2018 FedHealth Thought Leadership Compendium

June 25, 2018 • Civic Center • Silver Spring, MD

Thought Leadership Compendium Sponsored By

Table of Contents Saving Our Nation: Helping Government End the Opioid Epidemic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Community Systems Analysis: A Mixed Methods Approach to Evaluating the Integrated Effects of Public Interventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Navigating the HHSAR Salary Rate Limitation Clause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

JUNE 25, 2018

SAVING OUR NATION:

Helping Government End the Opioid Epidemic

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The opioid crisis is a confirmed epidemic, affecting millions of Americans. The impact reaches not only individuals but also families and the children around them, as well as entire communities. While policy makers are working hard to try and address this horrible situation, with supportive policies such as the Family First Prevention Services Act, CARA and 21st Century Cares, the policies alone are not enough to transform healthcare, public service and community organizations fast enough to get ahead of the crisis. Policies need to also evolve rapidly to keep pace with the constantly shifting course of the epidemic.

In the meantime, we need to capitalize on technology and data solutions that can help healthcare and government organizations create positive outcomes for more people and families across the nation.

EPIC CHALLENGES The epidemic facing America goes beyond just opioids, and is tied together with a wide variety of mental health issues, post-traumatic stress disorder, suicide, child safety and wellness. Some of the key challenges fall into several categories: Stigmas – We have to find ways to deal with the stigma in order to find and access the people who need treatment. There was a similar struggle when our nation first attempted to address the HIV/ AIDS crisis, so we should leverage lessons learned from that experience to better address tackling the stigma associated with mental health and addiction.

Prevention – A key to successful prevention is being able to predict and identify who is most at risk, to ensure treatment and counseling options are addressed quickly and effectively. This is an area that can be dramatically improved by technology, but systems are still being adapted and evolved to support the demand in certain areas.

Data Silos – We need more interagency collaboration and data sharing, so together we can all see the big picture of the situation as well

as the micro-details of community struggles and individual challenges. Most importantly, breaking down silos will enable us to find the current, often hidden, interconnectivity of various elements of the epidemic happening at the same time. By accessing more data together, our data can then be more relevant and effective in use as part of the solution, and will also help to assess how best to evolve policies and programs.

Funding – Federal agencies may not get majority of the funding coming out of Congressional approvals and programs, leaving states to address some of the biggest hurdles of the epidemic.

TECHNOLOGY NEEDS TO PLAY A KEY ROLE The medical community’s solution to address this crisis has been primarily through the use of drugs and counseling, which are, after all, the biggest assets in their current toolbox. But there is a gap, as the missing link has been the ability to look at precursors and indicators. This is an area where big data and data analytics technologies offer some of the greatest solution opportunities for government today. Government agencies looking to stem the tide of the opioid epidemic should make these technologies an area of focus.

The most important technologies available that provide the greatest potential benefits include: Predictive Analytics - We must leverage data that allows us to get in front of statistics instead of behind it, to mitigate the ultimately bad decisions that lead up to, and include, depression and suicide.

Connecting Data – Sharing and connecting information across agencies is an absolute key to being able to provide insights and solve the puzzle of this epidemic. In order to accomplish this, we must break down data silos and increase access, cooperation and sharing between agencies, nonprofits and public and private healthcare organizations. Cloud and data analytics are the two areas of technology that can be most effective in addressing this need.

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Early Warning Systems - 15 years ago CDC tried to develop an early warning system to help communities saves lives. This kind of solution should be considered again, and big data systems available today can make it possible.

Risk Estimations/Assessments – Big data has the ability to provide doctors and healthcare providers with the opportunity to asses risks, use data to facilitate decision support, identify levels of risk for suicide and overdose, and implement effective prevention strategies. By leveraging technology to achieve these objectives, big data could provide a powerful next step towards a solution.

SOME PROGRESS There has been some progress made to address the epidemic, which is the result of the hard work and efforts made by many across political, federal, state, nonprofit and commercial sectors. For example: De-criminalization – Perhaps one of the most significant aspects of progress in the fight against the epidemic is the shift in how the crisis was being categorized and handled in law enforcement and the courts system. It moved from being handled as a crime, with the result being prison time, to being treated as a legal medical condition.

This occurred after the epidemic had an enormous spike in the higher income socioeconomic brackets of our communities. Ultimately this resulted in an enormous amount of more people getting treatment, but it is happening slowly and the process needs to be sped up.

New CDC Guidelines - While some have criticized the new CDC guidelines that have emerged over the past two years, overall there has been positive response to the improved guidelines around prescriptions. Also, new systems for monitoring and supporting delivery of pharmaceuticals have led to lower drug prescription rates.

New Funding- Funding is on its way, with more than $13B anticipated in appropriations over 3 years. However, debate continues as to whether funding approved will yet be adequate to address the epidemic.

Federal Leadership - Strong federal government leaders in key agencies have been driving the effort nationally to address the epidemic, and their work in coming together and bringing focus and awareness to the epidemic is a huge positive force in our hope for resolution. Key agencies playing a key role include Centers for Disease Control, Department of Defense, Federal Drug Administration, Department of Health and Human Services – SAMHSA, and the National Institute of Health.

STILL MUCH TO DO In treating the suffering, government has a critical role to play in meeting the needs of children, families, and underserved communities. Pain is not just medical pain; it is caused also by the need for access to opportunities, such as jobs, housing and education. Beyond public services, all institutions and groups within our community have to be a part of the total solution – from schools and colleges, to employers and nonprofits.

And there is still much to do. Government industry is well equipped and ready to provide guidance to federal, state and local organizations on how to prioritize solutions and best use the influx of new funding to generate maximum results.

However, policies need to continue to evolve, to help continue to fight stigmas associated with so many aspects of this epidemic, and also ensure that solutions reach the upper socioeconomic brackets as well as address the underserved within all of our communities.

Technology also needs to be prioritized as a key part of the solution and leveraged to break down silos and help the government and our medical communities have the information and insight they need to support, fund and provide the best possible care, education, prevention and treatments for all.

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Community Systems Analysis: A Mixed Methods Approach to Evaluating the Integrated Effects of Public Health Interventions Government funding is increasingly being provided to communities to achieve system-level outcomes (rather than or in addition to individual-level behavior change). For example, support is provided to develop collaborative relationships with community partners, build service delivery infrastructure, enhance organizational and leadership capacity, change policies, and provide prevention and other services to meet the Healthy People 2020 objectives.

Private national foundations are also supplementing traditional support to targeted grantees with institutional investments intended to have broad catalytic community effects. Evaluating the success of this type of initiative requires analytic designs that examine system-level outcomes as well as contextual factors within a community that promote or impede intervention effectiveness.

Community Systems Analysis (CSA) is a longitudinal, community-matrixed approach MayaTech developed to analyze multiple sources of data from targeted communities to assess contextual factors, facilitators of, and barriers to intervention success and sustainability.1 CSA uses each study community as its own comparison or control, collecting data to reflect changes over time (retrospectively and prospectively), particularly when locating and replicating the study design in an independent comparison community is functionally or fiscally impractical.

CSA is used to assess integrated effects of multi-component and/or multi-site initiatives at the system level (e.g., changes in the community’s norms, epidemiological data, policies, environments, or other structural changes). The primary data sources are groups of community stakeholders identified in collaboration with the grantee community.

Conceptually, this approach captures reflective data on planning (stakeholders, such as community planning groups; advisory councils; health department managers; community-based organizations (CBO) board members; and intervention funders); intervention programming (stakeholders, such as staff of CBOs or coalitions including front-line staff and project directors; social services staff at partnering agencies; health department staff; and program participants); and policy (including elected and appointed officials; watchdog groups; and advocacy organizations). Perspectives from each source offer data that are critical to broad intervention impacts. This includes variables such as community awareness of and receptivity to prevention or other public health efforts; availability and leveraging of community resources; enhancement of organizational, leadership and policy capacity; and plans for sustainability of processes or outcomes.

CSA allows key stakeholders (community partners and funders) to assess changes in such outcome variables and the contextual factors that might influence them over the course of a funding cycle. It is a culturally competent approach to conducting embedded case study research (i.e., with the broad intervention or initiative as the overall case and the individual communities as single case studies embedded within the larger initiative). For example, in evaluating the Minority AIDS Initiative (MAI) of the Centers for Disease Control and Prevention (CDC), MayaTech implemented CSA with four local communities, conducting multiple focus groups and interviews with stakeholders (300 participants over three years) with varied roles and of diverse demographic backgrounds who worked and lived in the communities. The resulting comprehensive time-series data proved to be the only information available for CDC’s responses to the Congressional Black Caucus and Congressional Hispanic Caucus on questions of MAI funding effectiveness. Moreover, CDC staff used the data to produce two peer-reviewed journal articles.2,3 CSA was used similarly in MayaTech’s national evaluation of the Office on Women’s Health Coalition for a Healthier Community Initiative.4 In CSA, each community is studied as a single entity; and single-case and cross-case analyses are conducted. This approach is consistent with best practices in studying the effects of initiatives that are anchored by partnerships, coalitions, collaborations, or linkages.5-7 Moreover, CSA is guided by the Social-Ecological Model (SEM) and CDC’s Framework for Public Health Evaluation.8 The SEM is an approach to health promotion and prevention that recognizes that most public health system approaches are complex and need to be evaluated using comprehensive

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approaches to determine the extent to which multiple levels of influence are integrated to impact health behavior and ultimately health outcomes. Those levels of influence include intra- and inter-personal factors, community and organizational/institutional factors, and public policies.9-13 Several important indicators should be tracked in comprehensive public health systems approaches that incorporate a socio-ecological framework. These indicators include the following system-level constructs, for which data should be collected as fully as practical: Awareness, Receptivity, Collaboration, Coordination, Capacity Enhancement, Leveraging of Resources, and Sustainability Planning.

All too often, attempts at addressing public health challenges have been focused only on the individual and his/her behavior, for understandable funding and political constraints. Furthermore, those attempts yield desired outcomes that are short-lived, if realized at all. Of course, individual or person-level outcomes (changes in knowledge, behavior, and/or attitudes of participants in interventions) are critically important and often the central focus of evaluations. However, those individual outcomes are subject to withering away in the absence of the community’s capacity and will to change. The Community Systems Analysis model recognizes that public health interventions targeted at individual behavior change exist in a rich and dynamic community context that can be supportive or subversive of the desired outcome. To assess whether those investments are worthwhile, we need to understand how they actually are being absorbed by and integrated in targeted communities. To be sure, this approach takes effort and resources. However, it produces highly nuanced information for intervention management and public policy assessment. _______________________________ 1

Randolph, S.M., & Mayas, J-M. (2003, June). Community systems analysis: A conceptual approach to policy-oriented prevention research. Paper presented at the annual meeting of the Society for Prevention Research, Washington, DC. 2 Eshel A, Moore A, Mishra M, Wooster J, Toledo C, Uhl G, Agüero LW. (2008). Community stakeholders' perspectives on the impact of the minority AIDS initiative in strengthening HIV prevention capacity in four communities. Ethnicity & Health, 13(1), 39-54.

3 Wooster J, Eshel A, Moore A, Mishra M, Toledo C, Uhl G, Aguero LW. (2011). Opening up their doors: perspectives on the involvement of the African American faith community in HIV prevention in four communities. Health Promotion & Practice. 12(5), 769-78.

4 Alexander S, Randolph-Cunningham SM, Kowalczyk S, Oravecz L, Hill KA. (2017). Gender-based, public health systems approaches to improving women and girls’ health: Results from the USA Office on Women’s Health, Coalition for a Healthier Community Initiative. J Community Med Public Health Care 4: 031, 1-7. Retrieved June 6, 2018 at http://www.heraldopenaccess.us/fulltext/Community-Medicine&-Public-Health-Care/Gender-Based-Public-Health-Systems-Approaches-to-Improving-Women-and-Girls-Health-Results-from-the-USAOffice-on-Womens-Health-Coalition-for-a-Healthier-Community-Initiative.pdf.

5 LoConte NK, Weeth-Feinstein L, Conlon A, Scott S. (2013). Engaging health systems to increase colorectal cancer screening: Community–clinical outreach in underserved areas of Wisconsin. Preventing Chronic Disease, 10:130180. DOI: http://dx.doi.org/10.5888/pcd10.130180.

6 Dowda, M; Sallis, F; McKenzie, TL; Rosengard, P; Koh, HW. (2005). Evaluating the sustainability of SPARK physical education: A case study of translating research into practice. Research Quarterly for Exercise and Sport, 76(1), 11-17.

7 Porterfield, D, Hinnant, L, Kane, H, Horne, J, McAleer, K, & Roussel, A. (2012). Linkages Between Clinical Practices and Community Organizations for Prevention: A Literature Review and Environmental Scan. Am J Public Health. June, 102(Suppl 3): S375–S382. Published online 2012 June. doi:10.2105/AJPH.2012.300692. Retrieved June 6, 2018 at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3478082/.

8 Centers for Disease Control and Prevention (1999). Framework for program evaluation in public health. Morbidity and Mortality Weekly Report, 48(RR-11), 1-41.

9 McLeroy, K. R., Bibeau, D., Steckler, A., & Glanz, K. (1988). An ecological perspective on health promotion programs. Health Education Quarterly, 15, 351–377.

10 Stokols, D. (1996). Translating social ecological theory into guidelines for community health promotion. American Journal of Health Promotion, 10, 282–298.

11 Richards, L., Potvin, L., Kishchuk, N., Prlic, H., & Green, L. (1996). Assessment of the Integration of the ecological approach in health promotion programs. American Journal of Health Promotion, 10, 318–327.

12 National Cancer Institute. (2005) Theory at a Glance – A Guide For Health Promotion Practice. 2nd ed. Available at https://cancercontrol.cancer.gov/brp/research/theories_project/theory.pdf.

13 Green, L., Richard, L., & Potvin, L. (1996). Ecological foundations for health promotion. American Journal of Health Promotion, 10, 270–281.

Shelly Kowalczyk, MSPH, CHES, is a Senior Research Specialist in the Research and Evaluation Division, and Technical Vice President and Manager of The Center for Community Prevention and Treatment Research (CPTR) at The MayaTech Corporation.

MayaTech supports federal and private foundation evaluations of public health interventions. For additional information, email cptr@mayatech.com or visit www.mayatech.com.

VISION | INTEGRITY | KNOWLEDGE | SOLUTIONS 8401 Colesville Road, Suite 430, Silver Spring, MD 20910 | www.mayatech.com

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NAVIGATING THE HHSAR SALARY RATE LIMITATION CLAUSE By: Daniel P. Graham and Tyler E. Robinson, Vinson & Elkins, LLP Government contractors are no strangers to attempts by the Federal Government to impose limits on employee compensation. The allowability of compensation costs for senior executives of Government contractors is capped by statute (10 U.S.C. § 2324(e)(1)(P) and 41 U.S.C. § 4304(a)(16)) at a benchmark compensation cap amount determined in accordance with a statutory formula.

Many contractors with the Department of Health and Human Services (“HHS”) must also comply with HHS Acquisition Regulation (“HHSAR”) 352.231-70, Salary Rate Limitation. This clause implements annual restrictions that Congress has included in HHS appropriations bills since 1990 and is mandatory for solicitations and contracts when a cost-reimbursement, fixed-price level-of-effort, time-and-materials, or labor-hour contract is contemplated. HHSAR 331.101-70. The clause broadly provides that contractors “shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated.” HHSAR 352.231-70(a).

Contractors should bear in mind four points in structuring proposals in response to solicitations containing the HHSAR Salary Rate Limitation clause: •

First, the clause does not prohibit what a contractor can pay to an employee, only the amount of direct salary that can be paid for with contract funds. A contractor is free to pay employees more than the Executive Schedule rate, so long as contract funds are not used to cover the excess.

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Second, the limitation only applies to “direct salary,” and expressly excludes “fringe benefits, overhead, and general and administrative expenses” from the definition of direct salary.

Accordingly, in determining whether the compensation provided to an employee exceeds the limitation in the HHSAR clause, contractors should not consider fringe benefits and associated indirect costs.

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Third, the clause’s limitations do not apply to salaries that are allocated to indirect, overhead, or general and administrative cost pools. This point also flows from the definition of “direct salary.”

The clause defines “direct salary” as “the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract.” HHSAR 352.231-70(b). As a result, where an individual’s salary properly may be charged both directly and indirectly to cost objectives (be careful to avoid a violation of CAS 402!), the limitation applies only to those portions of an employee’s salary allocated directly to contracts.

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Fourth, the clause applies on a per contract basis, not on a per person basis. Although the clause itself is silent on this point, official guidance published by HHS states that the limitation applies on a per contract basis and only prevents the use of contract funds from a single contract to pay more than the Executive Schedule threshold. If an employee’s salary is allocable to multiple contracts, the limitation only governs the amount allocated to each contract.

If the above sounds counterintuitive, it is. The HHSAR Salary Rate Limitation clause is ill-conceived, having been forced on HHS through appropriations language. The clause’s implementation of those appropriations restrictions often raises more questions than it answers, such as how the limitation applies to consultants.

HHS has taken the position that the clause does apply to consultants, which appears to be an extension ©2017 Vinson & Elkins LLP

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of HHS’s (erroneous) position that all consultants are subcontractors (they are not). Regardless, since most consultants are reimbursed on a labor hour basis using rates that do not differentiate between salary and fringe benefits, overhead, and G&A, compliance with the clause can be particularly difficult. And, in the highly specialized healthcare industry where many consultants are highly educated, trained, and credentialed physicians and nurses, the amounts paid to consultants can often exceed the Executive Schedule threshold. This is but one example of the myriad complications and pitfalls that surround the HHSAR Salary Rate Limitation clause.

Vinson & Elkins has extensive experience counseling and representing contractors supporting the Medicare, TRICARE, VA, and Medicaid programs. Please reach out to Daniel P. Graham or Tyler E. Robinson if you have any questions.

This article is intended for educational and informational purposes only and does not constitute legal advice or services. These materials represent the views of and summaries by the author. They do not necessarily reflect the opinions or views of Vinson & Elkins LLP or of any of its other attorneys or clients.

Daniel P. Graham is a partner in Vinson & Elkins’ Washington, D.C. office and serves as the Administrative Partner in Charge of the firm’s Government Contracts Group. Dan’s practice focuses on government contracts, bid protests, Contract Disputes Act appeals, prime/subcontractor disputes, government cost accounting matters, identifying and resolving organizational and personal conflicts of interest, suspension and debarment proceedings, mergers and acquisitions, business restructures and reorganizations, internal investigations and commercial litigation. Dan also advises clients on compliance with ethics laws and regulations, including post-employment restrictions applicable to government employees.

Tyler E. Robinson is a senior associate in Vinson & Elkins’ Washington, D.C. office. Tyler counsels and represents government contractors and subcontractors on a variety of legal issues including bid protests, contract claims and disputes, subcontracting issues, government and internal investigations, and suspension and debarment.

Confidential & Proprietary ©2017 Vinson & Elkins LLP

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