Law and the Public’s Health The nation needs only one emergency such as Ebola to be reminded that public health laboratories are a pillar of the public health system. This installment of Law and the Public’s Health explores implications of the emerging health insurance regulatory framework for their stability and sustainability. This article was published on July 31, 2015, at www.publichealthreports.org. Sara Rosenbaum, JD George Washington University Milken Institute School of Public Health at the Department of Health Policy and Management Washington, DC
PUBLIC HEALTH LABORATORIES AND THE AFFORDABLE CARE ACT: WHAT THE NEW HEALTH-CARE SYSTEM MEANS FOR PUBLIC HEALTH PREPAREDNESS Mary-Beth Malcarney, JD, MPH Naomi Seiler, JD Katie Horton, JD, MPH, RN
The 2014 worldwide outbreak of Ebola Zaire virus serves as a sobering reminder of the importance of public health laboratories (PHLs) in identifying and tracking communicable disease. This installment of Law and the Public’s Health describes how changes in health insurance and delivery under the Affordable Care Act may affect the financial environment in which PHLs operate, and discusses legal and policy options for ensuring their ongoing ability to effectively respond to public health needs in an era of system transformation. BACKGROUND: PHLs AND THE AFFORDABLE CARE ACT PHLs are a critical component of the public health system, protecting the nation’s health by helping to identify and track communicable diseases, prepare and respond to terrorist attacks, monitor environmental health hazards, and track food safety.1 In recent decades, the United States has faced numerous new or recurring infectious disease threats, including anthrax, severe acute respiratory syndrome (SARS), 2009 H1N1, Middle East Respiratory Syndrome, and, most recently, the global outbreak of Ebola Zaire virus. Timely confirmatory testing of communicable disease is crucial for accurate decisions related to patient care, contact tracing, and environmental decontamination. Optimal functioning of the public health and health-
care systems to meet these infectious disease threats depends on the unique services that state and local PHLs provide.2 Despite substantial efforts to prepare for new Ebola cases—with 46 PHLs having the capacity to test for Ebola as of December 20143—PHLs face significant budget, workforce, and other challenges that threaten their ability to respond to serious outbreaks.4,5 President Obama has requested $1.83 billion in emergency funding from Congress for the Centers for Disease Control and Prevention (CDC) to improve Ebola readiness within public health departments and laboratories.6 Although enhanced federal resources will be indispensable in combating the current epidemic, PHLs today face additional challenges beyond discretionary funding concerns. Unlike the SARS and H1N1 outbreaks of the past, PHLs responding to Ebola are working within a health-care system that is transforming in response to the coverage and delivery system reforms of the Affordable Care Act in ways that could threaten PHLs’ sustainability. The Affordable Care Act and expanded coverage of laboratory services The Affordable Care Act has resulted in a major expansion of health insurance. Through the establishment of new, subsidized health insurance marketplaces in every state and expansion of Medicaid, the U.S. Congressional Budget Office has estimated that the number of insured people grew by 12 million in 2014.7 By 2016, a projected 25 million more will be insured, including 13 million more covered by Medicaid and the Children’s Health Insurance Program (CHIP).7 The newly insured will gain coverage for many laboratory services. The Affordable Care Act requires all health insurance plans sold in the individual and small group markets, inside or outside the new state-level Exchanges Marketplaces, as well as Medicaid coverage for the newly eligible expansion population, to cover
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certain “essential health benefits.”8,9 Essential health benefits consist of 10 distinct benefit classes, including laboratory services. In addition, the Affordable Care Act requires significantly expanded insurance coverage without cost sharing of a comprehensive set of preventive services, including many types of laboratory tests.10 These laboratory tests include tests for conditions that typically engage the involvement of the public health sector, such as human immunodeficiency virus, chlamydia, and lead poisoning. AFFORDABLE CARE ACT COVERAGE EXPANSIONS: POTENTIAL IMPLICATIONS FOR PHLs AND PUBLIC HEALTH EMERGENCY PREPAREDNESS The expansion of health insurance and preventive service coverage under the Affordable Care Act raises two important sustainability concerns for PHLs, both of which impact their preparedness to serve the public’s health. First, screening and testing services provided by PHLs have been largely covered by public funds, including city, county, state, and federal sources. PHLs have historically used a portion of infectious disease funding from public sources to maintain capacity to carry out activities related to other core functions. In many jurisdictions, these funding streams have helped PHLs maintain staff with specialized expertise to conduct outbreak surveillance and contain epidemics. However, as more individuals gain insurance coverage, discretionary funds for PHLs could be scaled back on the assumption that financial support for laboratory services will come through insurance reimbursement.11 There are a number of problems with this assumption. One problem relates to the fact that many PHLs historically have been supported through direct financing and may lack the capacity to bill insurers for services because of software and/or staffing limitations. Some states also have restrictive mandates that, for example, prohibit PHLs from charging any fee, even to a third-party insurer.12 Even where PHLs have the authority and capacity to bill for services, they may find that their fees are non-competitive in relation to the low fees offered by high-volume private, clinical, and commercial laboratories.13 The inability to compete on price may in turn create barriers to insurance network inclusion. Second, even where billing and network inclusion are in place, insurance coverage and payments may be insufficient to cover the cost of PHL operations. Despite coverage expansions under the Affordable Care Act, millions of people will continue to lack insurance coverage, and millions more may experience breaks in
coverage as they move among sources of insurance.14,15 Continued dependence on public financing by millions of people would be coupled with disruptions flowing from network exclusion. The result, in the absence of direct financing, can be expected to be a serious drop in testing and significant budget shortfalls.16 One option is to place greater dependence on private testing laboratories during disease outbreaks, effectively delegating to private laboratories front-line responsibility during periods when rapid outbreak testing and response are crucial. But this level of reliance would greatly threaten national and local preparedness. Private laboratories focus on individual patient care and are not legally or programmatically structured to safeguard the health of entire communities. They are susceptible to market forces and cost-containment pressures that may disincentivize the need to maintain readiness with adequate equipment. They may lack the expertise to handle complex and emerging communicable diseases. Furthermore, private laboratories are not integrated into the broader public health system and, consequently, do not serve other critical core functions addressed by PHLs, such as contact tracing, environmental decontamination, and providing surge capacity to other PHLs during times of crisis.1,17 DISCUSSION Integrating PHLs into health system transformation efforts now underway in the wake of the Affordable Care Act thus becomes a crucial challenge for public health law and policy. Several options might be considered in this regard. Clearly, the starting point is ensuring that all PHLs are capable of billing insurers for covered services. A second step is to ensure that PHLs are capable of billing at competitive rates, by providing ongoing direct financing for core public health functions and testing activities related to uninsured populations and services. An option for ensuring that PHLs do not become dangerously marginalized as an unintended consequence of health system change is to require their inclusion in networks offered by public and private health insurers, including Medicaid managed care organizations, health plans participating in CHIP, and health plans sold in the individual and small group market, whether inside or outside health insurance Exchanges. In addition, in defining the classes of “essential community providers”—safety net providers who must be included at certain levels in state-level Exchanges18—the federal government could designate PHLs as such a provider type, thereby promoting their participation in health plans.
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Network inclusion of PHLs could be considered for all forms of testing or, alternatively, for those tests that are related to certain key conditions with major public health implications, such as sexually transmitted diseases, communicable disease outbreaks, and other health conditions of public health importance. In the absence of mandated inclusion, states might consider incentivizing inclusion in various health insurance markets by, for example, giving higher quality ratings for health plans whose networks include PHLs. The Centers for Medicare & Medicaid Services (CMS), which oversees the Medicare Advantage market (now enrolling 30% of all Medicare beneficiaries19), could similarly give higher star ratings to Medicare Advantage plans that include PHLs in their networks. PHLs might also take steps to position themselves for inclusion in emerging provider networks as a result of advances in clinical integration, such as the formation of accountable care organizations, a new mode of clinically and financially integrated service delivery whose formation and operation are promoted under the Affordable Care Act.20,21 Accountable care organizations are expected to engage with patients not only with respect to individual clinical care, but also at the population level, making PHLs—long accustomed to population-level interventions—attractive laboratory partners. Efforts by CMS to promote system transformation through various strategies, such as State Innovation Models,22 could be structured to emphasize transformation efforts that include PHLs. In carrying out community health needs assessment activities mandated under the Affordable Care Act,23 tax-exempt hospitals also could include PHLs in their needs assessments and implementation strategies. PHLs offer expertise in clinical prevention and screening, and their inclusion in initiatives to change the way that health care is financed and delivered will help ensure a sustained revenue source going forward, thereby reducing the need for direct financing for uninsured populations and services. CONCLUSION The Affordable Care Act and ongoing changes in the health-care system have had important consequences for PHLs, including reduced testing volume and funding. Combined with perennial budget cuts, these changes may threaten PHLs’ ability to respond swiftly to ongoing public health needs and unexpected health threats. If direct financing of clinical laboratory services disappears, and if insurance and delivery system regulation fails to halt their network exclusion, PHLs will struggle to maintain essential funding and capacity.
Through a combination of transformation incentives, base funding for core and uninsurable activities, and careful use of regulatory authority related to provider networks, policy makers can preserve this core public health function. Mary-Beth Malcarney is an Assistant Research Professor, Naomi Seiler is an Associate Research Professor, and Katie Horton is a Research Professor, all in the Department of Health Policy at the Milken Institute School of Public Health at the George Washington University in Washington, D.C. Address correspondence to: Mary-Beth Malcarney, JD, MPH, George Washington University, Milken Institute School of Public Health, Department of Health Policy, 2175 K St. NW, Ste. 500, Washington, DC 20037; tel. 202-994-4214; e-mail . ©2015 Association of Schools and Programs of Public Health
REFERENCES 1. Association of Public Health Laboratories. The core functions of state public health laboratories. 2010 [cited 2014 Nov 3]. Available from: URL: http://www.aphl.org/aboutaphl/publications/documents /com_2010_corefunctionsphls.pdf 2. Witt-Kushner J, Astles JR, Ridderhof JC, Martin RA, Wilcke B Jr, Downes FP, et al. Core functions and capabilities of state public health laboratories: a report of the Association of Public Health Laboratories. MMWR Recomm Rep 2002;51(RR14):1-8. 3. Association of Public Health Laboratories. APHL responds to Ebola Zaire [cited 2014 Dec 10]. Available from: URL: http://www.aphl .org/aphlprograms/preparedness-and-response/pages/ebola-zaire .aspx 4. Levi J, Segal LM, Lieberman DA, St. Laurent R. Outbreaks 2013: protecting Americans from infectious diseases. Washington: Trust for America’s Health; 2014. Also available from: URL: http:// healthyamericans.org/assets/files/TFAH2013OutbreaksRpt07.pdf [cited 2014 Nov 10]. 5. The impact of state and local budget cuts on public health preparedness. Washington: Institute of Medicine, Forum on Medical and Public Health Preparedness for Catastrophic Events; 2011. Also available from: URL: http://www.iom.edu/~/media/files /activity%20files/PublicHealth/MedPrep/impact%20of%20state %20and%20local%20budget%20cuts%20on%20PHP.pdf [cited 2014 Nov 10]. 6. The White House (US), Office of the Press Secretary. Fact sheet: emergency funding request to enhance the U.S. government’s response to Ebola at home and abroad. 2014 Nov 5 [cited 2014 Nov 10]. Available from: URL: http://www.whitehouse.gov/thepress-office/2014/11/05/fact-sheet-emergency-funding-requestenhance-us-government-s-response-eb 7. Congressional Budget Office (US). Updated estimates of the effects of the insurance coverage provisions of the Affordable Care Act, April 2014 [cited 2014 Nov 10]. Available from: URL: https://www .cbo.gov/publication/45159 8. Pub. L. No. 111-148 §§1302(b), 2001(c), 124 Stat. 855 (March 2010). 9. Final rule on Medicaid and Children’s Health Insurance Programs: essential health benefits in alternative benefit plans, eligibility notices, fair hearings and appeal processes, and premiums and cost sharing; Exchanges: eligibility and enrollment. 78 Fed Reg 42160. 10. §2713, added by Pub. L. No. 111-148 §1001 (2010). 11. Hinrichs SH, Zarcone P. The Affordable Care Act, meaningful use, and their impact on public health laboratories. Public Health Rep 2013;128(Suppl 2):7-9. 12. Loring C, Neil RB, Gillim-Ross L, Bashore M, Shah S. Using feefor-service testing to generate revenue for the 21st century public health laboratory. Public Health Rep 2013;128(Suppl 2):97-104. 13. Association of Public Health Laboratories. The role of public health
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14.
15.
16. 17.
laboratories in STD testing. 2011 [cited 2014 Dec 9]. Available from: URL: http://www.aphl.org/aboutAPHL/publications/documents /ID_2011May_STDIssueBrief.pdf Nardin R, Zallman L, McCormick D, Woolhandler S, Himmelstein D. The uninsured after implementation of the Affordable Care Act: a demographic and geographic analysis. Health Aff Blog 2013 Jun 6 [cited 2014 Dec 15]. Available from: URL: http://healthaffairs .org/blog/2013/06/06/the-uninsured-after-implementation-of-theaffordable-care-act-a-demographic-and-geographic-analysis Bergal J. Churning between Medicaid and Exchanges could leave gaps in coverage, experts warn. The Washington Post 2014 Jan 5 [cited 2014 Dec 15]. Available from: URL: http://www .washingtonpost.com/national/health-science/churning-betweenmedicaid-and-exchanges-could-leave-gaps-in-coverage-expertswarn/2014/01/05/cf858d7e-73fa-11e3-8def-a33011492df2_story .html Drainoni ML, Sullivan M, Sequeira S, Bacic J, Hsu K. Health reform and shifts in funding for sexually transmitted infection services. Sex Transm Dis 2014;41:455-60. Centers for Disease Control and Prevention (US). Public health
18. 19.
20. 21. 22. 23.
preparedness: mobilizing state by state [cited 2014 Nov 15]. Available from: URL: http://www.bt.cdc.gov/publications/feb08phprep /section1/phlab.asp Pub. L. No. 111-148, §1311, 124 Stat. 855 (March 2010). Kaiser Family Foundation. Medicare Advantage fact sheet. May 2014 [cited 2014 Dec 13]. Available from: URL: http://kaiserfamily foundation.files.wordpress.com/2014/05/2052-18-medicareadvantage.pdf Pub. L. No. 111-148, §3022, 124 Stat. 855 (March 2010). Centers for Medicare & Medicaid Services (US). Pioneer ACO model [cited 2014 Nov 8]. Available from: URL: http://innovation.cms .gov/initiatives/pioneer-ACO-model Centers for Medicare & Medicaid Services (US). State innovation models initiative: general information [cited 2014 Nov 8]. Available from: URL: http://innovation.cms.gov/initiatives/state-innovations Internal Revenue Service (US). New requirements for 501(c)(3) hospitals under the Affordable Care Act. March 2014 [cited 2014 Nov 8]. Available from: URL: http://www.irs.gov/charities-&-nonprofits/charitable-organizations/new-requirements-for-501(c) (3)-hospitals-under-the-Affordable-Care-Act
In recent years a series of compelling legal flashpoints have emerged at the intersection of public health and religious freedom. This installment of Law and the Public’s Health provides a comprehensive overview of the issues by Professor James G. Hodge, Jr. This article was published on August 7, 2015, at www.publichealthreports.org. Sara Rosenbaum, JD George Washington University Milken Institute School of Public Health at the Department of Health Policy and Management Washington, DC
RESPECTING RELIGIOUS FREEDOMS AND PROTECTING THE PUBLIC’S HEALTH James G. Hodge, Jr., JD, LLM
The history of public health law in the United States has always been about compromise. As noted recently by U.S. Surgeon General Vivek Murthy, the authority to protect and promote communal health is balanced with constitutional or other legal rights of individuals to act or behave as they wish provided they do not harm others.1 In many cases, the scales are appropriately weighted to respect individual freedoms while advancing the public’s health (e.g., public health surveillance activities). In other instances, furtherance of individual rights (e.g., to bear arms) can negatively impact health outcomes across populations. For decades, Americans’ religious freedoms under federal and state constitutions (and corresponding statutes and regulations) have been counterbalanced successfully with public health mandates. A prominent example entails the exemption of people from school vaccination requirements in 48 states based on religious freedoms undergirded, but not assured, by the First Amendment and encapsulated in statutory laws. While
these exceptions have been challenged legally and politically, most recently following the 2015 measles outbreak,2 widespread support for limited religious exceptions for vaccines remains. When used sparingly within communities, these vaccination exemptions may have minimal public health impacts. The public health balancing act concerning religious freedoms, however, may be in the process of recalibration. Since the U.S. Supreme Court disallowed use of the controlled substance peyote as part of religious practices in 1990,3 multiple versions of the Religious Freedom Restoration Act (RFRA) have been passed, first by Congress in 19934 and later by 22 states. Fierce debates regarding Indiana’s 2015 passage of RFRA centered on potential private-sector sexual orientation discrimination led to an amendment clarifying that the act does not allow such discrimination.5 The primary objective of RFRAs nationally—respecting individuals’ religious beliefs—is laudable. These rights are among the first recognized by the Constitutional Framers and are essential to the fabric of the nation.6 Yet, continued expansion of religious freedoms runs the risk of shifting trade-offs with essential governmental public health objectives. RFRA applications have the potential to adversely affect public health practices, programs, and objectives depending on (1) who qualifies as a “person” for the purposes of the
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PUBLIC HEALTH LABORATORIES AND THE AFFORDABLE CARE ACT: WHAT THE NEW HEALTH-CARE SYSTEM MEANS FOR PUBLIC HEALTH PREPAREDNESS Mary-Beth Malcarney, JD, MPH Naomi Seiler, JD Katie Horton, JD, MPH, RN
The 2014 worldwide outbreak of Ebola Zaire virus serves as a sobering reminder of the importance of public health laboratories (PHLs) in identifying and tracking communicable disease. This installment of Law and the Public’s Health describes how changes in health insurance and delivery under the Affordable Care Act may affect the financial environment in which PHLs operate, and discusses legal and policy options for ensuring their ongoing ability to effectively respond to public health needs in an era of system transformation. BACKGROUND: PHLs AND THE AFFORDABLE CARE ACT PHLs are a critical component of the public health system, protecting the nation’s health by helping to identify and track communicable diseases, prepare and respond to terrorist attacks, monitor environmental health hazards, and track food safety.1 In recent decades, the United States has faced numerous new or recurring infectious disease threats, including anthrax, severe acute respiratory syndrome (SARS), 2009 H1N1, Middle East Respiratory Syndrome, and, most recently, the global outbreak of Ebola Zaire virus. Timely confirmatory testing of communicable disease is crucial for accurate decisions related to patient care, contact tracing, and environmental decontamination. Optimal functioning of the public health and health-
care systems to meet these infectious disease threats depends on the unique services that state and local PHLs provide.2 Despite substantial efforts to prepare for new Ebola cases—with 46 PHLs having the capacity to test for Ebola as of December 20143—PHLs face significant budget, workforce, and other challenges that threaten their ability to respond to serious outbreaks.4,5 President Obama has requested $1.83 billion in emergency funding from Congress for the Centers for Disease Control and Prevention (CDC) to improve Ebola readiness within public health departments and laboratories.6 Although enhanced federal resources will be indispensable in combating the current epidemic, PHLs today face additional challenges beyond discretionary funding concerns. Unlike the SARS and H1N1 outbreaks of the past, PHLs responding to Ebola are working within a health-care system that is transforming in response to the coverage and delivery system reforms of the Affordable Care Act in ways that could threaten PHLs’ sustainability. The Affordable Care Act and expanded coverage of laboratory services The Affordable Care Act has resulted in a major expansion of health insurance. Through the establishment of new, subsidized health insurance marketplaces in every state and expansion of Medicaid, the U.S. Congressional Budget Office has estimated that the number of insured people grew by 12 million in 2014.7 By 2016, a projected 25 million more will be insured, including 13 million more covered by Medicaid and the Children’s Health Insurance Program (CHIP).7 The newly insured will gain coverage for many laboratory services. The Affordable Care Act requires all health insurance plans sold in the individual and small group markets, inside or outside the new state-level Exchanges Marketplaces, as well as Medicaid coverage for the newly eligible expansion population, to cover
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certain “essential health benefits.”8,9 Essential health benefits consist of 10 distinct benefit classes, including laboratory services. In addition, the Affordable Care Act requires significantly expanded insurance coverage without cost sharing of a comprehensive set of preventive services, including many types of laboratory tests.10 These laboratory tests include tests for conditions that typically engage the involvement of the public health sector, such as human immunodeficiency virus, chlamydia, and lead poisoning. AFFORDABLE CARE ACT COVERAGE EXPANSIONS: POTENTIAL IMPLICATIONS FOR PHLs AND PUBLIC HEALTH EMERGENCY PREPAREDNESS The expansion of health insurance and preventive service coverage under the Affordable Care Act raises two important sustainability concerns for PHLs, both of which impact their preparedness to serve the public’s health. First, screening and testing services provided by PHLs have been largely covered by public funds, including city, county, state, and federal sources. PHLs have historically used a portion of infectious disease funding from public sources to maintain capacity to carry out activities related to other core functions. In many jurisdictions, these funding streams have helped PHLs maintain staff with specialized expertise to conduct outbreak surveillance and contain epidemics. However, as more individuals gain insurance coverage, discretionary funds for PHLs could be scaled back on the assumption that financial support for laboratory services will come through insurance reimbursement.11 There are a number of problems with this assumption. One problem relates to the fact that many PHLs historically have been supported through direct financing and may lack the capacity to bill insurers for services because of software and/or staffing limitations. Some states also have restrictive mandates that, for example, prohibit PHLs from charging any fee, even to a third-party insurer.12 Even where PHLs have the authority and capacity to bill for services, they may find that their fees are non-competitive in relation to the low fees offered by high-volume private, clinical, and commercial laboratories.13 The inability to compete on price may in turn create barriers to insurance network inclusion. Second, even where billing and network inclusion are in place, insurance coverage and payments may be insufficient to cover the cost of PHL operations. Despite coverage expansions under the Affordable Care Act, millions of people will continue to lack insurance coverage, and millions more may experience breaks in
coverage as they move among sources of insurance.14,15 Continued dependence on public financing by millions of people would be coupled with disruptions flowing from network exclusion. The result, in the absence of direct financing, can be expected to be a serious drop in testing and significant budget shortfalls.16 One option is to place greater dependence on private testing laboratories during disease outbreaks, effectively delegating to private laboratories front-line responsibility during periods when rapid outbreak testing and response are crucial. But this level of reliance would greatly threaten national and local preparedness. Private laboratories focus on individual patient care and are not legally or programmatically structured to safeguard the health of entire communities. They are susceptible to market forces and cost-containment pressures that may disincentivize the need to maintain readiness with adequate equipment. They may lack the expertise to handle complex and emerging communicable diseases. Furthermore, private laboratories are not integrated into the broader public health system and, consequently, do not serve other critical core functions addressed by PHLs, such as contact tracing, environmental decontamination, and providing surge capacity to other PHLs during times of crisis.1,17 DISCUSSION Integrating PHLs into health system transformation efforts now underway in the wake of the Affordable Care Act thus becomes a crucial challenge for public health law and policy. Several options might be considered in this regard. Clearly, the starting point is ensuring that all PHLs are capable of billing insurers for covered services. A second step is to ensure that PHLs are capable of billing at competitive rates, by providing ongoing direct financing for core public health functions and testing activities related to uninsured populations and services. An option for ensuring that PHLs do not become dangerously marginalized as an unintended consequence of health system change is to require their inclusion in networks offered by public and private health insurers, including Medicaid managed care organizations, health plans participating in CHIP, and health plans sold in the individual and small group market, whether inside or outside health insurance Exchanges. In addition, in defining the classes of “essential community providers”—safety net providers who must be included at certain levels in state-level Exchanges18—the federal government could designate PHLs as such a provider type, thereby promoting their participation in health plans.
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Network inclusion of PHLs could be considered for all forms of testing or, alternatively, for those tests that are related to certain key conditions with major public health implications, such as sexually transmitted diseases, communicable disease outbreaks, and other health conditions of public health importance. In the absence of mandated inclusion, states might consider incentivizing inclusion in various health insurance markets by, for example, giving higher quality ratings for health plans whose networks include PHLs. The Centers for Medicare & Medicaid Services (CMS), which oversees the Medicare Advantage market (now enrolling 30% of all Medicare beneficiaries19), could similarly give higher star ratings to Medicare Advantage plans that include PHLs in their networks. PHLs might also take steps to position themselves for inclusion in emerging provider networks as a result of advances in clinical integration, such as the formation of accountable care organizations, a new mode of clinically and financially integrated service delivery whose formation and operation are promoted under the Affordable Care Act.20,21 Accountable care organizations are expected to engage with patients not only with respect to individual clinical care, but also at the population level, making PHLs—long accustomed to population-level interventions—attractive laboratory partners. Efforts by CMS to promote system transformation through various strategies, such as State Innovation Models,22 could be structured to emphasize transformation efforts that include PHLs. In carrying out community health needs assessment activities mandated under the Affordable Care Act,23 tax-exempt hospitals also could include PHLs in their needs assessments and implementation strategies. PHLs offer expertise in clinical prevention and screening, and their inclusion in initiatives to change the way that health care is financed and delivered will help ensure a sustained revenue source going forward, thereby reducing the need for direct financing for uninsured populations and services. CONCLUSION The Affordable Care Act and ongoing changes in the health-care system have had important consequences for PHLs, including reduced testing volume and funding. Combined with perennial budget cuts, these changes may threaten PHLs’ ability to respond swiftly to ongoing public health needs and unexpected health threats. If direct financing of clinical laboratory services disappears, and if insurance and delivery system regulation fails to halt their network exclusion, PHLs will struggle to maintain essential funding and capacity.
Through a combination of transformation incentives, base funding for core and uninsurable activities, and careful use of regulatory authority related to provider networks, policy makers can preserve this core public health function. Mary-Beth Malcarney is an Assistant Research Professor, Naomi Seiler is an Associate Research Professor, and Katie Horton is a Research Professor, all in the Department of Health Policy at the Milken Institute School of Public Health at the George Washington University in Washington, D.C. Address correspondence to: Mary-Beth Malcarney, JD, MPH, George Washington University, Milken Institute School of Public Health, Department of Health Policy, 2175 K St. NW, Ste. 500, Washington, DC 20037; tel. 202-994-4214; e-mail . ©2015 Association of Schools and Programs of Public Health
REFERENCES 1. Association of Public Health Laboratories. The core functions of state public health laboratories. 2010 [cited 2014 Nov 3]. Available from: URL: http://www.aphl.org/aboutaphl/publications/documents /com_2010_corefunctionsphls.pdf 2. Witt-Kushner J, Astles JR, Ridderhof JC, Martin RA, Wilcke B Jr, Downes FP, et al. Core functions and capabilities of state public health laboratories: a report of the Association of Public Health Laboratories. MMWR Recomm Rep 2002;51(RR14):1-8. 3. Association of Public Health Laboratories. APHL responds to Ebola Zaire [cited 2014 Dec 10]. Available from: URL: http://www.aphl .org/aphlprograms/preparedness-and-response/pages/ebola-zaire .aspx 4. Levi J, Segal LM, Lieberman DA, St. Laurent R. Outbreaks 2013: protecting Americans from infectious diseases. Washington: Trust for America’s Health; 2014. Also available from: URL: http:// healthyamericans.org/assets/files/TFAH2013OutbreaksRpt07.pdf [cited 2014 Nov 10]. 5. The impact of state and local budget cuts on public health preparedness. Washington: Institute of Medicine, Forum on Medical and Public Health Preparedness for Catastrophic Events; 2011. Also available from: URL: http://www.iom.edu/~/media/files /activity%20files/PublicHealth/MedPrep/impact%20of%20state %20and%20local%20budget%20cuts%20on%20PHP.pdf [cited 2014 Nov 10]. 6. The White House (US), Office of the Press Secretary. Fact sheet: emergency funding request to enhance the U.S. government’s response to Ebola at home and abroad. 2014 Nov 5 [cited 2014 Nov 10]. Available from: URL: http://www.whitehouse.gov/thepress-office/2014/11/05/fact-sheet-emergency-funding-requestenhance-us-government-s-response-eb 7. Congressional Budget Office (US). Updated estimates of the effects of the insurance coverage provisions of the Affordable Care Act, April 2014 [cited 2014 Nov 10]. Available from: URL: https://www .cbo.gov/publication/45159 8. Pub. L. No. 111-148 §§1302(b), 2001(c), 124 Stat. 855 (March 2010). 9. Final rule on Medicaid and Children’s Health Insurance Programs: essential health benefits in alternative benefit plans, eligibility notices, fair hearings and appeal processes, and premiums and cost sharing; Exchanges: eligibility and enrollment. 78 Fed Reg 42160. 10. §2713, added by Pub. L. No. 111-148 §1001 (2010). 11. Hinrichs SH, Zarcone P. The Affordable Care Act, meaningful use, and their impact on public health laboratories. Public Health Rep 2013;128(Suppl 2):7-9. 12. Loring C, Neil RB, Gillim-Ross L, Bashore M, Shah S. Using feefor-service testing to generate revenue for the 21st century public health laboratory. Public Health Rep 2013;128(Suppl 2):97-104. 13. Association of Public Health Laboratories. The role of public health
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14.
15.
16. 17.
laboratories in STD testing. 2011 [cited 2014 Dec 9]. Available from: URL: http://www.aphl.org/aboutAPHL/publications/documents /ID_2011May_STDIssueBrief.pdf Nardin R, Zallman L, McCormick D, Woolhandler S, Himmelstein D. The uninsured after implementation of the Affordable Care Act: a demographic and geographic analysis. Health Aff Blog 2013 Jun 6 [cited 2014 Dec 15]. Available from: URL: http://healthaffairs .org/blog/2013/06/06/the-uninsured-after-implementation-of-theaffordable-care-act-a-demographic-and-geographic-analysis Bergal J. Churning between Medicaid and Exchanges could leave gaps in coverage, experts warn. The Washington Post 2014 Jan 5 [cited 2014 Dec 15]. Available from: URL: http://www .washingtonpost.com/national/health-science/churning-betweenmedicaid-and-exchanges-could-leave-gaps-in-coverage-expertswarn/2014/01/05/cf858d7e-73fa-11e3-8def-a33011492df2_story .html Drainoni ML, Sullivan M, Sequeira S, Bacic J, Hsu K. Health reform and shifts in funding for sexually transmitted infection services. Sex Transm Dis 2014;41:455-60. Centers for Disease Control and Prevention (US). Public health
18. 19.
20. 21. 22. 23.
preparedness: mobilizing state by state [cited 2014 Nov 15]. Available from: URL: http://www.bt.cdc.gov/publications/feb08phprep /section1/phlab.asp Pub. L. No. 111-148, §1311, 124 Stat. 855 (March 2010). Kaiser Family Foundation. Medicare Advantage fact sheet. May 2014 [cited 2014 Dec 13]. Available from: URL: http://kaiserfamily foundation.files.wordpress.com/2014/05/2052-18-medicareadvantage.pdf Pub. L. No. 111-148, §3022, 124 Stat. 855 (March 2010). Centers for Medicare & Medicaid Services (US). Pioneer ACO model [cited 2014 Nov 8]. Available from: URL: http://innovation.cms .gov/initiatives/pioneer-ACO-model Centers for Medicare & Medicaid Services (US). State innovation models initiative: general information [cited 2014 Nov 8]. Available from: URL: http://innovation.cms.gov/initiatives/state-innovations Internal Revenue Service (US). New requirements for 501(c)(3) hospitals under the Affordable Care Act. March 2014 [cited 2014 Nov 8]. Available from: URL: http://www.irs.gov/charities-&-nonprofits/charitable-organizations/new-requirements-for-501(c) (3)-hospitals-under-the-Affordable-Care-Act
In recent years a series of compelling legal flashpoints have emerged at the intersection of public health and religious freedom. This installment of Law and the Public’s Health provides a comprehensive overview of the issues by Professor James G. Hodge, Jr. This article was published on August 7, 2015, at www.publichealthreports.org. Sara Rosenbaum, JD George Washington University Milken Institute School of Public Health at the Department of Health Policy and Management Washington, DC
RESPECTING RELIGIOUS FREEDOMS AND PROTECTING THE PUBLIC’S HEALTH James G. Hodge, Jr., JD, LLM
The history of public health law in the United States has always been about compromise. As noted recently by U.S. Surgeon General Vivek Murthy, the authority to protect and promote communal health is balanced with constitutional or other legal rights of individuals to act or behave as they wish provided they do not harm others.1 In many cases, the scales are appropriately weighted to respect individual freedoms while advancing the public’s health (e.g., public health surveillance activities). In other instances, furtherance of individual rights (e.g., to bear arms) can negatively impact health outcomes across populations. For decades, Americans’ religious freedoms under federal and state constitutions (and corresponding statutes and regulations) have been counterbalanced successfully with public health mandates. A prominent example entails the exemption of people from school vaccination requirements in 48 states based on religious freedoms undergirded, but not assured, by the First Amendment and encapsulated in statutory laws. While
these exceptions have been challenged legally and politically, most recently following the 2015 measles outbreak,2 widespread support for limited religious exceptions for vaccines remains. When used sparingly within communities, these vaccination exemptions may have minimal public health impacts. The public health balancing act concerning religious freedoms, however, may be in the process of recalibration. Since the U.S. Supreme Court disallowed use of the controlled substance peyote as part of religious practices in 1990,3 multiple versions of the Religious Freedom Restoration Act (RFRA) have been passed, first by Congress in 19934 and later by 22 states. Fierce debates regarding Indiana’s 2015 passage of RFRA centered on potential private-sector sexual orientation discrimination led to an amendment clarifying that the act does not allow such discrimination.5 The primary objective of RFRAs nationally—respecting individuals’ religious beliefs—is laudable. These rights are among the first recognized by the Constitutional Framers and are essential to the fabric of the nation.6 Yet, continued expansion of religious freedoms runs the risk of shifting trade-offs with essential governmental public health objectives. RFRA applications have the potential to adversely affect public health practices, programs, and objectives depending on (1) who qualifies as a “person” for the purposes of the
Public Health Reports / September–October 2015 / Volume 130
