,,ii #aaeth ,,congress #b;d ,session ,s4 #bcab ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #af1 #bjah,mr4 ,cassidy introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to provide a moratorium on registration of new non-rural section #cdj;,b hospitals and associated sites1 and for other purposes4 #a4 ,short title ,this ,act may be cited as ,helping ,ensure ,low-income ,patients have ,access to ,care and ,treatment or the ,,help ,act4 #b4 ,moratorium on registration of new non-rural section #cdj;,b hospitals and associated sites ,section #cdj;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77 is amended-- 7#a7 in paragraph 7#d77,l71 by striking ,a subsection 7d7 hospital and inserting ,subject to paragraph 7#aa71 a subsection 7d7 hospital2 and 7#b7 by adding at the end the following3 7#aa7 ,moratorium on registration of certain hospitals and associated sites of such hospitals ,during the #b-year period beginning on the date of enactment of the ,helping ,ensure ,low-income ,patients have ,access to ,care and ,treatment ,act-- 7,a7 an entity described in paragraph 7#d77,l7 shall not be considered a covered entity under this section unless such entity was a covered entity on ,december #ca1 #bjag 7as evidenced by the entity having been identified as a covered entity as of ,december #ca1 #bjag1 under the covered entity identification system established under subsection 7d77#b77;,b77iv772 and 7,b7 no site shall be added to the covered entity identification system established under subsection 7d77#b77;,b77iv7 or be permitted to begin participating in the drug discount program under this section1 as a child site or otherwise1 on the basis of association with a covered entity described in paragraph 7#d77,l7 unless such site was identified as a child site as of ,december #ca1 #bjag1 under the system established under subsection 7d77#b77;,b77iv74 7#ab7 ,regulations to be issued during the moratorium period to implement statutory requirements clarifying hospital eligibility criteria and hospital child site standards and enhancing hospital transparency 7,a7 ,issuance of regulations 7i7 ,in general ,during the moratorium period under paragraph 7#aa71 the ,secretary shall promulgate regulations through notice and comment rulemaking to implement the standards and requirements described in subparagraph 7,b74 7ii7 ,deadline ,such final regulations shall be promulgated and take effect-- 7,i7 before the end date of the moratorium described in paragraph 7#aa72 or 7,,ii7 in the event that any of such regulations have not taken effect by such end date1 the moratorium under subparagraph 7#aa7 shall be extended until such regulations are final and effective4 7iii7 ,limitation ,the authority to promulgate regulations under this paragraph is limited to setting forth the details necessary and appropriate to carry out the requirements of subparagraph 7,b7 efficiently1 effectively1 and in conformity with such subparagraph4 7,b7 ,standards and requirements 7i7 ,hospital ,child ,site ,standards 7,i7 ,in general ,hospitals described in subparagraphs 7,l7 and 7,m7 of paragraph 7#d7 may register off-campus outpatient facilities associated with the hospital 7also known as child sites7 to participate in the drug discount program under this section 7beginning after the moratorium under paragraph 7#aa7 ends71 if-- 7aa7 the site is listed on the hospital's most recently filed ,medicare cost report on a line that is reimbursable under the ,medicare program 7or1 if the hospital is a children's hospital that does not file a ,medicare cost report1 the hospital submits to the ,secretary a signed statement certifying that the facility would be correctly included on a reimbursable line of a ,medicare cost report if the hospital filed a cost report72 7bb7 such cost report demonstrates that the services provided at the facility have associated costs and charges for hospital outpatient department services under title ,,xviii of the ,social ,security ,act 7or1 if the hospital is a children's hospital that does not file a ,medicare cost report1 the hospital submits to the ,secretary a signed statement certifying that the services provided at the facility include or consist solely of outpatient services72 7cc7 the facility is wholly owned by the covered entity2 7dd7 the ,secretary has made a determination1 under the process described in section #dac4fe7;b7 of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 that the facility meets the ,medicare provider-based standards under section #dac4fe of title #db1 ,code of ,federal ,regulations 7or any successor regulations72 7ee7 the facility provides a full range of outpatient services1 in addition to drugs2 and 7ff7 the facility adheres to the charity care policy and any sliding fee scale policy of the parent hospital4 7,,ii7 ,de-registration ,if at any time following registration one or more of the standards listed above are no longer satisfied1 a registered hospital shall immediately notify the ,secretary1 de-register the facility1 and keep the facility from making any purchases under the drug discount program under this section or representing to third parties that it may purchase under such program4 7ii7 ,hospital eligibility standards for hospitals not owned or operated by a unit of ,state or local government ,for purposes of subparagraphs 7,l77i7 and 7,m7 of paragraph 7#d73 7,i7 ,a private hospital has been formally granted governmental powers by a unit of ,state or local government if-- 7aa7 the ,secretary receives a certification from a ,state or local governmental entity that such governmental entity has formally delegated1 through ,state or local statute or regulation or1 if permitted by applicable ,state or local law1 through a contract with a ,state or local government1 to the hospital a power1 described in detail in the certification2 7bb7 the power delegated as described in item 7aa7-- 7,,aa7 is a bona fide power that is usually or exclusively exercised by sovereign governments1 and is not merely the power to provide health care services on behalf of the government or to otherwise act on behalf of the government2 and 7,,bb7 in the case of a hospital1 is limited to the power to tax1 issue government bonds1 or quarantine individuals with communicable diseases2 and 7cc7 the certification described in item 7aa7 is accessible to the public as part of the information describing the hospital in the covered entity identification system established under subsection 7d77#b77;,b77iv7 7provided that such system specifies1 for each covered entity hospital1 whether it is publicly owned or operated1 a private nonprofit hospital formally granted governmental powers by a unit of ,state or local government1 or a private nonprofit hospital with a contract with a ,state or local government to provide health care services to low-income individuals who are ineligible for ,medicare and ,medicaid74 7,,ii7 ,a private hospital has a contract with a ,state or local government to provide health care services to low-income individuals who are not entitled to benefits under ,medicare or ,medicaid if-- 7aa7 the hospital submits a copy of the contract to the ,secretary for review2 7bb7 the ,secretary determines that the contract creates an enforceable obligation for the hospital to provide direct medical care to low-income individuals ineligible for ,medicare and ,medicaid in an amount that represents at least #aj percent of the hospital's total costs of care2 and 7cc7 the contract is available to the public as part of the information describing the hospital in the covered entity identification system established under subsection 7d77#b77;,b77iv74 7,,iii7 ,if at any time a hospital not owned or operated by a unit of ,state or local government no longer meets one or more requirements under subclause 7,i7 or 7,,ii71 the hospital shall immediately notify the ,secretary1 dis-enroll from the drug discount program under this section1 and stop making purchases under such program and representing to third parties that it may purchase under such program4 7iii7 ,hospital transparency requirements 7,i7 ,hospital requirements to identify section #cdj;,b drugs ,in the case of covered entity hospitals described in subsections 7,l7 and 7,m7 of paragraph 7#d73 7aa7 ,claims for covered outpatient drugs purchased under the drug discount program under this section shall be submitted to public and private payors using the #cdj;,b modifier established by the ,secretary under the prospective payment system for hospital outpatient department services1 in conformance with paragraph 7#bb7 of section #ahcc7t7 of the ,social ,security ,act1 subsection 7h7 of #ahdg;,a1 subparagraph 7,f7 of section #aibg7;a77#e71 and paragraph 7#e7 of section #aheg7;g71 that is ,,jg 7or ,,tb in the case of a claim for reimbursement under such system submitted by a hospital described in subparagraph 7,m7 of paragraph 7#d774 7bb7 ,such hospitals shall report to the ,secretary on an annual basis1 in a form and manner specified by the ,secretary-- 7,,aa7 the hospital's aggregate annual revenue from drugs purchased under the program under this section1 minus its aggregate annual acquisition costs for such drugs broken out by hospital and by each child site2 7,,bb7 the patient mix1 broken down by expected payment source 7including at least the ,medicare program under title ,,xviii of the ,social ,security ,act1 a ,state plan under the ,medicaid program under title ,,xix of such ,act1 private insurance1 and uninsured71 for each child site of the hospital listed in the covered entity information system established under subsection 7d77#b77;,b77iv71 the costs incurred at each site for charity care 7as described in line #bc of ,worksheet ,s-#aj--;,hospital ,uncompensated and ,indigent ,care ,data to the ,medicare cost report or as reported in any successor form72 7,,cc7 the percent of total revenues at each site derived from infusion or injection of physician-administered drugs2 and 7,,dd7 with respect to such hospital and each child site of the hospital1 the names of all third-party vendors or other similar entities that the covered entity contracts with to provide services associated with the program under this section 7broken down by covered entity and by each child site74 7,,ii7 ,public availability ,the ,secretary shall make the information reported to the ,secretary under subclause 7,i77bb7 available to the public 7with redactions of any information the ,secretary determines to be proprietary or confidential1 and in no case shall the report attribute specific discount information1 including the ceiling price1 to any individual drug product7 in an annual compilation of the reported information available on the internet website of the ,department of ,health and ,human ,services1 and as part of the information describing the hospital and the relevant child site in the covered entity identification system established under subsection 7d77#b77;,b77iv74 4 #c4 #cdj;,b claims modifier 7a7 ,medicaid ,section #aibg7;a77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;a77#e77 is amended by adding at the end the following3 7,f7 #cdj;,b claims modifier 7i7 ,in general ,all claims submitted to a ,medicaid fee-for-service program or a medicaid managed care organization 7as defined in section #aijc7m77#a77;,a77 for reimbursement of a unit of a covered outpatient drug subject to an agreement under section #cdj;,b of the ,public ,health ,service ,act shall include the #cdj;,b modifier established by the ,secretary under the prospective payment system for hospital outpatient department services under section #ahcc7t7 that is ,,jg or the ,submission ,clarification ,code of #bj developed by the ,national ,council for ,prescription ,drug ,programs 7,,ncpdp74 7ii7 ,data sharing ,each single ,state agency shall make available to a manufacturer of a covered outpatient drug any fee-for-service or managed care claim for reimbursement for a unit of such drug for the purpose of verifying the propriety of any claim for a rebate payment under an agreement under subsection 7b7 with respect to such drug4 ,at the manufacturer's request1 in lieu of making such a claim available to the manufacturer1 the single ,state agency may instead provide a list of claims 7and relevant data concerning each claim7 for covered outpatient drugs that were purchased under an agreement under section #cdj;,b of the ,public ,health ,service ,act or other summary data specified by the manufacturer4 7iii7 ,report ,each single ,state agency shall publish an annual report on utilization of covered outpatient drugs subject to an agreement under section #cdj;,b of the ,public ,health ,service ,act by the ,medicaid fee-for-service program or a medicaid managed care organization 7as defined in section #aijc7m77#a77;,a77 during the preceding calendar year4 ,the ,state agency shall not include confidential patient-specific1 drug-specific1 or manufacturer-specific information in any such annual report4 4 7b7 ,medicare 7#a7 ,medicare part ,b 7,a7 ,hospital outpatient department services ,section #ahcc7t7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is amended by adding at the end the following paragraph3 7#bb7 #cdj;,b claims modifier ,all claims submitted under the system under this subsection for reimbursement of a unit of a covered outpatient drug subject to an agreement under section #cdj;,b of the ,public ,health ,service ,act shall include the #cdj;,b modifier established by the ,secretary under such system that is ,,jg 7or ,,tb in the case of a claim for reimbursement under such system submitted by a hospital described in subparagraph 7,m7 or 7,n7 of section #cdj;,b7a77#d7 of the ,public ,health ,service ,act or a rural sole community hospital described in subparagraph 7,o7 of such section74 4 7,b7 ,other part ,b claims ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is amended by adding the following new subsection3 7h7 #cdj;,b claims modifier ,all claims submitted under this part 7other than under the prospective payment system for hospital outpatient department services under section #ahcc7t77 for reimbursement of a unit of a covered outpatient drug subject to an agreement under section #cdj;,b of the ,public ,health ,service ,act shall include the #cdj;,b modifier established by the ,secretary under such payment system that is ,,jg4 4 7#b7 ,medicare ,advantage and ,medicare part ,d ,section #aheg7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77 is amended by adding at the end the following new paragraph3 7#e7 #cdj;,b claims modifier ,all claims submitted to a ,medicare ,advantage organization or a ,,pdp sponsor under this part and part ,d1 respectively1 for reimbursement of a unit of a covered outpatient drug subject to an agreement under section #cdj;,b of the ,public ,health ,service ,act shall include the #cdj;,b modifier established by the ,secretary under the prospective payment system for hospital outpatient department services under section #ahcc7t7 that is ,,jg or the ,submission ,clarification ,code of #bj developed by the ,national ,council for ,prescription ,drug ,programs 7,,ncpdp74 4 7#c7 ,report on utilization under ,medicare part ,b ,the ,secretary of ,health and ,human ,services shall publish an annual report on utilization under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 of covered outpatient drugs purchased subject to an agreement under section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7 during the preceding calendar year4 ,the ,secretary shall not include confidential patient-specific1 drug-specific1 or manufacturer-specific information in any such annual report4 7c7 ,effective date ,the amendments made by this section take effect on the date that is #f months after the date of enactment of this ,act and apply to claims submitted on or after that date4 #d4 ,reports to ,congress ,section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7 is amended by adding at the end the following3 7f7 ,reports to ,congress 7#a7 ,,oig report ,not later than #b years after the date of the enactment of this subsection1 the ,office of the ,inspector ,general shall submit to ,congress a final report on the level of charity care provided by covered entities described in subparagraphs 7,l7 and 7,m7 of subsection 7a77#d7 and separately by child sites of such covered entities4 7#b7 ,,gao reports 7,a7 ,initial report ,not later than #a year after the date of the enactment of this subsection1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report-- 7i7 analyzing the ,state and local government contracts intended to satisfy the requirement under subsection 7a77#d77,l77i7 for a covered entity to qualify as an entity described in subparagraph 7,l7 of subsection 7a77#d72 7ii7 assessing the amount of care such contracts obligate such entity to provide to low-income individuals ineligible for ,medicare under title ,,xviii of the ,social ,security ,act and ,medicaid under title ,,xix of such ,act2 and 7iii7 analyzing how these contracts define low-income individuals and whether the ,secretary reviews such determinations4 7,b7 ,subsequent report ,not later than #b years after the date of the enactment of this subsection1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a final report on the difference between the aggregate gross reimbursement and aggregate acquisition costs received by each such covered entity 7including child sites of such entity7 for drugs subject to an agreement under this section4 4