,,ii #aaith ,,congress #b;d ,session ,s4 #ebdd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,august #e1 #bjbf,mr4 ,moran 7for himself1 ,ms4 ,baldwin1 ,mrs4 ,capito1 ,mr4 ,kaine1 ,mr4 ,boozman1 and ,mr4 ,hickenlooper7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,public ,health ,service ,act with respect to the drug discount program1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,supporting ,underserved and ,strengthening ,transparency1 ,accountability1 and ,integrity ,now and for the ,future of #cdj;,b ,act or the ,,sustain #cdj;,b ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,sec4 #b4 ,sense of ,congress4,sec4 #c4 ,contract pharmacy4,sec4 #d4 ,patient definition4,sec4 #e4 #cdj;,b ,rebate ,model ,pilot ,program sunset4,sec4 #f4 ,child sites4,sec4 #g4 ,transparency4,sec4 #h4 ,enhancing program integrity4,sec4 #i4 ,preventing duplicate discounts4,sec4 #aj4 ,patient financial assistance4,sec4 #aa4 ,ensuring the equitable treatment of covered entities and pharmacies participating in the #cdj;,b drug discount program4,sec4 #ab4 ,user fee program4,sec4 #ac4 ,studies and reports4,sec4 #ad4 ,additional resources4,sec4 #ae4 ,definitions4,sec4 #af4 ,effective date4 #b4 ,sense of ,congress ,it is the sense of ,congress that the purpose of the drug discount program under section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7 is to stretch scarce ,federal resources and help safety net providers maintain1 improve1 and expand patient access to health care services by requiring drug manufacturers1 as a condition of participation in the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 and the ,medicare program under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq471 to provide discounts at the point of purchase to covered entities that serve a disproportionate share of low-income and underserved patients or medically vulnerable patients4 #c4 ,contract pharmacy 7a7 ,use of contract pharmacies ,section #cdj;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77 is amended by adding at the end the following3 7#aa7 ,contract pharmacies 7,a7 ,in general ,a covered entity may elect to use one or more wholly-owned pharmacies1 in addition to one or more contract pharmacies1 to acquire and dispense to patients of the covered entity covered outpatient drugs purchased by the covered entity pursuant to an agreement described in paragraph 7#a74 7,b7 ,limits on certain contract pharmacies 7i7 ,in general ,subject to clause 7ii71 each covered entity that elects to use one or more contract pharmacies to dispense covered outpatient drugs purchased by the covered entity pursuant to an agreement described in paragraph 7#a7 to patients of the covered entity shall cancel the contract with any such pharmacy that has not dispensed any covered outpatient drugs to such patients in the most recent #ab-month period4 7ii7 ,exceptions ,a covered entity is not required to cancel the contract of a pharmacy that has not dispensed covered outpatient drugs in the most recent #ab-month period1 as described in clause 7i71 if-- 7,i7 there is a change of ownership of the covered entity or pharmacy requiring a new contract to continue an established arrangement2 7,,ii7 there is a change to the covered entity's service area2 7,,iii7 the contract pharmacy is necessary for the covered entity to preserve access for emergency or contingency use2 or 7,,iv7 other circumstances exist1 as the ,secretary may determine appropriate4 7iii7 ,threshold for high number of contract pharmacies ,the ,secretary may develop a process that is not overly burdensome to the covered entities to increase audits on covered entities that use a high number of contract pharmacies1 as determined by the ,secretary4 7,c7 ,registration of contract ,a covered entity shall register with the ,secretary1 and annually recertify1 any contract for a contract pharmacy arrangement1 in accordance with such registration requirements as the ,secretary may establish through regulations4 ,such registration requirements shall include requiring the covered entity to do each of the following3 7i7 ,submit all contract pharmacy agreements to the ,secretary in a timely manner1 prior to implementing the contract pharmacy agreement4 7ii7 ,register each contract pharmacy arrangement with the ,secretary prior to implementing the contract pharmacy agreement4 7iii7 ,attest to the covered entity's compliance with the requirements under this section4 7,d7 ,contract review process ,the ,secretary shall establish a process to review written agreements between a covered entity and each of its contract pharmacies described in subparagraph 7,e77i71 to ensure compliance with the requirements under this subsection4 7,e7 ,improvements in contract pharmacy arrangement integrity ,to ensure the integrity of contract pharmacy arrangements described in this paragraph1 including to prevent diversion and duplicate discounts described in paragraph 7#e77;,a71 the ,secretary shall promulgate rules to carry out the following3 7i7 ,require a written agreement between a covered entity and one or more contract pharmacies of the covered entity4 ,each such agreement shall-- 7,i7 list the address of each contract pharmacy location that will dispense drugs on behalf of the covered entity or reference the list of such covered entity sites that are active sites in the #cdj;,b ,office of ,pharmacy ,affairs ,information ,system 7or a successor to such system72 7,,ii7 be signed and in effect not later than the day before the contract pharmacy begins dispensing covered outpatient drugs purchased under this section on behalf of the covered entity2 and 7,,iii7 include the standard contract provisions established under clause 7ii74 7ii7 ,develop standard contract provisions that are required to be included in each written agreement described in clause 7i71 including provisions providing that-- 7,i7 the contract pharmacy is required to provide pharmacy services2 7,,ii7 the contract pharmacy is required to provide data to the covered entity to support the submission by the covered entity of covered outpatient data to a clearinghouse contracted entity described in section #aaej;,d7a7 of the ,social ,security ,act2 7,,iii7 neither the contract pharmacy nor the covered entity will require a patient to use a certain pharmacy or to obtain a prescription from the covered entity1 or otherwise interfere with patient choice of a pharmacy provider1 except in the case of a covered entity participating in the program under section #bfaf2 7,,iv7 the contract pharmacy may provide other services to the covered entity or its patients at the option of the covered entity1 such as home care1 delivery1 or reimbursement services2 7,v7 regardless of the services provided by the contract pharmacy1 access to covered outpatient drugs purchased under this section will be restricted to patients of the covered entity2 7,,vi7 the contract pharmacy will provide the covered entity with any information requested consistent with customary business practices1 such as quarterly billing statements1 status reports of collections1 or receiving and dispensing records2 7,,vii7 the covered entity and the contract pharmacy will develop and implement a system to verify eligibility of patients1 in accordance with subsection 7b77#c71 and will establish and maintain safeguards to prevent diversion of covered outpatient drugs2 7,,viii7 the contract pharmacy may not use covered outpatient drugs purchased under this section to dispense prescriptions that are reimbursed under the ,medicaid program under title ,,xix of the ,social ,security ,act1 unless the covered entity1 the contract pharmacy1 and the ,state ,medicaid agency have established an arrangement to prevent duplicate discounts1 consistent with paragraph 7#e77;,a71 and such arrangement is reported to the ,secretary2 7,,ix7 the contract pharmacy agrees to be subject to annual independent audits commissioned by the covered entity2 and 7,x7 both the covered entity and the contract pharmacy shall be subject to audits1 by the ,secretary and drug manufacturers1 of records that pertain to the covered entity's compliance with paragraph 7#e71 to prevent diversion and violations of the duplicate discount prohibition4 7iii7 ,review written agreements1 at the time of registration or recertification1 or more frequently if the ,secretary determines necessary1 between covered entities and contract pharmacies to ensure compliance with the requirements under this section1 to analyze program operations1 and to provide program oversight4 7iv7 ,provide specific guidance to covered entities regarding the practices and procedures for contract pharmacy oversight1 including the scope and frequency of such oversight4 7v7 ,establish a retention period of at least #c years during which covered entities and contract pharmacies are required to maintain all relevant auditable records in relation to contract pharmacy arrangements1 including records relating to transactions of drugs purchased pursuant to an agreement under paragraph 7#a71 sufficient to demonstrate compliance with the requirements described in paragraph 7#e74 4 7b7 ,manufacturer requirements ,section #cdj;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a771 as amended by subsection 7a71 is further amended by adding at the end the following3 7#ab7 ,manufacturer requirements ,a manufacturer of a covered outpatient drug that is subject to an agreement with the ,secretary under paragraph 7#a7 shall1 as a condition of such agreement1 comply with the following requirements3 7,a7 ,offer the covered entity covered outpatient drugs for purchase at or below the applicable ceiling price described in paragraph 7#a7 regardless of whether the drug is dispensed directly by the covered entity or through a contract pharmacy of the covered entity4 7,b7 ,deliver or allow the delivery of covered outpatient drugs purchased by a covered entity at or below the applicable ceiling price described in paragraph 7#a7 to locations1 including pharmacy locations as requested by a covered entity1 in accordance with the covered entity's contract pharmacy agreements4 7,c7 ,not1 directly or indirectly1 place any of the following conditions on the offers made to a covered entity to purchase a covered outpatient drug at or below the applicable ceiling price described in paragraph 7#a7 for dispensing according to the applicable written contract pharmacy arrangements3 7i7 ,restricting distribution options only with respect to covered outpatient drugs1 covered entities1 or contract pharmacies4 7ii7 ,requiring the submission of claims data to the manufacturer1 except for submissions to the entity receiving the contract to maintain the clearinghouse under section #aaej;,d of the ,social ,security ,act4 7iii7 ,such other conditions as the ,secretary may prohibit through notice and comment rulemaking4 4 7c7 ,program integrity ,section #cdj;,b7d77#a77;,b77vi77,,iii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7d77#a77;,b77vi77,,iii77 is amended-- 7#a7 by striking intentionally charges and inserting the following3 8intentionally-- 7aa7 charges 2 7#b7 by striking the period and inserting a semicolon2 and 7#c7 by adding at the end the following3 7bb7 refuses to offer a covered outpatient drug for purchase at or below the ceiling price2 7cc7 refuses to deliver a covered outpatient drug purchased by a covered entity at or below the ceiling price2 or 7dd7 places conditions on the ability of a covered entity to purchase a covered outpatient drug at or below the ceiling price4 4 7d7 ,transparency ,paragraph 7#aa7 of section #cdj;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a771 as added by subsection 7a71 is amended by adding at the end the following3 7,f7 ,transparency ,each covered entity that uses one or more contract pharmacies as described in this paragraph shall make the following information about each contract pharmacy arrangement pursuant to this paragraph and registered under subparagraph 7,c7 available to the ,secretary for publication on the website of the ,department of ,health and ,human ,services3 7i7 ,the name of the covered entity1 including each child site1 that uses a contract pharmacy4 7ii7 ,the name and address of each contract pharmacy location to which the contract pharmacy arrangement applies4 7iii7 ,the effective date of the contract pharmacy arrangement4 7iv7 ,the last year a covered outpatient drug was dispensed under the contract pharmacy arrangement from each location4 7v7 ,the number of covered outpatient drugs dispensed annually from each location under this section4 7vi7 ,whether the contract pharmacy is a mail-order or payer-mandated pharmacy4 4 7e7 ,auditing ,section #cdj;,b7a77#e77;,c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,c77 is amended-- 7#a7 by striking ,a covered entity and inserting the following3 7i7 ,in general ,a covered entity 2 and 7#b7 by adding at the end the following3 7ii7 ,contract pharmacy audits 7,i7 ,in general ,a covered entity that uses one or more contract pharmacies shall permit the ,secretary or the manufacturer of a covered outpatient drug that the covered entity or pharmacy purchased under this section to audit at the ,secretary's or the manufacturer's expense the records of the covered entity and contract pharmacy to assess compliance with the contract pharmacy requirements under paragraph 7#aa7 with respect to drugs of the manufacturer4 7,,ii7 ,process ,in order to initiate an audit under subclause 7,i71 a manufacturer shall-- 7aa7 demonstrate credible allegations to the ,secretary about noncompliance under subparagraph 7,b7 or 7,c7 of paragraph 7#aa7 and evidence of good faith outreach to determine compliance1 including through-- 7,,aa7 notification to the covered entity in writing when the manufacturer determined that the covered entity may have violated the requirements under subparagraph 7,b7 or 7,c7 of paragraph 7#aa72 and 7,,bb7 providing the covered entity a #cj-;day period1 beginning on the date of notification under subitem 7,,aa71 to resolve the matter2 and 7bb7 submit to the ,secretary evidence of the credible allegations described in item 7aa7 to request authorization to proceed with an audit of the covered entity4 7,,iii7 ,corporate officers ,a corporate officer of the covered entity shall be responsible for corrections of noncompliance identified in an audit conducted under this clause4 7,,iv7 ,authority to establish audit process ,the ,secretary shall establish1 through notice and comment rulemaking1 a process for making a determination of a credible allegation under this clause1 a timeline for making such a determination1 and the audit process relating to the number1 scope1 and duration of audits authorized under this clause4 4 #d4 ,patient definition 7a7 ,patient definition 7#a7 ,in general ,section #cdj;,b7b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7b77 is amended to add at the end of the following3 7#c7 ,patient 7,a7 ,in general ,in this section1 the term patient1 with respect to a covered entity1 means an individual who-- 7i7 has received an outpatient health care service from the covered entity at any point within the preceding #b years2 7ii7 has a relationship with the covered entity such that the covered entity creates and maintains an auditable medical record in a form and manner consistent with ,state and ,federal law1 that demonstrates the existence of a patient relationship in accordance with this paragraph for each prescription or order for a covered outpatient drug1 and maintains such record for a period of at least #c years1 or longer if required by ,state or ,federal law2 and 7iii7 received a prescription or order for a covered outpatient drug-- 7,i7 from a practitioner as a result of an outpatient health care service described in clause 7i72 or 7,,ii7 as a result of a referral described in subsection 7a77#ac74 7,b7 ,,aids drug purchasing assistance program patients ,an individual registered in the program of a covered entity described in subsection 7a77#d77;,e7 is a patient of the covered entity for purposes of this paragraph4 7,c7 ,state or political subdivision of a ,state receiving funding under section #cah ,an individual who receives a drug purchased by a ,state or political subdivision of a ,state1 for the treatment of a disease or condition for which the ,state or political subdivision of a ,state has received such award under section #cah1 is a patient exclusively of the ,state or political subdivision of the ,state for the purpose of qualifying that prescription for #cdj;,b pricing under this section4 7,d7 ,exclusions ,for purposes of this section1 an individual shall not be considered a patient of a covered entity if the outpatient health care services received by the individual consist only of-- 7i7 the administration of a drug1 or the dispensing of a drug for subsequent self-administration or administration in the home setting2 or 7ii7 an infusion of a drug4 7,e7 ,exception for discharge prescriptions ,in the case of a patient discharged from an emergency department or inpatient hospital stay from a covered entity described in any of subparagraph 7,a7 through 7,o7 of subsection 7a77#d7 that results in an outpatient prescription1 a covered entity may provide such drug to the individual as a covered outpatient drug pursuant to the program under this section1 and shall be deemed to meet the requirements for establishment of a patient under subparagraph 7,a7 in the same manner and under the same conditions as the covered entity would provide such drug to such patient had the covered entity prescribed the drug4 7#d7 ,outpatient health care service ,the term outpatient health care service means an outpatient health care service-- 7,a7 that was furnished pursuant to a valid1 written order that is documented or a referral that is documented in the medical record for the patient that is maintained by the covered entity2 and 7,b7 7i7 for which reimbursement under title ,,xviii or ,,xix of the ,social ,security ,act would be available when the services were furnished2 7ii7 that can be identified by a ,,cpt established by the ,american ,medical ,association or ,,hcpcs code established by the ,centers for ,medicare ,medicaid ,services as of the date the services were furnished2 or 7iii7 in the case of covered entity described in any of subparagraphs 7,a7 through 7,k7 of subsection 7a77#d71 that is a service that is consistent with the scope of the grant or designation described in the applicable such subparagraph4 7#e7 ,practitioner ,the term practitioner means a health care practitioner who-- 7,a7 7i7 is an employee or independent contractor of a covered entity1 and the covered entity bills for such services and is responsible for the care furnished by such practitioner2 or 7ii7 furnishes health care services under an ongoing contractual obligation to a covered entity1 cooperative arrangement pursuant to section #ccj with a covered entity described in subsection 7a77#d77;,a71 or1 only in the case of a covered entity that is prohibited to enter into contractual obligations1 pursuant to medical staff membership with a covered entity1 such that the covered entity maintains clinical responsibility for the health care services that resulted in the patient receiving a prescription or order for the covered outpatient drug2 and 7,b7 is not excluded1 pursuant to section #aabh of the ,social ,security ,act1 from participation in the ,medicare program or a ,state health care program 7as defined in section #aabh7;h7 of the ,social ,security ,act74 4 7#b7 ,audits ,section #cdj;,b7a77#e77;,c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,c771 as amended by section #c7;e71 is further amended by adding at the end the following3 7iii7 ,audits relating to patient status 7,i7 ,in general ,a covered entity providing covered outpatient drugs pursuant to an agreement under paragraph 7#a7 shall permit the ,secretary and the manufacturer to audit1 at the ,secretary's or manufacturer's expense1 the records of the entity with respect to drugs of the manufacturer that directly pertain to the entity's compliance with-- 7aa7 treating individuals as patients of the entity only as described in subsection 7b77#c72 and 7bb7 the requirements for providing such drugs to referred patients pursuant to paragraph 7#ac74 7,,ii7 ,auditing ,the ,secretary shall audit the records of covered entities with respect to records described in this clause not less frequently than every #c years1 and shall audit high-risk and high-volume1 as defined by the ,secretary1 covered entities more frequently1 in a manner that is not overly burdensome to the covered entity4 ,the ,secretary shall establish a mechanism for manufacturers to request and authorize audits specific to referral prescription eligibility under paragraph 7#ac7 upon demonstration of a credible allegation of non-compliance4 7,,iii7 ,authority to establish process ,the ,secretary shall establish1 through notice and comment rulemaking1 a process for manufacturers and covered entities to make a good faith attempt to resolve any concerns identified by a manufacturer prior to the initiation of an audit under this clause4 ,a manufacturer shall provide to the covered entity the same materials that the manufacturer provided to the ,secretary to support a credible allegation under this clause1 as determined by the ,secretary4 4 7#c7 ,enforcement ,section #cdj;,b7a77#e77;,d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,d77 is amended-- 7,a7 by striking subparagraphs 7,a7 and inserting subparagraph 7,a72 7,b7 by striking ,if the ,secretary and inserting the following3 7i7 ,in general ,if the ,secretary 2 and 7,c7 by adding at the end the following3 7ii7 ,sanctions for noncompliance with patient status requirements ,if the ,secretary determines1 after an audit described in subparagraph 7,c77iii71 a covered entity to not be in compliance with the requirements of treating an individual as a patient of the covered entity as described in subsection 7b77#c7 or the requirements of paragraph 7#ac7-- 7,i7 the covered entity shall develop a corrective action plan1 which shall be subject to approval and monitoring by the ,secretary2 and 7,,ii7 if the ,secretary determines that the covered entity has not adequately corrected its noncompliance in accordance with such plan-- 7aa7 the covered entity shall be ineligible to participate in the drug discount program under this section for a period determined by the ,secretary1 not to exceed #c years2 and 7bb7 the ,secretary may order the covered entity to pay civil monetary penalties1 pursuant to subpart ,o of part #ajjc of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 with respect to any covered outpatient drugs purchased by the covered entity during the period in which the covered entity was found to be not in compliance with the requirements of treating an individual as a patient of the entity as described in subsection 7b77#c7 or the requirements of paragraph 7#ac74 4 7b7 ,covered entity registration ,section #cdj;,b7a77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is amended by adding at the end the following3 7,e7 ,covered entity registration ,as a condition for participation in the drug discount program under this section1 a covered entity shall register with the ,secretary and be listed on the #cdj;,b ,office of ,pharmacy ,affairs ,information ,system 7or a successor to such system74 4 7c7 ,treatment of certain prescriptions for patients referred to non-#cdj;,b providers ,section #cdj;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a771 as amended by section #c7;b71 is further amended by adding at the end the following3 7#ac7 ,referral prescriptions 7,a7 ,in general ,in the case of a patient of an eligible covered entity who is referred by such covered entity to a prescribing provider who is not providing care on behalf of a covered entity1 and such prescribing provider prescribes a drug within #ab months of the patient receiving such referral1 the eligible covered entity may provide such drug to such patient as a covered outpatient drug pursuant to the program under this section1 in the same manner and under the same conditions as the covered entity would provide such drug to such patient had the covered entity prescribed the drug1 in accordance with the requirements under subparagraph 7,c74 7,b7 ,eligible covered entity ,for purposes of this paragraph1 a covered entity is an eligible covered entity if such entity is-- 7i7 an entity described in any of subparagraphs 7,a7 through 7,k7 or 7,n7 of paragraph 7#d72 or 7ii7 a sole community hospital described in paragraph 7#d77,o74 7,c7 ,requirements 7i7 ,in general ,an eligible covered entity may provide a drug to a patient as described in subparagraph 7,a7 only if-- 7,i7 the covered entity has a documented relationship with the patient1 as described in subsection 7b77#c71 and has documentation of the provision of care provided by the covered entity and the prescribing provider and consultation with the prescribing provider regarding such patient1 including documentation of the referral and the prescription2 7,,ii7 the patient was referred to the prescribing provider who prescribed the drug by the covered entity2 7,,iii7 the prescription is filled at the covered entity's wholly-owned pharmacy or contract pharmacy2 7,,iv7 the covered entity maintains1 for a period of at least #c years1 documentation of compliance with this paragraph1 including all documents subject to audit under paragraph 7#e77;,c72 7,v7 the covered entity does not share the savings received from purchasing the covered outpatient drug with the prescribing provider2 and 7,,vi7 the covered entity meets such other requirements as the ,secretary may establish through notice and comment rulemaking4 7ii7 ,excepted drugs 7,i7 ,in general ,except as provided in subclause 7,,ii71 a covered entity may not provide a patient a covered outpatient drug pursuant to subparagraph 7,a7 if such drug-- 7aa7 is an infused drug2 7bb7 is a clinician-administered drug2 or 7cc7 otherwise requires administration by a clinician4 7,,ii7 ,exceptions ,a covered entity may provide a patient a covered outpatient drug described in subclause 7,i7 pursuant to subparagraph 7,a7 if-- 7aa7 the eligible covered entity is a covered entity described in paragraph 7#d77;,a7 and was providing infusion services necessary to deliver a required primary health service or an additional health service 7as defined in section #ccj7;b77#a77 pursuant to funding received under section #ccj1 as of the date of enactment of the ,,sustain #cdj;,b ,act2 or 7bb7 the ,secretary determines1 through notice and comment rulemaking1 that low-income1 medically underserved residents of the service area of the eligible covered entity lack access to infusion services within a reasonable distance and based on this determination1 the eligible covered entity receives approval from the ,secretary to provide these services pursuant to funding provided under section #ccj1 subject to all the requirements of that section4 7,d7 ,rule of construction ,nothing in this paragraph shall be construed to affect the application of subsection 7e74 7,e7 ,addressing significant volume of drugs provided to referred patients 7i7 ,in general ,the ,secretary shall audit any eligible covered entity that1 in any year1 provides covered outpatient drugs to patients who received a prescription for such drug from a provider who is not a covered entity in a volume that exceeds the lesser of-- 7,i7 #bj percent of the total number of covered outpatient drugs purchased by the covered entity at or below the applicable ceiling price and dispensed by the covered entity for the year2 or 7,,ii7 the average annual percentage over the most recent #c-year period1 of the total number of covered outpatient drugs purchased by the covered entity at or below the applicable ceiling price for the year and dispensed by the covered entity to patients1 that were dispensed to patients who received a prescription for such drug from a provider who is not a covered entity4 7ii7 ,hardship exceptions ,the ,secretary shall develop specific criteria for a hardship exceptions process1 that is not overly burdensome to a covered entity1 under which an eligible covered entity may exceed the threshold established under clause 7i7 without requiring an audit described in such clause only if the eligible covered entity provides required information to the ,secretary to demonstrate such hardship1 such as a medical need or workforce shortage1 in accordance with the criteria established by the ,secretary4 7iii7 ,reporting ,a covered entity shall report annually to the ,secretary-- 7,i7 the percentage of the covered entity's revenue under the drug discount program derived from drugs prescribed by a prescribing provider pursuant to this subsection2 and 7,,ii7 the percentage of the total number of covered outpatient drugs purchased by the covered entity that were prescribed by a prescribing provider pursuant to this subsection4 7iv7 ,public availability of information ,the ,secretary shall make aggregate information on eligible covered entities identified under clause 7i7 available on the website of the ,health ,resources and ,services ,administration1 in such form and manner that the ,secretary determines appropriate1 and shall not identify any specific covered entity4 7,f7 ,enforcement 7i7 ,corrective action plan ,in the case that the ,secretary finds that a covered entity has failed to comply with any requirement under this paragraph1 such covered entity shall be required to submit a corrective action plan to the ,secretary1 which shall be subject to approval and monitoring by the ,secretary4 7ii7 ,loss of referral authorization ,a covered entity that fails to comply with a corrective action plan within #ahj days of approval of such plan by the ,secretary under clause 7i7 shall become ineligible to provide covered outpatient drugs to referred patients under subparagraph 7,a7 for such period of time determined by the ,secretary under the corrective action plan1 not to exceed #c years4 7iii7 ,monetary penalties ,the ,secretary may impose civil monetary penalties1 pursuant to subpart ,o of part #ajjc of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 on a covered entity for any discounts received by such entity on covered outpatient drugs provided to referred patients under this paragraph1 if the covered entity is found to be noncompliant with the requirements of this paragraph with respect to the relevant drug4 7,g7 ,definitions ,for the purposes of this paragraph-- 7i7 the term prescribing provider means a licensed health care provider who prescribes a drug to a patient of a covered entity based on the referral of the patient by the covered entity to the provider2 and 7ii7 the term referral means a written1 electronic1 or otherwise documented order by a licensed health care provider ordering1 or the recertifying of the need for1 a health service4 4 7d7 ,,oig report on referral prescriptions ,the ,inspector ,general of the ,department of ,health and ,human ,services shall-- 7#a7 during the #ab-year period beginning on the date of enactment of this ,act1 conduct an annual study on covered outpatient drugs provided pursuant to prescriptions for referred patients under paragraph 7#ac7 of section #cdj;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a771 as added by subsection 7c72 and 7#b7 not later than #b years after the date of enactment of this ,act1 and for each of the next #aj years1 submit to ,congress a report on the study under paragraph 7#a74 #e4 #cdj;,b ,rebate ,model ,pilot ,program sunset ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall conclude the #cdj;,b ,rebate ,model ,pilot ,program1 or a substantially similar program established by the ,department of ,health and ,human ,services4 ,the #cdj;,b ,rebate ,model ,pilot ,program1 or a substantially similar program1 shall not be expanded4 ,one year after the date of enactment of this ,act1 the ,secretary shall discontinue the #cdj;,b ,rebate ,model ,pilot ,program1 or a substantially similar program1 and transition to the #cdj;,b ,drug ,discount ,program ,data ,clearinghouse established under section #aaej;,d of the ,social ,security ,act1 as added by section #i7;a74 #f4 ,child sites 7a7 ,in general ,section #cdj;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a771 as amended by section #d7;c71 is further amended by adding at the end the following3 7#ad7 ,child sites 7,a7 ,in general ,a covered entity described in subparagraph 7,l71 7,m71 7,n71 or 7,o7 of paragraph 7#d7 that owns and operates a child site that participates in the drug discount program under this section shall maintain documentation of1 and annually recertify to the ,secretary through such certification processes established under title ,,xviii of the ,social ,security ,act1 that each such child site is wholly-owned by the entity and clinically and financially integrated with the covered entity and providing care consistent with the policies of the covered entity1 including by-- 7i7 registering each child site with the ,secretary1 which1 in the case of a child site that is eligible for participation as described in subparagraph 7,b77ii71 shall include submission of the attestation 7absent billing requirements7 that the child site meets the ,medicare provider-based rules under section #dac4fe of title #db1 ,code of ,federal ,regulations 7or any successor regulations72 7ii7 applying the same financial assistance policy for patients as applies with respect to other sites operated by the covered entity2 and 7iii7 ensuring that each child site complies with the ,medicare provider-based rules under section #dac4fe of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 or meets the requirements of subparagraph 7,b77i74 7,b7 ,eligibility for child sites 7i7 ,in general ,a child site is eligible for participation in the drug discount program under this section1 through the eligibility of the covered entity that owns and operates such child site1 only if the covered entity demonstrates that the child site meets the following requirements3 7,i7 ,the child site applies the same financial assistance policy for patients as the covered entity4 7,,ii7 ,the child site ensures that the providers who order or dispense covered outpatient drugs purchased under this section at the child site or a contract pharmacy of the covered entity have clinical responsibility for health care services that result in the receipt of a prescription or order of the covered outpatient drug purchased under this section that is dispensed4 7,,iii7 ,the child site provides a clinically meaningful range of services1 as determined by the services that providers or suppliers employed by1 contracted with1 or authorized to provide services at1 the child site are qualified to deliver4 7,,iv7 ,the child site is operated under the same license as the covered entity1 except in areas where the ,state requires a separate license for the child site1 or in ,states where ,state law does not permit licensure of the child site and the covered entity under a single license4 ,if a ,state health facilities cost review commission or other agency that has authority to regulate the rates charged by providers in a ,state finds that a child site is not part of the covered entity1 the child site shall not be eligible for the drug discount program under this section4 7,v7 ,the clinical services of the child site and the covered entity are integrated as evidenced by the following3 7aa7 ,professional staff of the child site have clinical privileges at the covered entity4 7bb7 ,the covered entity maintains the same monitoring and oversight of the child site as for any other owned entity or subsidiary of the covered entity4 7cc7 ,the medical director of the child site maintains a reporting relationship with the chief medical officer or other similar official of the covered entity that has the same frequency1 intensity1 and level of accountability that exists in the relationship between the medical director of a department of the covered entity and the chief medical officer or other similar official of the covered entity1 and is under the same type of supervision and accountability as any other director1 medical or otherwise1 of the covered entity4 7dd7 ,medical staff committees or other professional committees at the covered entity are responsible for medical activities in the child site1 including quality assurance1 utilization review1 and the coordination and integration of services1 to the extent practicable1 between the child site and covered entity4 7ee7 ,medical records for patients treated in the child site are integrated into a unified retrieval system1 or have the ability to be readily accessed by the covered entity4 7ff7 ,inpatient and outpatient services of the child site and the covered entity are integrated1 and patients treated at the child site who require further care have full access to all services of the covered entity and are referred where appropriate to the corresponding inpatient or outpatient department or service of the covered entity4 7,,vi7 ,the financial operations of the child site are fully integrated within the financial system of the covered entity1 as evidenced by shared income and expenses between the covered entity and the child site4 ,for purposes of the ,medicare program under title ,,xviii of the ,social ,security ,act1 the costs of a child site are reported in the appropriate cost center or cost centers of the covered entity1 and the financial status of any child site is incorporated and readily identified in the covered entity's trial balance4 7,,vii7 ,the child site is held out to the public as part of the covered entity1 such that1 when patients enter the child site1 they are aware that they are entering the covered entity4 7,,viii7 ,the child site is operated under the ownership and control of the covered entity1 as evidenced by the following3 7aa7 ,the business enterprise that constitutes the child site is #ajj percent owned by the covered entity4 7bb7 ,the covered entity and the child site have the same governing body4 7cc7 ,the child site is operated under the same organizational documents as the covered entity1 and is subject to common bylaws and operating decisions of the governing body of the covered entity4 7dd7 ,the covered entity has final responsibility for administrative decisions1 final approval for contracts with outside parties1 final approval for personnel actions1 final responsibility for personnel policies 7such as fringe benefits or code of conduct71 and final approval for medical staff appointments at the child site4 7,,ix7 ,the reporting relationship between the child site and the covered entity have the same frequency1 intensity1 and level of accountability that exists in the relationship between the covered entity and its other departments1 as evidenced by compliance with the following requirements3 7aa7 ,the child site is under the direct supervision of the covered entity4 7bb7 ,the child site is operated under the same monitoring and oversight by the covered entity as any other department of the covered entity1 and is operated as any other department of the covered entity with regard to supervision and accountability4 ,the director or individual responsible for daily operations at the child site-- 7,,aa7 maintains a reporting relationship with a manager at the covered entity that has the same frequency1 intensity1 and level of accountability that exists in the relationship between the covered entity and its existing departments2 and 7,,bb7 is accountable to the governing body of the covered entity1 in the same manner as any department head of the covered entity4 7,x7 ,the following administrative functions of the child site are integrated with the functions of the covered entity3 billing services1 records1 human resources1 payroll1 employee benefit package1 salary structure1 and purchasing services4 ,either the same employees or group of employees handle such administrative functions for the child site and the covered entity1 or the administrative functions for both the child site and the covered entity are-- 7aa7 contracted out under the same contract agreement2 or 7bb7 handled under different contract agreements1 with the contract of the child site being managed by the covered entity4 7,,xi7 7aa7 ,the child site is listed on the covered entity's most recently filed ,medicare cost report on a line that is reimbursable under the ,medicare program 7or1 if the covered entity does not file a ,medicare cost report1 the covered entity submits to the ,secretary a signed statement certifying that the site would be correctly included on a reimbursable line of a ,medicare cost report if the covered entity filed a cost report74 7bb7 ,such cost report demonstrates that the services provided at the child site have associated costs and charges for covered entity outpatient department services under title ,,xviii of the ,social ,security ,act 7or1 if the covered entity does not file a ,medicare cost report1 the covered entity submits to the ,secretary a signed statement certifying that the services provided at the child site include or consist solely of outpatient services74 7ii7 ,,hrsa deeming 7,i7 ,in general ,if the ,administrator of the ,centers for ,medicare ,medicaid ,services has determined a site to be qualified as a provider-based entity and in compliance with the provider-based requirements under section #dac4fe of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 the ,secretary shall deem the site to have met the requirements described in clause 7i74 7,,ii7 ,rule of construction ,this clause shall authorize the ,secretary to establish a process to determine whether a child site1 as determined by the ,administrator of the ,centers for ,medicare ,medicaid ,services1 complies with the ,medicare provider-based rules under section #dac4fe of title #db1 ,code of ,federal ,regulations 7or any successor regulations74 7iii7 ,process for registration ,the ,secretary shall develop a process for the registration of child sites that are eligible for participation under clause 7i7 or 7ii74 7iv7 ,eligibility delay for certain child sites 7,i7 ,newly acquired sites 7aa7 ,in general ,except as provided in item 7bb71 a child site acquired by a covered entity after the date of enactment of the ,,sustain #cdj;,b ,act that was not eligible to participate in the drug discount program prior to such date shall not be eligible to participate in the drug discount program under this section until the date that is #c years after the date of such acquisition4 7bb7 ,hardship exemption ,the ,secretary may1 on a case-by-case basis1 determine that a newly acquired child site will be eligible to participate in the drug discount program under this section on a specified date within #ahj days after the date of acquisition by the covered entity4 7,,ii7 ,newly constructed sites ,a newly constructed child site that began operations after the date of enactment of the ,,sustain #cdj;,b ,act shall not be eligible to participate in the drug discount program as described in clause 7i7 unless such site meets all of the requirements under this subparagraph4 7,c7 ,inappropriate treatment of a provider as a child site ,not later than #ahj days after the first recertification of the covered entity that occurs after the date of enactment of the ,,sustain #cdj;,b ,act1 the ,secretary shall establish a process through notice and comment rulemaking for determining the status of a child site that1 prior to such date of enactment1 was deemed qualified as a child site but that does not meet the criteria set forth in this subsection4 7,d7 ,reports 7i7 ,,gao report on program integrity ,not later than #c years after the date of enactment of the ,,sustain #cdj;,b ,act1 the ,comptroller ,general of the ,united ,states shall submit to the appropriate committees of ,congress a report that analyzes relevant data1 including data made available pursuant to subsection 7d77#e71 and makes recommendations with respect to any policies needed to address program integrity issues associated with child sites in the drug discount program under this section4 7ii7 ,,hhs reports to ,congress ,not later than #b years after the date of enactment of the ,,sustain #cdj;,b ,act1 and every #b years thereafter1 the ,secretary shall submit to the appropriate committees of ,congress a report that analyzes the use of child sites in the drug discount program under this section1 and that-- 7,i7 characterizes the scope and nature of child sites in the drug discount program under this section1 including-- 7aa7 the number of newly acquired child sites2 7bb7 the number of newly constructed child sites2 7cc7 the concentration of the child sites across geographic areas2 and 7dd7 the payer-mix of the child sites2 7,,ii7 assesses the effect of eligibility delays described in subparagraph 7,b77iv72 and 7,,iii7 makes recommendations with respect to policies needed to address any issues identified in such report4 7iii7 ,,gao report on best practices ,not later than #a year after the date of enactment of the ,,sustain #cdj;,b ,act1 the ,comptroller ,general of the ,united ,states shall submit a report to the appropriate committees of ,congress that-- 7,i7 analyzes input solicited from relevant stakeholders1 including covered entities and manufacturers1 regarding potential best practices for ensuring savings received by child sites through participation in the drug discount program under this section are used to meaningfully improve access to care1 including by expanding access to health care services or health-related benefits for patients and communities served by the covered entity1 including child sites of the covered entity2 and 7,,ii7 makes recommendations to the ,secretary and appropriate committees of ,congress with respect to implementation of best practices identified and analyzed pursuant to subclause 7,i74 4 7b7 ,recordkeeping ,section #cdj;,b7a77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e771 as amended by section #d7;b71 is further amended by adding at the end the following3 7,f7 ,child site recordkeeping ,in the case of a covered entity that has registered a child site pursuant to paragraph 7#ad71 the covered entity shall maintain auditable records for a period of at least #c years and be subject to audits by the ,secretary of records that pertain to the compliance of the covered entity and child site with the provisions of paragraph 7#ad74 4 #g4 ,transparency 7a7 ,in general ,section #cdj;,b7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7d77 is amended by adding at the end the following3 7#e7 ,reporting of program savings 7,a7 ,in general ,not later than #a year after the date of enactment of the ,,sustain #cdj;,b ,act1 and annually thereafter1 each covered entity shall report to the ,secretary the following information with respect to the covered entity1 including with respect to all child sites and contract pharmacy arrangements1 for the preceding year3 7i7 ,the total number of individuals who were dispensed or administered covered outpatient drugs during such preceding year that were subject to an agreement under subsection 7a77#a74 7ii7 ,the total number of prescriptions dispensed or administered with covered outpatient drugs purchased under this section and billed to insurance1 organized by type of health insurance coverage 7as specified by the ,secretary1 including by the ,medicare program under title ,,xviii of the ,social ,security ,act1 the ,medicaid program under title ,,xix of such ,act1 the ,children's ,health ,insurance ,program under title ,,xxi of such ,act1 health insurance coverage offered in the individual or group market or a group health plan 7as such terms are defined in section #bgia71 and uninsured74 7iii7 7,i7 ,the cost incurred at each covered entity for charity care1 reported as a fraction1 where the numerator is the amount of charity care reported on worksheet ,s-#aj of the ,medicare cost report 7or any successor71 and the denominator is the total operating cost of the covered entity1 as reported for the most recent cost reporting period2 or 7,,ii7 in the case of a covered entity that is not required to submit a ,medicare cost report1 a qualitative description of the charity care provided by the covered entity1 to the extent applicable under the scope of the grant for a covered entity described in any of subparagraphs 7,a7 through 7,o7 of subsection 7a77#d71 in such manner that is not overly burdensome to covered entities1 as the ,secretary may require4 7iv7 ,at the option of the covered entity1 information pertaining to under-reimbursed care provided by the covered entity4 7v7 7,i7 ,a description1 submitted in a standardized form and manner prescribed by the ,secretary1 of the covered entity's use of the savings received through participation in the drug discount program under this section1 including a description of health care services or health-related benefits used to benefit the patients and communities served by the covered entity1 delineated by categories of services and benefits and populations served1 including such services and benefits provided to underserved1 uninsured1 or medically vulnerable patients and communities2 and 7,,ii7 an attestation by the chief executive officer1 chief executive financial officer1 or chief operating officer certifying that such savings have been used to benefit the patients and communities served by the covered entity4 7vi7 ,the financial demographics of patients of the covered entity1 including-- 7,i7 the percentage of patients eligible for financial assistance programs and sliding scale fees2 7,,ii7 the percentage of patients who reside in a health professional shortage area 7as defined in section #ccb7 or a medically underserved community 7as defined in section #gii;,b72 7,,iii7 the percentage of patients who reside in or are part of a medically underserved population 7as defined in section #ccj7;b77#c772 7,,iv7 the percentage of uninsured patients2 7,v7 the percentage of patients who are ,medicaid beneficiaries2 and 7,,vi7 the percentage of patients who are ,children's ,health ,insurance ,program beneficiaries4 7vii7 ,policies of the covered entity to promote access and adherence to prescribed medication4 7viii7 ,in the case of a nongovernmental hospital1 any contracts between such hospital and a ,state or local governmental entity1 and any modifications to any such contract4 7ix7 ,any third-party administrators in contract with the covered entity for the administration of the drug discount program4 7x7 ,the funding shortfall for the covered entity attributable to services provided to ,medicare and ,medicaid beneficiaries1 as reported on the ,internal ,revenue ,service ,form #iij4 7xi7 ,the number of patients using the outpatient services of the covered entity4 7xii7 ,operation costs to the covered entity related to the drug discount program under this section4 7,b7 ,records retention ,a covered entity shall retain records described in subparagraph 7,a7 for a period of at least #c years and provide such records and reports as the ,secretary determines necessary for purposes of carrying out this paragraph4 7,c7 ,availability of information 7i7 ,in general ,not later than #ij days after receiving the information reported by covered entities under paragraph 7#a71 the ,secretary shall publish such information on the public website of the ,department of ,health and ,human ,services1 which may include the website of the #cdj;,b ,office of ,pharmacy ,affairs ,information ,system 7or a successor to such system74 7ii7 ,format ,data published under clause 7i7 shall be published in an electronic and searchable format that shows each category of data reported both in the aggregate and identified by each type of covered entity described in subsection 7a77#d74 ,in carrying out this paragraph1 with respect to data reported pursuant to paragraph 7#a71 the ,secretary shall ensure that any proprietary information be redacted from contracts submitted pursuant to subparagraph 7,a77viii7 before posting such contracts4 7,d7 ,submission process ,not later than #a year after the date of enactment of the ,,sustain #cdj;,b ,act1 the ,secretary shall establish a process by which the information required to be submitted under subparagraph 7,a7 may be submitted directly to the #cdj;,b ,office of ,pharmacy ,affairs ,information ,system 7or a successor to such system74 7,e7 ,reports to ,congress ,not later than #a year after the date of the enactment of the ,,sustain #cdj;,b ,act1 and annually thereafter1 the ,secretary shall submit a report to the appropriate committees of ,congress on the information collected under subparagraph 7,a74 7,f7 ,regulations ,the ,secretary may promulgate regulations to carry out this paragraph4 4 7b7 ,auditing ,section #cdj;,b7a77#e77;,c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,c771 as amended by section #d7;a77#b71 is further amended by adding at the end the following3 7iv7 ,audits of program savings records ,a covered entity shall permit the ,secretary to audit1 at the ,secretary's expense1 the records of the covered entity used for purposes of reporting under subsection 7d77#e77;,a71 including how the discount from drugs subject to an agreement under paragraph 7#a7 is used by the covered entity4 4 #h4 ,enhancing program integrity 7a7 ,audits 7#a7 ,in general ,section #cdj;,b7a77#e77;,c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,c771 as amended by section #g7;b71 is further amended by adding at the end the following3 7v7 ,additional audits 7,i7 ,in general ,in addition to the audits otherwise authorized under this subparagraph1 the ,secretary may audit1 to assess compliance with requirements under this section-- 7aa7 covered entities1 including the child sites of a covered entity and contract pharmacies1 to identify any violations under this section1 including violations related to improperly claiming eligibility for the program under this section1 drug diversion1 duplicate discounts1 use of contract pharmacies1 or claiming a discount under this section on a drug that is not a covered outpatient drug purchased pursuant to an agreement under paragraph 7#a72 and 7bb7 manufacturers1 including to identify any failure to provide an accurate ceiling price4 7,,ii7 ,standards ,the ,secretary shall conduct audits described in this clause in accordance with generally accepted standards that the ,secretary determines appropriate and shall make the protocol for such audits publicly available4 7,,iii7 ,requirements ,the ,secretary may not close an audit described in subclause 7,i7 before a corrective action plan required by the ,secretary has been fully implemented1 as applicable4 7,,iv7 #cdj;,b vendor information ,to meet the requirements for submission of information for audits under this clause1 with respect to carrying out the program under this section1 a covered entity shall contract only with vendors agreeing to-- 7aa7 submit data to the ,secretary and independent outside auditors contracting with the covered entity as necessary to determine the covered entity's compliance with statutory and regulatory requirements under this program1 prohibitions on drug diversion and duplicate discounts1 use of contract pharmacies1 and claims for discounts on covered outpatient drugs purchased pursuant to agreements under paragraph 7#a72 and 7bb7 respond to requests from auditors in a timely manner1 as determined by the ,secretary4 7,v7 ,consequences of audit ,the ,secretary shall ensure that1 in the case of an audit finding that-- 7aa7 a covered entity did not meet one or more of the eligibility criteria for being a covered entity1 as defined in paragraph 7#d71 during the full period under review in an audit1 the audit results in consequences that are consistent and appropriate with the violation and that do not treat the failure to meet eligibility criteria as an issue that can be corrected retroactively2 or 7bb7 a manufacturer did not meet its requirements pursuant to an agreement under paragraph 7#a7 during the full period under review in an audit1 the audit results in consequences that are consistent and appropriate with the violation and that do not treat the failure to meet the criteria as an issue that can be corrected retroactively4 7,,vi7 ,regulations ,not later than #a year after the date of enactment of the ,,sustain #cdj;,b ,act1 the ,secretary shall establish1 through notice and comment rulemaking1 the audit and reporting procedures required by this clause4 4 7#b7 ,additional sanctions authority ,section #cdj;,b7d77#b77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7d77#b77;,b77 is amended-- 7,a7 in clause 7v77,,ii71 by inserting or where the covered entity knowingly and intentionally fails to implement a corrective action plan relating to a violation involving improperly claiming eligibility for the program under this section1 drug diversion1 duplicate discounts1 compliance with contract pharmacy requirements1 or claiming a discount on a drug that is not a covered outpatient drug 7or claiming a rebate on a drug in the case of an ,,aids drug purchasing assistance program1 as determined by the ,secretary71 within #ahj days of the ,secretary notifying the entity of the requirement for such plan1 unless the ,secretary determines it is appropriate to allow additional time for compliance1 after knowing and intentional12 and 7,b7 by adding at the end the following3 7vi7 ,increasing the frequency of audits conducted for entities previously found to be in violation of requirements of the drug discount program that relate to eligibility1 drug diversion1 duplicate discounts1 compliance with contract pharmacy requirements1 or claiming a discount on a drug that is not a covered outpatient drug 7or claiming a rebate on a drug in the case of an ,,aids drug purchasing assistance program described in subsection 7a77#d77;,e71 as determined by the ,secretary71 and assigning responsibility for making corrections relating to such a violation to a corporate officer of the covered entity4 7vii7 7,i7 ,establishing a process for a covered entity to develop and implement a corrective action plan1 and a process by which the ,secretary provides for proper and timely notification of a potential violation by a covered entity4 7,,ii7 ,disenrolling from the program a covered entity that fails to implement a corrective action plan within #ahj days of issuance of a final audit report related to a statutory violation involving improperly claiming eligibility for the program under this section1 drug diversion1 duplicate discounts1 compliance with contract pharmacy requirements1 claiming a discount on a drug that is not a covered outpatient drug 7or claiming a rebate on a drug in the case of an ,,aids drug purchasing assistance program described in subsection 7a77#d77;,e71 as determined by the ,secretary71 or failing to comply with reporting of program savings and use of program savings as required4 4 7b7 ,verification of private non-,profit hospital contracts with ,state or local governments ,section #cdj;,b7a77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e771 as amended by section #f7;b71 is further amended by adding at the end the following3 7,g7 ,verification of private non-profit hospital contracts with ,state or local governments 7i7 ,in general ,in the case of a private non-profit hospital that has a contract with a ,state or local government to provide health care services to low-income individuals who are not eligible for ,medicaid or ,medicare1 whether the hospital is registered or seeking to register for the drug discount program as a covered entity described under subparagraph 7,l71 7,m71 7,n71 or 7,o7 of paragraph 7#d71 the ,secretary shall take all of the following steps1 each of which shall be documented3 7,i7 ,prior to registering or approving annual recertification of such a hospital 7or while carrying out any program audit of such a hospital71 the ,secretary shall obtain and review the hospital's contract with a ,state or local government and shall verify and document that-- 7aa7 the document provided by the hospital is a contract1 in that it is a mutually binding agreement for the hospital to provide health care services or supplies in exchange for something of value2 7bb7 the contract clearly lists the name of the hospital and the unit of ,state or local government that are parties to the contract and is signed and appropriately dated by appropriate officials of the hospital and the unit of ,state or local government2 7cc7 the contract specifies an effective date2 7dd7 the contract clearly is in effect and not expired at the time of registration 7or at the time of recertification1 in the case of annual recertification1 or for the full period examined in an audit1 in the case of an audit72 and 7ee7 the contract explicitly requires that the hospital provide health care services1 and that such services must be provided to individuals who are both low-income and not eligible for either the ,medicaid program or the ,medicare program4 7,,ii7 ,the ,secretary shall verify the contracts meeting the requirements of clause 7i7 for all covered entities described in this subparagraph and registered as of the date of enactment of the ,,sustain #cdj;,b ,act by no later than #a year after the date of enactment of the ,,sustain #cdj;,b ,act4 7,,iii7 ,the ,secretary shall not register or recertify any covered entity described in this subparagraph if the entity's contract with a ,state or local government does not satisfy items 7aa7 through 7ee7 of subclause 7,i74 7ii7 ,process ,the ,secretary shall develop a process to verify the contracts meeting the requirement of clause 7i77,i71 including specifying a timeline4 4 7c7 ,verification of certain covered entities ,section #cdj;,b7a77#d77,l77i7 of the ,public ,health ,services ,act 7#db ,u4,s4,c4 #bef;b7a77#d77,l77i77 is amended by inserting 7provided that such a private non-profit hospital annually submits to the ,secretary verification of such an active contract with a ,state or local government and verification of its non-profit status7 before the semicolon4 #i4 ,preventing duplicate discounts 7a7 #cdj;,b drug discount program data clearinghouse ,part ,a of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is amended by adding the following the following new section3 #aaej;,d4 #cdj;,b drug discount program data clearinghouse 7a7 ,clearinghouse contracting entity ,not later than #a year after the date of enactment of this section1 the ,secretary shall enter into a contract with an independent1 third-party entity 7who shall be free of conflicts of interest with covered entities1 manufacturers1 health plans1 third-party administrators of health plans1 entities providing pharmacy benefit management services to health plans1 and of other conflicts of interest as specified by the ,secretary7 for purposes of carrying out the clearinghouse duties under subsection 7b7 with respect to the #cdj;,b drug discount program to prevent duplicate discounts and ensure proper accounting4 ,such contract shall provide that the third-party entity shall perform the duties described in subsection 7b7 and shall be for a #d-year term that may be renewed after a subsequent bidding process or using competitive procedures1 as defined in section #acb of title #da1 ,united ,states ,code4 7b7 ,duties ,with respect to #cdj;,b drugs that are dispensed to individuals who are entitled to or eligible for benefits under the ,medicare program under title ,,xviii1 the ,medicaid program under title ,,xix 7including benefits provided under the ,medicaid program through a managed care arrangement71 the ,children's ,health ,insurance ,program under title ,,xxi 7including benefits provided under the ,children's ,health ,insurance ,program through a managed care arrangement71 or a health plan1 a third-party entity with a contract in effect under subsection 7a7 shall-- 7#a7 request and receive1 in the most efficient and least burdensome manner practicable-- 7,a7 claims-level rebate file data under section #aibg1 from ,state ,medicaid agencies2 7,b7 claims-level data from covered entities2 and 7,c7 any other data specified by the ,secretary as necessary for the entity to carry out this section2 7#b7 request1 receive1 and maintain data described in paragraph 7#a7 in a confidential manner2 7#c7 ensure that claims-level data submissions by covered entities are complete and accurate1 and if not1 obtain complete and accurate data from the covered entity2 7#d7 notify the covered entity1 the ,secretary1 the ,state ,medicaid agency1 and the manufacturer of any violation described in subsection 7c7 to allow for remediation2 7#e7 provide the manufacturer of a #cdj;,b drug with claims-level data submitted by a covered entity1 so that the manufacturer may identify units of a #cdj;,b drug that may generate a rebate or discount under a voluntary rebate or discount arrangement1 such as those related to commercial plans2 7#f7 where feasible1 share with a covered entity1 the ,secretary1 a ,medicaid ,state agency1 or a manufacturer1 data the third-party entity identifies in a timely manner with the purpose of preventing any of the violations described in section #bgbi;,a7b77#b7 of the ,public ,health ,service ,act2 7#g7 determine total sales of #cdj;,b drugs to such individuals for purposes of being used as the basis for determining user fees under section #cdj;,b7a77#ae7 of such ,act2 and 7#h7 allow covered entities described in subparagraphs 7,a7 through 7,k7 of section #cdj;,b7a77#d7 of the ,public ,health ,service ,act1 which have the lowest decile of patient volume1 as calculated by the ,secretary1 to make submissions required under this section in an aggregated retrospective basis4 7c7 ,hardship exemption ,the ,secretary may1 on a case-by-case basis1 determine that a covered entity may submit aggregate data if the ,secretary determines that it is not feasible for the entity to submit claims-level data1 as required under this section4 7d7 ,restrictions on contracting entity ,the entity receiving a contract under subsection 7a7 shall-- 7#a7 ensure that it has no conflicts of interest1 including no direct contractual involvement with any covered entity1 payer1 or manufacturer participating in the drug discount program under section #cdj;,b of the ,public ,health ,service ,act2 7#b7 not disclose confidential information obtained through carrying out the clearinghouse duties under this section other than as necessary to carry out the purposes of this section1 including for program integrity functions2 7#c7 not sell or otherwise generate revenue by licensing or making available the data described in subsection 7b77#a72 and 7#d7 not collect pricing information regarding drugs that are not #cdj;,b drugs from covered entities4 7e7 ,duties of covered entity ,covered entities shall facilitate and participate in data transmission with the third-party entity with a contract in effect under subsection 7a71 including with respect to reporting on data available through contract pharmacies4 7f7 ,restrictions on manufacturer and ,,pbm use of data 7#a7 ,in general ,a manufacturer who receives data under subsection 7b77#e7 may use such data only for the purpose of preventing duplicate discounts and diversion under this section4 7#b7 ,restrictions on plans1 issuers1 and ,p,b,ms ,a health plan1 third-party administrator of a health plan1 or entity providing pharmacy benefit management services may use data received from the clearinghouse only for the purpose of preventing duplicate discounts and diversion under this section4 7#c7 ,enforcement ,any manufacturer or other person found by the ,secretary to have used data received under subsection 7b77#e7 for uses other than those described in paragraphs 7#a7 and 7#b71 such as for pricing or marketing1 shall be subject to civil monetary penalties1 pursuant to subpart ,o of part #ajjc of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 subject to the discretion of the ,secretary4 7g7 ,privacy requirements ,the information exchange required by subsection 7b7 shall occur in a manner consistent with the privacy1 security1 and breach notification regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif4 7h7 ,repayment to manufacturers ,the ,secretary shall require a covered entity to work with affected manufacturers regarding identified duplicate discounts for #cdj;,b drugs1 regardless of the method used to dispense the #cdj;,b drug1 which shall include repayment-- 7#a7 by the covered entity as a result of the covered entity's noncompliance with section #cdj;,b of the ,public ,health ,service ,act2 7#b7 by a ,state ,medicaid program of rebates improperly requested by the ,state ,medicaid program2 or 7#c7 by a ,state ,medicaid program where the financial benefit of the duplicate discount accrues to the ,state ,medicaid program1 regardless of whether the duplicate discount occurred under the fee-for-service or managed care payment arrangement4 7i7 ,definitions ,in this section3 7#a7 #cdj;,b drug ,the term #cdj;,b drug means a drug that is-- 7,a7 a covered outpatient drug 7as defined for purposes of section #cdj;,b of the ,public ,health ,service ,act72 and 7,b7 purchased under an agreement in effect under such section4 7#b7 ,covered entity ,the term covered entity means an entity described in section #cdj;,b7a77#d7 of the ,public ,health ,service ,act4 7#c7 ,diversion ,the term diversion1 with respect to a covered entity and a #cdj;,b drug1 means the resale or otherwise transferring of the drug to a person who is not a patient1 as defined in section #cdj;,b7b77#c7 of the ,public ,health ,service ,act1 of the covered entity4 7#d7 ,duplicate discount ,the term duplicate discount means a payment under title ,,xix for medical assistance described in section #aije7;a77#ab7 with respect to a #cdj;,b drug if the drug is subject to the payment of a rebate to the ,state under section #aibg4 7#e7 ,health plans ,the term health plan has the meaning given to that term in section #aabh;,c7c74 7#f7 ,manufacturer ,the term manufacturer has the meaning given to that term in section #aibg7k77#e74 4 7b7 ,prohibited actions of group health plans and ,p,b,ms 7#a7 ,in general ,a group health plan1 a health insurance issuer offering group or individual coverage 7as such terms are defined in section #bgia of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia771 or an entity providing pharmacy benefit management services may not interfere with the ability of covered entities1 contract pharmacies 7as such terms are defined in section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;b771 or manufacturers of drugs to prevent duplicate discounts or to recoup the full amount of any identified duplicate discounts pursuant to the drug discount program under section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;b74 7#b7 ,enforcement ,the ,secretary of ,health and ,human ,services shall impose civil monetary penalties1 pursuant to subpart ,o of part #ajjc of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 on any group health plan1 health insurance issuer1 or entity providing pharmacy benefit management services that violates paragraph 7#a74 7c7 ,oversight ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,administrator of the ,centers for ,medicare ,medicaid ,services and the ,administrator of the ,health ,resources and ,services ,administration1 shall issue a report to the appropriate committees of ,congress detailing coordinated efforts1 including through the use of existing resources to address duplicate discounts4 7d7 ,regulations ,the ,secretary of ,health and ,human ,services may promulgate such rules through notice and comment rulemaking as the ,secretary determines appropriate to advance the purpose of the drug discount program under section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7 and prevent duplicate discounts through the clearinghouse established by the amendment made by subsection 7a74 7e7 ,definition ,in this section1 the term duplicate discount has the meaning given such term in section #aaej;,d7h7 of the ,social ,security ,act1 as added by subsection 7a74 #aj4 ,patient financial assistance ,section #cdj;,b7a77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e771 as amended by section #h7;b71 is further amended by adding at the end the following3 7,h7 ,patient financial assistance 7i7 ,in general ,each covered entity shall-- 7,i7 ensure that its financial assistance policy is transparent to patients at point of care and publicly reported2 7,,ii7 apply such financial assistance policy to patients served by child sites and contract pharmacies2 and 7,,iii7 upon request of the ,secretary1 submit its financial assistance policy to the ,secretary4 7ii7 ,records ,the ,secretary shall require covered entities to maintain1 for a period of at least #c years1 auditable records related to the implementation and enforcement of this subparagraph4 7iii7 ,financial assistance policy defined ,in this subparagraph1 a financial assistance policy means-- 7,i7 7aa7 a written financial assistance policy described in section #eja7r77#d77;,a7 of the ,internal ,revenue ,code of #aihf1 provided1 at least1 to patients at #bjj percent of the ,federal poverty level or less2 and 7bb7 a sliding fee scale for covered outpatient drugs dispensed to patients under the drug discount program under this section1 as applicable2 or 7,,ii7 such other alternative policy as the ,secretary may determine with respect to a specific covered entity4 7iv7 ,oversight ,the ,comptroller ,general of the ,united ,states shall conduct a study and report to ,congress on the impact of requirements of this subparagraph on patient access to covered outpatient drugs purchased under this section4 7v7 ,language requirements ,a covered entity shall make the financial assistance policy described in clause 7i7 available to patients1 including patients served by child sites and contract pharmacies in plain language 7as defined in section #acaa7;e77#c77;,b7of the ,patient ,protection and ,affordable ,care ,act74 7vi7 ,rule of construction ,compliance with this subparagraph shall not be considered a prohibited act under section #aabh;,a1 #aabh;,b7b71 or #ahgg of the ,social ,security ,act4 7vii7 ,delayed effective date for certain entities ,with respect to a child site or contract pharmacy1 the requirements of this subparagraph shall apply beginning on the date that is #c years after the date of enactment of the ,,sustain #cdj;,b ,act4 4 #aa4 ,ensuring the equitable treatment of covered entities and pharmacies participating in the #cdj;,b drug discount program 7a7 ,group health plan and health insurance issuer requirements ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is amended by adding at the end the following3 #bgbi;,a4 ,requirements relating to the #cdj;,b drug discount program 7a7 ,in general ,a group health plan1 a health insurance issuer offering group or individual health insurance coverage1 or an entity providing pharmacy benefit management services on behalf of such a plan or issuer may not discriminate against a covered entity1 a #cdj;,b pharmacy1 or a participant1 beneficiary1 or enrollee of such plan or coverage by imposing requirements1 exclusions1 reimbursement terms1 or other conditions on such entity or #cdj;,b pharmacy that differ from those applied to entities or pharmacies that are not covered entities or #cdj;,b pharmacies on the basis that the entity or pharmacy is a covered entity or #cdj;,b pharmacy or that the entity or #cdj;,b pharmacy dispenses #cdj;,b drugs1 including by taking any action prohibited under subsection 7b74 7b7 ,specified prohibited actions ,a group health plan1 a health insurance issuer offering group or individual health insurance coverage1 or an entity providing pharmacy benefit management services on behalf of such a plan or issuer may not discriminate against a covered entity1 a #cdj;,b pharmacy1 or a participant1 beneficiary1 or enrollee of such plan or coverage by doing any of the following3 7#a7 ,reimbursing a covered entity or #cdj;,b pharmacy for a quantity of a #cdj;,b drug 7as defined in subsection 7d77 in an amount less than such plan1 issuer1 or entity providing pharmacy benefit management services 7as applicable7 would pay to any other similarly situated 7as specified by the ,secretary7 entity or pharmacy that is not a covered entity or a #cdj;,b pharmacy for such quantity of such drug on the basis that the entity or pharmacy is a covered entity or #cdj;,b pharmacy or that the entity or pharmacy dispenses #cdj;,b drugs4 7#b7 ,imposing any terms or conditions on any covered entity or #cdj;,b pharmacy1 with respect to any of the following that differ from such terms or conditions applied to other similarly situated 7as specified by the ,secretary7 entities or pharmacies that are not covered entities or #cdj;,b pharmacies on the basis that the entity or pharmacy is a covered entity or #cdj;,b pharmacy or that the entity or pharmacy dispenses #cdj;,b drugs3 7,a7 ,fees1 chargebacks1 clawbacks1 adjustments1 or other assessments4 7,b7 ,professional dispensing fees4 7,c7 ,restrictions or requirements regarding participation in standard or preferred pharmacy networks4 7,d7 ,requirements relating to the frequency or scope of audits or to inventory management systems using generally accepted accounting principles4 7,e7 ,any other restrictions1 conditions1 practices1 or policies that1 as specified by the ,secretary1 interfere with the ability of a covered entity to maximize the value of discounts provided under section #cdj;,b4 7#c7 ,interfering with an individual's choice to receive a #cdj;,b drug from a covered entity or #cdj;,b pharmacy1 whether in person or via direct delivery1 mail1 or other form of shipment4 7#d7 ,requiring a covered entity or #cdj;,b pharmacy to identify1 either directly or through a third party1 #cdj;,b drugs4 7#e7 ,refusing to contract with a covered entity or #cdj;,b pharmacy for reasons other than those that apply equally to entities or pharmacies that are not covered entities or #cdj;,b pharmacies1 or on the basis that-- 7,a7 the entity or pharmacy is a covered entity or a #cdj;,b pharmacy2 or 7,b7 the entity or pharmacy is described in any of subparagraphs 7,a7 through 7,o7 of section #cdj;,b7a77#d74 7#f7 ,with respect to a group health plan or health insurance issuer offering group or individual health insurance coverage1 denying coverage of a drug on the basis that such drug is a #cdj;,b drug4 7#g7 ,requiring a covered entity to make use of any #cdj;,b pharmacy in a manner that-- 7,a7 does not meet the requirements set forth in section #cdj;,b for the use of contract pharmacies2 or 7,b7 is inconsistent with patient need and access4 7#h7 ,failing to enable pharmacies to distinguish at the point-of-sale between private health plans and ,state ,medicaid plans sponsored by the same payer1 through methods such as using the same bank identification number and processor control number to identify individual enrolled in both types of plans4 7c7 ,civil monetary penalties ,the ,secretary shall impose monetary penalties1 pursuant to subpart ,o of part #ajjc of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 on any group health plan1 health insurance issuer offering group or individual health insurance coverage1 or entity providing pharmacy benefit management services on behalf of such a plan or issuer that violates the requirements of this section4 ,such penalty shall not exceed #e1jjj per violation per day4 ,the ,secretary shall issue proposed regulations to implement this subsection not later than #ahj days after the date of the enactment of this section and shall finalize such regulations not later than #a year after such date of enactment4 ,the penalties under this subsection may be in addition to other enforcement actions available under this title4 7d7 ,definitions ,for purposes of this section3 7#a7 ,contract pharmacy ,the term contract pharmacy has the meaning given such term in section #cdj;,b7b74 7#b7 ,covered entity ,the term covered entity has the meaning given such term in section #cdj;,b7a77#d74 7#c7 #cdj;,b drug ,the term #cdj;,b drug means a drug that is-- 7,a7 a covered outpatient drug 7as defined for purposes of section #cdj;,b72 and 7,b7 purchased under an agreement in effect under such section4 7#d7 #cdj;,b pharmacy ,the term #cdj;,b pharmacy means a pharmacy that is wholly-owned by a covered entity or that is a contract pharmacy4 4 7b7 ,medicare prescription drug plan and ,,ma-,,pd plan requirements ,section #ahfj;,d-#ab of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is amended by adding at the end the following new subsection3 7i7 ,nondiscrimination 7#a7 ,in general ,a ,,pdp sponsor offering a prescription drug plan or an ,,ma organization offering an ,,ma-,,pd plan may not require a covered entity to make use of any #cdj;,b pharmacy in a manner that-- 7,a7 does not meet the requirements set forth in section #cdj;,b of the ,public ,health ,service ,act for the use of #cdj;,b pharmacies2 or 7,b7 is inconsistent with patient need and access4 7#b7 ,definitions ,in this subsection-- 7,a7 the term contract pharmacy has the meaning given such term in section #cdj;,b7b7 of the ,public ,health ,service ,act2 7,b7 the term covered entity has the meaning given such term in section #cdj;,b of the ,public ,health ,service ,act2 and 7,c7 the term #cdj;,b pharmacy means a pharmacy that is wholly-owned by a covered entity or that is a contract pharmacy4 4 #ab4 ,user fee program 7a7 ,in general ,section #cdj;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a771 as amended by section #f7;a71 is further amended by adding at the end the following3 7#ae7 ,user fee program 7,a7 ,establishment of quarterly fee ,beginning in fiscal year #bjca1 the ,secretary shall in accordance with this section assess user fees on1 and collect such fees from1 each covered entity participating in the program under this section4 ,the fees shall be assessed for a fiscal year and collected quarterly during the last #c quarters of such fiscal year and the first quarter of the subsequent fiscal year1 and the total amount assessed and collected for a fiscal year shall be the amount specified in subparagraph 7,b77i7 for such year1 subject to subparagraph 7,c74 7,b7 ,assessment of user fees 7i7 ,amount of assessment ,the total amount of user fees authorized to be assessed and collected under subsection 7a7 for a fiscal year is-- 7,i7 #ej1jjj1jjj for fiscal year #bjca2 and 7,,ii7 for fiscal year #bjcb and each subsequent fiscal year1 the amount authorized to be assessed and collected in the previous fiscal year adjusted by the average annual percent change that occurred in the ,consumer ,price ,index for all urban consumers 7,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 in the #ab-month period ending ,june #cj preceding the fiscal year for which fees are being established4 7ii7 ,allocations of assessment by covered entity 7,i7 ,in general ,the total user fees assessed and collected under subparagraph 7,a7 each fiscal year with respect to each covered entity shall be an amount that is equal to the applicable percentage of covered outpatient drugs dispensed by such covered entity for the fiscal year multiplied by the amount specified in clause 7i7 for the fiscal year4 7,,ii7 ,applicable percentage ,for purposes of subclause 7,i71 the applicable percentage of each covered entity for a fiscal year shall be determined by-- 7aa7 dividing-- 7,,aa7 the number of prescriptions for covered outpatient drugs dispensed by the covered entity in the previous fiscal year2 by 7,,bb7 the total number of prescriptions for covered outpatient drugs dispensed by all covered entities in such fiscal year2 and 7bb7 multiplying the amount determined under item 7aa7 by #ajj4 7iii7 ,timing of assessment ,the ,secretary shall notify each covered entity subject to this section of the amount of the annual assessment imposed on such covered entity under this subsection not later than ,december #ca of the fiscal year for which such fees apply4 ,payments of such assessments shall be made in #d equal installments1 which shall be made by the last day of each quarter of the calendar year immediately following the notification4 7,c7 ,use of fees ,any fee collected under this paragraph shall be used by the ,secretary for purposes of administering this section and enhancing program integrity and oversight activities under this section1 including-- 7i7 the development of a multi-functional web-based system to collect fees under this paragraph2 7ii7 the establishment1 use1 and maintenance of the data clearinghouse under section #aaej;,d of the ,social ,security ,act2 7iii7 the improvement of the integrity1 transparency1 security1 searchability1 and reliability of the #cdj;,b ,office of ,pharmacy ,affairs ,information ,system 7or a successor to such system72 7iv7 improvements to the compliance tool used to integrate all information related to manufacturers that have entered into agreements with the ,secretary under paragraph 7#a7 and covered entities2 7v7 audits under this section of covered entities and such manufacturers2 and 7vi7 any other uses for the purposes of program integrity1 as the ,secretary determines appropriate4 7,d7 ,supplement not supplant ,any fees collected under this paragraph shall be used to supplement and not supplant amounts otherwise provided in appropriations ,acts to carry out this section4 7,e7 ,regulations ,the ,secretary may promulgate rules through notice and comment rulemaking as necessary to carry out the user fee program under this paragraph1 which shall include establishment of a process to provide for exceptions to the fee amount under subparagraph 7,b71 including the circumstances under which such exceptions may apply to certain covered entities4 7,f7 ,oversight of user fee program ,the ,inspector ,general of the ,department of ,health and ,human ,services shall-- 7i7 conduct an annual review of the user fee program under this paragraph for the first #e years of such program2 and 7ii7 not later than ,september #cj of each year for which a review is required under clause 7i71 submit to ,congress a report on the review conducted under clause 7i71 together with such recommendations as the ,inspector ,general determines appropriate4 4 7b7 ,conforming amendment ,section #cdj;,b7a77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#d77 is amended1 in the matter preceding subparagraph 7,a71 by inserting 1 has submitted user fees to the ,secretary in the amount assessed under paragraph 7#ae7 for the current year1 after paragraph 7#e74 #ac4 ,studies and reports 7a7 ,,gao report ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report on the debt collection practices of hospitals1 including hospitals that participate in the drug discount program under section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7 as covered entities described in subparagraphs 7,l7 through 7,o7 of subsection 7a77#d7of such section #cdj;,b4 7b7 ,,hhs study and report ,for the purpose of establishing reasonable dispensing fees for purposes of the drug discount program under section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b71 the ,secretary of ,health and ,human ,services shall-- 7#a7 conduct a study on such dispensing fees2 and 7#b7 not later than #b years after the date of enactment of this ,act1 submit to ,congress a report on the study under paragraph 7#a74 7c7 ,,aspe study ,the ,assistant ,secretary for ,planning and ,evaluation 7referred to in this subsection as the ,assistant ,secretary7 shall conduct a study on the interactions of the clearinghouse established under section #aaej;,d of the ,social ,security ,act 7as added by section #i7 and any data collection system established by the ,secretary to carry out section #aaic7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#b7;d77 or section #ahfj;,d-#ad;,b7b77#a77;,b7 of such ,act 7#db ,u4,s4,c4 #aciew-#aad;b7b77#a77;,b77 to limit duplicative discounts for outpatient prescription drugs4 ,the ,assistant ,secretary shall make recommendations to ,congress on ways to streamline and effectively operate such clearinghouse and data collection systems4 #ad4 ,additional resources 7a7 ,funding ,section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7d77#d77 is amended by adding at the end the following3 7f7 ,authorization of appropriations 7#a7 ,authorization of appropriations for audits1 investigations1 and other oversight and enforcement activities ,in addition to amounts made available under subsection 7d77#d71 there are authorized to be appropriated1 to the ,inspector ,general of the ,department of ,health and ,human ,services1 #c1jjj1jjj for each of fiscal years #bjbg through #bjca1 for purposes of conducting audits1 investigations1 and other oversight and enforcement activities with respect to the drug discount program under this section4 7#b7 ,authorization of appropriations for general purposes ,in addition to amounts made available under paragraph 7#a7 and subsection 7d77#d71 there are authorized to be appropriated #i1jjj1jjj for each of fiscal years #bjbg through #bjcj1 for purposes of implementing the activities under this section1 as added by the ,,sustain #cdj;,b ,act4 4 7b7 ,hiring authority2 regulations ,section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b71 as amended by subsection 7a71 is further amended by adding at the end the following3 7g7 ,hiring authority ,the ,administrator of the ,health ,resources and ,services ,administration may hire such additional staff as may be necessary for purposes of carrying out this section4 7h7 ,regulations ,the ,secretary shall promulgate regulations through notice and comment rulemaking1 as appropriate to implement this section4 4 #ae4 ,definitions ,section #cdj;,b7b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7b771 as amended by section #d7;a71 is further amended by adding at the end the following3 7#f7 ,child site ,in this section1 the term child site means a site that is wholly-owned and operated by a covered entity4 7#g7 ,contract pharmacy ,in this section1 the term contract pharmacy means a pharmacy with which a covered entity has contracted to dispense covered outpatient drugs on behalf of the covered entity whether distributed in person or via mail4 4 #af4 ,effective date ,this ,act1 including the amendments made by this ,act1 shall take effect on the date of enactment of this ,act4