Health Care Current: August 30, 2016

Medicaid final rule defines the future of LTSS

This weekly series explores breaking news and developments in the US health care industry, examines key issues facing life sciences and health care companies and provides updates and insights on policy, regulatory, and legislative changes.

Medicaid final rule defines the future of LTSS

Arizona was the last state to enter into the Medicaid program, which it did in 1982.1 Shortly after, it became the first state to establish a mandatory, statewide Medicaid managed care program.2 Establishing the Arizona Long Term Care System (ALTCS) in 1989, Arizona moved all long-term services and supports (LTSS) under managed care. More recently, managed LTSS (MLTSS) in Arizona has grown from approximately 39,000 enrollees in 20043 to over 58,000 in 2016.4

New Jersey, a state that launched MLTSS more recently in 2014, has already made significant progress in expanding the program’s reach. Specifically, New Jersey’s MLTSS program, part of its statewide managed care program NJ Family Care, started by integrating care for the state’s dually eligible Medicare and Medicaid population and has since expanded to include both nursing facility and home-and-community-based services (HCBS).5

Iowa is an even more recent example of a state that made the switch to MLTSS. Effective in January 2016, Iowa moved from primarily Medicaid fee-for-service (FFS) management of LTSS, behavioral health, and complex populations to IA Health Link, a fully-integrated managed care program that integrates HCBS waiver, behavioral health, and acute/physical services for all populations. IA Health Link had 604,664 members enrolled as of May 2016.6

Arizona, New Jersey, and Iowa are just three examples of the growth we’ve seen in MLTSS. Currently, 26 states are in various stages of implementing MLTSS programs,7 and MLTSS enrollment grew by 175 percent from 2013 to 2014.8 But, as interest in moving LTSS programs under managed care has grown, so has the federal government’s interest in ensuring these services are cost effective and high quality.

The growth in MLTSS programs prompted the Centers for Medicare and Medicaid Services (CMS) to issue consumer-centric, quality-focused guidance on the topic. The Medicaid managed care final rule issued in April 2016 is CMS’ first major update to this program in more than a decade (since 2002). It reflects program modernization based on years of policy development. For the first time, the rule includes guidance specific to MLTSS and discusses the expanding role for HCBS.9 The rule gives states more flexibility in program design and administration, emphasizes person-centered processes, and strengthens the need for health plans – or managed care organizations – and states to work together.

The issue of quality is front and center in the new regulations. The rule requires states to establish quality assessment and performance improvement programs, a state quality strategy, and a CMS-defined managed care quality rating system aligned with Qualified Health Plan (QHP) quality ratings. As a result, states will need to rank their managed care programs, including MLTSS plans, based on quality scores and publish these rankings on a regular basis. These new regulations impact states, health plans, and providers, and emphasize the need for these stakeholders to synergize how they achieve these evolving requirements.

The Medicaid population has complex needs and requires coordination between physical health, behavioral health, and long-term care providers. These groups may not have previously worked together within traditional models. Indeed, most long-term care providers, for example, mental health providers and providers that support persons with disabilities (both intellectual and physical), operate solely in Medicaid FFS so may not be as familiar with health plans. States are now tasked with monitoring quality and consumer choice in managed care in a way that is data driven, transparent, and cost and quality conscious. A lot of this work will be breaking new ground.

The final rule poses several challenges. Even today, many providers have limited and/or no electronic health records (EHRs), which limits clinical data collection, sharing, and care coordination capabilities. Many states have resource challenges, limited staff capacity and need training and targeted technical assistance.

But the paramount challenge is collecting data for quality measurement and reporting in an MLTSS/community setting. LTSS quality measures are generally not as well developed as those for acute care; no consistent, widely-accepted LTSS quality metrics exist yet. But, work is continuing in this area, and states, health plans, providers, members, and advocates can collaborate to measure outcomes better. These stakeholders should develop MLTSS quality measures that both capture care integration and align with measures and requirements in a state’s existing programs for external quality review, Medicaid waivers, CMS demonstration programs, and value-based care initiatives. Ideally, measures should be meaningful yet not be unduly burdensome for those who need to report the information.

States that are pursuing a full-risk approach to MLTSS will require a more complex, strategic plan to effectively coordinate integrated care models, data collection and sharing, plan oversight and measurement, and payment across long-term, physical and behavioral health benefits. These states, with guidance provided by the Medicaid managed care rule, may have an opportunity to leverage their broader Medicaid Managed Care Quality Strategy to increase quality and reduce growth in the cost of care. For example:

  • Providing incentives to health systems to reduce preventable readmissions
  • Encouraging health plans to invest in health information technology, including telehealth, to expand access
  • Aligning program quality measures with interventions that improve clinical outcomes, including improving individual’s ability to function, and that address social determinants of health

As MLTSS expands through full-risk or partial-risk capitated contracts, states and health plans are collaborating to develop models of care for the community setting that have enormous potential. Arizona, for example, is leveraging its relationships with the state’s health plans to use its Elderly and Physically Disabled program contracts to expand value-based purchasing (VBP) efforts – contracts that have had shared-savings requirements in place since 2012.10 This example of aligning an MLTSS program with broader VBP initiatives could produce quality improvement in service delivery while keeping both health plans and providers in mind.

States are at different stages of transformation. Care coordination within community settings is imperative for states, health plans, and MLTSS providers. While technology needs to catch up to help better manage this population, the building blocks are in place and states are motivated to get to the next level of LTSS delivery.

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1National Association of Medicaid Directors, Arizona Long Term Care System (ALTCS) Overview
2CMS, Managed Care in Arizona
3Paul Saucier, Jessica Kasten, Brian Burwell, Lisa Gold, The Growth of Managed Long-Term Services and Supports (MLTSS) Programs: A 2012 Update, July 2012
4Arizona Health Care Cost Containment System, AHCCS Population Highlights, August 2016
5Paul Saucier, Jessica Kasten, Brian Burwell, Lisa Gold, The Growth of Managed Long-Term Services and Supports (MLTSS) Programs: A 2012 Update, July 2012
6Iowa Department of Human Services, Iowa Health Link Managed Care Report: May 2016 Performance Data, July 26, 2016
7National Association of States United for Aging and Disability, State Medicaid Integration Tracker, June 10, 2016
8CMS, Medicaid Managed Care Enrollment and Program Characteristics, 2014
9CMS, Medicaid Managed Long Term Services and Supports (MLTSS)
10Brianna Ensslin and Alexandra Kruse, Center for Health Care Strategies, State Trends in the Delivery of Medicaid Long-Term Services and Supports, July 2016

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My Take

By Mark Price, Principal, US Public Sector Leader, Deloitte Consulting LLP


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CMS: ACOs reduced costs and improved care in 2015

The Performance Year Quality and Financial Results for Medicare Accountable Care Organizations (ACOs), published by CMS last week, show that ACOs saved the Medicare program more than $466 million in 2015. The data are from the more than 400 participating ACOs, including 12 Pioneer Model participants, and 392 Medicare Shared Savings Program (MSSP) participants. Of these participants, 125 qualified for shared savings payments by meeting quality and savings goals.

CMS says that, since the Medicare ACO programs started in 2012, they have generated over $1.29 billion in Medicare savings. Organizations continue to improve quality performance over time: 84 percent of MSSP organizations had better quality-of-care measures in 2015 than in 2014. Improvement was 15 percent or more for four preventive care measures – screening for risk of future falls, depression screening and follow up, blood pressure screening and follow up, and providing pneumonia vaccinations.

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Implementation & Adoption

HIMSS survey: Increased cybersecurity is highest priority; personnel and finances are biggest challenges

Due to recent high-profile breaches and ransomware attacks, securing health information is a top focus of health care providers, according to the 2016 Healthcare Information and Management Systems Society (HIMSS) Cybersecurity Study. The survey found that 85 percent of health care providers have made health information security an elevated business priority over the past year.

The 2016 HIMSS Cybersecurity Study surveyed information security leaders at health care providers about cybersecurity challenges. The top two: lack of appropriate cybersecurity personnel and lack of financial resources.

Ransomware is the biggest cybersecurity concern for 69 percent of surveyed health care providers. Other threats include phishing attacks and advanced persistent threat attacks. Cybersecurity vulnerabilities can come from email, mobile devices, and the internet of things (IoT). Most respondents believe the most common reason for attacking health information is for medical identify theft.

Acute and non-acute providers differ in their concerns about cybersecurity in some ways. For example, 87 percent of acute providers and 81 percent of non-acute providers made information security the highest business priority the past year. Other differences were reported among barriers to cybersecurity and motivating factors for increased cybersecurity efforts. Non-acute providers are more likely to cite personnel and financial resources as barriers and more likely to invest in cyber due to proactive (e.g., performed a risk assessment) rather than reactive reasons (e.g., phishing attack or virus/malware issue).

(Source: 2016 HIMSS Cyber Security Survey)

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Survey: More than half of Americans would participate in the Precision Medicine initiative

More than half (54 percent) of Americans would participate in the Precision Medicine Initiative Cohort Program (PMI-CP), according to a recent nationally representative survey done by researchers at the National Institutes of Health (NIH). Nearly eight in 10 said they support the program.

NIH aims to enroll more than 1 million individuals in the PMI-CP in the next four years. The President announced the initiative in January 2015, and funding for it was included in the spending bill that passed last year. The mission of the PMI-CP is to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized treatments. Precision medicine offers the potential for more targeted therapies and reduced adverse events.

The survey also looked at willingness to share specific types of information, opinions about incentives, and engagement with the researchers. Additional findings include:

Analysis: According to a recent article, The next frontier of patient-centered care, there are a number of reasons why the timing is right for the PMI-CP. Perhaps most importantly, patients appear ready for better and more treatments and cures. Others include the ongoing shift from a volume-based system to one that is based on value, the health information technology revolution that has led to major reductions in the cost of storing data and increases in analytical capabilities, and the widespread adoption of EHRs.

(Source: David J. Kaufman, Rebecca Baker, Lauren C. Milner, Stephanie Devaney, Kathy L. Hudson, “A Survey of US Adults’ Opinions about Conduct of a Nationwide Precision Medicine Initiative Cohort Study of Genes and Environment,” PLOS ONE, August 17, 2016)

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Patients’ ability to self-manage health linked to lower risk of chronic disease, hospitalizations

A new study from the Journal of Health Services Research found that confident, self-assured patients were less likely to develop a chronic disease, visit the emergency department (ED), or be hospitalized for an avoidable condition compared with those who were overwhelmed by their own care management. In the retrospective study, researchers reviewed electronic health records (EHRs) for approximately 98,000 adults at Fairview Health Services between 2011 and 2014. Key to the study was patients’ Patient Activation Measure (PAM) score, which gives patients a score of 0 to 100 based on their “activation” level in key areas (e.g., self-confidence in navigating the health care system and engaging with their care). Researchers sorted patients into activation levels between 1 and 4, with 1 being the lowest level of self-management and confidence and 4 being the highest.

Patients with poorer self-management skills (lower activation scores) showed a higher prevalence of chronic conditions, ED visits, and hospitalizations due to chronic conditions.

In the first year of the study, patients with the lowest activation scores were 62 percent more likely to have an avoidable hospitalization than those with the highest scores. Researchers found that this trend continued for several years, finding a 40 percent difference between the groups in the second year, and a 30 percent difference after three years.

The researchers concluded that a patient’s activation score can help predict a patient’s future risk of developing a chronic disease, needing expensive, avoidable medical services, and experiencing a decreased quality of life. By identifying patients with limited self-management skills early, health care providers may be able to apply targeted behavioral interventions through patient support and coordination to improve patient outcomes and reduce costs.

(Source: J. H. Hibbard, J. Greene, R. Sacks et al., “Improving Population Health Management Strategies: Identifying Patients Who Are More Likely to Be Users of Avoidable Costly Care and Those More Likely to Develop a New Chronic Disease,” Health Services Research, Aug. 23, 2016)

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Industry, FDA reach agreement on MDUFA goals

Last week, the US Food and Drug Administration (FDA) reached a preliminary agreement with the medical device industry and laboratory community for the fourth reauthorization of the Medical Device User Fee Amendments (MDUFA IV). The agreement would authorize the FDA to collect $999.5 million in user fees, plus adjustments for inflation from fiscal year (FY) 2017 to FY2022 under MDUFA IV. This agreement also lays out the agency and stakeholder priorities, which are to:

The current version of MDUFA, which expires in 2017, authorized the FDA to collect $595 million in user fees. The FDA says the increased amount will help it exceed the performance goals of MDUFA III. The agency reports that individual application fees will be lower and expects higher volume of applications to continue.

Many stakeholders support the current proposal. In a joint statement, Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association (MDMA), and the Medical Imaging & Technology Alliance (MITA) said that the agreement benefits the FDA, medical device innovators, and patients, and that the proposed enhancements to the review process in the agreement would empower the industry to develop cures and therapies to improve patient care.

Background: MDUFA, which is up for its fourth reauthorization, extends the scope of the Prescription User Fee Act (PDUFA) to include medical devices and clinical technologies. The amendments provide the medical device industry with guidance and support through the FDA approval process. In exchange for a clear pathway and agency support, the industry agrees to pay user fees when submitting an application for approval (see the August 9, 2016 Health Care Current).

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On the Hill & In the Courts

HHS identifies key barriers to expanding telehealth services

HHS sent Congress its report on federal telehealth policy. The report, prepared by the Office of the Assistant Secretary for Planning and Evaluation (ASPE), focuses on how delivery system reform and payment models that emphasize value over volume can improve quality of care and health outcomes and encourage greater efficiency and coordination.

Traditionally, Medicare payment for telehealth services has been limited to rural areas or Health Professional Shortage Areas (HPSAs), and Medicare payments for telehealth services have been relatively small ($14.4 million or 0.01 percent of total health care spending). However, some new programs and pilots are allowing greater flexibility in payment and coverage. As one example, HHS discusses the Next Generation Accountable Care Organization (ACO) program, which removes existing telehealth restrictions and allows beneficiaries to receive telehealth services regardless of where they live.

Widespread telehealth adoption faces several other policy challenges and market limitations:

Analysis: In a recent health policy brief, Realizing the potential of telehealth, Deloitte discusses how federal policy and payments for services are slowly catching up to the demand for telehealth. Payment, competition, licensure, and other issues have been barriers for many providers. As a result, telehealth has been primarily used by integrated delivery systems and government health services where the business model makes sense. However, some new drivers of adoption are the expansion of value-based payment models and the rise of consumerism.

(Source: HHS, “Report to Congress: E-health and Telemedicine,” August 12, 2016)

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CBO report: Health care spending continues to be a major driver of the federal deficit

Last week, the Congressional Budget Office (CBO) published an update on the economic outlook for the next decade. According to the report, health care spending is a contributor to the increasing federal deficit. CBO says the major factors leading to higher health care spending by the government are an aging population and rising prescription drug costs. The deficit was 2.4 percent of gross domestic product (GDP) in 2015 and is expected to rise to 3.2 percent by the end of this fiscal year. The CBO projects the deficit will grow over the next decade and reach 4.6 percent of the GDP by 2026.

The CBO says the majority of spending increases come from mandatory programs, specifically Social Security and government health programs. Health programs include Medicare, Medicaid, the Children's Health Insurance Program (CHIP) and premium tax credits (PTC) for health plans purchased through federal or state based exchanges. The CBO projects that outlays for the major health care programs will be $15.5 trillion, cumulatively, over the next decade. However, this projection is a small decrease from CBO’s estimates in March 2016 ($15.56 trillion) and in January 2016 ($15.61 trillion).

Federal outlays for major health care programs are expected to increase by 6 percent, or $55 billion, in 2016. Medicare outlays represent over half of the increase. Prescription drug spending is expected to increase 15 percent in 2016.

Medicare, Medicaid, and Social Security spending on people age 65 and older is expected to increase until 2026, at which point it will represent 40 percent of all federal non-interest spending.

The CBO also noted that the growth in health care spending had slowed significantly in recent years, with increases at their lowest point in recent decades.

(Source: Congressional Budget Office, “An Update to the Budget and Economic Outlook: 2016 to 2026,” August 2016)

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White House reminds governors about resource for opioid crisis: free training on medication-assisted treatment

Earlier this month, the White House wrote governors to emphasize the need for and availability of medication-assisted treatment (MAT) training for physicians. In the letter, Michael Botticelli, Director of National Drug Control Policy, said that the Administration is offering free MAT trainings for physicians across the country, including use of buprenorphine – an FDA-approved medication that helps promote long-term recovery for patients with opioid or heroin addictions.

According to the letter, 1,489 counties in the US lacked at least one physician certified to administer the treatment as of February 2016. The strongest need for these treatments is in rural areas of the country, areas targeted by the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver program. The program, operated by the Drug Enforcement Administration (DEA), certifies physicians to administer buprenorphine.

Related: As discussed in a recent Deloitte Insights publication from the Deloitte Center for Government Insights, Fighting the opioid crisis: An ecosystem approach to a wicked problem, government agencies can join forces with innovators, technologists, and experts beyond traditional stakeholder groups by incorporating “ecosystem” principles into their strategies. The DATA 2000 waiver program is one example of a federal effort to combat the opioid crisis in the country.

The publication discusses five common elements in effective ecosystem interventions to the opioid crisis:

  • Engage a broad community of “wavemakers” to innovate, convene, and fund its own solutions 
  • Establish an ecosystem integrator to “hold the whole” and create the space for aligned action by others
  • Attack the problem with a portfolio of interventions
  • Create an innovation engine to drive ideas for solutions that upend the problem (e.g., prized-based challenges, pay for success, and advanced analytics) 
  • Develop solutions embedded in well-functioning markets

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Around the Country

CMS to pilot network rating system for health plans in six states

Last week, CMS said that it plans to pilot ratings of health plan networks in six states that will use the federal exchange in 2017, scaling it back from initial plans to do this for all qualified health plans (QHPs) sold on The CMS pilot will rate QHP provider networks as “basic,” “standard,” or “broad” based on yet-to-be-released classifications. If the pilot is successful and useful for consumers, CMS will rate all QHPs in the future.

Industry analysts say that CMS may have scaled the pilot back over concerns about how to properly compare provider networks in areas with limited competition. CMS needs data from multiple plans in order to rank and compare them within an area.

CMS has not announced the states where the pilot will take place but has said it is likely to choose states that have QHPs with differing provider networks.

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Patient-generated data is changing the face of medical research

Researchers at Memorial Sloan Kettering Cancer Center are launching a small trial involving patient-generated data from wearables. The 40 patients all have multiple myeloma, a form of blood cancer. The patients will use wearable devices to track activity and sleep and answer survey questions focusing on quality of life measures like fatigue and appetite through a mobile app.

Pain is one of the most difficult symptoms to manage and assess in patients with multiple myeloma. The researchers believe there is a link between self-reported pain levels and activity and sleep patterns. The patients will track their sleep, activity, and self-reported quality of life for four months after wearing the device for one week to establish a baseline. The researchers are hoping to learn more about the utility of patient-generated data through mobile technology. If the trial passes the feasibility test, the team will likely expand it to other partners and types of cancer.

Many in the health care community recognize that success in cancer treatment cannot only be measured by impact on the disease, such as shrinking a tumor, but also by how patients are feeling and their quality of life. For example, the University of Pennsylvania Health System began a study last year to test wearables to monitor vital signs in cancer patients to see if the devices can improve patient experience and quality of care in the hospital. The study will determine if having patients wear the device on their arm while staying in the hospital leads to better rest and less disruption for the patient. With the device, care providers can monitor patients from a distance rather than interrupting them while they are sleeping to take vitals.

Analysis: Researchers and health care professionals are increasingly interested in using patient-reported outcomes (PROs) in clinical research and care delivery to improve quality of life and health outcomes. PROs typically include information about quality of life, symptoms (e.g., pain, nausea, energy loss, and sleep disturbances, function (disability), satisfaction with care, adherence to prescribed medications or other therapy, and perceived value of treatment.

Wearables and related mobile technologies are allowing large groups of patients to engage with each other and the health care system in new ways to share information and collect data. While consumer demand for wearables like wristbands, sports monitors, and other health monitors are driving growth, the research community, health systems, and the life sciences industry is also seeing opportunities.

Wearables are providing patient-generated health data that may foster better care and research. Health systems, clinicians, and researchers are developing ways to incorporate the benefits of these technologies to improve the quality of care.

(Sources: MobiHealthNews, “Memorial Sloan Kettering tests wearables, apps, in small cancer trial, July 21, 2016; PM Live, “Getting personal with wearable tech,” August 17, 2016).

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Breaking Boundaries

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