,,ii #aahth ,,congress #ast ,session ,s4 #bahh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bb1 #bjbc,ms4 ,smith introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to increase access to pre-exposure prophylaxis to reduce the transmission of ,,hiv4 #a4 ,short title ,this ,act may be cited as the ,pr,e,p ,access and ,coverage ,act of #bjbc4 #b4 ,findings2 sense of ,congress 7a7 ,findings ,congress finds the following3 7#a7 ,the ,centers for ,disease ,control and ,prevention estimates that approximately #a1bjj1jjj individuals in the ,united ,states are living with ,,hiv4 7#b7 ,in #bjba1 there were #cf1acf new diagnoses of ,,hiv in the ,united ,states4 7#c7 ,,hiv disproportionately impacts gay and bisexual men1 transgender women1 and1 in particular1 people of color4 ,in #bjba1 approximately #ga percent of new ,,hiv diagnoses were estimated to be among gay and bisexual men1 #dj percent of new ,,hiv diagnoses were among ,black people1 and #bi percent of new ,,hiv diagnoses were among ,latinx people4 ,recent studies suggest that transgender women are up to #di times more likely to be diagnosed with ,,hiv than the general population4 ,members of communities at the intersections of these groups are most heavily impacted4 7#d7 ,pre-exposure prophylaxis 7referred to in this section as ,pr,e,p7 is a daily antiretroviral medication that helps prevent individuals from acquiring ,,hiv4 ,daily ,pr,e,p use reduces the risk of getting ,,hiv from sex by more than #ii percent4 ,it reduces the risk of getting ,,hiv from injection drug use by at least #gd percent4 7#e7 ,many individuals at risk of exposure to ,,hiv do not use ,pr,e,p4 ,of the approximately #a1bjj1jjj individuals in the ,united ,states who could benefit from ,pr,e,p1 only #ca percent1 or #chb1cfd individuals1 filled prescriptions for the drug in #bjbb4 7#f7 ,pr,e,p usage is inconsistent across racial and gender lines4 ,in #bjbb1 only #aa percent of ,black_/,african ,american and #ba percent of ,hispanic_/,latinx individuals who were eligible for ,pr,e,p were prescribed it1 compared to #hb percent of eligible ,white individuals4 ,pr,e,p usage is low among women1 in particular among heterosexual women of color4 ,slightly less than #ab percent of women eligible for ,pr,e,p received a prescription in #bjbb4 7#g7 ,pr,e,p use helps strengthen families by allowing couples with partners of different ,,hiv statuses to prevent the transmission of ,,hiv4 7#h7 ,there are currently #b brand name drugs and #a generic drug approved by the ,food and ,drug ,administration for the use of ,pr,e,p on a daily basis4 ,a long-acting injectable ,pr,e,p drug has also been approved by the ,food and ,drug ,administration4 ,other types of ,,hiv prevention treatments1 including other long-acting injectables1 long-acting oral pills1 implants1 and vaginal rings are in the research pipeline4 ,these innovations can increase widespread use of ,pr,e,p along with adherence1 which can speed the ,nation's goal to end ,,hiv and address inequities in health care4 7#i7 ,section #bgac of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ac7 requires non-grandfathered private health insurance plans to cover preventive services without cost-sharing1 including such services with a rating of ,a or ,b under recommendations of the ,united ,states ,preventive ,services ,task ,force4 ,on ,june #aa1 #bjai1 the ,united ,states ,preventive ,services ,task ,force issued a final recommendation giving an ,a grade for ,pr,e,p for individuals at high risk of ,,hiv2 non-grandfathered private health insurance plans have to cover ,pr,e,p for such individuals without cost-sharing effective ,january #bjba4 ,updated ,united ,states ,preventive ,service ,task ,force guidance incorporating the new long-acting injectable ,pr,e,p drug is pending4 7#aj7 ,joint guidance issued by the ,department of ,labor1 the ,department of ,health and ,human ,services1 and the ,department of the ,treasury on ,july #ai1 #bjba1 clarifies that ancillary services necessary to maintain the ,pr,e,p regime1 including subsequent provider visits1 clinical testing1 and other services1 is required to be covered by health insurers without cost-sharing4 7#aa7 ,permanently expanding access to cost-free ,pr,e,p and ancillary services for all individuals1 including individuals who do not have health insurance1 through legislation1 is a critical step towards eliminating ,,hiv transmission4 7#ab7 ,post-exposure prophylaxis 7referred to in this section as ,,pep7 is a daily antiretroviral treatment which1 when initiated promptly after a sexual or other exposure to blood or body fluids that are associated with a high risk of ,,hiv transmission1 is highly effective at preventing ,,hiv transmission4 7#ac7 ,the ,centers for ,disease ,control and ,prevention recommends ,,pep for an individual who has experienced a high-risk exposure incident1 provided that the individual tests ,,hiv-negative1 initiates such treatment not later than #gb hours after exposure1 and continues the treatment for #bh days4 7#ad7 ,despite ,,pep's proven effectiveness in preventing ,,hiv transmission after high-risk sexual exposures1 including sexual assault1 awareness of ,,pep is low among individuals who would benefit from the treatment4 ,studies suggest that awareness of ,,pep and of the importance of its prompt initiation is particularly low among young gay and bisexual men of color1 transgender individuals1 and women of all gender identities4 7#ae7 ,adequate knowledge of guidelines issued by the ,centers for ,disease ,control and ,prevention for assessing indications for ,,pep and for initiating and sustaining ,,pep are low among health care providers and staff4 ,because ,,pep is an emergency intervention1 insufficient knowledge among providers and staff in hospital emergency rooms1 urgent care centers1 community health centers1 and primary care physicians is of particular concern4 7#af7 ,private and public health insurance plans and programs frequently impose requirements for coverage of ,,pep1 including pre-authorization requirements and requirements to obtain the medications through designated specialty pharmacies and mail-order programs that pose significant obstacles to timely initiation of treatment4 7#ag7 ,insurance deductibles and co-payments for ,,pep medications create significant barriers to ,,pep utilization by many individuals who have experienced high-risk incidents4 7#ah7 ,the ,federal ,government has a compelling interest in preventing new cases of ,,hiv4 ,lowering the prevalence of ,,hiv protects public health and saves on the cost of ,,hiv treatment4 7b7 ,sense of ,congress ,it is the sense of ,congress that the ,department of ,labor1 the ,department of ,health and ,human ,services1 and the ,department of the ,treasury should ensure compliance with the requirements described in paragraphs 7#i7 and 7#aj7 of subsection 7a74 #c4 ,coverage of ,,hiv testing and prevention services 7a7 ,private insurance 7#a7 ,in general ,section #bgac7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ac7;a77 is amended-- 7,a7 in paragraph 7#b71 by striking 2 and and inserting a semicolon2 7,b7 in paragraph 7#c71 by striking the period and inserting a semicolon2 7,c7 in paragraph 7#d71 by striking the period and inserting a semicolon2 7,d7 in paragraph 7#e71 by striking the period and inserting 2 and2 and 7,e7 by adding at the end the following3 7#f7 any prescription drug approved by the ,food and ,drug ,administration for the prevention of ,,hiv 7other than a drug subject to preauthorization requirements consistent with section #bgbi;,a71 administrative fees for such drugs1 laboratory and other diagnostic procedures associated with the use of such drugs1 and clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines1 without limitation4 4 7#b7 ,prohibition on preauthorization 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 ,prohibition on preauthorization requirements with respect to certain services ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not impose any preauthorization requirements with respect to coverage of the services described in section #bgac7;a77#f71 except that a plan or issuer may impose preauthorization requirements with respect to coverage of a particular drug approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 of this ,act if such plan or issuer provides coverage without any preauthorization requirements for a drug that is therapeutically equivalent4 4 7b7 ,coverage under ,federal ,employees ,health ,benefits program ,section #hijd of title #e1 ,united ,states ,code1 is amended by adding at the end the following3 7c7 ,any health benefits plan offered under this chapter shall include benefits for1 and may not impose any cost-sharing requirements for1 any prescription drug approved by the ,food and ,drug ,administration for the prevention of ,,hiv1 administrative fees for such drugs1 laboratory and other diagnostic procedures associated with the use of such drugs1 and clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines1 without limitation4 4 7c7 ,medicaid 7#a7 ,in general ,section #aije of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is amended-- 7,a7 in subsection 7a77#d7-- 7i7 by striking 2 and 7,d7 and inserting 2 7,d72 7ii7 by striking 2 and 7,e7 and inserting 2 7,e72 7iii7 by striking 2 and 7,f7 and inserting 2 7,f72 and 7iv7 by striking the semicolon at the end and inserting 2 and 7,g7 ,,hiv prevention services22 and 7,b7 by adding at the end the following new subsection3 7jj7 ,,hiv prevention services ,for purposes of subsection 7a77#d77;,g71 the term ,,hiv prevention services means prescription drugs for the prevention of ,,hiv acquisition1 administrative fees for such drugs1 laboratory and other diagnostic procedures associated with the use of such drugs1 and clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines1 without limitation4 4 7#b7 ,no cost-sharing ,title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is amended-- 7,a7 in section #aiaf1 by inserting ,,hiv prevention services described in section #aije7;a77#d77;,g71 after section #aije7;a77#d77;,c71 each place it appears2 and 7,b7 in section #aiaf;,a7b77#c77;,b71 by adding at the end the following new clause3 7xv7 ,,hiv prevention services described in section #aije7;a77#d77;,g74 4 7#c7 ,inclusion in benchmark coverage ,section #aicg7;b77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#g7;b77#g77 is amended-- 7,a7 in the paragraph header1 by inserting and ,,hiv prevention services after supplies2 and 7,b7 by striking includes for any individual described in section #aije7;a77#d77;,c71 medical assistance for family planning services and supplies in accordance with such section and inserting includes medical assistance for ,,hiv prevention services described in section #aije7;a77#d77;,g71 and includes1 for any individual described in section #aije7;a77#d77;,c71 medical assistance for family planning services and supplies in accordance with such section4 7d7 ,,chip 7#a7 ,in general ,section #bajc of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc71 as amended by section #aadje7;b77#a7 of ,public ,law #aag-afi1 is amended-- 7,a7 in subsection 7a71 by striking and 7#h7 and inserting 7#h71 7#aj71 7#aa71 and 7#ac72 and 7,b7 in subsection 7c71 by adding at the end the following new paragraph3 7#ac7 ,,hiv prevention services ,regardless of the type of coverage elected by a ,state under subsection 7a71 the child health assistance provided for a targeted low-income child1 and1 in the case of a ,state that elects to provide pregnancy-related assistance pursuant to section #baab1 the pregnancy-related assistance provided for a targeted low-income pregnant woman 7as such terms are defined for purposes of such section71 shall include coverage of ,,hiv prevention services 7as defined in section #aije7;jj774 4 7#b7 ,no cost-sharing ,section #bajc7;e77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7e77#b77 is amended by inserting ,,hiv prevention services described in subsection 7c77#ac71 before or for pregnancy-related assistance4 7#c7 ,effective date 7,a7 ,in general ,subject to subparagraph 7,b71 the amendments made by subsection 7c7 and this subsection shall take effect on ,january #a1 #bjbe4 7,b7 ,delay permitted if ,state legislation required ,in the case of a ,state plan approved under title ,,xix or ,,xxi of the ,social ,security ,act which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the plan to meet the additional requirements imposed by this section1 the ,state plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of the failure of the plan to meet such additional requirements before the #ast day of the #ast calendar quarter beginning after the close of the #ast regular session of the ,state legislature that ends after the #a-year period beginning with the date of the enactment of this section4 ,for purposes of the preceding sentence1 in the case of a ,state that has a #b-year legislative session1 each year of the session is deemed to be a separate regular session of the ,state legislature4 7e7 ,coverage and elimination of cost-,sharing under ,medicare 7#a7 ,coverage of ,,hiv prevention services under ,part ,b 7,a7 ,coverage 7i7 ,in general ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7,i7 in subparagraph 7,,ii71 by striking and at the end2 7,,ii7 in subparagraph 7,,jj71 by inserting and at the end2 and 7,,iii7 by adding at the end the following new subparagraph3 7,,kk7 ,,hiv prevention services 7as defined in subsection 7nnn772 4 7ii7 ,definition ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended by adding at the end the following new subsection3 7nnn7 ,,hiv prevention services ,the term ,,hiv prevention services means-- 7#a7 drugs or biologicals approved by the ,food and ,drug ,administration for the prevention of ,,hiv2 7#b7 administrative fees for such drugs2 7#c7 laboratory and other diagnostic procedures associated with the use of such drugs2 and 7#d7 clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines1 without limitation4 4 7,b7 ,elimination of coinsurance ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7i7 by striking and 7,,hh7 and inserting 7,,hh72 and 7ii7 by inserting before the semicolon at the end the following3 1 and 7,,ii7 with respect to ,,hiv prevention services 7as defined in section #ahfa7nnn771 the amount paid shall be #ajj percent of 7i7 except as provided in clause 7ii71 the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to such services under this part1 and 7ii7 in the case of such services that are covered ,,opd services 7as defined in subsection 7t77#a77;,b771 the amount determined under subsection 7t74 7,c7 ,exemption from ,part ,b deductible ,the first sentence of section #ahcc7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7b77 is amended-- 7i7 by striking 1 and 7#ac7 and inserting 7#ac72 and 7ii7 by striking #ahfa7n744 and inserting #ahfa7n71 and 7#ad7 such deductible shall not apply with respect to ,,hiv prevention services 7as defined in section #ahfa7nnn77#a7744 7,d7 ,effective date ,the amendments made by this paragraph shall apply to items and services furnished on or after ,january #a1 #bjbe4 7#b7 ,elimination of cost-sharing for drugs for the prevention of ,,hiv under part ,d 7,a7 ,in general ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is amended-- 7i7 in subsection 7b7-- 7,i7 in paragraph 7#a77;,a71 by striking and 7#i7 and inserting 1 7#i71 and 7#aj72 7,,ii7 in paragraph 7#b7-- 7aa7 in subparagraph 7,a71 by striking and 7#i7 and inserting 1 7#i71 and 7#aj72 7bb7 in subparagraph 7,c77i71 in the matter preceding subclause 7,i71 by striking and 7#i7 and inserting 7#i71 and 7#aj72 and 7cc7 in subparagraph 7,d77i71 in the matter preceding subclause 7,i71 by striking and 7#i7 and inserting 7#i71 and 7#aj72 7,,iii7 in paragraph 7#c77;,a71 in the matter preceding clause 7i71 by striking and 7#i7 and inserting 7#i71 and 7#aj72 7,,iv7 in paragraph 7#d77;,a77i71 by striking and 7#i7 and inserting 1 7#i71 and 7#aj72 and 7,v7 by adding at the end the following new paragraph3 7#aj7 ,elimination of cost-sharing for drugs for the prevention of ,,hiv ,for plan years beginning on or after ,january #a1 #bjbe1 with respect to a covered part ,d drug that is for the prevention of ,,hiv-- 7,a7 the deductible under paragraph 7#a7 shall not apply2 and 7,b7 there shall be no coinsurance or other cost-sharing under this part with respect to such drug4 2 and 7ii7 in subsection 7c71 by adding at the end the following new paragraph3 7#g7 ,treatment of cost-sharing for drugs for the prevention of ,,hiv ,the coverage is provided in accordance with subsection 7b77#aj74 4 7,b7 ,conforming amendments to cost-sharing for low-income individuals ,section #ahfj;,d-#ad7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is amended-- 7i7 in paragraph 7#a77;,d71 in each of clauses 7ii7 and 7iii71 by striking paragraph 7#f7 and inserting paragraphs 7#f7 and 7#g72 7ii7 in paragraph 7#b7-- 7,i7 in subparagraph 7,b71 by striking and 7#i7 and inserting 1 7#i71 and 7#aj72 7,,ii7 in subparagraph 7,d71 by striking paragraph 7#f7 and inserting paragraphs 7#f7 and 7#g72 and 7,,iii7 in subparagraph 7,e71 by striking paragraph 7#f7 and inserting paragraphs 7#f7 and 7#g72 and 7iii7 by adding at the end the following new paragraph3 7#g7 ,no application of cost-sharing or deductible for drugs for the prevention of ,,hiv ,for plan years beginning on or after ,january #a1 #bjbe1 with respect to a covered part ,d drug that is for the prevention of ,,hiv-- 7,a7 the deductible under section #ahfj;,d-#b7;b77#a7 shall not apply2 and 7,b7 there shall be no cost-sharing under this section with respect to such drug4 4 7f7 ,coverage of ,,hiv prevention treatment by ,department of ,veterans ,affairs 7#a7 ,elimination of medication copayments ,section #agbb;,a7a7 of title #ch1 ,united ,states ,code1 is amended by adding at the end the following new paragraph3 7#e7 ,paragraph 7#a7 does not apply to a medication for the prevention of ,,hiv4 4 7#b7 ,elimination of hospital care and medical services copayments ,section #agaj of such title is amended-- 7,a7 in subsection 7f7-- 7i7 by redesignating paragraph 7#e7 as paragraph 7#f72 and 7ii7 by inserting after paragraph 7#d7 the following new paragraph 7#e73 7#e7 ,a veteran shall not be liable to the ,united ,states under this subsection for any amounts for laboratory and other diagnostic procedures associated with the use of any prescription drug approved by the ,food and ,drug ,administration for the prevention of ,,hiv1 administrative fees for such drugs1 or for laboratory or other diagnostic procedures associated with the use of such drugs1 or clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines1 without limitation4 2 and 7,b7 in subsection 7g77#c71 by adding at the end the following new subparagraph3 7,c7 ,any prescription drug approved by the ,food and ,drug ,administration for the prevention of ,,hiv1 administrative fees for such drugs1 laboratory and other diagnostic procedures associated with the use of such drugs1 and clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines1 without limitation4 4 7#c7 ,inclusion as preventive health service ,section #agja7i7 of such title is amended-- 7,a7 in subparagraph 7,k71 by striking 2 and and inserting a semicolon2 7,b7 by redesignating subparagraph 7,l7 as subparagraph 7,m72 and 7,c7 by inserting after subparagraph 7,k7 the following new subparagraph 7,l73 7,l7 any prescription drug approved by the ,food and ,drug ,administration for the prevention of ,,hiv1 administrative fees for such drugs1 laboratory and other diagnostic procedures associated with the use of such drugs1 and clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines1 without limitation2 and 4 7g7 ,coverage of ,,hiv prevention treatment by ,department of ,defense 7#a7 ,in general ,chapter #ee of title #aj1 ,united ,states ,code1 is amended by inserting after section #ajgdo the following new section3 #ajgdp4 ,coverage of ,,hiv prevention treatment 7a7 ,in general ,the ,secretary of ,defense shall ensure coverage under the ,,tricare program of ,,hiv prevention treatment described in subsection 7b7 for any beneficiary under section #ajgd7;a7 of this title4 7b7 ,,hiv prevention treatment described ,,hiv prevention treatment described in this subsection includes any prescription drug approved by the ,food and ,drug ,administration for the prevention of ,,hiv1 administrative fees for such drugs1 laboratory and other diagnostic procedures associated with the use of such drugs1 and clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines1 without limitation4 7c7 ,no cost-,sharing ,notwithstanding section #ajge1 #ajge;a1 or #ajgd;g7a77#f7 of this title or any other provision of law1 there is no cost-sharing requirement for ,,hiv prevention treatment covered under this section4 4 7#b7 ,clerical amendment ,the table of sections at the beginning of such chapter is amended by inserting after the item relating to section #ajgdo the following new item3 #ajgdp4 ,coverage of ,,hiv prevention treatment4 4 7h7 ,indian health service testing1 monitoring1 and prescription drugs for the prevention of ,,hiv ,title ,,ii of the ,indian ,health ,care ,improvement ,act is amended by inserting after section #bbc 7#be ,u4,s4,c4 #afbav7 the following3 #bbd4 ,testing1 monitoring1 and prescription drugs for the prevention of ,,hiv 7a7 ,in general ,the ,secretary1 acting through the ,director of ,,hiv_/,,aids ,prevention and ,treatment under section #hcb1 ,indian tribes1 and tribal organizations1 shall provide1 without limitation1 funding for any prescription drug approved by the ,food and ,drug ,administration for the prevention of human immunodeficiency virus 7commonly known as ,,hiv71 administrative fees for that drug1 laboratory and other diagnostic procedures associated with the use of that drug1 and clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines4 7b7 ,authorization of appropriations ,there are authorized to be appropriated such sums as are necessary to carry out this section4 4 7i7 ,effective date ,the amendments made by subsections 7a71 7b71 7e71 7f71 7g71 and 7h7 shall take effect with respect to plan years beginning on or after ,january #a1 #bjbe4 #d4 ,prohibition on denial of coverage or increase in premiums of life1 disability1 or long-term care insurance for individuals taking medication for the prevention of ,,hiv acquisition 7a7 ,prohibition ,notwithstanding any other provision of law1 it shall be unlawful to-- 7#a7 decline or limit coverage of an individual under any life insurance policy1 disability insurance policy1 or long-term care insurance policy1 on account of the individual taking medication for the purpose of preventing the acquisition of ,,hiv2 7#b7 preclude an individual from taking medication for the purpose of preventing the acquisition of ,,hiv as a condition of receiving a life insurance policy1 disability insurance policy1 or long-term care insurance policy2 7#c7 consider whether an individual is taking medication for the purpose of preventing the acquisition of ,,hiv in determining the premium rate for coverage of such individual under a life insurance policy1 disability insurance policy1 or long-term care insurance policy2 or 7#d7 otherwise discriminate in the offering1 issuance1 cancellation1 amount of such coverage1 price1 or any other condition of a life insurance policy1 disability insurance policy1 or long-term care insurance policy for an individual1 based solely and without any additional actuarial risks upon whether the individual is taking medication for the purpose of preventing the acquisition of ,,hiv4 7b7 ,enforcement ,a ,state insurance regulator may take such actions to enforce subsection 7a7 as are specifically authorized under the laws of such ,state4 7c7 ,definitions ,in this section3 7#a7 ,disability insurance policy ,the term disability insurance policy means a contract under which an entity promises to pay a person a sum of money in the event that an illness or injury resulting in a disability prevents such person from working4 7#b7 ,life insurance policy ,the term life insurance policy means a contract under which an entity promises to pay a designated beneficiary a sum of money upon the death of the insured4 7#c7 ,long-term care insurance policy ,the term long-term care insurance policy means a contract for which the only insurance protection provided under the contract is coverage of qualified long-term care services 7as defined in section #ggjb;,b7c7 of the ,internal ,revenue ,code of #aihf74 #e4 ,public education campaign ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following3 #cii,v-#h4 ,pre-exposure prophylaxis and post-exposure prophylaxis education campaigns 7a7 ,public education campaign 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 in consultation with the ,director of the ,office of ,infectious ,disease and ,,hiv_/,,aids ,policy1 shall establish a public health campaign for the purpose of educating the public on medication for the prevention of ,,hiv acquisition4 7#b7 ,requirements ,in carrying out this subsection1 the ,secretary shall ensure cultural competency and efficacy within high-need communities in which ,pr,e,p or ,,pep are underutilized by developing the campaign in collaboration with organizations that are indigenous to communities that are overrepresented in the domestic ,,hiv epidemic1 including communities of color and the lesbian1 gay1 bisexual1 transgender1 and queer community4 ,the ,secretary shall ensure that the campaign is designed to increase awareness of the safety and effectiveness of ,pr,e,p and ,,pep1 the recommended clinical practices for providing ,pr,e,p-related and ,,pep-related clinical care1 and the local availability of ,pr,e,p and ,,pep providers1 and to counter stigma associated with the use of ,pr,e,p and ,,pep4 7#c7 ,evaluation of program ,the ,secretary shall develop measures to evaluate the effectiveness of activities conducted under this subsection that are aimed at reducing disparities in access to ,pr,e,p and ,,pep and supporting the local community4 ,such measures shall evaluate community outreach activities1 language services1 workforce cultural competence1 and other areas as determined by the ,secretary4 7b7 ,provider education campaign 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 the ,administrator of the ,health ,resources and ,services ,administration1 and the ,office of ,infectious ,disease and ,,hiv_/,,aids ,policy1 shall establish a provider campaign for the purpose of educating prescribers and other associated health professionals on medication for the prevention of ,,hiv acquisition4 7#b7 ,requirements ,in carrying out this subsection1 the ,secretary shall increase awareness and readiness among health care providers to offer ,pr,e,p or ,,pep1 as appropriate1 with a focus on areas of high-need communities in which ,pr,e,p or ,,pep is underutilized by developing an educational campaign with input from health care providers and organizations that are indigenous to communities that are overrepresented in the domestic ,,hiv epidemic1 including communities of color and the lesbian1 gay1 bisexual1 transgender1 and queer community4 ,the ,secretary shall ensure that the campaign is designed to increase awareness of the safety and effectiveness of ,pr,e,p and ,,pep1 the recommended clinical practices for providing ,pr,e,p-related and ,,pep-related clinical care1 cultural competency among ,pr,e,p and ,,pep prescribers1 and to counter stigma associated with the use of ,pr,e,p and ,,pep4 7#c7 ,evaluation of program ,the ,secretary shall develop measures to evaluate the effectiveness of activities conducted under this subsection that are aimed at increasing the number of health care professionals offering ,pr,e,p and ,,pep and reducing disparities in access to ,pr,e,p and ,,pep4 ,such measures shall evaluate availability of ,pr,e,p and ,,pep services1 education and outreach activities1 language services1 workforce cultural competence1 and other areas as determined by the ,secretary4 7c7 ,definitions ,in this section and section #cii,v-#i-- 7#a7 the term ,,pep means any drug or combination of drugs approved by the ,food and ,drug ,administration for preventing ,,hiv transmission after a sexual or other exposure associated with a high risk of ,,hiv transmission2 and 7#b7 the term ,pr,e,p means any drug approved by the ,food and ,drug ,administration for the purpose of pre-exposure prophylaxis with respect to ,,hiv4 7d7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbd through #bjbi4 4 #f4 ,patient confidentiality ,the ,secretary of ,health and ,human ,services shall amend the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 as necessary1 to ensure that individuals are able to access the benefits described in section #bgac7;a77#f7 under a family plan without any other individual enrolled in such family plan1 including a primary subscriber of or policyholder1 being informed of such use of such benefits4 #g4 ,pre-exposure prophylaxis and post-exposure prophylaxis funding ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq471 as amended by section #e1 is further amended by adding at the end the following3 #cii,v-#i4 ,pre-exposure prophylaxis and post-exposure prophylaxis funding 7a7 ,in general ,not later than #a year after the date of the enactment of the ,pr,e,p ,access and ,coverage ,act of #bjbc1 the ,secretary shall establish a program that awards grants to ,states1 territories1 ,indian ,tribes1 and directly eligible entities for the establishment and support of pre-exposure prophylaxis 7referred to in this section as ,pr,e,p7 and post-exposure prophylaxis 7referred to in this section as ,,pep7 programs4 7b7 ,applications ,to be eligible to receive a grant under subsection 7a71 a ,state1 territory1 ,indian ,tribe1 or directly eligible entity shall-- 7#a7 submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require1 including a plan describing how any funds awarded will be used to increase access to ,pr,e,p for uninsured and underinsured individuals and reduce disparities in access to ,pr,e,p and ,,pep for uninsured and underinsured individuals and reduce disparities in access to ,pr,e,p and ,,pep2 and 7#b7 appoint a ,pr,e,p and ,,pep grant administrator to manage the program4 7c7 ,directly eligible entity ,for purposes of this section1 the term directly eligible entity-- 7#a7 means a ,federally qualified health center or other nonprofit entity engaged in providing ,pr,e,p and ,,pep information and services2 and 7#b7 may include-- 7,a7 a ,federally qualified health center 7as defined in section #ahfa7;aa77#d7 of the ,social ,security ,act72 7,b7 a family planning grantee 7other than ,states7 funded under section #ajja2 7,c7 a rural health clinic 7as defined in section #ahfa7;aa77#b7 of the ,social ,security ,act72 7,d7 a health facility operated by or pursuant to a contract with the ,indian ,health ,service2 7,e7 a community-based organization1 clinic1 hospital1 or other health facility that provides services to individuals at risk for or living with ,,hiv2 and 7,f7 a nonprofit private entity providing comprehensive primary care to populations at risk of ,,hiv1 including faith-based and community-based organizations4 7d7 ,awards ,in determining whether to award a grant1 and the grant amount for each grant awarded1 the ,secretary shall consider the grant application and the need for ,pr,e,p and ,,pep services in the area1 the number of uninsured and underinsured individuals in the area1 and how the ,state1 territory1 or ,indian ,tribe coordinates ,pr,e,p and ,,pep activities with the directly funded entity1 if the ,state1 territory1 or ,indian ,tribe applies for the funds4 7e7 ,use of funds 7#a7 ,in general ,any ,state1 territory1 ,indian ,tribe1 or directly eligible entity that is awarded funds under subsection 7a7 shall use such funds for eligible ,pr,e,p and ,,pep expenses4 7#b7 ,eligible prep expenses ,the ,secretary shall publish a list of expenses that qualify as eligible ,pr,e,p and ,,pep expenses for purposes of this section1 which shall include-- 7,a7 any prescription drug approved by the ,food and ,drug ,administration for the prevention of ,,hiv1 administrative fees for such drugs1 laboratory and other diagnostic procedures associated with the use of such drugs1 and clinical follow-up and monitoring1 including any related services recommended in current ,united ,states ,public ,health ,service clinical practice guidelines1 without limitation2 7,b7 outreach and public education activities directed toward populations overrepresented in the domestic ,,hiv epidemic that increase awareness about the existence of ,pr,e,p and ,,pep1 provide education about access to and health care coverage of ,pr,e,p and ,,pep1 ,pr,e,p and ,,pep adherence programs1 and counter stigma associated with the use of ,pr,e,p and ,,pep2 7,c7 outreach activities directed toward physicians and other providers that provide education about ,pr,e,p and ,,pep2 and 7,d7 adherence services and counseling1 including personnel costs for ,pr,e,p navigators to retain patients in care4 7f7 ,report to ,congress ,the ,secretary shall1 in each of the first #e years beginning one year after the date of the enactment of the ,pr,e,p ,access and ,coverage ,act of #bjbc1 submit to ,congress1 and make public on the internet website of ,department of ,health and ,human ,services1 a report on the impact of any grants provided to ,states1 territories1 ,indian ,tribes1 and directly eligible entities for the establishment and support of pre-exposure prophylaxis programs under this section4 7g7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbd through #bjbi4 4 #h4 ,clarification ,this ,act1 including the amendments made by this ,act1 shall apply notwithstanding any other provision of law1 including ,public ,law #ajc-ada4 #i4 ,private right of action ,any person aggrieved by a violation of this ,act1 including the amendments made by this ,act1 may commence a civil action in an appropriate ,united ,states ,district ,court or other court of competent jurisdiction to obtain relief as allowed by law as either an individual or member of a class4 ,if the plaintiff is the prevailing party in such an action1 the court shall order the defendant to pay the costs and reasonable attorney fees of the plaintiff4 #aj4 ,enforcement 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 in consultation with the ,centers for ,disease ,control and ,prevention1 shall-- 7#a7 issue guidance regarding the implementation of the coverage requirements established under this ,act1 including the amendments made by this ,act1 including with respect to implementation of such coverage requirements2 7#b7 develop and disseminate educational materials1 including billing and coding documents2 7#c7 provide technical assistance to ,state insurance commissioners2 7#d7 provide technical assistance to eligible entities regarding responding to consumer complaints and assisting in resolving such complaints2 and 7#e7 work with other ,federal agencies to assist in enforcement and compliance4 7b7 ,compliance 7#a7 ,in general ,the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 and the ,secretary of the ,treasury1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 shall monitor compliance by group health plans and health insurance issuers with coverage requirements established under title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq471 as amended by section #c7 and shall take appropriate enforcement actions under the ,public ,health ,service ,act1 the ,employee ,retirement ,income ,security ,act of #aigd1 and the ,internal ,revenue ,code of #aihf4 7#b7 ,insurer submissions to the ,secretary ,beginning not later than #a year after the date of enactment of this ,act1 each group health plan and health insurance issuer offering group or individual health insurance coverage shall submit to the ,secretary of ,health and ,human ,services1 at such time as such secretary1 in coordination with the ,secretary of ,labor and the ,secretary of the ,treasury1 shall require1 but not less frequently than annually for the #aj-year period beginning on such date of enactment1 data demonstrating compliance with the coverage requirements described in paragraph 7#a71 including aggregate data on the number of claims received by such plans and issuers for ,,hiv prevention services and the cost-sharing for enrollees with respect to such claims4 7#c7 ,reports to ,congress ,not later than #b years after the enactment of this ,act and every #b years thereafter for the #aj-year period beginning on such date of enactment1 the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 and the ,secretary of the ,treasury 7collectively referred to in this section as the ,secretaries7 shall jointly submit to ,congress and make publicly available a report to assess the prevalence of noncompliance with the coverage requirements described in paragraph 7#a74 ,each such report shall include-- 7,a7 aggregate information about group health plans and health insurance issuers that the ,secretaries determine to be out of compliance with such requirements2 and 7,b7 steps the ,secretaries have taken to address incidences of such noncompliance4 7#d7 ,definitions ,in this subsection1 the terms group health plan1 health insurance coverage1 and health insurance issuer have the meanings given such terms in section #bgbi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia74