Avalere Health 2015 Industry Outlook

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2015 Industry Outlook

2 Introduction Industry Outlook 2015 Changes in healthcare financing, delivery, and organization are transforming the sector. Health plans and providers are revising their business models to remain profitable and competitive. Consumers are being asked to assume more responsibility for cost and the assessment of quality, often on the basis of very limited information. At the same time, life sciences companies are striving to anticipate the pace of change and establish competitive advantage in this value-driven market. This Outlook summarizes Avalere s perspective on the year ahead. For more information, contact us.

3 Industry Outlook 2015 Managed Care Key Trends Commercial Plans and Exchanges / Exchange marketplace enrollment is stable, growing, and tracking Avalere s projection models to reach 10.5 million enrolled by the end of 2015. Retention rates from 2014 appear to be strong. Rolling into the third open enrollment cycle, Avalere expects exchanges, and those health plans that participate, to become more active in shaping this market. These efforts will include increasing interest in evolving the sophistication of decision support tools that drive consumer choices and highlighting benefit design challenges, including narrow networks or high cost-sharing arrangements. In addition, regulators at the federal and state levels are expected to have active conversations to evaluate whether or not certain benefit and network designs are discriminatory to the consumer. This year will also be the first year that health plans report quality data to the Centers for Medicare & Medicaid Services (CMS), a test of the Quality Reporting System (QRS) that may raise questions about whether or not ratings will ultimately impact participation in the exchanges. Government Programs / Medicare Advantage plans are weathering the storm of the top-line benchmark payment cuts. Enrollment will surpass 16 million this year. Avalere expects the overall number of Medicare Advantage plans will continue to grow. (See Figure 1.) Regulatory debate will continue about the accuracy of risk-adjusted payments. Plans with existing market share, and those entering the market, will need to stay mindful of both the risk profile of local populations in which they serve and the behavior of providers serving those markets in order to maximize financial results. Medicare Advantage plans that move into more intelligent contracting arrangements with providers may find themselves at an advantage in their efforts to anticipate and manage the impact of the cost versus quality value equation. As risk shifts, health plans will need to consider effective oversight programs to ensure sustained performance and effective contracting relationships.

4 Managed Care Figure 1: Medicare Advantage Poised to Become De-Facto Reform Plan Number of MA Plans, 2011-2015 MA-Only MA-PD 3,000 2,500 Number of Plans 2,000 1,500 1,000 2,044 2,061 2,292 2,200 2,177 500 0 365 369 372 327 273 2011 2012 2013 2014 2015 N=2,409 N=2,430 N=2,664 N=2,527 N=2,450 Source: analysis using DataFrame and 2015 MA plan data released by CMS on September 18, 2014 Medicaid / Medicaid represents a growing market for health plans, with 10 million new enrollees as a result of the Affordable Care Act in 2014 and additional expansion likely in 2015. To date, 28 states and the District of Columbia are expanding Medicaid eligibility. (See Figure 2) The theme in 2015 for Medicaid health plans will be one of opportunity and growth, but with that growth will come increased scrutiny. CMS is expected to release a mega regulation that, among other outcomes, may place pressure on the Medicaid market to further align with the marketplace and Medicare. This alignment will create challenges for some plans but will also create opportunities for commercial plans to capture Medicaid lives by leveraging existing platforms.

5 Managed Care Figure 2: 28 States & DC Are Expanding Medicaid Eligibility; Others May Decide to Expand Source: Avalere State Reforms Insights, Updated January 27, 2015 Denotes states using or pursuing premium assistance models with exchange plans for parts of their expansion populations: AR and IA have received waiver approval and enrolled beneficiaries; NH plans to move newly eligible beneficiaries into premium assistance in 2016, pending waiver approval. Governors in TN and UT have been in active negotiations on waiver terms with CMS for their expansion plans; each plan still needs to pass its state legislature and gain official waiver approval before it can be implemented. Will Expand (28+DC) Will Not Expand (16) States to Watch (6) Specialty Drug Costs / The emergence of Sovaldi, and a range of other high-cost breakthrough therapies, has caused concern among the health plans about the growth trajectory of specialty products. Questions remain around how to anticipate and subsequently price for these products in a timely manner. Some states and plans have adopted strict utilization management techniques. Plans continue to explore innovative quality-based contracting, and other mechanisms to manage those costs. Biosimilars have the potential to start to change the pharmaceutical landscape in 2015. Most of the large-branded pharmaceutical companies have adopted strategies to handle these markets, and the FDA is making progress. With the first approval and launch likely in 2015, the U.S. market will start to have its first practical experience with these therapies. Want to learn more? Contact Lindy Hinman at 202-251-9657 or LHinman@avalere.com

6 Industry Outlook 2015 Providers Key Trends Alternative Payment Models Will Drive Dynamic Transfer of Risk / Figure 3: Integrated Customer Systems Managing Shared Risk Providers will increasingly test their ability to bear risk in 2015. CMS has set concrete goals and a specific timeline to tie an increasing proportion of Medicare fee-for-service (FFS) payments to quality or value across the next four years. This commitment by CMS will spur increased activity among Medicaid and commercial plans toward increased value-based models. Today/Future Payment Regardless of the risk arrangement, health plans may consider oversight programs to ensure contracted providers manage risk appropriately, and may develop mechanisms to pursue performance-based contracting to ensure performance year over year. That said, Avalere expects providers will continue to vary in their readiness as well as their willingness to participate and accept risk in alternative payment models. (See figure 3.) Employer Technology / Protocols Physician Consumer Cost Choice Pharmacy Insurance Hospital Government Transparency

7 Providers Accountable Care Organizations / Serving 7.8 million beneficiaries in 2014, Accountable Care Organizations (ACOs) represent a growing model by which providers can take on increased accountability for population health without restrictive networks. Early results from public and private sector ACOs are somewhat promising in their potential for improving quality and bending the cost curve. Additional years of experience with ACOs will indicate how well different population health accountability models perform in the coming years. In 2015, CMS is likely to provide additional flexibilities and offer opportunities to join the ACO program. Post-Acute Care / In 2014, post-acute care (PAC) represented 16.5 percent of Medicare spending and included skilled nursing facility (SNF) care, home health, inpatient rehabilitation and long-term care hospital services. In 2015, Avalere expects continued diminution of traditional FFS and expansion of managed care and alternative payment models. These trends will likely lead to lower SNF utilization on an absolute and per capita basis. PAC providers have demonstrated a willingness to participate in alternative payment models. Twenty-two percent of SNFs are now participating in the CMS bundled payment demonstration and Avalere expects most to move into the risk-bearing phase. Bundled payment models will continue to place a much higher premium on clinical efficiency and discipline, which will increase and strengthen PAC partnerships as health plans and hospitals develop narrow, high-performing PAC networks. Market Consolidation / Consolidation will continue in the provider marketplace, although it appears to be slowing as systems integrate and maximize the providers they have acquired to date. Mergers and acquisitions both of other hospitals and medical practices place health plans in challenging negotiating positions, leading to upward pressure on provider reimbursement and member premiums. Particularly in already concentrated markets, consolidation could threaten the ability of health plans to tailor narrow networks, or place higher cost systems in a non-preferred tier. Want to learn more? Contact Ellen Lukens at 202-459-6263 or ELukens@avalere.com Josh Seidman at 202-355-6028 or JSeidman@avalere.com

8 Industry Outlook 2015 Life Sciences Key Trends Defining Value / Policy discussions will continue to define value and incentivize innovative therapies for unment needs. The Precision Medicine and 21st Century Cures initiatives each included important elements that could significantly transform the process for developing and approving new treatments. Value determinations will be increasingly linked to cost and patient-reported outcomes (PROs). Diverse views of value across stakeholders increased pressures on life sciences companies to have robust evidence-generation strategies and engagement platforms. Avalere s 21st Century Cures Watch List Regulatory Post-Market Evidence Innovative Data Collection Patient Focus Data Access/ Transparency Funding Push Incentives e.g., vouchers Larger Pull Incentives e.g., market exclusivity expansion Shift and reduce approval/coverage burdens CMS Encourage CED FDA More surveillance responsibility Clinical trial recruitment strategies Health IT and interoperability Privacy concerns IRB reform Expansion of PDUFA V PFDD Program Clarity on development and use of PROs in labels Clinical data transparency Medicare payment transparency Encourage 21st Century Surveillance

9 Life Sciences Evolving Payer & Provider Landscape / The life sciences industry is re-envisioning what market access means in light of changing payment models, the incorporation of performance measures, the increasing role of coinsurance for patients, and the emergence of clinical pathways. Market trends suggest increasing cost-shifting to patients, the use of narrow networks, as well as expanded use of specialty tiers in formulary design. The growing use of performance measures tied to provider reimbursement and the shifting nature of decision-making through integrated delivery networks is changing the nature of market access, requiring targeted outreach and focused value messages. Additionally, life sciences companies are incorporating market access considerations earlier in product development to ensure research and development efforts optimize success at launch. Evidence Generation & Communication / Life sciences companies are aligning their research to address the needs of a growing universe of stakeholders as regulators, payers, physicians, patients, and others play a role in determining value. The industry continues to look to the FDA for clarity in standards for evidence communication to support greater discussions on the value of products. The use of real-world evidence (RWE) for regulatory and reimbursement purposes will continue to be refined and expanded. Lastly, evidence will increasingly be generated by more stakeholders including payers, professional societies, and international entities. Want to learn more? Contact Tanisha Carino at 202-207-3677 or TCarino@avalere.com Patient Engagement / Patient engagement continues as a prevailing trend in healthcare, from drug development and approval to provider payment and consumerism. This begins with the greater involvement of patients in the development of new therapies and continues with growing emphasis on individual decision-making and cost sharing. Life sciences companies recognize that patient input earlier in their evidence-development process can help strengthen product value propositions. Additionally, providers and plans continue to seek greater partnerships with life sciences companies to support patient engagement efforts through disease education, adherence programs, and shared decisionmaking tools. Patient engagement is also being facilitated by programs such as FDA s Patient-Focused Drug Development (PFDD) initiative. The industry and the FDA appreciate the importance of the patient voice in the drug development process and are attempting to gather patient feedback in multiple disease areas. However, it is unclear how information gathered from patients and patient advocacy groups will be used by FDA in the review process. Moreover, PROs are becoming an increasingly important component of the healthcare system given the rise of new payment and delivery models that rely on good definitions of value and, therefore, must ensure patient perceptions of that value are measured.

About Us is a strategic advisory company whose core purpose is to create innovative solutions to complex healthcare problems. Based in Washington, D.C., the firm delivers actionable insights, business intelligence, strategic communications, and custom analytics for leaders in healthcare business and policy. Avalere s experts span 250 staff drawn from Fortune 500 healthcare companies, the federal government (e.g., CMS, OMB, CBO and the Congress), top consultancies, and nonprofits. The firm offers deep substance on the full range of healthcare business issues affecting the Fortune 500 healthcare companies. Avalere s focus on strategy is supported by a rigorous, in-house analytic research group that uses public and private data to generate quantitative insight. Through events, publications, and interactive programs, Avalere insights are accessible to a broad range of customers. For more information, visit avalere.com, or follow us on Twitter @avalerehealth. Contact Us 1350 Connecticut Ave, NW Suite 900 Washington, DC 20036 Fax 202.467.4455 www.avalere.com Leila Nowroozi 202.207.3829 LNowroozi@avalere.com