Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk
Author: Deven McGraw, Partner, Healthcare Industry
Editor’s note: At the request of 23 public and private sector sponsors—including major life sciences companies, as well as U.S. and international regulators—the Institute of Medicine (IOM) created a committee to develop guiding principles and strategies for responsibly sharing clinical trial data. The committee’s report was issued on January 14 and includes four key recommendations, summarized briefly below. Click to download a free PDF of the full report. Manatt partner Deven McGraw, a member of the (IOM) committee, can provide firsthand insight into its findings and implications. To schedule a briefing with Deven and your team, click here.
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Clinical trial data should be shared responsibly in order to advance medical science and improve the health and well-being of the population. Responsible sharing of clinical trial data will allow other investigators to perform additional analyses and reproduce published findings, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments in clinical trials. Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new research ideas and ensuring that the efforts of clinical trial participants and investigators yield maximum scientific knowledge.
At the same time, sharing clinical trial data presents risks, burdens and challenges, including the need to:
- Protect the privacy and honor the consent of clinical trial participants.
- Safeguard the legitimate economic interests of sponsors (e.g., intellectual property rights).
- Guard against invalid secondary analysis, which could undermine trust or harm public health.
- Give researchers adequate time to analyze their data and achieve appropriate recognition for their intellectual contributions.
- Assuage the fear of research institutions that requirements for sharing clinical data will be unfunded mandates.
The Committee’s Goal
The objective of the IOM committee was to facilitate a global ecosystem for responsible sharing of clinical trial data, ultimately leading to better therapies. With that goal as a guidepost, the committee conducted its study, identifying four key principles for data sharing:
1. Maximize the benefits of clinical trials while minimizing the
risks of sharing clinical trial data.
2. Respect individual participants whose data are being shared.
3. Increase public trust in clinical trials and sharing trial data.
4. Conduct the sharing of clinical trial data in a fair manner.
The Committee’s Recommendations
Drawing on these principles, the committee developed four recommendations designed to maximize the benefits and minimize the risks associated with data sharing. The committee believes these recommendations will continue to be useful in the future, as circumstances change and unforeseen issues emerge.
- Recommendation #1: Stakeholders in clinical trials should foster a culture in which data sharing is the expected norm and should commit to responsible strategies aimed at maximizing the benefits, minimizing the risks and overcoming the challenges of sharing clinical data for all parties.
- Recommendation #2: Sponsors and investigators should share the various types of clinical trial data no later than the times specified in the committee’s report (e.g., the full analyzable data set with metadata no later than 18 months after study completion—with specified exceptions for trials intended to support a regulatory application—and the analytic data set supporting publication results no later than 6 months after publication).
- Recommendation #3: Holders of clinical trial data should mitigate the risks and enhance the benefits of sharing sensitive trial data by implementing operational strategies that include employing data use agreements; designating an independent review panel, including members of the lay public in governance; and making access to clinical trial data transparent.
- Recommendation #4: The sponsors of this study should take the lead, together with or via a trusted impartial organization(s), to convene a multi-stakeholder body with global reach and broad representation to address, in an ongoing process, the key infrastructure, technological, sustainability and workforce challenges associated with the sharing of clinical trial data.
Conclusion
The committee concludes that all stakeholders—participants, sponsors, regulators, investigators, research institutions, journals and professional societies—have roles in responsibly sharing clinical data, and details what each should do to foster a responsible data sharing culture. Its recommendations represent an attempt to balance the interests of the different stakeholders with the public interest of having the best information possible about the effectiveness and safety of therapies.
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The Future of MassHealth: Five Priority Issues
Authors: Patricia Boozang, Senior Managing Director | Stephanie Anthony, Director | Dori Glanz, Senior Analyst
Editor’s Note: Massachusetts has long been a national leader in health insurance coverage. Its Medicaid program, MassHealth, is the second largest payer of healthcare services in the state, with spending projected to reach $13.7 billion in state fiscal year 2015.
A new governor coming into office presented a unique opportunity to take a fresh look at MassHealth and its role in the Commonwealth’s healthcare system. In a new report for the Massachusetts Medicaid Policy Institute (MMPI), a program of the Blue Cross Blue Shield of Massachusetts Foundation, Manatt Health shares the results of over 40 interviews conducted with a range of stakeholders to determine the major opportunities and challenges for the MassHealth program. Based on the interviews, we identified the top five priorities for the new governor and examined key issues, policy options and impacts for each focus area. The article below provides an Executive Summary of the report’s findings. Click to download a free PDF of the full report.
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The past decade marked an era of seismic change in the Massachusetts healthcare market and one in which the Commonwealth led the nation in coverage and delivery system reform. In 2006, Massachusetts passed its comprehensive healthcare reform law (Chapter 58 of the Acts of 2006). It has since achieved nearly universal coverage through a combination of expanded Medicaid, private market reforms and individual subsidies to purchase coverage in the nation’s first health insurance exchange, the Massachusetts Health Connector (the Connector).
The national healthcare coverage reforms implemented earlier this year, part of the Affordable Care Act of 2010 (ACA), were modeled on the Commonwealth’s successful reform road map. Having closed the coverage gap for most residents of the Commonwealth, Massachusetts policymakers turned their attention to reining in healthcare spending growth across all payers, culminating in landmark legislation, Chapter 224 of the Acts of 2012. In the first full year following enactment of Chapter 224, the Commonwealth appears to be making progress. Total healthcare costs in the Commonwealth grew by 2.3 percent, well below the 3.6 percent benchmark set for 2013.1
As the steward of healthcare coverage and financing for an expected 1.7 million low- and moderate-income individuals, or one in four residents,2 MassHealth is at the center of these reforms. With anticipated expenditures of $13.7 billion in 2015, MassHealth spending represents over 30 percent of the state budget. This gross figure includes both state and federal Medicaid dollars, and the federal government reimburses more than half of this total dollar amount. The MassHealth program is expected to generate $7.7 billion in federal revenues this fiscal year, representing more than 80 percent of all federal revenues to be received by the Commonwealth.
As a result of this spending and revenue generation, MassHealth is a major contributor to the Commonwealth’s economy. MassHealth’s most important role, however, is articulated in its mission:
To improve the health outcomes of our diverse members,
their families and their communities, by providing access
to integrated healthcare services that sustainably promote
health, well-being, independence, and quality of life.
With this mission in mind, over the past decade MassHealth has implemented a sweeping array of initiatives, including eligibility expansions for children, single adults, and special-needs populations; alternative payment methods (APM) through its Primary Care Payment Reform Initiative (PCPRI); enhanced access to home- and community-based long-term care services; and One Care, a major delivery system reform for non-elderly adults who are eligible for both MassHealth and Medicare.
As MassHealth has grown over the last decade, it has become more administratively complex. MassHealth sits alongside 15 other agencies and departments under the Executive Office of Health and Human Services (EOHHS) and shares responsibilities for the Medicaid program with several of these agencies. MassHealth also has interdependencies with other parts of government, including the Executive Office of Administration and Finance and the Connector. The program has over 150 eligibility categories and is run by over 800 staff.
As a new governor takes office, there is a unique opportunity to take a fresh look at MassHealth. Given the program’s size and critical role in providing health coverage to one-quarter of the state’s residents, MassHealth will be one of the new governor’s top priorities.
From July through September of 2014, MMPI and Manatt Health conducted over 40 in-person and telephone interviews regarding the major opportunities and challenges for the MassHealth program. Interviewees included representatives of the provider community, the business community, insurers, consumers, and state and federal government, as well as Medicaid policy experts and former commissioners and directors.
Among the issues raised by stakeholders, the following five priorities emerged.
1. Elevate and Consolidate MassHealth Leadership.
MassHealth must have empowered leadership with the skill set, authority and accountability to implement the governor’s strategic direction. Many stakeholders suggest that MassHealth’s current administrative structure and status within state government impede effective program leadership and, ultimately, prevent state leaders from fully harnessing the program’s power to drive change. Galvanizing the agency may require restructuring MassHealth’s place within state government and elevating the role of the Medicaid Director.
2. Leverage MassHealth’s Purchasing Power to Accelerate Delivery System Reform.
MassHealth is missing a significant opportunity to use its purchasing clout to accelerate payment reform and delivery system transformation. Stakeholders urge MassHealth leaders to revamp the program’s fragmented purchasing approach and develop a comprehensive and cohesive purchasing strategy that better leverages the program’s size and purchasing power to achieve its Triple Aim goals.3
To achieve these goals, most stakeholders encourage MassHealth to push care management innovation to the provider level, with MassHealth retaining responsibility for purchaser functions. Many stakeholders feel that community health centers in particular can play a critical role in implementing these reforms because of their deep connections to the communities they serve and their ability to link to efforts that address social determinants of health, such as food sources, housing supports and social support resources.
3. Lead Behavioral Health Delivery and Payment Reform.
Unlike the other priority areas, behavioral health reform is acknowledged as “bigger than MassHealth” —meaning that the imperatives for improving the Commonwealth’s mental health and substance use disorder delivery system are critical to all residents of the state. But it disproportionately impacts MassHealth, as the largest payer for behavioral health services.
The consensus of stakeholders is that those impacted by mental illness and substance use disorders are unable to access the treatment they need. While MassHealth cannot single-handedly solve the problem, it must be a leader in addressing challenges in the state’s behavioral health delivery system through enhanced investment. Increased investment in the behavioral healthcare infrastructure also has the potential to reduce acute care medical costs, as untreated behavioral health disorders can lead to physical health issues or functional impairment.
4. Take on Comprehensive Long-Term Care Reform.
MassHealth’s dominant role in paying for long-term services and supports (LTSS) for a large and growing number of seniors and people with disabilities adds up to a looming crisis as we prepare for the aging of the baby boomers. The greatest opportunity to ensure MassHealth’s future sustainability is to reform the LTSS delivery and funding systems.
Stakeholders laud recent MassHealth efforts to expand access to community-based LTSS and integrate comprehensive services for high-need subpopulations. They express concern, however, about the lack of a more comprehensive strategy to ensure access to community-based LTSS that are person-centered and comply with the Americans with Disabilities Act (ADA). They also point to the need for MassHealth leaders to develop focused LTSS cost-containment strategies, to advance a strategic plan for the future role of nursing facilities as more care moves into the community, and to work with the private sector on a long-term LTSS financing plan to help ensure the financial sustainability of the MassHealth program.
5. Invest in MassHealth Infrastructure.
Transformation and innovation require investment in people and technology. Stakeholders identify the need for critical MassHealth infrastructure enhancements in several areas, including staffing covering a wide range of expertise and information technology (IT) systems.
Stakeholders particularly single out a need for MassHealth to invest in the subject-matter experts and IT systems necessary to perform high-level, sophisticated and timely data analytics. MassHealth holds a wealth of data that could better inform basic program metrics, key cost drivers, and reinvestment of savings. Not only will increasing data analytics improve MassHealth program operations and oversight, but making data and analysis publicly available will enhance MassHealth’s relationships with external stakeholders and deepen public understanding and support of the program.
Conclusion
By addressing these priorities, the new governor has the opportunity to demonstrate Massachusetts’ ongoing commitment to healthcare reform. Equally important, the Governor can position MassHealth as a major catalyst for transformation of the Commonwealth’s healthcare delivery system and continue Massachusetts’ legacy of national healthcare reform leadership by providing a model for Medicaid as a critical driver of payment and delivery system reform.
1 Massachusetts Center for Health Care Information and Analysis. Annual Report on the Performance of the Massachusetts Health Care System. September 2014
2 Massachusetts Medicaid Policy Institute, MassBudget, and the Massachusetts Law Reform Institute. The Fiscal Year 2015 Budget for MassHealth and Health Reform Programs. Budget Brief, September 2014.
3The Triple Aim is a framework developed by the Institute for Healthcare Improvement for optimizing health system performance through “(1) improving the patient experience of care (including quality and satisfaction); (2) improving the health of populations; and, (3) reducing the per capita cost of health care.” See http://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx.
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2015 Holds Promise—and Progress—for Post-Acute and Long-Term Care
Author: Stephanie Anthony, Director
Editor’s Note: Hospitals traditionally have viewed a patient’s discharge as the endpoint of their care responsibilities. Little attention was paid to the next steps in treatment once the patient left the building. In reality, however, hospital stays frequently are just one step in ongoing episodes of care. Ensuring a smooth transition from acute to post-acute and long-term care (PAC and LTC) settings is critical to achieving optimal health outcomes, as well as preventing unnecessary hospital readmissions and emergency department visits. In a new post on McKnight’s Long-Term Care News blog, summarized below, Manatt Health explores the numerous forces converging to make acute care providers focus on what happens to patients post-discharge.
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Both payers and acute care providers are taking notice of the critical role PAC and LTC services play in ensuring the continuity and quality of care, particularly for patients who are elderly, chronically ill or struggling with behavioral health issues. These patients historically have been served in unmanaged fee-for-service delivery systems. The Affordable Care Act (ACA), however, is driving fresh opportunities to improve quality and contain costs for these populations through new value-based purchasing arrangements. Clearly, the time is right for real change—and real progress—in the PAC and LTC arena.
What’s Driving the Change in PAC and LTC?
1. A dramatically changing population
According to the Congressional Budget Office, by 2050, 20% of the U.S. population will be 65 or older. Adding to the soaring demand for LTC and PAC services is the growth in younger patients with chronic and disabling conditions. To be prepared, PAC and LTC providers must develop:
- New treatment models that address chronic disease management, as well as integrated or coordinated care at the provider level across physical health, behavioral health and social support needs.
- New staffing models that are person-centered and interdisciplinary.
- New training curricula to ensure all providers and care managers are trained in emerging care coordination and management models that support patients with chronic and comorbid conditions.
2. Increased payer and policymaker attention on spending, quality and outcomes
There are significant opportunities to improve care and limit costs for populations with chronic conditions. Forces driving change include:
- Financial penalties for hospitals—and, soon, for skilled nursing facilities and other PAC providers—for avoidable hospital readmissions.
- A shift to value-based (versus volume-based) payments and a commitment to population health management to improve quality and control costs.
- Increased capitated managed care arrangements for elderly and disabled populations. To stay in network, PAC and LTC providers must demonstrate quality and cost effectiveness.
- A focus on standardized health and functional assessments to ensure that patients are placed in the lowest-cost setting that meets their needs.
- A rise in quality measurement and reporting. PAC and LTC providers must develop metrics to assess results—and implement improvements.
3. The integration of large health systems with PAC providers
Facing financial penalties for readmissions, health systems are increasingly looking to partner with PAC providers. There are several potential integration paths:
- Clinical integration. Seeking to increase hospital throughput, ease transitions across care settings and prevent readmissions, hospitals and health systems are developing screening criteria to identify high-need, high-cost populations who would benefit from care management/care coordination and referrals to PAC settings. To support improved care management and coordination, hospitals are investing in data analytics and information technology systems, sharing physician staff across acute and PAC settings, and developing effective treatment, transition and follow-up plans for patients and their families.
- Structural integration. Health systems are creating care systems—called continuing care networks or integrated delivery systems—that manage treatment across the care continuum.
- Financial integration. Hospitals and PACs are testing approaches for sharing financial risk and benefiting from mutual savings through emerging payment models that pay for episodes of care across multiple settings.
Conclusion
Acute, PAC and LTC providers are joining forces to ensure seamless care transitions, enhance quality and improve outcomes, while protecting their own financial futures. In this new environment, acute care providers must recognize the importance of PAC and LTC providers in supporting patients post–discharge, and lowering readmission rates and emergency room usage. PAC and LTC providers also must realize their own critical role in the care continuum, and adapt administratively, clinically, structurally and financially to the rapidly changing healthcare landscape.
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Captive PCs of Growing Interest to New York Behavioral Health Providers
Authors: Robert Belfort, Partner, Healthcare Industry | Anne O’Hagen Karl, Associate, Healthcare Industry
The Challenge Facing New York’s Behavioral Health Organizations
New York’s not-for-profit mental health and substance abuse providers are being asked by the state’s Medicaid program and private insurers to transform the way in which they deliver services. Rather than operating in narrow silos that focus on a discrete set of behavioral health services, these organizations are expected to integrate their care with the full spectrum of mental health and substance abuse treatment as well as primary care and other physical health services.
Unfortunately, the rigid regulatory framework governing the delivery of behavioral health services in New York is not well-suited to promote this goal. Behavioral health facilities and programs must generally be licensed by the Office of Mental Health, the Office of Alcohol and Substance Abuse Services or the Office of People With Development Disabilities under the Mental Hygiene Law. Medical clinics, referred to under New York law as diagnostic and treatment centers, must be licensed by the Department of Health under Article 28 of the Public Health Law.
Fitting integrated care models into this licensing scheme may be prohibitively expensive or entirely infeasible. For example, licensed clinics must meet strict architectural requirements that drive up the cost of facility development. In addition, they must generally deliver care at a specific service site. An organization providing behavioral health services on a periodic basis in a large number of changing locations (such as homeless shelters) cannot meet this requirement. Organizations that need the flexibility to provide behavioral health services in a client’s home face a similar obstacle. Finally, co-location of behavioral and physical health services may be difficult because of strict limits on the volume of medical care that may be delivered under a Mental Hygiene Law license and analogous restrictions on the delivery of behavioral health services under an Article 28 license.
While Performing Provider Systems may seek waivers of certain regulatory requirements under the Delivery System Reform Incentive Payments (DSRIP) program, those waivers are limited to DSRIP projects. Behavioral health providers that become aware of these impediments have been seeking an alternative to the traditional state licensing scheme.
New York’s Corporation Practice of Medicine Prohibition
Like many other states, New York generally prohibits unlicensed business or not-for-profit corporations from employing physicians to provide medical or behavioral health services. This prohibition on the “corporate practice of medicine” is not set forth in statute or regulation. Instead, it is based on judicial and administrative interpretations of New York’s licensing laws. Through various court decisions and agency opinions, the prohibition on the corporate practice of medicine has been applied not only to physicians, but to other healthcare professionals such as psychologists and licensed clinical social workers as well. Therefore, in seeking alternative models for care delivery, behavioral health providers must carefully navigate around the state’s corporate practice restrictions.
Legal Authority for Professional Corporations
The major exception to the corporate practice bar is the authority granted under the New York Business Corporation Law and the New York Limited Liability Company Law to create professional corporations (PCs) and professional service limited liability companies (PLLCs), respectively, to employ physicians and other healthcare professionals. In a PC or PLLC practicing medicine, only New York-licensed physicians actively involved in the entity may serve as shareholders/members or directors/managers.
Private medical practices are typically structured as PCs or PLLCs. PCs and PLLCs do not have to be licensed under the Mental Hygiene Law or the Public Health Law to deliver professional services and they are not tethered to particular service locations. As a result, they present an appealing alternative to behavioral health organizations seeking flexibility.
The “Captive PC” Model
The main challenge behavioral health organizations face when seeking to set up PCs or PLLCs is the requirement that all owners and governing body members must be licensed professionals. This obligation prevents a not-for-profit organization from maintaining ownership and control over a PC or PLLC in the same manner as a traditional subsidiary. Instead, an alternative model must be employed to assert control over the PC or PLLC through indirect means. This model is generally referred to as a “captive PC.”
Although the specific legal arrangements may vary, most captive PCs share several key features. For ease of explanation, we discuss below a PC established to practice medicine. The model operates similarly for PLLCs or for PCs delivering other professional services.
- First, a PC is established, the stock of which is owned by a licensed New York physician. The physician shareholder is often a high-level employee of the sponsoring not-for-profit organization.
- Second, the physician often enters into a stock transfer or similar agreement under which the organization is granted the right to direct the physician to transfer his or her shares in the professional corporation to another licensed physician designated by the organization.
- Third, although the physician is the owner of the captive PC’s stock, he or she does not typically invest his or her own money to capitalize the entity. Instead, the organization usually provides capital through a loan agreement. As a result, the bylaws of the captive PC generally prohibit the distribution of dividends by the captive PC to the shareholder.
- Fourth, the captive PC enters into a long-term management agreement under which the organization provides all of the space, equipment, supplies, administrative staff and other infrastructure necessary for the captive PC’s operation in return for a fee. The captive PC does not typically own any tangible assets and does not employ any individuals other than the physicians.
The Internal Revenue Service (IRS) has granted certain captive PCs affiliated with not-for-profit organizations a tax exemption. The IRS has taken the position in these cases that, notwithstanding the captive PC’s for-profit status, which is dictated by State law, the captive PC is essentially under the control of the not-for-profit organization and its legal structure ensures that it will advance the organization’s tax-exempt purpose. Several of the captive PCs that have been granted tax exemptions are located in New York.
Potential Benefits of a Captive PC
For organizations looking to advance their missions using innovative service delivery models, a captive PC can be an attractive option. It permits the delivery of care in a wide range of settings, without strict limits on the location or nature of the services being provided. The model also minimizes construction and ongoing compliance costs. Moreover, as New York shifts its Medicaid program to managed care, the favorable fee-for-service reimbursement licensed facilities receive in comparison to private practices has less impact. These are some of the reasons a number of New York’s behavioral health providers have been establishing or contemplating the creation of captive PCs over the past few years.
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The Healthcare Landscape Continues to Transform: How Can You Be Ready for the Major Changes Ahead?
Although we’ve come a long way in defining the specifics of our healthcare transformation since the passage of the Affordable Care Act (ACA), many critical details are just now emerging in upcoming federal regulations and policy guidance. These new rules will require that all healthcare stakeholders rethink how they manage their organizations and structure their business relationships.
To help our clients navigate this volatile healthcare environment, Manatt Health has been creating a series of analyses, fully explaining new federal healthcare guidance and its implications. With so many important changes still ahead, clients have requested that we continue delivering our analyses in 2015.
To meet this demand, we will provide ongoing “Federal Healthcare Guidance Summaries” in 2015, covering all new guidance issued over the coming year. Topics have been expanded this year to include not only Exchange and commercial market regulations but also Medicare and Medicaid managed care rules. Among the anticipated new regulations, revisions and policies we’ll cover are:
- HHS Notice of Benefit and Payment Parameters for 2016 and CMS 2016 Letter to Issuers in the Federally-Facilitated Marketplace. Draft versions of both documents were published at the end of 2014, and final versions are expected to be released by February 2015. These will set benefit parameters for 2016, and potentially 2017, including prescription drug minimum requirements, network adequacy standards, consumer assistance policies (availability of provider directories and formularies), and policy about how individuals will be reassigned to new plans if they do not actively select a new plan each year. Draft versions of both documents for 2017 will be published in late 2015 and also will be covered.
- Medicaid Managed Care regulation. CMS has said it intends to publish this spring its first major proposed revision to the Medicaid managed care regulations in more than a decade. Topics that likely will be covered include network adequacy, the relationship between Medicaid, Qualified Health Plans (QHPs) and other affordability programs created by the ACA, new provider contracting arrangements, and prescription drug coverage.
- Application of Mental Health Parity and Addiction Equity Act of 2008 to Medicaid Managed Care, CHIP, and Alternative Benefit Plans. This proposed regulation, scheduled to be published in the spring, would address unresolved issues regarding the interaction of the parity law with Medicaid expansion and managed care programs, as well as in the Children’s Health Insurance Program.
- Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Programs. CMS had proposed significant changes to the Medicare Advantage and Part D programs in early 2014. Many of the most controversial provisions relate to administration of Part D. CMS decided not to finalize those provisions but to address them in later rulemaking. Final CMS action is expected in 2015.
- Notices, Appeals and CHIPRA. In January 2013, CMS released proposed regulations requiring the coordination of Medicaid/CHIP eligibility notices and eligibility appeals processes to other insurance affordability programs. The proposed regulations also addressed the implementation of CHIPRA eligibility-related provisions including eligibility for newborns whose mothers were eligible for and receiving Medicaid or CHIP coverage at the time of birth. Final CMS action is expected in 2015.
- Application of Liens, Adjustments and Recoveries, Transfer-of-Asset Rules and Post-Eligibility Income Rules to MAGI Individuals. In February 2014, CMS issued a State Medicaid Director Letter providing guidance on how the long-term services and supports-related statutory and regulatory requirements, including the estate recovery rules, apply to individuals who are eligible for Medicaid under Modified Adjusted Gross Income (MAGI) eligibility rules and receive coverage for long-term services and supports. It is expected that CMS will release proposed regulations formalizing this guidance in 2015.
- Medicaid Premium Assistance. In January 22, 2013 draft regulations, CMS proposed letting states use Medicaid/CHIP funding to purchase coverage for eligible beneficiaries in the individual market, including through Qualified Health Plans in Marketplaces. Final guidance is expected in 2015.
- National Association of Insurance Commissioners’ (NAIC) Managed Care Plan Network Adequacy Model Act. On November 12, 2014, NAIC proposed revisions to its Network Adequacy Model Act. (The Act states that a managed care plan shall maintain a network sufficient in numbers and types of providers to assure that all services to covered persons be accessible without unreasonable delay.) During 2015, NAIC will be reviewing comments on the Model Act and likely promulgating final amendments. Concerns have been expressed that current network adequacy standards for health plans in Exchanges are inadequate, but the Department of Health and Human Services has indicated that it will await action by NAIC before considering further steps to enhance the federal network standards.
If you would like to subscribe to the guidance summaries, please call your Manatt contact or click to email Patricia Boozang.
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New Webinar: “Business Associate Compliance with HIPAA: Challenges and Solutions”
Register Free. Learn the Results of Our Recent Survey on How Well Business Associates Are Complying with HIPAA and How They Can Improve.
In 2009, Congress made Business Associates directly accountable to regulators for compliance with the Health Insurance Portability and Accountability Act (HIPAA). Regulations effecting that change were finalized in 2013. The enhanced accountability has raised pressing questions about Business Associates’ preparedness, effectiveness and experience in meeting compliance standards.
In a recent survey funded by the California HealthCare Foundation, Manatt Health assessed Business Associates’ compliance with their obligations to protect health information from the dual perspectives of Business Associates themselves and the Covered Entities they support. Now, in a new webinar for the World Healthcare Congress—“Business Associate Compliance with HIPAA: Challenges and Solutions”—we will share the compelling results with you. Then, we will delve into their real-world implications with a panel of thought leaders, representing both Business Associate and Covered Entity organizations.
Join us February 19 from 2:00 - 3:15 p.m. ET to explore the types of services Business Associates provide to Covered Entities…the approaches Business Associates and Covered Entities are taking to satisfy HIPAA’s privacy and security requirements…and innovative recommendations for improving results, from enhanced training to third-party certification. The program will reveal:
- The types of services Business Associates perform—and their sophistication levels.
- Common challenges Business Associates face in complying with HIPAA.
- Common issues Covered Entities deal with in managing their Business Associates.
- Business Associates’ capacity for compliance (i.e., due diligence).
- Experiences in negotiating Business Associate Agreements (BAAs)—and working with Business Associates during a breach.
- Rules governing Business Associates’ handling, return or destruction of protected health information.
- Perceptions of Business Associate compliance after the enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act.
- The best ways to reach and educate the Business Associate community to ensure ongoing HIPAA compliance.
- Continuing oversight of HIPAA compliance.
- Recommended strategies for improving Business Associate compliance with HIPAA.
Privacy and security are increasingly critical issues—with research showing that people are more concerned about the privacy of their health information than their non-health information. Don’t miss this chance to discover how to create a broader culture of awareness and compliance among both Business Associates and Covered Entities. Even if you can’t make our original airing on February 19, register now, and we’ll send you a link to listen on demand, at your convenience.
Presenters:
Deven McGraw, Partner, Healthcare Industry, Manatt, Phelps & Phillips, LLP
Plus a panel of leading Business Associates and Covered Entities
Date and time:
Thursday
February 19, 2015
2:00 p.m. to 3:15 p.m. NY time
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