Perspectives

Health Care Current: September 30, 2014

A venture capital approach to accelerate cures

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

Applying a venture capital approach to accelerate cures

Seventeen years ago many of us were tuned into the O.J. Simpson trial and preparing our telescopes for the last viewing of Hale-Bopp until the year 4397. For some that may seem like a long time ago, but 17 years is the short end of the typical life cycle for a scientific discovery in medicine. Many medicines take anywhere from 17 to 23 years to make their way into the day-to-day practice of doctors and hospitals.1 And, the majority of initially promising discoveries – 86 percent2 to over 95 percent3 by some estimates – fail to even make it that far.

Given the complexity of the medical research and development (R&D) process and the careful testing that is required to be sure biopharmaceutical products are safe and effective, these facts may be easy to understand. But, for many, they are not easy to accept.

As I covered recently in a blog post, “The Ebola outbreak: A call to action for a translational approach to R&D,” the goal of translational medicine (TM) is to bring a greater number of biopharmaceutical products into health care delivery more quickly and successfully. However, the current TM process has been regarded by many as complex and protracted. Government agencies and nonprofits (“funders”) often lack a systematic business framework to select and fund TM projects for maximum potential investment return. 

Venture capitalists (VC) currently play a major role in the U.S. economy, but there is more to be gained from them than just their investments. The VC model offers a framework for funders to integrate into their TM evaluation processes. VC practices for project identification and decision making, active project and portfolio management, and partnerships could help funders more effectively select and assess TM projects.

What core elements of VC could funders apply to their TM decisions? 

Rigorous project identification and decision making 
VCs use rigorous processes to assess and compare projects in a systematic and objective manner with respect to multiple factors. They seek out expertise before executing deals. By performing a similar business-centered project analysis, vetted with external multi-disciplinary experts, TM funders could undertake a more strategic project selection approach. Key questions for TM funders might include:

  • How should market considerations such as prevalence, burden of disease and available treatments be built into the vetting process?
  • What is the potential of scientific merit in terms of novelty of pathway and level of innovation?
  • Does the project have technical merit with respect to the potential feasibility of moving along the TM continuum?
  • Is there commercial viability or reimbursement potential in the project?
  • What is the potential level of financial/social return on investment? 
  • Does the project have potential for achieving positive impacts on health? 
  • Are there multi-disciplinary experts both internal and external, such as advisory boards, available to help determine where and how to invest?

Active project and portfolio management
VCs have strategic plans and portfolios that are carefully selected to align with the organization’s goals. They often invest in multiple industry segments and take a long-term strategic view of their investments. They typically provide managerial and technical support, such as consulting services or business training. Through active project and portfolio management, TM funders may be able to develop a balanced portfolio with a long-term impact view where projects are funded in stages based on the achievement of milestones. Depending on the projected long-term return on the TM investment, management decisions could be made about whether the project could be licensed, sold, engulfed into another project, or receive additional funding. Key questions for TM funders might include:

  • Does project collection (portfolio) reflect an integrated, complementary strategy or vision?
  • Is the time length of a project balanced/assessed against its level of potential success?
  • Is overall risk managed by achieving a balance between high-return and low-return projects? 
  • Are short- and long-term investment impacts assessed against other investment opportunities?
  • Could funding schedules be set to provide funding in series/rounds or stages based on meeting specific performance milestones?
  • What internal managerial and technical support, such as in the area of talent acquisition or business plan development, do the grantees require? Does the funder have the right in-house experts to deliver this support or do they need to be acquired?
  • Has the business plan development involved an iterative process with multiple stakeholders?

Collaboration and partnerships
VCs use their extensive networks to connect and facilitate collaboration among the start-up companies with which they have relationships. They also may identify and consolidate entities, such as those developing similar products, for greater efficiency and market positioning. A similar approach to partnerships/collaborations could provide TM funders a greater flow of data and effective practices. In this light, TM funders could consider questions such as:

  • What collaborative relationships, and grantee incentives to participate, might be established to facilitate the exchange of ideas and insights among similar projects? 
  • Does the funder have the right network of external experts to assist scientists in moving their project from lab to market?
  • Does a shared informatics infrastructure (for validating, evaluating, integrating, and sharing data among project stakeholders) exist or does it need to be created?  How could funders partner to improve, expand, or develop this infrastructure?

In 2013 VCs provided $29.6 billion worth of capital to more than 4,000 investments.4 In doing this, they provided millions of jobs and trillions in revenue. By looking to this framework, funders may be able to improve the pace, focus and adoption of high-impact TM projects to accelerate cures. 

It’s been 17 years since millions of teenagers were flocking to the CD stores to buy the Titanic movie soundtrack. Meanwhile, heart disease takes 600,000 lives per year, cancer takes nearly 1,600 lives per day and every 67 seconds someone is diagnosed with Alzheimer’s.5 Improvement in the translational timeline is needed now.

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P.S. For more on how translational sciences can benefit medical research, see the “NIH awards $17 million for 3D tissue chips research” story below and view Deloitte’s recent whitepaper, “Path to 21st Century Cures – A Call to Action." 

Sources:
1 Balas EA, Boren SA. Managing clinical knowledge for health care improvement. In: Bemmel J, McCray AT, eds. Yearbook of Medical Informatics. Stuttgart, Germany: Schattauer Publishing; 2000:65‐70.
2 Westfall JM, Mold J, Fagan L. Practice‐based research: “Blue Highways” on the NIH roadmap. JAMA. 2007;297:403–6. 22
3 NIH. About NCATS. Available at: http://www.ncats.nih.gov/about/about.html
4 Recent Stats & Studies. 2014  April 3, 2014]; Available from: http://www.nvca.org/index.php?option=com_content&view=article&id=344&Itemid=103 
5 Centers for Disease Control and Prevention, “Heart Disease Facts,” 2014; American Cancer Society, “Cancer Facts and Figures,” 2014; Alzheimer’s Association, “Alzheimer’s Facts and Figures”

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My Take

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

 

HHS: Marketplace will have 25 percent more issuers in 2015

Last Tuesday the U.S. Department of Health and Human Services (HHS) announced that the number of carriers participating in the health insurance marketplaces in 2015 will increase 25 percent from 2014 figures. Using data from 44 states, HHS determined that 77 new insurers will offer coverage on the marketplace for 2015. 67 of the issuers are new to the federally-facilitated marketplace (FFM) and 10 to the state-based marketplaces (SBM). HHS reported that 10 carriers in the FFM and four in the SBMs have not re-filed for participation in 2015 (all of these participated in 2014). Several states have double the number of carriers in 2015 compared with 2014.

States with large increases in number of carriers from 2014 to 2015:

The FFM, which runs in 36 states, had 191 carriers in 2014; that number will increase to 248 for 2015, a 30 percent increase, says HHS. In the eight SBM states that HHS had carrier information on, the total number of carriers will increase from 61 in 2014 to 67 in 2015 (10 percent). Research has found that the greater number of issuers operating in a rating area, the more affordable premiums for individuals and the lower costs for the federal government, and HHS has also concluded this creates greater variety of plan types offered to consumers.

(Gunja, Munira and Gee, Emily R., U.S. Department of Health & Human Services, ASPE, “Health Insurance Issuer Participation and New Entrants in the Health Insurance Marketplace in 2015,” September 23, 2014)

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Implementation & Adoption

 

MA enrollment rises and premiums remain stable; ACA payment changes will impact MA plans in 2015

On September 18 the Centers for Medicare & Medicaid Services (CMS) announced that Medicare Advantage (MA) enrollment reached an all-time high this year. CMS also indicated that while MA premiums will increase by $2.94 on average in 2015, reaching an average $33.90 per month per beneficiary, 61 percent of MA beneficiaries will not see any premium increases in 2015. Most MA beneficiaries (60 percent) are enrolled in a plan that has at least four stars out of the maximum five (CMS’s quality rating); this is an increase of 31 percent since 2012. 

Avalere Health recently published an analysis that speaks to the impact of Affordable Care Act (ACA) payment reforms on MA plans in 2015. Specifically:

  • MA plan participation: Many MA plans will face financial challenges in 2015 because the Quality Bonus Payment (QBP) demonstration is ending. This three-year demonstration provided bonus payments based on quality. 
  • QBP demonstration: In 2015 MA plans with 3 and 3.5 star quality ratings will no longer receive quality bonus payments.
  • MA payment rates: The ACA phases in new payment rates for MA plans; these rates are expected to affect plans enrolling more than 70 percent of MA enrollees. The rates involve reductions to the part of the payment formula that set the benchmarks; plans use these benchmarks to set their bids.
  • Low-cost Medicare Part D plans: In 2014 five insurers offering Part D plans with widespread enrollment offered monthly premiums below $30 per month. These enrolled 40 percent of all Part D enrollees. To keep premiums low, Part D plans are increasingly relying on preferred pharmacy networks. 
  • Part D benefit design: Part D plans are offering lower premiums, but to offset cost many are adding a standard deductible of $320 in 2015. Approximately three out of four plans do not offer coverage in the donut hole, 85 percent of plans use five or more formularies and more than 90 percent use a specialty tier system. 

Related: Avalere also analyzed the CMS Landscape Files for 2015 to find that the number of Part D standalone prescription drug plans will decrease by 14 percent from the current offering of more than 1,100 to little more than 1,000 in 2015. The analysis attributes the decrease to top plan sponsors such as Aetna, Cigna and UnitedHealth consolidating their offerings. As a result of this consolidation, many beneficiaries are expected to shift into lower-cost plans, with average premiums dropping from $39.33 in 2014 to $38.95 next year, according to their analysis. 

(Source: Christine Harhaj, Avalere Health, “CMS Medicare Landscape Focused on MA Plan Participation; Low-Cost PDPs Poised to Compete,” September 18, 2014; Christine Harhaj, Avalere Health, “Avalere Analysis Reveals Significant Consolidation Among PDPs,” September 22, 2014)

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FTC: Reference pricing debate missing important points

Last week in a blog post, researchers from the Federal Trade Commission (FTC) provided commentary on the increasing use of reference pricing strategies among health insurers in the U.S. Reference pricing is a practice in which insurers set a price for a procedure based on the price providers have agreed to (or one below it). If the consumer selects a provider that charges a higher price than the reference price, the consumer must pay the difference between the reference price and what the provider charges. In the blog the researchers argued that the debate around greater use of reference pricing is missing important points that should be discussed. These include: 

Increased competition among providers: The authors note that advocates for reference pricing often say that this practice could increase competition between providers, but the authors note that reference pricing is only a way for insurers and employers to leverage the competition that already exists among providers. The authors support this argument with an example from a monopoly market in which there is only one hospital. In such a market, insurers who introduce reference pricing for procedures such as knee replacements will not increase the competition in that market; consumers will just be forced to select a provider that is priced above the reference price because they have no other options for lower-cost providers of that service. 

Converse of narrow networks: Other advocates for reference pricing have said that it can be a better alternative to narrow network practices that insurers have been using to limit spending. However, the authors said that if reference prices are set too low, providers may not accept it as a full payment for their services; consumers may ultimately only have the choice to select among providers that have higher prices than the agreed upon reference price. 

The authors conclude that benefit designs that leverage practices like narrow networks and reference pricing can only help decrease costs and improve quality if there is already a sufficient degree of competition among providers in that market.  

Background: In May the U.S. Department of Labor published a frequently asked questions document that included reference pricing guidance. Insurers in the large group market and self-insured plans may use reference pricing and still comply with limits on out-of-pocket liability that the ACA requires. In 2011 the California Public Employees Retirement System (CalPERS) used a reference pricing model for 1.3 million individuals for hip and knee arthroplasty. The inpatient reference price for these procedures was set at $30,000. CalPERS found that consumers not only selected the lower-priced hospitals 30 percent more than before, but the prices at high-priced hospitals that were deemed as “non-designated” in the program (i.e., consumers would pay above the $30,000 for the procedures) also dropped by 34 percent. 

(Source: Brand, Keith, Garmon, Christopher, and Gaynor, Martin. Bureau of Economics, Federal Trade Commission, “Reference Pricing is not a Substitute for Competition in Health Care,” September 22, 2014)

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Study: telehealth practices could reduce costs and decrease health complications

Researchers published a meta-analysis of the use of telemedicine in the treatment of chronic disease to find that the use of this technology can produce benefits for the health care system. Specifically, telemedicine can help reduce and shorten hospital stays, reduce emergency department visits and decrease the severity of disease and number of deaths. Researchers analyzed data from literature published from 2000 through 2014 to find:

  • Congestive heart failure (CHF): The researchers used data from 19 studies to find that telemonitoring of CHF patients could reduce mortality by anywhere from 15 to 56 percent compared with patients who received normal care. 
  • Stroke: The researchers used data from 21 studies to find that the use of different types of telestroke technology (with the exception of telephone-only) could reduce mortality in patients by 25 percent for 12 months after the episode. 
  • Telemonitoring for CHF, stroke and COPD: Studies have shown that this technology can reduce hospital admissions and readmissions, shorten hospital stays and decrease visits to the emergency department. The researchers also found evidence that this technology can be cost-effective compared with the usual care that is given to these patients. 

Related: At the recent Healthcare Information and Management Systems Society (HIMSS) Health IT Policy Summit, groups of stakeholders and health IT advocates convened in Washington, D.C. to present lawmakers with their Congressional recommendations for the year. HIMSS recommended that lawmakers allow providers to use “store and forward capability,” increase the allowable sites of care and decrease barriers presented by clinical licensure laws across states. The recommendation to increase the allowable sites of care is tied to the current Medicare policy that allows the program to only pay for telehealth services if they are provided outside of a metropolitan statistical area or in a rural geographic Health Professional Shortage Area (as designated by the Health Resources and Services Administration). According to HIMSS, 80 percent of the country is excluded due to this requirement. 

(Source: Bashshur, Rashid L., Shannon, Gary W., and Smith, Brian R. Telemedicine and e-Health, “The Empirical Foundations of Telemedicine Interventions for Chronic Disease Management,” September 3, 2014)

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Life sciences trade associations requesting more transparency from CMS on Open Payments

Last week the presidents of three life sciences sector trade groups, the Biotechnology Industry Organization, Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America (PhRMA), sent a letter to CMS Administrator Marilyn Tavenner expressing continued support for the Open Payments program through the Physician Payment Sunshine Act but also requesting that CMS add context to the information shared  through the program. The group indicated that their organizations were not consulted about the content being posted on the Open Payments site and were not allowed to review how CMS will provide consumers context on the data that have been submitted to the website. Further, the group requested clarification as to why CMS is withholding as much as one-third of the information that companies have submitted to the website, even if it was submitted using CMS’s requirements. In the statement PhRMA published on its website, the group linked to an article that explained how additional context can be given that helps consumers understand the complex relationship that pharmaceutical and medical device companies can have with physicians. The article provides several examples of how this type of collaboration can help better health and increase innovation – one is an oncologist and biopharmaceutical company working together to develop a clinical trial on cancer treatment. 

Background: CMS has faced criticism from industry groups like these due to the technical issues that have occurred on the Open Payments site. In August CMS closed the site after a Kentucky physician found that the system had attributed payments to a Florida physician to his record and blogged about it (see the August 12, 2014 Health Care Current). Many industry stakeholders have also expressed frustration that CMS did not ultimately exempt indirect payments for continuing medical education from the Sunshine Act reporting requirements. On Friday, September 19, 2014, Representatives Michael Burgess (TX) and Allyson Schwartz (PA) introduced legislation that would exempt these payments from the reporting requirements under the Open Payments program.  

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On the Hill and In the Courts

 

GAO: CCIIO’s policies and procedures around financial management insufficient

A recent U.S. Government Accountability Office (GAO) analysis of financial management policies and procedures for the Center for Consumer Information and Insurance Oversight (CCIIO) at CMS determined that the agency relies on overly manual procedures that are “labor intensive and time consuming” to collect and compile the information GAO requested. GAO requested information from CCIIO on the agency’s past, current and future financial resources and found that CMS was unable to provide estimates for some of this content. GAO was able to verify the reliability of CMS’s total fiscal year (FY) 2014 obligation estimate of $3.7 billion, the number of staff as of September 30, 2013, and the $79.8 million in salary expenses from March 2010 through FY2013. However, GAO was unable to verify the other information CMS sent, including: 

  • CCIIO-related expenses such as polling, focus groups, advertisement, and other public relations activities. 
  • Staff from CMS and other areas of HHS that were reassigned to CCIIO. 

GAO’s oversight investigation found two issues that contributed to CMS’s inability to provide the requested information: The core financial system for CMS does not provide an effective means of capturing CCIIO-related activities and spending, and CMS does not have review and approval procedures in place to ensure requested data are accurate. Internal procedures for CMS are also not aligned with federal accounting and internal control standards. To address internal issues, GAO recommended that CMS identify options to develop an independently verifiable system that is timely. In a response letter, HHS said that it does not concur with the recommendations that GAO outlined in the report. HHS believes it tracks financial appropriation according to federal law and regulations requirements and that it has standard operating procedures that are current and clearly documented. 

(Source: GAO, “PPACA: Procedures for Reporting Certain Financial Management Information Should be Improved,” September, 2014)

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ACP survey: 6 percent of physicians would drop Medicaid if the Pay Parity program is not extended

In April the American College of Physicians (ACP) conducted a survey of its member physicians and found that 6 percent of physicians who were enrolled in the Medicaid Primary Care Pay Parity Program would drop out of the program if the program expires on December 31, 2014 as currently required by law. This policy, set by the ACA to last two years, requires Medicaid to pay primary care physicians no less than what Medicare would pay for the same services. ACP’s survey found that approximately 40 percent of physicians indicated that they would accept fewer Medicaid patients if the program was not extended. According to ACP, these primary care physicians in Medicaid would see an average cut of 41 cents per 1 dollar to their pay if the program expires. ACP is one of the groups that supports the Pay Parity program. A bill in the House sponsored by Representative John Lewis (GA) would extend the increased pay policy for five years. In the Senate, Senator Sherrod Brown (OH) introduced the Ensuring Access to Primary Care for Women and Children Act, which would extend the program to 2016 and add certain types of providers to the policy. Under the bill obstetricians, gynecologists, advanced practice clinicians, rural health clinics, federally qualified health centers, nurse practitioners, physician assistants and certified nurse-midwives who bill at least 60 percent of their Medicaid services for primary care would receive rates no lower than those for Medicare. 

Related: The Center for Health Care Strategies published a report on Monday, September 22 that used analysis from policy experts and other stakeholders to review the success and shortcomings of the Medicaid Pay Parity program. Medicaid pays an average of 66 percent of Medicare rates for all services and 58 percent for primary care services. According to the authors, six states have plans to use state funding to extend the policy after December if neither the Lewis bill nor Brown bill is successful. The authors say that providers gave mixed responses to the policy, with some being unaware the policy even existed, and others being negative or enthusiastic. Some providers in states had difficulty implementing the Pay Parity program and were less positive about their experience to date due to the use of Medicaid managed care contracts. The brief listed several recommendations for improving the program to include promoting value-based payments and implementing rate increases in Medicaid managed care. 

(Source: Maia Crawford and Tricia McGinnis, Center for Health Care Strategies, “Medicaid Primary Care Rate Increase: Considerations Beyond 2014,” September 2014; American College of Physicians, “Why Congress Must Save the Medicaid Primary Care Pay Parity Program,” September 2014)

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NIH awards $17 million for 3D tissue chips research

Last week the National Institutes of Health (NIH) announced that it was awarding $17 million in funding to 11 research organizations to develop 3D human tissue chips. Led by the National Center for Advancing Translational Sciences, the Tissue Chip for Drug Screening program will help these 11 groups develop technology that could be used to test the safety and efficacy of drugs before they are tested on human subjects. The chips can mimic biological responses that are seen in organs such as the heart, liver, kidney and gastrointestinal and nervous systems. While they can be used individually to study the response of single tissue and organs, they can also be integrated into a system that mimics the entire human organ system. This system can then be used to test the effects of drugs in real time. The program is an initiative between the NIH, Defense Advanced Research Projects Agency, and the U.S. Food and Drug Administration. 

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Study: Rates of U.S. diabetic adults leveled off from 2008 to 2012

The Journal of the American Medical Association (JAMA) published a report last week on diabetes prevalence (includes new cases and old cases of patients who are still alive) and incidence (only measures change in disease and is limited to new cases) among adults ages 20 to 79. The researchers found that the annual percentage change in both measures from 2008 to 2012 was not significant. Compared with the sharp increases observed from 1990 to 2008, rates seem to have leveled off in more recent years. Incidence and prevalence doubled between 1990 and 2008, but the rates suggest small changes from 2008 to 2012 in both measures:

Indicator 1990 2008 2012 1990-2008
percent change
2008 -2012
percent change
Prevalence (old and new cases) per 100 persons 3.5 percent 7.9 percent 8.3 percent +4.5 percent +0.6 percent
Incidence (only new cases) per 1000 persons 3.2 percent 8.8 percent 7.1 percent +4.7 percent -5.4 percent


The study also found that while diabetes prevalence and incidence leveled off for the population as a whole, disparities remain across ethnic groups and by education level and age. According to the report, the number of new cases (incidence) continued to increase among Blacks and Hispanics and overall cases (prevalence) also increased among those with a high school education or less. Young adults ages 20 to 44 had a higher increase in prevalence than older adults over this time period. The results were obtained from a sample of 664,969 adults using the Centers for Disease Control and Prevention’s National Health Interview Survey (NHIS).

(Source: Geiss, Linda S., Wang, Jing, Cheng, Yiling J., Thompson, Theodore J., Barker, Lawrence, Li, Yanfeng, Albright, Ann L., Gregg, Edward W. JAMA, “Prevalence and Incidence Trends for Diagnosed Diabetes Among Adults Aged 20 to 79 Years, United States, 1980-2012,” September 21, 2014)

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Around the Country

 

Report: to keep premiums low, insurers made changes to provider networks in 2014, expected to continue on to 2015

The Robert Wood Johnson Foundation analyzed state-level information and regulations and conducted interviews to examine provider network adequacy standards across six states: Colorado, Maryland, New York, Oregon, Rhode Island, and Virginia. The researchers found that to meet requirements imposed by the ACA, insurers made significant provider network changes to the plans sold both on the individual market inside and outside of the health insurance marketplaces in 2014. This included the following: 

  • Insurers in four of the six states modified or changed provider networks for 2014 in response to ACA market reforms; some of the insurers in the two states that did not make significant changes in 2014 did so for 2015 to offer lower premiums next year. 
  • Pricing was the main factor plans used to determine whether to include a provider in their plan network. Insurers did not report designing networks based on provider performance on quality measures or patient outcomes. 
  • Some insurers shifted from offering both preferred provider organizations (PPO) and health maintenance organizations (HMO) to only offering HMOs. This was in response to the ACA requirement that if insurers offer out-of-network benefits, they must be extended to individuals both inside and outside of the marketplace. The shift essentially removed out-of-network benefits. 
  • Insurers adopted “tiering” strategies in which consumers pay lower cost-sharing when they obtain care from a tier of preferred providers and higher cost-sharing for care received from less preferred providers in the network. 

Insurers changed individual provider network designs in 2014 as a strategy to curb cost and are expected to continue adopting similar strategies to deliver affordable premiums. Officials from all six states expected insurers to continue to narrow networks in 2015. While the ACA imposed network requirements on insurers, most states and the federally-facilitated marketplace offer considerable flexibility in meeting network adequacy requirements. The narrow network strategy has prompted concerns that it may lead to lower quality of care and higher financial risk to the consumer, but many states have not made regulatory changes to address these concerns; only half of the states required insurers to improve access to provider directories. State officials and insurers indicated that consumers have not complained about narrow networks and they did not expect states to change their current oversight of networks policies. 

(Source: Corlette, Sabrina, Lucia, Kevin, and Ahn, Sandy. Robert Wood Johnson Foundation, “Implementation of the Affordable Care Act: Cross-Cutting Issues: Six-State Case Study on Network Adequacy,” September, 2014)

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PCORI advances patient-centered care through building the evidence base for innovative use of technology

The Patient-Centered Outcomes Research Institute (PCORI) is a nonprofit, nongovernmental organization authorized in the ACA to fund comparative effectiveness research (CER) with the goal of improving the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers and policy makers make informed health decisions. Recently, PCORI highlighted some of the projects it supports that use health information technology (IT) to advance patient care and outcomes. 

One element of PCORI is PCORnet, the National Patient-Centered Clinical Research Network that aims to provide researchers with data gathered in clinics and other real-world settings. To foster observational and experimental CER, PCORnet data will be stored in standardized, interoperable formats and have robust security protocols that protect confidentiality. 

PCORnet draws from 29 health data networks that either originate in health care systems or are patient led. One network that is operated by a group of patients is The Health eHeart Alliance. This project’s goal is to collect more data on heart health from a large population than any study has done to date, and researchers are leveraging social media to recruit participants and provide them with the platform to share their own data. In addition to this unique data collection system, the project uses remote monitoring of blood pressure and heart rate, mobile apps, and online portals. Building an evidence base for these types of platforms to improve health outcomes and patient experience will be critical to their adoption.

Other PCORI-funded studies are exploring a wide variety of approaches to the use of IT in advancing health and health care. These studies range from testing a system-level intervention of computerized tools designed to reduce end-of-life cancer pain with standard hospice care, to a study involving the National Stroke Association that focuses on the attitudes of post-stroke patients and caregivers toward mobile technologies that support complex care management. These projects and others capitalize on the far-ranging capabilities of IT, as well as widespread use and consumer reliance on smartphones and other electronic devices. As PCORI’s portfolio of studies grows, it is expected that health IT will play an increasingly important role. 

Analysis: As PCORI continues to disseminate research findings and is increasingly in the spotlight, the public will want to know: is the country’s investment in PCORI’s research delivering results and providing its value proposition? Is the research meeting the goal of incorporating the patient’s perspective? Are PCORI’s funded projects scalable beyond the research populations and geographies? Are patients’ differences (disease, race, ethnicity, psychosocial issues, etc.) reflected in personalizing the research? Will PCORI need to broaden its focus from comparative clinical effectiveness to also include cost effectiveness research in light of our country’s health care cost conundrum?

A major focus of the ACA was driving better value for our country’s health care investments. PCORI was established to bring focus to comparative clinical effectiveness to foster the patient’s perspective in optimizing patient outcomes. The HITECH Act incentivized the implementation of electronic medical records via Meaningful Use criteria. PCORnet has the potential to leverage these ACA and health IT regulations to provide the digital infrastructure to facilitate clinical data sharing and clinical insights to help disseminate PCORI’s research more quickly than the historical 17 year bench-to-bedside translation of basic science to patient care.

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Breaking Boundaries

 

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