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Health Care Current: May 31, 2016

Collaboration at every level: Solving the country’s opioid crisis

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.

Collaboration at every level: Solving the country’s opioid crisis

“Ridding our communities of substance misuse and addiction will take more than one bill, or one budget, or one program... It’s going to require constant aggressive teamwork from Beacon Hill to our communities.”1

Governor Charlie Baker said these words as he signed comprehensive opioid legislation into law for Massachusetts in March 2016. The sentiment, however, holds true across the country. While my home state is one of many states taking steps to treat, educate about, and prevent opioid abuse, no one solution exists to this crisis that is consuming the nation. It is an issue that should be more personal than it is political. Opioid abuse impacts nearly every state, city, neighborhood, and family in the country.

The numbers are staggering. Drug overdose is now the leading cause of accidental death in the US, ahead of car accidents and suicide, and claimed 47,055 lives in 2014 alone.2 Six in 10 of these deaths involved some type of opioid, including both prescription drugs and heroin. To put this into perspective, since 2000, the rate of overdose deaths involving opioids has more than doubled; it grew from 6.2 deaths per 100,000 Americans in 2000 to 14.7 per 100,000 in 2014.3

But, it is more complicated than that. Three out of four Americans who are addicted to heroin were introduced to opioids through prescription drugs.4 This linkage adds to the complexity of the problem, as heroin use and opioid abuse impact different geographies, age groups, and genders, and deserve different approaches.

This problem has directly impacted organizations across the health care system as they struggle to manage the staggering costs. In 2012, the cost of inpatient hospitalizations related to opioid abuse reached $15 billion.5 This figure has nearly quadrupled since 2002.

Similar to addiction treatment and recovery, the solution to this crisis will not be a one-size-fits all strategy and will require options and specialized intervention from many different groups. To solve this problem, we need to coordinate across the ecosystem – from state and federal government agencies to health plans, health care providers, and life sciences companies.

It is going to take all hands on deck to reverse the trend.

For state government agencies, the first step is acknowledging that this is not a regional issue but rather a nationwide problem and should be a legislative priority in each state. States can play a role in increasing access to treatment options via public insurance programs, developing harm reduction strategies that include broader administration of Naloxone – the medication used to block the effects of opioids and prevent overdose – and investing in social programs that focus on prevention. States can also use their regulatory authority in the form of Medicaid demonstration waivers to tailor service delivery to meet their population’s treatment needs. The recent legislation in Massachusetts, for example, mandates a seven-day limit on opioids prescribed for the first time and also creates funding for addiction screening for both middle and high school students.

The federal government should lead by example. Federal agencies such as the US Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA) can collaborate on the guidelines and education materials that they are developing. A sign of this in action is the recent CDC guidelines for prescribing opioids for chronic pain.6 There also is a role for the US Food and Drug Administration (FDA) in labeling regulations, prescriber and patient education, and furthering the development of new abuse-deterrent opioids. FDA is already noting this, as in late March, it announced labeling changes to help warn consumers about misuse, abuse, addiction, overdose, and death related to opioid medications.7

Health plans, hospitals, and life sciences companies must also continue in the fight. Health care providers should be aware of their role in the problem and get up to speed on prescribing strategies, non-opioid pain medications, and combination therapies. Emergency department (ED) physicians need to reinforce their role as the first line of defense and better connect at-risk patients with public health and/or state agencies for support. Based upon recent data indicating that the number of opioid prescriptions in the US is falling, this work may already be underway.8

Health plans can play a role in helping the health care system deliver some of these alternative treatment plans. By taking a forward-thinking approach, health plans could change their coverage and reimbursement structures to encourage the use of combination therapies and pain management alternatives. In Massachusetts, Blue Cross Blue Shield of Massachusetts (BCBSMA) tackled this issue head-on, creating a Pain Medication Safety Program that requires prior authorizations for short and long-acting opioid prescriptions and imposes checks and balances between physicians and pharmacists to identify and curb multiple prescriptions.9

Finally, as more life sciences companies share this proactive, forward-thinking approach, these organizations can be instrumental in developing new opioid antagonists to the market to help reverse the trend.

We all need to work together to tackle this epidemic and correct the course. There is a role for each and every one of us to combat the opioid abuse crisis in this country and to intervene, heal, and prevent. But, it is going to take all hands on deck.

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My Take

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


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CMS announces CPC+ACO option for physician practices

Last Friday, May 27, 2016, the US Centers for Medicare and Medicaid Services (CMS) announced that it would allow no more than 1,500 physician practices to dually participate in the Comprehensive Primary Care Plus (CPC+) program and the Medicare Shared Savings Program (MSSP). The announcement comes after Farzad Mostashari, Bob Kocher, and Mark McClellan wrote in The Evidence Base that creating a the Comprehensive Primary Care Plus Accountable Care Organization (CPC+ACO) model could encourage more small physician practices to adopt alternative payment models and lower total costs of care. They wrote that a combined CPC+ACO option could offer monthly management fees with incentives to lower health care costs and reduce the likelihood that primary care practices would leave the MSSP (see the May 17, 2016 Health Care Current).

Under the CPC+ model, CMS will test two alternative payment models for primary care management with approximately 5,000 physician practices starting in January 2017. Primary care practices can select from two tracks. The authors said that many primary care physician groups might exit the MSSP for CPC+ if faced with choosing between the two. Notably, clinicians that participate in CPC+ would qualify for Advanced Alternative Payment Model (APM) incentive payments under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) proposed rule that was published in early May (see the May 3, 2016 Health Care Current).

(Source: Farzad Mostashari, Bob Kocher, and Mark McClellan, The Evidence Base, “A Comprehensive Strategy for Primary Care Payment Reform in Medicare,” May 9, 2016)

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Implementation & Adoption

NYT: Opioid prescriptions have declined over the past three years

Despite the increasing rate of overdose deaths involving opioids in the US, some data suggest that the tides may be shifting. A recent New York Times review of several sources found that between 2013 and 2015 the number of opioid prescriptions in the US declined.

  • IMS Health reported a 12 percent decline in the number of prescriptions since 2013
  • Symphony Health Solutions reported an 18 percent decline during the same time period; beginning in 2013, the number of these prescriptions began to decline in 49 out of 50 states.

Federal warnings and prescribing guidelines may be working, and providers may be changing their behavior. As an example, state prescription drug monitoring programs (PDMPs) are cited as a potential cause for the decline in the number of prescriptions in Tennessee. After the state made checking the PDMP database mandatory for health care professionals in 2013, it saw a 14 percent decline from 2012 to 2015. Also, many medical schools have incorporated education on the dangers of prescribing opioids into their programs. While the current number of opioid prescriptions in the US may still be high, PDMPs, medical education, and other factors may continue to contribute to their decline.

(Source: Abby Goodnough and Sabrina Tavernise, New York Times, “Opioid Prescriptions Drop for First Time in Two Decades,” May 20, 2016)

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Study: Medicare Advantage enrollees less likely to die in a hospital than individuals in traditional Medicare

A recent study found that people who are continuously enrolled in Medicare Advantage are less likely to die in a hospital than people continuously enrolled in Medicare fee-for-service. Researchers analyzed differences in the location of death (e.g., hospital, home) and found that:

  • Medicare Advantage enrollees were 43 percent less likely to die in a hospital 
  • Medicare Advantage enrollees with cancer were nearly 80 percent less likely to die in a hospital 
  • Higher wealth and education are associated with increased hospice use and reduced odds for dying in hospital

The study was conducted using data on Medicare beneficiaries from the Health and Retirement Study who died between 2008 and 2010.

Analysis: Financial incentives in Medicare Advantage may be one of the reasons why the odds of dying in a hospital are lower for enrollees. Hospice care is carved out of Medicare Advantage, so health plans are not responsible for enrollees’ costs once they enroll in hospice care. Once beneficiaries are admitted into hospice care, Medicare Part A is responsible for the costs. This policy may encourage health plans to promote hospice care.

(Source: Elizabeth Edmiston Chen and Edward Alan Miller, Research on Aging, “A Longitudinal Analysis of Site of Death: The Effects of Continuous Enrollment in Medicare Advantage Versus Conventional Medicare,” May 2016)

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Survey: Many ACOs would drop from MSSP if required to share in losses for MACRA incentive payments

The National Association of Accountable Care Organizations (NAACOS) surveyed 144 ACOs from 40 states and found that many are concerned about not qualifying for Advanced APM incentive payments under MACRA. The survey collected information about ACOs’ operating costs, willingness to accept downside financial risk (risk for financial losses), and what effects they were expecting from MACRA.

In order to qualify as an Advanced APM under MACRA, participating ACOs must assume more than nominal financial risk. The “nominal risk” definition CMS proposed includes downside risk, which is when organizations are responsible for a share of losses when expenditures exceed an established benchmark. Track 1 of MSSP does not require organizations to share in downside risk, and therefore does not qualify as an Advanced APM. In order to receive the Advanced APM bonus, which is 5 percent starting in 2019, MSSP would have to require participating ACOs to accept downside financial risk.

NAACOS asked ACOs about this issue. More than half (56 percent) of the respondents reported that they would likely not continue with MSSP if they were not eligible for the 5 percent Advanced APM bonus. Forty-three percent reported that they would likely not continue in MSSP if they were required to share losses in order to qualify for the 5 percent bonus payment.

84 percent of ACOs surveyed say that they would be ready and willing to share losses or participate in a payment model with downside risk within 6 years; 44 percent say they would be ready in one-to-three years. The respondents estimate that the start-up operational costs for an ACO averages $1.6 million.

NAACOS says that CMS should add more flexibility to Advanced APM qualifying pathways or reconsider the standards and timeline for risk assumption to better support participation from ACOs in today’s CMS programs.

Related: MACRA established Advanced APMs and the Merit-Based Incentive Payment System (MIPS). Both options change how clinicians are paid, intending to improve the way care is delivered, make performance data more available, and increase information sharing through certified electronic health record (EHR) technology (see the May 3, 2016 Health Care Current).

(Source: National Association of Accountable Care Organizations, “ACO Cost and MACRA Implementation Survey” May 2016)

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The Office of Civil Rights clarifies how new nondiscrimination rule applies to ERISA plans

Last week, the US Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) clarified how the Affordable Care Act’s (ACA) anti-discrimination provision applies to self-funded employers that use third-party administrators (TPAs). OCR says that TPAs will be covered by the rule, but that self-insured employer groups will not. This rule reduces the potential for an employer to be held responsible if a TPA violates the anti-discrimination provision.

Employers who self-fund their health plans, and therefore assume the financial risk of providing health care benefits to their employees, are governed by the Employee Retirement Income Security Act of 1974 (ERISA). ERISA gives employers the authority to design their benefits packages. Many employers hire TPAs to handle claims.

In clarifying the provision, OCR states that the rule does extend to TPA companies, but not to the employer that hired that TPA. OCR has the authority to decide whether any alleged discrimination in an ERISA plan is occurring at the administration level or in the plan design itself and will take action if it is determined to be an issue of administration. The Equal Employment Opportunity Commission (EEOC) will continue to have jurisdiction over anti-discrimination provisions for the benefit design of ERISA plans.

Background: HHS issued the final rule on May 13, 2016. It prohibits discrimination against any individual on the basis of race, color, nationality, sex, age, or disability. The rule is effective July 18, 2016 and prohibits discrimination in:

  • Any health program or activity, any part of which is receiving federal financial assistance, including credits, subsidies, or contracts of insurance
  • Any program or activity that is administered by an Executive Agency
  • Any entity established under Title I of the ACA

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On the Hill & In the Courts

FDA draft guidance promotes EHR interoperability, in support of clinical investigations

This month, the FDA issued draft guidance for the use of data from EHRs in clinical investigations and medical research. The FDA clarifies expectations for using EHRs as a data source in clinical investigations of medical products so that the FDA will accept the data as evidence in decision-making when it reviews manufacturers’ applications for product approval.

The agency provides the following preliminary recommendations:

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Survey: Fewer people failing to get needed medical care due to cost

CDC reports that fewer people are having trouble accessing medical care because of cost issues. The National Center for Health Statistics (NCHS) (part of the CDC) bases this statement on 15 health measures from its 2015 National Health Interview Survey (NHIS).

The percentage of people who failed to obtain medical care due to cost decreased from 2010 to 2015 (6.9 percent to 4.5 percent). In 2015, adults age 18-64 were more likely than children under age 18 and adults 65 and older to have failed to obtain needed medical care due to cost. Additionally, African Americans and Hispanics were more likely than Whites to have failed to obtain needed medical care due to cost.

The analysis also revealed that the number of people uninsured in 2015 was lower than in 2010 (28.6 vs. 48.6 million) (see the May 24, 2016 Health Care Current).

(Source: CDC, National Center for Health Statistics, National Health Interview Survey, 2015)

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Around the Country

Machine learning and predictive analytics speeds diagnoses

With headlines about Zika and Ebola getting the public’s attention, speed and efficiency are critical in diagnosing an infectious disease. Traditionally, physicians have to go through a long list of symptoms to rule out everything from influenza to an allergic reaction, but machine learning is advancing techniques and helping physicians make more accurate, timely diagnoses. Machine learning is a type of artificial intelligence (AI) that provides computers with the ability to learn without being explicitly programmed. It is similar to data mining in that both processes search through to data to identify patterns. But, instead of extracting data for humans to understand, the computers use the data to detect patterns and adjust analysis accordingly.

Machine learning is enabling real-time, automated, infectious disease detection and diagnosis through analyzing data from electronic health records, nursing triage forms, and lab results to quickly alert physicians of possible or confirmed cases of many illnesses. Some machine learning systems are able to geographically map where disease outbreaks have occurred, a useful tool for public health officials in containing an outbreak.

Some hospitals, including NorthShore University HealthSystem, Northwestern Memorial Hospital, and Loyola University Medical Center, are using machine learning for faster diagnosis and to predict what patients in the emergency room will likely need hospitalization. UPMC has its own model that merges predictive analytics with claims and local demographic data to help identify which patients are likely to show up in the emergency department in the near future.

Analysis: Machine learning is helping transform health care by automating tasks and enabling health care systems to better predict and prevent future risks. Improving the accuracy and timeliness of diagnoses and potentially improving population health by identifying illness and patterns of behavior are ways that machine learning is aiding in analysis and interventions. In the last several years, interest in machine learning and other types of AI has surged. Venture capital investments in companies developing and commercializing AI-related products and technology are growing, and global investments reached an estimated $55 billion in 2015. The future of machine learning in health care will likely move to the consumer in the form of mobile apps that can diagnose certain conditions, such as skin conditions or insect bites, by analyzing digital photos.

(Sources: David Schatsky, “Machine learning is going mobile,” Deloitte Insights, April 2016; Nathan Benaich, “Investing in Artificial Intelligence,” Tech Crunch, December, 2015)

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Breaking Boundaries

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