,i #aacth ,,congress #ast ,session ,h4 ,r4 #bica ,,in ,,the ,,house ,,of ,,representatives ,august #a1 #bjac ,mr4 ,coble introduced the following bill2 which was referred to the ,committee on the ,judiciary ,a ,,bill ,to amend the false claims provisions of title #ca1 ,united ,states ,code1 with respect to health care programs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,fairness in ,health ,care ,claims1 ,guidance1 and ,investigations ,act4 #b4 ,rules for actions under false claims provisions based on claims submitted under certain health care programs 7a7 ,in general ,subchapter ,,iii of chapter #cg of title #ca1 ,united ,states ,code1 is amended by adding at the end the following3 #cgcd4 ,rules for certain actions based on health care claims 7a7 ,in general ,in the case of any action that is brought under section #cgcj and is based on a claim submitted with respect to a ,federal health care program1 sections #cgbi through #cgcc shall apply only to the extent that such sections are consistent with the provisions of this section4 7b7 ,investigations of false claims to ,federal health care programs 7#a7 ,in general ,before requesting any information from a physician1 hospital1 or other provider or supplier of health care services1 by any formal or informal means1 directly or in cooperation with an investigating law enforcement agency1 in connection with an investigation reasonably expected to concern #aj or more claims submitted to a ,federal health care program by or on behalf of a single entity1 the ,attorney ,general shall certify1 in writing1 that-- 7,a7 each agency responsible for promulgating relevant regulations1 guidelines1 and billing instructions1 directly or through intermediaries1 has examined all regulations1 guidelines1 and billing instructions relevant to the allegations1 all communications between the alleged perpetrator and the agency and its intermediaries1 and each of the allegedly false claims2 7,b7 in the view of the responsible agency officials and the ,attorney ,general1 the allegations under investigation are viable1 and the relevant regulations1 guidelines and billing instructions were unambiguous during the relevant time period2 and 7,c7 if proven to be true1 the allegations are appropriately pursued under section #cgbi4 7#b7 ,if certification not made ,if the ,attorney ,general 7or his or her designee7 is unable to make the certifications required under paragraph 7#a71 and the allegations were included in an action brought by a person under section #cgcj7;b71 the ,attorney ,general shall notify the court and the court shall dismiss these allegations4 7c7 ,actions if amount of damages are material amount ,notwithstanding sections #cgbi through #cgcc1 no action may be brought under section #cgcj 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 amount4 7d7 ,actions for claims submitted in reliance on official guidance ,notwithstanding sections #cgbi through #cgcc1 no action may be brought under section #cgcj based on a claim submitted or an overpayment retained with respect to a ,federal health care program-- 7#a7 in good faith reliance on erroneous information supplied by an agency 7or an agent thereof7 about matters of fact at issue2 7#b7 in good faith reliance on written statements of ,federal policy that affects the claim or overpayment that were provided by a ,federal agency 7or an agent thereof72 or 7#c7 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 submitted1 or of the person retaining the overpayment1 in which no findings were made that the claim or overpayment violated the regulations1 guidelines1 or instructions applicable to the ,federal health care program at issue in the claim or overpayment4 7e7 ,action for claims submitted by persons in substantial compliance with model compliance plan ,notwithstanding sections #cgbi through #cgcc1 no action may be brought under section #cgcj based on a claim submitted by or on behalf of a person1 or an overpayment retained1 with respect to a ,federal health care program if the claim is submitted1 or the overpayment retained1 in substantial compliance with a model compliance plan issued by the ,secretary of ,health and ,human ,services with respect to that ,federal health care program4 7f7 ,standard of proof ,in any action brought under section #cgcj with respect to a claim submitted1 or an overpayment retained1 with respect to a ,federal health care program1 section #cgca7;c7 shall be applied by substituting clear and convincing evidence for a preponderance of the evidence4 7g7 ,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 submitted1 or an overpayment retained1 with respect to a ,federal health care program under provisions of law other than section #cgbi4 7h7 ,definitions2 special rules ,for purposes of this section-- 7#a7 the term claim means a claim as defined in section #cgbi7;c72 7#b7 the term ,federal health care program means-- 7,a7 any plan or program that provides health care benefits1 whether directly1 through insurance1 or otherwise1 and that is funded directly1 in whole or in part1 by the ,united ,states ,government2 7,b7 any ,state health care program1 as defined in section #aabh7;h7 of the ,social ,security ,act2 or 7,c7 any qualifying health plan offered through an ,exchange established under1 or any other health plan established under1 the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh72 7#c7 the amount of damages alleged to have been sustained by the ,united ,states ,government with respect to a claim submitted by 7or on behalf of7 a person shall be treated as a material amount only if such amount exceeds a proportion 7specified in regulations promulgated by the ,secretary of ,health and ,human ,services in consultation with the ,secretary of ,defense7 of the total of the amounts for which claims were submitted by 7or on behalf of7 such person-- 7,a7 to the same ,federal health care program1 and 7,b7 for the same calendar year1 as the claim upon which an action under section #cgcj is based2 7#d7 in determining whether an amount of damages is a material amount under paragraph 7#c71 with respect to a person-- 7,a7 the amount of damages for more than #a 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 person2 and 7,b7 if damages for more than #a claim are aggregated in accordance with subparagraph 7,a71 the proportion referred to in paragraph 7#c7 shall be determined by comparing the amount of such aggregate damages to the total of the amounts for which claims were submitted by 7or on behalf of7 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 submitted2 7#e7 the term intermediary means1 with respect to a ,federal health care program1 a contractor with an agency1 a ,state1 or other entity that is engaged in the implementation of that ,federal health care program2 and 7#f7 the term ,state means each of the several ,states1 the ,district of ,columbia1 and any territory or possession of the ,united ,states4 4 7b7 ,conforming amendment ,the table of sections for chapter #cg of title #ca1 ,united ,states ,code1 is amended by adding at the end the following new item3 #cgcd4 ,rules for certain actions based on health care claims4 4 7c7 ,effective date ,the amendments made by this section shall apply to any action or investigation under sections #cgbi through #cgcc of title #ca1 ,united ,states ,code1 that is pending on1 or commenced on or after1 the date of the enactment of this ,act4