,i #aahth ,,congress #b;d ,session ,h4 ,r4 #gfce ,,in ,,the ,,house ,,of ,,representatives ,march #ab1 #bjbd,ms4 ,matsui introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend title ,,iii of the ,social ,security ,act to ensure the accessibility of drugs furnished under the #cdj;,b drug discount program4 #a4 ,short title ,this ,act may be cited as ,the #cdj;,b ,pharmaceutical ,access ,to ,invest in ,essential1 ,needed ,treatments ,support ,act of #bjbd or ,the #cdj;,b ,,patients ,act of #bjbd4 #b4 ,findings and purposes 7a7 ,findings ,congress finds the following3 7#a7 ,section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7 enables covered entities to stretch scarce resources as far as possible1 reaching more patients and providing more comprehensive services than without such program2 7#b7 ,section #cdj;,b requires drug manufacturers to offer discounted prices on covered outpatient drugs to covered entities participating in the program1 as a condition of participating in the ,medicaid or ,medicare ,part ,b programs1 and drug manufacturers must offer #cdj;,b pricing to covered entities and sell #cdj;,b and deliver #cdj;,b drugs to covered entities when requested irrespective of the manner or location through which a #cdj;,b drug is dispensed4 7#c7 ,savings from section #cdj;,b enables hospitals1 clinics1 and health centers' to provide comprehensive services to the communities they serve1 and covered entities are in the best position to assess the use of their savings for community needs4 7#d7 ,since the early years of the #cdj;,b program1 covered entities have contracted with pharmacies to dispense covered outpatient drugs purchased by a covered entity at #cdj;,b pricing to patients of the covered entity1 consistent with how ,congress intended for covered entities to use the program4 7#e7 ,covered entities use savings generated through #cdj;,b contract pharmacy relationships to stretch scarce resources and support patient care1 consistent with the purpose of the program4 7#f7 ,section #cdj;,b requires drug manufacturers to offer #cdj;,b pricing for drugs purchased by covered entities regardless of the manner or location in which a drug is dispensed1 including drugs dispensed through contract pharmacies4 7#g7 ,section #cdj;,b does not allow drug manufacturers to place conditions on the ability of a covered entity to purchase or use a covered outpatient drug at #cdj;,b pricing regardless of the manner or location in which a drug is dispensed1 including by restricting a covered entity's ability to dispense #cdj;,b drugs to patients through a contractual relationship with a contracted pharmacy or refusing to ship covered outpatient drugs to a pharmacy or location identified by a covered entity4 7#h7 ,section #cdj;,b's inflationary penalty provisions1 which have saved #g billion in ,medicare ,part ,d spending between #bjac and #bjag1 have a proven record of reducing drug price increases1 and use of #cdj;,b in contract pharmacies contributes to these savings4 7#i7 ,specialty drugs1 which are often used to treat chronic1 serious1 or life-threatening conditions such as cancer1 rheumatoid arthritis1 growth hormone deficiency1 and multiple sclerosis1 play a critical role in the care provided by covered entities4 ,these drugs often require specialized handling1 are not usually available to walk-in customers1 and are typically available only through specialty or mail order pharmacies that are located hundreds of miles from a covered entity4 ,the use of contract pharmacy arrangements under ,section #cdj;,b are often the only means by which covered entities can access these vital drugs4 7b7 ,purposes ,the purposes of this ,act are the following3 7#a7 ,to clarify that section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7 requires drug manufacturers to offer #cdj;,b pricing for drugs purchased by a covered entity regardless of the manner or location in which the drug is dispensed1 and section #cdj;,b prohibits drug manufacturers from placing conditions on the ability of covered entities to purchase and use #cdj;,b drugs1 regardless of the manner or location in which they are dispensed4 7#b7 ,to clarify that covered entities under section #cdj;,b may contract with pharmacies to dispense on a covered entity's behalf drugs purchased by a covered entity under section #cdj;,b to generate savings to assist covered entities to stretch resources to provide care to more patients and provide more comprehensive services1 and the requirements and prohibitions that apply to manufacturers under section #cdj;,b apply in the case of a covered entity that elects to contract with a pharmacy to dispense #cdj;,b drugs4 #c4 ,ensuring the accessibility of drugs furnished under the #cdj;,b drug discount program 7a7 ,in general ,section #cdj;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking that the manufacturer furnish and inserting the following3 that-- 7,a7 the manufacturer furnish 2 7,b7 by striking ceiling price71 and and inserting ceiling price722 7,c7 by striking shall require that the manufacturer offer and inserting the following3 7,b7 the manufacturer offer 2 and 7,d7 by striking the period at the end and inserting the following3 1 regardless of the manner or location in which the drug is dispensed2 and 7,c7 the manufacturer not place conditions on the ability of a covered entity to purchase and use a covered outpatient drug at or below the applicable ceiling price1 regardless of the manner or location in which the drug is dispensed1 including but not limited to placing limits on the delivery of drugs1 placing limits on the mechanisms through which drugs may be purchased1 placing limits on where such drugs may be delivered1 administered1 or dispensed1 requiring a covered entity's assurance of compliance with requirements under this section1 or requiring the submission of claims data or other information1 except that1 notwithstanding this subparagraph1 the manufacturer may impose such conditions after receiving advance approval from the ,secretary 7or1 with respect to conditions specified by the ,secretary1 without such advance approval7 if such conditions would not discourage covered entities from purchasing the manufacturer's drugs through the drug discount program under this section or otherwise undermine the objective of this section1 either by singling out covered entities from other customers for such conditions or by imposing conditions that disproportionately impact covered entities4 2 and 7#b7 by adding at the end the following new paragraph3 7#aa7 ,contract ,pharmacies ,the requirements and prohibitions under subsection 7a77#a7 shall apply1 in the case of a covered entity that elects to contract with one or more pharmacies to dispense covered outpatient drugs purchased by a covered entity at or below the applicable ceiling price described in paragraph 7#a71 to patients of the covered entity4 4 7b7 ,manufacturer compliance ,section #cdj;,b7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7 is amended-- 7#a7 in paragraph 7#a77;,b77vi71 by inserting in the case of an overcharge after penalties2 7#b7 in paragraph 7#a77;,b71 by adding at the end the following3 7vii7 ,the imposition of sanctions in the form of civil monetary penalties in the case of a violation of subsection 7a77#a7 or subsection 7a77#aa71 other than an overcharge1 which-- 7,i7 shall be assessed according to standards established in regulations to be promulgated by the ,secretary not later than #ahj days after the date of enactment2 7,,ii7 shall apply to any manufacturer with an agreement under this section that knowingly and intentionally violates a requirement under subsection 7a77#a7 or subsection 7a77#aa71 other than an overcharge2 7,,iii7 shall not exceed #b1jjj1jjj for each day of such violation2 7,,iv7 shall be determined by the ,secretary1 taking into account factors such as the nature and extent of the violation and harm resulting from such violation1 including1 where applicable1 the number of drugs affected and the number of covered entities affected2 and 7,v7 shall continue to be imposed each day until such manufacturer is no longer in violation of a requirement under subsection 7a77#a7 or subsection 7a77#aa71 other than an overcharge4 2 and 7#c7 in paragraph 7#c71 by adding at the end the following3 7,d7 ,not later than #ahj days after the date of the enactment of this subparagraph1 the ,secretary shall promulgate regulations to permit covered entities to assert claims of violations of subsection 7a77#a7 and subsection 7a77#aa7 under the process promulgated under subparagraph 7,a74 4