Health Care Current: April 7, 2015
Accelerating research through the power of patients: The race for Michael
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.
- My Take
- Implementation & Adoption
- On the Hill & In the Courts
- Around the Country
- Breaking Boundaries
Accelerating research through the power of patients: The race for Michael
One of my simplest joys is to walk our youngest son, Zander, and our dog, Tarot, to the bus stop at the top of our small cul-de-sac. The first day of school this year was particularly exciting, as we were joined by our neighbor, Michael, now ready to start kindergarten. With a kiss from his mother, Jenny, a wave from his little sister, Lila, and a good luck bark from Tarot, Michael followed Zander onto the bus for his first day of school. In the week that followed, Michael, smiling and eager as always, was there each morning.
And then he wasn’t.
Only a few days after starting school, Michael began experiencing trouble with his eye. An exam led to an MRI, which then led to a biopsy. The diagnosis was devastating: Michael had a brainstem tumor – Diffuse Intrinsic Pontine Glioma (DIPG). This news could not have been worse. While DIPG represents only 10-15 percent of childhood brain tumors, it is the most common cause of death from brain tumors in children, typically striking kids between ages five and seven. Unlike many other pediatric cancers, there has been little progress in improving treatments or cure rates over the last few decades.
In March, Jenny created the My Hero Michael Mosier Facebook page to share his story. Hundreds of people joined this community, many to offer support, many going through the same struggle, and, sadly, many sharing the tragic loss of their own children to DIPG.
While social media may seem superficial at times, it has served an important role in health care and is transforming the way we approach and cope with diseases. Web communities and social media platforms allow patients and caregivers to connect to each other, update friends and family, share questions and answers and obtain badly needed emotional and financial support. Many have recognized the value of the data being shared, and some sites aggregate learnings. However, only recently has the government sought to harness this information in a meaningful way to advance and accelerate medical research.
Established by the Affordable Care Act (ACA), the Patient-Centered Outcomes Research Institute (PCORI) began funding research in December 2012. PCORI is now the largest single research funder focused on patient-centered comparative effectiveness research (CER). The goal of PCORI is to determine which treatment options work best in particular circumstances.
In 2013, PCORI established a clinical research network, PCORnet, dedicated to patient-centered priorities in CER. PCORnet allows researchers to easily access data from millions of people across the country and use the collected data for many different research efforts. Participating organizations and leadership teams include patients, advocacy groups, clinicians, academic centers and practice-based research networks. Half of the projects are focused on rare diseases.
The core components of PCORnet are the Clinical Data Research Networks (CDRNs), research networks based on health care delivery systems and Patient-Powered Research Networks (PPRNs), groups of patients and their partners who form a network and participate in research. There are 18 PPRNs made of patients and/or caregivers who use an online network to actively engage in patient-centered CER.
One example includes iConquerMS, which aims to obtain medical data and other information from 20,000 of the 400,000 Americans living with multiple sclerosis (MS). Its eventual goal is to provide researchers with insight to develop more effective treatments. Many patients with MS have trouble knowing what therapies will work best for them. The website gives patients the opportunity to offer research questions and share information on their daily lives and quality of life. This type of information may not be captured as well in a traditional clinical trial (see the March 17, 2015 Health Care Current for more on iConquerMS).
PCORI isn’t the only group embracing social media and patient engagement. Some pharmaceutical companies have utilized social networking sites to provide ongoing focus groups with patients and doctors. Capturing information on patients’ and physicians’ experiences with different diseases, devices and treatments supplements data from formal research trials and can enhance information on off-label prescription drug use.
As the government, through programs such as PCORI, and the health care industry continue efforts to place patients at the center of care, these initiatives will help to create structure around current data collection practices. Until recently, many of these initiatives lacked common standards. Now, PCORI has outlined four cross-cutting best practice standards for patient-centeredness. For a study to be “patient centered,” researchers must engage people representing the population of interest, retain study participants representative of the spectrum of that population, use patient-reported outcomes when appropriate and support the dissemination of results. PCORI is promoting the uptake of these patient-centeredness standards and working to engage stakeholders to strengthen research practices.
Empowered patients could be more actively engaged with their providers and in their health care, and collecting and analyzing large amounts of certain kinds of “real world” data provided by patients can inform the research process. Hopefully, by collecting and strategically sharing information from large patient populations, cures can come faster.
For Michael, a cure can’t come fast enough. A few months ago, he was like any other kid, riding his bike and shooting baskets in his driveway with his father. Now he is in a motorized wheelchair, amid aggressive chemotherapy and radiation. Throughout it, he has faced everything with extraordinary bravery. Family and friends have rallied around him, and last week, all the staff and students at our elementary school dressed in yellow (his favorite color) and lined the halls cheering him as he left early for another treatment.
As neighbors, we do what we can. Recently, we got our families together for a barbecue at our house. The kids played with Tarot in the back yard and then made ice cream. Sitting in our kitchen with Mark and Jenny, I came to appreciate the simple joy of eating hot dogs with our kids.
PS - Michael’s parents, Jenny and Mark, are supporting other families in treatment and raising funds for brain tumor research by establishing a Race for Hope DC team. My wife and I have joined and will be cheering them on in our yellow “Team Big Hero Michael” shirts.*
* This article should not be deemed or construed to be for the purpose of soliciting donations for Race for Hope. It is not an endorsement of the services or products provided by Race for Hope.
By Harry Greenspun, M.D., Director, Deloitte Center for Health Solutions, Deloitte LLP
Study: Medicare Advantage beneficiaries are more satisfied with their plans than traditional Medicare enrollees
Last week, Morning Consult released results from a survey of Medicare enrollees that found most older adults are happy with their traditional Medicare plan (85 percent) or Medicare Advantage (MA) plan (88 percent). African American respondents were more pleased with their MA plan than Whites and Hispanics. Low-income MA enrollees were also more satisfied with their out-of-pocket costs than individuals with traditional Medicare plans. MA enrollees were more likely to be satisfied with specific plan benefits, such as costs, preventive care coverage and prescription drug coverage, than traditional Medicare enrollees:
As of 2014, there are more than 3,600 plan options in the MA program that have 15.8 million enrollees. Enrollment grew 9 percent over 2013, as 1.3 million individuals were new enrollees. A study earlier this year found that more MA enrollment is coming from people new to Medicare. Even though the majority (78 percent) of newly eligible Medicare beneficiaries enroll in coverage under traditional Medicare, the share of those choosing MA has increased since 2006. In 2011, 22 percent of new Medicare enrollees opted for MA coverage over the traditional program, compared with 15 percent in 2006. The same study also found that dual eligible individuals are more likely than non-dual eligibles to switch from MA plans into traditional plans (10.1 percent annually).
(Source: Morning Consult, “National Seniors Poll on Medicare Plan Satisfaction,” March 27, 2015)
Implementation & Adoption
Chief actuary of Social Security: SSDI will be depleted by 2016
According to the Social Security chief actuary, the Social Security Disability Insurance (SSDI) program trust fund will be depleted by late 2016. If the trust fund is depleted, disability benefits will be cut by 19 percent that year. As a result, the Obama administration has proposed in its 2016 budget to shift funding from the Old-Age and Survivors Insurance (OASI) trust fund into the SSDI trust fund. The administration notes that Congress has passed legislation that reallocates funds between the two trust funds in the past, and that the reallocation “will have no effect on the overall health of the OASI and SSDI trust funds on a combined basis.” On the first day of this Congressional session, however, the House passed a rule that prohibits the government from transferring funds between the two funds unless Congress takes steps to improve overall finances for the Social Security program.
The depletion of the SSDI fund has the potential to disrupt the commercial disability market. According to the Bureau of Labor Statistics, only 34 percent of all US workers have access to long-term disability, and 40 percent have access to short-term disability. The Council for Disability Awareness monitors the market through a survey of 19 companies that represent 75 percent of the commercial disability insurance market. In 2013, these 19 companies paid out a total of $9.8 billion in payments for disability claims—this is a 1.6 percent increase over 2012. Private plans pay secondary to the SSDI program. When they were asked about their concerns for the future of long-term disability, the companies frequently expressed worry about delays in the SSDI program and the financial challenges and changes that would be necessary to get the program “on a sound financial footing.” Most recent estimates indicate that private disability insurance will save the federal government $25 billion over 10 years. According to America’s Health Insurance Plans, commercial disability plans cover approximately 65,000 employees a year. These individuals rely less or not at all on public programs, saving the federal government approximately $30,000 per employee per year.
AHRQ: Recommendations to improve primary care through health IT
Last month, the Agency for Healthcare Research and Quality (AHRQ) recommended adoption of health information technology (health IT) practices that support quality improvement in primary care. The recommendations were drawn from insights from a panel of eight key experts with backgrounds in quality improvement, primary care transformation, health policy, human factors engineering, health IT and clinical practice. The recommendations also reflect the experience of three organizations that have successfully leveraged health IT to support quality improvement strategies. These organizations include a small private primary care practice, a large academic primary care organization and a health information network that provides health IT software and assistance primarily to practices that serve indigent populations.
Four key factors that support health IT use in primary care quality improvement emerged:
(Source: Higgins, Tricia C., Crosson, Jesse, Peikes, Deborah, McNellis, Robert, Genevro, Janice, Meyers, David, Agency for Healthcare Research and Quality, “Using Health Information Technology to Support Quality Improvement in Primary Care”, March 2015)
Alliance for Health Reform briefing: Tackling the challenge of rising health care costs
Last week, the Alliance for Health Reform convened a Capitol Hill briefing to explore recent trends in health care costs in the public and private sectors. Though total health care spending reached $2.9 trillion in 2013, panelists noted a prolonged slowing in the rate of growth of health spending. Much of this slow growth is accredited to insurance reforms, care delivery changes and the sluggish recovering economy. However, economists debate how much each component has contributed to “flattening the cost curve.” Panelists stressed that analysts will monitor spending to see if it picks up as the economy improves, study the impacts of the ACA and observe how increased industry consolidation will impact spending. The panelists noted:
- Health care spending in 2013 accounted for roughly 17.4 percent of gross domestic product (GDP). Though this is double the share of 1980, it has remained level since 2009. It is now on pace with economic growth.
- The US spent $9,255 per person on health care in 2013. On average, other wealthy countries spend about half as much per person on health as the US.
- Medicare and private insurance growth have been similar over the past few decades but recently Medicare growth has slowed more than private insurance.
- Though the public perceives pharmaceutical costs to be a large portion of overall health expenditures, it makes up roughly ten percent of national health expenditures.
To some degree, growth of health care costs is inevitable. People are living longer with more chronic diseases and are better off economically. However, the panelists stressed that reducing unneeded services, improving quality and aligning financial incentives could limit unnecessary growth down the road. The panelists emphasized that in order to increase efficiency, the health system should:
- Engage patients to support more efficient care
- Move away from fee-for-service reimbursement and encourage value in care delivery
- Encourage medical schools to teach integrated, coordinated and team-based care
- Scale systems and processes used at the most efficient, highest quality practices to become the standard of care
SCOTUS: Providers cannot sue state Medicaid agencies over low rates
Last week, the US Supreme Court ruled 5-4 that providers cannot sue state Medicaid agencies if they feel their payment rates are set too low. Justice Antonin Scalia wrote the majority opinion for Armstrong v. Exceptional Child Center Inc. and said that states cannot sue because the Supremacy Clause of the US Constitution says that federal law overrules state law. The majority of the justices agreed that private parties do not have a say in whether or not state plans “assure that payment are consistent with efficiency, economy and quality of care.”
The dissenting justices expressed concern that this ruling will have consequences for the future of the Medicaid program. While providers may ask the US Department of Health and Human Services to intervene when they believe payment rates are too low, Justice Sonia Sotomayor wrote that the agency has many programs to oversee and the means by which it can intervene are “drastic” measures.
Background: The case originated from five habilitation services centers that serve individuals with intellectual and developmental disabilities. The centers argued that the Idaho state Medicaid agency was keeping payment rates too low despite studies that showed the costs of care had increased. Idaho officials arguing in opposition to the centers claimed that neither providers nor patients should be able to use the courts to gain higher reimbursement rates. The Obama administration and 27 states supported Idaho’s position on the matter, as did the US Chamber of Commerce.
On the Hill & In the Courts
CMS discusses payment policies for biosimilars
Last week, the US Centers for Medicare and Medicaid Services (CMS) discussed how it will approach payment for biosimilars in Medicare Parts B and D. Discussion about biosimilars has picked up across the industry since the US Food and Drug Administration (FDA) approved the first biosimilar last month (see the March 10, 2015 Health Care Current). In one of the documents, CMS addressed frequently asked questions around reimbursement in Medicare Part B:
- Part B reimbursement: Medicare will pay 106 percent of the wholesale acquisition cost for a biosimilar product until the average sales price (ASP) is available. Once the ASP is available, Medicare will pay the ASP plus 6 percent of the ASP for biosimilars.
- Billing codes: Biosimilars will have separate codes from their reference products. CMS will issue additional billing code guidance in the future.
- Part D reimbursement: CMS acknowledged that, while the first biosimilar product to be approved will mostly be administered through services covered under Part B policies, in some circumstances they will be covered under Part D.
In a separate document, CMS discussed some of the implications the first biosimilar approval has for Part D payment policy. CMS indicated that, while health plans currently may make formulary changes that involve creating incentives for beneficiaries that encourage use of generics, the agency will treat biosimilar products differently. CMS does not view biosimilars to be similar enough to their reference product to be treated the same way as generics for small molecule drugs. It plans to review any formulary change requests involving biosimilar products.
CMS considers biosimilars similar enough that having only a reference product and its biosimilar product in a certain class will not fulfill the requirement to have two drugs offered in each formulary therapeutic category. Many low-income beneficiaries will also be required to pay higher co-pays for biosimilar drugs because they do not meet the CMS definition of a generic drug.
Analysis: CMS is sending a clear signal that the agency is, at least initially, viewing the biosimilar market like the traditional small molecule generic market. Under the Part D guidance, biosimilars will not be considered as different from the reference product for the purpose of satisfying the Part D requirement. At the same time, CMS is creating caveats for formulary management. Biosimilars may be added to formularies at any time as a benefit “enhancement,” but they will be reviewed by individual plans’ pharmacy and therapeutics committees. The guidance also states that biosimilars and reference drugs are going to be considered as different products for the purposes of Part D transition supply and notice requirements. This means that enrollees who have been taking the reference biologic should receive a transition supply when only the biosimilar is covered. Conversely, enrollees already taking a biosimilar should receive a transition supply when the reference drug is the only formulary product. While the ACA excludes biosimilars from the drug discount program and they won’t be subject to the 50 percent discounts required on brand name drugs when enrollees reach the coverage gap, this may entice companies to maintain a competitive/comparable price to the brand product. Ultimately, there is a great deal of learning that will go on once more biosimilars are in the market and the competitive dynamics become more clear.
Highlights from state Medicaid ACO initiatives
The Commonwealth Fund examined initiatives in several states that aim to bring the accountable care organization (ACO) model to their Medicaid programs. The researchers found that many of the Medicaid ACOs were largely successful in reducing cost and quality across several key indicators in early adopter states. These three states based their programs on the following core elements:
Related: In a brief this month, the Center for Health Care Strategies examined improving and integrating care for the dual eligible population—beneficiaries eligible for both Medicare and Medicaid—through enrollment in Medicaid ACOs. After reviewing the same early state experiences with Medicaid ACOs, the authors concluded that enrolling dual eligibles only in the Medicaid ACOs is not likely to reduce costs, improve care coordination or increase savings for the states or other payers. They urged states to carefully evaluate the complexities of including this population in Medicaid ACOs. This may include ensuring Medicare services are included in cost measurement and building incentives for Medicare or Medicaid providers to reduce costs.
The February 17, 2015 Health Care Current covered the launch of the third phase of the Medicaid ACO Learning Collaborative project to work with states developing and implementing Medicaid ACOs. The program, a collaboration between the states, the Center for Health Care Strategies and the Commonwealth Fund, has already seen five member states implement Medicaid ACOs with two more planning to launch soon. The early adopters in this program emphasize integrating non-medical social services to address the need of Medicaid populations.
(Source: The Commonwealth Fund, “A Unicorn Realized? Promising Medicaid ACO Programs Really Exist,” March 11, 2015)
Around the Country
Nebraska expands nurse practitioners’ scope of practice
Last month, Nebraska joined nineteen other states when it passed a bill to expand the scope of practice for nurse practitioners in primary care. The governor signed LB 107 into law on March 5. The law empowers nurse practitioners to treat and diagnose patients in primary care on their own. They must have one year of supervised care provision under a doctor or experienced provider before they are able to do so.
Advocates, such as the American Association of Nurse Practitioners (AANP), praised the bill, saying that it will help meet the need for primary care in rural areas throughout the state. According to AANP, the Institute of Medicine has long called for states to adopt similar legislation, citing research that indicates patient outcomes do not differ under the care of a nurse practitioner. However, opponents of the bill, including the American Medical Association (AMA), have expressed concern that this move could lead to further fragmentation and favor the previous model of physician-led teams.
The legislatures of seven other states are also considering independent practice bills. The Nebraska legislature passed a very similar bill in 2014, but the former governor vetoed it.
Related: Deloitte reviewed workforce challenges for Kentucky in early 2013 in the Kentucky Health Care Workforce Capacity Report. One of the findings suggested that “enabling mid-level practitioners to effectively address unmet health care supply, especially in relation to primary care, represents a compelling opportunity.” According to this analysis, adding 6 percent of the advance practice registered nurses to the primary care practitioner supply would have addressed the gap in primary care that existed at that time.
Limiting scope of practice for mid-level providers presents challenges to access, the report noted. Mid-level practitioners who are unable to practice autonomously may depend more on physicians to be able to practice and they may be less likely to take on risk, such as opening a new practice to reach underserved areas. The cost of collaborative agreements between mid-level providers and physicians may also be prohibitively expensive as many physicians charge mid-level practitioners monthly fees to continue these relationships. Sometime after this report, Kentucky passed its own scope of practice law. The state now allows nurse practitioners to prescribe medications on their own, which may lead to better disease management in patients with chronic diseases, especially those who live in rural areas of the state.
Tool encourages patient engagement and shared decision-making
Shared decision-making (SDM), the collaborative process that enables patients and clinicians to make health care decisions together, has become an increasingly important goal in health care. The collaborative process ideally considers the leading scientific evidence available as well as the patient’s values and preferences. When patients do not feel like they have the opportunity to engage in shared decision-making about their care, they may become frustrated, confused and anxious. A new tool, the Patient Passport, is designed to increase patient engagement and system-level change by helping patients communicate their needs and preferences with providers.
The Patient Passport was created in 2014 by a multi-stakeholder National Quality Forum (NQF) Action Team and is based on existing tools used by the United Kingdom’s National Health Service and the Mattel Children’s Hospital UCLA. The tool uses pictures and simple language to start conversations and encourage patients to share stories beyond their health conditions. Examples include their concerns about being hospitalized, quality of life goals, activities they need assistance with and requests for counseling around end-of-life or other issues, as well as assistance in understanding medical terms. The tool also aims to make office workflow easier and more effective by presenting office staff with important patient information—such as medications, conditions and what works or doesn’t work to cope with health conditions.
Several hospitals are now either piloting the Patient Passport or plan to do so in the future. The Patient Passport has been integrated by one NQF member organization into a free mobile app.
Analysis: SDM is increasingly becoming more important in the health care industry. Although communication tools to improve the exchange of patient information have been in existence for decades, only recently have tools such as the Patient Passport emerged.
The Patient Passport shares some features with the medical record or personal health record; however by capturing and emphasizing patient preferences, the Patient Passport helps patients start a conversation with providers in order to express their needs and preferences, thereby increasing patient engagement and SDM.
The Patient Passport tool on its own will not engage patients and family members as active members of their health care team. Processes to use patient-reported information should be in place as a basis for honoring these preferences and SDM, in addition to ensuring that all members of the patient’s care team are aware of this information. For example, office staff should be trained on the tool, how it works and its value. Ways to measure SDM and effectiveness of tools like the Patient Passport on patient experience and health outcomes will also continue to evolve the practice of patient engagement and physician communication.