I 113th CONGRESS 1st Session H. R. 2931 IN THE HOUSE OF REPRESENTATIVES August 1, 2013 Mr. Coble introduced the following bill; which was referred to the Committee on the Judiciary A BILL To amend the false claims provisions of title 31, United States Code, with respect to health care programs, and for other purposes.

1. Short title This Act may be cited as the Fairness in Health Care Claims, Guidance, and Investigations Act . 2. Rules for actions under false claims provisions based on claims submitted under certain health care programs (a) In general Subchapter III of chapter 37 of title 31, United States Code, is amended by adding at the end the following: 3734. Rules for certain actions based on health care claims (a) In general In the case of any action that is brought under section 3730 and is based on a claim submitted with respect to a Federal health care program, sections 3729 through 3733 shall apply only to the extent that such sections are consistent with the provisions of this section. (b) Investigations of false claims to Federal health care programs (1) In general Before requesting any information from a physician, hospital, or other provider or supplier of health care services, by any formal or informal means, directly or in cooperation with an investigating law enforcement agency, in connection with an investigation reasonably expected to concern 10 or more claims submitted to a Federal health care program by or on behalf of a single entity, the Attorney General shall certify, in writing, that— (A) each agency responsible for promulgating relevant regulations, guidelines, and billing instructions, directly or through intermediaries, has examined all regulations, guidelines, and billing instructions relevant to the allegations, all communications between the alleged perpetrator and the agency and its intermediaries, and each of the allegedly false claims; (B) in the view of the responsible agency officials and the Attorney General, the allegations under investigation are viable, and the relevant regulations, guidelines and billing instructions were unambiguous during the relevant time period; and (C) if proven to be true, the allegations are appropriately pursued under section 3729. (2) If certification not made If the Attorney General (or his or her designee) is unable to make the certifications required under paragraph (1), and the allegations were included in an action brought by a person under section 3730(b), the Attorney General shall notify the court and the court shall dismiss these allegations. (c) Actions if amount of damages are material amount Notwithstanding sections 3729 through 3733, no action may be brought under section 3730 that is based on a claim submitted or an overpayment retained with respect to a Federal health care program unless the amount of damages alleged to have been sustained by the United States Government with respect to such claim or overpayment is a material amount. (d) Actions for claims submitted in reliance on official guidance Notwithstanding sections 3729 through 3733, no action may be brought under section 3730 based on a claim submitted or an overpayment retained with respect to a Federal health care program— (1) in good faith reliance on erroneous information supplied by an agency (or an agent thereof) about matters of fact at issue; (2) in good faith reliance on written statements of Federal policy that affects the claim or overpayment that were provided by a Federal agency (or an agent thereof); or (3) in good faith reliance on an audit or review by an agency of the person submitting the claim or on whose behalf the claim was submitted, or of the person retaining the overpayment, in which no findings were made that the claim or overpayment violated the regulations, guidelines, or instructions applicable to the Federal health care program at issue in the claim or overpayment. (e) Action for claims submitted by persons in substantial compliance with model compliance plan Notwithstanding sections 3729 through 3733, no action may be brought under section 3730 based on a claim submitted by or on behalf of a person, or an overpayment retained, with respect to a Federal health care program if the claim is submitted, or the overpayment retained, in substantial compliance with a model compliance plan issued by the Secretary of Health and Human Services with respect to that Federal health care program. (f) Standard of proof In any action brought under section 3730 with respect to a claim submitted, or an overpayment retained, with respect to a Federal health care program, section 3731(c) shall be applied by substituting clear and convincing evidence for a preponderance of the evidence . (g) Rule of construction Nothing in this section shall be construed to limit the authority of the Government of the United States to recover damages with respect to a claim submitted, or an overpayment retained, with respect to a Federal health care program under provisions of law other than section 3729. (h) Definitions; special rules For purposes of this section— (1) the term claim means a claim as defined in section 3729(c); (2) the term Federal health care program means— (A) any plan or program that provides health care benefits, whether directly, through insurance, or otherwise, and that is funded directly, in whole or in part, by the United States Government; (B) any State health care program, as defined in section 1128(h) of the Social Security Act; or (C) any qualifying health plan offered through an Exchange established under, or any other health plan established under, the Patient Protection and Affordable Care Act ( Public Law 111–148 ); (3) the amount of damages alleged to have been sustained by the United States Government with respect to a claim submitted by (or on behalf of) a person shall be treated as a material amount only if such amount exceeds a proportion (specified in regulations promulgated by the Secretary of Health and Human Services in consultation with the Secretary of Defense) of the total of the amounts for which claims were submitted by (or on behalf of) such person— (A) to the same Federal health care program, and (B) for the same calendar year, as the claim upon which an action under section 3730 is based; (4) in determining whether an amount of damages is a material amount under paragraph (3), with respect to a person— (A) the amount of damages for more than 1 claim may be aggregated only if the acts or omissions resulting in such damages were part of a pattern of related acts or omissions by such person; and (B) if damages for more than 1 claim are aggregated in accordance with subparagraph (A), the proportion referred to in paragraph (3) shall be determined by comparing the amount of such aggregate damages to the total of the amounts for which claims were submitted by (or on behalf of) such person to the same Federal health care program for each of the calendar years for which any claim upon which such aggregate damages were based was submitted; (5) the term intermediary means, with respect to a Federal health care program, a contractor with an agency, a State, or other entity that is engaged in the implementation of that Federal health care program; and (6) the term State means each of the several States, the District of Columbia, and any territory or possession of the United States. . (b) Conforming amendment The table of sections for chapter 37 of title 31, United States Code, is amended by adding at the end the following new item: 3734. Rules for certain actions based on health care claims. . (c) Effective date The amendments made by this section shall apply to any action or investigation under sections 3729 through 3733 of title 31, United States Code, that is pending on, or commenced on or after, the date of the enactment of this Act.