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Closing The Rural Health Connectivity Gap: How Broadband Funding Can Better Improve Care


April 1st, 2015

Broadband access is not usually highlighted in policy prescriptions for improving outcomes and lowering costs of health care. But it is a prerequisite for a range of technologies that can provide more cost-effective and higher-quality care, such as video consultation, remote patient monitoring, and electronic health record operability. And in many places—particularly rural areas that have the most to gain from telemedicine and connectivity—broadband remains too expensive, unreliable, or simply not available at the speeds required to enable innovations in care. This “connectivity gap” remains an important obstacle to achieving better care in rural areas.

Federal statutes and regulations provide subsidies, administered by the Federal Communications Commission (FCC), that attempt to close the connectivity gap. But these subsidies have been underutilized because they are too hard to use; they have also not kept pace with changes in health care delivery and broadband technology. Below, we examine the connectivity gap and current federal efforts to address it, and we offer proposals to make those efforts more up-to-date and effective.

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The Final Stage Of Meaningful Use Rules: Will EHRs Finally Pay Off?


March 25th, 2015

Six years ago, President Obama signed into law the HITECH Act, which spelled out a path to a nationwide health information technology infrastructure.  The goal was simple:  every doctor, nurse, and hospital in America should use electronic health records — and do it in a way that leads to better care delivered more efficiently.  The Act provided $30 billion in incentives for providers and hospitals who met the criteria for “Meaningful Use”, which the Obama administration was given the authority to define.  The rules were set up to be rolled out in three stages, and while the first two stages have been out for a while, the criteria for the third and final stage of Meaningful Use (MU) were finally released on March 20.

David Blumenthal, the first national coordinator under HITECH, used the analogy of the Meaningful Use program as an escalator — with the first stage focused on just getting people on board and each stage requiring a higher level of use — which would focus on demonstrating better care through advanced EHR use.  Put more simply, the goal of the three stages was to first get providers to just start using EHRs, and then over time to get them to use the systems more frequently, more robustly, and ultimately, in ways that lead to better, more efficient care.

The new stage 3 rule reflects both the successes and the failures of the first two stages.  It moves toward making the EHR market more open and competitive, and providing more choices, in ways that I think are helpful — but possibly not helpful enough.

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Should Health Lawyers Pay Attention To The Administration’s Privacy Bill?


March 13th, 2015

Health care lawyers justifiably ignored the 2012 Obama administration consumer privacy framework because it expressly and broadly exempted entities subject to HIPAA, stating “To avoid creating duplicative regulatory burdens, the Administration supports exempting companies from consumer data privacy legislation to the extent that their activities are subject to existing Federal data privacy laws.”

In contrast, the administration’s 2015 draft bill, the Consumer Privacy Bill of Rights Act, though based on that framework, substantially affects health care entities, including those subject to HIPAA, and so demands more attention in the health law community.

The “HIPAA clause” in the draft bill is subtly different (and noticeably narrower than its preemption of state law clause): “If a covered entity is subject to a provision of this Act and a comparable provision of a Federal privacy or security law [the list includes HIPAA] such provision of this Act shall not apply to such person to the extent that such provision of Federal privacy or security law applies to such person.”

The “provision” wording is key; most of the key substantive provisions in the draft bill—those going to consent, withdrawal of consent, context, and data minimization—do not crosswalk to any comparable provisions in HIPAA. For HIPAA mavens this has the potential of “more stringent than” all over again, but at a higher stakes table. (For nonmavens, this refers to questions raised by HIPAA’s language leaving intact state laws “more stringent than” HIPAA’s privacy protections.)

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Takeaways From Health Affairs’ Big Data Twitter Chat


March 9th, 2015

Recently, we at Health Affairs hosted a Twitter chat with the Patient Centered Outcomes Research Institute (PCORI) on the topic of big data. The chat was a follow-up to the Health Affairs issue, “Using Big Data To Transform Care.

During the Twitter chat, we moderated a question-and-answer session with PCORI’s Rachael Fleurence, Comparative Effectiveness Research (CER) Methods and Infrastructure Program Director, and Sarah Greene, CER Methods and Infrastructure Associate Director, while many users joined in the conversation with #healthdatachat.

So how does PCORI define “big data?” PCORI responded with the following tweet: “rapid accrual of large quantities of diverse patient experience data.” 

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Where Is HITECH’s $35 Billion Dollar Investment Going?


March 4th, 2015

On April 16, 2013, we released “REBOOT: Re-examining the Strategies Needed to Successfully Adopt Health IT,” outlining concerns with implementation of the Health Information Technology and Economic and Clinical Health (HITECH) Act. Specifically, we asked: What have the American people gotten for their $35 billion dollar investment?

Two years after releasing the white paper, and six years since enactment of the HITECH Act, the question remains. There is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care.

We have been candid about the key reason for the lackluster performance of this stimulus program: the lack of progress toward interoperability. Countless electronic health record vendors, hospital leaders, physicians, researchers, and thought leaders have told us time and again that interoperability is necessary to achieve the promise of a more efficient health system for patients, providers, and taxpayers.

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To Advance Medical Innovation, Put International Best Practices In A National Context


March 4th, 2015

Editor’s note: This post is part of a series of several posts related to the 4th European Forum on Health Policy and Management: Innovation & Implementation, held in Berlin, Germany on January 29 and 30, 2015. For updates on the Forum’s results please check the Center for Healthcare Management’s website or follow on Twitter @HCMatColumbia.

Innovation is a driving force of any nation’s economy, shaping the delivery of new services and the development of new products. Nowhere is this more true than in the US health care system which represents nearly a fifth of GDP. Medical innovation has catalyzed improvements in the tools and therapies used to deliver health care, the practices of managing its delivery, and even the financing of its delivery.

These innovations evolve primarily through research supported by universities and government institutions including the National Institutes of Health (NIH). Research supported by the NIH allows for development of treatments that target a large number of diseases and conditions. However, identifying new therapies is only a fraction of the work needed to ensure that the right patients receive that treatment at the right time, the right dose, and for the right reasons.

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The Challenges Of Developing A Sustainable Network For The Care Of The Chronically Ill


February 11th, 2015

Editor’s note: This post is part of a series of several posts related to the 4th European Forum on Health Policy and Management: Innovation & Implementation, held in Berlin, Germany on January 29 and 30, 2015. For updates on the Forum’s results please check the Center for Healthcare Management’s website or follow on Twitter @HCMatColumbia.

Health care systems the world over are searching for new organizational models to deliver better clinical outcomes, improved customer satisfaction, and lower costs. In any such systems, quality will no longer be the sole province of clinicians and the responsibility for cost containment will no longer fall solely on payors. Increasingly, clinical care and social service providers, patients, and payors alike have a role to play in achieving the best clinical outcomes for patients and the best economic outcomes for the system as a whole, signifying a value based health delivery system.

As primary and acute care networks embark on this move from volume to value, the special needs of chronic populations, those that comprise 45 percent of domestic health care spending — or $1.2 trillion annually, can easily be lost and, with them, the ability to address a very significant gap between quality outcomes and cost controls.

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How To Restore The Innovation Ecosystem For Medical Technology


February 10th, 2015

The recent February issue of Health Affairswhich features a series of articles on innovation, provides us with an opportunity to examine the state of America’s innovation ecosystem for medical technology. This ecosystem has produced a myriad of medical advances, ranging from advanced imaging to molecular diagnostics, minimally invasive surgical tools, and incredibly sophisticated implants. These technologies have shortened hospital stays, reduced the economic burden of disease, and saved and improved millions of lives.

But the system is severely stressed. Policy improvements are essential if America is to remain a world leader in medical devices and diagnostics and fulfill its potential for medical progress in this century of the life sciences. In the following blog post, we will look at the current state of the medical technology industry and make some policy recommendations covering regulatory approval processes, payment and coverage policies, and tax policy.

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Health Affairs Event Reminder: Biomedical Innovation


February 3rd, 2015

Biomedical innovation lengthens and enriches our lives through breakthroughs in medications and care, but it is has also been the leading source of health care cost growth over the past few decades. The February 2015 thematic issue of Health Affairs examines the topic from many perspectives.

You are invited to join us on Thursday, February 5, at a forum featuring authors from the new issue at the W Hotel in Washington, DC. Panels will cover pharmaceuticals; biotechnology; medical devices; and accelerating, diffusing, and financing innovation.

WHEN: 
Thursday, February 5, 2015
9:00 a.m. – 12:30 p.m.

WHERE: 
W Hotel Washington
515 15th Street NW
Washington, DC, Great Room, Lower Level

REGISTER NOW!

Follow live Tweets from the briefing @Health_Affairs, and join in the conversation with #HA_BiomedInnovation.

See the full agenda. Among the confirmed speakers are:

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Health Affairs’ February Issue: Biomedical Innovation


February 2nd, 2015

The February issue of Health Affairs includes a number of studies examining issues pertaining to biomedical innovation. Some of the subjects covered: how declining economic returns for new drugs may affect future investments, the changing landscape of Medicare coverage determinations for medical interventions, the slowly emerging US biosimilar market, and more.

With declining economic returns, can manufacturers afford to continue investing?

Ernst Berndt of Massachusetts Institute of Technology’s Alfred P. Sloan School of Management and coauthors compared present values of average lifetime pharmaceutical revenues to present values of average drug research and development, and lifetime operating costs. Upon examining new prescription drugs launched over four distinct time periods between 1991 and 2009, the authors found that net economic returns reached a peak in the late 1990s and early 2000s.

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Beyond Law Enforcement: The FTC’s Role In Promoting Health Care Competition And Innovation


January 26th, 2015

By now, the Federal Trade Commission’s (FTC) law enforcement efforts in the health care area are well known. We have successfully challenged several hospital and physician practice mergers in the last few years. We also continue to pursue anticompetitive pharmaceutical patent settlements, following a victory at the Supreme Court in the Actavis case. Speaking of the Court, it is currently reviewing a case we brought against the North Carolina Board of Dental Examiners, alleging that its members conspired to exclude non-dentists from providing teeth whitening services in North Carolina.

Perhaps less publicized are the FTC’s various non-enforcement efforts in health care. Arguably most significant among those is the advocacy that the agency conducts in favor of competition principles before state legislatures and other policymakers. I will discuss our advocacy efforts in the health care space in this post, and then turn to the subject of telemedicine, an area in which FTC competition policy may play a significant role.

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Health Affairs Briefing: Biomedical Innovation


January 20th, 2015

Biomedical innovation lengthens and enriches our lives through breakthroughs in medications and care, but it is has also been the leading source of health care cost growth over the past few decades. The upcoming February 2015 thematic issue of Health Affairs examines the topic from many perspectives.

You are invited to join us on Thursday, February 5, at a forum featuring authors from the new issue at the W Hotel in Washington, DC.  Panels will cover pharmaceuticals; biotechnology; medical devices; and accelerating, diffusing, and financing innovation.

WHEN: 
Thursday, February 5, 2015
9:00 a.m. – 12:30 p.m.

WHERE: 
W Hotel Washington
515 15th Street NW
Washington, DC, Great Room, Lower Level

Register Now!

Follow live Tweets from the briefing @Health_Affairsand join in the conversation with #HA_BiomedInnovation.

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The Strategic Challenge Of Electronic Health Records


December 16th, 2014

Despite a 2005 prediction that electronic health records (EHRs) would save $81 billion, RAND Corporation just validated clinicians’ complaints in a report describing EHRs as “a unique and vexing challenge to physician professional satisfaction.” The American Medical Association also published EHR “usability priorities” – strong evidence that current EHRs don’t support doctors in practicing medicine.

In a world of Apple-typified simplicity, why is it so hard to get the right EHR? Because, unlike Apple, EHR designers haven’t started with the question of how value can be created for users of the technology. Technology isn’t the problem. The challenge is in articulating clinicians’ information needs and meeting them by making the right tradeoffs between corporate and business unit strategies.

EHRs can, and should, provide relevant information when and where clinicians need it, recognizing that care is not a commodity and that different care processes have different information needs. User interfaces must anticipate clinicians’ needs rather than require individual user design. EHRs need to eliminate low-information pop-ups and alarms and instead provide alerts and reminders that are both timely and relevant. They must be designed with assiduous attention to data entry requirements, replacing blind mandates with thoughtful assignment of the task and the timing.

In this post I look at how rethinking the design of EHRs can better balance the different strategic needs within care delivery organizations.

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The Innovation Conundrum In Health Care


December 12th, 2014

Editor’s note: This post is part of a series of several posts related to the 4th European Forum on Health Policy and Management: Innovation & Implementation, to be held in Berlin, Germany on January 29 and 30, 2015. For more information or to request your personal invitation contact the Center for Healthcare Management.

It is never too early for new technology in health care. In contrast to the innovator’s dilemma in other industries where the adoption can be sluggish because current customers may not be able to use the future’s toolbox, in medicine innovators always can be assured of an audience when announcing the “life-saving impact” of something new.

Coverage and widespread implementation usually are a different story, but creating hype and demand for unusual and unfamiliar medical technology has never been hard. But who then drives the invention, diffusion, application, and evaluation of such innovation?

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Using Mobile Technology To Overcome Jurisdictional Challenges To A Coordinated Immunization Policy


November 14th, 2014

On March 20, 2014, the Government of Canada and the federal Minister of Health announced the release of ImmunizeCanada (ImmunizeCA), a smart phone application (app) designed to both provide accurate information on immunization for Canadians and allow them to track their and their family members’ immunizations. Based on a prototype developed for parents in Ontario and in partnership with the Canadian Public Health Association, our development team received funding from the Public Health Agency of Canada to build a national immunization app. Our task was to build an Apple- and Android-compatible app, containing all 13 provincial/territorial schedules and vaccine information from each jurisdiction in both Canadian official languages (French and English).

The application uses demographic information entered by the user and the most recent recommended provincial vaccination schedule to create a custom profile for multiple family members. It allows parents to track and carry their children’s immunizations records on their mobile device. The application also permits the creation of adult-specific schedules and includes information on travel vaccines. It is also possible to sync the app with your smartphone calendar, generate appointment reminders, print or share an immunization record by email, and access answers to common questions.

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Health Care Accelerators: An Innovative Response To Federal Policy Mandates


November 12th, 2014

Health-focused startup “accelerators” are a new approach to developing solutions to problems in health care. An accelerator serves as a short-term incubator for startups to build innovative new businesses through funding, mentorship, network access and coaching.

Accelerators have been a critical part of the technology economy and innovation ecosystem since the 2006 launch of YCombinator. Health care-focused accelerators emerged in 2011, largely as a result of changes in national health care policy–including the HITECH Act and the Affordable Care Act–and the perceived new opportunities these changes created. Since that time, there has been tremendous growth in accelerators across the nation supported by a diverse set of stakeholders, part of a larger innovation economy that has formed in response to federal policy making.

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ONC’s 10-Year Roadmap Towards Interoperability Requires Changes To The Meaningful Use Program


November 3rd, 2014

When I first started using an electronic health record (EHR) almost 20 years ago, many policy makers misunderstood how EHRs worked. They assumed that care was somehow made better just by having an EHR, and thus began to build the case for policy aimed at supporting EHR adoption. Fortunately as the HITECH Act of 2009 makes clear, a maturation of thinking has occurred; it is not the mere presence of technology, but good technology used in meaningful ways that can improve care.

Magical thinking about EHRs has disappeared, but a similar irrational belief has taken its place– this time around the concept of interoperability, the ability of systems to communicate with each other. Today there are two widely held concerns about the current state of interoperability. The first concern is that the Meaningful Use program, the federal EHR incentive program created by the HITECH Act, was doomed from the outset because it did not begin with the requirement that EHRs be capable of communicating with each other.

The other is that while it was acceptable not to have required full interoperability at the outset; now it is the single most important task at hand. By this account, interoperability must be put on a fast track, because the American people will be unlikely to reap any benefits from health information technology without it. I strongly disagree with both of these positions.

First, if the Office of the National Coordinator for Health Information Technology (ONC) had conditioned the start of Stage 1 of Meaningful Use on full interoperability of EHRs, I believe that the already slow rate of EHR adoption would grind to a halt. Vendor development and purchase decisions would go on indefinite hold awaiting final interoperability specifications. But by moving forward with the status quo of partial interoperability, most providers, nurses, clinical, and nonclinical staff now have at least basic if not reasonably good health IT functionality and literacy. For example, the majority of prescriptions for non-controlled substances are now sent electronically — not a complete remedy for medication errors, but an important move away from those errors due to illegible handwriting. And more importantly, many tens of millions of patients have received (many for the first time) summaries of their health care visits and hospitalizations that provide a list of their active problems, medications, and medical allergies, not to mention written instructions.

Secondly, many providers and provider systems have gone ahead, even where interoperability is limited to laboratory data, with quality improvement programs that leverage their EHRs for analytics, point-of-care decision support, and patient education and engagement tools. As an example, in 2012 the Department of Health and Human Services and the Centers for Disease Control and Prevention, together with the American College of Cardiology and the American Heart Association launched Million Hearts® – a program of education, screening, and treatment – with an end point of preventing one million new heart attacks and strokes over 5 years.

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Ebola And EHRs: An Unfortunate And Critical Reminder


October 28th, 2014

The Dallas hospital communication lapse that led to the discharge of a Liberian man with Ebola symptoms is an example of the failure of American health care system to effectively share health information, even within single institutions. It is not possible to know whether a faster response would have saved Thomas Eric Duncan’s life or reduced risk to the community and health workers.

What is clear is that rapid sharing of information is one of the elements critical to halting the spread of Ebola. Had all members of the initial care team known of the patient’s recent arrival from an Ebola-stricken country and acted appropriately to quarantine Mr. Duncan, this would have limited the chance of exposing the public and enabled faster preventive protocols for treating personnel.

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Examining The Present And Future Of The Health Spending Growth Slowdown


September 3rd, 2014

Each year, Health Affairs publishes national health spending projections for the coming decade by authors at the Centers for Medicare and Medicaid Services Office of the Actuary (OACT). The articles provide important documentation of past trends and insight about future spending, using transparent, vetted assumptions.

In this year’s study, Andrea Sisko and coauthors reveal that the recent slowdown in health care spending growth has continued. Specifically, the authors report that national health care spending in 2013 is predicted to have increased by only 3.6 percent — the fifth consecutive year of spending growth below 4 percent. [Editor’s note: Health Affairs also publishes annual retrospective health spending reports from OACT — the journal expects to publish OACT’s final numbers for 2013 spending in December.]

When interpreting the data, it is important to distinguish between the spending growth driven by increased spending per beneficiary and growth driven by increases in the number of beneficiaries. This is particularly relevant for Medicare (which is experiencing an influx in baby boomers) and Medicaid (which is experiencing Affordable Care Act (ACA) driven enrollment growth). Certainly, aggregate spending is an important statistic. The budgetary implications of rapid Medicare spending growth due to growth in the number of beneficiaries are similar to the implication of spending growth driven by growth in spending per beneficiary.

Yet the normative interpretation of spending growth will depend dramatically on the cause. We should celebrate aging baby boomers, increases in longevity and wellbeing. Similarly, higher Medicaid enrollment was the intended outcome of the ACA and, at least in many circles, is considered a good thing (relative to growth in the number of uninsured). Of course, such an increase in enrollment creates pressure on public budgets.

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Rescue Me: The Challenge Of Compassionate Use In The Social Media Era


August 27th, 2014

The Development of Brincidofovir and its Possible Use to Treat Josh Hardy

Last March 4, seven-year old Josh Hardy lay critically ill in the intensive care unit at St Jude Children’s Hospital in Memphis, Tennessee with a life-threatening adenovirus infection. His weakened immune system was unable to control the infection, a complication of a bone marrow stem cell transplant he needed as a result of treatments for several different cancers since he was 9 months old.

His physicians tried to treat the adenovirus with an anti-viral agent, Vistide (IV cidofovir), but had to stop due to dialysis-dependent renal failure. They were aware of another anti-viral in Phase 3 clinical development, brincidofovir, an oral compound chemically related to Vistide. In earlier clinical testing brincidofovir had shown the potential for enhanced antiviral potency and a more favorable safety profile.

Chimerix (where one of us, Moch, was CEO), a 55 person North Carolina-based biopharmaceutical company, had previously made brincidofovir available to more than 430 critically ill patients in an expanded access program for the treatment of serious or life-threatening DNA viral infections, including adenovirus as well as herpes viruses (such as cytomegalovirus) and polyomaviruses.  This program started in 2009 as a series of individual physician-sponsored emergency INDs — investigational new drug exemptions issued in physician-certified compassionate use situations.

The program evolved via word of mouth to the extent that brincidofovir was made available under emergency INDs for more than 215 patients. During 2011, Chimerix received funding from Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to provide brincidofovir to an additional 215 critically ill patients for the purpose of gaining insights into the potential use of brincidofovir as a medical countermeasure against smallpox. (Department of Health and Human Services Contract No. HHSO100201100013C.  For further information on brincidofovir Study CMX001-350, see ClinicalTrials.gov Identifier NCT01143181.)

When BARDA funding ended in 2012, Chimerix stopped accepting new requests for compassionate use under its expanded access program. Although requests continued from physicians around the world, the company decided that it was in the best interests of the greatest number of patients to devote its limited human and financial resources to the clinical development pathway necessary for FDA approval of brincidofovir.

This post examines the implications of the ultimately successful campaign waged by Josh Hardy’s family to obtain access to brincidofovir for their son. We discuss several issues raised by the Hardy case, including the overarching question of whether it is fair for social media or influence of any form to play a role in determining which patients get access to experimental treatments; whether rescuing individual patients in need can be reconciled with an evidence-based regulatory approval process for new therapies; and whether there is a duty to “rescue” terminally ill patients by paying for access to experimental therapies.

Finally, we propose a new framework for regulating access to experimental treatments.

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