#aafth ,,congress #ast ,session ,h4 ,r4 #ihg ,,an ,,act ,to amend the ,patient ,protection and ,affordable ,care ,act to provide for ,federal ,exchange outreach and educational activities4 #a4 ,short title ,this ,act may be cited as the ,strengthening ,health ,care and ,lowering ,prescription ,drug ,costs ,act4 #b4 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,title ,i--,lowering ,prescription ,drug ,costs ,subtitle ,a--,bringing low-,cost options and competition while keeping incentives for new generics ,sec4 #aja4 ,change conditions of first generic exclusivity to spur access and competition4 ,subtitle ,b--,protecting consumer access to generic drugs ,sec4 #aaa4 ,unlawful agreements4 ,sec4 #aab4 ,notice and certification of agreements4 ,sec4 #aac4 ,forfeiture of #ahj-;day exclusivity period4 ,sec4 #aad4 ,commission litigation authority4 ,sec4 #aae4 ,statute of limitations4 ,subtitle ,c--,creating and restoring equal access to equivalent samples ,sec4 #aba4 ,actions for delays of generic drugs and biosimilar biological products4 ,sec4 #abb4 ,,rems approval process for subsequent filers4 ,sec4 #abc4 ,rule of construction4 ,subtitle ,d--,study on role of ,federal assistance in drug development ,sec4 #aca4 ,study on role of ,federal assistance in drug development4 ,subtitle ,e--,pharmacy ,school ,outreach ,sec4 #ada4 ,pharmacy school outreach4 ,subtitle ,f--,reports ,sec4 #aea4 ,effects of increases in prescription drug price4 ,title ,,ii--,health ,insurance ,market ,stabilization ,sec4 #bja4 ,preserving ,state option to implement health care marketplaces4 ,sec4 #bjb4 ,providing for additional requirements with respect to the navigator program4 ,sec4 #bjc4 ,federal ,exchange outreach and educational activities and annual enrollment targets4 ,sec4 #bjd4 ,short-term limited duration insurance rule prohibition4 ,sec4 #bje4 ,protection of health insurance coverage in certain ,exchanges4 ,sec4 #bjf4 ,sense of ,congress relating to the practice of silver loading4 ,sec4 #bjg4 ,consumer outreach1 education1 and assistance4 ,sec4 #bjh4 ,,gao report4 ,sec4 #bji4 ,report on the effects of website maintenance during open enrollment4 ,title ,,iii--,budgetary ,effects ,sec4 #cja4 ,determination of budgetary effects4 ,i ,lowering ,prescription ,drug ,costs ,a ,bringing low-,cost options and competition while keeping incentives for new generics #aja4 ,change conditions of first generic exclusivity to spur access and competition ,section #eje7;j77#e77;,b77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 is amended-- 7#a7 in subclause 7,i71 by striking #ahj days after and all that follows through the period at the end and inserting the following3 #ahj days after the earlier of-- 7aa7 the date of the first commercial marketing of the drug 7including the commercial marketing of the listed drug7 by any first applicant2 or 7bb7 the applicable date specified in subclause 7,,iii74 2 and 7#b7 by adding at the end the following new subclause3 7,,iii7 ,applicable date ,the applicable date specified in this subclause1 with respect to an application for a drug described in subclause 7,i71 is the date on which each of the following conditions is first met3 7aa7 ,the approval of such an application could be made effective1 but for the eligibility of a first applicant for #ahj-;day exclusivity under this clause4 7bb7 ,at least #cj months have passed since the date of submission of an application for the drug by at least one first applicant4 7cc7 ,approval of an application for the drug submitted by at least one first applicant is not precluded under clause 7iii74 7dd7 ,no application for the drug submitted by any first applicant is approved at the time the conditions under items 7aa71 7bb71 and 7cc7 are all met1 regardless of whether such an application is subsequently approved4 4 ,b ,protecting consumer access to generic drugs #aaa4 ,unlawful agreements 7a7 ,agreements prohibited ,subject to subsections 7b7 and 7c71 it shall be unlawful for an ,,nda or ,,bla holder and a subsequent filer 7or for two subsequent filers7 to enter into1 or carry out1 an agreement resolving or settling a covered patent infringement claim on a final or interim basis if under such agreement-- 7#a7 a subsequent filer directly or indirectly receives from such holder 7or in the case of such an agreement between two subsequent filers1 the other subsequent filer7 anything of value1 including a license2 and 7#b7 the subsequent filer agrees to limit or forego research on1 or development1 manufacturing1 marketing1 or sales1 for any period of time1 of the covered product that is the subject of the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h74 7b7 ,exclusion ,it shall not be unlawful under subsection 7a7 if a party to an agreement described in such subsection demonstrates by clear and convincing evidence that the value described in subsection 7a77#a7 is compensation solely for other goods or services that the subsequent filer has promised to provide4 7c7 ,limitation ,nothing in this section shall prohibit an agreement resolving or settling a covered patent infringement claim in which the consideration granted by the ,,nda or ,,bla holder to the subsequent filer 7or from one subsequent filer to another7 as part of the resolution or settlement includes only one or more of the following3 7#a7 ,the right to market the covered product that is the subject of the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h7 in the ,united ,states before the expiration of-- 7,a7 any patent that is the basis of the covered patent infringement claim2 or 7,b7 any patent right or other statutory exclusivity that would prevent the marketing of such covered product4 7#b7 ,a payment for reasonable litigation expenses not to exceed #g4e million in the aggregate4 7#c7 ,a covenant not to sue on any claim that such covered product infringes a patent4 7d7 ,enforcement by ,federal ,trade ,commission 7#a7 ,general application ,the requirements of this section apply1 according to their terms1 to an ,,nda or ,,bla holder or subsequent filer that is-- 7,a7 a person1 partnership1 or corporation over which the ,commission has authority pursuant to section #e7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#b772 or 7,b7 a person1 partnership1 or corporation over which the ,commission would have authority pursuant to such section but for the fact that such person1 partnership1 or corporation is not organized to carry on business for its own profit or that of its members4 7#b7 ,unfair or deceptive acts or practices enforcement authority 7,a7 ,in general ,a violation of this section shall be treated as an unfair or deceptive act or practice in violation of section #e7;a77#a7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a774 7,b7 ,powers of ,commission ,except as provided in subparagraph 7,c7 and paragraphs 7#a77;,b7 and 7#c7-- 7i7 the ,commission shall enforce this section in the same manner1 by the same means1 and with the same jurisdiction1 powers1 and duties as though all applicable terms and provisions of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 were incorporated into and made a part of this section2 and 7ii7 any ,,nda or ,,bla holder or subsequent filer that violates this section shall be subject to the penalties and entitled to the privileges and immunities provided in the ,federal ,trade ,commission ,act4 7,c7 ,judicial review ,in the case of a cease and desist order issued by the ,commission under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of this section1 a party to such order may obtain judicial review of such order as provided in such section #e1 except that-- 7i7 such review may only be obtained in-- 7,i7 the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit2 7,,ii7 the ,united ,states ,court of ,appeals for the circuit in which the ultimate parent entity1 as defined in section #hja4a7;a77#c7 of title #af1 ,code of ,federal ,regulations1 or any successor thereto1 of the ,,nda or ,,bla holder 7if any such holder is a party to such order7 is incorporated as of the date that the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h7 or an approved application that is deemed to be a license for a biological product under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh2 #abd ,stat4 #hag7 is submitted to the ,commissioner of ,food and ,drugs2 or 7,,iii7 the ,united ,states ,court of ,appeals for the circuit in which the ultimate parent entity1 as so defined1 of any subsequent filer that is a party to such order is incorporated as of the date that the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h7 is submitted to the ,commissioner of ,food and ,drugs2 and 7ii7 the petition for review shall be filed in the court not later than #cj days after such order is served on the party seeking review4 7#c7 ,additional enforcement authority 7,a7 ,civil penalty ,the ,commission may commence a civil action to recover a civil penalty in a district court of the ,united ,states against any ,,nda or ,,bla holder or subsequent filer that violates this section4 7,b7 ,special rule for recovery of penalty if cease and desist order issued 7i7 ,in general ,if the ,commission has issued a cease and desist order in a proceeding under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of this section-- 7,i7 the ,commission may commence a civil action under subparagraph 7,a7 to recover a civil penalty against any party to such order at any time before the expiration of the #a-year period beginning on the date on which such order becomes final under section #e7;g7 of such ,act 7#ae ,u4,s4,c4 #de7;g772 and 7,,ii7 in such civil action1 the findings of the ,commission as to the material facts in such proceeding shall be conclusive1 unless-- 7aa7 the terms of such order expressly provide that the ,commission's findings shall not be conclusive2 or 7bb7 such order became final by reason of section #e7;g77#a7 of such ,act 7#ae ,u4,s4,c4 #de7;g77#a771 in which case such findings shall be conclusive if supported by evidence4 7ii7 ,relationship to penalty for violation of an order ,the penalty provided in clause 7i7 for violation of this section is separate from and in addition to any penalty that may be incurred for violation of an order of the ,commission under section #e7l7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7l774 7,c7 ,amount of penalty 7i7 ,in general ,the amount of a civil penalty imposed in a civil action under subparagraph 7,a7 on a party to an agreement described in subsection 7a7 shall be sufficient to deter violations of this section1 but in no event greater than-- 7,i7 if such party is the ,,nda or ,,bla holder 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who gave the value described in subsection 7a77#a771 the greater of-- 7aa7 three times the value received by such ,,nda or ,,bla holder 7or by such subsequent filer7 that is reasonably attributable to the violation of this section2 or 7bb7 three times the value given to the subsequent filer 7or to the other subsequent filer7 reasonably attributable to the violation of this section2 and 7,,ii7 if such party is the subsequent filer 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who received the value described in subsection 7a77#a771 #c times the value received by such subsequent filer that is reasonably attributable to the violation of this section4 7ii7 ,factors for consideration ,in determining such amount1 the court shall take into account-- 7,i7 the nature1 circumstances1 extent1 and gravity of the violation2 7,,ii7 with respect to the violator1 the degree of culpability1 any history of violations1 the ability to pay1 any effect on the ability to continue doing business1 profits earned by the ,,nda or ,,bla holder 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who gave the value described in subsection 7a77#a771 compensation received by the subsequent filer 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who received the value described in subsection 7a77#a771 and the amount of commerce affected2 and 7,,iii7 other matters that justice requires4 7,d7 ,injunctions and other equitable relief ,in a civil action under subparagraph 7,a71 the ,united ,states district courts are empowered to grant mandatory injunctions and such other and further equitable relief as they deem appropriate4 7#d7 ,remedies in addition ,remedies provided in this subsection are in addition to1 and not in lieu of1 any other remedy provided by ,federal law4 7#e7 ,preservation of authority of ,commission ,nothing in this section shall be construed to affect any authority of the ,commission under any other provision of law4 7e7 ,federal ,trade ,commission rulemaking ,the ,commission may1 in its discretion1 by rule promulgated under section #eec of title #e1 ,united ,states ,code1 exempt from this section certain agreements described in subsection 7a7 if the ,commission finds such agreements to be in furtherance of market competition and for the benefit of consumers4 7f7 ,antitrust laws ,nothing in this section shall modify1 impair1 limit1 or supersede the applicability of the antitrust laws as defined in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 and of section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section #e applies to unfair methods of competition4 ,nothing in this section shall modify1 impair1 limit1 or supersede the right of a subsequent filer to assert claims or counterclaims against any person1 under the antitrust laws or other laws relating to unfair competition4 7g7 ,definitions ,in this section3 7#a7 ,agreement resolving or settling a covered patent infringement claim ,the term agreement resolving or settling a covered patent infringement claim means any agreement that-- 7,a7 resolves or settles a covered patent infringement claim2 or 7,b7 is contingent upon1 provides for a contingent condition for1 or is otherwise related to the resolution or settlement of a covered patent infringement claim4 7#b7 ,commission ,the term ,commission means the ,federal ,trade ,commission4 7#c7 ,covered patent infringement claim ,the term covered patent infringement claim means an allegation made by the ,,nda or ,,bla holder to a subsequent filer 7or1 in the case of an agreement between two subsequent filers1 by one subsequent filer to another71 whether or not included in a complaint filed with a court of law1 that-- 7,a7 the submission of the application described in subparagraph 7,a7 or 7,b7 of paragraph 7#i71 or the manufacture1 use1 offering for sale1 sale1 or importation into the ,united ,states of a covered product that is the subject of such an application-- 7i7 in the case of an agreement between an ,,nda or ,,bla holder and a subsequent filer1 infringes any patent owned by1 or exclusively licensed to1 the ,,nda or ,,bla holder of the covered product2 or 7ii7 in the case of an agreement between two subsequent filers1 infringes any patent owned by the subsequent filer2 or 7,b7 in the case of an agreement between an ,,nda or ,,bla holder and a subsequent filer1 the covered product to be manufactured under such application uses a covered product as claimed in a published patent application4 7#d7 ,covered product ,the term covered product means a drug 7as defined in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g7771 including a biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i774 7#e7 ,,nda or ,,bla holder ,the term ,,nda or ,,bla holder means-- 7,a7 the holder of-- 7i7 an approved new drug application filed under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 for a covered product2 or 7ii7 a biologics license application filed under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 with respect to a biological product2 7,b7 a person owning or controlling enforcement of the patent on-- 7i7 the list published under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 in connection with the application described in subparagraph 7,a77i72 or 7ii7 any list published under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 comprised of patents associated with biologics license applications filed under section #cea7;a7 of such ,act 7#db ,u4,s4,c4 #bfb7;a772 or 7,c7 the predecessors1 subsidiaries1 divisions1 groups1 and affiliates controlled by1 controlling1 or under common control with any entity described in subparagraph 7,a7 or 7,b7 7such control to be presumed by direct or indirect share ownership of #ej percent or greater71 as well as the licensees1 licensors1 successors1 and assigns of each of the entities4 7#f7 ,patent ,the term patent means a patent issued by the ,united ,states ,patent and ,trademark ,office4 7#g7 ,statutory exclusivity ,the term statutory exclusivity means those prohibitions on the submission or approval of drug applications under clauses 7ii7 through 7iv7 of section #eje7;c77#c77;,e7 7#e- and #c-year exclusivity71 clauses 7ii7 through 7iv7 of section #eje7;j77#e77;,f7 7#e-year and #c-year exclusivity71 section #eje7;j77#e77;,b77iv7 7#ahj-;day exclusivity71 section #ebg 7orphan drug exclusivity71 section #eje;,a 7pediatric exclusivity71 or section #eje;,e 7qualified infectious disease product exclusivity7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e71 #cee7;j77#e77;,b77iv71 #cee7;j77#e77;,f71 #cfj;cc1 #cee;a1 #cee;f71 or prohibitions on the submission or licensing of biologics license applications under section #cea7k77#f7 7interchangeable biological product exclusivity7 or section #cea7k77#g7 7biological product reference product exclusivity7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#f71 7#g774 7#h7 ,subsequent filer ,the term subsequent filer means-- 7,a7 in the case of a drug1 a party that owns or controls an abbreviated new drug application submitted pursuant to section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or a new drug application submitted pursuant to section #eje7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba,u4,s4,c4 #cee7;b77#b77 and filed under section #eje7;b77#a7 of such ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or has the exclusive rights to distribute the covered product that is the subject of such application2 or 7,b7 in the case of a biological product1 a party that owns or controls an application filed with the ,food and ,drug ,administration under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 or has the exclusive rights to distribute the biological product that is the subject of such application4 7h7 ,effective date ,this section applies with respect to agreements described in subsection 7a7 entered into on or after the date of the enactment of this ,act4 #aab4 ,notice and certification of agreements 7a7 ,notice of all agreements ,section #aaaa7g7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7#ba ,u4,s4,c4 #cee note7 is amended by inserting or the owner of a patent for which a claim of infringement could reasonably be asserted against any person for making1 using1 offering to sell1 selling1 or importing into the ,united ,states a biological product that is the subject of a biosimilar biological product application before the period at the end4 7b7 ,certification of agreements ,section #aaab of such ,act 7#ba ,u4,s4,c4 #cee note7 is amended by adding at the end the following3 7d7 ,certification ,the ,chief ,executive ,officer or the company official responsible for negotiating any agreement under subsection 7a7 or 7b7 that is required to be filed under subsection 7c7 shall1 within #cj days of such filing1 execute and file with the ,assistant ,attorney ,general and the ,commission a certification as follows3 ,i declare that the following is true1 correct1 and complete to the best of my knowledge3 ,the materials filed with the ,federal ,trade ,commission and the ,department of ,justice under section #aaab of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc1 with respect to the agreement referenced in this certification-- 7#a7 represent the complete1 final1 and exclusive agreement between the parties2 7#b7 include any ancillary agreements that are contingent upon1 provide a contingent condition for1 were entered into within #cj days of1 or are otherwise related to1 the referenced agreement2 and 7#c7 include written descriptions of any oral agreements1 representations1 commitments1 or promises between the parties that are responsive to subsection 7a7 or 7b7 of such section #aaab and have not been reduced to writing4 4 4 #aac4 ,forfeiture of #ahj-;day exclusivity period ,section #eje7;j77#e77;,d77i77,v7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is amended by inserting section #aaa of the ,strengthening ,health ,care and ,lowering ,prescription ,drug ,costs ,act or after that the agreement has violated4 #aad4 ,commission litigation authority ,section #af7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #ef7;a77#b77 is amended-- 7#a7 in subparagraph 7,d71 by striking or after the semicolon2 7#b7 in subparagraph 7,e71 by inserting or after the semicolon2 and 7#c7 by inserting after subparagraph 7,e7 the following3 7,f7 under section #aaa7;d77#c77;,a7 of the ,strengthening ,health ,care and ,lowering ,prescription ,drug ,costs ,act2 4 #aae4 ,statute of limitations 7a7 ,in general ,except as provided in subsection 7b71 the ,commission shall commence any administrative proceeding or civil action to enforce section #aaa of this ,act not later than #f years after the date on which the parties to the agreement file the ,notice of ,agreement as provided by section #aaab7;c77#b7 and 7d7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7#ba ,u4,s4,c4 #cee note74 7b7 ,civil action after issuance of cease and desist order ,if the ,commission has issued a cease and desist order under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of section #aaa of this ,act and the proceeding for the issuance of such order was commenced within the period required by subsection 7a7 of this section1 such subsection does not prohibit the commencement1 after such period1 of a civil action under section #aaa7;d77#c77;,a7 against a party to such order or a civil action under subsection 7l7 of such section #e for violation of such order4 ,c ,creating and restoring equal access to equivalent samples #aba4 ,actions for delays of generic drugs and biosimilar biological products 7a7 ,definitions ,in this section-- 7#a7 the term commercially reasonable1 market-based terms means-- 7,a7 a nondiscriminatory price for the sale of the covered product at or below1 but not greater than1 the most recent wholesale acquisition cost for the drug1 as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 7,b7 a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection 7b77#b77;,a77iv72 and 7,c7 no additional conditions are imposed on the sale of the covered product2 7#b7 the term covered product-- 7,a7 means-- 7i7 any drug approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any combination of a drug or biological product described in clause 7i72 or 7iii7 when reasonably necessary to support approval of an application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as applicable1 or otherwise meet the requirements for approval under either such section1 any product1 including any device1 that is marketed or intended for use with such a drug or biological product2 and 7,b7 does not include any drug or biological product that appears on the drug shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless-- 7i7 the drug or biological product has been on the drug shortage list in effect under such section #ejf;,e continuously for more than #f months2 or 7ii7 the ,secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage4 7#c7 the term device has the meaning given the term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#d7 the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or for licensing pursuant to an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 7#e7 the term license holder means the holder of an application approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or the holder of a license under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for a covered product2 7#f7 the term ,,rems means a risk evaluation and mitigation strategy under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 the term ,,rems with ,,etasu means a ,,rems that contains elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 7#h7 the term ,secretary means the ,secretary of ,health and ,human ,services2 7#i7 the term single1 shared system of elements to assure safe use means a single1 shared system of elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 and 7#aj7 the term sufficient quantities means an amount of a covered product that the eligible product developer determines allows it to-- 7,a7 conduct testing to support an application under-- 7i7 subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 and 7,b7 fulfill any regulatory requirements relating to approval of such an application4 7b7 ,civil action for failure ,to provide sufficient quantities of a covered product 7#a7 ,in general ,an eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the ,united ,states alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable1 market-based terms4 7#b7 ,elements 7,a7 ,in general ,to prevail in a civil action brought under paragraph 7#a71 an eligible product developer shall prove1 by a preponderance of the evidence-- 7i7 that-- 7,i7 the covered product is not subject to a ,,rems with ,,etasu2 or 7,,ii7 if the covered product is subject to a ,,rems with ,,etasu-- 7aa7 the eligible product developer has obtained a covered product authorization from the ,secretary in accordance with subparagraph 7,b72 and 7bb7 the eligible product developer has provided a copy of the covered product authorization to the license holder2 7ii7 that1 as of the date on which the civil action is filed1 the product developer has not obtained sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7iii7 that the eligible product developer has submitted a written request to purchase sufficient quantities of the covered product to the license holder and such request-- 7,i7 was sent to a named corporate officer of the license holder2 7,,ii7 was made by certified or registered mail with return receipt requested2 7,,iii7 specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered product to the eligible product developer and a means for electronic and written communications with that individual2 and 7,,iv7 specified an address to which the covered product was to be shipped upon reaching an agreement to transfer the covered product2 and 7iv7 that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable1 market-based terms-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ca days after the date on which the license holder received the request for the covered product2 and 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by #ca days after the later of-- 7aa7 the date on which the license holder received the request for the covered product2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with subparagraph 7,b74 7,b7 ,authorization for covered product subject to a ,,rems with ,,etasu 7i7 ,request ,an eligible product developer may submit to the ,secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu4 7ii7 ,authorization ,not later than #abj days after the date on which a request under clause 7i7 is received1 the ,secretary shall1 by written notice1 authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu for purposes of-- 7,i7 development and testing that does not involve human clinical trials1 if the eligible product developer has agreed to comply with any conditions the ,secretary determines necessary2 or 7,,ii7 development and testing that involves human clinical trials1 if the eligible product developer has-- 7aa7 7,,aa7 submitted protocols1 informed consent documents1 and informational materials for testing that include protections that provide safety protections comparable to those provided by the ,,rems for the covered product2 or 7,,bb7 otherwise satisfied the ,secretary that such protections will be provided2 and 7bb7 met any other requirements the ,secretary may establish4 7iii7 ,notice ,a covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the ,,rems for the covered product4 7#c7 ,affirmative defense ,in a civil action brought under paragraph 7#a71 it shall be an affirmative defense1 on which the defendant has the burden of persuasion by a preponderance of the evidence-- 7,a7 that1 on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-- 7i7 neither the license holder nor any of its agents1 wholesalers1 or distributors was engaged in the manufacturing or commercial marketing of the covered product2 and 7ii7 neither the license holder nor any of its agents1 wholesalers1 or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable1 market-based terms2 7,b7 that-- 7i7 the license holder sells the covered product through agents1 distributors1 or wholesalers2 7ii7 the license holder has placed no restrictions1 explicit or implicit1 on its agents1 distributors1 or wholesalers to sell covered products to eligible product developers2 and 7iii7 the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable1 market-based terms from the agents1 distributors1 or wholesalers of the license holder2 or 7,c7 that the license holder made an offer to the individual specified pursuant to paragraph 7#b77;,a77iii77,,iii71 by a means of communication 7electronic1 written1 or both7 specified pursuant to such paragraph1 to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms-- 7i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ad days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #g days after the date on which the eligible product developer received such offer from the license holder2 or 7ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by the date that is #bj days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #aj days after the date on which the eligible product developer received such offer from the license holder4 7#d7 ,remedies 7,a7 ,in general ,if an eligible product developer prevails in a civil action brought under paragraph 7#a71 the court shall-- 7i7 order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7ii7 award to the eligible product developer reasonable attorney's fees and costs of the civil action2 and 7iii7 award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable1 market-based terms1 if the court finds1 by a preponderance of the evidence-- 7,i7 that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification2 or 7,,ii7 that the license holder failed to comply with an order issued under clause 7i74 7,b7 ,maximum monetary amount ,a monetary amount awarded under subparagraph 7,a77iii7 shall not be greater than the revenue that the license holder earned on the covered product during the period-- 7i7 beginning on-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 the date that is #ca days after the date on which the license holder received the request2 or 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 the date that is #ca days after the later of-- 7aa7 the date on which the license holder received the request2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with paragraph 7#b77;,b72 and 7ii7 ending on the date on which the eligible product developer received sufficient quantities of the covered product4 7,c7 ,avoidance of delay ,the court may issue an order under subparagraph 7,a77i7 before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause 7ii7 or 7iii7 of subparagraph 7,a71 or the amount of any such award4 7c7 ,limitation of liability ,a license holder for a covered product shall not be liable for any claim under ,federal1 ,state1 or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section1 including transportation1 handling1 use1 or disposal of the covered product by the eligible product developer4 7d7 ,no violation of ,,rems ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is amended by adding at the end the following new subsection3 7l7 ,provision of samples not a violation of strategy ,the provision of samples of a covered product to an eligible product developer 7as those terms are defined in section #aba7;a7 of the ,strengthening ,health ,care and ,lowering ,prescription ,drug ,costs ,act7 shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug4 4 7e7 ,rule of construction 7#a7 ,definition ,in this subsection1 the term antitrust laws-- 7,a7 has the meaning given the term in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab72 and 7,b7 includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section applies to unfair methods of competition4 7#b7 ,antitrust laws ,nothing in this section shall be construed to limit the operation of any provision of the antitrust laws4 #abb4 ,,rems approval process for subsequent filers ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 as amended by section #aba1 is further amended-- 7#a7 in subsection 7g77#d77;,b7-- 7,a7 in clause 7i7 by striking or after the semicolon2 7,b7 in clause 7ii7 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following3 7iii7 accommodate different1 comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section #eje7;j71 and the applicable listed drug4 2 7#b7 in subsection 7i77#a71 by striking subparagraph 7,c7 and inserting the following3 7,c7 7i7 ,elements to assure safe use1 if required under subsection 7f7 for the listed drug1 which1 subject to clause 7ii71 for a drug that is the subject of an application under section #eje7;j7 may use-- 7,i7 a single1 shared system with the listed drug under subsection 7f72 or 7,,ii7 a different1 comparable aspect of the elements to assure safe use under subsection 7f74 7ii7 ,the ,secretary may require a drug that is the subject of an application under section #eje7;j7 and the listed drug to use a single1 shared system under subsection 7f71 if the ,secretary determines that no different1 comparable aspect of the elements to assure safe use could satisfy the requirements of subsection 7f74 2 7#c7 in subsection 7i71 by adding at the end the following3 7#c7 ,shared ,,rems ,if the ,secretary approves1 in accordance with paragraph 7#a77;,c77i77,,ii71 a different1 comparable aspect of the elements to assure safe use under subsection 7f7 for a drug that is the subject of an abbreviated new drug application under section #eje7;j71 the ,secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section #eje7;j7 or #eje7;b7 that references the same listed drug4 2 and 7#d7 by adding at the end the following3 7m7 ,separate ,,rems ,when used in this section1 the terms different1 comparable aspect of the elements to assure safe use or different1 comparable approved risk evaluation and mitigation strategies means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section #eje7;j7 that uses different methods or operational means than the strategy required under subsection 7a7 for the applicable listed drug1 or other application under section #eje7;j7 with the same such listed drug1 but achieves the same level of safety as such strategy4 4 #abc4 ,rule of construction 7a7 ,in general ,nothing in this subtitle1 the amendments made by this subtitle1 or in section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 shall be construed as-- 7#a7 prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this subtitle2 or 7#b7 in any way negating the applicability of a ,,rems with ,,etasu1 as otherwise required under such section #eje-a1 with respect to such covered product4 7b7 ,definitions ,in this section1 the terms covered product1 eligible product developer1 license holder1 and ,,rems with ,,etasu have the meanings given such terms in section #aba7;a74 ,d ,study on role of ,federal assistance in drug development #aca4 ,study on role of ,federal assistance in drug development 7a7 ,in general ,not later than #b years after the date of the enactment of this ,act1 the ,secretary of the ,health and ,human ,services shall enter into a contract with the ,national ,academy of ,medicine to conduct a study on1 and submit to ,congress a report on1 the following3 7#a7 ,the percentage of drugs developed in the ,united ,states using at least some amount of ,federal funding from any ,federal source4 7#b7 ,the average cost incurred by a drug developer to develop a drug4 7#c7 ,the average amount of revenue and profits made by drug developers from the sales of drugs4 7#d7 ,the percentage of such revenue and profits that are reinvested into research and development of new drugs4 7#e7 ,the appropriate percentage1 if any1 of such revenue and profits the ,secretary1 in consultation with the ,national ,academy of ,medicine1 recommends should be returned to ,federal entities for ,federal funding used in the development of the drugs involved4 7b7 ,enforcement ,a drug developer shall1 as a condition of receipt of any ,federal funding for the development of drugs1 comply with any request for the data necessary to perform the study under subsection 7a74 7c7 ,confidentiality ,this section does not authorize the disclosure of any trade secret1 confidential commercial or financial information1 or other matter listed in section #eeb7;b7 of title #e1 ,united ,states ,code4 7d7 ,definitions ,in this section3 7#a7 ,the term drug has the meaning given such term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#b7 ,the term drug developer means an entity that submitted1 and received approval of1 an application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 ,e ,pharmacy ,school ,outreach #ada4 ,pharmacy school outreach ,the ,secretary of ,health and ,human ,services and the ,secretary of ,education shall make every effort necessary to ensure appropriate outreach to institutions of higher education to ensure that students and faculty at schools of pharmacy are provided with materials regarding generic drugs and biosimilar biological products1 including materials on-- 7#a7 how generic drugs and biosimilar biological products are equivalent or similar to brand-name drugs2 7#b7 the approval process at the ,food and ,drug ,administration for generic drugs and biosimilar biological products2 7#c7 how to make consumers aware of the availability of generic drugs and biosimilar biological products2 7#d7 requirements for substituting generic drugs and biosimliar biological products in place of corresponding drugs products2 and 7#e7 the impacts of generic drugs and biosimilar biological products on consumer costs4 ,f ,reports #aea4 ,effects of increases in prescription drug price ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit a report to the ,congress on the extent to which increases in prescription drug prices may have caused ,medicare beneficiaries to forego recommended treatment1 including failing to fill prescriptions4 ,,ii ,health ,insurance ,market ,stabilization #bja4 ,preserving ,state option to implement health care marketplaces 7a7 ,in general ,section #acaa of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#d77;,b71 by striking under this subsection and inserting under this paragraph or paragraph 7#a72 and 7,b7 by adding at the end the following new paragraph3 7#f7 ,additional planning and establishment grants 7,a7 ,in general ,there shall be appropriated to the ,secretary1 out of any moneys in the ,treasury not otherwise appropriated1 #bjj million to award grants to eligible ,states for the uses described in paragraph 7#c74 7,b7 ,duration and renewability ,a grant awarded under subparagraph 7,a7 shall be for a period of #b years and may not be renewed4 7,c7 ,limitation ,a grant may not be awarded under subparagraph 7,a7 after ,december #ca1 #bjbc4 7,d7 ,eligible ,state defined ,for purposes of this paragraph1 the term eligible ,state means a ,state that1 as of the date of the enactment of this paragraph1 is not operating an ,exchange 7other than an ,exchange described in section #aee4bjj7;f7 of title #de1 ,code of ,federal ,regulations74 2 and 7#b7 in subsection 7d77#e77;,a7-- 7,a7 by striking operations4--,in establishing an ,exchange under this section and inserting operations4-- 7i7 ,in general ,in establishing an ,exchange under this section 7other than in establishing an ,exchange pursuant to a grant awarded under subsection 7a77#f77 2 and 7,b7 by adding at the end the following3 7ii7 ,additional planning and establishment grants ,in establishing an ,exchange pursuant to a grant awarded under subsection 7a77#f71 the ,state shall ensure that such ,exchange is self-sustaining beginning on ,january #a1 #bjbe1 including allowing the ,exchange to charge assessments or user fees to participating health insurance issuers1 or to otherwise generate funding1 to support its operations4 4 7b7 ,clarification regarding failure to establish ,exchange or implement requirements ,section #acba7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjda7;c77 is amended-- 7#a7 in paragraph 7#a71 by striking ,if and inserting ,subject to paragraph 7#c71 if2 and 7#b7 by adding at the end the following new paragraph3 7#c7 ,clarification ,this subsection shall not apply in the case of a ,state that elects to apply the requirements described in subsection 7a7 and satisfies the requirement described in subsection 7b7 on or after ,january #a1 #bjad4 4 #bjb4 ,providing for additional requirements with respect to the navigator program 7a7 ,in general ,section #acaa7;i7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;i77 is amended-- 7#a7 in paragraph 7#b71 by adding at the end the following new subparagraph3 7,c7 ,selection of recipients ,in the case of an ,exchange established and operated by the ,secretary within a ,state pursuant to section #acba7;c71 in awarding grants under paragraph 7#a71 the ,exchange shall-- 7i7 select entities to receive such grants based on an entity's demonstrated capacity to carry out each of the duties specified in paragraph 7#c72 7ii7 not take into account whether or not the entity has demonstrated how the entity will provide information to individuals relating to group health plans offered by a group or association of employers described in section #beaj4c-e7;b7 of title #bi1 ,code of ,federal ,regulations 7or any successor regulation71 or short-term limited duration insurance 7as defined by the ,secretary for purposes of section #bgia7;b77#e7 of the ,public ,health ,service ,act72 and 7iii7 ensure that1 each year1 the ,exchange awards such a grant to-- 7,i7 at least one entity described in this paragraph that is a community and consumer-focused nonprofit group2 and 7,,ii7 at least one entity described in subparagraph 7,b71 which may include another community and consumer-focused nonprofit group in addition to any such group awarded a grant pursuant to subclause 7,i74 ,in awarding such grants1 an ,exchange may consider an entity's record with respect to waste1 fraud1 and abuse for purposes of maintaining the integrity of such ,exchange4 4 7#b7 in paragraph 7#c7-- 7,a7 by amending subparagraph 7,c7 to read as follows3 7,c7 facilitate enrollment1 including with respect to individuals with limited ,english proficiency and individuals with chronic illnesses1 in qualified health plans1 ,state medicaid plans under title ,,xix of the ,social ,security ,act1 and ,state child health plans under title ,,xxi of such ,act2 2 7,b7 in subparagraph 7,d71 by striking and at the end2 7,c7 in subparagraph 7,e71 by striking the period at the end and inserting a semicolon2 7,d7 by inserting after subparagraph 7,e7 the following3 7,f7 conduct public education activities in plain language to raise awareness of the requirements of and the protections provided under-- 7i7 the essential health benefits package 7as defined in section #acjb7;a772 and 7ii7 section #bgbf of the ,public ,health ,service ,act 7relating to parity in mental health and substance use disorder benefits72 and 2 7,e7 by inserting after subparagraph 7,f7 7as added by subparagraph 7,d77 the following new subparagraph3 7,g7 provide referrals to community-based organizations that address social needs related to health outcomes4 2 and 7,f7 by adding at the end the following flush left sentence3 ,the duties specified in the preceding sentences may be carried out by such a navigator at any time during a year4 2 7#c7 in paragraph 7#d77;,a7-- 7,a7 in the matter preceding clause 7i71 by striking not2 7,b7 in clause 7i7-- 7i7 by inserting not before be2 and 7ii7 by striking 2 or and inserting a semicolon2 7,c7 in clause 7ii7-- 7i7 by inserting not before receive2 and 7ii7 by striking the period and inserting a semicolon2 and 7,d7 by adding at the end the following new clauses3 7iii7 maintain physical presence in the ,state of the ,exchange so as to allow in-person assistance to consumers2 7iv7 receive training on how to assist individuals with enrolling for medical assistance under ,state plans under the ,medicaid program under title ,,xix of the ,social ,security ,act or for child health assistance under ,state child health plans under title ,,xxi of such ,act2 and 7v7 receive opioid specific education and training that ensures the navigator can best educate individuals on qualified health plans offered through an ,exchange1 specifically coverage under such plans for opioid health care treatment4 2 and 7#d7 in paragraph 7#f7-- 7,a7 by striking ,funding4--,grants under and inserting ,funding4-- 7,a7 ,state ,exchanges ,subject to subparagraph 7,c71 grants under 2 and 7,b7 by adding at the end the following new subparagraphs3 7,b7 ,federal ,exchanges ,for purposes of carrying out this subsection1 with respect to an ,exchange established and operated by the ,secretary within a ,state pursuant to section #acba7;c71 the ,secretary shall obligate #ajj million out of amounts collected through the user fees on participating health insurance issuers pursuant to section #aef4ej of title #de1 ,code of ,federal ,regulations 7or any successor regulations7 for fiscal year #bjbj and each subsequent fiscal year4 ,such amount for a fiscal year shall remain available until expended4 7,c7 ,state ,exchanges ,for the purposes of carrying out this subsection1 with respect to an ,exchange operated by a ,state pursuant to this section1 there is authorized to be appropriated #be million for fiscal year #bjbj and each subsequent fiscal year4 ,each ,state receiving a grant pursuant to this subparagraph shall receive a grant in an amount that is not less than #a million4 4 7b7 ,study on effects of funding cuts ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall study the effects of funding cuts made for plan year #bjai with respect to the navigator program 7as described in section #acaa7;i7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;i777 and other education and outreach activities carried out with respect to ,exchanges established by the ,secretary of ,health and ,human ,services pursuant to section #acba7;c7 of such ,act4 ,such study shall describe the following3 7#a7 ,how such funding cuts negatively impacted the ability of entities under such program to conduct outreach activities and fulfill duties required under such section #acaa7;i74 7#b7 ,the overall effect on-- 7,a7 the number of individuals enrolled in health insurance coverage offered in the individual market for plan year #bjai2 and 7,b7 the costs of health insurance coverage offered in the individual market4 7c7 ,promote transparency and accountability in the administration's expenditures of exchange user fees ,for plan year #bjbj and each subsequent plan year1 not later than the date that is #c months after the end of such plan year1 the ,secretary of ,health and ,human ,services shall submit to the appropriate committees of ,congress and make available to the public an annual report on the expenditures by the ,department of ,health and ,human ,services of user fees collected pursuant to section #aef4ej of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 ,each such report for a plan year shall include a detailed accounting of the amount of such user fees collected during such plan year and of the amount of such expenditures used during such plan year for the federally facilitated ,exchange operated pursuant to section #acba7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjda7;c77 on outreach and enrollment activities1 navigators1 maintenance of ,healthcare4gov1 and operation of call centers4 7d7 ,effective date ,the amendments made by this section shall apply with respect to plan years beginning on or after ,january #a1 #bjbj4 #bjc4 ,federal ,exchange outreach and educational activities and annual enrollment targets 7a7 ,in general ,section #acba7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjda7;c771 as amended by section #bja7;b77#b71 is further amended by adding at the end the following new paragraphs3 7#d7 ,outreach and educational activities 7,a7 ,in general ,in the case of an ,exchange established or operated by the ,secretary within a ,state pursuant to this subsection1 the ,secretary shall carry out outreach and educational activities for purposes of informing individuals about qualified health plans offered through the ,exchange1 including by informing such individuals of the availability of coverage under such plans and financial assistance for coverage under such plans4 ,such outreach and educational activities shall be provided in a manner that is culturally and linguistically appropriate to the needs of the populations being served by the ,exchange 7including hard-to-reach populations1 such as racial and sexual minorities1 limited ,english proficient populations1 individuals residing in areas where the unemployment rates exceeds the national average unemployment rate1 individuals in rural areas1 veterans1 and young adults7 and shall be provided to populations residing in high health disparity areas 7as defined in subparagraph 7,e77 served by the ,exchange1 in addition to other populations served by the ,exchange4 7,b7 ,limitation on use of funds ,no funds appropriated under this paragraph shall be used for expenditures for promoting non-,,aca compliant health insurance coverage4 7,c7 ,non-aca compliant health insurance coverage ,for purposes of subparagraph 7,b73 7i7 ,the term non-,,aca compliant health insurance coverage means health insurance coverage1 or a group health plan1 that is not a qualified health plan4 7ii7 ,such term includes the following3 7,i7 ,an association health plan4 7,,ii7 ,short-term limited duration insurance4 7,d7 ,funding ,out of any funds in the ,treasury not otherwise appropriated1 there are hereby appropriated for fiscal year #bjbj and each subsequent fiscal year1 #ajj million to carry out this paragraph4 ,funds appropriated under this subparagraph shall remain available until expended4 7,e7 ,high health disparity area defined ,for purposes of subparagraph 7,a71 the term high health disparity area means a contiguous geographic area that-- 7i7 is located in one census tract or ,,zip code2 7ii7 has measurable and documented racial1 ethnic1 or geographic health disparities2 7iii7 has a low-income population1 as demonstrated by-- 7,i7 average income below #ach percent of the ,federal poverty line2 or 7,,ii7 a rate of participation in the special supplemental nutrition program under section #ag of the ,child ,nutrition ,act of #aiff 7#db ,u4,s4,c4 #aghf7 that is higher than the national average rate of participation in such program2 7iv7 has poor health outcomes1 as demonstrated by-- 7,i7 lower life expectancy than the national average2 or 7,,ii7 a higher percentage of instances of low birth weight than the national average2 and 7v7 is part of a ,metropolitan ,statistical ,area identified by the ,office of ,management and ,budget4 7#e7 ,annual enrollment targets ,for plan year #bjbj and each subsequent plan year1 in the case of an ,exchange established or operated by the ,secretary within a ,state pursuant to this subsection1 the ,secretary shall establish annual enrollment targets for such ,exchange for such year4 4 7b7 ,study and report ,not later than #cj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall release to ,congress all aggregated documents relating to studies and data sets that were created on or after ,january #a1 #bjad1 and related to marketing and outreach with respect to qualified health plans offered through ,exchanges under title ,i of the ,patient ,protection and ,affordable ,care ,act4 #bjd4 ,short-term limited duration insurance rule prohibition 7a7 ,findings ,congress finds the following3 7#a7 ,on ,august #c1 #bjah1 the ,administration issued a final rule entitled ,short-,term1 ,limited-,duration ,insurance 7#hc ,fed4 ,reg4 #chbab74 7#b7 ,the final rule dramatically expands the sale and marketing of insurance that-- 7,a7 may discriminate against individuals living with preexisting health conditions1 including children with complex medical needs and disabilities and their families2 7,b7 lacks important financial protections provided by the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh71 including the prohibition of annual and lifetime coverage limits and annual out-of-pocket limits1 that may increase the cost of treatment and cause financial hardship to those requiring medical care1 including children with complex medical needs and disabilities and their families2 and 7,c7 excludes coverage of essential health benefits including hospitalization1 prescription drugs1 and other lifesaving care4 7#c7 ,the implementation and enforcement of the final rule weakens critical protections for up to #acj million ,americans living with preexisting health conditions and may place a large financial burden on those who enroll in short-term limited-duration insurance1 which jeopardizes ,americans' access to quality1 affordable health insurance4 7b7 ,prohibition ,the ,secretary of ,health and ,human ,services1 the ,secretary of the ,treasury1 and the ,secretary of ,labor may not take any action to implement1 enforce1 or otherwise give effect to the rule entitled ,short-,term1 ,limited ,duration ,insurance 7#hc ,fed4 ,reg4 #chbab 7,august #c1 #bjah771 and the ,secretaries may not promulgate any substantially similar rule4 #bje4 ,protection of health insurance coverage in certain ,exchanges ,in the case of an ,exchange that the ,secretary of ,health and ,human ,services operates pursuant to section #acba7;c77#a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjda7;c77#a771 the ,secretary may not implement any process that would terminate the health insurance coverage of an enrollee solely because such enrollee did not actively enroll during the most recent open enrollment period4 #bjf4 ,sense of ,congress relating to the practice of silver loading ,it is the sense of ,congress that the ,secretary of ,health and ,human ,services should not take any action to prohibit or otherwise restrict the practice commonly known as silver loading 7as described in the rule entitled ,patient ,protection and ,affordable ,care ,act2 ,,hhs ,notice of ,benefit and ,payment ,parameters for #bjbj published on ,april #be1 #bjai 7#hd ,fed4 ,reg4 #agecc774 #bjg4 ,consumer outreach1 education1 and assistance 7a7 ,open enrollment reports ,for plan year #bjbj and each subsequent year1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in coordination with the ,secretary of the ,treasury and the ,secretary of ,labor1 shall issue biweekly public reports during the annual open enrollment period on the performance of the ,federal ,exchange4 ,each such report shall include a summary1 including information on a ,state-by-,state basis where available1 of-- 7#a7 the number of unique website visits2 7#b7 the number of individuals who create an account2 7#c7 the number of calls to the call center2 7#d7 the average wait time for callers contacting the call center2 7#e7 the number of individuals who enroll in a qualified health plan2 and 7#f7 the percentage of individuals who enroll in a qualified health plan through each of-- 7,a7 the website2 7,b7 the call center2 7,c7 navigators2 7,d7 agents and brokers2 7,e7 the enrollment assistant program2 7,f7 directly from issuers or web brokers2 and 7,g7 other means4 7b7 ,open ,enrollment ,after ,action ,report ,for plan year #bjbj and each subsequent year1 the ,secretary1 in coordination with the ,secretary of the ,treasury and the ,secretary of ,labor1 shall publish an after action report not later than #c months after the completion of the annual open enrollment period regarding the performance of the ,federal ,exchange for the applicable plan year4 ,each such report shall include a summary1 including information on a ,state-by-,state basis where available1 of-- 7#a7 the open enrollment data reported under subsection 7a7 for the entirety of the enrollment period2 and 7#b7 activities related to patient navigators described in section #acaa7;i7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;i771 including-- 7,a7 the performance objectives established by the ,secretary for such patient navigators2 7,b7 the number of consumers enrolled by such a patient navigator2 7,c7 an assessment of how such patient navigators have met established performance metrics1 including a detailed list of all patient navigators1 funding received by patient navigators1 and whether established performance objectives of patient navigators were met2 and 7,d7 with respect to the performance objectives described in subparagraph 7,a7-- 7i7 whether such objectives assess the full scope of patient navigator responsibilities1 including general education1 plan selection1 and determination of eligibility for tax credits1 cost-sharing reductions1 or other coverage2 7ii7 how the ,secretary worked with patient navigators to establish such objectives2 and 7iii7 how the ,secretary adjusted such objectives for case complexity and other contextual factors4 7c7 ,report on advertising and consumer outreach ,not later than #c months after the completion of the annual open enrollment period for the #bjbj plan year1 the ,secretary shall issue a report on advertising and outreach to consumers for the open enrollment period for the #bjbj plan year4 ,such report shall include a description of-- 7#a7 the division of spending on individual advertising platforms1 including television and radio advertisements and digital media1 to raise consumer awareness of open enrollment2 7#b7 the division of spending on individual outreach platforms1 including email and text messages1 to raise consumer awareness of open enrollment2 and 7#c7 whether the ,secretary conducted targeted outreach to specific demographic groups and geographic areas4 #bjh4 ,,gao report ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a study that analyzes the costs and benefits of the establishment of ,state-administered health insurance plans to be offered in the insurance market of such ,states that choose to administer and offer such a plan4 #bji4 ,report on the effects of website maintenance during open enrollment ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report examining whether the ,department of ,health and ,human ,services has been conducting maintenance on the website commonly referred to as ,healthcare4gov during annual open enrollment periods 7as described in section #acaa7;c77#f77;,b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;c77#f77;,b77 in such a manner so as to minimize any disruption to the use of such website resulting from such maintenance4 ,,iii ,budgetary ,effects #cja4 ,determination of budgetary effects ,the budgetary effects of this ,act1 for the purpose of complying with the ,statutory ,pay-,as-,you-,go ,act of #bjaj1 shall be determined by reference to the latest statement titled ,budgetary ,effects of ,,paygo ,legislation for this ,act1 submitted for printing in the ,congressional ,record by the ,chairman of the ,house ,budget ,committee1 provided that such statement has been submitted prior to the vote on passage4 ,passed the ,house of ,representatives ,may #af1 #bjai4;,clerk4