,i #aagth ,,congress #b;d ,session ,h4 ,r4 #icba ,,in ,,the ,,house ,,of ,,representatives ,november #af1 #bjbb,ms4 ,speier 7for herself1 ,mr4 ,nadler1 and ,ms4 ,porter7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,public ,health ,service ,act to provide for the development and publication of independent value assessments for drugs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,independent ,drug ,value ,assessment ,act4 #b4 ,independent value assessments for drugs ,part ,d of title ,,iii of the ,public ,health ,service ,act 7#ba ,u4,s4,c4 #bed;b et seq47 is amended by adding at the end the following3 ,,xiii ,independent value assessments for drugs #cdj;,j4 ,independent value assessments 7a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary for ,planning and ,evaluation1 shall complete1 by contract under subsection 7e71 an independent value assessment for any drug-- 7#a7 that is approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 or licensed under section #cea7;a7 of the ,public ,health ,service ,act1 on or after the day that is #a year after the date of enactment of this section2 or 7#b7 for which a new indication or use is approved or licensed under such section #eje7;c7 or #cea7;a7 on or after such day4 7b7 ,timeline ,the ,secretary shall ensure that an independent value assessment required by subsection 7a7 is completed not later than #ij days after the effective date of the approval or licensure involved4 7c7 ,previously approved drugs ,the ,secretary shall-- 7#a7 not later than #e years after the date of enactment of this section1 complete1 by contract under subsection 7e71 an independent value assessment for no fewer than #be drugs not described in subsection 7a72 and 7#b7 in selecting drugs for assessment under paragraph 7#a71 prioritize-- 7,a7 drugs in the top #ce percent of expenditures for particular drugs under part ,b or ,d of title ,,xviii of the ,social ,security ,act2 and 7,b7 drugs approved as a breakthrough therapy pursuant to section #ejf7;a71 as a fast track product pursuant to section #ejf7;b71 or pursuant to accelerated approval under section #ejf7;c74 7d7 ,publication ,the ,secretary shall publish each independent value assessment prepared under subsection 7a7 or 7c7 on the public website of the ,department of ,health and ,human ,services without modification1 except that the ,secretary may redact any confidential or proprietary information in accordance with applicable law4 7e7 ,contracts 7#a7 ,in general ,to the extent and in the amounts made available in advance in appropriations ,acts1 the ,secretary shall enter into a contract with an eligible entity to develop an independent value assessment under this section4 7#b7 ,eligible entities ,to be eligible to prepare an independent value assessment under this section1 an entity-- 7,a7 shall be a nonprofit organization1 a university1 a federally funded research and development center1 or another type of organization that is determined by the ,secretary to be capable of developing such an independent value assessment2 7,b7 shall not be an entity that-- 7i7 is involved in the manufacturing1 research1 and development of drugs2 or 7ii7 operates fully insured and self-insured health plans1 pharmaceutical benefit managers1 or other entities that pay for drugs2 and 7,c7 shall be1 as determined by the ,secretary1 independent of any other entity described in subparagraph 7,b74 7#c7 ,information 7,a7 ,information in possession of ,,hhs ,the ,secretary shall ensure that any organization under contract to develop an independent value assessment under this section has access to all of the information in the possession of the ,department of ,health and ,human ,services that is necessary to complete the assessment4 7,b7 ,information in possession of manufacturer ,the manufacturer of any drug for which an independent value assessment is being developed under this section shall1 at the request of the ,secretary or the entity under contract to develop the independent value assessment1 provide to the ,secretary or entity1 as applicable1 information in the possession of the manufacturer that is necessary to complete the assessment4 7,c7 ,additional information ,an entity under contract to develop an independent value assessment under this section for a drug shall offer manufacturers1 patient advocates1 clinical experts1 and members of the public an opportunity to submit additional information and analyses for consideration before the independent value assessment is complete4 7f7 ,prohibitions ,the ,secretary shall prohibit the use in any independent value assessment under this section of-- 7#a7 any analysis based on the quality-adjusted life year2 and 7#b7 any research findings that do not weigh the value of each year of life gained from treatment equally for all patients no matter their severity of illness1 age1 or pre-existing disability4 7g7 ,definitions ,in this section3 7#a7 ,the term independent value assessment means an economic analysis that-- 7,a7 analyzes the benefits of a particular drug for the average patient and for various subgroups of patients1 as determined by the ,secretary1 and the benefits of the drug on a standalone basis and in comparison with other approved treatments1 including-- 7i7 an economic analysis of direct benefits to the patient1 including to the quality and duration of life of the patient2 and 7ii7 an economic analysis of indirect benefits1 including-- 7,i7 benefits to the earnings capacity of the patient2 7,,ii7 benefits to family members1 employers1 and caregivers of the patient2 and 7,,iii7 benefits to the health care system1 including savings to public- and private-sector payers resulting from potential use of health services that is avoided due to the benefits of the particular drug2 and 7,b7 includes an estimate of a price1 price range1 or a proposed value-based payment arrangement for the particular drug that is commensurate with the economic benefits of the particular drug1 including a list and explanation of the factors that support the estimated price1 price range1 or proposed value-based payment arrangement4 7#b7 ,the term value-based payment arrangement-- 7,a7 means a form of payment for a drug1 other than a fixed payment per dose or other standard administration of the drug1 that takes into consideration the effectiveness of the drug2 and 7,b7 may include an overall payment for a course of treatment with the drug1 an overall payment to cover all indicated uses of the drug for a particular population1 or another approach to payment1 any of which may include a provision to vary the amount of the payment based on the effectiveness of the drug for an individual or a population1 as the case may be4 4