning of subsection (b)(2)(C)), if the patient is subsequently admitted to the out-of-network facility for care, the cost-sharing requirement (expressed as a copayment amount, coinsurance rate, or deductible) with respect to any out-of-network services is the same requirement that would apply if such services were provided by a participating provider, unless the enrollee, once stable and in a condition to receive such information, including having sufficient mental capacity—

“(A) has been provided by the facility, prior to the provision of any post-stabilization, out-of-network service at such facility, with—

“(i) paper and electronic notification that the practitioner or facility is an out-of-network health care provider and the out-of-network rate of the provider, as applicable, and the option to affirmatively consent to receiving services from such practitioner or facility; and

“(ii) the estimated amount that such provider may charge the participant, beneficiary, or enrollee for such items and services involved;

“(B) has been provided by the plan or coverage, prior to the provision of any post-stabilization, out-of-network service at such facility, with—

“(i) paper and electronic notification that the practitioner or facility is an out-of-network health care provider and the out-of-network rate of the provider, as applicable, and the option to affirmatively consent to receiving services from such practitioner or facility;

“(ii) a list of in-network practitioners or facilities that could provide the same services, and an option for a referral to such providers; and

“(iii) information about whether prior authorization or other care management limitations may be required in advance of receiving in-network care at the facility; and

“(C) has acknowledged that the out-of-network treatment may not be covered or may be covered at an out-of-network cost-sharing amount, requiring higher cost-sharing obligations of the enrollee than if the service were provided at an in-network facility, and has assumed, in writing, full responsibility of out-of-pocket costs associated with services furnished after the enrollee has been stabilized, from the out-of-network practitioner or facility, as applicable.

“(2) REQUIREMENTS OF NOTICE.—The notice under paragraph (1) shall be in a format determined by the Secretary to give a reasonable layperson clear comprehension of the terms of the agreement, including all possible financial responsibilities, including the requirements that the notice—

“(A) does not exceed one page in length;

“(B) is readily identifiable for its purpose and as a contract of consent;

“(C) clearly states that consent is optional;

“(D) includes an estimate of the amount that such provider will charge the participant, beneficiary, or enrollee for such items and services involved; and

“(E) be available in the 15 most common languages in the facility’s geographic area, with the facility making a good faith effort to provide oral notice in the enrollee’s primary language if it is not one of such 15 languages.

“(g) Prohibition on billing more than an in-Network rate under certain circumstances.—

“(1) IN GENERAL.—A facility or practitioner furnishing—

“(A) emergency services, as defined in subsection (b)(2), regardless of the State in which the patient resides;

“(B) services at an in-network facility described in subsection (e); or

“(C) out-of-network services furnished after the enrollee has been stabilized (within the meaning of subsection (b)(2)(C)), where the notice and option for referral required under subsection (f)(1) have not been provided to the enrollee and the assumption of responsibility for out-of-pocket costs under subsection (f)(2) has not been obtained,

may not bill an enrollee in a group health plan or group or individual health insurance coverage for amounts beyond the cost-sharing amount that would apply under subsection (b)(1)(C)(ii)(II), (e), or (f), as applicable.

“(2) NOTICE.—A facility furnishing services described in paragraph (1) shall provide enrollees in a group health plan or group or individual health insurance coverage with a one-page notice, in 16-point font, upon intake at the emergency room or being admitted at the facility of the prohibition on balance billing under paragraph (1) and who to contact for recourse if they are sent a balance bill in violation of such paragraph. The facility shall be responsible for obtaining the signature from the enrollee on such notice. The Secretary shall issue regulations within 6 months of the date of enactment of the Lower Health Care Costs Act on the requirements for the notice under this paragraph.

“(3) ENFORCEMENT.—

“(A) IN GENERAL.—Subject to subparagraph (B), a facility or practitioner that violates a requirement under paragraph (1) shall be subject to a civil monetary penalty of not more than $10,000 for each act constituting such violation.

“(B) PROCEDURE.—The provisions of section 1128A of the Social Security Act, other than subsections (a) and (b) and the first sentence of subsection (c)(1) of such section, shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A of the Social Security Act.

“(C) SAFE HARBOR.—The Secretary shall waive the penalties described under subparagraph (A) with respect to a facility or, practitioner who unknowingly violates paragraph (1) with respect to an enrollee, if such facility or practitioner, within 30 days of the violation, withdraws the bill that was in violation of paragraph (1), and, as applicable, reimburses the group health plan, health insurance issuer, or enrollee, as applicable, in an amount equal to the amount billed in violation of paragraph (1), plus interest, at an interest rate determined by the Secretary.

“(h) Maintaining State surprise billing protections.—

“(1) IN GENERAL.—Notwithstanding section 514 of the Employee Retirement Income Security Act of 1974, except with respect to self-insured group health plans, nothing in this section shall prevent a State from establishing or continuing in effect an alternate method under State law for determining the appropriate compensation for services described in subsection (b), (e), or (f).

“(2) ADDITIONAL APPLICATION.—In the case of group health plans or health insurance coverage in the individual or group market offered in a State that has not enacted an alternate method described in paragraph (1), such as arbitration or a benchmark, or for services described in subsection (b), (e), or (f) that are not covered by such State's alternate method described in paragraph (1), the provisions of this section shall apply.

“(3) SELF-INSURED PLANS.—Subsections (b), (e), and (f) shall apply to a self-insured group health plan that is not subject to State insurance regulation.”.

(b) Coverage under Federal Employees Health Benefits Program.—Section 8904 of title 5, United States Code, is amended by adding at the end the following:

“(c) Any health benefits plan offered under this chapter shall be treated as a group health plan or group or individual health insurance coverage for purposes of subsections (e) through (g) of section 2719A of the Public Health Service Act (42 U.S.C. 300gg–19a) (except for paragraph (3) of such subsection (g)).”.

(a) In general.—Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.) is amended by adding at the end the following:

(b) Non-Federal governmental plans.—Section 2722(a)(2)(E) of the Public Health Service Act (42 U.S.C. 300gg–21(a)(2)(E)) is amended by inserting “, except that such election shall be available with respect to section 2729A” before the period.

The amendments made by sections 101, 102, and 103 shall take effect beginning in the second plan year that begins after the date of enactment of this Act.

(a) In general.—Part A of title XXVII of the Public Health Service Act is amended by inserting after section 2719A (42 U.S.C. 300gg–19a) the following:

(b) Effective date.—Section 2719B of the Public Health Service Act, as added by subsection (a), shall take effect on the date that is 1 year after the date of enactment of this Act.

Not later than 1 year after the effective date described in section 104, and annually for the following 4 years, the Secretary of Health and Human Services, in consultation with the Federal Trade Commission and the Attorney General, shall—

(1) conduct a study on—

(A) the effects of the amendments made by sections 101, 102, and 103, including any patterns of vertical or horizontal integration of health care facilities, providers, group health plans, or health insurance issuers;

(B) the effects of the amendments made by sections 101, 102, and 103 on overall health care costs; and

(C) recommendations for effective enforcement of 2729A as added by section 103, including potential challenges to addressing anti-competitive consolidation by health care facilities, providers, group health plans, or health insurance issuers; and

(2) submit a report on such study to the Committee on Health, Education, Labor, and Pensions, the Committee on Commerce, Science, and Transportation, the Committee on Finance, and the Committee on the Judiciary of the Senate and the Committee on Education and Labor, the Committee on Energy and Commerce, the Committee on Ways and Means, and the Committee on the Judiciary of the House of Representatives.

(a) In general.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following:

“(o) Additional requirements with respect to patents.—

“(1) APPROVED APPLICATION HOLDER LISTING REQUIREMENTS.—

“(A) IN GENERAL.—Beginning on the date of enactment of the Lower Health Care Costs Act, within 60 days of approval of an application under subsection (a) or (k), the holder of such approved application shall submit to the Secretary a list of each patent required to be disclosed (as described in paragraph (3)).

“(B) PREVIOUSLY APPROVED OR LICENSED BIOLOGICAL PRODUCTS.—

“(i) PRODUCTS LICENSED UNDER SECTION 351 OF THE PHSA.—Not later than 30 days after the date of enactment of the Lower Health Care Costs Act, the holder of a biological product license that was approved under subsection (a) or (k) before the date of enactment of such Act shall submit to the Secretary a list of each patent required to be disclosed (as described in paragraph (3)).

“(ii) PRODUCTS APPROVED UNDER SECTION 505 OF THE FFDCA.—Not later than 30 days after March 23, 2020, the holder of an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act that is deemed to be a license for the biological product under this section on March 23, 2020, shall submit to the Secretary a list of each patent required to be disclosed (as described in paragraph (3)).

“(C) UPDATES.—The holder of a biological product license that is the subject of an application under subsection (a) or (k) shall submit to the Secretary a list that includes—

“(i) any patent not previously required to be disclosed (as described in paragraph (3)) under subparagraph (A) or (B), as applicable, within 30 days of the earlier of—

“(I) the date of issuance of such patent by the United States Patent and Trademark Office; or

“(II) the date of approval of a supplemental application for the biological product; and

“(ii) any patent, or any claim with respect to a patent, included on the list pursuant to this paragraph, that the Patent Trial and Appeal Board of the United States Patent and Trademark Office determines in a decision to be invalid or unenforceable, within 30 days of such decision.

“(2) PUBLICATION OF INFORMATION.—

“(A) IN GENERAL.—Within 1 year of the date of enactment of the Lower Health Care Costs Act, the Secretary shall publish and make available to the public a single, easily searchable, list that includes—

“(i) the official and proprietary name of each biological product licensed under subsection (a) or (k), and of each biological product application approved under section 505 of the Federal Food, Drug, and Cosmetic Act and deemed to be a license for the biological product under this section on March 23, 2020;

“(ii) with respect to each biological product described in clause (i), each patent submitted in accordance with paragraph (1);

“(iii) the date of approval and application number for each such biological product;

“(iv) the marketing status, dosage form, route of administration, strength, and, if applicable, reference product, for each such biological product;

“(v) the licensure status for each such biological product, including whether the license at the time of listing is approved, withdrawn, or revoked;

“(vi) with respect to each such biological product, any period of any exclusivity under paragraph (6), (7)(A), or (7)(B) of subsection (k) of this section or section 527 of the Federal Food, Drug, and Cosmetic Act, and any extension of such period in accordance with subsection (m) of this section, for which the Secretary has determined such biological product to be eligible, and the date on which such exclusivity expires;

“(vii) information regarding any determination of biosimilarity or interchangeability for each such biological product; and

“(viii) information regarding approved indications for each such biological product, in such manner as the Secretary determines appropriate.

“(B) UPDATES.—Every 30 days after the publication of the first list under subparagraph (A), the Secretary shall revise the list to include—

“(i) (I) each biological product licensed under subsection (a) or (k) during the 30-day period; and

“(II) with respect to each biological product described in subclause (I), the information described in clauses (i) through (viii) of subparagraph (A); and

“(ii) any updates to information previously published in accordance with subparagraph (A).

“(C) NONCOMPLIANCE.—Beginning 18 months after the date of enactment of the Lower Health Care Costs Act, the Secretary, in consultation with the Director of the United States Patent and Trademark Office, shall publish and make available to the public a list of any holders of biological product licenses, and the corresponding biological product or products, that failed to submit information as required under paragraph (1), including any updates required under paragraph (1)(C), in such manner and format as the Secretary determines appropriate. If information required under paragraph (1) is submitted following publication of such list, the Secretary shall remove such holders of such biological product licenses from the public list in a reasonable period of time.

“(3) PATENTS REQUIRED TO BE DISCLOSED.—In this section, a ‘patent required to be disclosed’ is any patent for which the holder of a biological product license approved under subsection (a) or (k), or a biological product application approved under section 505 of the Federal Food, Drug, and Cosmetic Act and deemed to be a license for a biological product under this section on March 23, 2020, believes a claim of patent infringement could reasonably be asserted by the holder, or by a patent owner that has granted an exclusive license to the holder with respect to the biological product that is the subject of such license, if a person not licensed by the holder engaged in the making, using, offering to sell, selling, or importing into the United States of the biological product that is the subject of such license.”.

(b) Disclosure of patents.—Section 351(l)(3)(A)(i) of the Public Health Service Act (42 U.S.C. 262(l)(3)(A)(i)) is amended by inserting “included in the list provided by the reference product sponsor under subsection (o)(1)” after “a list of patents”.

(c) Review and Report on Noncompliance.—Not later than 30 months after the date of enactment of this Act, the Secretary shall—

(1) solicit public comments regarding appropriate remedies, in addition to the publication of the list under subsection (o)(2)(C) of section 351 of the Public Health Service Act (42 U.S.C. 262), as added by subsection (a), with respect to holders of biological product licenses who fail to timely submit information as required under subsection (o)(1) of such section 351, including any updates required under subparagraph (C) of such subsection (o)(1); and

(2) submit to Congress an evaluation of comments received under paragraph (1) and the recommendations of the Secretary concerning appropriate remedies.

(d) Regulations.—The Secretary of Health and Human Services may promulgate regulations to carry out subsection (o) of section 351 of the Public Health Service Act (42 U.S.C. 262), as added by subsection (a).

(e) Rule of construction.—Nothing in this Act, including an amendment made by this Act, shall be construed to require or allow the Secretary of Health and Human Services to delay the licensing of a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262).

(a) Submission of patent information for brand name drugs.—

(1) IN GENERAL.—Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended to read as follows:

“(b) (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—

“(i) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use;

“(ii) a full list of the articles used as components of such drug;

“(iii) a full statement of the composition of such drug;

“(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;

“(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;

“(vi) specimens of the labeling proposed to be used for such drug;

“(vii) any assessments required under section 505B; and

“(viii) the patent number and expiration date, of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug, and that—

“(I) claims the drug for which the applicant submitted the application and is a drug substance patent or a drug product patent; or

“(II) claims the method of using the drug for which approval is sought or has been granted in the application.

“(B) If an application is filed under this subsection for a drug, and a patent of the type described in subparagraph (A)(viii) that claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include such patent information.

“(C) Upon approval of the application, the Secretary shall publish the information submitted under subparagraph (A)(viii).”.

(2) GUIDANCE.—The Secretary of Health and Human Services shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required under subsection (b)(1)(A)(i) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by paragraph (1).

(b) Conforming changes to requirements for subsequent submission of patent information.—Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended—

(1) by inserting before the first sentence the following: “Not later than 30 days after the date of approval of an application under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subclause (I) or (II) of subsection (b)(1)(A)(viii), except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application. The holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subclause (I) or (II) of subsection (b)(1)(A)(viii) that is issued after the date of approval of the application, not later than 30 days of the date of issuance of the patent, except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application.”;

(2) by inserting after “the patent number and the expiration date of any patent which” the following: “fulfills the criteria in subsection (b) and”;

(3) by inserting after the third sentence (as amended by paragraph (1)) the following: “Patent information that is not the type of patent information required by subsection (b)(1)(A)(viii) shall not be submitted under this paragraph.”; and

(4) by inserting after “could not file patent information under subsection (b) because no patent ” the following: “of the type required to be submitted in subsection (b)”.

(c) Listing of exclusivities.—Subparagraph (A) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the following:

“(iv) For each drug included on the list, the Secretary shall specify any exclusivity period that is applicable, for which the Secretary has determined the expiration date, and for which such period has not yet expired under—

“(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E) of this section;

“(II) clause (iv) or (v) of paragraph (5)(B) of this subsection;

“(III) clause (ii), (iii), or (iv) of paragraph (5)(F) of this subsection;

“(IV) section 505A;

“(V) section 505E;

“(VI) section 527(a); or

“(VII) section 505(u)”.

(d) Orange book updates with respect to invalidated patents.—

(1) IN GENERAL.—

(A) AMENDMENTS.—Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)), as amended by subsection (c), is further amended by adding at the end the following:

“(v) In the case of a listed drug for which the list under clause (i) includes a patent or patent claim for the drug, or a patent or a patent claim for the use of such drug, and where the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office has canceled any claim of the patent relating to such drug or such use pursuant to a decision by the Patent Trial and Appeal Board in an inter partes review conducted under chapter 31 of title 35, United States Code, or a post-grant review conducted under chapter 32 of that title, and from which no appeal has been taken, or can be taken, the holder of the applicable approved application shall notify the Secretary, in writing, within 14 days of such cancellation, and, if the patent has been deemed wholly inoperative or invalid, or if a patent claim has been canceled, the revisions required under clause (iii) shall include striking the patent or information regarding such patent claim from the list with respect to such drug.”.

(B) APPLICATION.—The amendment made by subparagraph (A) shall not apply with respect to any determination with respect to a patent or patent claim that is made prior to the date of enactment of this Act.

(2) NO EFFECT ON FIRST APPLICANT EXCLUSIVITY PERIOD.—Section 505(j)(5)(B)(iv)(I) is amended by adding at the end the following: “This subclause shall apply even if a patent is stricken from the list under paragraph (7)(A), pursuant to paragraph (7)(A)(v), provided that, at the time that the first applicant submitted an application under this subsection containing a certification described in paragraph (2)(A)(vii)(IV), the patent that was the subject of such certification was included in such list with respect to the listed drug.”.

Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)) is amended—

(1) in paragraph (1)—

(A) in subparagraph (A)(i), by inserting “, 10.31,” after “10.30”;

(B) in subparagraph (E)—

(i) by striking “application and” and inserting “application or”;

(ii) by striking “If the Secretary” and inserting the following:

“(i) IN GENERAL.—If the Secretary”; and

(iii) by striking the second sentence and inserting the following:

“(ii) PRIMARY PURPOSE OF DELAYING.—

“(I) IN GENERAL.—For purposes of this subparagraph, a petition or supplement to a petition may be considered to be submitted with the primary purpose of delaying an application under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act, if the petitioner has the purpose of setting aside, delaying, rescinding, withdrawing, or preventing submission, review, or the approval of such an application.

“(II) FACTORS.—In determining whether a petition was submitted with the primary purpose of delaying an application, the Secretary may consider the following factors:

“(aa) Whether the petition was submitted in accordance with paragraph (2)(B), based on when the petitioner knew or reasonably should have known the relevant information relied upon to form the basis of such petition.

“(bb) Whether the petitioner has submitted multiple or serial petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions.

“(cc) Whether the petition was submitted close in time to a known, first date upon which an application under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act could be approved.

“(dd) Whether the petition was submitted without any relevant data or information in support of the scientific positions forming the basis of such petition.

“(ee) Whether the petition raises the same or substantially similar issues as a prior petition to which the Secretary has responded substantively already, including if the subsequent submission follows such response from the Secretary closely in time.

“(ff) Whether the petition requests changing the applicable standards that other applicants are required to meet, including requesting testing, data, or labeling standards that are more onerous or rigorous than the standards applicable to the listed drug, reference product, or petitioner’s version of the same drug.

“(gg) The petitioner's record of submitting petitions to the Food and Drug Administration that have been determined by the Secretary to have been submitted with the primary purpose of delay.

“(hh) Other relevant and appropriate factors, which the Secretary shall describe in guidance.

“(III) GUIDANCE.—The Secretary may issue or update guidance, as appropriate, to describe factors the Secretary considers in accordance with subclause (II).”;

(C) by adding at the end the following:

“(iii) REFERRAL TO THE FEDERAL TRADE COMMISSION.—The Secretary shall establish procedures for referring to the Federal Trade Commission any petition or supplement to a petition that the Secretary determines was submitted with the primary purpose of delaying approval of an application. Such procedures shall include notification to the petitioner and an opportunity for judicial review after the issuance of an order by the Federal Trade Commission.”;

(D) by striking subparagraph (F);

(E) by redesignating subparagraphs (G) through (I) as subparagraphs (F) through (H), respectively; and

(F) in subparagraph (H), as so redesignated, by striking “submission of this petition” and inserting “submission of this document”;

(2) in paragraph (2)—

(A) by redesignating subparagraphs (A) through (C) as subparagraphs (C) through (E), respectively;

(B) by inserting before subparagraph (C), as so redesignated, the following:

“(A) IN GENERAL.—A person shall submit a petition to the Secretary under paragraph (1) before filing a civil action in which the person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act. Such petition and any supplement to such a petition shall describe all information and arguments that form the basis of the relief requested in any civil action described in the previous sentence.

“(B) TIMELY SUBMISSION OF CITIZEN PETITION.—A petition and any supplement to a petition shall be submitted within 60 days after the person knew, or reasonably should have known, the information that forms the basis of the request made in the petition or supplement.”;

(C) in subparagraph (C), as so redesignated, by—

(i) in the heading, striking “within 150 days”;

(ii) in clause (i), striking “during the 150-day period referred to in paragraph (1)(F),”; and

(iii) amending clause (ii) to read as follows:

“(ii) on or after the date that is 151 days after the date of submission of the petition, the Secretary approves or has approved the application that is the subject of the petition without having made such a final decision.”;

(D) by amending subparagraph (D), as so redesignated, to read as follows:

“(D) DISMISSAL OF CERTAIN CIVIL ACTIONS.—

“(i) PETITION.—If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph (A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.

“(ii) TIMELINESS.—If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph (B), the court shall dismiss with prejudice the action for failure to timely file a petition.

“(iii) FINAL RESPONSE.—If a civil action is filed against the Secretary with respect to any issue raised in a petition timely filed under paragraph (1) in which the petitioner requests that the Secretary take any form of action that could, if taken, set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act before the Secretary has issued a final response to any such petition submitted, the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.”; and

(E) in subparagraph (E), as so redesignated—

(i) in clause (ii), by striking “, if issued”; and

(ii) in clause (iii), by striking “final agency action as defined under subparagraph (2)(A)” and inserting “the final response to the petitioner”; and

(3) in paragraph (4)—

(A) by striking “Exceptions” and all that follows through “This subsection does” and inserting “Exceptions—This subsection does”;

(B) by striking subparagraph (B); and

(C) by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly.

Section 351(k)(7) of the Public Health Service Act (42 U.S.C. 262(k)(7)) is amended by adding at the end the following:

“(D) DEEMED LICENSES.—

“(i) NO ADDITIONAL EXCLUSIVITY THROUGH DEEMING.—An approved application that is deemed to be a license for a biological product under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a) for purposes of subparagraphs (A) and (B).

“(ii) LIMITATION ON EXCLUSIVITY.—Subparagraph (C) shall apply to any reference product, without regard to whether—

“(I) such product was first licensed under subsection (a); or

“(II) the approved application for such product was deemed to be a license for a biological product as described in clause (i).

“(iii) APPLICABILITY.—Any unexpired period of exclusivity under section 527 or section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act with respect to a biological product shall continue to apply to such biological product after an approved application for the biological product is deemed to be a license for the biological product as described in clause (i).”.

Section 505(j)(5)(B)(iv)(I) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)(I)) is amended—

(1) by striking “180 days after the date” and inserting “180 days after the earlier of the following:

“(aa) The date”; and

(2) by adding at the end the following:

“(bb) The date on which all of the following conditions are first met:

“(AA) An application for the drug submitted by an applicant other than a first applicant could receive approval, if no first applicant were eligible for 180-day exclusivity under this clause.

“(BB) Thirty-three months have passed since the date of submission of an application for the drug by one first applicant, if there is only one first applicant, or, in the case of more than one first applicant, 33 months have passed since the date of submission of all such applications.

“(CC) Approval of an application for the drug submitted by at least one first applicant would not be precluded under clause (iii).

“(DD) No application for the drug submitted by any first applicant is approved at the time the conditions under subitems (AA), (BB), and (CC) are all met, regardless of whether such an application is subsequently approved.”.

Subpart 1 of part F of title III of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by adding at the end the following:

Section 351(j) of the Public Health Service Act (42 U.S.C. 262(j)) is amended—

(1) by striking “except that a product” and inserting “except that—

“(1) a product”;

(2) by striking “Act.” and inserting “Act; and”; and

(3) by adding at the end the following:

“(2) no requirement under such Act regarding an official compendium (as defined in section 201(j) of such Act), or other reference in such Act to an official compendium (as so defined), shall apply with respect to a biological product subject to regulation under this section.”.

Chapter V of the Federal Food, Drug, and Cosmetic Act is amended—

(1) in section 505 (21 U.S.C. 355)—

(A) in subsection (c)(3)(E)—

(i) in clause (ii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and

(ii) in clause (iii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;

(B) in subsection (j)(5)(F)—

(i) in clause (ii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and

(ii) in clause (iii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;

(C) in subsection (l)(2)(A)(i), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;

(D) in subsection (s), in the matter preceding paragraph (1), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and

(E) in subsection (u)(1), in the matter preceding subparagraph (A)—

(i) by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and

(ii) by striking “same active ingredient” and inserting “same active moiety”;

(2) in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F))—

(A) in clause (i), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;

(B) in clause (ii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and

(C) in clause (v), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;

(3) in section 524(a)(4)(C) (21 U.S.C. 360n(a)(4)(C)), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;

(4) in section 529(a)(4)(A)(ii) (21 U.S.C. 360ff(a)(4)(A)(ii)), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and

(5) in section 565A(a)(4)(D) (21 U.S.C. 360bbb–4a(a)(4)(D)), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”.

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) is amended by adding at the end the following: “With respect to an application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) with a filing date that is not later than September 23, 2019, the Secretary shall continue to review and approve such application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), even if such review and approval process continues after March 23, 2020. Effective on the later of March 23, 2020, or the date of approval of such application under such section 505, such approved application shall be deemed to be a license for the biological product under section 351 of the Public Health Service Act.”.

Section 527(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(c)) is amended by adding at the end the following:

“(3) APPLICABILITY.—This subsection applies to any drug designated under section 526 that was approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act after the date of enactment of the FDA Reauthorization Act of 2017, regardless of the date of on which such drug was designated under section 526.”.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

“(z) Prompt Approval of Drugs When safety information Is Added to Labeling.—

“(1) GENERAL RULE.—A drug for which an application has been submitted or approved under subsection (b)(2) or (j) shall not be considered ineligible for approval under this section or misbranded under section 502 on the basis that the labeling of the drug omits safety information, including contraindications, warnings, precautions, dosing, administration, or other information pertaining to safety, when the omitted safety information is protected by exclusivity under clause (iii) or (iv) of subsection (j)(5)(F), clause (iii) or (iv) of subsection (c)(3)(E), or section 527(a), or by an extension of such exclusivity under section 505A or 505E.

“(2) LABELING.—Notwithstanding clauses (iii) and (iv) of subsection (j)(5)(F), clauses (iii) and (iv) of subsection (c)(3)(E), or section 527, the Secretary shall require that the labeling of a drug approved pursuant to an application submitted under subsection (b)(2) or (j) that omits safety information described in paragraph (1) include a statement of any appropriate safety information that the Secretary considers necessary to assure safe use.

“(3) AVAILABILITY AND SCOPE OF EXCLUSIVITY.—This subsection does not affect—

“(A) the availability or scope of exclusivity or an extension of exclusivity described in subparagraph (A) or (B) of section 505A(o)(3);

“(B) the question of the eligibility for approval under this section of any application described in subsection (b)(2) or (j) that omits any other aspect of labeling protected by exclusivity under—

“(i) clause (iii) or (iv) of subsection (j)(5)(F);

“(ii) clause (iii) or (iv) of subsection (c)(3)(E); or

“(iii) section 527(a); or

“(C) except as expressly provided in paragraphs (1) and (2), the operation of this section or section 527.”.

Section 351(k)(2)(A)(iii) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)(iii)) is amended—

(1) in subclause (I), by striking “; and” and inserting a semicolon;

(2) in subclause (II), by striking the period and inserting “; and”; and

(3) by adding at the end the following:

“(III) may include information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product.”.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503C the following:

Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.), as amended by section 103, is amended by adding at the end the following:

(a) In general.—Section 2729B of the Public Health Service Act, as added by section 301, is amended by adding at the end the following:

“(b) Protecting Health Plans Network Design Flexibility.—

“(1) IN GENERAL.—A group health plan or a health insurance issuer offering group or individual health insurance coverage shall not enter into an agreement with a provider, network or association of providers, or other service provider offering access to a network of service providers if such agreement, directly or indirectly—

“(A) restricts the group health plan or health insurance issuer from—

“(i) directing or steering enrollees to other health care providers; or

“(ii) offering incentives to encourage enrollees to utilize specific health care providers;

“(B) requires the group health plan or health insurance issuer to enter into any additional contract with an affiliate of the provider as a condition of entering into a contract with such provider;

“(C) requires the group health plan or health insurance issuer to agree to payment rates or other terms for any affiliate not party to the contract of the provider involved; or

“(D) restricts other group health plans or health insurance issuers not party to the contract, from paying a lower rate for items or services than the contracting plan or issuer pays for such items or services.

“(2) ADDITIONAL REQUIREMENT FOR SELF-INSURED PLANS.—A self-insured group health plan shall not enter into an agreement with a provider, network or association of providers, third-party administrator, or other service provider offering access to a network of providers if such agreement, directly or indirectly requires the group health plan to certify, attest, or otherwise confirm in writing that the group health plan is bound by the terms of the contract between the service provider and a third-party administrator that the group health plan is not party to and is not allowed to review.

“(3) EXCEPTION FOR CERTAIN GROUP MODEL ISSUERS.—Paragraph (1)(A) shall not apply to a group health plan or a health insurance issuer offering group or individual health insurance coverage with respect to a health maintenance organization (as defined in section 2791(b)(3)) if such health maintenance organization operates primarily through exclusive contracts with multi-specialty physician groups, nor to any arrangement between such a health maintenance organization and its affiliates.

“(4) ATTESTATION.—A group health plan or a health insurance issuer offering group or individual health insurance coverage shall annually submit to, as applicable, the applicable authority described in section 2723 or the Secretary of Labor, an attestation that such plan or issuer is in compliance with the requirements of this subsection.

“(c) Maintenance of existing HIPAA, GINA, and ADA protections.—Nothing in this section shall modify, reduce, or eliminate the existing privacy protections and standards provided by reason of State and Federal law, including the requirements of parts 160 and 164 of title 45, Code of Federal Regulations (or any successor regulations).

“(d) Regulations.—The Secretary, in coordination with the Secretary of Labor and the Secretary of the Treasury, not later than 1 year after the date of enactment of the Lower Health Care Costs Act, shall promulgate regulations to carry out this section.

“(e) Rule of construction.—Nothing in this section shall be construed to limit network design or cost or quality initiatives by a group health plan or health insurance issuer, including accountable care organizations, exclusive provider organizations, networks that tier providers by cost or quality or steer enrollees to centers of excellence, or other pay-for-performance programs.”.

(b) Effective date.—Section 2729B of the Public Health Service Act (as added by section 301 and amended by subsection (a)) shall apply with respect to any contract entered into after the date of enactment of this Act. With respect to an applicable contract that is in effect on the date of enactment of this Act, such section 2729B shall apply on the earlier of the date of renewal of such contract or 3 years after such date of enactment.

(a) In general.—Subpart C of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191 et seq.) is amended by adding at the end the following:

(b) GAO report.—

(1) IN GENERAL.—The Comptroller General of the United States shall conduct a study on—

(A) the performance of the entity awarded a contract under section 735(a) of the Employee Retirement Income Security Act of 1974, as added by subsection (a), under such contract;

(B) the privacy and security of the information reported to the entity; and

(C) the costs incurred by such entity in performing such duties.

(2) REPORTS.—Not later than 2 years after the effective date of the first contract entered into under section 735(a) of the Employee Retirement Income Security Act of 1974, as added by subsection (a), and again not later than 4 years after such effective date, the Comptroller General of the United States shall submit to Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

(c) Clerical amendment.—The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 is amended by inserting after the item relating to section 734 the following new item:

“Sec. 735. Designation of a nongovernmental, nonprofit transparency organization to lower Americans’ health care costs.”.

Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.), as amended by sections 301 and 302, is further amended by adding at the end the following:

(a) In general.—

(1) AMENDMENT.—Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following:

(2) RULEMAKING.—Not later than 1 year after the date of enactment of this Act, the Secretary shall promulgate final regulations to define the term “extenuating circumstance” for purposes of section 399V–7(c)(3)(B) of the Public Health Service Act, as added by paragraph (1).

(b) Group health plan and health insurance issuer requirements.—Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11), as amended by section 304, is further amended by adding to the end the following:

(c) Effective date.—The amendments made by subsections (a) and (b) shall take effect 6 months after the date of enactment of this Act.

Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.), as amended by section 305, is further amended by adding at the end the following:

(a) Study.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study to—

(1) describe what is known about profit- and revenue-sharing relationships in the commercial health care markets, including those relationships that—

(A) involve one or more—

(i) physician groups that practice within a hospital included in the profit- or revenue-sharing relationship, or refer patients to such hospital;

(ii) laboratory, radiology, or pharmacy services that are delivered to privately insured patients of such hospital;

(iii) surgical services;

(iv) hospitals or group purchasing organizations; or

(v) rehabilitation or physical therapy facilities or services; and

(B) include revenue- or profit-sharing whether through a joint venture, management or professional services agreement, or other form of gain-sharing contract;

(2) describe Federal oversight of such relationships, including authorities of the Department of Health and Human Services and the Federal Trade Commission to review such relationships and their potential to increase costs for patients, and identify limitations in such oversight; and

(3) as appropriate, make recommendations to improve Federal oversight of such relationships.

(b) Report.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit a report on the study conducted under subsection (a) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Education and Labor and the Committee on Energy and Commerce of the House of Representatives.

(a) Group health plans.—Section 408(b)(2) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1108(b)(2)) is amended—

(1) by striking “(2) Contracting or making” and inserting “(2)(A) Contracting or making”; and

(2) by adding at the end the following:

“(B) (i) No contract or arrangement for services between a covered plan and a covered service provider, and no extension or renewal of such a contract or arrangement, is reasonable within the meaning of this paragraph unless the requirements of this clause are met.

“(ii) (I) For purposes of this subparagraph:

“(aa) The term ‘covered plan’ means a group health plan as defined section 733(a).

“(bb) The term ‘covered service provider’ means a service provider that enters into a contract or arrangement with the covered plan and reasonably expects $1,000 (or such amount as the Secretary may establish in regulations to account for inflation since the date of enactment of the Lower Health Care Costs Act, as appropriate) or more in compensation, direct or indirect, to be received in connection with providing one or more of the following services, pursuant to the contract or arrangement, regardless of whether such services will be performed, or such compensation received, by the covered service provider, an affiliate, or a subcontractor:

“(AA) Brokerage services, for which the covered service provider, an affiliate, or a subcontractor reasonably expects to receive indirect compensation or direct compensation described in item (dd), provided to a covered plan with respect to selection of insurance products (including vision and dental), recordkeeping services, medical management vendor, benefits administration (including vision and dental), stop-loss insurance, pharmacy benefit management services, wellness services, transparency tools and vendors, group purchasing organization preferred vendor panels, disease management vendors and products, compliance services, employee assistance programs, or third-party administration services.

“(BB) Consulting, for which the covered service provider, an affiliate, or a subcontractor reasonably expects to receive indirect compensation or direct compensation described in item (dd), related to the development or implementation of plan design, insurance or insurance product selection (including vision and dental), recordkeeping, medical management, benefits administration selection (including vision and dental), stop-loss insurance, pharmacy benefit management services, wellness design and management services, transparency tools, group purchasing organization agreements and services, participation in and services from preferred vendor panels, disease management, compliance services, employee assistance programs, or third-party administration services.

“(cc) The term ‘affiliate’, with respect to a covered service provider, means an entity that directly or indirectly (through one or more intermediaries) controls, is controlled by, or is under common control with, such provider, or is an officer, director, or employee of, or partner in, such provider.

“(dd)(AA) The term ‘compensation’ means anything of monetary value, but does not include non-monetary compensation valued at $250 (or such amount as the Secretary may establish in regulations to account for inflation since the date of enactment of the Lower Health Care Costs Act, as appropriate) or less, in the aggregate, during the term of the contract or arrangement.

“(BB) The term ‘direct compensation’ means compensation received directly from a covered plan.

“(CC) The term ‘indirect compensation’ means compensation received from any source other than the covered plan, the plan sponsor, the covered service provider, or an affiliate. Compensation received from a subcontractor is indirect compensation, unless it is received in connection with services performed under a contract or arrangement with a subcontractor.

“(ee) The term ‘responsible plan fiduciary’ means a fiduciary with authority to cause the covered plan to enter into, or extend or renew, the contract or arrangement.

“(ff) The term ‘subcontractor’ means any person or entity (or an affiliate of such person or entity) that is not an affiliate of the covered service provider and that, pursuant to a contract or arrangement with the covered service provider or an affiliate, reasonably expects to receive $1,000 (or such amount as the Secretary may establish in regulations to account for inflation since the date of enactment of the Lower Health Care Costs Act, as appropriate) or more in compensation for performing one or more services described in item (bb) under a contract or arrangement with the covered plan.

“(II) For purposes of this subparagraph, a description of compensation or cost may be expressed as a monetary amount, formula, or a per capita charge for each enrollee or, if the compensation or cost cannot reasonably be expressed in such terms, by any other reasonable method, including a disclosure that additional compensation may be earned but may not be calculated at the time of contract if such a disclosure includes a description of the circumstances under which the additional compensation may be earned and a reasonable and good faith estimate if the covered service provider cannot otherwise readily describe compensation or cost and explains the methodology and assumptions used to prepare such estimate. Any such description shall contain sufficient information to permit evaluation of the reasonableness of the compensation or cost.

“(III) No person or entity is a ‘covered service provider’ within the meaning of subclause (I)(bb) solely on the basis of providing services as an affiliate or a subcontractor that is performing one or more of the services described in subitem (AA) or (BB) of such subclause under the contract or arrangement with the covered plan.

“(iii) A covered service provider shall disclose to a responsible plan fiduciary, in writing, the following:

“(I) A description of the services to be provided to the covered plan pursuant to the contract or arrangement.

“(II) If applicable, a statement that the covered service provider, an affiliate, or a subcontractor will provide, or reasonably expects to provide, services pursuant to the contract or arrangement directly to the covered plan as a fiduciary (within the meaning of section 3(21)).

“(III) A description of all direct compensation, either in the aggregate or by service, that the covered service provider, an affiliate, or a subcontractor reasonably expects to receive in connection with the services described in subclause (I).

“(IV) (aa) A description of all indirect compensation that the covered service provider, an affiliate, or a subcontractor reasonably expects to receive in connection with the services described in subclause (I)—

“(AA) including compensation from a vendor to a brokerage firm based on a structure of incentives not solely related to the contract with the covered plan; and

“(BB) not including compensation received by an employee from an employer on account of work performed by the employee.

“(bb) A description of the arrangement between the payer and the covered service provider, an affiliate, or a subcontractor, as applicable, pursuant to which such indirect compensation is paid.

“(cc) Identification of the services for which the indirect compensation will be received, if applicable.

“(dd) Identification of the payer of the indirect compensation.

“(V) A description of any compensation that will be paid among the covered service provider, an affiliate, or a subcontractor, in connection with the services described in subclause (I) if such compensation is set on a transaction basis (such as commissions, finder’s fees, or other similar incentive compensation based on business placed or retained), including identification of the services for which such compensation will be paid and identification of the payers and recipients of such compensation (including the status of a payer or recipient as an affiliate or a subcontractor), regardless of whether such compensation also is disclosed pursuant to subclause (III) or (IV).

“(VI) A description of any compensation that the covered service provider, an affiliate, or a subcontractor reasonably expects to receive in connection with termination of the contract or arrangement, and how any prepaid amounts will be calculated and refunded upon such termination.

“(iv) A covered service provider shall disclose to a responsible plan fiduciary, in writing a description of the manner in which the compensation described in clause (iii), as applicable, will be received.

“(v) (I) A covered service provider shall disclose the information required under clauses (iii) and (iv) to the responsible plan fiduciary not later than the date that is reasonably in advance of the date on which the contract or arrangement is entered into, and extended or renewed.

“(II) A covered service provider shall disclose any change to the information required under clauses (iii) and (iv) as soon as practicable, but not later than 60 days from the date on which the covered service provider is informed of such change, unless such disclosure is precluded due to extraordinary circumstances beyond the covered service provider's control, in which case the information shall be disclosed as soon as practicable.

“(vi) (I) Upon the written request of the responsible plan fiduciary or covered plan administrator, a covered service provider shall furnish any other information relating to the compensation received in connection with the contract or arrangement that is required for the covered plan to comply with the reporting and disclosure requirements under this Act.

“(II) The covered service provider shall disclose the information required under clause (iii)(I) reasonably in advance of the date upon which such responsible plan fiduciary or covered plan administrator states that it is required to comply with the applicable reporting or disclosure requirement, unless such disclosure is precluded due to extraordinary circumstances beyond the covered service provider's control, in which case the information shall be disclosed as soon as practicable.

“(vii) No contract or arrangement will fail to be reasonable under this subparagraph solely because the covered service provider, acting in good faith and with reasonable diligence, makes an error or omission in disclosing the information required pursuant to clause (iii) (or a change to such information disclosed pursuant to clause (v)(II)) or clause (vi), provided that the covered service provider discloses the correct information to the responsible plan fiduciary as soon as practicable, but not later than 30 days from the date on which the covered service provider knows of such error or omission.

“(viii) (I) Pursuant to subsection (a), subparagraphs (C) and (D) of section 406(a)(1) shall not apply to a responsible plan fiduciary, not­with­stand­ing any failure by a covered service provider to disclose information required under clause (iii), if the following conditions are met:

“(aa) The responsible plan fiduciary did not know that the covered service provider failed or would fail to make required disclosures and reasonably believed that the covered service provider disclosed the information required to be disclosed.

“(bb) The responsible plan fiduciary, upon discovering that the covered service provider failed to disclose the required information, requests in writing that the covered service provider furnish such information.

“(cc) If the covered service provider fails to comply with a written request described in subclause (II) within 90 days of the request, the responsible plan fiduciary notifies the Secretary of the covered service provider's failure, in accordance with subclauses (II) and (III).

“(II) A notice described in subclause (I)(cc) shall contain—

“(aa) the name of the covered plan;

“(bb) the plan number used for the annual report on the covered plan;

“(cc) the plan sponsor's name, address, and employer identification number;

“(dd) the name, address, and telephone number of the responsible plan fiduciary;

“(ee) the name, address, phone number, and, if known, employer identification number of the covered service provider;

“(ff) a description of the services provided to the covered plan;

“(gg) a description of the information that the covered service provider failed to disclose;

“(hh) the date on which such information was requested in writing from the covered service provider; and

“(ii) a statement as to whether the covered service provider continues to provide services to the plan.

“(III) A notice described in subclause (I)(cc) shall be filed with the Department not later than 30 days following the earlier of—

“(aa) the covered service provider's refusal to furnish the information requested by the written request described in subclause (I)(bb); or

“(bb) 90 days after the written request referred to in subclause (I)(cc) is made.

“(IV) If the covered service provider fails to comply with the written request under subclause (I)(bb) within 90 days of such request, the responsible plan fiduciary shall determine whether to terminate or continue the contract or arrangement under section 404. If the requested information relates to future services and is not disclosed promptly after the end of the 90-day period, the responsible plan fiduciary shall terminate the contract or arrangement as expeditiously as possible, consistent with such duty of prudence.

“(ix) Nothing in this subparagraph shall be construed to supersede any provision of State law that governs disclosures by parties that provide the services described in this section, except to the extent that such law prevents the application of a requirement of this section.”.

(b) Applicability of existing regulations.—Nothing in the amendments made by subsection (a) shall be construed to affect the applicability of section 2550.408b–2 of title 29, Code of Federal Regulations (or any successor regulations), with respect to any applicable entity other than a covered plan or a covered service provider (as defined in section 408(b)(2)(B)(ii) of the Employee Retirement Income Security Act of 1974, as amended by subsection (a)).

(c) Individual market coverage.—Subpart 1 of part B of title XVII of the Public Health Service Act (42 U.S.C. 300gg–41 et seq.) is amended by adding at the end the following:

(d) Transition rule.—No contract executed prior to the effective date described in subsection (e) by a group health plan subject to the requirements of section 408(b)(2)(B) of the Employee Retirement Income Security Act of 1974 (as amended by subsection (a)) or by a health insurance issuer subject to the requirements of section 2746 of the Public Health Service Act (as added by subsection (c)) shall be subject to the requirements of such section 408(b)(2)(B) or such section 2746, as applicable.

(e) Effective date.—The amendments made by subsections (a) and (c) shall take effect 2 years after the date of enactment of this Act.

(a) In general.—Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.), as amended by section 306, is further amended by adding at the end the following:

(b) Effective date.—Section 2729G of the Public Health Service Act, as added by subsection (a), shall apply with respect to plan years beginning on or after January 1, 2021.

Section 2726 of the Public Health Service Act (42 U.S.C. 300gg–26) is amended—

(1) in subsection (a), by adding at the end the following:

“(8) COMPLIANCE REQUIREMENTS.—

“(A) NONQUANTITATIVE TREATMENT LIMITATION (NQTL) REQUIREMENTS.—In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits, the plan or coverage shall perform comparative analyses about the design and application of nonquantitative treatment limitations (referred to in this paragraph as the ‘NQTL’) in accordance with the following process, and make available to the Secretary upon request within 60 days beginning January 1, 2020, and within 30 days beginning January 1, 2021, the following information:

“(i) The specific plan or coverage language regarding the NQTL, that applies to such plan or coverage, and a description of all mental health or substance use disorder and medical/surgical services to which it applies in each respective benefits classification.

“(ii) The factors used to determine that an NQTL will apply to mental health or substance use disorder benefits and medical/surgical benefits.

“(iii) The evidentiary standard (both identified and deidentified) for the factors identified in clause (ii) and any other evidence relied upon to design and apply the NQTL to mental health or substance use disorder benefits and medical/surgical benefits.

“(iv) The comparative analyses demonstrating that the processes and strategies used to design the NQTL, as written and in operation, and the as written processes and strategies used to apply the NQTL for mental health or substance use disorder benefits are comparable to, and are applied no more stringently than, the processes and strategies used to design the NQTL, as written and in operation, and the as written processes and strategies used to apply the NQTL to medical/surgical benefits.

“(v) A disclosure of the specific findings and conclusions reached by the plan or coverage that the results of the analyses described in this subparagraph indicate that the plan or coverage is in compliance with this section.

“(B) SECRETARY REQUEST PROCESS.—

“(i) SUBMISSION UPON COMPLAINT.—The Secretary shall request that a group health plan or a health insurance issuer offering group or individual health insurance coverage submit the comparative analyses described in subparagraph (A) if the Secretary has received any complaints from plan participants or participating providers about such a plan or coverage that involve mental health or substance use disorder benefits.

“(ii) RANDOM SUBMISSIONS.—The Secretary shall request the comparative analyses described in subparagraph (A) from no fewer than 50 plans or coverages selected at random, annually, and such plans or coverages shall not—

“(I) be the same plans or coverages for which the comparative analyses are requested under clause (i);

“(II) be the same plan or coverage being investigated by the Department regarding NQTLs or that has been investigated by the Department regarding NQTLs within the last 5 years; and

“(III) be the same plan or coverage that has been selected under clause (i) or (ii) within the last 5 years.

“(iii) ADDITIONAL INFORMATION.—In instances in which the Secretary has concluded that the plan or coverage has not submitted sufficient information for the Secretary to review the comparative analyses described in subparagraph (A), as requested under clauses (i) and (ii), the Secretary shall specify to the plan or coverage the information the plan or coverage must submit to be responsive to the request under clauses (i) and (ii) for the Secretary to review the comparative analyses described in subparagraph (A) for compliance with this section.

“(iv) REQUIRED ACTION.—In instances in which the Secretary has reviewed the comparative analyses described in subparagraph (A), as requested under clauses (i) and (ii), and determined that the plan or coverage is not in compliance with this section, the Secretary shall specify to the plan or coverage the actions the plan or coverage must take to be in compliance with this section. Documents or communications produced in connection with the Secretary’s recommendations to the plan or coverage shall not be subject to disclosure pursuant to section 552 of title 5, United States Code.

“(v) REPORT.—Not later than 1 year after the date of enactment of this paragraph, and annually thereafter, the Secretary shall submit to the Committee on Education and Labor of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report that contains—

“(I) each of the comparative analyses requested under clauses (i) and (ii), except that the identity of each plan or coverage and any contracted entity of a plan or coverage shall be redacted;

“(II) the Secretary’s conclusions as to whether each plan or coverage submitted sufficient information for the Secretary to review the comparative analyses requested under clauses (i) and (ii) for compliance with this section;

“(III) for each plan or coverage that did submit sufficient information for the Secretary to review the comparative analyses requested under clause (i), the Secretary’s conclusions as to whether and why the plan or coverage is in compliance with this section;

“(IV) the Secretary’s specifications described in clause (iii) for each plan or coverage that the Secretary determined did not submit sufficient information for the Secretary to review the comparative analyses requested under clauses (i) and (ii) for compliance with this section; and

“(V) the Secretary’s specifications described in clause (iv) of the actions each plan or coverage that the Secretary determined is not in compliance with this section must take to be in compliance with this section, including the reason why the Secretary determined the plan or coverage is not in compliance.

“(C) COMPLIANCE PROGRAM GUIDANCE DOCUMENT UPDATE PROCESS.—

“(i) IN GENERAL.—The Secretary shall include select instances of noncompliance that the Secretary discovers upon reviewing the comparative analyses requested under clauses (i) and (ii) of subparagraph (B) in the compliance program guidance document described in section 2726(a)(6), as it is updated every 2 years, except that all instances shall be deidentified and such instances shall not disclose any protected health information or individually identifiable information.

“(ii) GUIDANCE AND REGULATIONS.—Not later than 18 months after the date of enactment of this paragraph, the Secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section.

“(iii) STATE.—Any instances of noncompliance the Secretary discovers upon reviewing the comparative analyses requested under clauses (i) and (ii) of subparagraph (B) shall be shared with a State for coverage offered by a health insurance issuer in the group market, in accordance with section 2726(a)(6)(B)(iii)(II).”.

(a) ERISA.—Section 715 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185d) is amended—

(1) in subsection (a)(1), by striking “(as amended by the Patient Protection and Affordable Care Act)” and inserting “(including any subsequent amendments to such part)”; and

(2) in subsection (b)—

(A) by striking “(as amended by the Patient Protection and Affordable Care Act)” and inserting “(including any subsequent amendments to such part)”; and

(B) by striking “(as so amended)”.

(b) IRC.—Section 9815 of the Internal Revenue Code of 1986 is amended—

(1) in subsection (a)(1), by striking “(as amended by the Patient Protection and Affordable Care Act)” and inserting “(including any subsequent amendments to such part)”; and

(2) in subsection (b)—

(A) by striking “(as amended by the Patient Protection and Affordable Care Act)” and inserting “(including any subsequent amendments to such part)”; and

(B) by striking “(as so amended)”.

(c) Applicability.—The amendments made by subsections (a) and (b) shall take effect as though included in the enactment of the Patient Protection and Affordable Care Act (Public Law 111–148).

Any obligation on a third-party administrator under this Act (including the amendments made by this Act) shall not affect any other direct or indirect requirement under any other provision of Federal law that applies to third-party administrators offering services to group health plans.

The Public Health Service Act is amended by striking section 313 of such Act (42 U.S.C. 245) and inserting the following:

Section 317(k)(1) of the Public Health Service Act (42 U.S.C. 247b(k)(1)) is amended—

(1) in subparagraph (C), by striking “; and” and inserting a semicolon;

(2) in subparagraph (D), by striking the period and inserting a semicolon; and

(3) by adding at the end the following:

“(E) planning, implementation, and evaluation of activities to address vaccine-preventable diseases, including activities to—

“(i) identify communities at high risk of outbreaks related to vaccine-preventable diseases, including through improved data collection and analysis;

“(ii) pilot innovative approaches to improve vaccination rates in communities and among populations with low rates of vaccination;

“(iii) reduce barriers to accessing vaccines and evidence-based information about the health effects of vaccines;

“(iv) partner with community organizations and health care providers to develop and deliver evidence-based interventions, including culturally and linguistically appropriate interventions, to increase vaccination rates;

“(v) improve delivery of evidence-based vaccine-related information to parents and others; and

“(vi) improve the ability of State, local, tribal, and territorial public health departments to engage communities at high risk for outbreaks related to vaccine-preventable diseases; and

“(F) research related to strategies for improving awareness of scientific and evidence-based vaccine-related information, including for communities with low rates of vaccination, in order to understand barriers to vaccination, improve vaccination rates, and assess the public health outcomes of such strategies.”.

(a) Development and dissemination of an evidence-Based strategies guide.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Director of the Centers for Disease Control and Prevention, not later than 2 years after the date of enactment of this Act, shall—

(1) develop a guide on evidence-based strategies for State, territorial, and local health departments to use to build and maintain effective obesity prevention and reduction programs, and, in consultation with stakeholders that have expertise in Tribal health, a guide on such evidence-based strategies with respect to Indian Tribes and Tribal organizations for such Indian Tribes and Tribal organizations to use for such purpose, both of which guides shall—

(A) describe an integrated program structure for implementing interventions proven to be effective in preventing and reducing the incidence of obesity; and

(B) recommend—

(i) optimal resources, including staffing and infrastructure, for promoting nutrition and obesity prevention and reduction; and

(ii) strategies for effective obesity prevention programs for State and local health departments, Indian Tribes, and Tribal organizations, including strategies related to—

(I) the application of evidence-based and evidence-informed practices to prevent and reduce obesity rates;

(II) the development, implementation, and evaluation of obesity prevention and reduction strategies for specific communities and populations;

(III) demonstrated knowledge of obesity prevention practices that reduce associated preventable diseases, health conditions, death, and health care costs;

(IV) best practices for the coordination of efforts to prevent and reduce obesity and related chronic diseases;

(V) addressing the underlying risk factors and social determinants of health that impact obesity rates; and

(VI) interdisciplinary coordination between relevant public health officials specializing in fields such as nutrition, physical activity, epidemiology, communications, and policy implementation, and collaboration between public health officials and community-based organizations; and

(2) disseminate the guides and current research, evidence-based practices, tools, and educational materials related to obesity prevention, consistent with the guide, to State and local health departments, Indian Tribes, and Tribal organizations.

(b) Technical assistance.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall provide technical assistance to State and local health departments, Indian Tribes, and Tribal organizations to support such health departments in implementing the guide developed under subsection (a)(1).

(c) Indian Tribes; Tribal organizations.—The terms “Indian Tribe” and “Tribal organization” have the meanings given the terms “Indian tribe” and “tribal organization”, respectively, in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).

Title III of the Public Health Service Act is amended by inserting after section 330M (42 U.S.C. 254c–19) the following:

Subtitle C of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh–31 et seq.) is amended by adding at the end the following:

(a) In general.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”), in consultation with experts representing a variety of clinical specialties, State, tribal, or local public health officials, researchers, epidemiologists, statisticians, and community organizations, shall establish a program to award competitive grants to eligible entities for the purpose of—

(1) identifying, developing, or disseminating best practices to improve maternal health care quality and outcomes, eliminate preventable maternal mortality and severe maternal morbidity, and improve infant health outcomes, which may include—

(A) information on evidence-based practices to improve the quality and safety of maternal health care in hospitals and other health care settings of a State or health care system, including by addressing topics commonly associated with health complications or risks related to prenatal care, labor care, birthing, and post­par­tum care;

(B) best practices for improving maternal health care based on data findings and reviews conducted by a State maternal mortality review committee that address topics of relevance to common complications or health risks related to prenatal care, labor care, birthing, and post­par­tum care; and

(C) information on addressing determinants of health that impact maternal health outcomes for women before, during, and after pregnancy;

(2) collaborating with State maternal mortality review committees to identify issues for the development and implementation of evidence-based practices to improve maternal health outcomes and reduce preventable maternal mortality and severe maternal morbidity;

(3) providing technical assistance and supporting the implementation of best practices identified in paragraph (1) to entities providing health care services to pregnant and postpartum women; and

(4) identifying, developing, and evaluating new models of care that improve maternal and infant health outcomes, which may include the integration of community-based services and clinical care.

(b) Eligible entities.—To be eligible for a grant under subsection (a), an entity shall—

(1) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; and

(2) demonstrate in such application that the entity has a demonstrated expertise in data-driven maternal safety and quality improvement initiatives in the areas of obstetrics and gynecology or maternal health.

(c) Authorization of appropriations.—To carry out this section, there is authorized to be appropriated such sums as may be necessary for each of fiscal years 2020 through 2024.

Title VII of the Public Health Service Act is amended by striking section 763 (42 U.S.C. 294p) and inserting the following:

Not later than 2 years after date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall, through a contract with an independent research organization, study and make recommendations for accredited schools of allopathic medicine, osteopathic medicine, and nursing, and other health professional training programs on best practices related to training to reduce and prevent discrimination, including training related to implicit biases, in the provision of health care services related to prenatal care, labor care, birthing, and postpartum care.

Section 317K(a)(2) of the Public Health Service Act (42 U.S.C. 247b–12(a)(2)) is amended by adding at the end the following:

“(E) (i) The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other offices and agencies, as appropriate, shall establish or continue a competitive grant program for the establishment or support of perinatal quality collaboratives to improve perinatal care and perinatal health outcomes for pregnant and postpartum women and their infants. A State or Indian Tribe may use funds received through such grant to—

“(I) support the use of evidence-based or evidence-informed practices to improve outcomes for maternal and infant health;

“(II) work with clinical teams; experts; State, local, and, as appropriate, tribal public health officials; and stakeholders, including patients and families, to identify, develop, or disseminate best practices to improve perinatal care and outcomes; and

“(III) employ strategies that provide opportunities for health care professionals and clinical teams to collaborate across health care settings and disciplines, including primary care and mental health, as appropriate, to improve maternal and infant health outcomes, which may include the use of data to provide timely feedback across hospital and clinical teams to inform responses, and to provide support and training to hospital and clinical teams for quality improvement, as appropriate.

“(ii) To be eligible for a grant under clause (i), an entity shall submit to the Secretary an application in such form and manner and containing such information as the Secretary may require.”.

(a) Grants.—Title III of the Public Health Service Act is amended by inserting after section 330N of such Act, as added by section 404, the following:

(b) Report on grant outcomes and dissemination of best practices.—

(1) REPORT.—Not later than April 1, 2025, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that describes—

(A) the outcomes of the activities supported by the grants awarded under the amendments made by this section on maternal and child health;

(B) best practices and models of care used by recipients of grants under such amendments; and

(C) obstacles identified by recipients of grants under such amendments, and strategies used by such recipients to deliver care, improve maternal and child health, and reduce health disparities.

(2) DISSEMINATION OF BEST PRACTICES.—Not later than October 1, 2025, the Secretary of Health and Human Services shall disseminate information on best practices and models of care used by recipients of grants under the amendments made by this section (including best practices and models of care relating to the reduction of health disparities, including such disparities associated with racial and ethnic minority populations, in rates of maternal mortality and severe maternal morbidity) to relevant stakeholders, which may include health providers, medical schools, nursing schools, relevant State, tribal, and local agencies, and the general public.

(a) Community health centers funding.—Section 10503(b)(1)(F) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(1)(F)) is amended by striking “fiscal year 2019” and inserting “each of fiscal years 2019 through 2024”.

(b) National Health Service Corps.—Section 10503(b)(2)(F) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(2)(F)) is amended by striking “and 2019” and inserting “through 2024”.

(c) Teaching Health Centers that operate Graduate Medical Education Programs.—Section 340H(g)(1) of the Public Health Service Act (42 U.S.C. 256h(g)(1)) is amended by striking “and 2019” and inserting “through 2024”.

(d) Application of provisions.—Amounts appropriated pursuant to this section for each of fiscal years 2019 through 2024 shall be subject to the requirements contained in Public Law 115–245 for funds for programs authorized under sections 330 through 340 of the Public Health Service Act.

(e) Conforming amendments.—Paragraph (4) of section 3014(h) of title 18, United States Code, as amended by section 50901 of Public Law 115–123, is amended by striking “and section 50901(e) of the Advancing Chronic Care, Extenders, and Social Services Act” and inserting “, section 50901(e) of the Advancing Chronic Care, Extenders, and Social Services Act, and section 411(d) of the Lower Health Care Costs Act”.

(a) Type I.—Section 330B(b)(2)(D) of the Public Health Service Act (42 U.S.C. 254c–2(b)(2)(D)) is amended by striking “and 2019” and inserting “through 2024”.

(b) Indians.—Subparagraph (D) of section 330C(c)(2) of the Public Health Service Act (42 U.S.C. 254c–3(c)(2)(D)) is amended by striking “and 2019” and inserting “through 2024”.

(a) In general.—Part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg et seq.) is amended by inserting after section 2715A the following:

(b) Effective date.—Section 2715B of the Public Health Service Act, as added by subsection (a), shall take effect 1 year after the date of enactment of this Act.

Part 1 of subtitle D of the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. 17931 et seq.) is amended by adding at the end the following:

(a) In general.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study to—

(1) describe the roles of Federal agencies and the private sector with respect to protecting the privacy and security of individually identifiable health information transmitted electronically to and from entities not covered by the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note);

(2) identify recent developments regarding the use of application programming interfaces to access individually identifiable health information, and implications for the privacy and security of such information;

(3) identify practices in the private sector, such as terms and conditions for use, relating to the privacy, disclosure, and secondary uses of individually identifiable health information transmitted electronically to or from entities, selected by an individual, that are not subject to the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996; and

(4) identify steps the public and private sectors can take to improve the private and secure access to and availability of individually identifiable health information.

(b) Report.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report concerning the findings of the study conducted under subsection (a).

(a) In general.—Section 3022(b) of the Public Health Service Act (42 U.S.C. 300jj–52(b)) is amended by adding at the end the following new paragraph:

“(4) APPLICATION OF AUTHORITIES UNDER INSPECTOR GENERAL ACT OF 1978.—In carrying out this subsection, the Inspector General shall have the same authorities as provided under section 6 of the Inspector General Act of 1978 (5 U.S.C. App.).”.

(b) Effective date.—The amendment made by subsection (a) shall take effect as if included in the enactment of the 21st Century Cures Act (Public Law 114–255).