,i #aaith ,,congress #ast ,session ,h4 ,r4 #fehj ,,in ,,the ,,house ,,of ,,representatives ,december #aj1 #bjbe,mrs4 ,miller-,meeks introduced the following bill2 which was referred to the ,committee on ,veterans' ,affairs ,a ,,bill ,to amend title #ch1 ,united ,states ,code1 to make certain improvements in the administration of the national formulary of the ,department of ,veterans ,affairs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,va ,national ,formulary ,act of #bjbe4 #b4 ,codification and improvement of ,department of ,veterans ,affairs national formulary 7a7 ,in general ,chapter #gc of title #ch1 ,united ,states ,code1 is amended by adding at the end the following new subchapter3 ,,vi ,national ,formulary #gche4 ,national formulary 7a7 ,establishment ,the ,secretary shall maintain a national formulary that shall consist of a list of all drugs and supplies that shall be available by prescription through all medical facilities of the ,department4 ,the ,pharmacy ,benefits ,management ,service of the ,department shall be responsible for managing the national formulary4 7b7 ,local formulary restrictions 7#a7 ,the national formulary shall be implemented uniformly across all ,department medical facilities4 ,except as provided in paragraph 7#b71 no ,veterans ,integrated ,service ,network or individual medical center may maintain a local formulary that includes a drug or medication not listed on the national formulary4 7#b7 ,a drug that is not on the national formulary may be provided to a veteran if-- 7,a7 the drug is provided under the nonformulary medication request process under section #gchg of this title2 or 7,b7 the ,under ,secretary for ,health 7or the ,under ,secretary's designee at the national level7 has explicitly approved a waiver allowing a ,veterans ,integrated ,service ,network or facility to carry the drug for a defined patient population or clinical program4 7#c7 7,a7 ,the ,director of a ,veterans ,integrated ,service ,network or of a medical facility may request a waiver under paragraph 7#b77;,b7 through the ,pharmacy ,benefits ,management ,services4 7,b7 ,the ,secretary shall establish a centralized review process for considering such waiver requests1 which shall include an assessment of clinical need1 safety1 and cost-effectiveness4 ,a waiver issued under this paragraph shall be time-limited and reviewed periodically for continuing necessity4 7,c7 ,nothing in this subsection shall be construed to limit the ability of a clinician to prescribe a nonformulary drug for a veteran when medically necessary in accordance with section #gchg of this title4 7c7 ,public communication of formulary decisions 7#a7 ,the ,secretary shall communicate regularly with the general public regarding the management of the national formulary4 ,such communication may include public briefings or online announcements to explain formulary decisions4 7#b7 ,in the case of any change to the national formulary that the ,secretary determines may significantly affect veteran care or access 7including the exclusion of a medication that was previously commonly used1 or the addition of a new high-cost therapy with usage restrictions71 the ,secretary shall publish a summary of the rationale for the change 7including consideration of clinical evidence and outcomes7 and1 when feasible1 hold a public briefing or stakeholder call to discuss the change and address questions4 7d7 ,reporting requirements 7#a7 ,the ,secretary shall submit to the ,committees on ,veterans' ,affairs of the ,senate and ,house of ,representatives an annual appeals report that includes a detailed description of nonformulary decisions and appeals made during the year covered by the report4 7#b7 ,not less frequently than annually during the five-year period beginning on the date of the enactment of this section1 the ,secretary shall submit to the ,committees on ,veterans' ,affairs of the ,senate and ,house of ,representatives1 and make publicly available1 a report that includes a summary of any changes made to the national formulary of the ,department during the preceding year4 ,each such report shall include a list of all drugs added to or removed from the formulary1 and any modifications to usage criteria or prior authorization requirements1 during the year covered by the report4 #gchf4 ,pharmacy and ,therapeutics ,committee 7a7 ,establishment ,there is established within the ,veterans ,health ,administration a ,pharmacy and ,therapeutics ,committee 7in this section referred to as the ,committee7 to support the ,pharmacy ,benefits ,management ,services in managing the national formulary of the ,department4 7b7 ,composition ,the members of the ,committee shall be selected by the ,secretary and shall be physicians from major clinical specialties1 clinical pharmacists1 and pharmacoeconomists who are employees of the ,department4 ,in selecting members of the ,committee1 the ,secretary shall ensure the inclusion of individuals with expertise in geriatric care and mental health care for veterans4 7c7 ,conflicts of interest 7#a7 ,the ,secretary shall ensure that each member of the ,committee is free of any conflict of interest with the pharmaceutical industry4 7#b7 ,the ,secretary shall-- 7,a7 require each member of the ,committee to annually disclose financial interests2 and 7,b7 prohibit the participation by any member in formulary decisions for which the member has a financial conflict of interest4 7d7 ,timely review of new medications ,the ,committee shall meet not less often than monthly 7or bimonthly7 to review newly approved drugs by the ,food and ,drug ,administration4 ,the goal of the ,committee with respect to each such newly approved drug shall be to make a national formulary inclusion or exclusion decision by not later than #abj days after the date on which the drug is approved1 to the extent practicable4 7e7 ,evidence-,based decision making ,the ,committee shall make decisions with respect to the national formulary of the ,department based on evidence-based drug monographs1 clinical data 7including data on real-world use and outcomes71 and pharmacoeconomic analyses of cost-effectiveness4 ,in making such decisions1 the ,committee shall consider the applicable clinical practice guidelines of the ,department and of the ,department of ,defense to ensure alignment with best practices in veteran care4 7f7 ,transparency of decisions ,for each significant addition to or removal from the national formulary of the ,department1 the ,secretary shall make publicly available on an appropriate website of the ,department a summary of the clinical rationale for the addition or removal1 including a description of the evidence and guidelines considered4 ,such summaries may not include proprietary pricing information or trade secrets4 #gchg4 ,nonformulary drug request process 7a7 ,electronic request system ,the ,secretary shall acquire or develop and implement a standardized electronic system for handling requests by clinicians of the ,department for drugs not included in the national formulary of the ,department4 ,this system shall be integrated with the electronic health record system of the ,department to allow treating clinicians to submit nonformulary drug requests as part of the prescribing workflow4 7b7 ,timeliness of decisions ,the ,secretary shall establish a process to ensure that any request by a ,department clinician for a nonformulary drug is decided upon promptly4 ,under such process1 an initial decision on a nonformulary request shall be communicated to the requesting clinician within #if hours after the request is submitted4 ,in any case where a nonformulary request is denied1 the veteran 7and the requesting clinician7 shall be informed of the denial and of the right to appeal under subsection 7e74 ,if an appeal is filed1 a decision with respect to the appeal shall be rendered not later than seven days after the date on which the appeal is submitted4 7c7 ,consistent criteria and approval standards ,the ,secretary shall establish uniform criteria for evaluating nonformulary drug requests1 which shall be applied across all ,veterans ,integrated ,service ,networks 7herinafter referred to as ,v,i,s,ns7 and medical facilities of the ,department to ensure consistency4 ,such criteria shall be evidence-based and shall be made available to ,department clinicians4 7d7 ,portability of approvals ,an approval for a nonformulary drug under this section shall be valid throughout the ,veterans ,health ,administration4 ,in the case of a veteran for whom a nonformulary drug has been approved and who chooses to receive hospital care or medical services at a different medical center or ,,visn of the ,department1 the nonformulary approval 7including any established renewal date or duration of approval7 shall remain in effect at the new location1 subject to the same clinical conditions or monitoring requirements that were originally imposed4 7e7 ,appeals process 7#a7 ,the ,secretary shall establish a tiered appeals process for nonformulary drug decisions4 ,at a minimum1 such process shall provide-- 7,a7 an opportunity for review of an initial denial by a secondary clinical reviewer or pharmacy committee at the regional or ,,visn level2 and 7,b7 a further opportunity for appeal to a national-level authority within the ,pharmacy ,benefits ,management ,services of the ,department1 whose decision shall be final within the ,department4 7#b7 ,the ,secretary shall ensure that all clinicians of the ,department are informed of the appeals process and that appeals are resolved within the timeframe specified in subsection 7b74 #gchh4 ,formulary management and drug therapy programs 7a7 ,periodic therapeutic class reviews ,in order to maintain a clinically appropriate and up-to-date formulary1 the ,secretary shall require regular reviews of groups of drugs by therapeutic class4 7b7 ,medication therapy management and drug use review 7#a7 ,the ,secretary shall provide drug therapy management for veterans1 with a particular focus on polypharmacy and high-risk medications4 7#b7 ,as part of such drug therapy management1 clinical pharmacy specialists shall provide comprehensive drug reviews for veterans who are on complex regimens of drugs or are at increased risk of adverse drug events4 7#c7 ,the ,secretary shall-- 7,a7 conduct regular reviews of drug use to identify trends1 including inappropriate prescribing1 drug duplication1 or need for dose optimization2 and 7,b7 provide interventions1 including provider education or patient outreach1 based on the results of such reviews in order to improve therapeutic outcomes and promote drug safety and adherence4 4 7b7 ,clerical amendment ,the table of sections at the beginning of such chapter is amended by adding at the end the following new items3 ,subchapter ,,vi--,national ,formulary#gche4 ,national formulary4#gchf4 ,pharmacy and ,therapeutics ,committee4#gchg4 ,nonformulary drug request process4#gchh4 ,formulary management and drug therapy programs4 4 #c4 ,department of ,veterans ,affairs pharmaceutical purchasing agreements 7a7 ,formulary-,based pricing and value-,based agreements 7#a7 ,in general ,subchapter ,,ii of chapter #ha of title #ch1 ,united ,states ,code1 is amended by inserting after section #habi the following new section3 #hacj4 ,pharmaceutical purchasing agreements and value-based initiatives 7a7 ,negotiation of supplemental discounts 7#a7 ,in addition to the limitations on the prices of drugs in effect pursuant to section #habf of this title1 the ,secretary may negotiate additional discounts or price concessions with manufacturers of drugs procured by the ,department4 7#b7 ,in conducting negotiations under this paragraph1 the ,secretary may-- 7,a7 take into consideration the placement or tiered status of a drug on the national formulary of the ,department2 and 7,b7 enter into an agreement with a manufacturer under which the manufacturer offers a discounted price or rebate for a drug in exchange for preferred status for the drug on the national formulary of the ,department1 if the ,secretary determines the agreement will provide clinically appropriate outcomes for veterans and net cost savings or value to the ,department4 7#c7 ,nothing in this subsection shall be construed to supersede the price limitations under section #habf of this title4 ,the ,secretary shall ensure that any agreement entered into under this subsection with respect to a drug that is a covered drug under such section results in prices that are lower than the maximum price allowed under such section for such drug4 7b7 ,use of flexible purchasing arrangements 7#a7 ,to the extent practicable1 the ,secretary shall use industry best practices in the procurement of drugs and medical supplies1 including the use of blanket purchase agreements1 ordering agreements1 and other volume-leveraging contracts to achieve favorable pricing4 7#b7 ,the ,secretary may pursue value-based purchasing arrangements with manufacturers of drugs and biological products to be included on the national formulary4 ,such arrangements may include contracts under which the manufacturer agrees to provide the drugs or biological products to the ,secretary in exchange for payment in an amount that is determined based upon the effectiveness of the drug or biological product for veterans to whom the drug or biological product is prescribed4 ,if the ,secretary enters into such a contract under this paragraph1 the ,secretary shall ensure that the contract includes a mechanism to monitor the effectiveness of the drug or biological product and to adjust payments or rebates accordingly4 7c7 ,outcome and cost-,effectiveness evaluations 7#a7 ,the ,secretary shall conduct periodic reviews of the outcomes and budgetary effects associated with major changes to the national formulary or pharmaceutical initiatives of the ,department4 ,not later than #ahj days after concluding a periodic review under this paragraph1 the ,secretary shall submit to the ,committees on ,veterans' ,affairs of the ,senate and ,house of ,representatives the results of the review4 7#b7 ,not later than one year after implementing any significant action affecting the national formulary1 including adding a high-cost drug with usage criteria or removing a clinically used drug from the formulary1 the ,secretary shall evaluate the effects of that action on veteran health outcomes1 drug use patterns1 and overall costs to the ,department4 ,the ,secretary shall make findings from such evaluations available to the ,committees on ,veterans' ,affairs of the ,senate and ,house of ,representatives and use the findings to inform future formulary decisions and purchasing agreements4 7d7 ,biological product defined ,in this section1 the term biological product has the meaning given such term in section #cea7;i77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i77#a774 4 7#b7 ,clerical amendment ,the table of sections at the beginning of such chapter is amended by adding at the end the following new item3 #hacj4 ,pharmaceutical purchasing agreements and value-based initiatives4 4 7b7 ,establishment of tiered schedule for copayments 7#a7 ,in general ,section #agbb;,a of title #ch1 ,united ,states ,code1 is amended by adding at the end the following new subsection3 7d7 7#a7 ,for the purpose of encouraging the use of clinically appropriate1 cost-effective drugs by veterans while maintaining access to nonformulary drugs that are medically necessary1 the ,secretary shall establish a tiered schedule for the amount of the copayments charged to veterans for drugs furnished under this chapter4 7#b7 ,under the tiered schedule established under this subsection1 the amount of a copayment for a #cj-;day supply of a generic drug or a drug listed on the national formulary of the ,department shall be lower than amount of a copayment a #cj-;day supply of a brand-name drug or a drug not included on such national formulary4 4 7#b7 ,update of cross-reference ,subsection 7a77#c77;,d7 of such section is amended by striking section #dia and inserting section #bgcb4 #d4 ,veterans ,formulary ,advisory ,committee 7a7 ,establishment ,the ,secretary of ,veterans ,affairs shall establish an advisory committee1 to be known as the ,veterans ,formulary ,advisory ,committee 7in this section referred to as the ,advisory ,committee74 ,the ,advisory ,committee shall provide veteran and clinician input on the national formulary of the ,department of ,veterans ,affairs4 7b7 ,membership ,the ,advisory ,committee shall consist of not more than ten members and shall include front-line clinical providers or pharmacists of the ,department who are not involved in national formulary decision-making and other stakeholder representatives as the ,secretary considers appropriate4 7c7 ,meetings ,the ,advisory ,committee shall meet at regular intervals 7at least semiannually7 and shall review proposed formulary changes4 7d7 ,responsibilities ,the ,advisory ,committee may provide to the ,secretary and to the ,pharmacy and ,therapeutics ,committee established under section #gchf of title #ch1 ,united ,states ,code1 the independent feedback or recommendations of the ,advisory ,committee regarding proposed additions1 removals1 and restrictions pertaining to the national formulary1 including with respect to any potential effects on veteran patients4 ,recommendations of the ,advisory ,committee shall be advisory in nature4 7e7 ,termination ,the ,advisory ,committee shall terminate on the date that is two years after the date of the establishment of the ,advisory ,committee4