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“(I) shall be assessed according to standards and procedures established in regulations to be promulgated by the Secretary within one year of the date of the enactment of the America's Affordable Health Choices Act of 2009;

“(II) shall not exceed $5,000 for each instance of overcharging a covered entity that may have occurred; and

“(III) shall apply to any manufacturer with an agreement under this section that knowingly charges a covered entity a price for purchase of a drug that exceeds the maximum applicable price under subsection (a)(1) or that knowingly violates

any other provision of this section. "(2) COVERED ENTITY COMPLIANCE. —

“(A) IN GENERAL.–From amounts appropriated under paragraph (4), the Secretary shall provide for improvements in compliance by covered entities with the requirements of this section in order to prevent diversion and violations of the duplicate discount provision and other requirements under subsection (a)(5).

“(B) IMPROVEMENTS.—The improvements described in subparagraph (A) shall include the following:

“(i) The development of procedures to enable and require covered entities to update at least annually the information on the Internet website of the Department of Health and Human Services relating to this section.

“(ii) The development of procedures for the Secretary to verify the accuracy of information regarding covered entities that is listed on the website described in clause (i).

"(iii) The development of more detailed guidance describing methodologies and options available to covered entities for billing covered drugs to State Medicaid agencies in a manner that avoids duplicate discounts pursuant to subsection (a)(5)(A).

“(iv) The establishment of a single, universal, and standardized identification system by which each covered entity site can be identified by manufacturers, distributors, covered entities, and the Secretary for purposes of facilitating the ordering, purchasing, and delivery of covered drugs under this section, including the processing of chargebacks for such drugs.

“(v) The imposition of sanctions in the form of civil monetary penalties, which

“(I) shall be assessed according to standards and procedures established in regulations promulgated by the Secretary;

“(II) shall not exceed $5,000 for each violation; and

“(III) shall apply to any covered entity that knowingly violates subparagraph (a)(5)(B) or knowingly and violates any other provision of this section.

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“(vi) The exclusion of a covered entity from participation in the program under this section, for a period of time to be determined by the Secretary, in cases in which the Secretary determines, in accordance with standards and procedures established in regulations, that

“(I) a violation of a requirement of this section was repeated and knowing; and

“(II) imposition of a monetary penalty would be insufficient to reasonably ensure compliance. “(vii) The referral of matters as appropriate to the Food and Drug Administration, the Office of Inspector General of Department of Health and Human Serv

ices, or other Federal agencies. “(3) ADMINISTRATIVE DISPUTE RESOLUTION PROCESS.–From amounts appropriated under paragraph (4), the Secretary may establish and implement an administrative process for the resolution of the following:

“(A) Claims by covered entities that manufacturers have violated the terms of their agreement with the Secretary under subsection (a)(1).

“(B) Claims by manufacturers that covered entities have violated subsection (a)(5)(A) or (a)(5)(B). "(4) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this subsection, such sums as may be necessary for fiscal year 2010 and each succeeding

fiscal year.”. (b) CONFORMING AMENDMENTS.—Section 340B(a) (42 U.S.C. 256b(a)) is amended

(1) by adding at the end of paragraph (1) the following: "Such agreement shall require that the manufacturer offer each covered entity covered drugs for purchase at or below the applicable ceiling price if such drug is made available to any other purchaser at any price. Notwithstanding any other provision of law, if the Secretary requests a manufacturer to enter into a new agreement that complies with current law, the manufacturer will have the option of signing a new agreement or being determined to not have entered into an agreement with the Secretary that meets the requirements of this section.”; and

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

"(11) QUARTERLY REPORTS.—An agreement described in paragraph (1) shall require that the manufacturer furnish the Secretary with reports on a quarterly basis that include the following information:

“(A) The price for each covered drug subject to the agreement that, according to the manufacturer, represents the maximum price that covered entities may permissibly be required to pay for the drug (referred to in this section as the ‘ceiling price').

“(B) The component information used to calculate the ceiling price as determined necessary to administer the requirements of the program under this section.

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