Health Care Current: May 24, 2016

Changing expectations: Preparing the physician of the future

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.

Changing expectations: Preparing the physician of the future

My oldest son Benjamin and I have shared a lot of great experiences, including playing in a rock band together. When he decided long ago that he wanted to follow in my footsteps and be a doctor, I knew what was in store for him. He worked incredibly hard through high school and then tirelessly in college. He suffered through organic chemistry just as I did, and, now nearing the finish line, awaits his MCAT scores. Relatively unchanged from when I took them in 1985, he will be judged on his knowledge of biology, physics, psychology, reasoning, and other pre-med requirements. With his scores in hand, he will apply, interview, and (hopefully) be accepted to medical school.

Strikingly, while the process for vetting potential medical students has changed little in the 30 years since I applied, the practice of medicine has changed dramatically. Doctors must now understand population health and value-based payment models. They must work in care teams and be able to utilize a dizzying array of new technology tools. More importantly, they must also learn to operate in a system that will not revolve around them, but will instead be consumer-centered.

We discussed this in a recent report, Preparing the doctor of the future: Medical school and residency program evolution. The expectations of physicians are changing. Instead of simply providing the highest possible quality care, many hospital CEOs want innovative leaders and clinicians, as well as employees with technology and data analytics skills. Consumers expect to partner with doctors instead of relying passively on them to make treatment decisions. And with the health care system moving toward a value-based model, physicians anticipate needing new business, health information technology (HIT), and communication skills to practice effective value-based care (VBC).

So how are medical schools evolving to prepare the physician of the future?

To prepare physicians to practice in a VBC world, medical schools like the Mayo Clinic are incorporating contemporary “health systems” education into curriculum, teaching policy, the basics of health insurance, VBC, the Affordable Care Act (ACA), and government programs.

Other schools are experimenting with new ways to integrate tech tools. Hofstra Northwell School of Medicine has students use testing and imaging tools in the traditional anatomy class to better teach how technology can enhance clinical practice. While cadavers are still used to help students evolve into professionals, looking at organs from the inside helps students learn about anatomy in practice, rather than in theory. Many schools have also been looking for ways to harness and utilize “big data” in medical education. For example, one New York University Medical School initiative, “Health Care by the Numbers,” emphasizes the use of big data and technology for patient and population management. The program also allows students to track their own performance in quality improvement, safety, and value-added care.

Finally, the practice of medicine is moving beyond the traditional individualistic mentality and leveraging other clinicians’ skills. Integrating patients’ and caregivers’ perspectives will be key to success in the future. Some schools are adjusting their curricula to incorporate more team-based learning experiences. For instance, at Hofstra Northwell students spend their first eight weeks of medical school training to become certified emergency medical technicians (EMTs) and then spend time working alongside EMTs in the community. Doing this gives them opportunities to learn how to work in teams, communicate with patients, better understand social determinants of health, and gain a greater appreciation for the different roles and responsibilities comprising the health care system.

Many medical schools are using new ways to teach about the health care system, integrating technology into the practice of medicine and helping physicians learn the leadership and communication skills required to effectively connect with patients and team members. These changes may improve quality of care while also improving the experience of receiving care.

As Benjamin awaits his scores, I can see myself in him, checking the mailbox each day. Soon he will be donning a lab coat and heading into a gross anatomy lab, just as I did. However, for him to be successful in the future, our paths will have to diverge. At some point, he will call me to tell me about something he is learning and I hope to say, “Wow, we never did that.”

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My Take

By Harry Greenspun, MD, Director, Deloitte Center for Health Solutions, Deloitte Services LP


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House v. Burwell could have widespread effects on the exchanges if it is upheld

On Thursday, May 12, US District Court Judge Rosemary Collyer ruled in favor of the House in House of Representatives v. Burwell, saying that the administration unconstitutionally spent money that Congress did not appropriate when it subsidized out-of-pocket costs for people enrolled in the public health insurance exchanges.

According to Modern Healthcare’s analysis of an Urban Institute report from early 2016, if the ruling is upheld, it could have widespread effects on exchange plans:

Background: The US Department of Health and Human Services (HHS) provides funding to health plans, which in turn reduce out-of-pocket costs (e.g., deductibles, copayments, and coinsurance) for approximately 56 percent (5.6 million) of exchange enrollees. Judge Collyer stayed her decision pending an appeal, so the ruling will not go into effect until after an appeals court reviews the case. But, the ACA requires health plans to reduce out-of-pocket costs for consumers at certain income levels. If the ruling were to go into effect, health plans may seek larger rate increases in future years to pay for the lower cost sharing for low-income consumers.

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Implementation & Adoption

Exchange plans see a drop in generic drug copayments, rise in out-of-pocket cost limits

A new report from the Commonwealth Fund found that while copayments on generic drugs in exchange plans decreased, out-of-pocket limits, annual deductibles, and non-preferred-brand name drug costs rose slightly. The study compared plans at every metal level not eligible for subsidies offered on the exchanges in 2016 to ones offered in 2015. Researchers then matched those plans to the most recent data available from employer-based health plans.

These data show how the market has adapted so far to increases in medical care expenses. Because cost-sharing in exchange health plans is tied to constant actuarial values and several other cost-sharing protections apply, exchange plans may not reduce the overall value of what is covered. Changes to cost-sharing may be more limited than is possible for employers, who can reduce the value of what is covered and change other benefit parameters. While increased cost-sharing may reduce the use of appropriate and inappropriate services, purchase habits indicate that consumers are shifting toward less expensive plans with higher deductibles.

(Source: Commonwealth Fund, “Changes in Consumer Cost-Sharing for Health Plans Sold in the ACA's Insurance Marketplaces, 2015 to 2016,” May 12, 2016)

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NCHS: National uninsured rate below 10 percent for first time

According to a report released last week by the National Center for Health Statistics (NCHS) at the US Centers for Disease Control and Prevention (CDC), 9.1 percent of people in the US – or about 28.6 million Americans – were uninsured in 2015. Among adults ages 18-64, the percentage who were uninsured decreased from 16.3 percent in 2014 to 12.8 percent in 2015. The findings are estimates based on data from the 2015 National Health Interview Survey, which surveyed 103,789 respondents.

The uninsured rate steadily declined after 2013, when expanded health care coverage under the ACA began.

In addition to the overall rate of uninsured, report includes 2015 coverage statistics by age group, public and private health care coverage, and whether individuals used exchanges. The percentage of adults ages 18-64 who had private insurance coverage, including through the health insurance exchanges, in 2015 was 69.7 percent, up from 67.3 percent in 2014.

(Source: National Center for Health Statistics, “Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, 2015,” May 2016)

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Study: Private-sector employers can help drive health care toward value-based care

Proliferation of new payment systems and care delivery models under the ACA may empower employers to drive the industry toward value-based care. Today, many employers still rely on health benefits where the underlying payment structure is based on fee-for-service (FFS). A new report from the American Health Policy Institute and the Pacific Business Group on Health explores how employers are attempting to change this.

While federal programs like Medicare and Medicaid generally change with legislation, private-sector employers often have flexibility to make changes more quickly. Many employers have begun to look beyond today’s typical health plan relationships to work directly with health systems and use payment methods that reward efficiency in resource use and better population health.

Employers are developing high-performance networks through accountable care organizations (ACOs), primary-care medical homes, and Centers for Excellence. The report highlighted many examples; here are three:

By shifting the financial risk to providers, employers can encourage service coordination and constant health innovation. Direct negotiation with providers allows employers to design networks with less variability in quality and cost.

(Source: Emma Hoo and David Lansky, American Health Policy Institute, “Medical Network and Payment Reform Strategies to Increase Health Care Value,” May 2016)

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Equal Employment Opportunity Commission’s final rules on wellness programs address incentives and protect confidentiality

Recent Equal Employment Opportunity Commission (EEOC) rules say that employers may reward or penalize employees and their spouses based on their participation in workplace wellness programs and still remain in compliance with the American with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA). Wellness programs can be either participatory (e.g., attending a nutrition class) or health contingent (e.g., meeting goals to walk a certain amount in a day, or reducing participant’s blood pressure or cholesterol by a certain percentage).

Many employers are increasingly using measures that come from health risk assessments (HRA) to capture health status. HRAs may include disability-related queries and biometric tests (including blood pressure or cholesterol measures). HRAs often ask participants to disclose genetic information through questions about family history. These measures fall under the scope of non-discrimination through the ADA and protection of genetic information through GINA.

In the two new rules, one setting regulation under the ADA, and the second under GINA, EEOC says that employers may offer incentives to employees and their spouses as a part of their health insurance benefits or outside of their health insurance benefits if the program meets certain requirements (summarized below).

Enacted through the Health Insurance Portability and Accountability Act (HIPAA) and expanded by the ACA, the US Departments of Labor, Health and Human Services, and Treasury have regulated wellness programs offered through employers’ health insurance. EEOC expands the scope of regulation to include programs that leverage biometric, genetic, or disability-related information and to cover wellness programs not offered through employer-based insurance.

Notably, the rules do not allow employees to avoid HRAs by submitting a note from a medical professional stating that they are under their care. It also limits incentives to 30 percent of the total cost of the coverage for tobacco cessation programs that require biometric testing or other medical procedures (programs that only ask simple questions may offer incentives up to 50 percent of the total cost). The Commission ruled that the ADA’s ‘safe-harbor’ provision, which prohibits discriminatory insurance underwriting against persons with disabilities, does not apply to wellness programs. It also said that GINA still prohibits employers from collecting genetic information on children.

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On the Hill & In the Courts

FDA seeks industry and expert comment on use of 3D printing in medical settings

On May 10, 2016, the US Food and Drug Administration (FDA) published early thinking on additive manufacturing (AM), more commonly known as 3D printing, and how it can be used in medical settings. Based on recommendations from a public workshop with industry and academic leaders, the document does not establish legally enforceable responsibilities, but instead provides the FDA’s ideas for possible AM regulation. The document centers on two topics:

  • Design and manufacturing standards: The FDA says that AM manufacturers should be documenting each step in their design and manufacturing process. Given that 3D printable devices are customizable, there are no standardized Quality System (QS) pathways capable of categorizing them. The FDA indicates that manufacturers should maintain a detailed “production flow diagram.” The proposed diagram identifies each critical step in the manufacturing process, as well as a high-level summary of each of these steps, including acknowledgements of any possible interaction effects at each stage. FDA indicates that information should include: sizing design, software workflow, material controls, post processing and process validation, as well as quality data. 
  • Device testing: A device’s market approval will depend on its classification, a factor on which the FDA is seeking comment. The agency’s current idea is to classify the device on whether it is load-bearing, implantable, or is available in standard sizes rather than matched to patients’ medical imaging, among other factors. FDA proposes that manufacturers provide data on: the range of sizes available, applicable mechanical testing procedures, device tolerance and fatigue, cleaning and sterilization processes, biocompatibility or further labeling considerations which could affect interaction, and more.

This document does not address 3D printed biologics, nor does it include point-of-care manufacturing, where hospitals or clinicians may print common devices from standardized, readily available blueprints. However, it does open the idea for device submission for approval on multiple pathways. Many analysts say the draft guidance shows the FDA is committed to keeping up with rapidly changing medical technology.

(Source: Food and Drug Administration “Technical Considerations for Additive Manufactured Devices: Draft Guidance for Industry and Food and Drug Administration Staff,” May 2016)

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Connecticut and Vermont pass laws to combat opioid abuse

Connecticut and Vermont joined other New England states like Massachusetts and Maine to pass legislation to limit opioid prescriptions. Vermont’s law requires the state’s Health Commissioner to adopt rules before the law goes into effect.

The Connecticut law:

  • Limits most first-time opioid prescriptions to seven days
  • Increases access to the prescription drug monitoring program; authorized prescribers will be able to authorize other licensed health care professionals to use the prescription drug monitoring program on their behalf
  • Gives immunity provisions to all providers administering naloxone, a drug that counters the effects of an overdose
  • Requires municipalities to ensure that emergency responders are equipped with naloxone, and prohibits insurers from requiring prior authorization for opioid antagonists
  • Expands drug and alcohol abuse treatment programs to include acupuncture for treating alcohol and drug abuse

The law expands 2015 legislation that set requirements for the prescription drug monitoring program, authorized pharmacists to prescribe naloxone, and required health care providers to complete continuing education in pain management and prescribing controlled substances.

The Vermont law:

  • Calls for regulations to set evidence-based limits to the number of pills that can be prescribed to patients
  • Establishes a 35-member Controlled Substances and Pain Management Advisory Council to replace the state’s 29-member Unified Pain Management System Advisory Council and provide input to the state’s Health Commissioner when codifying opioid limits
  • Appropriates $182,000 for the purchase and distribution of naloxone rescue kits, including a portion for emergency medical service personnel
  • Mandates prescription drug monitoring reporting for pharmacies and other entities that dispense Schedule II-IV controlled substances 
  • Requires provider training and continuing education
  • Establishes a pilot project to provide acupuncture services to Medicaid-eligible residents with chronic pain
  • Requires reimbursement for telemedicine visits for substance use and disorder treatments
  • Establishes a prescription drug disposal program for unneeded and unwanted prescriptions

The law increases the fee that pharmaceutical manufacturers and labelers pay to the Department of Vermont Health Access from 0.5 percent of the previous year’s drug spending to 1.5 percent in order to pay for many of the provisions.

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Around the Country

FDA to finalize “compassionate use” plan for investigational drugs, parallel to many state efforts

According to the deputy center director for science operations at FDA’s Center for Drug Evaluation and Research (CDER), the FDA will soon finalize updates to the compassionate use plan for patients seeking access to investigational drugs. This comes at the same time the Reagan-Udall Foundation is building an online navigator to help patients and physicians understand the application process. Reagan Udall is a not-for-profit organization created to develop tools and methods for the FDA to evaluate the effectiveness and safety of products.

Twenty-eight states have “right to try” laws that authorize some use of investigational drugs outside of the FDA’s clinical trial process. The online navigator tool created by the Reagan-Udall Foundation will help provide physicians with information on how to make a request and the subsequent review process.

Compassionate use, often known as expanded access or “right to try,” is a process that exists for physicians to request that FDA authorize the use of an investigational drug outside of a clinical trial a patients with a terminal illness or no other treatment options. The drug developer and the physician treating the patient must petition the FDA on behalf of the patient. Currently this process can take up to 100 hours to complete. The FDA proposal seeks to reduce the application time to 45 minutes.

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Unraveling the mystery of the microbiome

On May 13, the White House Office of Science and Technology (OSTP) announced the National Microbiome Initiative (NMI), a collaboration with federal agencies and private-sector stakeholders to advance the understanding of microbiomes. Microbiomes are communities of microorganisms, including bacteria, fungi, and yeast, that live on people, plants, soil, water, and in the atmosphere. Scientists have known for years that our world is swarming with microbial species, but are just recently scratching the surface of how the microbiome can influence our health. Imbalanced microbiomes are linked with chronic disease including obesity, diabetes, and asthma, possibly cancer, as well as disruptions in agriculture and weather.

The White House is proposing around $121 million in federal spending on the microbiome in the next two years. The funding would go to the Department of Energy, National Institutes of Health, National Science Foundation, NASA, and the Department of Agriculture. Private donors, such as the Bill and Melinda Gates Foundation, Juvenile Diabetes Research Foundation, and several universities will start funding projects sooner. Most of the efforts will focus on developing new scientific tools for understanding how microbiomes work and how that varies depending on the particular ecosystem. Specific projects seek to deepen understanding of how microbes affect diabetes, multiple sclerosis, and a project to explore whole-genome sequencing to check if patients harbor antibiotic-resistant superbugs.

The NMI has three goals, which it developed through a fact-finding process that included federal agencies, non-government scientists, and the public. The goals are to:

  • Support interdisciplinary research to answer basic research questions about microbiomes in diverse ecosystems
  • Develop platform technologies to generate insights and help share knowledge of microbiomes
  • Expand the microbiome workforce

Analysis: The University of California San Diego, one of the universities participating in the NMI, is investing $12 million into its own microbiome research efforts. The university has several ongoing projects, including an interdisciplinary effort to build a 3D map of the chemistry associated with cystic fibrosis (CF) and how it shapes the lung microbiome. The goal of the map is to develop more effective, highly personalized treatments for the potentially fatal lung infections that affect patients with CF. The university is also sequencing the gut microbiomes of people with inflammatory bowel disease such as Crohn’s disease and comparing them to healthy gut microbiomes. The researchers aim to identify microbiomarkers associated with responses to different treatments, which may allow for more specific diagnoses, prognoses, and potentially more personalized treatments for these conditions.

Researchers are also interested in studying infants to see how breastfeeding, the introduction of antibiotics, and other factors influence the microbiome. A team of researchers in Canada is studying ways to prevent asthma in infants, using clues from their digestive system after discovering that infants at the highest risk of asthma were frequently missing four common types of gut bacteria.

NMI is multidisciplinary. It brings together experts from different fields – including microbiologists, physicists, technologists, ecologists, and experts in data analytics and modeling – just to name a few.

(Sources: Marie-Claire Arrieta et al., “Early infancy microbial and metabolic alterations affect risk of childhood asthma,” Science of Translational Medicine, September 30, 2015; Jo Handelsman, “Announcing the National Microbiome Initiative,” White House blog, May 13, 2016)

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Breaking Boundaries

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