HIV Health Care Access Working Group

Transcription

1 December 22, 2014 HIV Health Care Access Wrking Grup Centers fr Medicare and Medicaid Services Department f Health and Human Services Attentin: CMS-9944-P P.O. Bx 8016 Baltimre, MD Re: Ntice f Payment and Benefit Parameters fr 2016 The HIV Health Care Access Wrking Grup (HHCAWG) appreciates the pprtunity t cmment n the prpsed rule, Ntice f Benefit and Payment Parameters fr HHCAWG is a calitin f mre than 100 natinal and cmmunity-based rganizatins representing peple living with HIV, HIV medical prviders, public health prfessinals, and advcates wh are cmmitted t ensuring access t vital HIV-related preventin, care, and treatment services. Standards and prtectins gverning the Affrdable Care Act s (ACA s) Essential Health Benefits requirements, nn-discriminatin mandates, plan transparency, and netwrk adequacy must ensure that insurance cverage wrks fr peple living t HIV and ther chrnic cnditins. T prvide meaningful access t care fr peple living with HIV, we urge HHS t cnsider the recmmendatins and cmments detailed belw. ESSENTIAL HEALTH BENEFITS (EHB) APPROACH We strngly urge HHS t adpt a new prcess bth fr defining EHB and fr ensuring meaningful stakehlder invlvement at bth the state and federal levels fr 2017 and beynd. Specifically, we urge HHS t mve away frm a benchmark mdel, which enshrines current disparities and gegraphic variatin int the insurance market. Instead, HHS shuld adpt an apprach that sets a higher and clearly defined natinal standard fr benefits cverage that meets the care and treatment needs f peple living with HIV and ther chrnic cnditins. The benchmark apprach has resulted in disparities in scpe f cverage bth amng states and amng Qualified Health Plans (QHPs) within states. We als urge HHS t cnsider mre rbust stakehlder engagement in the prcess used t assess the current EHB apprach and what apprach it shuld adpt beynd This prcess must include meaningful engagement pprtunities fr current enrllees, vulnerable ppulatins, and cnsumer advcates, with final prducts reflecting their input. Finally, while we understand that state-based Marketplaces (SBMs) have the primary respnsibility fr ensuring apprpriate implementatin f the EHB standards, in rder t ensure as little state variability in benefits as pssible, we urge HHS t cnsider a SBM implementatin and plan mnitring reprting system, t be reprted n their wn r a federal website.

2 PRESCRIPTION DRUG STANDARD We strngly supprt a strnger prescriptin drug standard that ensures that peple living with HIV and ther chrnic cnditins have access t the medicatins they need t stay healthy, including new therapeutic agents as they becme available. In many states, we cntinue t see plans that d nt cver HIV medicatins r that place medicatins n the highest cst-sharing tier with prhibitively high c-insurance. Of particular cncern are frmularies that d nt list newly FDA-apprved drugs and single-tablet antiretrviral regimens amng the available ptins fr treating HIV. These types f benefit designs have excluded peple living with HIV frm certain plans, and expsed new enrllees t unaffrdable cst-sharing, burdensme appeals and exceptins prcesses, and ptential disruptins in treatment, highlighting the need fr strnger prtectins. We supprt the prpsal t replace the current prescriptin drug cunt standard based n the U.S. Pharmacpeia s (USP) classificatin system with the requirement that health insurance issuers adpt a pharmacy and therapeutics (P&T) cmmittee t ensure that plans cver a sufficient number f prescriptin drugs. Cupled with adptin f P&T cmmittees, we supprt the prpsal t replace the existing United States Pharmacpeia (USP) drug classificatin standard with a new standard based n American Hspital Frmulary Services (AHFS). P&T Cmmittees We supprt the prpsed standards that wuld gvern the rle and respnsibilities f P&T cmmittees. With respect t the membership and cmpsitin f each plan s P&T cmmittee, we generally supprt the standards defined by the Medicare Part D Prescriptin Drug Prgram and the Natinal Assciatin f Insurance Cmmissiners; hwever, in additin t these standards, we prpse the fllwing clarificatins and additinal federal versight t encurage an efficient and transparent prescriptin drug review prcess: Cmpsitin f P&T cmmittees must be diverse enugh t ensure decisins with regard t frmulary inclusin and utilizatin management take int accunt access t care fr vulnerable ppulatins. The recent Office f the Inspectr General (OIG) reprt n Medicare Part D P&T cmmittees fund that the number f members per cmmittee ranged dramatically, frm three t 62 members. We recmmend that HHS regulate the number f cmmittee members t ensure adequate representatin. Because treatment f HIV, hepatitis C, and ther chrnic and cmplex cnditins requires specialized knwledge, we urge HHS t require cmmittees t cnsult prviders with expertise in management f the relevant cnditin fr each drug cnsidered. This culd be accmplished via a standard expert panel prcedure r sub-cmmittee structure made up f prviders with specific expertise in the relevant area. We als urge HHS t require that cmmittees have at least ne cnsumer representative. The cnsumer shuld be a current and active member f the health plan. We supprt a federal flr fr cnflict f interest standards, including requiring a percentage f members t be free f cnflict with the plan and pharmaceutical manufacturers. Similar t Medicare Part D, we supprt strng disclsure

3 requirements with regard t ptential cnflicts. Disclsure requirements shuld include: financial interests in pharmaceutical manufacturers, relatinships with ther entities that culd benefit frm a particular frmulary decisin, and any emplyment relatinship with the plan. Fr each frmulary decisin, we supprt a recusal prcedure that requires cmmittee members t recuse themselves if a cnflict is identified. Because there appears t be a lack f unifrmity with regard t Medicare Part D cnflict f interest disclsure and recusal prcesses, we urge HHS t issue additinal sub-regulatry guidance n cnflict f interest and recusal plicies and prcedures, including best practices, t help plans implement strng cnflict f interest requirements. When available, natinally recgnized treatment guidelines that are regularly updated t reflect treatment advances must be cnsidered in the deliberatin f whether r nt t include a medicatin n a frmulary and any limitatins placed n access t that medicatin. This is particularly true fr treatment f HIV, a cnditin fr which there are established medically accepted guidelines (see federal guidelines, including fr antiretrviral treatment (ART) and preventin and treatment f pprtunistic infectins at 1 We supprt reference t the accepted treatment guidelines prvided in the Natinal Guideline Clearinghuse (but d nt believe inclusin in a natinally recgnized treatment guideline shuld be the nly criterin fr inclusin f a drug n a frmulary). Specific reasn fr deviating frm the guidelines shuld be included in detailed meeting minutes. The prcess and prcedure, including relevant timelines, by which P&T cmmittees review prescriptin drugs fr inclusin n plan frmularies, including the prescriptin drugs that have been cnsidered, reasns fr inclusin r exclusin n frmularies, and detailed minutes frm cmmittee meetings, shuld be publically available n the issuer s website. This includes ntificatin f when the cmmittee is meeting and which drugs are up fr review. We urge HHS t cnsider adding an appeals prcess requirement fr all P&T cmmittee decisins. Any cnsumer r plan prvider shuld have the right t request that prescriptin drug be placed n a plan s frmulary. We supprt requirements with regard t the frequency that P&T cmmittees must meet t ensure that new medicatins are reviewed and added t frmularies in a timely manner and recmmend that the cmmittee be required t meet quarterly. In additin, we urge HHS t require that cmmittees review a new FDA-apprved drug prduct (r new FDA-apprved indicatin) within 30 days and make a cverage decisin within 90 days. 1 Prcedures and prtectins that respect clinical recmmendatins with regard t brand-name as ppsed t generic equivalents are als crucial t ensuring treatment adherence. (Surce: Melanie Thmsn, et al., Guidelines fr Imprving Entry Int and Retentin in Care and Antiretrviral Adherence fr Persns With HIV: Evidence-Based Recmmendatins Frm an Internatinal Assciatin f Physicians in AIDS Care Panel, Annals f Internal Medicine Jun; 156 (11):

4 Finally, we supprt strng mnitring and versight f P&T cmmittee cmpsitin and plicies and prcedures. Thugh we understand that primary versight and enfrcement resides with the state, we urge HHS t identify federal mnitring and versight standards t ensure that prpsed federal requirements are apprpriately implemented. Fr instance, we urge HHS t require submissin f P&T cmpsitin, any disclsed cnflicts, and the review prcesses and standards the P&T cmmittee adpts fr federal apprval. We urge HHS t require plans t implement P&T cmmittees fr the 2016 plan year. All health plans already perate P&T cmmittees fr ther lines f business, such as Medicare Part D, Medicare Advantage, and cmmercial prducts. Plans have extensive experience perating P&T cmmittees and there are widely-accepted, standardized guidelines in place fr the cmmittees. American Hspital Frmulary Service (AHFS) Classificatin System In additin t the P&T cmmittee requirement, we supprt replacing the current USP classificatin system with the AHFS system (with sme caveats and cntingent upn reslutin f the questins we raise belw). The AHFS classificatin system may better address the needs f peple living with HIV, hepatitis C, and ther cmplex chrnic cnditins; hwever, we believe the fllwing issues and cncerns need t be reslved befre HHS adpts a new classificatin system: The classificatin fr Antiretrvirals (included at 8:18:08) appears t cntain nuanced subclasses that culd encmpass all f the recmmended HIV medicatins. Hwever, it is unclear whether and hw the classificatin system references the full list f medicatins including cmbinatin therapies cntained in the back prtin f the AHFS (the first reference t the antiretrviral class nly includes generic drugs in the drug list and excludes brand-name and cmbinatin therapies). We urge incrpratin f the full medicatin list int the antiretrviral class and subclasses in rder t arrive at a full drug list. A full drug list is essential t ensure that drug cunts used t measure cmpliance with the EHB benchmark standard cntain all f the HIV medicatins, including cmbinatin therapies (this was a significant shrtcming f the USP versin 5.0 standard and resulted in HIV cmbinatin therapies being excluded frm the HHS drug cunts and subsequently frm QHP frmularies 2 ). Because f the difficulty in accessing the AHFS withut a subscriptin, we recmmend that HHS ffer additinal stakehlder engagement pprtunities befre mving t a new drug classificatin system, including allwing stakehlders t access relevant prtins f the AHFS 2 The simplicity f single tablet regimen ARVs supprts treatment adherence and decreases the likelihd f hspitalizatin. Ra GA, Suttn SS, Hardin J, et al. Impact f highly active antiretrviral therapy regimen n adherence and risk f hspitalizatin in veterans with HIV/AIDS. 53rd Interscience Cnference n Antimicrbial Agents and Chemtherapy, Denver, abstract H-1464, 2013

5 as well as mre detailed infrmatin n hw HHS intends t use the AHFS in cnjunctin with a benchmark and drug cunt standard. We understand that the print versin f the AHFS is updated annually by the American Sciety f Health System Pharmacists, with the nline versin updated regularly thrughut the year. T accunt fr newly apprved medicatins, we recmmend the standard be tied t the nline versin f the AHFS. We urge HHS t implement the new drug classificatin system fr the 2016 benefit year. Alternatively, while HHS creates standards and prcedures t gvern the new P&T cmmittee standards and the new AHFS standard, we urge HHS t adpt the updated USP guidelines (versin 6.0). Because f the inadequacy f the nw utdated USP classificatin system (versin 5.0) currently in effect, plans are nt accuntable fr prviding the range f medicatins peple living with HIV, hepatitis C, and ther chrnic cnditins need t stay healthy. Finally, we cntinue t believe that the Medicare Part D prtectin fr six prtected classes f medicatins is the best way t ensure inclusin f essential HIV medicatins and the ther imprtant classes n plan frmularies and urge HHS t recnsider applying this imprtant prtectin t the ACA s Essential Health Benefits prvisins. Frmulary Exceptins Prcess We strngly supprt the HHS prpsal t amend the frmulary exceptins prcess fr clinically apprpriate prescriptin drugs nt included n a plan s frmulary. We very much supprt a standard appeal prcess in additin t the 24-hur appeal prcess fr exigent circumstances. We supprt the prpsed secndary external review prcess if the first exceptin request is denied, and urge HHS t institute an autmatic review prcess fr denials t alleviate burden n the cnsumer t initiate a secndary review. The plan shuld be able t demnstrate that an HIV specialist is cnsulted fr all requests invlving ARVs. We als supprt clarificatin that when a drug is prvided as a result f the exceptins prcess, the drug becmes part f the Essential Health Benefits, and any cst sharing assciated with the drug cunt tward the beneficiary s annual ut-f-pcket maximum. We urge HHS t include transparency requirements regarding the exceptins prcess. Health insurance issuers shuld be required t publish statistics n the utcmes f frmulary exceptin requests. These statistics shuld include the number f ttal frmulary requests that have been adjudicated, the AHFS class and categry f the medicatins that have been requested, and the number f exceptins requests that have resulted in access t the requested prescriptin drug by class and categry f the AHFS classificatin system. Ideally, these statistics wuld be in an easily searchable frmat n the plan r the regulatr s website. Frmulary Transparency Cnsumers must be able t review a plan s full frmulary, any prir authrizatin r ther utilizatin management restrictins, and assciated ut-f-pcket csts in rder t make an infrmed decisin t enrll in the plan that will best be able t meet care and treatment needs. Currently, mst issuers present QHP frmulary

6 cinsurance infrmatin as a percentage f the rate negtiated with pharmacies. Withut the ttal cst f prescriptin medicatins, cst-sharing and cinsurance infrmatin by percentage is nt helpful t cnsumers wh want t assess the verall affrdability f QHPs. This is particularly true fr peple living with HIV and ther chrnic cnditins wh depend n access t affrdable drugs t stay healthy. We strngly urge that HHS require issuers t prvide cmplete and accurate frmulary infrmatin as applicable t each plan ffered in a standard frmat 3, including the actual ut-f-pcket csts that will be impsed n enrllees. This infrmatin must be accessible t thse cmparing plans as well as enrllees f the plan. Frmularies shuld be updated mnthly. We als supprt federal versight t ensure that plans d nt change their frmulary cmpsitin r increase prescriptin cst-sharing mid-year (except fr adding medicatins t the frmulary), and urge HHS t cnsider state laws and regulatins prpsing similar prtectins (e.g., Nevada 4 ). 45 CFR allws issuers t make unifrm mdificatins t a prduct nly at the time f cverage renewal, and we believe increased federal mnitring and versight are necessary t ensure that plans adhere t this requirement. Finally, we supprt requiring issuers t submit frmulary infrmatin in a standard machine-readable file. Mail rder pharmacies (45 CFR (e)) We strngly supprt the prpsal requiring enrllees the ptin t access medicatins at a brick-and-mrtar r ther nn-mail rder pharmacy, including the requirement that any additinal cst sharing wuld cunt tward a beneficiary s annual ut-f-pcket maximum. We urge HHS t require that the cst sharing assciated with use f a retail pharmacy be cmparable t cst sharing attached t use f a mail rder pharmacy t ensure that individuals are nt mnetarily penalized fr availing themselves f the right t use a retail pharmacy. Allwing enrllees with chrnic cnditins t pt ut f a mail rder pharmacy requirement, as sme states regulatins require, 5 is essential t supprt uninterrupted access t medicatins and adherence t cmplex treatment regimens. This is particularly true fr cnsumers with unstable husing r with trusted relatinships with pharmacists that help supprt treatment adherence. This prtectin is als in line with the recent settlement agreement in respnse t a class actin lawsuit against United Health Care. The terms f the settlement require peple living with HIV t be able pt ut f 3 Medicare s plan finder ffers prescriptin pricing cmparisn functinality cupled with pharmacy lcatin infrmatin. It is lcated here: 4 Nevada Department f Business and Industry LCB File N. R prhibits insurers frm changing their drug frmularies after the end f pen enrllment withut apprval by the Cmmissiner f Insurance except in certain, limited circumstances. The text f the prpsed regulatin is available at Amendment-v2.pdf. 5 MD Ins. Cde prhibits impsing additinal cpayments r deductibles n cnsumers wh prefer t fill their prescriptins at a cmmunity pharmacy instead f a mail rder pharmacy. Ala. Cde allws a cnsumer t select the pharmacy r pharmacist f his r her chice t furnish pharmaceutical services. The text f the legislatin is available at

7 the plan s mail rder requirement. We believe plans are in a psitin t implement this change fr 2016 and urge HHS t require that they d s. Temprary cverage f nn-frmulary drugs We supprt temprary cverage f nn-frmulary drugs during the first 30 days f cverage fr beneficiaries transitining t a QHP. Hwever, we encurage HHS t make the transitin plicy a requirement instead f an ptin fr QHPs. This is essential fr peple living with HIV and ther chrnic cnditins fr whm changes in established treatment regimens can result in treatment resistance and ther harmful disruptins in care. We als urge HHS t cnsider adding a requirement that plans prvide cverage fr the entire curse f nging treatment (beynd 30 days) in the event that treatment leading t cure is f a finite duratin. Nn-discriminatin (45 CFR ) We strngly supprt the language included in the Preamble with regard t discriminatry plan design, but urge HHS t include specific regulatry language t ensure that prescriptin drug benefit designs d nt discriminate against, and discurage enrllment f, individuals living with HIV and ther chrnic cnditins. We strngly urge HHS t cnsider the fllwing: Require frmularies t ensure access t specialty drugs (where n generic equivalent exists) that are widely accepted in treatment guidelines r best practices. Fr example, this wuld include cverage f all HIV antiretrviral drugs, including fixed-dse cmbinatins and single tablet regimens, in accrdance with HIV treatment guidelines and best practices. We urge HHS t include reference t natinal treatment guidelines in regulatry language t ensure that frmularies include widely recmmended treatment regimens fr chrnic and cmplex cnditins. Prhibit any plan design that impses mre than a reasnable c-pay amunt, such as $150, fr specialty drugs 6 (where n generic equivalent exists) that are widely accepted in treatment guidelines r best practices. Currently, issuers f QHPs frequently place the mst prescribed antiretrvirals n the higher cstsharing tiers r n specialty tiers, while putting HIV drugs that are less prescribed n the lwer tiers. This practice is prblematic because specialty tier drugs generally rely n c-insurance, d nt have a cst-sharing cap r tier exceptins prcess. Additinally, peple with HIV may nt have a chice t use lwer-cst medicatins as HIV drug regimens are ften nt interchangeable and are prescribed accrding t unique patient needs, including tlerability, drug interactins and viral resistance, in keeping with federal HIV treatment 6 Fr purpses f these regulatry actins specialty drugs are defined as fllws: Pharmaceutical prducts that are typically high in cst and have ne r mre f the fllwing characteristics: injectable, infused, inhaled, r ral therapeutic agents, r prducts f bitechnlgy; cmplex drug therapy fr a chrnic r cmplex cnditin, and/r high ptential fr drug adverse effects; specialized patient training n the administratin f the drug (including supplies and devices needed fr administratin) and crdinatin f care is required prir t drug therapy initiatin and/r during therapy; unique patient cmpliance and safety mnitring requirements; r, unique requirements fr handling, shipping, and strage.

8 guidelines. Changing HIV medicatins culd have serius negative health cnsequences fr peple living with HIV in additin t increased csts t the health care system. We als ask that HHS mnitr and evaluate innvative state plicies 7 and legislatin that put in place cst prtectins fr peple living with HIV and ther chrnic cnditins wh require access t expensive medicatins t infrm federal prtectins. Prhibit QHP utilizatin management (UM) techniques that are used primarily t deny r restrict access t care fr peple with chrnic and cmplex health cnditins. Fr instance, requiring step therapy fr HIV treatment r impsing unnecessarily burdensme prir authrizatin requirements n HIV medicatins are discriminatry utilizatin management techniques (indeed, Medicare Part D prhibits use f such techniques as applied t HIV medicatins); denying treatment t individuals living with past r current substance use disrders unless they meet particular abstinence requirements; and placing arbitrary limitatins n access t treatment based n disease prgressin. An utlier analysis is inadequate fr mnitring QHPs fr discriminatry UM techniques; we strngly urge HHS t cmpare QHP UM techniques t emplyer-based cverage. Prtectins against discriminatry plan designs are nly as strng as their enfrcement mechanisms. We strngly urge HHS t develp rbust mnitring and versight mechanisms under 1331 f the ACA and t develp guidance t states that will be the first line f enfrcement fr discriminatry plan designs. It is therefre essential that HHS develp regulatins implementing the ACA s ther nn-discriminatin prvisins (e.g., 1557) as well as sub-regulatry guidance that is prvider, activity, and prgram-specific and that prvides the necessary details f what cnstitutes discriminatry activity, including the circumstances under which HHS will enfrce nn-discriminatin mandates in the absence f state actin. T this end, we suggest that rbust but nt verly burdensme data cllectin and reprting requirements be used, including data cllected frm cnsumer surveys and plan data invlving denials f cverage, t mnitr cmpliance at the state and federal levels. HABILITATIVE SERVICES (45 CFR (a)(5)) We supprt the prpsal t implement a federally defined unifrm definitin f habilitative services and believe this will help address cnfusin and variability in scpe f cverage fr habilitative services natinally. Hwever, we urge HHS t cnsider implementing a definitin that wuld prvide a unifrm and rbust federal flr fr cverage f these imprtant services rather than an ptin fr states t use. NETWORK ADEQUACY STANDARDS (45 CFR ) 7 Fr instance, Delaware recently passed legislatin that caps cinsurance/c-payment fees fr specialty tier drugs at $150 per mnth fr up t a 30-day supply f any single specialty tier drug, available at pen.

9 We are cncerned by the prpsal t delay strengthening prvider netwrk requirements until the Natinal Assciatin f Insurance Cmmissiners (NAIC) finalizes its Health Plan Benefit Plan Netwrk Access and Adequacy Mdel Act. We strngly urge HHS t adpt in the 2016 prpsed rule the plicies highlighted belw s as nt t delay imprving access t health care prviders fr anther tw years. Peple with HIV wh are managed by expert HIV medical prviders have better health utcmes and receive mre cst-effective care. We are cncerned that plans are cntinuing t discurage enrllment by peple living with HIV by nt ffering HIV expertise within their netwrks r by nt identifying HIV prviders within their netwrks. Enacting the recmmendatins belw, which where nted are included in the NAIC mdel act, wuld help t ensure that plans have sufficient HIV expertise within their prvider netwrks: Define reasnable access standard In the 2015 letter t issuers, CMS indicated that the reasnable access standard wuld be defined in terms f time and distance in future rulemaking. It is imprtant t define the reasnable access standard in 2016, and we urge fr this standard t be set in this rule r in the subsequent FY 2016 issuer guidance. In additin, we are cncerned that in the absence f a defined standard fr reasnable access that it will be evaluated based n utlier tests, which leaves t much discretin t QHPs. We urge HHS t cnsider the Health Resurces and Services Administratin (HRSA) standards with regard t travel and wait times (available at: ml). Sme states, such as Washingtn, have already explicitly defined reasnable access. 8 Require exceptins fr ut-f-netwrk prviders We urge HHS t require plans t allw enrllees t request an exceptin fr an ut-f-netwrk prvider at n additinal cst t the enrllee if their expertise is unavailable within the plan s prvider netwrk r inaccessible due t unreasnable travel r wait times. In additin, as prpsed in the NAIC mdel act - cverage fr ut-f-netwrk prviders when the expertise is unavailable in netwrk shuld be cnsidered as in-netwrk fr the purpses f determining patient respnsibility fr cst sharing and fr cunting tward the ut-f-pcket limit. Develp mre rbust transparency requirements fr prvider directries We supprt the prpsal t require QHPs t update their prvider directries at least mnthly as stated in the preamble ideally the updates wuld clser t real time, e.g., n a weekly basis. We urge yu t define this standard in the 2016 rule when it is finalized. In additin, we urge yu t require plans t: Identify Essential Cmmunity Prviders in the directries, including by type 8 Wash. Rev. Cde creates explicit standards fr netwrk adequacy that insurers must meet, including hspital access within thirty minutes fr urban enrllees and sixty minutes fr rural enrllees as well as specific access requirements fr specific services, such as behaviral health and essential health benefits. This regulatin is available at

10 Indicate the date f the last update t the directry in an easily accessible lcatin Include a search functin fr prviders by name r specialty as suggested in the FY 2015 letter t issuers Require 30-day transitin cverage fr new enrllees We urge yu t require rather than recmmend that QHPs cver ut-f-netwrk prviders fr at least 30-days t allw fr a transitin perid fr new enrllees whse prviders are nt included in a QHP s prvider netwrk. This is a reasnable requirement and fr peple with HIV and thers with chrnic cnditin is medically necessary t ensure that they have sufficient time t identify a prvider with the apprpriate expertise within their new QHP netwrk. This is warranted given the difficulties accessing up-t-date prvider directry infrmatin and the challenges that QHPs reprt maintaining accurate directry infrmatin. In additin t the recmmendatins abve, we strngly supprt the requirement fr prvider directry data t be available in machine-readable files as anther step tward imprving transparency f prvider netwrks. ESSENTIAL COMMUNITY PROVIDERS (45 CFR ) In additin t the netwrk adequacy standards and versight, strng requirements with regard Essential Cmmunity Prviders (ECPs) are crucial in ensuring that qualified prviders experienced in reaching and engaging vulnerable ppulatins are included in plan netwrks. We urge HHS t cnsider the fllwing: Expanding the ECP definitin While we supprt expanding access t safety-net health care prviders, we urge HHS t ensure that all eligible ECPs predminantly serve lw incme and medically underserved ppulatins t ensure that access t health care is imprved fr these ppulatins. Increase the minimum flr fr ECP inclusin Given the diversity f ECP types and the imprtance f cntinuity f care fr the lw incme and medically underserved patients wh rely n their services, the current 30% ECP requirement is inadequate. Additinally - if the pl f ECPs is expanded it will be easier fr QHPs t meet the minimum threshld withut ensuring access t the unique expertise prvided by the ECP prvider types, such as Ryan White prviders. In the 2016 letter t issuers r ther rulemaking, we strngly urge yu t require QHPs t cntract with all qualified ECP prviders r t significantly increase the base threshld, e.g., t a threshld in the range f 50% t 75% f ECPs in a service area. Require plans t cntract with at least ne ECP in each ECP categry We urge yu t ensure that the expertise prvided by each f the ECP prvider types is represented in a plan s netwrk by requiring plans t cntract with at least ne f each ECP type in each cunty in the service area, including a Ryan White prvider. At a minimum, we urge yu t add a requirement t the final

11 rule that specifies that QHPs are expected t ffer a meaningful cntract with adequate reimbursement t supprt service delivery t the ECP s target ppulatin t at least ne f each ECP type. Review and enhance the state marketplace ECP plices We are cncerned that sme state administered Marketplaces define ECPs with a fcus n primary care excluding Ryan White prviders as eligible ECPs. We urge yu t ensure that state Marketplaces are at a minimum meeting all federal standards and are supprting access t the critical expertise ffered by all f the ECP prvider types. ENROLLMENT OF QUALIFIED INDIVIDUALS INTO QHPS (45 CFR (e)) We supprt strnger cnsumer prtectins with regard t plan deadlines fr payment f the first mnth s premium effectuating cverage available in Federally Facilitated Marketplaces. Variability in plan deadlines cupled with the administrative cmplexity f crdinating Ryan White Prgram premium payments n behalf f beneficiaries has resulted in terminatin f cverage and disruptins in access t care. We supprt the prpsal t allw cnsumers additinal time after the cverage effective date t make their first premium payment (e.g., ten days after the cverage effective date). SPECIAL ENROLLMENT PERIODS (45 CFR (D)(4) AND (D)(6)) We supprt the creatin f a special enrllment perid fr individuals in nn-medicaid expansin states wh were previusly ineligible fr premium tax credits and cst-sharing reductins because husehld incme was belw 100% FPL, but experienced a change in incme making that persn eligible fr premium tax credits and cst-sharing reductins utside f the pen enrllment perid. We als supprt the prpsal t create a special enrllment perid fr enrllment errrs resulting frm activities f nn-exchange entities (including inadvertent actins and errrs). This shuld include actins f agents and brkers and issuer applicatin assisters that may have resulted in enrllment in insufficient cverage. In additin, we urge HHS t adpt a special enrllment perid t allw enrllees t change plans in the event their current plans make significant mid-year changes t scpe f cverage (e.g., change the prescriptin drug frmulary), affrdability (e.g., change the tier and assciated cst sharing fr a particular medicatin), r plan design (e.g, change the specialty pharmacy specialty r mail rder requirements). HARDSHIP EXEMPTIONS (45 CFR ) We supprt the prpsed clarificatins t exemptins frm the individual mandate t align with previusly released CMS and IRS guidance, including: Individuals wh are nt a dependent f anther taxpayer and whse grss incme is less than the minimum threshld fr filing a federal incme tax return. In this case, the individual des nt need t apply fr an exemptin frm the Marketplace, but instead can chse the exemptin when he/she files federal taxes. Alternatively, the exemptin is autmatic fr peple wh d nt wish t file federal taxes.

12 Members f federally-recgnized Tribes and thse individuals wh are eligible fr services thrugh the Indian Health Service (IHS), a Tribal health facility, r an Urban Indian rganizatin (ITU) qualify fr an exemptin frm the individual mandate and may apply fr the exemptin either thrugh btaining a certificate frm the Exchange/Marketplace r when they file federal taxes. Thank yu fr the pprtunity t ffer cmments t this prpsed rule and fr yur cmmitment t implementing the ACA in ways that ensure access t preventin, care, and treatment fr peple living with HIV and ther chrnic cnditins. Please cntact Amy Killelea with the Natinal Alliance f State & Territrial AIDS Directrs (akillelea@nastad.rg), Andrea Weddle with the HIV Medicine Assciatin (aweddle@hivma.rg), r Rbert Greenwald with the Treatment Access Expansin Prject (rgreenwa@law.harvard.edu) if we can be f assistance. Respectfully Submitted by members f the HIV Health Care Access Wrking Grup, AIDS Actin Baltimre AIDS Actin Cmmittee f MA AIDS Alliance fr Wmen, Infants, Children, Yuth & Families AIDS Fundatin f Chicag The AIDS Institute AIDS Prject Ls Angeles AIDS Treatment Data Netwrk AIDS United American Academy f HIV Medicine Assciatin f Nurses in AIDS Care Cmmunity Access Natinal Netwrk Cmmunities Advcating Emergency AIDS Relief (CAEAR) Calitin Gay Men s Health Crisis Gergia AIDS Calitin Gd s Lve We Deliver Harlem United Health and Disability Advcates HealthHIV HIVictrius, Inc. HIV Medicine Assciatin HIV Preventin Justice Alliance Husing Wrks Lambda Legal Ls Angeles LGBT Center Mveable Feast Natinal Alliance f State and Territrial AIDS Directrs Natinal Minrity AIDS Cuncil The Natinal Wrking Psitive Calitin Prject Infrm San Francisc AIDS Fundatin Suth Carlina Campaign t End AIDS Treatment Access Expansin Prject Treatment Actin Grup VillageCare