Health Update - March 2015

by Manatt, Phelps & Phillips, LLP
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In This Issue:

  • Supporting Informed Decision Making in the Health Insurance Marketplace: A Progress Report
  • Medicaid Expansion States See Significant Budget Savings and Revenue Gains
  • Privacy, HIPAA and Informed Consent: Issues and Opportunities
  • Antitrust Update: Joint FTC and DOJ Workshop on Healthcare Competition Highlights the Importance of Antitrust
  • CMS Introduces the “Next-Generation ACO Model”
  • New Manatt Webinar: “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks”
  • New Webinar from Manatt and Bloomberg BNA: “Best Practices for Using Social Media in Healthcare: Maximizing Impact, Mitigating Risk.”

Supporting Informed Decision Making in the Health Insurance Marketplace: A Progress Report

Authors: Jocelyn Guyer, Director | Naomi Shine, Analyst

Editor’s note: As Affordable Care Act (ACA) implementation moves forward and the marketplace continues to evolve, there is a growing interest in consumer behaviors and the decision making process. Recognizing that selecting the right plan—one that meets both a family’s healthcare needs and its financial realities—is key to consumer satisfaction, advocates and policymakers are increasingly focused on ensuring people have the tools required to support informed choices.

In a new report for the National Partnership on Women and Families, summarized below, Manatt Health reveals how effectively the marketplace is providing consumers with reliable information about health plan options. Drawing on current literature, expert interviews and primary research, it also assesses new tools and promising practices currently used on marketplace websites. Finally, it offers recommendations for how the marketplace can improve the consumer experience. Click here to download a free PDF of the full report.

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Background and Methodology

A key goal of the ACA is to create an insurance market in which consumers have the ability to compare coverage options across standardized criteria and identify the plans that best meet their families’ healthcare needs. To measure progress against that critical objective, Manatt Health looked at how well the marketplace—composed of the federally-facilitated marketplace (Healthcare.gov) and 14 state-run marketplaces—is providing consumers with key information about available health plans.1 We also identified innovative practices being implemented to enhance the consumer browsing experience and support informed decision making.

Findings are based on a review of marketplace websites conducted between November 15th and December 23rd 2014. To determine which aspects of the marketplace websites are central to supporting effective decision making, Manatt Health reviewers interviewed academics, foundation staff, consumer advocates and representatives of patient groups. The interviews revealed four critical elements of website design:

1. Enhanced anonymous browsing,
2. Direct access to key plan features,
3. Useful plan display and availability of consumer tools, and
4. Easy website navigation and links for assistance.

Manatt Health evaluated the performance of marketplace websites across these four dimensions. There were two levels of review:

  • First, Manatt conducted a high-level review of all 15 marketplace websites—Healthcare.gov (which serves as the marketplace website for 37 states2), as well as the marketplace websites of 14 states.3
  • Second, Manatt performed a more in-depth analysis of six select marketplace websites: Healthcare.gov, as well as the marketplace web sites of California, Colorado, Connecticut, New York and Washington state. In reviewing the six sites, Manatt took a detailed look at how they employ the anonymous browsing features to present information on plan choice and provide consumers with decision support tools.

Key Findings

For the 2015 open enrollment period, marketplace websites have adopted notable features that enhance transparency and support informed consumer decision making. At the same, however, consumers still face a wide array of plan choices—and it can be challenging to find the information needed to select a plan quickly and easily. As the marketplace evolves, it will be important to continue identifying and sharing promising best practices to improve consumer support and satisfaction.

Our research on open enrollment 2015 shows that:

  • Nearly all marketplace websites now allow consumers to “window shop” for plans. In the early days of the first open enrollment period, consumers were disappointed to find that they could not see their plan options unless they first established a marketplace account. Now, however, consumers’ ability to “browse anonymously” or “window shop” prior to creating an account appears to be emerging as the standard practice. In fact, 13 of the 15 marketplaces studied, including Healthcare.gov, allow consumers to review plan options through an anonymous browsing function.4
  • Some marketplace websites are creating new, easier ways for consumers to search for their providers and prescription drugs. Most consumers want health plans that include their preferred providers in-network and cover their prescription drugs. Four state-run marketplace websites5—Colorado, Kentucky, Maryland and Washington—offer tools that make it easier to find plans based on provider and prescription preferences. These four sites provide integrated provider directories as part of their anonymous browsing function. When prompted, consumers can enter the name of a preferred provider and receive a list of available plans that include that provider in their networks. Along with its integrated provider directory, the Colorado marketplace website also features an integrated prescription drug directory that gives consumers quick and easy visibility into which plans cover their medications.
  • More marketplace websites are offering consumers “smart tools” and interactive features. As part of their anonymous browsing features, some marketplace websites are utilizing promising tools that are aimed at helping consumers quickly and easily personalize their plan selections.
    • Washington’s marketplace website has created a “plan wizard” that allows people to enter information about their plan preferences. The plan wizard then provides the consumer with customized plan options.
    • Healthcare.gov now gives individuals the flexibility to decide how much personal information they want to enter when anonymously browsing for plans. Consumers can elect to provide personal information, if they wish to view more accurate premium estimates that take into account eligibility for financial assistance.
    • Connecticut and Washington highlight silver-level plan options for consumers who, when anonymously browsing for plans, appear eligible for cost-sharing reductions. These marketplace websites reorder displayed plan options to show silver-level plans first—an important feature since individuals who are eligible for cost-sharing reductions may only take advantage of them in a silver-level plan.6

Recommendations

In each of the four core areas identified as critical to effective website design, there are a number of specific steps marketplaces should consider to improve consumers’ plan selection experience. These include effective strategies that emerged in the 2015 open enrollment period, as well as from private sector plan selection tools.

1. Enhanced anonymous browsing

  • Enable enhanced anonymous browsing as comprehensively as possible.
  • Provide consumers with the option of a customized anonymous browsing experience that presents plan options reflecting each individual’s eligibility for financial assistance.

2. Direct access to plan features

  • Facilitate consistent and direct consumer access to information on key plan features, including provider directories, prescription drug formularies and deductibles, as well as other cost-sharing information.
  • Establish integrated provider and prescription drug directories.
  • Display comprehensive information on quality ratings and enrollee satisfaction.

3. Useful plan display and availability of consumer tools

  • Display plans in an order that takes into account multiple factors of importance to consumers, including eligibility for cost-sharing reductions, total out-of-pocket costs and provider preferences.
  • Utilize “smart tools” that walk consumers through key steps in selecting health plans.

4. Easy website navigation and links for assistance

  • Conduct regular usability analyses to observe directly how end users access, utilize and comprehend plan data and decision-making tools.
  • Support robust consumer feedback loops, soliciting information on consumers’ experiences and satisfaction with plan selection tools.

Conclusions

For the 2015 enrollment period, Healthcare.gov and marketplace websites across the states have adopted features that enhance transparency and support informed decision making. The ability to browse plans anonymously is now standard practice. In addition, many marketplace websites enable consumers to tailor their plan searches to align with their specific circumstances and preferences. In addition, some, including Healthcare.gov, give people the flexibility to shape how much financial and health information they wish to share as part of the browsing experience.

At the same time, marketplace websites could do more to ensure that consumers have direct access to critical data about their health plan choices and tools to help them make sense of that information. Marketplaces should implement integrated provider and prescription drug directories that let consumers search for plans by their preferred providers and prescription medications. They also should offer tools that equip consumers to evaluate plans across multiple dimensions, not just on premium cost alone.

In addition, all marketplace websites should offer “smart tools” that guide consumers through the plan selection process. Many of these tools are already in place in other federal healthcare programs and the private sector.

As we move forward, advocates and policymakers should continue to share information on emerging practices for improving accessibility, usability and consumer comprehension. Highlighting and sharing best practices will help ensure that the marketplace delivers on its fundamental mission: helping individuals and families enroll in plans that meet their healthcare needs and fit their budgets.

1For purposes of this study and report, the District of Columbia is considered a state. The District of Columbia operates its own marketplace website: DC Health Link.

2The websites that rely on Healthcare.gov are Alabama, Alaska, Arizona, Arkansas, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin and Wyoming.

3California, Colorado, Connecticut, District of Columbia, Hawaii, Idaho, Kentucky, Maryland, Massachusetts, Minnesota, New York, Rhode Island, Vermont and Washington. Note that additional states, such as Oregon, are considered state-based marketplaces, but they rely on Healthcare.gov to carry out eligibility and enrollment functions on their behalf.

4At one point, the Vermont marketplace website did offer an anonymous browsing feature. The state decided to remove this feature, however, upon deciding that the tool was unnecessary given that only two issuers offered plans in its marketplace. Vermont administrators felt there were better ways to present consumers with their options. While the District of Columbia’s marketplace website does not offer comprehensive anonymous browsing, it does have a tool that allows consumers to compare plans across key dimensions. This tool stops short of displaying premium data.

5Though Massachusetts offers an integrated provider directory, reviewers found it to be non-functioning after repeated efforts to filter by specific providers.

645 C.F.R. § 155.305(g) (2010).

Medicaid Expansion States See Significant Budget Savings and Revenue Gains

Authors: Deborah Bachrach, Partner, Healthcare Industry | Patricia Boozang, Senior Managing Director | Dori Glanz, Manager

Editor’s note: Early data from two states—Kentucky and Arkansas—shows more than $1 billion in savings after just the first year of Medicaid expansion. In a new issue brief for the Robert Wood Johnson Foundation’s State Health Reform Assistance Network, Manatt Health examines the financial gains as a result of Medicaid expansion in Kentucky and Arkansas. Key points are summarized below. Click here to download a free PDF of the full issue brief, featuring an at-a-glance chart summarizing early results of budget savings and revenue growth in both states.

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Kentucky and Arkansas, two states that expanded Medicaid to cover adults up to 133 percent of the federal poverty level (FPL), are seeing significant savings in their state budgets that will cover all expansion-related costs well beyond state fiscal year (SFY) 2021.

  • Kentucky estimates saving $820 million, net of costs, from SFY ’14 to SFY ’21.
  • Arkansas estimates saving $370 million, net of costs, from SFY ’14 to SFY ’21.

For states that are considering Medicaid expansion, Kentucky and Arkansas are examples of how expansion can produce savings and generate new revenue for state budgets. Both states report expansion-related savings, and Arkansas reports new revenues. When projected forward, these financial gains are likely to exceed expansion-related costs for years to come, while generating major increases in coverage and reducing the number of uninsured.

Three Major Categories of Budget Savings and Revenue Gains

While data is still limited, the savings and increased revenue seen in expansion states fall into three major categories:

1. State savings from using new federal funds. Historically, many states have supported programs and services for the uninsured—such as mental and behavioral health programs, public health programs and inpatient healthcare services for prisoners—with state general fund dollars. With expansion, virtually all of the beneficiaries of these programs and services are able to secure Medicaid coverage in the new adult category, which means states can fund these services with federal—not state—dollars. Kentucky saved $9 million in 2014 as enrollees in behavioral and mental health programs were fully covered by Medicaid.

2. State savings from enhanced federal matching. States are saving money as they now are able to cover those most in need with 100 percent federal funding. In the past, states often used waivers or specialized Medicaid eligibility categories to provide at least some coverage to high-need enrollees, such as “medically needy” individuals, pregnant women and the disabled. They typically had to pay between 30 and 50 percent of the coverage costs for these individuals. With expansion, these individuals are now eligible for full Medicaid coverage—which means they (and the state) will save money while receiving full Medicaid benefits. Arkansas saved $17.5 million in 2014 by accessing the 100 percent federal match for adults previously enrolled in waiver programs and targeted categorical eligibility groups who transitioned to the new adult group.

3. Revenue gains. Many states raise revenue through assessments or fees on providers and health plans. As provider and health plan revenue increases with expansion, this translates into additional revenue for states. Arkansas saw revenue gains of $4.7 million in 2014.

Conclusion

Twenty-six states have expanded Medicaid—and many are beginning to report comparable economic information to the financial gains shown in the early results from Kentucky and Arkansas. All states are finding additional benefits ranging from significant drops in the number of uninsured to a reduction in uncompensated care costs to the creation of tens of thousands of jobs.

Privacy, HIPAA and Informed Consent: Issues and Opportunities

Author: Deven McGraw, Partner, Healthcare Industry

In a feature Pro Q&A, Politico interviewed Manatt Partner Deven McGraw—a member of the federal Health Information Technology (HIT) Policy Committee and chair of its Privacy and Security Workgroup—on some of the hottest topics in health IT: privacy, the Health Insurance Portability and Accountability Act (HIPAA) and informed consent. Below is a summary of some of the key insights that Deven shared. Click here to access the Politico Pro web site.

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Balancing Protecting Privacy and Driving Learning

We need to have data protections and limitations in place that safeguard privacy—and ensure people fully understand their privacy rights. At the same time, we can’t be so protective that we are actually obstructing data uses that people need—and that would benefit patients.

Consumers are burdened by a healthcare system that costs too much and delivers too little. While data is not a set of magic beans, it is a catalyst for creating knowledge that can improve healthcare quality and drive treatment advances. Although privacy protections are well intentioned, some can inadvertently become roadblocks to uses of data that, in fact, we should be encouraging rather than discouraging.

There’s a huge contrast between what patient groups and privacy advocates are saying. Patient groups often express frustration with the lack of data access while privacy advocates, who ostensibly represent patients, tend to call for greater control over data.

Privacy advocates sometimes are not as familiar with the healthcare space. Therefore, they may end up on the opposite end of the spectrum from someone who understands the urgent need for sharing health data—and the importance of balancing that need appropriately with privacy protections. When advocating for privacy in the healthcare space, it’s critical to keep both of those interests in mind—the importance of sharing data to advance learning, as well as the need to enforce protections to safeguard privacy.

Establishing Trust and Transparency

The Affordable Care Act (ACA) established that insurers can’t make decisions about covering people based on their health information—but that only applies to one kind of insurance. Other types of insurance—for example, long-term care insurance, life insurance and disability insurance—are not affected by the nondiscrimination protections in the ACA. In those cases, insurers still can make decisions about people based on their health risk. In addition, if individuals don’t qualify for the Americans with Disabilities Act, their employers can still use some health information as a factor in making certain employment decisions. Health information also can be used as the basis for financial decisions—such as whether someone qualifies for a mortgage or credit.

There’s a lot of talk about transparency to individuals about who has accessed their records and for what purposes. But if people have confidence that the system isn’t going to use their health information against them—and have an effective means of redress if they suspect or know about unauthorized access—they may be far less interested in having detailed information about all the ways their data is being used.

Questions remain about what the best mechanism is for establishing trust around how sensitive data is used. Should we give institutions that actively engage individuals and already have earned their trust some leeway with respect to the strictness of laws around sharing health data? Or should we create a stringent regulatory environment that applies across the board? It’s important to consider the impact of current protections on data flows we are trying to encourage.

Today we use “notice and consent” as a way of achieving both transparency and some individual control over data usage. Far too often, however, “notice and consent” serves as a way for entities to achieve endorsement of existing data practices.

Understanding That Trust Is About “Who” Rather Than “What”

The effort in the U.K. to create a single database with everyone’s health records did not go over well, nor would it go over well in the U.S. We are not trying to create or use a massive database with everyone’s healthcare records in it. Instead, we are trying to support the episodic sharing of data without collecting it all in one place. Some states are setting up all-payer claims databases to evaluate care more carefully, but that is unlikely to be a viable option at a centralized, national level.

Trust is complicated. Building trust is much less about technology and much more about people. It’s really about the “who” rather than the “what.”

Anticipating What’s Next

It’s fortunate that we have HIPAA. It gives us a baseline set of rules. However, it doesn’t cover sections of the economy—such as mobile apps and social networks—where we don’t yet have “guardrails” in place.

We have the Federal Trade Commission (FTC) to crack down on unfair and deceptive trade practices, but it doesn’t offer as clear a set of guidelines as HIPAA. Consequently a consumer’s health data is protected with comprehensive rules in one space but not another—and it might move in and out of that protected space frequently.

Clearly, Congress needs to authorize rules for the space that’s not covered. We also need to raise public awareness—and be more transparent in sharing with people how we are using their data rather than just detailing what HIPAA permits. We should be having honest conversations with people about what actually happens to their information, even at a categorical (vs. an individualized) level.

For example, people should be aware that there is no such thing as a free app. If people are sharing data with a company and they didn’t pay for the app they are using, chances are strong the company’s business model involves using that data to make money. That is a tradeoff many consumers are willing to make—but they should be aware of it.

Congress is starting to explore how HIPAA can be problematic for research uses of data. But privacy legislation is hard to move in Congress. Even before the current divisive political environment, legislation would lead to disagreements among consumer advocates and industry sectors about where the “sweet spot” line—the balance between protecting privacy and sharing knowledge—should be drawn. In today’s politicized world, we face an even tougher battle.

In a regulatory environment, there’s a little more space and time—and less opportunity for politics to be the lead consideration in decision making. Productive discussions can’t take place in media headlines. It’s far better to have them as part of a robust public comment period.

It’s a good thing that Congress, in a bipartisan way, is interested in how we make more data available for research, so we can build the learning healthcare system that consumers and patients need. When Congress starts writing bills, people who care about privacy interests will come forward and make sure we have the dialogue about protection. They’ll want to ensure the conversation is not one-sided but addresses the need for privacy protections, as well as the benefits of data sharing.

Antitrust Update: Joint FTC and DOJ Workshop on Healthcare Competition Highlights the Importance of Antitrust

Author: Lisl Dunlop, Partner, Litigation

Editor’s Note: On February 24 and 25 in Washington, DC, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) held a joint Antitrust Division Workshop, “Examining Healthcare Competition.” In the article below, Manatt Partner Lisl Dunlop, who participated in the workshop, summarizes key insights shared during the day-and-a-half session.

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In a day and a half of panels covering the gamut of the U.S. healthcare landscape, commentators at the “Examining Healthcare Competition” workshop rejected the notion that consolidation was necessary to achieve the benefits of healthcare reform. Dr. Ezekiel Emmanuel framed the main issue, examining competition policy against the backdrop of megatrends that are transforming healthcare, including:

  • Changes in payment structures to focus on value and risk and move away from fee-for-service models.
  • The digitization of healthcare, providing real-time data sources to monitor performance and quality, as well as open new avenues for healthcare delivery.
  • The proliferation of new players in the healthcare space, with care delivered from more and varied points. For example, we see non-physician healthcare professionals, such as pharmacists, playing a greater role in healthcare delivery and decisions.

The workshop provided an update on developments across a full range of issues—including health insurance exchange operations, network design, accountable care organizations and other innovative health delivery models—but its major theme was consolidation. Panels discussed when consolidation is happening, when it is necessary or desirable, and when antitrust regulations should prevent it.

Emmanuel commented on the high volume of consolidation—both horizontally (hospitals acquiring hospitals) and vertically (hospitals acquiring physician groups or insurers acquiring hospitals). He posited that consolidation may be effective when associated with risk-based payment systems but raised concerns about consolidating in a fee-for-service environment. That same concern was echoed in subsequent panels.

FTC and DOJ Heads Provide Insights Into Agency Enforcement

The heads of both the FTC and the DOJ shared insights into agency enforcement, with a specific focus on healthcare markets. The FTC has consistently maintained that the aims of the Affordable Care Act (ACA) can be achieved without horizontal consolidation. The FTC has stood firm in saying that it will consider hospital mergers on the same basis as other transactions.

In her address, FTC Chairwoman Edith Ramirez extended the FTC’s concerns around consolidation to include mergers between entities at different levels of the healthcare supply chain—for example, urban hospitals buying suburban ones or hospitals buying different types of providers, such as laboratories or imaging providers. She cautioned that, as healthcare providers scramble to adapt to a changing market and regulatory environment, they should not put antitrust law in the background.

Assistant Attorney General Bill Baer used his remarks to focus on the possibilities for anticompetitive conduct by various healthcare stakeholders. For instance, he highlighted the potential for health insurers to skirt around procompetitive mechanisms (i.e., tiering and narrow networks), by implementing anticompetitive contracting practices, such as anti-tiering, anti-steering and most-favored-nations (MFN) clauses.

Separately, Baer focused on contracting practices dominant providers sometimes use to insulate themselves from competition. He cited United Regional Healthcare System’s contract provisions inhibiting insurers from contracting with competing providers as a prime example of that type of anticompetitive contracting. The DOJ has a history of enforcement in this area, foreshadowing its continued focus.

Panels Educated Regulators About the Evolving Industry

Several of the workshop panels appeared designed to educate the antitrust regulators on developments and experiences in different aspects of the healthcare landscape rather than home in on particular issues of potential antitrust concern. The common refrain was that the industry is still evolving, with panelists stressing that it is too soon to make confident predictions about how the markets established by the ACA will function in the mid to long term. Commentators focused their discussions on:

  • Developments and innovations in provider network design, contracting practices and health insurance exchanges.
  • Current trends toward narrow and tiered networks, participation in exchanges and premium movements.
  • State regulatory activity in the healthcare arena, such as Massachusetts’ establishment of cost increase limits.
  • Alternatives to fee-for-service payment, with a focus on risk-sharing models and integrated health systems.
  • The striking growth in the establishment of Medicare/Medicaid and commercial ACOs, as well as the efficiency, quality and cost benefits of ACO structures.

The penultimate panel at the workshop addressed provider consolidation issues. The panel was dominated by healthcare economists, including Dr. Martin Gaynor and Dr. Leemore Dafny, both of whom have served as FTC economists.

The panelists’ overwhelming response to consolidation was that it does not necessarily lead to achieving healthcare reform’s goals—improving quality through more integrated care, lower costs and better use of resources. They strongly expressed that healthcare reform goals cannot be used as a justification for consolidation. Notably, the panel’s evidence included a range of factors, including:

  • If providers consolidate and as a consequence have market power, they will have no incentive to move away from fee-for-service based payment models to adopt pay-for-performance or risk-sharing payment models.
  • Where insurance markets are concentrated, providers are moving into insurance. Devolving all risk down to the provider level, however, is not efficient. Payers provide a range of services that employers and patients need and that providers do not perform well.
  • Hospitals that acquire physician groups do not perform better on quality and cost measures than those that simply align with physician groups or maintain the status quo.

The panel spent surprisingly little time discussing the recent Ninth Circuit St. Luke’s decision. Commentators did note that the courts in that case rejected the efficiency claims made by the merging parties, because they could be achieved by other means and did not overcome the likely price increase from the consolidation. (For more on the St. Luke’s case, click here to read the “Antitrust Update” in our February issue.)

Conclusion

As providers consolidate, whether horizontally or vertically, they need to ensure they consider and address potential antitrust issues. Regulators are clearly monitoring healthcare mergers and focused on enforcing antitrust laws for hospital mergers as rigorously as for any other transaction. The St. Luke’s decision is an important wake-up call that claiming a transaction will help achieve healthcare reform’s goals of better outcomes and lower costs does not outweigh antitrust concerns.

CMS Introduces the “Next-Generation ACO Model”

Authors: David Oakley, Counsel, Healthcare and Insurance | Ian Spatz, Senior Advisor | Anne O. Karl, Associate, Healthcare Industry

On March 10, the Centers for Medicare & Medicaid Services (CMS) announced a new Accountable Care Organization (ACO) model. An initiative of the Center for Medicare and Medicaid Innovation (CMMI), the “Next-Generation ACO Model” offers provider groups experienced in coordinating care the opportunity to assume higher levels of financial risk and reward than are available under the current Pioneer Model and Medicare Shared Savings Program (MSSP).

The objective of the “Next-Generation ACO Model” is to test whether strong financial incentives for ACOs, coupled with tools to support better patient engagement and care management, will lead to improved health outcomes and lower costs for Original Medicare fee-for-service beneficiaries. The model will be evaluated based on how well it delivers better care for individual patients, better population health and slower spending growth.

What’s Important to Know About the New Model?

The new model is a further refinement of the Medicare ACO program. It responds to concerns that ACOs and other stakeholders have raised about the current models.

CMS expects about 15-20 ACOs with at least 10,000 participants (7,500 in rural areas) to participate in the “Next-Generation Model,” representing a variety of provider organization types and geographic regions. (Click here for specific eligibility criteria.) It’s important for those considering the new model to understand that:

  • The ACOs coming into the new model cannot simultaneously be participating in another Medicare ACO model or program, but prior participation in Pioneer or MSSP may be helpful.
  • The model requires ACOs to take on much more risk than other models. Among the options is full risk capitation.
  • ACO payments will be based on prospective benchmarks rather than the current retrospective benchmarks. At the start of each year, the ACO will know what its spending targets are.
  • At this time, only Parts A and B utilization are included in the model, not Part D.
  • Covered benefits for Parts A and B are “as is,” without the limitations found in Medicare Advantage health plan arrangements, such as restrictions on out-of-network usage or requirements for primary care physician gatekeepers.
  • ACOs will need to confirm that their level of assumed financial risk does not conflict with state laws or regulations on provider risk. This can be a gray area where careful presentations may affect regulatory conclusions.

What’s Included in the New Model?

The new model indicates that CMS is listening. It incorporates many changes based on the feedback that CMS received during the Pioneer ACO and MSSP process. Among the new features it includes are:

  • The option for full risk capitation (not shared savings) to the ACO.
  • The option for CMS to process claims from providers and then pass them to the ACO for payment, so that ACOs can negotiate discounts or alternative amounts.
  • Minor incentives for patients for their formal cooperation with the ACO. (The cash incentives may raise some controversies around the model.)
  • A higher risk to the ACO than to CMS, compared with most former models.
  • An improved patient alignment process for determining the Medicare patients for whom the ACO should be responsible.

The new model includes refined benchmarking methods that reward quality performance, reward attainment and improvement in cost containment, and transition away from references to the ACO’s historical expenditures. In addition, the model provides a selection of alternative payment mechanisms to support moving from fee-for-service reimbursements to capitation. It also includes several tools to help ACOs improve their engagement with beneficiaries, including:

  • Waivers of current Medicare coverage restrictions, so that ACO patients have enhanced access to home visits, telehealth services and skilled nursing facilities.
  • A reward payment to beneficiaries for receiving care from the ACO.
  • A process letting beneficiaries confirm their alignment with a particular ACO, even if the alignment process might not align that patient with that ACO.
  • A collaboration between CMS and ACOs to support clearly communicating to beneficiaries the characteristics and potential benefits of the ACO in relation to their care.

The new model will consist of three initial performance years and two optional one-year extensions. CMS will publicly report the performance of Next-Generation ACOs on quality metrics, including patient experience ratings, on its website.

Responses to the Request for Applications are due on June 1, 2015. For more information on Next-Generation ACOs, click here.

New Manatt Webinar: “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks”

Click here to Register Free, and Earn CLE Credit.

Join Us March 31 from 1:00 to 2:00 p.m. ET—and Learn to Create a Global Ecosystem That Protects Stakeholders While Advancing Medicine.

Sharing clinical trial data responsibly is critical to advancing medical science. At the same time, it presents complex challenges—from protecting participants’ privacy to safeguarding intellectual property rights. How can we develop a global ecosystem that balances the interests of stakeholders with the drive to improve the health of people around the world?

At the request of 23 public- and private-sector sponsors—including major life sciences companies, as well as U.S. and international regulators such as the FDA and NIH—the Institute of Medicine (IOM) created a multidisciplinary committee to address that critical question. In a new report, the committee provides guiding principles, strategies and recommendations for responsibly sharing clinical trial data. Now Manatt Partner Deven McGraw, a member of the IOM committee, shares firsthand insight into the report’s findings and implications at a new webinar, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks.”

During the webinar, presented through PharmaVoice, you’ll learn how business models, academic culture and sponsor and investigator incentives need to change to support the sustainable sharing of clinical trial data. Don’t miss this important opportunity to:

  • Discover the committee’s four key recommendations for sharing clinical trial data responsibly.
  • Explore the guiding principles for sharing clinical trial data, and the committee’s approach to applying them.
  • Examine the roles and responsibilities of key stakeholders, including participants, funders and sponsors, regulatory agencies, investigators, research institutes and universities, journals, disease advocacy organizations and professional societies.
  • Understand what data should be shared—and when.
  • Identify approaches for mitigating risks and creating a true learning system for sharing clinical trial data.
  • Look ahead to the future of data sharing in a changing landscape, including addressing infrastructure, technical, work force and sustainability challenges.

Sharing clinical trial data can accelerate new discoveries, stimulate new research and drive the development of safer, more effective therapies. Find out how we can work together to create a culture of sharing while protecting the rights and interests of all stakeholders. This is a critical program for anyone involved in advancing medical treatments. Even if you can’t make our original airing on March 31 from 1:00 to 2:00 p.m. ET, click here to register now, and we’ll send you an on-demand link to view the session, at your convenience.

Presenter: Deven McGraw, Partner, Healthcare Industry

Note: This program has been approved for 1.0 General Credit in California and 1.0 Professional Practice Credit in New York.

New Webinar from Manatt and Bloomberg BNA: “Best Practices for Using Social Media in Healthcare: Maximizing Impact, Mitigating Risk.”

Click here, and Enter Promo Code LGAEXT100 to Register Free. Join Us on April 29 from 1:00 – 2:30 p.m. ET, and Earn CLE Credit.

For a generation more likely to seek health information online than see a doctor, social media is playing an increasingly critical role in healthcare decisions. Today, more than 40% of consumers say that the information they read in social media affects how they deal with their health1—and two-thirds of doctors use social media for professional purposes.2

With statistics like these, it’s not surprising that a growing number of healthcare entities are incorporating social media into their communication plans. But how can you effectively harness social media’s power to reach and influence your target audiences? And how can you be sure you minimize the risks that often accompany an active social media presence?

In a new webinar for Bloomberg BNA, “Best Practices for Using Social Media in Healthcare,” Manatt answers those crucial questions. First, we will present emerging approaches to inform, engage and motivate patients and physicians. Then, we will take a detailed look at execution risks—both generally and specific to healthcare—and provide clear, actionable strategies for safeguarding your organization. During the session, you will:

  • Explore how patients and providers are using social media in healthcare—and the role it plays in healthcare decisions.
  • Discover the most effective social media techniques within healthcare for both consumer and professional audiences.
  • Benefit from the cross-fertilization of ideas, learning how innovations from other sectors can be adapted to healthcare.
  • Examine the issues around the Health Insurance Portability and Accountability Act (HIPAA)—and ensure your social media programs are in compliance.
  • Find out how you can avoid liability for content posted by others.
  • Learn the regulatory requirements around endorsements/testimonials, hashtags, re-tweeting of third-party content and other key challenges—and be prepared to meet them.

Don’t miss this chance to examine the full gamut of issues—from ensuring privacy to avoiding liability—and understand how to run a high-impact social media campaign without putting your organization in legal jeopardy. Even if you can’t make the April 29 date, register now, and we’ll send you a link to view the program on demand. To reserve your place, click here and enter promo code LGAEXT100 to register free.

Presenters: Jon Glaudemans, Managing Director | Linda Goldstein, Partner and Chair, Advertising, Marketing and Media Division

NOTE: CLE credit is available for this program.

1Source: Mediabistro

2Source: EMR Thoughts

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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