Health Care Current: February 16, 2016

The next frontier of patient-centered care

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.

The next frontier of patient-centered care

Many of us began 2016 with a list of New Year’s resolutions that may or may not have lapsed by now. While some of us may need motivation to get back on track to achieve whatever goals we set, the National Institutes of Health (NIH) started the year with a daunting but very exciting task—to move the Precision Medicine Initiative Cohort Program (PMI-CP) ahead by recruiting one million or more Americans to be part of this large research cohort. The initiative and its many volunteers has the potential to be the platform to expand our knowledge of precision medicine approaches that can benefit the nation. Moreover, it may even change the way we prevent and treat many of the diseases that currently have no cure.

Last fall, a Working Group Report from the Advisory Committee to the Director of the NIH, which is made up of federal government, academic, research, non-profit patient advocates, health plan, and technology companies, put forth recommendations for the PMI-CP that were approved by the NIH. The recommendations serve as a blueprint for how the NIH can assemble and recruit the cohort over the next few years and recommend that any individual living in America be allowed to volunteer. The Advisory Committee outlines mechanisms to keep the cohort of volunteers engaged over time and recommends that they have the ability to set preferences around how much of their personal information they disclose. The Committee also details data considerations, including recommending electronic health records (EHRs) be a core data set in combination with data from health plans, participant surveys, mobile health technologies, and biologic investigations. Governance structure, policy considerations, and biobanking considerations are also outlined in the recommendations.

While health care system stakeholders have been discussing “patient-centered care” for years, this is an initiative that truly puts the patient at the center. But, it will not be easy. This begs the question, “Is the US ready for an undertaking of this magnitude?”

The Advisory Committee’s report says that there are a number of reasons why the timing is right for the PMI-CP. There is widespread agreement that in health care, the status quo is not acceptable. 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 are a few examples of the current transformation happening in health care. Early adopters among health care consumers are going online, using social media, and engaging in mobile health—and the trend is growing every year.1 Other stakeholders have put increased focus on the value of patient-generated data to improve clinical research and care delivery. Perhaps most importantly, patients are ready for better and more treatments and cures.

Of course, there are challenges to overcome. Patients and consumers will likely have privacy and security concerns, and interoperability efforts are still nascent to date. It will be extremely important to communicate what the PMI-CP is, what potential it has to improve health outcomes and lead us to cures that have eluded us, and what expectations are from each stakeholder. The NIH will need to draw on the full network of health care stakeholders to overcome these challenges. Consumers and providers will be on the front lines of these efforts, and researchers, non-profit advocacy groups, government entities, policymakers, health plans, the life sciences industry, and technology companies will all have a significant role.

While it sounds daunting, I am confident that as a nation, we can make progress in 2016 and in the coming years. There are many models of diverse stakeholders coming together to share data we can draw from. For example, the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital has created an environment for stakeholders to share data to improve the way clinical trials are conducted around the world. Just last week, the Obama Administration requested $1 billion to fund the National Cancer Moonshot, an initiative to cure cancer.2 Improving data sharing and organization is a key component of the moonshot effort. Finally, we continue to see extended impact from the Human Genome Project, which demonstrated that the US is capable of achieving unprecedented milestones in sharing and analyzing vast amounts of data to benefit human health.

Now that the blueprint for the Precision Medicine Initiative Cohort Program has been set, we can continue the momentum of NIH-supported breakthroughs in basic science, clinical research, and translational medicine. The time is right for this initiative to advance the goal of getting targeted treatments and cures to patients.

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PS – For more information, contact Juergen Klenk, Principal, Deloitte Consulting LLP

Deloitte 2015 Survey of US Health Care Consumers
Office of the Press Secretary, The White House, “Fact Sheet: Investing in the National Cancer Moonshot,” February 1, 2016

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My Take

By Terri Cooper, PhD, Principal and the Federal Health Sector Leader, Deloitte Consulting, LLP


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Obama Administration budget includes funding for new Medicare and Medicaid initiatives and Precision Medicine and Cancer Moonshot programs

The White House released its proposed fiscal year (FY) 2017 budget last week and is requesting $82.8 billion in discretionary funding for the U.S. Department of Health and Human Services (HHS). This is slightly less than the $83.8 billion requested for FY2016.

Some notable requests in the administration’s health care agenda:

  • National Institutes of Health (NIH): $31.1 billion to support biomedical research at NIH; this includes $300 million to support the Precision Medicine Initiative, $755 million for the Moonshot Initiative, and $195 million for the BRAIN Initiative, which aims to find cures for disorders like Alzheimer’s, schizophrenia, autism, and more. 
  • Investments in health centers: $5.1 billion for health centers; this includes $3.75 billion in mandatory funding to serve 27 million patients.
  • Combating Antibiotic Resistant Bacteria (CARB): $1.1 billion to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria and to support research on innovative ways to reduce or manage resistance.
  • Long-Term Care Services and Supports: The budget includes an increase of $10 million to fund home- and community-based service through HHS’s Administration for Community Living, which provides supportive services such as in-home personal care, respite care, and transportation assistance.

The budget detailed savings of $242 billion over the next decade from the administration’s health care agenda. Notable among the proposals:

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Implementation & Adoption

New special enrollment period for federal exchange will give some another opportunity to apply for 2016 coverage

CMS announced last week that the agency will allow thousands of individuals previously ineligible for premium tax credits to apply for premium subsidies and sign up for a health insurance exchange plan through Approximately 43,000 individuals failed to file their 2014 tax returns and were therefore ineligible for premium tax credits to subsidize their health coverage during the 2016 open enrollment period. Without the premium subsidies, many were left unable to afford a plan. The administration is giving these individuals until March 31, 2016 to file their 2014 tax return and sign up for a plan on the federal exchange.

The Obama administration recently eliminated some of the special enrollment periods (see the January 26, 2016 Health Care Current), thereby restricting options for getting coverage after the January 31, 2016 open enrollment deadline. While the administration is working to eliminate the number of additional sign-up periods to increase the stability for insurers, the agency noted that it remains committed to helping people understand and meet the Affordable Care Act’s (ACA) new requirements.

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Study: Most regionally ranked hospitals are in at least one exchange plan, but participation rates are still declining

Most (95 percent) hospitals with high rankings from the US News and World Reports list of Best Regional Hospitals are in network for at least one exchange plan, according to the Robert Wood Johnson Foundation. Researchers reviewed changes in network participation among a cohort of US hospitals from 2015 to 2016 to find that most of these regionally ranked hospitals are included in at least one exchange plan.

Consumer organizations have raised concerns that exchange enrollees may not have access to high-quality hospitals in their plans’ networks. Other studies have found that exchange plans are more likely to be preferred provider organization (PPO) plans rather than health maintenance organization (HMO) plans. HMOs typically have more limited networks than PPOs. This study suggests that many of these plans still allow members to access high-performing hospitals and that access did not change significantly between 2015 and 2016, when fewer PPOs have been offered.

However, the study also found that these hospitals participated in fewer networks in 2016 than in 2015; 57 percent of them were in fewer networks. The change was more pronounced in some parts of the country than in others, and more of these hospitals are in only one plan’s network. In 2015 only 7 percent of these hospitals were in only one plans’ network. In 2016, that number increased to 20 percent.

Analysis: This research comes only a few months after CMS issued its draft 2017 letter for health plans participating in the federally facilitated exchanges, which outlined guidelines it proposes use to evaluate networks for health plans in states that do not have their own standards (see the January 12, 2016 Health Care Current). CMS will require states to use time and distance standards to measure network adequacy in exchange plans and will conduct adequacy reviews in certain states (which will be determined at a later date). CMS plans to publish network adequacy ratings for QHPs for consumers; the rating will be based on other QHPs available in the same county.

While many consumer advocacy groups say that exchange enrollees need broader provider networks to increase access, many health plans say that limiting networks is one way that they have to decrease the costs of coverage. The Deloitte Center for Health Solutions 2015 Survey of Heath Care Consumers also found that exchange consumers are more willing than ever to accept limited provider networks for lower prices. The exchanges have improved access to care, but affordability remains a problem, and tradeoffs like these may be part of the solution.

(Source: Katherine Hempstead, Robert Wood Johnson Foundation, “Most Regionally Ranked Hospitals Stay In-Network with Marketplace Plans, But Participation Declines,” February 5, 2016)

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Senate HELP Committee bill aims to improve health information technology access, prevent information blocking, and encourage interoperability

Last week, the Senate Health, Education, Labor, and Pension (HELP) Committee, led by Chairman Lamar Alexander and Ranking Member Patty Murray, passed bipartisan legislation to improve health information technology. The Improving Health Information Technology Act aims to:

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On the Hill & In the Courts

House lawmakers request comments on the site-neutral payment policy

On February 5, Representative Fred Upton, Chairman of the House Energy and Commerce Committee, and Representative Joe Pitts, Chairman of the Subcommittee on Health, sent a letter to the health care community asking for feedback on implementation of a site neutral payment policy that passed in the Bipartisan Budget Act of 2015, as well on changes Congress should consider to site-neutral payments in general. Under the new policy, Medicare will pay for outpatient procedures using the Ambulatory Surgical Center Prospective Payment System or the Medicare Physician Fee Schedule if the procedures are in outpatient departments of hospitals that executed CMS provider agreements after November 2, 2015.

Many health care experts have been concerned that hospitals are buying physician practices and converting them into outpatient departments to get higher payments, since Medicare typically pays more for care in outpatient departments. However, the American Hospital Association (AHA) opposes the site-neutral payment provision, saying that it does not reflect hospitals’ higher costs. Others have said that the new policy does not specify which hospital outpatient departments are exempt from the new law, and lawmakers need to offer more clarity around this point. Representatives Upton and Pitts said in their letter that Congress has received substantial feedback already. Some groups say this policy should go into effect without changes; others say they need more clarification and perhaps changes.

Lawmakers will consider this and any additional feedback they receive until February 19, 2016.

Analysis: As explained in the February 12, 2016 RegPulse blog post, the change in payment policy for these hospital outpatient departments is a major consideration for health systems because of the policy’s potential effect on operations, revenue streams, and volume. It is likely to have significant impact on health systems’ physician payment agreements, participation in the 340B Drug Pricing Program, and reporting and other administrative processes. That same day, AHA sent a letter to Andy Slavitt, Acting Administrator of CMS, urging the agency to apply the policy so that it would not affect hospital outpatient departments in some circumstances.

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CMS finalizes rule requiring providers to repay overpayments made in the last six years

Last week, CMS finalized a rule that will require health care providers to return overpayments from Medicare that they have received in the last six years. The proposed rule came out in 2012, but many providers said that the original time frame of 10 years was unreasonable and came with high administrative costs, so CMS had not finalized the regulations until now.

In the final rule, CMS reduced the time period from ten to six years. CMS says this time frame will not add additional burden onto providers because state and federal laws require them to keep records and claims going back as long as seven years in some cases. Providers that fail to report overpayments may be prosecuted under the False Claims Act, which prohibits charging the federal government for services not rendered, double billing, and more. As a result, providers could be charged financial penalties or be barred from billing Medicare for good.

Now, providers or supplies are required to report and return any overpayment they discover within 60 days of identifying it. CMS said that it expects the additional cost burden associated with identifying, reporting, and returning any over payments will be approximately $120.87 million to $201.45 million.

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Report finds uninsured rate continues to fall, particularly in Medicaid expansion states

Eight states had significant decreases in the number of uninsured residents, according to a new report released by the CDC. Using data from the National Health Interview Survey from January to September 2015, the CDC found 7.2 million fewer uninsured that year than in 2014 and 16.0 million fewer than in 2013. Eight states had statistically significant declines in their uninsurance rates: Arizona, California, Colorado, Florida, Illinois, Kentucky, Michigan, and New York.

The analysis revealed additional trends:

  • In total, fewer people reported being uninsured (36.0 million people or 11.5 percent in 2014 vs. 28.8 million people or 9.1 percent in 2015)
  • The uninsured rate among adults ages 18-64 decreased (16.3 percent in 2014 vs. 12.9 percent in 2015)
  • Private insurance coverage for adults 18-64 increased from 2014 to 2015 (67.3 percent to 70.0 percent)
  • Public insurance coverage for adults 18-64 increased from 2014 to 2015 (17.7 to 18.6 percent)

Under the ACA, 37 states and the District of Columbia expanded Medicaid coverage to newly eligible populations. The CDC found that during the first nine months of 2015, adults ages 18-64 in Medicaid expansion states were less likely to be uninsured than those in Medicaid expansion states.

(Source: Michael Martinez et al. “Health Insurance Coverage: Early Release of Estimates from the National Health Interview Survey, January-September 2015,” CDC, February 2016)

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Around the Country

Report looks at health insurance exchange enrollment experiences in California

The California HealthCare Foundation recently published a review of customers’ experiences with Covered California, the state’s health insurance exchange. Many policy analysts see it as one of the most successful state exchanges, having enrolled 1.3 million Californians in health plans as of June 2015. However, the qualitative review of customer experiences shows several areas for improving the website.

The report focused on 30 participants’ experiences enrolling or re-enrolling in plans during the second open enrollment period from November and December 2014 and 12 participants’ experiences during the third open enrollment period from November to December 2015. Researchers watched and recorded the enrollment process, giving participants 45-90 minutes if they were renewing coverage and 90-120 minutes if they were first-time enrollees.

Homepage design improved between the two enrollment periods, reducing confusion of applicants. However, during both enrollment periods, many participants had trouble when they spent time reviewing plan options in the “window shopping” part of the site, not realizing that they would be unable to select and purchase a plan through that part of the site. This confusion delayed the application process for many individuals. Additionally, many enrollees found the guidance and application questions on income and household size unclear. Finally, the researchers found that the forms and processes on the site frustrated many applicants.

From these findings, the report outlined recommendations to improve the consumer experience:

Finally, the researchers recommended that Covered California conduct regular usability tests for continuous quality improvement and use website analytics to help identify where in the online enrollment process applicants are experiencing delays or errors.

(Source: “Room for Improvement: Consumers’ Experience Enrolling Online with Covered California,” California Health Care Foundation, February 2016)

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App may lead to better outcomes for women at risk of preterm delivery

Researchers at King’s College London developed an app that could help physicians better identify women at risk of having premature babies (born before 37 weeks gestation). The app was tested in two studies of high-risk women. It uses an algorithm that combines the gestation of previous pregnancies and the length of the cervix with levels of biomarkers found in surrounding fluid.

Two studies on the app were published in recent issues of the journal Ultrasound in Obstetrics & Gynecology. One study focused on women who were high risk because of a previous pregnancy but who were showing no symptoms of preterm labor. The other study focused on the likelihood of preterm births in women who were showing symptoms of early labor. Both studies showed that the app predicted the risk for pre-term birth far better than each risk factor (previous pregnancy, cervical length, or biomarker levels) taken alone. The researchers conclude that clinicians can use the app to improve the probability of premature delivery and to potentially tailor treatment. More research is needed to refine and evaluate the model in practice and to determine whether the app helps improve outcomes. Currently the app is available for free.

Analysis: Every year 15 million babies are born preterm, and more than a million of these babies die of prematurity-related complications. Babies who do survive are at increased risk of serious complications, including breathing problems, intellectual disabilities, and others. Babies born just a few weeks before 37 weeks have higher rates of hospitalization and illness than full-term infants. Though new digital health apps are coming onto the market rapidly, only a small amount of these apps have been systematically evaluated and validated. There is great potential for these tools to help improve health of individuals and communities, but that their use should be driven by data and demonstrated evidence of their safety and efficacy. These studies are an early assessment of how a digital app might be used to identify at-risk women by combining biomarkers with clinically meaningful symptoms.

(Sources: K Kuhrt, N Hezelgrave, C Foster, PT Sheed, AH Shennan, “Development and validation of a tool incorporating quantitative fetal fibronectin to predict spontaneous preterm birth in symptomatic women, Ultrasound in Obstetrics & Gynecology, February 2, 2016; K Kuhrt, E Smout, N Hezelgrave, PT Sheed, J Carter, AH Shennan, “Development and validation of a tool incorporating cervical length and quantitative fetal fibronectin to predict spontaneous preterm birth in asymptomatic high-risk women,” Ultrasound in Obstetrics & Gynecology, January 5, 2016; World Health Organization, November 2015)

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Breaking Boundaries

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