National Association of Community Health Centers

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1 Natioal Associatio of Commuity Health Ceters Parterships betwee Federally Qualified Health Ceters ad Local Health Departmets for Egagig i the Developmet of a Commuity-Based System of Care Prepared by Feldesma Tucker Leifer Fidell LLP for the Natioal Associatio of Commuity Health Ceters October 2010

2 Natioal Associatio of Commuity Health Ceters Ackowledgmets / Disclaimer Parterships betwee Federally Qualified Health Ceters ad Local Health Departmets for Egagig i the Developmet of a Commuity-Based System of Care familiarizes the reader with federally qualified health ceters ad local health departmets ad explores various collaborative models that optimize resources ad promote improved health care access ad quality improvemet. While this guide does ot describe the full scope of partership optios, it provides guidace to support the reader s efforts i evaluatig, selectig, ad implemetig a partership that is appropriate for a particular commuity. This publicatio was prepared for the Natioal Associatio of Commuity Health Ceters (NACHC) by attoreys with the law firm of Feldesma Tucker Leifer Fidell LLP (FTLF). It is desiged to provide accurate ad authoritative iformatio i regard to the subject matter covered. While icorporatig certai priciples of federal law, this guide is published with the uderstadig that it does ot costitute, ad is ot a substitute for, legal, fiacial or other professioal advice. Further, this guide does ot purport to provide advice based o specific state law. Federally qualified health ceters ad local health departmets should cosult kowledgeable legal cousel ad fiacial experts to structure ad implemet a partership that is legally, fiacially, ad operatioally appropriate give the particular federally qualified health ceter s ad local health departmet s respective goals, objectives, expectatios, ad resources. Natioal Associatio of Commuity Health Ceters 2

3 Parterships betwee Federally Qualified Health Ceters ad Local Health Departmets Natioal Associatio of Commuity Health Ceters (NACHC) Established i 1971, NACHC serves as the atioal voice for America s Health Ceters ad as a advocate for heath care access for the medically uderserved ad uisured. NACHC s missio is to promote the provisio of high quality, comprehesive ad affordable health care that is coordiated, culturally ad liguistically competet, ad commuity directed for all medically uderserved populatios. Natioal Associatio of Couty ad City Health Officials (NACCHO) NACCHO is the atioal oprofit orgaizatio represetig the approximately 2,860 local health departmets (LHDs) atiowide, icludig members i all public health regios. NACCHO serves every LHD i the atio, without regard to the uit of govermet with which a departmet is associated. These iclude LHDs associated with couties; cities; combied couty-city etities; tows; multi-tow, multi-couty, or other regioal etities withi a state; tribes; ad states. NACCHO s visio is health, equity, ad well-beig for all people i their commuities through public health policies ad services. NACCHO s missio is to be a leader, catalyst, ad voice for LHDs i order to esure the coditios that promote health ad equity, combat disease, ad improve the quality ad legth of lives. For more iformatio cotact: Marcie Zakheim, Esq. or Carrie S. Bill, Esq. Feldesma Tucker Leifer Fidell LLP th Street, N.W. Fourth Floor Washigto, DC Telephoe (202) mzakheim@ftlf.com or cbill@ftlf.com Kathy McNamara, RN, MA Natioal Associatio of Commuity Health Ceters 7200 Wiscosi Aveue Suite 210 Bethesda, MD Telephoe (301) kmcamara@achc.com Jeifer Joseph, PhD, MSEd Natioal Associatio of Couty ad City Health Officials th Street, N.W. Seveth Floor Washigto, DC Telephoe (202) jjoseph@accho.org xxxxxxx NACHC gratefully ackowledges Cidy Phillips, Laure Shirey, Jeifer Joseph, Marisela Rodela, Reba Novich, ad Robert Pestrok of the Natioal Associatio of Couty ad City Health Officials (NACCHO) for their ivaluable collaboratio o the developmet ad writig of this guide. Additioally, NACHC thaks members of NACCHO s HIV/STI Prevetio ad Access ad Itegrated Services Workgroups for graciously sharig their kowledge of LHDs ad providig editorial support. Natioal Associatio of Commuity Health Ceters 3

4 Parterships betwee Federally Qualified Health Ceters ad Local Health Departmets Table of Cotets Itroductio Federally Qualified Health Ceter-Local Health Departmet Parterships: A Strategic Alliace Patiet Protectio ad Affordable Care Act The Patiet-Cetered Medical Home Model of Care Meaigful Use of Health Iformatio Techology Partership Beefits 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Federally Qualified Health Ceter Fudametals Defiig a Federally Qualified Health Ceter Key Federally Qualified Health Ceter Requiremets Cost-Based Reimbursemet, Federal Tort Claims Act, Sectio 340B Drug Pricig, ad Ati-Kickback Safe Harbor Protectio Federally Qualified Health Ceter Scope of Project Cosideratios Local Health Departmet Fudametals Fuctio Goverace Fudig Relatioship to State Health Departmet Jurisdictios Workforce Services 3 The Plaig Process: Layig the Foudatio for a Successful Partership Essetials of a Successful Partership Establishig a Partership Questios to Guide the Plaig Process Cofidetiality Agreemet Health Iformatio Exchage ad Patiet Privacy Cosideratios 4 Federally Qualified Health Ceter-Local Health Departmet Partership Models Key Cosideratios ad Agreemet Terms Referral Arragemets Co-Locatio Arragemets Purchase of Services Arragemets 5 Additioal Legal Cosideratios Coclusio ad Next Steps Appedix A Natioal Associatio of Commuity Health Ceters 4

5 Parterships betwee Federally Qualified Health Ceters ad Local Health Departmets Itroductio Federally qualified health ceters (hereiafter FQHCs or Commuity Health Ceters ( CHCs )) ad local heath departmets (hereiafter LHDs ) share a commo missio to improve commuity health, particularly amog vulerable ad uderserved populatios. FQHCs ad LHDs curretly work collaboratively o behalf of their residets i may commuities across the coutry. Today, the reasos for partership betwee FQHCs ad LHDs are particularly compellig. The passage of the Patiet Protectio ad Affordable Care Act (the health reform law ) sigals a overhaul of the health care system, with a importat emphasis o primary care, prevetio, ad collaboratio amog a commuity s health care providers. A core compoet of the health reform law is the expasio of the patiet cetered medical home model of care delivery, which calls for patiet care to be coordiated ad itegrated across the health care system. Both the Patiet Protectio ad Affordable Care Act ad the expasio of the patiet cetered medical home model preset fresh opportuities for health ad commuity leaders to work together to desig ad implemet local health delivery ad care systems that: Address the health issues of uderserved ad vulerable commuities; Improve ad documet value; Geerate positive patiet ad commuity experieces of care ad egagemet i health; ad Improve the health of target populatios with a emphasis o promotig health equity ad elimiatig health disparities. FQHCs ad LHDs differ i some substative ways. FQHCs are charged with the delivery of a full cotiuum of primary ad prevetive care services, ad eablig services. LHDs are charged with populatio health, which may or may ot iclude health care delivery. Likewise, as federally-fuded etities, FQHCs structure ad regulatios are relatively uiform compared to LHDs, whose goverace ad activities vary widely from state to state ad from commuity to commuity. However, the two etities are well positioed to be strog parters ad there is a log history of comig together to improve both idividual ad populatio health. Parterships betwee Federally Qualified Health Ceters ad Local Health Departmets for Egagig i the Developmet of a Commuity-Based System of Care provides a overview of several partership opportuities available to FQHCs ad LHDs seekig to improve health outcomes i their commuity, while promotig cost-effective care. Through the les of partership, LHD readers will beefit from iformatio preseted about the key features of FQHCs ad the various federal requiremets applicable to the program. Likewise, FQHC readers will gai isight ito LHDs. Natioal Associatio of Commuity Health Ceters 5

6 Parterships betwee Federally Qualified Health Ceters ad Local Health Departmets Specifically, this guide addresses: The Patiet Protectio ad Affordable Care Act, the patiet cetered medical home model of care, ad the meaigful use of health iformatio techology as drivers i FQHC- LHD parterships; Beefits associated with FQHC-LHD parterships; Key features of FQHCs ad LHDs ad their relevace to FQHC-LHD parterships; Health iformatio exchage ad patiet privacy cosideratios withi the cotext of FQHC-LHD parterships; ad Various partership models, icludig key terms for writte agreemets to implemet a affiliatio approach that is compliat with applicable FQHC federal rules ad requiremets. Natioal Associatio of Commuity Health Ceters 6

7 Parterships betwee Federally Qualified Health Ceters ad Local Health Departmets 1 Federally Qualified Health Ceter-Local Health Departmet Parterships: A Strategic Alliace Parterships are ecessary to maximize resources, to reduce duplicatio of effort, ad to improve quality, efficiecy, ad accessibility of health care services. The chagig face of America s uderserved populatio, the restricted resources uder which FQHCs ad LHDs operate, ad the desire ad eed for more fully-fuctioig ad better prepared public health ad primary care systems all demad a health care system based i local parterships. Curretly, FQHCs ad LHDs successfully parter to address a variety of public health ad primary care priorities, icludig but ot limited to the followig: HIV prevetio ad testig; STD testig, care ad treatmet; Detal health; Behavioral health; Chroic disease prevetio; Materal ad child health; ad Emergecy preparedess. NACHC ad NACCHO: A Joit Missio to Promote Collaboratio betwee FQHCs ad LHDs O Jue 1, 2010, the Natioal Associatio of Commuity Health Ceters (NACHC) ad the Natioal Associatio of Couty ad City Health Officials (NAC- CHO) collectively wrote a letter to their respective members, statig NACCHO ad NACHC recogize that a ew collaboratio betwee our two orgaizatios ca help our respective members address the challeges of health system reform. The letter further oted that excellet models of local collaboratio curretly exist ad that together the orgaizatios pla to discover more models, to lear from them, ad to ecourage the developmet of such costructive relatioships atiowide. A. Patiet Protectio ad Affordable Care Act The passage of the Patiet Protectio ad Affordable Care Act ( the health reform law ) i 2010 provides for a sigificat fiacial ivestmet i programs based i public health, primary care, ad commuity collaboratio. This ivestmet reflects a atioal shift towards emphasizig welless ad prevetio, cliical itegratio, ad collaborative commuity based care. Ideed, it is well settled that reform will ot be successful without such collaboratio. Collaboratio betwee FQHCs ad LHDs is therefore ot oly desirable, it is ecessary give the priorities set forth i health reform. Health Reform ad FQHC-LHD Collaboratio Through collaboratio, FQHCs ad LHDs may positio themselves to participate i fudig opportuities. There are several relevat fudig opportuities described i the health reform law, icludig the followig: Commuity health teams (Pub. L ): The health reform law states that health teams composed of commuity-based, iterdiscipliary medical professioals will be established to support primary care medical homes Natioal Associatio of Commuity Health Ceters 7

8 1 Federally Qualified Health Ceter-Local Health Departmet Parterships: A Strategic Alliace that are withi hospital areas served by those etities. This provisio allows LHDs to receive fuds to establish a commuity health team ad collaborate with local primary care providers, icludig FQHCs. Commuity-based prevetio ad welless programs (Pub. L ): The health reform law establishes that there will be grats for LHDs to carry out 5-year pilot programs to provide public health commuity itervetios. Amog other requiremets, LHDs are required to demostrate the capacity to establish relatioships with commuity-based cliical parters, such as FQHCs. Primary care extesio programs (Pub. L ): The health reform law authorizes grats to states to establish primary care extesio programs. These programs rely o the collaboratio of LHDs ad FQHCs to idetify commuity health priorities ad participate i commuity-based efforts to address these primary care priorities. I additio to these opportuities preseted i the health reform law, both the Ceters for Disease Cotrol ad Prevetio (CDC) ad the Health Resources ad Services Admiistratio (HRSA) have made public health ad primary care collaboratio a priority, resultig i the availability of fudig to support collaborative efforts. From Fragmetatio to a High Performace Health System Accordig to a Commowealth Fud Commissio o a High Performace Health System report, fragmetatio i the health care delivery system fosters frustratig ad dagerous patiet experieces, especially for patiets obtaiig care from multiple providers i a variety of settigs. Fragmetatio also leads to waste ad duplicatio, hiderig providers ability to deliver high-quality, efficiet care. 1 The Commissio idetified the followig six attributes of a ideal health care delivery system: 1. Patiets cliically relevat iformatio is available to all providers at the poit of care ad to patiets through electroic health record systems. 2. Patiet care is coordiated amog multiple providers, ad trasitios across care settigs are actively maaged. 3. Providers (icludig urses ad other members of care teams) both withi ad across settigs have accoutability to each other, review each other s work, ad collaborate to reliably deliver high-quality, highvalue care. 4. Patiets have easy access to appropriate care ad iformatio, icludig after hours; there are multiple poits of etry to the system; ad providers are culturally competet ad resposive to patiets eeds. 5. There is clear accoutability for the total care of patiets. 6. The system is cotiuously iovatig ad learig i order to improve the quality, value, ad patiet experiece of health care delivery. 1 Commowealth Fud, Orgaizig the Health Care Delivery System for High Performace (2008). Natioal Associatio of Commuity Health Ceters 8

9 1 Federally Qualified Health Ceter-Local Health Departmet Parterships: A Strategic Alliace B. The Patiet-Cetered Medical Home Model of Care The 2010 health reform law promotes delivery system iovatio ad improvemet through systems of care such as patiet-cetered medical homes ad accoutable care delivery models. Health reform provides structure ad icetives for providers to orgaize themselves ad share savigs uder a accoutable care orgaizatio (ACO), deliver care via the patiet-cetered medical home (PCMH) model, ad receive budled ad global paymets for acute ad post-acute care. The PCMH cocept, origially itroduced by the America Academy of Pediatrics (AAP) i 1967, received further edorsemet i 2007 whe AAP, together with the America Academy of Family Physicias (AAFP), America College of Physicias (ACP), ad America Osteopathic Associatio (AOA), issued the Joit Priciples of the Patiet-Cetered Medical Home. Now widely accepted amog medical orgaizatios ad associatios, the prevailig medical home cocept is represeted i the Joit Priciples, which emphasize a patiet s ogoig relatioship with a persoal physicia, a whole perso orietatio, team approaches to care, care itegratio ad coordiatio, ehaced access, quality, safety, ad paymet for added value. As oe approach i a larger strategy to trasform how health care is delivered i the Uited States, the PCMH illumiates the role of primary care i cotrollig costs, improvig quality, ad improvig the patiet experiece of care. This framework aims to trasform primary care practices i both the public ad private sectors to esure accessible, timely, comprehesive, patiet-cetered primary care ad effective coordiatio with other providers. Orgaizatios such as the Natioal Committee for Quality Assurace (NCQA) have created widelysupported stadards for recogitio as a PCMH. NCQA s Physicia Practice Coectios Patiet Cetered Medical Home recogitio program is based upo meetig specific elemets i ie stadard categories. The Primary Care Developmet Corporatio (PCDC) offers a How-To Maual for safety et providers ad orgaizatios seekig to achieve NCQA medical home recogitio. Similarly, the America College of Physicias (ACP) has developed a Medical Home Builder SM tool that provides step-bystep istructios, tools, ad resources. NCQA Physicia Practice Coectios Patiet Cetered Medical Home Recogitio Program 2 PPC-PCMH Recogitio is based o meetig specific elemets icluded i ie stadard categories: 1. Access ad Commuicatio 2. Patiet Trackig ad Registry Fuctios 3. Care Maagemet 4. Patiet Self-Maagemet ad Support 5. Electroic Prescribig 6. Test Trackig 7. Referral Trackig 8. Performace Reportig ad Improvemet 9. Advaced Electroic Commuicatio Note: NCQA stadards were recetly ope for public commet; a proposal to collapse ad reduce the categories from ie to six is uder cosideratio. 2 Natioal Associatio of Commuity Health Ceters 9

10 1 Federally Qualified Health Ceter-Local Health Departmet Parterships: A Strategic Alliace Yet as the Uited States seeks to optimize primary care, i part by advacig the cocept of the patiet-cetered medical home (PCMH), some of the key values of the CHC model a wholeperso orietatio, accessibility, affordability, high quality, ad accoutability could well iform tomorrow s primary care paradigm for all Americas. Despite the challeges they face, the CHCs are already built o a premise resemblig that of the PCMH, a holistic cocept ecompassig highly accessible, coordiated, ad cotiuous team-drive delivery of primary care that relies o the use of decisio-support tools ad ogoig quality measuremet ad improvemet. 3 Medical home iitiatives withi safety et populatios are i abudace, ad FQHC egagemet is o the rise. Over 40 FQHCs have already achieved NCQA medical home recogitio. Accordig to the Natioal Academy for State Health Policy, more tha 35 state Medicaid agecies have legislated medical home iitiatives, with may fully egaged i demostratios, ad the Medicare-Medicaid Advaced Primary Demostratio Iitiative was aouced i September The Safety Net Medical Home Iitiative, a five-year demostratio lauched i 2008 by the Commowealth Fud, Qualis Health, ad the MacColl Istitute for Healthcare Iovatio, relies heavily o FQHCs as it seeks to produce a replicable atioal model for implemetig the PCMH i safety et primary care practices. A Natioal Demostratio Project by the America Academy of Family Physicias (AAFP) radomized 36 family practice sites to facilitated versus self-directed groups i implemetatio of the PCMH model. They foud that trasformatio of practices required a tremedous amout of resources ad exteral support. Ad while greater adoptio of medical home compoets was associated with improvemet i measures of quality, prevetio ad chroic disease care, patiet ratigs declied i both the facilitated ad self-directed groups durig this trasformatio process. This evaluatio reports that the jury is still out o the actual impact o quality of care ad patiet outcomes.realistically, it may require reform of the larger delivery system, itegratig primary care with the larger health care system, for the full impact of a PCMH implemetatio to result i statistically sigificat ehacemets to most patiet quality-of-care outcomes. 5 A 2009 study by the Commowealth Fud examied FQHC capacity to fuctio as a medical home based o the presece or absece of five idicators developed from the Natioal Committee for Quality Assurace s medical home measures: Patiet Trackig ad Registry Fuctios; Test Trackig; Referral Trackig; Ehaced Access ad Commuicatio; ad Performace Reportig ad Improvemet. Twety-ie percet of FQHCs had capacity i all five domais; 55% i 3-4 domais; ad 16% i 0-2 domais. A key opportuity for improvemet is i care coordiatio across differet settigs of care. 4 3 Health Care Reform ad Primary Care The Growig Importace of the Commuity Health Ceter, Eli Y. Adashi, MD, H. Jack Geiger, MD, ad Michael D. Fie, MD. New Eglad Joural of Medicie 362: (2010). 4 Ehacig the Capacity of Commuity Health Ceters to Achieve High Performace, Fidigs from the 2009 Commowealth Fud Natioal Survey of Federally Qualified Health Ceters, Michelle M. Doty, Melida K. Abrams, Susa E. Heradez, Kristof Stremikis, ad Ae C. Beal, May Summary of the Natioal Demostratio Project ad Recommedatios for the Patiet-Cetered Medical Home, Bejami F. Crabtree, PhD, Paul A. Nuttig, MD, MSPH, William L. Miller, MD, MA, Kurt C. Stage, MD, PhD, Elizabeth E. Stewart, PhD ad Carlos Roberto Jaé, MD, PhD Aals of Family Medicie 8:S80-S90 (2010) doi: /afm Natioal Associatio of Commuity Health Ceters 10

11 1 Federally Qualified Health Ceter-Local Health Departmet Parterships: A Strategic Alliace While the health reform law is atioal i scope, the task of implemetig it ad ultimately trasformig the way health care is delivered i this coutry will fall o state ad local public health ad primary care systems. Meaigful trasformatio will require a uprecedeted level of cooperatio ad itegratio amog various systems of health care delivery both public ad private. Furthermore, the PCMH or health care home for uderserved ad vulerable populatios must support ad build idividual efficacy to maitai or improve health while providig a structure for commuity participatio i the operatio of the health care home. Safety et practices should be egaged parters i a commuity health system that esures access ad coordiatio with specialty care, diagostic services, public health services, health iformatio exchages, hospitals, ad other care settigs as well as agecies ad commuity orgaizatios providig social, educatio, housig, ad other services ecessary to maitai ad improve health. For uderserved ad vulerable patiets, the health care home should fuctio as more of a village, requirig the trasformatio of the local primary care ad public health systems ad strog leadership from withi each. C. Meaigful Use of Health Iformatio Techology It is essetial that FQHCs ad LHDs establish the ability to exchage iformatio for the purposes of coordiatig care for their shared patiets ad to provide the ability to improve populatio health. The Ceters for Medicare ad Medicaid Services released its Fial Rule o the Medicare ad Medicaid Electroic Health Record Icetive Program o July 28, 2010 i the Federal Register. 6 These rules require that eligible professioals use health iformatio techologies, particularly electroic health records, that have the capability to exchage key cliical iformatio (for example, problem list, medicatio list, medicatio allergies, diagostic test results), amog providers of care ad patiet authorized etities electroically to improve care coordiatio. 7 Eligible professioals workig i FQHCs ad meetig the 30% eedy idividuals patiet volume threshold will be required to demostrate successful exchage of cliical iformatio by their secod year of participatio i the Medicaid Icetive Program to receive a icetive paymet for that year. I subsequet years they will be required to have the ability to exchage this data o a regular basis. The rules also specify that eligible professioals may choose to have the capability to submit electroic sydromic surveillace data to public health agecies ad actual submissio i accordace with applicable law ad practice ad/or the capability to submit electroic data to immuizatio registries or immuizatio iformatio systems ad actual submissio accordig to applicable law ad practice as a elemet of meaigful use for purposes of qualifyig for a icetive paymet uder the Icetive Program. 8 These two optios, alog with the capacity to submit electroic data o reportable lab results to public health agecies (applicable oly to hospitals), comprise the objectives aimed at improvig populatio ad public health. For more iformatio regardig electroic health records ad meaigful use, readers may refer to the Departmet of Health ad Huma Services (DHHS) website Fed. Reg , July 28, Fed. Reg , July 28, Fed. Reg , July 28, Natioal Associatio of Commuity Health Ceters 11

12 1 Federally Qualified Health Ceter-Local Health Departmet Parterships: A Strategic Alliace D. Partership Beefits The potetial beefits of FQHC-LHD parterships exted beyod the four walls of the exam room ad ito the greater commuity. Parterships put the well-beig of a commuity ito greater focus with overall goals to improve access to care, improve health outcomes, ad decrease health disparities. Specifically, a FQHC-LHD partership may: Systems of Care Ehace the capacity of commuity providers to provide value, high quality, cost-effective medical homes for vulerable populatios. Assist low-icome idividuals to access the full rage of safety et services ad public beefits available i the commuity (e.g., food stamps, substace abuse couselig, Medicaid eligibility, ad other social services). Geerate more positive patiet ad commuity experieces of care ad egagemet i health. Resources Help to avoid the uecessary duplicatio of services, lowerig the costs of providig care ad ultimately stregtheig the existig safety et delivery system. Reduce the eed for more expesive i-patiet ad specialty care services as well as emergecy room visits, resultig i sigificat savigs to a commuity s health care system. Allow limited federal, state ad local resources to be targeted ad allocated to areas that most require them. Cliical Outcomes Reduce chroic disease through the reductio of risk factors, such as smokig. Reduce the spread of ifectious disease i the commuity. Improve immuizatio rates agaist vaccieprevetable diseases. Improve access to preatal care; educate wome about well-baby care, childhood immuizatios, ad utritio; prevet motherto-baby trasmissio of HIV; ad decrease premature birth ad morbidity. Public Health Moitorig Support comprehesive commuity public health assessmets through collaboratio ad sharig of surveillace ad other populatiobased data. Allow providers to gather vital patiet level data through disease registries. Facilitate the parter otificatio process for HIV ad other sexually trasmitted diseases. Natioal Associatio of Commuity Health Ceters 12

13 Parterships betwee Federally Qualified Health Ceters ad Local Health Departmets 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets A. Federally Qualified Health Ceter Fudametals 1. Defiig a Federally Qualified Health Ceter A FQHC is a public or private o-profit, charitable, tax-exempt orgaizatio that receives fudig uder Sectio 330 of the Public Health Service Act (Sectio 330), or is determied by the Departmet of Health ad Huma Services (DHHS) to meet requiremets to receive fudig without actually receivig a grat (i.e., a FQHC lookalike ). 9 FQHCs serve as the health care home for 20 millio people atioally through over 7,500 service delivery sites. 10 It is estimated that FQHCs save the atioal health care system up to $24 billio a year. This icludes $6.7 billio i savigs for the federal share of the Medicaid program, ad is drive by lower utilizatio of costly specialty care, emergecy departmets, ad hospitals. 11 FQHCs successfully overcome barriers to care because they are located i high-eed areas; are ope to all residets of their service areas; offer services that facilitate access to care, such as outreach ad trasportatio; ad tailor their services to their patiets ad their commuities uique cultural ad health eeds. 12 FQHC patiets are some of the atio s most vulerable idividuals. Recet surveys idicate: 13 71% of patiets have family icomes at or below the Federal Poverty Level (FPL). 38% of patiets are uisured. 36% of patiets deped o Medicaid. Roughly half of FQHC patiets live i ecoomically depressed ier city commuities with the other half residig i rural areas. FQHC Patiets by Icome Level, 2009 Over 200% FPL 7.5% % FPL 6.6% 9 Sectio 1861(aa)(4) of the Social Security Act. 10 Fact Sheet- America s Health Ceters. NACHC, August Available at 11 Fact Sheet- America s Health Ceters. NACHC, August Available at % FPL 14.5% 12 Sectio 330 of the Public Health Service Act (42 U.S.C. 254b) ad its implemetig regulatios (42 C.F.R. Part 51c). 100% FPL ad Below 71.4% 13 Fact Sheet- America s Health Ceters. NACHC, August Available at Note: Federal Poverty Level (FPL) for a family of three i 2009 was $18,310. (See aspe.hhs.gov/poverty/08poverty.shtml.) Based o percet kow. Percets may ot total 100% due to roudig. Source: Bureau of Primary Health Care, HRSA, DHHS, 2009 Uiform Data System. Natioal Associatio of Commuity Health Ceters 13

14 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets [Commuity Health Ceters] provide quality care at prices that people ca afford, with the digity ad respect they deserve, ad i a way that takes ito accout the challeges that they face i their lives. Presidet Barack Obama, Remarks by the Presidet o Commuity Health Ceters, December 2009 FQHC Patiets by Race/Ethicity, 2009 America Idia/ Alaska Native 1% Race More tha oe race 5% White 62% Note: Based o percet kow. Percets may ot total 100% due to roudig. Source: Bureau of Primary Health Care, HRSA, DHHS, 2009 Uiform Data System. FQHC Patiets by Isurace Status, 2009 Other Public 3% Medicare 7% Asia/Hawaiia/Pacific Islader 1% Africa America 27% Private 15% Medicaid/SCHIP 36% All Others 67% Uisured 38% Ethicity Hispaic/Latio 33% Note: Other Public may iclude o-medicaid SCHIP. Percets may ot total 100% due to roudig. Source: Bureau of Primary Health Care, HRSA, DHHS, 2009 Uiform Data System. America s Health Ceters owe their existece to a remarkable tur of evets i U.S. history, ad to a few determied commuity health ad civil rights activists workig i lowicome commuities durig the 1960s. Millios of Americas, livig i ier-city eighborhoods ad rural areas throughout the coutry, suffered from deep poverty ad a desperate eed for health care. Amog those determied to seek chage was H. Jack Geiger, the a youg doctor ad civil rights activist. Geiger had studied i South Africa ad witessed how a pioeerig commuity health model had wrought astoishig improvemets i public health. I the 1960s, as Presidet Johso s declared War o Poverty bega to ripple through America, the first proposal for the U.S. versio of a commuity health ceter sprug to life at the Office of Ecoomic Opportuity. Fudig was approved i 1965 for the first two eighborhood health ceter demostratio projects, oe i Bosto, Massachusetts, ad the other i Moud Bayou, Mississippi. You ca read more about the history of the health ceter movemet, ad lear about the pioeers who helped make it happe, at a olie exhibit o global health lauched by the Natioal Library of Medicie. More iformatio about FQHCs is also available at the Faces of Hope Campaig, which was lauched to raise awareess about Commuity Health Ceters. 15 For more tha 40 years, health ceters i the Uited States have delivered comprehesive, high-quality primary health care to patiets regardless of their ability to pay Health Ceters: America s Primary Care Safety Net, Reflectios o Success, DHHS, HRSA, BPHC, Jue 2008, p NACHC s press kit is available at Natioal Associatio of Commuity Health Ceters 14

15 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets U.S.C. 254b(k)(3)(H); 42 C.F.R. 51c Public etities may iclude, but are ot limited to, public hospitals ad muicipal health departmets. Public etities are specifically defied i HRSA PIN : Cofirmig Public Agecy Status uder the Health Ceter Program ad FQHC Look-Alike Program available at policy/pi1001/ U.S.C. 254b(r)(2)(A). What is a Public Health Ceter? I order to qualify for Sectio 330 fudig, a orgaizatio must, amog other requiremets, be a oprofit private or public etity ad must have a cosumer-directed board of directors that meets specific requiremets with respect to board member selectio, compositio, ad the exercise of broad policy ad oversight authorities. 16 Recogizig that most public etities 17 are ot, ad legally could ot, be govered by a cosumer-directed board, Cogress revised Sectio 330 i 1978 to authorize the DHHS to exped up to 5 percet of the aual Sectio 330 appropriatio i support of public health ceters with goverig boards that do ot fully exercise all of the required authorities. 18 Public health ceters may receive Sectio 330 fudig or may be desigated as a FQHC look-alike. Guidace issued by HRSA, set forth i Policy Iformatio Notice (PIN) 99-09: Implemetatio of the Balaced Budget Act Amedmet, explais that there are two models of public health ceters. Oe is a direct model, i which the public etity meets all of the Sectio 330 FQHC program requiremets. The direct model is extraordiarily ucommo due to the fact that seemigly few public etities have, or legally could have, a board that meets Sectio 330 selectio ad compositio requiremets. The other model is a co-applicat arragemet, which cosists of a public etity ad a co-applicat etity that collectively meet all Sectio 330 requiremets. The public etity receives the grat fuds or lookalike desigatio, ad the co-applicat etity serves as the FQHC s goverig board. Together, the two joitly fuctio as the public health ceter. HRSA PIN stipulates that uder the coapplicat model, the co-applicat board for the public health ceter must meet the Sectio 330 compositio ad resposibility requiremets as described o pages of this guide, except for the requiremet that the board establish persoel ad fiacial maagemet policies for the public health ceter. HRSA PIN also allows for certai joit decisio-makig betwee the public etity ad the co-applicat board, although the board must maitai certai autoomous authorities. LHDs are eligible to apply for desigatio as a public health ceter if they meet the applicable Sectio 330 requiremets, may of which are highlighted o pages of this guide, ad qualify as a public agecy, defied as follows: The orgaizatio is a state or a political subdivisio of a state with oe or more sovereig powers. The orgaizatio is a istrumetality of govermet, such as those exempt uder Iteral Reveue Code Sectio 115. The orgaizatio is a subdivisio, muicipality, or istrumetality of a U.S. affiliated sovereig state that is formally associated with the Uited States. The orgaizatio is operated by a Idia tribe or tribal or Idia orgaizatio uder the Idia Self-Determiatio Act or urba Idia orgaizatio uder the Idia Health Care Improvemet Act. For more iformatio o establishig a public health ceter, see NACCHO s issue brief, Developig Quality Applicatios for Commuity Health Ceter Fudig. Natioal Associatio of Commuity Health Ceters 15

16 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets 2. Key Federally Qualified Health Ceter Requiremets HRSA ecourages FQHCs to affiliate with other etities, but expects them to remai diliget i complyig with all Sectio 330-related requiremets. 19 It is of utmost importace that FQHCs ad their parterig LHDs cosider Sectio 330 statutory, regulatory, ad policy requiremets throughout the evaluatio ad implemetatio of ay affiliatio. A thorough review of legal cosideratios helps esure that the partership is appropriately structured, reduces exposure to liability, ad protects a FQHC s desigatio. Corerstoes of the FQHC Model There are four corerstoes of the FQHC model, all of which must cotiue to be satisfied uder ay collaboratio. Specifically, the FQHC must: 1. Be located i a federally-desigated medically uderserved area or serve a federally-desigated medically uderserved populatio; 2. Serve all residets of the FQHC s service area or all residets who belog to a targeted special populatio (i.e., migrat ad seasoal farmworkers, homeless idividuals, ad residets of public housig) if the FQHC receives fudig to serve such special populatio, regardless of a idividual s or family s ability to pay; 3. Provide a full cotiuum of primary ad prevetive care services; ad 4. Be govered by a idepedet commuity-based board of directors that complies with all Sectio 330-related size, compositio, ad selectio requiremets ad maitais ad autoomously exercises all authorities ad resposibilities required of a FQHC goverig board. Orgaizatioal Requiremets FQHC orgaizatioal requiremets are set forth i various sources, most otably Sectio 330 of the Public Health Service Act, 20 the DHHS FQHC implemetig regulatios, 21 ad HRSA PIN 98-23: Health Ceter Program Expectatios. Medically Uderserved Area / Medically Uderserved Populatio A orgaizatio must serve a federally-desigated Medically Uderserved Area (MUA) or Medically Uderserved Populatio (MUP) to qualify as a FQHC. MUAs ad MUPs are federal desigatios made by HRSA for defied geographic areas/ populatio groups with isufficiet health resources. Scope of Services FQHCs are required to provide, either directly or through a established arragemet, health services related to family medicie, iteral medicie, pediatrics, obstetrics ad gyecology, diagostic laboratory ad radiological services, pharmaceutical services as appropriate, ad defied prevetive health services. 22 FQHCs are also required to provide (amog other thigs): 23 Patiet case maagemet services; 19 Throughout the guide, the terms affiliatio, collaboratio, ad partership may be used iterchageably to idicate collaborative models of providig care; the use of oe term over the other does ot reflect a particular legal structure U.S.C. 254b C.F.R. 51c. 22 For the complete list of required services, see 42 U.S.C. 254b(b)(1)(A) U.S.C. 254b(2)(b)(1)(A). Natioal Associatio of Commuity Health Ceters 16

17 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Services that eable patiets to utilize the FQHC s medical services, icludig outreach ad trasportatio services; ad Educatio of patiets ad the geeral populatio served by the FQHC regardig the availability ad proper use of health services. Accordig to HRSA PIN : Specialty Services ad Health Ceters Scope of Project, health services related to metal health ad substace abuse treatmet are cosidered by HRSA to be primary health care services ad are icluded amog the health services that FQHCs are required to provide directly or through cotracts or established arragemets uder Sectio FQHCs may also provide additioal health services that are ot icluded as required primary health services, yet are appropriate to meet the health eeds of the populatio served by the FQHC. 25 FQHCs may iclude specialty services i their scope of project, upo approval by HRSA, if they ca demostrate that the service is a logical extesio of or related to the primary care services provided ad that there is a eed for the service amog the FQHC s patiets. For example, if a FQHC has a large diabetic populatio, services such as ophthalmology, podiatry, ad edocriology may be ecessary compoets of treatmet plas ad, thus, extesios of or related to the primary care furished to this populatio. All of a FQHC s patiets must have reasoable access to the FQHC s full scope of services, either directly or through formal established arragemets. Therefore, the FQHC does ot have to make its full scope of services available at each of its sites, provided that all patiets ca reasoably access all services offered by the FQHC, either at the FQHC s other site(s) or through a established formal arragemet (e.g., referral) with aother provider. There is o formula for determiig reasoable access. To assess if access is reasoable, it is recommeded that FQHCs evaluate the distace betwee sites ad trasportatio barriers. As described i the Scope of Project sectio begiig o page 23 of this guide, this requiremet must be carefully cosidered if a FQHC seeks to add a ew site ad/or service to its scope of project. Schedule of Charges ad Discouts FQHCs must serve all residets of their respective service area, regardless of a idividual s or family s ability to pay. With respect to reimbursemet for such services, FQHCs must have a schedule of charges cosistet with locally prevailig rates ad desiged to cover the FQHC s reasoable costs of operatio. FQHCs also must provide discouts based o ability to pay. 26 Specifically, FQHCs must: Charge patiets whose aual icome is above 200% of the Federal Poverty Level ad thirdparty payors without applyig ay discouts; ad Apply discouts based o ability to pay for uisured ad uderisured patiets whose aual icome is above 100% ad at or below 200% of the Federal Poverty Level. FQHCs may collect, at most, a omial fee from uisured ad uderisured patiets whose aual icome is at or below 100% of the Federal Poverty Level HRSA PIN : Specialty Services ad Health Ceters Scope of Project, p. 5 available at 25 Health Care for the Homeless gratees are required to provide substace abuse services (42 U.S.C. 254b (h)(2)) U.S.C. 254b(k)(3)(G)(i); see also 42 C.F.R. 51c.303(f) U.S.C. 254b(k)(3)(G)(i); see also 42 C.F.R. 51c.303(f). Natioal Associatio of Commuity Health Ceters 17

18 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Sectio 330 also requires FQHCs to assure that o patiet will be deied health care services due to a idividual s iability to pay for such services ad that ay fees or paymets required by the FQHC for such services will be reduced or waived to eable the FQHC to fulfill the assurace. 28 FQHCs must apply their fee schedules ad correspodig schedules of discouts to all patiets, for all services provided withi its scope of project. For example, a FQHC is prohibited from providig LHD patiets with free care, uless such idividuals qualify for a full discout based o their icome level. Procuremet Requiremets ad Stadards FQHCs that are Sectio 330 gratees must comply with the federal procuremet requiremets ad stadards regardig the purchase of goods ad services usig federal grat fuds. 29 The purpose of the federal procuremet requiremets ad stadards is to esure that goods ad services are obtaied i a effective ad efficiet maer. I geeral, the procuremet requiremets ad stadards cotai provisios requirig FQHCs to: (1) establish ad maitai writte stadards of coduct for all employees, cotractors, agets, ad directors, icludig a coflict of iterest provisio; (2) provide for, ad maximize, ope ad free competitio; (3) establish ad maitai writte procuremet procedures; (4) maitai procuremet records; ad (5) maitai a cotract admiistratio system to esure coformace with the terms ad coditios of the cotract, icludig procedures to moitor ad oversee a cotractor s performace. The federal procuremet requiremets ad stadards, as well as the FQHC s applicable policies ad procedures, must be reviewed closely if, as part of a partership with a LHD, the FQHC purchases goods ad/or services. Goverig Board Requiremets A core compoet of the FQHC model is the commuity-based goverig board. Sectio 330, its implemetig regulatios, ad guidace require the followig: Board Compositio 30 The board size should be betwee 9 25 members. At a miimum, a majority of the board members must be active cosumers of the FQHC s services (i.e., persos who utilize the FQHC as their pricipal source of primary care ad have doe so withi the last two years) who collectively represet the idividuals beig served by the FQHC i terms of various demographic factors, such as ecoomic status, race, ethicity, ad geder. The remaiig o-cosumer board members must be represetative of the FQHC s commuity, ad should be selected for their expertise i various fields. No more tha oe-half of the o-cosumer board members may be idividuals who derive more tha te percet of their aual icome from the health care idustry. No member of the board of directors may be a employee of the FQHC or a immediate family member of a employee (i.e., spouse, child, paret, or siblig), by blood, marriage, or adoptio U.S.C. 254b(k)(3)(G)(iii) C.F.R. Part 74 (or Part 92 if the etity is a public health ceter). For more iformatio regardig key FQHC cotract issues, see NACHC Issue Brief, Risk Maagemet Series #2: Key Cotract Issues Facig Health Ceters, November 2002 available at aspx?product_code=rm_2_ C.F.R. 51c.304. Natioal Associatio of Commuity Health Ceters 18

19 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets FQHC Board Resposibilities ad Authorities The FQHC board must exercise the followig authorities: 31 Directly employ ad approve the selectio, aual evaluatio ad dismissal of the Executive Director/Chief Executive Officer. Prepare ad approve the aual budget ad project pla, icludig the aual Sectio 330 grat applicatio or FQHC look-alike certificatio/applicatio. Adopt ad, as ecessary, update fiacial maagemet practices, persoel policies ad procedures, ad health care policies ad procedures. Evaluate the FQHC s activities. Establish ad maitai collaborative relatioships with other health care providers ad social agecies i the relevat service area. Maitai a commitmet to provide services to the medically uderserved populatios(s) served by the FQHC. Evaluate itself for compliace with Sectio 330 requiremets. Assure that the FQHC is operated i compliace with applicable federal, state ad local laws, regulatios, ad policies. For more iformatio regardig public health ceter co-applicat board authorities, see page 15. Role of the FQHC Board i Implemetig FQHC-LHD Parterships It is critical that a FQHC s board of directors is ivolved i key decisios about LHD parterships. This is particularly relevat if a partership ivolves establishig a ew site ad/or the expasio of services. I evaluatig potetial FQHC-LHD parterships, FQHC board members should ask the followig questios: Is the partership with the LHD cosistet with the FQHC s missio? Is the partership with the LHD fiacially viable or would it jeopardize the fiacial stability of the FQHC ad/or its ability to provide the full cotiuum of required primary care, prevetive, ad eablig services? Is prior regulatory approval ecessary to establish the proposed partership with the LHD? I all circumstaces, the board of directors must approve chages i a FQHC s cliical, fiscal, ad quality assurace or quality improvemet policies ad procedures; the scope of services; ad the site locatios ad hours of operatio. Participatio i the FQHC s Board of Directors: Beefits ad Limitatios A FQHC ad LHD may collectively decide that it would beefit the partership to allow the LHD to omiate a represetative to serve o the FQHC s board of directors. It is essetial that FQHCs ad LHDs cosider the followig HRSA restrictios regardig board member selectio ad removal i such situatios where aother orgaizatio (i.e., the LHD) is grated represetatio o the FQHC s goverig board, or some other level of ivolvemet i a FQHC s goverace. 32 I particular, HRSA policies establish that idividuals that are represetatives of aother orgaizatio may ot comprise a majority of the FQHC board members, a majority of the o-cosumer C.F.R. 51c HRSA PIN 97-27: Affiliatio Agreemets of Commuity ad Migrat Health Ceters, p. 13 available at ad HRSA PIN 98-24: Amedmet to PIN Regardig Affiliatio Agreemets of Commuity ad Migrat Health Ceters available at policy/pi9824.htm. Natioal Associatio of Commuity Health Ceters 19

20 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets members, or a majority of members of the Executive Committee, ad may ot serve as the Board Chairperso. I additio, o other orgaizatio may preclude the selectio, or require the dismissal, of board members it has ot appoited. With respect to the board s authorities, as described o the previous page, o other orgaizatio may: have overridig approval authority, have veto authority (through super-majority requiremet or other meas), ad/or have dual majority authority. 3. Cost-Based Reimbursemet, Federal Tort Claims Act, Sectio 340B Drug Pricig, ad Ati-Kickback Safe Harbor Protectio Participatio i the FQHC program provides umerous beefits that may support FQHC-LHD parterships. The four most otable iclude access to the followig: 1. Cost-related reimbursemet for services provided to Medicare, Medicaid, ad Childre s Health Isurace Program (CHIP) beeficiaries; 2. Coverage for the FQHC ad its providers uder the Federal Tort Claims Act (FTCA); 3. Discout drug pricig uder Sectio 340B of the Public Health Service Act; ad 4. Federal Ati-Kickback statute protectio uder the safe harbor for FQHC gratees. Some beefits, such as FTCA coverage ad the Ati- Kickback statute FQHC safe harbor protectio, are oly available to FQHCs that receive Sectio 330 fudig. Other beefits, such as cost-related reimbursemet ad Sectio 340B drug pricig, are available to FQHCs that receive Sectio 330 fudig ad to FQHC look-alikes. Take special ote that the FQHC beefits are oly available whe services are provided by the FQHC withi its scope of project (i.e., the FQHC is the billig provider, services are provided o behalf of the FQHC, services are provided to FQHC patiets, etc.). (Scope of project is described more i depth begiig o page 23.) Both FQHCs ad LHDs should cosider these beefits whe evaluatig partership opportuities, with a eye towards reducig costs ad icreasig access to services across the etire commuity health care system. Cost-Related Reimbursemet I recogitio of the support ad eablig services provided by FQHCs for which they do ot get separately reimbursed ad to esure that they do t have to use Sectio 330 fuds for patiets without a payor source (e.g., Medicare ad Medicaid), FQHC gratees ad look-alikes have access to reimbursemet for Medicare, Medicaid, ad CHIP services through (1) the prospective paymet system or a alterative, state-approved paymet methodology, which, for Medicaid ad CHIP services, is predicated o a cost-based reimbursemet methodology; ad (2) cost-based reimbursemet for Medicare services. 33 This meas that, for the most part, FQHCs will receive a higher rate of reimbursemet from Medicaid, Medicare, ad CHIP tha most other health care etities do for similar services. 33 Accordig to the health reform law, Medicare reimbursemet will trasitio to a prospective paymet system i Sectio of Patiet Protectio ad Affordable Care Act of Natioal Associatio of Commuity Health Ceters 20

21 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Federal Tort Claims Act Coverage (FTCA) FTCA provides professioal liability ad medical malpractice coverage for services provided by a FQHC withi its scope of project. 34 To be eligible for FTCA coverage, a FQHC must receive fuds uder Sectio 330 ad be deemed eligible for coverage. Oce deemed uder FTCA, the FQHC, its officers, directors, employees, ad eligible cotractors are cosidered federal employees immue from suit for medical malpractice claims while actig withi the scope of their employmet ad providig services withi the HRSA-approved scope of project. If a FQHC patiet decides to brig a malpractice lawsuit agaist the FQHC, its employee, covered cotractor, etc., the patiet caot sue the FQHC or the provider directly, but must file the claim agaist the Uited States. Such claims are reviewed ad/or litigated by the DHHS, Office of the Geeral Cousel ad the Departmet of Justice. FTCA is specifically oly available for: The deemed FQHC (as well as its directors ad officers); FQHC employees that provide services o a full-time or part-time basis; Idividually cotracted providers who furish services i the fields of geeral iteral medicie, family practice, geeral pediatrics, ad obstetrics ad gyecology, regardless of the umber of hours worked; ad Idividually cotracted providers who furish services i other fields of practice, so log as they provide such services to FQHC patiets for a aual average of 32 ½ hours a week (i.e., o a full-time basis). As such, FTCA coverage is available oly to the FQHC ad to the employees/cotractors listed above; it caot be exteded to a LHD or its em- FTCA Checklist FQHCs must respod yes to all of the followig questios to assure that FTCA coverage is available for services provided by the FQHC providers uder the FQHC-LHD partership. Satisfyig these questios does ot, however, guaratee FTCA coverage. FQHCs are ecouraged to cosult with HRSA to cofirm FTCA coverage. Does the FQHC receive Sectio 330 fudig? Is the FQHC deemed eligible for FTCA coverage? Are the services provided o behalf of the FQHC ad icluded withi the FQHC s approved scope of project? Is the site where services are provided icluded withi the FQHC s approved scope of project (or does the site meet a defied exceptio for o- FQHC facilities)? Does the idividual qualify as a FQHC patiet ad is he or she appropriately registered? Are the providers FQHC employees, OR, if the providers are cotractors to the FQHC, is the cotractual agreemet directly betwee the FQHC ad the idividual health professioal providig services to the FQHC s patiets, ad does the cotracted provider meet the hour requiremets described above? Are the services provided icluded withi the provider s scope of employmet/cotract? Is the FQHC resposible for billig the payor for the FQHC s services provided to the patiets? 34 Extesive discussio of the legal basis for FQHC FTCA coverage as well as the legal requiremets ad limitatios to such coverage, ca be foud i HRSA PIN 99-08; HRSA PAL 99-15; HRSA PIN ; HRSA PIN ; HRSA PIN ; ad HRSA PIN available at gov/policy/default.htm. HRSA plas to release a FTCA Policy Maual, which will provide all FTCA related PINS ad PALS i oe easy referece. See also HRSA PIN : Defiig Scope of Project ad Policy for Requestig Chages available at Natioal Associatio of Commuity Health Ceters 21

22 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets ployees (uless they are idividually cotracted to the FQHC ad satisfy the above criteria). I additio, with certai limited exceptios, FTCA oly covers services provided to the FQHC s patiets served at a site withi the FQHC s scope of project, as described o pages Discout Drug Pricig Uder Sectio 340B of the Public Health Service Act 35 FQHC gratees ad look-alikes are eligible to participate i the discout drug pricig program uder Sectio 340B of the Public Health Service Act. Sectio 340B drugs may be distributed either directly by a FQHC pharmacy or through cotract with a retail pharmacy. 36 Drugs purchased uder the Sectio 340B program may be dispesed oly to the FQHC s patiets. As such, the FQHC caot supply 340B drugs to idividuals who are ot registered FQHC patiets. 37 A idividual is ot a patiet for Sectio 340B purposes if he or she oly receives services related to the dispesig of a drug or drugs for subsequet self-admiistratio or admiistratio i the home. I other words, a relatioship based solely o case maagemet is isufficiet to establish the idividual as a FQHC patiet. A FQHC s ability to purchase drugs at discouted prices provides the FQHC with a effective meas to lower drug prices for its uisured patiets ad to provide better health care for its patiets. The savigs is particularly importat to cosider whe structurig parterships with LHDs give the sigificat health care eeds amog idividuals that seek care at LHDs. (For more iformatio regardig the availability of Sectio 340B drugs i the cotext of a referral arragemet betwee a FQHC ad LHD, see page 44.) 340B Drug Pricig Checklist FQHCs must respod yes to all of the followig questios to assure that Sectio 340B drug pricig is available uder the FQHC-LHD partership. As with FTCA, satisfyig these questios does ot guaratee access to Sectio 340B drug pricig. To cofirm access to Sectio 340B drug pricig, FQHCs are ecouraged to register ad cosult with the Office of Pharmacy Affairs at HRSA. Does the idividual qualify as a FQHC patiet ad is he or she appropriately registered? Is the FQHC resposible for orderig ad purchasig the drugs? Ca the FQHC, at a miimum, break-eve from a reimbursemet perspective? Ca the FQHC establish a trackig system (or a alterative system approved by the Office of Pharmacy Affairs) to esure that the drugs purchased uder the Sectio 340B program are ot resold, trasferred, or diverted to o-fqhc patiets? 35 Sectio 340B of the Public Health Service Act (42 U.S.C. 256b), as ameded by Sectio 602 of P.L (11/11/92). 36 Note that federal law precludes a cotract pharmacy from dispesig 340B drugs to Medicaid patiets uless that pharmacy has made arragemets with the state Medicaid agecy that will eable the state to avoid seekig a rebate from a maufacturer for a drug purchased uder 340B. 37 Accordig to Sectio 340B, a idividual curretly qualifies as a patiet whe the followig requiremets are satisfied: (See 61 Fed. Reg (October 24, 1996): (1) the FQHC has established a relatioship with the idividual ad maitais records of the idividual s health care; (2) the idividual receives health care services from a health care professioal who is either employed by or provides health care uder a cotractual or other arragemet (e.g., referral for cosultatio) with the FQHC, such that the resposibility for care remais with the FQHC; ad (3) the idividual receives a health care service or a rage of services from the FQHC cosistet with the service or rage of services for which the etity received FQHC status (i.e., the services are withi the FQHC s approved scope of project). Natioal Associatio of Commuity Health Ceters 22

23 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Federal Ati-Kickback Statute Protectio Uder the Safe Harbor for FQHC Gratees The purpose of the federal Ati-Kickback statute is to discourage arragemets that could result i higher costs to the federal govermet or egatively impact the quality of care provided to beeficiaries of federal health care programs, such as the Medicaid ad Medicare programs. I particular, the statute prohibits ay perso or etity from kowigly or willfully solicitig or receivig (or offerig ad payig) remueratio directly or idirectly, i cash or i kid, to iduce patiet referrals or the purchase or lease of equipmet, goods or services, payable i whole or i part by a federal health care program. 38 Remueratio is defied broadly to iclude the trasfer of aythig of value, icludig reduced cost (or o cost) ret or equipmet, reduced cost (or o cost) purchase of services agreemets, rebates, ad free goods ad/or services. For example, uder the Ati-Kickback statute, a private practice physicia is prohibited from acceptig free space from a hospital i exchage for referrig patiets that are erolled i a federal health care program (e.g., Medicare, Medicaid, CHIP). Cogress ad the Office of the Ispector Geeral ( OIG ), the federal agecy with legal authority to eforce the federal Ati-Kickback statute, have created safe harbors to exempt certai busiess practices from costitutig violatios of the federal Ati-Kickback statute. I 2007, the OIG at DHHS established regulatory stadards for a FQHC safe harbor. 39 The safe harbor protects from prosecutio certai arragemets betwee FQHC gratees ad providers/suppliers of goods, items, services, doatios, ad loas that cotribute to the FQHC s ability to maitai or icrease the availability or ehace the quality of services provided to its medically uderserved patiets. For such protectio, the arragemet must be codified i a writte agreemet ad meet several stadards that are set forth i regulatio. 40 For example, the FQHC must have a reasoable expectatio that the arragemet will cotribute meaigfully to services to the uderserved, ad the FQHC must periodically (at least aually) re-evaluate the arragemet to esure that it cotiues to meet the origial expectatio. Accordigly, it may be permissible for a FQHC to receive doatios (moetary ad i-kid) ad/or obtai low cost (or o cost) leases ad/or purchase agreemets from a LHD ad/or other commuity health care providers with which it has a referral relatioship, provided that the doatios, leases, agreemets, etc. are part of a arragemet to maitai/icrease services provided to the FQHC s medically uderserved patiets, ad provided that the parties execute a writte agreemet that satisfies the safe harbor requiremets. If a FQHC seeks to eter ito such a arragemet, it should cosult kowledgeable local cousel for guidace. 4. Federally Qualified Health Ceter Scope of Project Cosideratios Defiig Scope of Project: Sites ad Services Scope of project defies the services, sites, providers, service area, ad target populatio that the total approved Sectio 330 grat-related project supports (or, i the case of FQHC look-alikes, the services, sites, providers, service area, ad target populatio that the FQHC desigatio supports) U.S.C. 1320a-7b(b) Fed Reg (October 4, 2007), as codified at 42 C.F.R (w) C.F.R (w) HRSA PIN , p. 2 available at pi0801/ ad HRSA PIN : Federally Qualified Health Ceter Look-Alike Guidelies ad Applicatio available at Natioal Associatio of Commuity Health Ceters 23

24 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Services: As oted o pages 16 17, Sectio 330 requires FQHCs to provide, either directly or through formal established arragemets, all required primary care services. FQHCs may also provide additioal health services that are appropriate to meet the eeds of their patiets. Oce a service is icluded i scope, it must be reasoably available to all patiets ad provided, regardless of a idividual s or family s ability to pay. (Additioal iformatio o services is provided below.) Sites: A site is ay place where a FQHC provides services to a defied geographic service area or populatio o a regularly scheduled basis. (Additioal iformatio o sites is provided below.) Providers: Providers are idividual health care professioals who deliver services o behalf of the FQHC o a regularly scheduled basis ad who exercise idepedet judgmet as to the services furished durig a ecouter. Service Area: The service area is the geographic area that is served by the FQHC. Target Populatio: The target populatio is the medically uderserved commuity or special populatio served by the FQHC (which may be a sub-set of the service area or may iclude the etire service area). A FQHC s scope of project is importat because it (amog other thigs): Determies the maximum potetial scope of FTCA coverage (subject to certai exceptios). Provides the ecessary iformatio which eables FQHCs to purchase discouted drugs Defies the services ad sites eligible for costbased reimbursemet uder Medicare, Medicaid, ad CHIP. What is a Health Ceter Site for Purposes of Scope of Project? HRSA broadly defies a service site as ay locatio where a gratee provides primary health care services to a defied service area or target populatio as appropriate for providig health care services to the target populatio. 42 If a locatio where services are provided satisfies the followig four coditios, the the locatio should qualify as a site for purposes of scope of project, subject to approval by HRSA Providers geerate face-to-face ecouters with patiets. 2. Providers exercise idepedet judgmet i providig services. 3. Services are provided directly by or o behalf of the FQHC the FQHC board retais cotrol ad authority over the provisio of the services at the locatio. 4. Services are provided o a regularly scheduled basis. It is importat to ote that a fully-equipped mobile va that is staffed by FQHC cliicias providig direct primary care services (e.g., primary medical or oral health services) at various locatios o behalf of the FQHC is cosidered a service site. 44 Evaluatig whether a locatio qualifies as a site is of critical importace i the cotext of FQHC- LHD parterships where the FQHC seeks to provide services at a ew locatio. If the locatio does ot through the Sectio 340B drug pricig program. 42 HRSA PIN , p HRSA PIN , p HRSA PIN , p. 6. Natioal Associatio of Commuity Health Ceters 24

25 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets qualify as a FQHC site, the the FQHC may ot add the locatio to its HRSA-approved scope of project, ad it is likely that the FQHC will ot be eligible to receive cost-based reimbursemet, FTCA coverage, Sectio 340B prescriptio drugs, ad other FQHCrelated beefits. What is a FQHC Service for Purposes of Scope of Project? As described o pages 16 17, Sectio 330 requires FQHCs to provide, either directly or by cotract or referral, certai required primary ad prevetive health services, as well as eablig services. FQHCs also may provide additioal health services that are ot required, yet are appropriate to meet the health eeds of the populatio served by the FQHC. 45 I additio, all of a FQHC s patiets must have reasoable access to the FQHC s full scope of services, either directly or through formal established arragemets. The FQHC does ot have to make its full scope of services available at each of its sites, provided that all patiets ca reasoably access all services offered by the FQHC, either at the FQHC s other site(s) or through a established formal arragemet (e.g., cotract or referral) with aother provider. There is o formula for determiig reasoable access. To assess if access is reasoable, a FQHC should evaluate the distace betwee the two sites ad the availability of public trasportatio. If a FQHC-LHD partership icludes the FQHC s additio of a ew service ad/or site, the FQHC must examie whether all patiets will have access to the FQHC s full scope of services. If a FQHC does ot add a ew service or site, but rather adds LHD patiets as FQHC patiets, thereby expadig the FQHC s patiet base, the FQHC must examie whether the ew patiets will have access to the FQHC s full scope of services. Chagig a Health Ceter s Scope of Project FQHCs must obtai HRSA s prior approval before addig or removig a service, or addig, removig, or relocatig a site, from its scope of project. Failure to secure HRSA s prior approval for the chage i scope may have serious cosequeces, icludig: No FTCA malpractice coverage for the employed or cotracted FQHC practitioers, or for the FQHC itself vis-à-vis such services/sites. Allegatios that the FQHC diverted Sectio 340B drugs by providig them to idividuals who are ot FQHC patiets. I order to obtai HRSA s approval, the chage i scope request must: 46 Documet that the requested chage ca be fully accomplished with o additioal federal support. 47 Not shift resources away from providig services to the curret target populatio. Further the FQHC s missio by icreasig or maitaiig access ad improvig or maitaiig quality of care for the target populatio. Be fully cosistet with Sectio 330 ad the Health Ceter Program Expectatios (HRSA PIN 98-23), icludig appropriate goverig board represetatio for chages i service sites ad populatios served. Provide for appropriate credetialig/privilegig of providers U.S.C. 254b (2) (b)(1)(a). 46 HRSA PIN , pp HRSA PIN , p 20. A FQHC requestig to add a service or site must demostrate that adequate reveue will be geerated to cover all expeses as well as a appropriate share of overhead costs icurred by the FQHC i admiisterig the ew service or site. Natioal Associatio of Commuity Health Ceters 25

26 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Not elimiate or reduce access to a required Protect people from health problems ad service. health hazards; Not result i the dimiutio of the FQHC s total Give people iformatio they eed to make level or quality of health services curretly pro- healthy choices; vided to the target populatio. Egage the commuity to idetify ad solve Demostrate that the FQHC cotiues to serve a health problems; medically uderserved area i whole or i part, Develop public health policies ad plas; or a medically uderserved populatio. Eforce public health laws ad regulatios; Demostrate approval by the FQHC s board of Help people receive health services; directors. Maitai a competet public health workforce; Not sigificatly affect the curret operatio of ad aother FQHC located i the same or adjacet Evaluate ad improve programs ad service area. itervetios. For additioal iformatio, FQHCs should review HRSA PIN : Defiig Scope of Project ad Policy for Requestig Chages, which provides comprehesive guidace regardig the process for obtaiig approval for a chage i scope of project. B. Local Health Departmet Fudametals Fuctio Local health departmets (LHDs) are the govermetal public health presece at the local level, resposible for creatig ad maitaiig coditios that keep people healthy. A LHD may be a locally govered health departmet, a brach of a state health departmet, a state-created district or regio, a departmet govered by ad servig a multi-couty area, or ay other arragemet that has govermetal authority ad is resposible for public health fuctios at the local level. Whether they directly provide a service, broker particular capacities, or otherwise esure that the ecessary work is beig doe, LHDs have a cosistet resposibility to: 48 Moitor health status ad uderstad health issues facig the commuity; LHDs uderstad the specific health issues cofrotig the commuity, icludig how physical, behavioral, evirometal, social, ad ecoomic coditios affect health. They ivestigate health problems ad health threats ad prevet ad cotrol adverse health effects from commuicable diseases, disease outbreaks from usafe food ad water, chroic diseases, evirometal hazards, ijuries, ad risky health behaviors. LHDs also lead plaig ad respose activities for public health emergecies ad collaborate with other local respoders ad with state ad federal agecies to itervee i other emergecies with public health sigificace (e.g., atural disasters). I a ideal cotext ad eviromet, LHDs coordiate the broader public health system s efforts i a itetioal, o-competitive, ad o-duplicative maer. They implemet health promotio programs 48 The stadards are framed aroud the Te Essetial Public Health Services, which have bee reworded to more accurately reflect the specific LHD roles ad resposibilities related to each category. I additio, these stadards are cosistet with the Natioal Public Health Performace Stadards Program (NPHPSP), servig to specify the role of govermetal LHDs while the NPHPSP addresses the public health system as a whole. Natioal Associatio of Commuity Health Ceters 26

27 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets ad egage the commuity to address public health issues. They develop parterships with public ad private healthcare providers ad istitutios (such as FQHCs), commuity-based orgaizatios, ad other govermet agecies (e.g., housig authority, crimial justice, educatio) egaged i services that affect health to collectively idetify, alleviate, ad act o the sources of public health problems. LHDs also address health disparities; serve as a essetial resource for local goverig bodies ad policymakers o up-to-date public health laws ad policies; ad provide sciece-based, timely, ad culturally competet health iformatio ad health alerts to the media ad to the commuity. Likewise, LHDs provide expertise to others who treat or address issues of public health sigificace ad esure compliace with public health laws ad ordiaces, usig eforcemet authority whe appropriate. LHDs employ well-traied staff ad esure that they have the ecessary resources to implemet best practices ad evidece-based programs ad itervetios. LHDs cotribute to the evidece base of public health ad strategically pla their services ad activities, evaluate performace ad outcomes, ad make adjustmets as eeded to cotiually improve their effectiveess, ehace the commuity s health status, ad meet the commuity s expectatios. All LHDs derive their authority ad resposibility from the state ad local laws that gover them. LHDs legal authorities may iclude itervetios such as madatory isolatio ad quaratie or the authority to eter ad ispect property, records, or equipmet ad require corrective actios for violatios. However, there is wide variability i LHDs capacity, authority, resources, ad compositio of the broader local public health system withi which they fuctio. As a result of these differeces, how LHDs meet their resposibilities whether they directly provide a service, broker particular capacities, or otherwise esure that the ecessary work is beig doe will vary. The LHD may have the capacity to perform all of the fuctios o its ow; it may call upo the state to provide assistace for some fuctios; it may develop arragemets with other orgaizatios i the commuity or with eighborig LHDs to perform some fuctios; or it may cotrol the meas by which other etities perform some fuctios. I some jurisdictios, other govermet agecies may have the authority to perform services that affect public health, ad/or resources for public health may be housed i a differet agecy. LHDs ca help FQHCs address critical elemets of esurig service delivery ad expasio i a variety of ways, icludig the followig: Cotributig ifrastructure support; Helpig FQHCs coect with their commuity; Collectig, providig, ad coordiatig commuity data; Providig a populatio-based perspective o local issues to iform FQHC commuicatios; Coveig commuity members, with local boards that iclude FQHC represetatives; Collaboratig o FQHC applicatios for fudig; Idetifyig appropriate populatios, geographic areas, ad parters for collaboratio; Usig regulatory authority to address idetified public health threats; ad Eforcig public health laws ad regulatios. Natioal Associatio of Commuity Health Ceters 27

28 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Goverace LHDs ca be govered by local authorities (e.g., local board of health, couty or city elected officials), by the state health agecy, or both. As show i the map below, as of 2008, LHDs i 29 states had local goverace, whereas six states ad Washigto, DC, had state goverace, ad 13 had mixed goverace. I 2008, about 80 percet of all LHDs reported that they had a associated local board of health. Members of local boards of health may be elected, appoited, or desigated based o a elected or o-elected positio. Local boards of health serve may fuctios withi their commuities, such as adoptig public health regulatios, settig ad imposig fees, approvig the LHD budget, hirig or firig the top agecy admiistrator, ad requestig a public health levy. I 2008, adoptig public health regulatios (73%) ad settig ad imposig fees (68%) were the two most commo fuctios of local boards of health. LHD Goverace Type, by State All LHDs i the state are uits of local govermet All LHDs i the state are uits of state govermet Some LHDs i the state are uits of local govermet ad others are uits of state govermet No participats: Hawaii ad Rhode Islad Source: 2008 Natioal Profile of Local Health Departmets Natioal Associatio of Commuity Health Ceters 28

29 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Fudig Fudig for local public health activities comes from a umber of sources, icludig local, state, ad federal govermet; reimbursemet from Medicare, Medicaid, ad other isurers; regulatory fees ad fees paid for patiet services; ad miscellaeous sources such as private foudatios. I geeral, it ca be said that LHD reveues from local, state, federal pass-through, ad Medicare ad Medicaid, as a percet of total reveues, vary widely by state. As reflected i the chart below, i 2008, local fuds were the highest source of reveue for LHDs, comprisig 25 percet of all reveues, followed by state direct (20%), ad federal pass-through (17%). Percetage Distributio of Total Aual LHD Reveues, By Reveue Source Relatioship to the State Health Departmet Like LHDs, state health departmets also vary widely ad have varied structures, fuctios, goverace, ad fudig. State health departmets perform a umber of the core public health fuctios, icludig the followig: Medicare 5% Federal Direct 2% Fees 11% Medicaid 10% Other 7% Disease trackig ad ivestigatio; Maiteace of birth ad death records; Delivery of chroic disease prevetio ad cotrol programs; Federal Pass-Through 17% Local 25% raged from 1,458 to 1,629 by reveue source Note: Due to roudig, percetages do ot add to 100. *Amog LHDs reportig detailed reveue data. Source: 2008 Natioal Profile of Local Health Departmets Not Specified 2% State Direct 20% Admiistratio ad trackig of immuizatios; Coductig a wide rage of laboratory services; Delivery of materal ad child health programs; ad Maagig state bioterrorism preparedess. State health departmets are typically fuded by the federal govermet, state budgets through appropriatios made by a state s legislature, ad, less ofte, by private sources, such as foudatios. Federal fudig ca come i several forms, icludig: 1) formula grats, such as the Materal ad Child Health Block Grat (Title V) ad the Prevetive Health ad Health Services Block Grat; 2) competitive grats through which departmets apply for federal fuds for specific iitiatives o topics such as utritio ad physical activity; 3) data collectio ad aalysis fuds to gather ad iterpret critical health iformatio about the populatios they serve; ad 4) health isurace fuds to admiister such programs as Medicaid ad the Childre s Health Isurace Program (CHIP). The states role i goverig local public health varies accordig to the structure ad resposibilities of the state health departmet ad icludes the followig: Cetralized: The state health departmet operates the LHDs, ad the local departmet fuctios uder the state departmet s authority. Decetralized: Local govermets orgaize ad operate LHDs. Shared systems: LHDs operate uder the shared authority of the state health departmet, the local govermet, ad/or local boards of health. Mixed systems: LHDs provide local public health services ad are orgaized ad operated by uits of local govermet i some jurisdictios ad the state health departmet i other jurisdictios. Natioal Associatio of Commuity Health Ceters 29

30 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets State Associatios of Couty ad City Health Officials (SACCHOs) are orgaizatios that represet LHDs or officials at the state level. Some SACCHOs are a office i their state s departmet of health ad may are iformal orgaizatios that are admiistered by voluteers. SACCHOs ofte host regular meetigs of local public health officials ad are very ivolved with local public health issues at the state level. The Natioal Associatio of Couty ad City Health Officials (NACCHO) collaborates with SACCHOs o may projects, icludig joit meetigs, membership iitiatives, educatio ad traiig, ad atioal advocacy for local public health. SACCHOs also work closely with state departmets of health ad other state ad atioal public health orgaizatios. Jurisdictios LHDs serve a variety of jurisdictio types. As of 2008, most LHDs serve idividual couties (60%), while others serve combied city-couty jurisdictios (11%), multi-couty or other district or regioal level jurisdictios (9%), tows or towships (11%), ad cities (7%). Local public health capacity varies greatly amog states, ragig from states with little local public health ifrastructure ad few resources to states that serve every couty ad muicipality through local public health. I geeral, multi-couty or regioal health departmets that have access to more resources provide a more comprehesive set of services tha smaller departmets. The figure o the right shows the percetage of LHDs servig small, medium ad large populatios as well as the percetage of U.S. populatio served withi each category. Natioal Profile Study The Natioal Associatio of Couty ad City Health Officials (NACCHO) Natioal Profile of Local Health Departmets study (Profile study) is the key source of iformatio to characterize LHDs at the atioal level. The Profile study series collects iformatio o a rage of public health ifrastructure topics from all LHDs i the Uited States. The most recet Profile study was coducted i 2008 ad surveyed a study populatio that cosisted of 2,794 LHDs. The purpose of the Profile study is to advace ad support the developmet of a database to describe ad uderstad LHDs structure, fuctio, ad capacities. The 2008 Profile study icluded a assessmet of the overall structure, fuctio, workforce ad availability of public health activities ad services at the local level; it also icluded a assessmet to uderstad what govermetal ad o-govermetal etities provided these services at the local level. Percetage of LHDs ad Percetage of U.S. Populatio Served, by Size of Populatio Served 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 12% 64% 41% Percetage of U.S. Populatio Served Percetage of all LHDs 31% 46% 0% Small Medium Large (<50,000) (50, ,000) (500,000+) Size of Populatio Served 5% =2,794 Source: 2008 Natioal Profile of Local Health Departmets Natioal Associatio of Commuity Health Ceters 30

31 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Workforce The workforce compositio of LHDs varies greatly across jurisdictios. I 2008, most LHDs (89%) had less tha 100 full-time equivalets (FTEs), about 20 percet of LHDs had less tha five FTEs ad oly five percet had 200 or more FTEs. The total media umber of FTEs raged from three (for LHDs servig populatios less tha 10,000) to 585 (for LHDs servig populatios of oe millio or more). The total media umber of staff raged from five (for LHDs servig populatios less tha 10,000) to 692 (for LHDs servig populatios of oe millio or more). Although LHD staffig varies across jurisdictios, most LHDs geerally maitai a few core job fuctios. I 2008, more tha 90 percet of LHDs employed clerical staff, urses, ad maagers. Evirometal health workers, emergecy preparedess coordiators, health educators, ad utritioists were employed by more tha 50 percet of all LHDs. The 2008 Profile study suggests that occupatios represeted at LHDs vary by the size of the populatios they serve. Amog LHDs servig the smallest populatios (less tha 10,000), 85 percet employed clerical staff ad 82 percet employed urses; amog LHDs servig the largest populatios (1,000,000 or more), all (100%) employed staff i these categories. Evirometal health specialists were employed by 54 percet of LHDs servig the smallest populatios ad 88 percet of LHDs servig the largest populatios. About oe fourth of the LHDs servig populatios of less tha 10,000 employed health educators ad utritioists, whereas almost all LHDs (97%) servig populatios of oe millio or more reported employmet of health educators ad 88 percet reported employmet of utritioists. As of 2008, for all LHDs, the media umber of FTEs was 15, which geerally icluded five urses, four clerical staff, oe maager, oe evirometal health specialist, ad oe health educator o staff. As size of the populatio served icreased, LHDs teded to have more occupatios represeted i staffig patters, with oe emergecy preparedess coordiator ad at least oe utritioist at LHDs servig 50,000 or more, ad at least oe physicia at LHDs servig 100,000 or more. The two tables that follow provide detailed iformatio about the workforce of LHDs by size of populatio served. Mea ad Media Number of Employees ad FTEs at LHDs, by Size of Populatio Served Number of Employees Source: 2008 Natioal Profile of Local Health Departmets Number of FTEs Size Populatio Served Mea Media Mea Media <10, ,000 24, ,000 49, ,000 99, , , , , , , ,000,000+ 1, All LHDs =2,234 =2,205 Natioal Associatio of Commuity Health Ceters 31

32 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Media FTEs ad Staffig Patters for LHDs, by Size of Populatio Served Servig 10,000 24,999 Servig 50,000 99,999 Servig 100, ,999 8 FTEs, icludig: 31 FTEs, icludig: 81 FTEs, icludig: 1 Maager/Director 1 Maager/Director 5 Maagers/Directors 3 Nurses 8 Nurses 17 Nurses 2 Clerical Staff 7 Clerical Staff 18 Clerical Staff 1 EH Specialist 3 EH Specialists 9 EH Specialists 1 Nutritioist 3 Nutritioists 1 Health Educator 2 Health Educators 1 EP Coordiator 1 EP Coordiator raged from 1,794 to 1,992 based o occupatio Note: Numbers do ot add to totals because listed occupatioal categories were ot exhaustive of all LHD occupatios. Source: 2008 Natioal Profile of Local Health Departmets 1 Physicia 1 Epidemiologist 1 IS Specialist 1 BH Professioal Services Services provided by LHDs vary broadly by jurisdictio ad populatio served. These services iclude but are ot limited to immuizatio services; screeig for diseases ad coditios; treatmet for commuicable diseases; materal ad child health services; primary care ad other health services; populatio-based primary prevetio services; surveillace ad epidemiology; evirometal health; regulatio, ispectio, ad licesig; ad other activities. The table o the right presets the 10 activities ad services provided most frequetly i LHD jurisdictios by LHDs. LHDs egage i a umber of activities ad provide services that cotribute directly ad idirectly to the provisio of primary care services. While they do ot ecessarily eed to provide primary care services, they do eed to assure that the health eeds of the commuity are beig met ad that vulerable populatios, i particular, have access to high-quality care. The LHD may have the capacity to provide all of these services o its ow or may Percetage of LHD Jurisdictios with 10 Most Frequet Activities ad Services Available Through LHDs Directly Percetage of Rak Activity or Service Jurisdictios 1 Adult Immuizatios Provisio 88% 2 Commuicable/Ifectious Disease Surveillace 88% 3 Child Immuizatios Provisio 86% 4 Tuberculosis Screeig 81% 5 Food Service Establishmet Ispectio 77% 6 Evirometal Health Surveillace 75% 7 Food Safety Educatio 74% 8 Tuberculosis Treatmet 72% 9 Tobacco Use Prevetio 70% 10 Schools/Daycare Ceter Ispectio 68% Source: 2008 Natioal Profile of Local Health Departmets Natioal Associatio of Commuity Health Ceters 32

33 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets develop arragemets with other orgaizatios i the commuity (such as FQHCs), with eighborig LHDs, or with the state to perform some services. I 2008, LHDs varied i their capacity to provide persoal care ad primary prevetative services ad ofte provided these services through arragemets with other govermetal agecies, icludig the state. These services iclude oral health, home healthcare, comprehesive primary care, behavioral/metal health services, ad substace abuse services. For oral health, home healthcare, ad comprehesive primary care, the LHD was the govermetal agecy most likely to provide these services; for behavioral/metal health services ad substace abuse services, other local govermetal agecies were most likely to provide these services. The first graph that follows shows the percetage of LHD jurisdictios i which primary care ad other health services were provided ad by which govermetal agecy. The secod graph shows the percetage of LHDs providig each service by the size of the populatio served. Percetage of LHD Jurisdictios with Other Health Services Provided by Govermetal Agecies Oral Health Home Healthcare Comprehesive Primary Care Behavioral/Metal Health Services Substace Abuse Services O% 20% 40% 60% 80% 100% Percetage of Jurisdictios LHD Direct LHD Cotract LHD Direct ad Cotract* Other Local Govermetal Agecy* State Agecy* *Provided by other agecy oly, ot LHD. Selected agecy combiatios oly; does ot iclude all possible combiatios. Source: 2008 Natioal Profile of Local Health Departmets Percetage of LHDs Providig Other Health Services, by Size of Populatio Served 25,000 50, ,000 Service All LHDs <25,000 49,999 99, , ,000+ Oral Health 29% 20% 24% 33% 43% 57% Home Healthcare 25% 28% 25% 26% 18% 11% Comprehesive Primary Care 11% 7% 9% 16% 16% 25% Behavioral/Metal Health Services 9% 5% 9% 12% 13% 27% Substace Abuse Services 7% 4% 7% 8% 9% 24% Source: 2008 Natioal Profile of Local Health Departmets Natioal Associatio of Commuity Health Ceters 33

34 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Other health care services that most LHDs provided i 2008 were Materal ad Child Health (MCH) home visits (63%), Wome, Ifats ad Childre (WIC) services (62%), ad family plaig services (54%). Early Periodic Screeig, Diagosis, ad Treatmet (EPSDT) program services were offered by 44 percet of LHDs. I additio, LHDs also provided Well Child Cliics (41%), preatal care (33%), ad obstetrical care (10%). I 2008, primary prevetio services for tobacco, utritio, chroic disease, uiteded pregacies, ad physical activity were foud i more tha 80 percet of local jurisdictios. However, LHDs reported that primary prevetio services were most frequetly provided by o-govermetal orgaizatios. LHD activity i the area of primary prevetio services is described i the first table below. The percetage of LHDs offerig populatio-based primary prevetio services raged from 70 percet (tobacco use primary prevetio) to 12 percet (primary prevetio of metal illess). I 2008, govermetal agecies provided screeig i more tha 70 percet of LHD jurisdictios for tuberculosis, high blood pressure, blood lead, HIV/ AIDS, ad other STDs. For all of these selected diseases ad coditios, the LHD was the most ofte cited govermetal agecy that providig screeig services. The secod graph that follows exhibits the percetage of LHD jurisdictios with screeig services for select diseases ad coditios provided by govermetal agecies, icludig LHDs. Percetage of LHD Jurisdictios with Selected Populatio-Based Primary Prevetio Services Provided by LHDs, by Size of Populatio Served 25,000 50, ,000 Primary Prevetio Service All LHDs <25,000 49,999 99, , ,000+ Tobacco 70% 63% 73% 75% 75% 84% Nutritio 68% 58% 68% 73% 81% 85% Chroic Disease Programs 53% 44% 57% 58% 62% 79% Physical Activity 53% 45% 55% 57% 63% 73% Uiteded Pregacy 51% 44% 53% 53% 60% 71% Ijury 39% 33% 38% 43% 49% 62% Substace Abuse 24% 21% 25% 28% 24% 33% Violece 22% 18% 22% 24% 28% 44% Metal Illess 12% 10% 11% 15% 13% 20% Source: 2008 Natioal Profile of Local Health Departmets Natioal Associatio of Commuity Health Ceters 34

35 2 Defiig Safety Net Providers: Federally Qualified Health Ceters ad Local Health Departmets Percetage of LHD Jurisdictios with Screeig for Selected Diseases ad Coditios Provided by Govermetal Agecies Tuberculosis High Blood Pressure Blood Lead Other STDs HIV/AIDs Diabetes Cacer Cardiovascular Disease O% 20% 40% 60% 80% 100% Percetage of Jurisdictios LHD Direct LHD Cotract LHD Direct ad Cotract Other Local Govermetal Agecy* State Agecy* *Provided by other agecy oly, ot LHD. Selected agecy combiatios oly; does ot iclude all possible combiatios. Source: 2008 Natioal Profile of Local Health Departmets The Role of LHDs i Commuity Health Assessmets FQHCs seekig to coduct a commuity health assessmet should look to their LHD as a key parter with uique skills, capacities, ad perspectives i populatio health. As part of their charge to moitor health status to idetify ad address commuity health problems, LHDs ofte coduct or parter with other orgaizatios to coduct commuity health assessmets (CHAs). Nearly two thirds of LHDs have either coducted a CHA i the past year or pla to do so i the ext three years. I 2011, the Volutary Natioal Accreditatio of Local Health Departmets Program will provide a additioal icetive for coductig CHAs. A coditio for LHD accreditatio will be participatio i or coduct of a CHA that will iform additioal requiremets for the developmet of a commuity health improvemet pla (CHIP) ad a departmet strategic pla. There are may frameworks, models, ad tools for CHAs that ca be used idepedetly or i cojuctio with oe aother, icludig the followig: Mobilizig for Actio Through Plaig ad Parterships (MAPP); Plaed Approach to Commuity Health (PATCH); Assessmet Protocol for Excellece i Public Health (APEX PH); Protocol for Assessig Commuity Excellece i Evirometal Health (PACE-EH); ad Natioal Public Health Performace Stadards Program (NPHPSP). Natioal Associatio of Commuity Health Ceters 35